Fundamentals of Patent Prosecution 2013:

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2 INTELLECTUAL PROPERTY Course Handbook Series Number G-1139 Fundamentals of Patent Prosecution 2013: A Boot Camp for Claim Drafting & Amendment Writing Co-Chairs Jonathan Berschadsky Angelo J. Bufalino Jennifer R. Bush Wendy A. Choi Adda C. Gogoris Richard T. McCaulley, Jr. Michael A. Molano Kevin E. Noonan, Ph.D. Louis S. Sorell To order this book, call (800) 260-4PLI or fax us at (800) Ask our Customer Service Department for PLI Order Number 41887, Dept. BAV5. Practising Law Institute 810 Seventh Avenue New York, New York 10019

3 This work is designed to provide practical and useful information on the subject matter covered. However, it is sold with the understanding that the publisher is not engaged in rendering legal, accounting or other professional services. If legal advice or other expert assistance is required, the services of a competent professional should be sought. Copyright 2013 by Practising Law Institute. All rights reserved. Printed in the United States of America. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form by any means, electronic, mechanical, photocopying, recording, or otherwise without the prior written permission of Practising Law Institute

4 17 PATENT DRAFTING AND PROSECUTION: THE INTRINSIC RECORD AND ITS IMPACT ON PATENT LITIGATION (MARCH 1, 2013) Michael P. Kahn Joseph Van Tassel Gabriele Amodeo Ropes & Gray LLP If you find this article helpful, you can learn more about the subject by going to to view the on demand program or segment for which it was written. 551

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6 BIOGRAPHICAL INFORMATION MICHAEL P. KAHN is a partner in Ropes & Gray s Intellectual Property group. An experienced trial lawyer who focuses his practice on patent and trade secret litigation and advising clients concerning intellectual property strategy, Michael is experienced in all aspects of intellectual property litigation, from discovery through trial and appeal. Michael s litigation and trial experience spans a variety of technologies, including pharmaceuticals, medical devices, software, consumer products and electrical, chemical, computer science and mechanical engineering. JOSEPH VAN TASSEL is an associate in Ropes & Gray s Intellectual Property group. Before joining the firm, Joseph clerked on the United States Court of Appeals for the Sixth Circuit. GABRIELE AMODEO is a technical advisor in Ropes & Gray s intellectual property group. Prior to joining Ropes & Gray, Gabriele obtained his Ph.D. in Biological Sciences at Columbia University

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8 I. INTRODUCTION There comes a time in every patent infringement litigation when the trial lawyers ask, Why did the prosecuting attorney do or say THAT? Whether it is an issue of how claims are drafted, how the invention is described in the specification, how prior art is distinguished or why alternative arguments are presented to the PTO the approach taken to patent drafting and prosecution can have a profound impact on litigation. This article addresses the components of the intrinsic record and highlights a few key scenarios that if attended to properly during drafting and prosecution can help make the intrinsic record as trial-ready as possible. This article highlights the importance of ongoing communication between litigation and patent prosecution teams to ensure a consistent and cohesive strategy. II. THE INTRINSIC RECORD A. The Claims Choice of Form Matters The way claims are drafted, and how the technology is implemented by competitors, determines the type of infringement that must be proven in litigation. For example, direct infringement of simple apparatus claims may be straightforward, while indirect infringement of method claims that are practiced only by certain customers will be more complex, due to knowledge and intent requirements. 1 Litigation over certain method claims has the added complexity of requiring evidence of direct infringement by clients/customers as a condition precedent to liability. For other method claims it is also important to consider whether the claims are drafted in such a manner so as to permit infringement by a single actor. Where infringement is spread among two or more parties, there is an issue of divided infringement. This is a complicated and developing area of the law. 1. See Global-Tech Appliances, Inc. v. SEB S.A., 131 S. Ct. 2060, 2065, 2068 (2011); DSU Med. Corp. v. JMS Co., 471 F.3d 1293, (Fed. Cir. 2006) (en banc)

