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  • 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
  • Pgr2026-00036Institution denied
    PTAB · Aug 13, 2026 · PGR2026-00036 · APJ John A Squires · PGR · Institution

    PGR institution was denied because the petitioner failed to show it was more likely than not that at least one challenged claim was unpatentable.

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

      “Pursuant to 35 U.S.C. § 324(a), after review of the merits, the petitioner has failed to show that it is more likely than not that at least one of the claims challenged in the petition is unpatentable. Accordingly, institution of post-grant review is denied in the following proceeding:” slip op. at 2

    None
    Patents in suitUS 12,370,153
  • Ipr2026-00338Institution denied
    PTAB · Aug 13, 2026 · IPR2026-00338 · APJ John A Squires · IPR · Director review

    The Director denied institution of IPR2026-00338 after review of discretionary and non-merits considerations.

    RulingsDirector review decision
    • Director reviewDirector review, deniedDenied

      “NOTICE Pursuant to 35 U.S.C. § 314(a), after review of discretionary and non- merits considerations, institution of inter partes review is denied in the following proceedings: IPR2026-00268* IPR2026-00338 Pursuant to 35 U.S.C. §§ 314(a) and 324(a), after review of” slip op. at 1

    • Other 314aInstitution denied discretionary otherInstitution denied

      “NOTICE Pursuant to 35 U.S.C. § 314(a), after review of discretionary and non- merits considerations, institution of inter partes review is denied in the following proceedings: IPR2026-00268* IPR2026-00338 Pursuant to 35 U.S.C. §§ 314(a) and 324(a), after review of” slip op. at 1

    Discretionary denial
    Patents in suitUS 8,738,103
  • Ipr2026-00268Institution denied
    PTAB · Aug 13, 2026 · IPR2026-00268 · APJ John A Squires · IPR · Director review

    The Director denied institution of IPR2026-00268 after reviewing discretionary and non-merits considerations.

    RulingsDirector review decision
    • Other 314aInstitution denied discretionary otherInstitution denied

      “NOTICE Pursuant to 35 U.S.C. § 314(a), after review of discretionary and non- merits considerations, institution of inter partes review is denied in the following proceedings: IPR2026-00268* IPR2026-00338 Pursuant to 35 U.S.C. §§ 314(a) and 324(a), after review of” slip op. at 1

    Discretionary denial
    Patents in suitUS 11,885,358
  • 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
  • Ipr2026-00330Institution denied
    PTAB · Aug 6, 2026 · IPR2026-00330 · APJ John A Squires · IPR · Director review

    The Director denied institution of IPR2026-00330 after review of discretionary and non-merits considerations.

    RulingsDirector review decision
    • Other 314aInstitution denied discretionary otherInstitution denied

      “NOTICE Pursuant to 35 U.S.C. § 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of inter partes review and post-grant review is denied in the following proceedings: IPR2026-00295 IPR2026-00297 PGR2026-00023* IPR2026-00296 PGR2026-00039* IPR2026-00330 Pursuant to 35 U.S.C. §§ 314(a), after review of discretionary” slip op. at 1

    Discretionary denial
    Patents in suitUS 11,949,962
  • Ipr2026-00297Institution denied
    PTAB · Aug 6, 2026 · IPR2026-00297 · APJ John A Squires · IPR · Director review

    The Director denied institution of IPR2026-00297 after review of discretionary and non-merits considerations.

    RulingsDirector review decision
    • Director reviewDirector review, deniedDenied

      “NOTICE Pursuant to 35 U.S.C. § 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of inter partes review and post-grant review is denied in the following proceedings: IPR2026-00295 IPR2026-00297 PGR2026-00023* IPR2026-00296 PGR2026-00039* IPR2026-00330 Pursuant to 35 U.S.C. §§ 314(a), after review of discretionary” slip op. at 1

    • Other 314aInstitution denied discretionary otherInstitution denied

      “NOTICE Pursuant to 35 U.S.C. § 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of inter partes review and post-grant review is denied in the following proceedings: IPR2026-00295 IPR2026-00297 PGR2026-00023* IPR2026-00296 PGR2026-00039* IPR2026-00330 Pursuant to 35 U.S.C. §§ 314(a), after review of discretionary” slip op. at 1

    Discretionary denial
    Patents in suitUS 12,079,667
  • Ipr2026-00296Institution denied
    PTAB · Aug 6, 2026 · IPR2026-00296 · APJ John A Squires · IPR · Director review

    The Director denied institution of IPR2026-00296 after review of discretionary and non-merits considerations.

    RulingsDirector review decision
    • PTAB / AIA Trials › Discretionary denialInstitution denied discretionary otherInstitution denied

      “NOTICE Pursuant to 35 U.S.C. § 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of inter partes review and post-grant review is denied in the following proceedings: IPR2026-00295 IPR2026-00297 PGR2026-00023* IPR2026-00296 PGR2026-00039* IPR2026-00330 Pursuant to 35 U.S.C. §§ 314(a), after review of discretionary” slip op. at 1

    Discretionary denial
    Patents in suitUS 10,810,050
  • Ipr2026-00295Institution denied
    PTAB · Aug 6, 2026 · IPR2026-00295 · APJ John A Squires · IPR · Director review

    The Director denied institution of IPR2026-00295 after review of discretionary and non-merits considerations.

    RulingsDirector review decision
    • Director reviewDirector review, deniedDenied

      “NOTICE Pursuant to 35 U.S.C. § 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of inter partes review and post-grant review is denied in the following proceedings: IPR2026-00295 IPR2026-00297 PGR2026-00023* IPR2026-00296 PGR2026-00039* IPR2026-00330 Pursuant to 35 U.S.C. §§ 314(a), after review of discretionary” slip op. at 1

    • Other 314aInstitution denied discretionary otherInstitution denied

      “NOTICE Pursuant to 35 U.S.C. § 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of inter partes review and post-grant review is denied in the following proceedings: IPR2026-00295 IPR2026-00297 PGR2026-00023* IPR2026-00296 PGR2026-00039* IPR2026-00330 Pursuant to 35 U.S.C. §§ 314(a), after review of discretionary” slip op. at 1

    Discretionary denial
    Patents in suitUS 11,656,915
  • 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.