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  • PTAB · Oct 15, 2026 · PGR2025-00030 · APJ Susan L C Mitchell · PGR · Final written decision

    Claims 1, 2, and 6–30 are unpatentable under §112(a) for lack of written description and lack of enablement; the §103 ground was not reached.

    RulingsFinal written decision
    • Additional discoveryAdditional discovery, deniedDenied

      “Patent Owner filed a Motion for Additional Discovery (Paper 42), Petitioner opposed the motion (Paper 44), and the Board denied the motion (Paper 47).” slip op. at 3

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

      “of the ’758 patent supports an understanding that some activity is required for a polypeptide to be a “modified PH20 polypeptide,” and it is the enzymatic activity of hyaluronidase specifically that is the most frequently identified activity recited in the Definitions section of the ’758 patent. Indeed, both the definitions of “PH20” and “modified PH20 polypeptide” require hyaluronidase activity. See Ex. 1001, 45:54–55, 50:39–41 (“PH20 refers to a type of hyaluronidase that . . . is neutral-active” and “neutral active refers to the ability . . . to enzymatically catalyze the cleavage of hyaluronic acid at neutral pH”); 48:43–46 (“A modified PH20 polypeptide can have up to 150 amino acid replacements so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.”). Similar language is used later in the definition of a “conjugate” to explain that even when the modified PH20 polypeptide is linked to another polypeptide or chemical moiety it “retains hyaluronidase activity.” Id. at 63:39–46. In contrast, the discussion regarding the potential use of “modified PH20 polypeptides that are inactive” as antigens in contraception vaccines appears only in non-definitional sections of the ’758 patent. Id. at 72:63–65, 75:60–62. Accordingly, we find that this disclosure does not modify the definition’s explicit requirement that the claimed “modified PH20 polypeptide” exhibit hyaluronidase activity. Id. at 48:38–46.” slip op. at 21

    • Skill levelOther

      “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

      “this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”16) 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 ¶¶ 111–251 (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 mutants retained hyaluronidase activity, even with the single substitution data provided by the ’758 patent.” slip op. at 56

    Patent outcomesUS 12,054,758 unpatentable
    Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 12,054,758
  • PTAB · Oct 15, 2026 · PGR2025-00024 · APJ Susan L C Mitchell · PGR · Final written decision

    Claims 1, 2, 6–15, and 17–30 are unpatentable under §112(a) for lack of written description and enablement; the §103 ground was not reached.

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

      “this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”16) 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 ¶¶ 111–250 (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 mutants retained hyaluronidase activity, even with the single substitution data provided by the ’590 patent.” slip op. at 56

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

      “6. Analysis Petitioner has the burden to identify how the Specification allegedly” slip op. at 75

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

      “4. Analysis Based on the evidence of record, we agree with Patent Owner that Petitioner has not provided any persuasive reason to particularly target the leucine at position 307 of a PH20 polypeptide for modification as recited in claim 1 of the ’590 patent. It is undisputed that neither of the cited prior art references, the ’429 patent or Chao, specifically identifies or discusses position 307 of the PH20 polypeptide. See, e.g., Pet. 88‒109; PO Resp. 86‒ 93. We are not persuaded by Petitioner’s argument that multiple sequence alignments identify amino acids that are tolerated at particular positions (see Pet. 99‒109), because tolerance is not a positive reason to make a substitution. “It is not enough, even after KSR, to support a determination of obviousness that a reference includes a broad generic disclosure and a common utility to that in the claims and other prior art references—there must be some reason to select a species from the genus.” Knauf Insulation, Inc. v. Rockwool Int’l A/S, 788 F. App’x 728, 733 (Fed. Cir. 2019). Dr. Park identified 379 positions in PH20 (i.e., ~85% of the protein) with evolutionary variation, that is, where “homologous proteins have tolerated different amino acids at those positions.” Ex. 1004 ¶ 31. Dr. Park distributes the twenty standard amino acids into four categories depending on their roles in forming secondary structure such as alpha helices or beta sheets, with each category having a minimum of six members. See id. ¶ 70. Nothing in the prior art or Dr. Park’s analysis directs the ordinary artisan to position 307 itself. Although Dr. Hecht asserts that the ’429 patent suggests conservative mutations generally, Petitioner did not point us to any specific teaching or” slip op. at 126

