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  • PTAB · Nov 17, 2025 · PGR2024-00035 · APJ Cynthia M Hardman · PGR · Final written decision

    Claims 1–20 are unpatentable as obvious over the cited prior art, based on the Board’s findings across the four asserted grounds.

    RulingsFinal written decision
    • Skill levelOther

      “II. ANALYSIS A. Level of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art” slip op. at 12

    • Expert testimonyPatent owner expert discountedDecided for patent owner

      “person or designer of ordinary skill in the art. See Reply 7; Ex. 2001 ¶ 5. Patent Owner asserts that Mr. Kirkpatrick’s testimony is nevertheless relevant because it “informs the opinion of expert witnesses who do qualify as POSITAs” (i.e., Dr. Rojas). PO Resp. 4–5. But the level of ordinary skill in the art as defined here does not mention patents or patent drawings, and Patent Owner has not explained why or in what capacity a person of ordinary skill in the art would have consulted with a patent illustrator.15 For these reasons, we accord no weight to Mr. Kirkpatrick’s opinions on how a person of ordinary skill in the art would have viewed the figures. See” slip op. at 26

    • BurdenFwd all claims unpatentableUnpatentable

      “Petitioner has the burden of proving unpatentability of the challenged claims by a preponderance of the evidence. 35 U.S.C. § 326(e). Having reviewed the parties’ arguments and cited evidence, for the reasons we discuss below, we find that Petitioner has demonstrated by a preponderance of the evidence that claims 1–20 are unpatentable as obvious over the cited prior art.” slip op. at 2

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

      “For the above reasons, and after considering Patent Owner’s” slip op. at 47

    Patent outcomesUS 11,932,441 unpatentable
    § 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,932,441
  • PTAB · Nov 27, 2024 · PGR2022-00025 · APJ Susan L C Mitchell · PGR · Final written decision

    Claims 1–19 are unpatentable because the ’201 patent lacks written description support for the claimed genus of CRF1 receptor antagonists under § 112(a).

    RulingsFinal written decision
    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

      “[A] sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. at 1350 (citing Regents, 119 F.3d at 1568–69). Moreover, “an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials.” Id. (citing Regents, 119 F.3d at 1568 (quoting Fiers, 984 F.2d at 1171)). Furthermore, “functional claim language can meet the written description requirement when the art has established a correlation between structure and function.” Id. (citing Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed. Cir. 2002) (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001))). “[M]erely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” Id.” slip op. at 42

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “According to Petitioner, a person of ordinary skill in the relevant art (“POSA”) “would have a medical degree or a Ph.D. in a field related to endocrinology, and would have knowledge of hormone regulation and disorders, as well as knowledge of the treatment regimens employed to treat such disorders . . . [and] would also have at least three years of experience conducting research concerning endocrine disorders, including CAH or other adrenal disorders.” Pet. 26–27 (citing Ex. 1005 ¶ 34 (Dr. Carey Declaration)). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. Because Petitioner’s definition of a person of skill in the art appears commensurate with the level of skill reflected in the asserted art in this case as well as the ’201 patent itself, see, e.g., Exs. 1024, 1025, 2003, 2004, 2005, we apply Petitioner’s proposed level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating prior art itself can reflect the appropriate level of ordinary skill in the art). C.” slip op. at 22

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “For these reasons, we do not find persuasive the testimony of Patent Owner’s expert, Dr. Dobs, that: By describing adjustments of dosing protocols to achieve an A4 reduction from baseline, and describing this use of tildacerfont as just one embodiment of the claimed use of the entire well-known, well-characterized, and discrete class, the specification reasonably conveyed to a POSA that the invention extended to the particularly claimed use of the entire recited class. Ex. 2014 ¶ 82. On the contrary, far from being a “well-known, well-characterized, and discrete class” the prior art teaches a heterogeneous assembly of different classes of small molecule CRF1 receptor antagonists (Type I, Type II, and “atypical”) displaying a very considerable variety of structures, both in terms of the core pharmacophore (e.g., monocyclic, bicyclic, tricyclic, phenolic, cyclohexyl amide, etc.) as well as in the various side groups. Moreover, the challenged claims recite only “a CRF1 receptor antagonist or a pharmaceutically acceptable salt thereof,” the scope of which also encompasses the much larger (and, according to Williams) much more effective large-molecule (peptide) CRF1 receptor antagonists, about which the Specification is entirely silent. See Ex. 1029, Abstr., 1065. Furthermore, despite Dr. Dobs’ testimony that “[t]he [prior art] references explain the typical CRF1 antagonist consists of a core nitrogen heterocycle with an aryl substituent adjacent to the core nitrogen atom and a branched alkyl group attached at the opposite end of the core,” Dr. Dobs also acknowledged that the “atypical CRF1 receptors depicted in Figures 11 and 12 of Williams had different structures, and lacked the nitrogen heterocyclic core.” Ex. 1042, 127:9–14, 130:13–131:16; see also Ex. 2014 ¶ 83. Additionally, Petitioner’s expert, Dr. Cutler, testified, by way of example, in his Reply Declaration that two of the ‘“first-generation CRF1 antagonists’ identified in Figure 1 of the Williams article do not fall within the Figure 2 structure Dr. Dobs relies upon.” Ex. 1047 ¶ 93. Indeed, with respect to the alleged core pharmacophore that Dr. Dobs” slip op. at 54

