No UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT. PERFECT SURGICAL TECHNIQUES, INC., Appellant,

Transcription

1 No UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT PERFECT SURGICAL TECHNIQUES, INC., Appellant, v. OLYMPUS AMERICA, INC. and OLYMPUS MEDICAL SYSTEMS CORPORTATION, Appellees. On Appeal From the United States Patent and Trademark Office Before The Patent Trial and Appeal Board Case IPR APPELLANT S OPENING BRIEF Robert E. Freitas Daniel J. Weinberg Joshua L. Young FREITAS ANGELL & WEINBERG LLP 350 Marine Parkway, Suite 200 Redwood Shores, California Telephone: (650) Facsimile: (650) Attorneys for Appellant Perfect Surgical Techniques, Inc.

2 CERTIFICATE OF INTEREST Counsel for Appellant Perfect Surgical Techniques, Inc. ( PST ) certifies the following: 1. The full name of every party or amicus represented by me is: Perfect Surgical Techniques, Inc. 2. The name of the real party in interest represented by me is: N/A 3. All parent corporations and any publicly held companies that own 10 percent or more of the stock of the party or amicus curiae represented by me are: N/A 4. The names of all law firms and the partners or associates that appeared for the party or amicus now represented by me in the trial court or agency or are expected to appear in this court are: Robert E. Freitas Jason S. Angell Daniel J. Weinberg Joshua L. Young FREITAS ANGELL & WEINBERG LLP 350 Marine Parkway, Suite 200 Redwood Shores, CA Telephone: (650) Facsimile: (650) rfreitas@fawlaw.com jangell@fawlaw.com dweinberg@fawlaw.com jyoung@fawlaw.com

3 TABLE OF CONTENTS Page STATEMENT OF RELATED CASES... 1 JURISDICTIONAL STATEMENT... 1 STATEMENT OF THE ISSUES... 1 STATEMENT OF THE CASE... 2 STATEMENT OF FACTS... 3 SUMMARY OF THE ARGUMENT ARGUMENT I. STANDARD OF REVIEW II. III. DR. NEZHAT CONCEIVED THE 384 INVENTION BEFORE THE PUBLICATION OF JP 551 AND HE AND MR. HESLIN WERE REASONABLY DILIGENT IN REDUCING THE INVENTION TO PRACTICE DURING THE CRITICAL PERIOD A. Dr. Nezhat Conceived The Invention Of The 384 Patent Before February 10, B. Dr. Nezhat And Mr. Heslin Continuously Exercised Reasonable Diligence From February 9, 1998 To May 1, THE BOARD S FAILURE TO CONSIDER ALL OF THE EVIDENCE REQUIRES REVERSAL A. The Board Acknowledged That It Did Not Consider Evidence of Mr. Heslin s Activities During The Critical Period B. The Board Wrongly Focused On Isolated Intervals, Rather Than the Entire Critical Period C. The Board Applied An Erroneous Standard To The Evidence Of Diligent Pursuit Of The Application i-

4 TABLE OF CONTENTS (continued) Page IV. JP 551 SHOULD NOT HAVE BEEN CONSIDERED BY THE BOARD AND THERE WAS NO EVIDENCE TO ESTABLISH THE PRIORITY DATE OF JP V. THE BOARD S IMPROPER CONSTRUCTION OF THE TERM PERFORATED RESULTED IN AN INCORRECT FINDING OF UNPATENTABILITY VI. CONCLUSION ii-

5 TABLE OF AUTHORITIES Page(s) Federal Cases Arlington Indus., Inc. v. Bridgeport Fittings, Inc., 632 F.3d 1246 (Fed. Cir. 2011) Brown v. Barbacid, 276 F.3d 1327 (Fed. Cir. 2002) Brown v. Barbacid, 436 F.3d 1376 (Fed. Cir.2006)... 21, 39, 40 Burroughs Wellcome Co. v. Barr Labs, Inc., 40 F.3d 1223 (Fed. Cir. 1994) In re Enhanced Sec. Research, LLC, 739 F.3d 1347 (Fed. Cir. 2014)... 28, 30 In re Garner, 508 F.3d 1376 (Fed. Cir. 2007) In re Gartside, 203 F.3d 1305 (Fed.Cir.2000) Ireland v. Smith, 97 F.2d 95 (C.C.P.A. 1938) Jones v. Evans, 46 F.2d 197 (C.C.P.A. 1931)... 37, 38, 39 K&K Jump Start/Chargers, Inc. v. Schumacher Elec. Corp., 52 F. App x 135 (Fed. Cir. 2002)... 31, 33 Loral Fairchild Corp. v. Matsushita Elec., 266 F.3d 1358 (Fed. Cir. 2001) Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572 (Fed. Cir. 1996)... 17, 19 Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292 (Fed. Cir. 2015) iii-

6 Monsanto Co. v. Mycogen Plant Sci., Inc., 261 F.3d 1356 (Fed. Cir. 2001)... 17, 31 Morway v. Bondi, 203 F.2d 742 (C.C.P.A. 1953) In re Mulder 716 F.2d 1542 (Fed. Cir. 1983) Phillips v. AWH Corp., 415 F.3d 1303 (Fed.Cir.2005) (en banc) Price v. Symsek, 988 F.2d 1187 (Fed.Cir.1993)...passim Rines v. Morgan, 45 C.C.P.A. 743 (1957)... 21, 31 Round Rock Research, LLC v. Sandisk Corp., 81 F. Supp. 3d 339, (D. Del. 2015)... 19, 21 Singh v. Brake, 317 F.3d 1334 (Fed. Cir. 2003) In re Skvorecz, 580 F.3d 1262 (Fed. Cir. 2009) Spansion, Inc. v. Int l Trade Comm n, 629 F.3d 1331 (Fed. Cir. 2010) In re Steed, 802 F.3d 1311 (Fed. Cir. 2015)... 15, 34 In re Sullivan, 362 F.3d 1324 (Fed. Cir. 2004) SuperGuide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870 (Fed. Cir. 2004) Thorner v. Sony Computer Entm t Am. LLC, 669 F.3d 1362 (Fed. Cir. 2012) iv-

7 Zhongshan Broad Ocean Motor Co., Ltd., Broad Ocean Motor LLC, & Broad Ocean Techs., LLC, Petitioners, IPR , 2015 WL (Jan. 21, 2015)... 44, 45 Federal Statutes 5 U.S.C. 706(2)(A) U.S.C U.S.C U.S.C. 102(a) U.S.C. 102(g) Regulations 37 C.F.R (a) C.F.R C.F.R C.F.R (b)...passim 37 C.F.R (b) Other Authorities Manual of Patent Examining Procedure v-

8 STATEMENT OF RELATED CASES U.S. Patent No. 6,030,384 ( 384 patent ) is also the subject of the following district court case: Perfect Surgical Techniques, Inc. v. Olympus America Inc., Gyrus Medical, Inc., and Gyrus ACMI, Inc., Case No. 4:12-cv PJH (N.D. Cal.). PST is aware of no other related cases. JURISDICTIONAL STATEMENT The Patent Trial and Appeal Board ( Board ) had jurisdiction over Olympus America, Inc. and Olympus Medical Systems Corporation s (collectively, Olympus ) petition under 35 U.S.C. 6. Olympus filed a petition for inter partes review of the 384 patent. A55. The Board issued a final written decision on June 8, A2. PST timely filed its notice of appeal on August 4, U.S.C This Court has jurisdiction under 28 U.S.C. 1295(a)(4)(A). STATEMENT OF THE ISSUES Whether the Board erred in finding that the inventor failed to exercise reasonable diligence in constructively reducing to practice the invention of the 384 patent during the critical period. Whether the Board s consideration of a partially translated foreign prior art reference was appropriate under 37 C.F.R (b). Whether Olympus proved that claims 1, 4-6, 8, 9, 11, 12, 38, 41-44, 46, 47, -1-

9 and 49 are unpatentable under 35 U.S.C. 102(b) or 103(a) over Japanese Application Publication No. JP H A. STATEMENT OF THE CASE On December 20, 2013 Olympus filed a corrected petition requesting inter partes review of claims 1, 4-6, 8-9, 11-12, 38, 41-44, 46-47, and 49 of the 384 patent. A41. On June 16, 2014, the Board instituted inter partes review on three grounds: On the theory that claims 1, 4-6, 8, 9, 11, 12, 38, 41-44, 46, 47, and 49 were anticipated by Japanese Application Publication No. JP H A ( JP 551 ). On the theory that claims 1, 4-6, 8, 9, 11, 12, 38, 41-44, 46, 47, and 49 would have been obvious over JP 551. On the theory that claims 1, 4-6, 8, 9, 11-12, 43, 44, 46, and 47 would have been obvious over JP 551 and French Patent No. FR 598,149 ( FR 149 ). A479. PST filed a patent owner response accompanied by the declarations of Dr. Camran Nezhat, James Heslin, Jee Shin, Florence Leto, and expert witness Dr. Robert Tucker. Olympus replied. See A931. PST also filed a motion to exclude evidence. See A1722. PST s motion was opposed. See A1748. Oral hearing was held on February 23, On June 8, 2015, the Board -2-

10 issued a final written decision, in which it determined that Olympus had shown by a preponderance of the evidence that claims 1, 4-6, 8, 9, 11, 12, 38, 41-44, 46, 47, and 49 of the 384 patent were anticipated by, and obvious over, JP 551. A46. The Board also determined that Olympus had shown by a preponderance of the evidence that claims 1, 4-6, 8, 9, 11-12, 43, 44, 46, and 47 would have been obvious over JP 551 and FR 149. Id. The Board denied PST s motion to exclude evidence as untimely filed, but nevertheless expunged sua sponte Exhibits Id. STATEMENT OF FACTS Inventor Dr. Camran Nezhat. Dr. Camran Nezhat, the inventor of the 384 patent, has been called the Father of Modern Operative Laparoscopy. A693. Laparoscopy is a minimally invasive surgical technique that utilizes small incisions and thin tools to improve outcomes and shorten recovery times for patients. As a laparoscopic surgeon, with a sub-speciality in reproductive endocrinology and infertility, Dr. Nezhat has been lauded for his contributions as a surgeon, teacher, author, researcher, and inventor. A666, 2. Since beginning to practice medicine in 1980, Dr. Nezhat has dedicated his life to improving the lives of his patients. See A667, 6; A1209:2-5. This commitment has included designing novel laparoscopic instruments. See -3-

11 A1203:14-16 ( [B]ecause of my experience, I try to develop something to make things easier. ). One problem encountered in Dr. Nezhat s medical practice involved the overheating of human tissue during various laparoscopic procedures such as endometrial ablation, a surgery pioneered by Dr. Nezhat, and one that he frequently performs. A1331: Endometrial ablation surgically destroys the endometrial lining of the uterus, with the goal of reducing excessive menstrual flow. See A1313, 7-8; A1332:24- A1333:5. To remove the tissue growing inside the uterus, Dr. Nezhat used instruments that applied an electrical current to the tips of bipolar forceps thereby heating and cutting away the tissue grasped by the forceps. See A1334:9-A1335:1. Before the conception of the invention at issue in this case, the primary tool laparoscopic surgeons used to cut tissues inside the body was the Kleppinger grasping forceps. See id. The Kleppinger forceps used electricity to heat tissue to the point at which it becomes coagulated and/or necrosed. Id. Problematically, the Kleppinger forceps focused energy, at best, over a 5-6 millimeter area, an area large enough to impact healthy tissue. A1335:4-7. Additionally, the outside of the Kleppinger forceps would become extremely hot during the procedure, thereby increasing the chances of accidental tissue damage. Id. Dr. Nezhat s Conception Of The Invention Of The 384 Patent. Dr. Nezhat often pondered a way to improve the Kleppinger forceps: -4-

12 A1312:5-11. How could we make it safer? How could we make women I help they want to have children, and they have a lot of pain with their period, and endometriosis. So I like to see how we could create the least amount of damage to the adjacent organs. Beginning as early as 1996, Dr. Nezhat began to conceive an idea that would minimize the outward spread of heat in electrosurgery by placing positive and negative electrodes in positions on forceps to focus the electric charge more precisely. Id.; A125 (2:13-16). One such configuration laterally spaced the electrode members on either or both of the jaws to prevent current flow outside of the region between the electrodes. A125 (2:21-22). Dr. Nezhat s invention also included tissue penetrating elements. Id. at 2: When configured to align, the tissue penetrating elements enable the electrical current to be focused with minimal heating of tissue outside of the treatment region. Id. at 2:49-54 ( By then applying high frequency electrical energy to the lines in a bipolar manner, current flux will be focused to within that portion of the tissue which lies between the adjacent lines, with minimum heating of tissue outside of the parallel lines. ). While the Kleppinger forceps applied energy over a 5-6 millimeter area, the forceps of the 384 invention was far more precise, capable of applying energy over an area limited to 1-2 millimeters. A1335:3-7. Additionally, unlike the -5-

13 Kleppinger forceps, the outside of the 384 forceps remained cool during operation and was thus safer. Id. Dr. Nezhat, with assistance from his business partner, Tsaba Truckai, created a series of drawings depicting Dr. Nezhat s invention. The drawings were attached to a laboratory notebook, and the pages of the notebook were subsequently signed and dated by various individuals, including Dr. Nezhat s brother, a colleague at Stanford Hospital, Mr. Truckai, and a venture capitalist who worked with Dr. Nezhat. The Process That Led To The Application That Resulted In The 384 Patent. Dr. Nezhat was encouraged by his Stanford University colleagues to seek patent protection for his invention. See A1339:7-9; A1340:8-13. As a first step, Dr. Nezhat hired attorney James Heslin, in March The two met while Dr. Nezhat was advising a company developing minimally invasive heart surgery techniques, for which Mr. Heslin served as patent counsel. A1506: :4. Mr. Heslin was a well-known patent attorney specializing in medical device patents with the intellectual property law firm Townsend & Townsend & Crew LLP. A669, 10. From the start of the representation, including when Mr. Heslin sent Dr. Nezhat the first draft of the application that would become the 384 patent on January 28, 1998, up to the filing of the application on May 1, 1998, Dr. Nezhat -6-

14 had regular communication with Mr. Heslin. A1259: :4. In describing his working relationship with Mr. Heslin throughout the drafting process, Dr. Nezhat characterized Mr. Heslin as very picking [sic] and said he asked many questions, which required Dr. Nezhat to go back and forth and bring him things and have many conversations. A1260:2-1261:8; A1261: Mr. Heslin, in turn, described Dr. Nezhat as a careful and serious client who despite his own active medical practice took the time to closely study and understand the draft claims and provide meaningful and useful feedback to me. A1549:1-5. During the development of the patent application, both men maintained robust professional lives. Throughout 1998, Dr. Nezhat had an active surgery and consultative practice. His schedule in early 1998 was typical of his usual medical practice and included performing approximately four to six surgeries per week, with at least one or more surgeries occurring on each day. A686, 12. When Dr. Nezhat was not in surgery, he was either meeting with patients or teaching students. Id. Dr. Nezhat worked an average of 80 hours each week. Id. In 1998, Dr. Nezhat also published ten peer-reviewed papers, A , wrote four medical text book chapters, A713, gave three guest lectures in Italy, A739, and performed a surgical demonstration at a conference in Georgia, A728. Meanwhile, Mr. Heslin, conducted his own busy practice as founder and leader of the medical device technology patent group at the Townsend firm. A755, -7-

15 2. Mr. Heslin represented numerous clients in various aspects of managing and protecting their intellectual property, and had a full docket of matters that regularly required him to work 50 hours a week or more. A756, 6. In 1998, it was Mr. Heslin s usual practice to dictate the text of whatever he was drafting, and send what he dictated to his secretary or his firm s word processing department for transcription. A1528: It would be common that several days, sometimes as many as eight, would elapse before a completed transcription would be prepared. Id. at The Preparation of the Initial and Subsequent Drafts of the Patent Application. On January 29, 1998, Mr. Heslin finalized the initial draft of the application that lead to the issuance of the 384 patent, and forwarded the draft along with a letter dated January 28, 1998 to Dr. Nezhat. See A Excerpts from this initial draft, as well as several pages of Dr. Nezhat s laboratory notebook, closely mirror claims 1, 4-6, 8-9, 11-12, 38, 41-44, 46-47, and 49 of the 384 patent. A While carrying out his busy medical practice, Dr. Nezhat carefully reviewed the draft application and endeavored to work with Mr. Heslin to define the scope of his inventions for the patent. A , 14. At deposition, Dr. Nezhat remembered that during this period, [Mr. Heslin] would ask me to do something on his patent application. It says, comment on this, comment on that, fix this, what -8-

16 is that. So I had to go and research it and come up with the answer with my work. An [sic] of course you remember I have many other things to do too, so in between I would find out and I d communicate back to him. A1305:7-14. According to Mr. Heslin, Dr. Nezhat was a careful and serious client who took the time to study the application closely, understand the draft claims, and provide meaningful and useful feedback. A , 13; A1549:1-5. On March 2, 1998, Dr. Nezhat faxed his comments on the initial draft to Mr. Heslin. A927 (March 12 fax thanking Dr. Nezhat for his March 2 fax), A , 14. On or about March 4, 1998, Mr. Heslin prepared a series of questions to Dr. Nezhat regarding the application. After the questions were transcribed, Mr. Heslin sent them to Dr. Nezhat on Thursday, March 12, Immediately after the weekend, on Monday, March 16, Mr. Heslin met in person with Dr. Nezhat and Mr. Truckai, to discuss the draft patent application. A687, 15. Mr. Heslin s attorney billing records show that on April 7, 1998, Mr. Heslin made further revisions to the patent application, A758, 11, and on April 13, 1998, Mr. Heslin transmitted the revised draft of the application to Dr. Nezhat. Id. On May 1, 1998, Mr. Heslin finalized and filed the application. A634 A758, 11. Mr. Heslin s work in connection with the preparation and filing of the patent application was consistent with his usual practice for all clients and matters. A634-9-

17 A758, 12. Between the initial draft application in late January, and the filing on May 1, the number of claims increased from 19 to 26, and eight drawings were added. A758, In his deposition, Mr. Heslin noted on several or more occasions [he and Dr. Nezhat] would discuss in great detail what the claims meant and what they may cover, and that he was very - - he wanted to be very precise in that. A1549:8-11. Mr. Heslin remembered that Dr. Nezhat was very serious about his application. And that s why I m reasonably sure there were telephone conferences that I just didn t even bother recording, because at some point you can t keep charging for the same conversation. A1549: :3. Following prosecution of the application in the Patent and Trademark Office, the 384 patent was duly issued on February 29, A117. Olympus s Reliance On JP 551. Olympus s petition for inter partes review relied on several prior art references. One of these references was a Japanese patent application, Application Publication No. JP H A ( JP 551 ), which, except for the first page, was translated into English. A221. The non-translated first page contained bibliographic information, including the application s date of publication. A221; A954. None of the translated pages mentioned the publication date, so the information available to the Board did not include any evidence in English that would have provided a basis for determining that JP 551 is prior art. -10-

18 Olympus alleged in its petition that JP 551 was published on February 2, A76. As explained below, Olympus now acknowledges that this is not the publication date of JP 551, and Olympus does not claim that it ever presented any evidence substantiating the publication date alleged in the petition. Appended to the English translation of JP 551 was a translator s certification stating that to the best of [the translator s] knowledge and belief the attached English translation is a true and correct translation by [the translator] of [JP 551] published on February 10, A295. In its Patent Owner s Response, PST noted Olympus s failure to provide a fully translated copy of JP 551, as required under 37 C.F.R In addition, PST noted that JP 551 failed to disclose perforations, as claimed in the 384 patent, to permit the release of steam during use. In conjunction with its reply brief, Olympus submitted a translated copy of the bibliographic page. A954. The partially translated copy presented with Olympus s petition was certified on November 12, A295. The reply translation, containing only the first page, was certified on October 16, 2014, long after the filing of the petition. A955. SUMMARY OF THE ARGUMENT PST presented undisputed, strongly corroborated documentary and testimonial evidence that demonstrates both prior conception of the invention of the 384 patent and the continuous exercise of reasonable diligence toward -11-

19 constructive reduction to practice during the critical period. None of the facts presented by PST are subject to material dispute. Under the undisputed facts and the settled law, PST established a date of invention preceding the publication of JP 551, and JP 551 cannot provide a basis for a conclusion that the challenged claims of the 384 patent are unpatentable. Billing records from prosecuting attorney James Heslin s former law firm establish without dispute that three drafts of the application that led to the 384 patent were prepared by Mr. Heslin and reviewed in depth by Dr. Nezhat during the critical period of February 9, 1998 (the day before the publication date of JP 551 eventually argued by Olympus) to May 1, 1998 (the date of constructive reduction to practice through the filing of the application that resulted in the 384 patent). It is undisputed that, during the critical period, Dr. Nezhat and Mr. Heslin regularly spoke by telephone, met once in person, and revised the application to include ten additional claims and eight additional drawings. Mr. Heslin even testified that Dr. Nezhat was the type of involved client who called so frequently that Mr. Heslin did not find it appropriate to bill for each call. Contrary to long and clearly settled law, the Board did not consider all of the evidence in its assessment of whether PST proved the exercise of reasonable diligence during the critical period. Instead, the Board reviewed the activities of Dr. Nezhat, and, after finding the evidence of his actions insufficient through the -12-

20 application of an erroneous legal standard, announced that it was not going to consider the evidence of Mr. Heslin s activity. Thus, contrary to established Federal Circuit precedent, because some of the evidence was allegedly insufficient, the Board did not consider the balance of the evidence. The Board s remarkable failure to consider all of the evidence requires reversal of its determination that the challenged claims are unpatentable. The Board similarly applied an erroneous legal standard by focusing on evidence of diligence during isolated intervals of time, rather than the entire critical period. This Court s precedent does not allow consideration of segments of the critical period, or impose a requirement that an applicant work on reduction to practice every day during the critical period or provide a daily accounting of his or her activities. A proper review of the evidence, taking account of the entire critical period, and not slanted by a focus on isolated dates on which no activity occurred, shows beyond any question that Dr. Nezhat and Mr. Heslin exercised diligence far beyond that required to satisfy the governing legal standard. Other than the arguments that led the Board away from the analysis required by the case law, Olympus provided no answer for the overwhelming evidence of diligence. Additionally, the Board improperly considered a foreign prior art reference that was not presented in the manner required by 37 C.F.R (b). Olympus alleged in its petition for inter partes review that JP 551 was prior art that -13-

21 rendered the 384 patent unpatentable. JP 551 is a Japanese language for which a complete translation was required, but Olympus did not submit one. Instead, Olympus submitted a partial translation of the reference that omitted the bibliographic information contained on the first page of the application. Problematically, this page contained the only reference to the publication date of JP 551. Rather than hold Olympus to the clear standard set forth by 37 C.F.R (b), the Board allowed the certificate of translation that was appended to the translation to serve as evidence sufficient to establish the priority date of the JP 551 reference. The Board s use of the of the translation certificate to serve as dispositive evidence of the JP 551 publication date was plainly erroneous because the form of the certification was inconsistent with the governing law and did not amount to an affidavit sufficient to establish by testimony the date of publication of JP 551. By overlooking Olympus s failure to comply with this unambiguous regulation, the Board disregarded its own regulation, and wrongly found sufficient evidence of the publication date of JP 551 when there was no sufficient evidence of record. Olympus s failure to present the translation of the bibliographic information of JP 551 was defective and should not have been considered by the Board. Lastly, the Board s improper construction of the term perforated, resulted in an erroneous finding that claims 11, 38, 41-44, 46, 47, and 49 are unpatentable. -14-

22 Contrary to established Federal Circuit precedent, the Board imported the term passages into its construction of the claim to perforated. The term passages is found nowhere in the claims, and appears only once in the specification. JP 551 discloses a slit in the clamping members of a forceps through which a knife member may be inserted. The Board s finding that the slit disclosed by JP 551 anticipates the perforations claimed by the 384 patent rests on its erroneous importation of passages into its construction of the term perforations. Even when applying the broadest reasonable construction standard, the Board must follow general principles of claim construction. The Board s failure to do so is clear error that requires reversal. ARGUMENT I. STANDARD OF REVIEW The Court reviews the Board s legal conclusions on priority, conception, and reduction to practice without deference. Brown v. Barbacid, 276 F.3d 1327, 1332 (Fed. Cir. 2002) (citing Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376 (Fed.Cir.1986)). The Court reviews the Board determinations as to diligence for support by substantial evidence in the record. In re Steed, 802 F.3d 1311, 1317 (Fed. Cir. 2015). The Board s factual findings are reviewed for substantial evidence. Id. (citing Dickinson v. Zurko, 527 U.S. 150 (1999); In re Gartside, 203 F.3d 1305, 1315 (Fed.Cir.2000)). The Board s interpretation of PTO -15-