    • Additional discoveryAdditional discovery, deniedDenied

      “Patent Owner filed a Motion for Additional Discovery (Paper 41), Petitioner opposed the motion (Paper 43), and the Board denied the motion (Paper 46).” slip op. at 3

    Patent outcomesUS 12,060,590 unpatentable
    § 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 12,060,590
  • PTAB · Oct 14, 2026 · IPR2022-00817 · APJ Zhenyu Yang · IPR · Remand

    On remand, the Board found Travers ’075 did not enable RCR amplification followed by SMRT sequencing and held claims 1–30 not shown unpatentable under the asserted obviousness grounds.

    RulingsRemand decision
    • RemandOther

      “B. Scope on Remand On remand, we are bound by the terms of the Federal Circuit’s mandate. Intell. Pixels Ltd. v. Sony Interactive Ent. LLC, 181 F.4th 1216, 1220 (Fed. Cir. 2026) (“An administrative agency is bound by the mandate of a reviewing court much as a lower court is bound by the mandate of a higher court.”). According to the Federal Circuit, on appeal, Patent Owner “UW argues that ‘Travers ’075 does not enable the sequencing of an RCR concatemer using PacBio’s SMRT sequencing,’ and therefore because paragraph 122 is not enabled, it cannot be relied on for disclosing amplification followed by sequencing.” Paper 50, 14. Because “[t]he Board did not reach this issue,” the Federal Circuit “remand[ed] the case for consideration of this issue by the Board in the first instance.” Id. Thus, consistent with the court’s mandate, we must decide “whether Travers ’075 enabled RCR amplification followed by SMRT sequencing.” Id. at 8.” slip op. at 4

    • BurdenNot shown unpatentable

      “A prior art reference is presumed to be enabled. Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir. 2003) (holding that “a presumption arises that both the claimed and unclaimed disclosures in a prior art patent are enabled”); In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012) (extending the presumption to prior art printed publications). A patent owner, however, may present persuasive evidence that the relevant disclosures of a prior art are not enabled and therefore are not pertinent prior art. Amgen, 314 F.3d at 1355; In re Antor Media, 689 F.3d at 1289 (discussing the applicant’s burden to submit rebuttal evidence of nonenablement during prosecution); Apple Inc. v. Corephotonics, Ltd., 861 Fed. App’x. 443, 450 (Fed. Cir. 2021) (“[R]egardless of the forum, prior art patents and publications enjoy a presumption of enablement, and the patentee/applicant has the burden to prove nonenablement for such prior art.”). “[T]here is no absolute requirement for a relied-upon reference to be self-enabling in the § 103 context, so long as the overall evidence of what was known at the time of invention establishes that a skilled artisan could have made and used the claimed invention.” Raytheon Techs. Corp. v. Gen. Elec. Co., 993 F.3d 1374, 1376–77 (Fed. Cir. 2021). But, “if an obviousness case is based on a non-self-enabled reference, and no other prior art reference or evidence would have enabled a skilled artisan to make the claimed invention, then the invention cannot be said to have been obvious.” Id. at 1377.” slip op. at 15

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

      “The Federal Circuit stated that “the elements of the challenged claim are expressly taught by Travers ’075. Travers ’075 discloses performing RCR amplification followed by SMRT sequencing in a single embodiment.” Paper 50, 14. As a result, “no finding regarding a motivation to combine to arrive at those claimed elements is required.” Id. at 9. In addition, it was error to require Petitioner to show that a skilled artisan “would have had a reasonable expectation of success in performing RCR replication of SMRTbell templates followed by SMRT sequencing.” Id. at 13. “Unless remanded by [an appellate] court, all issues within the scope of the appealed judgment are deemed incorporated within the mandate and thus are precluded from further adjudication.” Engel Indus., Inc. v. Lockformer Co., 166 F.3d 1379, 1383 (Fed. Cir. 1999). Therefore, the only issue for us to decide is “whether Travers ’075 enabled RCR amplification followed by SMRT sequencing.” Paper 50, 8.” slip op. at 14

