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

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

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

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

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

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

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

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

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

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

    Patent outcomesUS 11,998,854 mixed
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · Graham · Nautilus
    Patents in suitUS 11,998,854
  • 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 · Mar 10, 2025 · PGR2024-00049 · APJ Jo-Anne M Kokoski · PGR · Institution

    The Board denied institution because Petitioner did not show the patent was eligible for PGR; the challenged claims were supported by the 2006 priority application.

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

      “Accordingly, we determine that Petitioner does not demonstrate that it is more likely than not that the challenged claims lack written support in the Specification (and the ’634 application). That is, on this record, it appears that the challenged claims properly claim priority to the ’634 application and, accordingly, have an effective filing date in October 2006. 2. Conclusion: PGR Eligibility For the foregoing reasons, and based on the record before us, we determine that Petitioner has not demonstrated that it is more likely than not that the ’202 patent has, or had, at least one claim having an effective filing date on or after March 16, 2013. Accordingly, we determine that the ’202 patent is entitled to the filing date of the ’634 application (October 18, 2006), and, thus, the ’202 patent is not eligible for post-grant review.” slip op. at 18

    • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageTerm construed board ownDecided for patent owner

      “Accordingly, the ’202 patent consistently and repeatedly characterizes the invention as incorporating tobacco in some form and ties the stated benefits of the invention to the inclusion of tobacco. Moreover, the Specification is directed to smoking articles containing tobacco, all of the embodiments include tobacco, and “the present invention” is described as a smoking article, where the smoking article includes tobacco. Consequently, we determine that “smoking article” as it is used in the challenged claims is limited to devices that include tobacco. See Mosaic Brands, Inc. v. Ridge Wallet LLC, 55 F.4th 1354, 1361 (Fed. Cir. 2022) (finding claimed “lip” is limited to “extrudable plastic materials” where specification states that “the device of the present invention is constructed of extrudable plastic materials” and “emphasizes the benefits of using extrudable plastics and describes them as benefits of the invention as a whole”); Poly-Am., L.P. v. described in the specification has inwardly extended short seals and every section of the specification indicates the importance of inwardly extended short seals. These two facts provide together a proper reason to limit the claims in this way.”); Phillips v. AWH Corp., 415 F.3d 1303, 1312–1317 (Fed. Cir. 2005) (en banc) (“[T]he specification may reveal an intentional disclaimer, or disavowal, of claim scope by the inventor. In that instance as well, the inventor has dictated the correct claim scope, and the inventor’s intention, as expressed in the specification, is regarded as dispositive.”).” slip op. at 13

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateNot shown unpatentable

      “Petitioner’s argument is dependent on accepting Petitioner’s assertion that the claims include a smoking article that does not contain tobacco, which we have not done. Instead, as set forth above, we construe “smoking article” as being limited to devices that include tobacco. See § II.B.2, supra. Based on our construction of “smoking article” and the evidence of record in this proceeding, we determine that the challenged claims are supported by the specification of the ’202 patent, which is identical to the specification of all of the continuations in the chain leading back to the October 18, 2006 that the specification of the ’202 patent and every patent in its priority chain “have identical specifications”); Prelim. Resp. 13 (noting that Petitioner does not identify other limitations in the challenged claims “allegedly lacking support in the ’202 patent family’s applications dating back to U.S. App. No. 11/550,634, filed on October 18, 2006”). Accordingly, we determine that Petitioner does not demonstrate that it is more likely than not that the challenged claims lack written support in the Specification (and the ’634 application). That is, on this record, it appears that the challenged claims properly claim priority to the ’634 application and, accordingly, have an effective filing date in October 2006.” slip op. at 17

    Claim construction§ 112 disclosurecites Phillips
    Patents in suitUS 11,925,202
  • PTAB · Jan 29, 2025 · PGR2024-00043 · APJ John G New · PGR · Institution

    The Board instituted PGR on all challenged claims, finding a sufficient likelihood that claims are anticipated or obvious under Grounds 1–10; it found Ground 11’s enablement challenge insufficient.

