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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 6, 2026 · IPR2025-00629 · APJ Scott C Moore · IPR · Final written decision

    Original claim 12 is not unpatentable; substitute claim 37 is added, while substitute claims 21–28 and 30–36 are denied as obvious.

    RulingsFinal written decision
    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

      “F.3d at 1279–80, we begin our analysis with the Specification of the ’711 Patent. The Specification indicates when a UAV (such as the recited “reference aerial vehicle”) navigates autonomously, it flies without manual control, and can, for example, track and fly to a target using information captured onboard the vehicle itself. See Ex. 1001, 3:24–28 (“[I]t may not be desirable to manually control the interceptor aerial vehicle to follow the target UAV. In some embodiments, the interceptor aerial vehicle is able to autonomously track and fly to the target UAV using machine vision based on images captured by a camera of the interceptor aerial vehicle.”). The Specification also indicates that “autonomous” means more than just “automatic flight,” and clarifies that autonomous navigation occurs when a UAV that previously received a target location from an external source subsequently turns and flies itself towards the received location. See, e.g., id. at 4:15–17 (disclosing that the detected location of a target may be provided to an interceptor “to allow it to automatically and autonomously fly toward the direction of the detected location”); 15:64–16:3 (automatic and autonomous navigation occurs when an interceptor’s navigation component and/or flight controller receive the location of a target, and adjust the interceptor “to turn and fly towards the received location . . . based on the received location”); 16:49–60 (“For example, a flight direction and/or speed of an interceptor aerial vehicle are automatically and autonomously adjusted based on a location and size of the target within the captured image. . . . This allows the flight path of the interceptor aerial vehicle to be dynamically adjusted to track and follow a moving target.”).” slip op. at 11

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

      “have had reason to combine Beard and Laufer in the manner proposed by Petitioner, the combination would not satisfy the Autonomous Navigation limitation required by claim 12 because Laufer’s autopilot commands are generated by and transmitted from a remote command center (i.e., Laufer’s central controller 115). PO Resp. 15–16. In its Reply, Petitioner does not dispute that Laufer’s autopilot commands are generated by Laufer’s central controller 115, which is remote from the aircraft being controlled. See Reply 13–17. Petitioner asserts, however, that the combination still satisfies the Autonomous Navigation limitation because these autopilot commands are generated without human input. See id. Based on the complete trial record, Patent Owner’s arguments are persuasive. See PO Resp. 15–16; PO Sur-reply 42, 1–6; Ex. 2025 ¶¶ 84–87. The flight of Beard’s UAV 100 under the control of Laufer’s autopilot commands does not satisfy the Autonomous Navigation limitation of claim 12, as we have construed that limitation, because Laufer’s autopilot commands are generated at a location that is remote from UAV 100 (Laufer’s central controller 115.) See, e.g., Ex. 1010 ¶ 40 (“Central controller 115 uses autopilot command module 440 to generate autopilot aircraft commands”), ¶¶ 26, 30 (clarifying that central controller 115 and the controlled interceptor aircraft are separate devices that may communicate through a “wireless connection”), Fig. 4 (depicting “aircraft control commands 475” being generated externally from the depicted “Interceptor Aircraft”); see also Ex. 2025 ¶¶ 95–95. Petitioner never disputes that, in the proposed combination, Laufer’s central controller 115 would remain external to Beard’s UAV 100. See Reply 13–17. Instead, Petitioner relies on its proposed construction of the Autonomous Navigation limitation, which would have encompassed such an arrangement. See id. Our construction of the Autonomous Navigation limitation, which did not adopt Petitioner’s claim construction position, is dispositive of Petitioner’s argument. We thus determine that Petitioner has not shown by a preponderance of the evidence that claim 12 would have been obvious over Beard and Laufer.” slip op. at 15

    • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part

      “the legal requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121. Lectrosonics, Paper 15 at 4, 7–8. For the reasons that follow, we determine that Patent Owner has satisfied this burden. 1. Proposal of a Reasonable Number of Substitute Claims A motion to amend must “propose a reasonable number of substitute claims.” 35 U.S.C. § 316(d)(1)(B); see also 37 C.F.R. § 42.121(a)(3) (“A motion to amend may cancel a challenged claim or propose a reasonable number of substitute claims.”). “There is a rebuttable presumption that a reasonable number of substitute claims per challenged claim is one (1) substitute claim.” Lectrosonics, IPR2018-01129, Paper 15 at 4; see also 37 C.F.R. § 42.121(a)(3). Patent Owner has shown it proposes a reasonable number of substitute claims by proposing a single substitute claim for each of challenged claims 1–4, 8–11, and 13–20. MTA 1–2, Claims App. Petitioner does not argue otherwise. See generally MTA Opp. We determine that Patent Owner meets this requirement. 2. Amendments Respond to a Ground of Unpatentability “A motion to amend may be denied where … [t]he amendment does not respond to a ground of unpatentability involved in the trial.” 37 C.F.R. § 42.121(a)(2)(i). Patent Owner has responded to the grounds of unpatentability involved in this proceeding by amending the claims in response to the Petition’s asserted prior art. See MTA 2, 25, Claims App. Petitioner does not argue otherwise. See generally MTA Opp. We determine that Patent Owner meets this requirement. 3. No Enlargement of the Scope of the Claims An amendment may not seek to enlarge the scope of the claims of the patent. 35 U.S.C. § 316(d)(3); 37 C.F.R. §§ 42.121(b)(1)–(b)(2). Patent Owner asserts that the amendments in the Motion do not enlarge the scope of the claims of the patent because each proposed substitute claim “retains all of the limitations of the corresponding challenged claim, and each proposed independent substitute claim adds further limitations.” See MTA 2, Claims App. Petitioner does not argue otherwise. See generally MTA Opp. We determine that Patent Owner meets this requirement. 4. No Introduction of New Matter An amendment may not introduce new matter. 35 U.S.C. § 316(d)(3);” slip op. at 22

    • 112 supportDecided for patent owner

      “Having considered the evidence and argument cited by both parties, we determine there is sufficient written description support for the disputed portions of limitations [37.e1], [37.e3,] and [37.e4]. The ’452 application discloses selecting between groups of processing schemes (e.g., algorithms) depending on a confidence level, where the groups are, for example: high cost, high robustness algorithms; medium cost, medium robustness algorithms; and low cost, low robustness algorithms. See Ex. 2019 ¶¶ 146–147. These schemes or algorithms may be neural networks. See, e.g., id. ¶ 50 (including neural network as a type of algorithm); see also id. ¶¶ 109–110); see generally MTA Opp 1 (not disputing that schemes may be neural networks). Specifically, the ’452 application describes “algorithms that process video frames of one or more video data streams,” and “produce a prediction of objects within the video f[r]ame, as well as a confidence number that is a measure of quality for that prediction.” Id. ¶ 141. The ’452 application also discloses the concept of switching between neural networks based on confidence levels. In particular, the ’452 application discloses that a “process cycles through the processing schemes to produce a detection of an object,” for example, where “if the confidence number is higher than an activation number, an action is performed to stop or change a running group (i) and select or switch to group (ii).” Id. ¶ 146. More particularly, “a processing scheme from the group of (i) High cost (low refresh rate), high robustness algorithm[s] can select a cheaper processing scheme from the group of (ii) Medium cost, medium robustness algorithms.” Id. The ’452 application additionally discloses that schemes or algorithms (e.g., neural networks) are applied to individual video frames, and that the confidence levels that determine which neural network will be applied in the future are also derived from individual video frames. For example, as discussed above, the ’452 application describes that “[t]he processing schemes produce a prediction of objects within the video f[r]ame, as well as a confidence number that is a measure of quality for that prediction.” Ex. 2019 ¶ 141 (emphases added). The ’452 application also describes selecting and applying an individual neural network, rather than only selecting and applying a group of processing schemes. For example, as highlighted above, the ’452 application describes that “a processing scheme from the” “High” group “can select a cheaper processing scheme from the” “Medium” group. Id. ¶ 146 (emphases added). In our view, these disclosures, read together, would reasonably convey to one skilled in the art that the inventor had possession of the disputed subject matter described above. See Ariad, 598 F.3d at 1351.” slip op. at 24

    Patent outcomesUS 10,514,711 mixed
    Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · Graham · Nautilus
    Patents in suitUS 10,514,711
  • 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
  • PTAB · Sep 1, 2026 · PGR2025-00017 · APJ Jeffrey N Fredman · PGR · Final written decision

    Claims 1, 2, 6–15, and 17–30 are unpatentable because the challenged claims lack written-description support and are not enabled.

