• CSPC Megalith Biopharmaceutical Co., Ltd. v. Lepu Biopharma Co. Ltd.All claims unpatentable
  PTAB · Oct 8, 2026 · IPR2025-00685 · APJ Ryan H Flax · IPR · Final written decision

  Claims 1–23 are unpatentable as obvious over Wei and Liu, and over Leanna, Wei, and Liu.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “appears to be generally consistent with the level of skill presented in the cited prior art. See generally, e.g., Exs. 1005–1008; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself may reflect an appropriate level of skill in the art). However, as at institution, we reject the portion of Petitioner’s proposed definition that includes having “access to other individuals with that knowledge and experience,” as not reflecting the individual level of skill of a given skilled artisan. See, e.g., Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986) (holding that “[t]he person of ordinary skill is a hypothetical person who is presumed to be aware of all the pertinent prior art.”) (emphasis added, footnotes omitted); but see Indivior Inc. v. Dr. Reddy’s Labys., S.A., 930 F.3d 1325, 1343 (Fed. Cir. 2019) (no clear error in determination that “a person of ordinary skill . . . ‘would be on a team with an engineer or scientist . . . .’”). Consequently, we find the person of ordinary skill in the art was a person who had a Ph.D. in immunology, molecular biology, cellular biology, or a similar field, or an M.D. with similar experience, and had at least five years of experience with antibodies and antibody engineering.” slip op. at 11

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

    “Petitioner submits that no term of the Challenged Claims requires construction to resolve the challenges in this Petition.” Pet. 32. We did not construe any terms in our Institution Decision. See DI 6–7. Patent Owner presents no express positions on claim construction. See generally Resp. For the purposes of this Decision, no terms of the challenged claims require construction. Phillips, 415 F.3d at 1312–13. D. slip op. at 12

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “2 G. Wei et al., US 2015/0071923 Al, pub. March 12, 2015. Ex. 1005 (“Wei”). 3 J. Liu, CN 103772504 A, pub. May 7, 2014. Ex. 1007. The Liu reference is published in Simplified Chinese and Petitioner filed a certified English translation, to which we refer herein. See Ex. 1008 (“Liu”). Patent Owner does not contest the accuracy of the translation. See generally Resp. 4 M.R. Leanna & C.L. Becker, WO 2014/152199 A1, pub. Sept. 25, 2014. Ex. 1006 (“Leanna”). 5 Based on our review of each deposition transcript in view of the record as a whole, although each witness appears competent, we are left with the impression that Dr. Bournazos’s testimony is somewhat more credible than Dr. Atanackovic’s. This conclusion is based, inter alia, on each witness’s ability to recall the relevant record and respond to questions on evidentiary and technical issues.” slip op. at 8

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

    “We find that combining Liu’s BA03 antibody with Wei’s ADC platform would have been desirable, predictable, and routine for the ordinarily skilled artisan based on the facts that: (1) cetuximab was a wellknown and well-studied, U.S. regulatory approved, anti-EGFR antibody that would have served as a starting point for new cancer therapies; (2) humanization of therapeutic antibodies is generally desired (and “[e]very antibody can be humanized” and it is advantageous according to Patent Owner’s counsel); (3) BA03 was a well-known humanized version of cetuximab that had several known advantages over cetuximab in addition to lower immunogenicity from humanization; and (4) Wei taught a similar cetuximab-derived antibody, and a humanized cetuximab-derived antibody, each provided in an ADC with a well-known and validated off-the-shelf linker-drug platform, i.e., vc-MMAE, that exhibited a strong anti-tumor response. See, e.g., Ex. 1001, 1:57–2:32, 2:50–3:1, 5:6–53, 18:3–33, 19:26– 29; Ex. 1002 ¶¶ 14, 38, 42–43, 45–53, 56–73, 84–92, 109–117, 178–189, 202–271; Ex. 1005 ¶¶ 9–10, 229–232, 434, 437, 476, 491–506, 664–675, 685, 688, 715, 732, 1103, 1092–1141; Ex. 1008 ¶¶ 3–6, 60, 74, 141–160; Ex. 2027 ¶¶ 7–8, 38, 50, 57 (confirming our understandings regarding the claimed antibody and linker-drug payload); Ex. 2023, 173, 300; see also Resp. 1, 5–6, 23 (Patent Owner made the “choice” to use the prior-art-known BA03 antibody, and known-candidate cytotoxic payload MMAE); Hr’g Tr. 34:20–23, 36:6–38:20, 47:16–50:16 (Patent Owner’s counsel’s argument). When Liu’s BA03 antibody is provided in an ADC with a vc- MMAE or a Mc-vcPAB-MMAE platform (and used as cancer therapy as the references instruct) the invention of the challenged claims is achieved.” slip op. at 52

  Patent outcomesUS 10,792,370 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 10,792,370
• Imperative Care, Inc. v. Inari Medical, Inc.All claims unpatentable
  PTAB · Oct 6, 2026 · IPR2025-00728 · APJ Timothy G Majors · IPR · Final written decision

