• 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
• Uatp IP LLC v. Slick Slide LLCSome claims unpatentable
  PTAB · Oct 2, 2026 · PGR2024-00054 · APJ Brian D Range · PGR · Final written decision

  Claims 22–26 are unpatentable based on obviousness; claims 1–17, 27, and 28 were not shown unpatentable. Patent Owner’s motion to terminate was denied.

  RulingsFinal written decision

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

    “1. Mesh Layer Petitioner contends “no formal claim construction is necessary in this” slip op. at 13

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

    “5. Analysis On this complete record, we determine that Petitioner’s arguments do” slip op. at 31

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

    “form of nylon and some form of Teflon (and possible combinations thereof) having the specific coefficient of friction range given in limitation [1c] breaks down, because the building blocks of the obviousness argument are not sufficiently identified in Phillips alone, nor in the supporting testimony. Accordingly, we determine that Petitioner’s arguments and evidence fail to show that Phillips renders the challenged claims obvious. 6. Conclusion Based on the foregoing, we determine that Petitioner has not established by a preponderance of the evidence that claims 1–4, 6, and 7 would have been anticipated by or obvious in view of Phillips.” slip op. at 33

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

    “2. Products and Nexus We first consider the issue of whether certain evidence relied upon by” slip op. at 20

  Patent outcomesUS 11,998,854 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · Graham · Nautilus
  Patents in suitUS 11,998,854
• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Oct 2, 2026 · PGR2025-00046 · APJ Jeffrey N Fredman · PGR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

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

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

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

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

    “6. Analysis Petitioner has the burden to identify how the Specification allegedly” slip op. at 74

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

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

  Patent outcomesUS 12,091,692 unpatentable
  § 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,091,692
• Shenzhen Tuozhu Technology Co., Ltd. v. Stratasys, Inc.All claims unpatentable
  PTAB · Sep 28, 2026 · IPR2025-00611 · APJ Christopher L Ogden · IPR · Final written decision

  Claims 1–10, 12, 13, 19, and 20 are unpatentable under § 103 over the stated Douglas–Mark and Hamilton-based grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “The parties agree that experience could substitute for a degree, and vice versa. Pet. 3; PO Resp. 10. The parties’ proposed levels of ordinary skill are substantially similar. For this decision, as in the Institution Decision, we adopt Petitioner’s proposed level, which is supported by credible testimonial evidence and is consistent with the problems addressed in the ’774 patent. See Ex. 1001, 1:16–52. Our decision would be the same, however, if we were to adopt Patent Owner’s proposal.” slip op. at 7

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

    “Neither Petitioner nor Patent Owner argues that we need to construe any claim terms explicitly. See Pet. 2–3; PO Resp. 10. However, the parties contest two material claim-construction issues which we address below. To the extent that the parties’ positions depend on interpreting other claim language in a particular way, we discuss the relevant claim language below in the context of the parties’ arguments regarding the prior art.” slip op. at 8

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

    “We disagree with Patent Owner that a person of ordinary skill in the art would have understood that limitation 1.2 must be performed before limitations 1.3 or 1.4. See Ex. 1001, 35:21–24. See Interactive Gift Exp., Inc. v. Compuserve Inc., 256 F.3d 1323, 1342 (Fed. Cir. 2001) (“Unless the steps of a method actually recite an order, the steps are not ordinarily construed to require one.” (citing Loral Fairchild Corp. v. Sony Corp., 181 F.3d 1313, 1322 (Fed. Cir. 1999)). The evidence suggests that a “target printer” is any printer that is ultimately selected for fabricating the object, and such a printer could send its configuration information either before or after that determination is made in limitation 1.2. This interpretation does not render the word “target” meaningless. At some point, a printer must be determined to be the target printer, which is the one intended to ultimately fabricate the three-dimensional object. But the target printer still exists, and is capable of being queried, before that determination is made. We find the examples in the ’774 patent pertinent to this question. The ’774 patent states that “the target printer may include more than one printer.” Ex. 1001, 18:66–67. In discussing the step of “query target printer for properties 306” (Fig. 3A), the ’774 patent states that “[i]n one aspect, numerous queries are sent to numerous printers, e.g., for use in selecting one or more of the printers as the target printer.” Id. at 19:8–10. Alternatively, “the query is sent to a printer that is not necessarily the target printer as described herein, e.g., when the query or information received from a response to the query is used for the selection of the target printer.” Id. at 19:11–14. Importantly, the second embodiment states that the queried printer “is not necessarily the target printer,” suggesting that the queried printer could be the target printer even before it is determined to be such. Id. at 19:11–12 (emphasis added). Based on the evidence of record, a person of ordinary skill in the art would have understood that the “target printer” can be determined after the query recited in limitation 1.3 or the reception of configuration information recited in limitation 1.4. Thus, the evidence does not impose an ordering between limitations 1.2 and 1.3 or between limitations 1.2 and 1.4. The evidence also does not support Patent Owner’s argument that the two reverse-order examples in the ’774 patent are unclaimed embodiments.” slip op. at 10