    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 9

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “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”14) 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 53

    • 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”14) 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 53

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

      “an enzyme has folded,” Dr. Naismith states, “there would need to be additional evidence to justify a conclusion that the folded enzyme is sufficiently stable to retain its folded state” and “a POSA would not believe an enzyme had ‘properly folded’ if it did not maintain activity over a meaningful period or if it formed aggregates within a short period.” Id. ¶ 59.” slip op. at 78

    Patent outcomesUS 12,110,520 unpatentable
    § 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 12,110,520
  • PTAB · Aug 31, 2026 · IPR2024-01357 · APJ Kevin W Cherry · IPR · Final written decision

    The Board held all challenged original claims unpatentable as obvious and granted the contingent motion to amend for substitute claims 30 and 32–49; substitute claim 31 was denied.

    RulingsFinal written decision
    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “E. Credibility of Dr. Doolittle Patent Owner argues that we should give no weight to Dr. Doolittle’s testimony because, “[o]n cross examination, Prof. Doolittle repeatedly contradicted himself, dodged questions, and tried to shoehorn new and nonresponsive opinions into his answers to Patent Owner’s questions.” PO Resp. 25. Patent Owner raises two major complaints about Dr. Doolittle. First, Patent Owner argues that he took inconsistent positions by asserting in these IPR proceedings that the claims were entitled to their plain and ordinary meaning, while in the parallel district court proceeding, asserting that certain claim terms were indefinite. Id. at 26–28. Second, Patent Owner argues that Dr. Doolittle “repeatedly dodged questions and tried to shoehorn new and nonresponsive opinions into his answers to Patent Owner’s questions,” and that “[d]uring cross examination Patent Owner was forced to object to Prof. Doolittle’s nonresponsive answers no less than eighteen times.” Id. at 28. We strongly disagree with Patent Owner’s characterization of Dr. Doolittle’s testimony. We have reviewed the entirety of both of Dr. Doolittle’s depositions. We are impressed with his forthrightness, candor, and good humor in the face of Patent Owner’s counsel’s aggressive questioning. Contrary to Patent Owner’s assertions, we find that his testimony was well-reasoned, forthright, honest, and entitled to significant weight. Dr. Doolittle explained the different claim construction positions We also strongly disagree that Dr. Doolittle’s answers were nonresponsive or “evasive” as Patent Owner argues. Patent Owner’s numerous attempts to “strike” portions of his testimony belie Dr. Doolittle’s efforts to honestly and in good faith respond to Patent Owner’s counsel’s questions. Ex. 2025, 22:10–23:15, 25:9–26:14, 30:14–22, 40:3-9, 58:12–59:1, 60:18–61:13, 65:1–10, 83:15–84:16, 92:15–95:20, 96:18–99:9, 102:22–106:16, 135:3–136:22. An answer is not “non-responsive” simply because it does not conform to the conclusion you want or undermines the logic underlying your questioning. Dr. Doolittle explained his answers and addressed the issues Patent Owner asked about. Accordingly, we decline Patent Owner’s invitation to give Dr. Doolittle’s testimony no weight. Instead, we assess Dr. Doolittle’s testimony on a case-by-case basis as discussed below.” slip op. at 21

    • Skill levelOther

      “B. Level of Ordinary Skill in the Art We consider the asserted ground of unpatentability in view of the” slip op. at 10

