• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  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
• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  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
• Activision Blizzard, Inc. v. Milestone Entertainment, LLCNo claims unpatentable
  PTAB · Oct 14, 2026 · IPR2025-00712 · APJ Kevin W Cherry · IPR · Final written decision

  Claims 1, 3–9, 13, 17, 18, 23, 25, 26, 28, and 29 were not shown unpatentable because Walker was not prior art and Kelly did not teach limitations 1[d.i] and 1[d.ii].

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference not prior artPriority date awardedDecided for patent owner

    “b) Walker Priority Date Under Dynamic Drinkware, the Petitioner is required to show that “the provisional application provides support for the claims of the patent or published application.” In re Riggs, 131 F.4th 1377, 1384 (Fed. Cir. 2025). Thus, Petitioner must show that (1) at least one claim of Walker is supported by its provisional (U.S. Provisional Application No. 60/378,289 (the “’289PROV”) and (2) the specific subject matter relied upon as prior art is supported by the ’289PROV. Id. Petitioner does provide a detailed explanation about how the ’289PROV supports claim 1 of Walker. See Reply 5–10. However, as Patent Owner argues, Petitioner fails to show that the ’298PROV provides support for the specific subject matter relied on in Walker. See Sur-Reply 3–9. Petitioner only explains how the ’298PROV discloses “predetermined criteria” but does not provide any other explanation for how the other subject matter relied on in Walker is supported by the ’298PROV. Thus, we find that Petitioner has failed to show that Walker is entitled a priority date before May 1, 2003. See Riggs, 131 F.3d at 1384 (noting while “a prior art patent or published application cannot be accorded the benefit of its provisional application’s filing date absent a showing that the provisional application provides support for the claims of the patent or published application,” the challenger must also show that “the specific portions of the patent specification identified and relied on” to demonstrate purported invalidity have written description support).” slip op. at 25

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

    “evidence that Kelly teaches limitations 1[d.i] and 1[d.ii]. As Patent Owner persuasively argues, “the recorded information regarding particular game play events” of limitations 1[d.i] and 1[d.ii] refers to “memory to . . . record game play information regarding particular game play events” in limitation 1[b.ii], but Petitioner does not map “the game play events” identified in limitation 1[b.ii] to limitations 1[d.i] and 1[d.ii]. In its Reply, Petitioner does not dispute Patent Owner’s assertion, but largely reiterates its arguments from the Petition. However, none of these arguments or evidence demonstrates that the “game play events” in limitations 1[d.i] and 1[d.ii] are same the “game play events” that are allegedly stored in limitation 1[b.ii]. Even if we accept Petitioner’s contention that it was not identifying button presses or the “game identifier,” but rather includes “game states and game events in the game process,” Petitioner provides no evidence or even arguments that what it has identified here relates to what it has identified for limitations 1[d.i] and 1[d.ii]. See Pet. 29–33 (citing Ex. 1005, 25:23–24, 26:59–27:1, 32:27–33, 37:1–10, 38:66–39:7 40:33–45, 56:49–51, 57:27–33). For these reasons, Petitioner has failed to show by a preponderance of the evidence that Kelly teaches or suggests limitations 1[d.i] and 1[d.ii]. Accordingly, we find that Petitioner has failed to show that claim 1 would have been obvious over Kelly. 2. Claims 3–9, 13, 17, 18, 23, 25, 26, 28, and 29 Claims 3–9, 13, 17, 18, 23, 25, 26, 28, and 29 all depend (either directly or indirectly) from claim 1. See PO Resp. 16 (explaining that the arguments for independent claim 1 also apply to the dependent claims inherent the deficiencies asserted with respect to the independent claims). We find Patent Owner’s arguments availing, as explained above. Accordingly, we find that Petitioner has failed to show by a preponderance of the evidence that claims 3–9, 13, 17, 18, 23, 25, 26, 28, and 29 would have been obvious over Kelly.” slip op. at 44

