• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Sep 1, 2026 · PGR2025-00017 · APJ Jeffrey N Fredman · PGR · Final written decision

  Claims 1, 2, 6–15, and 17–30 are unpatentable because the challenged claims lack written-description support and are not enabled.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 9

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “been able to use the data in the Specification to make reasonable predictions about the effect of multiple modifications on hyaluronidase activity, we view this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”14) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–230 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple” slip op. at 53

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

    “been able to use the data in the Specification to make reasonable predictions about the effect of multiple modifications on hyaluronidase activity, we view this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”14) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–230 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple” slip op. at 53

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable

    “an enzyme has folded,” Dr. Naismith states, “there would need to be additional evidence to justify a conclusion that the folded enzyme is sufficiently stable to retain its folded state” and “a POSA would not believe an enzyme had ‘properly folded’ if it did not maintain activity over a meaningful period or if it formed aggregates within a short period.” Id. ¶ 59.” slip op. at 78

  Patent outcomesUS 12,110,520 unpatentable
  § 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,110,520
• Savant Technologies LLC D/B/A GE Lighting / Ledvance LLC et al. v. Feit Electric Company, Inc.All claims unpatentable
  PTAB · Aug 31, 2026 · IPR2025-00260 · APJ Kevin W Cherry · IPR · Final written decision

  The Board held all challenged claims 1–3, 6, 7, 9–14, 16–21, 25, 26, and 29 unpatentable as obvious and granted the motion to amend for substitute claims 30–49.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “E. Credibility of Dr. Doolittle Patent Owner argues that we should give no weight to Dr. Doolittle’s testimony because, “[o]n cross examination, Prof. Doolittle repeatedly contradicted himself, dodged questions, and tried to shoehorn new and nonresponsive opinions into his answers to Patent Owner’s questions.” PO Resp. 25. Patent Owner raises two major complaints about Dr. Doolittle. First, Patent Owner argues that he took inconsistent positions by asserting in these IPR proceedings that the claims were entitled to their plain and ordinary meaning, while in the parallel district court proceeding, asserting that certain claim terms were indefinite. Id. at 26–28. Second, Patent Owner argues that Dr. Doolittle “repeatedly dodged questions and tried to shoehorn new and nonresponsive opinions into his answers to Patent Owner’s questions,” and that “[d]uring cross examination Patent Owner was forced to object to Prof. Doolittle’s nonresponsive answers no less than eighteen times.” Id. at 28. We strongly disagree with Patent Owner’s characterization of Dr. Doolittle’s testimony. We have reviewed the entirety of both of Dr. Doolittle’s depositions. We are impressed with his forthrightness, candor, and good humor in the face of Patent Owner’s counsel’s aggressive questioning. Contrary to Patent Owner’s assertions, we find that his testimony was well-reasoned, forthright, honest, and entitled to significant weight. Dr. Doolittle explained the different claim construction positions We also strongly disagree that Dr. Doolittle’s answers were nonresponsive or “evasive” as Patent Owner argues. Patent Owner’s numerous attempts to “strike” portions of his testimony belie Dr. Doolittle’s efforts to honestly and in good faith respond to Patent Owner’s counsel’s questions. Ex. 2025, 22:10–23:15, 25:9–26:14, 30:14–22, 40:3-9, 58:12–59:1, 60:18–61:13, 65:1–10, 83:15–84:16, 92:15–95:20, 96:18–99:9, 102:22–106:16, 135:3–136:22. An answer is not “non-responsive” simply because it does not conform to the conclusion you want or undermines the logic underlying your questioning. Dr. Doolittle explained his answers and addressed the issues Patent Owner asked about. Accordingly, we decline Patent Owner’s invitation to give Dr. Doolittle’s testimony no weight. Instead, we assess Dr. Doolittle’s testimony on a case-by-case basis as discussed below.” slip op. at 21

  • Skill levelOther

    “B. Level of Ordinary Skill in the Art We consider the asserted ground of unpatentability in view of the understanding of a person of ordinary skill in the art (“POSITA” or “POSA”). In assessing the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (quoting Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d Relying on the declaration testimony of its expert, Dr. Doolittle, Petitioner contends that an ordinarily skilled artisan for the ’678 patent “would have had an undergraduate degree (i.e., B.S., B.S.E. or the equivalent) in electrical engineering, materials science, physics, or a similar discipline” and “would also have one to two years of experience in the field of LED packaging design.” Pet. 5–6. Petitioner additionally contends that “[m]ore education could substitute for experience, and vice versa.” Id. Petitioner further contends that “[t]his person would have been capable of understanding and applying the teachings of the ’678 patent and the prior-art references discussed herein,” and “[m]oreover, the prior art reflects the level of skill at the time of the claimed invention.” Id. (citing Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); Ex. 1102 ¶¶ 38–42). Patent Owner states that “solely for the purposes of this proceeding, Patent Owner and its technical expert employ the same level of skill in the art as Petitioners.” PO Resp. 24–25. Thus, we adopt Petitioner’s articulation of the level of ordinary skill in the art, which is consistent with the ’678 patent and the asserted prior art, and we apply it in our obviousness analysis below.” slip op. at 10