  Claims 1–7, 9, 10, 15–18, and 20–24 are unpatentable as obvious over Schaffer with Hartley or Eller; claims 1–3, 5, 6, 9, 15–18, and 21–24 are also obvious over Hartley and Eller.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “Petitioner’s proposed POSA definition lacks specificity. That definition, if interpreted generically, could mean that a person may qualify as a POSA if they had, for example, a B.S. in mechanical engineering and only two years of experience designing any type of product in any field. That is too broad. We find that a POSA would have had the agreed-upon educational credentials—an undergraduate degree in mechanical engineering or a related engineering discipline. Ex. 1003 ¶ 35; Ex. 2033 ¶ 61. We find that a POSA would also have had 2–4 years of design or engineering experience related to products in the field of the invention, which involves endovascular devices and the surgical procedures that use such devices. Ex. 1001, 1:16–54 (background of the invention). Such devices include, but are not limited to, hemostasis valves and catheters for testimony of the parties’ experts, the POSA need not have had first-hand experience designing hemostasis valves. See, e.g., Ex. 1037 (Zalesky Tr.), 72:11–73:7 (testifying direct experience “designing” hemostasis valves or aspiration catheters is not necessary, but “general experience with vascular devices and procedures” is required). Further, as Dr. Zalesky testified, the POSA’s experience related to developing such devices “could be as simple as bench testing and looking at clinical data.” Id. at 74:5–75:1. Lastly, a POSA would have understood such devices’ design requirements as determined by the needs of the physician, patient, and procedure, which understanding may be informed by work experience or study. Ex. 2030, 24:5–21.” slip op. at 12

  • Expert testimonyPetitioner expert creditedPatent owner expert creditedMixed

    “above (supra Section III.C), a filament requires flexibility, Petitioner has not demonstrated that Schaffer describes that feature in its valves. Instead, Patent Owner persuades us that Schaffer describes “rigid U-shaped actuating members—not a ‘filament.’” PO Resp. 23–24.13 We find Dr. Zalesky’s interpretation of Schaffer more credible than Mr. Thornton’s on the question of whether a POSA would have regarded Schaffer’s actuating members as being substantially rigid structures. Ex. 2033 ¶¶ 91–100 (testifying, inter alia, that a POSA would have understood from Schaffer’s disclosure about making the actuator and actuating members from machining pre-existing amounts of metals and/or plastics, and further explaining that flexible parts would deform and be difficult to machine through conventional techniques); Ex. 1005 ¶¶ 81–82. Mr. Thornton testifies that Schaffer’s disclosed manufacturing techniques for the actuator/actuating members are only examples and “a person of ordinary skill in the art could have simply purchased pre-made [and flexible] flat wire or plastic tapes or ribbons.” Ex. 1003 ¶ 79. Such testimony invokes, at best, obviousness-based reasoning. This does not establish that Schaffer alone describes a filament sufficient to anticipate the claims. Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1296 (Fed.” slip op. at 28

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner

    “Patent Owner cites intrinsic evidence in support of its interpretation, which include claim 1’s recitation of an “active tensioning mechanism” comprising the filament and the Specification’s description of a filament that can be both “loosened” and “tightened.” PO Resp. 14–17 (citing, e.g., Ex. 1001, 9:36–37, 9:53–56 (teaching “the filament 150 is tightened” when the actuator buttons are released and “the filament 150 is loosened” when the buttons are pressed to open the valve)); see also Ex. 2025, 1288 (defining “tension” as to “tighten to a desired or appropriate degree”). These descriptions from the patent are more consistent with the view that the filament is characteristically flexible, not rigid. 10 We reached the same conclusion, based on substantially the same records, in the Institution Decision and the Final Written Decisions in the 1157, 156, and 289 IPRs. Inst. Dec. 14–18; Ex. 1042, 14–24; Ex. 1048, 16–23; Ex. 1049, 14–17 (noting the parties’ agreement at oral hearing that there was no additional argument or evidence about whether a filament requires flexibility that was not already addressed in related matters). After we construed the “filament” term to require flexibility at institution, Petitioner provided no further argument or evidence on this issue in its authorized trial briefing or at oral hearing. See generally Pet. Reply. embodiments (where the filament forms one or more loops like depicted and described in Figures 6–7) require a flexible structure. See, e.g., Ex. 2032, 15–16 (explaining that the device would not work to constrict the tubular sidewall and lumen (analogous to the elongate member defining a lumen of the claims here) if the filament forming the loop(s) was inflexible); Ex. 1001, Figs. 6–7 (filament 150, with sub-filaments 150-A and 150-B). Although flexibility of the filament in the patent’s “bight” embodiments (e.g., as shown in Figures 8 and 9) is less clear, there is a dearth of evidence from Petitioner—either intrinsic or extrinsic to the patent—showing why a POSA would have understood the bights as embracing rigid structures. See Ex. 1001, Figs. 8–9. Moreover, as admitted by Petitioner’s expert, that a filament may be made from various materials described in the patent (e.g., synthetics or metals) does not, absent more information, lead to a conclusion that a filament is “rigid.” Ex. 2030, 125:2–126:4 (testifying “the relative stiffness or rigidity is not clear from those . . . materials without knowing much more information”).” slip op. at 16

