• 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
• Sandoz Inc. v. Boehringer Ingelheim International GmbHInstitution denied
  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
• Dell Technologies Inc. / Dell Inc. v. Videolabs, Inc.Institution denied
  PTAB · Oct 4, 2022 · IPR2022-00701 · APJ Jeffrey S Smith · IPR · Institution

  The Board denied institution because JP029 supports claims 1–4 as of April 26, 2002, making the June 2002 Draft H.264 Standard unavailable as prior art for the 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) (2020). Institution of an inter partes review requires that “the information presented in the petition and . . . any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). The dispositive issue here is whether Patent Owner shows that the effective filing date of the ’059 patent extends to the filing date of its foreign application, thereby antedating two of Petitioner’s asserted prior art references. For the reasons set forth below, we determine that Petitioner does not show that there is a reasonable likelihood that Petitioner will prevail with respect to the sole challenged claim. Accordingly, we deny inter partes review of the ’059 patent.” slip op. at 2

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

    “Ex. 2001 ¶ 46 (emphasis added) (citing Ex. 1004 (H.324, 1998), Fig. 1, 1–2). In other words, according to the testimony of Dr. Richardson, which the record supports and Petitioner does not dispute, the applicable standards, known to artisans of ordinary skill prior to the filing date of JP029, show multiplexing and demultiplexing the coded audio and video, thereby satisfying claim 1’s limitations for multiplexing and demultiplexing coded audio data, contrary to Patent Owner’s arguments. See Pet. 25.” slip op. at 19

  • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer not foundDecided for patent owner

    “argument, Petitioner has not shown that such a disclaimer exists in the prosecution history. The purported disavowal of claim scope with respect to the plain meaning of a claim term must be unambiguous, clear, and unmistakable to one of ordinary skill in the art. Elbex Video, Ltd. v. Sensormatic Elecs. Corp., 508 F.3d 1366, 1371 (Fed. Cir. 2007) (citations omitted). Petitioner has not made such a showing. Rather, Petitioner points to language that was added to the claim during prosecution, namely, “performing arithmetic coding on a first bit of the binary data corresponding to each absolute value of the coefficients,” and concludes that this language requires coding a first bit separately from the remaining bits, using separate probability tables. Pet. Reply 10 (citing Ex. 1012, 656). We agree with Patent Owner, that the plain meaning of this claim language does not require coding a first bit separately from the remaining bits, using separate probability tables. Prelim. Resp. 57–58. Turning to the prosecution history, Petitioner does not explain how the applicant’s remarks to the Examiner in the prosecution history show a clear and unmistakable disavowal of claim scope. See Pet. Reply 9–10. Further, the applicant did not state to the Examiner that the claim requires coding a first bit separately from the remaining bits, using separate probability tables. See Ex. 1012, 662–664. On this limited record, it is not clear how the applicant’s arguments in the prosecution history persuasively show that the applicant made a clear and unmistakable disavowal of claim scope. Therefore, we construe the claim according to its plain and ordinary meaning, which does not require coding a first bit separately from the remaining bits using separate probability tables as alleged by Petitioner.” slip op. at 25

  • Strike new argumentNew argument disregardedDecided for patent owner

    “We agree with Patent Owner. Petitioner’s claim construction regarding prosecution history disclaimer does not address “unanticipated and incorrect statements” made by Patent Owner “regarding the law with respect to written description and the disclosure of the subject patent and priority applications, to which Petitioners need to respond.” Ex. 1041. Specifically, Petitioner does not allege an incorrect statement in Patent Owner’s contention that “Petitioner admits that JP029 discloses performing the encoding on all bits of binary data, including the ‘first bit’ of data.” Prelim. Resp. 55 (citing Pet. 29). Nor does Petitioner allege an incorrect statement in Patent Owner’s contention that “Petitioner’s expert opines – with no explanation or citation – that the claims require ‘separately arithmetically encoding/decoding a first bit of binary data using a separate probability table from the probability table (or tables) used to encode/decode the remaining bits of binary data.’ Nothing in the claims require this.” Id. at 57 (citing Ex. 1003 ¶ 52). Instead, Petitioner, for the first time in its Reply, proposes construing the claim beyond its plain and ordinary meaning in order to rebut Patent Owner’s contention that the plain and ordinary meaning of the claim does not require coding a first bit separately from the remaining bits, using separate probability tables. Petitioner has not explained how Patent Owner made an incorrect statement, nor has Petitioner explained why Patent Owner’s construction of the claim based on the claim’s plain and ordinary meaning was unanticipated. See Pet. 7 (“[T]he Petition does not present any controversy over claim meaning and the Board need not construe any terms.”); see id. at 8 (“Petitioner maintains that the Challenged Claims would have been obvious under any reasonable construction.”). Petitioner’s new claim construction alleging prosecution history disclaimer, and Petitioner’s corresponding new argument based on the alleged disclaimer, are untimely.” slip op. at 24