23 regulations is entitled to substantial deference, unless the interpretation is plainly erroneous or inconsistent with the regulation. In re Garner, 508 F.3d 1376, 1378 (Fed. Cir. 2007). Actions of the Board that are arbitrary, capricious, an abuse of discretion, unsupported by substantial evidence, or otherwise not in accordance with law will be set aside. In re Sullivan, 362 F.3d 1324, 1326 (Fed. Cir. 2004); 5 U.S.C. 706(2)(A). Claim construction is a question of law, which this court reviews without deference. Arlington Indus., Inc. v. Bridgeport Fittings, Inc., 632 F.3d 1246, (Fed. Cir. 2011) (citing Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1456 (Fed.Cir.1998) (en banc). II. DR. NEZHAT CONCEIVED THE 384 INVENTION BEFORE THE PUBLICATION OF JP 551 AND HE AND MR. HESLIN WERE REASONABLY DILIGENT IN REDUCING THE INVENTION TO PRACTICE DURING THE CRITICAL PERIOD. Under pre-aia 35 U.S.C. 102(a), a person shall be entitled to a patent unless the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent. The application that resulted in the 384 patent was filed on May 1, A634; A117. In its petition for inter partes review, Olympus attempted to prove that the 384 invention was unpatentable because an unexamined Japanese patent application, JP 551, anticipated and made obvious the claims of the 384 patent. After alleging in its petition that JP 551 was published on February 2, 1998, Olympus eventually argued that it was -16-

24 published on February 10, 1998, and thus was described in a printed publication in... a foreign country before the 384 patent s May 1, 1998, filing date. Pre-AIA 35 U.S.C. 102(g) allows patent owners to establish an earlier date, and thereby antedate prior references, by showing an earlier conception followed by reasonable diligence in reducing the invention to practice. See Singh v. Brake, 317 F.3d 1334, 1340 (Fed. Cir. 2003). [T]he person who first conceives, and, in a mental sense, first invents... may date his patentable invention back to the time of its conception, if he connects the conception with its reduction to practice by reasonable diligence on his part, so that they are substantially one continuous act. Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1577 (Fed. Cir. 1996) (quoting Price v. Symsek, 988 F.2d 1187, 1190 (Fed.Cir.1993)). To antedate the JP 551 reference, PST had the burden of proving that Dr. Nezhat conceived the 384 invention prior to the date on which JP 551 was published, and that Dr. Nezhat exercised reasonable diligence in reducing the 384 invention to practice from a date just prior to the other party s conception to... [the date of] reduction to practice [by the party first to conceive]. Monsanto Co. v. Mycogen Plant Sci., Inc., 261 F.3d 1356, 1369 (Fed. Cir. 2001) (quoting Mahurkar, 79 F.3d at 1577). The invention of the 384 patent was constructively reduced to practice through the filing of the application that resulted in the issuance of the 384 patent -17-

25 on May 1, Thus, to antedate JP 551, PST had to prove that Dr. Nezhat conceived the 384 invention on or before February 9, 1998, and that he and Mr. Heslin exhibited reasonable diligence toward the filing of the application between February 9, 1998 and May 1, A. Dr. Nezhat Conceived The Invention Of The 384 Patent Before February 10, Conception is the formation of a definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice. Burroughs Wellcome Co. v. Barr Labs, Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994). An idea is sufficiently definite for conception when the inventor has a specific, settled idea, a particular solution to the problem at hand, not just a general goal or research plan he hopes to pursue. Spansion, Inc. v. Int l Trade Comm n, 629 F.3d 1331, 1356 (Fed. Cir. 2010) (quoting Burroughs Wellcome, 40 F.3d. at 1228). With its patent owner response, PST submitted the declarations of Dr. Nezhat, Mr. Heslin, Florence Leto, an employee of Mr. Heslin s former law firm, whose declaration was intended solely offered to authenticate records, and Jee Y. Shin, a venture capitalist who witnessed Dr. Nezhat s laboratory notebook. This testimonial evidence demonstrated conception of the claimed inventions in the 384 patent no later than January 28, 1998, and before the alleged February 10, 1998 publication date of JP 551. See A , 7-11; A ,

26 Corroboration by independent evidence is required where a party seeks to show conception through the inventor s testimony. See Round Rock Research, LLC, 81 F. Supp. 3d at (citing In re Jolley, 308 F.3d 1317, 1321 (Fed.Cir.2002). This Court applies a rule of reason analysis when assessing the sufficiency of corroboration of an inventor s testimony. See Loral Fairchild Corp. v. Matsushita Elec., 266 F.3d 1358, 1363 (Fed. Cir. 2001); Mahurkar, 79 F.3d at An evaluation of all pertinent evidence must be made so that a sound determination of the credibility of the inventor s story may be reached. Round Rock Research, LLC, 81 F. Supp. 3d at (citing Mahurkar, 79 F.3d at 1577) (internal quotation marks omitted). The billing records maintained by Mr. Heslin s former law firm establish that he finalized a draft of the 384 application on January 28, 1998, and faxed the draft to Dr. Nezhat on January 29, In addition, Dr. Nezhat s laboratory notebook shows that the ideas for the complete invention were definite before that date. A ; A ; A Excerpts from the initial draft of the application, and Dr. Nezhat s laboratory notebook, closely mirror claims 1, 4-6, 8-9, 11-12, 38, 41-44, 46-47, and 49 of the 384 patent. A , 11. The date of Dr. Nezhat s laboratory notebook is corroborated by the declaration of Jee Y. Shin. See generally A , 1-7, A Ms. Shin testified to the existence of her signature on the pages of the notebook, placed -19-

27 there on February 25, 1997, well before February Moreover, Ms. Shin testified that [t]he words, drawings, images, and descriptions of the drawings shown on [the notebook] were present on the pages in February A763; A The record also includes Mr. Heslin s January 28, 1998 letter to Dr. Nezhat that attached the initial draft of the patent application. A579. Mr. Heslin testified that Exhibit 2004 is a true and correct copy of his correspondence to Dr. Nezhat. A , 7. Moreover, the letter is signed by Mr. Heslin and dated January 28, A579. Mr. Heslin s testimony and the accompanying exhibits sufficiently corroborate the date of conception. Accordingly, the evidence establishes that by at least February 9, 1998, the inventions were definite, permanent, and complete in Dr. Nezhat s mind. B. Dr. Nezhat And Mr. Heslin Continuously Exercised Reasonable Diligence From February 9, 1998 To May 1, The critical period in this case is modest, less than three months. The evidence shows without conflict that throughout this brief period, progress toward filing a patent application was diligently pursued by Dr. Nezhat and his lawyer. The only challenge Olympus could present was based on the mistaken idea that PST was required to show activity on every day during the critical period, or its close corollary, that a finding of diligence could be avoided by pointing only to the -20-

28 dates on which no activity occurred, rather than by considering all of the evidence, as a whole. There is no rule requiring a specific type of activity in determining whether the applicant was reasonably diligent in proceeding toward actual or constructive reduction to practice during the critical period. Round Rock Research, LLC v. Sandisk Corp., 81 F. Supp. 3d 339, 349 (D. Del. 2015) (citing Brown v. Barbacid, 436 F.3d 1376, 1380 (Fed. Cir.2006)). It is also not necessary for a party alleging prior invention to prove that he or she dropped all other work and concentrated solely on the particular invention involved throughout the critical period. Rines v. Morgan, 45 C.C.P.A. 743, 250 F.2d 365, 369 (1957). The patent owner s burden on the reasonable diligence issue does not include a requirement to provide evidence of activity on every single day during the critical period if a satisfactory explanation is evidenced. Round Rock, 81 F. Supp. 3d at 349 (citing Monsanto, 261 F.3d at 1369). An inventor s testimony concerning his or her diligence must be corroborated and the sufficiency of the corroboration is evaluated under the rule of reason. Brown, 436 F.3d at 1380 (citing Jolley, 308 F.3d at 1328); see also Price, 988 F.2d at The Federal Circuit held in Symsek, that all of the evidence put forth by [the movant], including any of his corroborated testimony, -21-

29 must be considered as a whole, not individually, in determining whether [the movant] proved conception and reduction to practice. 988 F.2d at In its patent owner s response, PST presented a range of evidence that demonstrates that Dr. Nezhat and Mr. Heslin continuously exercised reasonable diligence during the critical period between February 9, 1998, and May 1, The Board did not make any findings adverse to the credibility of Dr. Nezhat, Mr. Heslin or any of the other witnesses. Likewise, the Board did not make any findings rejecting the authenticity of any of the documentary evidence offered by PST. When all of the evidence is considered as a whole, PST s collection of undisputed testimony and documentary evidence overwhelmingly satisfies its evidentiary burden of proving reasonable diligence. On January 29, Mr. Heslin sent a letter dated January 28, 1998 to Dr. Nezhat, along with the first draft of the application that eventually resulted in the issuance of the 384 patent. A copy of the letter was presented to the Board, its creation is noted in Mr. Heslin s law firm billing records, and Dr. Nezhat and Mr. Heslin both testified about the letter in their respective declarations. A579; A598, A600; A669; A On March 2, 1998, Dr. Nezhat submitted comments on the initial draft of the application to Mr. Heslin. A , 14; A , 10; A927. On March 4, 1998, the law firm billing records, authenticated by Mr. Heslin s and Ms. Leto s -22-

30 declaration testimony, show Mr. Heslin reviewed Dr. Nezhat s comments and drafted questions for further clarification. A927; A , 10. On March 12, 1998, Mr. Heslin faxed a letter containing these questions to Dr. Nezhat, which is included in the record and confirmed by Mr. Heslin s declaration testimony. A927; A , 10. Dr. Nezhat s declaration testimony also states he received these questions on or around March 12, A687, 15. Mr. Heslin s deposition testimony establishes that in 1998, it was his usual practice to dictate the text of whatever he was drafting, and send what he dictated to his secretary or the firm s word processing department for transcription. A1528: It would not be unusual for multiple days, sometimes as many as eight, to pass before the word processing staff completed the transcription of a given document. A1528:1-12. This dynamic likely accounts for the gap in time between Mr. Heslin drafting questions on March 2 and faxing the questions to Dr. Nezhat on March 12. Within days of sending Dr. Nezhat his questions, on March 16, 1998, Dr. Nezhat and his business partner Mr. Truckai met with Mr. Heslin. The meeting was recorded in Mr. Heslin s law firm s billing records, and categorized under the matter number associated with the 384 patent. A598, A604. Declaration testimony of Dr. Nezhat and Mr. Heslin confirms that they attended the meeting. A687, 15; A758,

31 The law firm billing records, verified by Mr. Heslin s and Ms. Leto s declaration testimony, show that on April 7, 1998, Mr. Heslin reviewed and revised the application. A598, A604; A758, 11. On April 13, 1998, after the April 7 revisions had been transcribed, Mr. Heslin sent a letter to Dr. Nezhat that included a second draft of the patent application. In the body of the letter, Mr. Heslin stated that he tried to reflect Dr. Nezhat s comments from when we last met, which included illustrating and describing the benefits of various alternative electrode embodiments. Mr. Heslin also requested Dr. Nezhat s final comments regarding the draft so that it can be finalized and filed in the near future. A copy of this letter was presented to the Board, its creation is noted in Mr. Heslin s law firm billing records, and Dr. Nezhat and Mr. Heslin testified to the sending and receiving the letter in their respective declarations. A607; A687, 16; A758, 11. Within weeks, the final application was finalized and filed on May 1, A634; A117; A687, 16; A758, 11. The undisputed evidence described above establishes that during the entire critical period, Dr. Nezhat and Mr. Heslin reasonably diligently pursued the constructive reduction to practice of Dr. Nezhat s invention. Between February 9 and March 2, Dr. Nezhat completed a careful review of the application for what would become his first patent and sent his comments to Mr. Heslin. Between -24-

32 March 3 and March 4, Mr. Heslin reviewed these comments and dictated questions for Dr. Nezhat. By March 12, Mr. Heslin s questions were transcribed and sent to Dr. Nezhat. Between March 13 and March 16, Dr. Nezhat prepared answers to Mr. Heslin s questions and the two met in person to discuss the application on March 16. Between March 17 and April 13, Mr. Heslin completed a second draft of the application and sent a copy to Dr. Nezhat. Between April 14 and April 30, Dr. Nezhat provided final comments regarding the draft so that it [could] be finalized and filed in the near future. On May 1, Mr. Heslin filed the application. When all of the evidence described above is considered as a whole, Dr. Nezhat s and Mr. Heslin s reasonable diligence during the critical period cannot seriously be questioned. See Price, 988 F.2d at1196. As already noted, the Board made no findings suggesting that Dr. Nezhat and the other witnesses presented by PST were anything but truthful. There were no findings that any of the documentary evidence presented by PST was not authentic, or was not prepared, sent, or received at or about the times reflected on the documents or in the testimony of PST s witnesses. The Board s conclusion that PST failed to prove the exercise of reasonable diligence was based on the application of legal standards inconsistent with those clearly set forth in the familiar decisions of this Court, and a shocking disregard of all of the evidence of -25-

33 Mr. Heslin s activities in pursuit of the filing of the application for what became the 384 patent. III. THE BOARD S FAILURE TO CONSIDER ALL OF THE EVIDENCE REQUIRES REVERSAL. Despite the undisputed testimony and documentary evidence showing a continuous, diligent process directed to the constructive reduction to practice of the invention of the 384 patent, the Board concluded that PST did not provide evidence sufficient to demonstrate Dr. Nezhat s exercise of reasonable diligence during the critical period. A22. The Board s decision in this regard is the result of two critical misapplications of the settled Federal Circuit law regarding diligence, and a failure to appreciate a third central principle of the law. First, the Board admittedly did not consider all of the evidence because it did not consider the evidence of Mr. Heslin s activities during the critical period. Second, the Board did not consider all the evidence... as a whole, and instead looked to isolated days and intervals of time independently from the other evidence. By focusing on the dates on which Dr. Nezhat did not act, the Board imposed a standard inconsistent with the settled rule that a patent owner need not demonstrate activity on every day during the critical period to establish the inventor s diligence. -26-

34 A. The Board Acknowledged That It Did Not Consider Evidence of Mr. Heslin s Activities During The Critical Period The Board surprisingly did not consider all of the evidence offered by PST. The Board explicitly acknowledged it did not address the activities of Mr. Heslin, Dr. Nezhat s patent attorney, during the critical period. The Board s failure to consider evidence that is critical to the assessment of whether Dr. Nezhat exercised diligence in the constructive reduction to practice of his invention requires that the Board s unpatentability finding be reversed. Applying the erroneous standard discussed below, the Board concluded that Dr. Nezhat s activities, taken alone, did not demonstrate the exercise of reasonable diligence. A22. Despite the longstanding command that all of the evidence be considered, the Board announced that it would therefore not consider the evidence of Mr. Heslin s activities. Id. The Board s refusal to do so was inconsistent with the requirement that it consider all of the evidence and, in a case in which a constructive reduction of practice the filing of a patent application is in issue, the Board s failure to consider the efforts of the inventor s prosecuting attorney is inexplicable. Contrary to the Board s startling statement that it was not required to consider the evidence of Mr. Heslin s activities because Dr. Nezhat s activities were supposedly not sufficient, a patent owner may prove the exercise of reasonable diligence exclusively by the activities of the prosecuting attorney when -27-

35 constructive reduction to practice is in issue. A party may prove due diligence by showing his attorney s efforts to achieve a constructive reduction to practice. In re Enhanced Sec. Research, LLC, 739 F.3d 1347, 1358 (Fed. Cir. 2014) (citing Bey v. Kollonitsch, 806 F.2d 1024, 1027 (Fed. Cir. 1986)) ( Clearly, reasonable diligence can be shown if it is established that the attorney worked reasonably hard on the particular application in question during the continuous critical period. ) Throughout the critical period, Dr. Nezhat worked closely with Mr. Heslin to finalize the application. Evidence of Mr. Heslin s activity was particularly important, and worthy of consideration, because at various times during the critical period, diligence was unsurprisingly carried out primarily by Mr. Heslin, as he revised the application and prepared questions for Dr. Nezhat. Despite the obvious need for a prosecuting attorney or patent agent to execute many of the tasks essential to the filing of an application, and the extensive contributions shown without dispute to have been made by Mr. Heslin during the critical period, the Board did not reach and, therefore, [did] not address whether Patent Owner provides sufficient evidence to demonstrate Mr. Heslin s continuous exercise of reasonable diligence for the entire critical period. 1 A22. 1 The Board s identification of separate questions as to whether Dr. Nezhat and Mr. Heslin exercised reasonable diligence clearly demonstrates its failure to understand the requirements of the law. The question is whether PST proved that Dr. Nezhat, based on all of the activities of all who participated in the constructive reduction to practice of the invention, exercised reasonable diligence. There is no basis on -28-

36 This mistaken application of an erroneous legal standard would require reversal under any circumstances, but the Board s error is of particular significance here. The entire critical period follows Dr. Nezhat s retention of Mr. Heslin to prepare a patent application. By the beginning of the critical period, Mr. Heslin had already prepared the initial draft of the patent application. Ignoring the activities of Mr. Heslin at this time is an especially critical mistake because much of what would take place would center on him, and all of the diligence directed to the filing of the application would involve either Mr. Heslin s individual activities or his interaction with his client, Dr. Nezhat. Mr. Heslin s activities are unquestionably a substantial part of the overall evidence of diligence, and the Board s failure to consider them was prejudicial in the extreme. See In re Enhanced Sec. Research, LLC, 739 F.3d at Moreover, the failure to consider Mr. Heslin s conduct caused the Board to penalize Dr. Nezhat for purported inactivity during a nearly four week period of the critical period, even though the evidence clearly established that the only relevant conduct during that period was that of Mr. Heslin, not Dr. Nezhat. Specifically, the Board found that [a]fter the March 16, 1998, conference, and until receiving a second draft of the patent application on April 13, which the activities of Dr. Nezhat s lawyer can be treated as if they are not a part of Dr. Nezhat s exercise of diligence, and no justification for the Board s failure to consider evidence of Mr. Heslin s activities because it considered Dr. Nezhat s activities insufficient. -29-

37 1998, Dr. Nezhat does not identify any specific activities undertaken or the dates of those activities, in furtherance of the filing of the patent application. A21. But this sub-period, between Mr. Heslin s meeting with Dr. Nezhat and the date Mr. Heslin sent Dr. Nezhat the next draft of the patent application, involved Mr. Heslin making revisions and changes to the draft application. The undisputed evidence clearly bears this out. Mr. Heslin received Dr. Nezhat s comments on the initial draft of the patent application on or around March 2, Mr. Heslin spent at least part of March 3 reviewing Dr. Nezhat s comments. Mr. Heslin s time records confirm that he prepared a letter to Dr. Nezhat. The letter was sent to Dr. Nezhat on March 12. Within days, Mr. Heslin and Dr. Nezhat met at Mr. Heslin s office to discuss the application. It stands to reason that their meeting including a discussion of at least the issues outlined in the letter of March 12. Armed with information from their meeting, Mr. Heslin then spent the next few weeks preparing a further revision of the application, which his time records confirm included drafting the new application on April 7, and then transmitting the typewritten draft to Dr. Nezhat on April 13. This entire period involved Mr. Heslin s conduct, not Dr. Nezhat s. The Board s refusal to examine Mr. Heslin s activities, and its critique of Dr. Nezhat during this time, is improper. The Board had a duty to examine all of the evidence of diligence for the entire critical period, -30-

38 including both that of Dr. Nezhat and Mr. Heslin. The failure to evaluate all of the evidence is a mistake for which reversal is required. A court or agency required to consider whether a patent owner has proved the exercise of reasonable diligence is required to consider all of the evidence. It makes no sense to say, as the Board did, that, because some of the evidence is insufficient, the rest of the evidence will not be considered. The Board s failure to consider all of the evidence requires that its unpatentability finding be reversed. B. The Board Wrongly Focused On Isolated Intervals, Rather Than the Entire Critical Period. This Court has recognized there need not necessarily be evidence of activity on every single day if a satisfactory explanation is evidenced. Monsanto Co., 261 F.3d at See also K&K Jump Start/Chargers, Inc. v. Schumacher Elec. Corp., 52 F. App x 135, 140 (Fed. Cir. 2002) ( [I]t is not necessary that every minute of every day during the critical period be accounted for and that the inventor and his attorney do not need to neglect all their other work to focus solely on the invention. ); Rines v. Morgan, 250 F.2d 365, 369 (C.C.P.A. 1957) ( [I]t is not necessary that an inventor or his attorney should drop all other work and concentrate on the particular invention involved )). The case law also requires that the evidence be viewed as a whole, and not with an excessive focus on isolated events or periods of time. Symsek, 988 F.2d at Despite these settled principles, the approach the Board took was directed to periods of time during -31-

39 which activity did not occur, and to disregard of the overall context demonstrating a steady, continuous process that resulted in the completion and filing of the application without the passage of a lengthy period of time. The Board attempted to justify its approach by noting that [e]ven a short period of unexplained inactivity may be sufficient to defeat a claim of diligence. A16. As support, the Board cited the frequently misunderstood decision in In re Mulder, a case in which the patentee presented literally no evidence of diligence. 716 F.2d 1542, (Fed. Cir. 1983). 2 Mulder is often cited to illustrate the short period point made by the Board because the critical period in that case was only two days. What Mulder actually holds is that a patentee having the burden to prove diligence may not meet that burden when it does not present any evidence, no matter how short the critical period may be. Id. at Mulder offers nothing of significance in a case in which there is evidence of diligence. In Mulder, the patentee offered no evidence at all, apparently believing that the critical period was so short that a finding that he failed to exercise diligence could not be made. Id. The patentee failed to recognize that he had the burden of proof, and that his burden could not be discharged without some evidence. The Court explained that the patentee s evidentiary burden could not drop below the 2 The Board also cited Morway v. Bondi, 203 F.2d 742, 749 (C.C.P.A. 1953), and Ireland v. Smith, 97 F.2d 95, 99 (C.C.P.A. 1938), but neither case discusses the significance of a short period of unexplained activity. -32-

40 point of eliminating all proof of diligence, no matter how short the period to be covered. Id. Mulder says nothing that makes it plausible that a lack of diligence could be found if the patentee presented evidence of diligence and the critical period was two days, or that two days of unexplained inactivity in an overall context demonstrating the exercise of reasonable diligence would be meaningful, given that it is not necessary that every minute of every day during the critical period be accounted for. K&K Jump Start/Chargers, Inc., at 140 (Fed. Cir. 2002). In any event, the evidence in this case does not involve unexplained inactivity. It is undisputed that Dr. Nezhat and Mr. Heslin were working on the completion of the patent application and that their work was completed within a few weeks. Any points of inactivity are amply explained by the undisputed evidence of Dr. Nezhat s and Mr. Heslin s professional commitments, the time needed for study of the application, and the logistical circumstances associated with transcription and communication of the drafts of the application and written communications between client and lawyer. Throughout its decision, the Board faults Dr. Nezhat for not remembering with enough specificity the daily events that occurred over fifteen years ago, imposing an unjustified memory test with no foundation in the case law. First, the Board stated that Dr. Nezhat is unable to identify any single date on which he worked on preparing the application... [between January 28, 1998, and March 2, -33-

41 1998], and that Dr. Nezhat provides no testimony regarding his actions... from February 10, 1998, until March 1, A20. The Board s mention of the period between January 28 and February 9 was improper. The critical period did not begin until February 9, just preceding the effective date of the adverse reference, to the actual or constructive reduction to practice. In re Steed, 802 F.3d 1311, 1317 (Fed. Cir. 2015). It does not matter what Dr. Nezhat did or did not do before February 9, and the Board s reference to the longer period of the time creates a distraction from the matters at hand. In any event, what is the point of discussing the period preceding March 2 at all? The record shows without conflict that, during that time, Dr. Nezhat worked on the application in a serious manner. Billing records maintained by Mr. Heslin s former firm establish that Mr. Heslin faxed a draft of the application to Dr. Nezhat on Thursday, January 29, A fax sent by Mr. Heslin to Dr. Nezhat on Wednesday, March 4, thanks Dr. Nezhat for his Monday, March 2 letter that provided feedback on the initial draft. While Dr. Nezhat is unable to remember on which single date[s] he worked on the draft, undisputed testimony from Mr. Heslin and Dr. Nezhat shows that during the critical time Dr. Nezhat communicated regularly with Mr. Heslin, A1259:24- A1260:4, and that Dr. Nezhat was a careful and serious client who took the time to study closely and understand the draft claims and provide meaningful and useful feedback. A1549:1-5; A , 13. This testimony is corroborated by Dr. -34-