    • ExcludeMotion to exclude, deniedMixed

      “with chemical terminology”; “could not answer questions regarding the chemical structures in the prior art articles”; “did not know whether CRF1 receptor antagonists contained the structural features she deemed ‘essential’ in her Declaration”; and “agreed that tildacerfont has structurally unique features” (see Ex. 1042, 52–53, 125–126, 126–128, 128–130) goes to the weight that we assign to such testimony, but we do not find that such testimony, in light of Dr. Dobs’ extensive qualifications as an endocrinologist set forth above, deems Dr. Dobs unqualified to testify concerning the written description issue in this proceeding. For these reasons explained above, Petitioner’s Motion to Exclude Dr. Dobs’ written description opinions in paragraphs 20 and 75–87 of Exhibit 2014 is denied.” slip op. at 11

    Patent outcomesUS 11,007,201 unpatentable
    § 112 disclosurecites Phillips
    Patents in suitUS 11,007,201
  • PTAB · Nov 26, 2024 · PGR2021-00088 · APJ John G New · PGR · Final written decision

    Claims 1–25 are unpatentable because the ’908 patent lacks written description support under § 112(a); the Board did not reach Grounds 1–3 or 5.

    RulingsFinal written decision
    • ExcludeMotion to exclude, deniedMixed

      “To the extent that Dr. Dobs has admitted that she is “not comfortable with chemical terminology”; “could not answer questions regarding the chemical structures in the prior art articles”; “did not know whether CRF1 receptor antagonists contained the structural features she deemed ‘essential’ in her Declaration”; and “agreed that tildacerfont has structurally unique features” (see Ex. 1038, 52–53, 125–126, 126–128, 128–130), we will weigh her testimony regarding those matters accordingly. However, for the reasons explained above, Petitioner’s Motion to Exclude Dr. Dobs’ written description opinions in paragraphs 19 and 80–91 of Exhibit 2014 is denied.” slip op. at 10

    • Strike new argumentOther

      “Analysis Patent Owner’s Exhibits 2020–2026 play no part in our reasoning and were not relied upon by the Board in reaching our Decision. Petitioner’s Motion to strike Exhibits 2020–2026 is therefore dismissed as moot.” slip op. at 23

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “typically possess a medical degree or a Ph.D. in a field related to endocrinology, and would have knowledge of hormone regulation and disorders, as well as knowledge of the treatment regimens employed to treat such disorders. Pet. 60 (citing Ex. 1005 ¶ 34). Petitioner argues that such a person of ordinary skill would also have at least three years of experience conducting research concerning endocrine disorders, including CAH or other adrenal disorders. Id. Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. Because we find Petitioner’s definition to be consistent with the demonstrable level of skill in the art (see, e.g., Exs. 1009, 1025, 2003, 2004, 2005), and in the absence of a different proposed definition of the level of skill in the art by Patent Owner, we adopt Petitioner’s definition.” slip op. at 26

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “For these reasons, we do not find persuasive the testimony of Patent Owner’s expert, Dr. Dobs, that: By describing adjustments of dosing protocols to achieve at least a 10% reduction from baseline, and describing this use of tildacerfont as just one embodiment of the claimed use of the entire well-known, well-characterized, and discrete class, the specification reasonably conveyed to a POSA that the invention extended to the particularly claimed use of the entire recited class. Ex. 2014 ¶ 87. On the contrary, far from being a “well-known, well-characterized, and discrete class” the prior art teaches a heterogeneous assembly of different classes of small molecule CRF1 receptor antagonists (Type I, Type II, and “atypical”) displaying a very considerable variety of structures, both in terms of the core pharmacophore (e.g., monocyclic, bicyclic, tricyclic, phenolic, cyclohexyl amide, etc.) as well as in the various side groups. Moreover, the challenged claims recite only “a CRF1 receptor antagonist or a pharmaceutically acceptable salt thereof,” the scope of which also encompasses the much larger (and, according to Williams) much more effective large-molecule (peptide) CRF1 receptor antagonists, about which the Specification is entirely silent. See Ex. 1029, Abstr., 1065.” slip op. at 56

    Patent outcomesUS 10,849,908 unpatentable
    § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
    Patents in suitUS 10,849,908
  • PTAB · Jul 31, 2024 · PGR2023-00016 · APJ Stephen E Belisle · PGR · Final written decision

    Claims 1–3, 5, 7–10, 12, 14–17, and 19 are unpatentable based on lack of written description, indefiniteness, anticipation, and obviousness.

