- Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.All claims unpatentablePTAB · 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 PhillipsPatents in suitUS 11,007,201 - Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.All claims unpatentablePTAB · 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 PhillipsPatents in suitUS 10,849,908 - Syngenta Crop Protection AG v. Upl Ltd.All claims unpatentablePTAB · 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 · GrahamPatents in suitUS 11,445,727 - PTAB · Jul 23, 2024 · IPR2024-00669 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–8 and 11, finding a reasonable likelihood of success on at least one claim under the Saadat grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’077 patent’s challenged claims. Also, we decline to deny the Petition on a discretionary basis. Therefore, we institute an inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355 (2018).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“As discussed below (Section IV.D), we determine at this stage that Saadat is prior art. There is no argument from Patent Owner that Saadat was presented previously to the Office. Pet. 96 (Petitioner’s unrebutted argument that Saadat was not previously considered by the Examiner). And, beyond the unsuccessful attempt to antedate and, thus, disqualify Saadat as prior art, at this stage of the proceeding Patent Owner offers no argument or evidence to rebut Petitioner’s contention that Saadat anticipates and renders obvious the ’077 patent’s claims under Grounds 1–3. See generally Prelim. Resp. 8–26 (Patent Owner’s priority date arguments). For the above reasons, we find that Patent Owner has not shown that substantially the same prior art or arguments (i.e., Saadat and arguments based thereon) were previously presented to the Office and, thus, Patent Owner has not satisfied step one of Advanced Bionics’ two-step framework. Advanced Bionics, Paper 6 at 8. On this record, even if we accept Patent Owner’s contentions about the Office’s prior consideration of Makower or Fang (art asserted under Grounds 5 and 6), we do not find that § 325(d) is sufficiently implicated based on our determination on the priority issue and Petitioner’s otherwise uncontested argument that the challenged claims are unpatentable over Saadat—issues we discuss in more detail below.” slip op. at 10
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not propose an alternate definition of the POSA’s qualifications or contest Petitioner’s definition. See generally Prelim. Resp. We apply Petitioner’s proposed POSA level, which appears to be consistent with the level of skill shown in the prior art of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends that, “[f]or purposes of this IPR, the Board need not construe any terms.” Pet. 18. Patent Owner similarly does not propose any express claim construction for any of the challenged claims at this time. See generally Prelim. Resp. and based on our review of the record, we determine that no express construction of any claim term is necessary to determine whether to institute inter partes review. Realtime Data, 912 F.3d at 1375.” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · GrahamPatents in suitUS 11,679,077 - PTAB · Jul 23, 2024 · IPR2024-00279 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted review of claims 1–3, 7, 9, 10, and 17–25 on all petitioned grounds, finding a reasonable likelihood of success on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–3, 7, 9, 10, and 17–25 of the ’675 patent are unpatentable.” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“Specification of the ’675 patent provides written description support for the challenged claims. The challenged claims are purportedly directed to treating a nasal condition comprising “delivering energy to the target tissue” to reduce mucus secretion or congestion. Ex. 1001, claims 1 and 17. As noted by Petitioner, the ’675 patent Specification does not describe the use to energy to treat a nasal condition in the manner recited in the claims. Pet. 24–25. Rather, the ’675 patent Specification discloses the use of neurotoxins to treat nasal conditions, and, more specifically, that neurotoxins are used to disrupt neural signals in the targeted tissue and, therein, disable mucus secretion by such tissues. Ex. 1001, 3:25–34, 8:18–21, 8:38–60, achieve cell membrane permeabilization or poration and effectuate the delivery of neurotoxin into to target cells. See, e.g., id. at 4:49–51, 8:4–21. Here, we note that the challenged claims do not recite administering neurotoxins, but instead only require the delivery of energy to the target tissue to administer therapy.” slip op. at 16
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedDecided for petitioner
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Reference is prior artInstituted
“probe in a nasopharyngeal passage of a patient for the ablation of a posterior nasal nerve. Id. at 30 (citing Ex. 1002 ¶¶ 85–99). Petitioner also contends that “Saadat explains that RF ablation disrupts neural activity to reduce or eliminate rhinitis symptoms, including mucus secretion and congestion.” Id. at 36 (citing Ex. 1003, 3:6–14 (“Ablating [posterior nasal] nerves leads to a decrease in or interruption of parasympathetic nerve signals that contribute to congestion and rhinorrhea in patients with chronic rhinitis (allergic or vasomotor).”), 16:44–51; Ex. 1002 ¶ 103). Patent Owner at this stage does not offer any arguments addressing Petitioner’s substantive showing, which we find sufficient for institution purposes. See generally Prelim. Resp. Rather, Patent Owner contends Saadat is not prior art because the ’675 patent is entitled to rely upon the July 21, 2006, filing date of the ’090 application. Id. at 24. For the reasons discussed above, we determine that the Specification of the ’675 patent fails to provide adequate written description support for the challenged claims, and thus, the challenged claims are entitled to an effective filing date no earlier than October 22, 2019. Saadat is a U.S. patent that issued June 4,” slip op. at 33