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

      “Under 35 U.S.C. § 324, the Board “may not authorize a post-grant review to be instituted unless … the information presented in the petition … if such information is not rebutted would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” For the reasons we explain below, we institute post-grant review of the ’943 patent.” slip op. at 2

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

      “asserted reference qualifies as prior art is public accessibility. See In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986). “[A]t the institution stage, 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.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 13 (PTAB Dec. 20, 2019) (precedential).” slip op. at 15

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

      “priority benefit of the ’720 provisional application (at top center). See Ex. 1001, code (60) (listing “provisional application No. 5,995,873, filed on Oct. 2, 2006”). However, simply to claim the priority benefit of an earlier application is not necessarily to receive it. See In re NTP, Inc., 654 F.3d 1268, 1276 (Fed. Cir. 2011) (holding that “a patent’s claims are not entitled to an earlier priority date merely 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.”). As the diagram shows (and as we have verified), the ’529 application was a continuation-in-part of the preceding ’329 application. See Ex. 1001, code (63). However, the ’529 application was abandoned on February 10, 2016 (See Ex. 1052), and the succeeding application, U.S. Patent Application Ser. No. 15,474,875 (the “’875 application”) which is listed in the ’943 patent as being a continuation-in-part of the ’529 application, was not filed until March 30, 2017. See Ex. 1001, code (63) (stating that “said application No. 15/474,875 is a continuation-in-part of application No. 12/508,529”). Put simply, the ’875 application was not filed until over a year after the ’529 application was abandoned. As 35 U.S.C. § 120 states, in relevant part: An application for patent for an invention disclosed in the manner provided by section 112(a) (other than the requirement to disclose the best mode) in an application previously filed in the United States, or as provided by section 363 or 385, which names an inventor or joint inventor in the previously filed application shall have the same effect, as to such invention, as though filed on the date of the prior application, if filed before the patenting or abandonment of or termination of proceedings on the first application or on an application similarly entitled to the benefit of the filing date of the first application and if it contains or is amended to contain a specific reference to the earlier filed application. (emphasis added). In other words, if there is a “break in the chain” of priority caused by the abandonment or termination of an application claiming priority prior to filing of a subsequent application, the subsequent application loses the priority benefit of the abandoned or terminated application, as well as the priority benefit of all applications that antedate that abandoned or terminated application. Such is the case presently before us. Based on the current record, we are persuaded that the abandonment of the ’529 application prior to filing of the continuation-in-part ’875 application broke the priority chain leading to the ’720 provisional application, and the ’943 patent cannot, therefore, claim the priority benefit of the ’720 provisional application’s October 2, 2006 filing date. Consequently, the earliest date of which the ’943 patent could possibly claim the priority benefit is that of U.S. Patent Provisional Application Ser. No. 61/403,680 (the “’680 provisional application”) (located at the top of the left branch of the “family tree” depicted above), which has a filing date of September 20, 2010. See Ex. 1001, code (60). Burnett (i.e., the ’329 application) was filed on October 2, 2007 and thus antedates the ’680 provisional application. Consequently, Patent Owner’s argument fails based on the current record, and Burnett is prior art to the ’943 patent.” slip op. at 55

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

      “Patent Owner’s request that we exercise our discretion under § 325(d) is not tenable. In deciding whether to exercise our discretion under § 325(d) in situations where only some of the challenges fall within its scope, we evaluate the challenges and determine whether § 325(d) is sufficiently implicated that its statutory purpose would be undermined by instituting on all challenges. If so, the panel will evaluate whether the entire petition should be denied.” See USPTO, SAS Q&As (June 5, 2018) at D1, available at: https://www.uspto.gov/sites/default/files/ documents/ sas_qas_20180605.pdf; see also Kansas State Univ. Res. Found., PGR2022- 00021, Paper 11 at 7–8 & n.3 (Vidal Feb. 24, 2023) (holding that “the Board will further evaluate … whether § 325(d) is sufficiently implicated that its statutory purpose would be undermined by instituting review on all challenges presented in the Petition”). We having instituted post grant review based at least upon claim 1 of Ground 1 of the Petition. Even if the panel agreed with Patent Owner that Grounds 5–8 present “the same or substantially the same prior art or arguments” previously presented to the Office, § 325(d) would not be “sufficiently implicated” due to the 7 other asserted grounds. We therefore do not proceed with the § 325(d) analysis established in Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) and decline to exercise our discretion to deny the petition on that basis.” slip op. at 41

    Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites Phillips · KSR
    Patents in suitUS 11,844,943
  • PTAB · Nov 27, 2024 · PGR2022-00025 · APJ Susan L C Mitchell · PGR · Final written decision

    Claims 1–19 are unpatentable because the ’201 patent lacks written description support for the claimed genus of CRF1 receptor antagonists under § 112(a).

