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  • PTAB · Sep 1, 2026 · PGR2025-00017 · APJ Jeffrey N Fredman · PGR · Final written decision

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

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

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

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

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

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

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

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

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

    Patent outcomesUS 12,110,520 unpatentable
    § 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 12,110,520
  • PTAB · Aug 31, 2026 · IPR2023-00199 · APJ John A Hudalla · IPR · Final written decision

    Claims 1, 4, 7, and 8 are unpatentable as obvious over Na and Kim (claim 1) and Na and Hong (claims 4, 7, and 8); other grounds were not reached.

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

      “Manufacturing Resources International, Inc. (“Patent Owner” or “MRI”) filed a Preliminary Response. Paper 7 (“Prelim. Resp.”). Taking into account the arguments presented by Patent Owner in the preliminary record, we determined that the information presented in the Petition established that there was a reasonable likelihood that Petitioner would prevail with respect to its unpatentability challenges. Pursuant to 35 U.S.C. § 314, we instituted this proceeding on June 20, 2023, as to all challenged claims and all grounds of unpatentability presented in the Petition. Paper 9 (“Dec. on Inst.”).” slip op. at 2

    • ExcludeMotion to exclude, deniedDenied

      “Petitioner’s Motion to Strike Petitioner moves to strike Exhibits 2055, 2056, and 2058–2061 as being improper new evidence filed by Patent Owner with its Sur-reply in contravention of 37 C.F.R. § 42.23(b). Exclude Mot. 1–5. We have not relied on any of these exhibits in rendering this Decision. Accordingly, we dismiss as moot Petitioner’s Motion to Strike.” slip op. at 73

    • Skill levelSkill level board ownDecided for patent owner

      “record, we adopted the following definition of the level of ordinary skill in our Decision on Institution: [A] POSITA would have had a bachelor’s degree in a pertinent discipline, such as mechanical engineering, physics, applied physics, product design, or a related field, and would also have had 2–4 years of experience working with electronic displays, including the thermal management, product design issues, and failure modes, associated with such displays, or 5–7 years of experience in the field working with electronic displays and would have developed a similar understanding of thermal management, product design issues, and failure modes, associated with electronic displays. Dec. on Inst. 11. The parties’ positions have not changed since the time of institution, and we discern no reason to change the definition. Thus, we apply the same definition. We are satisfied that this definition comports with the level of skill necessary to understand and implement the teachings of the ’595 patent and the asserted prior art. Notwithstanding, we note that our analysis would not change if we adopted either party’s proposed definition in toto.” slip op. at 12

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “appear nowhere outside of the claims in the ’595 patent. This fact alone tends to undermine Patent Owner’s suggestion that the “posterior surface” must be distinct from the “rear side.” In addition, Patent Owner’s cited portions of the Specification merely refer to the “posterior surface” as being the surface opposite that on which the LEDs are mounted to which heat from the LEDs is transferred. See Ex. 1001, 4:53–55, 4:57–60. They are inconclusive as to whether the “posterior surface” must be distinct from the “rear side.” Further, Mr. Gershowitz’s testimony in support of a “distinct” construction is based on his interpretation of the words “on the” in claim 4’s recited “posterior surface on the rear side of the PCB.” Ex. 2006 ¶ 128. Specifically, he testifies that “[i]f the posterior surface was the rear side of the PCB, the claim would have said so.” Id. He does not cite any support in the Specification of the ’595 patent for his interpretation. See id. Given that his testimony amounts to speculation divorced from the context of the Specification, Mr. Gershowitz’s testimony is entitled to little weight. We also have considered Mr. Smith-Gillespie’s testimony in support of Petitioner’s contention that an ordinarily skilled artisan “would have understood that the rear outermost surface of the PCB is the recited ‘posterior surface.’” Pet. Reply 20 (citing Pet. 83; Ex. 1002 ¶ 243). He cites a passage in the Specification of the ’595 patent that states: “The PCB may comprise a metal core PCB and the posterior surface of the PCB may be metallic so that air within the constricted convection channel may cool the metallic posterior surface (and subsequently the backlight assembly) more easily and efficiently.” Ex. 1002 ¶ 243 (emphasis omitted) (quoting Ex. 1001, 4:60–65). We accord Mr. Smith-Gillespie’s testimony more weight than Mr. Gershowitz’s testimony given that Mr. Smith-Gillespie’s testimony is rooted in disclosures about metal core PCBs in the ’595 patent. It also gives some credence to the notion that the “posterior surface” and the “rear side” could be one and the same. Based on the record before us, we do not agree with Patent Owner that” slip op. at 19