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

    “lower wavelength might offer, there were other drawbacks that a person of ordinary skill would have to balance. But “a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine.” Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). Indeed, Petitioner has shown several references—including, Basin-2005, Shimizu, and Stokes—that made this tradeoff. Moreover, “[o]bviousness does not require absolute predictability of success. . . . [A]ll that is required is a reasonable expectation of success.” In re O’Farrell, 853 F.2d 894, 903–04 (Fed. Cir. 1988). We find that the prior art of record demonstrates that a person of ordinary skill in the art at the time of the invention would have such an expectation in making the combination of Basin-2007 and Basin-2005. Accordingly, we find that Petitioner has shown by a preponderance of the evidence that there would have been motivation to combine Basin-2007 and Basin-2005 with a reasonable expectation of success. 4. Summary We have reviewed Petitioner’s contentions regarding claims 1–3, 6, 9, 10, 16–21, and 25 (Pet. 19–53), and find that Petitioner has shown by a preponderance of the evidence that Basin-2007 and Basin-2005 teach the limitations of those claims, and that there would have been a motivation to combine the references in the manner suggested with a reasonable considerations does not outweigh the strong showing of obviousness. Accordingly, we find that Petitioner has shown by a preponderance of the evidence that claims 1–3, 6, 9, 10, 16–21, and 25 would have been obvious over Basin-2007 and Basin-2005.” slip op. at 41

  • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia no nexusDecided for petitioner

    “1. Nexus In order for secondary considerations to be awarded “substantial” slip op. at 22

  Patent outcomesUS 8,604,678 unpatentable
  § 103 obviousness§ 112 disclosurecites Phillips · Graham
  Patents in suitUS 8,604,678
• Savant Technologies LLC D/B/A GE Lighting / Ledvance LLC et al. v. Feit Electric Company, Inc.All claims unpatentable
  PTAB · Aug 28, 2026 · IPR2024-01357 · APJ Kevin W Cherry · IPR · Final written decision

  Claims 1–3, 6, 7, 9, 10, 16–21, 25, 26, and 29 are unpatentable; substitute claims 30–49 were not reached.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art We consider the asserted ground of unpatentability in view of the” slip op. at 10

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “E. Credibility of Dr. Doolittle Patent Owner argues that we should give no weight to Dr. Doolittle’s testimony because, “[o]n cross examination, Prof. Doolittle repeatedly contradicted himself, dodged questions, and tried to shoehorn new and nonresponsive opinions into his answers to Patent Owner’s questions.” PO Resp. 25. Patent Owner raises two major complaints about Dr. Doolittle. First, Patent Owner argues that he took inconsistent positions by asserting in these IPR proceedings that the claims were entitled to their plain and ordinary meaning, while in the parallel district court proceeding, asserting that certain claim terms were indefinite. Id. at 26–28. Second, Patent Owner argues that Dr. Doolittle “repeatedly dodged questions and tried to shoehorn new and nonresponsive opinions into his answers to Patent Owner’s questions,” and that “[d]uring cross examination Patent Owner was forced to object to Prof. Doolittle’s nonresponsive answers no less than eighteen times.” Id. at 28. We strongly disagree with Patent Owner’s characterization of Dr. Doolittle’s testimony. We have reviewed the entirety of both of Dr. Doolittle’s depositions. We are impressed with his forthrightness, candor, and good humor in the face of Patent Owner’s counsel’s aggressive questioning. Contrary to Patent Owner’s assertions, we find that his testimony was well-reasoned, forthright, honest, and entitled to significant weight. Dr. Doolittle explained the different claim construction positions We also strongly disagree that Dr. Doolittle’s answers were nonresponsive or “evasive” as Patent Owner argues. Patent Owner’s numerous attempts to “strike” portions of his testimony belie Dr. Doolittle’s efforts to honestly and in good faith respond to Patent Owner’s counsel’s questions. Ex. 2025, 22:10–23:15, 25:9–26:14, 30:14–22, 40:3-9, 58:12–59:1, 60:18–61:13, 65:1–10, 83:15–84:16, 92:15–95:20, 96:18–99:9, 102:22–106:16, 135:3–136:22. An answer is not “non-responsive” simply because it does not conform to the conclusion you want or undermines the logic underlying your questioning. Dr. Doolittle explained his answers and addressed the issues Patent Owner asked about. Accordingly, we decline Patent Owner’s invitation to give Dr. Doolittle’s testimony no weight. Instead, we assess Dr. Doolittle’s testimony on a case-by-case basis as discussed below.” slip op. at 21

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

    “lower wavelength might offer, there were other drawbacks that a person of ordinary skill would have to balance. But “a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine.” Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). Indeed, Petitioner has shown several references—including, Basin-2005, Shimizu, and Stokes—that made this tradeoff. Moreover, “[o]bviousness does not require absolute predictability of success. . . . [A]ll that is required is a reasonable expectation of success.” In re O’Farrell, 853 F.2d 894, 903–04 (Fed. Cir. 1988). We find that the prior art of record demonstrates that a person of ordinary skill in the art at the time of the invention would have such an expectation in making the combination of Basin-2007 and Basin-2005. Accordingly, we find that Petitioner has shown by a preponderance of the evidence that there would have been motivation to combine Basin-2007 and Basin-2005 with a reasonable expectation of success.” slip op. at 41

  • Obviousness (§103) › Objective indicia / secondary considerationsDecided for petitioner

    “7. Summary As discussed above, we find that Patent Owner has failed to show a” slip op. at 35

  Patent outcomesUS 8,604,678 unpatentable
  § 103 obviousness§ 112 disclosurecites Phillips · Graham
  Patents in suitUS 8,604,678
• Medtronic, Inc. v. Moskowitz Family LLCInstituted
  PTAB · Aug 20, 2026 · IPR2026-00162 · APJ John A Squires · IPR · Director review

  The Director granted the petition and instituted inter partes review of claims 8, 9, 13, and 17–21 based on Palmatier.