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

      “[A] sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. at 1350 (citing Regents, 119 F.3d at 1568–69). Moreover, “an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials.” Id. (citing Regents, 119 F.3d at 1568 (quoting Fiers, 984 F.2d at 1171)). Furthermore, “functional claim language can meet the written description requirement when the art has established a correlation between structure and function.” Id. (citing Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed. Cir. 2002) (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001))). “[M]erely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” Id.” slip op. at 42

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “According to Petitioner, a person of ordinary skill in the relevant art (“POSA”) “would have a medical degree or a Ph.D. in a field related to endocrinology, and would have knowledge of hormone regulation and disorders, as well as knowledge of the treatment regimens employed to treat such disorders . . . [and] would also have at least three years of experience conducting research concerning endocrine disorders, including CAH or other adrenal disorders.” Pet. 26–27 (citing Ex. 1005 ¶ 34 (Dr. Carey Declaration)). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. Because Petitioner’s definition of a person of skill in the art appears commensurate with the level of skill reflected in the asserted art in this case as well as the ’201 patent itself, see, e.g., Exs. 1024, 1025, 2003, 2004, 2005, we apply Petitioner’s proposed level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating prior art itself can reflect the appropriate level of ordinary skill in the art). C.” slip op. at 22

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “For these reasons, we do not find persuasive the testimony of Patent Owner’s expert, Dr. Dobs, that: By describing adjustments of dosing protocols to achieve an A4 reduction from baseline, and describing this use of tildacerfont as just one embodiment of the claimed use of the entire well-known, well-characterized, and discrete class, the specification reasonably conveyed to a POSA that the invention extended to the particularly claimed use of the entire recited class. Ex. 2014 ¶ 82. On the contrary, far from being a “well-known, well-characterized, and discrete class” the prior art teaches a heterogeneous assembly of different classes of small molecule CRF1 receptor antagonists (Type I, Type II, and “atypical”) displaying a very considerable variety of structures, both in terms of the core pharmacophore (e.g., monocyclic, bicyclic, tricyclic, phenolic, cyclohexyl amide, etc.) as well as in the various side groups. Moreover, the challenged claims recite only “a CRF1 receptor antagonist or a pharmaceutically acceptable salt thereof,” the scope of which also encompasses the much larger (and, according to Williams) much more effective large-molecule (peptide) CRF1 receptor antagonists, about which the Specification is entirely silent. See Ex. 1029, Abstr., 1065. Furthermore, despite Dr. Dobs’ testimony that “[t]he [prior art] references explain the typical CRF1 antagonist consists of a core nitrogen heterocycle with an aryl substituent adjacent to the core nitrogen atom and a branched alkyl group attached at the opposite end of the core,” Dr. Dobs also acknowledged that the “atypical CRF1 receptors depicted in Figures 11 and 12 of Williams had different structures, and lacked the nitrogen heterocyclic core.” Ex. 1042, 127:9–14, 130:13–131:16; see also Ex. 2014 ¶ 83. Additionally, Petitioner’s expert, Dr. Cutler, testified, by way of example, in his Reply Declaration that two of the ‘“first-generation CRF1 antagonists’ identified in Figure 1 of the Williams article do not fall within the Figure 2 structure Dr. Dobs relies upon.” Ex. 1047 ¶ 93. Indeed, with respect to the alleged core pharmacophore that Dr. Dobs” slip op. at 54

    • ExcludeMotion to exclude, deniedMixed

      “with chemical terminology”; “could not answer questions regarding the chemical structures in the prior art articles”; “did not know whether CRF1 receptor antagonists contained the structural features she deemed ‘essential’ in her Declaration”; and “agreed that tildacerfont has structurally unique features” (see Ex. 1042, 52–53, 125–126, 126–128, 128–130) goes to the weight that we assign to such testimony, but we do not find that such testimony, in light of Dr. Dobs’ extensive qualifications as an endocrinologist set forth above, deems Dr. Dobs unqualified to testify concerning the written description issue in this proceeding. For these reasons explained above, Petitioner’s Motion to Exclude Dr. Dobs’ written description opinions in paragraphs 20 and 75–87 of Exhibit 2014 is denied.” slip op. at 11

    Patent outcomesUS 11,007,201 unpatentable
    § 112 disclosurecites Phillips
    Patents in suitUS 11,007,201
  • PTAB · Nov 26, 2024 · PGR2021-00088 · APJ John G New · PGR · Final written decision

    Claims 1–25 are unpatentable because the ’908 patent lacks written description support under § 112(a); the Board did not reach Grounds 1–3 or 5.