    Patent outcomesUS 8,854,595 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,854,595
  • PTAB · Aug 28, 2026 · IPR2024-01357 · APJ Kevin W Cherry · IPR · Final written decision

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

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

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

    • Expert testimonyPetitioner expert creditedDecided for petitioner

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

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

      “lower wavelength might offer, there were other drawbacks that a person of ordinary skill would have to balance. But “a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine.” Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). Indeed, Petitioner has shown several references—including, Basin-2005, Shimizu, and Stokes—that made this tradeoff. Moreover, “[o]bviousness does not require absolute predictability of success. . . . [A]ll that is required is a reasonable expectation of success.” In re O’Farrell, 853 F.2d 894, 903–04 (Fed. Cir. 1988). We find that the prior art of record demonstrates that a person of ordinary skill in the art at the time of the invention would have such an expectation in making the combination of Basin-2007 and Basin-2005. Accordingly, we find that Petitioner has shown by a preponderance of the evidence that there would have been motivation to combine Basin-2007 and Basin-2005 with a reasonable expectation of success.” slip op. at 41

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

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

    Patent outcomesUS 8,604,678 unpatentable
    § 103 obviousness§ 112 disclosurecites Phillips · Graham
    Patents in suitUS 8,604,678
  • Anthony Inc. v. Controltec, LLCAll claims unpatentable
    PTAB · Aug 25, 2026 · IPR2025-00559 · APJ Barry L Grossman · IPR · Final written decision

    Claims 1–20 are unpatentable as obvious over the five asserted grounds based on Carter, Beatenbough, King, Gatling, and Kotani.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “We find unpersuasive Mr. Pollock’s testimony that we limit the level of ordinary skill to “refrigerated display cases” because defining the level of skill as an engineer with experience “working with refrigerated display cases” does not relate to the technology disclosed and claimed in the ’181 patent, which is controlling condensation and conserving energy. E.g., Ex. 1001, 2:17–21 (“The invention is proactive in preventing condensation temperature at frame and door surfaces is reached. Power is then cycled off at a set point above dew point to save energy.” (emphases added)). An electrical engineer with a bachelor’s degree and 2 years of experience focused on lighting systems for refrigerated display cases would have “experience working with refrigerated display cases,” and thus meet Patent Owner’s proposed level of skill. Such a person, however, would not be experienced in controlling condensation, dew point sensor positioning, and condensation algorithm design, which is the focus of the disclosed and claimed invention, and which Mr. Pollock states “materially affect performance, energy use, and reliability” in controlling condensation in a refrigerated display case. Ex. 2014 ¶ 11. We also note that Mr. Pollock’s qualifications are a “B.S. in Mechanical Engineering, cum laude, from Drexel University (1998), with focus on thermal and mechanical systems, thermodynamics, and HVAC&R (Heating, Ventilation, Air Conditioning & Refrigeration).” Ex. 2014 ¶ 3. Accordingly, based on the prior art, the sophistication of the disclosed technology in the ’181 patent, finding Mr. Pollock’s testimony on this issue too general, and crediting Dr. Henze’s testimony with substantial probative weight, we adopt Petitioner’s definition of the level of ordinary skill. We modify it to state that more academic training will offset less experience, and more experience will offset less academic training, as did Dr. Henze (Ex. 1003 ¶ 31). Thus, in this proceeding a person of ordinary skill would have a bachelor’s degree in mechanical engineering, electrical engineering, or a comparable field and at least three to five years of professional experience working with heating, ventilating, air conditioning, and refrigeration” slip op. at 16

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “The fundamental role of expert testimony is that “the expert’s scientific, technical, or other specialized knowledge will help the trier of fact [here, the Board] to understand the evidence or to determine a fact in issue.” Fed. R. Evid. 702(a). The testimony must be “based on sufficient facts or data” (id. at 702(b)); must be “the product of reliable principles and methods” (id. at 702(c)); and must reflect “a reliable application of the principles and methods to the facts of the case” (id. at 702(d)). We determine, based on the record before us, that Dr. Henze’s Declaration testimony meets these requirements. He provides, as required, the facts and data to support his testimony. Indeed, Federal Rule of Evidence 702 and the Code of Federal Regulations require him to do so. See 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Expert testimony that “merely repeats, verbatim, the conclusory assertion for which it is offered to support,” or that “does not cite to any additional supporting evidence or provide any technical reasoning to support” the testimony is entitled to little weight. Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9, 15 (PTAB Aug. 24, 2022) (Precedential) (emphasis added).” slip op. at 31