    RulingsFinal written decision
    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable

      “B. Claims 1–20 of the ’705 Patent Petitioner argues that claims 1–20 of the ’705 patent have an effective” slip op. at 19

    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
    • Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteUnpatentable
    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
    Patent outcomesUS 11,297,705 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · Nautilus
    Patents in suitUS 11,297,705
  • PTAB · Jul 26, 2024 · PGR2023-00017 · APJ Zhenyu Yang · PGR · Final written decision

    Claims 1–10 are unpatentable: claims 1, 3–5, 7, 9, and 10 are anticipated by Godoy; claims 1–10 are anticipated by Tobler; other grounds were not reached.

    RulingsFinal written decision
    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “record (Ex. 1022, Attachments 5, 6) and the ResearchGate page (id., Attachments 7–10), to further support her opinion that the Godoy report was publicly available before November 4, 2016. Id. ¶¶ 31–38, 42–48. She testifies that “ResearchGate contains many search features which would allow an interested POSA to find the Godoy report, e.g., key word searching.” Id. ¶ 48. Dr. Jacobsen, who has personally used the service, agrees that in ResearchGate, “you can start to search for publications using keywords and things like that, authors.” Ex. 1043, 66:1–67:10. For these reasons, we again find Dr. Hall-Ellis’s testimony credible.” slip op. at 32

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

      “record (Ex. 1022, Attachments 5, 6) and the ResearchGate page (id., Attachments 7–10), to further support her opinion that the Godoy report was publicly available before November 4, 2016. Id. ¶¶ 31–38, 42–48. She testifies that “ResearchGate contains many search features which would allow an interested POSA to find the Godoy report, e.g., key word searching.” Id. ¶ 48. Dr. Jacobsen, who has personally used the service, agrees that in ResearchGate, “you can start to search for publications using keywords and things like that, authors.” Ex. 1043, 66:1–67:10. For these reasons, we again find Dr. Hall-Ellis’s testimony credible.” slip op. at 32

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

      “several lists, Petitioner has met its burden in showing that an ordinarily skilled artisan would at once envisage the fungicidal combination of claim 1 from its disclosure. Accordingly, Tobler anticipates claim 1. We address Patent Owner’s arguments below.” slip op. at 44

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

      “28 Because Petitioner has shown that asserted prior art references anticipate claims 1 and 3–10, we do not address whether these claims would have been obvious over De Oliveira, either alone or in view of Wiglesworth, Tobler, and Godoy. 29 Having determined that Petitioner has shown all challenged claims are unpatentable under other grounds, we do not address this obvious ground. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1359 (2018) (holding a petitioner “is entitled to a final written decision addressing all of the claims it has challenged”); Bos. Sci. Scimed, Inc. v. Cook Grp. Inc., 809 F. App’x 984, 990 (Fed. Cir. 2020) (recognizing that the “Board need not address issues that are not necessary to the resolution of the proceeding” and, thus, agreeing that the Board has “discretion to decline to decide additional instituted grounds once the petitioner has prevailed on all its challenged claims”).” slip op. at 81

    Patent outcomesUS 11,445,727 unpatentable
    § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 11,445,727
  • PTAB · May 22, 2023 · PGR2022-00009 · APJ Monica S Ullagaddi · PGR · Final written decision

    Claims 1–5, 7–12, and 14–19 are unpatentable based on lack of written description, anticipation by Bruning, or obviousness over Bruning and Kabel.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “lighting device.” Accordingly, we determine that the level of ordinary skill in the art is “a bachelor’s degree in electrical engineering, or similar technical field, with two years of relevant experience in the field of design and/or development of LEDs and circuits,” as Petitioner proposes and that “the field of design and/or development” would be “in the context of lighting devices” as Patent Owner proposes, in which “[a]n increase in experience could compensate for less education.” Id.; Pet. 24 (citing Ex. 1002 ¶ 46).” slip op. at 15

    • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer foundDecided for patent owner

      “theoretically fall under the “or greater” portion of the amended claim limitation “forward voltage of 6V or greater,” Applicant distinguished Colby on the basis that the 120V AC voltage from a wall outlet is not “the minimum voltage difference required between the anode and cathode of the LEDs in the claimed circuit to allow current to flow through the LEDs.” See Ex. 1023, 9 (emphasis added). Applicant’s argument specifically identifies the claim language at issue––“forward voltage of 6V or greater”––and specifically states that it is not disclosed because Colby does not disclose the minimum voltage and instead, discloses something else, something larger–– 120V AC voltage. Accordingly, we conclude that Applicant disclaimed any voltage that is more than “the minimum voltage difference required between the anode and cathode of the LEDs in the claimed circuit to allow current to flow through the LEDs” from the scope of “forward voltage.”” slip op. at 25

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

      “4. 35 U.S.C. § 112(a) With respect to the written description requirement, we are persuaded” slip op. at 32

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

      “Basis § Unpatentable Unpatentable Lack of written description, 3, 10, 17 112(a) 3, 10, 17 Lack of enablement 3, 10, 17 112(b) Indefiniteness 3, 10, 17 Lack of written description, 4, 11, 18 112(a) 4, 11, 18 Lack of enablement 4, 11, 18 112(b) indefiniteness 4, 11, 18” slip op. at 77

    Patent outcomesUS 10,932,341 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · Nautilus
    Patents in suitUS 10,932,341
  • PTAB · Jan 4, 2023 · PGR2021-00096 · APJ Iftikhar Ahmed · PGR · Final written decision

    Claims 1–18 are unpatentable; the contingent motion to amend proposing claims 19–36 is denied, and the parties’ motions to exclude are denied in part and granted in part.