9 1. Divided Infringement A Type of Direct Infringement The patent statute creates liability for both direct 2 and indirect 3 infringement of patent claims. Typically, in order to directly infringe under 35 U.S.C. 271(a), a single party must practice all elements of an asserted claim. 4 Further, in order to establish indirect infringement, whether by inducement or contributory infringement, a patentee is required to show, among other elements, that there was a predicate act of direct infringement. 5 There is a perceived loophole, however, in the statutory infringement framework. While a direct infringer may be liable for performing all steps of a claimed method and an indirect infringer may be liable for inducing another to perform all steps of a claimed method, there may be no liability if those same two parties split up the steps and each performed only some of them. A clever party, therefore, potentially could avoid liability by having another person perform one or more of the claimed steps. In such circumstances, the infringement would be divided. In an attempt to address this perceived loophole, the Federal Circuit, in BMC Resources v. Paymentech, held that an accused infringer could be held liable for direct infringement when it performed some of the claimed steps and directed or controlled another to perform the rest. 6 This direction or control standard, grounded in agency principles, was designed to prevent parties who mastermind divided infringement schemes from escaping liability. 7 The court acknowledged, however, that this standard did not close the divided infringement loophole completely as parties could still enter into arms-length agreements to avoid infringement See 35 U.S.C. 271(a). 3. Indirect infringement includes both inducement under 35 U.S.C. 271(b) and contributory infringement under 35 U.S.C. 271(c). 4. See Akamai Techs., Inc. v. Limelight Networks, Inc., 692 F.3d 1301, 1307 (Fed. Cir. 2012) (en banc) (per curiam). 5. Id. at 1308; BMC Res., Inc. v. Paymentech, L.P., 498 F.3d 1373, 1380 (Fed. Cir. 2007), overruled in part by Akamai Techs., 692 F.3d at BMC Res., 498 F.3d at Id. 8. Id

10 2. The Inducement Only Rule The precedent in this area was sufficiently murky that the Federal Circuit in 2012 agreed to consider en banc the appropriate standard for infringement by multiple parties performing the various steps of a claimed method. Instead of addressing this issue by refining its direct infringement precedent, however, in a combined opinion covering both Akamai Technologies v. Limelight Networks and McKesson Technologies v. Epic Systems, the en banc court determined that instances of so-called divided infringement could all be resolved through the inducement doctrine. 9 In so doing, the court overturned the portion of BMC that held, in order for a party to be liable for induced infringement, some other single entity must be liable for direct infringement. 10 The court held that held that the predicate direct infringement required under 271(b) can exist even when no single entity could be held liable as a direct infringer under 271(a). 11 The court reasoned that [i]t would be a bizarre result to hold someone liable for inducing another to perform all the steps of a method claim but to hold harmless one who goes further by actually performing some of the steps himself. 12 Accordingly, a patentee with asserted claims practiced only by multiple parties, under the new standard articulated by the Federal Circuit, 13 must proceed under an inducement theory, which requires proof that (1) the accused infringer knew of the patent; (2) the accused infringer performed some of the steps of the claimed method; (3) the accused infringer induced one or more additional parties to perform the remaining steps of the claimed method (with the requisite intent); and (4) the other parties actually performed these remaining steps Akamai Techs., 692 F.3d at Id. 11. Id. at Id. at The Court did not address under what circumstance multiple parties may be liable for direct infringement under 35 U.S.C. 271(a) or reconsider the direction or control standard. 14. See e.g., id. at

