• GE Healthcare Ltd. v. The Johns Hopkins UniversityInstituted
  PTAB · Jan 14, 2026 · PGR2025-00059 · APJ Devon Zastrow Newman · PGR · Institution

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

  RulingsInstitution decision

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

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

  • Skill levelSkill level petitioner adoptedDecided for petitioner

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

  • Expert testimonyPetitioner expert discountedDecided for patent owner

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

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

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

  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 12,115,233
• Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Maxell LtdNo claims unpatentable
  PTAB · Oct 31, 2025 · IPR2024-00777 · APJ Jameson Lee · IPR · Final written decision

  Claims 16–27 were not shown unpatentable because Petitioner failed to account for limitations 16[b] and 16[i] and their counterparts across the asserted obviousness grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner proposes that a person of ordinary skill in the art “would have a Bachelor of Science degree in Electrical Engineering, Computer Engineering, Computer Science, Human Computer Interaction, or a related technical field, with at least one year of experience working in the field of user interfaces and/or content management.” PO Resp. 11 (citing Ex. 2040 ¶ 53). The Decision on Institution adopted Petitioner’s proposed level of ordinary skill in the art. Inst. Dec. 10. We find Patent Owner’s stated level to be less precise than that proposed by Petitioner in that the modifier “at least” used by Patent owner imposes no upper bound on the amount of experience possessed by one of ordinary skill in the art. Also, Patent Owner states: “The difference between the Board’s definition and Patent Owner’s (EX2040. ¶53) does not change the arguments set forth herein.” PO Resp. 11. Thus, we continue to adopt Petitioner’s stated level of ordinary skill in the art.4 4 All of our findings and conclusions would still be the same, however, had we applied Patent Owner’s articulation of the level of ordinary skill in the art.” slip op. at 8

  • Prior constructionPrior construction adoptedDecided for patent owner

    “In its Reply, Petitioner does not assert that the district court’s construction is incorrect. We agree with Patent Owner that the district court’s construction is better than Petitioner’s proposed construction, because for reasons indicated by Patent Owner, which are not disputed by Petitioner, settings in the computer, e.g., dedicated folders for each user are the user profiles, rather than simply data alone of any kind. Further, when asked about the appropriateness of the district court’s construction, counsel for Petitioner expressed that Petitioner has no objection to the Board’s adopting the district court’s construction for “user profile”: JUDGE LEE: So, you’d be fine with just going with the District Court’s construction? MR. HEINTZ: Yes, Your Honor. Tr. 15:22–24. For the foregoing reasons, we adopt the district court’s construction for “user profile,” i.e., “a collection of settings and information associated with a user.”” slip op. at 13

  • BurdenNot shown unpatentable

    “PO Resp. 30–31 (Figure 26 omitted). In its Reply, Petitioner still does not provide an articulated reason for placing user profile selection buttons, labeled with user names, within Horn’s panes 2601 or 2602. Reply 12–14. Although Horn does describe personalized profile, Petitioner points to no disclosure of Horn as to how a user would have selected his or her own profile from among a plurality of user profiles. Petitioner presents no reason for placing these user profile selection buttons, labeled with user names, gleaned from or suggested by Baumgartner, within either pane 2601 or pane 2602 in Horn’s workspace view. Further, pane 2602 contains “a list of all collections defined by MFS and the user,” and pane 2601 lists the source examined by the user to create his or her collections. Ex. 1005, 19:41–46. That disclosure suggests the contents of panes 2601 and 2602 are tied to one particular user. No rational basis is articulated by Petitioner to place user profile selection buttons within these panes which appear to be in the profile space of one user. For the foregoing reasons, Petitioner has not adequately accounted for limitation 16[b].” slip op. at 22

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

    “The test for sufficiency of a written description under 35 U.S.C. § 112 is whether the earlier application’s disclosure “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The specification must “clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.” Id. The Court of Appeals for the Federal Circuit has explained: One shows that one is “in possession” of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious. Id. (“[T]he applicant must also convey to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.”) (emphasis in original). One does that by such descriptive means as words, structures, figures, diagrams, formulas, etc., that fully set forth the claimed invention. Although the exact terms need not be used in haec verba, see Eiselstein v. Frank, 52 F.3d 1035, 1038, 34 USPQ2d 1467, 1470 (Fed.Cir.1995) (“[T]he prior application need not describe the claimed subject matter in exactly the same terms as used in the claims. . . .”), the specification must contain an equivalent description of the claimed subject matter. A description which renders obvious the invention for which an earlier filing date is sought is not sufficient. Lockwood v. American Airlines, Inc., 107 F.3d 1565 (Fed. Cir. 1997).” slip op. at 31

  Patent outcomesUS 11,017,815 not shown unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 11,017,815
• Microchip Technology Inc. v. Aptiv Technologies AGInstituted
  PTAB · Jul 15, 2024 · PGR2024-00011 · APJ Jean R Homere · PGR · Institution

  The Board instituted PGR on claims 1–15 and all asserted grounds, finding a reasonable likelihood that at least claim 1 is obvious over Chang, Chang II, and POSITA knowledge.