§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,610,675 - PTAB · May 1, 2024 · PGR2024-00009 · APJ Tina E Hulse · PGR · Institution
The Board instituted PGR on claims 1–8, 12, and 20 on all asserted grounds, finding the petition showed a reasonable likelihood that at least one claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 324(a), which provides that 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.” Upon considering the arguments and evidence presented by the parties, we determine Petitioner has shown that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not contest Petitioner’s definition of the level of ordinary skill in the art for purposes of its Preliminary Response. Prelim. Resp. 20. Although defining a person of ordinary skill in the art as a “team” of individuals is not conventional, because Patent Owner does not dispute the definition at this stage of the proceeding, we adopt Petitioner’s definition as it appears to be consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. 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” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“Patent Owner “agrees that the preamble is limiting as a statement of the intentional purpose for which the method is performed—treating patients with CLL or SLL.” Prelim. Resp. 18. But Patent Owner disagrees with an “attempt to rewrite an express definition in the specification” and adds a safety requirement that is not recited in the definition of “therapeutically effective amount” in the Specification. Id. at 19. Patent Owner contends “therapeutically effective amount” should be construed according to its express definition in the Specification to mean “a sufficient amount of an agent or a compound being administered which will relieve to some extent one or more of the symptoms [of a] B-cell lymphoproliferative disorder (BCLD) . . . [or] reduction and/or alleviation of the signs, symptoms, or causes of BCLD.” Id. (citing Ex. 1001, 24:58–63). Notwithstanding its proposed construction, Patent Owner posits that “a precise construction of ‘therapeutically effective amount’ is not necessary to resolve the dispute here” and “[e]ven under Petitioner’s flawed construction of ‘therapeutically effective amount,’ Petitioner fails to meet its burden to warrant institution.” Id. at 20. Having considered the parties’ respective arguments at this stage of the proceeding, we agree that the preamble is limiting as a statement of intentional purpose. See Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1342 (Fed. Cir. 2021) (stating the Federal Circuit “has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound”). Moreover, we find Patent Owner has the better position that the term “therapeutically effective amount” should be construed according to its express definition in the Specification and not according to the separate and distinct definition of “effective amount,” as Petitioner suggests. That is, we decline to import a safety limitation to the term “therapeutically effective amount” that only appears in the definition for “effective amount.” Compare Ex. 1001, 24:58–62 with id. at 24:66–25:2” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“an “attempt to rewrite an express definition in the specification” and adds a safety requirement that is not recited in the definition of “therapeutically effective amount” in the Specification. Id. at 19. Patent Owner contends “therapeutically effective amount” should be construed according to its express definition in the Specification to mean “a sufficient amount of an agent or a compound being administered which will relieve to some extent one or more of the symptoms [of a] B-cell lymphoproliferative disorder (BCLD) . . . [or] reduction and/or alleviation of the signs, symptoms, or causes of BCLD.” Id. (citing Ex. 1001, 24:58–63). Notwithstanding its proposed construction, Patent Owner posits that “a precise construction of ‘therapeutically effective amount’ is not necessary to resolve the dispute here” and “[e]ven under Petitioner’s flawed construction of ‘therapeutically effective amount,’ Petitioner fails to meet its burden to warrant institution.” Id. at 20. Having considered the parties’ respective arguments at this stage of the proceeding, we agree that the preamble is limiting as a statement of intentional purpose. See Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1342 (Fed. Cir. 2021) (stating the Federal Circuit “has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound”). Moreover, we find Patent Owner has the better position that the term “therapeutically effective amount” should be construed according to its express definition in the Specification and not according to the separate and distinct definition of “effective amount,” as Petitioner suggests. That is, we decline to import a safety limitation to the term “therapeutically effective amount” that only appears in the definition for “effective amount.” Compare Ex. 1001, 24:58–62 with id. at 24:66–25:2 amount” but not “therapeutically effective amount”). Thus, we construe the term “therapeutically effective amount” to mean “a sufficient amount of an agent of a compound being administered which will relieve to some extent one or more of the symptoms [of] B-cell lymphoproliferative disorder (BCLD).”” slip op. at 9
