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  • PTAB · May 31, 2022 · IPR2021-00268 · APJ John E Schneider · IPR · Final written decision

    Claim 2 is unpatentable as anticipated by Stamler and, alternatively, obvious over Stamler.

    RulingsFinal written decision
    • BurdenDecided for petitioner

      “2. Anticipation2 “Under 35 U.S.C. § 102, every limitation of a claim must identically appear in a single prior art reference for it to anticipate the claim.” Gechter v. Davidson, 116 F.3d 1454, 1457 (Fed. Cir. 1997). “[U]nless a reference discloses within the four corners of the document not only all of the 2 As noted above, the pre-AIA provisions of 35 U.S.C. apply to the ’086 patent. the same way as recited in the claim, it cannot be said to prove prior invention of the thing claimed and, thus, cannot anticipate under 35 U.S.C. § 102.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).” slip op. at 8

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

      “Under § 120, a patent is entitled to the priority date of an earlier filed application if (1) the written description of the earlier filed application discloses the invention claimed in the later filed application sufficient to satisfy the requirements of § 112; (2) the applications have at least one common inventor; (3) the later application is filed before the issuance or abandonment of the earlier filed application; and (4) the later application contains a reference to the earlier filed application. In re NTP, Inc., 654 F.3d 1268, 1277 (Fed. Cir. 2011); see also 35 U.S.C. § 120 . As discussed above and in our Decision to Institute, the ’086 patent meets this criterion. While we agree with Petitioner that the face of the ’086 patent does not include a citation of the ‘701 application, the specification does contain a clear claim of priority back to the ’701 application. Ex. 1001, col. 1. ll. 7–13; Ex. 1004 1.” slip op. at 12

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “the art offered by Patent Owner in the ’1795 IPR, which, as noted above, also involved the ’086 patent, should apply to this proceeding, namely “someone with a Ph.D. in biochemistry or similar field in the pharmaceutical sciences, with familiarity and experience with pharmacokinetics.” Pet. 33. Patent Owner does not dispute Petitioner’s definition and, indeed, Patent Owner’s expert, Dr. Amiji, used the same definition in his analysis. Ex. 2014 ¶ 21. For purposes of this Decision, therefore, we adopt Petitioner’s description. We also note that the applied prior art reflects the appropriate level of skill at the time of the claimed invention and supports Petitioner’s definition. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 14

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

      “We have considered the arguments presented by the parties, and find that our initial construction is proper for the reasons set forth in the ’1795 proceeding. Ex. 1018 12–14. We decline to adopt Patent Owner’s construction that calls for an isolation step separate from the process used to manufacture synthetic NR.” slip op. at 16

    Patent outcomesUS 8,383,086 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 8,383,086
  • 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 · Mar 16, 2022 · CBM2020-00023 · APJ Justin T Arbes · CBM · Final written decision

    Claims 1–12 are unpatentable under § 101; proposed substitute claim 13 is unpatentable under §§ 101 and 103 over Pictet, and the revised motion to amend is denied.

    RulingsFinal written decision
    • Patent Eligibility (§101) › Alice/Mayo step one — 'directed to'Step1 directed to exceptionUnpatentable

      “all directed to “time-based trade analysis” “improperly describes the claims at too high a level of abstraction, as warned against in” Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335, 1337 (Fed. Cir. 2016). PO Resp. 5–6. We disagree. Petitioner’s articulation of the abstract idea to which claim 1 is allegedly directed is appropriately focused and tied to the specific language of the limitations of the claim. Petitioner explains how the recited “price data” and “current system position information” are the key inputs for time-based trade analysis and how calculating a trade recommendation using sub-models based on different times of day constitutes such analysis. See Pet. 31–34. Further, “time-based trade analysis” is not a general field, but rather a particular practice, namely the analysis of potential trades based on time. That type of analysis is reflected expressly in claim 1 via the use of a plurality of sub-models where each is based on “a different time of day.” Petitioner’s analysis is persuasive, as it is consistent with the language of claim 1 and supported by the testimony of Mr. Donefer, which we credit.6 Based on the full record developed during trial, we are persuaded that claim 1 recites time-based trade analysis. Doing so is a fundamental economic practice, which is one of the certain methods of organizing human activity identified in the Guidance, and, thus, an abstract idea.” slip op. at 21