  RulingsDirector review decision

  • Director reviewOther

    “Before JOHN A. SQUIRES, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. DECISION Granting Institution of Inter Partes Review” slip op. at 1

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “1 US 9,445,919 B2, issued Sept. 20, 2016 (Ex. 1057). 2 At this preliminary stage, Petitioner establishes a reasonable likelihood that Palmatier anticipates or renders obvious the challenged claims (Pet. 22–66), and Patent Owner does not challenge Petitioner’s showings as to Palmatier.” slip op. at 2

  • BurdenDecided for petitioner

    “1 US 9,445,919 B2, issued Sept. 20, 2016 (Ex. 1057). 2 At this preliminary stage, Petitioner establishes a reasonable likelihood that Palmatier anticipates or renders obvious the challenged claims (Pet. 22–66), and Patent Owner does not challenge Petitioner’s showings as to Palmatier.” slip op. at 2

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportDecided for petitioner

    “Patent Owner does present some evidence of conception, diligence, and constructive reduction to practice, but Petitioner persuasively disparages that evidence on the preliminary record. For example, Patent Owner relies on April and May 2011 emails exchanged between two or more of the named inventors (Exs. 2027–2031, 2056, 2057, 2059) and a declaration from one of the named inventors, Dr. Nathan Moskowitz (Ex. 2024), to show conception of the claimed subject matter. Prelim. Resp. 8–61. Patent Owner also relies on Dr. Moskowitz’s declaration and emails (Exs. 2045, 2049, 2050) to show reasonably continuous diligence leading up to the filing of a provisional patent application. Id. at 63–66. Petitioner asserts that the documentary evidence does not show conception of the claimed “ridges,” in part, because a key email attachment regarding an embodiment for ridges has not been provided. Pet. Reply 1–4. Petitioner also asserts that Patent Owner’s relies on the declaration testimony from only one named inventor, which is vague and should be the subject of cross-examination. Id. Given these disputes, during trial, the parties are free to develop the record as to the asserted prior conception and diligent reduction to practice of the claimed subject matter, relative to Palmatier’s filing date.” slip op. at 3

  § 102 anticipation
  Patents in suitUS 12,011,367
• Par Health, Inc. v. Inforlife, S.A.Institution denied
  PTAB · Aug 20, 2026 · PGR2026-00036 · APJ John A Squires · PGR · Institution

  The Director denied institution because the petition did not show that Biomed was publicly accessible as prior art, so it failed to show any challenged claim was unpatentable.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “sufficiently that Biomed qualifies as a prior art printed publication. The Board’s precedential decision in Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 (PTAB Dec. 20, 2019) (precedential), addresses prior-art qualification in the related context of instituting an inter partes review. Hulu states that “the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” Id. at 13; see also Jazz Pharm. Inc. v. Amneal Pharm., LLC. 895 F.3d 1347, 1356 (Fed. Cir. 2018) (“[T]he IPR petitioner . . . had the burden to prove that a particular reference is a printed publication.”). The same guidance applies to post-grant reviews, albeit with the “more likely than not” standard applicable. See 35 U.S.C. § 324(a); Hulu, Paper 29 at 13 n.5. Hulu also states that “there is no presumption in favor of institution or in favor of finding a reference to be a printed publication under [37] § 42.108(c).” Hulu, Paper 29 at 16.” slip op. at 3

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable

    “sufficiently that Biomed qualifies as a prior art printed publication. The Board’s precedential decision in Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 (PTAB Dec. 20, 2019) (precedential), addresses prior-art qualification in the related context of instituting an inter partes review. Hulu states that “the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” Id. at 13; see also Jazz Pharm. Inc. v. Amneal Pharm., LLC. 895 F.3d 1347, 1356 (Fed. Cir. 2018) (“[T]he IPR petitioner . . . had the burden to prove that a particular reference is a printed publication.”). The same guidance applies to post-grant reviews, albeit with the “more likely than not” standard applicable. See 35 U.S.C. § 324(a); Hulu, Paper 29 at 13 n.5. Hulu also states that “there is no presumption in favor of institution or in favor of finding a reference to be a printed publication under [37] § 42.108(c).” Hulu, Paper 29 at 16. In this case, Petitioner merely cites a “date of revision” appearing within Biomed. Pet. 6 (citing Ex. 1005, 11). Yet, a revision date alone does not establish that Biomed was disseminated or made publicly available. And, although indicia appearing within a reference can sometimes support the printed publication status of the reference, I find the record to be devoid of any such indicia, or other evidence, supporting that Biomed was publicly disseminated or accessible by the June 15, 2021 “date of revision.” See Hulu, Paper 29 at 16–18. Thus, Petitioner fails to show that it is more likely” slip op. at 3

