Federal Circuit Review

Federal Circuit Review Claim Construction Volume Two Issue Five February 2010 In This Issue: g The Interchangeability Of Terms Creates A Definition g Express Definitions Control... Sometimes g Claim Construction For Issues Other Than Infringement And Validity This issue will review several Federal Circuit decisions from 2009 that highlight the Federal Circuit s application of its precedent that a patentee can be its own lexicographer and expressly define terms used in the claims, and how this precedent interacts with the other principles of claim construction, including the use of extrinsic evidence. This issue will also look at several cases from last year where claim construction played a role in issues other than patent infringement or validity. The Interchangeability Of Terms Creates A Definition In Edwards Lifesciences LLC v. Cook Inc., 582 F.3d 1322 (Fed. Cir. 2009), the Federal Circuit equated using terms in a specification interchangeably to defining them to have the same meaning. The claims-in-suit were directed to grafts used in treating aneurisms and various blood vessel diseases without open surgery. Regarding one of several constructions that it appealed from the district court, Edwards argued that the use of both graft and intraluminal graft in the claims and the specification required the two terms to have two different constructions, and that importing intraluminal into the construction of graft was improper. In further support of its argument, Appellant pointed to the removal during prosecution of the modifier intraluminal from some of the claims, as well as evidence that declarations in the prosecution history described surgically-implanted (i.e., non-intraluminal) grafts as grafts. The Federal Circuit, citing to its precedent in CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359 (Fed. Cir. 2002), held that the inventors essentially created a definition by using graft and intraluminal graft interchangeably in the specification. In this case, the specification consistently uses the words graft and intraluminal graft interchangeably.... The interchangeable use of the two terms is akin to a definition equating the two. Id. at 1329. www.willkie.com In further support, the Federal Circuit noted that 1) the specification described only intraluminal devices, 2) the preferred embodiment was described as the present invention, and 3) the claim language supported the district court s construction. With respect to Appellant s prosecution history arguments, the Federal Circuit rejected the first because the removal of the modifier intraluminal from the claim was accompanied by remarks that the claim defines an intraluminal

Federal Circuit Review graft. Furthermore, the use of the term graft to refer to non-intraluminal grafts occurred only in declarations submitted in an attempt to provoke an interference. Because no interference was issued, we cannot infer that the examiner relied on the declarations for any reason. Id. at 1331. Edwards also challenged the district court s construction of the word malleable, which did not appear in the claims but rather in the district court s initial claim construction. Because the parties disputed whether a wire was malleable if it exhibited any resilience, the district court resolved the issue by finding that the specification defined malleable to mean without resilience. On appeal, Edwards argued that the district court erred in looking to the specification to define a term that was in the claim construction but not in the claims, and that the inventor acting as his own lexicographer applies only to words the inventor actually used in the claims. Id. at 1333. Further, Edwards argued that the definition that the district court pointed to was used only in the context of a preferred embodiment, and was thus limited to that embodiment only and not applicable to the specification as a whole. The Federal Circuit again affirmed the district court s determination that the patentee s definition found in the specification overrides any ordinary meaning of the word malleable that might allow for substantial resilience. Id. at 1334. It acknowledged that [a]s Edwards points out, we do not ordinarily construe words that are not in the claims. Id. However, here the court correctly looked to the words in the specification, including the word malleable, to provide an initial construction. Id. Since the definition of malleable itself was subsequently disputed, the district court properly looked to the specification to clarify its initial construction. Id. With respect to Edwards s second argument, the location within the specification in which the definition appears is irrelevant. Id. (citing Boss Control, Inc. v. Bombardier Inc., 410 F.3d 1372, 1378 (Fed. Cir. 2005)). Furthermore, the Federal Circuit agreed with the district court that the use of i.e. in the specification s definition signals an intent to define the word to which it refers... and that definition was not limited to the embodiment being discussed. Id. Cases referenced Boss Control, Inc. v. Bombardier Inc., 410 F.3d 1372, 1378 (Fed. Cir. 2005) CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359 (Fed. Cir. 2002) Edwards Lifesciences LLC v. Cook Inc., 582 F.3d 1322 (Fed. Cir. 2009) Express Definitions Control... Sometimes In Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363 (Fed. Cir. 2009), the Federal Circuit held that an express definition recited in the specification was controlling on the issue of claim construction. The asserted claims of one of the patents-in-suit (the 244 patent ) were directed to methods for achieving high concentrations of omega-3 HUFA in an animal. The patent stated: The term animal means any organism belonging to the kingdom Animalia. However, the district court construed the claim term animal to mean any member of the kingdom Animalia, except humans. Id. at 1379. Based on this construction, Martek stipulated to non-infringement by Lonza.