    • Patent Eligibility (§101) › Alice/Mayo step two — inventive conceptStep2 no inventive conceptUnpatentable

      “We disagree. Claim 1 does not recite a distributed system architecture, sub-model calculations executed concurrently in parallel, or real-time operation for a large number of users, all of which Patent Owner relies on to show a patent-eligible application of the alleged abstract idea. See Reply 6, 8; Ex. 1038 ¶¶ 22, 25–26. Claim 1 broadly recites “calculating trade recommendation information from each of a plurality of trading sub-models,” each “based on a different time of day,” and “calculating a trade recommendation . . . based on said trade recommendation information from each of said trading sub-models.” The claim does not specify how, when, or by what component the calculations are performed. Thus, Patent Owner’s contention that steps (d) and (e) do not represent well-understood, routine, and conventional activity is not commensurate with the language of the claim. With respect to what is actually recited in the claim, we are persuaded based on the full trial record that the calculations are the abstract idea itself (i.e., the fundamental economic practice of “time-based trade analysis”), rather than additional elements that could transform the claim into a patent-eligible application of an abstract idea. See supra Section II.F.1.b; BSG Tech LLC v. BuySeasons, Inc., 899 F.3d 1281, 1290 (Fed. Cir. 2018) (“[A] claimed invention’s use of the ineligible concept to which it is directed cannot supply the inventive concept that renders the invention ‘significantly more’ than that ineligible concept.”). Regardless, though, Petitioner also has provided persuasive evidence regarding the conventionality of steps (d) and (e), particularly given the broad manner in which they are recited in the claim. See, e.g., Ex. 1004 ¶¶ 69–84; Ex. 1021, 115 (“It is widely documented that return volatility varies systematically over the trading day and that this pattern is highly correlated with the intraday variation of trading volume and bid-ask spreads.”); Ex. 1019, 13 (“Trading models offer a real-time analysis of foreign exchange movements and generate explicit trading recommendations. These models are based on the continuous collection and treatment of foreign exchange quotes by market makers around the clock at the tick-by-tick frequency level.”); Ex. 1031, 728–732 (describing modeling that accounts for time periods of different levels of activity, such as when particular FX markets are open, and using time intervals of “hours, days, weeks or years”). Petitioner also has provided a detailed explanation citing persuasive evidence that, even if claim 1 did require distributed parallel processing and real-time trading model calculations, both were well-understood, routine, and conventional at the time of the ’534 patent. See Reply 9–11, 15–17; Ex. 1038 ¶¶ 23 (citing, for example, Ex. 1031, 228–232), 29–35 (citing, for example, Ex. 1031, 718). We credit Mr. Donefer’s testimony, which is supported by evidence in the record and unrebutted—Patent Owner did not address the evidence discussed in the Petition and Mr. Donefer’s initial declaration in its Response, did not file a Sur-Reply addressing Mr. Donefer’s reply declaration and cited evidence, and did not provide any contrary evidence in the record. See Reply 1, 3.” slip op. at 30

