Case 1:13-cv GBL-TCB Document 33 Filed 05/11/15 Page 1 of 17 PageID# 2015

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Case 1:13-cv-01566-GBL-TCB Document 33 Filed 05/11/15 Page 1 of 17 PageID# 2015 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF VIRGINIA Alexandria Division CONKWEST, INC. Plaintiff, v. MICHELLE K. LEE, Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent and Trademark Office, Defendant. Civil Action No. 1:13-cv-01566-GBL-TCB PLAINTIFF S MOTION IN LIMINE TO PRECLUDE DEFENDANT FROM RELYING ON EVIDENCE NOT TIMELY DISCLOSED UNDER RULE 26(A(2

Case 1:13-cv-01566-GBL-TCB Document 33 Filed 05/11/15 Page 2 of 17 PageID# 2016 Pursuant to the Final Pretrial Order dated March 20, 2015 (Dkt. # 30, Plaintiff CoNKwest, Inc. ( CoNKwest respectfully moves in limine to exclude Klingemann et al., Blood, 1994, 84, Suppl. 1 at 498 ( the 1994 Abstract (Defendant s Trial Exhibit No. 69, and to preclude Defendant, the U.S. Patent and Trademark Office ( PTO, and its expert, Dr. Lanier, from offering any testimony or argument at trial that relies on the 1994 Abstract. Despite having been aware of the existence of the 1994 Abstract for several months prior to the close of discovery, Defendant, in violation of Fed. R. Civ. P. 26(a(2 and the Joint Discovery Plan (Dkt. # 8, waited to disclose the 1994 Abstract to Plaintiff until March 10, 2015, at the start of the deposition of Defendants expert, Dr. Lanier. Dr. Lanier, however, did not discuss, reference or provide any opinions regarding the 1994 Abstract in his expert report, served prior to his deposition on February 13, 2015. Nor did the PTO produce the 1994 Abstract in time for Plaintiff s expert to consider it when preparing his rebuttal expert report, served on March 3, 2015. Defendant s untimely disclosure was not substantially justified and Defendant did not seek leave to serve a supplemental expert report from Dr. Lanier to address the 1994 Abstract. Moreover, the belated disclosure during the Lanier deposition near the close of discovery was highly prejudicial as it deprived Plaintiff of the opportunity to adequately prepare for Dr. Lanier s deposition and allowed Plaintiff s expert only a few days to consider and form additional expert testimony regarding the 1994 Abstract before the close of discovery. The reasons for this Motion are fully set forth in the accompanying Brief in Support and Declaration of Liane M. Peterson, dated May 11, 2015. 2

Case 1:13-cv-01566-GBL-TCB Document 33 Filed 05/11/15 Page 3 of 17 PageID# 2017 Date: May 11, 2015 Respectfully submitted, /s/ Liane M. Peterson Liane M. Peterson (Va. Bar No. 65828 Margareta Sorenson (admitted pro hac vice Foley & Lardner LLP 3000 K Street, N.W. 6th Floor Washington, D.C. 20007-5109 (202 672-5300 lpeterson@foley.com msorenson@foley.com Cynthia Rigsby (admitted pro hac vice Foley & Lardner LLP 777 East Wisconsin Avenue Milwaukee, WI 53202-5306 (414 271-2400 crigsby@foley.com Counsel for Plaintiff 4822-4992-4643. 3

Case 1:13-cv-01566-GBL-TCB Document 33 Filed 05/11/15 Page 4 of 17 PageID# 2018 CERTIFICATE OF SERVICE I, Liane M. Peterson, hereby certify that on May 11, 2015 a true and correct copy of the foregoing pleading or paper was served using the Court s CM/ECF system, with electronic notification of such filing to the following counsel of record: Dennis C. Barghaan, Jr. Assistant U.S. Attorney 2100 Jamieson Avenue Alexandria, Virginia 22314 Attorney for the Defendant Mary L. Kelly Sarah E. Craven Associate Solicitors USPTO 600 Dulaney St. Alexandria, Virginia 22314 Of Counsel for the Defendant By: /s/ Liane M. Peterson Liane Peterson Foley & Lardner, LLP 3000 K Street, N.W. 6th Floor Washington, D.C. 20007-5109 (202 672-5300 lpeterson@foley.com Counsel for the Plaintiff 4

