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  • 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
  • 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
  • PTAB · Oct 5, 2026 · IPR2025-00598 · APJ David C Mckone · IPR · Final written decision

    Claims 1–31 were not shown unpatentable under either § 103 ground because the asserted combinations did not teach required claim limitations.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedOther

      “admissions by Patent Owner in litigation, contends that a person of ordinary skill in the art would have had “a Master of Science (M.S.) degree in electrical engineering or computer science, and five years of work experience in a related field” and that “[a]dditional educational experience could substitute for some of the work experience.” Pet. 5 (citing Ex. 1002 ¶¶ 36–37). “Patent Owner does not dispute Petitioner’s proposed level of skill in the art (Petition, 5) at this time.” PO Resp. 6. On the complete record, we adopt Petitioner’s description of the level of ordinary skill in the art, as it is uncontested and is consistent with the technology described in the ’347 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

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

      “In the Preliminary Response, “Patent Owner accept[ed] the Petition’s claim construction.” Prelim. Resp. 6. However, in the Patent Owner Response, Patent Owner argues that “the claims of the ’347 Patent require no construction as they are valid under their plain and ordinary meaning.” PO Resp. 6. Based on the complete record, we do not find it necessary to provide express claim constructions of any claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 9

    • Expert testimonyPetitioner expert discountedDecided for patent owner

      “Beel actually discloses the following: [0321] On the peripheral device 32 the video packets are received at the corresponding plug and play port, e.g. the USB port 11, read by the Human Interface Driver (HID) interface handler 13, unpacked to remove HID protocol headers in an unpacker 20 and then transmitted to the communications network by a transmitter 21. The network can be wireless for example WiFi or LiFi network. [0322] Having been routed over a communications network to the base unit 33, the incoming stream is read from the communications interface such as a WiFi access point 22, unpacked in an unpacker 25, decoded in a decoder 26 and then inserted into a suitable composition such as an OpenGL based composition in the compositor 29 for display on a central display device. Ex. 1005 ¶¶ 321–322 (emphasis added to portions quoted by Petitioner). Patent Owner notes that “[t]he Petition mistakenly cites to ¶ 322 of Beel but quotes ¶ 321.” PO Resp. 20 n.3. However, it appears that Petitioner has grafted together a portion of paragraph 321 that introduces peripheral device 32 with a portion of paragraph 322, which discusses features of base unit 33. However, this grafting has been done in such a way as to convey (incorrectly) that peripheral device 32, not base unit 33, includes unpacker 25, decoder 26, and compositor 29 that process the first processed video data received by the first peripheral device to generate second video data. Dr. Almeroth’s testimony, which copies Petitioner’s incorrectly altered quotation to paragraph 322 of Beel, is unreliable as to this claim limitation and is entitled to no weight.4 Thus, Petitioner has no expert testimony on which to rely for this claim limitation.” slip op. at 19

    • Strike new argumentNew argument disregardedDecided for patent owner

      “5 At the oral argument, when challenged on its reliance on paragraph 322, Petitioner argued that paragraph 321 of Beel teaches this limitation. Tr. 22:26–23:24. Petitioner did not make this argument in the Petition and, instead, raised it for the first time during oral argument; thus, it will not be considered. See Dell Inc. v. Acceleron, LLC, 884 F.3d 1364, 1369 (Fed. Cir. 2018) (“Unless it chose to exercise its waiver authority under 37 C.F.R. § 42.5(b), the Board was obligated to dismiss Dell’s untimely argument given that the untimely argument in this case was raised for the first time during oral argument.”). Even if we were to consider this new argument, it would not be persuasive. As Patent Owner observes (PO Resp. 20), any processing performed by peripheral device 32 in paragraph 321 is on data received from the processing device and destined for the base station via the network, rather than data flowing in the direction of the first processed video data of claim 1.” slip op. at 22

    Patent outcomesUS 11,966,347 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · Graham
    Patents in suitUS 11,966,347
  • 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
  • Apple Inc. v. Proxense, LLCAll claims unpatentable
    PTAB · Sep 17, 2026 · IPR2025-00562 · APJ Thu A Dang · IPR · Final written decision

    Claims 1–20 are unpatentable as obvious over Giobbi ’157, Giobbi ’139, and Dua; the Board also finds the claims unpatentable under the Broadcom grounds.

