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  • 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 · Feb 10, 2025 · IPR2024-01054 · APJ Michael T Cygan · IPR · Institution

    Institution denied for claims 1–15 because Petitioner did not show Seet was prior art, defeating the reasonable-likelihood showing for every asserted obviousness ground.

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

      “review. See 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2023). The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons given below, on this record, Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of any one of claims 1–15 of the ’768 patent. Accordingly, we do not institute an inter partes review of the ’768 patent.” slip op. at 2

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner

      “Petitioner fails to show that the full scope of claim 9 of Seet is described in the Seet provisional. Seet expressly defines the claim term “media,” stating that, as it is “used herein,” “media” includes audio, video, software, and pictures. Ex. 1006 ¶ 50 (“Media content may include one . . . of audio . . ., video . . ., software . . ., and pictures”). Such a statement provides a clear definition of the term “media” that includes video, software, and pictures, in addition to audio. In addition to the express definition, Seet elsewhere indicates that its media includes video and other non-audio signals and databases. See, e.g., Ex. 1006 ¶¶ 26 (“if the media stream 102 is a video broadcast, each media item may comprise a television show or segment, an advertisement, or any other type of video”), 42–46 (creating databases of “videos,” “faces,” and “files”), 49 (“any signal that contains repeating content over any broadcast medium can benefit from the procedure described herein.”). Accordingly, the use of media in claim 9 for its claimed “media content database” and “media stream[s]” also includes both audio and non-audio media.” slip op. at 14

    • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateNot shown unpatentable

      “We agree with Patent Owner that Petitioner has not met its burden to show that Seet is prior art. Seet is not entitled to the benefit of its provisional filing date unless a claim in Seet has written description support in the Seet provisional. See Dynamic Drinkware, 800 F.3d at 1381–82. As the “‘hallmark’ of written description, . . . 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 Laboratories Private Ltd., 111 F.4th 1358, 1375 (Fed. Cir. 2024) (citation and emphasis omitted).” slip op. at 12

    • Skill levelSkill level board ownDecided for patent owner

      “B. Level of Ordinary Skill in the Art Petitioner asserts that a person of ordinary skill in the art [“POSITA”] at the critical time would have had “a bachelor’s degree in electrical engineering, computer engineering, computer science, or equivalent degree with at least two years of relevant industry experience, including in digital media content delivery.” Pet. 2 (citing Ex. 1003 ¶ 32). Patent Owner argues that the level of ordinary skill should include persons lacking a formal degree but possessing considerable industry experience designing and implementing automated content recognition systems, and that such systems are the relevant industry experience. Prelim. Resp. 6–7. For purposes of this Decision, we adopt Petitioner’s proposed level of ordinary skill, modified by the more inclusive standards of Patent Owner, as it appears to be consistent with the specification of the ’768 patent and the prior art of record.” slip op. at 7

    Claim construction§ 102 anticipation§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 8,510,768
  • 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
  • PTAB · Nov 7, 2022 · PGR2022-00037 · APJ Devon Zastrow Newman · PGR · Institution

    The Board denied institution because Petitioner did not show that the patent was eligible for post-grant review; the challenged claims were entitled to the pre-AIA priority date.

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

      “Accordingly, we find that Petitioner has not identified any challenged claim that has an effective filing date on or after March 16, 2013. For this reason, we find that Petitioner has not shown sufficiently that the ’265 patent is eligible for post-grant review. IV. CONCLUSION After considering the evidence and arguments presently before us, we determine Petitioner has not shown that the ’265 patent is eligible for post-grant review. Accordingly, we do not institute a post-grant review. V. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(d), the Petition is denied.” slip op. at 29