The Federal Circuit reversed. When a patentee explicitly defines a claim term in the patent specification, the patentee s definition controls. Id. at 1380 (citing Phillips v. AWH Corp., 415 F.3d 1303, 1321 (Fed. Cir. 2005) (en banc)). Here, Martek explicitly defined the term animal in the 244 patent... That definition controls. Thus, because it is undisputed that humans are members of the kingdom Animalia, it was error for the district court to limit the claim term animal to exclude humans. Id. Thus, even though the specification was directed exclusively to embodiments that were for non-human animals, the claims could not be limited as such. In summary, absent a clear intention to restrict the invention to particular members of the kingdom Animalia, we cannot limit the claims to the listed preferred embodiments. Id. at 1381. Judges Lourie and Rader dissented. 1 This case illustrates the unusual situation in which a purported definition of a claim term in the written description is totally negated by the remainder of the text of the patent. Martek s attempt at lexicography does not conform to the way in which it otherwise describes the invention. Id. at 1383. The dissenting judges focused on the specification as a whole: [R]ather than reading in isolation the single line in the specification that Martek argues provides a definition of animal, one should review the entire patent to determine the proper construction of the term. Id. In seeming contrast to Martek, the Federal Circuit found that the express definition did not control in Callaway Golf Co. v. Acushnet Co., 576 F.3d 1331 (Fed. Cir. 2009). The claims-in-suit were directed to golf balls with a cover layer having a Shore D hardness of 60 or more.... The parties disagreed whether this hardness measurement should be taken when the cover is on the golf ball or as a sample of the cover material off the ball. The district court held that the claim limitation required that the Shore D hardness measurement of the cover layer be taken on the ball. Id. at 1336. Acushnet focused on the fact that the specification noted several times that hardness values therein are measured in accordance with ASTM method D-2240, a well-known standard that expressly states that hardness should not be measured on rounded or curved surfaces. Id. at 1337. The Federal Circuit disagreed with Acushnet and affirmed the district court s construction, holding that the patents-in-suit make clear that, when read in context, the reference to ASTM D-2240 does not require hardness of the cover layer to be tested off the ball. Id. at 1338. While the specification discussed taking hardness measurements off the ball, there were also express discussions of hardness measurements taken on intermediate and finished balls. Id. These examples confirm that hardness was to be measured on the ball. Id. The Federal Circuit also determined that testimony from Acushnet s own witnesses confirmed that one of skill in the art in the golf ball industry understood that while the ASTM standard was generally adhered to, hardness measurements are generally taken on the ball. Such evidence of accepted practice within the art, when not at variance with the intrinsic evidence, is relevant to the question of how a person of skill in the pertinent field would understand a term. Id. (citing Philips, 415 F.3d at 1318). 1 This case presented an unusual situation in which the argument on appeal was heard by a panel of five Federal Circuit judges. 3

Federal Circuit Review The Federal Circuit similarly declined to restrict a claim s scope in Ecolab, Inc. v. FMC Corp., 569 F.3d 1335 (Fed. Cir. 2009). The claims-in-suit were directed to using a chemical, PAA, for sanitizing fowl that has been killed, plucked and eviscerated.... The patent specification explicitly states that the term sanitize denote[s] a bacterial population reduction to a level that is safe for human handling and consumption. Id. at 1344. The district court instructed the jury that sanitized meat was not necessarily safe for consumption until it was cooked, and the jury found infringement. On appeal, Ecolab argued that the judge s construction that sanitize did not mean that the meat was safe for consumption without cooking was contrary to the express definition in the specification. In its analysis, the Federal Circuit first found that FMC acted as a lexicographer: It is well-settled that an inventor may act as his own lexicographer to define a patent term... as FMC clearly chose to do here notably failing to state that the invention can make poultry safe for consumption only after it is cooked. Id. (citing Philips, 415 F.3d at 1316). The Federal Circuit then discussed its precedent in Chef Am., Inc. v. Lamb-Weston, Inc., 358 F.3d 1371 (Fed. Cir. 2004) that redrafting claims is improper, even if they are clearly erroneous. In Chef Am., the claim at issue stated that cookie dough be heated to a temperature in the range of about 400-850 F. Clearly, the patentee meant that the user should set the oven so as to heat the dough at 400-850, rather than to 400-850 ; otherwise, the dough would be burned to a crisp and the claims would be nonsensical. Still, this court held that in accordance with our settled practice we construe the claim as written, not as the patentees wish they had written it. As written, the claims unambiguously requires that the dough be heated to a temperature of 400 F to 850 F. Ecolab, 569 F.3d at 1345 (emphasis in original) (quoting Chef Am., 358 F.3d at 1374). However, the court declined to follow Chef Am. because it determined that the definition for sanitize was not unambiguous: In the present case, the definition of sanitize is ambiguous in that it does not indicate when consumption is to take place the definition does not indicate whether the consumption would occur immediately after application of PAA or, for example, at a later time after the meat is cooked. Id. To resolve the ambiguity, the Federal Circuit used extrinsic evidence in the form of Ecolab s expert s testimony. [Ecolab s expert] admitted that in-plant inspectors examine poultry that has been treated with PAA to determine if it is fit for human consumption. [citation omitted] Surely, the inspectors do not require the poultry to be fit for consumption in its uncooked state. Id. Accordingly, the Federal Circuit rejected Ecolab s argument and affirmed the district court s construction. Cases referenced Callaway Golf Co. v. Acushnet Co., 576 F.3d 1331 (Fed. Cir. 2009) Chef Am., Inc. v. Lamb-Weston, Inc., 358 F.3d 1371 (Fed. Cir. 2004) Ecolab, Inc. v. FMC Corp., 569 F.3d 1335 (Fed. Cir. 2009) Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363 (Fed. Cir. 2009) Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc) 4