    RulingsFinal written decision
    • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) does not applyDecided for petitioner

      “IPR2024-00783, Ex. 1001, 22:36–49. As the Federal Circuit stated, when a disputed claim limitation does not employ “means for” language, the presumption is that each of the terms conveys sufficiently definite structure or act and, thus, is not subject to § 112 ¶ 6. See Dyfan, 28 F.4th at 1367. Based on the record before us, this presumption that each of the terms is not subject to § 112 ¶ 6 is not overcome.” slip op. at 17

    • Skill levelOther

      “differences between the claimed subject matter and the prior art are such that the subject matter, as a whole, “would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence of non-obviousness. See Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966).” slip op. at 25

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “We find persuasive Dr. Wolfe’s supporting testimony that a POSITA would have understood the terms “PDK” and “RDC” to have “definite structure.” Ex. 1013 ¶¶ 35–56. In particular, we find persuasive Dr. Wolfe’s testimony that the term “PDK,” for example, “encompasses at least ‘a collection of circuit components that includes an antenna, a transceiver, and a controller and memory for storing information particular to a user.’” Id. ¶ 35. Dr. Wolfe’s testimony is consistent with the Specification of the ’188 patent. See Ex. 1001, 5:42–6:7, 3:48–62. In particular, the Specification of the ’188 patent describes a microchip that stores information in memory and responds through an antenna when probed, which is consistent with Dr. Wolfe’s testimony. Id.; Ex. 1001, 1:30–62.” slip op. at 19

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

      “differences between the claimed subject matter and the prior art are such that the subject matter, as a whole, “would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence of non-obviousness. See Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966).” slip op. at 25

    Patent outcomesUS 9,049,188 unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 9,049,188
  • PTAB · Sep 3, 2026 · IPR2025-00673 · APJ Michael R Zecher · IPR · Final written decision

    Claims 1–7 are unpatentable as obvious over the combined teachings of the asserted references, including Shin and Aoyama and Shimomura and Iwase.

    RulingsFinal written decision
    • PTAB / AIA Trials › Motions to amend / substitute claimsOther

      “1 SoundClear also filed a Contingent Motion to Amend that proposed to replace originally challenged claim 5 of the ’675 patent with proposed substitute claim 8. Paper 21. We, however, granted SoundClear’s request to withdraw its Contingent Motion to Amend and, as a result, the Contingent Motion to Amend will no longer be considered in this proceeding. Paper 30.” slip op. at 2

    • Skill levelOther

      “2. Level of Skill in the Art In determining whether an invention would have been obvious, we” slip op. at 21

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundMotivation not foundMixed

      “combination because (1) configuring Shin’s processor 120 accordingly “would have been trivial, involving straightforward changes to enhance the processor’s approach to simplifying and abbreviating its output”; and (2) this approach was well-known as evidenced by Ha’s disclosure of replacing “team meeting” and “date” with “schedules” based on the user’s environment.6 Id. at 27–28 (first quoting Ex. 1011 ¶ 97, then quoting Ex. 1011 ¶ 98) (citing Ex. 1002 ¶ 102; Ex. 1011, Fig. 7).” slip op. at 33

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “4. Dr. Stern’s Testimony is Reliable In its Patent Owner Response, SoundClear contends that “Dr. Stern’s” slip op. at 125

    Patent outcomesUS 11,244,675 unpatentable
    § 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,244,675
  • PTAB · Sep 1, 2026 · PGR2025-00017 · APJ Jeffrey N Fredman · PGR · Final written decision

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

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 9

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “been able to use the data in the Specification to make reasonable predictions about the effect of multiple modifications on hyaluronidase activity, we view this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”14) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–230 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple” slip op. at 53