42 Nezhat having provided comments on the initial draft, which prompted Mr. Heslin to send a series of follow up questions to Dr. Nezhat on March 4. It cannot be denied that Dr. Nezhat carried out these activities between the Thursday in late January on which the draft was sent, and the Monday in early March when he sent his comments. What is it about the fact that Dr. Nezhat does not remember the telephone calls and studies he carried out during this time on a specific day or days that renders his exercise of diligence unreasonable? Why, given that Dr. Nezhat is a busy surgeon with an active practice who cared enough about his first patent application to make careful comments, is there cause for concern that he does not remember when he took the actions the record shows he unquestionably took? And how, given that the law does not require that he work on the application every day, can he be faulted for his lack of an extraordinary memory about which specific days he did things no one denies he did? The Board s focus on the limitations of Dr. Nezhat s memory and its failure to appreciate the entire evidentiary record is contrary to Federal Circuit precedent. This Court explained in Symsek, that all of the evidence put forth by [the movant], including any of his corroborated testimony, must be considered as a whole, not individually, in determining whether [the movant] proved conception and reduction to practice. 988 F.2d at All of the evidence of the process that occurred between February 9, 1998 and May 1, 1998, considered as a whole -35-

43 establishes that Dr. Nezhat endeavored earnestly to review, understand, and improve the drafts of his first patent application, and that Mr. Heslin performed as a responsible prosecuting attorney. The documentary evidence corroborates Dr. Nezhat and Mr. Heslin s testimony of a diligent and continuous process, and demonstrates that reasonable diligence was exercised. Dr. Nezhat s inability to remember specific dates on which he performed his work on the application does not undermine his exercise of diligence under Federal Circuit precedent. Next, the Board faults Dr. Nezhat because he is able to identify only two dates on which he took specific actions... between March 2, 1998, and May 1, So what? In this passage, the Board accepts that Dr. Nezhat has identified two dates on which he took specific actions but, for reasons that are not explained, this is deemed an indication of insufficient diligence. The two dates to which the Board refers are the dates of Dr. Nezhat s March 2 fax and his March 16 meeting with Mr. Heslin. By focusing on individual dates, rather than the evidence as a whole, the Board omits consideration of the practical realities of how a patent application is developed. Dr. Nezhat sent his comments regarding the first draft of the application on March 2, and on March 4 Mr. Heslin dictated follow-up questions. The word processing department in Mr. Heslin s firm transcribed these questions into a letter that was sent to Dr. Nezhat on March 12. The Board faults Dr. Nezhat because he does not recall when or how he responded to those -36-

44 questions and that he does not identify any specific activities undertaking or the dates of those activities...[between March 16, 1998, and April 13, 1998], but it does not deny that he responded, or explain how or why the specifics of what he did within this modest range of days is consequential under this Court s settled precedent. Dr. Nezhat s recollection of when or how he responded to questions is not critical. What matters is that the billing records establish beyond question that Mr. Heslin sent questions to Dr. Nezhat, the two met in-person shortly thereafter, and Mr. Heslin completed a second draft of the patent application in early April. This evidence, when viewed as a whole, supports a finding that Dr. Nezhat and Mr. Heslin exercised reasonable diligence in reducing the invention of the 384 patent to practice. In Monsanto, the Court cited Jones v. Evans, 46 F.2d 197, 202 (C.C.P.A. 1931). In Jones, the Court of Customs and Patent Appeals explained that [I]n deciding this matter, some consideration must be had of the difficulties which ensue when a device of as delicate and intricate a character as this is being perfected... It would be a manifest perversion of justice to say that the original inventor of this system of control should lose the benefit of his invention by the mere fact that a possible interval from April 16th to early in July elapsed, in which it does not affirmatively appear that any steps were being taken toward the filing of a proper application for patent. It may be that the machinery which appellant had set in motion in the General Electric Company was moving slowly, but not to such an extent, in our opinion, -37-

45 that the appellant should be caused to lose the fruits of his invention thereby. 46 F.2d at 202. The record in this case establishes that between January 28, 1998, and May 1, 1998, an application for what would become the 384 patent was revised, amended, discussed, and finalized. Between February 9, 1998, and May 1, 1998, Dr. Nezhat reviewed and provided feedback regarding two drafts of the patent, and approved the final application. During that time, Dr. Nezhat and Mr. Heslin met in person, corresponded by faxes and letters, and spoke on the telephone more times than Mr. Heslin felt comfortable billing. The entire critical period, not the periods of inactivity, was the required point of focus. C. The Board Applied An Erroneous Standard To The Evidence Of Diligent Pursuit Of The Application. In addition to failing to consider all of the evidence, the Board applied an improper legal standard to the evidence it considered. The Board found that Dr. Nezhat gave Mr. Heslin comments regarding the initial draft of the application, that Dr. Nezhat received follow up questions from Mr. Heslin, and that a conference between Dr. Nezhat and Mr. Heslin occurred on March 16, A The Board concluded, however, that the evidence was inadequate because PST provided no evidence regarding the nature of the interactions underlying this undisputed evidence. See A20 ( No evidence is presented as to the nature of those comments. ); see also A21( [Dr. Nezhat does not recall when or how he -38-

46 responded to those questions ); Id. ( No evidence is presented as to the nature of this conference. ). This unrealistic assessment of the evidence is unjustified. Of course, there was evidence about the nature of the comments and the conference. The comments and the conference addressed the patent application that client and lawyer were seeking to complete in an accurate and complete manner. There is no case law supporting the idea that Dr. Nezhat was required to prove whether he corrected Mr. Heslin s spelling or his use of technical terminology, or asked him to modify a discussion of the prior art, or whether Dr. Nezhat or Mr. Heslin was the inspiration for the new claims and drawings, or anything else. As already noted, [t]here is no rule requiring a specific kind of activity in determining whether the applicant was reasonably diligent in proceeding toward an actual or constructive reduction to practice. Brown, 436 F.3d at The nature of the admitted interactions between client and lawyer is relevant only insofar as it can be determined whether they involved the completion of the application. On this point, there is no dispute, and the Board committed legal error when it imposed on Dr. Nezhat a burden to specify the nature of interactions that undeniably involved the completion of the application. The Board s interest in the nature of these interactions was not grounded in the law. The Board s failure to appreciate or acknowledge the nature of the interactions between Dr. Nezhat and Mr. Heslin is difficult to understand given the -39-

47 documentary evidence that Olympus did not challenge and the Board did not question. Dr. Nezhat s comments followed his receipt of the first draft of the application. The comments prompted follow up questions from Mr. Heslin. Their correspondence culminated in a meeting between the two men. The Board does not dispute or question the credibility of the documents or testimony confirming that these events took place. Rather, the Board apparently takes issue with the absence of a detailed account regarding what was said during the meetings. Such an account is not warranted by the law, and not necessary for a reasonable evaluation of the evidence. The basic inquiry is whether, on all of the evidence, there was reasonably continuing activity to reduce the invention to practice. Brown, 436 F.3d at On this, there can be no dispute. Each of the events in question consisted of an interaction between an inventor and a prosecuting attorney that indisputably moved the patent application closer to being filed. Each of these events demonstrates reasonably continuing activity, regardless of its specific nature. The Board did not find that the events did not occur, and the absence of specific details about their nature, forgotten over time, does not diminish their evidentiary weight under the proper legal standard set forth in this Court s decisions. -40-

48 IV. JP 551 SHOULD NOT HAVE BEEN CONSIDERED BY THE BOARD AND THERE WAS NO EVIDENCE TO ESTABLISH THE PRIORITY DATE OF JP 551. The Board improperly considered a foreign prior art reference that was not presented in the manner required by 37 C.F.R (b). By overlooking Olympus s failure to comply with this unambiguous regulation, the Board disregarded its own regulation, and wrongly found sufficient evidence of the publication date of JP 551 when there was no sufficient evidence of record. Olympus alleged in its petition for inter partes review that JP 551 was prior art that rendered the 384 patent unpatentable. JP 551 is a Japanese language patent application for which a full translation was required. 37 C.F.R (b) provides [w]hen a party relies on a document or is required to produce a document in a language other than English, a translation of the document into English and an affidavit attesting to the accuracy of the translation must be filed with the document. Olympus did not submit a full English language translation of JP 551 with its petition for inter partes review. See A221. The first page of the application contained bibliographic information, including the application s publication date, but that particular page was not translated. See id.; A954. Nevertheless, the Board concluded that Olympus met its obligation under section 42.63(b) by filing the Japanese language copy of JP 551, a partial English translation of JP 551 that excluded the bibliographic information, and a certificate -41-

49 attesting to the accuracy of the translation. A14. None of that amounts to compliance with the governing rules and, as a result, there was not sufficient evidence on which the Board could base a finding that JP 551 was prior art to the 384 patent. The Board acknowledged that although the page containing the publication date of JP 551 was not translated, the translator s certification states the publication date. A The Board s reliance on the certification of the translator, however, was improper. To the extent the translator s certification constitutes testimony regarding the publication date of JP 551, a purpose for which the certification clearly was not offered, the testimony must have been submitted in accordance with the governing rules. It was not. Under 37 C.F.R (a), [u]ncompelled direct testimony must be submitted in the form of an affidavit. Strict guidelines have been placed on affidavits in proceedings before the Patent and Trademark Office. 28 U.S.C governs affidavits and provides: Wherever, under any law of the United States or under any rule, regulation, order, or requirement made pursuant to law, any matter is required or permitted to be supported, evidenced, established, or proved by the sworn declaration, verification, certificate, statement, oath, or affidavit, in writing of the person making the same (other than a deposition, or an oath of office, or an oath required to be taken before a specified officer other than a notary public), such matter may, with like force and effect, be supported, evidenced, established, or -42-

50 proved by the unsworn declaration, certificate, verification, or statement, in writing of such person which is subscribed by him, as true under penalty of perjury, and dated, in substantially the following form: (1) If executed without the United States: I declare (or certify, verify, or state) under penalty of perjury under the laws of the United States of America that the foregoing is true and correct. Executed on (date). (Signature). See also 37 C.F.R ( Any document to be filed in the Patent and Trademark Office and which is required by any law, rule, or other regulation to be under oath may be subscribed to by a written declaration, provided the declarant is on the same document, warned that willful false statements and the like are punishable by fine or imprisonment, or both (18 U.S.C. 1001) and may jeopardize the validity of the application or any patent issuing thereon. ). Here, the Japanese translator, who executed the certification in Tokyo, Japan, states that he accurately translated the JP 551 reference, but does not state so under penalty of perjury under the laws of the United States of America. The translator also was not warned on the document that willful false statements and the like are punishable by fine or imprisonment, or both. Accordingly, the Board s reliance on a translation certificate to establish the publication date of JP 551 was plainly erroneous because the form of the certification was inconsistent with the governing law and did not amount to an affidavit sufficient to establish by testimony the date of publication of JP

51 The Board also found that the publication date is discernible from the Japanese language documents itself, when following the guidance set forth in Section (a) of the Manual of Patent Examining Procedure, which explains how to convert Japanese dates to Gregorian calendar dates. A13. But the rules governing IPR do not allow for the conversions described in the MPEP. Rather, compliance with section 42.63(b) is mandatory. Olympus was obligated to produce a full translation of JP 551 when it filed its petition. Failure to comply with section 42.63(b) rendered JP 551 defective and incapable of demonstrating the date of publication. See Zhongshan Broad Ocean Motor Co., Ltd., Broad Ocean Motor LLC, & Broad Ocean Techs., LLC, Petitioners, IPR , 2015 WL , at *6 (Jan. 21, 2015). In Zhongshan, the petitioner submitted a translated copy of a Japanese patent but did not include an affidavit attesting to the accuracy of the translation. Id. at *4. The Board explained that because the petitioner did not comply with section 42.63(b), the reference was defective and incapable of rendering the challenged patent unpatentable. Id. at *6. ( Accordingly, we do not consider [the reference] and, as a result, deny the Petition with respect to the anticipation grounds based on [the reference]. ). The petitioner in Zhongshan, like Olympus, A938, stated that it was unaware it had omitted the certification until it received the patent owner s response, and subsequently attempted to correct the mistake. Id. at *5. The Board -44-

52 explained that the petitioner s correction was inadequate because the petitioner did not simply forget to attach the translator s certification, but [r]ather, the mistake resulted from a failure to obtain the attesting affidavit at all--until attention later was drawn to the error by Patent Owner. Id. at *6. Olympus, just like the petitioner in Zhongshan, did not have a translated copy of the first page of JP 551 when it submitted its petition. The translation of JP 551 initially offered by Olympus was certified on November 12, A295. A belated translation of the bibliographic information, which the Board refused to consider as improper reply evidence, A13 n. 6, was certified nearly a year later, on October 16, A955. Like the failure to present the mandatory translation certification in Shongshan, the failure to present the translation of the bibliographic information of JP 551 here was defective and JP 551 should not have been considered by the Board. The Board faults PST for not objecting to the incomplete translation of JP 551 when trial was instituted. A14. Instead, PST raised Olympus s failure to comply with section 42.63(b) in its patent owner s response. But, as PST explained during the hearing, [PST has] no objection to the absence of the evidence... the obligation... on the Petitioner is to present sufficient evidence... to show a prima facie case in the Petition. And they failed. And an objection to evidence that does not satisfy their burden,... doesn t make a lot of sense. A1856:7-8, Indeed, the failure to translate the bibliographic information of -45-

53 JP 551 deprived the record of sufficient evidence to establish that JP 551 constitutes prior art to the 384 patent. That failure alone is sufficient to reject the grounds of unpatentability proposed by Olympus. The evidence presented is insufficient to prove anticipation or obviousness. An evidentiary objection was not required. As a result, there was not sufficient evidence to find the 384 patent unpatentable. V. THE BOARD S IMPROPER CONSTRUCTION OF THE TERM PERFORATED RESULTED IN AN INCORRECT FINDING OF UNPATENTABILITY. Independent claim 38, and several dependent claims, of the 384 patent teach [a] bipolar surgical instrument comprising... a pair of opposed jaws... wherein at least one of the jaws is perforated to permit the release of steam during use. A146: The Board construed several terms, but only its construction of the term perforated was disputed by PST. A9. Based on its improper construction, the Board incorrectly found that claims 11, 38, 41-44, 46, 47, and 49 of the 384 patent are unpatentable. In inter partes review, claim terms in an unexpired patent are given their broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R (b). The words of a claim are generally given their ordinary meaning as understood by a person of ordinary skill in the art, except when the patentee disavows the full scope of a claim term in the specification. See -46-

54 Thorner v. Sony Computer Entm't Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012) (citing Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed.Cir.2005) (en banc); Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1580 (Fed.Cir.1996)). Where the specification makes clear that the invention does not include a particular feature, that feature is deemed to be outside the reach of the claims of the patent, even though the language of the claims, read without reference to the specification, might be considered broad enough to encompass the feature in question. Thorner at 1366 (quoting SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1341 (Fed.Cir.2001)). Claims 11, 25, 36, and 38 of the 384 patent include at least one of the jaws is perforated to permit the release of steam during use. See A145:65-67; A145:51-52; A146:31-32; A146: The specification states that [o]ptionally, either or both of the jaws may be perforated or otherwise provided with passages in order to permit the release of steam which is a byproduct of tissue heating. A143: The statement in the specification that the jaws may be perforated or otherwise provided with passages does not suggest that perforations are passages. To the contrary, the language evidences an intentional choice by Dr. Nezhat to distinguish perforations from passages. Despite this, the Board interpreted perforated or otherwise provided with passages to mean that passages [are] another form of perforations. A9 (emphasis in original). -47-

55 This conclusion, and the Board s construction of the term perforated, is the direct result of the improper importation of passages into the claims of the 384 patent. In SuperGuide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004), the Court stated that it is important not to import into a claim limitations that are not a part of the claim. 358 F.3d at 875 (citing Electro Med. Sys. S.A. v. Cooper Life Sci., Inc., 34 F.3d 1048, 1054 (Fed.Cir.1994)). Here, the Board wrongly construed the term perforated to mean at least one jaw has one or more perforations or passages formed there through,.... A11. The Board tried to bolster its construction by referencing non-technical dictionary definitions for perforate, see A10 ( [t]o pierce or puncture; particularly, to make a line or series of holes for such purposes as identification, decoration, or easy separation ), and perforation, see id. ( [a]ny hole made by boring, punching, or piercing ). But like the claims of the 384 patent, none of these definitions include the word passage, and instead describe holes made by piercing, puncturing, boring, or punching. While the Board included a non-technical dictionary definition of passage, see A11 ( an opening or entrance into, through, or out of something ), the Board ignored that that the patentee explicitly distinguished perforations from passages in the specification. See Phillips, 415 F.3d at 1316 (en banc) ( [O]ur cases recognize that the specification may reveal a special definition given to a claim term by the -48-

56 patentee that differs from the meaning it would otherwise possess. In such cases, the inventor s lexicography governs. ). The Board s construction is not even defensible under the broadest reasonable interpretation standard. A8. Even when applying the broadest reasonable interpretation, the Board may not construe claims so broadly that its constructions are unreasonable under general claim construction principles. Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292, 1298 (Fed. Cir. 2015); see also In re Skvorecz, 580 F.3d 1262, 1267 (Fed. Cir. 2009) ( The protocol of giving claims their broadest reasonable interpretation... does not include giving claims a legally incorrect interpretation. ). The Board s disregard of Dr. Nezhat s intentional exclusion of term passages from the meaning of perforations, and its importation of passages from the specification into the claims, are clear errors of law. Based on the improper construction of perforated, the Board incorrectly found that claims 11, 38, 41-44, 46, 47, and 49 are unpatentable. Decision at 31 ( In view of our construction of the limitation: wherein at least one of the jaws is perforated to permit the release of steam during use, we are persuaded that slit 65 of JP 551 discloses the recited, perforated jaw of claims 11 and 38. ). JP 551 discloses a slit in the clamping members of the forceps through which a knife member maybe inserted. The slit, or passage, in the view of the Board, is not -49-

57 a perforation, which, as defined by the Board s dictionary, is a hole made by boring, punching, or piercing. A10. As a result of the incorrect claim construction, the Board s finding that claims 11, 38, 41-44, 46, 47, and 49 are unpatentable must be reversed. VI. CONCLUSION. For the foregoing reasons, the Court should reverse the Board s final written decision finding that claims 1, 4-6, 8-9, 11-12, 38, 41-44, 46-47, and 49 of the 384 patent are unpatentable. Date: December 2, 2015 Respectfully submitted, /s/daniel J. Weinberg Daniel J. Weinberg -50-

58 CERTIFICATE OF SERVICE It is certified that copies of the foregoing has been served via electronic mail transmission addressed to the persons at the address below: Deborah E. Fishman Katie J.L. Scott KAYE SCHOLER LLP Steven I. Weisburd ARENT FOX LLP Date: December 2, 2015 /s/daniel J. Weinberg Daniel J. Weinberg -51-

59 CERTIFICATE OF COMPLIANCE Pursuant to Federal Rule of Appellate Procedure 32(a)(7)(C), I certify that the Appellant s Opening Brief is proportionally spaced, in a typeface of 14 points or more and contains 11,836 words, exclusive of those materials not required to be counted under Rule 32(a)(7)(B)(iii). /s/daniel J. Weinberg Daniel J. Weinberg -52-

60 ADDENDUM Final Written Decision dated June 8, 2015 U.S. Patent 6,030,

61 Case: Document: 15 Page: 1 Filed: 12/02/2015 No UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT PERFECT SURGICAL TECHNIQUES, INC., Appellant, v. OLYMPUS AMERICA, INC. and OLYMPUS MEDICAL SYSTEMS CORPORTATION, Appellees. On Appeal From the United States Patent and Trademark Office Before The Patent Trial and Appeal Board Case IPR APPELLANT S OPENING BRIEF Robert E. Freitas Daniel J. Weinberg FREITAS ANGELL & WEINBERG LLP 350 Marine Parkway, Suite 200 Redwood Shores, California Telephone: (650) Facsimile: (650) Attorneys for Appellant Perfect Surgical Techniques, Inc.

62 Case: Document: 15 Page: 2 Filed: 12/02/2015 following: CERTIFICATE OF INTEREST Counsel for Appellant Perfect Surgical Techniques, Inc. certifies the 1. The full name of every party or amicus represented by me is: Perfect Surgical Techniques, Inc. 2. The name of the real party in interest represented by me is: N/A 3. All parent corporations and any publicly held companies that own 10 percent or more of the stock of the party or amicus curiae represented by me are: N/A 4. The names of all law firms and the partners or associates that appeared for the party or amicus now represented by me in the trial court or agency or are expected to appear in this court are: Robert E. Freitas Jason S. Angell Daniel J. Weinberg Joshua L. Young FREITAS ANGELL & WEINBERG LLP 350 Marine Parkway, Suite 200 Redwood Shores, CA Telephone: (650) Facsimile: (650) rfreitas@fawlaw.com jangell@fawlaw.com dweinberg@fawlaw.com jyoung@fawlaw.com

63 Case: Document: 15 Page: 3 Filed: 12/02/2015 TABLE OF CONTENTS Page STATEMENT OF RELATED CASES... 1 JURISDICTIONAL STATEMENT... 1 STATEMENT OF THE ISSUES... 1 STATEMENT OF THE CASE... 2 STATEMENT OF FACTS... 3 SUMMARY OF THE ARGUMENT ARGUMENT I. STANDARD OF REVIEW II. III. OLYMPUS S FAILURE TO IDENTIFY THE LEVEL OF ORDINARY SKILL IN THE ART IS FATAL INDEPENDENT OF ITS FAILURE TO IDENTIFY THE LEVEL OF ORDINARY SKILL, OLYMPUS FAILED TO PROVE A MOTIVATION TO COMBINE THE 717 PATENT AND THE 546 PATENT A. The 717 Patent Teaches A Different, But Effective, Method For The Uniform Heating Of Tissue B. Olympus Did Not Prove A Reason Or Motivation To Combine Its Prior Art References C. There Is No Improvement Upon Which To Base A Motivation To Combine The 717 And 546 Patents IV. CONCLUSION i-

64 Case: Document: 15 Page: 4 Filed: 12/02/2015 TABLE OF AUTHORITIES Page(s) Federal Cases Belden Inc. v. Berk-Tek LLC, 2015 WL (Fed. Cir. Nov. 5, 2015) Belkin Int l, Inc. v. Kappos, 696 F.3d 1379 (Fed. Cir. 2012) Chore-Time Equip., Inc. v. Cumberland Corp., 713 F.2d 774 (Fed. Cir. 1983) Circuit Check Inc. v. QXQ Inc., 795 F.3d 1331 (Fed. Cir. 2015) Consol. Edison Co. v. N.L.R.B., 305 U.S. 197 (1938) In re Constr. Equip. Co., 665 F.3d 1254 (Fed. Cir. 2011) Daiichi Sankyo Co., Ltd. v. Apotex, Inc., 501 F.3d 1254 (Fed. Cir. 2007) Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356 (Fed. Cir. 2006) Ecolochem, Inc. v. S. California Edison Co., 227 F.3d 1361 (Fed. Cir. 2000) In re Gartside, 203 F.3d 1305 (Fed. Cir. 2000) Graham v. John Deere Co., 383 U.S. 1 (1966)...passim Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363 (Fed. Cir. 2008) In re Kahn, 441 F.3d 977 (Fed. Cir. 2006) ii-