11 3. Best Practices Keep It Simple, Where Possible Particular attention must be paid to how method claims are drafted (if they are necessary at all) and whether they can be practiced readily by a single actor. The Federal Circuit, in BMC Resources, noted that divided infringement can usually be offset by proper claim drafting because [a] patentee can usually structure a claim to capture infringement by a single party. 15 Most method claims can be drafted in unitary form by focusing on one entity and whether it supplies or receives any given element. 16 Drafting claims with divided infringement issues also injects an element of uncertainty because there is a risk that the inducement only standard will not endure. The Federal Circuit was closely divided in this case with a 6-5 majority issuing a per curiam opinion. 17 Moreover, the concept that there can be direct infringement without any direct infringers has generated concern and clear judicial dissent. 18 Even if the inducement only rule remains, it is more complicated than direct infringement because of the nature of the infringement proof. Direct infringement is a strict liability offense, meaning that a patentee need only establish that an accused infringer practiced each and every element of the claimed invention in order to establish liability. 19 As set forth above, induced infringement, on the other hand, requires the patentee to prove that the accused infringer had knowledge of the patent and the specific intent to induce infringement, in addition to proving the predicate act(s) of direct infringement. 20 It many cases, these complications can be avoided at the outset by careful attention to claim drafting. 15. BMC Res., 498 F.3d at Mark A. Lemley, et al., Divided Infringement Claims, 33 AIPLA Q.J. 255, 272 (2005). 17. Akamai Techs., 692 F.3d at See id. at 1328 (Newman, J., dissenting) (noting the quandary of how there can be direct infringement but no direct infringers ); id. at (Linn, J., dissenting) (arguing that direct infringement should not be defined differently under 271(b) than it is under 271(a)). 19. BMC Res., 498 F.3d at Id.; See also Akamai Techs., 692 F.3d at

12 B. The Claims Choice of Words Matters Too 1. Lexicography What Happens When You re Not Clear It is not necessary to invent new words or new ways to define known words in order to show you have a patentable invention. The choice of terminology and how words are used and described will have a profound impact on shaping litigation. It is well established that the words of a claim are generally given their ordinary and customary meaning, [although] a patentee may choose to be his [or her] own lexicographer and use terms in a manner other than their ordinary meaning, as long as the special definition of the term is clearly stated in the patent specification or file history. 21 Indeed, the specification and prosecution history, which constitute the intrinsic record, are the primary resources for claim construction. 22 In particular, claim construction starts with the language of the claims themselves, followed by the specification (of which they are a part), and then the prosecution history. Only when ambiguity remains, will courts then consider extrinsic evidence. 23 Courts treat extrinsic evidence with some measure of skepticism, discounting, for example, expert testimony that contradicts the intrinsic record. 24 What happens, however, when a claim uses ambiguous terminology that cannot be construed using the intrinsic record? Even simple words can create such disputes. For example, in Hoechst Celanese Corp. v. BP Chemicals Ltd., the parties disputed the meanings of the terms stable and dimension. 25 In Hoechst, the parties disagreed over whether a dimension could refer to volume, and each side provided dictionary definitions to support their proposed interpretations. 26 Ultimately, the court determined that the 21. Hoechst Celanese Corp. v. BP Chems. Ltd., 78 F.3d 1575, 1578 (Fed.Cir.1996), citing Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). 22. Vitronics Corp., 90 F.3d at 1582 (Fed. Cir. 1996); Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir. 2005) (en banc). 23. Vitronics Corp., 90 F.3d at See Key Pharms v. Hercon Labs. Corp., 161 F 3d 709, 716 (Fed. Cir. 1998). See also Phillips, 415 F.3d at Hoechst Celanese Corp., 78 F.3dat Id. at

