- Adobe Inc. v. Jonathan E. JaffeInstitutedPTAB · Mar 7, 2025 · IPR2024-01352 · APJ Bach V Hoang · IPR · Institution
The Board instituted review of claims 1–6 on all asserted grounds, finding a reasonable likelihood that claim 1 would have been obvious over Glass.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Parallel Proceeding Petitioner “stipulates that if the requested review is instituted, Petitioner will not pursue in the related litigation the grounds raised or that v. Masimo Corp., IPR2020-01019, Paper 12 at 19 (PTAB Dec. 1, 2020) (precedential as to Section II.A)). Petitioner’s stipulation here mitigates any concerns of duplicative efforts between the District Court proceeding and the Board, as well as concerns of potentially conflicting decisions. Sotera Wireless, Paper 12 at 19. Thus, we find that this factor weighs strongly in favor of not exercising discretion to deny institution under 35 U.S.C. § 314(a).4” slip op. at 11
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“and evidence, summarized above, we are persuaded, on this record, that Petitioner shows a reasonable likelihood of prevailing in demonstrating that claim 1 would have been obvious over Glass. 2. Institution of Inter Partes Review Because we are persuaded that Petitioner has shown a reasonable likelihood of prevailing in demonstrating that the subject matter of claim 1 would have been obvious over Glass, we institute an inter partes review of all claims and all challenges raised in the Petition. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 365 (2018) (stating 35 U.S.C. § 314 “simply requires [the Director] to decide whether the petitioner is likely to succeed on ‘at least 1’ claim. Once that single claim threshold is satisfied, it doesn’t matter whether the petitioner is likely to prevail on any additional claims; the Director need not even consider any other claim before instituting review.”); 37 C.F.R. § 42.108(a).” slip op. at 34
- Skill levelSkill level petitioner adoptedDecided for petitioner
“For purposes of this Decision, we adopt Petitioner’s proposed level of ordinary skill, as articulated above. We are satisfied that Petitioner’s proposed definition generally comports with the level of skill necessary to 5 The current record does not include allegations or evidence of objective indicia of nonobviousness. prior art. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (noting that the prior art itself may reflect an appropriate level of skill in the art). This definition is also supported by the testimony of Dr. Xiong. See Ex. 1002 ¶¶ 81–83. We note, however, that the open-ended language “at least” expands the range of education and experience indefinitely with no upper bound. Therefore, we do not adopt this aspect of Petitioner’s formulation.” slip op. at 15
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed petitioner constructionDecided for petitioner
“Petitioner’s construction is reasonably based on remarks made during prosecution of the ’828 Patent by Applicant in Applicant’s December 3, 2003 Amendment. Pet. 9–10 (citing Ex. 1002, 277). In that Amendment, Applicant stated [e]xemplary structure or method steps corresponding to this claim feature is shown in Fig. 2A of the subject application, which illustrates a processor 157 which is “tightly coupled” to a memory. . . . Because the processor is “tightly coupled” to the memory, it will be virtually impossible for a user to supply false information to the memory by breaking the conductive trace or lead between the memory and the processor. This means, for example, that there is no possibility for altering the image before the authentication information is generated. Ex. 1002, 277. In discussing the difficulty “to supply false information to the memory by breaking the conductive trace or lead between the memory and the processor” (id. (emphasis added)), Applicant implies that “tightly coupled” components are connected using a conductive trace or lead. Petitioner notes that the Specification does not describe any particular means Ex. 1003 ¶ 94). As such, Petitioner’s proposed construction is at least suggested by the intrinsic record, and we adopt it for the purposes of our decision on institution.” slip op. at 17
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 6,757,828 - PTAB · Feb 14, 2025 · IPR2024-01330 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR of claims 3, 4, and 12–19 on all asserted obviousness grounds, finding a reasonable likelihood of success and declining § 325(d) denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the arguments and evidence presented in the papers, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition, and we decline to exercise our discretion to deny institution under 35 U.S.C. § 325(d). Accordingly, we institute an inter partes review of the challenged claims of the ’746 Patent.