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

    “We disagree that Petitioner’s arguments are based on impermissible hindsight, because they are based on the disclosures in Douglas and Mark, and Petitioner has articulated a persuasive reason to combine those references without referring to the ’774 patent itself, as we discuss below. See In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971) (an obvious rationale is not improper hindsight if it “takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure”).” slip op. at 29

  Patent outcomesUS 11,886,774 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,886,774
• Shenzhen Root Technology Co., Ltd. v. Willow Blossom Holdco Limited And Willow Innovations, Inc.All claims unpatentable
  PTAB · Sep 25, 2026 · IPR2025-00554 · APJ Barry L Grossman · IPR · Final written decision

  Claims 17–19 and 21–33 are unpatentable as obvious under each asserted § 103 ground.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Factors pertinent to a determination of the level of ordinary skill in the art include: (1) educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of workers active in the field. Env’t Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696–697 (Fed. Cir. 1983) (citing Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376, 1381–82 (Fed. Cir. 1983)). Not all such factors may be present in every case, and one or more of these or other factors may predominate in a particular case. Id. Moreover, these factors are not exhaustive but are merely a guide to determining the level of ordinary skill in the art. Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). In determining a level of ordinary skill, we also may look to the prior art, which may reflect an appropriate skill level. Okajima, 261 F.3d at 1355.” slip op. at 17

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

    “according to the Phillips standard,” and that “no formal claim constructions are necessary for purposes of resolving controversies in this proceeding. Pet. 3. We agree. Given the lack of dispute on this record, we do not perceive the need to construe any claim limitation. Claims must be construed “only to the extent necessary to resolve the controversy.” AstraZeneca AB v. Mylan Pharms. Inc., 19 F.4th 1325, 1345 (Fed. Cir. 2021) (quoting Vivid Techs., Inc. v. American Science & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“Because we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy,’ we need not construe the claim preambles here where the construction is not ‘material to the [obviousness] dispute.’” (citations omitted)).” slip op. at 18

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “We find Mr. Bauer’s testimonial evidence persuasive and undisputed as to why a person of ordinary skill, a degreed engineer with two years of experience designing human breast pump equipment, would modify Furrer to use a battery as a power source, and have a reasonable degree of confidence that it would work successfully.” slip op. at 26

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

    “We find Mr. Bauer’s testimonial evidence persuasive and undisputed as to why a person of ordinary skill, a degreed engineer with two years of experience designing human breast pump equipment, would modify Furrer to use a battery as a power source, and have a reasonable degree of confidence that it would work successfully. Concerning the proposed combination of Furrer and Alvarez, Mr. Bauer testifies why a person of ordinary skill would combine Furrer and Alvarez, explaining that: a POSITA6 would have turned to the teachings of Alvarez to implement Furrer’s vacuum pump using a conventional pump controller having a portable, battery-powered pump to not only increase portability and to allow the user to move about when using the device but also to provide improved control for the system. Ex. 1003 ¶ 138. Mr. Bauer also testifies: a POSITA would have recognized that Alvarez advantageously provides details for such a conventional vacuum pump suitable for safely and controllably delivering negative pressure using a “[c]ontroller 115 [that] “houses the power source and drive mechanism for pumping device 100, and also contains hardware for various functions, such as controlling pumping device 100, milk production quantification, and communication with other devices. 6 “POSITA” is a patent law acronym for a “person of ordinary skill in the art.” Id. ¶ 139 (citing Ex. 1005 ¶ 69). Mr. Bauer further explains that Alvarez discloses that a “pump unit2100 [disclosed in Alvarez] preferably include[es] a controller and processor 2104 as well as a motor 2102 for actuating the device.” Id. (citing Ex. 1005 ¶ 115); see also id. ¶¶ 140–142 (providing “second,” “third,” and “fourth” reasons why a person of ordinary skill would have been motivated to combine Furrer and Alvarez). Mr. Bauer concludes from his analysis that “a person skilled in the art” slip op. at 26

  Patent outcomesUS 11,806,454 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,806,454
• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  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
• Ajinomoto Co., Inc. v. Abtis Co., Ltd.No claims unpatentable
  PTAB · Aug 3, 2026 · IPR2025-00283 · APJ Lilan Ren · IPR · Final written decision

  The Board cancelled claim 11 and granted substitute claims 14–16, finding Petitioner had not shown those claims unpatentable on any asserted ground.

