Marine Polymer Tech., Inc. .Hemcon, Inc.
Justia.com Opinion Summary: Plaintiff owns the 245 Patent, originally issued in 2005, and claims p-GlcNAc, a polymer extracted from another polymer called chitin, that accelerates hemostasis (a process that causes bleeding to stop) and is useful in trauma units for treating serious wounds. The district court found infringement. While the case was pending, the patent was re-examined; the scope of the claims changed. In 2011, the Federal Circuit vacated an injunction and award of damages and remanded. The court subsequently granted reconsideration en banc and affirmed the district court. Although the district court did not have the reexamination before it, the Federal Circuit considered arguments with respect to reexamination and concluded, as an alternative ground for affirmance, that intervening rights do not apply to claims that have not been amended and are not new.
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This is a revision of a Previous Opinion originally issued on September 26, 2011
United States Court of Appeals for the Federal Circuit __________________________ MARINE POLYMER TECHNOLOGIES, INC., Plaintiff-Appellee, v. HEMCON, INC., Defendant-Appellant. __________________________ 2010-1548 __________________________ Appeal from the United States District Court for the District of New Hampshire in Case No. 06-CV-100, Judge Joseph A. DiClerico, Jr. ____________________________ Decided: March 15, 2012 ____________________________ BRIAN M. POISSANT, Jones Day, of New York, New York, for plaintiff-appellee on rehearing en banc. With him on the brief were JULIE M. BAHER, LYNDA Q. NGUYEN and OGNIAN V. SHENTOV. Of counsel was GREGORY A. CASTANIAS, of Washington, DC. RAYMOND A. KURZ, Hogan Lovells US LLP, of Washington, DC, for defendant-appellant on rehearing en banc. With him on the brief were CELINE JIMENEZ CROWSON and KEITH B. OâÄôDOHERTY. MARINE POLYMER v. HEMCON 2 MICHAEL A. GOLLIN, Venable LLP, of Washington, DC, for amicus curiae Biotechnology Industry Organization on rehearing en banc. With him on the brief were WILLIAM D. COSTON, MARTIN L. SAAD, MEAGHAN H. KENT and FABIAN M. KOENIGBAUER. EDWARD R. REINES, Weil, Gotshal & Manges, LLP, of Redwood Shores, California, for amici curiae HewlettPackard Company, et al. on rehearing en banc. With him on the brief was NATHAN GREENBLATT. MATTHEW C. PHILLIPS, Stoel Rives LLP, of Portland, Oregon, for amicus curiae Intellectual Ventures Management LLC, on rehearing en banc. With him on the brief were NATHAN C. BRUNETTE and MATTHEW C. RAINEY, Intellectual Ventures Management, LLC, of Bellevue, Washington. MITCHELL G. STOCKWELL, Kilpatrick Townsend & Stockton LLP, of Atlanta, Georgia, for amicus curiae Jan K. Voda, M.D., on rehearing en banc. ROBERT G. STERNE, Sterne, Kessler, Goldstein & Fox, P.L.L.C., of Washington, DC, for amici curiae Soverain Software LLC, et al., on rehearing en banc. With him on the brief was JON E. WRIGHT. MATTHEW J. MOORE, Latham & Watkins LLP, of Washington, DC, for amici curiae Geico Corporation, et al. With him on the brief were JULIE M. HOLLOWAY and ADAM M. GREENFIELD. __________________________ 3 MARINE POLYMER v. HEMCON Before RADER, Chief Judge, NEWMAN, LOURIE, BRYSON, GAJARSA, 1 LINN, DYK, PROST, REYNA, and WALLACH, Circuit Judges. 2 Opinion for the court in part filed by Circuit Judge LOURIE, in which Chief Judge RADER and Circuit Judges NEWMAN, BRYSON, and PROST join in full, and in which Circuit Judge LINN joins in part II. Opinion filed by Circuit Judge DYK, dissenting in part, in which Circuit Judges GAJARSA, REYNA, and WALLACH join in full, and in which Circuit Judge LINN joins in parts IâÄďII. LOURIE, Circuit Judge. Defendant-Appellant HemCon, Inc. (âÄúHemConâÄĚ) appeals from a judgment of the United States District Court for the District of New Hampshire holding that HemCon infringed U.S. Patent 6,864,245 (âÄúthe âÄô245 patentâÄĚ) assigned to Plaintiff-Appellee Marine Polymer Technologies, Inc. (âÄúMarine PolymerâÄĚ). On September 26, 2011, a panel of this court reversed the district courtâÄôs decision, concluding that HemCon had acquired intervening rights in the âÄô245 patent based on actions taken by Marine Polymer during a parallel reexamination proceeding. Marine Polymer Techs., Inc. v. HemCon, Inc., 659 F.3d 1084 (Fed. Cir. 2011) (âÄúPanel OpinionâÄĚ), vacated, 2012 U.S. App. LEXIS 1155 (Fed. Cir. Jan. 20, 2012). Upon reconsideration en banc, we affirm the judgment of the district court by an equally divided court. Although the district court did not have the reexamination before it or decide the Circuit Judge GAJARSA assumed senior status on July 31, 2011. 2 Circuit Judges MOORE and OâÄôMALLEY did not participate in the decision. 1 MARINE POLYMER v. HEMCON 4 effect of that issue on its decision, we also consider HemConâÄôs arguments with respect to the reexamination and a majority of this court concludes as an alternative ground for affirmance that intervening rights do not apply to claims that have not been amended and are not new. BACKGROUND Marine Polymer owns the âÄô245 patent, which discloses and claims preparations of poly-Î²-1âÜí4-Nacetylglucosamine (âÄúp-GlcNAcâÄĚ), a naturally occurring polysaccharide polymer produced by organisms such as arthropods, fungi, and microalgae. Purified p-GlcNAc has utility in various industrial, pharmaceutical, and biomedical applications. For example, p-GlcNAc promotes hemostasis (i.e., stoppage of bleeding or hemorrhage) and is therefore useful in trauma units for treating serious wounds. The âÄô245 patent places particular emphasis on âÄúbiocompatibleâÄĚ compositions of p-GlcNAc. In this context, biocompatibility relates to a compoundâÄôs biological reactivity or tendency to elicit deleterious reactionsâÄĒe.g., necrosis, erythema, edema, cellular degenerationâÄĒupon exposure to living cells or tissues. E.g., âÄô245 patent col.42 ll.36âÄď38, col.44 ll.15âÄď16. The specification describes four tests that can be used to assess the biocompatibility of a substance: an elution test, an implantation test, an intracutaneous injection test, and a systemic injection test. Id. col.42 ll.1âÄď3. The disclosed elution test involves exposing a test substance to a solution to create an extract, exposing cultured test cells to the extract, and then observing the cells for signs of cytotoxicity. See id. col.42 ll.6âÄď62. The implantation test involves implanting a sample of the test substance into an animalâÄôs muscle tissue and scoring the severity of any adverse local reactions. See id. col.42 l.64 âÄď col.43 l.64. The intracutaneous 5 MARINE POLYMER v. HEMCON injection test calls for preparing an extract of the test substance, injecting small volumes of the extract into the skin of an animal, and monitoring the injection sites for reactivity. See id. col.43 l.65 âÄď col.44 l.56. Finally, in the systemic injection test, animals are monitored for weight changes and other overt signs of toxicity after receiving intravenous or intraperitoneal injections of a test substance extract. See id. col.44 l.57 âÄď col.45 l.42. In describing these biocompatibility tests, the specification indicates that their requirements are met if a given test substance shows no more than mild or slight reactivity. For example, scores on the elution test range from zero to four on a scale of biological reactivity, where zero represents no reactivity, one represents slight reactivity, two represents mild reactivity, and three or four represent moderate or severe reactivity, respectively, and a substance can satisfy the elution test âÄúif none of the cultures treated with the test article show a greater than mild reactivity.