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  • 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
  • PTAB · Apr 28, 2025 · PGR2024-00048 · APJ Stacey G White · PGR · Institution

    The Board denied institution because Petitioner did not show it was more likely than not that claims 1–6 were unpatentable.

    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). We may not institute a post-grant review 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(a) (2024). Upon considering the evidence and arguments presented, we determine, as discussed below, that Petitioner has not demonstrated that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable. Therefore, we deny1 Petitioner’s request to institute post-grant review of claims 1–6.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner’s declarant, Dr. Khatri, proposes a definition of the person of ordinary skill in the art. Ex. 2001 ¶ 24. Dr. Khatri, however, notes that his opinions would be the same under either his proposal or Petitioner’s proposal. Id. ¶¶ 25–26. Patent Owner states that, for purposes of the Preliminary Response, it “adopts Petitioner’s definition of a person of ordinary skill in the art.” Prelim. Resp. 13 (citing Pet. 22–23; Ex. 2001 ¶¶ 22–26). We determine that the current record supports Petitioner’s description of an ordinarily skilled artisan. For purposes of this Decision, therefore, we adopt Petitioner’s description of an ordinarily skilled artisan. We also note that the applied prior art reflects the appropriate level of skill at the time of the claimed invention. See Okajima, 261 F.3d at 1355.” slip op. at 12

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

      “Petitioner proposes constructions for the claim terms “MLC memory modules” and “SLC memory module.” Pet. 23–28. Patent Owner disagrees with Petitioner’s constructions, but does not contest them because it argues that construction of these terms is not necessary to resolve the parties’ disputes. Prelim. Resp. 14. Based on the record presented, we determine that no claim term requires an explicit construction to decide whether Petitioner satisfies the “more likely than not” standard for instituting a post- grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017).” slip op. at 13

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable

      “using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.” The Federal Circuit has held that “[t]he written description requirement is met when the disclosure relied on for support ‘reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.’” RAI Strategic Holdings, Inc. v. Philip Morris Prods. S.A., 92 F.4th 1085, 1088 (Fed. Cir. 2024) (quoting Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (citation omitted)). The written description inquiry is a question of fact, is context specific, and must be determined on a case-by-case basis. Ariad, 598 F.3d at 1351 (citing Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985); Capon v. Eshhar, 418 F.3d 1349, 1357–58 (Fed. Cir. 2005)). “[T]he level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.” Id. (citing Capon, 418 F.3d at 1357–58). Factors used to evaluate the sufficiency of a disclosure include: 1) “the existing knowledge in the particular field”; 2) “the extent and content of the prior art”; 3) “the maturity of the science or technology”; and 4) “the predictability of the aspect at issue.” Id. (citing Capon, 418 F.3d at 1359). As support for the term “memory space,” the ’612 patent explains that because “the SLC NAND flash is used to boost the lifetime (endurance) of the storage system, it can be considerably lesser in amount than the MLC NAND flash.” Ex. 1001, 5:20–23; see Ex. 2001 ¶ 51. As an example, the ’612 specification states that “a system may set SLC NAND flash equal to 12.5% or 25% of MLC NAND flash (total non-volatile memory storage space=MLC+SLC).” Ex. 1001, 5:23–25; see Ex. 2001 ¶¶ 51, 62. In addition, we find persuasive Dr. Khatri’s testimony that one of ordinary skill in the art would have understood that “there are two spaces—MLC and SLC—where data is stored, and the total memory space is the combination of the two.” Ex. 2001 ¶ 51. Further, the ’612 patent’s Figure 1 depicts “memory space,” e.g., dynamic random-access memory (DRAM) 20, one or more disks 24, MLC NAND flash memory module 26, and SLC NAND flash memory module 28. Ex. 1001, 5:37–45, Fig. 1; see Ex. 2001 ¶ 64. The ’612 patent’s Figure 4 also depicts “memory space,” e.g., NAND flash memory bank 56 comprising “a plurality of MLC NAND flash memory modules 60a and a plurality of SLC NAND flash memory modules 62a” and NAND flash memory bank 58 comprising “a plurality of MLC NAND flash memory modules 60b and a plurality of SLC NAND flash memory modules 62b.” Ex. 1001, 7:8–14, Fig. 4; see Ex. 2001 ¶ 64. On the record before us, we find the above noted disclosures to be sufficient to support the disputed claim language. For these reasons, the ’612 patent’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.” See Ariad, 598 F.3d at 1351.” slip op. at 15

    Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · Nautilus
    Patents in suitUS 11,854,612
  • 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
  • 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
  • PTAB · Mar 17, 2025 · PGR2024-00047 · APJ Steven M Amundson · PGR · Institution

    The Board denied institution because Petitioner did not show it was more likely than not that any of claims 1–7 was unpatentable.