    RulingsFinal written decision
    • ExcludeMotion to exclude, deniedMixed

      “To the extent that Dr. Dobs has admitted that she is “not comfortable with chemical terminology”; “could not answer questions regarding the chemical structures in the prior art articles”; “did not know whether CRF1 receptor antagonists contained the structural features she deemed ‘essential’ in her Declaration”; and “agreed that tildacerfont has structurally unique features” (see Ex. 1038, 52–53, 125–126, 126–128, 128–130), we will weigh her testimony regarding those matters accordingly. However, for the reasons explained above, Petitioner’s Motion to Exclude Dr. Dobs’ written description opinions in paragraphs 19 and 80–91 of Exhibit 2014 is denied.” slip op. at 10

    • Strike new argumentOther

      “Analysis Patent Owner’s Exhibits 2020–2026 play no part in our reasoning and were not relied upon by the Board in reaching our Decision. Petitioner’s Motion to strike Exhibits 2020–2026 is therefore dismissed as moot.” slip op. at 23

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “typically possess a medical degree or a Ph.D. in a field related to endocrinology, and would have knowledge of hormone regulation and disorders, as well as knowledge of the treatment regimens employed to treat such disorders. Pet. 60 (citing Ex. 1005 ¶ 34). Petitioner argues that such a person of ordinary skill would also have at least three years of experience conducting research concerning endocrine disorders, including CAH or other adrenal disorders. Id. Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. Because we find Petitioner’s definition to be consistent with the demonstrable level of skill in the art (see, e.g., Exs. 1009, 1025, 2003, 2004, 2005), and in the absence of a different proposed definition of the level of skill in the art by Patent Owner, we adopt Petitioner’s definition.” slip op. at 26

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “For these reasons, we do not find persuasive the testimony of Patent Owner’s expert, Dr. Dobs, that: By describing adjustments of dosing protocols to achieve at least a 10% reduction from baseline, and describing this use of tildacerfont as just one embodiment of the claimed use of the entire well-known, well-characterized, and discrete class, the specification reasonably conveyed to a POSA that the invention extended to the particularly claimed use of the entire recited class. Ex. 2014 ¶ 87. On the contrary, far from being a “well-known, well-characterized, and discrete class” the prior art teaches a heterogeneous assembly of different classes of small molecule CRF1 receptor antagonists (Type I, Type II, and “atypical”) displaying a very considerable variety of structures, both in terms of the core pharmacophore (e.g., monocyclic, bicyclic, tricyclic, phenolic, cyclohexyl amide, etc.) as well as in the various side groups. Moreover, the challenged claims recite only “a CRF1 receptor antagonist or a pharmaceutically acceptable salt thereof,” the scope of which also encompasses the much larger (and, according to Williams) much more effective large-molecule (peptide) CRF1 receptor antagonists, about which the Specification is entirely silent. See Ex. 1029, Abstr., 1065.” slip op. at 56

    Patent outcomesUS 10,849,908 unpatentable
    § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
    Patents in suitUS 10,849,908
  • PTAB · Jan 11, 2024 · IPR2022-01158 · APJ Zhenyu Yang · IPR · Final written decision

    Claims 1–28 are unpatentable because Eltoukhy anticipates them; the Board found they were not entitled to a priority date before Eltoukhy’s publication.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Level of Ordinary Skill in the Art In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). Furthermore, the prior art itself can reflect the appropriate level of ordinary skill in the art. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Here, Petitioner asserts that an ordinarily skilled artisan “would typically have an advanced degree, such as a Ph.D., with research experience in genomics, molecular biology, bioinformatics, or a related field, or could have less education but significant professional experience in one or more of these fields.” Pet. 8–9 (citing Ex. 1002 ¶ 38). Patent Owner states that for the purposes of this proceeding, it does not dispute Petitioner’s definition of the skill level. PO Resp. 2 (citing Ex. 2023 ¶¶ 21, 22). After reviewing the record, we adopt Petitioner’s definition as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention.” slip op. at 7