âÄĚ Id. col.42 ll.41âÄď62. But with regard to the claimed p-GlcNAc compositions, the specification also states that âÄúthe p-GlcNAc of the invention exhibits no detectable biological reactivity, as assayed by elution tests, intramuscular implantation in rabbits, intracutaneous injection in rabbits, and systemic injections in mice.âÄĚ Id. col.41 l.66 âÄď col.42 l.3; see also col.45 l.44 âÄď col.49 l.66 (reporting biocompatibility test results for p-GlcNAc showing zero reactivity on each test). The âÄô245 patent issued with 22 claims, all of which recite âÄúbiocompatibleâÄĚ compositions of p-GlcNAc. A majority of those claims recite the âÄúbiocompatibleâÄĚ limitation generically. Independent claim 6 is representative: A biocompatible poly-Î²-1âÜí4-N-acetylglucosamine comprising up to about 150,000 Nacetylglucosamine monosaccharides covalently at- MARINE POLYMER v. HEMCON 6 tached in a Î²-1âÜí4 conformation and having a molecular weight of up to about 30 million daltons in which at least one N-acetylglucosamine monosaccharide has been deacetylated. Id. col.72 ll.5âÄď10 (emphasis added). In addition, the âÄô245 patent contains several dependent claims that recite specific scores on the elution test. For example, claim 12 claims: âÄúThe biocompatible poly-Î²-1âÜí4-Nacetylglucosamine of any one of claims 6âÄď11 which has an elution test score of 0.âÄĚ Id. col.72 ll.33âÄď35 (emphasis added). Claims 3 and 20 also specify zero scores on the elution test; analogous claims 4, 5, 13, 14, 21, and 22 require elution test scores of one or two. E.g., id. col.72 ll.33âÄď41. Marine Polymer sued HemCon in March 2006, alleging that HemCon infringed the âÄô245 patent. During subsequent Markman proceedings, Marine Polymer argued that âÄúbiocompatibleâÄĚ p-GlcNAc should be construed to mean âÄúbiomedically pure [p-GlcNAc] that reproducibly exhibits acceptably low levels of adverse bioreactivity, as determined by biocompatibility tests.âÄĚ Marine Polymer Techs., Inc. v. HemCon, Inc., No. 06-CV100, 2008 WL 1995454, at *1 (D.N.H. May 6, 2008). HemCon countered that âÄúbiocompatibleâÄĚ should be read as limiting the claims to p-GlcNAc that had been âÄúharvested from plant microalgae,âÄĚ or, in the alternative, should be interpreted broadly to mean âÄúsuited for biomedical applications.âÄĚ Id. at *1âÄď2. The district court considered, and ultimately rejected, each of the partiesâÄô proposed constructions after reviewing the âÄô245 patentâÄôs claim language, written description, and prosecution history. Instead, the district court concluded that âÄúbiocompatibleâÄĚ p-GlcNAc, as claimed in the âÄô245 patent, means p-GlcNAc âÄúwith low variability, high purity, and no detectable biological 7 MARINE POLYMER v. HEMCON reactivity as determined by biocompatibility tests.âÄĚ Id. at *10. Marine Polymer then moved for summary judgment that HemCon literally infringed claims 6, 7, 10âÄď12, 17, and 20 of the âÄô245 patent. Applying its claim construction, the district court granted Marine PolymerâÄôs motion and held that HemCon had infringed all seven asserted claims. A jury trial followed to determine validity and damages. The jury made factual findings relating to obviousness and determined that the âÄô245 patent was not anticipated by the cited prior art. With respect to damages, the jury found that Marine Polymer was entitled to a reasonable royalty of $29,410,246. After the jury verdict, HemCon filed motions for judgment as a matter of law (âÄúJMOLâÄĚ) on anticipation, on the juryâÄôs factual findings relating to obviousness, and challenging the damages award as not supported by substantial evidence. The district court denied each of the motions and made a further legal determination that the asserted claims were not obvious under 35 U.S.C. Â§ 103. The district court entered a permanent injunction on September 16, 2010, barring HemCon from further infringement of the asserted claims, and issued its final judgment on September 22, 2010. HemCon appealed the decision to this court. In August 2009, while the infringement litigation was still before the district court, HemCon filed a request for ex parte reexamination of the âÄô245 patent in the United States Patent and Trademark Office (âÄúPTOâÄĚ). HemConâÄôs reexamination request cited ten prior art referencesâÄĒall of which, according to HemCon, raised substantial new questions of patentability for the âÄô245 patent given the construction of âÄúbiocompatibleâÄĚ adopted by the district court. J.A. 40740âÄď41. In response, the PTO granted HemConâÄôs reexamination request, initiated reexamination proceedings, and issued a non-final office action on April MARINE POLYMER v. HEMCON 8 1, 2010. 3 In this first office action, the examiner adopted a construction of âÄúbiocompatibleâÄĚ different from the district courtâÄôs, concluding that under its broadest reasonable interpretation, the term meant âÄúlow variability, high purity, and little or no detectable reactivity.âÄĚ J.A. 39503 (emphasis added). Noting that dependent claims 4, 5, 13, 14, 21, and 22 of the âÄô245 patent required elution test scores of one or two (corresponding to slight or mild reactivity on that test as defined in the specification), the examiner explained that the district courtâÄôs construction requiring âÄúno detectable biological reactivityâÄĚ conflicted with those claims, while his interpretation avoided such inconsistency. The examiner then rejected all of the original 22 claims as invalid under his broader construction in light of the cited prior art. In so doing, he relied primarily on three prior art referencesâÄĒa scientific article (Sandford) and two patents (Peniston and Malette)âÄĒ finding that each reference explicitly disclosed nearly all of the limitations of every claim. With respect to the âÄúbiocompatibleâÄĚ limitation, the examiner explained that any difference between the claimed biocompatibility and that disclosed by Sandford, Peniston, and Malette was âÄúminorâÄĚ and would have been obvious to a person of ordinary skill in the art at the time of the invention. J.A. 39507; see also 39517, 39522. In response, Marine Polymer addressed âÄúthe improper dependency noted by the ExaminerâÄĚ by cancelling all six claims that had recited elution test scores of one or two (i.e., claims that expressly required at least some reactivity), while leaving each of the remaining claims 1âÄď3, 6âÄď12, and 15âÄď20 unaltered. Having deleted the inconsistent claims, Marine Polymer argued that âÄúthe [district courtâÄôs] Ex parte reexamination of the âÄô245 patent was conducted under Reexamination Control No. 90/009,555. 3 9 MARINE POLYMER v. HEMCON interpretation of the term âÄėbiocompatibleâÄô should be adopted in this reexaminationâÄĚ in view of various consistent teachings within the specification. J.A. 37688âÄď90. With all conflicting claims cancelled, the examiner âÄúagree[d] with the [district] courtâÄôs construction of the term biocompatible as derived from the specification of the . . . âÄô245 patent.âÄĚ J.A. 39481. Furthermore, the examiner withdrew all rejections in view of that narrower construction and confirmed the remaining claims as patentable. Id. The PTO did not provide notice of its intent to issue a reexamination certificate for the âÄô245 patent until November 3, 2010, after the district court had entered final judgment in Marine PolymerâÄôs infringement action. HemCon timely appealed from the district courtâÄôs judgment, and on November 18, 2010, a motions panel of this court granted a stay of the damages award and permanent injunction pending appeal. On March 29, 2011, the PTO issued the final reexamination certificate (âÄúâÄô245 Reexam. Cert.