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

      “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, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). Indeed, Petitioner has shown several references—including, Basin-2005, 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 Basin-2007 and Basin-2005. Accordingly, we find that Petitioner has shown by a preponderance of the evidence that there would have been motivation to combine Basin-2007 and Basin-2005 with a reasonable expectation of success. 4. Summary We have reviewed Petitioner’s contentions regarding claims 1–3, 6, 9, 10, 16–21, and 25 (Pet. 19–53), and find that Petitioner has shown by a preponderance of the evidence that Basin-2007 and Basin-2005 teach the limitations of those claims, and that there would have been a motivation to combine the references in the manner suggested with a reasonable considerations does not outweigh the strong showing of obviousness. Accordingly, we find that Petitioner has shown by a preponderance of the evidence that claims 1–3, 6, 9, 10, 16–21, and 25 would have been obvious over Basin-2007 and Basin-2005.” slip op. at 41

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

      “1. Nexus In order for secondary considerations to be awarded “substantial” slip op. at 22

    Patent outcomesUS 8,604,678 unpatentable
    § 103 obviousness§ 112 disclosurecites Phillips · Graham
    Patents in suitUS 8,604,678
  • PTAB · Aug 28, 2026 · IPR2024-01357 · APJ Kevin W Cherry · IPR · Final written decision

    Claims 1–3, 6, 7, 9, 10, 16–21, 25, 26, and 29 are unpatentable; substitute claims 30–49 were not reached.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “B. Level of Ordinary Skill in the Art We consider the asserted ground of unpatentability in view of the” slip op. at 10

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “E. Credibility of Dr. Doolittle Patent Owner argues that we should give no weight to Dr. Doolittle’s testimony because, “[o]n cross examination, Prof. Doolittle repeatedly contradicted himself, dodged questions, and tried to shoehorn new and nonresponsive opinions into his answers to Patent Owner’s questions.” PO Resp. 25. Patent Owner raises two major complaints about Dr. Doolittle. First, Patent Owner argues that he took inconsistent positions by asserting in these IPR proceedings that the claims were entitled to their plain and ordinary meaning, while in the parallel district court proceeding, asserting that certain claim terms were indefinite. Id. at 26–28. Second, Patent Owner argues that Dr. Doolittle “repeatedly dodged questions and tried to shoehorn new and nonresponsive opinions into his answers to Patent Owner’s questions,” and that “[d]uring cross examination Patent Owner was forced to object to Prof. Doolittle’s nonresponsive answers no less than eighteen times.” Id. at 28. We strongly disagree with Patent Owner’s characterization of Dr. Doolittle’s testimony. We have reviewed the entirety of both of Dr. Doolittle’s depositions. We are impressed with his forthrightness, candor, and good humor in the face of Patent Owner’s counsel’s aggressive questioning. Contrary to Patent Owner’s assertions, we find that his testimony was well-reasoned, forthright, honest, and entitled to significant weight. Dr. Doolittle explained the different claim construction positions We also strongly disagree that Dr. Doolittle’s answers were nonresponsive or “evasive” as Patent Owner argues. Patent Owner’s numerous attempts to “strike” portions of his testimony belie Dr. Doolittle’s efforts to honestly and in good faith respond to Patent Owner’s counsel’s questions. Ex. 2025, 22:10–23:15, 25:9–26:14, 30:14–22, 40:3-9, 58:12–59:1, 60:18–61:13, 65:1–10, 83:15–84:16, 92:15–95:20, 96:18–99:9, 102:22–106:16, 135:3–136:22. An answer is not “non-responsive” simply because it does not conform to the conclusion you want or undermines the logic underlying your questioning. Dr. Doolittle explained his answers and addressed the issues Patent Owner asked about. Accordingly, we decline Patent Owner’s invitation to give Dr. Doolittle’s testimony no weight. Instead, we assess Dr. Doolittle’s testimony on a case-by-case basis as discussed below.” slip op. at 21

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

      “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, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). Indeed, Petitioner has shown several references—including, Basin-2005, 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 Basin-2007 and Basin-2005. Accordingly, we find that Petitioner has shown by a preponderance of the evidence that there would have been motivation to combine Basin-2007 and Basin-2005 with a reasonable expectation of success.” slip op. at 41

    • Obviousness (§103) › Objective indicia / secondary considerationsDecided for petitioner

      “7. Summary As discussed above, we find that Patent Owner has failed to show a” slip op. at 35

    Patent outcomesUS 8,604,678 unpatentable
    § 103 obviousness§ 112 disclosurecites Phillips · Graham
    Patents in suitUS 8,604,678
  • PTAB · May 18, 2026 · PGR2025-00006 · APJ Cynthia M Hardman · PGR · Final written decision

    Claims 1–4 and 8–13 are unpatentable under §112(a) for lack of written description and enablement, and under §103 as obvious over the ’429 patent and Chao.