  RulingsFinal written decision

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted

    “must determine whether the motion to amend meets the statutory and regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121. Lectrosonics, Paper 15 at 4. In that regard, Patent Owner bears the burden of persuasion to show that: (1) the amendment proposes a reasonable number of substitute claims; (2) the amendment responds to a ground of unpatentability involved in the trial; (3) the amendment does not seek to enlarge the scope of the claims of the patent or introduce new subject matter;” slip op. at 9

  • ExcludeMotion to exclude, deniedDenied

    “In this case, Patent Owner’s expert “Dr. Zhou signed the second declaration, stood behind its contents, and was available for cross-examination.” Paper 35, 4. Petitioner does not dispute this statement. Paper 39, 1. Petitioner does not identify any specific undue prejudice caused by Exhibit 2008. For example, Petitioner argues that “the failure to impress upon a witness that a statement is under oath goes to the heart of its reliability as evidence” and that “as the Board has recognized, hearsay is inherently unreliable” without specifying what statement in Exhibit 2008 lacks reliability. Paper 39, 4. Because Petitioner does not provide specific evidence of undue prejudice, we find Petitioner has suffered no such undue prejudice in this case. See Liquidia, 2021 WL 4860773 at *25. We therefore deny Petitioner’s Motion to Exclude on the basis of lack of authenticity. With regard to the assertion that Exhibit 2008 is hearsay, Petitioner objects to the exhibit because the testimony is based “on other informal and unpublished documents that are hearsay under FRE 802.” Paper 29, 1. Petitioner does not specify what such “informal and unpublished documents” are. See id. Federal Rule of Evidence 703 expressly states, “[a]n expert may base an opinion on fact or data in the case that the expert has been made aware of or personally observed.” The facts or data “need not be deny Petitioner’s Motion to Exclude on the basis of hearsay.” slip op. at 50

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

    “Petitioner’s argument is unpersuasive. Paragraph 59 of the ’503 application describes formula 8-1 but does not support Petitioner’s argument that other unknown formulas may be included in the recited modified heavy chains. Ex. 2003 ¶ 59. Petitioner’s hypothesis that the recited heavy chains may (or may not) encompass unknown formulas is also inapposite to the written description inquiry before us — that is, whether the inventor was in possession of the subject matter recited in claims 14–16 based on the disclosure including formulas 8-1, 8-2, and 8-3. See PowerOasis, 522 F.3d at 1306.” slip op. at 14

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledNot shown unpatentable

    “These arguments in the Sur-Reply are unpersuasive to show a lack of enablement first and foremost because the arguments do not specifically provide evidence showing that any purported experimentation is undue. See Sur-Reply 2–8 (asserting, but without providing evidence under any specific Wands factors, that the examples and guidance in the specification do not extend to the broad scope of all antibodies); see Wands, 858 F.2d at 737. We again emphasize that the analysis of undue experimentation does not necessarily require every Wands factor to be explicitly addressed but the analysis must be based on “weighing many factual considerations” depending on the nature of the invention and underlying art. Cephalon, Inc. v. Watson Pharms., Inc., 707 F.3d 1330, 1336 (Fed. Cir. 2013). The assertion that the claim scope is broad alone does not suffice to show a lack of enablement based on the record before us. Moreover, as we note supra, Petitioner’s claim scope argument is based on the false premise that the scope of claims 14–16 is as broad as the claim term “antibody” without taking into account all other claim elements. For example, Petitioner does not disagree with Patent Owner’s statement that “[t]he ’675 Patent’s specification discloses the structural modification site, the chemistry used to modify that residue, and working examples demonstrating the modification” (Reply 2), but asserts only that “[t]he disclosure of SSFI that only binds to IgG1 Fc domains (SEQ ID NO:1) is . . . . inconsistent with the expansive scope of the claims.” Sur-Reply 5. Petitioner’s argument that the claims encompass proteins that lack a lysine reside at a 248 position improperly excludes from the claim language the “lysine residue at 248 position . . . [as] determined by the EU numbering system” that claims 14–16 require. As Dr. Zhou testifies, “each proposed lysine residue at position 248 (EU numbering) is covalently modified with a specific attachment with a terminal bio-orthogonal click-chemistry functional group. The specification describes targeted transfer of a chemical functional group to lysine 248” and when claims 14–16 are considered in their entirety, which includes all claim elements, “[a] POSA would understand the claim itself to limit the modified antibodies to those with lysine at position 248.” Ex. 2004 ¶ 48; Ex. 2008 ¶ 47. We also note that Patent Owner states “a POSA would understand that the phrase ‘one or more modified heavy chain’ encompasses antibodies within typical DAR distributions (i.e., fractional numbers) rather than requiring a distinct process for producing antibodies bearing modified heavy chains in exact integers.” Reply 2–3. Moreover, Patent Owner states that PepTalk Presentation demonstrates that “a POSA would understand antibody conjugation products to exist as mixtures rather than discrete whole number species” because PepTalk Presentation “presents DAR values as non-integer measurements, i.e. DARs of 1.8 and 1.9 reflecting such distributions.” Id. at 3 (citing Ex. 1007, 28). According to Patent Owner, “preparations having an average DAR of approximately 1.8 (commonly referred to in practice as ‘DAR2’) may reflect typical reaction distributions in which some antibodies contain two modified heavy chains while others contain fewer.” Id. at 3 (citing Ex. 2008 ¶ 46). Petitioner does not rebut these statements. See Sur-Reply 2–8. Based on the foregoing, the evidence before us does not show any” slip op. at 27