âÄĚ), which cancelled dependent claims 4, 5, 13, 14, 21, and 22 and confirmed the patentability of claims 1âÄď3, 6âÄď12, and 15âÄď20 in accordance with the examinerâÄôs decision. âÄô245 Reexam. Cert. col.2 ll.1âÄď6. A panel of this court heard oral arguments in HemConâÄôs appeal from the district courtâÄôs judgment on June 7, 2011, and issued a decision on September 26, 2011, in which a majority reversed the district courtâÄôs judgment on infringement and vacated the injunction and the damages award on grounds that HemCon had acquired intervening rights during reexamination of the âÄô245 patent. Panel Opinion, 659 F.3d at 1090âÄď95. Marine Polymer petitioned for en banc rehearing, and on January 20, 2012, the full court granted Marine PolymerâÄôs petition for rehearing and vacated the judgment of the panel. Marine Polymer Techs., Inc. v. HemCon, Inc., No. 2010-1548, 2012 U.S. MARINE POLYMER v. HEMCON 10 App. LEXIS 1155 (Fed. Cir. Jan. 20, 2012). For the reasons described below, we now affirm the judgment of the district court. DISCUSSION I. The District CourtâÄôs Decision A. Jurisdiction and Standards of Review We have jurisdiction to entertain this appeal under 28 U.S.C. Â§ 1295(a)(1). We address claim construction as a matter of law, which we review without formal deference on appeal, although we give respect to the judgments of the district courts. Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1456 (Fed. Cir. 1998) (en banc). We review grants of summary judgment de novo, reapplying the same standard applied by the district court under Federal Rule of Civil Procedure 56(a). Iovate Health Scis., Inc. v. Bio-Engineered Supplements & Nutrition, Inc., 586 F.3d 1376, 1380 (Fed. Cir. 2009). Our review of a district courtâÄôs denial of JMOL is governed by regional circuit law, Union Carbide Chems. & Plastics Tech. Corp. v. Shell Oil Co., 425 F.3d 1366, 1372 (Fed. Cir. 2005), and the First Circuit reviews a district courtâÄôs denial of JMOL de novo, Astro-Med, Inc. v. Nihon Kohden Am., Inc., 591 F.3d 1, 13 (1st Cir. 2009). In such situations, âÄúa juryâÄôs verdict must be upheld unless the facts and inferences, viewed in the light most favorable to the verdict, point so strongly and overwhelmingly in favor of the movant that a reasonable jury could not have reached the verdict.âÄĚ Id. (quoting Borges Colon v. Roman-Abreu, 438 F.3d 1, 14 (1st Cir. 2006)). In reviewing a district courtâÄôs denial of JMOL on damages, the First Circuit reverses only where âÄúreasonable persons could not have reached the conclusion that the jury embraced.âÄĚ Visible Sys. Corp. v. Unisys Corp., 11 MARINE POLYMER v. HEMCON 551 F.3d 65, 74 (1st Cir. 2008) (quoting Attrezzi, LLC v. Maytag Corp., 436 F.3d 32, 37 (1st Cir. 2006)). Statutory interpretation is a matter of law that we consider de novo. Aristocrat Techs. Austl. Pty. Ltd. v. IntâÄôl Game Tech., 543 F.3d 657, 660 (Fed. Cir. 2008). B. Claim Construction HemCon argues that the district courtâÄôs construction of âÄúbiocompatibleâÄĚ to mean âÄúlow variability, high purity, and no detectable biological reactivity as determined by biocompatibility testsâÄĚ was erroneous and warrants reversal of the judgment. In supporting this assertion, HemCon relies primarily on the presence of the six dependent claims in the original âÄô245 patent (eventually cancelled in reexamination) that required elution test scores of one or two, as well as passages in the written description characterizing certain biocompatibility tests as being satisfied despite detectable bioreactivity. HemCon therefore proposes a broader alternative construction, âÄúsuitable for biomedical applications,âÄĚ that it argues would better align with the teachings in the specification and render the asserted claims invalid. We disagree. The district courtâÄôs interpretation of âÄúbiocompatibleâÄĚ is supported by intrinsic evidence, and we therefore uphold that construction. Our claim construction analysis begins with the language of the claim itself, as it would have been understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312âÄď13 (Fed. Cir. 2005) (en banc) (quoting Vitrionics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) (âÄúwe look to the words of the claims themselves . . . to define the scope of the patented inventionâÄĚ)). Faced with widely varying proposed definitions from the parties, the district court did not find that âÄúbiocompatibleâÄĚ had a plain and ordinary meaning to MARINE POLYMER v. HEMCON 12 one skilled in the art. The district court properly looked first to the claims of the âÄô245 patent and determined that they âÄúdo not define âÄėbiocompatible.âÄôâÄĚ Marine Polymer, 2008 WL 1995454, at *3. Although several of the dependent claims specify that the âÄúbiocompatibleâÄĚ p-GlcNAc may exhibit mild reactivity in an elution test (i.e., âÄúan elution test score of 1âÄĚ or âÄúan elution test score of 2âÄĚ), the majority of the claims use the term âÄúbiocompatibleâÄĚ generically, without any reference to a biocompatibility test score. Because the term âÄúbiocompatibleâÄĚ admits of no limitation based on the context of the claims, the district court properly turned to the teachings of the specification. The specification teaches that the p-GlcNAc âÄúof the inventionâÄĚ has âÄúa high degree of biocompatibilityâÄĚ and directs the reader to a portion of the specification that âÄúdemonstrates the high biocompatibility of the p-GlcNAc of the invention.âÄĚ âÄô245 patent col.10 ll.49âÄď62. Further, the cited material provides empirical test results showing that the p-GlcNAc of the invention exhibited zero reactivity on each disclosed biocompatibility test, id. col.45 ll.45âÄď 50, col.46 ll.10âÄď11 and 66âÄď67, col.49 ll.26âÄď29, and summarizes the results as follows: âÄú[I]t is demonstrated that the p-GlcNAc of the invention exhibits no detectable biological reactivity, as assayed by elution tests, intramuscular implantation in rabbits, intracutaneous injection in rabbits, and systemic injections in mice.âÄĚ Id. col.41 l.66 âÄď col.42 l.3. Thus, the specification supports the district courtâÄôs claim construction. See, e.g., Netcraft Corp. v. eBay, Inc., 549 F.3d 1394, 1398 (Fed. Cir. 2008) (âÄú[T]he common specificationâÄôs repeated use of the phrase âÄėthe present inventionâÄô describes the invention as a whole . . . .âÄĚ); Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1308 (Fed. Cir. 2007) (âÄúWhen a patent thus describes the features of the âÄėpresent inventionâÄô as a 13 MARINE POLYMER v. HEMCON whole, this description limits the scope of the invention.âÄĚ); Honeywell IntâÄôl, Inc. v. ITT Indus., Inc., 452 F.3d 1312, 1318 (Fed. Cir. 2006) (limiting claims to a fuel filter where âÄúthe written description refers to the fuel filter as âÄėthis inventionâÄô or âÄėthe present inventionâÄôâÄĚ). 4 HemConâÄôs arguments highlighting an inconsistency between the district courtâÄôs construction and the claims requiring non-zero elution test scores, while not baseless, essentially amount to a conflict between teachings in the specification and the doctrine of claim differentiation. As we have held, claim differentiation is âÄúnot a hard and fast rule and will be overcome by a contrary construction dictated by the written description or prosecution history.