  • Expert testimonyPetitioner expert creditedDecided for patent owner

    “programmable variable parameter sets to achieve the mandated parameters,” we find that Patent Owner sufficiently explained “the notes from the 12/4/02 meeting reflect that the inventors proposed that their invention could raise the global payout percentage ‘to 75%’ – a mandated parameter – by ‘increas[ing] % of wins by the level 2,’ i.e., a secondary game level – a variable parameter.” See PO Resp. 28–32, 37, 38; Ex. 2016; Ex. 2017 ¶¶ 23–24, 41–42; Ex. 2012 ¶ 90, 63–64. Indeed, Mr. Crevelt confirmed that that a POSITA would unequivocally regard disclosure of “win rate[s]” and “global payout percentage[s]” as disclosing the claimed “mandated parameters” that are achieved by utilizing variable parameters. See Ex. 2020, 15:7–18:4, 19:14–21:16, 24:25–25:15 (global payout percentages), 21:18– 24:24 (win rates).” slip op. at 33

  Patent outcomesUS 11,393,279 not shown unpatentable
  § 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 11,393,279
• Activision Blizzard, Inc. v. Milestone Entertainment, LLCNo claims unpatentable
  PTAB · Oct 14, 2026 · IPR2025-00708 · APJ Kevin W Cherry · IPR · Final written decision

  Claims 1, 3–5, 12, 13, 18–20, 22, 24–26, 29, 42, 44–47, and 50 were not shown unpatentable over Kelly or Walker and Schneier.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “understanding of a person of ordinary skill in the art (“POSITA”). In assessing the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (quoting Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986)). “[O]ne or more factors may predominate.” Id. 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. 14 (citing Ex. 1003 ¶¶ 62–65). 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 ’336 patent Specification and the asserted prior art references, based on our review of the record. Patent Owner states that “[f]or the purposes of this response, Patent Owner 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,” and “this POR and supporting declarations apply Petitioner’s proposed level of skill.” PO Resp. 8. Thus, we adopt Petitioner’s articulation of the level of ordinary skill in the art, which is consistent with the ’336 patent and the asserted prior art, and we apply it in our obviousness analysis below.” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We determine that no terms require express construction to resolve the parties’ disputes in this case. See id. slip op. at 13

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “b) Walker Priority Date Under Dynamic Drinkware, the Petitioner is required to show that “the provisional application provides support for the claims of the patent or published application.” In re Riggs, 131 F.4th 1377, 1384 (Fed. Cir. 2025). Thus, Petitioner must show that (1) at least one claim of Walker is supported by its provisional (U.S. Provisional Application No. 60/378,289 (the “’289PROV”) and (2) the specific subject matter relied upon as prior art is supported by the ’289PROV. Id. Petitioner does provide a detailed explanation about how the ’289PROV supports claim 1 of Walker. See Reply 6–12. However, as Patent Owner argues, Petitioner fails to show that the ’298PROV provides support for the specific subject matter relied on in Walker. See Sur-Reply 3–8. Petitioner only explains how the ’298PROV discloses “predetermined criteria” but does not provide any other explanation for how the other subject matter relied on in Walker is supported by the ’298PROV. Thus, we find that Petitioner has failed to show that Walker is entitled a priority date before May 1, 2003. See Riggs, 131 F.3d at 1384 (noting while “a prior art patent or published application cannot be accorded the benefit of its provisional application’s filing date absent a showing that the provisional application provides support for the claims of the patent or published application,” the challenger must also show that “the specific portions of the patent specification identified and relied on” to demonstrate purported invalidity have written description support).” slip op. at 24