Case 1:13-cv-01566-GBL-TCB Document 33 Filed 05/11/15 Page 5 of 17 PageID# 2019 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF VIRGINIA Alexandria Division CONKWEST, INC. Plaintiff, v. MICHELLE K. LEE, Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent and Trademark Office, Defendant. Civil Action No. 1:13-cv-01566-GBL-TCB BRIEF IN SUPPORT OF PLAINTIFF S MOTION IN LIMINE TO PRECLUDE DEFENDANT FROM RELYING ON EVIDENCE NOT TIMELY DISCLOSED UNDER RULE 26(A(2

Case 1:13-cv-01566-GBL-TCB Document 33 Filed 05/11/15 Page 6 of 17 PageID# 2020 TABLE OF CONTENTS TABLE OF AUTHORITIES... iv I. INTRODUCTION... 1 II. FACTS... 2 III. ARGUMENT... 4 A. The Federal Rules Provide for Preclusion of Untimely Expert Disclosures... 4 B. Dr. Lanier s Opinion Was Untimely and Not a Proper Supplementation.... 5 C. Preclusion Is An Appropriate Remedy Under The Circumstances... 6 1. CoNKwest Was Surprised and Prejudiced by Dr. Lanier s New Testimony Concerning the 1994 Abstract And That Surprise Cannot Be Cured... 7 2. Consideration of the 1994 Abstract is Not Important to the Issues to be Decided, Would Disrupt Trial, and Defendant Cannot Justify the Untimely Disclosure... 8 IV. CONCLUSION... 9 i

Case 1:13-cv-01566-GBL-TCB Document 33 Filed 05/11/15 Page 7 of 17 PageID# 2021 Federal Cases TABLE OF AUTHORITIES Page(s Akeva L.L.C. v. Mizuno Corp., 212 F.R.D. 306 (M.D.N.C. 2002...5 Barlow v. Gen. Motors Corp., 595 F. Supp. 2d 929 (S.D. Ind. 2009...6 Colony Apartments v. Abacus Project Mgmt., Inc., 197 Fed. Appx. 217 (4th Cir. 2006...5 East West, LLC v. Rahman, No. 1:11cv1380, 2012 U.S. Dist. LEXIS 133381 (E.D. Va. Sept. 17, 2012...6, 7 Gallagher v. Southern Source Packaging, LLC, 568 F. Supp.2d 624 (E.D.N.C. 2008...5 Gerawan Farming, Inc. v. Rehrig Pac. Co., 2013 U.S. Dist. LEXIS 67957 (E.D. Cal. May 13, 2013...7 O2 Micro Int'l, Ltd. v. Monolithic Power Sys., 467 F.3d 1355 (Fed. Cir. 2006...4 Federal Statutes 35 U.S.C. 102(b...2 Fed. R. Civ. P. 26(a(2... passim Fed. R. Civ. P. 26(e(1... passim Fed. R. Civ. P. 37(c(1...4, 6 ii

Case 1:13-cv-01566-GBL-TCB Document 33 Filed 05/11/15 Page 8 of 17 PageID# 2022 Pursuant to Local Rule 7(F(1, Plaintiff, CoNKwest, Inc. ( CoNKwest respectfully submits the following Brief in support of its Motion in Limine to Preclude Defendant from Relying on Evidence Not Timely Disclosed Under Rule 26(a(2. I. INTRODUCTION At his March 10, 2015 deposition, well after the deadline for expert disclosures, the Defendant s expert witness, Dr. Lanier, disclosed for the first time that he intended to rely on and provide opinions based on an abstract entitled A cytotoxic NK-cell clone for effective immunological purging of leukemic cells from blood, by Klingemann et al., Blood, 1994, 84, Suppl. 1 at 498 ( the 1994 Abstract. (Declaration of Liane M. Peterson ( Peterson Decl. at 2 and Ex. A, also Defendant s Trial Exhibit No. 69. Defendant had never produced this document to Plaintiff before. Id. Yet, given the November 13, 2014 printing date that appeared on a document identifying the Abstract, the Defendant had been aware of the 1994 Abstract for at least four months. (Id. at 3 and Ex. B. There is no substantial justification for Dr. Lanier s failure to address the 1994 Abstract in his February 13, 2015 expert report, or for Defendant failing to otherwise disclose that it intended to rely on the 1994 Abstract in a more timely manner. Plaintiff was harmed by this untimely disclosure as it had no time to properly prepare for Dr. Lanier s deposition, in view of this new evidence, and little time to prepare a response or obtain additional discovery. Indeed, such late disclosures are precisely the kind of trial by ambush that the federal rules and the Court s scheduling orders seek to prevent. Accordingly, CoNKwest respectfully requests that the 1994 Abstract be excluded, and that the Defendant and Dr. Lanier be precluded from offering any testimony or argument at trial that relies on the 1994 Abstract. 1