âÄĚ Seachange IntâÄôl, Inc. v. C-Cor, Inc., 413 F.3d 1361, 1369 (Fed. Cir. 2005); see also Laitram Corp. v. Rexnord, Inc., 939 F.2d 1533, 1538 (Fed. Cir. 1991) (âÄúClaim differentiation is a guide, not a rigid rule.âÄĚ). Such description appears in the specification here, as indicated above. We also find HemConâÄôs focus on the possibility of nonzero âÄúpassingâÄĚ scores on the disclosed biocompatibility tests unpersuasive. In describing âÄúMaterials and MethodsâÄĚ for the four disclosed biocompatibility tests, the specification indicates that, for example, test substances 4 Judge DykâÄôs opinion argues the details of claim construction based on the assertion that neither party argued the construction arrived at by the district court. We are not bound by the arguments of the parties, however, and neither was the district court. Exxon Chem. Patents, Inc. v. Lubrizol Corp., 64 F.3d 1553, 1555 (Fed. Cir. 1995). Moreover, Judge Dyk suggests that we are deciding claim construction based only on one example, to the exclusion of others. In fact there is only one example of the claimed p-GlcNAc in the specification; the rest of the cited âÄúexamplesâÄĚ provide various methods of purifying, characterizing, or using the disclosed product. MARINE POLYMER v. HEMCON 14 may âÄúmeet the biocompatibility test if none . . . show a greater than mild reactivity.âÄĚ âÄô245 patent col.42 ll.42âÄď44. But such language appears only in generalized descriptions of these test methods; when read as a whole, the specification makes clear that the p-GlcNAc of the invention outperforms baseline standards and shows âÄúno detectable biological reactivity as determined by biocompatibility tests.âÄĚ The district courtâÄôs construction of âÄúbiocompatibleâÄĚ as meaning p-GlcNAc âÄúwith low variability, high purity, and no detectable biological reactivity as determined by biocompatibility testsâÄĚ is therefore affirmed by an equally divided court. 5 C. Infringement Following its decision on claim construction, the district court ruled on summary judgment that HemCon infringed claims 6, 7, 10âÄď12, 17, and 20 of the âÄô245 patent. On appeal, HemConâÄôs noninfringement challenge regarding claims 6, 7, 10, 11, and 17 hinges entirely on its failed claim construction arguments, and HemCon does not otherwise dispute its infringement of these claims. With regard to claims 12 and 20, HemCon raises an additional defense, arguing that the district court lacked sufficient evidence to establish literal infringement because HemConâÄôs products allegedly cannot undergo elution testing as required by those claims. However, HemCon has waived that argument by failing to raise it in opposing summary judgment, and we therefore need not consider it here. Pandrol USA, LP v. Airboss Ry. Prods., Inc., 320 F.3d 1354, 1366âÄď67 (Fed. Cir. 2003). Accordingly, we affirm We also note that, while not a basis for our affirmance, the PTO arrived at the same conclusion upon interpreting the term in its parallel reexamination proceeding. 5 15 MARINE POLYMER v. HEMCON the district courtâÄôs judgment regarding infringement of claims 6, 7, 10âÄď12, 17, and 20 by an equally divided court. D. Damages Finally, HemCon seeks to overturn the juryâÄôs award of $29,410,246 in damages as unreasonable and not supported by substantial evidence. Specifically, HemCon argues that Marine PolymerâÄôs expert lacked a sufficient basis for his testimony on what would constitute a reasonable royalty rate and that the jury improperly relied on the entire market value for its damages calculation. During trial, both parties presented expert testimony on damages. Marine PolymerâÄôs expert testified that, based on his evaluation of the case, a reasonable royalty would range from about 26âÄď34% of HemConâÄôs infringing sales, and he settled on 30%, or $29,410,246, as the appropriate award. In contrast, HemConâÄôs expert testified that 2âÄď4% of all infringing sales represented the correct range, concluding that Marine PolymerâÄôs reasonable royalties would total $2,767,589. Both experts used the total sales of the accused products containing the infringing biocompatible p-GlcNAc as the royalty base. The use of the entire market value as the royalty base is acceptable to the extent that the patent owner proves that âÄúthe patent-related feature is the basis for customer demand.âÄĚ Lucent Techs., Inc. v. Gateway, Inc., 580 F.3d 1301, 1336 (Fed. Cir. 2009) (internal quotations omitted). The district court correctly found that the record contains substantial evidence to support a damages award based on the entire market value of HemConâÄôs infringing products, including âÄúevidence pertaining to the importance of biocompatible pGlcNAc in HemConâÄôs products and its significance for market demand.âÄĚ Marine Polymer Techs., Inc. v. Hem- MARINE POLYMER v. HEMCON 16 Con, Inc., No. 06-CV-100, 2010 WL 3070201, at *4 (D.N.H. Aug. 3, 2010). Ultimately, the jury was entitled to evaluate this conflicting evidence and credit the testimony of Marine PolymerâÄôs expert over that of HemCon, as it did. The jury also heard testimony from witnesses for both parties, including HemConâÄôs own president, describing the claimed p-GlcNAc as âÄúcriticalâÄĚ to the core hemostatic function of the accused products. In sum, based on the evidence of record, the juryâÄôs damages award was supported by substantial evidence. In such cases, we may not âÄúsubstitute [our] choice for that of the jury.âÄĚ Brooktree Corp. v. Advanced Micro Devices, Inc., 977 F.2d 1555, 1580 (Fed. Cir. 1992). The damages award is therefore affirmed by an equally divided court. II. Intervening Rights In addition, HemCon argues that the asserted claims of the âÄô245 patent changed in scope during reexamination, HemCon thereby acquired intervening rights in those claims, and the district courtâÄôs finding of infringement should therefore be reversed. To support its intervening rights defense, HemCon asserts that the district courtâÄôs interpretation of âÄúbiocompatibleâÄĚ incorrectly narrowed the term by requiring âÄúno detectable biological reactivity.âÄĚ According to HemCon, the district courtâÄôs construction conflicts not only with statements in the written description, but also with the presence of dependent claims reciting elution test scores of one or twoâÄĒclaims that permit slight or mild reactivity and were in the original version of the âÄô245 patent that was before the district court. HemCon contends that âÄúbiocompatible,âÄĚ at least as represented in the âÄô245 patent before reexamination, therefore must have encompassed low, non-zero levels of 17 MARINE POLYMER v. HEMCON bioreactivity, so that the proper construction at that time was necessarily broader than the district courtâÄôs interpretation. Next, HemCon argues that, by cancelling dependent claims 4, 5, 13, 14, 21, and 22 and persuading the examiner to adopt the district courtâÄôs construction of âÄúbiocompatibleâÄĚ during reexamination, Marine Polymer effected a substantive change in the scope of each remaining claimâÄĒessentially, from allowing some reactivity in the originally issued claims to permitting âÄúno detectable biological reactivityâÄĚ after reexamination. Citing our decision in Laitram Corp. v. NEC Corp., 163 F.3d 1342, 1346âÄď47 (Fed. Cir. 1998), HemCon argues that the key to intervening rights lies in determining âÄúwhether the scope of the reexamined claims differs from the original claims.