    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 understanding of a person of ordinary skill in the art (sometimes referred to 3 US 7,767,429 B2, issued Aug. 3, 2010 (the “’429 patent”) (Ex. 1005). 4 Chao et al., Structure of Human Hyaluronidase-1, a Hyaluronan Hydrolyzing Enzyme Involved in Tumor Growth and Angiogenesis, 46 BIOCHEMISTRY 6911–20 (2007) (Ex. 1006). 5 Patent Owner withdrew the Declaration of Dr. Triggs-Raine. PO Resp. 10 n.6. herein as “POSA”) as of the effective filing date of the challenged claims. Petitioner contends that one of ordinary skill in the art would have had an undergraduate degree, a Ph.D., and post-doctoral experience in scientific fields relevant to study of protein structure and function (e.g., chemistry, biochemistry, biology, biophysics). From training and experience, the person would have been familiar with factors influencing protein structure, folding and activity, production of modified proteins using recombinant DNA techniques, and use of biological assays to characterize protein function, as well with techniques used to analyze protein structure (i.e., sequence searching and alignments, protein modeling software, etc.). Pet. 16.” slip op. at 7

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

      “5. Evidence and Analysis “The construction of claims is simply a way of elaborating the normally terse claim language in order to understand and explain, but not to change, the scope of the claims.” Embrex, Inc. v. Serv. Eng’g Corp., 216 F.3d 1343, 1347 (Fed. Cir. 2000). We first turn to the intrinsic evidence because “the specification is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.” Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc). “[T]he specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.” Id. at 1316. [T]he definition in the patent documents controls the claim interpretation. . . . Any other rule would be unfair to competitors who must be able to rely on the patent documents themselves, without consideration of expert opinion that then does not even exist, in ascertaining the scope of a patentee’s right to exclude. Southwall Tech., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1578 (Fed. Cir. 1995). a) Intrinsic evidence Our analysis begins with the claims and Specification of the ’262 patent. Claim 1 recites a “modified PH20 polypeptide” that also requires the polypeptide sequence is 95% identical to one of the 35 recited SEQ ID NOs and with at least one of seven amino acids at position 317 of the reference sequence. The ’262 patent states “PH20 refers to a type of hyaluronidase that occurs in sperm and is neutral-active.”7 Ex. 1001, 45:45– 46; cf. id. at 68:33–37. The ’262 patent further explains that “[r]eference to PH20 includes precursor PH20 polypeptides and mature PH20 polypeptides (such as those in which a signal sequence has been removed), truncated forms thereof that have activity, and includes allelic variants and species variants, variants encoded by splice variants, and other variants.” Id. at 45:62–67. The ’262 patent states that “PH20 polypeptides also include those that contain chemical or posttranslational modifications and those that do not contain chemical or posttranslational modifications.” Id. at 46:4–7.” slip op. at 15