  RulingsInstitution decision

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

    “review. 35 U.S.C. § 324(a) (2018); 37 C.F.R. § 42.4(a) (2023) (“The Board institutes the trial on behalf of the Director.”). Section 324(a) provides that a post-grant review may not 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.” Upon considering the evidence and arguments in the Petition (including its supporting testimonial evidence) and the evidence and arguments in the Preliminary Response (including its supporting testimonial evidence), we determine that the information presented shows that it is more likely than not that Petitioner would prevail with respect to at least one of the challenged claims. Accordingly, we institute post-grant review on all” slip op. at 2

  • Other 314aDenied

    “Petitioner hereby stipulates that, if the PTAB institutes this post-grant review, Petitioner will not pursue invalidity of the Challenged Claims in a parallel district court proceeding on the same grounds or any grounds that could have reasonably been raised before the PTAB in this Petition. Pet. 106. Petitioner cites the Director’s Memorandum, Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation, issued June 21, 2022 (“Guidance Memo”)3 in support of its contentions. Pet. 106.” slip op. at 11

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied

    “§ 325(d), the Board uses the following two-part framework: (1) determining whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. Med-El Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential). In applying the two-part framework, we consider several non-exclusive factors, including: (a) the similarities and material differences between the asserted art and the prior art involved during examination; (b) the cumulative nature of the asserted art and the prior art evaluated during examination; (c) the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection; (d) the extent of the overlap between the arguments made during examination and the manner in which petitioner relies on the prior art or patent owner distinguishes the prior art; (e) whether petitioner has pointed out sufficiently how the examiner erred in its evaluation of the asserted prior art; and (f) the extent to which additional evidence and facts presented in the petition warrant reconsideration of the prior art or arguments. Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to Section III.C.5, first paragraph) (“Becton, Dickinson”). Becton, Dickinson factors (a), (b), and (d) relate to whether the art or arguments presented in the Petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, Paper 6 at 10. Factors (c), (e), and (f) “relate to whether the petitioner has demonstrated a material error by the Office” in its prior consideration of that art or arguments. Id. Only if the same or substantially the same art or arguments were previously presented to the Office do we consider whether the petitioner has demonstrated a material error by the Office. Id. “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9.” slip op. at 14

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “At the time of the invention, a POSITA would have had a bachelor’s degree in computer science, electrical engineering, or an equivalent, and two years of professional experience working with computer network protocols such as USB. Lack of work experience can be remedied by additional education, and vice versa. Id. (citations omitted). At this stage, we find Patent Owner’s proposed level of a POSITA to be consistent with the problems and solutions disclosed in the ’643 patent and prior art of record, and adopt it as our own for purposes of this Decision. See, e.g., In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (approving the determination of the level of ordinary skill in the art by appeal to the references of record). We nonetheless invite the parties to further address this issue, if they deem it necessary and appropriate. The parties should also specifically explain how different definitions for one of ordinary skill in the art relate to specific arguments and issues of unpatentability or claim construction, to the extent that a dispute remains as to who constitutes a POSITA.” slip op. at 20

  Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · Graham · Nautilus
  Patents in suitUS 11,681,643
• Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentable
  PTAB · Jun 11, 2024 · IPR2022-01602 · APJ Devon Zastrow Newman · IPR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

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

  • Expert testimonyPetitioner expert creditedDecided for petitioner

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

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

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

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

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

  Patent outcomesUS 9,956,087 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 9,956,087
• Intel Corporation v. Ax Wireless, LLCInstitution denied
  PTAB · Mar 5, 2024 · IPR2023-01146 · APJ Michael T Cygan · IPR · Institution

  The Board denied institution on all grounds because Petitioner did not show Huang or Sun was prior art to claims 1–10, which it argued were obvious over those references.