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

      “3. Analysis On the full record developed during trial, we are persuaded by Patent Owner’s argument. Petitioner’s analysis of the independent claims described above only loosely corresponds to the actual limitations recited in the claim. The Federal Circuit has “cautioned that courts ‘must be careful to avoid oversimplifying the claims’ by looking at them generally and failing to account for the specific requirements of the claims.” McRO, Inc. v. Bandai Namco Games America Inc., 837 F.3d 1299, 1313 (Fed. Cir. 2016) (quoting In re TLI Commc’ns LLC Patent Litig., 823 F.3d 607, 611 (Fed. Cir. 2016)). Petitioner’s analysis of the claim limitations appears to do. Petitioner’s argument that “the essence of all the claims” is captured by a single claim element (f3) not only ignores that that limitation recites performing two specific software tasks simultaneously—which we are not persuaded is an abstract idea—but also asks us to disregard multiple technical aspects recited in the claims, such as identifying a link, determining whether an installation client is available on the device, invoking the installation client, and redirecting to the device an app store. See, e.g., Ex. 1001, 21:6–35. That is, under Step 2A of the Guidance, we are neither persuaded that limitation f3, which Petitioner points us to, recites an abstract idea (Prong 1), nor that the other limitations recited in the independent claims fail to integrate the alleged abstract idea into a practical application (Prong 2). Petitioner characterizes the claims as directed to multitasking, which Petitioner describes as representing a basic task in organizing human activity. Pet. 30. Although the Guidance recognizes certain methods of organizing human activity, including certain activity between a person and a computer, as constituting a patent-ineligible abstract idea, we are not persuaded that the claims here fall within the scope of such activity. See Guidance, 84 Fed. Reg. at 52 (listing fundamental economic principles or practices, commercial or legal interactions, and managing personal behavior or relationships as organizing human activity); October 2019 Update at 5 (“this grouping is limited to activity that falls within the enumerated sub-groupings . . . , and is not to be expanded beyond these enumerated sub-groupings except in rare circumstances”). The claimed invention may result in multitasking on the device, but the claims are directed to downloading and installing an application in the background instead of directing the user to an application, and do not recite an abstract idea. And although that process does result in improving user experience, the claims recite more than that mere result; they recite specific steps—invoking, without exiting the foreground software application, the installation client for downloading and installing applications on the device to run in the background—that accomplish the desired result. See Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1305–06 (Fed. Cir. 2018) (finding a method that employs a new kind of file in a computer security system directed to a non-abstract improvement in computer functionality, rather than the abstract idea of computer security writ large). Petitioner thus fails to establish sufficiently that the claims are directed patent ineligible subject matter under Step 2A of the Guidance. We also agree with Patent Owner that the challenged claims are somewhat similar to those that the Federal Circuit held patentable in DDR Holdings. The claims there were directed to a method of generating a composite webpage that combined visual elements of a host website with content from a third-party, e.g., by combining the logo, background color, and fonts of the host website with product information from a merchant. DDR Holdings, 773 F.3d at 1248. When a user clicked on a link on the host website, the system would construct the composite web page comprising a look and feel description from the host website along with content based on product information from the merchant’s product catalog. Id. at 1250. The court held those claims were not directed at an abstract idea because they addressed the problem of retaining website visitors that, absent the claimed invention, would be instantly transported away from a host’s website after clicking on an advertisement and activating a hyperlink. Id. at 1257.” slip op. at 29

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

      “1. Independent Claim 1 a) “A mobile device configured for running software applications, comprising:” Petitioner contends that Pasha discloses computer system 600, which” slip op. at 38

    • 112 supportMotion to amend, deniedDenied

      “4. Support in the Original Disclosure A motion to amend may not present substitute claims that introduce new subject matter. 35 U.S.C. § 326(d)(3); 37 C.F.R. § 42.221(a)(2)(ii) (“A motion to amend may be denied where . . . [t]he amendment seeks . . . introduce new subject matter.”). “Normally, a claim element without support in the original disclosure (i.e., the application as originally filed) merits a rejection under 35 U.S.C. § 112 for lack of written description support.” Lectrosonics, Paper 15, 7. Accordingly, a motion to amend must set forth written description support in the originally filed disclosure of the subject patent for each proposed substitute claim.” Id.” slip op. at 74