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

      “four species tested, and particularly in a primate model that is physiologically more similar to humans, shows that a POSA would not have understood even unmodified PH20 polypeptides to provide a contraceptive effect in humans and most other species. The data Patent Owner relies upon at most shows an immunocontraceptive effect for unmodified PH20 polypeptides limited to guinea pigs. It does not evidence that a POSA would have understood that the recited modified polypeptides would provide such an effect or otherwise be useful in a contraceptive vaccine. Accordingly, even if the term “modified PH20 polypeptides” were interpreted to include inactive polypeptides that can serve as antigens to provide a contraceptive effect, the preponderance of the evidence does not show that a POSA would have understood the inventors to be in possession of the full scope of the recited polypeptides capable of such use. 7. Analysis We find the preponderance of the evidence supports a finding that the claims fail to comply with the written description requirement. “Every patent must describe an invention. It is part of the quid pro quo of a patent.” Ariad, 598 F.3d at 1345. In determining compliance with the written description requirement for nucleic acid genus claims, the Federal Circuit has identified two extremes. In Capon, claims relying on known nucleotide sequences with known functions were found to satisfy the written description requirement. Capon v. Eshhar, 418 F.3d 1349, 1358 (Fed. Cir. 2005). At the other end, Juno found that for broad claims to a nucleic acid encoding a chimeric T cell receptor with a functional requirement to bind a target, “the written description ‘must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.’” Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337 (Fed. Cir. 2021) (quoting Ariad, 598 F.3d at 1349). As explained above, claim 1 requires modified PH20 polypeptides with some hyaluronidase activity. See supra Section II.B. Based on this claim interpretation, we find the evidence in this case closer to Juno than Capon, and that the ’262 patent does not disclose sufficient structural features in the PH20 sequences associated with hyaluronidase or” slip op. at 57

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

      “6. Analysis Petitioner has the burden to identify how the specification allegedly fails to enable the claims. We address the Wands factors and the parties’ respective arguments and evidence. a) Breadth of Claims and Nature of the Invention Dr. Park states, regarding the breadth of claim 1, that he “calculated the number of distinct polypeptides that exist that meet the specified criteria.” Ex. 1004 ¶ 173. Dr. Park’s table is reproduced below: Dr. Park’s table shows that the “number of distinct peptides is extremely large by all accounts, ranging from 1049 to 1066.” Id. Dr. Hecht agrees, stating the “sequence identity language causes the claims to encompass an immense number of distinct PH20 polypeptides.” Ex. 1003 ¶ 120. To illustrate how large a number like 1066 is, Dr. Hecht states that an “aggregate weight of the smallest set containing one molecule of each of the PH20 mutants would be . . . = 1.37 x 1027 kg. The weight of the Earth is ‘only’ ~ 5.97 x 1024 kg.” Id. ¶ 123. That is, Dr. Hecht states that a complete set of one single molecule of protein that comprises all possible mutations in PH20 as recited in claim 1 would weigh about one thousand times more than the entire mass of planet Earth. See id. In deposition, Dr. Hecht stated “my sense was that the ’262 patent lists a minuscule and highly biased sample of what would be within that fence, in the sense that it only lists single amino acid substitutions while at the same time it’s attempting to claim things that have 20 or more substitutions.” Ex. 2076, 203:6‒12. When asked if a sequence “gives you enough information to tell whether that amino acid sequence is 95 percent identical to SEQ ID NO. 3”, Dr. Hecht answered “Yes, but that’s all it tells you. It doesn’t tell you anything about active, precipitated, aggregated, folded. It doesn’t tell you anything.” Id. at 204:11‒19.” slip op. at 70

    Patent outcomesUS 12,152,262 unpatentable
    Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 12,152,262
  • PTAB · Apr 15, 2026 · IPR2025-00104 · APJ Michael A Valek · IPR · Institution

    The Board instituted IPR on claims 1, 2, 4–7, and 9–18 based on all presented grounds, finding a reasonable likelihood of success on obviousness grounds 1A and 1B.

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

      “to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). The petitioner ultimately bears the burden of persuasion to prove unpatentability of each challenged claim by a preponderance of the evidence. 35 U.S.C. § 316(e). This burden never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). The Board may authorize an inter partes review if we determine that the information presented in the Petition shows a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314(a).” slip op. at 9

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “(“POSITA”) would have “had at least a bachelor’s degree in electrical engineering, computer engineering, or computer science, and two years of experience in the field [of] consumer electronics, with exposure to digital camera technology and wireless communications.” Pet. 5 (citing Ex. 1030 ¶¶ 94–95).” slip op. at 10

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

      “We find it unnecessary to construe any claim term to decide whether Petitioners satisfy the “reasonable likelihood” standard for instituting trial. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 11

