• Avation Medical, Inc. v. Emkinetics, Inc.All claims unpatentable
  PTAB · Jan 7, 2026 · PGR2024-00043 · APJ Ryan H Flax · PGR · Final written decision

  Claims 1–39 are unpatentable under Grounds 1–10; Petitioner did not prove lack of enablement under Ground 11, and Patent Owner’s motion to exclude was denied.

  RulingsFinal written decision

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

    “REAL PARTIES-IN-INTEREST Petitioner identifies Avation Medical, Inc. as the real party-in-interest. Pet. x. Patent Owner identifies EMKinetics, Inc. as the real party-in-interest. Paper 5, 1; Paper 6, 1. Neither party contests the other’s assertions on this. C.” slip op. at 3

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A POSA at the time of the claimed invention would have had an undergraduate degree in the field of biomedical engineering or a related discipline, such as electrical engineering, and at least two years of experience in the design and/or analysis of biomedical devices. Additional work experience could substitute for a formal degree and vice versa. Ex.1003, ¶21. Pet. 20 (citing Ex. 1003). Patent Owner does not contest this proposed definition or offer an alternative. See generally Resp. We accept and use Petitioner’s uncontested definition of the ordinarily skilled artisan, which appears to comport with the level of skill in the art reflected in the prior art of record and the ’943 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may]” slip op. at 19

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

    “same claim construction standard that is used to construe patent claims in a civil action in federal district court. 37 C.F.R. § 42.200(b). In construing claims, district courts and the Board here, by default, give claim terms their ordinary and customary meaning, which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner states that, “no terms require construction for purposes of this Petition.” Pet. 21. Patent Owner presents no express position on claim construction. See generally Resp. We do not expressly construe any claim terms. E.” slip op. at 20

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

    “question, based on factual findings. VidStream, 981 F.3d at 1063–64. Moreover, public accessibility is the touchstone in determining whether a reference is a printed publication and such depends on whether the reference was available to interested, ordinarily skilled persons exercising reasonable diligence, which is determined on a case-by-case basis. Id. at 1065. Particularly pertinent here is that “[w]hen there is an established publisher there is a presumption of public accessibility as of the publication date.” Id. Hulu (which cites VidStream on this issue) concerned, inter alia, whether certain asserted references were shown to be publicly available and could be considered as prior art. Hulu, 2021 WL 487622. Hulu holds that, although testimonial evidence is one way to prove public accessibility, there are also a variety of hallmarks of publication and other evidence that may be considered as a totality of the evidence to determine if an asserted reference was publicly accessible and prior art. Id. at *10–13, 21. Facts to be considered in analyzing the issue, other than testimonial evidence, include, for example, whether there is an established publisher, a copyright date/notice, other publication-related dates (impression, printing, etc.), an ISBN number, citations to the reference before (and to a lesser degree, after) the priority date at issue corroborating its availability and/or that the publisher was established, and whether the reference’s “purpose of publishing . . . was ‘dialogue with an intended audience.’” Id. at *10–21 (citing Valve Corp. v. Ironburg Inventions Ltd., 8 F.4th 1364, 1374 (Fed. Cir. 2021)).” slip op. at 30

  Patent outcomesUS 11,844,943 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · Graham
  Patents in suitUS 11,844,943
• Straumann USA, LLC v. Smart Denture Conversions, LLCInstituted
  PTAB · Dec 10, 2025 · PGR2025-00054 · APJ Ryan H Flax · PGR · Institution

  The Board instituted PGR on claims 1–16 on all four grounds, finding at least one claim more likely than not unpatentable based on obviousness, indefiniteness, or lack of written description.