  • Obviousness (§103) › Analogous artNot reached

    “sufficiently that Biomed qualifies as a prior art printed publication. The Board’s precedential decision in Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 (PTAB Dec. 20, 2019) (precedential), addresses prior-art qualification in the related context of instituting an inter partes review. Hulu states that “the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” Id. at 13; see also Jazz Pharm. Inc. v. Amneal Pharm., LLC. 895 F.3d 1347, 1356 (Fed. Cir. 2018) (“[T]he IPR petitioner . . . had the burden to prove that a particular reference is a printed publication.”). The same guidance applies to post-grant reviews, albeit with the “more likely than not” standard applicable. See 35 U.S.C. § 324(a); Hulu, Paper 29 at 13 n.5. Hulu also states that “there is no presumption in favor of institution or in favor of finding a reference to be a printed publication under [37] § 42.108(c).” Hulu, Paper 29 at 16. In this case, Petitioner merely cites a “date of revision” appearing within Biomed. Pet. 6 (citing Ex. 1005, 11). Yet, a revision date alone does not establish that Biomed was disseminated or made publicly available. And, although indicia appearing within a reference can sometimes support the printed publication status of the reference, I find the record to be devoid of any such indicia, or other evidence, supporting that Biomed was publicly disseminated or accessible by the June 15, 2021 “date of revision.” See Hulu, Paper 29 at 16–18. Thus, Petitioner fails to show that it is more likely” slip op. at 3

  § 102 anticipation§ 103 obviousness
  Patents in suitUS 12,370,153
• Alliance Laundry Systems, LLC v. Payrange LLCSome claims unpatentable
  PTAB · Aug 19, 2026 · PGR2025-00028 · APJ George R Hoskins · PGR · Final written decision

  Claims 1–6 and 8–20 are unpatentable under § 102, § 103, or § 101; claim 7 was not shown unpatentable because the asserted grounds did not establish its limitations.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “1. Legal Standards “Anticipation requires that every limitation of the claim in issue be” slip op. at 10

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundMixed

    “2016) (alteration in original) (quoting Kinetic Concepts, 688 F.3d at 1368). Further, an assertion of obviousness “cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” KSR, 550 U.S. at 418 (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)); accord In re NuVasive, Inc., 842 F.3d 1376, 1383 (Fed. Cir. 2016) (stating that “conclusory statements” amount to an “insufficient articulation[] of motivation to combine”; “instead, the finding must be supported by a ‘reasoned explanation’” (quoting In re Lee, 277 F.3d 1338, 1342 (Fed. Cir. 2002))); In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016) (“To satisfy its burden of proving obviousness, a petitioner cannot employ mere conclusory statements. The petitioner must instead articulate specific reasoning, based on evidence of record, to support the legal conclusion of obviousness.”).” slip op. at 36

  • Patent Eligibility (§101) › Alice/Mayo step one — 'directed to'Step1 directed to exceptionMixed

    “because the “user interface” limitations merely apply the recited abstract idea on a generic mobile device without meaningfully limiting the abstract idea. See 2025 Guidance, at 4–5. For example, these limitations do not reflect an improvement to the functioning of the mobile device (or any other computer device), and instead are “mere instructions to implement an abstract idea or other exception on” the mobile device. Id. Indeed, the ’423 patent specification describes only a generic “swipe-to-pay” feature. See, e.g., Ex. 1001, 7:13–33, Figs. 8C, 10A–10D. This supports our conclusion here that the claim 11 limitations do not integrate the recited abstract idea into a practical application. See MPEP § 2106.04(d)(1) (“[T]he specification should be evaluated to determine if the disclosure provides sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement,” and “it must describe” slip op. at 108

  • Patent Eligibility (§101) › Alice/Mayo step two — inventive conceptStep2 no inventive conceptMixed

    “because the “user interface” limitations merely apply the recited abstract idea on a generic mobile device without meaningfully limiting the abstract idea. See 2025 Guidance, at 4–5. For example, these limitations do not reflect an improvement to the functioning of the mobile device (or any other computer device), and instead are “mere instructions to implement an abstract idea or other exception on” the mobile device. Id. Indeed, the ’423 patent specification describes only a generic “swipe-to-pay” feature. See, e.g., Ex. 1001, 7:13–33, Figs. 8C, 10A–10D. This supports our conclusion here that the claim 11 limitations do not integrate the recited abstract idea into a practical application. See MPEP § 2106.04(d)(1) (“[T]he specification should be evaluated to determine if the disclosure provides sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement,” and “it must describe” slip op. at 108

  Patent outcomesUS 11,972,423 mixed
  § 101 eligibility§ 102 anticipation§ 103 obviousnesscites Alice · Mayo · Bilski · Enfish · Electric Power · KSR · Graham
  Patents in suitUS 11,972,423
• CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentable
  PTAB · Aug 13, 2026 · IPR2025-00505 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1, 3–6, and 8–14 are unpatentable as obvious over the first § 103 combination; claims 2, 7, and 15 were not shown unpatentable because the art did not support the claimed drug sequence.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that [t]he person of ordinary skill in the art (POSA) would have been an M.D. and/or Pharm. D who would have completed training in medical oncology, particularly in the field of gastrointestinal (GI) cancers, or a Ph.D. in clinical pharmacology, pharmaceutical sciences, pharmaceutics, and/or drug delivery, also particularly in the field of GI cancers, or their equivalents, along with at least 1-2 years of post-doctoral experience. Pet. 26 (citing Ex. 1002 ¶¶ 44–46). Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 9