    • Expert testimonyPatent owner expert creditedDecided for patent owner

      “polymerase-template complexes in the same ZMW.” Id. (citing Ex. 1035, 39). Citing the Larrea Declaration, Petitioner contends that loading of multiple templates “is easily mitigated.” Id. at 18 (citing Ex. 1033 ¶ 19; Ex. 1035, 39). We are not persuaded by this argument either. Dr. Larrea testifies that one of the two methods to “easily mitigate[]” loading multiple templates into a single ZMW is “bioinformatically trimming the read to only the high-quality region (HQR).” Ex. 1033 ¶ 19. Dr. Larrea, however, provides no support for this testimony. In fact, he does not even explain what a “high-quality region (HQR)” is. We, thus, accord little weight to this testimony. See Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 (August 24, 2022) (precedential) (holding “conclusory and unsupported” declaration testimony is entitled to little weight).” slip op. at 26

    Patent outcomesUS 10,760,127 not shown unpatentable
    § 103 obviousness
    Patents in suitUS 10,760,127
  • PTAB · Oct 13, 2026 · IPR2025-00710 · APJ Scott A Daniels · IPR · Final written decision

    Claims 1–7, 9, 13, and 16–20 are unpatentable as obvious over Schneier and over Schneier with Okita; claim 8 was not shown unpatentable under either ground.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “On this record, Petitioner’s proposed level of ordinary skill in the art is not contradicted and is consistent with the technology and descriptions in the ’294 patent and the asserted prior art references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). For purposes of this Decision, we rely on Petitioner’s proposed level of ordinary skill in the art.” slip op. at 7

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “Petitioner indicates that “[t]his Petition establishes that the prior art meets each of the claim limitations under any reasonable construction. Thus, no express construction is required.” Pet. 13 (citing Ex. 1003 ¶ 86). In its Response, Patent Owner indicates that no constructions are necessary “because under any reasonable construction of the claim terms, the prior art fails to disclose or suggest the claimed features.” PO Resp. 4–5. Because there is no dispute between the parties as to any particular claim term and because the claims, as a whole, are reasonably clear on their face, no specific claim construction is necessary in this proceeding.” slip op. at 8

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableNot shown unpatentableMixed

      “rather than 10 credits, does not have a temporal component. Ex. 1008, 63:31–34. Rather, it describes an option for the user or player to obtain a discount at a particular point in time if the player is willing to purchase 20 rather than 10 credits. Id. Petitioner’s citations to this embodiment do not 9. Pet. 31; Pet. Reply 3–7 (citing Ex. 1008, 63:31–34). In this embodiment the $0.30 and $0.50 multipliers are constant, and the user is simply choosing between two existing options at a particular time to potentially take advantage of a $0.20 discount on credits. Comparatively, the $0.30 and $0.50 multipliers are different, but they are not “variable over time,” as required by claim 9. Ex. 1001, 47:38–40.” slip op. at 17

    • Expert testimonyPetitioner expert discountedDecided for patent owner

      “and reliance on Figure 19 do not in any way explain how updating game costs by meter 502 with a new Cost_Table is relevant to a credit multiplier or even a multiplier being varied over time. Ex. 1003 ¶ 155. Considering this evidence, we determine that Petitioner and Mr. Crevelt’s reliance mainly on snippets from Schneier’s “Updating Cost Information protocol” embodiment does not sufficiently explain why or how a person of ordinary skill in the art would have understood updating game cost to encompass varying a multiplier of credits over time. We also note that during his deposition, Mr. Crevelt was given opportunity to clarify his testimony as to Figure 19 and explain the cost updating embodiment in Schneier, and mostly demurred. See Ex. 2004:158:4–182:6. Explaining his reliance on Figure 19, Mr. Crevelt stated: A: And whatever latest price from that updated cost information coming from the central site is -- is variable, it’s variable as time proceed[s]. It’s a – it’s a, much of a complicated section, and -- but the information is in the Schneier patent and shows that it could have -- it should change over time. Id. at 158:23–159:5. Mr. Crevelt further stated that: A: . . . for a metered play where you’re buying so much time or so many credits or so many games on a specific game and when it runs out, then have you to buy more, and that variable can change over time. relates Schneier’s “updated cost,” with the claimed “multiplier” and “variable,” and does not adequately explain how they are equivalent or interconnected. See, e.g., id. at 160:16–23 (Mr. Crevelt testifying that “we can go from the description of figure 19, which starts at basically the top of column 56 in the Schneier patent, and . . . describes this process in detail of how the information is transferred from one place to the other and updated.”). Mr. Crevelt concludes that Schneier’s description is “complicated,” and from Figure 19 asserts the cost somehow includes a credit multiplier that “could” or “should” change over time. Id. at 158:23– 159:5. Overall, this testimony fails to sufficiently explain or point to persuasive evidence in Schneier as to how or why a person of ordinary skill in the art would have understood that the Figure 19 cost updating embodiment discloses a time-variable multiplier as required in claim 8.” slip op. at 20