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,672,803 - Kinderfarms LLC v. Genexa Inc.InstitutedPTAB · Mar 25, 2024 · PGR2023-00051 · APJ Deborah Katz · PGR · Institution
Instituted PGR of claims 1–24 on all asserted grounds; the Board found the §103 challenges more likely than not to render claim 1 unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” See 35 U.S.C. § 324(a).” slip op. at 6
- Skill levelSkill level patent owner adoptedDecided for patent owner
“B. Level of Skill Each party puts forth a characterization of the ordinarily skilled artisan in the field of the claims of the ’795 patent. (See Pet. 13 (citing Crowley Decl., Ex. 1003, ¶¶ 90–91); see Prelim. Resp. 3–4.) The parties’ proposed characterizations of the ordinarily skilled artisan are sufficiently similar that adoption of either would lead to the same result, institution. Thus, for the purposes of this Decision only, we adopt Patent Owner’s characterization of the ordinarily skilled artisan as having a bachelor of science degree in a relevant life sciences field, such as, chemistry, biochemistry, or pharmacy, with at least two years of work or laboratory experience in pharmaceutical formulations, and access to one or more team members having experience in pharmaceutical formulation and pharmaceutical regulatory approvals, or, in the alternative, at least three to four years of work or laboratory experience in pharmaceutical formulations, and access to one or more team members having experience in pharmaceutical formulation and pharmaceutical regulatory approvals. (See Prelim. Resp. 3–4.) We also note that the level of skill of an ordinarily skilled artisan is revealed by the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1354–55 (Fed. Cir. 2001) (holding that the absence of specific findings on the level of skill in the art does not give rise to reversible error “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, 225 USPQ 34, 38 (Fed.Cir.1985)).” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction Petitioner puts forth constructions of certain terms used in the claims of the ’795 patent. (See Pet. 14–19.) Patent Owner does not dispute any of these constructions specifically, but at this point, argues that we need not construe any terms “to resolve the present controversy.” (Prelim. Resp. 2.) We agree that an express construction is not required at this point in the proceeding. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“[t]he test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 425 (CCPA 1981). Thus, at this point in the proceeding, Patent Owner’s argument is not persuasive because it does not address the teachings in the prior art that Petitioner asserts would render the formulations claimed in the ’795 patent obvious.” slip op. at 20
Claim construction§ 103 obviousness§ 112 disclosurecites KSRPatents in suitUS 11,617,795 - Atea Pharmaceuticals, Inc. v. Gilead Sciences, Inc.Institution deniedPTAB · Feb 21, 2024 · PGR2023-00046 · APJ Susan L C Mitchell · PGR · Institution
The Board denied institution because Atea did not show claim 1 was more likely than not unpatentable for lack of written description, lack of enablement, or anticipation.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of post-grant review is authorized by statute only when “the information presented in the petition . . . demonstrate[s] 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; see 37 C.F.R. § 42.4. Upon considering the Petition, Preliminary Response, and the cited evidence, we conclude that Petitioner has not satisfied its burden under 35 U.S.C. § 324 to show that it is more likely than not that claim 1 is unpatentable.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“The major differences between Petitioner’s and Patent Owner’s definitions of a skilled artisan include the number of years of drug discovery experience that is necessary and the breadth of the fields of endeavor with which a POSA should be familiar. We agree with Patent Owner that a POSA includes a team of skilled artisans with skill sets in the various aspects of drug development, but determine that Petitioner has addressed those necessary skill sets in its definition. We also determine on this record that Petitioner has assessed adequately the level of experience needed, and do not agree with Patent Owner that greater years of experience are necessary for a POSA in this instance. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) (“A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.”). 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 ’361 patent itself, we apply Petitioner’s proposed level of ordinary skill in the art to determine whether it is more likely than not that Petitioner would prevail on its challenges to claim 1. 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).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“C. Claim Construction We construe claims “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.200. Therefore, we construe the challenged claims under the framework set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would be 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. Only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Both parties agree that we need not construe any claim terms here to resolve the issues in this proceeding. See Pet. 16; Prelim. Resp. 18–19. We agree with the parties that we need not construe any claim terms in this proceeding to resolve whether to institute a post-grant review.” slip op. at 11