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

    “In the DI, the Board stated that the ordinary understanding of a claim reciting a “method of treating metastatic adenocarcinoma of the pancreas” that comprises “administering an antineoplastic therapy to the patient” in order “to treat the metastatic adenocarcinoma of the pancreas” is that the “treatment” would have more than a de minimis therapeutic benefit or efficacy for the patient being treated. DI 14. We, however, rejected the notion that the claims “would require some particular degree of clinical efficacy” because “the level of clinical efficacy is not a claim limitation.” Id.” slip op. at 12

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached

    “The parties, however, disagree over whether each recited dose must be the starting dose. Petitioner argues that “claim 1 requires that the method of treatment is a first-line therapy, but does not require that the claimed doses be used as a starting dose.” Paper 51, 1. In contrast, Patent Owner argues that “[t]he specification describes that the recited dose of each drug is a ‘starting’ or ‘initial’ dose.” Paper 50, 2 (citing Ex. 1001, 13:38–45, 30:5–7). For purposes of this Decision, we do not need to resolve this dispute. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating that claim terms need only be construed to the extent necessary to resolve the controversy). As explained below, we agree with Petitioner that, even if claim 1 recites the starting dose for each drug, Petitioner has shown, by a preponderance of the evidence, that the prior art teaches each dose and a POSA would have had a reason to start with the recited doses. See infra Section II.G.3; Paper 51, 3 n.2. Because we find that the prior art teaches or suggests the claimed subject matter even under Patent Owner’s proposed narrower claim interpretation, we need not further construe the disputed claim language.” slip op. at 16

  Patent outcomesUS 11,344,552 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,344,552
• Embody, Inc. / Zimmer Biomet Holdings, Inc. v. Lifenet HealthSome claims unpatentable
  PTAB · Aug 4, 2026 · IPR2025-00249 · APJ Michael J Fitzpatrick · IPR · Final written decision

  Claims 1 and 4–8 are unpatentable: claims 1 and 4–6 as obvious over Huang2 and Kuo, and claims 7–8 as anticipated by Huang2; claims 2–3 were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for patent owner

    “(“POSITA”) “would be a Ph.D. student with a minimum of two years of experience in their faculty advisor’s laboratory” and would have an understanding of “electrospinning fibers, including for tissue engineering, tissue engineering techniques, and using/performing FFT analysis.” Pet. 20– 21 (citing Ex. 1003 § II.C7). Patent Owner does not dispute Petitioner’s proposal but specifies the set of disciplines within which the Ph.D. would have been earned, namely “bioengineering, chemical engineering, mechanical engineering, or a related engineering discipline.” PO Resp. 6. We adopt and apply Petitioner’s proposal as clarified by Patent Owner regarding the Ph.D. discipline.” slip op. at 7

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner

    “At the outset, we agree with Patent Owner that the Specification purports to define “major peaks” in the following sentence: “The ‘major peaks’ herein refer to peaks higher than the average of the peaks in the result.” Ex. 1001, 13:28–29. We determine that this language satisfies at least two of the criteria set forth in Alnylam. Specifically, the sentence at “refers to” to explain what qualifies as major peaks. That is not the end of the inquiry, however, as we find there is still some ambiguity as to whether the patentee intended to define “major peaks” so as to require so-called “minor peaks” in the claimed invention. See Bell Atlantic, 262 F.3d at 1268 (“[T]he intrinsic evidence must ‘clearly set forth’ or ‘clearly redefine’ a claim term so as to put one reasonably skilled in the art on notice that the patentee intended to so redefine the claim term.”). Importantly, the Specification does not treat the existence of minor peaks as prerequisites for the existence of major peaks. Indeed, the Specification does not discuss “minor peaks” at all. See generally Ex. 1001. Likewise, none of the claims of the ’227 patent, whether challenged or unchallenged, recites “minor peaks” or any additional peaks beyond the disputed “major peaks.” Id. at 23:30–24:42. Nor does the Specification include an example of FFT analysis results in which the average of the peaks therein is calculated and those higher than the average are identified as major peaks.8” slip op. at 9

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundMixed

    “Petitioner has the better position. Huang2 teaches crosslinking and provides a reason for doing so (stability). In particular, Huang2 states: “To better mimic skin ECM, electrospun collagen fibers have been fabricated, however, the rapid degradation and poor mechanical properties determine that either crosslinking or combination with other materials is necessary to obtain a stable scaffold.” Ex. 1005, 1791 (emphasis added). It is true that, in describing work actually carried out, Huang2 states that blending with PCL was performed and does not mention crosslinking. See id. at 1792 (“Nanofibrous matrices of PCL and Collagen at a weight ratio of 3:1 were fabricated using electrospinning as previously described.”). However, the prior art – here, Huang2 – is not limited to that which it describes having created. See In re Mills, 470 F.2d 649, 651 (C.C.P.A. 1972) (“a reference is not limited to the disclosure of specific working examples”); see also In re Lemelson, 397 F.2d 1006, 1009 (CCPA 1968) (“The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.”); In re Fritch, 972 F.2d 1260, 1264 (Fed. Cir. 1992) (“It is well settled that a prior art reference is relevant for all that it teaches to those of ordinary skill in the art.”). Huang2 teaches two stabilization methods when using collagen in scaffolds. Huang2 states that one or the other “is necessary to obtain a stable scaffold” (when using collagen), but it does not preclude or teach away from using Patent Owner-cited testimony of Dr. Mikos is not as definitive as Patent Owner suggests; Dr. Mikos’s testimony is that a person of ordinary skill in the art “typically would not have done both.” Ex. 2015 ¶64 (emphasis added). The bottom line is that Huang2 teaches the person of ordinary skill in the art two ways to stabilize scaffolds/matrices comprised of collagen, provides a reason for doing so (stability), and does not teach away from using both. We are persuaded that a “scaffold comprising crosslinked fibers comprising collagen” would have been obvious in view of the cited teachings of Huang2.” slip op. at 33