  RulingsInstitution decision

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

    “II. ANALYSIS A. Legal Standards Petitioner bears the burden to demonstrate unpatentability. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). For purposes of institution, Petition bears the burden to establish, by a reasonable likelihood that at least one of the challenged claims would have been obvious over the cited art. See 35 U.S.C. § 314(a). Where unpatentability rests on a document that is prior art to a challenged patent but for that patent’s priority claim to an earlier effective filing date, such a priority claim is not presumed valid. PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1305 (Fed. Cir. 2008) (noting that the USPTO does not routinely determine whether such priority claims meet the requirements of 35 U.S.C. § 120).” slip op. at 5

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “understanding of a person of ordinary skill in the art at the time of the invention. Id. at 13, 17. Petitioner asserts that a person of ordinary skill in the art would have had at least a Master’s degree in electrical engineer-ing or a similar discipline, and/or at least two to three years of experience working or conducting research in wireless commu-nication protocols, or an equivalent combination of education and experience. Pet. 6 (citing Ex. 1003 ¶¶ 71, 72). Patent Owner does not contest Petitioner’s assertion as to the level of ordinary skill in the art. Prelim. Resp. 6. We are persuaded, on the present record, that Petitioner’s proposal is consistent with the problems and solutions in the ’146 patent and prior art of record. We adopt Petitioner’s definition of the level of skill for the purposes of this Decision.” slip op. at 6

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

    “action under 35 U.S.C. § 282(b), including construing the claim in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent. 37 C.F.R. § 42.100(b) (2022). The Board is required to construe “only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.” Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Petitioner and Patent Owner, in extended briefing, contest the construction of the phrase “detecting, from the received wireless packet, the second header field which repeats the first header field,” as it appears in claim 1. Pet. 9; Prelim. Resp. 1; Pet. Reply 3; PO Sur-Reply 3. However, both parties appear to agree that the plain and ordinary meaning of the term should apply. See Pet. 6; Prelim. Resp. 15. Further, Petitioner has clarified that its statements as to the scope of the term are directed to its assertions that the ’146 patent lacks support for the claimed subject matter in its parent applications. Pet. Reply. 5–6. Consequently, we address claim construction arguments in their context of the parties’ priority contentions. See infra at II.D.1.” slip op. at 7

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

    “Patent Owner has shown sufficient written description support for the claims, including the disputed “detecting” limitation. The “decode-to-learn- ‘D’” description in the specification of the ’146 patent and in the provisional application to which the ’146 patent claims priority describe a specific procedure for the claimed “detecting, from the received wireless packet, the second header field which repeats the first header field.”3 See Ex. 1001, 2 Petitioner specifically asserts that Huang qualifies under 35 U.S.C. §102(b). Pet. 2, 19 (“by more than a year”). However, Huang’s patent issuance date of April 28, 2020 does not qualify under § 102(b) because it is less than one year before the December 29, 2020 filing date of the ’146 patent. Nevertheless, Petitioner has made an effective showing that Sun would qualify as prior art sufficient to shift the burden of production to Patent Owner. 3 Patent Owner does not explicitly show support for each of the applications in the priority chain. Patent Owner also cites to a Pre-Grant Publication rather than the underlying application despite the fact that such a Publication may include amendments to the originally filed application that would not evidence written description. See 37 C.F.R. § 1.215 (a); MANUAL OF PATENT EXAMINING PROCEDURE §1121; Ex. 2003, 7 (showing amendments 3:1–11; Ex. 2001 ¶ 35; Ex. 1008, 5–6; PO Sur-Reply 6. The “D” information is received in the wireless packet, and the receiver determines therefrom whether there is a second header field that repeats the first header field. See Ex. 1008, 5–6; PO Sur-Reply 6. The written description further includes descriptions of other embodiments for receiver detection with variable repetition, including detection “without knowing D a priori.” Ex. 1001, 2:18–3:59.” slip op. at 9

  Claim construction§ 112 disclosure
  Patents in suitUS 11,212,146
• Neuroderm Ltd. v. Abbvie Inc.Other
  PTAB · Oct 31, 2023 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Final written decision

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

  RulingsFinal written decision

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

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

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

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

  • ExcludeMotion to exclude, deniedDenied

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

  • Strike new argumentNew argument consideredDenied

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

  § 112 disclosure
  Patents in suitUS 11,091,507
• Inari Agriculture, Inc. v. Corteva Agriscience LLCInstituted
  PTAB · Oct 13, 2023 · PGR2023-00022 · APJ Devon Zastrow Newman · PGR · Institution

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

  RulingsInstitution decision

  • Skill levelSkill level board ownOther

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

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

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

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

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

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

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

  § 112 disclosureDiscretionary denial
  Patents in suitUS 11,371,055
• Truist Bank v. United Services Automobile AssociationInstitution denied
  PTAB · May 16, 2023 · IPR2023-00144 · APJ Terrence W Mcmillin · IPR · Institution

  The Board denied institution on all challenged claims because Oakes supports the claimed mobile device, is not prior art, and the petition therefore did not meet the reasonable-likelihood threshold.