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

      “To interpret “stable,” we begin with how the term is used in independent claims 7 and 19. Both terms recite “stable” in relation to the pharmaceutical formulation as a whole by reciting “wherein the formulation is stable.” Ex. 1001, 189:62–190:27. From this, we conclude that the ordinary artisan, as defined above to have a relevant advanced degree and at least two years of experience in development or manufacture of therapeutic protein formulations, would have understood that the components of a “stable” formulation would maintain their integrity and desired function following preparation, including when stored as described. This meaning is supported by the following language in the specification pertaining to the disclosed pharmaceutical compositions: Pharmaceutical compositions according to the present invention are described in further details hereinbelow. In one aspect, the pharmaceutical compositions disclosed herein are physico-chemically stable and maintain the integrity of an antibody comprised in said pharmaceutical composition, for example when stored for 8 weeks at 40° C. as shown hereinbelow. Ex. 1001, 84:20–26. We also note, as Petitioner argued, that the prosecution history supports that the formulation components needed to remain functional during storage, and that Patent Owner cited to formulation integrity after a storage period of 8 weeks at 40° C as evidence of such integrity. Ex. 1004, 7380. As disclosed in the ’265 patent, Examples 9 and 12 measure function and identity of the components following storage to confirm formulation stability.” slip op. at 11

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

      “burden of showing that claim 7 or 14 lacks written description support in the priority application, which Petitioner has conceded provides the same support as the ’265 patent specification. In this regard, we agree that the reasoning in Fresenius likewise applies: there is no legal requirement that a patent specification must include test results or working examples demonstrating stability for every possible composition that is covered by the claims. Fresenius at 13, citing Ariad Pharms., 598 F.3d at 1352 (stating that “the written description requirement does not demand either examples or an actual reduction to practice”). Formulations 2 and 3, disclosed in the ’265 patent specification, which Petitioner acknowledges falls within the scope of claims 7 and 14 (Pet. 26–27 (citing Ex. 1002 ¶¶ 134, 135)), were shown to be stable for 8 weeks in a syringe. Moreover, the ordinary artisan was provided with guidance in making such formulations from the teachings of the specification and has additional knowledge from the art. See Ex. 1001, 85:32–94:35. Claims 7 and 14 identify specific structures (risankizumab) and required excipients within a defined pH range, which are stable as confirmed by testing results presented in the specification. Prelim. Resp. 33; Ex. 1001, 94:14–36. On this record, we conclude that the evidence presented does not establish that it is more likely than not that an ordinarily skilled artisan would not have reasonably believed that the inventors of the ’265 patent possessed the claimed subject matter, each limitation of which is demonstrated as supported in the specification. As we have interpreted the claim term “wherein the formulation is stable” to mean “wherein the formulation maintains the functional integrity of the antibody and other components, for example when stored for 8 weeks at 40° C,” the specification supports maintenance of functional integrity as shown by the stability of Formulations 2 and 3, including when stored for a period of time. For this reason, we find that Petitioner has not shown that the ordinary artisan would not have understood the inventors of the ’265 patent possessed the subject matter of claims 7 and 14 as of the filing date of the priority application.” slip op. at 23

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

      “We acknowledge that in the Fresenius case, the extensive testing disclosed in that specification supported the ordinary artisan’s ability to formulate stable compounds using such guidance, and that the specification here discloses less testing. See, e.g., Sur-Reply. 8–9. Nevertheless, it is Petitioner’s burden on this issue, and we are not persuaded that the concerns raised by Dr. Klibanov provide sufficient evidence of actual instability to justify institution on this record. See, e.g., Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 F.2d 1569, 1577 (Fed. Cir. 1984) (finding lack of evidence that district court erred in upholding claims as enabled where defendant did not identify inoperable embodiments despite extensive testing). In particular, we are persuaded that, on this record, Petitioner’s lack of evidence of instability of any formulation falling within the limitations of claim 14 indicates that Petitioner has not established sufficiently, for purposes of trial institution, that it is more likely than not that an ordinarily skilled artisan would not have been able to practice the full scope of claim 14 invention based on the teachings of the specification.” slip op. at 28

    Claim construction§ 112 disclosurecites Phillips
    Patents in suitUS 11,078,265
  • PTAB · May 16, 2022 · PGR2022-00004 · APJ Devon Zastrow Newman · PGR · Institution

    The Board denied institution on all challenged claims because Petitioner did not show the patent was eligible for post-grant review.