  Claim construction§ 112 disclosurecites Graham
  Patents in suitUS 7,970,059
• Dell Technologies Inc. / Dell Inc. v. Videolabs, Inc.Institution denied
  PTAB · Oct 4, 2022 · IPR2022-00629 · APJ Jeffrey S Smith · IPR · Institution

  The Board denied institution because Patent Owner established claim 1’s priority to JP665, antedating the references relied on in both obviousness grounds.

  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) (2020). Institution of an inter partes review requires that “the information presented in the petition and . . . any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). The dispositive issue here is whether Patent Owner shows that the effective filing date of the ’878 patent extends to the filing date of its foreign application, thereby antedating two of Petitioner’s asserted prior art references. For the reasons set forth below, we determine that Petitioner does not show that there is a reasonable likelihood that Petitioner will prevail with respect to the sole challenged claim. Accordingly, we deny inter partes review of the ’878 patent.” slip op. at 2

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

    “. . . each application in the chain leading back to the earlier application must comply with the written description requirement of 35 U.S.C. §112.” Lockwood, 107 F.3d at 1571. To satisfy this written description requirement, a priority application must “reasonably convey[] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharm., 598 F.3d at 1351. “It is the specification itself that must demonstrate possession,” and “a description that merely renders the invention obvious does not satisfy the requirement.” Id. at 1352.” slip op. at 12

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Relying on its expert, Dr. Schonfeld, Petitioner contends as follows: A POSITA at the time would have had at least an undergraduate degree in Electrical Engineering, Computer Science, Computer Engineering, or a related field (or equivalent work experience in the that field), and two or more years of experience with audio, image, or video coding. Ex. 1003, ¶ 24. The relevant experience would include a working understanding of the then-existing audio and video coding standards, including ongoing work on emerging standards. Id. Pet. 15 (citing Ex. 1003 ¶ 24). Dr. Schonfeld adds that “a POSITA would have a working understanding of the then existing audio and video encoding standards (e.g., H.263), as well as ongoing work on emerging standards (e.g., H.26L/H.264).” 1003 ¶ 24. Dr. Richardson, Patent Owner’s expert, agrees with, and applies, Dr. Schonfeld’s proposed level of ordinary skill. Ex. 2001 ¶ 30 (citing Ex. 1003 ¶ 24). Based on a review of the preliminary record, for purposes of the Institution Decision, we adopt Petitioner’s proposed level of ordinary skill in the art, as agreed upon by Dr. Schonfeld and Dr. Richardson, because it is consistent with the evidence of record, including the asserted prior art and ’878 patent specification.” slip op. at 9

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

    “As Petitioner argues, it is not necessary to explicitly construe any claim terms. See Pet. 7. Any construction would have no effect in the analysis of the dispositive priority issue here. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (stating that “we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 10

  Claim construction§ 112 disclosurecites Graham
  Patents in suitUS 8,139,878
• Dell Technologies Inc. / Dell Inc. v. Videolabs, Inc.Institution denied
  PTAB · Oct 4, 2022 · IPR2022-00628 · APJ Karl D Easthom · IPR · Institution

  The Board denied institution because Patent Owner established priority to JP665, antedating the references asserted against sole challenged claim 1.