Claim Construction For Issues Other Than Infringement And Validity Several Federal Circuit decisions in 2009 serve as a reminder that claim construction is critical not just for litigating infringement and validity but for many other issues such as inventorship and priority. The Federal Circuit also affirmed that principles of claim construction cannot be disregarded by the Patent Office during examinations. In University of Pittsburgh of the Commonwealth System of Higher Education v. Hedrick, 573 F.3d 1290 (Fed. Cir. 2009), the inventorship of the patent-in-suit hinged upon the construction of the claim term adipose-derived stem cells. The patent application that issued as the patent-in-suit listed seven inventors, but the University of Pittsburgh subsequently filed a district court action seeking to remove all but the first two inventors, Katz and Llull. Four of the removed inventors argued that the proper construction of adipose-derived should have included that the stem cells are a distinct species from the mesenchymal stem cells obtainable from bone marrow tissue that had been known in the prior art. Such a construction would have allowed them to argue that because their research proved this distinction, they should be properly named as inventors. The district court found that the plain meaning of term adipose-derived ( derived from fat tissue ) was supported by the specification and that there was no disavowal of any other meaning during prosecution. Consequently, the district court found that the invention as claimed was conceived of by Katz and Llull before the involvement of the other originally-named inventors. The Federal Circuit found that while the specification distinguished between the prior art mesenchymal stem cells and the inventive adipose stem cells, it did not state that these cells were different species from each other, and rejected appellants argument. The court cannot impute a reason for the difference in isolation requirements of cells harvested from bone marrow versus those harvested from adipose tissue by requiring them to be of a separate species. Id. at 1297. That other similar prior art cells are described differently than the inventive cells does not rise to an intent to deviate from the meaning of the terms describing the inventive cells. Id. Appellants also advanced a prosecution history argument that the term adipose-derived was limited by an interview summary that stated that Katz and Llull agreed that a submission to distinguish between adipose derived stem cell and bone marrow derived stem cell will be submitted. Id. The Federal Circuit disagreed: This is not a disavowal. The examiner s summary is certainly terse, and its terseness does not allow a definition of any claim terms. It does not state why the adipose-derived stem cells in the invention are distinct from mesenchymal stem cells, and thus does not explicitly characterize the invention at all, let alone in a specific manner to overcome prior art. [citation omitted] A wide chasm exists between the weak inference from the summary that adipose-derived stem cells in this invention must be a different species from mesenchymal stem cells and a clear and unmistakable disavowal as required to limit a claim term. Id. Thus, the district court s construction was affirmed.

Federal Circuit Review In Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366 (Fed. Cir. 2009), the Federal Circuit reversed a court s award of priority because the district court used the wrong specification to construe the interference counts (claims). Agilent s Schembri patent was drawn into an interference with Affymetrix s Besemer application when Affymetrix copied the Schembri claims into the Besemer application. During the interference, Agilent filed a preliminary motion before the Board of Examiners challenging whether the Besemer application failed to adequately describe the claimed invention as required under 35 U.S.C. 112, 1. The Board awarded priority of the invention to Affymetrix because it found that the earlier-filed Besemer application supported the claimed invention. Agilent sought review of this decision from the Northern District of California, which construed the claims and granted summary judgment to Affymetrix that the Besemer application met the written description requirement. The Federal Circuit reversed, finding that the district court erred in construing the claims in light of the Besemer application instead of in light of the Schembri patent from which the claims were copied. In explaining its decision, the court examined two of its prior decisions, In re Spina, 975 F.2d 854 (Fed. Cir. 1992) and Rowe v. Dror, 112 F.3d 473 (Fed. Cir. 1997). In Spina, the Federal Circuit, in determining that a specification contained an adequate written description of the claim at issue, interpreted the claim in light of the disclosure from which the claim had been copied. In contrast, in Rowe the Federal Circuit found that copied claims that had their validity challenged by prior art should be construed in light of the host disclosure, and not the specification from which the claims were copied. It explained these differing results in Rowe: [The] Spina rule sought to ensure that the PTO would only declare an interference if both parties had a right to claim the same subject matter. However, that rule does not apply in cases, such as this one, where the issue is whether the claim is patentable to one or the other party in light of prior art. Rowe, 112 F.3d at 479. The Federal Circuit provided the following summary of the law in Agilent: To be clear, as this court explained in Rowe, when a party challenges written description support for an interference count or the copied claim in an interference, the originating disclosure provides the meaning of the pertinent claim language. When a party challenges a claim s validity under 102 or 103, however, this court and the Board must interpret the claim in light of the specification in which it appears. 567 F.3d at 1375. Accordingly, [t]his case calls for application of the Spina rule, because the question is whether the copying party s specification [Besemer] adequately supported the subject matter claimed by the other party [Schembri]. Id. (quoting Rowe, 112 F.3d at 479). After properly construing the claims in light of the Schembri application, the Federal Circuit found that the claimed invention was not adequately described by the Besemer application, and ruled in favor of Agilent that the Besemer application failed to meet the written description requirement. 6