  RulingsInstitution decision

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

    “inter partes review may not be instituted unless the information presented in the Petition and the Preliminary 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) (2018); 37 C.F.R. § 42.4(a) (“The Board institutes trial on behalf of the Director”).” slip op. at 2

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

    “Prelim. Resp. 24–26. We determine that this argument and evidence is more persuasive and better supported than Petitioner’s contrary arguments and evidence. We determine that Patent Owner’s position that a skilled artisan in the relevant time frame would have found clear support for the full-scope of the invention claimed including a “mobile device” as recited and construed as a “handheld computing device” is well-supported. In contrast, Petitioner’s argument and evidence are based on an improper claim construction and lack substantial supporting evidence. For these reasons, we determine that Oakes does provide written description support for “mobile device” as recited in the challenged claims of the ’432 patent and the ’432 patent is entitled to claim priority to the filing date of the application that issued as Oakes. As a result, Oakes is not prior art to the ’432 patent and all the challenges in the Petition fail because they rely on Oakes as prior art.” slip op. at 28

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

    “On this record and for purposes of deciding whether to institute trial, we construe “mobile device” as “handheld computing device,” because both parties ask us to adopt the District Court’s claim construction. 8 We do not 8 Petitioner does not dispute that we should “adopt[ ] the claim constructions [Patent Owner] advanced and the Court adopted in [the PNC Litigation].” include the phrase “excluding laptops” as part of this construction as the arguments in support of this construction in the Petition are contradicted by the evidence and Petitioner has otherwise failed to support the inclusion of this phrase in the construction.” slip op. at 18

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner’s proposal is consistent with the technology described in the Specification of the ’432 patent and the cited prior art. For that reason, and in order to determine whether Petitioner has demonstrated a reasonable likelihood of showing the unpatentability of at least one of the challenged claims, we adopt Petitioner’s proposed level of skill in the art.” slip op. at 13

  Claim construction§ 112 disclosurecites Phillips
  Patents in suitUS 10,482,432
• Risen (Suzhou) Pharma Tech. Co. Ltd. v. Alzheon, Inc.Institution denied
  PTAB · Jan 13, 2023 · PGR2022-00051 · APJ Jamie T Wisz · PGR · Institution

  The Board denied institution on all challenged claims, finding no reasonable likelihood of unpatentability under §§ 101 and 112(a), and denying Grounds 4–6 under § 325(d).

  RulingsInstitution decision

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

    “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.” Upon considering the arguments and evidence, we determine that the information presented fails to demonstrate it is more likely than not that at least one of the challenged claims of the ’742 patent is unpatentable for ineligibility, lack of written description, or non-enablement. We also exercise our discretion to deny institution of post-grant review under 35 U.S.C. § 325(d). slip op. at 2

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

    “tramiprosate “showed a significant overall treatment effect” in “an APOE4+ sub-group,” including APOE4 homozygotes; “therapeutic interventions applied earlier in the course of AD more likely might achieve the goal of disease modification;” and that “AD would be optimally treated before significant cognitive impairment, during its pre-symptomatic or pre-clinical stages …”) (emphases removed). Accordingly, Caltagirone was previously presented to the Office and we also find that Caltagirone’s disclosures are substantially similar to, or cumulative of, other references previously considered by the Examiner.” slip op. at 49

  • Adverse judgmentAdverse judgmentOther

    “D. Statutory Disclaimer After the filing of the Petition in this proceeding, Patent Owner filed a statutory disclaimer, disclaiming claims 9 and 11–15 of the ’742 patent, effective October 7, 2022. Prelim. Resp. 12; Ex. 2001, 1. “No post-grant review will be instituted based on disclaimed claims.” 37 C.F.R. § 42.207(e). We do not analyze the validity of claims 9 and 11–15 based on Petitioner’s challenges (e.g., Grounds 2 and 3) because these claims have been statutorily disclaimed.” slip op. at 5