  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) (2020). Institution of an inter partes review requires that “the information presented in the petition and . . . any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). The dispositive issue here is whether Patent Owner shows that the effective filing date of the ’238 patent extends to the filing date of its foreign application, thereby antedating two of Petitioner’s asserted prior art references. For the reasons set forth below, we determine that Petitioner does not show that there is a reasonable likelihood that Petitioner will prevail with respect to the sole challenged claim. Accordingly, we deny inter partes review of the ’238 patent.” slip op. at 2

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

    “In summary, contrary to Petitioner’s arguments, an artisan of ordinary skill would not have read JP665’s disclosed video improvements to H.26L as limited only to a coded video system (i.e., without audio) in the face of known related audio/video coding standards specifically contemplating video coding standards including H.26L and its predecessor H.263. Moreover, the parties agree that an artisan of ordinary skill would have known of the existing audio and video encoding standards. Ex. 1003 ¶ 24; Ex. 2001 ¶ 30; supra § IIIB. Therefore, Patent Owner shows that JP665 conveys possession of a component (video) used in a known system as defined by known standards (coded audio and video in multiplexing and demultiplexing systems) as required by claim 1’s preamble, element 1a, and element 1b. Based on the full record as generally summarized above, Patent Owner establishes priority of the ’238 patent to JP665, thereby antedating Bjontegaard and JVT-C167, which the Petition relies upon to allege obviousness in Grounds 1 and 2, respectively. This priority showing is fatal to the Petition’s obviousness showing.” slip op. at 22

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

    “In summary, contrary to Petitioner’s arguments, an artisan of ordinary skill would not have read JP665’s disclosed video improvements to H.26L as limited only to a coded video system (i.e., without audio) in the face of known related audio/video coding standards specifically contemplating video coding standards including H.26L and its predecessor H.263. Moreover, the parties agree that an artisan of ordinary skill would have known of the existing audio and video encoding standards. Ex. 1003 ¶ 24; Ex. 2001 ¶ 30; supra § IIIB. Therefore, Patent Owner shows that JP665 conveys possession of a component (video) used in a known system as defined by known standards (coded audio and video in multiplexing and demultiplexing systems) as required by claim 1’s preamble, element 1a, and element 1b. Based on the full record as generally summarized above, Patent Owner establishes priority of the ’238 patent to JP665, thereby antedating Bjontegaard and JVT-C167, which the Petition relies upon to allege obviousness in Grounds 1 and 2, respectively. This priority showing is fatal to the Petition’s obviousness showing.” slip op. at 22

  § 103 obviousness§ 112 disclosurecites Graham
  Patents in suitUS 7,769,238
• Human Power Of N Company v. Heartbeet LtdInstitution denied
  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
• Human Power Of N Company v. Heartbeet LtdInstitution denied
  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
• Human Power Of N Company v. Heartbeet Ltd.Institution denied
  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
• ROKU, Inc. v. Universal Electronics, Inc.Rehearing denied
  PTAB · May 13, 2021 · IPR2019-01595 · APJ Minn Chung · IPR · Rehearing

  The Board denied rehearing of its decision denying institution on claims 1 and 2, finding no abuse of discretion on priority entitlement or motivation to combine Darbee and Golender.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “II. STANDARD OF REVIEW “The burden of showing a decision should be modified lies with the party challenging the decision,” and the challenging party “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed” in a 1 Petitioner also filed a request for the Precedential Opinion Panel (“POP”) to review the Decision (Paper 13 (Notification of Receipt of POP Request)), which the POP denied (Paper 14 (Order)). paper of record. 37 C.F.R. § 42.71(d). Because Petitioner seeks rehearing of our Decision denying institution of trial based on the Petition, it must show an abuse of discretion. See 37 C.F.R. § 42.71(c) (“When rehearing a decision on petition, a panel will review the decision for an abuse of discretion.”). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus., Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988). Thus, a request for rehearing is not an opportunity merely to disagree with the Board’s assessment of the arguments or weighing of the evidence, or to present new arguments or evidence that could have been presented in the Petition.” slip op. at 2

