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  • PTAB · Jan 14, 2026 · PGR2025-00059 · APJ Devon Zastrow Newman · PGR · Institution

    The Board instituted post-grant review of claims 1–4 on all four asserted grounds, finding a sufficient preliminary showing of obviousness and lack of enablement.

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

      “V. CONCLUSION Petitioner has, at this stage, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1–4 of the ’233 patent is hereby instituted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 40

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner does not proffer a description of a POSA. See generally, Prelim. Resp. For the purposes of this decision, on the record at this time, we find that Petitioner’s definition appears consistent with the level of skill shown in the prior art references of record, and apply it herein. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). We invite the parties to further address the definition of a POSA during trial should they find it necessary.” slip op. at 7

    • Expert testimonyPetitioner expert discountedDecided for patent owner

      “In addition, the opinion stated in the Pomper Declaration that “the term of ‘low molecular weight’ is well accepted in the chemical arts” and the declarant “recognize[s] that low molecular weight compounds would have a molecular weight of typically from about 50 Daltons to about 1,500 Daltons” is offered by a co-inventor. We, as factfinder, have discretion to weigh the credibility of expert witnesses and to give each item of evidence such weight as appropriate. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”). In this case, we find that the published references on metabolites do not support the opinion. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d at 1368 (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”) US-121, of which Dr. Pomper is lead inventor, also uses the term “low molecular weight”—without further characterization of the term—and is uninformative as to the meaning of the term. See Ex. 1006, ¶ 12. In addition, Patent Owner’s definition does not appear to apply to all compounds claimed in US-121.5” slip op. at 11

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

      “limited to Patent Owner’s proposed “from about 50 Daltons to about 1,500 Daltons.” The cited evidence relied on in the Pomper Declaration to define “low molecular weight” as a term well accepted in the chemical arts relates to metabolomics and metabolites. See Ex. 1002, 169, (specifically, ¶ 17 of Dr. Pomper’s declaration). Patent Owner admits that Dr. Pomper’s testimony is about molecules that differ from the claimed imaging and radiotherapeutic agents targeting FAP-α, but argues that the testimony is still relevant for purposes of explanation. Prelim Resp. 21. While it may be relevant, the testimony is not persuasive in light of the Specification. We find the uncontested fact that several of the B moieties alone—without the A moiety or L linker—specifically identified in the ’233 patent fall outside of Patent Owner’s proposed definition persuasive, as we normally do not interpret claim terms in a way that excludes examples disclosed in the specification. See, e.g., Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1305 (Fed. Cir. 2007) (rejecting proposed claim interpretation that would exclude disclosed examples in the specification). The cases cited by Patent Owner supporting that a claim term may be construed to exclude embodiments where the prosecution history supports such construction are factually distinguishable from the instant case as they regard instances of specific prosecution history disclaimer, clear prosecution disavowal, or relate to a specific definition of the terms in the Specification for the term being construed. Here, “low molecular weight” is not defined in the Specification, but, as Petitioner argues (see Pet. 21–25) is characterized as “demonstrat[ing] faster pharmacokinetics and a higher specific signal within clinically convenient times after administration” and that it “can be synthesized in radiolabeled form more easily.” Ex.1001, 13:33–50, 14:56– 16:14, 17:9–20. We are persuaded by the testimony of Dr. Zeglis, Petitioner’s declarant, that compounds weighing over 1500 Da may share those same behaviors, along with certain identified B moieties disclosed as embodiments. See Ex. 1003 ¶ 83.” slip op. at 10

    Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 12,115,233
  • PTAB · Sep 19, 2025 · PGR2025-00025 · APJ Kimberly Mcgraw · PGR · Institution

    The Board instituted PGR on claims 1–19 and all asserted grounds, finding it more likely than not that claim 1 is anticipated by the Gatorade Label.

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

      “if “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Post-grant review is available for patents that issue from applications that at one point contained at least one claim with an effective filing date on or after March 16, 2013. See Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), §§ 3(n)(1), 6(f)(2)(A). After considering the briefing and the evidence of record, for the reasons set forth below, we determine that Petitioner has shown that the ’422 Patent is eligible for post-grant review and has shown it is more likely than not that at least one challenged claim of the ’422 Patent is unpatentable under § 324(a). Accordingly, we institute a post-grant review of the challenged claims of the ’422 Patent.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “B. Level of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art “would possess at least (1) a Bachelor’s degree in chemistry or a related field, with (2) five years of experience in material identification and characterization using multiple analytical methods and field sampling, or equivalent research or professional experience.” Pet. 12 (citing Ex. 1014 ¶ 24). Patent Owner does not dispute Petitioner’s definition for one of ordinary skill in the art nor provide a proposed definition of its own. See generally Prelim. Resp. For the purposes of this Decision, we adopt Petitioner’s undisputed proposal regarding the level of one of ordinary skill in the art.” slip op. at 7

    • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer foundDecided for patent owner

      “336. The applicant explained that not all combinations of shrink films and light blocking materials are recyclable. Id. at 335. The applicant explained that films can be compatible with PET recycling in two ways, (1) the film can float in water and be separated from PET that sinks in water or (2) the PET films crystallize and “can be recovered with the PET stream.” Id. at 336 (citing “A Resource Document by the Association of Plastic Recyclers (APR)”) (found at Ex. 1002, 323–332) (emphasis omitted). The applicant explained that “removing the label before or during the recycling process is not evidence of the recyclability of the label” and that “[r]emoving the label during the recycling process is not equivalent to actually recycling the label.” Id. at 335. As such, a POSITA reading the prosecution history would understand that a label is not recyclable with a PET container, as recited by the independent claims, by removing the label from the PET recycle stream before or during the recycling process.” slip op. at 10