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

    “We find that Petitioner has failed to show by a preponderance of the evidence that Kelly teaches limitation 1[f]. As Patent Owner persuasively argues, “the game play events” of limitation 1[f] refers to “game play events” in limitation 1[d], but Petitioner does not map “the game play events” identified in limitation 1[d] to limitation 1[f]. In its Reply, Petitioner does not dispute Patent Owner’s assertion, but merely reiterates its arguments from the Petition. See Reply 23–24, 26. However, none of these arguments or evidence demonstrates that the “game play events” in limitation 1[f] are same the “game play events” that are allegedly stored in limitation 1[d]. Even if we accept Petitioner’s contention that it was not identifying button presses, but rather includes “game states and game events in the game process,” Petitioner provides no evidence or even arguments that what it has identified here relates to what it has identified for limitation 1[f]. See Pet. 25–26 (citing Ex. 1005, 25:23–24, 32:27–33, 40:33–45, 56:49–51). For these reasons, Petitioner has failed to show by a preponderance of the evidence that Kelly teaches or suggests limitation 1[f]. Accordingly, we find that Petitioner has failed to show that claim 1 would have been obvious over Kelly. 2. Claims 3–5, 12, 13, 18–20, 22, 24–26, 29, 42, 44–47, and 50 Claims 3–5, 12, 13, 18–20, 22, 24–26, 29, 42, 44–47, and 50 all depend from claim 1. See PO Resp. 16 (explaining that the arguments for independent claim 1 also apply to the dependent claims inherent the deficiencies asserted with respect to the independent claims). We find Patent Owner’s arguments availing, as explained above. Accordingly, we find that Petitioner has failed to show by a preponderance of the evidence that claims 3–5, 12, 13, 18–20, 22, 24–26, 29, 42, 44–47, and 50 would have been obvious over Kelly.” slip op. at 40

  Patent outcomesUS 8,529,336 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 8,529,336
• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Oct 2, 2026 · PGR2025-00046 · APJ Jeffrey N Fredman · PGR · Final written decision

  Claims 1, 2, 5, and 7–33 are unpatentable because the Petitioner proved lack of written description and lack of enablement; the Board did not find the claims obvious.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8

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

    “been able to use the data in the Specification to make reasonable predictions about the effect of multiple modifications on hyaluronidase activity, we view this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”15) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–230 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple” slip op. at 54

  • 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 74

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

    “E. Ground III - Obviousness 1. Principles of Law The Supreme Court in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398” slip op. at 117

  Patent outcomesUS 12,091,692 unpatentable
  § 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,091,692
• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Oct 1, 2026 · PGR2025-00052 · APJ Cynthia M Hardman · PGR · Final written decision

  Claims 1–17 are unpatentable for lack of written description, lack of enablement, and indefiniteness; the Board did not find them unpatentable as obvious.

  RulingsFinal written decision

  • 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 7

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

    “Specification of the ’345 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 ’345 patent. Indeed, the definitions of “PH20” and “modified PH20 polypeptide” both require hyaluronidase activity. See Ex. 1001, 44:20–21, 49:4–7 (“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”); 47:8–11 (“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 61:60–67. 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 ’345 patent. Id. at 71:16-18, 74:11–13. 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 47:3–11.” slip op. at 20

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

    “description (see Capon, 418 F.3d at 1357–58), Patent Owner is trying to extend that to include that which is at most obvious from the prior art, as opposed to what is actually described. That is, it may have been obvious to a POSA to align PH20 sequences with other known hyaluronidase enzymes and to use the crystal structure of a different hyaluronidase (Hyal-1) in SWISS-MODEL to generate a three-dimensional structure, but none of that is described in the common disclosure itself. “[A] description that merely renders the invention obvious does not satisfy the [written description] requirement.” Ariad, 598 F.3d at 1352. While a POSA might be able to embark on their own research program to try to find suitable multiply-modified PH20 polypeptides, the four corners of the written description do not demonstrate possession of such. See id. at 1356‒57 (recognizing that “[p]erhaps one of ordinary skill could discover this information, but this does not alter our conclusion that the description . . . just represent[s] a wish or arguably a plan for future research”) (internal quotation omitted).” slip op. at 66

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

    “instances of epistasis are “rare” and an inactive PH20 polypeptide “will stay inactive . . . absent intentional ‘rescue’ mutations.” See Sur-reply 12–14. But the claims encompass far more than combinations of just two substitutions, and even Dr. Petsko concedes there are “billions” of sequences within the recited sequence space that will not properly fold. See Ex. 2070 ¶ 347; see also Ex. 1133 ¶ 237 (“While some [residues critical to protein structure] can be predicted (e.g., highly conserved positions), many others cannot without experimentation.”). Accordingly, we find Petitioner’s position more persuasive than Patent Owner’s competing position and evidence.” slip op. at 108

