- PTAB · Dec 11, 2025 · IPR2025-01025 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on all challenged claims and all asserted grounds, finding a reasonable likelihood that claim 1 is unpatentable over Garrison with Laub and/or Aklog.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’910 patent’s challenged claims. We institute inter partes review on all challenged claims and on all asserted grounds. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018); 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“(“POSA”) “would have had an undergraduate degree in mechanical engineering or a related engineering discipline and 2-4 years of catheter design experience and, where necessary, would have consulted with a physician regarding the methods of treatment.” Pet. 18 (citing Ex. 1003 ¶¶ 35–36).” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“standard used in a civil action before the courts under 35 U.S.C. § 282(b), including construing claim language in accordance with its ordinary and customary meaning as understood by the POSA, in view of the patent’s specification and considering the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only construe terms where the parties dispute a term’s meaning and only to the extent needed to resolve the controversy. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019).” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“To show unpatentability based on a combination of teachings, “[a]n obviousness determination [also] requires finding both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” CRFD Rsch., Inc. v. Matal, 876 F.3d 1330, 1340 (Fed. Cir. 2017) (internal quotation marks omitted).” slip op. at 12
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,974,910 - PTAB · Dec 11, 2025 · IPR2025-01021 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–12, 14–31, and 33–38 on all asserted grounds, finding a reasonable likelihood of success on at least claim 1.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“its challenge to the claims under Grounds 1A–4A. We have also considered Patent Owner’s counterarguments, which we find unavailing at this stage for reasons explained below. See infra Section III.E.3. Upon considering the parties’ argument and evidence, we find that Petitioner has established that it is reasonably likely to succeed in showing that at least claim 1 would have been obvious under Grounds 1A–4A. Based on the preliminary record, Petitioner persuades us that a POSA would have had reasons for adding a stopcock (or similar flow-control valve) to Laub’s system between the catheter and the cited clot canister and pressure source, as suggested by Garrison. See, e.g., Ex. 1006 ¶¶ 130–134; Ex. 1012, Fig. 1A; Ex. 1006, Fig. 34. Petitioner persuades us that Laub’s system, modified as proposed, would allow a user to close the valve while a pressure source (e.g., a pump) creates a negative pressure and vacuum between the valve and the pressure source, which vacuum may then be applied to a distal portion of the catheter upon opening the valve to facilitate a rapid aspiration of a portion of a PE into the clot canister. Pet. 38–42; Ex. 1003 ¶¶ 48, 103–114.” slip op. at 30
- Skill levelSkill level petitioner adoptedDecided for petitioner
“(“POSA”) “would have had an undergraduate degree in mechanical engineering or a related engineering discipline and 2-4 years of catheter design experience and, where necessary, would have consulted with a physician regarding the methods of treatment.” Pet. 13 (citing Ex. 1003 ¶ 35). Patent Owner counters that Petitioner’s proposed definition is “insufficient” but does not, in the Preliminary Response, explain why it is “insufficient” or propose a definition of its own. Prelim. Resp. 20 (citing333 Ex. 2005 ¶ 52).14 Instead, in advancing Patent Owner’s counterarguments, “Patent Owner applies Petitioner’s definition.” Id. For this Decision, we apply Petitioner’s POSA definition, which appears to be reasonable and consistent with the prior art.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“specification and considering the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only construe terms where the parties dispute a term’s meaning and only to the extent needed to resolve the controversy. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019). Petitioner contends that the term “filament” in, for example, dependent claim 11 means at least “one or more threads, lines, cords, ropes, ribbons, flat wires, sheets, or tapes.” Pet. 15. Patent Owner notes its disagreement with Petitioner’s interpretation of the term “filament” in related proceedings (e.g., IPR2025-00289). Prelim. Resp. 20 n.3. But Patent Owner contends that the claim construction issue in related proceedings “is not germane” to Patent Owner’s arguments in the present case and, thus, the Board need not construe that term (or any other term of the ’333 patent’s challenged claims) at this time. We need not, at this stage, further construe the ’333 patent’s claims to address the issues that are presently in dispute.