65 Case: Document: 15 Page: 5 Filed: 12/02/2015 Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342 (Fed. Cir. 2012) Koninklijke Philips Elecs. N.V. v. Cinram Int l Inc., 2010 WL (D. Mass. Dec. 10, 2010) In re Kotzab, 217 F.3d 1365 (Fed. Cir. 2000) KSR Int l Co. v. Teleflex Inc., 550 U.S. 398 (2007)...passim Malico, Inc. v. Cooler Master USA Inc., 594 F. App x 621 (Fed. Cir. 2014) Oatey Co. v. IPS Corp., 665 F. Supp. 2d 830 (N.D. Ohio 2009) Randall Mfg. v. Rea, 733 F.3d 1355 (Fed. Cir. 2013) Ruiz v. A.B. Chance Co., 357 F.3d 1270 (Fed. Cir. 2004) Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.2d 714 (Fed. Cir. 1991) In re Sullivan, 362 F.3d 1324 (Fed. Cir. 2004) Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356 (Fed. Cir. 2008) Suprema, Inc. v. Int l Trade Commn., 742 F.3d 1350 (Fed. Cir. 2013) Wonderland NurseryGoods Co., Ltd. v. Thorley Industries, LLC, 988 F. Supp. 2d 479 (W.D. Pa. 2013) Zoltek Corp. v. United States, 95 Fed. Cl. 681 (Fed. Cl. 2010) iii-

66 Case: Document: 15 Page: 6 Filed: 12/02/2015 Federal Statutes 5 U.S.C. 706(2)(A) U.S.C. 103(a) iv-

67 Case: Document: 15 Page: 7 Filed: 12/02/2015 STATEMENT OF RELATED CASES U.S. Patent No. 6,682,527 ( 527 patent ) is the subject of the following district court case: Perfect Surgical Techniques, Inc. v. Olympus America Inc., Gyrus Medical, Inc., and Gyrus ACMI, Inc., 12-cv PJH (N.D. Cal.). Appellant Perfect Surgical Techniques, Inc. ( PST ) and Appellees Olympus America, Inc. and Olympus Medical Systems Corporation (collectively, Olympus ) are also involved in the following appeal pending before this Court relating to U.S. Patent No. 6,030,384: Perfect Surgical Techniques, Inc. v. Olympus America, Inc. and Olympus Medical Systems Corporation, No PST is aware of no other related cases. JURISDICTIONAL STATEMENT Olympus filed a petition for inter partes review of U.S. Patent No. 6,682,527. A41. The Patent Trial and Appeal Board ( Board ) had jurisdiction over Olympus s petition under 35 U.S.C. 6. The Board issued a final written decision on June 8, A2. PST timely filed its notice of appeal on August 4, U.S.C This Court has jurisdiction under 28 U.S.C. 1295(a)(4)(A). STATEMENT OF THE ISSUES Whether Olympus s failure to present evidence of the level of ordinary skill in the art precludes a finding of obviousness. -1-

68 Case: Document: 15 Page: 8 Filed: 12/02/2015 Whether the evidence presented by Olympus is sufficient to support a finding of obviousness when it sheds no light on the central question of whether a person having ordinary skill in the art would have been motivated to combine the prior art references on which Olympus relied. Whether Olympus proved that Claims 17-23, 26, 29, and 30 of U.S. Patent No. 6,682,527 would have been obvious over the combination of U.S. Patent No. 5,954,717 and U.S. Patent No. 6,139,546. STATEMENT OF THE CASE On December 20, 2013, Olympus filed a corrected petition requesting inter partes review of Claims of the 527 patent. A41. Olympus s petition asserted twenty-one different grounds for finding various claims of the 527 patent unpatentable. A On June 16, 2014, the Board instituted inter partes review on four grounds: On the theory that Claims 17, 18, 21, 22, 29, and 30 would have been obvious over a combination of U.S. Patent No. 5,954,717 ( 717 patent ) and U.S. Patent No. 6,139,546 ( 546 patent ); On the theory that Claim 19 would have been obvious over a combination of the 717 patent, the 546 patent, and U.S. Patent No. 6,398,779 ( 779 patent ); On the theory that Claims 20 and 26 would have been obvious over a combination of the 717 patent, the 546 patent, and U.S. Patent No. 6,936,047-2-

69 Case: Document: 15 Page: 9 Filed: 12/02/2015 ( 047 patent ); and On the theory that Claim 23 would have been obvious over the combination of the 717 patent, the 546 patent, and International Publication WO 97/40882 A2 ( WO 882 ). A870. Olympus s other arguments were rejected and the petition was denied as to claims 24, 25, 27, and 28 of the 527 patent. Id. Olympus filed a request for rehearing as to claims 24, 25, 27, and 28, and the request was denied. A885; A910. PST filed a patent owner response accompanied by the declaration of expert witness Dr. Robert Tucker, and Olympus replied. A929; A951; A1003. An oral hearing was held on February 23, A1483. On June 8, 2015, the Board issued a final written decision in which it determined that Olympus had shown by a preponderance of the evidence that Claims 17, 18, 21, 22, 29, and 30 would have been obvious over a combination of the 717 and 546 patents, Claim 19 would have been obvious over the 717, 546, and 779 patents, Claims 20 and 26 would have been obvious over the 717, 546, and 047 patents, and Claim 23 would have been obvious over the 717 and 546 patents and WO 882. A STATEMENT OF FACTS The 527 patent describes a generator for use in electrosurgery that allows for the effective and efficient therapeutic treatment of tissue. A110 (2:20-23) ( The present invention provides improved methods, systems, and apparatus for -3-

70 Case: Document: 15 Page: 10 Filed: 12/02/2015 effective and efficient delivery of radio frequency (RF) energy to electrodes of bipolar surgical instruments.... ). Radio frequency energy is supplied by the generator to bipolar surgical instruments that grasp treatment regions anywhere in the body, with the power level increasing at a predetermined rate from an initial level. A102 at Abstract. The patent discusses the difficulty of delivering an effective therapeutic level of heat to tissue to be treated without premature impedance (electrical resistance) caused by, among other things, charring of the tissue. A110 (1:30-33). When a surgical treatment of tissue is completed through desiccation of the tissue, impedance is an acceptable or desired result, but premature impedance can interfere with the successful completion of the surgeon s objective. Id. at 2: Charring greatly increases electrical resistance and can result in termination of the treatment before the tissue is uniformly heated. Id. at 1:34-37; id. at 2:52-57 ( [I]mpedance... can be undesirable if it occurs prematurely since it results in an immediate fall-off of the energy delivery.... ). Another cause of a premature increase in electrical resistance can be the formation of a vapor layer between the electrodes and the target tissue. A vapor layer results from heating of the water within the tissue as the temperature approaches the local boiling point. Id. at 2:62-67; A111 (3:1-5) ( The thin gaseous layer appears to spread from an initial nucleation site to cover most or all of the electrode surfaces in a very short time -4-

71 Case: Document: 15 Page: 11 Filed: 12/02/2015 period, resulting in the premature increase in electrode-tissue interface impedance which is very large when compared to the total system impedance prior to formation of the gaseous layer. ) Before the invention of the 527 patent, the approaches to combat premature impedance were complex, and generally used a slow and low-powered procedure to heat tissue without charring. A110 (1:43-52) ( many approaches... relied on slow, low power level, gradual heating of the tissue to avoid the formation of charred or otherwise desiccated, high radio frequency impedance regions within the target tissue ). These approaches were not always successful, and they typically resulted in the undesirable prolongation of the surgical procedure. Id. at 1: The 527 patent claims a way to control the level of radio frequency energy delivered to the target tissue so as to prevent both charring of the tissue and the formation of a vapor layer, while producing the desired electrosurgical effect. The invention relies on unique methods of radio frequency power delivery to uniformly and thoroughly heat the target tissue without charring the target tissue. Id. at 2: The power delivered to the tissue is increased at a predetermined rate from an initial level. A111 (3:18-20). This initial level of power and predetermined rate of increase are used specifically to avoid creating a vapor layer and to permit an impedance increase to occur only as a natural result of complete -5-

72 Case: Document: 15 Page: 12 Filed: 12/02/2015 tissue desiccation. Id. at 3:20-22; A110 (2:54-56) ( [W]hile such an increase in impedance is the natural consequence of tissue desiccation, it can be undesirable if it occurs prematurely.... ). Both the initial level of power and the predetermined rate of increase can be preselected by the user depending on different factors such as electrode size, the target tissue type, and the degree of tissue perfusion. A111 (3:23-26). The 527 patent claims a distinction over the prior art methods by reducing complexity, cost, and treatment time, through its method of achieving complete, thorough, and uniform heating of the target tissue without premature impedance. A110 (1:62-65). Independent Claim 17 of the 527 patent provides as follows: 17. A radio frequency generator comprising: a radio frequency power source having a controlled voltage output and a bipolar connection for bipolar forceps having first and second jaws with first and second electrode members; and means for automatically increasing power delivered to the bipolar forceps; wherein the increasing means increases the power at a predetermined rate from an initial level, the initial level and predetermined rate avoiding formation of a vapor layer while permitting an impedance increase to occur as a result of complete tissue dessication. A114 (10:4-15). Claim 17 is the only independent claim at issue, and all of the other claims at issue depend from Claim 17, either directly or indirectly. The Olympus petition alleged that the 527 patent is unpatentable over -6-

73 Case: Document: 15 Page: 13 Filed: 12/02/2015 various combinations of the prior art, but trial was instituted only on the four theories mentioned above. A870. Each of these theories requires the combination of the 717 and 546 patents. The 717 patent describes a method and system to ablate tissue with energy emanating from one or more needle electrodes. A545 (1:9-11). Like the 527 patent, the 717 patent identifies certain issues relating to the heating of tissue for purposes of desiccation through the use of electrodes. Both patents address the need to deliver power in such a way as to heat the tissue to be treated uniformly while avoiding charring. See id. at 1: The 717 patent teaches a way to meet this objective through a method that contradicts that of the 527 patent. Unlike the 527 patent which teaches starting from an initial level and increasing power at a predetermined rate the solution offered by the 717 patent is to heat the tissue to a point of high impedance, and then to reduce the power before re-energizing the electrode to complete tissue desiccation. A546 (3:31-51). Specifically, the threephase method of heating tissue in the 717 patent comprises: (1) an elevated power level is first supplied at which an abrupt increase in electrode-tissue interface impedance is observed; (2) power is sharply reduced to permit a decrease in impedance; and (3) the electrode is reenergized at a level below the initial elevated level which an abrupt increase in impedance is observed. Id. at 3:31-51; A550 (11:53-61). The method of the 717 patent is effective, according to its disclosure, -7-

74 Case: Document: 15 Page: 14 Filed: 12/02/2015 in addressing the underlying problem of uniformly heating tissue, and the 717 patent asserts that it does so notwithstanding the formation of a vapor layer. A546 (3:27-30); A ( 23); A820 ( The methods, systems, and apparatus of the present invention have been found to be useful and effective regardless of the actual mechanism which is responsible for the change in impedance. ). Olympus acknowledged, and the Board agreed in its institution and final written decisions, that the 717 patent does not expressly describe the particular algorithm used to increase power from an initial level to the new set point level. A80; A857; A14. Thus, Olympus fail[ed] to demonstrate a reasonable likelihood of prevailing in showing that US 717 anticipates claim 17. A857. Olympus therefore had to rely on a combination of the 717 patent with another reference to replicate the invention of the 527 patent, and to prove that the combination would have been obvious to a person having ordinary skill in the art at the time of the invention of the 527 patent. Despite the absence of a demonstration by Olympus of any need to modify the concededly effective method of the 717 patent, the Board instituted inter partes review on the basis that algorithms used to increase power are taught in the 546 patent. A The 546 patent teaches a method of controlling power delivery to multiple electrodes connected to time-varying tissue loads. A530 (14:18-25); A517; A960 ( 24). It discloses an algorithm to control the power -8-

75 Case: Document: 15 Page: 15 Filed: 12/02/2015 delivered to multiple electrodes in a heating interval and measure the impedance during a separate interval. A531 (15:1-26); A518; A960 ( 24). Olympus argued that the 546 patent discusses an algorithm which increases power over time at a predetermined rate in accordance with a Power Control Parameter Schedule, referring to figures 11, 12, and 15A. A74-77; A517; A518; A521. The Board found that there was a reasonable likelihood that independent Claim 17 the 527 patent would have been obvious over a combination of the 717 and 546 patents. A The Board construed six terms of the 527 patent using the broadest reasonable interpretation standard. A847-53; A8. The means-plus-function term of Claim 17 recites: [M]eans for automatically increasing power delivered to the bipolar forceps; wherein the increasing means increases the power at a predetermined rate from an initial level, the initial level and predetermined rate avoiding formation of a vapor layer while permitting an impedance increase to occur as a result of complete tissue dessication. A114 (10:9-15). The Board concluded that the function is automatically increasing power delivered to the bipolar forceps [via a bipolar connection]. A848-49; A8. Further, the Board determined that the means for automatically increasing power must (1) have an initial level; (2) must increase power at a predetermined rate from that initial level; and (3) the initial level and -9-

76 Case: Document: 15 Page: 16 Filed: 12/02/2015 predetermined rate must be chosen to avoid formation of a vapor layer, e.g., avoid exceeding the impedance limit, while permitting an impedance increase to occur as a result of complete tissue desiccation. A849-51; A8. In doing so, the Board rejected Olympus s attempt to interpret Claim 17 in such a way as to read out the limitation that the power be increased so as to avoid formation of a vapor layer. A850 ( we are not persuaded by Petitioner s selective reading of the claim language or by its selective reading of the Specification ). Lastly, the corresponding structure was identified as the digital controller programmed to perform the disclosed algorithm. A9-11. The evidence presented by Olympus consisted principally of a declaration from Roger Odell. Mr. Odell provided expert opinions purporting to support Olympus s position, but he did not (and Olympus did not) offer evidence on the first of the Graham factors considered in an obviousness challenge, the level of ordinary skill in the art. PST therefore argued that Olympus had not carried its burden of proof. The absence of this critical element from Olympus s presentation was not disputed. In its final written decision, the Board agreed that [n]either Petitioner nor its declarant proposes a definition for a person of ordinary skill in the art. A12. However, the Board stated, without explanation, that the prior art adequately reflects a level of ordinary skill in the art. A The Board did not identify the level of skill it perceived in the art. -10-

77 Case: Document: 15 Page: 17 Filed: 12/02/2015 Although Mr. Odell s testimony was not connected to any level of skill, the Board adopted PST s definition of ordinary skill to the extent that it is necessary. Id. A Bachelor s Degree in either Physics, Electrical Engineering, or Mechanical Engineering and two to three years experience working in the field of electrosurgery. A person of ordinary skill in the art would be familiar with electrode designs and heating biological tissue through the application of various forms of electromagnetic energy, including RF energy. The Board found that Olympus had demonstrated by a preponderance of the evidence that Claims 17-23, 26, 29, and 30 of the 527 patent would have been obvious over a combination of the 717 and 546 patents, alone or in combination with 779, 047, or WO 882. A28. SUMMARY OF THE ARGUMENT Olympus failed to present evidence sufficient to support a finding of a motivation to combine the teachings of the 717 and 546 patents. Obviousness and the motivation to combine prior art references are evaluated from the perspective of one having ordinary skill in the relevant art. It is thus crucial to establish the level of ordinary skill so that the perspective from which any evidence presented by the parties will be evaluated can be understood. The foundational inquiry into the level of ordinary skill in the art is an important protection against the use of hindsight, and it is necessary to allow for the unbiased consideration of -11-

78 Case: Document: 15 Page: 18 Filed: 12/02/2015 the evidence in the manner required by section 103, Graham v. John Deere Co., 383 U.S. 1, (1966), and the decisions of this Court. Olympus did not present any evidence of the level of ordinary skill in the art. It was therefore not possible for the Board to determine that the challenged claims would have been obvious to a person having ordinary skill in the art, or to find that a person of ordinary skill would have been motivated to combine the references on which Olympus relied. Absent a definition of the level of ordinary skill in the art, Olympus could not provide a relevant frame of reference for the opinions offered by its expert, and it did not do so. The Board recognized the deficiency in Olympus s presentation, but improperly attempted to look past it. Nothing the Board said provides a basis on which the problem presented by Olympus s complete failure to address the initial step in obviousness analysis required by Graham can be ignored or avoided. The 717 patent, Olympus s primary reference, provides an effective solution for uniformly heating tissue without charring. The solution provided by the 717 patent is different from that provided by PST s 527 patent. The method of the 717 patent effectively heats tissue without charring by using the formation of a vapor layer to set an upper bound on power delivery. Olympus did not present any evidence of record explaining what would have motivated one of ordinary skill in the art to modify or attempt to improve the effective method of the 717 patent, -12-

79 Case: Document: 15 Page: 19 Filed: 12/02/2015 let alone to combine it with the power delivery algorithm of the 546 patent, Olympus s secondary reference. Without evidence providing a reason why a person having ordinary skill would have sought to modify or attempt to improve the 717 method, there was no basis on which the Board could find a motivation to modify or combine the 717 patent with another reference. The Board attempted to remedy the deficiencies in Olympus s proof by implying that the combination would have been an improvement, but the Board does not specify the improvement, and incantation about improvement is not an end run around the absence of a reason to combine prior art references. Absent a motivation to combine, the existence of known elements independently present in the art is insufficient to render the claims of a challenged patent obvious. ARGUMENT I. STANDARD OF REVIEW. The Board s legal conclusions and statutory interpretation are reviewed de novo. Belkin Int l, Inc. v. Kappos, 696 F.3d 1379, 1381 (Fed. Cir. 2012). The Board s ultimate determination on the question of obviousness is reviewed de novo, and the underlying factual findings are reviewed for substantial evidence. In re Gartside, 203 F.3d 1305, 1316 (Fed. Cir. 2000). The level of ordinary skill in the pertinent art is a question of fact. Randall Mfg. v. Rea, 733 F.3d 1355,

80 Case: Document: 15 Page: 20 Filed: 12/02/2015 (Fed. Cir. 2013). The existence of a reason for a person of ordinary skill to combine references is a question of fact. In re Constr. Equip. Co., 665 F.3d 1254, 1255 (Fed. Cir. 2011). Substantial evidence is such relevant evidence as a reasonable mind might accept as adequate to support a conclusion. Consol. Edison Co. v. N.L.R.B., 305 U.S. 197, 229 (1938). Actions of the Board that are arbitrary, capricious, an abuse of discretion, unsupported by substantial evidence, or otherwise not in accordance with law will be set aside. In re Sullivan, 362 F.3d 1324, 1326 (Fed. Cir. 2004); 5 U.S.C. 706(2)(A). Obviousness is not established simply by showing that all elements of a challenged patent claim are present in a proposed combination of prior art references the evidence must establish that a person having ordinary skill in the art would have been motivated to combine the references. Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360 (Fed. Cir. 2006) (quoting In re Fulton, 391 F.3d 1195, (Fed. Cir. 2004)) ( Where... all claim limitations are found in a number of prior art references, the factfinder must determine [w]hat the prior art teaches, whether it teaches away from the claimed invention, and whether it motivates a combination of teachings from different references. ). Citing United States v. Adams, 383 U.S. 39, 40 (1966), the Supreme Court has confirmed that a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, -14-

81 Case: Document: 15 Page: 21 Filed: 12/02/2015 independently, known in the prior art. KSR Int l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Further, it can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does. Id. II. OLYMPUS S FAILURE TO IDENTIFY THE LEVEL OF ORDINARY SKILL IN THE ART IS FATAL. Olympus admittedly did not present any evidence of the level of ordinary skill in the art, and its expert did not tie the opinions he expressed to the understanding of a person having ordinary skill in the art. Without evidence of the level of skill in the art, and expert testimony that a person with the requisite level of skill and no more would have been motivated to make the combinations asserted by Olympus, the Board had no basis for a conclusion that the combination of the 717 patent and the 546 patent on which Olympus relied would render the 527 patent obvious. In virtually all aspects of patent law, evaluations must be performed from the perspective of one having ordinary skill in the art. See Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1361 (Fed. Cir. 2008) (claim construction, identification of claim elements, determination of infringement, what a prior art reference discloses or teaches, and whether a patent claim would have been obvious are all evaluated from the perspective of one of ordinary skill in the art); 35 U.S.C. 103(a) (a patent is not available if the invention would have been -15-

82 Case: Document: 15 Page: 22 Filed: 12/02/2015 obvious at the time the invention was made to a person having ordinary skill in the art ). In the determination of whether a patent combining known elements would have been obvious, the focal question is whether the combination would have been obvious to a person having ordinary skill in the art. KSR, 550 U.S. at The Supreme Court explained in Graham that the starting point in obviousness analysis is establishing the level of ordinary skill in the pertinent art. Graham v. John Deere Co., 383 U.S. 1, (1966). Obviousness analysis literally cannot begin without identification of the level of ordinary skill in the art. From there, the scope and content of the prior art must be determined, and any differences between the prior art and the claims at issue must be ascertained. Id. Attention to the level of ordinary skill in the art cannot be avoided under Graham, and evaluation of the prior art from the perspective of a person having ordinary skill in the art serves an additional role in obviousness analysis. In evaluating patentability under section 103, it is critical that the evaluation of the art be from the perspective of one of ordinary skill in the art at the time of the invention. In re Kotzab, 217 F.3d 1365, 1369 (Fed. Cir. 2000). This is necessary to guard[] against entry into the tempting but forbidden zone of hindsight, a zone essential to Olympus s arguments. In re Kahn, 441 F.3d 977, 986 (Fed. Cir. 2006) (quoting In re Dembiczak, 175 F.3d 994, (Fed. Cir. 1999) (abrogated on other grounds) (internal quotations omitted)). -16-

83 Case: Document: 15 Page: 23 Filed: 12/02/2015 The level of ordinary skill in the art is a fact that must be based on evidence. Graham, 383 U.S. at 17; Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.2d 714, 718 (Fed. Cir. 1991) ( The importance of resolving the level of ordinary skill in the art lies in the necessity of maintaining objectivity in the obviousness inquiry.... Hence, the level of ordinary skill in the art is a factual question that must be resolved and considered. ). The evidence of the level of ordinary skill often takes the form of a brief and to the point comment by an expert witness, but regardless of how extensive the presentation on the level of ordinary skill may be, evidence is required. In evaluating the level of skill in the art, it is appropriate to consider factors such as (1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field. Daiichi Sankyo Co., Ltd. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). It is undisputed that Olympus did not identify the level of ordinary skill in the art in any aspect of its presentation. A There was no allegation in the petition of a level of skill, and no evidence of a standard in Mr. Odell s declaration or any of Olympus s other evidence. Id. Olympus s failure is glaring because it would have been a simple matter for Mr. Odell to specify the level of skill in the art, as PST expert Dr. Robert Tucker did. From there, Mr. Odell could have used -17-

84 Case: Document: 15 Page: 24 Filed: 12/02/2015 the typical convention of stating that all of his opinions are presented from the perspective of a person having ordinary skill in the art. Mr. Odell did not take these basic, and commonly taken, steps. The Board acknowledged Olympus s failure of proof. A12 ( Neither Petitioner nor its declarant proposes a definition for a person of ordinary skill in the art. ). Any of the evidence submitted from Olympus or its expert thus has no legal relevance and sheds no light on the question of obviousness because it is not presented through the proper lens of one having ordinary skill in the art. Statements such as this is what a person of ordinary skill would understand the terms of the reviewed claims to mean have no legal relevance without an identification of the level of skill on which the statements are based. No such statement, and nothing in the record, provides substantial evidence sufficient to satisfy the statutory requirement by evaluating obviousness from the perspective of one of ordinary skill in the art at the time of the invention. Although it recognized the deficiency in Olympus s evidence, the Board attempted to solve the problem at institution by asserting that an articulation of the level of skill in the art is not necessary. A858; A Citing Litton Indus. Prod., Inc. v. Solid State Sys. Corp., 755 F.2d 158, (Fed. Cir. 1985), the Board determined that the prior art adequately reflects a level of ordinary skill in the art. A Oddly enough, but not surprising given the actual state of the -18-

85 Case: Document: 15 Page: 25 Filed: 12/02/2015 evidence, the Board did not identify the level of skill it found the prior art to reflect. Moreover, the statement from Litton is a quote from Chore-Time Equip., Inc. v. Cumberland Corp., 713 F.2d 774, 779 n.2 (Fed. Cir. 1983), where the Court stated that only in certain situations, such as one involving relatively simple and understandable technology, would a specific finding on the level of ordinary skill in the art be unnecessary because the prior art itself is representative of the relevant level of ordinary skill. The art in this case, which involves the application of forms of electromagnetic energy through the use of electrosurgical systems and methods to heat biological tissue, is not relatively simple and understandable technology. See A966 ( 34) ( The total electrosurgery literature is extremely large and most skilled in the art subspecialize in their development. ). It is thus critical in this case, as in almost all cases, to any determination of obviousness first to understand the level of ordinary skill in the art. Olympus took the Board s comment at institution and ran with it, arguing that no express statement of or expert testimony regarding the level of ordinary skill is necessary unless the level of ordinary skill in the art is material to the determination of obviousness. A12. It is difficult to understand why Olympus considered this idea to be exculpatory. The level of ordinary skill is material to the determination of obviousness in any but the simplest of cases. PST had no -19-

