• 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 · PGR2025-00027 · APJ George R Hoskins · PGR · Final written decision

  Claims 1–6 and 8–20 are unpatentable under § 101; claim 7 was not shown unpatentable.

  RulingsFinal written decision

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

    “Pet.”) pursuant to 35 U.S.C. §§ 321–329 to institute a post-grant review of U.S. Patent No. 11,966,920 B2 (Ex. 1001, “the ’920 patent”), claims 1–20. We issued an Institution Decision (Paper 12) granting the petitioned review. slip op. at 2

  • Skill levelOther

    “B. Level of Ordinary Skill in the Art Petitioner contends a person having ordinary skill in the art pertaining” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

    “thereby supporting our conclusion that the plain and ordinary meaning of “affordance” in claim 1 refers to an interactive user interface element.” slip op. at 30

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

    “For the foregoing reasons, we conclude Petitioner’s reliance on Low’s” slip op. at 21

  Patent outcomesUS 11,966,920 mixed
  Claim construction§ 101 eligibility§ 103 obviousnesscites Alice · Mayo · Bilski · Berkheimer · Enfish · Electric Power · KSR
  Patents in suitUS 11,966,920
• Viance, LLC v. Koppers Performance Chemicals, Inc.Institution denied
  PTAB · Aug 19, 2026 · PGR2026-00023 · APJ John A Squires · PGR · Director review

  The Director denied the PGR petition and instituted no trial because Petitioner failed to identify Venator as a real party in interest within the statutory filing period.

  RulingsDirector review decision

  • PTAB / AIA Trials › Real party in interest / privityInstitution denied rpiDecided for patent owner

    “However, as I previously explained, RPIs are not limited to entities that are actually funding and controlling the proceeding but include entities that have the ability to control the proceeding. See Tianma, IPR2025-01579, Paper 12 at 9–10. Petitioner argues that its two owners do not have unilateral control of Petitioner. However, unilateral control is not the standard, and control of Petitioner is vested solely in its two owners as members of the Board of Directors. See Moyes Decl. ¶ 7. Accordingly, I am not persuaded that Venator and Lanxess do not have the ability to control” slip op. at 3

  • PTAB / AIA Trials › §315(b) time barDecided for patent owner

    “Patent Owner further argues that Petitioner cannot correct its RPI listing because adding an RPI would require a new filing date that places the Petition outside the 9-month window for filing a PGR. DD Opp. 11–12 (citing Corning, IPR20214-00440, Paper 68 at 24). Patent Owner is correct. See Sun Pharm. Indus., Inc. v. Biofrontera, Inc., PGR2026-00021, Paper 12 at 4 (Director May 26, 2026) (denying PGR petition because Petitioner did not meet the requirement to name all RPI within the statutory timeframe for filing a PGR petition). Accordingly, this Petition is denied, and Petitioner may file an IPR petition listing the appropriate real parties in interest.3” slip op. at 4

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

    “listing because adding an RPI would require a new filing date that places the Petition outside the 9-month window for filing a PGR. DD Opp. 11–12 (citing Corning, IPR20214-00440, Paper 68 at 24). Patent Owner is correct. See Sun Pharm. Indus., Inc. v. Biofrontera, Inc., PGR2026-00021, Paper 12 at 4 (Director May 26, 2026) (denying PGR petition because Petitioner did not meet the requirement to name all RPI within the statutory timeframe for filing a PGR petition). Accordingly, this Petition is denied, and Petitioner may file an IPR petition listing the appropriate real parties in interest.3 In consideration of the foregoing, it is: ORDERED that the Petition is denied, and no trial is instituted.” slip op. at 4

  Discretionary denial
  Patents in suitUS 12,370,716
• Tesla, Inc. v. Intellectual Ventures II LLCSome claims unpatentable
  PTAB · Aug 18, 2026 · IPR2025-00339 · APJ Kristen L Droesch · IPR · Final written decision

  Claims 22, 23, 28, and 30 are unpatentable over Choi, Labaziewicz, and Yu; claims 1–3, 10–12, 24, 25, 32, and 33 were not shown unpatentable.