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

      “To determine how a person skill in the art would determine if a shrink label is “recyclable” as recited in the independent claims, we look to how the Specification of the ’422 Patent describes or defines recyclable shrink labels. For example, the ’422 Patent states that PET shrink films are generally considered recyclable if no inks are retained on the film after a caustic wash cycle typically used in PET reclaiming processes. Ex. 1001, 6:61–65. The ’422 Patent further states that labels are fully recyclable if the polymers used are clear, preferably clear PET, and the labels include inks that can be washed off in a “typical PET recycling wash (caustic wash).” Id. at 11:44– 49; see also id. at 11:49–54 (describing embodiments in which the labels are free or substantially free of inks that cannot be washed off in a caustic wash or where the labels are free or substantially free of color plastics that cannot be recycled). The ’422 Patent further discusses “industry standards” for determining whether various embodiments of shrink labels are recyclable. See, e.g., id. at 11:29–53. For example, the Specification states that the “Association for Plastic Recyclers (APR) Critical Guidance Protocol for Clear PET Articles with Labels and Closures (PET-CG-02)” (Ex. 1005) can certify that a film is fully recyclable with a container or bottle. Id. at 11:34– 38. Additionally, the Specification states that labels “are recyclable according to the Evaluation of the Near Infrared (NIR) Sorting Potential of a Whole Plastic Article (SORT-B-01)” (Ex. 1010) and/or the “Evaluation of Sorting Potential for Plastic Articles Utilizing Metal, Metalized, or Metallic Printed Components (SORT-B-03)” (Ex. 1011). Ex. 1001, 11:39–44. The ’422 Patent further states that embodiments of the labels “are fully recyclable. For example, the labels may include inks that can be washed off in a typical PET recycling wash (caustic wash) and the polymers” are preferably clear PET. Id. at 11:44–48. The ’422 Patent thus provides various descriptions or standards to determine the recyclability of shrink labels. For the purposes of addressing the anticipation and obviousness grounds, we determine that any of these standards can be used to determine if a shrink label is “recyclable.” We note that our construction is preliminary and is based on the present record. We invite the parties to further the address the construction of “wherein the recyclable shrink label is recyclable with a PET container” during trial.” slip op. at 12

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · Nautilus
    Patents in suitUS 11,961,422
  • PTAB · Apr 8, 2025 · PGR2024-00054 · APJ Julia Heaney · PGR · Institution

    The Board instituted PGR on claims 1–17 and 22–28 and all asserted grounds, finding a sufficient likelihood that at least one challenged claim is unpatentable.

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

      “Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a) (2018). Upon consideration of the parties’ submissions and the evidence of record, we determine that Petitioner has demonstrated that it is more likely than not that at least one claim challenged in the Petition is unpatentable. Further, Patent Owner has not persuaded us that it is appropriate to exercise our discretion not to institute review. Accordingly, we institute a post-grant review of all claims and all grounds asserted in the Petition.1” slip op. at 2

    • Skill levelSkill level patent owner adoptedOther

      “On this record, we do not find Patent Owner’s proposed experience level of at least five years in measurement and analysis of coefficient of friction to be supported. As to the necessity of experience in textile engineering and fiber science, Patent Owner’s position, although not supported by declarant analysis of the factors listed above, is consistent with the disclosure of the ’854 patent, which describes features of a mesh layer in textile and fiber terms. See e.g., Ex. 1001, 10:17–11:14, 12:65–13:8, 14:20–24. On the whole, however, we do not discern on this record how specific experience in textile engineering and fiber science of a person of ordinary skill would materially alter the outcome at this stage of the proceeding. For purposes of this decision only, we apply Patent Owner’s proposed definition of a person of ordinary skill in the art, except for the requirement of five years of experience in measurement and analysis of coefficient of friction. The level of skill in the art remains an open issue in this proceeding. Further submissions by the parties may include argument and evidence that would assist in the resolution of this issue at the close of trial.” slip op. at 8

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

      “Petitioner contends “no formal claim construction is necessary in this proceeding.” Pet. 10; Reply 1, 4. Patent Owner contends the terms “mesh layer” and “coefficient of friction” require construction. Prelim. Resp. 14–16; Sur-reply 2–5. We have considered the parties’ arguments and discuss them below with regard to each of the terms Patent Owner contends should be construed. Because our determination that Petitioner demonstrates at least one challenged claim meets the threshold for institution (see SAS Inst., 138 S. Ct. at 1359–60) is not based on construing the term “mesh layer” or “coefficient of friction,” we determine we need not construe either claim term at this stage of the proceeding. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)). As further discussed below, we invite the parties to address claim construction at trial.” slip op. at 9

    • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageDisclaimer not foundDecided for petitioner

      “We agree with Petitioner that the ’854 patent specification does not include clear and explicit lexicography or a disclaimer that would support requiring “coefficient of friction” to be determined by a specific ASTM test method. The portion of the specification Patent Owner asserts as a definition of “coefficient of friction” (see Ex. 1001, 11:31–42) is a description of an embodiment; we find it does not express patentee intent to redefine the term. Further, the statement that “the coefficient of friction … may be determined using the … ASTM D1894 standard test method” (id. at 11:32–35) indicates that use of that specific test method is optional. Accordingly, in the absence of patentee lexicography or disavowal, we do not limit the scope of the term “coefficient of friction” to require that it be measured by a specific ASTM standard. Luminara Worldwide, LLC v. Liown Elecs. Co., 814 F.3d 1343, 1353 (Fed. Cir. 2016) (“Absent lexicography or disavowal, we do not depart from the plain meaning of the claims.”); In re Am. Acad. Of Sci. Tech Ctr., 367 F.3d 1359, 1369 (Fed. Cir. 2004) (“We have cautioned against reading limitations into a claim from the preferred embodiment described in the specification, even if it is the only embodiment described, absent clear disclaimer in the specification.”). We note that the ’854 patent specification sets forth a definition for the coefficient of friction between the surfaces of the mesh material and the slide surface. Ex. 1001, 4:38–46. As stated above, however, we do not expressly construe any claim term at this stage of the proceeding. Should the parties address the construction of “coefficient of friction” at trial, we will make a determination after the close of evidence and any hearing.” slip op. at 13