    Patent outcomesUS 10,825,294 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,825,294
  • PTAB · Oct 13, 2026 · IPR2025-00709 · APJ Scott A Daniels · IPR · Final written decision

    Claims 1, 2, 4, 6, 8, 10, 14–18, 21–23, 25, 27, and 29 are unpatentable as obvious over Schneier and over Schneier with Okita; claim 9 was not shown unpatentable.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner states it “does not dispute Petitioners’ proposed level of skill, and under any level of skill a POSITA would not understand the asserted Grounds to raise any unpatentability issue.” PO Resp. 4. Patent Owner states further that “this [Patent Owner Response] and supporting declarations apply Petitioner’s proposed level of skill.” Id. On this record, Petitioner’s proposed level of ordinary skill in the art is not contradicted and is consistent with the technology and descriptions in the ’635 patent and the asserted prior art references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). For purposes of this Decision, we rely on Petitioner’s proposed level of ordinary skill in the art.” slip op. at 7

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “Petitioner indicated in the Petition that “[t]his Petition establishes that the prior art meets each of the claim limitations under any reasonable construction.[] Thus, no express construction is required.” Pet. 12–13 (citing Ex. 1003 ¶ 85). In its Response, Patent Owner indicates that no constructions are necessary “because under any reasonable construction of the claim terms, the prior art fails to disclose or suggest the claimed features.” PO Resp. 4–5. Because there is no dispute between the parties as to any particular claim term and because the claims, as a whole, are reasonably clear on their face, no specific claim construction is necessary in this proceeding.” slip op. at 8

    • Expert testimonyPetitioner expert discountedDecided for patent owner

      “We also note that during his deposition, Mr. Crevelt was given opportunity to clarify his testimony as to Figure 19 and explain the cost updating embodiment in Schneier, and mostly demurred. See Ex. 2004, 158:4–182:6. Explaining his reliance on Figure 19, Mr. Crevelt stated: A: And whatever latest price from that updated cost information coming from the central site is -- is variable, it’s variable as time proceed[s]. It’s a – it’s a, much of a complicated section, and -- but the information is in the Schneier patent and shows that it could have -- it should change over time. Id. at 158:23–159:5. Mr. Crevelt further stated that: A: . . . for a metered play where you’re buying so much time or so many credits or so many games on a specific game and when it runs out, then have you to buy more, and that variable can change over time. Id. at 161:2–6. These explanations are unpersuasive because the testimony relates Schneier’s “updated cost,” with the claimed “multiplier” and “variable,” and does not adequately explain how they are equivalent or interconnected. See, e.g., id. at 160:16–23 (Mr. Crevelt testifying that “we can go from the description of figure 19, which starts at basically the top of column 56 in the Schneier patent, and . . . describes this process in detail of how the information is transferred from one place to the other and updated.”). Mr. Crevelt concludes that Schneier’s description is “complicated,” and from Figure 19 asserts the cost somehow includes a credit multiplier that “could” or “should” change over time. Id. at 158:23– 159:5. Overall, this testimony fails to sufficiently explain or point to in the art would have understood that the Figure 19 cost updating embodiment discloses a time-variable multiplier as required in claim 9.” slip op. at 21

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableNot shown unpatentableMixed