âÄĚ Corrected Br. for Defendant-Appellant at 37, 2010 WL 5650491. HemCon thus concludes that this perceived âÄúsubstantive changeâÄĚ to the surviving claims of the âÄô245 patent during reexamination triggered intervening rights with respect to those claims. Under HemConâÄôs view, substantive change applies especially to claims 6, 7, 10, 11, and 17, which, reciting no numerical result in any biocompatibility test, are generic in that respect. Furthermore, HemCon argues that even claims 12 and 20 were substantially changed in scope when the examiner adopted the district courtâÄôs construction of âÄúbiocompatibleâÄĚ during reexamination, despite the fact that those claims have at all times required an elution test score of zero (corresponding to âÄúno signs of cellular reactivityâÄĚ on that test, âÄô245 patent col.42 ll.39âÄď40). HemCon argues that while claims 12 and 20 specified no reactivity on the elution test prior to reexamination, they nevertheless covered products exhibiting slight reactivity on other biocompatibility tests until Marine Polymer successfully MARINE POLYMER v. HEMCON 18 pressed the more restrictive âÄúno detectable biological reactivityâÄĚ construction during reexamination. 6 Marine Polymer disagrees and argues that intervening rights cannot apply with respect to claims that have not been amended or newly introduced in the reexamination proceeding. 7 The doctrine of intervening rights first developed as courts recognized that permitting substantive changes to the scope of patent claims through post-issuance procedures left âÄúthe door . . . open for gross injusticeâÄĚ where a third party, having already begun to make, use, or sell a given article, finds its previously lawful activities rendered newly infringing under a modified patent. See Sontag Chain Stores Co. v. NatâÄôl Nut Co., 310 U.S. 281, 293âÄď95 (1940). In such situations, the defendant âÄúacquired at least a right to continue to use the [articles] as if it held a license therefor under the reissued patent.âÄĚ Id. at 294âÄď95 (quoting Ashland Fire Brick Co. v. Gen. Refractories Co., 27 F.2d 744, 746 (6th Cir. 1928)). With respect to reissued patents, the concept of intervening rights was codified by the Patent Act of 1952, and the statute provides for two types of intervening rights: (1) intervening rights that abrogate liability for infringing claims added to or modified from the original patent if the accused products were made or used before the reissue, often HemConâÄôs position is supported by amici curiae Hewlett-Packard Co., Broadcom Corp., Cisco Systems, Inc., Dell, Inc., eBay, Inc., Facebook, Inc., Google Inc., and SAP America, Inc.; and GEICO Corp., FedEx Corp., and MacyâÄôs, Inc. 7 Marine PolymerâÄôs position is supported by amici curiae Jan K. Voda; Intellectual Ventures Management LLC; the Biotechnology Industry Association and Pharmaceutical Research and Manufacturers of America; Soverain Software LLC and Tessera, Inc.; and Sealy Corp. 6 19 MARINE POLYMER v. HEMCON referred to as absolute intervening rights; and (2) intervening rights that apply as a matter of judicial discretion to mitigate liability for infringing such claims even as to products made or used after the reissue if the accused infringer made substantial preparations for the infringing activities prior to reissue, often referred to as equitable intervening rights. See 35 U.S.C. Â§ 252 (2006). Intervening rights do not accrue, however, where the accused product or activity infringes a claim that existed in the original patent and remains âÄúwithout substantive changeâÄĚ after reissue. Seattle Box Co. v. Indus. Crating & Packing, Inc., 731 F.2d 818, 827âÄď28 (Fed. Cir. 1984). Although intervening rights originated as a defense against patents modified through reissue procedures, the doctrine has since been extended to the context of patent reexamination. Pursuant to 35 U.S.C. Â§Â§ 307(b) and 316(b), respectively, both ex parte and inter partes reexaminations can give rise to intervening rights. For example, Â§ 307(b) provides as follows: Any proposed amended or new claim determined to be patentable and incorporated into a patent following a reexamination proceeding will have the same effect as that specified in section 252 of this title for reissued patents on the right of any person who made, purchased, or used within the United States, or imported into the United States, anything patented by such proposed amended or new claim, or who made substantial preparation for the same, prior to issuance of a certificate under the provisions of subsection (a) of this section. MARINE POLYMER v. HEMCON 20 35 U.S.C. Â§ 307(b) (emphasis added). 8 Thus, after a patent emerges from reexamination, the statute makes available absolute and equitable intervening rights to the same extent provided in the reissue statute, but only with respect to âÄúamended or newâÄĚ claims in the reexamined patent. With regard to HemConâÄôs intervening rights argument, we must first note that the reexamination of the âÄô245 patent was a separate and distinct proceeding that is not properly before us on appeal. It did not conclude until after trial, so the district court did not consider, nor could it have considered, the reexamination in rendering its judgment. The panel noted that the issue of intervening rights arose after the district court judgment, but concluded that it had the discretion to consider that issue on appeal because it was an event as to which judicial notice is appropriate. Exercising that discretion, the panel held that, in light of its reversal of the district courtâÄôs claim construction, HemCon is entitled to intervening rights and that the district courtâÄôs judgment of infringement therefore must be reversed. Although we reject the premise of HemConâÄôs argument regarding intervening rightsâÄĒthat the district courtâÄôs claim construction prior to reexamination of the âÄô245 patent was erroneousâÄĒwe conclude, as an alternative ground for decision, that even if the district courtâÄôs claim construction was erroneous, HemConâÄôs intervening rights argument must fail because it disregards the plain and unambiguous language of Â§ 307(b). Section 307(b) governs intervening rights arising from ex parte reexamination and specifies that only âÄúamended or newâÄĚ claims Section 316(b), governing intervening rights available after inter partes reexamination, contains essentially identical language. 8 21 MARINE POLYMER v. HEMCON incorporated into a patent during reexamination âÄúwill have the same effect as that specified in section 252,âÄĚ i.e., will be susceptible to intervening rights. HemCon ignores this threshold statutory requirement and asks that we proceed directly to the subsidiary âÄúsubstantive changeâÄĚ analysis, which derives from Â§ 252. See Kaufman Co. v. Lantech, Inc., 807 F.2d 970, 975âÄď77 (Fed. Cir. 1986) (explaining the relationship between Â§Â§ 252 and 307(b) and holding that âÄúidentical,âÄĚ as used in Â§ 252, means âÄúwithout substantive changeâÄĚ). But under Â§ 307(b), the first question when assessing whether intervening rights arose from a reexamination is whether the asserted claim is âÄúamended or newâÄĚ; if the answer is no, that ends the inquiry. Only if the claim at issue is new or has been amended may the court proceed to the second step in the analysis and assess the substantive effect of any such change pursuant to Â§ 252. Such a framework is consistent with our holding in Laitram. There, our focus rested on whether the claims had been substantively changed precisely because the claims had been changedâÄĒthere was no question that the claims at issue had been amended in reexamination, so the dispute centered on the second step in the intervening rights analysis, viz., whether those literal amendments to the claim language had effected substantive changes in claim scope. See Laitram, 163 F.3d at 1344 (âÄúThe parties dispute whether the scope of the original claims was substantively changed following several amendments made during the reexamination of the . . . patent.