  Patent outcomesUS 11,896,675 not shown unpatentable
  § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · Nautilus
  Patents in suitUS 11,896,675
• Shenzhen Root Technology Co., Ltd. v. Willow Blossom Holdco LimitedAll claims unpatentable
  PTAB · Jul 30, 2026 · IPR2025-00560 · APJ Barry L Grossman · IPR · Final written decision

  Claims 1–29 are unpatentable under each asserted obviousness ground, including Chang and Fang, because Petitioner proved unpatentability by a preponderance of the evidence.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Additionally, we note that Patent Owner did not cross-examine Mr. Ryan Bauer, who provided a detailed, 169-page expert report providing, on behalf of Petitioner, his opinions about the issues in this proceeding. See Exhibit 1003. Mr. Bauer’s testimonial evidence in this proceeding remains unrebutted.” slip op. at 3

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that a person of ordinary skill in the art would have had “bachelor’s degree in mechanical engineering or a similar field and at least two years of experience designing human breast pump equipment. More education could substitute for experience and vice versa.” Pet. 8 (citing Ex. 1003 ¶¶ 15–18). Mr. Bauer’s Declaration testimony states he considered some of the factors listed above. Ex. 1003 ¶ 17. Mr. Bauer testifies that based on his background and experience, in his opinion, the level of ordinary skill is as stated by Petitioner. Id. at 18. Based on the prior art, the sophistication of the disclosed technology in the ’381 patent, and Mr. Bauer’s undisputed testimony, we adopt Petitioner’s definition of the level of ordinary skill.” slip op. at 17

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

    “Petitioner asserts that the Examiner construed the term “self- contained, in-bra wearable device” to mean “complete, or having all that is needed, in itself’ and is capable of being worn in a bra.” Pet. 8 (citing Ex. 1005, 2290).14 According to Petitioner, “[Patent Owner] did not dispute this construction, and Petitioner applies it herein.” Id. Petitioner contends that all other terms “should receive their plain and ordinary meaning.” Id. We do not perceive the need to construe any claim limitation. Claims must be construed “only to the extent necessary to resolve the controversy.” AstraZeneca AB v. Mylan Pharms. Inc., 19 F.4th 1325, 1345 (Fed. Cir. 2021) (quoting Vivid Techs., Inc. v. American Science & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“Because we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy,’ we need not construe the claim preambles here where the construction is not ‘material to the [obviousness] dispute.’” (citations omitted)).” slip op. at 17

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

    “(3) 1[a][1] a diaphragm configured to prevent milk from reaching an air pump by forming a seal around its outer edge; Petitioner relies on Fang for the disclosure of a diaphragm, as stated in this clause. Pet. 25–26. Petitioner asserts the proposed combination of elements suggest a breast pump device that would have used a diaphragm pump including first and second diaphragm housing components and an elastic diaphragm, “in accordance with Fang’s suggestions.” Id. at 25. As also asserted by Petitioner, Fang discloses that flexible diaphragm 7 (i.e., a membrane) is configured to prevent milk from reaching the pump. Id. at 26 (citing Ex. 1009 ¶ 19 (“The elastic diaphragm 7 is used to prevent milk from flowing into the air pump main unit 8.”). Mr. Bauer testifies: The flexible diaphragm [diaphragm 7 in Fang] forms a watertight and airtight seal around its outer edge. In doing so, the diaphragm prevents the passage of milk from reaching the air pump and facilitates generation of negative pressure during operation. Fang also explains that the elastic diaphragm 7 deforms away from the nipple tunnel when a vacuum is created on a pumping chamber, which then creates negative air pressure in the nipple tunnel when a vacuum is created on a pumping chamber.” slip op. at 28

  Patent outcomesUS 11,813,381 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,813,381
• Samsung Display Co., Ltd. v. Pictiva Displays International Ltd.All claims unpatentable
  PTAB · Jul 22, 2026 · IPR2024-01095 · APJ Garth D Baer · IPR · Remand

  On remand, the Board maintained its finding that claims 2 and 17 are unpatentable under §103 over Diekmann and Ma, and Suzuki and Ma.