13 patentee s definition should govern because, unlike defendant s, it would not exclude the preferred embodiment. 27 In Wilson Sporting Goods Co. v. Hillerich & Bradsby Co., the court was faced with several terms that were used in the claims but neither used nor described elsewhere in the specification. 28 With no intrinsic evidence to address the terms directly, the Court concluded that the term was to be understood using its ordinary meaning. 29 In support of this meaning, the court resorted to dictionary definitions Best Practices Make A Clear Intrinsic Record When ambiguous claim terms are used, litigants risk having the constructions determined by extrinsic evidence that is unpredictable, inconsistent, and always subject to dispute. Careful attention to claim drafting and the choice of clear and understood terms, defined in the specification where needed, can avoid this scenario. C. The Specification Say What You Are, Not What You re Not The purpose of the specification is to provide a description of your invention in sufficient detail such that a person of ordinary skill in the art can (1) understand that you invented what you say you invented and (2) be able to use it without undue experimentation. 31 There is no requirement to explain in detail what you have not invented Avoiding Disclaimer Arguments Disclaimers are statements that disavow or surrender subject matter that would otherwise be covered by the claims. They can be found in a patent s specification or in a patent s prosecution 27. Id. at Wilson Sporting Goods Co. v. Hillerich & Bradsby Co., 442 F.3d 1322, (Fed. Cir. 2006). 29. Id. 30. Id. 31. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, (Fed. Cir. 2010). 32. See 35 U.S.C

14 history. 33 Disclaimers can be vitally important in patent litigation because they can impact both the construction of claim terms and the ability to assert infringement under the doctrine of equivalents. 34 Courts have found disclaimers in the specification where the patentee includes expressions of manifest exclusion or restriction, representing a clear disavowal of claim scope. 35 For example, in Gaus v. Conair, the Federal Circuit held that the specification made clear that the structure used in the accused device was excluded from the scope of the claimed invention. 36 The patent was directed towards protective circuitry that prevented fatal shocks when electrical appliances come in contact with water. 37 The critical claim language required a pair of spaced-apart electrically exposed conductive probe networks. The specification explained that one of the principal advantages of this structure was that it prevented the user from receiving any electrical shock, in contrast to prior art devices, including the accused device, which used just a single probe and subject users to a brief, but non-lethal shock. 38 The court rejected the patentee s argument that this was merely a description of a preferred embodiment because the specification stated that according to the invention the protective circuit accomplishes this disconnection before the user can be connected to voltage-carrying exposed parts via the fluid which has entered the housing, i.e., 33. See Phillips, 415 F.3d at 1316 ( [T]he specification may reveal an intentional disclaimer, or disavowal, of claim scope by the inventor. ); id. at 1317 ( [T]he prosecution history can often inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether the inventor limited the invention in the course of prosecution, making the claim scope narrower than it would otherwise be. ) 34. See Southwall Techs. v. Cardinal IG Co., 54 F.3d 1570, 1576 (Fed. Cir. 1995) ( Arguments and amendments made during the prosecution of a patent application and other aspects of the prosecution history, as well as the specification and other claims, must be examined to determine the meaning of terms in the claims. The prosecution history limits the interpretation of claim terms so as to exclude any interpretation that was disclaimed during prosecution. ). 35. Conoco, Inc. v. Energy & Envtl. Int l., 460 F.3d 1349, 1357 (Fed. Cir. 2006) (citing Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002) ( The patentee may demonstrate an intent to deviate from the ordinary and accustomed meaning of a claim term by including in the specification expressions of manifest exclusion or restriction, representing a clear disavowal of claim scope. )). 36. Gaus v. Conair Corp., 363 F.3d 1284, 1290 (Fed. Cir. 2004). 37. Id. at Id. at