86 Case: Document: 15 Page: 26 Filed: 12/02/2015 affirmative duty to establish that the level of ordinary skill in the art is material. If Olympus intended to rely on the idea that this is a rare case in which the level of ordinary skill is not material, it was incumbent on Olympus to do something more than offer an inapplicable platitude. That the prior art [allegedly] adequately reflects a level of ordinary skill in the art is not a solution for Olympus s failure of proof. There was no evidence presented from the perspective of one of ordinary skill, and no way for Olympus to meet its burden of proving that it would have been obvious to a person having ordinary skill to combine the asserted prior art references. PST identified the level of skill in the art at the time of the invention from which its evidence was presented and should have been evaluated. A ( 13-17). Although it suggested that articulation of the level of ordinary skill in the art was not necessary, the Board accepted PST s proffered level of ordinary skill: A Bachelor s Degree in either Physics, Electrical Engineering, or Mechanical Engineering and two to three years experience working in the field of electrosurgery. A person of ordinary skill in the art would be familiar with electrode designs and heating biological tissue through the application of various forms of electromagnetic energy, including RF energy. A12. Adopting the level of skill advocated by PST did not make Olympus s problem go away. The problem remains that Olympus s evidence was not presented from the level of skill described by PST. Olympus s expert stated that -20-

87 Case: Document: 15 Page: 27 Filed: 12/02/2015 [t]he opinions set forth in my declaration are based on my personal knowledge gained from my education, professional experience, and on the review of the documents and information described in this declaration. A782 ( 16). There is no way to understand this comment as reflecting the adoption of the level of skill advocated by PST, and no way the Board could interpret Mr. Odell s testimony and the balance of Olympus s evidence using PST s standard, or assuming without evidence that the evidence presented by Olympus was based on the level of ordinary skill advocated by PST. Mr. Odell did not give an opinion based on the standard advocated by PST. The opinions offered by Mr. Odell, who appears to be a person having extraordinary skill, are not sufficient to satisfy the obviousness standard set forth in section 103. A The reference point specified in section 103 is a person having ordinary skill in the art, and there is a risk that patents will unjustifiably be held obvious if too high a level of skill is used in obviousness analysis. That which is obvious to the extraordinarily skilled artisan is not necessarily within the ken of the person having ordinary skill. Any suggestion that because an expert meets or exceeds the qualifications of a proffered level of skill in the art, the expert then may testify as to what a person of ordinary skill in the art would know or understand, is not necessarily true. The opinions relevant under section 103 must be from the perspective of one of ordinary skill. It cannot be assumed that -21-

88 Case: Document: 15 Page: 28 Filed: 12/02/2015 because an expert has an extraordinary level of skill, the opinions he or she presents are made from the perspective of a person having an ordinary level of skill. This is a simple matter of proof, of which Olympus offered none. The requirement is not that an expert must be a person of ordinary skill at the time of the invention. Zoltek Corp. v. United States, 95 Fed. Cl. 681, 698 (Fed. Cl. 2010). Rather, the expert must opine as to what a person of ordinary skill in the art would know and do at the relevant time. Id. Experts of extraordinary skill are frequently used in patent cases, and they are regularly called upon to explain how they are able to testify to opinions based on a level of skill that is sometimes far less than theirs. Indeed, PST s expert is extraordinarily skilled in the relevant art, but, as, among other things, a professor, he was able to present opinions that were specifically given from the perspective of one of ordinary skill. A ( 15-16). Without a basis to support Olympus s expert opinions about what one of ordinary, but unidentified, skill in the art might have understood or been motivated to do, Olympus did not provide the Board with sufficient evidence to support a finding of a motivation to combine. At the hearing, the Board suggested that administrative patent judges themselves are persons having ordinary skill in the pertinent art. A1568 ( JUDGE PRATS: Do you think there is a distinction between these proceedings before the Board and infringement cases in District -22-

89 Case: Document: 15 Page: 29 Filed: 12/02/2015 Court as to the requirement for an expert witness? That is, here, you know, potentially in District Court you are talking about a lay jury; whereas here by definition the Board has a certain level of technical expertise. ). However, the technical background or expertise of an administrative patent judge (or circuit judge or district judge) is no substitute for the petitioner s or plaintiff s failure to present evidence of the level of ordinary skill. The role of the Board, and that of a court or jury, is to evaluate evidence, not to create it. As petitioner, Olympus had the burden of proof. It failed to meet its burden because it did not present any relevant evidence. III. INDEPENDENT OF ITS FAILURE TO IDENTIFY THE LEVEL OF ORDINARY SKILL, OLYMPUS FAILED TO PROVE A MOTIVATION TO COMBINE THE 717 PATENT AND THE 546 PATENT. A. The 717 Patent Teaches A Different, But Effective, Method For The Uniform Heating Of Tissue. Both the PST 527 patent and the prior art 717 patent teach effective, although different, methods for the uniform heating of tissue to be treated. The 527 patent describes a method by which tissue between the jaws of forceps can be desiccated through the delivery of power a forceps-based heating and cutting application. A114 (10:4-15). The 527 patent solves the problem of heating and drying tissue without charring it by increasing power at a predetermined rate from an initial level, the initial level and predetermined rate avoiding formation of a -23-

90 Case: Document: 15 Page: 30 Filed: 12/02/2015 vapor layer while permitting an impedance increase occur as a result of complete tissue dessication. Id. at 10: The invention of the 527 patent thus operates in a manner that avoids the formation of a vapor layer. The 717 patent describes a system to ablate tissue with energy emanating from one or more needle electrodes. A545 (1:12-25; 1:5-2:5); A The 717 patent discusses the common hypothesis that observed impedance increases during the heating of tissue in a desiccation procedure are attributable to the formation of a vapor layer. A546 (3:9-30); A959 ( 22). The inventors of the 717 patent sought to make use of this phenomenon in creating their solution to the problem of effectively heating tissue without charring. A536 at Abstract ( Methods for heating tissue by delivering radio frequency energy through tissue electrodes comprise controlling energy delivery so that an abrupt increase in impedance between the electrodes and the tissue is observed, typically in the form of an abrupt decrease in power delivered to the electrodes. ). The solution offered heats the tissue up to a point of high impedance, and then reduces the power. See A546 (3:31-51); A550 (11:53-61); A ( 23). The invention of the 717 patent is specifically predicated on the principle that impedance levels indicative of the formation of a vapor layer are to be used as upper bounds on the power delivered to the electrosurgical device. A ( 23). The 717 patent discloses a three-phase process for heating and drying tissue -24-

91 Case: Document: 15 Page: 31 Filed: 12/02/2015 where (1) an elevated power level is first supplied at which an abrupt increase in electrode-tissue interface impedance is observed, (2) power is sharply reduced to permit a decrease in impedance, and (3) the electrode is reenergized at a level below said elevated level. A546 (3:31-51); A550 (11:53-61). The 717 patent stresses the importance of the first phase in relation to the other phases for the complete operation of the claimed tissue heating method: The present invention still further depends, in least in part, on the observation that the abrupt rise in the electrode-tissue interface impedance diminishes very rapidly when the power delivery is stopped, typically disappearing within several seconds. Delivery of the radio frequency power can be resumed after the impedance has diminished, typically to impedance levels substantially equal to those observed prior to the abrupt increase. A545 (2:61-67) A546 (3:1). More specifically, the method first increases electrode-tissue interface impedance (phase one), then abruptly decreases the power delivery rate (phase two). A546 (3:31-51); A550 (11:53-61). The power drop off upon which the invention relies occurs after the initial abrupt increase, and typically occurs within fifteen seconds. A546 (3:39-44). The power level at which the power drop occurs is then considered a maximum power level that should not be exceeded during the reenergizing of the electrode (phase three). A546 (3:37-39). The 717 patent does not rely on the avoidance of a vapor layer but operates notwithstanding the formation a vapor layer. A ( 23); A ( 28-29). -25-

92 Case: Document: 15 Page: 32 Filed: 12/02/2015 B. Olympus Did Not Prove A Reason Or Motivation To Combine Its Prior Art References. Whether a claimed invention would have been obvious is a question of law, based on factual determinations regarding... the motivations to modify or combine prior art.... Belden Inc. v. Berk-Tek LLC, 2015 WL , at *5 (Fed. Cir. Nov. 5, 2015) (citing Randall, 733 F.3d at 1362). Post-KSR, some kind of motivation must be shown from some source, so that the jury can understand why a person of ordinary skill would have thought of either combining two or more references or modifying one to achieve the patented method. Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 (Fed. Cir. 2008) (citation omitted)). Putting aside its failure to identify the level of ordinary skill in the art, Olympus failed to prove a reason or motivation to modify the 717 patent, or to combine it with the 546 patent. When an invention is effective in its method of operation, a person having ordinary skill in the art would have no reason merely to seek to create a different device to perform that operation by combining it with features of another independently effective device. Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1369 (Fed. Cir. 2012) ( Because each device independently operates effectively, a person having ordinary skill in the art, who was merely seeking to create a better device to drain fluids from a wound, would have no reason to combine the features of both devices into a single device. ). This is also -26-

93 Case: Document: 15 Page: 33 Filed: 12/02/2015 true if there are no known deficiencies recognized in the primary prior art reference that would motivate one of ordinary skill to attempt to improve it. Wonderland NurseryGoods Co., Ltd. v. Thorley Industries, LLC, 988 F. Supp. 2d 479, 499 (W.D. Pa. 2013) (denying summary judgment of invalidity for obviousness because the accused infringer failed to show that one of ordinary skill would recognize deficiencies in the primary prior art reference that would lead one to attempt an improvement by combining items from the second prior art reference); Koninklijke Philips Elecs. N.V. v. Cinram Int l Inc., 2010 WL , at *4 (D. Mass. Dec. 10, 2010) (denying summary judgment of obviousness because of questions whether a person of ordinary skill in the art would have had a reason to modify the prior art reference, which operated in a diametrically opposite way from the claimed invention, to achieve the teachings of the claimed invention). Here, it is agreed that the invention of the 717 patent is effective in its chosen method of operation according to its disclosure. A546 (3:27-30); A ( 23); A820. There is no motivation for one of ordinary skill to look to another reference because the method described in the 717 patent provides an effective means for uniformly heating tissue to be treated. A ( 29-30). Olympus offered no reason why one of ordinary skill would seek to modify the 717 patent in the way it asserted to justify its obviousness arguments. Olympus pointed to no deficiencies in the 717 patent that would motivate one of ordinary skill to attempt -27-

94 Case: Document: 15 Page: 34 Filed: 12/02/2015 to improve it. To prove obviousness, Olympus had to make explicit the reason why one of ordinary skill in the art would seek to modify the invention of the 717 patent, but it did not. Moreover, the simple ability to modify the invention of the 717 patent without any reason for doing so, is also insufficient to establish obviousness. See KSR, 550 U.S. at 418 (explaining that, although courts need not seek out precise teachings on each claim limitation, courts must still determine whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue ); see also Malico, Inc. v. Cooler Master USA Inc., 594 F. App x 621, 628 (Fed. Cir. 2014) ( Even under a flexible and expansive approach to the obviousness inquiry, the raw ability to perform the rotation action [of the claimed invention] without any reason to do so does not establish obviousness. ); see also Suprema, Inc. v. Int l Trade Commn., 742 F.3d 1350, 1368 (Fed. Cir. 2013) reh g en banc granted, reversed on other grounds, 2015 WL (Fed. Cir. Sept. 14, 2015) (finding that because a person of skill in the art could very well use a method of another prior art reference is insufficient reason for the skilled artisan to specifically seek out that reference for a combination). There is also no evidence of record suggesting that one of ordinary skill would have had reason to combine the specific power delivery algorithm of the 546 patent with the method taught by the 717 patent. A ( 31). Olympus -28-

95 Case: Document: 15 Page: 35 Filed: 12/02/2015 did not, of course, offer any evidence of the level of ordinary skill, and it did not prove the existence of a reason to combine the 717 and 546 patents that would have been perceived by a person with any level of skill. Mr. Odell did not offer a specific opinion on a motivation to combine the 717 and 546 patents. Instead, Olympus resorted to the techniques familiar when hindsight is the name of the game. Mr. Odell did not offer specific comments about the reason for each of the combinations on which Olympus relied in its petition regarding Claim 17. The statement quoted by the Board was made with respect to the combination of the Erbe reference and the 546 patent a ground on which institution was denied. A856; A962 ( 27). For the other references, Mr. Odell said a combination would occur for the same reasons. Mr. Odell s one size fits all justification for multiple combinations does not fit the 717 patent. See A ( 28). Even assuming that justification applies as a motivation to combine the 717 and 546 references, the Board accepted that sole argument for combining the references: that they deal with the same problem (how to increase power at a predetermined rate) and are in the same field of technology (electrosurgery). That is not enough to establish obviousness. If it were, the teaching of the Supreme Court and this Court to the effect that the mere existence of all elements of a claim in a combination of prior art is not sufficient to establish obviousness -29-

96 Case: Document: 15 Page: 36 Filed: 12/02/2015 would be hollow indeed. That prior art references deal with the same problem and are in the same field is barely enough to constitute them relevant prior art. These basic concepts do not provide an answer to the question of why one of ordinary skill would be motivated to combine these particular references. See A78; A81; A15. Olympus also mischaracterized the problem addressed by the 717 patent as one of increasing the power at a predetermined rate. A ( 26-28). The problem identified in the 717 patent is how to heat tissue uniformly and effectively without charring. Id. The 717 patent solves this problem by using the formation of a vapor layer to set an upper bound on power delivery. It is certainly odd that Olympus would characterize the problem addressed by the 717 patent as increasing power at a predetermined rate, when the 717 patent offers no solution to increasing power at a predetermined rate. A857 (finding that the 717 patent does not anticipate the 527 patent because it does not disclose an algorithm including increasing power at a predetermined rate ). [R]ejections on obviousness cannot be sustained by mere conclusory statements; instead there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness. KSR 550 U.S. at 418 (quoting In re Kahn, 441 F.3d at 988). [T]he question is whether an inventor would look to this particular art to solve the particular problem at hand. Circuit -30-

97 Case: Document: 15 Page: 37 Filed: 12/02/2015 Check Inc. v. QXQ Inc., 795 F.3d 1331, 1335 (Fed. Cir. 2015); see also Oatey Co. v. IPS Corp., 665 F. Supp. 2d 830, 849 (N.D. Ohio 2009) ( The nature of the problem defines the scope of the prior art a person of reasonable skill in the art would consult in attempting to solve it. ). Any thought that the references could be combined, say because they are in the same field of art, is not sufficient evidence of a motivation to do so. The 717 patent solves the problem of uniformly heating tissue to be treated by heating the tissue to a high impedance level, what a skilled artisan understands as forming a vapor layer, and then reduces the power being transmitted to the tissue to a point at which the impedance values are lower. A ( 28); A965 ( 32) ( The 717 forms a vapor layer and then decreases the power ). Olympus and PST both agree that this method is effective. A546 (3:27-30); A ( 23); A820. There has been no reason offered for why one of ordinary skill would seek to modify this effective method of solving the stated problem of uniformly heating tissue to be treated, let alone look to the 546 patent. C. There Is No Improvement Upon Which To Base A Motivation To Combine The 717 And 546 Patents. Quoting KSR, the Board stated that if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. A18. Without pointing to a specific -31-

98 Case: Document: 15 Page: 38 Filed: 12/02/2015 improvement, the Board found the improvement idea to be sufficient reason to combine the teachings of the 717 and 546 patents. Id. A factfinder should be aware, of course, of the distortion caused by hindsight bias and must be cautious of arguments reliant upon ex post reasoning. KSR, 550 U.S. at 421; see Graham, 383 U.S. at 36 (warning against a temptation to read into the prior art the teachings of the invention in issue and instructing courts to guard against slipping into use of hindsight (quoting Monroe Auto Equip. Co. v. Heckethorn Mfg. & Supply Co., 332 F.2d 406, 412 (6th Cir. 1964))). Hindsight reasoning that us[es] the invention as a roadmap to find its prior art components, would discount the value of combining various existing features or principles in a new way to achieve a new result often the very definition of the invention. Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1275 (Fed. Cir. 2004); Ecolochem, Inc. v. S. California Edison Co., 227 F.3d 1361, 1371 (Fed. Cir. 2000) (stating we cannot use hindsight reconstruction to pick and choose among isolated disclosures in the prior art to deprecate the claimed invention ). There has been no evidence presented on what would motivate one of ordinary skill in the art to improve the 717 patent in any way, or even to abandon or modify its effective method. The Board cannot create evidence to come to a conclusion that there is an improvement achieved by the combination. There is no improvement presented other than to create the invention of the 527 patent in -32-

99 Case: Document: 15 Page: 39 Filed: 12/02/2015 hindsight, as Olympus and the Board did in this case. IV. CONCLUSION. For the foregoing reasons, the Court should reverse the Board s final written decision finding that Claims 17-23, 26, 29, and 30 of the 527 patent are unpatentable. Date: December 2, 2015 Respectfully submitted, /s/daniel J. Weinberg Daniel J. Weinberg -33-

100 Case: Document: 15 Page: 40 Filed: 12/02/2015 CERTIFICATE OF SERVICE It is certified that copies of the foregoing has been served via electronic mail transmission addressed to the persons at the address below: Deborah E. Fishman Katie J.L. Scott KAYE SCHOLER LLP Date: December 2, 2015 /s/daniel J. Weinberg Daniel J. Weinberg -34-

101 Case: Document: 15 Page: 41 Filed: 12/02/2015 CERTIFICATE OF COMPLIANCE Pursuant to Federal Rule of Appellate Procedure 32(a)(7)(C), I certify that the Appellant s Opening Brief is proportionally spaced, in a typeface of 14 points or more and contains 7,970 words, exclusive of those materials not required to be counted under Rule 32(a)(7)(B)(iii). /s/daniel J. Weinberg Daniel J. Weinberg -35-

102 Case: Document: 15 Page: 42 Filed: 12/02/2015 ADDENDUM Final Written Decision dated June 8, 2015 U.S. Patent 6,682,

103 Case: Document: 15 Page: 43 Filed: 12/02/2015 Paper 51 Tel: Entered: June 8, 2015 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD OLYMPUS AMERICA INC. and OLYMPUS MEDICAL SYSTEMS CORPORATION, Petitioner, v. PERFECT SURGICAL TECHNIQUES, INC., Patent Owner. Case IPR Patent 6,682,527 B2 Before FRANCISCO C. PRATS, BENJAMIN D. M. WOOD, and JAMES B. ARPIN, Administrative Patent Judges. ARPIN, Administrative Patent Judge. FINAL WRITTEN DECISION 35 U.S.C. 318(a) and 37 C.F.R

104 IPR Patent 6,682,527 B2 I. INTRODUCTION Olympus America Inc. and Olympus Medical Systems Corporation (collectively, Petitioner ) filed a corrected Petition requesting inter partes review of claims of Patent No. US 6,682,527 B2 (Ex. 1011, the 527 patent ) pursuant to 35 U.S.C Paper 5 ( Pet. ), 1 2. On June 16, 2014, we issued a Decision on Institution (Paper 15, Dec. on Inst. ), instituting inter partes review of claims 17 23, 26, 29, and 30 of the 527 patent. Dec. on Inst. 33. Subsequent to institution, Patent Owner filed a Patent Owner Response (Paper 28, PO Resp. ), and Petitioner filed a Reply (Paper 35, Pet. Reply ) thereto. The parties requested an oral hearing (Papers 38 and 39) and appeared before us on February 23, The record includes a transcript of the hearing. Paper 50 ( Tr. ). Case: Document: 15 Page: 44 Filed: 12/02/2015 We have jurisdiction under 35 U.S.C. 6(c). This Final Written Decision, issued pursuant to 35 U.S.C. 318(a) and 37 C.F.R , addresses issues and evidence raised during the inter partes review. For the reasons that follow, we determine that Petitioner has demonstrated by a preponderance of the evidence that claims 17 23, 26, 29, and 30 of the 527 patent are unpatentable. A. The 527 Patent The 527 patent discloses a radio frequency generator for use in electrosurgery. Ex. 1101, col. 5, ll Bipolar systems use two or more electrodes of opposite polarity that are in direct or indirect contact with the treated tissue. See id. at col. 1, ll ; col. 2, ll ; col. 7, ll Petitioner s declarant presented a block diagram of a bipolar system, reproduced below: 2

105 IPR Patent 6,682,527 B2 Case: Document: 15 Page: 45 Filed: 12/02/2015 Pet. 7 (citing Ex ). As shown in the block diagram above, in such bipolar systems, current flows from the radio frequency ( RF ) generator to the electrodes and through the treated tissue. Id. Among other things, the electrosurgical effect may be a function of the profile of the power output of the generator (e.g., the level of power, the variation of power over time, the frequency of the power, etc.). See Ex. 1101, col. 3, ll Regardless of the type of surgical instruments carrying the electrodes, the principles and tissue effects of electrosurgery are the same. See id. at col. 1, ll ; col. 5, ll ; see also Pet. 7 8 (citing Ex ). According to the Specification of the 527 patent, under certain circumstances, charring of the treated tissue (Ex. 1101, col. 1, ll ), and premature increase in impedance between the electrode and the tissue, may prevent complete, thorough, and uniform heating of the tissue under treatment (see id. at col. 2, ll ). The Specification of the 527 patent suggests that the cause of this premature increase in impedance is due to the formation of a vapor layer between the electrodes and the treated tissue. Id. at col. 2, l. 49 col. 3, l. 9. The 527 patent teaches that the problem of prematurely increased impedance may be avoided by selecting and applying an initial level of power to the electrodes and then increasing power from that initial level at a predetermined 3

106 IPR Patent 6,682,527 B2 Case: Document: 15 Page: 46 Filed: 12/02/2015 rate. Id. at col. 3, ll The initial level and predetermined rate are selected to avoid creating a vapor layer and to permit an impedance increase to occur as a result of complete tissue desiccation. Id. at col. 3, ll ; see also id. at col. 7, ll (describing the flow chart of Fig. 3). As to the predetermined rate, the 527 patent teaches that the rate may be preselected by a user depending on the electrode sizes, the target tissue type, the degree of tissue perfusion, and the initial power level, and that such rate may be linear and increase at a rate in the range from 1 W/sec to 100 W/sec, preferably from 1W/sec to 10/W sec. Id. at col. 3, ll ; see id. at col. 4, ll Figure 3 of the 527 patent is reproduced below with our annotations. 4

107 IPR Patent 6,682,527 B2 Case: Document: 15 Page: 47 Filed: 12/02/2015 The 527 patent explains: As seen in FIG. 3, voltage, current, and power levels are determined and the power level is tested at 20 millisecond intervals. If the power level read is more than 5 watts greater than a power set value, the system automatically terminates power delivery and enters the fault state, where it remains until the system is re-powered. At this same interval, tissue impedance is measured and tested by comparing the measured impedance to an impedance limit, the impedance limit typically being in the range from 50 ohms to 1000 ohms. If the measured impedance exceeds the impedance limit, the power delivery is automatically terminated and the system returns to ready state. Incremental and total energy levels are also calculated during this 20 millisecond interval. If the impedance limit is not exceeded, the power set level is increased at a predetermined rate from the initial level, wherein the initial level and predetermined rate are selected to avoid creating a vapor layer and to permit an impedance increase to occur as a result of complete tissue desiccation. Typically, the predetermined rate is from 1 W/sec to 100 W/sec, and the electrode members are energized at this increased power set value at 100 millisecond intervals. Id. at col. 7, ll (emphasis added). 1 B. Illustrative Claim Claim 17 is independent and is illustrative. The remaining challenged claims 18 23, 26, 29, and 30 depend from claim 17. Claim 17 is reproduced below with disputed limitations emphasized. 17. A radio frequency generator comprising: a radio frequency power source having a controlled voltage output and a bipolar connection for bipolar forceps having first and second jaws with first and second electrode members; and 1 Petitioner alleges that Figure 3 contains certain errors. Pet. 23 n.7. The alleged errors are not relevant to our analysis in this Decision. 5