  RulingsFinal written decision

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningOther

    “We decline Patent Owner’s invitation to construe “during a frame” of “independently controlling simultaneous data acquisition with each of the first and second channels during a frame” by importing the extraneous limitations “at some point between the beginning and the end of the exposure interval during which the image sensors capture a single image.” As pointed out by Petitioner, Patent Owner’s proposed construction is unsupported by the language of claim 22 and the ’180 Specification because Specification does not disclose an exposure interval nor suggest “during a frame” is limited to an exposure interval. Patent Owner and its expert Dr. Saber cite only extrinsic evidence (Exs. 2006, 2009) to support its argument that claim 22 should be limited to an “exposure interval during which the image sensors capture a single image.” See PO Resp. 16–17; Ex. 2020 ¶ 64. Similarly, Patent Owner relies only on extrinsic evidence (e.g., Ex. 2011, 1; Ex. 2022, 1; Ex. 2020 ¶ 66) to limit “during” to “at some point between the beginning and the end.” See id. at 18. When considered in the context of claim 22 and the ’180 Patent Specification which do not limit “during a frame” to an exposure interval, we find that we cannot rely on Patent Owner’s citations to extrinsic evidence to yield a reliable construction for “during a frame.” As demonstrated in the analysis below, we need not provide an explicit construction for “during a frame” to resolve the parties’ disputes regarding the merits of the patentability challenges. See Realtime, 912 F.3d at 1375. We apply the ordinary and customary meaning for “during a frame.” To the extent that an explicit identification of the ordinary and customary meaning may aid the understanding of our analysis, consistent with the language of claim 22 and the ’180 Patent Specification, we find that the ordinary and customary meaning for “during a frame” is “during the period of time that data for an image frame is acquired.” See Ex. 1001, code (57), 20:6–24, 25:23–35.” slip op. at 12

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “had a bachelor’s degree in electrical engineering, computer engineering, computer science, or a related field and 2-3 years of experience in digital imaging systems,” and that “[l]ess experience may be necessary with additional education, and likewise, less education may be necessary with additional work experience.” Pet. 6 (citing Ex. 1003 ¶¶ 16–19). Patent Owner does not dispute Petitioner’s definition. See generally PO Resp. We adopt Petitioner’s definition of a person of ordinary skill in the art because it is consistent with the level of skill reflected by the ’180 Patent Specification and the prior art of record.” slip op. at 20

  • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

    “Owner to show that Labaziewicz is not prior art because the ’180 Patent is entitled to the earliest August 25, 2004, filing date of the ’854 Provisional Application. See Dynamic Drinkware, 800 F.3d at 1379–1380. For a claim in a later-filed application to be entitled to the filing date of an earlier application, the earlier application must provide written description support for the claimed subject matter. Anascape, Ltd. v. Nintendo of Am. Inc., 601 F.3d 1333, 1337 (Fed. Cir. 2010). To satisfy the written description requirement, “a prior application itself must describe an invention, and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997); see also VasCath v. Mahurkar, 935 F.2d 1555, 1563–64 (Fed. Cir. 1991) (“[T]he applicant must . . . convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention . . . now claimed.” (emphasis omitted)), Ariad Pharm. Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010) (en banc) (“[I]t is the specification itself that must demonstrate possession.”). Patent Owner’s arguments fail to meet this burden of production because, aside from addressing deficiencies of written description support the ’854 Provisional Application provides written description support for all of the limitations of the claimed invention. See PO Resp. 60–64; PO Sur-reply 25–28. Specifically, Patent Owner does not address written description support in the ’854 Provisional Application for “independently controlling simultaneous data acquisition with each of the first and second channels during a frame”––limitation [22.3]––the heart of the parties’ claim construction disputes addressed above in Section II.A. See PO Resp. 60–64; PO Sur-reply 25–27. Accordingly, Patent Owner has not met its burden of production in coming forward with evidence or argument to show possession of the claimed invention in the ’854 Provisional Application. As a result, the burden of production does not shift back to Petitioner, and, therefore, the ’180 Patent is not entitled to the benefit of the August 25, 2004, filing date of the ’854 Provisional Application.” slip op. at 23

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

    “Petitioner does not present arguments that it would have been obvious to a person of ordinary skill in the art at the time of the invention to modify the teachings of Matsushima to acquire data for images 62A and 62B at the argues that Matsushima renders obvious this limitation. See id. at 21, 23, 30; PO Resp. 33–34 (“[T]he Petition provides no further explanation why Matsushima renders this limitation obvious.”). In the Reply for the first time, Petitioner asserts that “a POSITA would understand that Matsushima’s disclosure, including its multi-channel architecture, synchronous control of channels, and capturing two images that are scaled versions of the same scene, renders obvious simultaneous acquisition during a frame. Pet. Reply 13 (citing Ex. 1069 ¶ 49). We do not consider Petitioner’s belated argument because it exceeds the proper scope of a reply. A reply may only respond to arguments raised in the corresponding patent owner response. See 37 C.F.R. § 42.23. As explained in the Trial Practice Guide, “respond” “does not mean proceed in a new direction with a new approach as compared to the positions taken in a prior filing.” Trial Practice Guide at II.I. (December 2025)(citing 37 C.F.R. § 42.23).10 A reply that raises a new issue or belatedly presents evidence may not be considered. See id. For example, a “[p]etitioner may not submit new evidence or argument in reply that it could have presented earlier, e.g. to make out a prima facie case of unpatentability.” Id.” slip op. at 32