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · Graham
    Patents in suitUS 11,998,854
  • PTAB · Jun 11, 2024 · IPR2022-01602 · APJ Devon Zastrow Newman · IPR · Final written decision

    Claims 1–14 are unpatentable: claims 1–3 and 8–10 are anticipated by Weiman, and claims 4–7 and 11–14 are obvious over Weiman and Mozeleski; the revised motion to amend is denied.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Pet. 11 (citing Ex. 1002 (Drewry Decl.) ¶¶ 76–79). Patent Owner does not dispute Petitioner’s proposal. See generally Response. We adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the cited prior art and is undisputed on this record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 11

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “We find persuasive, and credit, Mr. Drewry’s testimony that (1) a POSITA would have appreciated that the proposed modification to replace Weiman’s screw/socket with Waugh’s angled version provides benefits including “avoiding selected muscular and abdominal anatomical structures,” and (2) such “benefits would have been desirable for certain applications, such as those where the patient’s anatomy dictates that OLIF would provide the patient with the best medical outcome.” Ex. 1044 (Drewry Second Supp. Decl.) ¶¶ 23–26; see also Ex. 1043 (Waugh), ¶¶ 54, 87–90 (describing use of angled screw holes to, e.g., “receive a fastener via a surgical pathway” and configured “to penetrate endplate tissue of a vertebral body”). We find the weight of evidence supports Petitioner’s articulation of a POSITA’s understanding of how to use angles to avoid anatomical features” slip op. at 61

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

      “Petitioner asserts that no terms require construction “because they are shown to be anticipated and/or obvious regardless of construction.” Pet. 12. Patent Owner did not propose any terms for construction. See generally Response. We determine that no claim terms require express construction to render this Decision.” slip op. at 18

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

      “j. Conclusion on Claim 1 For the above reasons, we determine that Petitioner has shown by a preponderance of the evidence that Weiman discloses each and every limitation of claim 1, and therefore anticipates claim 1.” slip op. at 28

    Patent outcomesUS 9,956,087 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 9,956,087
  • PTAB · Feb 6, 2024 · IPR2022-01417 · APJ Jeffrey W Abraham · IPR · Final written decision

    Claims 1–27 are unpatentable: claims 1, 2, 5–12 and 13, 14, 17–19, 22–24, 27 are anticipated; the remaining claims are obvious.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “had “a Bachelor’s Degree in a relevant engineering discipline such as electrical engineering and at least two years of relevant experience in the design and/or development of automotive electrical systems, or a Masters or more advanced degree in a relevant engineering discipline such as electrical engineering.” Pet. 6–7 (citing Ex. 1003 ¶ 46). Patent Owner does not challenge Petitioner’s definition or offer its own. In light of the record before us, we adopt Petitioner’s proposal regarding the level of ordinary skill in the art. Based on our review of the ’236 patent and the prior art of record, we determine that the definition offered by Petitioner comports with the qualifications a person would have needed to understand and implement the teachings of the ’236 patent and the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 9

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

      “Petitioner argues that “[a]ll of the claim terms are given their plain meaning, as understood by the [person of ordinary skill in the art], unless indicated otherwise.” Pet. 9. After considering the arguments and information Petitioner presents, we determine that we do not need to expressly construe any terms for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 10

    • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

      “with Petitioner that the ’236 patent is not entitled to the 2014 priority date of the original application, or any date earlier than April 21, 2021, which is the filing date of the ’236 patent. Whether the Specification complies with the written description requirement calls for a comparison of the scope of the claim with the scope of the description to determine whether the inventor has demonstrated possession of the claimed invention. See Ariad, 598 F.3d 1336 at 1353; Power Oasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306 (Fed. Cir. 2008). The independent claims of the ’236 patent each require (1) a load detection sensor “configured to detect presence of a vehicle battery” and (2) a reverse polarity sensor “configured to detect polarity of a vehicle battery.” Ex. 1001, 5:16–27 (claim 1), 6:7–22 (claim 13), 6:65–7:13 (claim 18), 8:1– 15 (claim 23). The Specification of the ’236 patent does not expressly disclose both a load detection sensor and reverse polarity sensor configured to perform the recited functions. Instead, the Specification identifies a single circuit, the “automatic detection module,” that “can automatically detect[] whether the load is detected” and “whether the electrode is connected with the automobile storage battery reversely.” Ex. 1001, 2:51–54. We are persuaded by Petitioner’s arguments that the disclosure of a single circuit capable of performing two functions does not demonstrate the inventors had possession of an invention that requires two separate sensors configured to perform separate functions as recited in the claims. See Ariad, 598 F.3d 1336 at 1352 (“[A] description that merely renders the invention obvious does not satisfy the [written description] requirement.”); Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000) (holding that “the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue,” but that “one skilled in the art, reading the original disclosure, must immediately discern the limitation at issue in the claims”); cf. PIN/NIP, Inc. v. Platte Chem. Co., 304 F.3d 1235, 1248 (Fed. Cir. 2002) (finding a claim for a method involving sequential application of two chemicals was invalid for lack of adequate written description where the specification indicated that the invention was a method of applying a “composition” containing the two chemicals). For all of the foregoing reasons, we agree with Petitioner that the Specification of the ’236 patent does not provide adequate written description support for distinct “load detection” and “reverse polarity” sensors, and, therefore, the challenged claims are not entitled to a priority date earlier than April 21, 2021, the filing date of the ʼ236 patent.” slip op. at 12