  RulingsInstitution decision

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

    “institute trial in a post-grant review. We institute a post-grant review only if the information presented in the petition filed under 35 U.S.C. § 321, if unrebutted, shows that it is more likely than not that at least one claim challenged in the petition is unpatentable. 35 U.S.C. § 324. On the existing record, we conclude that Petitioner demonstrates it is more likely than not that Petitioner would prevail in showing that at least one challenged claim of the ’781 patent is unpatentable under a presented ground. See generally Pet. Therefore, we grant institution of post-grant review. Our reasoning is discussed below.” slip op. at 2

  • PTAB / AIA Trials › Real party in interest / privityDecided for petitioner

    “STANDING Petitioner states that it certifies that: (1) the ’781 patent is available for post grant review because its earliest claimed effective filing date is October 9, 2018, and the patent issued less than nine months ago, on December 3, 2024; and (2) Petitioner is not barred or estopped from requesting a post grant review on the grounds in this petition. Pet. 5. This is sufficient. See 35 U.S.C. § 100(note)(A)–(B), § 321; 37 C.F.R. § 42.204(a). Patent Owner does not contest standing. See generally Prelim. Resp. B. REAL PARTIES-IN-INTEREST Petitioner states that “[t]he real parties-in-interest are Petitioner Straumann USA, LLC and its affiliates Institut Straumann AG and JJGC Indústria e Comércio de Materiais Dentários S.A.” Pet. 3. Patent Owner raises no objection and itself identifies “Smart Denture Conversions, LLC is the real party-in-interest.” Paper 4, 2; see generally Prelim. Resp. C.” slip op. at 3

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “At this point, we find little meaningful difference between the two proposed definitions. In fact, neither does Patent Owner’s witness, Mr. Leinsing, who states that his “opinions would not change under either definition.” Ex. 2011 ¶ 42. And, as set forth above, Patent Owner asserts that, for the sake of its present arguments, it matters not which of the two proposed definitions we use for this proceeding. Prelim. Resp. 21. Thus, at this stage, we accept and use Petitioner’s proposed definition of the ordinarily skilled artisan, which, unlike Patent Owner’s, does not implicate reliance on the knowledge of people other than the individual ordinarily skilled artisan. Petitioner’s definition appears to comport with the level of skill in the art reflected in the prior art of record and the ’781 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he prior art itself [may] reflect[] an appropriate level” of ordinary skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). This issue may be further developed at trial by the parties, if desired. C.” slip op. at 19

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

    “same claim construction standard that is used to construe patent claims in a civil action in federal district court thus, by default, we give claim terms their ordinary and customary meaning, which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” 37 C.F.R. § 42.200(b); Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner indicates that None of the claim terms of claims 1–16 need to be construed to determine the patentability issues presented in this petition. The petition applies the ordinary meaning of the claim language as it would be understood by a POSA after reading the ’781 patent. Ex. 1002, ¶130. Petitioner will propose a construction if Patent Owner argues or the Board determines that one is required for any term. Pet. 31 (citing Ex. 1002). And, Patent Owner presents no express position on claim construction at this point. See generally Prelim. Resp. At this stage of the proceeding, we do not expressly construe any claim terms; however, this position is preliminary and we may change it based on the fully developed record at trial.8 D.” slip op. at 19

  Claim construction§ 103 obviousness§ 112 disclosurecites Graham
  Patents in suitUS 12,156,781
• Straumann USA, LLC v. Smart Denture Conversions, LLCInstituted
  PTAB · Nov 21, 2025 · IPR2025-00956 · APJ Ryan H Flax · IPR · Institution

  The Board instituted IPR on claims 1–12 under all asserted grounds, finding a reasonable likelihood that at least one claim is unpatentable.