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

      “The Board is required to construe ‘only those terms that . . . are in controversy, and only to the extent necessary to resolve the controversy.’” Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Here, whether the preamble is or is not limiting is not argued by Petitioner. Moreover, whether the preamble is or is not limiting is not necessary to resolve this controversy because it would not affect the outcome of this case. 2. “Adapted for” Patent Owner asserts that the term “adapted for” in independent claims 1 and 8 has its “plain and ordinary meaning.” Id. at 14. Patent Owner does not, however, provide us with a specific identification of what is the “plain and ordinary” meaning. Petitioner does not address a specific construction for this term. Thus, it is not in controversy and we need not specifically construe this term. slip op. at 21

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

      “only when it is analogous to the claimed invention. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004) (“References within the statutory terms of 35 U.S.C. § 102 qualify as prior art for an obviousness determination only when analogous to the claimed invention.” (citing In re Clay, 966 F.2d 656, 658 (Fed. Cir. 1992))). The Federal Circuit has laid out two separate tests to determine whether a reference is analogous art to the claimed invention, i.e., whether one of ordinary skill in the art would even look to the teachings of that reference. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). These two tests are: “(1) whether the art is from the same field of [the inventor’s] endeavor” and “(2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” Id.; see also Netflix, Inc. v. DivX, LLC, 80 F.4th 1352, 1359 (Fed. Cir. 2023) (“Importantly, ‘the scope of any field of endeavor will vary with the factual description of each invention.’ Unlike the reasonable-pertinence test, the field-of-endeavor test does not look to the problem that the patent purports to address. It is enough that the prior art reference falls within the relevant field of endeavor of the patent-in-suit.”) (citations omitted); Unwired Planet, LLC v. Google Inc., 841 F.3d 995, 1001 (Fed. Cir. 2016) (“To determine if art is analogous, we look to ‘the purposes of both the invention and the prior art.’ If a reference disclosure and the claimed invention have a same purpose, the reference” slip op. at 42

    Patent outcomesUS 7,207,181 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 7,207,181
  • PTAB · Aug 20, 2026 · PGR2026-00036 · APJ John A Squires · PGR · Institution

    The Director denied institution because the petition did not show that Biomed was publicly accessible as prior art, so it failed to show any challenged claim was unpatentable.

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

      “sufficiently that Biomed qualifies as a prior art printed publication. The Board’s precedential decision in Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 (PTAB Dec. 20, 2019) (precedential), addresses prior-art qualification in the related context of instituting an inter partes review. Hulu states that “the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” Id. at 13; see also Jazz Pharm. Inc. v. Amneal Pharm., LLC. 895 F.3d 1347, 1356 (Fed. Cir. 2018) (“[T]he IPR petitioner . . . had the burden to prove that a particular reference is a printed publication.”). The same guidance applies to post-grant reviews, albeit with the “more likely than not” standard applicable. See 35 U.S.C. § 324(a); Hulu, Paper 29 at 13 n.5. Hulu also states that “there is no presumption in favor of institution or in favor of finding a reference to be a printed publication under [37] § 42.108(c).” Hulu, Paper 29 at 16.” slip op. at 3

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable

      “sufficiently that Biomed qualifies as a prior art printed publication. The Board’s precedential decision in Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 (PTAB Dec. 20, 2019) (precedential), addresses prior-art qualification in the related context of instituting an inter partes review. Hulu states that “the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” Id. at 13; see also Jazz Pharm. Inc. v. Amneal Pharm., LLC. 895 F.3d 1347, 1356 (Fed. Cir. 2018) (“[T]he IPR petitioner . . . had the burden to prove that a particular reference is a printed publication.”). The same guidance applies to post-grant reviews, albeit with the “more likely than not” standard applicable. See 35 U.S.C. § 324(a); Hulu, Paper 29 at 13 n.5. Hulu also states that “there is no presumption in favor of institution or in favor of finding a reference to be a printed publication under [37] § 42.108(c).” Hulu, Paper 29 at 16. In this case, Petitioner merely cites a “date of revision” appearing within Biomed. Pet. 6 (citing Ex. 1005, 11). Yet, a revision date alone does not establish that Biomed was disseminated or made publicly available. And, although indicia appearing within a reference can sometimes support the printed publication status of the reference, I find the record to be devoid of any such indicia, or other evidence, supporting that Biomed was publicly disseminated or accessible by the June 15, 2021 “date of revision.” See Hulu, Paper 29 at 16–18. Thus, Petitioner fails to show that it is more likely” slip op. at 3