108 IPR Patent 6,682,527 B2 means for automatically increasing power delivered to the bipolar forceps; wherein the increasing means increases the power at a predetermined rate from an initial level, the initial level and predetermined rate avoiding formation of a vapor layer while permitting an impedance increase to occur as a result of complete tissue dessication. 2 Ex. 1011, col. 10, ll (emphasis added). C. References, Declarations, and Depositions Petitioner and Patent Owner primarily rely upon the following references, declarations, and depositions: Exhibits Nos. Case: Document: 15 Page: 48 Filed: 12/02/2015 References, Declarations, and Depositions 1104 Patent No. US 6,139,546 ( US 546 ) 1105 Patent No. US 5,954,717 ( US 717 ) 1108 Patent No. US 6,398,779 B1 ( US 779 ) 1110 Patent No. US 6,936,047 B2 ( US 047 ) 1111 International Publication WO 97/40882 A2 ( WO 882 ) 1113 Declaration of Roger Odell 2002 Declaration of Dr. Robert Tucker 2005 Deposition Transcript of Dr. Robert Tucker D. Reviewed Grounds of Unpatentability We instituted inter partes review on the following grounds of unpatentability (Dec. on Inst. 33): Ground References Reviewed Claim(s) 103(a) US 717 and US , 18, 21, 22, 29, and 30 2 We understand dessication to be a misspelling or alternative spelling of the word desiccation. 6

109 IPR Patent 6,682,527 B2 Case: Document: 15 Page: 49 Filed: 12/02/2015 Ground References Reviewed Claim(s) 103(a) US 717, US 546, and US (a) US 717, US 546, and US (a) US 717, US 546, and WO and II. ANALYSIS A. Claim Construction In an inter partes review, claim terms in an unexpired patent are construed according to their broadest reasonable interpretation in light of the specification of the patent in which they appear. 37 C.F.R (b); In re Cuozzo Speed Techs., LLC, 778 F.3d 1271, (Fed. Cir. 2015) ( Congress implicitly adopted the broadest reasonable interpretation standard in enacting the AIA, and the standard was properly adopted by PTO regulation. ); Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,766 (Aug. 14, 2012). Moreover, claim terms are given their ordinary and customary meaning, as would be understood by one of ordinary skill in the art in the context of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). A patentee may act as his or her own lexicographer by providing a special definition for a claim term in the specification with reasonable clarity, deliberateness, and precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). Generally, in the absence of such a special definition or other considerations, limitations are not to be read into the claims from the specification. In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). 7

110 IPR Patent 6,682,527 B2 Case: Document: 15 Page: 50 Filed: 12/02/2015 In the Decision on Institution, we provided constructions for various terms of the challenged claims. Dec. on Inst Patent Owner does not challenge our constructions of these terms. See Tr. 95:12 97:5. Claim 17, however, recites means for automatically increasing power delivered to the bipolar forceps; wherein the increasing means increases the power at a predetermined rate from an initial level, the initial level and predetermined rate avoiding formation of a vapor layer while permitting an impedance increase to occur as a result of complete tissue dessication. Ex. 1011, col. 10, ll Petitioner only challenges our construction of this means-plus-function term. Pet. Reply 1 3. In the Petition, Petitioner proposed a construction for this means-plusfunction limitation. Pet In particular, Petitioner argued that we should apply a two-step analysis to this term: first, identify the particular function performed by the means, and, second, review the specification to identify the structure performing that function. Id. at 19; see Med. Instrumentation & Diagnostics Corp. v. Elekta AB, 344 F.3d 1205, 1210 (Fed. Cir. 2003). We agreed. Regarding the first step, we determined that, in the function of automatically increasing power delivered to the bipolar forceps, the reference to bipolar forceps is merely a statement of intended use of the claimed generator, and this function is read as increasing power delivered to the bipolar connection, not to the bipolar forceps. Dec. on Inst. 11; see Pet. 20. Further, we determined that the means for automatically increasing power must (1) have an initial level; (2) must increase power at a predetermined rate from that initial level; and (3) the initial level and predetermined rate must be chosen to avoid formation of a vapor layer, e.g., avoid exceeding the impedance limit (Ex. 1101, col. 7, ll ), while permitting an impedance increase to occur as a result of complete tissue dessication. Dec. on Inst. 11; see Pet

111 IPR Patent 6,682,527 B2 Regarding the second step, the Specification of the 527 patent discloses the means for automatically increasing power is a programmable digital controller, a control program embodied in a tangible medium, or other means for automatically increasing power delivered by the generator. In particular, the digital controller or other increasing means can be programmed to implement any of the methods described above independent of operator intervention. Ex. 1101, col. 4, ll ; see Pet. 22. Thus, Petitioner concludes that the corresponding structure must include the algorithm used to carry out the claimed function. Id. at (citing Aristocrat Techs. Austl. Pty Ltd. v. Int l Game Tech., 521 F.3d 1328, 1333 (Fed. Cir. 2008)). Again, we agreed. Referring to the discussion of Figure 3, as annotated above (see Ex. 1101, col. 7, ll. 1 20), we determined that the algorithm is depicted in Figure 3 (see Pet. 23). Dec. on Inst. 12. In particular, we determined that the algorithm Id. at 12. Case: Document: 15 Page: 51 Filed: 12/02/2015 carries out four functions: (1) it determines (by measuring or calculating) the voltage, current, power and impedance levels (Ex at Col. 7:1 3; Col. 7:6 7), (2) it shuts off power when the determined power level exceeds a predetermined level (Ex at Col. 7:3 5), (3) it shuts off power when the calculated impedance level exceeds a predetermined impedance level (Ex at Col. 7:9 12) and (4) it increases power from an initial level at a predetermined rate with the predetermined rate and initial level being selected to avoid the formation of a vapor layer (Ex at Col. 7:13 17). Nevertheless, Petitioner argues that we erred in construing the means-plusfunction limitation for two reasons. Pet. Reply 1 3; see PO Resp First, Petitioner argues that we improperly broadened the claimed function by ignoring the requirement to avoid formation of a vapor layer of the wherein clause of claim 1. Id. at 2. We disagree and note that we expressly stated that this 9

112 IPR Patent 6,682,527 B2 Case: Document: 15 Page: 52 Filed: 12/02/2015 requirement is both part of the description of the function of the limitation and a feature of the algorithm included in the corresponding structure described in the Specification. Dec. on Inst Second, Petitioner argues that [our] conclusion that the corresponding structure is an algorithm for increasing power is also incorrect. Pet. Reply 2 (citing Dec. on Inst. 13, 20). Petitioner argues that, [a]s an initial matter, an algorithm per se is not structure. Id. As noted above, however, we determined that means for automatically increasing power to the bipolar forceps may be a programmable digital controller. Ex. 1101, col. 4, ll ; see Pet The corresponding structure that performs the claimed function may include any computer or microprocessor, computer program, and/or algorithm. WMS Gaming, Inc. v. Int l Game Tech., 184 F.3d 1339, 1349 (Fed. Cir. 1999) ( In a means-plus-function claim in which the disclosed structure is a computer, or microprocessor, programmed to carry out an algorithm, the disclosed structure is not the general purpose computer, but rather the special purpose computer programmed to perform the disclosed algorithm. (citation omitted)). In Eon Corp. IP Holdings LLC v. AT&T Mobility LLC, the Federal Circuit confirmed that, on this point, WMS Gaming remains correctly decided and that the disclosure of a general purpose computer or a microprocessor as corresponding structure for a software function does nothing to limit the scope of the claim and avoid pure functional claiming. [Aristocrat, 521 F.3d at 1336.] As such, when a patentee invokes means-plus-function claiming to recite a software function, it accedes to the reciprocal obligation of disclosing a sufficient algorithm as corresponding structure. Eon Corp. IP Holdings, LLC v. AT&T Mobility LLC, No , , 2015 WL at *5 (Fed. Cir. May 6, 2015). Here, the Specification of the 527 patent has done so. Thus, we do not determine that the algorithm alone is the structure; instead, we conclude that the digital controller programmed to perform 10

113 IPR Patent 6,682,527 B2 the disclosed algorithm is the corresponding structure. Dec. on Inst. 12 ( Thus, Petitioner concludes that the corresponding structure must include the algorithm used to carry out the claimed function. We agree. (emphasis added; citations omitted)). Case: Document: 15 Page: 53 Filed: 12/02/2015 Only terms which are in controversy need to be construed, and then only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Because neither party challenges our constructions for the other claim terms construed in the Decision on Institution, and because we discern no reason based on the complete record now before us to change these constructions, to the extent necessary, we adopt those constructions for the Final Written Decision. No additional claim terms need to be construed. 1. Overview B. Grounds of Unpatentability We instituted inter partes review of claims 17 23, 26, 29, and 30 of the 527 patent on Petitioner s asserted grounds that each of these claims is rendered obvious over US 717 and US 546, alone or in combination with US 779, US 047, or WO 882. Pet. 4 6, A patent claim is obvious under 35 U.S.C. 103(a) if the differences between the claimed subject matter and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. KSR Int l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations, including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of skill in the art; and (4) objective evidence of nonobviousness, i.e., secondary 11

114 IPR Patent 6,682,527 B2 Case: Document: 15 Page: 54 Filed: 12/02/2015 considerations. 3 Graham v. John Deere Co., 383 U.S. 1, (1966). On this record, we are persuaded that Petitioner has demonstrated by a preponderance of the evidence that each of the claims 17 23, 26, 29, and 30 of the 527 patent is rendered obvious over US 717 and US 546, alone or in combination with US 779, US 047, or WO Person of Ordinary Skill in the Art Neither Petitioner nor its declarant proposes a definition for a person of ordinary skill in the art. PO Resp. 13; see Pet. Reply 3 4. Further, Petitioner argues that no express statement of or expert testimony regarding the level of ordinary skill is necessary unless the level of ordinary skill in the art is material to the determination of obviousness. Pet. Reply 3. Nevertheless, Petitioner s declarant provides testimony as to what a person of ordinary skill would understand the terms of the reviewed claims to mean. See, e.g., Ex ; see also PO Resp. 13 ( Mr. Odell states, at different times, that one of ordinary of skill would have considered certain combinations of references. ). Patent Owner contends that a person of ordinary skill in the art possesses a Bachelor s Degree in either Physics, Electrical Engineering, or Mechanical Engineering and two to three years experience working in the field of electrosurgery. A person of ordinary skill in the art would be familiar with electrode designs and heating biological tissue through the application of various forms of electromagnetic energy, including RF energy. PO Resp (citing Ex ). For purposes of the Decision on Institution, we determined that the prior art adequately reflects a level of ordinary 3 Patent Owner does not contend in the Patent Owner Response that secondary considerations are present, which would render the reviewed claims patentable over US 717 and US 546, alone or in combination with US 779, US 047, or WO

115 IPR Patent 6,682,527 B2 Case: Document: 15 Page: 55 Filed: 12/02/2015 skill in the art. Dec. on Inst. 21 (citing Litton Indust. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, (Fed. Cir. 1985)). Although Patent Owner contends that Petitioner s arguments are deficient because Petitioner fails to specify the level of ordinary skill in the art (PO Resp ), Patent Owner s declarant, Dr. Tucker, suggests that the level of ordinary skill in the art is not relevant to the determination whether the whether the teachings of US 717 and US 546 would have been combined. 4 E.g., Ex. 2005, 112:20 22 ( Q. So you would have the same opinion regardless of what the level of skill in the art was? A. Correct. ); see Pet. Reply 4 n.3. Petitioner s declarant, Mr. Odell, meets or exceeds the qualifications set forth in Patent Owner s definition of a person or ordinary skill in the art. See Ex , 7; Ex. 2005, 205:22 206:9; Pet. Reply 14 15; but see Tr. 86:11 25 (Patent Owner s counsel argues that Mr. Odell is not a person of more than ordinary skill in the art.). Further, Mr. Odell, as a person of equal or greater skill in the art, may testify as to what a person of ordinary skill in the art would know or understand. See Ex. 2005, 107:21 108:10. Therefore, to the extent that it is necessary, for purposes of this Decision, we adopt Patent Owner s definition of a person of ordinary skill in the art. 3. Obviousness over US 717 and US 546, Alone or in Combination with US 779, US 047, or WO 882 a. Claim 17 Petitioner argues that claim 17 is rendered obvious over US 717 and US 546. Pet According to Petitioner, US 717 recognizes substantially the same problem that is recognized in the 527 patent the possible formation of 4 Dr. Tucker does not address the level of ordinary skill in the art with respect to the combination of teachings of US 717 and US 546, with those of the other applied references. See Ex

116 IPR Patent 6,682,527 B2 Case: Document: 15 Page: 56 Filed: 12/02/2015 a vapor layer between the electrodes and tissue that would cause a premature spike in impedance and would prevent sufficient current from reaching the tissue to obtain the desired therapeutic effect. Id. at 39 (citing Ex. 1105, col. 3, ll. 9 30; col.7, ll ). Petitioner contends that US 717 discloses a radio frequency generator used in an ablation procedure. Id.; Pet. Reply 12. Petitioner further contends that the generator includes a bipolar output connection which is capable of being connected to bipolar forceps. Pet. 39 (citing Ex. 1105, col. 6, ll ). According to Petitioner, US 717 discloses a three-phase process for avoiding the premature creation of a vapor layer. Id. (citing Ex. 1105, col. 3, ll ). Petitioner argues that, in phases 2 and 3, the operation of the generator corresponds to the recited means for automatically increasing power of claim 17. Id. (citing Ex. 1105, col.7, ll ; col. 7, l. 52 col. 8, l. 2). Power is increased at a predetermined rate (id. at 40 (citing Ex. 1105, col. 5, ll. 9 30; col. 8, ll )), and this information is used to determine a maximum power level for phase 3 (id. (citing Ex. 1105, col.8, ll )). However, Petitioner acknowledges that US 717 does not expressly describe the particular algorithm used to increase power from an initial level to the new set point level. Id. Referring to Figure 11 of US 546, Petitioner argues that US 546 teaches a microprocessor-controlled, radio frequency generator which increases power over time at a predetermined rate in accordance with a Power Control Parameter Schedule. Id. at 34. Moreover, referring to Figures 12 and 15A of US 546, Petitioner argues that US 546 teaches algorithms used to increase the power. Id. at (citing Ex. 1104, col. 15, ll. 1 26); see Pet. Reply 11, Petitioner presents arguments supporting a conclusion of obviousness of claim 17 over US 717 and US 546 (Pet ), and Petitioner s declarant, Mr. Odell, provides a claim chart comparing the limitations of claim 17 to the 14

117 IPR Patent 6,682,527 B2 teachings of US 717 and US 546 (Ex. 1113, 35 43). According to Mr. Odell s claim chart, US 717 teaches all of the limitations of claim 17, except for the algorithm that is included in the corresponding structure of the means-plusfunction limitation. See supra Sec. II.A. Petitioner further argues that it would have been obvious to combine the teachings of US 546 to use a digital controller programmed to implement the disclosed power output function of the radio frequency generator described in US 717. Pet. 41; Ex 1113, 41. First, Petitioner argues that one of ordinary skill would have considered combining the teachings of US 717 and US 546 because both US 717 and US 546 deal with the same problem (how to increase power at a predetermined rate) in the same field of technology (electrosurgery). Pet. 38, 41. Second, Petitioner argues that US 546 shows an algorithm for increasing power at a predetermined rate as disclosed in US 717, and one skilled in the art would have been motivated to use such an algorithm to achieve the disclosed power increase. Id. Case: Document: 15 Page: 57 Filed: 12/02/2015 Patent Owner contends that Petitioner fails to justify combining the teachings of US 717 and US 546 to achieve the radio frequency generators recited in independent claim 17. PO Resp In particular, Patent Owner contends that US 717 teaches away from the use of an algorithm that functions to provide power in a way that avoids formation of a vapor layer. Id. at Further, Patent Owner contends that Petitioner provides no reason to combine the teachings of US 717 and US 546. Id. at Finally, Patent Owner contends that the proposed combination of US 717 and US 546 does not teach all of the limitations of claim 17. Id. at For the reasons that follow, we are not persuaded by Patent Owner s contentions. 15

118 IPR Patent 6,682,527 B2 Case: Document: 15 Page: 58 Filed: 12/02/2015 First, Patent Owner contends that US 717 teaches away from the use of an algorithm that functions to provide power in a way that avoids formation of a vapor layer. Id. at In particular, Patent Owner contends that US 717 teaches that power is raised until a vapor layer is formed then reduced. Id. at Thus, Patent Owner contends that US 717 teaches away from using an algorithm that avoids vapor layer formation. Id. at A reference may teach away from its modification (1) when a person of ordinary skill would be discouraged from deviating from the path set out in the reference; (2) when a person of ordinary skill would be led in a direction divergent from the path that was taken by the patentee; or (3) when the modification would render the resulting apparatus or method inoperable or unsuitable for the intended purpose of the modified reference. See In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Here, Patent Owner contends that Petitioner s proposed modification of US 717 would render its apparatus inoperable or unsuitable for its intended purpose. PO Resp ; see Plas-Pak Indus., Inc. v. Sulzer Mixpac AG, 600 Fed. Appx. 755, 758 (Fed. Cir. 2015) ( [C]ombinations that change the basic principles under which the [prior art] was designed to operate, In re Ratti, F.2d 810, 813 ([CCPA] 1959), or that render the prior art inoperable for its intended purpose, In re Gordon, 733 F.2d 900, 902 (Fed. Cir. 1984), may fail to support a conclusion of obviousness. ). In particular, Patent Owner contends that, based on Dr. Tucker s testimony, modifying US 717, such that power is delivered to its apparatus to avoid formation of the vapor layer, would alter a basic principle of operation of US 717. PO Resp. 18. Specifically, Patent Owner contends that the US 717 apparatus is intended to operate without regard to the formation of a vapor layer, and is predicated on the principle that impedance levels consistent with the existence of 16

119 IPR Patent 6,682,527 B2 a vapor layer are to be used as upper bounds on the power delivered to the electrosurgical device. Id. Nevertheless, Patent Owner acknowledges that US 717 teaches that Case: Document: 15 Page: 59 Filed: 12/02/2015 impedance increases during the heating of tissue in a desiccation procedure are associated with the formation of a vapor layer at or near the electrode-tissue interface. The described vapor layer spreads from the nucleation site to cover the electrodes within a short period of time, causing impedance increases and attendant problems with the delivery of energy to the target tissue. Id. at 15 (citing Ex. 1105, col. 3, ll. 9 30); see Ex , 28, 29. Further, as Dr. Tucker testified, US 717 teaches determining a maximum power level at which a vapor layer forms and then operating its apparatus at a fraction of the maximum power level, e.g., preferably percent of the maximum power level, to avoid formation of the vapor layer. Ex. 2005, 148:18 24, 149:20 150:11, 151:25 152:13; see Pet. Reply 7 8; Tr. 67:21 68:18. Thus, we are not persuaded that the proposed modification of US 717 in view of the teachings of US 546 to employ an algorithm to avoid formation of the vapor layer, once the power level at which a vapor layer forms is determined, would render the modified apparatus inoperable or unsuitable for the intended purpose of US 717. Second, Patent Owner contends that neither Petitioner nor Mr. Odell provides a reason to combine the teachings of US 717 and US 546 to achieve the radio frequency generator recited in claim 17. PO Resp In particular, Patent Owner contends that, even if Mr. Odell is correct that US 717 and US 546 address the same problem and are in the same field of technology, these similarities do not provide an adequate basis for a finding that one of ordinary skill in the art would have a reason to combine these references to achieve the recited generator. Id. at Moreover, because of the allegedly different approaches 17

120 IPR Patent 6,682,527 B2 Case: Document: 15 Page: 60 Filed: 12/02/2015 to the formation of a vapor layer between US 717 and the 527 patent, Patent Owner contends that Petitioner fails to show a sufficient reason to combine the teachings of US 717 and US 546. Id. at 21. We disagree. Petitioner argues that US 717 provides a sufficient reason to combine its teachings with those of US 546. Pet. Reply In particular, Petitioner argues that US 717 teaches increasing power from an initial power level to a power level that is a fraction of a previously determined, maximum power level. Pet. 39 (citing Ex. 1105, col. 3, ll ); Pet. Reply 12; see Ex. 1105, col. 3, ll ; Ex. 2005, 162:23 164:17, 44:11 46:6, 59:2 13, 96:13 98:3. Petitioner argues that US 717 also teaches that the power delivery can be under the control of a controller to increase power delivered to bipolar forceps automatically from an initial level at a predetermined rate. Pet ; Pet. Reply 12 14; see Pet. Reply 5 n.4 (citing Ex. 1105, col. 5, ll. 5 31; col. 10, ll ). Petitioner acknowledges that US 717 does not teach a specific program for increasing power (Pet ; Pet. Reply 11 12), but asserts that US 546 teaches such a program for increasing power at a predetermined rate from an initial level (see Pet , 41 n.12; Ex. 1104, col. 14, l. 43 col. 15, l. 64; col. 18, ll. 3 8, 18 38; Figs. 12 and 15A). [I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. KSR, 550 U.S. at 417 (citation omitted); see Pet. 38, 41 n.12. In view of the foregoing analysis, a preponderance of the evidence supports Petitioner s arguments. See also Ex. 1113, (discussing the teachings of US 717 and US 546); Ex. 2005, 103:1 106:21 (discussing the teachings of US 546). Thus, we are persuaded that the teachings of US 717 and US 546 provide sufficient reason for their combination, as argued by Petitioner. 18

121 IPR Patent 6,682,527 B2 Case: Document: 15 Page: 61 Filed: 12/02/2015 Third, Patent Owner contends that the proposed combination of US 717 and US 546 does not teach all of the limitations of claim 17. PO Resp As with Patent Owner s first contention, Patent Owner contends that the proposed modification of the teachings of US 717 in view of those of US 546 would render the resulting generator inoperable or unsuitable for US 717 s intended purpose. Id. Consequently, Patent Owner contends that the proposed combination cannot teach all of the limitations of independent claim 17. Id. For the reasons set forth above, we are not persuaded by Patent Owner s contention. See Pet. Reply Despite Patent Owner s arguments to the contrary (PO Resp ), we agree with Petitioner that independent claim 17 does not prohibit the determination of the power level at which a vapor layer forms before the radio frequency generator s means for automatically increasing power increases power at a predetermined rate from an initial level to a level less than that at which a vapor layer forms, thereby avoiding formation of a vapor layer while permitting an impedance increase to occur as a result of complete tissue dessication (Pet. Reply 8 10). See Tr. 61:23 62:2, 65:4 12, 65:17 66:13. We are persuaded by Petitioner that a person of ordinary skill in the art would have had reason to use the controller of US 717 to implement the power increase by an algorithm, such as that taught by US 546. Consequently, we are persuaded that Petitioner demonstrates by a preponderance of the evidence that claim 17 would have been rendered obvious over US 717 and US 546. b. Claims 29 and 30 Claims 29 and 30 depend directly from claim 17. Claim 29 recites [a] radio frequency generator as in claim 17, wherein the increasing means comprises a programmable digital controller, and claim 30 recites [a] radio frequency 19

122 IPR Patent 6,682,527 B2 Case: Document: 15 Page: 62 Filed: 12/02/2015 generator as in claim 17, wherein the increasing means comprises a control program embodied in a tangible medium. US 717 discloses [i]n still another aspect of the present invention, computer programs embodied in a tangible medium, such as a floppy disk, compact disk, tape, flash memory, hard disk memory, or the like, which set forth any of the methods described above, in computer-readable code. Such computer programs are useful with digital controllers which may be built into a radio frequency power supply or other electrosurgical power supply according to the present invention. Ex. 1105, col. 4, ll (emphases added). Patent Owner relies only on its arguments and evidence, discussed above, contesting the combination of the teachings of US 717 and US 546 with respect to independent claim 17 to overcome Petitioner s arguments and evidence with respect to these claims. 5 PO Resp. 10; Pet. Reply 1. We are persuaded that US 717 teaches or suggests the additional limitations of claims 29 and 30 and that a person of ordinary skill in the art would have had reason to combine the teachings of US 717 and US 546 to achieve the generator of the 527 patent, as recited in claims 29 and 30. Pet ; Ex ; see KSR, 550 U.S. at 417. Therefore, in view of the foregoing discussion of the combination of the teachings of US 717 and US 546 with respect to claim 17, we are persuaded that Petitioner has demonstrated by a preponderance of the evidence that US 717 and US 546 would have rendered obvious claims 29 and 30 of the 527 patent. 5 In the Scheduling Order (Paper 16, 2 3), we cautioned Patent Owner that any arguments for patentability not raised in the Patent Owner Response will be deemed waived. 20