  Patent outcomesUS 12,264,345 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · Nautilus
  Patents in suitUS 12,264,345
• Merck Sharp And Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Sep 25, 2026 · PGR2025-00039 · APJ Michael A Valek · PGR · Final written decision

  Claims 1–4 and 7–11 are unpatentable because the challenged claims lack written-description support and are not enabled.

  RulingsFinal written decision

  • Adverse judgmentAdverse judgmentOther

    “1 Although the Petition was directed to claims 1–11 of the ’185 patent, Patent Owner filed a statutory disclaimer of claims 5 and 6 prior to institution, leaving just claims 1–4 and 7–11 at issue. See Ex. 2003.” slip op. at 2

  • 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

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other

    “B. Claim Construction In a post-grant review, we interpret a claim “using the same claim” slip op. at 11

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

    “For these reasons, we find that a preponderance of the evidence” slip op. at 59

  Patent outcomesUS 12,104,185 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 12,104,185
• Merck Sharp And Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Sep 25, 2026 · PGR2025-00033 · APJ Michael A Valek · PGR · Final written decision

  Claims 1, 2, and 6–29 are unpatentable for lack of written description and enablement; the Board did not find them obvious over the ’429 patent and Chao.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “structural connections and three-dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 126–212, 297–342; Ex. 2068 ¶¶ 123–125, 245, 294–313, 318) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–230 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’652 patent.” slip op. at 58

  • 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 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Decided for petitioner

    “exclude the use of modified PH20 polypeptides as contraceptives—the only other possible utility described in the ’652 patent—is unavailing. Resp. 39. First, “[t]he fact that a patent asserts that an invention achieves several objectives does not require that each of the claims be construed as limited to structures that are capable of achieving all of the objectives.” Phillips, 415 F.3d at 1327 (citing Liebel–Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 908 (Fed. Cir. 2004)). Second, unlike the definitions of “PH20” and “modified PH20 polypeptide” in the “Definitions” section of the Specification, the passages describing possible contraceptive use do not contain any characteristics suggesting they are definitional in nature. See Alnylam, 138 F.4th at 133 (enumerating “characteristics” such as the fact that the text appears in the “Definitions” section, sets the term off in quotation marks, and uses phrases like “refer to” that indicate that specification language is definitional in nature). Accordingly, the statement that “[a]lso provided are modified PH20 polypeptides that are inactive, and that can be used, for example, as antigens in contraception vaccines” (Ex. 1001, 75:56–58), does not redefine the term, nor otherwise void the definitional language in the Specification stating that a “modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Id. at 48:47–49 (emphasis added).” slip op. at 26

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

    “1352. While a POSA might be able to embark on their own research program to try to find the genus of multiply-modified PH20 polypeptides recited in the challenged claims, the four corners of the written description here do not demonstrate the inventors were in possession of such. See id. at 1356–57 (recognizing that “[p]erhaps one of ordinary skill could discover this information, but this does not alter our conclusion that the description . . . just represent a wish or arguably a plan for future research”) (internal quotation omitted).” slip op. at 68

  Patent outcomesUS 12,049,652 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,049,652
• Savant Technologies LLC D/B/A GE Lighting / Elong International USA Inc. et al. v. Feit Electric Company, Inc.All claims unpatentable
  PTAB · Sep 14, 2026 · IPR2025-00698 · APJ Kevin W Cherry · IPR · Final written decision

  Claims 1–11, 18–20, 23–25, and 28 are unpatentable as obvious over the two combinations of prior art.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Thus, we adopt Petitioner’s articulation of the level of ordinary skill in the art, which is consistent with the ’539 patent and the asserted prior art, and we apply it in our obviousness analysis below.” slip op. at 9