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

      “testimony of Mr. Donefer, for why a person of ordinary skill in the art would have had reason to combine Pictet’s teachings and arrive at the method of proposed substitute claim 13. Id. at 24–25 (citing Ex. 1031, 716–723; Ex. 1038 ¶¶ 52–58, 75–77). Petitioner argues that a person of ordinary skill in the art “would have recognized that Pictet’s data collection and storage steps (i.e., steps (a)-(c)) provide inputs for the subsequent calculations (i.e., steps (d)-[(e)]),” “would have understood Pictet as teaching that the distributed parallel processing . . . applies to the implementation of the trading models performing those calculations,” and would have had “reason to use at least five of the parameters discussed [in Pictet] when configuring the rules governing the ‘grand’ model.” Id. at 24. Petitioner further contends that numerous types of parameters were routinely used when designing and evaluating trade models, and Pictet’s moving average . . . is no different. Moreover, Pictet describes two categories of threshold values (i.e., trend and overbought/oversold) and expressly teaches using “several threshold values of both types,” which at a minimum suggests four such parameters. The voting scheme is also an integral part of the weighted moving average Pictet describes. A [person of ordinary skill in the art] also had reason to incorporate a time parameter setting the amount of time in the past that is considered, since a [person of ordinary skill in the art] would have understood that price data from the distant past is less 984, 990 (Fed. Cir. 2020) (non-precedential) (recognizing that “the Board need not address issues that are not necessary to the resolution of the proceeding”). relevant to a moving average. Pictet also teaches using stop-loss and stop-profit parameters as part of its model implementation. Id. at 24–25 (citations omitted). We have reviewed Petitioner’s analysis and find it persuasive. Petitioner’s reasoning is consistent with the disclosure of Pictet and supported by the testimony of Mr. Donefer, which we credit. For the reasons stated by Petitioner and Mr. Donefer, we find that a person of ordinary skill in the art would have had reason to combine the cited teachings of Pictet in the manner asserted with a reasonable expectation of success.” slip op. at 53

    • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied

      “3. Patentability Pursuant to 37 C.F.R. § 42.221(d)(2), Petitioner “bears the burden of persuasion to show, by a preponderance of the evidence,” that proposed substitute claim 13 is unpatentable. Petitioner argues that proposed substitute claim 13 fails to recite patent-eligible subject matter under 35 U.S.C. § 101, is indefinite under 35 U.S.C. § 112, second paragraph, and would have been obvious under 35 U.S.C. § 103(a). Opp. 3–25. For the reasons explained below, we determine that Petitioner has met its burden to show, by a preponderance of the evidence, that claim 13 is unpatentable as claiming patent-ineligible subject matter under 35 U.S.C. § 101 and obvious under 35 U.S.C. § 103(a), and need not reach Petitioner’s arguments regarding definiteness under 35 U.S.C. § 112, second paragraph.” slip op. at 39

    Patent outcomesUS 7,496,534 unpatentable
    Claim construction§ 101 eligibility§ 103 obviousnesscites Alice · Mayo · Bilski · Berkheimer · Enfish · KSR · Graham
    Patents in suitUS 7,496,534
  • 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 · Feb 8, 2022 · PGR2021-00103 · APJ Patrick R Scanlon · PGR · Institution

    The Board instituted PGR on claims 1–28 and all petition grounds, finding the Luharuka, API 674, and Karassik challenge more likely than not to prevail on claim 1.

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

      “Under 35 U.S.C. § 324(a), a post-grant review may not be instituted “unless . . . the information presented in the petition . . . , if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” After considering the Petition and Patent Owner’s Preliminary Response, as well as all supporting evidence, we determine that Petitioner has satisfied the burden under 35 U.S.C. § 324(a) to show that it is more likely than not that at least one of the challenged claims is unpatentable.” slip op. at 2

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

      “These arguments are not persuasive, however, because Patent Owner does not explain adequately how the disclosures of Oehring and Shampine are cumulative of the disclosure of Mu. In this case, the mere fact that 8 We note that Exhibit 2007 does not have ¶ 95 cited by Patent Owner. not mean necessarily that the references are cumulative of Mu. For instance, Petitioner relies on Mu for allegedly disclosing several claim limitations including “receiving a demand hydraulic horse power (HHP) signal,” “the first output power being in the range of approximately 70% to 100% of a maximum continuous power (MCP) level,” and “the second output power . . . being in the range of approximately 70% of the MCP level to approximately a maximum intermittent power (MIP) level.” Pet. 19–41. Patent Owner does not direct us to any disclosure in Oehring or Shampine that are cumulative of these alleged teachings in Mu. Accordingly, we do not agree with Patent Owner that either of Oehring or Shampine is cumulative of Mu. As such, we determine that Petitioner’s reliance on Mu does not involve the same or substantially the same art or arguments previously presented to the Office, and the first part of the Advanced Bionics framework is not satisfied with respect to Mu. And although Crowe is cited in the ’764 patent (see Ex. 1001, code (56)), Petitioner’s reliance on Crowe is minimal. The ground based on Mu and Crowe, thus, does not implicate § 325(d).” slip op. at 8