  Patent outcomesUS 7,916,180 mixed
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 7,916,180
• CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentable
  PTAB · Aug 13, 2026 · IPR2025-01531 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1, 3–6, and 8–14 are unpatentable as obvious; claims 2, 7, and 15 were not shown unpatentable because the prior art did not establish the claimed drug sequence.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “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

  • ExcludeMotion to exclude, deniedDenied

    “Petitioner, as the moving party, bears the burden of proving that the material sought to be excluded is inadmissible under the Federal Rules of Evidence. See 37 C.F.R. §§ 42.20(c), 42.62(a); see also Trial Practice Guide (“TPG”)15 § II.K (“A motion to exclude must explain why the evidence is not admissible.”). For the reasons explained below, we deny Petitioner’s Motion.” slip op. at 17

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” 35 U.S.C. § 311(b). Whether a reference qualifies as a “printed publication” involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to the public. In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). A reference is publicly accessible upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence can locate it. Kyocera Wireless Corp. v. ITC, 545 F.3d 1340, 1350–51 (Fed. Cir. 2008). Conroy was published on May 12, 2011. Ex. 1003, 1. Conroy refers to Conroy Protocol (Ex. 1004), stating that “[t]he protocol, including the statistical analysis plan, is available with the full text of this article at NEMJ.org.” Ex. 1003, 3. When questioned whether he has “any reason to believe that the protocol would not have been provided on NEJM.org with this text when it was published,” Dr. Oberstein testified that “if they say they provided it, then I think they probably provided it.” Ex. 1210, 165:20–166:2. 17 Alternatively, to the extent necessary, under the circumstances of this case, we waive the requirement of § 42.63(b). See 37.C.F.R. § 42.5(b). In addition, Dr. Ratain testified that “most top journals require that the protocol be submitted at the time of initial submission, and it’s always published alongside any major paper.” Ex. 2073, 42:2–5. According to Dr. Ratain, “[c]ertainly, New England Journal of Medicine does that.” Id. at 42:6–7. We credit the testimony from both Dr. Oberstein and Dr. Ratain on this issue. Accordingly, we find Exhibit 1004 was publicly accessible at the same time Conroy was published. slip op. at 28

  Patent outcomesUS 11,344,552 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,344,552
• 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
• Crowdstrike, Inc. v. Gosecure, Inc.Some claims unpatentable
  PTAB · Aug 12, 2026 · IPR2025-00070 · APJ Neil T Powell · IPR · Final written decision

  Claims 1, 3–7, and 9–21 are unpatentable as obvious; claims 2 and 8 were not shown unpatentable because the asserted art did not meet their construed limitations.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “III. ANALYSIS LEVEL OF ORDINARY SKILL A. Petitioner explains the applicable level of skill in the art as follows: As of June 24, 2010, a person of ordinary skill in the art (POSITA) would be a person having a bachelor’s degree in computer science, computer engineering, or an equivalent, as well as two years of industry experience and who would have had a working knowledge of software security analysis, and dynamic malware analysis. Additional graduate education could substitute for professional experience, or significant experience in the field could substitute for formal education. Pet. 8 (Ex. 1003 ¶¶ 30–31). Patent Owner does not dispute Petitioner’s explanation of the level of skill in the art. See Ex. 2031 ¶¶ 15–16. We adopt Petitioner’s uncontested proposed level of ordinary skill in the art, which we find consistent with the level of ordinary skill in the art reflected by the ’872 patent and the prior art of record. See Okajima v.” slip op. at 12

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

    “We begin with the claim language in view of the Specification, which weighs heavily against Patent Owner’s position that we should rewrite “computer system” as narrowly referring to a “computing device.” PO Resp. 24. As Petitioner notes, the ’872 patent’s Specification uses “computer system” to refer to a wide range of equipment, from a component of a computing device, to a whole computing device, to a collection of computing devices. Reply 9–10 (citing Ex. 1001, 4:5–8, 11:15–18, 16:50–55). In one example, the Specification refers to “one or more other computer systems (e.g., protected network devices 136).” Ex. 1001, 18:52–53. Thus, the Specification lists “protected network devices 136” as only an example of “other computer systems,” demonstrating that “computer systems” refers to things other than protected network devices. Although Patent Owner may be correct that this passage more than a single computing device,” we find that other disclosures in the ’872 patent do. Specifically, the Specification uses the language “distributed computer system” when referring to numerous components, including “protected network devices” and an “IDS/IPS system.” Ex. 1001, 3:26–28; Reply 10. In addition to showing that a “computer system” is not limited to a single computing device, this conveys that a “computer system” according to the ’872 patent can include an IDS/IPS.” slip op. at 14