âÄĚ) (emphasis added). In contrast, the patent claims asserted here against HemCon were neither âÄúnewâÄĚ nor âÄúamendedâÄĚâÄĒclaims 6, 7, 10âÄď12, 17, and 20 contained identical language before and after reexamination. âÄô245 patent col.72 ll.5âÄď16, 25âÄď35, 50âÄď54, 60âÄď61; âÄô245 Reexam. Cert. col.2 ll.1âÄď5. Whether or not Marine PolymerâÄôs MARINE POLYMER v. HEMCON 22 arguments to the examiner and cancellation of claims during reexamination may have affected the remaining claimsâÄô effective scope, they did not âÄúamendâÄĚ those claims for intervening rights purposes or make them âÄúnew,âÄĚ which is what the statutory language requires. Intervening rights are therefore unavailable under Â§ 307(b) as a matter of law. HemCon sidesteps this issue by emphasizing the wellrecognized principle that arguments made during prosecution can affect the ultimate meaning of a claim termâÄĒ and thus the âÄúscopeâÄĚ of a claimâÄĒand then returning to its contention that intervening rights turn on whether claim scope changes during reexamination. HemCon thus posits that Marine PolymerâÄôs actions in reexamination rendered the asserted claims effectively âÄúamendedâÄĚ by disavowal or estoppel, even though the language of the claims was not formally changed. We disagree. While it is true that claims are properly interpreted to account for arguments and concessions made during prosecution, HemConâÄôs conclusion that the claims asserted here were âÄúamendedâÄĚ for purposes of Â§ 307(b) goes too far. In general parlance, âÄúamendâÄĚ means âÄúto alter . . . formally by adding, deleting, or rephrasing.âÄĚ American Heritage College Dictionary 42âÄď43 (3d ed. 1997). And even if the term were ambiguous standing alone, any doubts are resolved by its context within Â§ 307. Section 307(a) identifies three categories of claims in a reexamined patent: (1) claims that existed in the original patent but have been cancelled as unpatentable, (2) claims that existed in the original patent and have been confirmed as patentable, and (3) amended or new claims that did not exist in the original patent but have been found to be patentable and will be incorporated into 23 MARINE POLYMER v. HEMCON the patent by the PTO. 9 In providing for intervening rights, Â§ 307(b) is limited to the third category of claims, as evidenced by its corresponding reference to any âÄúamended or new claimâÄĚ that is âÄúincorporated into a patent.âÄĚ Any interpretation of âÄúamendedâÄĚ that includes disavowal or disclaimer by argument alone, as advocated by HemCon, would conflict with the rest of Â§ 307, for it is difficult to envision how arguments about claim meaning could be âÄúincorporated into a patentâÄĚ by the Director of the PTO. Finally, it is clear that âÄúamendedâÄĚ is a term of art in patent prosecution, 10 including reexamination proceedings, 11 and in that context connotes formal changes to the actual language of a claim. We thus The text of Section 307(a) reads as follows: In a reexamination proceeding under this chapter, when the time for appeal has expired or any appeal proceeding has terminated, the Director will issue and publish a certificate canceling any claim of the patent finally determined to be unpatentable, confirming any claim of the patent determined to be patentable, and incorporating in the patent any proposed amended or new claim determined to be patentable. 35 U.S.C. Â§ 307(a) (2006). 10 See, e.g., 37 C.F.R. Â§ 1.121(c) (âÄúAll claims being currently amended [shall] be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. . . . [A]dded subject matter must be shown by underlining the added text. . . . [D]eleted matter must be shown by strike-through . . . .âÄĚ); id. Â§ 1.114(c) (distinguishing between prosecution arguments and amendments to the specification, claims, or drawings). 11 See, e.g., 37 C.F.R. Â§1.530(d) (âÄúA proposed amendment in an ex parte or an inter partes reexamination proceeding is made by filing a paper directing that proposed specified changes be made to the patent specification, including the claims, or to the drawings.âÄĚ). 9 MARINE POLYMER v. HEMCON 24 cannot agree that a claim can be âÄúamendedâÄĚ for purposes of Â§ 307(b) without changing the claim language itself. HemCon also expresses concern that excluding its concept of amendment by argument from the ambit of Â§ 307(b) would âÄúcreate a significant loopholeâÄĚ in the intervening rights defenseâÄĒshrewd patentees would simply opt to rely on arguments rather than amendments to effectively change, and thereby preserve, otherwise invalid claims during reexamination without engendering intervening rights against those claims. Reply Br. for Defendant-Appellant at 25, 2011 WL 287045. We believe that is highly unlikely. If, in reexamination, an examiner determines that particular claims are invalid and need amendment to be allowable, one would expect an examiner to require amendment rather than accept argument alone. Indeed, Congress may well have expected that changes in claim scope during reexamination would ordinarily be made by amendment, which would avoid the risk of creating a loophole in the intervening rights defense. Moreover, if an argument does suffice to overcome a rejection, it is probably because the claims at issue are not unallowable. Thus, the fear of gamesmanship does not persuade us to rule contrary to the plain meaning of the statute. Various amici have in fact pointed out that such gamesmanship concerns run both ways, suggesting that HemConâÄôs interpretation of Â§ 307(b), if adopted, would invite putative infringers to initiate reexamination proceedings with marginal or noninvalidating prior art. Under HemConâÄôs rule, such a requestor could expect that, even if the reexamination ultimately confirms all claims as patentable without amendment, the patent owner will necessarily make substantive arguments in defending the claims, thereby allowing the requestor to allege intervening rights based on those arguments. In any event, we cannot and will not 25 MARINE POLYMER v. HEMCON speculate about possible consequences with respect to situations not before us and which we cannot foresee. The dissent criticizes our discussion of HemConâÄôs intervening rights defense at length, asserting that this important issue has been addressed only in dictum by the en banc court. However, because the original opinion dealt extensively with this issue, we must now decide the case as we find it and clarify the law. Regarding the clause in Â§ 307(b) restricting intervening rights to âÄúamended or newâÄĚ claims, the dissent relies heavily on analogy to other fields of law. While prior experience may at times be helpful in statutory interpretation, references to scattered permissive applications of the term âÄúamendedâÄĚ to, e.g., a product safety regulation and a private contract, are of limited utility in interpreting the specific patent statute before us. Clear statutory language and the long understanding of practitioners in a field trump interpretations from other fields. Furthermore, the dissent selectively quotes from amicus briefs arguing for a flexible interpretation of the intervening rights statute, but other amici argue for giving the statutory language its plain meaning. Clearly, nothing conclusive can be gleaned from the amicus briefs, but we, in addition to relying primarily on our own analysis, are more persuaded by those arguing for a faithful reading of the statutory text. The dissent makes a brief attempt to call upon the Supreme Court to support its view, but the quoted language of the Court was that a specification âÄúbe substantially changed, either by the addition of new matter or the omission of important particulars, so as to enlarge the scope of the invention as originally claimed.