    • Skill levelOther

      “This dispute presents a factual issue best decided on a complete record. Accordingly, for purposes of the Decision, we determine that no express finding is necessary, and that the level of ordinary skill in the art is reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). We note, however, that our obviousness analysis in this Decision would not differ if we adopted either Petitioner’s or Patent Owner’s definition.” slip op. at 11

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “Lastly, on the current record, we disagree with Patent Owner’s argument that Mr. Marscher is not qualified to serve as an expert in this proceeding. See Prelim. Resp. 8. Mr. Marscher’s declaration and curriculum vitae show that he has extensive education and experience in relevant fields. Ex. 1003 ¶¶ 8–17; Ex. 1004.” slip op. at 11

    Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · Graham
    Patents in suitUS 10,815,764
  • PTAB · Feb 8, 2022 · PGR2021-00102 · APJ Patrick R Scanlon · PGR · Institution

    The Board instituted PGR on claims 1–28 on all asserted grounds, finding a sufficient likelihood that at least one challenged claim is unpatentable.

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

      “Under 35 U.S.C. § 324(a), a post-grant review may not be instituted “unless . . . the information presented in the petition . . . , if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” After considering the Petition and Patent Owner’s Preliminary Response, as well as all supporting evidence, we determine that Petitioner has satisfied the burden under 35 U.S.C. § 324(a) to show that it is more likely than not that at least one of the challenged claims is unpatentable.” slip op. at 2

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

      “These arguments are not persuasive, however, because Patent Owner does not explain adequately how the disclosures of Oehring and Shampine are cumulative of the disclosure of Mu. In this case, the mere fact that 8 We note that Exhibit 2007 does not have ¶ 95 cited by Patent Owner. not mean necessarily that the references are cumulative of Mu. For instance, Petitioner relies on Mu for allegedly disclosing several claim limitations including “receiving a demand hydraulic horse power (HHP) signal,” “the first output power being in a selected range of a maximum continuous power (MCP) level,” and “the second output power . . . being in a selected range of the MCP level to a maximum intermittent power (MIP) level.” Pet. 19–41. Patent Owner does not direct us to any disclosure in Oehring or Shampine that are cumulative of these alleged teachings in Mu. Accordingly, we do not agree with Patent Owner that either of Oehring or Shampine is cumulative of Mu. As such, we determine that Petitioner’s reliance on Mu does not involve the same or substantially the same art or arguments previously presented to the Office, and the first part of the Advanced Bionics framework is not satisfied with respect to Mu. And although Crowe is cited in the ’459 patent (see Ex. 1001, code (56)), Petitioner’s reliance on Crowe is minimal. The ground based on Mu and Crowe, thus, does not implicate § 325(d).” slip op. at 8

    • Skill levelOther

      “This dispute presents a factual issue best decided on a complete record. Accordingly, for purposes of the Decision, we determine that no express finding is necessary, and that the level of ordinary skill in the art is reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). We note, however, that our obviousness analysis in this Decision would not differ if we adopted either Petitioner’s or Patent Owner’s definition.” slip op. at 11

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionTerm construed board ownOther

      “We agree with Patent Owner that Petitioner has not explained sufficiently what a “maximum power output value” means in the context of the ’459 patent. Nor has Petitioner explained sufficiently why “maximum intermittent power” should be tied to the “maximum power output value.” In contrast, Patent Owner’s proposed construction is supported by the Specification, although we do not agree with the last clause of the construction because the references to “typical” values do not assist in understanding the claim language. Accordingly, for purposes of this Decision, we preliminarily construe “maximum intermittent power” to mean “an elevated operating output level that the pump unit may operate intermittently throughout its operating life without excessive damage to the pump unit.”” slip op. at 14

    Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · Graham · Nautilus
    Patents in suitUS 10,907,459
  • 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
  • PTAB · Dec 10, 2021 · PGR2021-00088 · APJ John G New · PGR · Institution

    The Board denied institution on all five grounds, finding the petition did not show any challenged claim was likely unpatentable.

