• 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. v. Anonymous Media Research Holdings, LLCInstitution denied
  PTAB · Mar 24, 2025 · IPR2024-01349 · APJ Frederick C Laney · IPR · Institution

  The Board denied institution because claims 1–13 are entitled to the May 26, 2005 priority date, making the asserted references not prior art and the obviousness grounds unlikely to prevail.

  RulingsInstitution decision

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

    “to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016); see also 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”). This burden of persuasion never shifts to the patent owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). Thus, if Petitioner has not satisfied the threshold reasonable likelihood standard for institution, then institution will be denied. See id. at 1378–1379.” slip op. at 8

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

    “disclosed in the manner provided by the first paragraph of section 112 of this title in an application previously filed in the United States . . . shall have the same effect, as to such invention, as though filed on the date of the prior application.” (emphasis added). “In essence, this means that in a chain of continuing applications, a claim in a later application receives the benefit of the filing date of an earlier application so long as the disclosure in the earlier application meets the requirements of 35 U.S.C. § 112, ¶ 1, including the written description requirement, with respect to that claim.” Technology Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1326 (Fed. Cir. 2008). And to determine whether a parent application meets the written description requirement, “the disclosure must be considered as a whole, as the person of ordinary skill in the art would read it, to determine if it reasonably conveys possession” of the claimed invention. Allergan USA, Inc. v. MSN Labs. Private Ltd., 111 F.4th 1358, 1375 (Fed. Cir. 2024) (citation and emphasis omitted); see also Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345–46 (Fed. Cir. 2000) (the purpose of the written description requirement “is to ensure that the scope of the right to exclude . . . does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification”).” slip op. at 9

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

    “A claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the claimed subject matter and the prior art are such that the subject matter, as a whole, “would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) if presented, objective evidence of non-obviousness. See Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). As previously noted, the first factor regarding the scope of available prior art is the dispositive issue of this Petition, which is largely defined by the effective filing date of the challenged claims.” slip op. at 8

  • PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Denied

    “Because we determine that no inter partes review will be instituted on IPR2024-01350, we find it unnecessary to exercise exclusive jurisdiction over the ’849 patent. See Paper 9, 9. Therefore, Petitioner’s motion for the Board to exercise exclusive jurisdiction over the ’849 patent is denied. Petitioner further requests that all briefing in this proceeding be provided to the Certificates of Correction and Petitions branches for their consideration, citing Patent Owner’s “duties of candor and good faith.” Id. at 2, 10. However, in view of our determination not to institute review in this proceeding, we defer to the Certificates of Correction and Petitions branches to carry out their duly authorized duties. Honeywell Int’l Inc. v. Arkema Inc., 939 F.3d 1345, 1349 (Fed. Cir. 2019).” slip op. at 23

  § 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 10,719,849
• Samsung Electronics Co., Ltd v. Anonymous Media Research Holdings, LLCInstitution denied
  PTAB · Mar 21, 2025 · IPR2024-01350 · APJ Michael T Cygan · IPR · Institution

  Institution was denied for claims 1–15 because Petitioner did not show the asserted references were prior art; the claims were supported by the ’330 application’s 2005 filing date.

  RulingsInstitution decision

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

    “To prevail on its obviousness challenges, Petitioner must show that the ’848 patent is not entitled to the benefit of the ’330 application. This issue is dispositive because none of the references relied on by Petitioner qualify as prior art if the ’848 patent is entitled to the benefit of the May 26, 2005, filing date of the ’330 application. Pet. 6, 13. We start by explaining why Petitioner bears the burden of persuasion.” slip op. at 9

  • BurdenDecided for patent owner

    “1. The Burden of Persuasion “In an inter partes review . . ., the petitioner shall have the burden of proving a proposition of unpatentability by a preponderance of the evidence.” 35 U.S.C. § 316(e). That burden, termed the burden of persuasion, “is the ultimate burden assigned to a party who must prove something to a specified degree of certainty.” Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d 1375, 1378 (quoting Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1326–27 (Fed. Cir. 2008)). That burden never shifts to the patentee. Id. at 1379. In order for an inter partes review to be instituted, “the information presented in the petition filed under section 311 and any response filed under section 313 [must] show[] that there is a reasonable likelihood that the petitioner would prevail.” 35 U.S.C. § 314(a).” slip op. at 9

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

    “d) Analysis Petitioner has not shown a reasonable likelihood that it would prevail in showing that its asserted references, including Steuer 750 which is a publication of the ’330 application, are prior art to the ’848 patent. Petitioner has not shown that the ’330 application fails to provide written description support for claim 1 of the ’848 patent, which recites “video data” samples and representations.” slip op. at 16