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

      “demonstrating that Nook-015 discloses the limitations in claim 1. After reviewing the undisputed evidence and arguments Petitioner presents in the Petition regarding claim 1, we agree, for the reasons stated by Petitioner and supported by Dr. Wood’s testimony, that Nook-015 discloses an internal power supply, output port, load detection sensor, reverse polarity sensor, power switch, and microcontroller, all connected and configured as claim 1 requires. Ex. 1004, 3:17–26, 3:67–4:2, 4:20–38, 5:35–37, 5:50–54, 8:4–37; Ex. 1003 ¶¶ 78–79; Pet. 25–29. b. Claims 2 and 5–12 Claims 2 and 5–12 depend directly or indirectly from claim 1. Petitioner directs us to portions of Nook-015 that disclose the additional limitations in these claims. Pet. 29–33. Patent Owner does not dispute Petitioner’s arguments or evidence regarding these dependent claims. For the reasons stated by Petitioner and supported by Dr. Wood’s testimony, we agree that Nook-015 discloses the limitations recited in these claims, as discussed below.” slip op. at 20

    Patent outcomesUS 11,104,236 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 11,104,236
  • PTAB · Jan 24, 2024 · IPR2023-01184 · APJ Julia Heaney · IPR · Institution

    The Board instituted IPR on claims 1–19 and all petition grounds, finding a reasonable likelihood that claims 1, 2–4, 6–8, 15–16, and 18–19 are unpatentable.

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

      “Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). Upon consideration of the Petition and the evidence of record, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of all claims and all grounds asserted in the Petition.1” slip op. at 2

    • Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateOther

      “Although Petitioner has asserted the absence of specific supporting disclosure for claims 1, 15, and 18 from the ’780, ’317, and ’977 applications and the ’155, ’587, ’601, ’977, and ’753 provisional applications, the burden to show an effective filing date (or dates) of the challenged claims prior to April 22, 2010 falls on Patent Owner here because Petitioner has asserted prior art references with earlier effective dates. In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1376 (Fed. Cir. 2016) (In an inter partes review, “a patentee bears the burden of establishing that its claimed invention is entitled to an earlier priority date than an asserted prior art reference.”). An earlier effective filing date is not presumed because, as shown in the above figure, the ’783 application is a continuation-in-part to each of the ’780, ’317, and ’977 applications that have filing dates earlier than April 22, 2010. See PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1305 (Fed. Cir. 2008) (“When neither the PTO nor the Board has previously considered priority, there is simply no reason to presume that claims in a [continuation-in-part] application are entitled to the effective filing date of an earlier filed application.”). On this record, and in the absence of the development of any contrary argument, we find that Petitioner has demonstrated sufficiently for institution that each of the asserted references are prior art to the challenged claims. The parties will have an opportunity to present their positions on the issue of the effective filing date of the challenged claims further during trial.” slip op. at 11

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

      “of Kronberg, discloses or suggests all of the elements of claim 6. Pet. 28–34 (citing Ex. 1002 ¶¶ 107–148). More particularly, Petitioner argues that Adest discloses the limitations of claims 6, but to the extent there is a dispute that Adest discloses the “watchdog unit” limitation [6A], a person of ordinary skill in the art would have been motivated to combine the watchdog apparatus taught by Kronberg with the solar power system taught by Adest to monitor communications between signal mechanism 420 and power modules 405 of Adest. Id. at 32 (citing Ex. 1002 ¶ 127). Petitioner further argues that the watchdog taught by Kronberg was a well-known technique for detecting malfunctions at the time of the invention, and would have been one of a number of solutions for detecting the absence of a periodic signal. Id. (citing Ex. 1002 ¶¶ 128–129; Ex. 1009, 1269). Petitioner further argues that Kronberg “suggests that its watchdog apparatus is to be used to provide ‘automatic shutdown of critical devices in case of failure,’” consistent with Adest’s objective of shutting down a power generating facility when a transmitter fails to send a communication because of, for example, a fire or theft of a photovoltaic module. Id. at 32–33 (citing Ex. 1006, 1:12–15; Ex. 1005, 7:6–12).” slip op. at 19

    • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for patent owner

      “The limitation “means to poll the central controller to determine if an interruption of the communication is transient” presumptively invokes 35 U.S.C. § 112 ¶ 6. Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1348 (Fed. Cir. 2015) (en banc in relevant part). Claims subject to 35 U.S.C. § 112 ¶ 6 are construed in a “two-step process,” whereby we “first identify the claimed function,” and then “determine what structure, if any, disclosed in the specification corresponds to the claimed function.” Id. at 1351. Accordingly, our rules require that the Petition “identify the specific portions of the specification that describe the structure, material, or acts corresponding to each claimed function.” 37 C.F.R. § 42.104(b)(3). Further, “the corresponding structure for a § 112 ¶ 6 claim for a computer-implemented function is the algorithm disclosed in the specification” Aristocrat Techs. Austl. Pty Ltd. v. Int’l Game Tech., 521 F.3d 1328, 1333 (Fed. Cir. 2008) (quoting Harris Corp. v. Ericsson Inc., 417 F.3d 1241, 1249 (Fed. Cir. 2005)). Federal Circuit precedent requires disclosure of an algorithm in the specification for any computer-implemented function beyond “basic functions of a microprocessor.” See EON Corp. IP Holdings, LLC v. AT&T Mobility LLC, 785 F.3d 616, 623 (Fed. Cir. 2015) (“A microprocessor or general purpose computer lends sufficient structure only to basic functions of a microprocessor. All other computer implemented functions require disclosure of an algorithm.”). Petitioner does not identify any portion of the ’218 patent specification that describes corresponding structure for performing the claimed function of “poll[ing] the central controller to determine if an interruption of the communication is transient.” See Pet. 39. Accordingly, Petitioner has not identified sufficient corresponding structure for performing the function of this presumptive means-plus-function limitation.” slip op. at 22

    Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 8,823,218
  • 3M Company v. Bay Materials, LLCAll claims unpatentable
    PTAB · Jan 16, 2024 · IPR2022-01215 · APJ Grace Karaffa Obermann · IPR · Final written decision

    Claims 1–4, 7, 11–14, 16, 18, and 31 are unpatentable as anticipated by Yu; claims 1–4, 7, and 31 are also anticipated by Stewart.