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “We find that Petitioner has not shown, by a preponderance of the evidence, that Schaffer anticipates claim 1 or any of the other challenged claims, each of which requires at least one “filament.” We are unpersuaded above (supra Section III.C), a filament requires flexibility, Petitioner has not demonstrated that Schaffer describes that feature in its valves. Instead, Patent Owner persuades us that Schaffer describes “rigid U-shaped actuating members—not a ‘filament.’” PO Resp. 23–24.13 We find Dr. Zalesky’s interpretation of Schaffer more credible than Mr. Thornton’s on the question of whether a POSA would have regarded Schaffer’s actuating members as being substantially rigid structures. Ex. 2033 ¶¶ 91–100 (testifying, inter alia, that a POSA would have understood from Schaffer’s disclosure about making the actuator and actuating members from machining pre-existing amounts of metals and/or plastics, and further explaining that flexible parts would deform and be difficult to machine through conventional techniques); Ex. 1005 ¶¶ 81–82. Mr. Thornton testifies that Schaffer’s disclosed manufacturing techniques for the actuator/actuating members are only examples and “a person of ordinary skill in the art could have simply purchased pre-made [and flexible] flat wire or plastic tapes or ribbons.” Ex. 1003 ¶ 79. Such testimony invokes, at best, obviousness-based reasoning. This does not establish that Schaffer alone describes a filament sufficient to anticipate the claims. Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1296 (Fed.” slip op. at 27

  Patent outcomesUS 11,844,921 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,844,921
• Innoscience America, Inc. v. Infineon Technologies Americas Corp.No claims unpatentable
  PTAB · Jun 30, 2026 · IPR2025-00175 · APJ Jo-Anne M Kokoski · IPR · Final written decision

  Claims 1–17 were not shown unpatentable because Petitioner failed to establish that Usui’s interconnect structure or Yu’s metal gate stacks satisfy the construed “electrode stack” limitation.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “(“POSITA” or “POSA”) would have had “at least a four-year degree in electrical engineering or a closely related field, and at least two years of experience in semiconductor device design,” and “[a]dditional education could substitute for professional experience and vice versa.” Pet. 6 (citing Ex. 1002 ¶¶ 80–82). Patent Owner does not dispute Petitioner’s proposed level of ordinary skill. PO Resp. 1–76. Neither party explains why the outcome of this case would be affected by the adoption of the proffered definition of a person of ordinary skill in the art. In the Institution Decision, we adopted the assessment offered by Petitioner. Dec. 6–7. Because Petitioner’s definition of the level of skill in the art is consistent with the ’562 patent and the asserted prior art, we maintain Petitioner’s definition for purposes of this Final Written Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir 2001).” slip op. at 9

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

    “comprises the recited metals and has the recited thickness, which forms an electrical contact for use on a semiconductor device generally or a group III- V semiconductor in particular. This is consistent with our determination that “electrode stack” is a conductor that provides a path for current entering or leaving a medium such as a semiconductor device We disagree with Patent Owner that “electrode stack” as used in the challenged claims should be limited to the specific electrodes shown in the embodiments described in the Specification. See PO Resp. 4–9. Although the Specification describes embodiments using source, drain, and Schottky gate electrodes as electrical contacts, we see no reason to construe the term “electrode stack” itself to be limited to these components as Patent Owner proposes. Claims 1 and 13 expressly recite that electrode stacks comprise the claimed “electrical contact,” without expressly including or precluding any specific type of electrode. Ex. 1001, 5:54–63, 6:37–47. The Federal Circuit advises that the Specification “is not a substitute for, nor can it be used to rewrite, the chosen claim language. ‘Specifications teach. Claims claim.’” SuperGuide, 358 F.3d at 875 (quoting SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 n.14 (Fed. Cir. 1985) (en banc)). The Specification does teach electrical contacts that include source, drain, and Schottky gate electrodes, but claims 1 and 13 are directed to electrical contacts that are not expressly so limited. Patent Owner’s proposed construction would effectively rewrite the claim by adding limitations, which we decline to do under the guise of claim construction. See id. (“Though understanding the claim language may be aided by the explanations contained in the written description, it is important not to import into a claim limitations that are not a part of the claim.”). In view of the foregoing, we construe the claim term “electrode stack” to mean “a conductor that provides a path for current entering or leaving a medium such as a semiconductor device.”” slip op. at 17