Case 1:13-cv-01566-GBL-TCB Document 33 Filed 05/11/15 Page 9 of 17 PageID# 2023 II. FACTS On November 26, 2014, the parties entered a Joint Discovery Plan specifying that Defendant is required to serve expert disclosures required by Federal Rule 26(a(2 on or before February 13, 2015. (Dkt. # 8, p, 2. Pursuant to this plan, the PTO served the Expert Report of Lewis L. Lanier, Ph.D. ( the Lanier Report on February 13, 2015. (Peterson Decl. Ex. C, Lanier Report. While the Lanier Report cites a number of references in support of the alleged obviousness of claims 20, 26 and 27 of US Application 10/008,955 ( the 955 application, it makes no mention of the 1994 Abstract. (Id. Rather, the Lanier Report relies extensively on two references authored by the named inventor of the 955 application, Dr. Hans Klingemann: Klingemann et al., Biol. Blood & Marrow Transplant, 2:68 (1996 ( Klingemann 1996, Exhibit 22 to the Lanier Report (Peterson Decl. Ex. D; and Klingemann et al., Blood 87:4913 (1996 ( the 1996 Blood Letter, Exhibit 41 to the Lanier Report (Peterson Decl. Ex. B (collectively, the 1996 Klingemann References. Because these two references disclose only Dr. Klingemann s own work, and were published less than one year before the 955 filing date, they are not available art against the 955 application under pre-aia 35 U.S.C. 102(b. (See Peterson Decl. Ex. E, Klingemann Declaration dated March 3, 2015. To formally remove these references from the available art, Dr. Klingemann submitted a declaration in the instant action (Peterson Decl. Ex. E, which was promptly served on the Defendant and attached as Exhibit 39 to the reply expert report served by Plaintiff s expert, Dr. Jeffrey S. Miller on March 3, 2015 ( Miller Rebuttal Report according to the scheduled entered by the Court. (Peterson Decl. at 7 and Ex. F, Miller Rebuttal Report. Then, during his March 10, 2015 deposition, Dr. Lanier disclosed for the first time that he wanted to correct his expert report by adding the reference: 2

Case 1:13-cv-01566-GBL-TCB Document 33 Filed 05/11/15 Page 10 of 17 PageID# 2024 Q. Did you have another correction? A. I wanted to add an abstract to the materials of prior art, which is an abstract which was presented at the ASH meeting and published in "Blood" in 1994. (Peterson Decl. Ex. G, March 10, 2015 Deposition of Dr. Lanier ( Lanier Tr. at 7:17-21. When asked about the reasons for the late disclosure, Dr. Lanier testified: Q. When did you first learn about Exhibit 2? A. A couple days ago. Q. Did counsel provide it to you? A. Counsel provided it. Q. So it came to your attention when counsel provided a copy to you? A. Correct. Q. Why did you not include it in your report? A. We didn't have a copy of it at the time. Q. But you were aware of it at the time? A. I was not. Q. Who was? A. Counsel. (Peterson Decl. Ex. G, Lanier Tr. 41:3-15. The record indicates that Defendant knew of this reference, not just for a few days, but for a longer period of time prior to Dr. Lanier s deposition. The 1996 Blood Letter, which Dr. Lanier cited and relied upon in his expert report, cites only six references, one of which was the 1994 Abstract. (Peterson Decl. Ex. B at page 3, reference #4. Defendant appears to have been aware of the 1996 Blood Letter and thus, the 1994 Abstract cited therein, at least since November 13, 2014, according to the header of the document indicating that it was printed on November 13, 2014. (Peterson Decl. 3 and Ex. B at page 1, header Thus, it would appear that Defendant was aware of this new reference, or could have been aware with the exercise of reasonable diligence, since November 13, 2014, nearly four months before the PTO s untimely disclosure. 3