    • Obviousness (§103) › Analogous artNot reached

      “sufficiently that Biomed qualifies as a prior art printed publication. The Board’s precedential decision in Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 (PTAB Dec. 20, 2019) (precedential), addresses prior-art qualification in the related context of instituting an inter partes review. Hulu states that “the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” Id. at 13; see also Jazz Pharm. Inc. v. Amneal Pharm., LLC. 895 F.3d 1347, 1356 (Fed. Cir. 2018) (“[T]he IPR petitioner . . . had the burden to prove that a particular reference is a printed publication.”). The same guidance applies to post-grant reviews, albeit with the “more likely than not” standard applicable. See 35 U.S.C. § 324(a); Hulu, Paper 29 at 13 n.5. Hulu also states that “there is no presumption in favor of institution or in favor of finding a reference to be a printed publication under [37] § 42.108(c).” Hulu, Paper 29 at 16. In this case, Petitioner merely cites a “date of revision” appearing within Biomed. Pet. 6 (citing Ex. 1005, 11). Yet, a revision date alone does not establish that Biomed was disseminated or made publicly available. And, although indicia appearing within a reference can sometimes support the printed publication status of the reference, I find the record to be devoid of any such indicia, or other evidence, supporting that Biomed was publicly disseminated or accessible by the June 15, 2021 “date of revision.” See Hulu, Paper 29 at 16–18. Thus, Petitioner fails to show that it is more likely” slip op. at 3

    § 102 anticipation§ 103 obviousness
    Patents in suitUS 12,370,153
  • PTAB · Aug 19, 2026 · PGR2025-00027 · APJ George R Hoskins · PGR · Final written decision

    Claims 1–6 and 8–20 are unpatentable under § 101; claim 7 was not shown unpatentable.

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

      “Pet.”) pursuant to 35 U.S.C. §§ 321–329 to institute a post-grant review of U.S. Patent No. 11,966,920 B2 (Ex. 1001, “the ’920 patent”), claims 1–20. We issued an Institution Decision (Paper 12) granting the petitioned review. slip op. at 2

    • Skill levelOther

      “B. Level of Ordinary Skill in the Art Petitioner contends a person having ordinary skill in the art pertaining” slip op. at 11

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

      “thereby supporting our conclusion that the plain and ordinary meaning of “affordance” in claim 1 refers to an interactive user interface element.” slip op. at 30

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

      “For the foregoing reasons, we conclude Petitioner’s reliance on Low’s” slip op. at 21

    Patent outcomesUS 11,966,920 mixed
    Claim construction§ 101 eligibility§ 103 obviousnesscites Alice · Mayo · Bilski · Berkheimer · Enfish · Electric Power · KSR
    Patents in suitUS 11,966,920
  • PTAB · Aug 19, 2026 · PGR2025-00028 · APJ George R Hoskins · PGR · Final written decision

    Claims 1–6 and 8–20 are unpatentable under § 102, § 103, or § 101; claim 7 was not shown unpatentable because the asserted grounds did not establish its limitations.

    RulingsFinal written decision
    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

      “1. Legal Standards “Anticipation requires that every limitation of the claim in issue be” slip op. at 10

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

      “2016) (alteration in original) (quoting Kinetic Concepts, 688 F.3d at 1368). Further, an assertion of obviousness “cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” KSR, 550 U.S. at 418 (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)); accord In re NuVasive, Inc., 842 F.3d 1376, 1383 (Fed. Cir. 2016) (stating that “conclusory statements” amount to an “insufficient articulation[] of motivation to combine”; “instead, the finding must be supported by a ‘reasoned explanation’” (quoting In re Lee, 277 F.3d 1338, 1342 (Fed. Cir. 2002))); In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016) (“To satisfy its burden of proving obviousness, a petitioner cannot employ mere conclusory statements. The petitioner must instead articulate specific reasoning, based on evidence of record, to support the legal conclusion of obviousness.”).” slip op. at 36

    • Patent Eligibility (§101) › Alice/Mayo step one — 'directed to'Step1 directed to exceptionMixed