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

      “claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. 35 U.S.C. § 103; see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) when in evidence, objective evidence of nonobviousness.10 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). An obviousness determination requires finding a reason to combine accompanied by a reasonable expectation of achieving what is claimed in the challenged patent. See Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). “[A]ny need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” KSR, 550 U.S. at 419–20.” slip op. at 10

    Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 8,904,030
  • Nxtgen Toys, LLC v. Zipstring, LLCAll claims unpatentable
    PTAB · Feb 20, 2026 · IPR2024-01213 · APJ Richard H Marschall · IPR · Final written decision

    Claims 1–4, 12, and 15–17 are unpatentable; substitute claim 27 is allowed, while substitute claims 21–26 and 28 are denied as obvious.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends that a person having ordinary skill in the art at the time of the invention “was typically a person with a bachelor’s degree in mechanical engineering, aerospace engineering, physics, or other science or 6 Patent Owner does not rely on any objective indicia of nonobviousness in this proceeding. engineering based degree that [was] familiar with general principles of mechanics and aerodynamics with at least two years of experience in product design and development in the field of toys or other amusement type devices.” Pet. 32 (citing Ex. 1002 ¶¶ 2–6, 22–26). Patent Owner states that it submitted the following proposal for a POSITA in the related district court litigation: “[a POSITA] would have had at least a B.S. degree in Mechanical Engineering, Electrical Engineering, Aerospace Engineering, Industrial Design, Product Design, or similar field, with at least two years industry experience in one of these fields, and such POSITA would have been familiar with general principles of mechanics, fluid mechanics and aerodynamics.” PO Resp. 4–5. We note that the parties’ proposals overlap considerably, and neither party argues the inadequacy of the other party’s proposal or that any patentability issue in this case turns on the resolution of this issue. We find Petitioner’s definition consistent with the problems and solutions disclosed in the ’774 patent and prior art of record, and adopt it as our own. See, e.g., GPAC, 57 F.3d at 1579 (approving the determination of the level of ordinary skill in the art by appeal to the references of record). We would arrive at the same findings and conclusions in this Decision if we adopted Patent Owner’s proposal.” slip op. at 7

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

      “Id. at 1312–13. Only terms in controversy need be construed, and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Petitioner contends that no “term requires construction to resolve the invalidity grounds presented in this Petition since the prior art renders claims 1–4, 12, and 15–17 unpatentable under any reasonable interpretation of the claims.” Pet. 7. Patent Owner argues that it “does not believe express claim constructions are necessary during this proceeding because the claims can readily be given their ordinary and customary meaning in the context of the patent at the time it was filed.” PO Resp. 5. Based on the parties’ positions and our view of the record, we need not expressly construe any claim limitations to resolve the issues in this Decision. To the extent that any implicit claim construction issues relate to the issues raised by the parties, we address them in the context of the parties’ patentability arguments below.” slip op. at 9