  RulingsInstitution decision

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

    “institute trial in an inter partes review. We institute an inter partes review only if the information presented in the petition filed under 35 U.S.C. § 311, and any preliminary response filed under § 313, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314. After reviewing the parties’ submissions in view of the existing record, we conclude that Petitioner demonstrates a reasonable likelihood it would prevail in showing that at least one challenged claim of the ’992 patent is unpatentable under the presented grounds. See Pet. Therefore, we grant institution of inter partes review. Our reasoning is discussed below. A.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “These two proposed definitions of the ordinarily skilled artisan share many consistencies, for example, the types of degrees and experience such a person would have had, but differ in the number of years of experience. Petitioner proposes the ordinarily skilled artisan would have had at least five years of experience and Patent Owner proposes at least three years (which would necessarily include five years, too). Patent Owner also proposes that the ordinarily skilled artisan would have consulted a dentist, oral surgeon, prosthodontist, or periodontist with experience in dental implants and prosthetics. At this point, we find little meaningful difference between the two proposed definitions. In fact, neither does Patent Owner’s witness, Mr. Leinsing, who states that his “opinions would not change under either definition.” Ex. 2011 ¶ 40. Thus, at this stage, we accept and use Petitioner’s proposed definition of the ordinarily skilled artisan, which, unlike Patent Owner’s, does not implicate reliance on the knowledge of people other than the individual ordinarily skilled artisan. Petitioner’s definition appears to comport with the level of skill in the art reflected in the prior art of record and the ’992 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). This parties may further developed this issue at trial, if desired. C.” slip op. at 13

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

    “The Board interprets claim terms in an inter partes review using the same claim construction standard that is used to construe patent claims in a civil action in federal district court. 37 C.F.R. § 42.100(b). In construing claims, district courts and the Board here, by default, give claim terms their ordinary and customary meaning, which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc).” slip op. at 14

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

    “Here, the first claim limitation at issue is broad, i.e., different thread pattern/profile between a definite and a temporary screw, and the Specification’s and priority applications’ disclosure is narrow and specific, asymmetric buttress style threads in a temporary screw and symmetrical threads in a definite screw (are different). Any apparent predictability in or maturity of the relevant field here must be contrasted with the fact that the Specification, considering the ’992 patent itself or any of the identified priority applications, never once even discusses the (claimed) concept of specifically differing the thread style between a temporary and a definitive screw. Any differences in thread style are not called out by the disclosure, but are described and can be discerned only in relation to the respective threads’ functionality, i.e., Fig. 75’s temporary screw 190 has buttress-style threading so it can be pulled out rather than unscrewed from the abutment; Fig. 9’s definitive screw 75 has male threads that fill the female threads of the abutment 8 for a secure permanent engagement. Ex. 1001, 15:23–30, 21:25–44, 23:3–36; Ex. 1012, 97–98, Figs. 9, 75. And, although it is possible for a single disclosed species to provide written description support for a claimed genus, “a sufficient description of a 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; see also Synthes USA, LLC v. Spinal Kinetics, Inc., 734 F.3d 1332, 1344 (Fed. Cir. 2013). That does not appear to be the case here—the present record does not support that the described asymmetrical buttress, serrated style of different temporary screw threading (relative to that of the definitive screw and regardless of the direction of the threads for rotation) is sufficiently representative of the genus’s “different” thread patterns/profiles. See, e.g., Ex. 1006 (a buttress style thread does not function the same as a buttress reverse or 75º joint profile or rounded, or trapezoidal thread).” slip op. at 30

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · Graham
  Patents in suitUS 11,937,992
• Shenzhen Tuozhu Technology Co. Ltd. v. Stratasys, Inc.Institution denied
  PTAB · Oct 6, 2025 · IPR2025-00585 · APJ Lilan Ren · IPR · Institution

  The Board denied institution on claims 1–6, 10–19 because claim 1’s scope is ambiguous and the petition did not show a reasonable likelihood of prevailing on any asserted obviousness ground.

  RulingsInstitution decision

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

    “review. See 35 U.S.C. § 314 (2024); 37 C.F.R. § 42.4(a) (2024). Institution of an inter partes review requires that “the information presented in the petition . . . and any response . . . 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). For the reasons set forth below, we determine that the scope of claim 1 is ambiguous and that there is not a reasonable likelihood that Petitioner will prevail with respect to at least one challenged claim, and we deny inter partes review.1” slip op. at 2