      “because the “user interface” limitations merely apply the recited abstract idea on a generic mobile device without meaningfully limiting the abstract idea. See 2025 Guidance, at 4–5. For example, these limitations do not reflect an improvement to the functioning of the mobile device (or any other computer device), and instead are “mere instructions to implement an abstract idea or other exception on” the mobile device. Id. Indeed, the ’423 patent specification describes only a generic “swipe-to-pay” feature. See, e.g., Ex. 1001, 7:13–33, Figs. 8C, 10A–10D. This supports our conclusion here that the claim 11 limitations do not integrate the recited abstract idea into a practical application. See MPEP § 2106.04(d)(1) (“[T]he specification should be evaluated to determine if the disclosure provides sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement,” and “it must describe” slip op. at 108

    • Patent Eligibility (§101) › Alice/Mayo step two — inventive conceptStep2 no inventive conceptMixed

      “because the “user interface” limitations merely apply the recited abstract idea on a generic mobile device without meaningfully limiting the abstract idea. See 2025 Guidance, at 4–5. For example, these limitations do not reflect an improvement to the functioning of the mobile device (or any other computer device), and instead are “mere instructions to implement an abstract idea or other exception on” the mobile device. Id. Indeed, the ’423 patent specification describes only a generic “swipe-to-pay” feature. See, e.g., Ex. 1001, 7:13–33, Figs. 8C, 10A–10D. This supports our conclusion here that the claim 11 limitations do not integrate the recited abstract idea into a practical application. See MPEP § 2106.04(d)(1) (“[T]he specification should be evaluated to determine if the disclosure provides sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement,” and “it must describe” slip op. at 108

    Patent outcomesUS 11,972,423 mixed
    § 101 eligibility§ 102 anticipation§ 103 obviousnesscites Alice · Mayo · Bilski · Enfish · Electric Power · KSR · Graham
    Patents in suitUS 11,972,423
  • PTAB · Aug 13, 2026 · IPR2025-00505 · APJ Zhenyu Yang · IPR · Final written decision

    Claims 1, 3–6, and 8–14 are unpatentable as obvious over the first § 103 combination; claims 2, 7, and 15 were not shown unpatentable because the art did not support the claimed drug sequence.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that [t]he person of ordinary skill in the art (POSA) would have been an M.D. and/or Pharm. D who would have completed training in medical oncology, particularly in the field of gastrointestinal (GI) cancers, or a Ph.D. in clinical pharmacology, pharmaceutical sciences, pharmaceutics, and/or drug delivery, also particularly in the field of GI cancers, or their equivalents, along with at least 1-2 years of post-doctoral experience. Pet. 26 (citing Ex. 1002 ¶¶ 44–46). Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 9

    • Expert testimonyPatent owner expert creditedDecided for patent owner

      “We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9

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

      “In the DI, the Board stated that the ordinary understanding of a claim reciting a “method of treating metastatic adenocarcinoma of the pancreas” that comprises “administering an antineoplastic therapy to the patient” in order “to treat the metastatic adenocarcinoma of the pancreas” is that the “treatment” would have more than a de minimis therapeutic benefit or efficacy for the patient being treated. DI 14. We, however, rejected the notion that the claims “would require some particular degree of clinical efficacy” because “the level of clinical efficacy is not a claim limitation.” Id.” slip op. at 12

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached

      “The parties, however, disagree over whether each recited dose must be the starting dose. Petitioner argues that “claim 1 requires that the method of treatment is a first-line therapy, but does not require that the claimed doses be used as a starting dose.” Paper 51, 1. In contrast, Patent Owner argues that “[t]he specification describes that the recited dose of each drug is a ‘starting’ or ‘initial’ dose.” Paper 50, 2 (citing Ex. 1001, 13:38–45, 30:5–7). For purposes of this Decision, we do not need to resolve this dispute. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating that claim terms need only be construed to the extent necessary to resolve the controversy). As explained below, we agree with Petitioner that, even if claim 1 recites the starting dose for each drug, Petitioner has shown, by a preponderance of the evidence, that the prior art teaches each dose and a POSA would have had a reason to start with the recited doses. See infra Section II.G.3; Paper 51, 3 n.2. Because we find that the prior art teaches or suggests the claimed subject matter even under Patent Owner’s proposed narrower claim interpretation, we need not further construe the disputed claim language.” slip op. at 16

    Patent outcomesUS 11,344,552 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,344,552
  • PTAB · Aug 4, 2026 · IPR2025-00249 · APJ Michael J Fitzpatrick · IPR · Final written decision

    Claims 1 and 4–8 are unpatentable: claims 1 and 4–6 as obvious over Huang2 and Kuo, and claims 7–8 as anticipated by Huang2; claims 2–3 were not shown unpatentable.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for patent owner