  RulingsRemand decision

  • RemandDecided for petitioner

    “that is both n-doped and comprised of 8-hydroxy-quinolinolato-lithium (Liq). The district-court defendant’s first invalidity challenge relied primarily on Clix2, which lacked an n-doped ETL. Paper 48, 2, Paper 50, 3. Thus, the asserted combination required modifying Clix2’s non-doped ETL by adding an n-dopant. Clix2’s missing n-doped ETL appeared to be a focus at trial. See Ex. 2034, 917:1–18, 920:8–14. Here, in contrast, Petitioner proposed a more modest modification to materially different primary references, Suzuki and Diekmann, which both already have n-doped ETLs. See Paper 50, 2–3; Paper 54 8–9. As we explained in our Final Written Decision, because Patent Owner did not contest that Liq acts as an n-dopant in Ma, Petitioner’s combinations were obvious because they merely “substitute one known n-dopant for another to further the same goal of improving ETL conductivity.” Paper 54, 12. That simple-substitution analysis would not be the same when n-doping Clix2’s non-doped ETL. For this reason, we agree with Petitioner that the district-court Clix2-based combination “is a different combination with a materially different motivation-to-combine analysis,” as compared to the Diekmann/Suzuki and Ma combinations that are at issue here. Paper 50, 3.” slip op. at 2

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

    “Dependent claims 2 and 17 require an electron transport layer (ETL) that is both n-doped and comprised of 8-hydroxy-quinolinolato-lithium (Liq). The district-court defendant’s first invalidity challenge relied primarily on Clix2, which lacked an n-doped ETL. Paper 48, 2, Paper 50, 3. Thus, the asserted combination required modifying Clix2’s non-doped ETL by adding an n-dopant. Clix2’s missing n-doped ETL appeared to be a focus at trial. See Ex. 2034, 917:1–18, 920:8–14. Here, in contrast, Petitioner proposed a more modest modification to materially different primary references, Suzuki and Diekmann, which both already have n-doped ETLs. See Paper 50, 2–3; Paper 54 8–9. As we explained in our Final Written Decision, because Patent Owner did not contest that Liq acts as an n-dopant in Ma, Petitioner’s combinations were obvious because they merely “substitute one known n-dopant for another to further the same goal of improving ETL conductivity.” Paper 54, 12. That simple-substitution analysis would not be the same when n-doping Clix2’s non-doped ETL. For this reason, we agree with Petitioner that the district-court Clix2-based combination “is a different combination with a materially different motivation-to-combine analysis,” as compared to the Diekmann/Suzuki and Ma combinations that are at issue here. Paper 50, 3.” slip op. at 2

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

    “that is both n-doped and comprised of 8-hydroxy-quinolinolato-lithium (Liq). The district-court defendant’s first invalidity challenge relied primarily on Clix2, which lacked an n-doped ETL. Paper 48, 2, Paper 50, 3. Thus, the asserted combination required modifying Clix2’s non-doped ETL by adding an n-dopant. Clix2’s missing n-doped ETL appeared to be a focus at trial. See Ex. 2034, 917:1–18, 920:8–14. Here, in contrast, Petitioner proposed a more modest modification to materially different primary references, Suzuki and Diekmann, which both already have n-doped ETLs. See Paper 50, 2–3; Paper 54 8–9. As we explained in our Final Written Decision, because Patent Owner did not contest that Liq acts as an n-dopant in Ma, Petitioner’s combinations were obvious because they merely “substitute one known n-dopant for another to further the same goal of improving ETL conductivity.” Paper 54, 12. That simple-substitution analysis would not be the same when n-doping Clix2’s non-doped ETL. For this reason, we agree with Petitioner that the district-court Clix2-based combination “is a different combination with a materially different motivation-to-combine analysis,” as compared to the Diekmann/Suzuki and Ma combinations that are at issue here. Paper 50, 3.” slip op. at 2

  Patent outcomesUS 11,828,425 unpatentable
  § 103 obviousness
  Patents in suitUS 11,828,425

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.