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

      “Determining whether a patent is subject to the first-inventor-to-file provisions of the AIA, and therefore eligible for post-grant review, is straightforward when the patentee filed the application from which the patent issued before March 16, 2013, or when the patentee filed the application on or after March 16, 2013, without any priority claim. The determination is more complex, however, for a patent that issues from a “transition application,” that is, an application filed on or after March 16, 2013, that claims the benefit of an earlier filing date. See MPEP § 2159.04 (9th ed. Rev. 10.2019, June 2020). Entitlement to the benefit of an earlier date under 35 U.S.C. §§ 119, 120, 121, or 365 is premised on disclosure of the claimed invention “in the manner provided by § 112(a) (other than the requirement to disclose the best mode)” in the earlier application. See 35 U.S.C. §§ 119(e), 120. Thus, a patent that issues from a transition application is not available for post-grant review if the claimed subject matter complies with the written description and enablement requirements of § 112(a) for an ancestor application filed prior to March 16, 2013.” slip op. at 9

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

      “B. Legal Standard The test for written description support is “whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date” based on an “objective inquiry into the four corners of the specification.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). If this test fails, the application is not entitled to the benefit of the earlier filing date.” slip op. at 11

    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledDecided for patent owner

      “[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)). Undue experimentation is analyzed by applying the factors set forth in In re Wands, 858 F.2d 731 (Fed. Cir. 1988).5 Nothing more than objective enablement is required, and therefore it is irrelevant whether this teaching is provided through broad terminology or illustrative examples. In re Marzocchi, 439 F.2d 220, 223 (CCPA 1971); see also In re Howarth, 654 F.2d 103, 105 (CCPA 1981) (“An inventor need not, however, explain every detail since he is speaking to those skilled in the art.”). slip op. at 13

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “F. Person of Ordinary Skill in the Art Petitioner proposes that one of ordinary skill in the art would have had “an M.D. degree or a Ph.D. degree in biochemistry, pharmacology, nutrition chemistry, exercise physiology, or kinesiology, and at least two years of 2 This chart repeats the grounds as presented in Petitioner’s chart at Pet. 4. 3 Brunton, An Address on Blood Pressure in Man: Its estimation and indications for treatment, The British Medical Journal, pp. 64-67 (July 10, 1909) (Ex. 1032 “Brunton”). 4 Brunton et al., An Address on Longevity and the Means of Attaining It, The Lancet, Vol. 168, Issue 4342, pp. 1330–1355 (Nov. 17, 1906) (Ex. 1033 “Brunton 2”). post-doctoral research or clinical experience with physiology, biochemistry, or dietary supplements and formulation.” Pet. 13 (citing Ex. 1003 ¶ 21). Patent Owner does not challenge this definition at this time. Prelim. Resp. 7. For purposes of this decision, we apply Petitioner’s proposed definition as it is consistent with the level of skill presented in the ’747 patent and applied art. We also note that the level of ordinary skill in the art at the time of the invention may be reflected in the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 6

    Claim construction§ 112 disclosurecites Phillips
    Patents in suitUS 11,083,747
  • PTAB · Feb 25, 2022 · PGR2021-00110 · APJ Devon Zastrow Newman · PGR · Institution

    The Board denied institution because Petitioner did not show the ’555 patent was eligible for post-grant review; the challenged claims were entitled to pre-AIA effective filing dates.