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “We are not persuaded by Appellant’s citations to either reference. As discussed above, Petitioner’s Ground 1 is premised on a person of ordinary skill in the art altering the native flat sheet structure of Huang2 by rolling it into a jelly-roll structure as taught by Kuo. See Pet. 41 (Beginning its claim 2 arguments with the following: “Claim 1 is obvious for the reasons expressed above in § X.A., supra, which are incorporated herein.”); see also Pet. Reply 17 (“[B]ased on the explicit teaching of Kuo, a POSA would have been motivated to take the electrospun flat scaffold made by the techniques of Huang2, seed it with the desired cells, and roll it to treat a tendon and ligament.” (emphasis added)). Indeed, the paragraphs of Kuo that Petitioner cites for disclosing “scaffold sheets,” explicitly describe rolling them into jelly-roll like structures. See Ex. 1018 ¶7 (stating that “the sheet is spirally contacting a scaffold sheet of fibrous material with a cell; and rolling the scaffold sheet in a jelly-roll like manner to form a spirally wound tissue construct”), ¶22 (describing a method comprising “forming a tissue construct by contacting a scaffold sheet of fibrous material with a cell; and rolling the scaffold sheet in a jelly-roll like manner to form a spirally wound tissue construct” and implanting it in a patient). Petitioner fails to argue that that “one or more elongated sheets” recited in claim 2 would encompass the rolled structure of its proposed modification. Nor does Petitioner articulate a claim construction argument that could support such an argument. Petitioner has failed to prove, by a preponderance of the evidence, that claim 2 would have been obvious over Huang2 and Kuo.” slip op. at 42

  Patent outcomesUS 11,318,227 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Markman · KSR
  Patents in suitUS 11,318,227
• Embody, Inc. / Zimmer Biomet Holdings, Inc. v. Lifenet HealthAll claims unpatentable
  PTAB · Aug 4, 2026 · IPR2025-00248 · APJ Michael J Fitzpatrick · IPR · Final written decision

  Claims 1–3 and 5–12 are unpatentable as anticipated by Huang2; claim 4 is unpatentable as obvious over Huang2 and Kumbar. Lee grounds failed.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “understanding of “electrospinning fibers, including for tissue engineering, tissue engineering techniques, and using/performing FFT analysis.” Pet. 18– 19 (citing Ex. 1003 § II.C5). Patent Owner does not dispute Petitioner’s proposal but specifies the set of disciplines within which the Ph.D. would have been earned, namely “bioengineering, chemical engineering, mechanical engineering, or a related engineering discipline.” PO Resp. 5–6. We adopt and apply Petitioner’s proposal as clarified by Patent Owner regarding the Ph.D. discipline.” slip op. at 7

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner

    “A patentee “may choose to be his 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.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) (citing Hoechst Celanese Corp. v. BP Chemicals Ltd., 78 F.3d 1575, 1578 (Fed. Cir. 1996)); see Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir. 1995) (en banc) (“[A]ny special definition given to a word must be clearly defined in the specification.”), aff'd, 517 U.S. 370 (1996); CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). “[T]he intrinsic evidence must ‘clearly set forth’ or ‘clearly redefine’ a claim term so as to put one reasonably skilled in the art on notice that the patentee intended to so redefine the claim term.” Bell Atlantic Network Services, Inc. v. Covad Communications Group, Inc., 262 F.3d 1258, 1268 (Fed. Cir. 2001). Among the criteria to consider in whether the patentee acted as a lexicographer to define a claim term include (a) whether the patent specification included the statement in question under a section for marks, (c) whether the sentence uses the term “refer to,” which generally “conveys an intent for [that sentence] to be definitional,” and (d) whether there are other non-limiting terms (e.g., “for example,” or “include”) that contradict a definitional intent. Alnylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (alteration in original). At the outset, we agree with Patent Owner that the Specification purports to define “major peaks” in the following sentence: “The ‘major peaks’ herein refer to peaks higher than the average of the peaks in the result.” Ex. 1001, 13:6–7. We determine that this language satisfies at least two of the criteria set forth in Alnylam. Specifically, the sentence at issue sets out “major peaks” in quotation marks, and then uses the term “refers to” to explain what qualifies as major peaks. That is not the end of the inquiry, however, as we find there is still some ambiguity as to whether the patentee intended to define “major peaks” so as to require so-called “minor peaks” in the claimed invention. See Bell Atlantic, 262 F.3d at 1268 (“[T]he intrinsic evidence must ‘clearly set forth’ or ‘clearly redefine’ a claim term so as to put one reasonably skilled in the art on notice that the patentee intended to so redefine the claim term.”).” slip op. at 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner

