- Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,054,758 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · 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 · GrahamPatents in suitUS 12,060,590 - Google LLC v. Sandpiper CDN, LLCAll claims unpatentablePTAB · Oct 9, 2026 · IPR2025-00826 · APJ Michael T Cygan · IPR · Final written decision
Claims 1–23 are unpatentable under § 103, including over Glines alone and the additional asserted combinations.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner asserts that a person of ordinary skill in the art (“POSITA”) at the critical time “would have had at least a bachelor’s degree in computer science, electrical engineering, or a related field, and at least two years of work or research experience in the field of content delivery management or networks,” and that “additional education could substitute for work experience.” Pet. 3 (citing Ex. 1008 ¶¶ 51–53). Patent Owner provides substantially the same assessment. PO Resp. 16. We adopt Petitioner’s proposed level of ordinary skill, as it appears to be consistent with the specification of the ’112 patent and the prior art of record.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.100(b). Under this standard, the words of a claim generally are given their “ordinary and customary meaning,” which is the meaning the term would have to a person of ordinary skill at the time of the invention, in the context of the entire patent including the specification. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Neither party proposes any express claim construction. Pet. 3; PO Resp. 16. We address the parties’ interpretation of the scope of “causing said hostname to be resolved” in our discussion of Petitioner’s assertions for limitation [1.d]. Based on the record before us, we determine that no claim term requires express construction.” slip op. at 8
- Expert testimonyPetitioner expert creditedDecided for petitioner
- Strike new argumentNew argument consideredDecided for petitioner
“We do not agree. The Petition states that Glines discloses that the anycast is resolved by an ISP DNS server. Pet. 20. The Petition identifies Glines’s local ISP DNS resolver 18 as the claimed ISP DNS server. Id. The Petitioner further asserts that Glines’s ISP DNS resolver 18 sends the request to the DNS server 38, but states that “Glines’s local DNS resolver, an ISP DNS server, thus causes the hostname . . . to be resolved.” Id. at 21–22. The Petition also drew an analogy with the ’112 patent and the role of local DNS server 70a in the Petition. See Pet. 20–21. Because the Petition and the Reply both identify Glines’s local ISP DNS resolver 18 as causing the hostname to be resolved, Petitioner has not advanced a new theory of unpatentability in its Reply. 6 At oral argument, Patent Owner suggested a narrower claim reading, but admitted that this had not been briefed. Tr. 36:15–38:9, 44:9–16. We do not address this reading because it was not set forth in the briefing. In the briefing, Patent Owner took the broader reading discussed here. See Tr. 41:12–23; PO Sur-reply 7.” slip op. at 13
Patent outcomesUS 9,021,112 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,021,112 - CSPC Megalith Biopharmaceutical Co., Ltd. v. Lepu Biopharma Co. Ltd.All claims unpatentablePTAB · Oct 8, 2026 · IPR2025-00685 · APJ Ryan H Flax · IPR · Final written decision
Claims 1–23 are unpatentable as obvious over Wei and Liu, and over Leanna, Wei, and Liu.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“appears to be generally consistent with the level of skill presented in the cited prior art. See generally, e.g., Exs. 1005–1008; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself may reflect an appropriate level of skill in the art). However, as at institution, we reject the portion of Petitioner’s proposed definition that includes having “access to other individuals with that knowledge and experience,” as not reflecting the individual level of skill of a given skilled artisan. See, e.g., Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986) (holding that “[t]he person of ordinary skill is a hypothetical person who is presumed to be aware of all the pertinent prior art.”) (emphasis added, footnotes omitted); but see Indivior Inc. v. Dr. Reddy’s Labys., S.A., 930 F.3d 1325, 1343 (Fed. Cir. 2019) (no clear error in determination that “a person of ordinary skill . . . ‘would be on a team with an engineer or scientist . . . .’”). Consequently, we find the person of ordinary skill in the art was a person who had a Ph.D. in immunology, molecular biology, cellular biology, or a similar field, or an M.D. with similar experience, and had at least five years of experience with antibodies and antibody engineering.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner submits that no term of the Challenged Claims requires construction to resolve the challenges in this Petition.” Pet. 32. We did not construe any terms in our Institution Decision. See DI 6–7. Patent Owner presents no express positions on claim construction. See generally Resp. For the purposes of this Decision, no terms of the challenged claims require construction. Phillips, 415 F.3d at 1312–13. D. slip op. at 12