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

      “Under 35 U.S.C. § 324, the Board “may not authorize a post-grant review to be instituted unless … the information presented in the petition … if such information is not rebutted would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon consideration of the Petition, the Preliminary Response, and the evidence presently before us, we determine that Petitioner has failed to demonstrate that it is more likely than not that it would prevail in establishing the unpatentability of at least one challenged claim of the ’908 patent. We consequently deny institution of post-grant review.” slip op. at 2

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

      “The Specification expressly teaches that, with respect to the clinical phase 2 trial described in Example 4, “Patients will have overnight [pharmacokinetic/pharmacodynamics] PK/PD assessments performed at baseline, which include an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose.” Ex. 1001 col. 42, ll. 12–16. This is the same quotation and clinical trial relied upon by Dr. Barnes in his Declaration, and is the only definition of a “baseline” in the ’908 patent. See Ex. 1002, 36–37. We note that placebos were evidently not employed in the phase 2 clinical study of Example 4.3 Given the sole exemplary description of “baseline” in Example 4 of the Specification, we construe the claim term reciting “reduced by at least 10% from baseline” as meaning “a reduction of at least 10% in the level of ACTH (claim 1) or 17-OHP (claim 11) compared to measurements of ACTH or 17-OHP made prior to, and/or at the beginning of, administration of the drug.”” slip op. at 8

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

      “likely than not that independent claims 1 and 11 are anticipated by Grigoriadis. “For a claim to be anticipated, each claim element must be disclosed, either expressly or inherently, in a single prior art reference, and the claimed arrangement or combination of those elements must also be disclosed, either expressly or inherently, in that same prior art reference.” Therasense, Inc. v. Becton, Dickinson and Co., 593 F.3d 1325, 1332–33 (Fed. Cir. 2010). The single clinical trial taught by Example 6 of Grigoriadis does not establish a baseline value for patients against which to compare the data obtained from patients receiving 300 mg or 600 mg of the test drug, NBI- 77860 (verucerfont). See Ex. 1006 ¶¶ 90–94. Specifically, Example 6 does not establish a baseline “which include[s] an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose,” as disclosed by the ’908 patent. See Ex. 1001, col. 42, ll. 12–16. We therefore conclude that Grigoriadis fails to disclose expressly the limitations of claims 1 and 11 severally reciting “wherein [the] … hormone … level in the human is reduced by at least 10 % from baseline.”” slip op. at 16

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable

      “A reference may anticipate if a claim limitation that is not expressly disclosed is inherently disclosed because it “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010); see also Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (holding that the “very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question”).” slip op. at 17

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
    Patents in suitUS 10,849,908
  • PTAB · Aug 31, 2021 · PGR2020-00028 · APJ Cynthia M Hardman · PGR · Final written decision

    Claims 1–3, 9–13, and 21–30 are unpatentable for lack of enablement; claims 9–13 also lack written description. Petitioner did not prove anticipation or obviousness of claims 1–7 and 22–31.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “In determining the level of skill in the art, we consider factors including the type of problems encountered in the art, prior art solutions to those problems, and the sophistication of the technology. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). Because Petitioner’s proposed definition is consistent with the prior art of record and the sophistication of the technology demonstrated by the record, we apply it here.5” slip op. at 10

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

      “Based on the complete record developed at trial, we determine that to resolve the disputes herein, we do not need to expressly construe any claim term. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that construction is needed only for disputed terms, and only as necessary to resolve the controversy).” slip op. at 11