Case 1:13-cv-01566-GBL-TCB Document 33 Filed 05/11/15 Page 11 of 17 PageID# 2025 III. ARGUMENT A. The Federal Rules Provide for Preclusion of Untimely Expert Disclosures Dr. Lanier disclosed his intent to rely on the 1994 Abstract for the first time at his deposition, long after the Court-ordered deadline for service of Defendant s expert disclosures had passed. The late disclosure was not substantially justified, as the Defendant knew of, or should have known of, the 1994 Abstract prior to serving the Lanier Report. See supra Section II. Allowing the Defendant to rely on this evidence at trial is prejudicial to CoNKwest and would confer an unfair advantage to the Defendant. Accordingly, CoNKwest respectfully requests that Defendant and its expert, Dr. Lanier, be precluded from relying on or referencing the 1994 Abstract at trial. Pursuant to Rule 26 of the Federal Rules of Civil Procedure, an expert report must contain a complete statement of all opinions the witness will express and the basis and reasons for them. Fed. R. Civ. P. 26(a(2(B(i. The federal rules also impose a duty to supplement an expert report in a timely manner if the party learns that in some material respect the disclosure or response is incomplete or incorrect, and if the additional or corrective information has not otherwise been made known to the other parties during the discovery process or in writing. Fed. R. Civ. P. 26(e(1. Rule 37(c provides that [i]f a party fails to provide information or identify a witness as required by Rule 26(a or (e, the party is not allowed to use that information or witness to supply evidence on a motion, at a hearing, or at a trial, unless the failure was substantially justified or is harmless. Fed. R. Civ. P. 37(c(1; see also O2 Micro Int'l, Ltd. v. Monolithic Power Sys., 467 F.3d 1355, 1368-1369 (Fed. Cir. 2006 (holding that exclusion of expert opinions pursuant to Rule 37(c(1 was not an abuse of discretion when the party had failed to timely disclose the information in accordance with Rule 26(a(2. 4

Case 1:13-cv-01566-GBL-TCB Document 33 Filed 05/11/15 Page 12 of 17 PageID# 2026 While a party has a duty to supplement, this duty does not permit a party to make an end-run around the normal timetable for conducting discovery. Colony Apartments v. Abacus Project Mgmt., Inc., 197 Fed. Appx. 217, 223 (4th Cir. 2006; see also East West, LLC v. Rahman, No. 1:11cv1380, 2012 U.S. Dist. LEXIS 133381, at *21, (E.D. Va. Sept. 17, 2012 ( The mere fact that Defendants First Report does not state all of the opinions it would now like to admit does not give them free reign to submit those opinions under the guise of supplementation, and it certainly does not mean that the Court must now admit them.. Courts distinguish true supplementation, i.e. correction of inadvertent errors or omissions, from gamesmanship, and have repeatedly rejected attempts to supplement an expert report with a new and improved expert report. Gallagher v. Southern Source Packaging, LLC, 568 F. Supp.2d 624, 631 (E.D.N.C. 2008. Here, the Defendant was aware of the 1994 Abstract for several months prior to serving the Lanier Report, but only sought to add it once it learned that it could no longer rely on the Klingemann 1996 References. Thus, the PTO s late disclosure of the 1994 Abstract is not merely a correction to address an inadvertent omission, but rather, the type of gamesmanship that the federal rules seek to prevent. If the 1994 Abstract was the Defendant s backup argument or fallback position, Defendant was obligated to timely disclose it, not hold it close to the vest only to reveal it when their first argument failed. B. Dr. Lanier s Opinion Was Untimely and Not a Proper Supplementation. Rule 26(e provides for supplementation only if the initial disclosure is incomplete or incorrect, and if the additional or corrective information has not otherwise been made known to the other parties during the discovery process or in writing. Fed. R. Civ. P. 26(a(A. Rule 26(e does not cover failures of omission because the expert did an inadequate or incomplete preparation. Akeva L.L.C. v. Mizuno Corp., 212 F.R.D. 306, 310 (M.D.N.C. 2002. Nor does 5