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

    “issue upon which the priority determination turns—what the priority applications reasonably would have conveyed to a person of ordinary skill in the art—because Dr. Medvidovic did not provide any testimony on that issue. And we did not overlook or misapprehend any testimony of Dr. Medvidovic regarding what the priority applications reasonably would have conveyed to a person of ordinary skill in the art because we could not have overlooked or misapprehended any testimony that was not presented in the Medvidovic Declaration. As discussed above, Dr. Medvidovic’s testimony based on what is expressly disclosed in or necessarily follows from the disclosures of the priority applications was insufficient because Dr. Medvidovic did not explain adequately why the disclosures in the priority applications would not reasonably have conveyed to a person of ordinary skill in the art the subject matter of the User Action Limitation. Thus, Dr. Medvidovic’s testimony was insufficient to raise a genuine issue of material fact on the issue of what the priority applications reasonably would have conveyed to a person of ordinary skill in the art. Although Patent Owner’s declarant, Mr. Bear, provided detailed testimony and explanations regarding how a person of ordinary skill in the art would have understood the priority applications to describe the subject matter recited in the User Action Limitation (see Ex. 2001 ¶¶ 111–122, 126–127), Dr. Medvidovic did not provide adequate testimony or explanations to the contrary on the issue (see Ex. 1010 ¶¶ 53–63).” slip op. at 9

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “misapprehend or overlook 37 C.F.R. § 42.108(c). The mere fact that Dr. Medvidovic provided testimony different from the testimony of Mr. Bear does not by itself raise a genuine issue of material fact. See Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1325–26 (Fed. Cir. 2016) (“The mere existence in the record of dueling expert testimony does not necessarily raise a genuine issue of material fact.”). As the Request acknowledges, Dr. Medvidovic in his Declaration (Ex. 1010, “Medvidovic Declaration”) testified that the subject matter of the User Action Limitation is “neither expressly disclosed [in] nor necessarily follows from” the descriptions in the priority applications about event journal data. Req. 3 (emphases added) (citing Ex. 1010 ¶¶ 57–62). As discussed above, however, the test for determining compliance with the written description requirement under 35 U.S.C. § 112 is whether the original disclosure of the earlier-filed application reasonably would have conveyed to a person of ordinary skill in the art that the inventor had possession of the claimed subject matter at the time of the earlier-filed application. Ariad Pharm., 598 F.3d at 1351. The record shows that Dr. Medvidovic did not provide any testimony in his Declaration as to what the disclosures in the priority applications reasonably would have conveyed to a person of ordinary skill in the art. See Ex. 1010 ¶¶ 53–63. Nor did Dr. Medvidovic explain adequately in his Declaration why the disclosures in the priority applications would not reasonably have conveyed to a person of ordinary skill in the art the subject matter of the User Action Limitation. See id.” slip op. at 8

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Under Petitioner’s definition of the level of ordinary skill in the art, however, “less education can be remedied with additional work experience (e.g., 5–6 years).” Pet. 7 (citing Ex. 1010 ¶¶ 64–67). As stated in the Bear Declaration, Mr. Bear’s work experience includes at least 9 years of computer software programming using a variety of coding languages, such as BASIC, Pascal, C, C++, and 68000 Assembly Language. See Ex. 2001 ¶¶ 10–12. Thus, Mr. Bear is qualified to testify from the perspective of a person of ordinary skill in the art under Petitioner’s definition of a person of ordinary skill in the art. As discussed in the Decision, although we did not find the parties’ proposals for the level of ordinary skill in the art to be materially different, to the extent the testimony from the parties’ declarants on the level of ordinary skill in the art raised a genuine issue of material fact, we adopted and applied Petitioner’s definition for purposes of the Decision, being mindful of the rule that “a genuine issue of material fact created by such testimonial evidence will be viewed in the light most favorable to the petitioner solely for purposes of deciding whether to institute an inter partes review.” Dec. 9 (citing 37 C.F.R. § 42.108(c)). Thus, the record shows that, under Petitioner’s definition of the level of ordinary skill in the art adopted in consideration of § 42.108(c), the Decision appropriately credited Mr. Bear’s testimony on what the priority applications reasonably would have conveyed to a person of ordinary skill in the art.” slip op. at 11