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“As explained in the -459 IPR, we do not discern much of a substantive difference between the parties’ respective definitions in this proceeding beyond the number of years of experience after obtaining a doctoral degree. Compare Pet. 12, with Prelim. Resp. 21. For purposes of this Decision, we adopt Patent Owner’s definition as it appears to be reasonable and falls between Petitioner’s definitions asserted in the Petition and in its request for reexamination of the ’781 Patent. See Ex. 2001 ¶ 51. Moreover, Patent Owner’s definition appears 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 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))). To the extent the parties continue to disagree on the level of ordinary skill in the art, they should brief the issue further during trial.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Patent Owner states that it “does not believe that the Board must construe any claim terms in order to deny institution” and “reserves the right to assert claim construction positions should the Board institute IPR.” Prelim. Resp. 20. At this stage of the proceeding, we agree with the parties that no construction of any claim term is necessary for purposes of our Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,970,746 - PTAB · Jan 10, 2025 · IPR2024-00845 · APJ Carl M Defranco · IPR · Institution
The Board instituted review of the remaining challenged claims across three patents, granted EndyMed’s joinder motions, joined the proceedings, and terminated the three original IPRs.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“More importantly, as shown in the above comparison, the underlying premise of Serendia’s arguments here and in the 383 IPR remains substantially the same. Thus, for the same reasons discussed in our decision instituting the 383 IPR, we find that EndyMed demonstrates a reasonable likelihood of prevailing with respect to at least one of challenged claims 13 and 14 of the ’774 patent. See 383 IPR, Paper 17, 11–18. That is not to say, however, that Serendia may not ultimately persuade us at trial of the deficiency of EndyMed’s showing based on a preponderance of the evidence.” slip op. at 10
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Here, there is no dispute that EndyMed’s petition is materially identical to the petition in the 383 IPR. Instead, Serendia argues that joinder should be denied due to EndyMed’s “unreasonable and unjustifiable delay” in filing the petition and seeking joinder with the 383 IPR, despite being aware of the ’774 patent and Jeisys’s petition for “more than 7 months” before filing. PO Opp. 1–2. We disagree. EndyMed need not justify its delay where, as here, EndyMed satisfies the joinder requirement of filing the petition within one month of our institution of trial in the 383 IPR. See 37 C.F.R. § 42.122(b); see also 37 C.F.R. §§ 1.7(a), 42.1(a). Indeed, per our rules, EndyMed could not have filed the instant petition prior to institution of the IPR it was seeking to join. See 37 C.F.R. § 42.122(b) (“Any request for joinder must be filed . . . no later than one month after the institution date of any inter partes review for which joinder is requested.” (emphasis added)). And, although there is a one-year statutory bar from the date of service of a complaint alleging infringement for requesting inter partes review, that bar does not apply to a request for joinder. See 35 U.S.C. § 315(b). Thus, despite being filed more than one year from the service date of Serendia’s complaint alleging infringement of the ’774 patent, EndyMed’s petition and motion are nonetheless timely.” slip op. at 12
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Serendia also argues that joinder should be denied due to duplicative efforts with the parallel Delaware litigation, which involves the same parties and patent as here. See PO Opp. 3–4. That argument fails for the simple reason that EndyMed submits a Sotera stipulation, agreeing not to pursue in the Delaware litigation the same grounds that are asserted in the petition here or any grounds that reasonably could have been raised here. See Pet. Reply 1–2. And because a Sotera stipulation mitigates concerns of duplicative efforts, we decline to discretionarily deny institution where a petitioner makes such a stipulation. See Katherine K. Vidal, Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (June 21, 2022) (“Director Memo”), at 3, 7–8. Thus, we will not discretionarily deny the petition or joinder on the basis of the parallel Delaware litigation.6 Also, to the extent Serendia contends EndyMed should not be permitted to join and continue an IPR that would otherwise be terminated due to Serendia’s settlement with Jeisys, we disagree for several reasons. First, this is EndyMed’s first (and only) petition challenging the ’774 patent. As such, there is no risk of “repeated attacks” by the “same petitioner,” as was the case in Apple Inc. v. Uniloc 2017 LLC, IPR2020-00854, Paper 9, 5– 13 (October 28, 2020) (precedential), where joinder was denied because the 6 To the extent Serendia also relies on duplicative efforts with the pending ITC investigation, the Director has expressly stated that the Board “will not” discretionarily deny a petition based on a parallel ITC proceeding. See Director Memo, at 7.” slip op. at 13