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

    “distinguishes and contrasts build material property from operational parameters. The diagnostic test passage therefore only describes a diagnostic test of the build material property but does not describe a subsequent diagnostic test to assess whether an operational parameter is suitable for the printer. Based solely on the diagnostic test passage and the prosecution history, a possible interpretation may be that the operational parameter determination in claim element 1b encompasses the diagnostic testing in claim element 1c. That is, “performing a diagnostic test to determine whether the operational parameter is suitable for the three-dimensional printer” in claim element 1c is subsumed as part of “determining an operational parameter of a fabrication process using the three-dimensional printer based upon the data, the operational parameter including at least one of a build platform temperature, a build volume temperature, an infill requirement, a rafting requirement, a support structure requirement, and a cooling requirement” in claim element 1b.” slip op. at 15

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

    “benefit of the filing date of an earlier filed application only if the disclosure of the earlier application provides support for the claims of the later application, as required by 35 U.S.C. § 112.” PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306 (Fed. Cir. 2008); see also Research Corps. Techs. v. Microsoft Corp., 627 F.3d 859, 871–72 (Fed. Cir. 2010) (holding that claims of the later-filed application, which were not limited to a “blue noise mask,” were “not entitled to claim the benefit of their parent applications’ filing dates”); ICU Med., Inc. v. Alaris Med. Sys., 558 F.3d 1368, 1377–78 (Fed. Cir. 2009) (holding that “spikeless” claims “added years later during prosecution” were not supported by the specification which “describe[d] only medical valves with spikes”); Tronzo v. Biomet, Inc., 156 F.3d 1154, 1158–60 (Fed. Cir. 1998) (holding the generic shaped cup claims of the later-filed child application were not entitled to the filing date of the parent application that “disclosed only a trapezoidal cup and nothing more”). “To satisfy the written description requirement the disclosure of the prior application must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, [the inventor] was in possession of the invention.” PowerOasis, 522 F.3d at 1306 (emphasis omitted; alteration in original). The sufficiency of written description support is based on “an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc).” slip op. at 20

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person of ordinary skill in the art in the field in the relevant time frame would have had “(1) at least a bachelor’s degree in Mechanical Engineering, Computer Engineering, Chemical Engineering, Materials Science, or a related field, and (2) at least two years of research or industry experience in 3D printing or materials used for 3D printing.” Pet. 5 (citing Ex. 1003 ¶ 20). Petitioner also contends that “[a]dditional experience could substitute for a formal degree or formal training (and vice versa).” Id. (citing the same). Patent Owner contends that an ordinarily skilled artisan “would have had a bachelor’s degree in Mechanical Engineering, Computer Engineering, Electrical Engineering, Chemical Engineering, Materials Science, or a comparable field and at least two years of experience related to 3D printing, with additional experience potentially being a substitute for a formal degree or training (and vice versa).” Prelim. Resp. 12. For purposes of this decision, we adopt Petitioner’s definition of the level of ordinary skill in the art as it appears unopposed and consistent with the disclosures of the ’464 patent and the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9

  Claim construction§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 11,167,464
• Xencor, Inc. v. Merus N.V.Instituted
  PTAB · Sep 26, 2025 · IPR2025-00605 · APJ Tawen Chang · IPR · Institution

  The Board instituted IPR on claims 1–7 and all petitioned grounds, finding a reasonable likelihood that claim 1 is anticipated by Desjarlais or Moore or obvious over Lazar alone.

  RulingsInstitution decision

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

    “SAS, 138 S. Ct. at 1356. Thus, because we determine, based on the arguments and evidence on the present record, that there is a reasonable likelihood Petitioner would prevail with respect to claim 1, we institute an inter partes review of all challenged claims under each Ground presented in the Petition. Id.; see also 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). III. CONCLUSION For the reasons provided above, we find that Petitioner has demonstrated a reasonable likelihood of showing at trial that at least one of the challenged claims of the ’859 patent is unpatentable under at least one ground. Accordingly, we institute inter partes review of all challenged claims based on all the Grounds presented in the Petition.” slip op. at 49