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

      “1. “Sequence Reads” Petitioner argues that, for purposes of this Decision, no claim term needs specific construction beyond its plain and ordinary meaning. Pet. 10–11. Petitioner, however, seeks to provide context for understanding the scope of the term “sequence reads.” Specifically, Petitioner contends that “sequence reads” are produced by sequencing at least some of the tagged strands, whereas “consensus sequences” are generated by collapsing sequence reads. Id. at 11 (citing Ex. 1001, 4:45–47, 20:50–22:25, 23:29–57, 24:46–48, claim 1, claim 6). In the Decision to Institute, we agreed with Petitioner that “[t]he claims of the ’951 patent as well as the specification make clear that a ‘sequence read’ is different and distinct from a ‘consensus sequence.’” DI 7 (quoting Pet. 11). Patent Owner does not dispute Petitioner’s assertion. PO Resp. 12. Based on the complete record, we see no reason to change our determination of the scope of the term “sequence reads.”” slip op. at 8

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

      “We disagree with Patent Owner’s proposed construction of the terms “paired sequence reads” and “unpaired sequence reads.” Even though the ’951 patent Specification discloses grouping sequence reads “sharing a unique set of SMI tags” into paired families,4 “[t]he written description part of the specification itself does not delimit the right to exclude. That is the function and purpose of claims.” Phillips, 415 F.3d at 1312 (“[T]he claims of a patent define the invention to which the patentee is entitled the right to exclude.”). Here, claim 1 explicitly defines the terms “paired sequence reads” and “unpaired sequence reads.” Indeed, in the context of paired versus unpaired sequence reads, claim 1 specifies that the complementarity is related to the “original parent polynucleotide molecule,” and not the duplex tags. For example, claim 1 recites that “each unpaired read represents a first tagged strand having no second differently tagged complementary strand derived from an original parent polynucleotide molecule represented among said sequence reads in said set of sequence reads.” Ex. 1001, 37:50–55 (emphasis added). Thus, the plain claim language contradicts Patent Owner’s argument” slip op. at 11

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner

      “Claim 1 defines the terms “paired sequence reads” and “unpaired sequence reads” based on the complementarity of the target sequence strands derived from the “original parent polynucleotide molecule.” Ex. 1001, 37:46–55. As explained above, we reject Patent Owner’s contention that a sequence read is considered unpaired solely based on the complementarity of the SMI tags. See supra Section II.C.2. Due to the “errors introduced during sample preparation and sequencing” (Ex. 1029 ¶ 5), there are four outcomes when determining the complementarity of the sequence reads of two strands of SMI-linked target sequence: (1) the first SMI tag and the first strand target sequence are complementary to the second SMI tag and the second strand target sequence, respectively; (2) the first SMI tag is complementary to the second SMI tag but the first strand target sequence is not complementary to the second strand target sequence; (3) the first SMI tag is not complementary to the second SMI tag but the first strand target sequence is complementary to the second strand target sequence; and (4) the first SMI tag is not complementary to the second SMI tag, and the first strand target sequence is not complementary to the second strand target sequence. It is undisputed that Schmitt groups sequence reads into paired families based on the SMI tags, and Schmitt only considers sequences in which “information from both DNA strands was in perfect agreement.” Ex. 1029 ¶¶ 14, 96; PO Resp. 18. Thus, among the four outcomes, only scenario (1), in which both the SMI tags and the target sequences are complementary, represents a “paired sequence read,” which claim 1 defines as corresponding to “sequence reads generated from a first tagged strand and a second differently tagged complementary strand derived from an original parent polynucleotide molecule.” Ex. 1001, 37:46–50. Contrary to Patent Owner’s argument (see PO Resp. 26), in Schmitt,” slip op. at 18

    Patent outcomesUS 10,752,951 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
    Patents in suitUS 10,752,951
  • PTAB · Dec 1, 2023 · PGR2022-00025 · APJ Susan L C Mitchell · PGR · Remand

    The Board granted PGR of claims 1–19, finding claim 1 more likely than not anticipated by Grigoriadis and claims 1–19 more likely than not lacking written-description support.