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

      “The parties disagree about the appropriate definition of the ordinarily skilled artisan and, in particular, whether that artisan would have had experience or familiarity with the “processing of thermoformable polymer sheets” to form “orthodontic and dental appliances.” Resp. 16 (citing Ex. 2008 ¶ 14); see Pet. 14–15 n.1 (disagreeing with that proposition). Patent Owner’s definition is supported by the plain wording of challenged claim 18, which recites a dental appliance. Resp. 16 (citing Pet. 14 n.1); Ex. 1001, 26:50–52. The ’263 patent, moreover, includes an “extensive discussion of dental appliances and the unexpectedly good properties of dental aligners” thermoformed from polymeric sheets. Resp. 16; Ex. 1001, 1:20–47, 4:57–5:10, 5:26–6:6, 6:39–43, 10:25–51, 11:30–48, 12:22–24, 13:25–29, 21:1–6, 24:2–3, 24:30–57; see id. at 15:23– 38 (describing the thermoforming process for making dental appliances).” slip op. at 7

    • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

      “about 60A to about 85D” when employed as the two soft outer layers in an unclaimed and disfavored soft-hard-soft layer composition (id. ¶ 109) does not convey, with reasonable clarity, that the inventors had possession of the inventive hard-soft-hard layer composition in which the single soft, inner layer also is within that same hardness range (id. ¶ 110). Critically, when discussing the soft, inner layer of the inventive hard-soft-hard layer composition, the ’176 application nowhere indicates that the soft inner layer must have “a hardness of from about 60A to about 85D.” Id. ¶ 109 (discussing a prior art embodiment); see id. ¶¶ 7, 33–35, 109–110. Even if the hardness limitation of the challenged claims would have been obvious from the relied-upon disclosure in the ’176 application (id. ¶ 109), as a matter of law, that circumstance is insufficient to establish a filing date through that application. “Entitlement to a filing date does not extend to subject matter which is not disclosed, but would be obvious over what is expressly disclosed.” PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306 (Fed. Cir. 2008) (quotations omitted); see Pet. 21 (quoting that controlling precedent). Each of Patent Owner’s countervailing arguments is unpersuasive because, at best, Patent Owner attempts to show that it would have been obvious to import––from the description of the soft outer layers in an unclaimed and disfavored soft-hard-soft embodiment––a limitation not expressly imposed on the soft inner layer in the inventive hard-soft-hard embodiment. Ex. 2001 ¶ 109; Resp. 35–42. A showing of obviousness is not enough under the controlling precedent cited by Petitioner. PowerOasis, 522 F.3d at 1306.” slip op. at 9

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedDecided for petitioner

      “about 60A to about 85D” when employed as the two soft outer layers in an unclaimed and disfavored soft-hard-soft layer composition (id. ¶ 109) does not convey, with reasonable clarity, that the inventors had possession of the inventive hard-soft-hard layer composition in which the single soft, inner layer also is within that same hardness range (id. ¶ 110). Critically, when discussing the soft, inner layer of the inventive hard-soft-hard layer composition, the ’176 application nowhere indicates that the soft inner layer must have “a hardness of from about 60A to about 85D.” Id. ¶ 109 (discussing a prior art embodiment); see id. ¶¶ 7, 33–35, 109–110. Even if the hardness limitation of the challenged claims would have been obvious from the relied-upon disclosure in the ’176 application (id. ¶ 109), as a matter of law, that circumstance is insufficient to establish a filing date through that application. “Entitlement to a filing date does not extend to subject matter which is not disclosed, but would be obvious over what is expressly disclosed.” PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306 (Fed. Cir. 2008) (quotations omitted); see Pet. 21 (quoting that controlling precedent). Each of Patent Owner’s countervailing arguments is unpersuasive because, at best, Patent Owner attempts to show that it would have been obvious to import––from the description of the soft outer layers in an unclaimed and disfavored soft-hard-soft embodiment––a limitation not expressly imposed on the soft inner layer in the inventive hard-soft-hard embodiment. Ex. 2001 ¶ 109; Resp. 35–42. A showing of obviousness is not enough under the controlling precedent cited by Petitioner. PowerOasis, 522 F.3d at 1306.” slip op. at 9

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner

      “For the above reasons, we determine that the challenged claims are not entitled to the benefit of the filing date of the ’176 application because the application does not indicate that the inventors had possession of the hardness limitation of the claimed invention. See Reply 7–13 (Petitioner’s arguments on this issue). On the full trial record, we find that the earliest effective filing date to which the challenged claims are entitled is December 18, 2019, the filing date of the ’256 application from which the ’263 patent issued. Ex. 1001, codes (21), (22). Every challenged claim recites, or inherits via dependence, the hardness limitation “of from about 60A to about 85D” for the inner elastomeric layers of the inventive hard-soft-hard multilayer composition. Ex. 1001, 25:2–9 (independent claim 1), 26:1–8 (independent claim 11), 27:49–51 (independent claim 31). In view of our determination that the earliest effective filing date to which the challenged claims are entitled is December 18, 2019, we agree with Petitioner that Yu (Example 1) and Stewart (Example 2) qualify as prior art against the challenged claims. Pet. 43–49 (Petitioner’s persuasive arguments and evidence on point).” slip op. at 13

    Patent outcomesUS 10,870,263 unpatentable
    Claim construction§ 102 anticipation§ 112 disclosurecites Graham
    Patents in suitUS 10,870,263
  • PTAB · Nov 14, 2023 · IPR2022-00381 · APJ Julia Heaney · IPR · Final written decision

    Claims 1–10 and 12–18 are unpatentable as obvious; the revised contingent motion to amend is denied because proposed claims 19–25 lack written description support.