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

    “a chain of priority from the ’330 application to the ’848 patent contain at least the same disclosure as the ’330 application, Petitioner has not shown that the ’848 patent should not be given the benefit of the effective filing date of the ’330 application. The May 26, 2005 filing date of the ’330 application predates the December 1, 2005 publication date of Steuer 750, the August 13, 2013 issue date of Steuer 768, and the December 2, 2010 and May 27, 2010 publication and filing dates of Neumeier.10 Pet. 7; Ex. 1005, code (43); Ex. 1006, code (45); Ex. 1007, codes (43), (60).11 Therefore, Petitioner has not shown by a preponderance of the evidence that any of the asserted claims in the ’848 patent would have been obvious over the asserted combinations of Steuer 750, Steuer 768, and Neumeier.” slip op. at 22

  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 10,719,848
• 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
• Sophos Ltd. / Sophos Inc. v. Open Text Inc.Institution denied
  PTAB · Nov 29, 2023 · PGR2023-00031 · APJ Barbara A Parvis · PGR · Institution

  The Board denied institution because Petitioner did not show that any challenged claim was more likely than not unpatentable over the asserted obviousness or indefiniteness grounds.

  RulingsInstitution decision

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

    “review under 35 U.S.C. § 324 and 37 C.F.R. § 42.4. 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.” 35 U.S.C. § 324 (2018). Having considered the arguments and evidence presented by Petitioner and Patent Owner, we determine that Petitioner has not demonstrated that it is more likely than not that at least one of the claims challenged in the patent is unpatentable. Accordingly, we do not institute a post-grant review of the challenged claims of the ’869 patent.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Pet. 10 (citing Ex. 1004 ¶ 16). Patent Owner does not dispute Petitioner’s proposal. Prelim. Resp. 33. Considering the subject matter of the ’869 patent, the background technical field, and the asserted prior art, we agree with Petitioner’s proposed qualifications for an ordinary level of skill, except we decline to adopt “at least” as that language is vague and open-ended. Otherwise, Petitioner’s proposed definition is consistent with the level of skill reflected in the Specification of the ’869 patent and the asserted prior art references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Accordingly, for purposes of this Decision, and based on the current record, except as noted above, we adopt Petitioner’s assessment of the level of skill for one of ordinary skill in the art.” slip op. at 13

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

    “We agree with Patent Owner that the claims are directed to the classification stage, as they require extracting “a plurality of static data points” from an executable file and “generating a feature vector from [that] plurality of static data points using a classifier” (emphasis added). The claims also recite that the classifier has been “trained to classify” (emphasis added). Further, the claims recite that “features of the feature vector” are selectively turned on or off, indicating that the feature vector has been generated. We also agree with Patent Owner that Petitioner has not shown that Ideses teaches or suggests a classification method in which one or more features of a feature vector generated from a plurality of static data points are selectively turned on or off based on the value of the static data point. As explained in the summary of Ideses above, Ideses describes “methods and systems for generating classifiers” (Ex. 1005 ¶ 2) in which “extracted features [may be] identified for pruning to generate the group of classifying features,” and “the selection [may be] based on identifying a classification effectiveness rank for each of the features of the training software applications” or “based on identifying resource requirements for each of the features of the training software applications.” See id. ¶¶ 98, 99. “[T]he group of classifying features [may be] selected based on the significance of the extracted features,” such that “[s]ignificant features, such as those that have a large effect on the classification outcomes, may be retained” and “[i]nsignificant features, such as those that have a small, negligible or no effect on classification outcome may be pruned.” Id. ¶¶ 101, 106. Petitioner argues that “Ideses explains that in the method depicted in Figure 1, ‘[t]he full feature list is optionally selectively pruned,’ i.e., ‘selectively turned off’ as required by [1.e],” and “[f]urther, ‘each feature of the group is selected from-the-ground-up; added to the group as opposed to removed from or retained within a larger group,’ i.e., ‘selectively turned on’ as required by [1.e].” Pet. 33 (citing Ex. 1005 ¶ 71). Petitioner also argues element 1.e is taught by Ideses’s “approaches to pruning insignificant features,” which Petitioner argues are “to selectively includ[e]/exclud[e] features based on whether a feature coefficient ‘is within a predetermined range’ as required” by element 1.e. Id. at 34 (citing, e.g., Ex. 1005 ¶¶ 107, 109–110). But all of the selection and pruning described in Ideses concerns the” slip op. at 22