      “(“POSITA”) “would be a Ph.D. student with a minimum of two years of experience in their faculty advisor’s laboratory” and would have an understanding of “electrospinning fibers, including for tissue engineering, tissue engineering techniques, and using/performing FFT analysis.” Pet. 20– 21 (citing Ex. 1003 § II.C7). Patent Owner does not dispute Petitioner’s proposal but specifies the set of disciplines within which the Ph.D. would have been earned, namely “bioengineering, chemical engineering, mechanical engineering, or a related engineering discipline.” PO Resp. 6. We adopt and apply Petitioner’s proposal as clarified by Patent Owner regarding the Ph.D. discipline.” slip op. at 7

    • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner

      “At the outset, we agree with Patent Owner that the Specification purports to define “major peaks” in the following sentence: “The ‘major peaks’ herein refer to peaks higher than the average of the peaks in the result.” Ex. 1001, 13:28–29. We determine that this language satisfies at least two of the criteria set forth in Alnylam. Specifically, the sentence at “refers to” to explain what qualifies as major peaks. That is not the end of the inquiry, however, as we find there is still some ambiguity as to whether the patentee intended to define “major peaks” so as to require so-called “minor peaks” in the claimed invention. See Bell Atlantic, 262 F.3d at 1268 (“[T]he intrinsic evidence must ‘clearly set forth’ or ‘clearly redefine’ a claim term so as to put one reasonably skilled in the art on notice that the patentee intended to so redefine the claim term.”). Importantly, the Specification does not treat the existence of minor peaks as prerequisites for the existence of major peaks. Indeed, the Specification does not discuss “minor peaks” at all. See generally Ex. 1001. Likewise, none of the claims of the ’227 patent, whether challenged or unchallenged, recites “minor peaks” or any additional peaks beyond the disputed “major peaks.” Id. at 23:30–24:42. Nor does the Specification include an example of FFT analysis results in which the average of the peaks therein is calculated and those higher than the average are identified as major peaks.8” slip op. at 9

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

      “Petitioner has the better position. Huang2 teaches crosslinking and provides a reason for doing so (stability). In particular, Huang2 states: “To better mimic skin ECM, electrospun collagen fibers have been fabricated, however, the rapid degradation and poor mechanical properties determine that either crosslinking or combination with other materials is necessary to obtain a stable scaffold.” Ex. 1005, 1791 (emphasis added). It is true that, in describing work actually carried out, Huang2 states that blending with PCL was performed and does not mention crosslinking. See id. at 1792 (“Nanofibrous matrices of PCL and Collagen at a weight ratio of 3:1 were fabricated using electrospinning as previously described.”). However, the prior art – here, Huang2 – is not limited to that which it describes having created. See In re Mills, 470 F.2d 649, 651 (C.C.P.A. 1972) (“a reference is not limited to the disclosure of specific working examples”); see also In re Lemelson, 397 F.2d 1006, 1009 (CCPA 1968) (“The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.”); In re Fritch, 972 F.2d 1260, 1264 (Fed. Cir. 1992) (“It is well settled that a prior art reference is relevant for all that it teaches to those of ordinary skill in the art.”). Huang2 teaches two stabilization methods when using collagen in scaffolds. Huang2 states that one or the other “is necessary to obtain a stable scaffold” (when using collagen), but it does not preclude or teach away from using Patent Owner-cited testimony of Dr. Mikos is not as definitive as Patent Owner suggests; Dr. Mikos’s testimony is that a person of ordinary skill in the art “typically would not have done both.” Ex. 2015 ¶64 (emphasis added). The bottom line is that Huang2 teaches the person of ordinary skill in the art two ways to stabilize scaffolds/matrices comprised of collagen, provides a reason for doing so (stability), and does not teach away from using both. We are persuaded that a “scaffold comprising crosslinked fibers comprising collagen” would have been obvious in view of the cited teachings of Huang2.” slip op. at 33