Case 1:13-cv-01566-GBL-TCB Document 33 Filed 05/11/15 Page 13 of 17 PageID# 2027 Rule 26(e allow parties to spring late surprises on their opponents under the guise of a supplement to earlier disclosures. Barlow v. Gen. Motors Corp., 595 F. Supp. 2d 929, 935-36 (S.D. Ind. 2009. Here, the record suggests that the Defendant was likely aware of the 1994 Abstract well before the untimely disclosure during Dr. Lanier s deposition. See supra Section II. Dr. Lanier testified that counsel for Defendant was aware of the 1994 Abstract prior to its disclosure to Plaintiff. (Peterson Decl. Ex. G, Lanier Tr. at 41:3-15. Consistent with this testimony, the version of the 1996 Blood Letter that the Defendant marked during the deposition of Dr. Klingemann indicates that the Defendant had printed the 1996 Blood Letter on November 13, 2014, nearly four months prior to the Lanier Deposition. (Peterson Decl. at 3 and Ex. B. The 1994 Abstract is one of only two additional references authored by Dr. Klingemann in the 1996 Blood Letter, which Dr. Lanier relied on in his expert report. (Peterson Decl. Exs. B and C. It follows that with the exercise of reasonable diligence, the Defendant could have, and should have been on notice of the existence of the 1994 Abstract for months prior to service of Dr. Lanier s expert report. Yet, the Defendant did not disclose the 1994 Abstract until after it learned that the Klingemann 1996 references would no longer be relevant in light the sworn testimony provided by Dr. Klingemann in his declaration. (Peterson Decl. at 2 and Exs. A and E. Thus, the Defendant s belated disclosure of the 1994 Abstract was not a permissible supplementation under Rule 26(e. C. Preclusion Is An Appropriate Remedy Under The Circumstances Because Dr. Lanier s reliance on the 1994 Abstract was neither timely disclosed, nor a proper supplementation under Rule 26(e, the Defendant and Dr. Lanier should be precluded 6

Case 1:13-cv-01566-GBL-TCB Document 33 Filed 05/11/15 Page 14 of 17 PageID# 2028 from relying on the 1994 Abstract at trial. To determine whether exclusion is an appropriate remedy under Rule 37(c, this Court considers five factors: (1 the surprise to the party against whom the evidence would be offered; (2 the ability of that party to cure the surprise; (3 the extent to which allowing the evidence would disrupt the trial; (4 the importance of the evidence; and (5 the non-disclosing party s explanation for its failure to disclose the evidence. East West, LLC v. Rahman, 2012 U.S. Dist. LEXIS 133381, *15-16 (E.D. Va. Sept. 17, 2012. These factors weigh heavily in favor of precluding the Defendant from relying on the 1994 Abstract. Miller was given little time to review and prepare his rebuttal report taking away from the time 7 1. CoNKwest Was Surprised and Prejudiced by Dr. Lanier s New Testimony Concerning the 1994 Abstract And That Surprise Cannot Be Cured CoNKwest had only one opportunity to depose the Defendant s expert Dr. Lanier, and it prepared for that deposition with the understanding that the Lanier Report served pursuant to the Court s schedule comprised a complete disclosure of his opinions. The surprise introduction of the 1994 Abstract at the start of the Lanier deposition (Peterson Decl. at 2 deprived CoNKwest from the opportunity to adequately prepare for the deposition and to take additional discovery related to this reference. Moreover, the Defendant s decision to wait until the Lanier deposition to disclose the new reference provided the Defendant with an unfair tactical advantage that cannot be cured. Such late disclosures, even when made a few days before deposition have been found to be harmful. Gerawan Farming, Inc. v. Rehrig Pac. Co., 2013 U.S. Dist. LEXIS 67957 at *16 (E.D. Cal. May 13, 2013 (finding supplemental expert disclosure four days before the close of discovery and 48 hours before the expert deposition to be harmful. Plaintiff s expert, Dr. Miller, prepared a brief Supplemental Rebuttal report to respond to the newly added reference, but this does not cure the surprise or prejudice to CoNKwest. Dr.