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “that the identified layers in Usui’s interconnect metallurgy structure form an “electrode stack including a plurality of metal layers and a capping layer formed over said plurality of metal layers” as recited in claim 1. See Pet. 11–12 (citing Ex. 1002 ¶¶ 89–91). Neither Petitioner nor Dr. Zhao, however, provide adequate explanation or evidence as to why Usui’s interconnect metallurgy structure forms an “electrode stack,” i.e., a conductor that provides a path for current entering or leaving a medium such as a semiconductor device. Dr. Zhao’s testimony merely repeats the disclosures in Usui and concludes, without further technical detail, explanation, or reference to objective evidence, that Usui’s Figure 8 discloses an electrode stack. Ex. 1002 ¶¶ 89–91. Dr. Zhao’s testimony sets forth Petitioner’s conclusory assertions as though they are facts, rather than setting forth facts and evidence in support of those assertions. Compare id. with Pet. 11–12. Absent underlying facts or evidence to support Dr. Zhao’s opinion, the cited testimony “adds little to the conclusory assertion for which it is offered to support, and is entitled to little weight.” Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24, 2022) (precedential). In contrast, Patent Owner’s declarant Dr. Piner testifies, with evidentiary support, that interconnects (such as Usui’s interconnect metallurgy structure) and electrical contacts (such as that claimed in the ’562 patent) are not the same thing. See Ex. 2024 ¶¶ 63–70. For example, Dr. Piner explains: In other words, not all metals in a semiconductor device have the same purpose and could not be said to be interchangeable. By August 2009 it was well known to a POSA how to discern if a metal component in a transistor is an interconnect or serves as an electrical contact such as a gate contact or ohmic contact, based on the structure and functionality of the metal component. For example, interconnects are made up of metal strips and are deposited on insulators. EX-1011 (Mishra) at 216. Interconnects are low resistance conductors that can carry very high current densities. Id., 216, 217. Unlike Schottky contacts and ohmic contacts, interconnects do not provide non-linear IV response like Schottky contacts nor inject electrons and holes into semiconductors like ohmic contacts. Id., 218. As many of the references cited by Dr. Zhao illustrate, electrical contacts had their own highly complex design challenges. EX-1008 (Pearton), 41-59 (Pages 53-71 of 383) (discussing electrical contacts); EX-1017 (Kramer), 11-126 (Pages 18-130 of 151) (same). And while Dr. Zhao cites these as supporting a POSA’s knowledge of an electrical contact, none of these references describe electrical contacts as interconnects. Id. ¶ 71. Dr. Piner further testifies that Usui’s interconnect metallurgy structure is an interconnect, and not an electrical contact, because “Usui states that ‘[t]he structures fabricated by the process of the present invention are especially useful for forming electrical connections or wiring such as between active and/or passive devices of an integrated circuit structure.’” Id. ¶ 148 (citing Ex. 1004, 1:11–14) (alteration in original); see also id. ¶¶ 150– 151 (Dr. Piner testifying that Usui’s interconnect metallization structure is not an “electrode stack” under a broad definition of electrode). Dr. Piner’s testimony in this regard rebuts Petitioner’s and Dr. Zhao’s conclusory assertions to the contrary.” slip op. at 21

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “conductor that provides a path for current entering or leaving a medium such as a semiconductor device.” Thus, Petitioner must show that Usui’s layers 13–15, 18, and 19 provide a path for current entering or leaving a medium such as a semiconductor device. After reviewing the complete trial record, we are not persuaded that Petitioner has done so. Petitioner relies on the testimony of Dr. Zhao to support its contention that the identified layers in Usui’s interconnect metallurgy structure form an “electrode stack including a plurality of metal layers and a capping layer formed over said plurality of metal layers” as recited in claim 1. See Pet. 11–12 (citing Ex. 1002 ¶¶ 89–91). Neither Petitioner nor Dr. Zhao, however, provide adequate explanation or evidence as to why Usui’s interconnect metallurgy structure forms an “electrode stack,” i.e., a conductor that provides a path for current entering or leaving a medium such as a semiconductor device. Dr. Zhao’s testimony merely repeats the disclosures in Usui and concludes, without further technical detail, explanation, or reference to objective evidence, that Usui’s Figure 8 discloses an electrode stack. Ex. 1002 ¶¶ 89–91. Dr. Zhao’s testimony sets forth Petitioner’s conclusory assertions as though they are facts, rather than setting forth facts and evidence in support of those assertions. Compare id. with Pet. 11–12. Absent underlying facts or evidence to support Dr. Zhao’s opinion, the cited testimony “adds little to the conclusory assertion for which it is offered to support, and is entitled to little weight.” Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24, 2022) (precedential).” slip op. at 21

  Patent outcomesUS 8,686,562 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,686,562
• Innoscience America, Inc. v. Infineon Technologies Americas Corp.No claims unpatentable
  PTAB · Jun 12, 2026 · IPR2025-00094 · APJ Christopher M Kaiser · IPR · Final written decision

  Claims 1–16 were not shown unpatentable under any asserted obviousness ground because Petitioner failed to establish the proposed modifications and combinations.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that one of ordinary skill in the art “would have possessed at least a four-year degree in electrical engineering or a closely related field, and at least two years of experience in semiconductor device design.” Pet. 5 (citing Ex. 1003 ¶¶ 67–69). Petitioner also argues that “[a]dditional education could substitute for professional experience and vice versa.” Id. Patent Owner does not dispute Petitioner’s proposed level of ordinary skill. PO Resp. 1–76. Neither party explains why the outcome of this case would be affected by the adoption of the proffered definition of a person of ordinary skill in the art. Accordingly, and because it appears to be consistent with the ’003 patent and the asserted prior art, we adopt Petitioner’s assessment of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

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

    “Neither party proposes construing any claim terms. Pet. 6; Prelim. Resp. 1–76. In addition, as discussed below, we are able to determine the outcome of this proceeding without expressly construing any terms. Thus, we do not construe any terms for the purposes of this Decision. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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 8