    RulingsFinal written decision
    • Skill levelOther

      “1. Principles of Law In an inter partes review, the petitioner bears the ultimate burden of persuasion to show unpatentability, which never shifts to the patent owner. Dynamic Drinkware LLC v. National Graphics, Inc., 800 F.3d 1375, 1379– 1380 (Fed. Cir. 2015). “However, when a patent owner attempts to antedate an asserted prior art reference, the patent owner takes on a temporary burden of production.” Medtronic, Inc. v. Teleflex Innovations S.À.R.L., 68 F.4th 1298, 1303 (Fed. Cir. 2023) (citing Dynamic Drinkware, 800 F.3d at 1378– 79)). “Once that burden is met, the burden shifts back to the petitioner.” Id. “[A] patent’s claims are not entitled to an earlier priority date because the patentee claims priority. . . . Rather, for a patent’s claims to be entitled to an earlier priority date, the patentee must demonstrate that the claims meet the requirements of 35 U.S.C. § 120,” including a written description in the earlier-filed application that satisfies § 112. In re NTP, Inc., 654 F.3d 1268, 1276–77 (Fed. Cir. 2011) (citations omitted)); see also Research Corp. Techs., Inc. v. Microsoft Corp., 627 F.3d 859, 870–71 (Fed. Cir. 2010). “[T]he hallmark of written description is disclosure,” and “the test [for satisfaction of the written description requirement] requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The written description “must ‘clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed,’” and “reasonably” convey to those skilled in the art “that the inventor had possession of the claimed subject matter as of the filing date.” Id. (alteration in original). Stated another way, “one skilled in the art, reading the original disclosure, must immediately discern the limitation at issue in the claims.” Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). To provide sufficient written description support, “[a] ‘disclosure” slip op. at 13

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

      “3. Reason to Combine Petitioner contends it would have been obvious to a person of ordinary skill in the art to combine (1) Eckhardt’s method of disinfecting skin using any light source that emits light capable of sterilization or disinfection, with (2) Sosnin’s KrCl or XeBr light sources, which generate photons having a wavelength of 222 nm and 282 nm, respectively. Pet. 21– 22 (citing Ex. 1003 ¶¶ 40, 81; Ex. 1004 ¶¶ 31, 69; Ex. 1005, 1547). Petitioner contends a person of ordinary skill would have been motivated to combine the teachings of Eckhardt and Sosnin for several reasons: (1) Eckhardt’s teaching of using any light source capable of sterilization or disinfection, and specifically “narrow spectrum light (e.g., a line spectrum)” would have suggested to a person of ordinary skill in the art to incorporate other well-known germicidal UV light sources like Sosnin’s, and both references teach that their light sources kill bacteria; (2) a person of ordinary skill would have implemented Eckhardt’s high-level disclosure of using UV- C light to disinfect skin with Sosnin’s 222 nm excimer lamp because Sosnin’s lamp’s wavelength is within the range of 220 to 310 nm suggested by Eckhardt; (3) the effectiveness and relative safety of directing UV-C light of 222 nm on bare skin for disinfection was already understood by persons of ordinary skill in the art, even though there was general caution against exposing skin to excessive UV radiation. Pet. 22–24 (citing Ex. 1003 ¶¶ 40, 81–92; Ex. 1004 ¶¶ 5, 31, 69, 70; Ex. 1005, 1545–47; Ex. 1011 ¶¶ 28, 40; Ex. 1013 ¶ 8; Ex. 1015, 2:22–67; Ex. 1016, 2:23–26; Ex. 1017, 58).” slip op. at 25

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

      “with our analysis of the effective filing date of original claims 12–18 that Patent Owner does not meet its burden to demonstrate the inventor’s possession in the ’626 provisional of generating photons of at least two single line wavelengths. Having considered the additional disclosures of the ’626 provisional Patent Owner points to in its RMTA (see RMTA 9), we find that none of these disclosures describe using both 222 nm and 254 nm single line wavelengths. See Ex. 1008 ¶¶ 8, 12, 27, claim 9; Ex. 2047, 6–9. For example, the recitation of “apparatus that consists of a NUV source, ESP, ozone generator, mercury lamps, and humidifier with controls as defined in claims 3–8 and any combination therein” in claim 9 of the ’626 provisional generally identifies various sources that may be used, but would not have indicated to a person of ordinary skill that the inventor had possession of generating single line wavelengths of 222 nm and 254 nm. Mr. Lawal’s testimony supports this finding. Ex. 1053 ¶¶ 1–12. Accordingly, we determine that Patent Owner does not meet its burden to demonstrate written description support for generating photons of at least two single line wavelengths, in claims 19–25 of its RMTA.19 Because Patent Owner has not satisfied the statutory and regulatory prohibition against introducing new matter in the revised proposed substitute claims, we deny the RMTA as to claims 19–25. 35 U.S.C. § 326(d)(3); 37 C.F.R. § 42.221(a)(2)(ii). Accordingly, we need not reach the patentability challenges Petitioner raises with regard to claims 19–25.” slip op. at 77

    • Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteOther

      “19 We also determine that claim 19 does not particularly point out and distinctly claim the invention sought to be patented, as required by 35 U.S.C. § 112(b), because “the microorganisms” in element [19B] lacks antecedent basis.” slip op. at 78

    Patent outcomesUS 9,700,642 unpatentable
    § 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 9,700,642
  • PTAB · Oct 31, 2023 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Final written decision

    The Board cancelled claims 1–17 and denied substitute claims 18–30 for lack of written-description support; it did not reach the remaining grounds against the substitute claims.