123 IPR Patent 6,682,527 B2 c. Claims 18, 21, and 22 Petitioner also argues that dependent claims 18, 21, and 22 are unpatentable under 35 U.S.C. 103(a) as rendered obvious over US 717 and US 546. Claim 18 recites Case: Document: 15 Page: 63 Filed: 12/02/2015 [a] radio frequency generator as in claim 17, wherein the increasing means initiates a cycle where it measures an impedance of tissue, compares the measured impedance to an impedance limit, and increases the power level based on the predetermined rate if the measured impedance does not exceed the impedance limit. Petitioner argues that US 546 discloses using impedance monitoring to determine whether to continue or halt the increase of power to the bipolar connection. Pet (citing Ex. 1104, col. 15, ll ; Fig. 12 (showing impedance monitoring at steps 1214, 1218, 1222, 1226, 1230, and 1234)). Claim 21 recites [a] radio frequency generator as in claim 18, wherein the increasing means repeats the cycle. Petitioner argues that US 546 repeats the cycle of the corresponding algorithm for increasing power using impedance monitoring. Pet. 52 (citing Ex. 1104, col. 14, ll. 43 col. 15, l. 35; col. 17, ll. 3 44). Claim 22 recites [a] radio frequency generator as in claim 18, wherein the increasing means is activated only once for continual cycling. Petitioner argues that US 546 is activated only once for continual recycling. Pet. 53 (citing Ex. 1104, col. 14, ll. 43 col. 15, l. 35; col. 17, ll. 3 44). Patent Owner relies only on its arguments and evidence, discussed above, contesting the combination of the teachings of US 717 and US 546 with respect to independent claim 17 to overcome Petitioner s arguments and evidence with respect to these claims. PO Resp ; Pet. Reply 1. We are persuaded that US 546 teaches or suggests the additional limitations of claims 18, 21, and 22 and that a person of ordinary skill in the art would have had reason to combine the 21

124 IPR Patent 6,682,527 B2 Case: Document: 15 Page: 64 Filed: 12/02/2015 teachings of US 717 and US 546 to achieve the generator of the 527 patent, as recited in claims 18, 21, and 22. Pet ; see KSR, 550 U.S. at 417. Therefore, in view of the foregoing discussion of the combination of the teachings of US 717 and US 546 with respect to claim 17, we are persuaded that Petitioner has demonstrated by a preponderance of the evidence that US 717 and US 546 would have rendered obvious claims 18, 21, and 22 of the 527 patent. d. Claims 19, 20, 23, and 26 Claim 19 recites [a] radio frequency generator as in claim 18, wherein the impedance limit is selected to indicate the impedance increase due to complete tissue desiccation. Petitioner argues that the additional limitations of claim 19 are taught by US 779. In particular, Petitioner argues that US 779 teaches that one should select an impedance limit that corresponds to complete tissue seal. Pet. 51 (citing Ex. 1108, col.13, ll ). Further, Petitioner argues that US 779 shows a technique used to improve another device and that it would be obvious to use it to complement the primary references, US 717 and US 546. See Pet. 50 (citing KSR, 550 U.S. at 417). Claim 20 recites [a] radio frequency generator as claim 18 wherein the impedance limit is in the range from 50 ohms to 1000 ohms. Petitioner argues that claim 20 is rendered obvious over US 717, US 546, and US 047. Pet In particular, Petitioner argues that US 047 shows the identical range of impedance limits ( from about 50 to about 1000 ohms ) in the context of a bipolar surgical generator. See Ex. 1110, col. 4, ll Further, Petitioner argues that if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. Pet. 50 (quoting KSR, 550 U.S. at 417). 22

125 IPR Patent 6,682,527 B2 Case: Document: 15 Page: 65 Filed: 12/02/2015 Claim 23 recites [a] radio frequency generator as in claim 17, further comprising a user interface for inputting the rate of power increase, the initial power level, and an impedance limit. Petitioner argues that each of the additional limitations of claim 23 is taught by WO 882. Pet In particular, Petitioner argues that WO 882 teaches inputting values from which the rate of power increase, the initial power level, and an impedance limit are determined. Id. (citing Ex. 1111, 20:11 19; 22: 12 19; 23:26 33). Petitioner argues that a person skilled in the art would have reason to combine the teachings of US 717 and US 546 with those of WO 882, because, as Petitioner s declarant testifies (Ex , 49), the use of user interfaces in radio frequency generators was standard in the industry as of the filing date of the 527 patent and the use of the interface shown in WO 882 results in a combination of familiar elements according to known methods [which]... does no more than yield predictable results. Pet. 54 (quoting KSR, 550 U.S. at 416). Claim 26 recites [a] radio frequency generator as in claim 17, wherein the predetermined rate of power increase is in the range from 1 W/sec to 100 W /sec. Petitioner argues here that US 047 teaches raising the power at a predetermined rate of about 2 W/sec to 3 W/sec. Pet (citing Ex. 1110, col. 3, ll ; col. 4, ll (teaching an increase from 0 W to W over a period of 8 to 15 seconds)). Petitioner, thus, argues that the range for the rate taught by US 047 falls within the range recited in claim 26. In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) ( In cases involving overlapping ranges, we and our predecessor court have consistently held that even a slight overlap in range establishes a prima facie case of obviousness. ). Further, Petitioner argues that combining the teachings of US 047 with the teachings of US 717 and US 546 would have been obvious to a person of ordinary skill in the art since it is merely using a known 23

126 IPR Patent 6,682,527 B2 Case: Document: 15 Page: 66 Filed: 12/02/2015 technique used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. Pet. 57 (quoting KSR, 550 U.S. at 417). With respect to each of claims 19, 20, 23, and 26, Patent Owner relies only on its arguments and evidence, discussed above, contesting the combination of the teachings of US 717 and US 546 with respect to independent claim 17 to overcome Petitioner s arguments and evidence with respect to these claims. PO Resp ; Pet. Reply 1. We have reviewed Petitioner s evidence and are persuaded that the applied additional references teach or suggest all of the additional limitations of claims 19, 20, 23, and 26. Pet , 56 57; see Dec. on Inst , We also are persuaded that a person of ordinary skill in the art at the time of the invention would have had a reason to combine the teachings of each of US 779, US 047, and WO 882 with the combination of the teachings of US 717 and US 546. Therefore, in view of the foregoing discussion of the combination of the teachings of US 717 and US 546 with respect to claim 17, we are persuaded that Petitioner has demonstrated by a preponderance of the evidence that US 717 and US 546, in combination with US 779, US 047, or WO 882, would have rendered obvious claims 19, 20, 23, and 26 of the 527 patent. For the reasons set forth above, we are persuaded that Petitioner has demonstrated by a preponderance of the evidence that claims 17 23, 26, 29, and 30 of the 527 patent are rendered obvious over US 717 and US 546, alone or in combination with US 779, US 047, or WO 882. C. Patent Owner s Motion to Exclude Evidence Patent Owner filed a Motion to Exclude Evidence (Paper 40 ( PO Mot. )); Petitioner filed an Opposition to Patent Owner s Motion to Exclude Evidence 24

127 IPR Patent 6,682,527 B2 (Paper 43 ( Pet. Opp. )); and Patent Owner filed a Reply to Petitioner s Opposition to the Motion to Exclude Evidence (Paper 44 ( PO Reply to Opp. )). As an initial matter, Petitioner argues that Patent Owner s Motion to Exclude Evidence, filed on January 20, 2015, was untimely filed. Pet. Opp. 1. For the reasons set forth below, we agree and deny Patent Owner s Motion to Exclude Evidence as untimely filed. In our Scheduling Order, we set DUE DATE 4, the deadline for either party to file any motion to exclude evidence, as January 20, Paper 16, 5. This date was selected by us for DUE DATE 4 because January 19, 2015, was the date of the 2015 Martin Luther King, Jr. Day Federal Holiday. The Scheduling Order further stated that Case: Document: 15 Page: 67 Filed: 12/02/2015 This order sets due dates for the parties to take action after institution of the proceeding. The parties may stipulate to different dates for DUE DATES 1 through 5 (earlier or later, but no later than DUE DATE 6). A notice of the stipulation, specifically identifying the changed due dates, must be promptly filed. The parties may not stipulate to an extension of DUE DATES 6 and 7. Id. at 1 (emphasis added). On August 21, 2014, the parties filed a Notice of Stipulation to Adjust Schedule Due Dates 1 4, which among other dates changed DUE DATE 4 from January 20, 2015, to January 19, Paper 27, 3. Counsel for each party signed the Notice of Stipulation. Id. at 4. Patent Owner contends that, despite the parties stipulation changing DUE DATE 4 to January 19, 2015, the DUE DATE for filing Patent Owner s Motion to Exclude Evidence remained January 20, 2015, because January 19, 2015, was a Federal holiday. PO Reply to Opp. 1. Under 35 U.S.C. 21(b), [w]hen the day, or the last day, for taking any action or paying any fee in the United States Patent and Trademark Office falls on Saturday, Sunday, or a Federal holiday within the District of Columbia, the 25

128 IPR Patent 6,682,527 B2 Case: Document: 15 Page: 68 Filed: 12/02/2015 action may be taken, or the fee paid, on the next succeeding secular or business day. We understand that the statute applies to deadlines set by statute, rule or order; not to different dates stipulated to by the parties. Similarly, under 37 C.F.R. 1.7(a), when a deadline falls on a Federal holiday, action may be taken on the next succeeding business day. Section 1.7, however, applies to deadlines fixed by statute or by or under this part of this chapter. 6 See 37 C.F.R. 42.1(a) ( [Section 1.7] of this chapter also appl[ies] to proceedings before the Board, as do other sections of part 1 of this chapter that are incorporated by reference into this part. ). Although the Scheduling Order is an order made pursuant to 37 C.F.R. 42.5(c), the Scheduling Order permits the parties to change DUE DATES 1 5 set therein to different dates by stipulation. Paper 16, 1 (emphasis added). Moreover, given that filings with the Board may be made electronically (see 37 C.F.R. 42.6(b)(1)) and the Patent Review Processing System accepts filings twenty-four hours a day and seven days a week, we only require that stipulated DUE DATES 1 5 may be earlier or later [than the date set in the Scheduling Order], but no later than DUE DATE 6. Paper 16, 1. Within these limits, the Board observes stipulated dates, and stipulated dates are binding on the parties by their agreement. Here, the parties stipulated to January 19, 2015, as DUE DATE 4. As noted above, Patent Owner s Motion to Exclude Evidence was not filed on or before stipulated DUE DATE 4, and Patent Owner has provided no reason for its delay in filing its Motion to Exclude Evidence, which warrants our acceptance of its 6 S. Rept. No , at 2407 (1952) (With respect to 35 U.S.C. 21, [f]ixed by statute is omitted from the corresponding section of the existing statute as unnecessary. Saturday is added as a day on which action need not be taken. ; emphasis added). 26

129 IPR Patent 6,682,527 B2 Case: Document: 15 Page: 69 Filed: 12/02/2015 untimely Motion to Exclude Evidence. 7 Therefore, we deny Patent Owner s untimely Motion to Exclude Evidence. D. Improper Filing of Demonstrative Exhibits The panel may expunge any paper directed to a proceeding... that is not authorized under this part or in a Board order or that is filed contrary to a Board order. 37 C.F.R. 42.7(a). After reviewing Exhibits 1028 and 1029, we determine that these exhibits are not authorized by this part or in a Board order or are contrary to a Board order. According to Petitioner, Exhibit 1128 is a demonstrative exhibit in the form of a PowerPoint presentation containing excerpts of case law... as well as excerpts of other filed exhibits; and Exhibit 1129 is a demonstrative exhibit in the form of a PowerPoint presentation containing of a graph depicting the power output of the generator of the 717 patent versus time. Pet. Opp. 3 (Ex. 1128), 5 (Ex. 1129) (emphases added). As indicated in the Board s Office Trial Practice Guide, demonstrative exhibits may be presented at the oral hearing. 77 Fed. Reg , (Aug. 14, 2012). However, the filing of demonstrative exhibits was not authorized by our rules or by any order in this case. Moreover, our order granting the parties requests for an oral hearing expressly prohibits the filing of demonstrative exhibits without our prior authorization. Paper 42, 4 ( The parties shall not file any demonstrative exhibits in this case without prior authorization from the Board. ); see PO Reply to Opp. 4. Because Petitioner did not request authorization to file and we did not authorize the filing of these demonstrative 7 Patent Owner contends that Petitioner is not prejudiced by Patent Owner s late filing of the Motion to Exclude Evidence. PO Reply to Opp. 3. Nevertheless, as a general matter, if we accepted Patent Owner s late filing, Petitioner would have one day less to prepare its opposition to Patent Owner s Motion to Exclude Evidence than is permitted by the parties stipulation. Pet. Opp

130 IPR Patent 6,682,527 B2 exhibits at DUE DATE 3, we expunge Exhibits 1028 and See C&D Zodiac, Inc. v. B/E Aerospace, Inc., Case IPR , slip op. at 3 (PTAB Mar. 3, 2015) (Paper 30). Case: Document: 15 Page: 70 Filed: 12/02/2015 III. CONCLUSION After consideration of the Petition and the Patent Owner Response and for the reasons set forth above, we conclude that Petitioner has demonstrated by a preponderance of the evidence that claims 17 23, 26, 29, and 30 of the 527 patent are rendered obvious over US 717 and US 546, alone or in combination with US 779, US 047, or WO 882. that IV. ORDER In consideration of the foregoing, it is ORDERED that Petitioner has shown by a preponderance of the evidence A. Claims 17, 18, 21, 22, 29, and 30 are rendered obvious over US 717 and US 546; B. Claim 19 is rendered obvious over US 717, US 546, and US 779; C. Claims 20 and 26 are rendered obvious over US 717, US 546, and US 047; and D. Claim 23 is rendered obvious over US 717, US 546, and WO 882; FURTHER ORDERED that Patent Owner s Motion to Exclude Evidence is denied as untimely filed; FURTHER ORDERED that Exhibits 1028 and 1029 are expunged; and FURTHER ORDERED that, because this is a final decision, parties to the 28

131 IPR Patent 6,682,527 B2 Case: Document: 15 Page: 71 Filed: 12/02/2015 proceeding seeking judicial review of the decision must comply with the notice and service requirements of 37 C.F.R

132 IPR Patent 6,682,527 B2 Case: Document: 15 Page: 72 Filed: 12/02/2015 PETITIONER: Deborah E. Fishman KAYE SCHOLER LLP Steven I. Weisburd ARENT FOX LLP Robert E. Bugg DICKSTEIN SHAPIRO LLP PATENT OWNER: Jason S. Angell Robert E. Freitas Daniel J. Weinberg FREITAS ANGELL & WEINBERG LLP 30

133 Case: Document: 15 Page: 73 Filed: 12/02/2015 (12) United States Patent Strul US B2 (10) Patent No.: US 6,682,527 B2 (45) Date of Patent: Jan.27,2004 (54) METHOD AND SYSTEM FOR HEATING TISSUE WITH A BIPOLAR INSTRUMENT (75) Inventor: Bruno Strul, Portola Valley, CA (US) (73) Assignee: Perfect Surgical Techniques, Inc., Santa Clara, CA (US) ( *) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U.S.C. 154(b) by 506 days. (21) Appl. No.: 09/808,096 (22) Filed: (65) Mar. 13, 2001 Prior Publication Data US 2002/ A1 Sep. 19, 2002 (51) Int. Cl A61B 18/18 (52) U.S. Cl /51; 606/52; 606/34; 606/38 (58) Field of Search /51, 33, 45, 606/52, 34, 41, 48, 49, 50, 37, 38 (56) References Cited U.S. PATENT DOCUMENTS 4,016,886 A 4/1977 Doss eta!. 4,043,342 A 8/1977 Morrison, Jr. 5,098,431 A 3/1992 Rydell 5,151,102 A 9/1992 Kamiyama eta!. 5,217,460 A 6/1993 Knoepfter 5,370,645 A 12/1994 Klicek eta!. 5,383,876 A 1/1995 Nardella 5,403,312 A 4/1995 Yates eta!. 5,437,664 A 8/1995 Cohen eta!. 5,441,499 A 8/1995 Fritzsch 5,445,638 A 8/1995 Rydell et a!. 5,496,312 A 3/1996 Klicek 5,514,129 A 5/1996 Smith 5,527,313 A 6/1996 Scott eta!. 5,556,396 A 9/1996 Cohen eta!. 5,558,671 A 9/1996 Yates 5,582,611 A 12/1996 Tsuruta et a!. 5,599,344 A 2/1997 Paterson 5,655,085 A 8/1997 Ryan eta!. 5,662,680 A 9/1997 Desai 5,688,270 A 11/1997 Yates et a!. 5,693,051 A 12/1997 Schulze et a!. 5,695,494 A 12/1997 Becker 5,702,390 A 12/1997 Austin eta!. 5,772,659 A 6/1998 Becker eta!. 5,776,130 A 7/1998 Buysse eta!. 5,797,941 A 8/1998 Schulze et a!. 5,827,271 A 10/1998 Buysse eta!. 5,833,690 A 11/1998 Yates eta!. 5,954,717 A 9/1999 Behl eta!. (List continued on next page.) FOREIGN PATENT DOCUMENTS FR /1925 su /1967 wo wo 93/ /1993 wo wo 95/ /1995 wo wo 95/ /1995 Primary Examiner-Sang Y Paik.4ssistant Examiner-Fadi H. Dahbour (74) Attorney, Agent, or Firm-Townsend and Townsend and Crew LLP (57) ABSTRACT Methods for heating tissue completely, thoroughly, and uniformly comprise delivering radio frequency energy through a bipolar surgical instrument having first and second jaws with first and second electrode members within the treatment region. Tissue is grasped between the first and second jaws of the bipolar instrument. The electrode members are energized at a power level to deliver electrical energy to and heat tissue between the first and second electrode members. The power level is increa"sed at a predetermined rate from an initial level. The initial level and predetermined rate are selected to avoid creating a vapor layer and to permit an impedance increase to occur as a result of complete tissue desiccation. A tissue impedance may also be measured and compared to a preset impedance limit for terminating the power delivery when the measured impedance exceeds the impedance limit. 30 Claims, 6 Drawing Sheets

134 Case: Document: 15 Page: 74 Filed: 12/02/2015 US 6,682,527 B2 Page 2 U.S. PATENT DOCUMENTS 6,482,205 B1 * 11/2002 Bonnet /51 6,514,252 B2 * 2/2003 Nezhat et al /48 6,030,384 A * 2/2000 Nezhat /48 6,520,960 B2 * 2/2003 Blocher et al /51 6,033,399 A 3/2000 Gines 6,524,309 B1 * 2/2003 Watrelot et al /51 6,123,701 A * 9/2000 Nezhat /33 6,585,735 B1 * 7/2003 Frazier et al /51 6,132,429 A 10/2000 Baker 6,616,662 B2 * 9/2003 Scholer et al /51 6,162,220 A 12/2000 Nezhat 6,478,794 B1 * 11/2002 Trapp et al /45 * cited by examiner

135 Case: Document: 15 Page: 75 Filed: 12/02/2015 U.S. Patent Jan.27,2004 Sheet 1 of 6 US 6,682,527 B2 r POWER SOURCE USER CONTROLLER tiNTERFACE RADIO FREQUENCY STAGE ISOLATION BARRIER DEVICE I PATIENT FIG. 1

136 Case: Document: 15 Page: 76 Filed: 12/02/2015 U.S. Patent Jan.27,2004 Sheet 2 of 6 US 6,682,527 B2 POWER UP I RESET SYSTEM SELF TEST STANDBY READY ' PST MODE FATAL FAULT ' IMPEDANCE - LIMIT ' FIG. 2

137 Case: Document: 15 Page: 77 Filed: 12/02/2015 U.S. Patent Jan.27,2004 Sheet 3 of 6 US 6,682,527 B2 ENERGIZE TISSUE ELECTRODE AT POWER P 0 l DETERMINE VOLTAGE, CURRENT, POWER LEVELS l DETERMINE AND TEST POWER LEVEL PL! DETERMINE AND TEST IMPEDANCE LEVEL IL! DETERMINE INCREMENTAL AND TOTAL ENERGY! INCREASE POWER SET P 5 AT PREDETERMINED RATE! ENERGIZE ELECTRODE AT NEWP 5 VALUE. TERMINATE POWER DELIVERY FIG. 3

138 Case: Document: 15 Page: 78 Filed: 12/02/2015 V.s. Patent 200 Jan. 27,2004 Sheet 4 of6 Us 6,682,527 B2 \ FIG. 4A 222 FIG. 4C

139 Case: Document: 15 Page: 79 Filed: 12/02/2015 U.S. Patent Jan.27,2004 Sheet 5 of 6 US 6,682,527 B2 262 FIG. 5 14

140 Case: Document: 15 Page: 80 Filed: 12/02/2015 U.S. Patent Jan.27,2004 Sheet 6 of 6 US 6,682,527 B2 / r ', \..,/ / / / / / /,/ / / / / / I,; I / / ""'... I...? -... / / I T _, "' I / FIG. 6A ~ / / \ /... /... I / / / / / / "' / / / / / I /.c /... I / I I T / / / / FIG. 68 ~ / \. /... 0 j I I / / / / / / / /,; / I 222 / "'... I " / >-... I FIG. 6C /... / I T

141 Case: Document: 15 Page: 81 Filed: 12/02/ METHOD AND SYSTEM FOR HEATING TISSUE WITH A BIPOlAR INSTRUMENT BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to the use of radio frequency energy for heating and desiccating tissue. More particularly, the present invention relates to a control method, system, and apparatus for delivering radio frequency current to the tissue through electrodes disposed on bipolar surgical instruments. The delivery of bipolar radio frequency energy to target regions within tissue is known for a variety of purposes. Of particular interest to the present invention, radio frequency energy may be delivered by bipolar surgical instruments to regions in target tissue for the purpose of heating and/or desiccation, referred to generally as hyperthermia. Bipolar electrosurgical devices rely on contacting electrodes of US 6,682,527 B2 different polarity in close proximity to each other against or 20 into tissue. For example, bipolar forceps have been used for coagulating, cutting, and desiccating tissue, where opposed jaws of the forceps are connected to different poles of an electrosurgical power supply. The radio frequency current thus flows from one jaw to the other through the tissue 25 present therebetween. Use of such bipolar forceps is effective for a number of purposes and advantageous in that its effect is generally limited to the tissue held between the jaws without unwanted heating of adjacent tissues. A primary goal for the delivery of bipolar radio frequency 30 energy for hyperthermic treatments is the complete, thorough, and uniform heating of the treatment tissue without causing charring of the treatment tissue. Charring greatly increases electrical resistance through the tissue prematurely and can result in termination of the treatment before the 35 tissue is uniformly heated. Uniform heating of the target tissue, however, can be difficult to achieve, particularly in highly vascularized tissues where the variability in local blood flow can have a significant effect on the heating characteristics of the tissue. For example, creation of a 40 lesion in some highly perfused tissue locations may require twice as much power as an identically-sized lesion in less highly perfused locations. While a variety of approaches for achieving such complete, thorough, and uniform heating of tissue have been proposed, most such approaches are some- 45 what complex. In general, many approaches for achieving uniform tissue heating have relied on slow, low power level, gradual heating of the tissue to avoid the formation of charred or otherwise desiccated, high radio frequency impedance regions within the target tissue. Such approaches, 50 however, are complex, can result in undesirable prolongation of the treatment, and are not always successful. For these reasons, it would be desirable to provide improved treatment methods, systems, and apparatus which allow for effective and efficient delivery of radio frequency 55 energy to target tissue using electrodes disposed on bipolar devices. In particular, it would be desirable to provide such methods, systems, and apparatus which are useful with many or all bipolar surgical instruments which are now available or which might become available in the future. The 60 methods, systems, and apparatus should be simple to implement and use, and should preferably reduce the complexity, cost, and treatment time required to achieve complete, thorough, and uniform heating and/or desiccation of the target tissue \vithout charring the target tissue. At least some 65 of these objectives will be met by the invention described hereinafter DESCRIPTION OF THE BACKGROUND ART The heating of tissue with radio frequency current using the preferred bipolar surgical systems of the present invention is described in co-pending application Ser. Nos. 09/071, 689 filed May 1, 1998 and 09/303,007 filed Apr. 30, 1999, the full disclosures of which are incorporated herein by reference. Radio frequency power apparatus and methods are described in U.S. Pat. Nos. 5,954,717, 5,556,396; 5,514, 129; 5,496,312; 5,437,664; and 5,370,645; WO 95/20360, WO 95/09577, and WO 93/ Bipolar electrosurgical devices are described in U.S. Pat. Nos. 5,833,690; 5,797, 941; 5,702,390; 5,688,270; 5,655,085; 5,662,680; 5,582, 611; 5,527,313; 5,445,638; 5,441,499; 5,403,312; 5,383, 876; 5,217,460; 5,151,102; 5,098,431; 4,043,342; and 4,016,886; Soviet Union Patent Publication SU ; and French Patent No. 598,149. SUMMARY OF THE INVENTION The present invention provides improved methods, systems, and apparatus for effective and efficient delivery of radio frequency (RF) energy to electrodes of bipolar surgical instruments disposed in treatment tissue for inducing hyperthermia and other purposes. The treatment region resulting from bipolar radio frequency treatment may be located anywhere in the body where hyperthermic exposure may be beneficial. The treatment region may comprise and/or be located in tissue of or surrounding the liver, kidney, lung, bowel, stomach, pancreas, breast, uterus, prostate, muscle, membrane, appendix, other abdominal or thoracic organs, and the like. Treatments according the present invention will usually be effected by passing a radio frequency current through the treatment tissue region in a bipolar manner where paired treatment electrodes are employed to both form a complete circuit and to uniformly and thoroughly heat tissue therebetween. The paired electrodes will have similar or identical surface areas in contact with tissue and geometries so that current flux is not concentrated preferentially at either electrode (or electrode component such as a tissuepenetrating needle) relative to the other electrode(s). Such bipolar current delivery is to be contrasted \vith "monopolar" delivery where one electrode has a much smaller surface area and one or more "counter" or "dispersive" electrodes are placed on the patient's back or thighs to provide the necessary current return path. In the latter case, the smaller or active electrode will be the only one to effect tissue as a result of the current flux which is concentrated thereabout. It has been found that the delivery of bipolar radio frequency power to electrodes disposed in tissue can, if the power is delivered for a sufficient time and/or at a sufficient power delivery level or flux, result in an increase in the electrical impedance between the electrodes and tissue. While such an increase in impedance is the natural consequence of tissue desiccation, it can be undesirable if it occurs prematurely since it results in an immediate fall-off of energy delivery (for a voltage limited radio frequency power source). Accordingly, the present invention relies on unique methods of radio frequency power delivery to uniformly and thoroughly heat the target tissue without charring the target tissue. It is presently believed that the premature increase in electrode-tissue interface impedance may result from the formation of a thin gaseous or vapor layer over the electrode surfaces, apparently resulting from vaporization of water within the tissue as the temperature approaches the local boiling point. The thin gaseous layer appears to spread from