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

    “challenged claim. Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011). “This is so because inventions in most, if not all, instances rely upon building blocks long since uncovered, and claimed discoveries almost of necessity will be combinations of what, in some sense, is already known.” KSR, 550 U.S. at 418–419. On the other hand, an obviousness analysis “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418; accord In re Translogic Tech., Inc., 504 F.3d 1249, 1259 (Fed. Cir. 2007). However, a petitioner cannot satisfy its burden of proving obviousness by employing “mere conclusory statements.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016). Instead, a petitioner must articulate a reason why a person of ordinary skill in the art would have combined or modified the prior art references. In re NuVasive, Inc., 842 F.3d 1376, 1382 (Fed. Cir. 2016); see also Metalcraft of Mayville, Inc. v. The Toro Co., 848 F.3d 1358, 1366 (Fed. Cir. 2017) (“In determining whether there would have been a motivation to combine prior art references to arrive at the claimed invention, it is insufficient to simply conclude the combination would have been obvious without identifying any reason why a person of skill in the art would have made the combination.”); Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.”) (citing InTouch Techs., Inc. v. VGO Commc’ns, Inc., 751 F.3d 1327, 1352 (Fed. Cir. 2014)). In arguing for the obviousness of claim 1 over the combination of Bonn and Mizuta, Petitioner argues that a person of ordinary skill in the art would have modified Bonn to perform high-frequency signal amplification. Pet. 19–25. In particular, Petitioner argues that a person of ordinary skill in the art “would have found it obvious to modify the circuit of Figure 1 [of Bonn] and use Figure 7’s structure for high frequency signal amplification in place of mixer 40,” followed by additional modifications to the circuit of Figure 1. Id. at 22–25. These additional modifications include removing LO port 55, removing FET 20 (along with voltage source 80, capacitors 16, 26, and 34, resistor 18, and inductors 22 and 24), removing capacitor 34 and shorting gate structure 324 to ground, and removing resistors 46 and 48 and shorting terminal 51 to ground. Id. According to Petitioner, the motivation for these modifications was that “Bonn . . . teaches using its dual gate structures for signal amplification without signal mixing.” Id. at 22 (citing Ex. 1006, 11:26–37). On the record developed at trial, we disagree. Bonn does, as Petitioner argues, teach that “the dual gate FET structure of the present invention can be tailored to provide superior performance over the prior art dual gate FET structures in high frequency signal mixing as well as other applications such as high frequency signal amplification.” Ex. 1006, 11:33–37. But the tailoring that Bonn refers to relates to changes to the structure of the field-effect transistor itself, not to the circuitry surrounding that transistor. Id. (teaching that the reason that “the dual gate FET structure of the present invention can be tailored” is that “the parameters such as gate width, dopant concentration, and channel depth, under each gate of the dual gate FET are individually adjusted for optimum performance”). Thus, although Bonn might have motivated a person of ordinary skill in the art to have made changes to the dual-gate FET itself, we are not persuaded that it would have motivated the additional changes to the circuit of Bonn’s Figure 1.” slip op. at 11

  • Strike new argumentNew argument disregardedDecided for patent owner

    “Mishra’s Figure 5 is a second gate in favor of a new position. Petitioner’s new argument is that a person of ordinary skill in the art would have found it obvious to connect the field plate of Mishra’s Figure 5 to the source instead of the gate, converting the field plate into a second gate. Compare Pet. 83 (equating “drain side gate” with “field plate 66, Figure 5”), 86–88 (identifying field plate 66 as a “second gate”), with Reply 21–22 (identifying only the embodiment of Mishra’s Figure 10 as a source-connected field plate), 22–23 (arguing that Mishra teaches that the Figure 5 embodiment “could be arranged as ‘a single transistor with a dual gate structure’”). Although “the introduction of new evidence in the course of the trial is to be expected in inter partes review trial proceedings,” Genzyme Therapeutic Prods. LP v. Biomarin Pharm. Inc., 825 F.3d 1360, 1366 (Fed. Cir. 2016), the shifting of arguments is not, Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1286 (Fed. Cir. 2017). Accordingly, Petitioner’s change of arguments here is inappropriate. Moreover, even if we were to consider Petitioner’s inappropriate new argument, we would conclude that Petitioner does not support the argument with sufficient evidence. “Whether [an obviousness ground] is based on combining disclosures from multiple references, combining multiple embodiments from a single reference, or selecting from large lists of elements in a single reference, there must be a motivation to make the combination and a reasonable expectation that such a combination would be successful, otherwise a skilled artisan would not arrive at the claimed combination.” In re Stepan, 868 F.3d 1342, 1346 n.1 (Fed. Cir. 2017). Petitioner’s new argument relies on a person of ordinary skill in the art modifying the Figure 5 embodiment of Mishra to connect the field plate to the source rather than the gate. Reply 21–24. Petitioner does not, however, show that a person of ordinary skill in the art would have had a motivation to make this modification or a reasonable expectation that this combination would be successful. Id. Petitioner argues instead that “[n]o ‘reason’ is needed.” Id. at 24. Thus, Petitioner does not show by a preponderance of the evidence that claim 1 would have been obvious over the combination of Mishra and Ren.” slip op. at 19

  Patent outcomesUS 8,264,003 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,264,003
• Imperative Care, Inc. v. Inari Medical, Inc.All claims unpatentable
  PTAB · Jun 9, 2026 · IPR2025-00289 · APJ Timothy G Majors · IPR · Final written decision

  Claims 1–15 are unpatentable: claims 1–15 under Grounds 2 and 3, and claim 10 under Ground 4; Ground 1 did not establish unpatentability.