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

      “string, and that adding Scorch’s slot removes this arguably inconvenient process by allowing insertion and removal of a string without removing and reinstalling any aspects of the housing. See Pet 85–86 (citing Ex. 1002 ¶¶ 174–175; Ex. 1007, 3:30–3:53, 6:03; Ex. 1008, 3:46–4:45); Pet. Reply 18–20 (citing in part Ex. 2002 ¶ 187 (Dr. Janét’s testimony that Wagner’s removal and reinstallation of a cover “may be viewed as an inconvenient process”)). Making insertion and removal of the string easier and quicker provides a notable advantage over Wagner’s existing device. See id. Scorch itself supports this argument and the related expert testimony because it discusses insertion and removal of strings and stated that the slot allows a user to “swap them out really quick.” Ex. 1007, 3:30–53. Petitioner also persuasively argues that a POSITA would know how to add the slot while maintaining the proper operation of the device, such as allowing insertion and removal of the string and avoiding inadvertent exiting of the string from the device. See Pet. 86–87 (citing Ex. 1002 ¶¶ 175–176; Ex. 1007, 4:00–30, Ex. 1008, 2:49–52); Pet. Reply 19, 21 (citing Ex. 1002 ¶¶ 174–176). We find Petitioner’s arguments and reasoning in support of adding Scorch’s slot to Wagner’s housing straightforward and persuasive. Patent Owner’s arguments against the combination do not directly refute Petitioner’s reasoning or cast doubt on Scorch’s statement that its slot enables “quick” insertion and removal of a string—quicker than Wagner’s method that requires removal and replacement of a cover on its housing. See PO Resp. 16–22; PO Sur-reply 14–20; Ex. 2002 ¶ 187 (acknowledging inconvenience of Wagner’s existing process for insertion and removal of a string). Patent Owner suggests that Petitioner’s proposed combination fails to take into consideration certain drawbacks such as the risk of inadvertent string exit from the housing or slot, but Petitioner expressly addresses such concerns in the Petition. See PO Resp. 18 (stating that Scorch’s slotted funnel may allow the string to “shoot out the slot” and that Scorch addresses this by adding “a bent wire” to “prevent the string from coming out the side”); PO Sur-reply 16–17; Pet. 86–87 (arguing that Wagner’s flanges would help to trap the string in place, but if not, Scorch’s additional structures could be used to restring the string and “to further reduce the risk of a string inadvertently exiting” the device). We agree with Petitioner that a POSITA would understand how to incorporate Scorch’s slot without causing inadvertent removal of the string—using structures already present in Wagner and Scorch—and the need to add such unclaimed structurers does not teach away from the combination as Patent Owner suggests. See Pet. 86–87; PO Resp. 22. We also agree with Petitioner that a POSITA would understand how to make minor modifications, if necessary, to allow insertion and removal of the string around Wagner’s flanges. See Pet. Reply 21 (citing Ex. 1002 ¶¶ 174–176).” slip op. at 26

    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

      “refute Petitioner’s reasoning or cast doubt on Scorch’s statement that its slot enables “quick” insertion and removal of a string—quicker than Wagner’s method that requires removal and replacement of a cover on its housing. See PO Resp. 16–22; PO Sur-reply 14–20; Ex. 2002 ¶ 187 (acknowledging inconvenience of Wagner’s existing process for insertion and removal of a string). Patent Owner suggests that Petitioner’s proposed combination fails to take into consideration certain drawbacks such as the risk of inadvertent string exit from the housing or slot, but Petitioner expressly addresses such concerns in the Petition. See PO Resp. 18 (stating that Scorch’s slotted funnel may allow the string to “shoot out the slot” and that Scorch addresses this by adding “a bent wire” to “prevent the string from coming out the side”); PO Sur-reply 16–17; Pet. 86–87 (arguing that Wagner’s flanges would help to trap the string in place, but if not, Scorch’s additional structures could be used to restring the string and “to further reduce the risk of a string inadvertently exiting” the device). We agree with Petitioner that a POSITA would understand how to incorporate Scorch’s slot without causing inadvertent removal of the string—using structures already present in Wagner and Scorch—and the need to add such unclaimed structurers does not teach away from the combination as Patent Owner suggests. See Pet. 86–87; PO Resp. 22. We also agree with Petitioner that a POSITA would understand how to make minor modifications, if necessary, to allow insertion and removal of the string around Wagner’s flanges. See Pet. Reply 21 (citing Ex. 1002 ¶¶ 174–176). At best, Patent Owner’s arguments on this issue establish potential drawbacks in Petitioner’s proposed combination, but drawbacks alone do not defeat Petitioner’s obviousness rationale that includes readily apparent benefits. See Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n.8 (Fed. Cir. 2000) (“The fact that the motivating benefit comes at the expense of another benefit . . . should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another.”); Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (“a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine “). In addition, even if Patent Owner were correct that Wagner’s existing design works as well as Petitioner’s proposed combination, given all of the tradeoffs involved, that would not fatally undermine Petitioner’s showing. In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (obviousness does not require that the proposed combination “is the preferred, or most desirable, combination”). On this record, Petitioner’s (and Scorch’s) stated advantages that are achieved when adding Scorch’s slot to Wagner’s housing adequately support Petitioner’s motivation to combine rationale.” slip op. at 26

    Patent outcomesUS 11,674,774 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Nautilus
    Patents in suitUS 11,674,774
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