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

    “As Petitioner points out, the cited disclosure in the ’935 provisional does not “mention[] positions 364 and 368 together as a pair of positions for potential mutations on two chains.” Pet. 28 (citing Ex. 1002 ¶¶ 109–19). Although Patent Owner is correct that examples or actual reduction to practice are not required for adequate written description and “[a] specification may . . . contain a written description of a broadly claimed 34 invention without describing all species that [the] claim encompasses,” Prelim. Resp. 15 (quoting Ariad Pharms., 598 F.3d at 1352 and Cordis Corp. v. Medtronic AVE Inc., 339 F.3d 1352, 1365 (Fed. Cir. 2003)), the ’935 provisional must still “reasonably convey[] to those skilled in the art that the inventor[s] had possession of the claimed subject matter” as of the relevant date. Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 127 F.4th 896, 914 (Fed. Cir. 2025); Ariad, 598 F.3d at 1351. In this case, Table A of the ’935 provisional discloses a list of CH3 domain interface residues and identifies, for each interface residue in heavy chain A, the contacting residue in the corresponding chain B. Ex. 1030, 17, Table A. Table A does not, however, describe any particular substitutions or pairs of substitutions that should be made to the CH3 domains. See, e.g., Pet. 28 (citing Ex. 1002 ¶¶ 109–119). Table 7 of the ’935 provisional does identify specific amino acid substitutions in CH3 domains, including substitutions resulting in a positively charged residue at position 364 (e.g., S364K) and a negatively charged residue (e.g., L368D) at position 368. Ex. 1030, 52, Table 7. Patent Owner argues that this table “discloses specific positions for ‘identification of novel charge pair mutants.’” Prelim. Resp. 13 (citing Ex. 2010 ¶ 48). As Petitioner points out, however, while Example 13 of the ’935 provisional relates to identification of novel charge pair mutants, Table 7 itself was only a “first step” in this identification process. Ex. 1030, 51:6–17. In this step, “many interface contact residues in the IgG CH3 domain were scanned one by one or in groups for substitutions that would result in repulsion of 35 identical heavy chains” so that identified substitutions can then be used to generate antibodies “by engineering matched pairs of CH3 residues in one or more IgG heavy chains – CH3 regions” in follow up experiments. Id. Accordingly, Table 7 does not appear to describe heterodimer combinations, such as those that would result from a pairing of chains with different substitutions. Pet. 29–30 (citing, e.g., Ex. 1002 ¶¶ 111–118). As Petitioner further points out, the follow up experiments testing the matched pairs of CH3 residues did not include paired substitutions at positions 364 and 368. Id. at 29–31. Patent Owner points to disclosure in the ’935 provisional describing, as a distinguishing feature of its invention, the substitution of non-charged or neutral amino acids in wildtype CH3 with charged residues, which according to the ’935 provisional has the “advantage that at least one additional charge-charge interaction in the CH3 interface is created.” Prelim. Resp. 12 (citing, e.g., Ex. 2010 ¶¶ 42–48). For the same reasons discussed above, Petitioner has sufficiently established, for purposes of institution, that such disclosure would not reasonably convey to an ordinarily skilled artisan that the inventors had possession of the entire genus of heterodimeric antibodies comprising CH3 domains wherein a non-charged amino acid is replaced with a charged residue so as to create an additional charge-charge interaction in the CH3 interface. In this regard, we also note that “a description that merely renders the invention obvious does not satisfy the [written description] requirement.” Ariad, 598 F.3d at 1352.” slip op. at 34