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “We find that Dr. Dayan’s testimony on these points lacks sufficient supporting analysis. In opining that the tested substituents are representative of the steric and electrostatic properties across the claimed substituents, Dr. Dayan merely compares the properties of the tested substituents to each other. See, e.g., id. ¶¶ 52–56. He does not expressly compare them to the properties of the many remaining, untested substituents within the scope of the claims. See id.; see also Reply 14 (“At best, [Dr.] Dayan testified that the positive activity . . . at each substituent” suggests that the position is involved in herbicidal activity, “not that the tested compounds were sufficient to provide any reasonable expectation of success as to the billions of structurally diverse compounds covered” by the claims.). And although Dr. Dayan acknowledges that several tested compounds showed no herbicidal activity, he does not expressly explain how he took these compounds into account in nevertheless concluding that an ordinarily skilled artisan would expect at least some activity across all claimed substituents. See, e.g., Ex. 2011 ¶¶ 54–56 (noting exceptions to herbicidal activity). As one example, Dr. Dayan acknowledges the lack of activity shown in the data for substituents larger than hydrogen at the R6 position, but does not explain the impact of that data on the remaining claimed substituents. See id. ¶ 54 (Dr. Dayan noting that activity is “not as favored by larger alkyl groups” at R6, but nevertheless concluding that “one would expect at least some herbicidal activity” across all claimed R6 substituents). In contrast, Dr. Hunt compares the size and properties of the R6 substituents that showed no activity with the size and properties of other claimed but untested R6 substituents. Ex. 1003 ¶¶ 163, 166–68; Ex. 1029 ¶¶ 37, 38. This comparison indicates that the majority of R6 substituents are larger than the tested substituents, such that the vast majority of the claimed compounds (i.e., those with compounds having R6 substituents larger than those tested), could have no herbicidal activity. Ex. 1003 ¶ 167; Ex. 1029 ¶¶ 12, 37, 38. Thus, we find that the data in the Specification regarding at least position R6 gives a person of ordinary skill in the art reason to doubt that substantially all compounds within the full scope of claim 1 of the ’202 patent would exhibit herbicidal activity. Ex. 1003 ¶ 163; Ex. 1029 ¶¶ 11, 12, 38; In re Surrey, 370 F.2d 349, 355 (CCPA 1966) (“[W]here the applicant seeks to obtain a monopoly in exchange for his disclosure of a group of compounds there should be a disclosure which gives a reasonable assurance that all, or substantially all of them are useful.”).” slip op. at 29

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

      “We find that the need for iterative QSAR modeling, together with the sheer number of candidate compositions that must be synthesized (each of which would take at least a week to make) for both the modeling and herbicide testing, weighs against enablement, especially in light of the limited guidance in the Specification and the general unpredictability in the art. 3. Conclusion In sum, it is undisputed that claim 1 covers at least a billion compounds. The art is unpredictable, and the Specification indicates that not all of the compounds falling within claim 1 are effective herbicides. See, e.g., Pet. 22 (listing compounds that showed no herbicidal activity). Although the level of ordinary skill in the art is relatively high and the field is mature, Petitioner establishes by a preponderance of the evidence that the ’202 patent does not provide sufficient meaningful guidance or working examples across the full scope of claim 1 to allow a person of ordinary skill in the art to determine which other compounds across the full scope of the claim have herbicidal activity without undue experimentation.” slip op. at 45

    Patent outcomesUS 10,294,202 mixed
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR
    Patents in suitUS 10,294,202
  • PTAB · Jan 27, 2021 · PGR2019-00064 · APJ Christopher G Paulraj · PGR · Rehearing

    The Board denied Petitioner’s rehearing requests, leaving in place denial of institution based on the merits of the written-description and enablement challenges.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “II. DISCUSSION A party requesting rehearing has the burden to show a decision should be modified by specifically identifying all matters the party believes were misapprehended or overlooked, and the place where each matter was addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2