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

      “For the reasons discussed below, on the full trial record, we find that Patent Owner has not carried its burden of showing by a preponderance of the evidence that the proposed substitute claims introduce no new matter relative to the original disclosure. 35 U.S.C. § 326(d)(3); 37 C.F.R. § 42.221(d)(1); see also Paper 58, 2 (Patent Owner acknowledging that it “bears the burden to meet the regulatory and statutory requirements” for a motion to amend, including demonstrating that the substitute claims do not “introduce new matter”). Importantly, we note that Patent Owner fails to explain how the material cited in the claim chart supports the claims. See Mot. 15–16. Instead, Patent Owner provides only a claim chart with bare citations, leaving it to the panel to discern how the cited material supports the claim limitations. See id. Patent Owner’s failure to explain the citations constitutes a fatal error, as we have reviewed the passages cited by Patent Owner and are unable to discern where support is found for several of the substitute claim limitations. Where, as here, “the Board is unable to determine how the specification and drawings support the proposed substitute claims, the motion to amend may be denied.” Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019) (“TPG”),6 71.” slip op. at 15

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

      “Petitioner persuades us that the ’418 Application lacks adequate written description support for the formulation limitations of proposed substitute claim 18 [limitations 18a–8c]. As outlined by Petitioner and its declarants, the ’418 Application, including the Abstract, Field of the Invention, Summary of the Invention, and Detailed Description of the Invention sections, uniformly focuses on phosphate prodrugs of levodopa and carbidopa. See, e.g., Ex. 1004 (Sloan Decl.) ¶¶ 38–55, 64–69; Ex. 1003 (LeWitt Decl.) ¶¶ 89–97; Ex. 1047 (Forrest Decl.) ¶¶ 40–74, 80–92; Opp. 6– 10; Pet. 23–26, 49–55. We agree with Petitioner that “nothing in the specification suggests that the invention includes methods of subcutaneous infusion with anything other than the carbidopa prodrugs and L-dopa prodrugs of Formulas (I) and (II), respectively, or teaches how to get sufficient amounts of either L-dopa or carbidopa into solution, or achieve particular L-dopa plasma levels, without those particular prodrugs.” Pet. 27. Petitioner persuades us that the ’418 Application fails to contain “[so] much as a single generic sentence, anywhere in the application, suggesting the inventors possessed the claimed formulations.” Sur-reply 3. Additionally, the ’418 Application contains no example teaching administration of an aqueous formulation comprising carbidopa itself with levodopa itself or one of the three claimed levodopa prodrugs, let alone one that is suitable for continuous subcutaneous administration. See Ex. 1047 (Forrest Decl.) ¶¶ 61–72, 82–92. Patent Owner is correct that to establish written description support, neither “an actual reduction to practice,” nor a verbatim recitation of the claims is required. Sur-reply 4. Nevertheless, “[a]lthough examples are not always required to satisfy the written description requirement, the lack of any disclosure of examples may be considered when determining whether the claimed invention is adequately described.” Bos. Sci. Corp. v. Johnson & Johnson, 647 F.3d 1353, 1364 (Fed. Cir. 2011). Here, the lack of an actual reduction to practice or verbatim description of a formulation that falls within the scope of the claims is relevant, because we also see no other description or material in the ’418 Application that suggests the claimed methods extend to continuous subcutaneous administration of a composition comprising levodopa or one of the three claimed levodopa prodrugs, together with carbidopa, in an aqueous carrier.” slip op. at 28

    • ExcludeMotion to exclude, deniedDenied

      “All of the exhibits that are the subject of Patent Owner’s motion to exclude relate to the prior-art status and/or authenticity of Yacoby-Zeevi and ancillary related documents underlying Petitioner’s prior art-based challenges to the proposed substitute claims. See generally MTE. Because we deny Patent Owner’s request to enter proposed substitute claims 18–30 based on lack of written description support and do not reach Petitioner’s prior-art based challenges to the patentability of these claims, we do not rely on Exhibits 1005, 1007, 1040–1044, 1046, or 1048–1050 in this Decision. Accordingly we dismiss Patent Owner’s Motion to Exclude as moot.” slip op. at 49

    • Strike new argumentNew argument consideredDenied

      “On the other hand, Petitioner shows that Patent Owner took positions in its Motion to Amend that it only later sought to support with technical declarations. For example, in the Motion to Amend, Patent Owner elected to assert “that levodopa and carbidopa could be ‘interchanged’ in a formulation with their prodrugs, and that a skilled artisan could ‘perform a pharmacokinetic analysis to predict steady state levodopa plasma levels’ using the ‘parent compounds’ based on Example 24.” MTS 2 (citing Mot. 12–13). Patent Owner, however, “chose to forgo any expert support” on these issues at the time it filed its Motion to Amend, and instead waited until the Reply to submit technical declarations in support of these arguments. Id. We agree with Petitioner that although Patent Owner “was not required to anticipate the arguments that [Petitioner] would make in its Opposition” to the Motion to Amend, if Patent Owner “wanted to provide expert testimony to support the positions it actually took” in that Motion, “the TPG required [Patent Owner] to do so at that time, instead of waiting until [Petitioner] had limited ability to respond.” Id. at 5. Accordingly, we agree with Petitioner that in this respect at least some portions of Patent Owner’s Declarations are untimely, because it is “improper for a reply to present new evidence (including new expert testimony) that could have been presented in a prior filing.” TPG 74. Nevertheless, an order striking arguments and evidence in their entirety is an “exceptional remedy,” particularly under the circumstances here, where some portions of the Declarations are proper, while other portions are untimely. TPG 80. Moreover, “there is a strong public policy for making all information filed in an administrative proceeding available to the public.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012- 00010, Paper 59 at 40 (PTAB Feb. 24, 2014). Under the facts of this case, Patent Owner was permitted to file evidence to respond to Petitioner’s unpatentability claims, but also belatedly supported positions it made in earlier attorney argument. Petitioner’s Motion to Strike, however, challenges all of Patent Owner’s evidence, without acknowledging that some portions constitute proper reply. Although “[t]he Board is not required to attempt to sort proper from improper portions of the reply” (TPG 74, emphasis added), under the circumstances here, we agree with Patent Owner that Petitioner’s lack of specificity as to what it seeks to strike is fatal to Petitioner’s motion. Accordingly, we decline to strike the Declarations in their entirety as untimely.” slip op. at 46

    § 112 disclosure
    Patents in suitUS 11,091,507
  • PTAB · Oct 13, 2023 · PGR2023-00022 · APJ Devon Zastrow Newman · PGR · Institution

    The Board instituted PGR on claims 1–33 under all petition grounds, finding it more likely than not that at least one claim lacks written description and enablement.