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

      “been able to use the data in the Specification to make reasonable predictions about the effect of multiple modifications on hyaluronidase activity, we view this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”14) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–230 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple” slip op. at 53

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

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

    Patent outcomesUS 12,110,520 unpatentable
    § 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 12,110,520
  • PTAB · Aug 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
  • PTAB · Jul 28, 2026 · IPR2025-00491 · APJ Frederick C Laney · IPR · Final written decision

    Claims 1–18 are unpatentable as obvious over Beel and Dinka, with or without Christison; the Kaplan, Van de Laar, and Christison ground fails for lack of motivation to combine.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Pet. 9–10 (citing Ex. 1002 ¶¶ 36–37). “Patent Owner does not dispute Petitioner’s proposed level of skill in the art.” PO Resp. 6. On the complete record, we adopt Petitioner’s proposed definition of a person of ordinary skill in the pertinent art, as it is consistent with the ’972 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 10

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

      “Rather than addressing Petitioner’s proposals, Patent Owner states “the claims of the ’972 Patent require no construction as they are valid under their plain and ordinary meaning.” PO Resp. 6. Our decision in this matter does not turn on resolving any particular differences between the parties’ constructions. Therefore, because only those terms in controversy need to be construed, and only to the extent necessary to resolve the controversy, we determine that no claim term requires express construction in this proceeding and that the ordinary and customary meaning of the claim terms apply. See Realtime Data LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019).” slip op. at 11

    • Expert testimonyPatent owner expert discountedDecided for petitioner

      “device. The ’972 patent expressly defines endpoints broadly “as data sources or sinks.” Ex. 1001, 7:64–67. And the ’972 patent admits that Beel’s Figure 11 discloses the same endpoints depicted in the ’972 patent’s own Figure 4. Id. at 4:28–33, 16:44–67. Beel’s Figure 11 and accompanying description disclose a “[m]ass storage device 12,” a “USB audio device 14,” and a “USB HID device 13” on the peripheral device. Ex. 1005, Fig. 11, ¶¶ 320–323. Patent Owner’s own declarant conceded that a mass storage device is “a type of endpoint” (Ex. 1034, 43:19–21), and that “audio devices are endpoints” (id. at 57:5–61:4). We give reduced weight to Patent Owner’s contrary position to the extent it rests on the premise that a reference cannot disclose an endpoint unless it uses the word “endpoint” (Ex. 2030 ¶ 94; Ex. 1034, 43:19–44:16, 72:18–73:12); a premise that is inconsistent with the ’972 patent’s own broad definition and with the ’972 patent’s admission regarding Beel’s Figure 11. As additional support not separately emphasized by the parties in this connection, we note Dr. Almeroth’s technical explanation that, for data to pass from a functional device to a peripheral device, “both the functional device and the peripheral device must have ‘endpoints’”—a data source and a data sink—reasoning consistent with the ’972 patent’s definition. Ex. 1002 ¶ 125.” slip op. at 27