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “¶ 39). Petitioner further relies on Stokes to teach an average particle size that preferentially scatter blue . . . LED light as compared to yellow . . . light from the luminescent material.” Id. at 26–27 (citing Ex. 1108, 7:1–4). Petitioner argues that “a POSA would have been motivated to apply this principle to Krummacher, because it would increase the conversion of blue light to yellow light and improve the uniformity of the light source.” Id. at 27 (citing Ex. 1102 ¶ 237). Petitioner notes that “[c]onversion of blue light to yellow light is improved by maximizing the scattering of blue light.” Id. In addition, Petitioner asserts that “[u]niformity is improved by preferentially scattering the concentrated light from the blue-light LED chip instead of the disperse light emitted by the phosphor.” Id. at 28 (citing Ex. 1102 ¶ 237). Petitioner contends that “[a] POSA would have had a reasonable expectation of success applying this principle to Krummacher, because the relevant particle size range includes the range disclosed by Krummacher.” Id. Petitioner argues that “[a] POSA would have recognized selecting an average particle size as a design decision to be made based on a number of factors, including the light scattering properties of the particles, and well within the skill of the art.” Id. (citing Ex. 1102 ¶ 238). We find this explanation and the supporting testimony of Dr. Doolittle well-reasoned and supported and entitled to significant weight. Thus, we find that Petitioner has shown by a preponderance of the evidence that the combination of Krummacher and Stokes teaches limitation 1[c], and that a person of ordinary skill in the art would have been motivated to combine the references in the manner proposed.” slip op. at 40

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

    “¶ 39). Petitioner further relies on Stokes to teach an average particle size that preferentially scatter blue . . . LED light as compared to yellow . . . light from the luminescent material.” Id. at 26–27 (citing Ex. 1108, 7:1–4). Petitioner argues that “a POSA would have been motivated to apply this principle to Krummacher, because it would increase the conversion of blue light to yellow light and improve the uniformity of the light source.” Id. at 27 (citing Ex. 1102 ¶ 237). Petitioner notes that “[c]onversion of blue light to yellow light is improved by maximizing the scattering of blue light.” Id. In addition, Petitioner asserts that “[u]niformity is improved by preferentially scattering the concentrated light from the blue-light LED chip instead of the disperse light emitted by the phosphor.” Id. at 28 (citing Ex. 1102 ¶ 237). Petitioner contends that “[a] POSA would have had a reasonable expectation of success applying this principle to Krummacher, because the relevant particle size range includes the range disclosed by Krummacher.” Id. Petitioner argues that “[a] POSA would have recognized selecting an average particle size as a design decision to be made based on a number of factors, including the light scattering properties of the particles, and well within the skill of the art.” Id. (citing Ex. 1102 ¶ 238). We find this explanation and the supporting testimony of Dr. Doolittle well-reasoned and supported and entitled to significant weight. Thus, we find that Petitioner has shown by a preponderance of the evidence that the combination of Krummacher and Stokes teaches limitation 1[c], and that a person of ordinary skill in the art would have been motivated to combine the references in the manner proposed.” slip op. at 40