âÄĚ Russell v. Dodge, 93 U.S. 460, 463âÄď64 (1876). Such language does not control this case, which does not deal with the intro- MARINE POLYMER v. HEMCON 26 duction of new matter or the omission of important particulars so as to enlarge the scope of the invention as originally claimed. The claims remaining in the patent are the same as originally claimed. In sum, the plain directive of the governing statute before us does not permit HemCon to invoke intervening rights against claims that the PTO confirmed on reexamination to be patentable as originally issued. To be sure, patent applicantsâÄô actions and arguments during prosecution, including prosecution in a reexamination proceeding, can affect the proper interpretation and effective scope of their claims. But in rejecting HemConâÄôs request for intervening rights, we are not here interpreting claims. Rather, we are interpreting a statute that provides for intervening rights following reexamination only as to âÄúamended or newâÄĚ claims. The asserted claims of the âÄô245 patent are neither. CONCLUSION Accordingly, the final judgment of the district court is affirmed. AFFIRMED United States Court of Appeals for the Federal Circuit __________________________ MARINE POLYMER TECHNOLOGIES, INC., Plaintiff-Appellee, v. HEMCON, INC., Defendant-Appellant. __________________________ 2010-1548 __________________________ Appeal from the United States District Court for the District of New Hampshire in case no. 06-CV-0100, Judge Joseph A. DiClerico, Jr. __________________________ DYK, Circuit Judge, dissenting in part, with whom GAJARSA, REYNA, and WALLACH, Circuit Judges, join in full, and with whom LINN, Circuit Judge, joins in parts IâÄď II. The court took this case en banc to address when absolute intervening rights arise under 35 U.S.C. Â§ 307(b) during reexamination. In particular, the question is whether intervening rights accrue when the patentee limits the claim scope by argument rather than by formal amendment to the claim language. Despite the importance of the issue of intervening rights, as evidenced by the amicus briefs filed by numer- MARINE POLYMER v. HEMCON 2 ous companies and organizations, the court did not seek further briefing and argument by the parties. This approach to an important issue is in my view difficult to justify. Now, remarkably, the court having affirmed the district courtâÄôs judgment by an equally divided court, goes on to opine in dictum as to the issue of intervening rights even though that issue (as discussed below) has been resolved by the affirmance and also, in the majorityâÄôs view, âÄúis not properly before us on appeal.âÄĚ Maj. Op. at 20. This is an unusual and unfortunate approach to an important issue. This issue is likely to become even more important under the new Leahy-Smith America Invents Act (âÄúAIAâÄĚ) because of the increased availability of reexamination. The majorityâÄôs interpretation of the statute is both incorrect and certain to encourage improper strategic behavior by patent applicants. I dissent. I The starting point for an intervening rights determination is the meaning of the original claim language. The district court construed the key claim limitation (âÄúbiocompatiableâÄĚ) of the original patent claims to require âÄúpolymers . . . with low variability, high purity, and no detectable biological reactivity as determined by biocompatibility tests.âÄĚ Marine Polymer Techs., Inc. v. HemCon, Inc., No. 06-cv-100-JD, 2008 WL 1995454, at *10 (D.N.H. May 6, 2008) (emphasis added). Contrary to Judge LourieâÄôs opinion, it seems to me that the district courtâÄôs construction was palpably incorrect and inconsistent with our established claim construction jurisprudence. Some background is essential to an understanding of the claim construction issue. Marine Polymer asserted seven claims of U.S. Patent No. 6,864,245 (âÄúthe âÄô245 patentâÄĚ), directed to p-GlcNAc polymers, against HemCon. Independent claim 6 is representative and claims: 3 MARINE POLYMER v. HEMCON âÄúA biocompatible [p-GlcNAc polymer] comprising up to about 150,000 N-acetylglucosamine monosaccharides covalently attached in a Î²-1 4 conformation and having a molecular weight of up to about 30 million daltons in which at least one N-acetylglucosamine monosaccharide has been deacetylated.âÄĚ âÄô245 Pat. col.72 ll.5-10 (emphasis added). Marine Polymer acknowledges that p-GlcNAc polymers had been disclosed in the prior art. The polymer also exists in nature in chitin, the chief organic structural component in the cell walls of fungi or algae and the protective shells of insects and crustaceans, but had been difficult to isolate with high purity and low variability. The âÄô245 patent purported to disclose for the first time a âÄúbiocompatibleâÄĚ polymer in a purified form, along with methods for its purification from microalgae. With sufficient purity, these polymers have a number of biomedical applications, including, inter alia, as a means for the rapid control of severe blood loss. A purified polymer provides âÄúincreased effectiveness, reduced toxicity and improved bioavailabilityâÄĚ for its biomedical applications. Id. col.5 ll.3-4. There are substantial questions as to whether the prior art disclosed the claimed invention. That depends in significant part on the construction of the term âÄúbiocompatible,âÄĚ a term existing in each of the asserted claims. As noted above, the district court construed âÄúbiocompatibleâÄĚ p-GlcNAc to be limited to âÄúpolymers . . . with . . . no detectable biological reactivity as determined by biocompatibility tests.âÄĚ Marine Polymer, 2008 WL 1995454, at *10 (emphasis added). One might at the outset be somewhat skeptical of this construction because it was not proposed by either party and was indeed contrary to the patenteeâÄôs own proposed construction. In the district court, Marine Polymer conceded that âÄúbiocompatible p-GlcNAcâÄĚ could exhibit some MARINE POLYMER v. HEMCON 4 biological reactivity, arguing that the term should be interpreted to mean âÄúbiomedically pure [p-GlcNAc] that reproducibly exhibits acceptably low levels of adverse bioreactivity, as determined by biocompatibility tests.âÄĚ Claim Construction Order, Marine Polymer Techs., Inc. v. HemCon, Inc., No. 06-cv-100-JD, slip. op. at 2 (D.N.H. May 6, 2008) (emphasis added). Similarly, it argued in its memorandum that its sample p-GlcNAc âÄúshowed acceptably low adverse reactionsâÄĚ to each of the biocompatibility tests and that this construction of âÄúbiocompatible pGlcNAcâÄĚ was âÄúfully supportedâÄĚ by the claims and specification. Memorandum in Support of PlaintiffâÄôs Claim Construction, Marine Polymer Techs., Inc. v. HemCon, Inc., No. 06-cv-100-JD, at 7, 10-11 (D.N.H. Aug. 17, 2007), ECF No. 48-1. Whether or not Marine PolymerâÄôs own constructions are binding, 1 the district courtâÄôs construction is in fact contrary to the specification and to the claims themselves. The specification and claims are clear that âÄúbiocompatibleâÄĚ p-GlcNAc encompasses polymers that exhibit some biological reactivity. The specification âÄúis the single best guide to the meaning of a disputed term,âÄĚ Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc), and may define a term explicitly or by implication, Irdeto Access, Inc. v. Echostar Satellite Corp., 383 F.3d 1295, 1300 (Fed. Cir. 2004). Here, the specification defines âÄúbiocompatibleâÄĚ in a manner directly contrary to the district courtâÄôs construction of âÄúno detectable biological reactivity.