• Multi-Color Corporation v. Brook & Whittle LtdInstituted
  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
• Uatp IP LLC v. Slick Slide LLCInstituted
  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
• Avation Medical, Inc. v. Emkinetics, Inc.Instituted
  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
• Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.All claims unpatentable
  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
• Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.All claims unpatentable
  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
• Forte Biosciences, Inc. v. University Of MassachusettsAll claims unpatentable
  PTAB · Jun 24, 2024 · PGR2023-00014 · APJ Georgianna W Braden · PGR · Final written decision

  Claims 1–5 are unpatentable for lack of written description and enablement under § 112(a); the Board did not reach the § 103 challenge.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not contest Petitioner’s proposed definition, except to modify the level such that an ordinarily skilled artisan “would have been familiar with well-known inhibitors of IL-15 and IL-15R as described in the ’505 patent and recognized in the art as of April 2017.” Resp. 26–27 (citing Ex. 2005 ¶ 94). We adopt Petitioner’s level of ordinary skill in the art with Patent Owner’s proposed modification because it appears consistent with the problems addressed in the ’505 patent and the prior art of record.” slip op. at 7

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

    “this stage of the proceeding and that all terms are to given their plain and ordinary meaning. Pet. 23; Resp. 38. We agree. Construction is needed only for those terms “that are in controversy, and only to the extent necessary to resolve the controversy.” See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Here, we determine that no claim construction is necessary.” slip op. at 8

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

    “Finally, we are reminded that “a sufficient description of the genus . . . 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.” Ariad, 598 F.3d at 1350. “[F]unctional claim language can meet the written description requirement when the art has established a correlation between structure and function.” Id. Here, however, the challenged claims are directed to methods using a wide range of different types of compounds purported to be “IL-15/IL-15R inhibitors” that are not part of a known or readily identifiable class, do not target the same biological pathway, do not have any common structural features, and do not appear to always function as inhibitors. See Ex. 1018, Abstr., 1575–77, 1579; Ex. 1046, 189:4–19, 191:15–192:15, 193:18–196:22, 198:21–199:21, 197:12–198:19, 200:1–8, 207:11–14, 203:3–10, 207:15–21, 236:12–24; Ex. 1047 ¶¶ 19–23, 56, 63–64, 80–85. Therefore, we find there is neither a representative number of species disclosed, nor a sufficient” slip op. at 21

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

    “598 U.S. at 610. A “specification may call for a reasonable amount of experimentation to make and use a patented invention. What is reasonable in any case will depend on the nature of the invention and the underlying art.” Id. at 613. But the person of ordinary skill in the art cannot be left with merely “a hunting license” or obligated to engage in “painstaking experimentation” or “trial and error” to “see what works.” Id. at 614. Patent Owner argues that “the IL-15/IL-15R inhibitors disclosed in the specification were known in the art and “share the common ‘general quality’ of inhibiting a pathway known to be relevant to and having ‘particular fitness for the particular purposes’ of (id.) treating certain autoimmune diseases by blocking IL-15 signaling.” Sur-reply 14 (citing Ex. 1011, 22; Ex. 2013, 3; Ex. 2017, Abstr.; Ex. 2024, 17; Ex. 2025, 2–3, 6; Ex. 2027, 4; Ex. 2028, 9; Ex. 2029, 4; Ex. 2031, 23; Ex. 2118, 53:22–54:9; Ex. 1018, 1; Ex. 2005, ¶¶ 52–63, 80–83, 130; Ex. 1046, 231:20–25). Patent Owner’s argument is unavailing, however, because the record shows that different IL-15-specific inhibitors may operate in different ways that may result in differential effects, some of which may not include inhibition at all. See Ex. 1047 ¶¶21, 23, 40, 71; Ex. 1018, Abstr., 1576, 1579; Ex. 2013, 4:1– 8; Ex. 2014, 4:9–15; Ex. 2015 ¶ 22; Ex. 2025, 4:34–5:2; Ex. 1046, 166:21– 24, 168:25–169:5, 207:23–209:22, 210:4–17, 210:24–211:6; Ex. 1011, 1:67–2:4; Ex. 2005 ¶¶ 116, 134. Thus, we find that the record supports Drs. Abbas and Plott’s testimony, which we credit, that a person of ordinary skill in the art would be forced to hunt down and test every compound through painstaking Ex. 1002 ¶¶ 85–90, 92; Ex. 1047 ¶ 53 (Dr. Plott’s testimony that the “specification of the ’505 patent is essentially a black box (so far as which aspects of IL-15 signaling it inhibits and how it operates), leaving the reader to guess through trial and error which molecules might operate similarly to ChMBC7 and which do not.”); Ex. 1004 ¶ 61 (Dr. Plott’s testimony that “from the perspective of a clinician, the amount of experimentation required would be extremely burdensome and success would be speculative.”); Ex. 2007, 93:16–97:25, 38:208; Ex. 1046, 234:20–236:11. This is due to the fact that the claims (without limit) encompass any inhibition of any one of the various types of IL-15 signaling and various versions of the receptor, and even implicate other compounds that act on different targets but which inhibit the IL-15 signaling pathway. See Ex. 1047 ¶¶ 10, 53, 68; Ex. 2005 ¶ 71; Ex. 1046, 254:4–255:11, 158:12–160:20. The evidence has shown that IL-15/IL-15R inhibition is complicated and unpredictable, with some inhibitors also capable of enhancing forms of IL-15 signaling rather than preventing it. See Ex. 1047 ¶¶ 10, 25–26, 53; Ex. 2013, 2:10–18; Ex. 2014, 2:12–20; Ex. 2015 ¶ 3; Ex. 2025, 2:10–18; Ex. 2078, 267.” slip op. at 32