In In re Skvorecz, 580 F.3d 1262 (Fed. Cir. 2009), the Federal Circuit rejected an argument from the Patent Office that incorrectly broadened the scope of the claim by using the signal comprising during a reissue examination. The claimed invention was a wire chafing stand that has each leg of the stand offset from the point of attachment to the rim, preventing wedging of nested stands and allowing for easy separation. During reissue prosecution, the Examiner rejected the claims as anticipated by prior art ( Buff ), shown to the right: The Board sustained the anticipation rejection with respect to four of the five claims, arguing that wire 48 (highlighted at right) was a transverse member and not a leg that required an offset. The Federal Circuit agreed with the applicant that Buff s wire 48 is a leg of the Buff structure, stating that the Board s contrary statement is unsupported by any evidence. Id. at 1267. However, the Patent Office argued that claim 1 is nevertheless anticipated because it can be construed to include wire legs without offsets, because the claim uses the open-ended transition-term comprising. Id. In other words, the use of comprising allowed a structure covered by claim 1 to have additional elements, including legs without an offset. Thus the Board held that claim 1, when given its broadest interpretation, reads on the Buff structure and thus is anticipated. Id. The Federal Circuit reversed, as the examination expedient of broadest reasonable interpretation is not a rule of claim construction. Id. Here the examination expedient of broadest reasonable interpretation was incorrectly applied to interpret comprising to mean that not all the Skvorecz wire legs need have offsets, despite the claims that state that each wire leg has an offset. Id. at 1268. Because the proper construction of the claims required each and every leg to have an offset, the finding of anticipation by the Board was reversed. Cases referenced Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366 (Fed. Cir. 2009) In re Skvorecz, 580 F.3d 1262 (Fed. Cir. 2009) In re Spina, 975 F.2d 854 (Fed. Cir. 1992) Rowe v. Dror, 112 F.3d 473 (Fed. Cir. 1997) University of Pittsburgh of the Commonwealth System of Higher Education v. Hedrick, 573 F.3d 1290 (Fed. Cir. 2009) 7

Contact Information If you have any questions, please contact the authors of this newsletter listed below or the Willkie attorney with whom you regularly work. John M. DiMatteo (212) 728-8299 jdimatteo@willkie.com Michael W. Johnson (212) 728-8137 mjohnson1@willkie.com David D. Lee (212) 728-8674 dlee1@willkie.com About Willkie Farr & Gallagher LLP Established in 1888, Willkie comprises more than 700 lawyers in offices in New York, Washington, Paris, London, Milan, Rome, Frankfurt, and Brussels. Our diverse areas of expertise and pragmatic approach to the practice of law make our firm uniquely qualified to comprehensively serve the needs of our clients around the world. Willkie Farr & Gallagher LLP 787 Seventh Avenue New York, NY 10019-6099 Tel (212) 728-8000 Fax (212) 728-8111 Copyright 2010 by Willkie Farr & Gallagher LLP. All Rights Reserved. This newsletter may not be reproduced or disseminated in any form without the express permission of Willkie Farr & Gallagher LLP. This newsletter is provided for news and information purposes only and does not constitute legal advice or an invitation to an attorney-client relationship. While every effort has been made to ensure the accuracy of the information contained herein, Willkie Farr & Gallagher LLP does not guarantee such accuracy and cannot be held liable for any errors in or any reliance upon this information. Under New York s Code of Professional Responsibility, this material may constitute attorney advertising. Prior results do not guarantee a similar outcome. www.willkie.com New York Washington Paris London Milan Rome Frankfurt Brussels