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“pumps, like described in Laub, Aklog, and Garrison would, in the proposed modified systems, generate a vacuum pressure as claimed will be best assessed on a full record at trial. As an initial matter, claim 1 does not recite a “maximum level of aspiration in a rapid fashion.” At most, Patent Owner’s argument (if accepted) may weaken some of Petitioner’s reasoning for modifying the prior art. In any event, we are at this stage unpersuaded that a pump would not, when a fluid control valve is closed, generate a vacuum pressure and operate in the manner claimed. See, e.g., Ex. 1003 ¶¶ 103–105 (testifying that a stopcock and aspiration pump would generate a vacuum and provide for rapid aspiration). Garrison does not disclose that only syringes have such capability, and Garrison teaches, in the same paragraph where the cited alternative aspiration sources may be used in its systems (“active source[s] of aspiration may be an aspiration pump, a regular or locking syringe, a hand-held aspirator, hospital suction, or the like”). Ex. 1006 ¶ 134. Garrison’s disclosure is, thus, not limited to use of syringes or even peristaltic pumps (as allegedly depicted in Figure 34). We also note (as pointed out by Petitioner) that the ’333 patent indicates that both pumps and syringes generate and store negative/vacuum pressure in an aspiration system.18 Ex. 1001, 7:28–41, dependent claim 15 (aspiration source comprises “an electric pump”); Prelim. Reply 5. That a POSA would have understood that both syringes and pumps, like disclosed in Garrison, can generate a vacuum pressure to permit rapid aspiration of clots also finds further evidentiary support in Dr. Turk’s testimony that surgeons have used pumps and syringes for that purpose since the early 2010s. Ex. 1022 ¶ 23. Moreover, although Laub teaches that running a pump continuously at high flow rates can assist with dislodging clots, Petitioner persuades us on the present record that a POSA would see benefit in modifying Laub’s system to also allow for an initial or intermittent rapid burst of vacuum pressure to help remove a clot. Ex. 1003 ¶¶ 106, 109.” slip op. at 33
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,969,333 - PTAB · Oct 23, 2025 · IPR2025-00989 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on all challenged claims based on the asserted grounds, finding a reasonable likelihood of success on the Schaffer-Hartley and Schaffer-Eller combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’291 patent’s challenged claims. We institute inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018); 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). Findings and conclusions at this stage are preliminary and based on the current record. Any final decision will be based on a full trial record.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“We agree with Patent Owner that Petitioner’s proposed POSA definition lacks specificity. That definition, if interpreted generically, could mean that a person may qualify as a POSA if they had, for example, a B.S. in mechanical engineering and only two years of experience designing or engineering any type of product in any field. That is too broad. We find that a POSA would have had the agreed-upon educational credentials—an undergraduate degree in mechanical engineering or a related engineering discipline. Ex. 1003 ¶ 36; Ex. 2001 ¶ 73. We find that a POSA would also have had 2–4 years of design or engineering experience related to products in the field of the invention, which involves endovascular devices and the surgical procedures that use such devices. Ex. 1001, 1:24–60 (background of the invention). Such devices include, but are not necessarily limited to, hemostasis valves and catheters for minimally-invasive vascular surgeries. Id. And, consistent with the testimony of the parties’ experts, the POSA need not have had firsthand experience designing hemostasis valves. See, e.g., Ex. 1029 (Zalesky Tr.), 72:11–73:7 (testifying direct experience “designing” hemostasis valves or aspiration catheters is not necessary, but “general experience with vascular devices and procedures” is required); Ex. 2006 (Thornton Tr.), 180:13–19. Further, as Dr. Zalesky testified, the POSA’s experience related to developing such devices “could be as simple as bench testing and looking at clinical data.” Ex. 1029, 74:5–75:1. Lastly, a POSA would have had an” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“As noted above, the challenged claims require a “filament formed in a loop around the tubular sidewall” where, when a portion of the filament is pulled away from the loop, the loop’s diameter reduces, thereby reducing the diameter of the lumen formed by the tubular sidewall to seal the valve. See supra Section II.D. Every embodiment in the ’291 patent where the filament is described as forming a “loop” in the manner claimed involves a filament that is necessarily flexible. See, e.g., Ex. 1001, 13:17–29, Figs. 6–7. The valve would not work if the looped filament were somehow inflexible— pulling an end of the filament would not change the diameter of the loop, and the valve would not seal. Ex. 2001 ¶ 65 (testifying “a loop in a rigid component would necessarily be fixed in size” and the “inherent property of flexibility is essential to the loop structure of the claims”); Ex. 1023, 16–17” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We are unpersuaded that Schaffer