  RulingsFinal written decision

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

    “We have construed the “filament” term in multiple related proceedings and agreed with Patent Owner that the claimed filament requires flexibility. See Ex. 1050 (Final Written Decision in 156 IPR); IPR2024-01157, Paper 35 (Final Written Decision) at 15–24. Specifically, we determined that the evidence supports Patent Owner’s position that “a POSA would have understood the plain and ordinary meaning of the claimed ‘filament’ as a flexible length of material (e.g., one or more string(s), wire(s), tape(s)).” See, e.g., Ex. 1050, 23. We maintain that construction in this Decision for the reasons given by Patent Owner (see PO Resp. 24–32; PO Sur-reply 6–8), we disagree with Petitioner’s argument to the contrary (Pet. Reply 27–31), and we incorporate our analysis concerning the meaning of the filament term from the related proceedings identified above, which applies equally here.13 Ex. 1050 (Final Written Decision in 156 IPR); IPR2024-01157, Paper 35 (Final Written Decision) at 15–24. The parties agreed at the oral hearing that there is no additional argument or evidence 13 Although the ’005 patent is not directly related to the patents at issue in the 1157 and 156 IPRs, the ’519 Application that the ’005 patent purports to incorporate for providing all relevant disclosures about the filament term is a parent application to the challenged patents in the 1157 and 156 IPRs (see supra n.3). SightSound Techs., LLC v. Apple Inc., 809 F.3d 1307, 1316 (Fed. Cir. 2015) (“Where multiple patents derive from the same parent application and share many common terms, we must interpret the claims consistently across all asserted patents.”) (internal quotation marks omitted). We also construed the filament term consistently in other ongoing proceedings on related patents. See, e.g., Ex. 1045 (Institution Decision in the 728 IPR), 12–18; Ex. 1046 (Institution Decision in the 989 IPR), 13–21. already addressed in those related matters. Tr. 6:13–23, 23:19–26.” slip op. at 16

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art Petitioner contends that the person of ordinary skill in the art (“POSA”) in August 2018 “would have had an undergraduate degree in mechanical engineering or a related engineering discipline and 2–4 years of catheter design experience.” Pet. 17 (citing Ex. 1003 ¶ 35). Although Patent Owner states that it “disagrees” with Petitioner’s POSA definition, Patent Owner nevertheless applies that definition in this case. PO Resp. 32–33; see Tr. 22:23–23:5 (Patent Owner is “not disputing” Petitioner’s definition, asserting the definition “doesn’t make any difference in this case”).” slip op. at 13

  • Expert testimonyPatent owner expert creditedPetitioner expert creditedMixed

    “We credit Dr. Zalesky’s interpretation of Schaffer on whether the POSA would have understood Schaffer as describing rigid actuating members. Dr. Zalesky testifies, for example, that a POSA would have understood from Schaffer’s disclosures about the actuating members being “machined” from metal or plastic, that such actuating members would be rigid. Ex. 2026 ¶ 101 (explaining “machining is a manufacturing process in which the desired part . . . is created using the controlled removal of bulk material” to produce a “rigid material”); Ex. 1005 ¶ 82 (“The actuating member 55 and the actuating button 261 is machined from aluminum” and “[i]n another example, the actuating member 55 and the actuating button 261 are machined from plastic”); Ex. 2026 ¶¶ 102–103 (testifying the disclosed valve assembly technique in Schaffer (Ex. 1005 ¶ 83) also indicates that “rigid” actuating members are used). Mr. Thornton opines (without citation to any persuasive supporting disclosure) that a POSA “would have understood that Schaffer’s U-shaped actuating members would have preferably been formed from a thin, flexible material.” Ex. 1003 ¶ 113. But, at deposition, Mr. Thornton conceded that machined plastics and aluminum, like disclosed in Schaffer, are rigid. Ex. 2005, 168:2–6 (“Q. And you said that plastic that would be machined would be rigid, correct? A. I think that’s a fair statement.”). Although Mr. Thornton opines that Schaffer’s actuating members would “preferably”” slip op. at 29

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

    “For the reasons above, Petitioner has not established that the claimed “filament” is disclosed in the combination of Garrison and Schaffer and, thus, Petitioner has not shown by a preponderance of the evidence that claim 1 would have been obvious over Garrison and Schaffer. Petitioner’s challenge to independent claim 10 (and the claims that depend from claim 1 and claim 10) fails for similar reasons. Each of the challenged claims requires a “filament” and, given our construction of that term and our findings above that Schaffer does not teach or suggest the claimed filament, Petitioner has not proved by a preponderance of the” slip op. at 31