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

      “The test for written description support is “whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date” based on an “objective inquiry into the four corners of the specification.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). If this test fails, the application is not entitled to the benefit of the earlier filing date. The written description requirement is satisfied when the specification “set[s] forth enough detail to allow a person of ordinary skill in the art to understand what is claimed and to recognize that the inventor invented what is claimed.” University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 928 (Fed. Cir. 2004). The specification does not have to provide exact or verbatim textual support for the claimed subject matter at issue. Fujikawa v. Wattanasin, 93 F.3d 1559, 1570 (Fed. Cir. 1996). The Federal Circuit has clarified that [a]lthough [the applicant] does not have to describe exactly the subject matter claimed, . . . the description must clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed . . . . The test for sufficiency of support . . . is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter.” Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991) (citations omitted). Moreover, “the written description requirement does not demand either examples or an actual reduction to practice.” Capon v. Eshhar, 418 F.3d 1349, 1352 (Fed. Cir. 2005). “An applicant is not required to describe in the” slip op. at 12

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner proposes that one of ordinary skill in the art would have had “an M.D. degree or a Ph.D. degree in biochemistry, pharmacology, nutrition chemistry, exercise physiology, or kinesiology, and at least two years of post-doctoral research or clinical experience with physiology, biochemistry, exercise science, or dietary supplements and formulation.” Pet. 16 (citing Ex. 1003 ¶ 21). Patent Owner does not challenge this definition at this time. Prelim. Resp. 7. For purposes of this decision, we apply Petitioner’s proposed definition as it is consistent with the level of skill presented in the ’555 patent and applied art. We also note that the level of ordinary skill in the art at the time of the invention may be reflected in the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 7

    • Expert testimonyPetitioner expert discountedDecided for patent owner

      “We are unpersuaded that Dr. Volek’s reliance on Exhibit 1066 as the sole source of his conclusion that certain doses of inorganic nitrate would have been lethal in the context of the claimed methods is sufficient to establish undue experimentation under the Wands factors. As Patent Owner argues, the working example disclosed in PCT1 discloses administration of a dose Dr. Volek states would have been lethal, but was not. Rather, the result of that experiment was a demonstrated decrease in glucose consumption by the participants, a benefit of increased endurance. Ex. 1008 ¶ 106. We agree with Patent Owner that this case is distinguishable from those cited by Petitioner for the reasons explained by Patent Owner (Prelim. Resp. 31–33), and also from the recent case by our reviewing court, Amgen, Inc. v. Sanofi, 987 F.3d 1080 (Fed. Cir. 2021). In Amgen, the court found the claims lacked enablement because the claims recited dual functional limitations, and potentially millions of antibody candidates could be found to fall within those limitations. Id. at 1088. The court found the examples provided in the specification insufficient to enable the full scope of the claims given the high effort required to screen and identify all such antibodies. Id. Here, as Patent Owner has observed, the only effort required to practice claims within the range in light of the working example is to “simply administer a different dosage to the human for which increased exercise endurance is desired,” which would have been within the scope of the ordinarily skilled artisan. Prelim. Resp. 31. Moreover, Patent Owner correctly notes that methaemoglobinaemia15, the source of the lethality cited in Exhibit 1066, does not result via the claimed method. Prelim. Resp. 30, citing Ex. 1066 at 14–15. As Patent Owner explains, Petitioner’s sole cited Exhibit, 1066, discloses a risk of development of methaemoglobinaemia, a condition where more than 10% of the haemoglobin is transformed into methaemoglobin.” Id. When the conversion to haemoglobin exceeds 70% the condition can be fatal.” Ex. 1066 at 14–15. Patent Owner explains that the inventors discussed the risk of development of methaemoglobinaemia, and explained in PCT1 that their methods do not cause a significant rise in the methemoglobin level in the test subjects. Prelim. Resp. 30. Moreover, PCT1 discloses a working example where three test subjects were given a dose in the range Petitioner alleges would be lethal, with no ill result. Id., citing Ex. 1008 ¶ 106. Dr. Volek’s failure to address this discrepancy, or to provide alternate sources to explain why his conclusion is nonetheless correct, merits his brief testimony on this issue be assigned little probative” slip op. at 20