    • ExcludeMotion to exclude, grantedGranted in part

      “CTPG at 73–74. Accordingly, Rule 42.23(b) prohibits filing of new evidence other than deposition transcripts of the cross-examination of any reply witness with a sur-reply. Patent Owner does not argue that the opinions presented in paragraphs 4–13 of Dr. Mao’s declaration are within the scope of §42.23(b). See generally PO MTE Opp. Nor do we find it in the interests of justice to allow this evidence in the case file. Accordingly, we grant in part Petitioner’s Motion to Exclude paragraphs 4–13 of Exhibit 2013 pursuant to 37 C.F.R. § 42.23(b).22” slip op. at 90

    Patent outcomesUS 10,782,951 unpatentable
    § 101 eligibility§ 102 anticipationcites Alice · Enfish · Phillips · KSR · Graham
    Patents in suitUS 10,782,951
  • PTAB · Sep 1, 2021 · PGR2020-00031 · APJ Jason M Repko · PGR · Final written decision

    Claims 1–30 are unpatentable: claims 1–5, 15–19, 25, and 11–14, 28 on obviousness grounds; claims 6, 7, 9, 10, 23, 24, 29, 30 on anticipation; claims 20–22 on obviousness.

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

      “On September 2, 2020, we instituted an inter partes review of all challenged claims based on all grounds in the Petition. Paper 6 (“Inst. Dec.”). Patent Owner filed a Response. Paper 14 (“PO Resp.”). Petitioner filed a Reply. Paper 19 (“Pet. Reply”). Patent Owner filed a Sur-reply. Paper 20 (“Sur-reply”). An oral hearing was held on July 6, 2021. A transcript of that hearing has been entered into the record. Paper 28 (“Tr.”).” slip op. at 2

    • Skill levelDecided for petitioner

      “B. Level of Ordinary Skill in the Art According to Petitioner, A person of ordinary skill in the art at the time the ‘966 patent was filed (“POSITA”) would have had at least a Bachelor’s degree in electrical engineering or computer science or an equivalent field, or equivalent work experience and, in addition, at least two years’ experience with electronic voting machines, including familiarity with ballot marking devices (“BMDs”), optical character recognition, bar codes and hash functions. Pet. 24 (citing Shamos Decl. ¶¶ 50–51). In the Institution Decision, we applied Petitioner’s proposed definition. Inst. Dec. 6. Patent Owner does not dispute Petitioner’s proposed level of ordinary skill in the art. (PO Resp. 3). We continue to find that the level of ordinary skill identified by Petitioner (Pet. 24) is consistent with the record. See Inst. Dec. 6. Thus, we use the same definition here that we used in the Institution Decision.” slip op. at 6

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

      “testimony also support Petitioner’s conclusion that the accuracy of Brockhouse’s OCR could be improved. Pet. 56; Ex. 1005, 1:20–21 (disclosing that OCR is error prone); Shamos Decl. ¶ 231. On this record, Petitioner provides sufficient “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).” slip op. at 19

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

      “4. Claims 7, 9, 10, 24, and 30, Anticipation The Petition states that the statutory basis for challenging claims 7, 9, 10, 24, and 30 is “35 U.S.C. §§ 102 and/or 103.” Pet. 3. In this section, we consider anticipation under Section 102. Patent Owner does not contest Petitioner’s analysis. See generally PO Resp.; PO Sur-reply. Upon review of the entirety of the record, we credit the undisputed testimony of Dr. Shamos and are persuaded by Petitioner’s uncontested analysis. In particular, claims 7 and 24 depend from claims 6 and 23, respectively. Both claims 7 and 24 add “wherein the bar code is utilized to confirm the printed vote record is valid.” Ex. 1001, 9:30–31 (claim 7), 11:18–19 (claim 24). For claims 7 and 24, Petitioner asserts that Nadaf counts the vote only after confirming that the PVR is valid. Pet. 70 (citing Ex. 1007, 6:2–10). In the cited passages, Nadaf refers to the process as “confirming the institutional provenance and integrity of the content of the printed vote.” Ex. 1007, 6:2–6. According to Nadaf, “Only after being audited will the printed vote be validated for counting.” Id. at 6:7–10. On this record, Petitioner supports the assertion that Nadaf confirms the printed vote’s validity with the bar code, as recited. See Pet. 69–70. Thus, we determine that Petitioner has shown by a preponderance of the evidence that the subject matter of claim 7 and 24 are anticipated by Nadaf. Claim 9 recites a “two dimensional bar code.” Ex. 1001, 9:35–36. Claims 10 and 30 recite “a QR code bar code” Id. at 12:34–35. As for claims 9, 10, and 30, Petitioner asserts that Nadaf’s PVR contains both voter-readable text and a bar code encoded with voter selections. Pet. 71 (citing Ex. 1006, Fig. 4). Petitioner asserts that (1) Nadaf’s Figure 4 shows an example QR code and (2) a QR code is a two-dimensional bar code. Id. (citing Ex. 1007, 18:9; Ex. 1003 ¶ 296). On this record, Petitioner shows that Nadaf discloses the two-dimensional bar code that is a QR code, as recited in claims 9, 10, and 30. Thus, we determine that Petitioner has shown by a preponderance of the evidence that claims 9, 10, and 30 are anticipated by Nadaf.” slip op. at 56