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

      “We are not persuaded by Appellant’s citations to either reference. As discussed above, Petitioner’s Ground 1 is premised on a person of ordinary skill in the art altering the native flat sheet structure of Huang2 by rolling it into a jelly-roll structure as taught by Kuo. See Pet. 41 (Beginning its claim 2 arguments with the following: “Claim 1 is obvious for the reasons expressed above in § X.A., supra, which are incorporated herein.”); see also Pet. Reply 17 (“[B]ased on the explicit teaching of Kuo, a POSA would have been motivated to take the electrospun flat scaffold made by the techniques of Huang2, seed it with the desired cells, and roll it to treat a tendon and ligament.” (emphasis added)). Indeed, the paragraphs of Kuo that Petitioner cites for disclosing “scaffold sheets,” explicitly describe rolling them into jelly-roll like structures. See Ex. 1018 ¶7 (stating that “the sheet is spirally contacting a scaffold sheet of fibrous material with a cell; and rolling the scaffold sheet in a jelly-roll like manner to form a spirally wound tissue construct”), ¶22 (describing a method comprising “forming a tissue construct by contacting a scaffold sheet of fibrous material with a cell; and rolling the scaffold sheet in a jelly-roll like manner to form a spirally wound tissue construct” and implanting it in a patient). Petitioner fails to argue that that “one or more elongated sheets” recited in claim 2 would encompass the rolled structure of its proposed modification. Nor does Petitioner articulate a claim construction argument that could support such an argument. Petitioner has failed to prove, by a preponderance of the evidence, that claim 2 would have been obvious over Huang2 and Kuo.” slip op. at 42

    Patent outcomesUS 11,318,227 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Markman · KSR
    Patents in suitUS 11,318,227
  • PTAB · Aug 4, 2026 · IPR2025-00248 · APJ Michael J Fitzpatrick · IPR · Final written decision

    Claims 1–3 and 5–12 are unpatentable as anticipated by Huang2; claim 4 is unpatentable as obvious over Huang2 and Kumbar. Lee grounds failed.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “understanding of “electrospinning fibers, including for tissue engineering, tissue engineering techniques, and using/performing FFT analysis.” Pet. 18– 19 (citing Ex. 1003 § II.C5). Patent Owner does not dispute Petitioner’s proposal but specifies the set of disciplines within which the Ph.D. would have been earned, namely “bioengineering, chemical engineering, mechanical engineering, or a related engineering discipline.” PO Resp. 5–6. We adopt and apply Petitioner’s proposal as clarified by Patent Owner regarding the Ph.D. discipline.” slip op. at 7

    • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner

      “A patentee “may choose to be his own lexicographer and use terms in a manner other than their ordinary meaning, as long as the special definition of the term is clearly stated in the patent specification or file history.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) (citing Hoechst Celanese Corp. v. BP Chemicals Ltd., 78 F.3d 1575, 1578 (Fed. Cir. 1996)); see Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir. 1995) (en banc) (“[A]ny special definition given to a word must be clearly defined in the specification.”), aff'd, 517 U.S. 370 (1996); CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). “[T]he intrinsic evidence must ‘clearly set forth’ or ‘clearly redefine’ a claim term so as to put one reasonably skilled in the art on notice that the patentee intended to so redefine the claim term.” Bell Atlantic Network Services, Inc. v. Covad Communications Group, Inc., 262 F.3d 1258, 1268 (Fed. Cir. 2001). Among the criteria to consider in whether the patentee acted as a lexicographer to define a claim term include (a) whether the patent specification included the statement in question under a section for marks, (c) whether the sentence uses the term “refer to,” which generally “conveys an intent for [that sentence] to be definitional,” and (d) whether there are other non-limiting terms (e.g., “for example,” or “include”) that contradict a definitional intent. Alnylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (alteration in original). At the outset, we agree with Patent Owner that the Specification purports to define “major peaks” in the following sentence: “The ‘major peaks’ herein refer to peaks higher than the average of the peaks in the result.” Ex. 1001, 13:6–7. We determine that this language satisfies at least two of the criteria set forth in Alnylam. Specifically, the sentence at issue sets out “major peaks” in quotation marks, and then uses the term “refers to” to explain what qualifies as major peaks. That is not the end of the inquiry, however, as we find there is still some ambiguity as to whether the patentee intended to define “major peaks” so as to require so-called “minor peaks” in the claimed invention. See Bell Atlantic, 262 F.3d at 1268 (“[T]he intrinsic evidence must ‘clearly set forth’ or ‘clearly redefine’ a claim term so as to put one reasonably skilled in the art on notice that the patentee intended to so redefine the claim term.”).” slip op. at 8