Discretionary denialPatents in suitUS 10,869,812 - PTAB · Jan 10, 2025 · IPR2024-00844 · APJ Carl M Defranco · IPR · Institution
The Board instituted review of the remaining challenged claims, granted EndyMed’s joinder motions, joined the proceedings, and terminated the three new IPRs.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“More importantly, as shown in the above comparison, the underlying premise of Serendia’s arguments here and in the 383 IPR remains substantially the same. Thus, for the same reasons discussed in our decision instituting the 383 IPR, we find that EndyMed demonstrates a reasonable likelihood of prevailing with respect to at least one of challenged claims 13 and 14 of the ’774 patent. See 383 IPR, Paper 17, 11–18. That is not to say, however, that Serendia may not ultimately persuade us at trial of the deficiency of EndyMed’s showing based on a preponderance of the evidence.” slip op. at 10
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Here, there is no dispute that EndyMed’s petition is materially identical to the petition in the 383 IPR. Instead, Serendia argues that joinder should be denied due to EndyMed’s “unreasonable and unjustifiable delay” in filing the petition and seeking joinder with the 383 IPR, despite being aware of the ’774 patent and Jeisys’s petition for “more than 7 months” before filing. PO Opp. 1–2. We disagree. EndyMed need not justify its delay where, as here, EndyMed satisfies the joinder requirement of filing the petition within one month of our institution of trial in the 383 IPR. See 37 C.F.R. § 42.122(b); see also 37 C.F.R. §§ 1.7(a), 42.1(a). Indeed, per our rules, EndyMed could not have filed the instant petition prior to institution of the IPR it was seeking to join. See 37 C.F.R. § 42.122(b) (“Any request for joinder must be filed . . . no later than one month after the institution date of any inter partes review for which joinder is requested.” (emphasis added)). And, although there is a one-year statutory bar from the date of service of a complaint alleging infringement for requesting inter partes review, that bar does not apply to a request for joinder. See 35 U.S.C. § 315(b). Thus, despite being filed more than one year from the service date of Serendia’s complaint alleging infringement of the ’774 patent, EndyMed’s petition and motion are nonetheless timely.” slip op. at 12
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Serendia also argues that joinder should be denied due to duplicative efforts with the parallel Delaware litigation, which involves the same parties and patent as here. See PO Opp. 3–4. That argument fails for the simple reason that EndyMed submits a Sotera stipulation, agreeing not to pursue in the Delaware litigation the same grounds that are asserted in the petition here or any grounds that reasonably could have been raised here. See Pet. Reply 1–2. And because a Sotera stipulation mitigates concerns of duplicative efforts, we decline to discretionarily deny institution where a petitioner makes such a stipulation. See Katherine K. Vidal, Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (June 21, 2022) (“Director Memo”), at 3, 7–8. Thus, we will not discretionarily deny the petition or joinder on the basis of the parallel Delaware litigation.6” slip op. at 13
- PTAB / AIA Trials › §315(b) time barDecided for petitioner
“identical to the petition in the 383 IPR. Instead, Serendia argues that joinder should be denied due to EndyMed’s “unreasonable and unjustifiable delay” in filing the petition and seeking joinder with the 383 IPR, despite being aware of the ’774 patent and Jeisys’s petition for “more than 7 months” before filing. PO Opp. 1–2. We disagree. EndyMed need not justify its delay where, as here, EndyMed satisfies the joinder requirement of filing the petition within one month of our institution of trial in the 383 IPR. See 37 C.F.R. § 42.122(b); see also 37 C.F.R. §§ 1.7(a), 42.1(a). Indeed, per our rules, EndyMed could not have filed the instant petition prior to institution of the IPR it was seeking to join. See 37 C.F.R. § 42.122(b) (“Any request for joinder must be filed . . . no later than one month after the institution date of any inter partes review for which joinder is requested.” (emphasis added)). And, although there is a one-year statutory bar from the date of service of a complaint alleging infringement for requesting inter partes review, that bar does not apply to a request for joinder. See 35 U.S.C. § 315(b). Thus, despite being filed more than one year from the service date of Serendia’s complaint alleging infringement of the ’774 patent, EndyMed’s petition and motion are nonetheless timely.” slip op. at 12
