- Encube Ethicals PTV. Ltd. v. Dermavant Sciences GmbHAdverse judgmentPTAB · Mar 7, 2025 · IPR2024-00834 · APJ Tawen Chang · IPR · Adverse judgment
The Board entered adverse judgment against Patent Owner on all challenged claims, 1–4, 6–10, 16, 18, 21, and 22, following their disclaimer.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“Terminate Proceeding and Parties’ Joint Motion for Entry of Adverse Judgment (collectively “Motion”). The parties jointly request that the Board enter adverse judgment in light of the disclaimer filed by Patent Owner disclaiming all challenged claims. Mot. 1 (citing 37 C.F.R. § 42.73(b)(2)). The Motion attaches as an exhibit a disclaimer under 37 C.F.R. § 1.321(a), filed January 28, 2025, of claims 1–4, 6–10, 16, 18, 21, and 22 of the ’088 patent, which constitute all of the claims challenged in the inter partes review. Ex. 2001; Paper 1, 3.” slip op. at 2
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Denied
“Accordingly, we grant the Parties’ Joint Motion for Entry of Adverse Judgment. This Adverse Judgment is sufficient to dispose of this proceeding and Patent Owner’s Motion to Terminate is denied as moot.1” slip op. at 3
NonePatents in suitUS 11,590,088 - PTAB · Jan 28, 2025 · IPR2024-00312 · APJ Tina E Hulse · IPR · Adverse judgment
The Board granted Patent Owner’s request for adverse judgment after abandonment, entering judgment against Patent Owner on claims 1–28.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“Under 37 C.F.R. § 42.73(b), a party may request adverse judgment against itself at any time during a proceeding. “Abandonment of the contest” is considered to be a request for adverse judgment. 37 C.F.R. § 42.73(b)(4). Here, we instituted an inter partes review of claims 1–28 of the ’432 Patent, and Patent Owner has abandoned the contest in this proceeding. Accordingly, we consider Patent Owner’s abandonment of the contest as a request for adverse judgment, and we grant that request.” slip op. at 2
NonePatents in suitUS 9,486,432 - 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 - Fusion Orthopedics, LLC v. Extremity Medical, LLCSome claims unpatentablePTAB · Nov 4, 2024 · IPR2023-00894 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–10 and 12–15 are unpatentable; claim 11 was not shown unpatentable. Substitute claims 16–25 and 27–30 are unpatentable over Mazur; claim 26 was not reached.
RulingsFinal written decision- BurdenMixed
“It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.’” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (quoting 35 U.S.C. § 312(a)(3)). Here, however, not until its Reply does Petitioner belatedly suggest that Ferrante’s disclosure of bone screws with self-tapping ends equally meets the limitation of claim 10 (with respect to the first member) as with claim 11 (with respect to the second member), and that both claims are obvious in light of “evidence” from Ferrante “that it was well known to equip bone screws with self-tapping ends.” Reply 26–27. We do not discern these arguments in the Petition, and consider them waived. See Netflix, Inc. v. DivX, LLC, 84 F.4th 1371,1377 (Fed. Cir. 2023) (“While the Board should not take an overly mechanistic view of a petition and decline to address an argument because the petitioner did not present it with ideal vigor and clarity, the Board should also not have to decode a petition to locate additional arguments beyond the ones clearly made.”). In sum, Petitioner’s error in failing to first address limitations of claim 10 in the Petition specific to the Cognet/Ferrante combination indicates a failure to meet the particularity requirements for what must be in the petition and cannot be left to be filled in on reply. See 35 U.S.C. § 312(a)(3); 37 C.F.R. §§ 42.22(a)(2) (requiring, among other things, “a detailed explanation of the significance of the evidence”), 42.104(b)(4)–(5) (requiring that petition “specify where each element of the claim is found in the prior art patents or printed publication relied upon” and, regarding submitted evidence, state “the relevance of the evidence to the challenge raised, including identifying specific portions of the evidence that support the challenge”). Microsoft, 2022 WL 989403, at *6. Accordingly, Petitioner has not shown persuasively that claim 11 would have been obvious in light of Cognet and Ferrante for the reasons set forth in the Petition. slip op. at 41