Case 1:13-cv-01566-GBL-TCB Document 33 Filed 05/11/15 Page 15 of 17 PageID# 2029 he otherwise had to prepare for his deposition -- and CoNKwest was forced to devote additional resources to respond to the new reference on short notice, in the midst of depositions and near the close of the discovery period. Furthermore, the rebuttal does nothing to cure the prejudice CoNKwest suffered as a result of being deprived of an opportunity to adequately prepare to depose Dr. Lanier regarding the 1994 Asbtract, and to take additional discovery. 2. Consideration of the 1994 Abstract is Not Important to the Issues to be Decided, Would Disrupt Trial, and Defendant Cannot Justify the Untimely Disclosure As explained supra at Section II, the Defendant should have been aware of the 1994 Abstract since at least November 2014, months before serving the Lanier Report. However, the Defendant and Dr. Lanier deliberately chose to instead rely on the more detailed disclosure of the Klingemann 1996 References in the Lanier Report. The Defendant s attempt to add the 1994 Abstract to substitute for the Klingemann 1996 references is not substantially justified, and the its failure to offer a legitimate explanation for the untimely disclosure weighs strongly in favor of preclusion. In addition, Plaintiff s expert has opined that the 1994 Abstract would not render the claimed invention obvious. This, in combination with the fact that the 1994 Abstract was authored by the inventor of the 955 application himself, Dr. Klingemann, and not some other third party (see Peterson Decl. Ex. A, demonstrates that the 1994 Abstract has little, if any relevance to the ultimate issues to be decided in this matter. Moreover, the Defendant s belated disclosure of the 1994 Abstract was not only untimely, but incomplete as well, as Dr. Lanier has not adequately disclosed how he intends to rely on the 1994 Abstract in support of the Defendant s obviousness case. Therefore, CoNKwest would either need to seek additional discovery, which would disrupt to the trial schedule, or expend a disproportionate amount of time at trial to adequately address this late added reference. 8

Case 1:13-cv-01566-GBL-TCB Document 33 Filed 05/11/15 Page 16 of 17 PageID# 2030 IV. CONCLUSION For the above reasons, CoNKwest respectfully requests that the Court exclude the 1994 Abstract preclude the Defendant and its expert, Dr. Lanier, from offering any testimony or argument at trial that relies upon it. Date: May 11, 2015 Respectfully submitted, /s/ Liane M. Peterson Liane M. Peterson (Va. Bar No. 65828 Margareta Sorenson (admitted pro hac vice Foley & Lardner LLP 3000 K Street, N.W. 6th Floor Washington, D.C. 20007-5109 (202 672-5300 lpeterson@foley.com msorenson@foley.com Cynthia Rigsby (admitted pro hac vice Foley & Lardner LLP 777 East Wisconsin Avenue Milwaukee, WI 53202-5306 (414 271-2400 crigsby@foley.com Counsel for Plaintiff 9

Case 1:13-cv-01566-GBL-TCB Document 33 Filed 05/11/15 Page 17 of 17 PageID# 2031 CERTIFICATE OF SERVICE I, Liane M. Peterson, hereby certify that on May 11, 2015 a true and correct copy of the foregoing pleading or paper was served using the Court s CM/ECF system, with electronic notification of such filing to the following counsel of record: Dennis C. Barghaan, Jr. Assistant U.S. Attorney 2100 Jamieson Avenue Alexandria, Virginia 22314 Attorney for the Defendant Mary L. Kelly Sarah E. Craven Associate Solicitors USPTO 600 Dulaney St. Alexandria, Virginia 22314 Of Counsel for the Defendant By: /s/ Liane M. Peterson Liane Peterson Foley & Lardner, LLP 3000 K Street, N.W. 6th Floor Washington, D.C. 20007-5109 (202 672-5300 lpeterson@foley.com Counsel for the Plaintiff 10