  § 103 obviousness§ 112 disclosure
  Patents in suitUS 8,015,446
• Palo Alto Networks, Inc. v. Finjan, Inc.Institution denied
  PTAB · Mar 23, 2016 · IPR2015-02000 · APJ Thomas L Giannetti · IPR · Institution

  Institution was denied for claims 1–22 because the claims were entitled to the November 6, 1997 priority date, so the asserted references were not prior art.

  RulingsInstitution decision

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

    “B. The Applicable Legal Standard Under 35 U.S.C. § 120 Under 35 U.S.C § 120, to claim the benefit of the filing date from an earlier application, each application in the chain leading back to the earlier application must comply with the written description requirement of 35 U.S.C. § 112. Zenon Envtl., Inc. v. U.S. Filter Corp., 506 F.3d 1370, 1378 (Fed. Cir. 2007); see also In re Hogan, 559 F.2d 595, 609 (CCPA 1977) (“[T]here has to be a continuous chain of co-pending applications each of which satisfies the requirements of § 112 with respect to the subject matter presently claimed.”). If any application in the priority chain fails to include the requisite disclosure, the later-filed application is not entitled to the benefit of the filing date of applications preceding the break in the priority chain. Lockwood v. Am. Airlines Inc., 107 F.3d 1565, 1571–72 (Fed. Cir. 1997).” slip op. at 10

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

    “the ʼ194 or ʼ780 patents. Pet. 12. However, as Patent Owner points out, that is not the proper test. Prelim. Resp. 13–14. The claimed subject matter need not be described “in haec verba” in the original specification in order to satisfy the written description requirement. In re Wright, 866 F.2d 422, 425 (Fed. Cir. 1989). Rather, “the test . . . is whether a person of ordinary skill in the art would recognize that the applicant possessed what is claimed in the later filed application as of the filing date of the earlier filed application.” Noelle v. Lederman, 355 F.3d 1343, 1348 (Fed. Cir. 2004). We are persuaded that, on the record presented, this test has been met. We are persuaded that the disclosure in the ʼ194 patent of a security database storing “known Downloadables” provides written description support for the file cache recitation in the ʼ731 patent claims. Prelim. Resp. 17–19. Petitioner does not dispute that known Downloadables are files. Pet. 26 (“Touboul discloses generating and using a Downloadable ID (file identifier) to identify each Downloadable (file).”). Moreover, Petitioner specifically refers to components of the security database as caches: “Claim 1 [of the ʼ731 patent] is the obvious combination of a cache such as the cache taught by Tso with the scanner, security profile cache, and security policy cache in Touboul’s gateway as detailed below.” Pet. 20 (emphasis added). We see no basis to distinguish these descriptions of caches from the storage of Downloadables in the security database. Moreover, we are persuaded that a security database providing temporary storage of known Downloadables meets the requirements of a cache as “a memory for holding a file, at least temporarily.” See supra.” slip op. at 11

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “E. Conclusion We agree with Patent Owner that the ʼ731 patent claims are entitled to the benefit of the grandparent application filed on November 6, 1997. Accordingly, Touboul and the other art asserted by Petitioner does not qualify as prior art to the ʼ731 patent under 35 U.S.C. § 102(b), as asserted by Petitioner.” slip op. at 13

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “We are not persuaded, either, by Petitioner’s position, unsupported by any citation of authority, that Patent Owner’s decision not to claim the benefit of the earlier filing date during prosecution of the ʼ731 patent is an admission. Nor are we persuaded by the conclusory testimony of Petitioner’s expert on the filing date issue. See Rubin Decl. ¶ 69. Under our rules, expert testimony that does not have a proper basis is entitled to little or no weight. 37 C.F.R. § 42.65(a).” slip op. at 13

  § 102 anticipation§ 112 disclosure
  Patents in suitUS 7,418,731

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.