- BurdenNot shown unpatentable
“In applying the rubric set forth in Ariad to determine whether claim 1 has appropriate written description support, we can look for structural features common to the members of the subgenus of claim 1 so that one of skill in the art can “visualize or recognize” the members of the subgenus. See Ariad, 598 F.3d at 1350. To do this, we look “for blaze marks within the disclosure that guide attention to the claimed species or subgenus.” See Regents of the Univ. of Minn., 61 F.4th at 1356. In this regard, the fourteenth aspect of the third embodiment is the blaze mark that points to the subgenus of claim 1. We do not need to find blaze marks that identify the fourteenth aspect of the third embodiment as the only formula of merit or the only one that should be claimed. Rather, we look to the written description to see if it describes sufficient structural features common to the members of the subgenus of claim 1 such that a POSA can visualize or recognize the members of that subgenus, thereby demonstrating that the inventors possessed the subject matter of the claim at the time they filed their application.” slip op. at 20
Claim construction§ 102 anticipation§ 112 disclosurecites KSRPatents in suitUS 11,642,361 - Daiichi Sankyo, Inc. / Astrazeneca Pharmaceuticals, LP v. Seagen Inc.All claims unpatentablePTAB · Jan 16, 2024 · PGR2021-00030 · APJ Jeffrey N Fredman · PGR · Final written decision
Claims 1–5, 9, and 10 are unpatentable for lack of written description, lack of enablement, indefiniteness, and anticipation by Ogitani.
RulingsFinal written decision- Skill levelSkill level board ownOther
“respective definitions for the level of ordinary skill in the art. While there seems to be a slight difference in whether the ordinary artisan has ADC design experience obtained after a master’s degree or postdoctoral, neither party provides clear basis to explain how this will impact the analysis. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“III. CLAIM CONSTRUCTION We interpret claim terms using “the same claim construction standard” slip op. at 11
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable
“4. Analysis We note that “[i]t is not sufficient for purposes of the written” slip op. at 23
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“4. Analysis The facts here are consistent with the situation in Amgen, which” slip op. at 76
Patent outcomesUS 10,808,039 unpatentableClaim construction§ 102 anticipation§ 112 disclosurecites Phillips · NautilusPatents in suitUS 10,808,039 - PTAB · Dec 1, 2023 · PGR2022-00025 · APJ Susan L C Mitchell · PGR · Remand
The Board granted PGR of claims 1–19, finding claim 1 more likely than not anticipated by Grigoriadis and claims 1–19 more likely than not lacking written-description support.
RulingsRemand decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Institution of post-grant review is authorized by statute only when “the information presented in the petition . . . demonstrate[s] 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; see 37 C.F.R. § 42.4. Upon considering the Petition, Patent Owner Preliminary Response, and the cited evidence in light of the Director’s Decision, we conclude that Petitioner has satisfied its burden under 35 U.S.C. § 324 to show that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable. Therefore, we grant institution of a post-grant review.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Person of Ordinary Skill in the Art Factual indicators of the level of ordinary skill in the art include “the various prior art approaches employed, the types of problems encountered in the art, the rapidity with which innovations are made, the sophistication of the technology involved, and the educational background of those actively working in the field.” Jacobson Bros., Inc. v. U.S., 512 F.2d 1065, 1071 (Ct. Cl. 1975); see also Orthopedic Equip. Co. v. U.S., 702 F.2d 1005, 1011 (Fed. Cir. 1983) (quoting with approval Jacobson Bros.).” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner
“Independent claim 1 recites a method of treating CAH by reducing an A4 level “from baseline” after administering a CRF1 receptor antagonist to a CAH patient. See Ex. 1001, 47:51–48:5. 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, 41:55–59. 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 ’201 patent. See Ex. 1037, 36–37. We note that placebos were evidently not employed in the phase 2 clinical study of Example 4.5 Given the sole exemplary description of “baseline” in Example 4 of the Specification, we construe the claim term reciting “reduced from baseline” as meaning “a reduction in A4 level compared to an A4 level measurement made prior to, and/or at the beginning of, administration of the drug.”” slip op. at 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Reference is prior artInstituted
“A claim is unpatentable as anticipated under 35 U.S.C. § 102 only when “every element and limitation of the claim was previously described in a single prior art reference, either expressly or inherently, so as to place a person of ordinary skill in possession of the invention.” Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1082 (Fed. Cir. 2008). A reference may inherently anticipate if a claim limitation that is not expressly disclosed “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). Thus, 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.” Agilent Technologies, Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (emphasis added).” slip op. at 23
Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 11,007,201
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.