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“2 G. Wei et al., US 2015/0071923 Al, pub. March 12, 2015. Ex. 1005 (“Wei”). 3 J. Liu, CN 103772504 A, pub. May 7, 2014. Ex. 1007. The Liu reference is published in Simplified Chinese and Petitioner filed a certified English translation, to which we refer herein. See Ex. 1008 (“Liu”). Patent Owner does not contest the accuracy of the translation. See generally Resp. 4 M.R. Leanna & C.L. Becker, WO 2014/152199 A1, pub. Sept. 25, 2014. Ex. 1006 (“Leanna”). 5 Based on our review of each deposition transcript in view of the record as a whole, although each witness appears competent, we are left with the impression that Dr. Bournazos’s testimony is somewhat more credible than Dr. Atanackovic’s. This conclusion is based, inter alia, on each witness’s ability to recall the relevant record and respond to questions on evidentiary and technical issues.” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“We find that combining Liu’s BA03 antibody with Wei’s ADC platform would have been desirable, predictable, and routine for the ordinarily skilled artisan based on the facts that: (1) cetuximab was a wellknown and well-studied, U.S. regulatory approved, anti-EGFR antibody that would have served as a starting point for new cancer therapies; (2) humanization of therapeutic antibodies is generally desired (and “[e]very antibody can be humanized” and it is advantageous according to Patent Owner’s counsel); (3) BA03 was a well-known humanized version of cetuximab that had several known advantages over cetuximab in addition to lower immunogenicity from humanization; and (4) Wei taught a similar cetuximab-derived antibody, and a humanized cetuximab-derived antibody, each provided in an ADC with a well-known and validated off-the-shelf linker-drug platform, i.e., vc-MMAE, that exhibited a strong anti-tumor response. See, e.g., Ex. 1001, 1:57–2:32, 2:50–3:1, 5:6–53, 18:3–33, 19:26– 29; Ex. 1002 ¶¶ 14, 38, 42–43, 45–53, 56–73, 84–92, 109–117, 178–189, 202–271; Ex. 1005 ¶¶ 9–10, 229–232, 434, 437, 476, 491–506, 664–675, 685, 688, 715, 732, 1103, 1092–1141; Ex. 1008 ¶¶ 3–6, 60, 74, 141–160; Ex. 2027 ¶¶ 7–8, 38, 50, 57 (confirming our understandings regarding the claimed antibody and linker-drug payload); Ex. 2023, 173, 300; see also Resp. 1, 5–6, 23 (Patent Owner made the “choice” to use the prior-art-known BA03 antibody, and known-candidate cytotoxic payload MMAE); Hr’g Tr. 34:20–23, 36:6–38:20, 47:16–50:16 (Patent Owner’s counsel’s argument). When Liu’s BA03 antibody is provided in an ADC with a vc- MMAE or a Mc-vcPAB-MMAE platform (and used as cancer therapy as the references instruct) the invention of the challenged claims is achieved.” slip op. at 52
Patent outcomesUS 10,792,370 unpatentableClaim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 10,792,370 - Activision Blizzard, Inc. v. Milestone Entertainment, LLCAll claims unpatentablePTAB · Oct 8, 2026 · IPR2025-00711 · APJ Linda E Horner · IPR · Final written decision
Claims 1, 2, 4–7, 9, 11–13, 15, 19, 23, 24, and 29 are unpatentable as obvious over Kelly, Kelly and Paulsen, or Walker and Schneier.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“B. Level of Ordinary Skill in the Art There is no evidentiary dispute about the level of ordinary skill in the art.7 Based on the testimony of Mr. Crevelt, we determine that a person of ordinary skill in the art would have had at least a bachelor’s degree in computer science or computer engineering, with at least three years of experience in game development. Pet. 12 (citing Ex. 1003 ¶¶ 100–103). Additional experience could substitute for less education, and additional education could likewise substitute for less experience. Id. We determine that the level of ordinary skill in the art adopted above is consistent with the level of technical understanding and competence reflected in the ’164 patent Specification and the asserted prior art references, based on our review of the record.