  Patent outcomesUS 11,554,005 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,554,005
• Shenzhen Tuozhu Technology Co., Ltd. v. Stratasys, Inc.No claims unpatentable
  PTAB · Jun 9, 2026 · IPR2025-00321 · APJ Christopher M Kaiser · IPR · Final written decision

  The Board held claims 1, 2, 5–7, 9, 16, and 17 not unpatentable because the asserted combinations did not establish the required purge-tower teachings or prior-art status.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that one of ordinary skill in the art “would have had (1) at least a bachelor’s degree in Mechanical Engineering, Computer Engineering, Chemical Engineering, Materials Science, or a related field, and (2) at least two years of research or industry experience in 3D printing or materials used for 3D printing.” Pet. 5 (citing Ex. 1003 ¶¶ 14–16). Petitioner also argues that “[a]dditional experience could substitute for a formal degree or formal training (and vice versa).” Id. Patent Owner proposes a slightly different level of skill, arguing that a person of ordinary skill in the art “would have had a bachelor’s degree in Mechanical Engineering, Computer Engineering, Chemical Engineering, Materials Science, or a comparable field and at least two years of experience related to 3D printing, with additional experience potentially being a substitute for a formal degree or training (and vice versa).” Prelim. Resp. 24. Neither party explains why the outcome of this case would be affected by the adoption of any of the proffered definitions of a person of ordinary skill in the art. We adopt Petitioner’s assessment of the level of ordinary skill in the art, as it appears consistent with the ’324 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

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

    “According to the ’713 patent, “[p]urge tower 24 itself may be . . . recycled or otherwise discarded as desired.” Ex. 1001, 8:27–28. This description provides some support for Patent Owner’s view, because a purge tower too intimately integrated with the part would be difficult or impossible to recycle or discard. This is further supported by the ’713 patent’s statement that “purge tower 24 may be printed at any suitable location on build substrate 44 (i.e., at any location in the x-y build plane not occupied by 3D part 20 or support structure 22).” Id. at 8:30–34. It also is supported by Dr. Hickner’s testimony that the ’713 patent “clearly shows . . . the 24 purge tower separated from the part” and that “the purge tower is a separate physical object.” Ex. 2016, 28:8–10, 64:1–9. On the other hand, there is evidence supporting Petitioner’s view that, as long as the purge tower is generally separate from the part and the support structure, it may still make contact with those portions of the print. As noted above, “purge tower 24 may be printed at any suitable location on build substrate 44 (i.e., at any location in the x-y build plane not occupied by 3D part 20 or support structure 22).” Ex. 1001, 8:30–34. This language does not exclude locations adjacent to or in contact with the part or the support structure. Thus, determine that a “purge tower,” as that term is used in the context of the ’713 patent, may not be an integrated portion of a printed part or support structure but need not be free of all contact with the printed part or support structure.” slip op. at 9

  • BurdenNot shown unpatentable

    “There is evidence of record to support both Petitioner’s view and Patent Owner’s view. On the record developed at trial, however, we cannot say that the preponderance of the evidence favors Petitioner, who bears the burden of proof. See 35 U.S.C. § 316(e). Accordingly, Petitioner has not shown by a preponderance of the evidence that KISSlicer teaches printing a layer of a purge tower each time the printer switches one extruder to the operating mode. Because proving the obviousness of claims 1 and 16 requires such a showing, Petitioner has not shown by a preponderance of the evidence that claims 1 and 16 would have been obvious over the combination of Priedeman and KISSlicer. 5. Analysis of Remaining Claims Claims 2, 6, 7, 9, and 17 all depend, directly or indirectly, from claim 1 or claim 16. Accordingly, they all include the limitations of either claim 1 or claim 16. Because, as discussed above, Petitioner has not shown that the combination of Priedeman and KISSlicer teaches or suggests all the limitations of claims 1 and 16, Petitioner also has not proven by a preponderance of the evidence that claims 2, 6, 7, 9, and 17 would have been obvious over that combination of references.” slip op. at 21

  • Obviousness (§103) › Analogous artAnalogous artOther

    “On the record developed at trial, we agree with Petitioner. According to several industry forum posts, people interested in three-dimensional printing located the website where KISSlicer was posted between February 2012 and April 2012. Ex. 1028, 1 (post discussing and directing others to KISSlicer on April 11, 2012); Ex. 1031, 1 (two posts discussing KISSlicer on March 16, 2012, and March 21, 2012); Ex. 1032, 1 (two posts discussing KISSlicer on February 11, 2012, and February 14, 2012). Thus, not only was it possible for people of ordinary skill in the art to locate KISSlicer; people of ordinary skill in the art actually did locate it. Accordingly, Petitioner has shown by a preponderance of the evidence that KISSlicer was publicly accessible.” slip op. at 19

  Patent outcomesUS 9,421,713 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,421,713
• Shenzhen Tuozhu Technology Co., Ltd. v. Stratasys, Inc.All claims unpatentable
  PTAB · Jun 9, 2026 · IPR2025-00311 · APJ Christopher M Kaiser · IPR · Final written decision