Discretionary denialPatents in suitUS 9,320,536 - PTAB · Jan 10, 2025 · IPR2024-00843 · APJ Carl M Defranco · IPR · Institution
The Board instituted review of claims 13 and 14 of the ’774 patent, granted EndyMed’s motion for joinder with IPR2024-00383, and terminated IPR2024-00843.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“More importantly, as shown in the above comparison, the underlying premise of Serendia’s arguments here and in the 383 IPR remains substantially the same. Thus, for the same reasons discussed in our decision instituting the 383 IPR, we find that EndyMed demonstrates a reasonable likelihood of prevailing with respect to at least one of challenged claims 13 and 14 of the ’774 patent. See 383 IPR, Paper 17, 11–18. That is not to say, however, that Serendia may not ultimately persuade us at trial of the deficiency of EndyMed’s showing based on a preponderance of the evidence.” slip op. at 10
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Here, there is no dispute that EndyMed’s petition is materially identical to the petition in the 383 IPR. Instead, Serendia argues that joinder should be denied due to EndyMed’s “unreasonable and unjustifiable delay” in filing the petition and seeking joinder with the 383 IPR, despite being aware of the ’774 patent and Jeisys’s petition for “more than 7 months” before filing. PO Opp. 1–2. We disagree. EndyMed need not justify its delay where, as here, EndyMed satisfies the joinder requirement of filing the petition within one month of our institution of trial in the 383 IPR. See 37 C.F.R. § 42.122(b); see also 37 C.F.R. §§ 1.7(a), 42.1(a). Indeed, per our rules, EndyMed could not have filed the instant petition prior to institution of the IPR it was seeking to join. See 37 C.F.R. § 42.122(b) (“Any request for joinder must be filed . . . no later than one month after the institution date of any inter partes review for which joinder is requested.” (emphasis added)). And, although there is a one-year statutory bar from the date of service of a complaint alleging infringement for requesting inter partes review, that bar does not apply to a request for joinder. See 35 U.S.C. § 315(b). Thus, despite being filed more than one year from the service date of Serendia’s complaint alleging infringement of the ’774 patent, EndyMed’s petition and motion are nonetheless timely.” slip op. at 12
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Other
“Serendia also argues that joinder should be denied due to duplicative efforts with the parallel Delaware litigation, which involves the same parties and patent as here. See PO Opp. 3–4. That argument fails for the simple reason that EndyMed submits a Sotera stipulation, agreeing not to pursue in the Delaware litigation the same grounds that are asserted in the petition here or any grounds that reasonably could have been raised here. See Pet. Reply 1–2. And because a Sotera stipulation mitigates concerns of duplicative efforts, we decline to discretionarily deny institution where a petitioner makes such a stipulation. See Katherine K. Vidal, Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (June 21, 2022) (“Director Memo”), at 3, 7–8. Thus, we will not discretionarily deny the petition or joinder on the basis of the parallel Delaware litigation.6 Also, to the extent Serendia contends EndyMed should not be permitted to join and continue an IPR that would otherwise be terminated due to Serendia’s settlement with Jeisys, we disagree for several reasons. First, this is EndyMed’s first (and only) petition challenging the ’774 patent. As such, there is no risk of “repeated attacks” by the “same petitioner,” as was the case in Apple Inc. v. Uniloc 2017 LLC, IPR2020-00854, Paper 9, 5– 13 (October 28, 2020) (precedential), where joinder was denied because the 6 To the extent Serendia also relies on duplicative efforts with the pending ITC investigation, the Director has expressly stated that the Board “will not” discretionarily deny a petition based on a parallel ITC proceeding. See Director Memo, at 7.” slip op. at 13
Discretionary denialPatents in suitUS 9,775,774 - 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 - Jeisys Medical Inc. v. Serendia, LLCInstitutedPTAB · Aug 20, 2024 · IPR2024-00463 · APJ Carl M Defranco · IPR · Institution
The Board instituted IPR on claims 2–6, 8, 9, 13–16, and 18, finding a reasonable likelihood that at least claims 2, 8, and 13 are anticipated by Mehta.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Denied