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

      “Institution of post-grant review is authorized by statute only when “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.” 35 U.S.C. § 324; see 37 C.F.R. § 42.4. Upon considering the Petition, Patent Owner Preliminary Response, and the cited evidence in light of the Director’s Decision, we conclude that Petitioner has satisfied its burden under 35 U.S.C. § 324 to show that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable. Therefore, we grant institution of a post-grant review.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “B. Person of Ordinary Skill in the Art Factual indicators of the level of ordinary skill in the art include “the various prior art approaches employed, the types of problems encountered in the art, the rapidity with which innovations are made, the sophistication of the technology involved, and the educational background of those actively working in the field.” Jacobson Bros., Inc. v. U.S., 512 F.2d 1065, 1071 (Ct. Cl. 1975); see also Orthopedic Equip. Co. v. U.S., 702 F.2d 1005, 1011 (Fed. Cir. 1983) (quoting with approval Jacobson Bros.).” slip op. at 7

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

      “Independent claim 1 recites a method of treating CAH by reducing an A4 level “from baseline” after administering a CRF1 receptor antagonist to a CAH patient. See Ex. 1001, 47:51–48:5. The Specification expressly teaches that, with respect to the clinical phase 2 trial described in Example 4, “Patients will have overnight [pharmacokinetic/pharmacodynamics] PK/PD assessments performed at baseline, which include an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose.” Ex. 1001, 41:55–59. This is the same quotation and clinical trial relied upon by Dr. Barnes in his Declaration, and is the only definition of a “baseline” in the ’201 patent. See Ex. 1037, 36–37. We note that placebos were evidently not employed in the phase 2 clinical study of Example 4.5 Given the sole exemplary description of “baseline” in Example 4 of the Specification, we construe the claim term reciting “reduced from baseline” as meaning “a reduction in A4 level compared to an A4 level measurement made prior to, and/or at the beginning of, administration of the drug.”” slip op. at 10

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Reference is prior artInstituted

      “A claim is unpatentable as anticipated under 35 U.S.C. § 102 only when “every element and limitation of the claim was previously described in a single prior art reference, either expressly or inherently, so as to place a person of ordinary skill in possession of the invention.” Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1082 (Fed. Cir. 2008). A reference may inherently anticipate if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010). Thus, the “very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question.” Agilent Technologies, Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (emphasis added).” slip op. at 23

    Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites Phillips
    Patents in suitUS 11,007,201
  • PTAB · Dec 1, 2023 · PGR2021-00088 · APJ John G New · PGR · Remand

    The Board instituted PGR on claims 1–25 on all five grounds, finding the threshold met based on likely anticipation, obviousness, and lack of written-description support.

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

      “Under 35 U.S.C. § 324, the Board “may not authorize a post-grant review to be instituted unless … the information presented in the petition … if such information is not rebutted would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” In conformance with the Director’s Decision, and for the reasons we explain herein, we institute post-grant review of the ’908 patent.” slip op. at 2

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

      “The Specification expressly teaches that, with respect to the clinical phase 2 trial described in Example 4, “Patients will have overnight [pharmacokinetic/pharmacodynamics] PK/PD assessments performed at baseline, which include an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose.” Ex. 1001, col.42, ll. 12–16. This is the same quotation and clinical trial relied upon by Dr. Barnes in his Declaration, and is the only definition of a “baseline” in the ’908 patent. See Ex. 1002, 36–37. We note that placebos were evidently not employed in the phase 2 clinical study of Example 4.3 Given the sole exemplary description of “baseline” in Example 4 of the Specification, we construe the claim term reciting “reduced by at least 10% from baseline” as meaning “a reduction of at least 10% in the level of ACTH (claim 1) or 17-OHP (claim 11) compared to measurements of ACTH or 17-OHP made prior to, and/or at the beginning of, administration of the drug.”” slip op. at 10

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends that a person of ordinary skill in the art would typically possess a medical degree or a Ph.D. in a field related to endocrinology, and would have knowledge of hormone regulation and disorders, as well as knowledge of the treatment regimens employed to treat such disorders. Pet. 60 (citing Ex. 1005 ¶ 34). Petitioner argues that such a person of ordinary skill would also have at least three years of experience conducting research concerning endocrine disorders, including CAH or other adrenal disorders. Id. Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Preliminary Response. For the purposes of this Decision, because we find Petitioner’s definition to be consistent with the demonstrable level of skill in the art (see, e.g., Exs. 1009, 1025, 2003, 2004,” slip op. at 11

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundInstituted

      “A claim is unpatentable as anticipated under 35 U.S.C. § 102 only when “every element and limitation of the claim was previously described in a single prior art reference, either expressly or inherently, so as to place a person of ordinary skill in possession of the invention.” Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1082 (Fed. Cir. 2008). A reference may inherently anticipate if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010). Thus, the “very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question.” Agilent Technologies, Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (emphasis added).” slip op. at 23

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips
    Patents in suitUS 10,849,908
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