15 without subjecting the user to any shock. 39 The court concluded that the specification thus demonstrates that the invention itself requires that the user be completely protected from shock, in contrast to prior art devices that exposed the user to a brief, non-lethal shock. 40 In SciMed Life Systems v. Advanced Cardiovascular Systems, the Federal Circuit noted that [w]here 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. 41 The SciMed court concluded that the patentee had clearly disclaimed catheters with dual, side-by-side lumens (passageways) based on many statements in the written description that define the invention as employing a coaxial lumen structure and distinguish the prior art in part on the ground that it used a dual lumen structure. 42 In particular, the statement in the specification that asserted that all embodiments of the present invention included the use of a coaxial lumen was determined to be a clear assertion that this structure was a necessary element of the claimed invention and all other lumen structures were therefore excluded from the scope of the claims. 43 Similarly, the Federal Circuit has found disclaimer when applicants have specifically limited the invention to particular structures Id. at 1290 (citation omitted) (emphasis added). 40. Id. 41. SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1341 (Fed. Cir. 2001). 42. Id. at Id. at Watts v. XL Sys., Inc., 232 F.3d 887, 883 (Fed. Cir. 2000). See also id. at 882 (citing O.I. Corp. v. Tekmar Co., 115 F.3d 1576, 1581 (Fed. Cir. 1997) (limiting claims because the specification described only non-smooth or conical passages and distinguished over the prior art based on these characteristics); Wang Labs., Inc. v. America Online, Inc., 197 F.3d 1377, (Fed. Cir. 1999) (limiting claims to the only embodiment described, a character-based protocol, and specifically not encompassing a bit-mapped protocol); Modine Mfg. Co. v. United States Int l Trade Comm n, 75 F.3d 1545, 1551 (Fed. Cir. 1996) ( [W]hen the preferred embodiment is described in the specification as the invention itself, the claims are not necessarily entitled to a scope broader than that embodiment. ))

16 or even in situations where the advantages of a particular structure were described as important to the invention. 45 Descriptions that merely recite an embodiment of the invention, however, are not considered disclaimers. For example, in Liebel- Flarsheim Co. v. Medrad, Inc., the court held that although all the embodiments described in the common specification of the asserted patents included a particular structure (a pressure jacket), the specification did not contain a clear disavowal of embodiments lacking a pressure jacket. 46 The court found that language describing the use of a pressure jacket could reasonably be understood as a general description of the invention but that this language did not suggest that this structure was an essential component of the invention. 47 Even when a patent describes only a single embodiment, the Federal Circuit has rejected arguments that the patent claims must be construed as limited to that embodiment Best Practices Describe Embodiments Not The Invention These cases illustrate that care must be taken when drafting a patent specification to avoid unnecessarily limiting the scope of the claims. Case law suggests that use of words like key, necessary, important, or essential when describing a particular element of a claimed invention may result in a disclaimer of embodiments that do not include that element. Moreover, where the specification describes the invention rather than an embodiment of the invention, there is a higher risk of facing a disclaimer argument. D. The Prosecution History Only Say What You Have To While it may be necessary in some circumstances to limit the scope of the claims in order to distinguish the pending claims over particularly close prior art, there are many cases when multiple arguments 45. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1301 (Fed. Cir. 1999). 46. Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 908 (Fed. Cir. 2004). 47. Id. This conclusion was bolstered by the fact that the patent contained dependent claims that added a limitation requiring a pressure jacket. Id. at 910 (applying the doctrine of claim differentiation, which instructs that the presence of a dependent claim that adds a particular limitation raises a presumption that the limitation in question is not found in the independent claim ). 48. Phillips, 415 F.3d at See also Liebel-Flarsheim, 358 F.3d at