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

    “We agree with Patent Owner that the claims are directed to the classification stage, as they require extracting “a plurality of static data points” from an executable file and “generating a feature vector from [that] plurality of static data points using a classifier” (emphasis added). The claims also recite that the classifier has been “trained to classify” (emphasis added). Further, the claims recite that “features of the feature vector” are selectively turned on or off, indicating that the feature vector has been generated. We also agree with Patent Owner that Petitioner has not shown that Ideses teaches or suggests a classification method in which one or more features of a feature vector generated from a plurality of static data points are selectively turned on or off based on the value of the static data point. As explained in the summary of Ideses above, Ideses describes “methods and systems for generating classifiers” (Ex. 1005 ¶ 2) in which “extracted features [may be] identified for pruning to generate the group of classifying features,” and “the selection [may be] based on identifying a classification effectiveness rank for each of the features of the training software applications” or “based on identifying resource requirements for each of the features of the training software applications.” See id. ¶¶ 98, 99. “[T]he group of classifying features [may be] selected based on the significance of the extracted features,” such that “[s]ignificant features, such as those that have a large effect on the classification outcomes, may be retained” and “[i]nsignificant features, such as those that have a small, negligible or no effect on classification outcome may be pruned.” Id. ¶¶ 101, 106. Petitioner argues that “Ideses explains that in the method depicted in Figure 1, ‘[t]he full feature list is optionally selectively pruned,’ i.e., ‘selectively turned off’ as required by [1.e],” and “[f]urther, ‘each feature of the group is selected from-the-ground-up; added to the group as opposed to removed from or retained within a larger group,’ i.e., ‘selectively turned on’ as required by [1.e].” Pet. 33 (citing Ex. 1005 ¶ 71). Petitioner also argues element 1.e is taught by Ideses’s “approaches to pruning insignificant features,” which Petitioner argues are “to selectively includ[e]/exclud[e] features based on whether a feature coefficient ‘is within a predetermined range’ as required” by element 1.e. Id. at 34 (citing, e.g., Ex. 1005 ¶¶ 107, 109–110). But all of the selection and pruning described in Ideses concerns the” slip op. at 22

  § 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · Nautilus
  Patents in suitUS 11,409,869
• 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
• Ericsson Inc. v. Koninklijke KPN N.V.Some claims unpatentable
  PTAB · Oct 4, 2023 · IPR2022-00557 · APJ Kevin F Turner · IPR · Final written decision

  Claims 1, 10–12, 21, 22, 24, and 25 are unpatentable as obvious; claims 2, 3, 6, and 8 were not shown unpatentable; the contingent motion to amend is denied.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “a person of ordinary skill in the art at the time of the invention “would be a person with a B.S. degree in electrical engineering, computer engineering, or equivalent training or job experience, with two years of experience in computer networking technology, or a Master’s degree in electrical engineering, computer engineering, or other equivalent degree.” Pet. 13 (citing Ex. 1003 ¶ 47). Patent Owner indicates that it does not challenge the qualifications proposed by Petitioner for a person of ordinary skill in the art. PO Resp. 14. We find Petitioner’s proposal consistent with the level of ordinary skill in the art reflected by the prior art of record, see Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978), and, therefore, we continue to adopt Petitioner’s unopposed position as to the level of ordinary skill in the art for purposes of this decision.” slip op. at 7

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

    “associated sessions” With respect to the limitation “associated sessions,” Patent Owner asserted that the ’669 Patent defines those sessions as those that “should not be managed independent from each another,” and continues to assert the same in its Response. PO Resp. 14–15 (quoting Ex. 1001, 7:37–38). Based on the recitations of the Specification, we construe “associated sessions” as “sessions that should not be managed independent from each other,” as proffered by Patent Owner. Ex. 1001, 7:37–38. slip op. at 8

  • Prior constructionTerm construed board ownDecided for petitioner

    “Patent Owner asserts that the United States District Court for the Eastern District of Texas rejected Petitioner’s proposed construction in the District Court Case, and following briefing and oral argument in that proceeding, the District Court concluded that “composition session” means “a signaling session that is separate from the associated sessions and that is for facilitating management of the associated sessions.” PO Resp. 16. Having reviewed the District Court’s determination, we do not discern a significant difference in scope between it and Petitioner’s formulation, and we, thus, adopt its construction of “composition session” in the analysis below.” slip op. at 9

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

    “As such, we continue to determine that Petitioner has sufficiently established that an ordinarily skilled artisan would have had a rationale to combine the teachings of Foti with RFC 3261, RFC 4566, RFC 2326, Wright, and Lloyd, and would have had a reasonable expectation of success in achieving that combination, as we determined in the Institution Decision. See Inst. Dec. 17–18. We continue to be persuaded that one of ordinary skill in the art would have consulted and utilized disclosures in the RFC references to understand and implement the protocols disclosed by Foti. We are further persuaded by Petitioner’s arguments that such skilled artisans would have had a rationale to combine the teachings of Wright and Lloyd with those of Foti for the reasons provided. Petitioner has asserted that each of the supporting references would have been used by persons of ordinary skill in the art to modify or enhance the system described in Foti for the benefits described for the proposed changes. Absent reasons the references should not be combined, we determine that the motivation proffered by the Petition is sufficient to support the combination, under the preponderance of the evidence standard.” slip op. at 16

  Patent outcomesUS 9,667,669 mixed
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 9,667,669
• 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.