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

      “First, we agree with Patent Owner that, under the ordinary meaning of the claim language, the endpoint is an endpoint of the peripheral device, and that it must be “a data source or a data sink which is able to store or emit data, of the functional device exposed or made available on the first peripheral device.” Ex. 1001, 23:11–17. The limitation thus identifies a structure—an endpoint, residing on the peripheral device, that is a source or sink and that corresponds to (is “of”) the functional device—through which the communication recited in subsequent element (g) is carried out. By its terms, it imposes no requirement as to the direction in which data flows; it requires only that the endpoint be a data “source” or a data “sink” that is able to “store or emit” data. The operative transmit-and-receive communication “from the functional device to the processing device via the . . . endpoint” is recited in subsequent element (g), which we take up separately below. The disputed question under this limitation is therefore the structural one: whether Beel discloses, on the peripheral device, an endpoint that is “of the functional device.” Because the inquiry is structural and non-directional, we are not persuaded that the audio-out orientation of Beel’s described embodiment, on which Patent Owner relies, is dispositive of this limitation. device. The ’972 patent expressly defines endpoints broadly “as data sources or sinks.” Ex. 1001, 7:64–67. And the ’972 patent admits that Beel’s Figure 11 discloses the same endpoints depicted in the ’972 patent’s own Figure 4. Id. at 4:28–33, 16:44–67. Beel’s Figure 11 and accompanying description disclose a “[m]ass storage device 12,” a “USB audio device 14,” and a “USB HID device 13” on the peripheral device. Ex. 1005, Fig. 11, ¶¶ 320–323. Patent Owner’s own declarant conceded that a mass storage device is “a type of endpoint” (Ex. 1034, 43:19–21), and that “audio devices are endpoints” (id. at 57:5–61:4). We give reduced weight to Patent Owner’s contrary position to the extent it rests on the premise that a reference cannot disclose an endpoint unless it uses the word “endpoint” (Ex. 2030 ¶ 94; Ex. 1034, 43:19–44:16, 72:18–73:12); a premise that is inconsistent with the ’972 patent’s own broad definition and with the ’972 patent’s admission regarding Beel’s Figure 11. As additional support not separately emphasized by the parties in this connection, we note Dr. Almeroth’s technical explanation that, for data to pass from a functional device to a peripheral device, “both the functional device and the peripheral device must have ‘endpoints’”—a data source and a data sink—reasoning consistent with the ’972 patent’s definition. Ex. 1002 ¶ 125. Third, we find that the endpoint Beel discloses is a data source or a data sink that is “able to store or emit data, of the functional device.” We begin with the words of the limitation. The endpoint need only be “able to store or emit data”—language of capability, not a requirement that particular data actually traverse the endpoint in operation, and still less in a particular direction. And the endpoint is defined by the character of the data it handles: it is “a data source or a data sink,” which the ’972 patent instructs An audio endpoint, so understood, is characterized as an audio source or sink; its structure is not tied to any single instance of an audio device. On that understanding, Beel’s disclosure establishes the required capability directly. Beel discloses that “audio data is captured through a virtual sound card interface added as a logical device over the physical interface provided in the peripheral device,” Ex. 1005 ¶ 43, that the peripheral device “acts as a composite device comprising for instance a (virtual) audio speaker device,” id. ¶ 317, and that “audio data is captured at this interface . . . internally in the peripheral device 32” and streamed over the communications network, id. ¶ 319. Beel thus shows the endpoint on the peripheral device actually storing and emitting audio—and, correspondingly, video—data, which is the very type of data produced and consumed by the audio/visual functional devices connected to the base unit, including the microphones, cameras, speakers, and displays. Id. ¶ 120. An endpoint shown to store or emit audio and video data is necessarily one that is “able to store or emit” such data; the capability the limitation requires is thus established by Beel’s disclosure.” slip op. at 26

    Patent outcomesUS 10,684,972 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,684,972
  • PTAB · Jul 27, 2026 · IPR2025-00565 · APJ Michael R Zecher · IPR · Final written decision

    Claims 1–5 are unpatentable because Amazon showed they are anticipated by Shin; the Board did not reach Amazon’s contingent obviousness ground over Shin.

    RulingsFinal written decision
    • BurdenOther

      “Written Decision under 35 U.S.C. § 318(a) as to the patentability of claims 1–5 of the ’337 patent. For the reasons we identify below, we hold that Amazon has demonstrated by a preponderance of the evidence that these claims are unpatentable.” slip op. at 2

    • Skill levelOther

      “2. Level of Skill in the Art In determining whether an invention would have been obvious, we” slip op. at 18

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

      “1. Principles of Law To establish anticipation, “all of the elements and limitations of the” slip op. at 17

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed

      “1. Principles of Law To establish anticipation, “all of the elements and limitations of the” slip op. at 17

    Patent outcomesUS 11,069,337 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,069,337
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