    Patent outcomesUS 10,445,966 unpatentable
    § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
    Patents in suitUS 10,445,966
  • PTAB · Jul 28, 2020 · PGR2019-00027 · APJ Grace Karaffa Obermann · PGR · Final written decision

    Claims 1–29 are unpatentable as obvious over Harden combined with one or more of Varenna 2011, Gatti, and Muratore; the written-description challenge was not proven.

    RulingsFinal written decision
    • BurdenUnpatentable

      “Based on the full trial record, we find that Petitioner demonstrates by a preponderance of the evidence that the subject matter of claim 1 would have been obvious. Varenna 2011 teaches that neridronate “seems to possess an excellent efficacy profile” in treating CRPS. Ex. 1006, 233. In the context of reporting the use of “[n]eridronic acid for the treatment of bone metabolic diseases,” Gatti teaches that “[i]ntravenous high doses of bisphosphonates are increasingly used for the treatment of [CRPS].”13 Ex. 1008, 1305, 1308. Gatti also reports that a clinical trial of neridronic acid “is underway.” Id. Muratore teaches that neridronate was “efficacious in the treatment of [CRPS].” Ex. 1007, 89. Thus, on this record, each of these references sufficiently teaches the efficacy of neridronic acid or its salt in treating CRPS, suggesting that a person of ordinary skill in the art would have been motivated to use neridronic acid in treating CRPS. With respect to the limitation of claim 1 requiring that the neridronic acid be “parenterally administer[ed],” each of Varenna 2011, Gatti, and Muratore teaches intravenous administration of neridronic acid. Ex. 1006, 233; Ex. 1007, 89; Ex. 1008, 1308. Intravenous administration is a type of parenteral administration. Ex. 1004 ¶ 44. 13 Gatti uses the terms “reflex sympathetic dystrophy syndrome” and “algodystrophy.” Ex. 1008, 1308. On the present record, we interpret both of these terms as synonymous with “complex regional pain syndrome,” “CRPS,” “complex regional pain syndrome type I,” “CRPS I,” “reflex sympathetic algodystrophy,” “reflex sympathetic dystrophy,” and “causalgia.” Ex. 1006, 227 (equating “algodystrophy,” “complex regional pain syndrome type I,” and “CRPS I”); Ex. 1007, 89 (using the term “reflex sympathetic algodystrophy”); Ex. 1019, 713 (equating “complex regional pain syndrome,” “CRPS,” “reflex sympathetic dystrophy,” and “causalgia”). Harden teaches that the Budapest Criteria are used as “clinical diagnostic criteria for CRPS” and that they include changes in skin blood flow, by reference to the symptoms of “temperature asymmetry” and “skin color asymmetry.” Ex. 1009, 274 (Appendix II). Further, Harden teaches that 69.4% of patients diagnosed with CRPS were observed on examination to exhibit temperature asymmetry, and 83.9% were observed on examination to exhibit skin color asymmetry. Id. at 271 (Table 2). Thus, Harden teaches that a majority of patient with CRPS suffer from changes in skin blood flow. Because Varenna 2011, Gatti, and Muratore teach that neridronic acid is effective in treating CRPS, the combination of any of those references with Harden14 would have suggested to a person of ordinary skill in the art that neridronic acid would be effective in alleviating changes in skin blood flow associated with CRPS. Thus, the combination of Harden and one or more of Varenna 2011,” slip op. at 26

    • ExcludeMotion to exclude, deniedMixed

      “Assuming that “October 2011” is hearsay, it is still admissible evidence under Rule 807 of the Federal Rules of Evidence. See Opp. Mot. 3–4 (asserting this hearsay exception). Under Rule 807, a statement “is not excluded,” even if it is hearsay, if it meets two requirements. First, the statement must be “supported by sufficient guarantees of trustworthiness— after considering the totality of circumstances under which it was made and evidence, if any, corroborating the statement.” Fed. R. Evid. 807(a)(1). Second, the statement must be “more probative on the point for which it is offered than any other evidence that the proponent can obtain through reasonable efforts.” Id. at 807(a)(2). Here, both requirements are satisfied. The statement “October 2011” on the face of Varenna 2011 is offered to prove that Varenna 2011 was published in October 2011. This statement is accompanied by several guarantees of trustworthiness. The statements “Received on July 15, 2011” and “Accepted on August 30, 2011,” when offered as corroboration of the October 2011 publication date, are not hearsay. Fed. R. Evid. 801 (statement is hearsay only if offered in evidence “to prove the truth of the matter asserted in the statement”). Accordingly, they may be admitted for this purpose, and they corroborate a publication in October 2011. Moreover, Exhibits 1038 and 1040 also provide some evidence that Varenna 2011 was published in October 2011. Ex. 1038, 1 (article with same title as Varenna 2011 published in “Fascicolo 5 2011”); Ex. 1040, 1 (“Fascicolo 5 2011” published in 2011). Thus, the record contains sufficient guarantees of trustworthiness of Varenna 2011’s statement that Varenna 2011 was published in October 2011. See Opp. Mot. 3 (citing Ex. 1004 ¶¶ 39–40). We find that Varenna 2011’s statement, indicating that the reference was published in October 2011, is “more probative on the point for which it is offered than any other evidence that the proponent can obtain through reasonable efforts.” Fed. R. Evid. 807(a)(2). It is difficult to imagine evidence more probative of the publication date of a journal article than the article’s own contemporaneous statement about when it was published.19 See Opp. Mot. 2–4 (for well-supported arguments on point). Accordingly, we determine that the exception of Rule 807 applies, and we conclude that the statement “October 2011” in Varenna 2011 should not be excluded.” slip op. at 48

    • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner

      “regardless of whether the preambles are limiting. Even if the preambles are limiting, their scope is so broad as to be hardly different from no limitation at all. The specification of the ’774 patent defines “treating” as “includ[ing] any kind of treatment activity, including the diagnosis, cure, mitigation, or prevention of disease in man or other animals, or any activity that otherwise affects the structure or any function of the body of man or other animals.” Ex. 1002, 7:43–47. This definition exhibits “reasonable clarity, deliberateness, and precision” and is “‘set out . . . within the patent disclosure’ so as to give one of ordinary skill in the art notice of the change” in meaning. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (quoting Intellicall, Inc. v. Phonometrics, Inc., 952 F.2d 1384, 1387–88 (Fed. Cir. 1992)). Accordingly, we give effect to this definition of “treating.” Under the definition of “treating” in the specification of the ’774 patent, “[a] method of treating” changes in skin blood flow (claim 1) or abnormal sudomotor activity (claim 16) “associated with complex regional pain syndrome” means a method of diagnosing, curing, mitigating, or preventing that condition associated with complex regional pain syndrome, or otherwise affecting the structure or any function of the body of someone suffering from the condition associated with complex regional pain syndrome. To the extent that this requires carrying out the method on a patient suffering from changes in skin blood flow (claim 1) or abnormal sudomotor activity (claim 16) associated with complex regional pain syndrome, this is already part of the method recited in the body of the claims, Ex. 1002, 90:33–40, 91:14–21, so the preambles provide no additional limitation. To the extent that the preambles require some particular result to be brought about, that result could be the diagnosis, cure, mitigation, or prevention of the symptom in question, or it could be any effect at all on the structure or any function of the patient’s body. Thus, even when construed as limiting, the preambles provide little, if any, further restriction on the scope of the challenged claims beyond that set forth in the body of the claims.” slip op. at 9

    • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

      “regardless of whether the preambles are limiting. Even if the preambles are limiting, their scope is so broad as to be hardly different from no limitation at all. The specification of the ’774 patent defines “treating” as “includ[ing] any kind of treatment activity, including the diagnosis, cure, mitigation, or prevention of disease in man or other animals, or any activity that otherwise affects the structure or any function of the body of man or other animals.” Ex. 1002, 7:43–47. This definition exhibits “reasonable clarity, deliberateness, and precision” and is “‘set out . . . within the patent disclosure’ so as to give one of ordinary skill in the art notice of the change” in meaning. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (quoting Intellicall, Inc. v. Phonometrics, Inc., 952 F.2d 1384, 1387–88 (Fed. Cir. 1992)). Accordingly, we give effect to this definition of “treating.” Under the definition of “treating” in the specification of the ’774 patent, “[a] method of treating” changes in skin blood flow (claim 1) or abnormal sudomotor activity (claim 16) “associated with complex regional pain syndrome” means a method of diagnosing, curing, mitigating, or preventing that condition associated with complex regional pain syndrome, or otherwise affecting the structure or any function of the body of someone suffering from the condition associated with complex regional pain syndrome. To the extent that this requires carrying out the method on a patient suffering from changes in skin blood flow (claim 1) or abnormal sudomotor activity (claim 16) associated with complex regional pain syndrome, this is already part of the method recited in the body of the claims, Ex. 1002, 90:33–40, 91:14–21, so the preambles provide no additional limitation. To the extent that the preambles require some particular result to be brought about, that result could be the diagnosis, cure, mitigation, or prevention of the symptom in question, or it could be any effect at all on the structure or any function of the patient’s body. Thus, even when construed as limiting, the preambles provide little, if any, further restriction on the scope of the challenged claims beyond that set forth in the body of the claims. Moreover, as discussed below with respect to the asserted grounds of obviousness, Petitioner directs us to evidence that the prior art teaches or suggests the subject matter of the preambles, even when those preambles are construed as limiting in accordance with the meaning of “treating” provided in the specification.8 Thus, whether or not we treat the preambles as limiting, the outcome does not change. Given this circumstance, we treat the preambles of the challenged claims as limiting and assign them a meaning consistent with the specification’s definition of “treating.”” slip op. at 9

    Patent outcomesUS 10,039,774 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosure
    Patents in suitUS 10,039,774
  • PTAB · Jul 28, 2020 · PGR2019-00026 · APJ Grace Karaffa Obermann · PGR · Final written decision

    Claims 1–30 are unpatentable as obvious over Harden and one or more of Varenna 2011, Gatti, and Muratore; the written-description challenge fails.