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artDecided for petitioner

    “adequately describes a heterodimeric antibody comprising the recited charged residues at the recited positions of the CH3 domains, i.e., “a positively charged amino residue at position 364” at a first CH3 domain and “a negatively charged amino acid residue at position 368” of the second CH3 domain. Having considered the evidence of record at this preliminary stage of the proceeding, and for the reasons set forth below, we are persuaded that Petitioner has shown sufficiently, for purposes of institution, that the ’935 provisional does not provide adequate written description support for claim 1 of the ’859 patent and that, accordingly, Desjarlais and Moore qualify as prior art to that claim. As Petitioner points out, the cited disclosure in the ’935 provisional does not “mention[] positions 364 and 368 together as a pair of positions for potential mutations on two chains.” Pet. 28 (citing Ex. 1002 ¶¶ 109–19). Although Patent Owner is correct that examples or actual reduction to practice are not required for adequate written description and “[a] specification may . . . contain a written description of a broadly claimed 34 invention without describing all species that [the] claim encompasses,” Prelim. Resp. 15 (quoting Ariad Pharms., 598 F.3d at 1352 and Cordis Corp. v. Medtronic AVE Inc., 339 F.3d 1352, 1365 (Fed. Cir. 2003)), the ’935 provisional must still “reasonably convey[] to those skilled in the art that the inventor[s] had possession of the claimed subject matter” as of the relevant date. Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 127 F.4th 896, 914 (Fed. Cir. 2025); Ariad, 598 F.3d at 1351.” slip op. at 34

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

    “The ’859 patent does not provide an explicit definition of “immunoglobulin class.” Nevertheless, we do not construe that term to require “two heavy chains with four domains, VH, CH1, CH2, and CH3, and two Fab arms.” As an initial matter, the Specification teaches that antibodies include, 16 e.g., IgE and IgM — which have an additional CH4 domain in their heavy chains — as well as functional derivatives and/or fragments of known antibody isotypes. Ex. 1001, 11:44–48. Patent Owner’s proposed construction, which limits antibodies to those having two Fab arms and “two heavy chains with four domains, VH, CH1, CH2, and CH3,” excludes these embodiments and cannot be correct. Moreover, the ’859 patent defines antibody as containing “one or more domains” that bind an epitope on an antigen. Ex. 1001, 11:39–44. Thus, an antibody does not require two Fab arms as in a native immunoglobulin molecule.12 The ’859 patent also describes a preferred embodiment as “Ig-like molecules.” Id. at 11:49–52. Thus, we look to the definition of “Ig-like molecule” in the ’859 patent, i.e., “a proteinaceous molecule that possesses at least one immunoglobulin (Ig) domain,” to inform our understanding of the phrase “immunoglobulin class of proteins.” Ex. 1001, 11:4–6. Accordingly, we further construe “immunoglobulin class of proteins” to mean proteinaceous molecules comprising at least one domain that is derived from or shares sequence homology with an immunoglobulin domain.” slip op. at 16

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 11,926,859
• 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
• AT&T Mobility LLC / AT&T Services Inc. et al. v. Daingean Technologies Ltd.No claims unpatentable
  PTAB · Jul 14, 2025 · IPR2024-00402 · APJ Mary C Hoffman · IPR · Final written decision

  The Board granted Patent Owner’s revised non-contingent motion to amend, canceling claims 1–4 and substituting claims 7 and 8, which Petitioner did not prove unpatentable.

  RulingsFinal written decision

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted

    “whether the motion to amend meets the statutory and regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121.” See Lectrosonics, Inc. v. Zaxcom, Inc., IPR2018-01129, Paper 15 at 4 (PTAB Feb. 25, 2019) (precedential). A “patent owner bears the burden of persuasion to show, by a preponderance of the evidence, that the motion to amend complies” with the applicable statutory and regulatory requirements. 37 C.F.R. § 42.121(d)(1). Specifically, a patent owner must demonstrate the following: (1) the amendment proposes a reasonable number of substitute claims; (2) the amendment responds to a ground of unpatentability involved in the trial; (3) the amendment does not seek to enlarge the scope of the claims of the patent; and (4) the amendment does not introduce new matter. See 35 U.S.C. § 316(d); 37 C.F.R. § 42.121(a)–(b). For the reasons explained below, Patent Owner satisfies its burden of persuasion to show that the amendments comply with the applicable statutory and regulatory requirements.” slip op. at 8