  Claims 1, 3–11, and 17–22 are unpatentable as obvious over grounds using Mazumder and Mori; grounds relying on Henke fail because Henke is not analogous art.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “had a bachelor’s degree in Mechanical Engineering, Computer Engineering, Electrical Engineering, Materials Science, or a comparable field and at least two years of experience related to 3D printers including remote control of rapid fabrication systems.” Pet. 6 (citing Ex. 1003 ¶¶ 40–42). Petitioner also argues that “[a]dditional years of experience could substitute for an advanced-level degree (and vice versa).” Id. Patent Owner proposes a slightly different level of skill, arguing that a person of ordinary skill in the art “would have had a bachelor’s degree in Mechanical Engineering, Computer Engineering, Electrical Engineering, Materials Science, or a comparable field and at least two years of experience related to 3D printing, with additional experience potentially being a substitute for a formal degree or training (and vice versa).” PO Resp. 11–12. Neither party explains why the outcome of this case would be affected by the adoption of either of the proffered definitions of a person of ordinary skill in the art. We adopt Petitioner’s assessment of the level of ordinary skill in the art, as it appears consistent with the ’324 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9

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

    “There is also evidence that supports Petitioner’s proposed construction, under which a user interface may display both the image and the projection if it displays them at different times. This evidence includes statements in the specification that describe displaying an image “instead” of “a rendering of a three-dimensional model” and that describe displaying a “video image and/or model projection” rather than merely a video image and a model projection. Ex. 1001, 22:43–53, 24:52–55, Figs. 5, 7. It also includes arguments in the prosecution history distinguishing Taminger on the basis of failure of disclose any display of both an image and a projection at all, rather than on the basis of failure to disclose simultaneous display of both visualizations. Ex. 1002, 160, 161. Based on our review of all the probative evidence, we find that the preponderance of the evidence supports Petitioner’s view, so we construe the challenged claims as not requiring simultaneous display of the image and the projection.” slip op. at 15

  • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

    “With the problem solved by the ’324 patent defined as monitoring automated three-dimensional fabrication processes, we find that Mori is at least reasonably pertinent to the problem. Mori discloses “[a] machining status monitoring apparatus.” Ex. 1005, code (57), ¶ 43. That apparatus uses “actual CCD cameras . . . to image the workpiece.” Id. ¶ 49. It also has a “virtual image generating section” with “virtual CCD cameras” having “view points” that “match the view points of the actual CCD cameras.” Id. ¶¶ 59, 61, 62. This disclosure relates quite closely to monitoring an automated three-dimensional fabrication process and thus is at least reasonably pertinent to solving that problem. d) Conclusion For the reasons discussed above, Mori is both in the same field as the ’324 patent and at least reasonably pertinent to the problem solved by the ’324 patent. Accordingly, it is analogous art to the ’324 patent.” slip op. at 21

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

    “Regarding combining the teachings of Mazumder with those of Mori, the evidence of record shows that the print head of Mazumder’s three-dimensional printer could obscure portions of the actual camera’s view of the object being printed and that displaying Mori’s virtual image of the object in addition to Mazumder’s actual image of the object “would have allowed the user to of the remote computer to monitor the progress of the object even when the actual view of the object is partially or totally obscured.” Ex. 1003 ¶ 86. c) Conclusion Regarding Claim 1 For the reasons discussed above, the preponderance of the evidence shows that claim 1 would have been obvious over the combination of Mazumder and Mori.” slip op. at 26

  Patent outcomesUS 8,562,324 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,562,324
• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Jun 8, 2026 · PGR2025-00004 · APJ Susan L C Mitchell · PGR · Final written decision

  Claims 1–4, 7–19, and 22 are unpatentable under § 112(a) for lack of written description and enablement, and under § 103 as 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

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

    “1. Petitioner’s Position Petitioner asserts that the “terms used in the claims are either” slip op. at 12

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

    “7. Analysis We find the preponderance of the evidence supports a finding that the” slip op. at 59

  • 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 70

  Patent outcomesUS 12,018,298 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,018,298
• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  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
• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · May 12, 2026 · PGR2025-00003 · APJ Jeffrey N Fredman · PGR · Final written decision

  Claims 1–4 and 8–21 are unpatentable for lack of written description and enablement; obviousness over the ’429 patent and Chao was not shown.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “VII. 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 petitioner constructionDecided for petitioner

    “term “modified PH20 polypeptide” in the ’600 patent supports the understanding that some type of activity is required for a polypeptide to be a “modified PH20 polypeptide”, and that the enzymatic activity of hyaluronidase is the most frequently identified activity recited in the definitions section of the ’600 patent. Id. at 48:38–53, 50:9‒17, 51:15‒18, 52:41–47, 55:9–23, 63:37–44, 64:14–19. In contrast, the discussion regarding the potential use of “modified PH20 polypeptides that are inactive” as antigens in contraception vaccines appears only in a non-definitional section of the ’600 patent. Id. at 75:56–58, 72:60–62. Accordingly, it does not modify the definition’s explicit requirement that the claimed “modified PH20 polypeptide” exhibit hyaluronidase activity. Id. at 48:38–53.” slip op. at 19

  • 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) 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. For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–12 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’600 patent.” slip op. at 51

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

    “8. Conclusion We find that the balance of evidence supports a finding of undue” slip op. at 101

  Patent outcomesUS 11,952,600 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 11,952,600

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.