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “at least an M.D. or Ph.D. degree in a biomedical science or equivalent field. They would also have several years of clinical experience treating and/or conducting clinical trials of drugs for AD patients, or professional experience working in clinical trial design and execution related to drugs for AD or supervising such work. Pet. 14–15 (citing Ex. 1003 ¶ 62) (internal citation omitted). Patent Owner does not contest the characterization offered by Petitioner. Prelim. Resp. 12–13. For purposes of this Decision, we adopt Petitioner’s characterization as it is consistent with the level of skill in the art at the time of the invention as reflected by the ’742 patent and the cited 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§ 101 eligibility§ 112 disclosureDiscretionary denialcites Alice · Mayo · Graham
  Patents in suitUS 11,191,742
• Neuroderm Ltd. v. Abbvie Inc.Instituted
  PTAB · Nov 14, 2022 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Institution

  The Board instituted PGR on claims 1–17 based on all asserted grounds, finding the petition showed they more likely than not lacked written description support and enablement.

  RulingsInstitution decision

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

    “For the reasons explained below, we find that Petitioner has met the threshold showing for post-grant review of claims 1–17 with respect to the first challenge (written description support for the claimed genus). On that basis, we institute post-grant review of all challenged claims. See SAS Institute Inc. v. Iancu, 138 S. Ct. 1348, 1358 (2018); 37 C.F.R. § 42.208(a) (“When instituting post-grant review, the Board will authorize the review to proceed on all of the challenged claims . . . .”). We address this challenge first, then provide the parties guidance on Petitioner’s second written description challenge (support for carbidopa itself).” slip op. at 19

  • Skill levelSkill level board ownOther

    “Ex. 1006, 1 (citations omitted). Accordingly, when considering the ’507 patent’s purpose, the type of problems encountered in the art, and prior art solutions to those problems, it is clear that with respect to levodopa/carbidopa treatments for Parkinson’s Disease, the pharmaceutical formulation and its resulting pharmacokinetics and patient experience are intertwined, thus supporting a requirement that a person of ordinary skill in the art have knowledge or experience in each of these areas. See, e.g., Indivior Inc. v. Dr. Reddy’s Labs., S.A., 930 F.3d 1325, 1345 (Fed. Cir. 2019) (finding no clear error in district court’s compromise measure of level of ordinary skill in the art as a team comprising different skill sets). In view of the above considerations, we preliminarily find that a person of ordinary skill in the art would be a member of a team that includes person(s) with (a) a Ph.D. in a field related to the development of pharmaceuticals (for example, pharmacology, pharmacokinetics, pharmaceutics, pharmaceutical chemistry, organic chemistry, biochemistry, molecular biology, medicinal chemistry, formulation development, or a related field), or equivalent degree, and 2–4 years of experience in the analysis of pharmacokinetic data, pharmaceutical formulation development, and/or drug discovery or development, or a B.S. or M.S. degree in a field related to the development of pharmaceuticals, or equivalent degree, and 4–6 years of experience in the analysis of pharmacokinetic data, pharmaceutical formulation development, and/or drug discovery or development, and (b) a medical degree or equivalent degree with experience in treating patients with Parkinson’s disease. In subsequent briefing, should the parties propose any differences from the team approach articulated above, they should support their proposal and address the impact, if any, of the differences on the pertinent disputes in this proceeding. Any final determination on the level of ordinary skill in the art will be made on the full trial record.” slip op. at 15

  • Expert testimonyPetitioner expert creditedOther

    “Additionally, based on their statements of qualifications and curricula vitae, for purposes of this Decision we find Drs. LeWitt and Sloan qualified to provide technical opinions from the perspective of a person of ordinary skill in the art. Ex. 1003 ¶¶ 1–10, pp. 87–119 (Dr. LeWitt’s statement of qualifications and curriculum vitae); Ex. 1004 ¶¶ 1–11, pp. 45–71 (Dr. Sloan’s statement of qualifications).” slip op. at 16

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “We agree with the parties that the express definition provided during prosecution should be adopted. See, e.g., Biotec Biologische Naturverpackungen GmbH v. Biocorp, Inc., 249 F.3d 1341, 1346–47 (Fed. Cir. 2001) (construing claims in accordance with definition provided in declarations submitted during prosecution). Accordingly, we preliminarily construe the term “a compound comprising levodopa” in accordance with the full definition Dr. Okun provided during prosecution, i.e., “any molecule with a levodopa core moiety including levodopa itself, as well as prodrugs, salts, and hydrates of levodopa.”” slip op. at 17

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · Graham
  Patents in suitUS 11,091,507

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.