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Both parties rely on expert testimony for their respective positions relating to the number of years of experience needed to attain ordinary skill, but neither expert cites supporting evidence for their testimony. See Ex. 1002 ¶ 33; Ex. 2002 ¶ 15. Our decision is the same regardless of whether the length of experience is two years or three. We find Patent Owner’s proposed “wireless communications” is more consistent with the ’958 patent than Petitioner’s proposed “telecommunication,” which encompasses a variety of technologies including, e.g., landline and wireless telephones, cable, and satellite. See Ex. 1001, 1:11–62 (describing the invention in terms of wireless communications). Accordingly, we adopt a modified version of Petitioner’s proffered level of ordinary skill in the art, substituting “wireless communications” for “telecommunication.” Neither party, moreover, indicates the overall result would change based on a different definition.” slip op. at 18

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

    “We agree with Patent Owner that the recited second type SIBs exclude first type SIBs. The plain meaning of “first type” and “second type” indicates that the first type and second type are different in kind. RMTA 22 (App. A). Our interpretation is consistent with the Specification, which explains that second type SIBs exclude first type SIBs. As Patent Owner points out, the ’958 patent discloses “first type of system information (1TYP SIB) is . . . essential . . . for initial system access” and “second type of system information (2TYP SIB) is nonessential system information . . . defined as all other types of information, and thus excludes the [] information required for initial access.” Id. at 11–12 (citing Ex. 1001, 8:34– 46); see also Ex. 1001, Abstract (interchangeably using the terms second type and non-essential). Despite Petitioner’s argument that this disclosure is non-limiting and directed to a disclaimed example embodiment (Opp. 8–9), Petitioner could not identify any embodiment, among the approximately forty disclosed embodiments, describing something other than the first type SIB being essential information and the second type SIB being non-essential information. Tr. 22:18–26. Even the Petition acknowledges that “the ’958 Patent further classifies a second type of system information, the ‘non-essential’ SI, which is defined as all other types of information excluding that first type of information required for initial access.” Pet. 5. Furthermore, the prior art of record suggests that a person of ordinary skill would have understood second type SIBs exclude first type SIBs. See Ex. 1008 ¶ 48 (describing two categories of system information, “essential SI” and “Other SI”). Patent Owner’s expert also understood the recited first and second type SIBs as being mutually exclusive. See Ex. 1011, 49:10–13. For the above reasons, we do not agree with Petitioner that the recited second type SIB lacks any requirements, nor do we interpret claims 7 and 8 such that the first type SIB could be a second type SIB.” slip op. at 19

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

    “(d) Limitation 7h: Analysis We agree with Patent Owner that Petitioner’s arguments with respect to limitation 7h are insufficient because they fail to address the limitation as written and improperly incorporate previous arguments by reference. For example, Petitioner did not map the recited “group identifier” when opposing Patent Owner’s Revised Motion to Amend. See Opp. 16–17. In its Sur-reply, Petitioner contends that limitation 7h’s requirement of transmitting the group identifier was previously “set out in Patent Owner’s prior papers,” but does not refer to any specific papers or exhibits. Pet. Surreply 11–12. We decline to search for and piece together Petitioner’s arguments and evidence to develop a persuasive theory of unpatentability. See 37 C.F.R. section 42.6(a)(3). Petitioner similarly failed to address adequately where Lee discloses or suggests the recited “compressed format” and “plural parameters.” See Opp. 16–17. Aside from the above concerns, we also do not see sufficient explanation with respect to limitation 7h’s requirement that the transmitting by broadcast be based on a comparison of the value tag. Petitioner argues that, because Patent Owner does not dispute limitation 7g, “it would have been obvious to a POSITA to use the same value tag[] to determine the system information broadcast in Lee’s compressed format embodiment.” Pet. Sur-reply 12. This conclusory statement is not supported by any citations to evidence and was improperly introduced in the Sur-reply. Moreover, whether it was obvious to determine what system information is broadcast is not commensurate with the claim scope because limitation 7h requires that the broadcasting (not the broadcast content) be based on a comparison of the value tag. See supra III.B.4 and IV.B. Further, we are not persuaded that Lee’s transmitting by broadcast is” slip op. at 26

  Patent outcomesUS 10,841,958 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · Nautilus
  Patents in suitUS 10,841,958
• 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

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.