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

      “Petitioner’s arguments are unpersuasive because our construction of “stable” does not exclude the preferred embodiments. As Petitioner acknowledges, “[t]he Board did not construe ‘stable’ to be limited to formulations that are as stable as Humira or lose 20% of activity upon storage.” Id. at 3. Although our construction encompasses the “most” preferred embodiment (e.g., those that do not lose more than 5% of their activity during two years of long-term storage), it also encompasses other embodiments that are considered less preferred but nonetheless within the scope of what is defined to be “stable” in the specification, i.e., compositions that do “not lose more than 20%, or more preferably 15%, or even more preferably 10%” of activity. Ex. 1001, 9:28–33. Furthermore, consistent with the specification, our construction of “stable” encompasses embodiments in which stability is determined by comparison to the commercial formulation of adalimumab known in the prior art, i.e., Humira. Decision 8–9. We find no basis to construe “stable” to be limited to the only most preferred embodiment by requiring a loss of no more than 5% activity. See Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (stating “a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment”).” slip op. at 3

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

      “These arguments are also unpersuasive. As stated in the Decision: [W]e find that the specification provides a detailed disclosure of the testing used to assess stability (using Humira as the control), and identifies specific ingredients to be included and excluded from the claimed composition, and further identifies the pH that is necessary to achieve the claimed stability. Although there may be certain concentrations of adalimumab or certain types of buffers and sugars that may render the compositions more difficult to stabilize, Petitioner does not explain sufficiently why a POSA would not have known how to adjust or select those ingredients in order to achieve the claimed stable aqueous pharmaceutical composition. Decision 17. As further stated in the Decision: Moreover, even if a POSA would have needed to test whether a particular composition was stable, “[t]he fact that some experimentation is necessary does not preclude enablement; what is required is that the amount of experimentation ‘must not be unduly extensive.” PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564 (Fed. Cir. 1996) (citing Atlas Powder Co. v. E.I. DuPont De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984)). Indeed, even “a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the invention claimed.” Id. (citing Ex parte Jackson, 217 USPQ 804, 807 (BPAI 1982)). Id. at 17–18. Petitioner’s arguments do not persuade us that we committed legal or factual error in making the foregoing determinations. Accordingly, we are not persuaded that we abused our discretion in determining that Petitioner did not satisfy its burden with respect to the lack of enablement ground for claims 1–12.” slip op. at 5

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

      “the specification identifies with sufficient clarity each of the ingredients that must be included as part of the claimed composition (i.e., adalimumab, a buffer, polysorbate 80, and a sugar) and further provides a reason to exclude the ingredients that must not be included in theclaimed composition (i.e., mannitol, a citrate/phosphate buffer combination, and sodium chloride). Id. at 13–14. The Decision also explained how one of ordinary skill in the art would recognize that the inventors possessed the claimed invention: Patent Owner identifies teachings in the specification indicating the structural features required for achieving a stable adalimumab composition, which include: 1) avoiding the citrate/phosphate buffer combination in favor of another more stable buffer (such as an acetate buffer); 2) including polysorbate 80 as a stabilizer; 3) removing sodium chloride (NaCl) from the formulation; 4) using a sugar or polyol as the tonicity modifier in place of mannitol/NaCl; and 5) maintaining a pH of at least 5 (with an optimal pH near 5.2). Id. at 60 (citing Ex. 1001, 5:42–44, 21:40–47, 37:25–38:4, 38:1–7, 61:24–25). Patent Owner further asserts, and we agree, that the specification “provides working examples that demonstrate comparable or superior stability to the commercial Humira® formulation” and that Petitioner fails to demonstrate why a POSA would doubt that the formulations that demonstrated improved stability relative to Humira would be stable. Id. at 60–61. Id. at 14. Petitioner’s arguments do not persuade us that we committed legal or factual error in making the foregoing determinations. Accordingly, we are not persuaded that we abused our discretion in determining that Petitioner did not satisfy its burden with respect to the lack of written description ground for claims 1–12.” slip op. at 7

    Claim construction§ 112 disclosure
    Patents in suitUS 10,155,039

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.