  Patent outcomesUS 11,278,505 unpatentable
  Claim construction§ 112 disclosurecites Phillips
  Patents in suitUS 11,278,505
• Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.No claims unpatentable
  PTAB · Apr 16, 2024 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Final written decision

  The Board held claims 1–4, 8–14, and 18–26 not shown unpatentable because they were entitled to priority before the November 2018 Venclexta Label, which therefore was not prior art.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology, which would encompass the blood cancers recited in the claims. Neither party identifies a difference in the analysis or conclusions that would be based on differences in the ordinary skill in the art analysis. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. 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 7

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

    “The parties do not identify any issue relating to the preamble that would impact our analysis. We recognize that Patent Owner is suggesting that Petitioner’s expert, at least, is reading the word “clinical” into the treatment language of claim 1. However, the plain language of the claim 1 preamble states “treating lymphoma or leukemia in a human patient” and is supported by a straightforward definition in the Specification of the ’087 patent, expressly limiting the invention to treatment of human patients. See Ex. 1001, 16:25–38. We therefore find that the preamble terms do not need claim construction because there is no actual dispute suggesting that, for example, claim 1 implicitly recites the term “clinical.” See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 5

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledEntitled to earlier dateDecided for patent owner

    “d. Analysis Considering the Wands factors as a whole, we find that the limited breadth of the claims, presence of several working examples, significant amount of direction and guidance provided by the ’087 patent, predictability in treating blood cancers with Bcl-2 inhibitors like GDC-0199, and high level of skill in the art are balanced against a large quantity of experimentation. Based on our consideration of the entirety of the evidence, we find that a preponderance of the evidence supports the conclusion that undue experimentation would not have been required to make and use the invention commensurate in scope with the claims of the ’087 patent. One underlying theme of Petitioner’s contentions and Petitioner’s expert testimony is the repeated contention that clinical trials were not completed by Patent Owner. See, e.g., Pet. 48 (“venetoclax (GDC-0199) was not FDA-approved”); Ex. 1020 ¶ 193. We find these arguments unpersuasive as we agree with Patent Owner that “[i]t is well established that a patent may be secured, and typically is secured, before the conclusion of clinical trials.” In re Montgomery, 67 F.3d 1375, 1382 (Fed. Cir. 2012). Particularly as to the dependent claims, a preponderance of the evidence of record does not support a finding that undue experimentation would have been required to administer three different doses of GDC-0199 starting with 100 mg, to use multiple daily dosing cycles of one day, to continue until disease progression occurs, or to combine with other treatment compounds. We find that a preponderance of the evidence does not support Petitioner’s position that any of the dependent claims fail to comply with the enablement requirement.” slip op. at 23

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “Applying Rai and Wertheim to the instant facts, we agree with Patent Owner that, factually and legally, in the ’087 patent “the claimed dosages of 100 mg, 200 mg, and/or 400 mg of GDC-0199 are adequately supported.” PO Second Suppl. Brief 2 (citing PO Resp. 11, 27–29; PO Sur-reply 19, 21– 22; Ex. 1001, 24:20–29.) In particular, the ’087 patent describes all three specific dosage values 100 mg, 200 mg, and 400 mg in the context of an escalating drug dosage series and Petitioner points to no persuasive statements in the specification that dispute either the effectiveness or the operability of GDC-0199 at any of these dosages.” slip op. at 32

  Patent outcomesUS 11,110,087 not shown unpatentable
  Claim construction§ 102 anticipation§ 112 disclosure
  Patents in suitUS 11,110,087
• The Noco Company, Inc. v. Pilot, Inc.All claims unpatentable
  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
• Sma Solar Technology America LLC v. Tigo Energy, Inc.Instituted
  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

Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.