    “As discussed above, we agree with Patent Owner that the sentence it cites from the Specification of the ’223 patent bears sufficient hallmarks of lexicography. However, the Specification nonetheless lacks any indication that so-called “minor peaks” are a necessary component of the claimed invention. “Although it is firmly settled that an applicant may act as a 9 Figure 8B does not contain “major peaks” despite clearly depicting two “peaks higher than the average of the [three or possibly four] peaks in the result” because none of the peaks is a reflection of fiber alignment. 10 After presenting claim construction arguments based on Ayres 2008, Patent Owner confusingly states: “Finally, whether Ayres-2008 supports [Patent Owner’s] construction is irrelevant.” PO Sur-Reply 5 (emphasis added). definition that is contrary to the ordinary meaning of a claim term unless it communicates a deliberate and clear preference for this alternative definition.” Kumar v. Ovonic Battery Co., 351 F.3d 1364, 1368 (Fed. Cir. 2003). There is no indication that the patentee sought to require “minor peaks” within the scope of the claimed invention. Nor are we persuaded that a person of ordinary skill in the art would readily understand the scope of the term “major peaks” to require non-major peaks. We interpret the Specification’s statement that “‘major peaks’ herein refer to peaks higher than the average of the peaks in the result” (Ex. 1001, 13:6–7) to be teaching a person of ordinary skill in the art how to identify or discern “major peaks,” which indicate a principal axis of alignment, from any non-major peaks, which would be caused by something else. We conclude that a person of ordinary skill in the art would consider “major peaks” as used in the ’223 patent as referring to peaks that reflect the sole axis or primary axis of fiber alignment. See, e.g., id. at code (54) (“ALIGNED FIBER AND METHOD OF USE THEREOF”), code (57) (“A scaffold comprising an aligned fiber.”), 1:6–7 (“The invention relates to an aligned fiber and method of use thereof.”), 1:11–12 (“The invention relates to a scaffold comprising an aligned fiber.”), 13:16–17 (“Alignment of the fibers in the scaffold may be measured by a fast Fourier transform (FFT) analysis.”). This would certainly include peaks materially higher than the average of the peaks in the result, but it would not be limited to situations involving peaks of different heights or require so-called minor peaks. Based on the totality of the evidence before us, we do not construe the claims to require non-major peaks.” slip op. at 16

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “Petitioner argues that, for the aligned sample, a major peak occurs at about 90° as identified by Petitioner’s annotation (red arrow). Pet. 30–31. As support, Petitioner directs us to Huang2’s explicit description of what the peak indicates, namely that “[t]he narrow peak of the normalized intensity values in anisotropic [aligned] matrices (Figure 1C) indicated that PCL/Coll nanofibers aligned along a single axis (Fig. 1B).” Id. at 31 (alterations in original) (quoting Ex. 1005, 1794). Patent Owner disputes that the illustrated peak is a major peak solely based on the lack of any lesser peaks. See PO Resp. 13 (“[T]he height of the sole peak is identical to—not higher than—the average height of the peaks in the result.”). As discussed above, however, we do not construe “major peaks” as requiring the existence of non-major peaks. We find that the illustrated peak in the Aniso plot of the FFT analysis results (Figure 1C) is a major peak within the meaning of the claim. The evidence in support of this finding is overwhelming. First, the term “Aniso” as used in Huang2 refers to fibers “with alignment.” Ex. 1005, 1792. Huang2 describes fabricating such matrices of aligned fibers with electrospinning, the same method used to impart alignment in the ’223 patent. Id. at 1791–92. Huang2 visually confirms that the fibers in fact are aligned via scanning electron microscopy. Id. at Fig. 1B. Further, Huang2 explicitly states that the peak illustrated in the Aniso plot of the FFT analysis results (Figure 1C) is caused by the fact that the “PCL/Coll nanofibers aligned along a single axis (Fig. 1B).” Id. at 1794. This is precisely what electrospinning may yield aligned fibers and images of aligned fibers will yield FFT results with major peaks. Ex. 1001, 2:18–19, 4:46–60, 13:16–26. Additionally, Huang2 itself considers the peak illustrated in the Aniso plot of the FFT analysis to be significant, stating: “In contrast [to the Aniso plot], the lack of a significant peak for the fibers collected on a stationary surface [(i.e., without electrospinning)] demonstrated no preferred fiber orientation in the isotropic matrices” (i.e., the Iso plot). Ex. 1005, 1794. Indeed, the asserted major peak in the Aniso plot shown in Huang2’s Figure 1C is higher than any other data point on the plot. For these reasons, we find the peak to be a major peak.15 Petitioner acknowledges that Figure 1C only reports its results” slip op. at 32

  Patent outcomesUS 10,137,223 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Markman
  Patents in suitUS 10,137,223
• Ajinomoto Co., Inc. v. Abtis Co., Ltd.No claims unpatentable
  PTAB · Aug 3, 2026 · IPR2025-00283 · APJ Lilan Ren · IPR · Final written decision

  The Board cancelled claim 11 and granted substitute claims 14–16, finding Petitioner had not shown those claims unpatentable on any asserted ground.