17 are made when a single, strong argument, will suffice. In addition, there are many cases where extreme statements are made in what are otherwise background arguments that are neither directly responsive to arguments raised by the examiner, nor central to any prior art rejection. Those arguments, like statements in the specification (addressed above), have little impact on overcoming the prior art rejections but can have a debilitating impact on claim scope for purposes of infringement. 1. Avoiding Disclaimer Arguments and Estoppel Prosecution disclaimer can be amendment-based, resulting from narrowing amendments, or argument-based, resulting from arguments made by the applicant. Regardless of the source, prosecution disclaimer can restrict claim scope and foreclose the doctrine of equivalents through the operation of prosecution history estoppel. 49 Although there is a conceptual distinction between disclaimer and estoppel, the standard is the same; in both circumstances, the alleged disavowing actions or statements made during prosecution must be both clear and unmistakable. 50 Courts have found such clear and unmistakable surrender of claim scope in a number of cases. For example, in Bayer AG v. Elan Pharmaceutical Research., the Federal Circuit concluded that through its argument and declarations, the applicant clearly 49. While literal infringement requires a patentee to establish that the accused devices contains each limitation of the asserted claim, infringement under the doctrine of equivalents can occur where there are only insubstantial differences between the claim limitations and the accused product. Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1247, (Fed. Cir. 2000). Prosecution history estoppel, however, limits the range of equivalents available to a patentee by preventing recapture of subject matter surrendered during prosecution of the patent. PODS, Inc. v. Porta Stor, Inc., 484 F.3d 1359, 1367 (Fed. Cir. 2007) (quoting Southwall Techs, 54 F.3d at 1579). 50. Omega Eng g, Inc. v. Raytek Corp., 334 F.3d 1314, & n.1 (Fed. Cir. 2003) (setting forth the standard for prosecution disclaimer and noting that this standard is same as the doctrine of argument-based disclaimer in the context of the doctrine of equivalents); Conoco, 460 F.3d at 1364 (stating that to invoke argument-based estoppel the prosecution history must show a clear and unmistakable surrender of subject matter ). See also 5A CHISUM ON PATENTS 18.03[2][d] ( [D]ecisions suggest that the standard for argument-based estoppel, as a limitation on the doctrine of equivalents, is the same as the standard for prosecution disclaimer, as a tool for limiting the potentially broad, literal scope of a claim. )

18 disclaimed coverage outside of the expressly-claimed range. 51 The court based this conclusion on the fact that the applicant repeatedly argued that its claimed range... produced unique results and was a superior and inventive range and identified disadvantages to going outside the claimed range. 52 Similarly, in Southwall Technologies v. Cardinal IG, the court held that the patentee s explanation of how its pending claim avoided a prior art reference necessarily disclaimed an interpretation of sputter-deposited metal oxides that encompass[es] a two-step process in which metal is first deposited as a metal and then oxidized. 53 In a statement to the examiner, the patentee contrasted a prior art reference, which taught this two-step process, to the pending claim, which disclosed a single-step process for creating a layer of metal oxide. 54 Because the accused product was formed using this two-step process, the patentee was prevented from showing either literal infringement or infringement under the doctrine of equivalents. 55 Likewise, in Omega Engineering v. Raytek, the court found that a patentee s statements during prosecution disclaimed claim scope. The patentee s argument that the invention, differed from the prior art in certain respects, resulted in a claim construction that expressly excluded alternatives because the patentee made clear in a public record what his invention could not be Best Practices Be Aware Of The Impact Of Disclaimer The worst case scenario is an unnecessary disclaimer that surrenders coverage over an accused product that otherwise would have infringed. The cases above demonstrate that in order to secure the broadest possible claim coverage and to assert the broadest range of equivalents, a patent prosecutor should try to avoid unambiguously asserting what the invention is not. Courts have held that clear statements concerning why the prior art is different from the 51. Bayer, 212 F.3d at Id. 53. Southwall Techs., 54 F.3d at Id. 55. Id. at 1577, Omega Eng g, 334 F.3d at (emphasis added)