    RulingsInstitution decision
    • Skill levelSkill level board ownOther

      “Based on the information presented, we agree with Patent Owner that the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (prior art itself can reflect the appropriate level of ordinary skill in the art). We do not find it necessary to define the level of skill in the art at the time of the invention at this time. However, for purposes of deciding whether to institute trial, we find that Dr. Silverstone is qualified to provide helpful opinion testimony on the issues regarding which we cite his testimony in this decision. See Ex. 1003 ¶¶ 6–15.” slip op. at 7

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

      “Based on the above, we agree with Patent Owner that many of the arguments raised by the Examiner are highly similar to the challenges in this proceeding, particularly the written description challenge. However, some arguments differ. For instance, Petitioner’s enablement argument identifies that, contrary to Applicant’s statement during prosecution reproduced above, amino acids and protein structure outside the disclosed AAD-12 motif can also affect the activity of the claimed dioxygenases to degrade phenoxy auxin and pyridyloxy auxin. See Ex. 1003 ¶¶ 42–50, 79 (Dr. Silverstone describing the mechanics of protein binding and explaining why the ’055 patent disclosure fails to provide sufficient information to the skilled artisan to know which amino acids could be changed while retaining the ability to enzymatically degrade both phenoxy and pyridyloxy auxin herbicides). See also Pet. 27–34 (asserting, e.g., 85% homology to AAD-12 motif alone is insufficient to predict enzymatic degradation activity). While the Examiner’s rejections regarded the disclosure corresponding to the ability to degrade herbicides, the Examiner plainly relied on Applicant’s statements that the AAD-12 motif’s structure alone was responsible when deciding to withdraw the rejection. Ex. 1002, 355. The Examiner did not have the additional testimony supplied by the Silverstone declaration explaining otherwise. See Ex. 1003 ¶¶ 42–50, 79. Petitioner, through Dr. Silverstone, also addresses the effort the skilled artisan would have needed to undertake to determine what proteins outside of the AAD-12 motif would affect the ability of homologues to enzymatically degrade the recited herbicides, and provides evidence for consideration regarding the lack of a clear link between the AAD-12 motif and the ability to enzymatically degrade both phenoxy and pyridyloxy auxin herbicides. Ex. 1003, 347. Therefore, the arguments are not entirely overlapping. And while these issues do in part overlap with Petitioner’s arguments pertaining to enablement, we agree with Petitioner that the Examiner did not complete a written Wands analysis. Although we conclude that the arguments are not entirely overlapping, we proceed to the second step in the analysis, for completeness.” slip op. at 13

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

      “Because Petitioner has shown that it is more likely than not that Petitioner will prevail in showing that at least one claim lacks sufficient written description and is not enabled, we conclude the challenged claims are eligible for post-grant review. V. CONCLUSION After considering the evidence and arguments presently before us, we determine Petitioner has shown it is more likely than not that at least one challenged claim of the ’055 patent lacks written description and is unpatentable. Accordingly, we institute a post-grant review. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a), a post-grant review of claims 1–33 of the ’055 patent is instituted with respect to all grounds set forth in the Petition; and” slip op. at 57

    • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther

      “85% identity as “highly identical” in this field and that the “conserved motif residues comprise ‘the active site that is essential for catalytic activity.’” Prelim. Resp. 31 (citing Ex. 1001, 11:1–6)). However, on the record before us, we are unpersuaded that this is sufficient because the Specification lacks disclosure supporting that a polypeptide of, for example, 86% identity to SEQ ID NO: 2 would retain the ability to degrade herbicides if the 5 amino acids in the general formula of HX109D(X)111-134 T(X)136-261H(X)263-272R, and the required chain lengths are present. In this regard we are persuaded by the testimony of Dr. Silverstone (Ex. 1003 ¶¶ 48–93) regarding the limitations of the disclosure of the ’055 patent and the lack of information supporting the skilled artisan in understanding that the inventor possessed the entire claimed genus (e.g., lack of example at lower end of sequence identity and lack of information to assist the skilled artisan in predicting whether an α-ketoglutarate-dependent dioxygenase would interact with or degrade either phenoxy auxin herbicides and/or pyridyloxy auxin herbicides). Dr. Silverstone testifies, and we are persuaded on this record, that the skilled artisan would not have read the guidance in the disclosure and understood that the inventors possessed the ability to design a modified SEQ ID NO: 2 at the 85% identity level that retained the function of degrading the recited herbicides, let alone the full scope of the claimed genus. Id. Patent Owner argues that Dr. Silverstone’s testimony that conserved amino acids of the AAD-12 motif are present in other α- ketoglutarate-dependent dioxygenases but do not have the claimed dual activity (Ex. 1003 ¶ 48) is misplaced because it “ignores that the location and spacing of those residues in other αKG-dependent dioxygenases differ from those in the AAD-12 motif.” Prelim. Resp. 38. However, Patent Owner offers no evidence that supports its argument. Id. It is thus unpersuasive.” slip op. at 36

    § 112 disclosureDiscretionary denial
    Patents in suitUS 11,371,055
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