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

    “Finally, we do not agree with Patent Owner that “quantum efficiency” would have dissuaded a person of ordinary skill from making the combination. PO Resp. 36–38. To begin with, “[i]t’s not necessary to show that a combination is the best option, only that it be a suitable option.” Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 800 (Fed. Cir. 2021). Here, as demonstrated by, at least, Shimizu and Stokes, blue LEDs in this wavelength range were known to work as light sources for white-light LEDs. See Pet. 30–31. Additionally, we find persuasive Petitioner’s evidence that a person of ordinary skill in the art would not have been concerned solely with quantum efficiency, but also with overall luminous efficacy of a complete white LED package. Reply 9. As Dr. Schubert’s textbook explains, A fundamental drawback of UV pumped white LEDs is the energy loss (Stoke’s shift). The potential luminous efficacy of UV pumped white LED lamps is, therefore, markedly lower than that of white sources based on a blue LED exciting a yellow phosphor. Ex. 2014, 358–59; see also Ex. 1148, 87:5–88:4 (acknowledging Stokes shift). Thus, the evidence shows that, whatever gain in quantum efficiency a lower wavelength might offer, there were other drawbacks that a person of ordinary skill would have to balance. But “a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine.” Medichem, 437 F.3d at 1165. Indeed, Petitioner has shown several references—including, Shimizu and Stokes—that made this tradeoff. Moreover, “[o]bviousness does not require absolute predictability of success. . . . [A]ll that is required is a reasonable expectation of success.” In re O’Farrell, 853 F.2d 894, 903–04 (Fed. Cir. 1988). We find that the prior art of record demonstrates that a person of ordinary skill in the art at the time of the invention would have such an expectation in making the combination of Krummacher, Stokes, and Shimizu. Accordingly, we find that Petitioner has shown by a preponderance of the evidence that there would have been motivation to combine Krummacher, Stokes, and Shimizu with a reasonable expectation of success.” slip op. at 43

  Patent outcomesUS 8,614,539 unpatentable
  § 103 obviousnesscites Phillips · Graham
  Patents in suitUS 8,614,539
• Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentable
  PTAB · Sep 8, 2026 · PGR2025-00023 · APJ Per Curiam · PGR · Final written decision

  Claims 1–9 are unpatentable as anticipated by the ’629 publication; the claims are not entitled to the 2013 priority date.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “We find that a rigid requirement as to the subject of a POSITA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining that “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSITA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSITA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 22; Ex. 1065, 99:14–100:3. Accordingly, based on the entirety of the trial record, we find a POSITA with respect to the claims of the ’109 patent would have had a two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSITA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 9

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

    “Neither party proposes an express construction of any claim term. See Pet. 22–23 (not proposing any constructions); PO Resp. 23 (“Patent Owner agrees that the terms can be afforded their plain and ordinary meaning.”). However, Patent Owner states that some of Petitioner’s arguments implicitly construe claim 1 in an erroneous manner. PO Resp. 23–28. “For example, Petitioner argues that ‘an adequate written description would have to either disclose representative examples of the possible working cascades of various proteins or some accurate structural feature of the claimed proteins that allow them to function in the claimed assay as a whole.’” Id. at 23 (quoting Pet. 35). Patent Owner argues that, contrary to what Petitioner’s argument allegedly implies, “Claim 1 is directed to a method for producing an endotoxin assay agent” and does not require the use – Owner that claim 1 does not require the use of endotoxin assay agent. However, the claimed endotoxin assay agent must be capable of performing the assay, as counsel for Patent Owner acknowledged. Tr. 83:5–9.” slip op. at 10

  • BurdenNot shown unpatentable

    “In this case, to show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23–24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). In our Institution Decision, we stated: Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description. Inst. Dec. 12 (alterations in original). During trial, Petitioner did not present any further arguments in support of Ground 1. See generally Pet. Reply. Petitioner has failed to prove that claims 1–9 are unpatentable for failing to meet the written description requirement set forth in 35 U.S.C. § 112(a).” slip op. at 12

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

    “Although the evidence before us shows that, in 2013, a POSITA knew how to recombinantly express genes in expression systems such as CHO or HEK-293 cell lines, the evidence shows that this was true only for genes whose genetic sequences were known or readily available. See, e.g., Ex. 1069, 34:11–22 (“Q. Okay. So you would agree that the creation of the recombinant protein requires the underlying sequence of, as you said, the original animal? A. Of course.”) Because it is undisputed that, in 2013, the genetic sequence for Limulus polyphemus Factor C was unknown, or least not publicly available, Falko-Gunter does not support a finding of adequate written description here. See, e.g., Tr. 48:18–19 (“Patent Owner agrees that there had not been, as of 2013, the full length cDNA sequence for Limulus polyphemus Factor C published.”).” slip op. at 23

  Patent outcomesUS 11,959,109 unpatentable
  Claim construction§ 102 anticipation§ 112 disclosure
  Patents in suitUS 11,959,109

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.