19 claimed invention will define in the public record what the invention is not. Those should be arguments of last resort. It is also important to avoid making these sorts of arguments in the alternative. Such arguments are likely the result of a desire to move prosecution along expeditiously and the fact that it is hard to know what arguments the examiner will accept. While it is appropriate to be concerned about efficiency, it should not be at the peril of key claim scope. 57 Finally, if it is necessary to directly distinguish a prior art reference, give up only what you must. The Federal Circuit has noted that it frequently happens that patentees surrender more... than may have been absolutely necessary to avoid particular prior art but that in these cases the patentee is held to what they ultimately claim, not what they could have claimed if they had surrendered only what was necessary. 58 E. Prosecution History Secondary Considerations Of Non-Obviousness When facing rejections for obviousness, there is a way to overcome a prior art rejection without having to draw clear lines that may risk disclaimer. Effective reliance on the secondary considerations of non-obviousness can be a valuable tool during prosecution and scopesaving for litigation. In 2007, the Supreme Court addressed the obviousness standard in KSR International Co. v. Teleflex Inc. 59 In particular, KSR rejected a rigid application of the teaching, suggestion, or motivation test ( TSM ) test. 60 The TSM test provided that a finding of obviousness hinged upon whether there was some teaching, suggestion, or motivation to combine references to arrive at the claimed invention See PODS, 484 F.3d at 1368 ( Clear assertions made during prosecution in support of patentability, whether or not actually required to secure allowance of the claim, may also create an estoppel, because the relevant inquiry is whether a competitor would reasonably believe that the applicant had surrendered the relevant subject matter. (internal citations and quotation marks omitted)). 58. Norian Corp. v. Stryker Corp., 432 F.3d 1356, 1364 (Fed. Cir. 2005). 59. KSR Int l Co. v. Teleflex Inc., 550 U.S. 398 (2007). 60. Id. at See Winner Int l Royalty Corp. v. Wang, 202 F.3d 1340, 1348 (Fed. Cir. 2000), citing Gambro Lundia AB v. Baxter Healthcare Corp., 110 F.3d 1573, 1579 (Fed. Cir.1997) ( When an obviousness determination is based on multiple prior art

20 Instead, the Court held that the proper question when combining references is not whether the combination was obvious to the patentee but whether the combination was obvious to a person with ordinary skill in the art [and a] person of ordinary skill is also a person of ordinary creativity, not an automaton. 62 By apparently broadening the standard for obviousness, KSR increased the importance of the objective indicia, or so-called secondary considerations of nonobviousness. The Court also validated the standard articulated in Graham v. John Deere Co. of Kansas City: 63 Under s 103, the scope and content of the prior art are to be determined; differences between the prior art and the claims at issue are to be ascertained; and the level of ordinary skill in the pertinent art resolved. Against this background, the obviousness or nonobviousness of the subject matter is determined. Such secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented. As indicia of obviousness or nonobviousness, these inquiries may have relevancy. 64 Thus, a series of secondary considerations may be used to show non-obviousness, including commercial success, a long felt but unsolved need, the failure of others in the field, skepticism and unexpected results. 65, Such secondary considerations can be the most probative evidence of nonobviousness in the record. 66 The following is an overview of some of the key secondary considerations : references, there must be a showing of some teaching, suggestion, or reason to combine the references. ). 62. KSR Int l Co., 550 U.S. 398 at Id. at (citing Graham v. John Deere Co. of Kansas City, 383 U.S. 1 (1966)). 64. Graham v. John Deere Co. of Kansas City, 383 U.S. 1 at Id. at See also Manual of Patent Examining Procedure at 2141; Envtl. Designs, Ltd. v. Union Oil Co. of California, 713 F.2d 693, 698 (Fed. Cir. 1983) (referring to a process [that] had been denigrated by the experts );Raytheon Co. v. Roper Corp., 724 F.2d 951, 961 (Fed. Cir. 1983) (pointing to unexpected results as Objective Evidence of Nonobviousness ). 66. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 960 (Fed. Cir. 1986)