  RulingsFinal written decision

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted

    “must determine whether the motion to amend meets the statutory and regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121. Lectrosonics, Paper 15 at 4. In that regard, Patent Owner bears the burden of persuasion to show that: (1) the amendment proposes a reasonable number of substitute claims; (2) the amendment responds to a ground of unpatentability involved in the trial; (3) the amendment does not seek to enlarge the scope of the claims of the patent or introduce new subject matter;” slip op. at 9

  • ExcludeMotion to exclude, deniedDenied

    “In this case, Patent Owner’s expert “Dr. Zhou signed the second declaration, stood behind its contents, and was available for cross-examination.” Paper 35, 4. Petitioner does not dispute this statement. Paper 39, 1. Petitioner does not identify any specific undue prejudice caused by Exhibit 2008. For example, Petitioner argues that “the failure to impress upon a witness that a statement is under oath goes to the heart of its reliability as evidence” and that “as the Board has recognized, hearsay is inherently unreliable” without specifying what statement in Exhibit 2008 lacks reliability. Paper 39, 4. Because Petitioner does not provide specific evidence of undue prejudice, we find Petitioner has suffered no such undue prejudice in this case. See Liquidia, 2021 WL 4860773 at *25. We therefore deny Petitioner’s Motion to Exclude on the basis of lack of authenticity. With regard to the assertion that Exhibit 2008 is hearsay, Petitioner objects to the exhibit because the testimony is based “on other informal and unpublished documents that are hearsay under FRE 802.” Paper 29, 1. Petitioner does not specify what such “informal and unpublished documents” are. See id. Federal Rule of Evidence 703 expressly states, “[a]n expert may base an opinion on fact or data in the case that the expert has been made aware of or personally observed.” The facts or data “need not be deny Petitioner’s Motion to Exclude on the basis of hearsay.” slip op. at 50

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable

    “Petitioner’s argument is unpersuasive. Paragraph 59 of the ’503 application describes formula 8-1 but does not support Petitioner’s argument that other unknown formulas may be included in the recited modified heavy chains. Ex. 2003 ¶ 59. Petitioner’s hypothesis that the recited heavy chains may (or may not) encompass unknown formulas is also inapposite to the written description inquiry before us — that is, whether the inventor was in possession of the subject matter recited in claims 14–16 based on the disclosure including formulas 8-1, 8-2, and 8-3. See PowerOasis, 522 F.3d at 1306.” slip op. at 14

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledNot shown unpatentable

    “These arguments in the Sur-Reply are unpersuasive to show a lack of enablement first and foremost because the arguments do not specifically provide evidence showing that any purported experimentation is undue. See Sur-Reply 2–8 (asserting, but without providing evidence under any specific Wands factors, that the examples and guidance in the specification do not extend to the broad scope of all antibodies); see Wands, 858 F.2d at 737. We again emphasize that the analysis of undue experimentation does not necessarily require every Wands factor to be explicitly addressed but the analysis must be based on “weighing many factual considerations” depending on the nature of the invention and underlying art. Cephalon, Inc. v. Watson Pharms., Inc., 707 F.3d 1330, 1336 (Fed. Cir. 2013). The assertion that the claim scope is broad alone does not suffice to show a lack of enablement based on the record before us. Moreover, as we note supra, Petitioner’s claim scope argument is based on the false premise that the scope of claims 14–16 is as broad as the claim term “antibody” without taking into account all other claim elements. For example, Petitioner does not disagree with Patent Owner’s statement that “[t]he ’675 Patent’s specification discloses the structural modification site, the chemistry used to modify that residue, and working examples demonstrating the modification” (Reply 2), but asserts only that “[t]he disclosure of SSFI that only binds to IgG1 Fc domains (SEQ ID NO:1) is . . . . inconsistent with the expansive scope of the claims.” Sur-Reply 5. Petitioner’s argument that the claims encompass proteins that lack a lysine reside at a 248 position improperly excludes from the claim language the “lysine residue at 248 position . . . [as] determined by the EU numbering system” that claims 14–16 require. As Dr. Zhou testifies, “each proposed lysine residue at position 248 (EU numbering) is covalently modified with a specific attachment with a terminal bio-orthogonal click-chemistry functional group. The specification describes targeted transfer of a chemical functional group to lysine 248” and when claims 14–16 are considered in their entirety, which includes all claim elements, “[a] POSA would understand the claim itself to limit the modified antibodies to those with lysine at position 248.” Ex. 2004 ¶ 48; Ex. 2008 ¶ 47. We also note that Patent Owner states “a POSA would understand that the phrase ‘one or more modified heavy chain’ encompasses antibodies within typical DAR distributions (i.e., fractional numbers) rather than requiring a distinct process for producing antibodies bearing modified heavy chains in exact integers.” Reply 2–3. Moreover, Patent Owner states that PepTalk Presentation demonstrates that “a POSA would understand antibody conjugation products to exist as mixtures rather than discrete whole number species” because PepTalk Presentation “presents DAR values as non-integer measurements, i.e. DARs of 1.8 and 1.9 reflecting such distributions.” Id. at 3 (citing Ex. 1007, 28). According to Patent Owner, “preparations having an average DAR of approximately 1.8 (commonly referred to in practice as ‘DAR2’) may reflect typical reaction distributions in which some antibodies contain two modified heavy chains while others contain fewer.” Id. at 3 (citing Ex. 2008 ¶ 46). Petitioner does not rebut these statements. See Sur-Reply 2–8. Based on the foregoing, the evidence before us does not show any” slip op. at 27

  Patent outcomesUS 11,896,675 not shown unpatentable
  § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · Nautilus
  Patents in suitUS 11,896,675

Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.