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

      “to institute a post-grant review. We may not institute a post-grant review unless we determine that “the information presented in the petition filed under section 321, 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(a) (2024).” slip op. at 2

    • Patent Eligibility (§101) › Alice/Mayo step one — 'directed to'Not shown unpatentable

      “2. PETITIONER’S CONTENTIONS Petitioner challenges the ’546 patent’s claims as encompassing a” slip op. at 20

    • Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable

      “2. PETITIONER’S CONTENTIONS Petitioner challenges the ’546 patent’s claims as failing to satisfy” slip op. at 26

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

      “2. PETITIONER’S CONTENTIONS Petitioner challenges the ’546 patent’s claims as failing to satisfy” slip op. at 36

    § 101 eligibility§ 103 obviousness§ 112 disclosureDiscretionary denialcites Alice · Mayo · Phillips · KSR · Graham · Nautilus
    Patents in suitUS 11,830,546
  • 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
  • PTAB · Feb 5, 2024 · PGR2022-00044 · APJ Monica S Ullagaddi · PGR · Final written decision

    Claims 1–13 are unpatentable for lack of written description under § 112(a); the Board did not reach the anticipation and obviousness grounds based on HEVC265.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “B. Level of Ordinary Skill in the Art Petitioner contends that: A person of ordinary skill in the art at the priority date for the ’274 Patent (“POSITA”) would have had a bachelor’s degree in electrical or computer engineering, or a closely related scientific field such as physics or computer science, and two years of work experience with video processing. A lack of experience can be remedied with additional education (e.g., a Master’s degree), and likewise, a lack of education can be remedied with additional work experience (e.g., 4–5 years). This definition would apply at the earliest claimed priority date of the ’274 Patent as well as any later date. Pet. 12 (citing Ex. 1005 ¶¶ 50–52). Patent Owner does not dispute the level of ordinary skill in the art. See generally PO Resp. We adopt Petitioner’s definition as it appears to be consistent with the Specification of the ’274 patent and the cited reference.” slip op. at 14

    • PTAB / AIA Trials › §315(e) estoppelEstoppel appliesDecided for petitioner

      “A party is collaterally estopped from relitigating an issue if: (1) a prior action presents an identical issue; (2) the prior action actually litigated and adjudged that issue; (3) the judgment in that prior action necessarily required determination of the identical issue; and (4) the prior action featured full representation of the estopped party. VirnetX Inc. v. Apple, Inc., 909 F.3d 1375, 1377 (Fed. Cir. 2018) (citing Stephen Slesinger, Inc. v. Disney Enterprises, Inc., 702 F.3d 640, 644 (Fed. Cir. 2012)).” slip op. at 21

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportDecided for petitioner

      “For the reasons that follow, we determine that the ’928 application does not provide sufficient written description support, for at least independent claim 1 of the ’274 patent, so as to “reasonably convey[] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date” of the ’928 application. Ariad, 598 F.3d at 1351. Accordingly, we are persuaded that the ’928 application lacks sufficient written description support for the invention recited in claim 1 of the ’274 patent, and thus, claim 1 does not receive an effective filing date as early as that of the ’928 application (i.e., December 23, 2010). We further determine that Petitioner filed the Petition within the 9-month statutory period for requesting post-grant review in accordance with 35 U.S.C. § 321(c). The ’274 patent issued on September 14, 2021 (see Ex. 1001, code (45)), and the present Petition was accorded a filing date of June 9, 2022 (see Paper 5). Accordingly, the Petition was filed less than 9 months after the date of issuance of the ’274 patent. In view of the above, we are persuaded that the ’274 patent is eligible for post-grant review.” slip op. at 16

    Patent outcomesUS 11,122,274 unpatentable
    § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 11,122,274
  • 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
  • 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
  • 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
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