21 1. Commercial Success Commercial success demonstrates the impact of a clear need in the market for the patented features. However, information solely on numbers of units sold is insufficient to establish commercial success. 67 It is necessary to show a nexus between the patented feature and an increase in sales. 68 Moreover, once commercial success has been established, the party challenging the obviousness of the claims bears the burden of proving that the commercial success was a result of market forces unrelated to the inventiveness of the patent Long Felt But Unsolved Need [L]ong felt need is analyzed as of the date of an articulated identified problem and evidence of efforts to solve that problem. 70 A mere recitation of long felt need will not be sufficient, without more, to establish non-obviousness. 71 In Perfect Web Technologies, the court held that the patentee had not provided evidence of how long their unmet need had persisted or when it first came about. 72 In contrast, in Procter & Gamble Co. v. Teva Pharmaceuticals USA, Inc., the court held that a drug to treat osteoporosis did meet a long felt but unsolved need because at the time of filing, osteoporosis was a serious disease without adequate treatments. 73 It is especially important to note that the standard for long felt need must be applied at the time of filing. 74 In Procter & Gamble, the court rejected Teva s argument that the long-felt need must be unmet when the invention is available to satisfy that need In re Baxter Travenol Labs., 952 F.2d 388, (Fed. Cir. 1991). 68. Solder Removal Co. v. U.S. Intern. Trade Com n, 582 F.2d 628, 637 (C.C.P.A. 1978). ( A nexus must be established between the merits of the claimed invention and evidence of commercial success before that evidence may become relevant to the issue of obviousness. ). 69. See Crocs, Inc. v. Int l Trade Comm n, 598 F.3d 1294, 1311 (Fed. Cir. 2010). 70. Texas Instruments Inc. v. U.S. Int l Trade Comm n, 988 F.2d 1165, 1178 (Fed. Cir. 1993). 71. Perfect Web Technologies, Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1333 (Fed. Cir. 2009). 72. Id. 73. Procter & Gamble Co. v. Teva Pharmaceuticals USA, Inc., 566 F.3d 989, 998 (Fed. Cir. 2009). 74. Id. 75. Id

22 3. Failure of Others As with commercial success, reliance of the failure of others as a secondary consideration must be strongly linked to the claimed invention. In Ormco Corp. v. Align Tech., Inc., the court rejected an alleged failure of others to produce an invisible orthodontic system because there was no suggestion that the prior attempts failed because the devices lacked the claimed features. 76 Similarly, the failure of others should be substantial in order to be accorded proper weight. For example, in B.F. Goodrich Co. v. Aircraft Braking Sys. Corp., the court rejected a claim of failure of others because there was only a brief time period during which manufacturers sought a solution to the problem Unexpected Results A showing of superior results alone is not sufficient to establish that the results were necessarily unexpected. 78 In Pfizer, Inc. v. Apotex, Inc., the court held that in order to properly evaluate whether a superior property was unexpected, the [district] court should have considered what properties were expected. 79 In that case, the court held that the patentee failed to prove the expectations of a person of ordinary skill in the art as a predicate to the unexpected results. 80 Moreover, results must be considered in light of the closest prior art when determining if they are unexpected. 81 In Pfizer, the court found that the art being relied on for comparison was the not the closest art, and the court rejected the comparison altogether Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1313 (Fed. Cir. 2006). 77. B.F. Goodrich Co. v. Aircraft Braking Sys. Corp., 72 F.3d 1577, 1583 (Fed. Cir. 1996). 78. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). 79. Id. 80. Id. 81. Id. at 1370 (quoting In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed.Cir.1991)). 82. Id. at

23 5. Best Practices Secondary Considerations Can Be The Primary Choice Secondary considerations can provide a forceful approach to combatting claims of obviousness during prosecution and litigation. In order to facilitate the success of these arguments, it may be beneficial to set forth some of the evidence of these secondary considerations in the specification. Evidence of skepticism or failed attempts by others adds depth and meaning to the invention and the invention story, which is often set forth in the specification under the Background of the Invention. It is also helpful to document this evidence at the time of patent filing because the contemporaneous evidence will be easier to identify, rather than waiting until years later during litigation. This information, if properly incorporated into the specification, can provide a ready-made counter-argument to obviousness rejections and may, indeed, avoid them. III. CONCLUSION At each step, decisions during drafting and prosecution can have key implications for whether and how the resulting claims may be asserted. Frequent communication between trial and prosecution teams and ongoing consideration of the issues raised above can help prevent unnecessary difficulties and impediments. Some of the more valuable impacts on litigation may reside in arguments that never see the inside of the courtroom due to careful work by the drafting and prosecuting attorneys

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