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

      “G. Claim Construction In a post-grant review, we apply the same claim construction standard as would be used by a district court to construe a claim in a civil action involving the validity or infringement of a patent. 37 C.F.R. § 42.200(b) (2020). Under that standard, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id.; Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc); Thorner v. Sony Comput. Entm’t Am. LLC, 669 F.3d 1362, 1365–66 (Fed. Cir. 2012). Pet. 23–24. Patent Owner does not propose a construction for “inorganic nitrate.” Prelim Resp. 8–9. For purposes of determining whether to institute trial of the challenged claims, we determine it is not necessary to construe “inorganic nitrate.” Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in the context of an AIA proceeding).” slip op. at 7

    Claim construction§ 112 disclosurecites Phillips
    Patents in suitUS 10,835,555
  • PTAB · Jan 11, 2022 · PGR2021-00094 · APJ Devon Zastrow Newman · PGR · Institution

    The Board denied institution because Petitioner did not show that any challenged claim had an effective filing date on or after March 16, 2013, as required for PGR eligibility.

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

      “To institute a post-grant review, we must determine whether 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). Upon consideration of the Petition and the Preliminary Response, for the reasons set forth below, we determine that Petitioner has not shown that the ’813 patent is eligible for post-grant review. Accordingly, we do not institute a post-grant review of the challenged claims of the ’813 patent.” slip op. at 2

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

      “as would be used by a district court to construe a claim in a civil action involving the validity or infringement of a patent. 37 C.F.R. § 42.200(b) (2021). Under that standard, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id.; Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc); Thorner v. Sony Comput. Entm’t Am. LLC, 669 F.3d 1362, 1365–66 (Fed. Cir. 2012). Petitioner proposes construction of two terms, “inorganic nitrate” and “requiring a reduction in systolic blood pressure.” Pet. 26–27. Of these terms, Patent Owner does not propose a construction for “inorganic nitrate” (Prelim Resp. 7). For purposes of determining whether to institute trial of the challenged claims, we determine it is not necessary to construe “inorganic nitrate.” Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in the context of an AIA proceeding).” slip op. at 7

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

      “We are persuaded that Petitioner’s proposed definition is unduly restrictive. The claims do not clarify the meaning of “requiring a reduction in systolic blood pressure”; hence, we rely on relevant disclosures in the specification and prosecution history. Phillips, 415 F.3d at 1312–19. The prosecution history adds no clarity to the meaning of this term. As noted by Patent Owner, the specification states that the claimed method seeks to lower the systolic blood pressure in a subject needing such a reduction “preferably to normal levels (about 140/80 mmHg”) and provides an example of a 43-year-old with hypertension whose “blood pressure was 142/99 on the day when the experiment started.” Prelim. Resp. 8–9. We agree with Patent Owner that these disclosures provide general guidance to the person of ordinary skill in the art that the upper bounds of normal systolic blood pressure is about 140 mmHg, and that a person “requiring a reduction in systolic blood pressure” is someone whose systolic blood pressure exceeds that general measurement. Moreover, as discussed above, Petitioner states that a person of ordinary skill in the art would have had a medical degree or equivalent study in fields such as “biochemistry, pharmacology, nutrition chemistry, or kinesiology” (Pet. 13) such that the term would have been interpreted by persons with a sophisticated understanding of human physiology according to the facts and circumstances presented and with the guidance of “about 140 mmHg” providing a general measurement guideline. We conclude that the plain and ordinary meaning of a person “requiring a reduction in systolic blood pressure” is a person having higher than about 140 mmHg systolic blood pressure.” slip op. at 9

    • Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateNot shown unpatentable

      “The test for written description support is “whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date” based on an “objective inquiry into the four corners of the specification.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010) (en banc). If this test fails, the application is not entitled to the benefit of the earlier filing date.” slip op. at 14

    Claim construction§ 112 disclosurecites Phillips
    Patents in suitUS 10,842,813

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.