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner argues that it is not necessary for the Board to provide an express construction for any claim term because the Petition “establishes the prior art meets each claim limitation under any reasonable construction.” Pet. 13. Patent Owner similarly submits that “[t]he Board need not construe any terms at this stage, because under any reasonable construction of the claim terms, the prior art fails to disclose or suggest the claimed features.” Resp. 8–9. Patent Owner notes, however that “it has relied on the plain meaning of ‘frequency of play’ in Claim 7.” Id. at 9. We agree that no explicit claim construction is necessary for this decision because, even were we to adopt Patent Owner’s proffered plain meaning of “frequency of play,” Petitioner has demonstrated that the prior art renders obvious this claim limitation. To the extent the parties’ arguments raise any implicit issues of claim construction, we address those issues within the context in which they are raised in our analysis below.” slip op. at 11
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“Patent Owner does not contest Petitioner’s showing that Kelly renders obvious the subject matter of claims 1, 2, 4–6, 11–13, 15, 19, 23, 24, and 29. Resp., passim; Tr. 50:4–13.8 We have reviewed Petitioner’s arguments and 8 Patent Owner argued in its Preliminary Response that Kelly does not disclose limitations [1.c.iii] and [1.c.v]. Prelim. Resp. 10–12. In our Institution Decision, we did not find these contentions persuasive based on the initial record. Dec. 20–24. Patent Owner has not presented these or any other arguments contesting Ground 1 as to claim 1 in its Response. Resp., the evidence and, based on that analysis, we find that Petitioner has shown by a preponderance of evidence that Kelly renders obvious the subject matter recited in these claims.” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“and Paulsen render obvious claims 2 and 4. Pet. 36–40. Petitioner submits that to the extent Kelly’s player account is not player’s club information or information on non-cash amounts, a person having ordinary skill in the art would have been motivated to implement these features based on the teachings of Paulsen. Id. Specifically, Petitioner asserts that Paulsen teaches player tracking cards and player tracking programs including player tracking points. Id. at 38–40 (citing Ex. 1007 ¶¶ 8, 9, 49). Petitioner argues that a person having ordinary skill in the art would have been led to add these features to Kelly’s system to provide a more detailed view of tracking play, which would allow for rewarding patronage and engagement. Id. at 36–37, 39–40 (citing Ex. 1003 ¶ 264; Ex. 1007 ¶ 10). Paulsen discloses a “gaming machine bonusing method utilizing a player tracking card.” Ex. 1007, code (54). Paulsen discloses that player tracking programs and player tracking cards were used in the art to provide rewards, or “comps,” to players based on the player’s level of patronage (e.g., to the player’s playing frequency and/or total amount of game plays at a given casino). Id. ¶ 8. These rewards were intended to maintain a player’s interest in additional game play during a visit and provide loyalty incentives to players. Id. at ¶ 9.” slip op. at 29
Patent outcomesUS 11,335,164 unpatentableClaim construction§ 103 obviousnessPatents in suitUS 11,335,164 - Pgr2026-00034InstitutedPTAB · 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
NonePatents in suitUS 12,419,895 - Ipr2026-00364InstitutedPTAB · 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
NonePatents in suitUS 12,301,627 - Ipr2026-00339InstitutedPTAB · 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
NonePatents in suitUS 11,644,693 - Ipr2026-00325InstitutedPTAB · 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
NonePatents in suitUS 12,301,627 - Ipr2026-00340Institution deniedPTAB · Oct 8, 2026 · IPR2026-00340 · APJ John A Squires · IPR · Institution
The Director denied institution of IPR2026-00340 because the petitioner failed to show a reasonable likelihood of prevailing on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Pursuant to 35 U.S.C. § 314(a), after review of the merits, the petitioner has failed to show a reasonable likelihood of prevailing with respect to at least one of the claims challenged in the petition. Accordingly, institution of inter partes review is denied in the following proceedings: IPR2026-00340” slip op. at 2
NonePatents in suitUS 11,644,693
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.