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

    “Based on our review of the complete record, we find Petitioner’s arguments and evidence to be more persuasive. Patent Owner does not dispute Petitioner’s argument and evidence that capturing detailed information like Goel’s activity sources, activity targets, and association was recognized as enhancing threat analysis. Pet. 44 (citing Ex. 1003 ¶ 79); see PO Resp. 55–59; Sur-Reply 15–17. Additionally, contrary to Patent Owner’s suggestion, we find that the Petition does not propose incorporating Goel’s kernel hooks into Capalik’s system. See Pet. 41–46. Patent Owner contends that the Petition’s reference to modifying Capalik by “adding lines of code” suggests implementing the code disclosed in Goel include kernel hooks. Id. Notwithstanding Patent Owner’s assertion otherwise, this is an unpersuasive bodily incorporation argument, as the Petition never says an ordinarily skilled artisan would have used the exact lines of code from Goel in Capalik. Rather, the Petition says that an ordinarily skilled artisan would have had sufficient skill to implement straightforward code modifications to identify activity sources, targets, and associations: a [person of ordinary skill in the art] would have understood that modifying Capalik’s system (e.g., Linux-based) to additionally monitor, identify, and store each individual activity of an attack including “activity sources, activity targets, and associations” would have required straightforward modifications to programs/code instructions, which would have been well-within the skillset of a [person of ordinary skill in the art]. Pet. 46. Patent Owner argues that Petitioner does not explain how an ordinarily skilled artisan would have modified Capalik without using kernel hooks. Sur-Reply 17. But Patent Owner does not cite any evidence to counter Dr. Jakobsson’s testimony that an ordinarily skilled artisan would have had the skill to apply Goel’s general teaching of identifying sources, targets, and associations to Capalik’s system. Ex. 1003 ¶ 182. On the whole, the evidence does not support Patent Owner’s position that the combination would have required substantially increased detection risk. Moreover, even if the combination would have somewhat increased detection risk, Petitioner persuades us that an ordinarily skilled artisan still would have had reason to combine the references teachings. Patent Owner’s allegations of increased detection risk do not negate the undisputed evidence that the combination would have provided the advantage of improved threat analysis. Pet. 44 (citing Ex. 1003 ¶¶ 175–182). Ultimately, Patent Owner’s that activity logging be undetectable.” PO Resp. 56 (emphasis added) (citing Ex. 1004 ¶ 6). This exaggerates Capalik’s disclosure. Although the cited paragraph suggests that certain systems unfortunately may be detectable by some users, it does not convey that it is a requirement for the system to be categorically undetectable. See Ex. 1004 ¶ 6.8 In sum, Petitioner persuades us by a preponderance of the evidence that it would have been obvious to modify Capalik “to identify and store unauthorized activities including the activity source, activity target, and association of each activity.” Pet. 41–46; PO Resp. 55–59; Reply 20–22; Sur-Reply 15–17.” slip op. at 47

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for patent owner

    “arguments and evidence, we determine that Patent Owner fails to sufficiently show a nexus between any of its objective indicia evidence and the claimed invention. See Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019) (“The patentee bears the burden of showing that a nexus exists”). A showing of sufficient nexus is required to establish that the evidence relied upon traces its basis to a novel element in the claim, not to something in the prior art. Institut Pasteur & Universite Pierre Et Marie Curie v. Focarino, 738 F.3d 1337, 1347 (Fed. Cir. 2013). Objective evidence that results from something that is not “both claimed and novel in the claim” lacks a nexus to the merits of the invention. In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (emphasis omitted). Thus, establishing nexus involves a showing that novel elements in the claim, not prior-art elements, account for the objective evidence of nonobviousness. Id. As discussed above, Petitioner shows that Capalik teaches all limitations of claim 1. Petitioner persuades us that none of claim 1’s elements individually nor any combination thereof is novel over Capalik’s disclosure. Accordingly, claim 1 is not novel over Capalik, which disproves Patent Owner’s assertion of nexus. PO Resp. 73–76. Moreover, even if claim 1 were novel, Patent Owner otherwise fails to show nexus for its commercial success, praise, or copying assertions. Patent Owner’s evidence does not show that Petitioner’s commercial product embodies claim 1. For example, we agree with Petitioner that Patent Owner “failed to analyze any meaningful detail regarding” how the Falcon Platform allegedly meets limitation 1(d). Reply 28–29. In particular, Patent Owner has not sufficiently addressed limitation 1(d) with the following argument: “1[D] The Falcon Platform transmitted to other computer systems” slip op. at 37

  Patent outcomesUS 9,954,872 mixed
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 9,954,872
• 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.