- Beone Medicines USA, Inc. / Beigene, Ltd. v. Pharmacyclics LLCAll claims unpatentablePTAB · May 1, 2025 · PGR2024-00009 · APJ Sheridan K Snedden · PGR · Final written decision
Claims 1–8, 12, and 20 are unpatentable for lack of written description under § 112(a); the Board did not reach the enablement, anticipation, or obviousness grounds.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986).” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.200(b). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Moreover, “claim terms need only be construed ‘to the extent necessary to resolve the controversy.’” See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). The parties agree that the preamble of the claims should be limiting and that the terms “optionally substituted fused heterocyclic ring system” and “irreversible” BTKIs should be construed consistent with the definitions provided in the Specification. Pet. 42–45; see also id. at 42 (citing Ex. 1001, 19:57–20:7 (defining “optionally substituted” or “substituted”), 14:51–52 (defining “fused”), 15:66–16:21 (defining “heterocycle”), 14:36–44 (defining “ring” and “ring system”), 26:23–25 (defining “irreversible Btk inhibitor”); PO Resp. 26.” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.200(b). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Moreover, “claim terms need only be construed ‘to the extent necessary to resolve the controversy.’” See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). The parties agree that the preamble of the claims should be limiting” slip op. at 14
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable
“To satisfy written description for the claimed genus of iBTKIs, the Specification must describe either a representative number of members of the genus or structural features common to the members of the genus with enough precision that a POSA can visualize or recognize the members of the genus. See Ariad, 598 F.3d at 1350. Patent Owner concedes that the Specification does not describe a representative number of members of the genus, stating “this is a common structural features case.” Tr. 65:25–66:3. We, therefore, focus our analysis on whether the Specification adequately describes common structural features of the genus. We find that it does not.” slip op. at 30
Patent outcomesUS 11,672,803 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 11,672,803 - 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 - Intas Pharmaceuticals Ltd. v. Atossa Therapeutics, Inc.All claims unpatentablePTAB · Jan 29, 2025 · PGR2023-00043 · APJ Tina E Hulse · PGR · Final written decision
Claims 1, 2, 4, 15, and 20–22 are anticipated by Ahmad; claims 3, 5–14, and 16–19 are obvious over the cited prior art.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“As explained in our Institution Decision, we adopted Patent Owner’s definition because we do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art—both definitions provide for a highly skilled POSA with experience in formulating drugs. Dec. Inst. 8. Petitioner’s counsel confirmed during the hearing that there was no substantive difference between the parties’ definitions. Tr. 7:25–8:5. 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 art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). We, therefore, adopt Patent Owner’s definition of a POSA. Moreover, we find that Dr. McConville, Dr. Bihovsky, and Dr. Davies are all qualified to opine from the perspective of a skilled artisan as all are persons of at least ordinary skill in the art, based on either party’s definition.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“When read as a whole, however, we find compelling that the Specification consistently identifies (Z)-endoxifen salts as separate from (Z)- endoxifen. Throughout the Specification—including in the Abstract and the Summary of the Invention—the ’334 Patent refers to “(Z)-endoxifen and salts thereof,” suggesting that references to “(Z)-endoxifen” alone do not include the salt forms unless expressly identified as such. See, e.g., id. at Abstract (“The present disclosure provides . . . methods of making (Z)- endoxifen or a salt thereof”), 2:60–62 (Summary of the Invention stating same); 6:4–6 (Summary of the Invention stating “process for manufacturing (Z)-endoxifen or salts thereof”). Moreover, the Specification states that although endoxifen is available commercially as an (E)/(Z) isomer free base mixture, as well as ≥98% (Z)- endoxifen HCL and (Z)-endoxifen citrate salts, “[t]here remains a need for (Z)-endoxifen free base preparations that are sufficiently stable for preparation of pharmaceutical compositions.” Id. at 82:3–5, 82:37–39. Accordingly, the Specification states, “[p]rovided herein in the present disclosure are preparations of endoxifen free base that are . . . at least 90% (Z)-endoxifen free base.” Id. at 82:43–45. Taking the language of the claims and the Specification as a whole, we determine that the intrinsic evidence supports construing the limitation “the compound of Formula (III) is (Z)-endoxifen” to be limited to the (Z)- endoxifen free base form and excludes the salt and solvate forms.” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“presumption of enablement, and the patentee/applicant has the burden to prove nonenablement for such prior art”). As such, Apple instructs us that a petitioner need not provide evidence in its petition to show a prior art patent is enabling as part of its burden to prove anticipation. Id. at 449–50 (finding the Board erred in shifting the burden to the petitioner to provide evidence in its petition to show prior art patent publication was enabling). Thus, it is Patent Owner’s burden to establish by a preponderance of the evidence that Ahmad is not enabling. Before we turn to the substantive grounds, we must first resolve the parties’ disputes over several legal issues regarding enablement. First, Patent Owner asserts that “[w]hile the claims of a prior art patent are presumed enabled, . . . [t]here is no presumption that every prophetic example in the specification is enabled, especially where that prophetic example is not explicitly claimed.” PO Resp. 32 (citations omitted). This is an incorrect statement of the law. The Federal Circuit has clearly stated that “a presumption arises that both the claimed and unclaimed disclosures in a prior art patent are enabled.” Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1354–55 (Fed. Cir. 2003). Patent Owner may rebut that presumption, but that presumption of enablement exists nonetheless for both the claimed and unclaimed disclosures.” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“We find Petitioner has the better position. Ahmad itself provides the reason to combine Ahmad’s formulation with Cole’s enteric coating, stating in the stomach” and to “prevent release of medication before it reaches the small intestine.” Ex. 1003, 18:19–24. It was known that endoxifen could be susceptible to degradation in the acidic conditions of the stomach, and a POSA would have been motivated to use an enteric capsule to avoid acidic degradation and improve bioavailability. Ex. 1031 ¶ 6 (citing Ex. 1019, 1353). We credit Dr. McConville’s testimony that applying enteric coatings would have been routine (Ex. 1020 ¶ 71; Ex. 1031 ¶ 5), which is consistent with Ahmad’s disclosure that the enteric coating “can be done as methods known in the art.” Ex. 1003, 18:27–29. Similarly, the ’334 Patent states that “enteric tablets, enteric caplets, or enteric capsules of the present disclosure may be prepared by techniques known in the art.” Ex. 1001, 39:28–30. Moreover, the fact that Cole uses paracetamol as a model drug and not endoxifen is of no concern to our obviousness analysis. We credit the formulation expertise of Dr. McConville, who explains that “[i]n the case of an enteric coated capsule, it is the degradation of the enteric coating and the capsule that will control the release of the drug, not the nature of the drug itself.” Ex. 1031 ¶ 7 (citing Ex. 1008, 84). Thus, a POSA would have understood that the capsule in Cole would have the same benefits for use with other drugs, such as endoxifen. Id. Patent Owner and Dr. Davies identify certain complications that may plague enteric-coated endoxifen formulations and HPMC capsules, such as “potential interactions between enteric coatings and pharmaceutical compositions” and “variations in release profiles.” PO Resp. 63–64; Ex. 2020 ¶¶ 164, 166. But we are not persuaded by that argument, because we agree with Dr. McConville that Patent Owner and Dr. Davies fail to cite any credible evidence of such complications between enteric coatings and interactions. Ex. 1031 ¶¶ 8, 10. Having considered the arguments and evidence presented by the parties, we find that the combination of Ahmad and Cole teaches each limitation of claims 5–8, 16, and 17 and that a POSA would have had a reason to use the enteric coating and HPMC capsules of Cole with the (Z)- endoxifen formulation of Ahmad to reach the claimed invention with a reasonable expectation of success. See Ex. 1020 ¶¶ 84–97; Ex. 1031 ¶¶ 5–16.” slip op. at 34
Patent outcomesUS 11,572,334 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,572,334 - 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 - Symrise AG / Symrise Inc. v. Inolex Investment CorporationAll claims unpatentablePTAB · Nov 1, 2024 · IPR2023-01035 · APJ Tina E Hulse · IPR · Final written decision
The Board granted cancellation of claims 1–6, 8–10, and 22–28, and denied substitute claims 29–44 because Wright ’451 rendered them obvious.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art at the time of the invention (“POSA” or “POSITA”) would have had “a bachelor’s degree and two or more years of experience or a master’s degree in organic synthesis or chemical engineering, with education substituting for experience and vice versa.” Pet. 15 (citing Ex. 1002 ¶ 16). Patent Owner took no position on the level of ordinary skill in the art in its Preliminary Response. Prelim. Resp. 8. In our Institution Decision, we adopted Petitioner’s definition. Dec. Inst. 6–7. In its Motion to Amend, Patent Owner states that it accepts the Board’s definition for purposes of this proceeding. MTA 24. We, therefore, see no reason to disturb our definition of the level of ordinary skill in the art as it appears to be consistent with the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Although neither party expressly proposes a construction for the term “conversion,” the parties appear to differ in their interpretations of that term. Petitioner interprets “conversion” to mean the percent conversion of the 1- alcohol. See Pet. Opp. RMTA 6–7 (interpreting “conversion” as percentage of remaining 1-alcohol); Ex. 1040, 109:2–11. Patent Owner, on the other hand, interprets “conversion” to mean the total percentage of alkenes that have been produced. Ex. 2010 ¶ 123 (interpreting “conversion” as percentage of total alkenes). During oral argument, counsel for Patent Owner conceded that “conversion can mean either.” Tr. 27:18–28:13. Without the benefit of briefing by the parties, we decline to expressly construe the term “conversion,” as our Decision would be the same under either interpretation, as discussed further below. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (finding only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy). Moreover, we do not find it necessary to expressly construe any other claim terms for purposes of this Decision. Id.” slip op. at 10
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“2. Analysis A patent claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which said claimed invention pertains. See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations, including (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of skill in the art; and (4) objective evidence of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). Objective evidence of nonobviousness may include” slip op. at 13
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedDecided for petitioner
“We are not persuaded. “[A]ny superior property must be unexpected to be considered as evidence of non-obviousness.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). We must, therefore, first consider what results were expected to determine what a POSA would have considered to be unexpected. Id. As seen by the table below, Wright ’451’s disclosure fully encompasses the temperature ranges and purported unexpected results recited by substitute claim 29 and shown in Table 2 of the ’048 Patent: Reference Reaction Calcination Conversion Regioselectivity Rate13 Temperature Temperature Wright ’451 about 220 °C about 200 °C greater than about 90% to to about to 600 °C about 95% about 99% 440 °C Substitute 240 °C to about 420 °C at least 95% to about Claim 29” slip op. at 23
Patent outcomesUS 10,995,048 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,995,048 - 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.