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We also find persuasive Mr. Dominguez’s explanation that one of ordinary skill in the art would have understood “bore” as including stepped diameter holes, sometimes described as a bore having a counterbore. See generally Ex. 1018 ¶¶ 4–29; Reply 3–10. Three of Mr. Dominguez’s illustrative examples are reproduced in the annotated figures below. The above figures show Mr. Dominguez’s annotated illustrations from the Jackson (Ex. 1019, Fig. 3), Brånemark (Ex. 1021, Fig. 4), and Ray (Ex. 1025, Fig. 1) references as discussed at paragraphs 10, 12, and 13, respectively, of Mr. Dominguez’s Second Declaration. With reference to the above figures, Mr. Dominguez testifies that “Jackson describes a bone repair set screw in which ‘[t]he bore 27 comprises a first bore section 31, a second bore section 32,’ etc. delineated by shoulders 41, 42, etc. (Ex. 1019, 5:24– 43)” (Ex. 1018 ¶ 10); “Brånemark describes an osseous implantation device having body 1ʺ with first and second holding portions 21ʺ, 31ʺ and ‘an inner through bore with a first portion 4ʺ in the first holding portion and a second portion 5ʺ in the second holding portion.’” Ex. 1021, 4:44–46” (id. ¶ 12); and Ray discloses surgical calipers including “handle 12 having ‘stepped cylindrical bore 14,’” wherein “[c]ollar 20 of a shaft inserted in the bore ‘rests against a step of the bore 14’ (2:14–15)” (id. ¶ 13). Patent Owner responds that Mr. Dominguez’s examples “that allegedly show a single bore encompassing two or more stepped-diameter holes or a counterbore . . . . are specific to these references and divorced from the disclosures of the ’166 patent.” Sur-Reply 7. Insofar as the ’166 patent makes no mention of the term “bore” outside the claims, and Mr. Dominguez’s examples are all taken from the field of orthopedic surgery, we do not find this argument persuasive. Patent Owner further appears to contend that exemplary references to a “cylindrical stepped down bore” or a “stepped cylindrical bore” are too specific to be within the scope of the term “bore.” Sur-Reply 7–8. As these terms merely describe species within a larger genus, and Patent Owner presents no cogent reason to exclude them, we do not find this argument availing. Relatedly, we are also not persuaded by Patent Owner’s argument that “the prior art treats a ‘bore’ as an element that is distinct from a ‘counterbore.’” Id. at 8. Rather, we credit Mr. Dominguez’s testimony that “[a] counterbore is not a structure unto itself, a counterbore is part of a larger structure” as exemplified by numerous examples including Laps (Ex. 1028 ¶ 33 (sensor assembly wherein “bore 16 includes a counterbore 18”)); Martinez (Ex. 1029, 3:61 (surgical cutting instrument wherein “bore 56 has a counterbore 64”)); Zang (Ex. 1030, 2:49 (bone anchor having a “bore [that] includes a counterbore”)); Ledet (Ex. 1022, 29:3–5 (vertebral fixation plate having “through holes . . . . countersunk, or counterbored to accommodate the head of a bone screw”)); Seo (Ex. 1031, 3:45 (chair leg employing “counterbored bore 23”)); and Exner (Ex. 1032, 2:16 (extrusion press including “counterbored axial bore 6”)). Ex. 1018 ¶¶ 17–23. That a reference may refer to a figure as showing “bore 103” with “counterbore 105 . . . formed on one end” does not indicate that they are distinct structures as Patent Owner contends, but merely that the focus of each term is directed to the entire bore or to a particular aspect of the bore, i.e., its counterbore. See” slip op. at 22
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner subsequently proposed an alternative definition, as a person having “[a] Bachelor’s Degree in biomedical and/or mechanical engineering or similar training and . . . at least three years of experience with implant devices used for internal fixation of bones.” POR 5 (citing Ex. 2012 ¶¶ 32–33). According to Patent Owner, “[t]his hypothetical person would be capable of performing various design tasks and would understand the basic mechanical features and operation of orthopaedic implant devices [and] have an appreciation for orthopaedic fusion techniques and the medical issues and concerns faced by a doctor/surgeon charged when performing operations to implant orthopaedic devices.” Id. Despite some differences in wording, Patent Owner asserts (and Petitioner does not contest) that any “distinction between the parties’ proposed definitions of a POSITA does not affect the arguments set forth herein.” Id. (citing Ex. 2012 ¶ 34). Consistent with this view, we find the parties’ constructions equally applicable in light of the prior art of record and the disclosure of the ’166 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). We adopt, for convenience, Petitioner’s definition, but our analysis does not change depending on which of the two articulations are applied here. H.