“Videndum clarified the Board’s application of the General Plastic/Valve framework. For instance, in Ford, the Director explained that “[u]nder existing Office policy and precedent, the Board does not recognize a ‘significant relationship’ between parties [i.e., serial petitioners] having different accused products that merely engage in court-ordered pretrial coordination.” Ford, at 9 (emphasis added). And, in Videndum, the Director further explained that where “the first and second petitioners are neither the same party, nor possess a significant relationship under Valve, General Plastic factor one necessarily outweighs the other General Plastic factors.” Videndum, at 6–7. Thus, per Ford and Videndum, we will not discretionarily deny a later petition in view of an earlier petition where the earlier and later petitioners are neither the same party nor have a significant relationship. After reviewing the record, we find that no significant relationship exists with Cartessa to justify application of the General Plastic/Valve framework. Contrary to Serendia’s assertions about the joint submissions of Jeisys and Cartessa in the parallel ITC proceeding (see Prelim. Resp. 8–10), the relevant facts and circumstances here are akin to those in Ford. More specifically, like the “court-ordered” coordination of the petitioners in Ford, the collaboration of Jeisys and Cartessa as co-respondents in the ITC proceeding was mandated by the rules of the ITC proceeding, and, thus,” slip op. at 8
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“We agree with Jeisys. Mehta is not substantially the same as Mehta ’705. What Mehta ’705 omits, but Mehta includes, is an embodiment comprising “graphical user interface 320” and “tissue characteristic indicator 350” that allows a user to monitor the needle’s “location” in the tissue so as to decide when the needle is placed at a “desired depth.” Ex. 1006, 32:46– 13 US 8,540,705 B2, issued Sep. 24, 2013 (Ex. 1011). 14 Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) (precedential). 33:29, Figs 10A–10F. Nowhere do we discern a similar embodiment in Mehta ’705. At best, Mehta ’705 discloses a “display screen” for displaying a “variety of information to the physician . . . such as treatment delivery settings, electrode impedance, electrode temperature, tissue temperature, treatment duration, power delivered, energy delivered, etc.” Ex. 1011 (Mehta ’705), 29:44–58, Figs. 10A, 10B. But, notably lacking from Mehta ’705 is any disclosure of determining the “depth” and “location” of the needle’s placement in the tissue, let alone means for doing so, which Mehta discusses at length and upon which Jeisys relies to meet the “desired distance” limitation. See Ex. 1006, 32:46–33:61; Pet. 27–28. Because Mehta includes disclosure relevant to the disputed “desired distance” limitation that is absent from Mehta ’705, Serendia fails to satisfy the first part of the Advanced Bionics framework. See Wolfspeed, Inc. v. The Tr. of Purdue Univ., IPR2022-00761, Paper 13, at 7–8 (PTAB Mar. 30, 2023) (Vidal, K.) (reference not “substantially the same prior art” when it includes disclosure relevant to unpatentability grounds not present in references previously before the Office). And to the extent Serendia makes a similar argument with respect to the asserted secondary references of Na, Lee, and Livneh, it is of no consequence given Serendia’s failed showing with respect to the primary reference of Mehta.15 Thus, we decline to exercise our discretion to deny institution under 35 U.S.C. § 325(d).” slip op. at 11
- Skill levelSkill level petitioner adoptedOther
“Jeisys proposes, and Serendia agrees, that we should adopt the level of ordinary skill in the art as defined in the parallel ITC proceeding, that is, (1) 7–10 years of experience with developing and/or using treatment systems for delivery of electromagnetic radiation energy to skin or other tissues, and (2) a related graduate engineering degree or M.D. . . . [and] may have worked as part of a multidisciplinary team and drawn upon not only his or her own skills, but also would have taken advantage of certain specialized skills of others on the team when solving a technical problem. Pet. 11 (citing Ex. 1005, at 14); Prelim. Resp. 33 (accepting Jeisys’s definition of the level of skill in the art). For purposes of this proceeding, we see no reason to depart from that definition, as it appears consistent with the level reflected in the asserted prior art.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We need not formally construe the “desired distance” limitation in order to resolve whether institution is appropriate. That is because, on the current record, the asserted prior art satisfies the “desired distance” limitation regardless of which parties’ proposed construction we adopt. 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)). Nonetheless, the parties are free to further explore the appropriate construction of “desired distance” at trial, in particular, whether the plain language of the claims limits their scope to extendable needles (as opposed to fixed needles), and whether construing the “desired distance” limitation as being based on a user’s selection improperly reads a preferred embodiment into the claims.” slip op. at 14