142 Case: Document: 15 Page: 82 Filed: 12/02/2015 US 6,682,527 B2 3 an initial nucleation site to cover most or all of the electrode surfaces in a very short time period, resulting in the premature increase in electrode-tissue interface impedance which is very large when compared to the total system impedance prior to formation of the gaseous layer. The methods, 5 systems, and apparatus of the present invention have been found to be useful and effective regardless of the actual mechanism which is responsible for the premature increase in impedance. In a first particular aspect of the present invention, a 10 method for heating a treatment region of tissue comprises introducing a bipolar surgical instrument, such as forceps, graspers, or the like, having first and second jaws with first and second electrode members within the treatment region. Tissue is grasped between the first and second jaws of the 15 bipolar instrument. The electrode members are energized at a power level to deliver electrical energy to and heat tissue between the first and second electrode members. The power level is increased at a predetermined rate from an initial level. The initial level and predetermined rate are selected to 20 avoid creating a vapor layer and to permit an impedance increase to occur as a result of complete tissue desiccation. The predetermined rate of power increase may be preselected by a user depending on the electrode sizes, the target tissue type, the degree of tissue perfusion, and the initial 25 power level. Typically, the predetermined rate of power increase will be linear and increase at a rate in the range from 1 W/sec to 100 W/sec, preferably from 1 W/sec to 10 W /sec. Thus, the initial power level and predetermined rate of power increase allow for controlled delivery of bipolar radio 30 frequency energy without premature impedance resulting from the formation of the thin gaseous layer. Furthermore, the increase in the power level at a predetermined rate from an initial level permits a natural impedance increase to occur as a result of complete tissue desiccation. It may be further desirable to measure tissue impedance. The measured impedance may be compared to an impedance limit, wherein the impedance limit will be preselected by the user to indicate the impedance increase due to complete tissue desiccation, typically in the range from 50 ohms to ohms, preferably from 250 ohms to 750 ohms. If the measured impedance exceeds the impedance limit, the power delivery is automatically terminated. Additionally, the energizing of the electrode members and increasing the power level at a predetermined rate may be repeated at least 45 once after termination until all the tissue between the electrode members is completely desiccated without charring the target tissue. Thus, complete heating and desiccation of tissue can be further optimized by monitoring tissue impedance and terminating the power delivery at a maxi- 50 mum impedance limit. As an added safety feature, the power delivery may also be automatically terminated after a preset amount of time, typically after period of 5 minutes, regardless of measured impedance so as to avoid overheating of the target tissue or unwanted heating of adjacent tissue. 55 Alternatively, the power delivery may be manually terminated with the use of a radio frequency off switch that will immediately terminate power delivery. In general, electrode members are energized with radio frequency energy supplied as a radio frequency current 60 using a controlled voltage supply. The use of such radio frequency power sources is preferred because the limited voltage available decreases the likelihood of arcing or sparking from the electrode members into the tissue. Usually, the power supply will be operated at a level which 65 depends on the electrode sizes, the target tissue type, and the degree of tissue perfusion. Typically, the power supply will 35 4 provide power in the range from 5 W to 150 W, preferably from 10 W to 80 W, and a frequency in the range from 100 khz to 2 MHz, preferably from 400kHz to 500kHz, during all phases of the above-described methods. The electrode members are energized typically for a time less than 5 minutes, preferably for a time in a range from 10 seconds to 1 minute. Additionally, at least one of the electrode members may comprise a plurality of tissue penetrating elements, the tissue penetrating elements engaging the ti5sue before the electrode members are energized. In further aspects of the present invention, systems are provided which comprise an electrosurgical power supply, typically a radio frequency generator, in combination with written, electronic, or other instructions setting forth any of the methods set forth above. In still another aspect of the present invention, computer programs embodied in a tangible medium, such as a floppy disk, compact disk, tape, flash memory, hard disk memory, read only memory (ROM), internet/modem instructions, and the like, may set forth any of the methods described above, in computer-readable code. Such computer programs are useful with digital controllers which may be built into a radio frequency generator or other electrosurgical power supply according to the present invention. Alternatively, such programs may be useful with general purpose computers, which can be interfaced with conventional electrosurgical power supplies for the control thereof according to any of the methods of the present invention. In a still further aspect of the present invention, radio frequency generators are provided which comprise a radio frequency power source having both a controlled voltage output and a standard bipolar connection for bipolar forceps or the like. The radio frequency generator will further comprise means for automatically increasing power delivered to the bipolar connection. The increasing means increases the power at a predetermined rate from an initial level. The initial level and predetermined rate avoid formation of a vapor layer while permitting an impedance increase to occur as a result of complete tissue desiccation. The predetermined rate of power increase will be preselected by a user depending on the electrode sizes as well as the initial power level, typically being linear and increasing at a rate in the range from 1 W/sec to 100 W/sec, preferably from 1 W /sec to 10 W /sec. The increasing means may initiate a cycle where it measures an impedance of tissue, compares the measured impedance to an impedance limit, and increases the power level based on the predetermined rate of power increase if the measured impedance does not exceed the impedance limit. The impedance limit is selected to indicate the impedance increase due to complete tissue desiccation, typically in the range from 50 ohms to 1000 ohms, preferably from 250 ohms to 750 ohms. Furthermore, the increasing means repeats the cycle and need only be activated once for continual cycling. The increasing means may comprise a programmable digital controller, a control program embodied in a tangible medium, or other means for automatically increasing power delivered by the generator. In particular, the digital controller or other increasing means can be programmed to implement any of the methods described above independent of operator intervention. The radio frequency generator may further comprise a user interface for inputting the rate of power increase, the initial power level, and an impedance limit. The user interface may further comprise a front panel display that displays at least one of the following: a real-time impedance, total

143 Case: Document: 15 Page: 83 Filed: 12/02/ energy delivered, and/or instantaneous power delivered. Optionally, the user interface may comprise an audible alarm which indicates the current delivery of power in addition to appropriate generator status signals. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a functional flow diagram illustrating an overview of the bipolar radio frequency power apparatus of the present invention. US 6,682,527 B2 FIG. 2 is a flow chart illustrating method steps of the 10 present invention which are implemented automatically by the digital controller of FIG. 1. FIG. 3 is a flow chart illustrating method steps of the present invention which are implemented automatically in the PST mode of FIG. 2. FIGS. 4A-4C illustrate an exemplary bipolar surgical instrument which may be employed in the methods and systems of the present invention. FIG. 5 is an alternative view of the instrument of FIGS. 20 4A-4C. FIGS. 6A-6C illustrate use of the of the bipolar instrument of FIGS. 4A-4C in treating a target tissue region according the methods of the present invention. DESCRIPTION OF THE SPECIFIC EMBODIMENTS Methods, systems, and apparatus according to the present invention will rely on the controlled delivery of radio frequency power to electrode members of a bipolar surgical instrument placed at or within a treatment tissue region of a patient for heating and/or desiccating the treatment tissue. FIG. 1 illustrates a functional flow diagram of an overview of the bipolar radio frequency power apparatus of the present invention. The radio frequency power apparatus or generator 2 comprises a radio frequency power source having a controlled voltage output and a bipolar connection for bipolar forceps or the like. The desired radio frequency power may be supplied by a conventional general purpose electrosurgical power source operating at a frequency between 100kHz to 2 MHz, preferably from 400kHz to 500 khz, with a conventional sinusoidal or non-sinusoidal wave form. Preferred power sources will operate at relatively low fixed voltages, typically from 100 V to 240 V. In all cases, current will be selected based on electrode sizes, target tissue type, and the degree of tissue perfusion, to provide an operating power in the range from 5 W to 150 W, preferably from 10 W to 80 W, for a time less than 5 minutes, preferably for a time in a range from 10 seconds to 1 minute. Preferably, the radio frequency generator 2 will further incorporate means for automatically increasing power delivered to the bipolar connection. Such increasing means may comprise a programmable digital controller, such as a computer microprocessor, a control program embodied in a tangible medium, or other means for automatically increasing power delivered by the generator. Advantageously, the digital controller or other increasing means can be programmed to implement any of the methods described herein independent of operator intervention. The increasing means or controller will increase the power at a predetermined rate from an initial level, the initial level and predetermined rate avoiding formation of a vapor layer while permitting an impedance increase to occur as a result of complete tissue desiccation. Usually, the rate of increase is in the range from 1 W/sec to 100 W/sec, preferably from 1 W/sec to 10 W /sec. The increasing means or controller may also initiate a cycle where it measures an impedance of tissue, compares 6 the measured impedance to an impedance limit, and increases the power level based on the predetermined rate of power increase if the measured impedance does not exceed the impedance limit. The impedance limit is selected to 5 indicate the impedance increase due to complete tissue desiccation, typically in the range from 50 ohms to 1000 ohms, preferably from 250 ohms to 750 ohms. Furthermore, the increasing means repeats the cycle and need only be activated once for continual cycling. The generator 2 may further comprise a user interface for inputting the rate of power increase, the initial power level, and an impedance limit. The interface may also comprise a front panel display that displays at least one of a real time impedance, total energy delivered, and maximum power 15 delivered. These display values are typically updated at 300 millisecond intervals. Additionally, the user interface may comprise an audible alarm for notifying the user that power is currently being delivered. The alarm usually beeps for 25 short periods at 3 second intervals. Optionally, the user interface may have a radio frequency off S\vitch that will immediately shut off delivery of radio frequency energy to the electrode members. This off switch serves as a back-up method to the impedance limit method to terminate power delivery. The power source as controlled by the controller and/or user interface then connects to a radio frequency stage for delivery of energy to the patient via electrodes of the bipolar device. As an added safety feature, an isolation barrier is placed between the radio frequency delivery stage and the 30 patient to minimize electrocution hazards. The radio frequency generator 2 is interfaced with the bipolar device/ patient using a conventional cable. An exemplary radio frequency generator 2, as described above, having the capabilities suitable for the present invention is the PST Model , which runs on a MOTOROLA 68HC11 microprocessor with "C" programming language software, available from Perfect Surgical Techniques, Inc., Palo Alto, Calif., assignee of the present invention. Referring now to FIG. 2, method steps of the present 40 invention which are implemented automatically by the programmable digital controller of the radio frequency generator of FIG. 1 will be generally described. After power up/reset of the generator system, the system enters a self-test state to verify that system hardware and software are func- 45 tioning normally. Failure of any self-test causes the system to enter a fatal fault state, where it remains until the system is re-powered. After successful completion of all self-tests, the system automatically enters the standby state. The standby state is a non-finctional state and no radio frequency 50 energy can be delivered in this state. The system remains in the standby state until the user requests a change to an operational mode by pressing the ready switch. While in the ready state, the system can be commanded to deliver controlled bipolar radio frequency power via a PST mode, 55 which is described in more detail below, or a standard bipolar mode. FIG. 3 is a flow chart illustrating method steps of the present invention which are implemented automatically in the PST Mode. Initially, a method for heating a treatment 60 region of tissue comprises introducing a bipolar surgical instrument having first and second jaws with first and second electrode members within the treatment region (FIG. 6A). Tissue is grasped between the first and second jaws of the bipolar instrument (FIG. 6C). The electrode members are 65 then energized at an initial power level Po in the PST mode to deliver electrical energy to and heat tissue between the first and second electrode members.

144 Case: Document: 15 Page: 84 Filed: 12/02/2015 US 6,682,527 B2 7 8 As seen in FIG. 3, voltage, current, and power levels are determined and the power level is tested at 20 millisecond intervals. If the power level read is more than 5 watts greater than a power set value, the system automatically terminates power delivery and enters the fault state, where it remains 5 until the system is re-powered. At this same interval, tissue impedance is measured and tested by comparing the measured impedance to an impedance limit, the impedance limit typically being in the range from 50 ohms to 1000 ohms. If the measured impedance exceeds the impedance limit, the 10 power delivery is automatically terminated and the system returns to ready state. Incremental and total energy levels are also calculated during this 20 millisecond interval. If the impedance limit is not exceeded, the power set level is increased at a predetermined rate from the initial level, wherein the initial level and predetermined rate are selected 15 to avoid creating a vapor layer and to permit an impedance increase to occur as a result of complete tissue desiccation. Typically, the predetermined rate is from 1 W/sec to 100 W/sec, and the electrode members are energized at this increased power set value at 100 millisecond intervals. The above described sequence of steps are automatically repeated until all the tissue between the first and second electrode members is completely desiccated with minimal charring to the treatment tissue. The electrodes are energized with bipolar radio frequency current supplied with a con- 2s trolled voltage power supply, as described in FIG. 1. In some instances, at least one of the electrode members may comprise a plurality of tissue penetrating elements, the tissue penetrating elements engaging the tissue before the electrode members are energized (FIG. 6C). Furthermore, ener- 30 gizing of the electrode members and increasing the power level steps may be repeated at least once after power delivery termination. As an added safety feature, the system will also terminate power delivery in the PST mode after a preset amount of time, typically after a period of 5 minutes, 35 at which time it will return to the ready state, to ensure that the treatment tissue is not overheated. Referring now to FIGS. 4A-4C and 5, a preferred bipolar surgical instrument with electrode members for use with the methods and apparatus of the present invention will be 40 described. A bipolar surgical instrument 200 having an arrangement of surface electrodes 202 and 204 and rows 206 and 208 of tissue-penetrating electrodes, is illustrated. The rows 206 and 208 of tissue-penetrating electrodes are mounted in an electrically conductive insert which in tum is 45 mounted in a cavity in instrument housing 214. The insert is free to reciprocate within the cavity and is mounted on a rod 220 having a knob 222 and a pair of pins 224. The rod 220 is received in a channel in the bottom of the insert, and the pins 224 extend outwardly through a pair of inclined slots in 50 the insert and then through slots 234 in the side of the housing 214. In this way, axial movement of the rod 220 (caused by pulling or pushing on the knob 222) can cause the insert to rise or lower within the cavity. In turn, this causes the tissue-penetrating electrodes 206 and 208 to reciprocate 55 between a lowered configuration (FIG. 4A) and a raised configuration (FIG. 4B). The outer electrodes 202 and 204 are received in a plate 240 which is mounted over the cavity in housing 214. The plate 240 has a pair of slots for receiving the electrodes and 204, respectively. Additionally, plate 240 has a plurality of holes along lines spaced inwardly from the slots. Additionally, a channel 248 is formed along the center line of the plate 240 to receive a cutting blade 250, as best seen in FIG. 4C. The housing 214 forms a lower jaw structure and a hinged lever assembly 260 forms the upper jaw structure. The lever 260 includes a cover section 262 and a lever arm section 264. A center or fulcrum section is secured between brackets 270 formed on the top of housing 214. In this way, the cover section 262 can be moved between an open configuration (FIG. 4A) and a closed configuration (FIGS. 6B and 6C) by lifting and lowering the lever arm section 264. The bottom of the cover section 262 is best illustrated in FIG. 5. The bottom includes a pair of top surface electrodes 280 and 282, a relief channel284 for receiving the cutting blade 250, and relief holes 286 for receiving the upper tips of the tissuepenetrating electrodes when they are raised. The cutting blade 250 is formed at a forward end of an elongate blade structure having a pair of knobs 254 at its opposite or proximal end. The body portion of the blade is received in a slot in a handle portion 15 of the housing 214. The knobs extend on a connecting shaft out through a slot 17 in the handle 15. Thus, the blade can be advanced and retracted axially by moving the knob 254 from a retracted configuration (FIGS. 4A and 4B) to an advanced configu- 20 ration (FIG. 4C). The knob is disposed in the channel248 so that it will pass and cut through tissue which has been previously desiccated by applying radio frequency energy through the electrode structures of instrument 200, as described below. Referring now to FIGS. 6B-6C, a treatment region of tissue T may be located anywhere in the body where hyperthermic exposure may be beneficial. The treatment region may comprise and/or be located in tissue of or surrounding the liver, kidney, lung, bowel, stomach, pancreas, breast, uterus, prostate, muscle, membrane, appendix, other abdominal or thoracic organs, and the like. Initially, the cover 262 will be open and the tissuepenetrating electrodes 206 and 208 will be retracted into the housing 14 (FIGS. 6A and 4B). After introducing a bipolar surgical instrument 200 into a patient and positioning a target tissue structure between the open cover 262 and plate 240 of the housing 14, as shown in FIG. 6A, the cover can be closed grasping the tissue (as shown in FIG. 6B). The tissue-penetrating electrodes are then raised by pulling knob 222 (FIG. 6C), causing the electrodes 206 and 208 to engage the tissue before energizing the electrodes. Surface electrodes 202, 204, 280, and 282 in contrast, \vill compress on opposite sides of the tissue, but will not penetrate into the tissue. Radio frequency current will then be applied to the tissue according to the PST mode protocols as described above, with the surface electrodes being attached to one pole of radio frequency generator 2 and the tissue-penetrating electrodes being attached to the other pole. The electrical field will thus be concentrated between an outermost pair of surface electrodes (202/280 or 204/282) and the adjacent tissue-penetrating electrodes (206 or 208). Alternatively, the pole attachments of the radio frequency generator may be configured to provide an electrical field that is concentrated between the surface electrodes (202 and 204) or between the rows of tissue penetrating electrodes (206 and 208). The tissue may be completely desiccated with all the advantages of the use of a tissue-penetrating electrode energized by a bipolar radio frequency generator as described above. After complete desiccation is achieved, the blade 250 can be advanced to cut through the parallel segments of desiccated tissue which have been formed. While the above is a complete description of the preferred embodiments of the invention, various alternatives, 65 modifications, and equivalents may be used. Therefore, the above description should not be taken as limiting the scope of the invention which is defined by the appended claims.

145 Case: Document: 15 Page: 85 Filed: 12/02/ US 6,682,527 B2 What is claimed is: 1. A method for heating a treatment region of tissue, said method comprising: introducing a bipolar surgical instrument having first and second jaws with first and second electrode members 5 within the treatment region; grasping tissue between the first and second jaws; energizing the electrode members at a power level to deliver electrical energy to and heat tissue between the 10 first and second electrode members; and increasing the power level at a predetermined rate from an initial level, wherein the initial level and predetermined rate are selected to avoid creating a vapor layer and to permit an impedance increase to occur as a result of 15 complete tissue desiccation. 2. A method as in claim 1, further comprising measuring tissue impedance. 3. A method as in claim 2, further comprising comparing the measured impedance to an impedance limit, and automatically terminating power delivery if the measured impedance exceeds the impedance limit. 4. A method as in claim 3, wherein the impedance limit is selected to indicate the impedance increase due to complete tissue desiccation. 5. A method as in claim 3, wherein the impedance limit is in the range from 50 ohms to 1000 ohms. 6. A method as in claim 3, further comprising repeating the energizing and increasing steps at least once after termination until all the tissue between the first and second 30 electrodes is completely desiccated without charring the treatment tissue. 7. A method as in claim 1, further comprising terminating power delivery automatically after a preset amount of time. 8. A method as in claim 1, wherein the electrode members are energized with radio frequency current. 9. A method as in claim 8, wherein the radio frequency current is supplied with a controlled voltage power supply. 10. A method as in claim 1, wherein at least one of the electrode members comprises a plurality of tissue penetrating elements, the tissue penetrating elements engaging the tissue before the electrode members are energized. 11. A method as in claim 1, wherein the power level is in a range from 5 W to 150 W. 12. A method as in claim 1, wherein the predetermined rate of power increase is in the range from 1 W/sec to 100 W/sec. 13. A method as in claim 1, wherein the electrode members are energized for a time less than 5 minutes. 14. A method as in claim 1, wherein the tissue comprises 50 tissue of or surrounding the liver, kidney, lung, bowel, stomach, pancreas, breast, uterus, prostate, muscle, membrane, appendix, other abdominal organs, or other thoracic organs. 15. A system comprising: a radio frequency generator; and A computer program embodied in a tangible medium, wherein the program sets forth a method according to claim A radio frequency generator comprising: a radio frequency power source having a controlled voltage output and a bipolar connection for bipolar forceps having first and second jaws with first and second electrode members; and means for automatically increasing power delivered to the bipolar forceps; wherein the increasing means increases the power at a predetermined rate from an initial level, the initial level and predetermined rate avoiding formation of a vapor layer while permitting an impedance increase to occur as a result of complete tissue dessication. 18. A radio frequency generator as in claim 17, wherein the increasing means initiates a cycle where it measures an impedance of tissue, compares the measured impedance to an impedance limit, and increases the power level based on the predetermined rate if the measured impedance does not 20 exceed the impedance limit. 19. A radio frequency generator as in claim 18, wherein the impedance limit is selected to indicate the impedance increase due to complete tissue desiccation. 20. A radio frequency generator as in claim 18, wherein 25 the impedance limit is in the range from 50 ohms to 1000 ohms A radio frequency generator as in claim 18, wherein the increasing means repeats the cycle. 22. A radio frequency generator as in claim 18, wherein the increasing means is activated only once for continual cycling. 23. A radio frequency generator as in claim 17, further comprising a user interface for inputting the rate of power increase, the initial power level, and an impedance limit. 24. A radio frequency generator as in claim 23, wherein the user interface further comprises a front panel display that displays at least one of real-time impedance, total energy delivered, and instantaneous power delivered. 25. A radio frequency generator as in claim 23, wherein the user interface further comprises an audible alarm which 40 indicates the delivery of power. 26. A radio frequency generator as in claim 17, wherein the predetermined rate of power increase is in the range from 1 W/sec to 100 W/sec. 27. A radio frequency generator as in claim 17, wherein a 45 time of power delivery is less than 5 minutes. 28. A radio frequency generator as in claim 17, wherein the power source operates at a frequency in the range from 100kHz to 2 MHz and a power level in the range from 5 W to 150W. 29. A radio frequency generator as in claim 17, wherein the increasing means comprises a programmable digital controller. 30. A radio frequency generator as in claim 17, wherein the increasing means comprises a control program embodied 55 in a tangible medium. instructions setting forth the method of claim 1. * * * * *