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

      “As discussed above, we agree with Patent Owner that the sentence it cites from the Specification of the ’223 patent bears sufficient hallmarks of lexicography. However, the Specification nonetheless lacks any indication that so-called “minor peaks” are a necessary component of the claimed invention. “Although it is firmly settled that an applicant may act as a 9 Figure 8B does not contain “major peaks” despite clearly depicting two “peaks higher than the average of the [three or possibly four] peaks in the result” because none of the peaks is a reflection of fiber alignment. 10 After presenting claim construction arguments based on Ayres 2008, Patent Owner confusingly states: “Finally, whether Ayres-2008 supports [Patent Owner’s] construction is irrelevant.” PO Sur-Reply 5 (emphasis added). definition that is contrary to the ordinary meaning of a claim term unless it communicates a deliberate and clear preference for this alternative definition.” Kumar v. Ovonic Battery Co., 351 F.3d 1364, 1368 (Fed. Cir. 2003). There is no indication that the patentee sought to require “minor peaks” within the scope of the claimed invention. Nor are we persuaded that a person of ordinary skill in the art would readily understand the scope of the term “major peaks” to require non-major peaks. We interpret the Specification’s statement that “‘major peaks’ herein refer to peaks higher than the average of the peaks in the result” (Ex. 1001, 13:6–7) to be teaching a person of ordinary skill in the art how to identify or discern “major peaks,” which indicate a principal axis of alignment, from any non-major peaks, which would be caused by something else. We conclude that a person of ordinary skill in the art would consider “major peaks” as used in the ’223 patent as referring to peaks that reflect the sole axis or primary axis of fiber alignment. See, e.g., id. at code (54) (“ALIGNED FIBER AND METHOD OF USE THEREOF”), code (57) (“A scaffold comprising an aligned fiber.”), 1:6–7 (“The invention relates to an aligned fiber and method of use thereof.”), 1:11–12 (“The invention relates to a scaffold comprising an aligned fiber.”), 13:16–17 (“Alignment of the fibers in the scaffold may be measured by a fast Fourier transform (FFT) analysis.”). This would certainly include peaks materially higher than the average of the peaks in the result, but it would not be limited to situations involving peaks of different heights or require so-called minor peaks. Based on the totality of the evidence before us, we do not construe the claims to require non-major peaks.” slip op. at 16

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

      “Petitioner argues that, for the aligned sample, a major peak occurs at about 90° as identified by Petitioner’s annotation (red arrow). Pet. 30–31. As support, Petitioner directs us to Huang2’s explicit description of what the peak indicates, namely that “[t]he narrow peak of the normalized intensity values in anisotropic [aligned] matrices (Figure 1C) indicated that PCL/Coll nanofibers aligned along a single axis (Fig. 1B).” Id. at 31 (alterations in original) (quoting Ex. 1005, 1794). Patent Owner disputes that the illustrated peak is a major peak solely based on the lack of any lesser peaks. See PO Resp. 13 (“[T]he height of the sole peak is identical to—not higher than—the average height of the peaks in the result.”). As discussed above, however, we do not construe “major peaks” as requiring the existence of non-major peaks. We find that the illustrated peak in the Aniso plot of the FFT analysis results (Figure 1C) is a major peak within the meaning of the claim. The evidence in support of this finding is overwhelming. First, the term “Aniso” as used in Huang2 refers to fibers “with alignment.” Ex. 1005, 1792. Huang2 describes fabricating such matrices of aligned fibers with electrospinning, the same method used to impart alignment in the ’223 patent. Id. at 1791–92. Huang2 visually confirms that the fibers in fact are aligned via scanning electron microscopy. Id. at Fig. 1B. Further, Huang2 explicitly states that the peak illustrated in the Aniso plot of the FFT analysis results (Figure 1C) is caused by the fact that the “PCL/Coll nanofibers aligned along a single axis (Fig. 1B).” Id. at 1794. This is precisely what electrospinning may yield aligned fibers and images of aligned fibers will yield FFT results with major peaks. Ex. 1001, 2:18–19, 4:46–60, 13:16–26. Additionally, Huang2 itself considers the peak illustrated in the Aniso plot of the FFT analysis to be significant, stating: “In contrast [to the Aniso plot], the lack of a significant peak for the fibers collected on a stationary surface [(i.e., without electrospinning)] demonstrated no preferred fiber orientation in the isotropic matrices” (i.e., the Iso plot). Ex. 1005, 1794. Indeed, the asserted major peak in the Aniso plot shown in Huang2’s Figure 1C is higher than any other data point on the plot. For these reasons, we find the peak to be a major peak.15 Petitioner acknowledges that Figure 1C only reports its results” slip op. at 32

    Patent outcomesUS 10,137,223 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Markman
    Patents in suitUS 10,137,223

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.