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 10,869,812 - PTAB · Jul 26, 2024 · IPR2024-00459 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 1–20 over all six asserted obviousness grounds, finding a reasonable likelihood of success and declining discretionary denial under §§ 325(d) and 314(a).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the arguments and evidence presented in the papers, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition and we decline to exercise our discretion to deny institution under 35 U.S.C. §§ 314(a) and 325(d). Accordingly, we institute an inter partes review of the challenged claims of the ’781 Patent.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“Owner, a POSA would have had “a doctoral degree in medicine, chemistry, biochemistry, biology, or a related field and 1–2 years of experience in the processing and analysis of biological samples, including fecal samples.” Id. at 47 (citing Ex. 2001 ¶ 43). Patent Owner also indicates that such a person could have been an individual or a member of a team of scientists addressing fecal sample processing and analysis. Id. Patent Owner notes that Petitioner’s proposal in the Petition is significantly different from the proposal in its ex parte reexamination request, which merely required a bachelor’s degree and several years of experience processing biological samples. Id. at 46; Ex. 1021, 7.8 Patent Owner also contends that the level of skill set forth in the Petition requires an extraordinary level of skill within an overly narrow focus. Prelim. Resp. 47. Regardless, Patent Owner states that its expert, Dr. Backman, is a person of at least ordinary skill and the claims of the ’781 Patent would not have been obvious under any of the parties’ proposed definitions of the level of ordinary skill in the art.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“At this stage of the proceeding, we agree with the parties that no construction of any claim term is necessary for purposes of our Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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))). C.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“shown sufficiently that a POSA would have had a reason to modify the assay of Lenhard to combine Vilkin’s iFOBT and Itzkowitz’s collection process and DNA stabilization buffer with a reasonable expectation of success. Lenhard expressly states that “[t]he combination of [HIC1 methylation analysis with gFOBT] resulted in increased detection rates for CRCs” and includes data that supports this statement. See Ex. 1004, 147, 146 (Table 4); see also id. at 143 (“The combination of HIC1 methylation analysis with FOBT allowed for the detection of two thirds of CRCs.”). We find these positive statements and supporting data in Lenhard are sufficient to provide a “rational underpinning” to combine the gFOBT and DNA test at this stage of the proceeding. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Moreover, we are persuaded on this record that Vilkin’s explanation of the benefits of iFOBT over gFOBT provide a reason to replace Lenhard’s gFOBT with Vilkin’s iFOBT assay. See Ex. 1005, 2519. And we agree at improve Lenhard’s assay by requiring a patient to directly defecate into a sealable container and add a stabilization buffer to the sample so it could be shipped to a laboratory without freezing, as described in Itzkowitz. See Ex. 1002 ¶¶ 148–158.” slip op. at 17
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 11,634,781 - Jeisys Medical Inc. v. Serendia, LLCInstitutedPTAB · Jul 23, 2024 · IPR2024-00384 · APJ Carl M Defranco · IPR · Institution
The Board instituted IPR on claims 1–8 and 11–18 after finding a reasonable likelihood that claim 11 is anticipated by Mehta.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Decided for petitioner
“Videndum clarified the Board’s application of the General Plastic/Valve framework. For instance, in Ford, the Director explained that “[u]nder existing Office policy and precedent, the Board does not recognize a ‘significant relationship’ between parties [i.e., serial petitioners] having different accused products that merely engage in court-ordered pretrial coordination.” Ford, at 9 (emphasis added). And, in Videndum, the Director further explained that where “the first and second petitioners are neither the same party, nor possess a significant relationship under Valve, General Plastic factor one necessarily outweighs the other General Plastic factors.” Videndum, at 6–7. Thus, per Ford and Videndum, we will not discretionarily deny a later petition in view of an earlier petition where the earlier and later petitioners are neither the same party nor have a significant relationship. After reviewing the record, we find that no significant relationship exists with Cartessa to justify application of the General Plastic/Valve framework. Contrary to Serendia’s assertions about the joint submissions by Jeisys and Cartessa in the parallel ITC proceeding (see Prelim. Resp. 10– 11), the relevant facts and circumstances here are akin to those in Ford. More specifically, like the “court-ordered” coordination of the petitioners in Ford, the collaboration of Jeisys and Cartessa as co-respondents in the ITC proceeding was mandated by the rules of the ITC proceeding, and, thus,” slip op. at 8