      “Discount Credit Pricing Structure The $0.20 discount described by Schneier for purchasing 20 credits, rather than 10 credits, does not have a temporal component. Ex. 1008, 63:31–34. Rather, it describes an option for the user or player to obtain a discount at a particular point in time if the player is willing to purchase 20 rather than 10 credits. Id. Petitioner’s citations to this embodiment do not address the idea of a time component, i.e., “over time,” as required by claim 9. Pet. 31; Pet. Reply 3–7 (citing Ex. 1008, 63:31–34). In this embodiment the $0.30 and $0.50 multipliers are constant, and the user is simply choosing between two existing options at a particular time to potentially take advantage of a $0.20 discount on credits. Comparatively, the $0.30 and $0.50 multipliers are different, but they are not “variable over time,” as required by claim 9. Ex. 1001, 47:38–40.” slip op. at 18

    Patent outcomesUS 10,650,635 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,650,635
  • Pgr2026-00034Instituted
    PTAB · Oct 8, 2026 · PGR2026-00034 · APJ John A Squires · PGR · Institution

    Institution of PGR2026-00034 is granted because the petitioner showed the required likelihood of prevailing on at least one challenged claim.

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

      “Pursuant 35 U.S.C. §§ 314(a) and 324(a), after review of the merits, the petitioner has shown a reasonable likelihood of prevailing with respect to at least one of the claims challenged in the petition, or that it is more likely than not that at least one of the claims challenged in the petition is unpatentable, as appropriate, and no other non-discretionary considerations warrant denial of institution. Accordingly, institution of inter partes review and post-grant review is granted in the following proceedings:1” slip op. at 2

    None
    Patents in suitUS 12,419,895
  • Ipr2026-00364Instituted
    PTAB · Oct 8, 2026 · IPR2026-00364 · APJ John A Squires · IPR · Institution

    Institution of inter partes review is granted for IPR2026-00364 because the petitioner showed a reasonable likelihood of prevailing on at least one challenged claim.

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

      “the petitioner has shown a reasonable likelihood of prevailing with respect to at least one of the claims challenged in the petition, or that it is more likely than not that at least one of the claims challenged in the petition is unpatentable, as appropriate, and no other non-discretionary considerations warrant denial of institution. Accordingly, institution of inter partes review and post-grant review is granted in the following proceedings:1” slip op. at 2

    None
    Patents in suitUS 12,301,627
  • Ipr2026-00339Instituted
    PTAB · Oct 8, 2026 · IPR2026-00339 · APJ John A Squires · IPR · Institution

    Institution of inter partes review in IPR2026-00339 is granted after the petitioner showed a reasonable likelihood of prevailing on at least one challenged claim.

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

      “the petitioner has shown a reasonable likelihood of prevailing with respect to at least one of the claims challenged in the petition, or that it is more likely than not that at least one of the claims challenged in the petition is unpatentable, as appropriate, and no other non-discretionary considerations warrant denial of institution. Accordingly, institution of inter partes review and post-grant review is granted in the following proceedings:1” slip op. at 2

    None
    Patents in suitUS 11,644,693
  • Ipr2026-00325Instituted
    PTAB · Oct 8, 2026 · IPR2026-00325 · IPR · Institution

    The Board instituted IPR2026-00325 after finding a reasonable likelihood that the petitioner would prevail on at least one challenged claim.

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

      “Pursuant 35 U.S.C. §§ 314(a) and 324(a), after review of the merits, the petitioner has shown a reasonable likelihood of prevailing with respect to at least one of the claims challenged in the petition, or that it is more likely than not that at least one of the claims challenged in the petition is unpatentable, as appropriate, and no other non-discretionary considerations warrant denial of institution. Accordingly, institution of inter partes review and post-grant review is granted in the following proceedings:1” slip op. at 2

    None
    Patents in suitUS 12,301,627
  • Ipr2026-00373Institution denied
    PTAB · Oct 8, 2026 · IPR2026-00373 · APJ John A Squires · IPR · Director review

    The Director denied institution in IPR2026-00373 after reviewing 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 proceeding: IPR2026-00373 PGR2026-00055” slip op. at 1

    Discretionary denial
    Patents in suitUS 12,274,325
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