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“one of ordinary skill in the art would understand that “bore,” as used in the context of claims 1 and 12, encompasses a multi-diameter passage, and in particular, one having stepped longitudinal cross sections such as that shown in Cognet’s Figure 1. See generally DI 11–13. For the reasons that follow, we conclude that one of ordinary skill in the art would have understood “bore” as such. Relying on the testimony of Mr. Dominguez, Petitioner initially proposed a construction of “bore” as “a usually cylindrical hole made by or as if by the turning or twisting movement of a tool.” Pet. 16 (citing Ex. 1002 ¶ 58). Petitioner’s proposal relied on Mr. Dominguez’s testimony that “[a] bore is a cylindrical hole made by the spinning rotation of a twist drill cutting tool. It is typically made by removing material from a solid or hollow object, similar to a tunnel or orifice.” Ex. 1002 ¶ 58. Pointing to its annotation of Cognet’s Figure 1, above, Patent Owner argued that that the term “bore” excludes a tunnel made by “two adjacent bores.” See Prelim. Resp. 21–25. In view of the then-available evidence, we provisionally construed “bore” as a hole or passage made by or as if by the turning or twisting movement of a tool such that its interior walls have cylindrical lateral cross-sections, and which do not exclude holes or passages having tapered or stepped longitudinal cross-sections. DI 13.” slip op. at 19
Patent outcomesUS 11,298,166 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,298,166 - Apotex Inc. v. Novo Nordisk A/SInstitutedPTAB · Sep 11, 2024 · IPR2024-00631 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted review of claims 1–10 on all petitioned grounds, finding a reasonable likelihood of unpatentability, and granted Apotex’s motion to join the Mylan IPR.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“discretionary. See Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016); see also 35 U.S.C. § 314(a). In Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential), the Board set forth six non-exclusive factors for determining “whether efficiency, fairness, and the merits support the exercise of authority to deny institution in view of an earlier trial date in the parallel proceeding.” Id. at 6. These factors are as follows: 1. whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; 2. proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; 3. investment in the parallel proceeding by the court and the parties; 4. overlap between issues raised in the petition and in the parallel proceeding; 5. whether the petitioner and the defendant in the parallel proceeding are the same party; and 6. other circumstances that impact the Board’s exercise of discretion, including the merits. Id. at 5–6. In evaluating these factors, we take a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review. Id. at 6. The Director has also issued interim guidance to the Board on applying the factors. See Katherine K. Vidal, Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review under 35 U.S.C. § 314 and 37 C.F.R. § 42.4(a). 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).” slip op. at 2
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Under 37 C.F.R. § 42.5(b), we “may waive or suspend a requirement of [part 42 of the Board’s rules] and may place conditions on the waiver or suspension.” Here, we agree with Petitioner that it has shown sufficient reason for us to waive the one-month from institution joinder motion deadline. See 37 C.F.R. § 42.122(b). Petitioner waited until it had a sufficient business reason to file this Petition, and subsequently promptly filed its Petition and Motion for Joinder. Most critically, Petitioner raises no new unpatentability grounds, the trial schedule for the Mylan IPR need not be adjusted, and Petitioner agrees to serve in a silent understudy role. We determine that joinder with the Mylan IPR is appropriate under the circumstances. Accordingly, we grant Petitioner’s Motion for Joinder.” slip op. at 13
Discretionary denialPatents in suitUS 10,335,462 - PTAB · Jul 30, 2024 · IPR2024-00201 · APJ John G New · IPR · Adverse judgment
After Patent Owner disclaimed all challenged claims, the Board entered adverse judgment against Patent Owner under 37 C.F.R. § 42.73(b).
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include: … (2) Cancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” 37 C.F.R. § 42.73(b). According to our reviewing court, 37 C.F.R. § 42.73(b) gives the Board authority to construe a patent owner’s actions in disclaiming all challenged claims in an instituted trial as a request for an adverse judgment. Arthrex, Inc. v. Smith & Nephew, Inc., 880 F.3d 1345, 1349 (Fed. Cir. 2018). In the present inter partes review, Patent Owner has disclaimed all challenged claims of the ’601 patent, such that there are none left to be contested by the Petition. We consequently view Patent Owner’s filing of the Disclaimer, removing the last of the challenged claims from this inter partes review, and its request for termination of the proceeding, as a constructive request for adverse judgment against itself under § 42.73(b). Arthrex, 880 F.3d at 1349. Because there are no challenged claims left for the Petition to contest in this proceeding, adverse judgment against Patent Owner is granted.” slip op. at 2
NonePatents in suitUS 10,888,601
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.