- Skill levelSkill level board ownOther
“Jeisys proposes, and Serendia agrees, that one of ordinary skill in the relevant art would have had (1) 7–10 years of experience with developing and/or using treatment systems for delivery of electromagnetic radiation energy to skin or other tissues, and (2) a related graduate engineering degree or M.D. . . . [and] may have worked as part of a multidisciplinary team and drawn upon not only his or her own skills, but also would have taken advantage of certain specialized skills of others on the team when solving a technical problem. Pet. 14–15 (citing Ex. 1003 ¶ 50); see also Prelim. Resp. 32 (accepting Jeisys’s definition of the level of skill in the art). For purposes of this proceeding, we adopt the parties’ assessment of the level of ordinary skill in the art.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“We need not formally construe the “desired distance” limitation in order to resolve whether institution is appropriate. That is because, on the current record, the asserted prior art satisfies the “desired distance” limitation regardless of which parties’ proposed construction we adopt. 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)). Nonetheless, the parties are free to further explore the appropriate construction of “desired distance” at trial, in particular, whether the plain language of the claims limits their scope to “extendable” needles, and whether construing the “desired distance” limitation as being based on a user’s selection improperly reads a preferred embodiment into the claims.” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“We disagree with Serendia’s analysis of Mehta. As Jeisys correctly explains, Mehta discloses the “desired distance” limitation even assuming Serendia’s construction of that limitation, i.e., that the needles are extendable to a depth selected by the user. See Pet. 33. Indeed, although Mehta may not use the term “desired distance” expressly, it comes about as close as one would expect from an anticipatory disclosure. For example, as Jeisys notes, Mehta discloses an embodiment that includes “depth markings” on the needles (i.e., probes) that allow the user to determine a desired depth of the needles— The electrodes of the probe array can also include any number of visually distinguishing features (e.g., depth markings, colors, shades, etc.) that enable a physician to observe proper placement. . . . This ensures that the probe is not driven too far into tissue. Alternatively, the probe can be marked with one or more features that allow the physician to determine the depth of insertion of the probe. Id. (citing Ex. 1004, 13:37–45 (emphases added)). Notably, as Jeisys also explains, Mehta discloses another embodiment, depicted in Figures 10A–F, having a graphical user interface 320 (“GUI”) that displays the actual and target depths of needles so as to avoid placement of the needles in an undesired region. See id. at 32–34 (citing Ex. 1004, 10:38–39, 12:5–8, 32:63–33:43; Ex. 1003 ¶¶ 101–104). The GUI, as described, “can provide information for a physician (or other medical staff) to monitor various treatment parameters as well as other information regarding the placement of the array 108 or probes 104 when inserted in the tissue” and “maintain visual contact with the treatment device and tissue being treated.” Ex. 1004, 11:1–13. To do so, the GUI incorporates a “tissue characteristic indicator (whether visual, virtual, audible, or other feedback)” that allows the user to monitor the needle’s actual location in the tissue and advance the needle a desired distance for providing treatment— FIG. 10B illustrates a tissue characteristic indicator showing a virtual depiction 350 of the depth or location of the probe array. . . . [T]he virtual depth/location depiction 350 can illustrate an actual placement of the probe array 340. . . . [T]he system can be configured to show (or the system can have an option to show) additional probe array information. For example, the virtual depth/location depiction 350 can also show a desired probe location (e.g., array 342 can represent the desired depth of placement for providing a treatment). . . . As shown by FIG. 10B, providing the virtual depth/location depiction 350 allows the physician to not only identify whether the array is located within the desired tissue layer but also allows the physician to observe the angle of the electrode array in tissue. . . . Therefore, the physician would be informed that further advancement of the probes is necessary to place the probes within the second layer 326 (which corresponds to the dermal layer). Id. at 32:46–33:29 (emphases added); see also id. at 33:57–66 (further describing “virtual depth/location depiction 350”).” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 9,320,536
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.