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

      “INTRODUCTION A. Background Grünenthal GmbH (“Petitioner”) filed a Petition (Paper 2, “Pet.”) requesting a post-grant review of claims 1–30 of U.S. Patent No. 9,931,352 B2 (Ex. 1001, “the ’352 patent”). Antecip Bioventures II LLC (“Patent Owner”) did not file a Preliminary Response. We instituted review of all challenged claims on each of the grounds asserted in the Petition. Paper 6 (“Dec. Inst.”).” slip op. at 2

    • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingOther

      “regardless of whether the preambles are limiting. Even if the preambles are limiting, their scope is so broad as to be hardly different from no limitation at all. The specification of the ’352 patent defines “treating” as “includ[ing] any kind of treatment activity, including the diagnosis, cure, mitigation, or prevention of disease in man or other animals, or any activity that otherwise affects the structure or any function of the body of man or other animals.” Ex. 1001, 7:43–47. This definition exhibits “reasonable clarity, deliberateness, and precision” and is “‘set out . . . within the patent disclosure’ so as to give one of ordinary skill in the art notice of the change” in meaning. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (quoting Intellicall, Inc. v. Phonometrics, Inc., 952 F.2d 1384, 1387–88 (Fed. Cir. 1992)). Accordingly, we give effect to this definition of “treating.” Under the definition of “treating” in the specification of the ’352 patent, “[a] method of treating” hyperalgesia (claim 1) or edema (claim 17) “associated with complex regional pain syndrome” means a method of diagnosing, curing, mitigating, or preventing that condition associated with complex regional pain syndrome, or otherwise affecting the structure or any function of the body of someone suffering from the condition associated with complex regional pain syndrome. To the extent that this requires carrying out the method on a patient suffering from hyperalgesia (claim 1) or edema (claim 17) associated with complex regional pain syndrome, this is already part of the method recited in the body of the claims, Ex. 1001, 90:39–43, 91:23–27, so the preambles provide no additional limitation. To the extent that the preambles require some particular result to be brought about, that result could be the diagnosis, cure, mitigation, or prevention of the symptom in question, or it could be any effect at all on the structure or any function of the patient’s body. Thus, even when construed as limiting, the preambles provide little, if any, further restriction on the scope of the challenged claims beyond that set forth in the body of the claims. Moreover, as discussed below with respect to the asserted grounds of obviousness, Petitioner directs us to evidence that the prior art teaches or suggests the subject matter of the preambles, even when those preambles are construed as limiting in accordance with the meaning of “treating” provided in the specification.8 Thus, whether or not we treat the preambles as limiting, the outcome does not change. Given this circumstance, we treat the preambles of the challenged claims as limiting, and assign them a meaning consistent with the specification’s definition of “treating.”” slip op. at 8

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

      “Petitioner’s asserted references provides data showing that administering neridronic acid improves the symptoms of CRPS. PO Resp. 18–19. But “[o]bviousness does not require absolute predictability of success. . . . [A]ll that is required is a reasonable expectation of success.” In re O’Farrell, 853 F.2d 894, 903–904 (Fed. Cir. 1988). It is sufficient that Varenna 2011, Gatti, and Muratore would have informed the ordinarily skilled artisan that successful treatment of CRPS and its symptoms was likely; there is no requirement that Petitioner show that the prior art taught that success was certain.” slip op. at 15

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

      “qualifies as a printed publication under 35 U.S.C. § 102. PO Resp. 4–17; PO Sur-Reply 14–21. “To qualify as a printed publication, a reference ‘must have been sufficiently accessible to the public interested in the art.’” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (quoting In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989)). “A reference will be considered publicly accessible if it was disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” Id. (quoting Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545 F.3d 1340, 1350 (Fed. Cir. 2008)) (internal quotation marks omitted). Thus, there are two ways to show that a reference was sufficiently accessible: show it was disseminated or show it was “otherwise made available to the extent that” interested people of ordinary skill in the art could have located it after exercising reasonable diligence. Id. Here, according to Petitioner, the asserted references “are articles published in periodical journals by an identified and reputable publisher.” Reply 3.11 Petitioner argues that the references were “disseminated on the[ir] stated publication date[s].” Id. at 5. We agree.” slip op. at 18

    Patent outcomesUS 9,931,352 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosure
    Patents in suitUS 9,931,352
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