âÄĚ The specification first discusses the concept of biocompatibility in the See Key Pharms. v. Hercon Labs. Corp., 161 F.3d 709, 715 (Fed. Cir. 1998) (âÄúOrdinarily, doctrines of estoppel, waiver, invited error, or the like would prohibit a party from asserting as âÄėerrorâÄô a position that it had advocated at the trial.âÄĚ). 1 5 MARINE POLYMER v. HEMCON Detailed Description of the Invention, stating that âÄú[t]he p-GlcNAc of the invention exhibits a high degree of biocompatibility.âÄĚ âÄô245 Pat. col.10 ll.49-50. The specification does not provide at this point what constitutes an acceptably high degree of biocompatibility, but it discloses that âÄú[b]iocompatability may be determined by a variety of techniques, including, but not limited to such procedures as the elution test, intramuscular implantation, or intracutaneous or systemic injection into animal subjects.âÄĚ Id. col.10 ll.50-53. Each of these four âÄúbiocompatibility testsâÄĚ is later described in detail, including the particular materials, methods, and conditions to properly perform each test on a p-GlcNAc sample. The specification also discusses the results of each of the four tests, and specifically defines what constitutes âÄúmeet[ing]âÄĚ the requirements of the particular âÄúbiocompatibility test.âÄĚ See id. col.42 ll.42-43. Judge LourieâÄôs opinion itself concedes that the specification contemplates non-zero âÄúpassingâÄĚ scores on the biocompatibility tests. See Lourie Op. at 1112. Notably, for each of the four tests, the specification does not require that there be no biological reactivity but provides that the test is satisfied where at least some reactivity is present. For example, with respect to the elution test, the specification states that âÄú[t]he test article (i.e., p-GlcNAc) meets the biocompatibility test if none of the cultures treated with the test article show a greater than mild reactivity.âÄĚ âÄô245 Pat. col.42 ll.41-43 (emphasis added). Likewise, the specification explains that the biocompatibility test using the other methods is met even if the polymer exhibits some biological reactivity. See id. col.43 ll.54-60, col.44 ll.25-26, col.45 ll.41-43. Nowhere does the specification disavow or disclaim from the scope of the claims polymers exhibiting these levels of reactivity. If a polymer exhibiting some reactivity nonetheless MARINE POLYMER v. HEMCON 6 meets the specificationâÄôs explicit requirements for âÄúbiocompatibility,âÄĚ it cannot be that such polymer is not âÄúbiocompatibleâÄĚ within the meaning of the claims. Thus, the specification contemplates some level of reactivity that is compatible with use in biomedical applications. If this description of biocompatibility in the specification were not enough, the presence of six independent claims in the original patent dictate that the âÄúbiocompatibleâÄĚ limitation allow some exhibition of reactivity. Six dependent claims in the original patent specifically required that the âÄúbiocompatibleâÄĚ p-GlcNAc have an elution test score of either one or two, which correspond to âÄúslightâÄĚ or âÄúmildâÄĚ reactivity respectively and is directly inconsistent with a construction requiring no reactivity. âÄô245 Pat. col.42 ll.50-55. If âÄúbiocompatibleâÄĚ requires that there be no reactivity, but these dependent claims require slight or mild reactivity, they are nullified and become utterly meaningless. Marine Polymer itself concedes that these six claims were rendered meaningless by the district courtâÄôs construction, and that âÄúthe dependent claims requiring non-zero elution test scores conflict with [the district courtâÄôs] construction.âÄĚ AppelleeâÄôs Br. 28. Where a particular construction of an independent claim would nullify claims that depend from it, the doctrine of claim differentiation creates a presumption that such a construction is improper. See Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 910 (Fed. Cir. 2004). We adopt a construction of a term which renders claims invalid or meaningless when it is the âÄúonly claim construction that is consistent with the claimâÄôs language and the written description.âÄĚ Rhine v. Casio, Inc., 183 F.3d 1342, 1345 (Fed. Cir. 1999) (emphasis added). In other words, this presumption can be overcome only where a contrary construction is âÄúdictatedâÄĚâÄĒi.e., compelledâÄĒby the written description or prosecution history. Seachange 7 MARINE POLYMER v. HEMCON IntâÄôl, Inc. v. C-Cor, Inc., 413 F.3d 1361, 1369, 1370-72 (Fed. Cir. 2005) (holding that the presumption established by claim differentiation was rebutted because the written description âÄúconsistentlyâÄĚ referred to the claim term in a specific manner and arguments made during prosecution amounted to a clear and unambiguous disclaimer of claim scope). Here, there is an alternate claim construction, one construing âÄúbiocompatibleâÄĚ to mean âÄúlittle or no detectable reactivity,âÄĚ which preserves the validity of these six dependent claims. Nothing in the written description or prosecution history overcomes the presumption by dictating or compelling the conclusion that âÄúbiocompatibleâÄĚ is limited to exhibiting âÄúno detectable reactivity.âÄĚ In supporting the district courtâÄôs claim construction Judge LourieâÄôs opinion ignores or dismisses much of this compelling evidence. The opinion suggests that the examinerâÄôs adoption of the district courtâÄôs construction supports the correctness of that construction. Lourie Op. at 12 n.5. Quite the contrary. During reexamination, Marine Polymer asked the examiner to adopt the district courtâÄôs construction of âÄúbiocompatibleâÄĚ in evaluating whether the claims were invalid as anticipated or obvious. The examiner, however, rejected the district courtâÄôs construction and held that the âÄúbiocompatibilityâÄĚ limitation was not limited to no reactivity but instead permitted âÄúlittle or no detectable reactivity.âÄĚ J.A. 39503. The examiner explained that this definition âÄúavoids creating the situation where claims 4, 5, 13, 14, 21 and 22 would be improper for failing to further limit the claims from which they depend.âÄĚ J.A. 39504. Only after these dependent claims were canceled to create consistency with the district courtâÄôs construction of âÄúbiocompatibleâÄĚ did the examiner accept the district courtâÄôs construction. The examiner explained that âÄú[w]ith the cancellation of the claims which required that the elution test scores were 1 MARINE POLYMER v. HEMCON 8 or 2, the Examiner now agrees with the courtâÄôs definition of the term biocompatible.âÄĚ J.A. 39481. Apart from its reliance on the examiner, Judge LourieâÄôs opinion rests its conclusion as to the correctness of the district courtâÄôs construction almost exclusively on the fact that there are two instances in the entire specification where it refers to the p-GlcNAc âÄúof the invention.âÄĚ See Lourie Op. at 10-12. These two references, however, do not limit the scope of the term âÄúbiocompatible.âÄĚ With respect to the first, discussed above, the specification simply notes