describes a valve with a filament as claimed. If, as construed above (supra Section III.C), the filament requires flexibility, Petitioner has not demonstrated that Schaffer describes such a feature in its valves. Instead, we agree with Patent Owner that a POSA would more likely understand Schaffer’s two U-shaped actuating members as being rigid features. Prelim. Resp. 33–36. We agree with Patent Owner that Petitioner implicitly admits that Schaffer’s actuating members are rigid leakage around tools inserted through the central lumen when in use and compared to the use of a flexible string or wire (of Hartley or Eller). Prelim. Resp. 34 (citing Pet. 51). We also find Dr. Zalesky’s interpretation of Schaffer more plausible than Mr. Thornton’s on the question of whether a POSA would have regarded Schaffer’s actuating members as being rigid structures. Ex. 2001 ¶¶ 78–85 (testifying, inter alia, that a POSA would have understood from Schaffer’s disclosure about making the actuator and actuating members from machining pre-existing amounts of metals and/or plastics, and further explaining that flexible parts would deform and be difficult to machine through conventional techniques); Ex. 1005 ¶¶ 81–82. Mr. Thornton opines that Schaffer’s disclosed manufacturing techniques for the actuator/actuating members are only examples and “a person of ordinary skill in the art could have simply purchased pre-made [flexible] flat wire or plastic tapes or ribbons.” Ex. 1003 ¶ 96. Such opinion invokes, at best, obviousness-based reasoning. This does not establish that Schaffer alone describes a filament sufficient to anticipate the claims. Furthermore, Mr. Thornton’s opinion that a POSA “would have understood that Schaffer’s U-shaped actuating members would have preferably been formed from a thin, flexible material” finds no support in Schaffer itself. Ex. 1003 ¶ 95. This opinion is also at odds with his testimony in related cases about an alleged formation of gaps with Schaffer’s actuating members, which suggested those members had a set “size” and lacked flexibility. See IPR2025-01157 (Ex. 1003 ¶ 81 (testifying a POSA “would have recognized that Hartley’s flexible string may better seal the valve than Schaffer’s metallic/plastic actuating members” because, “if a tool did not fit the size of” slip op. at 31
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,865,291 - PTAB · Oct 16, 2025 · IPR2025-00776 · APJ John G New · IPR · Institution
Instituted review of claims 9, 11, 32–58, 60–62, and 64–67 on all remaining petition grounds, after finding a reasonable likelihood that claim 9 is unpatentable over Thomas and Faucette.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“For the reasons set forth below, we determine that Petitioner has demonstrated that there is a reasonable likelihood that at least one of claims 9, 11, 32–58, 60–62, and 64–67 of the ’802 patent is unpatentable, and we on the Grounds set forth in the Petition.” slip op. at 2
- Settled expectationsOther
“Patent Owner also filed a Request with the Acting Director of the USPTO seeking discretionary denial of institution of inter partes review (Paper 6, the “Request”). Petitioner subsequently filed a brief opposing Patent Owner’s Request (Paper 8). On September 3, 2025, the Acting Director denied Patent Owner’s Request for discretionary denial of institution of inter partes review and referred the case to the panel for an institution decision on the merits (Paper 11).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill would have an M.D. or a Ph.D. degree in virology, immunology, and vaccinology, and at least 3 years of experience in one or more of the research, design, development, and testing of antiviral vaccines. Pet. 17. Petitioner asserts that a person of ordinary skill may be part of a multidisciplinary team having such experience. Id. (citing Ex. 1002 ¶ 81). Patent Owner does not dispute the level of skill asserted by Petitioner.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party requests construction of any claim terms. Petitioner asserts that all claim terms should be given their ordinary and customary meaning, and Patent Owner does not disagree. See Pet. 17. Accordingly, we find, for the purposes of this Decision, that no terms of the challenged claims requires construction beyond the ordinary and customary meaning of the terms, as understood by a person of ordinary skill in the art at the time of the invention. Phillips, 415 F.3d at 1312–13; see also Vivid Techs., Inc. v. construes claims only to the extent necessary to resolve a dispute).” slip op. at 10
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 11,730,802 - PTAB · Oct 10, 2025 · IPR2025-00728 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on all challenged claims and all five grounds, finding a reasonable likelihood of success based on at least one claim, including claim 1 over Hartley and Eller.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’921 patent’s challenged claims.1 We institute inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018); 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). Findings and conclusions at this stage are preliminary and based on the current record. Any final decision will be based on a full trial record.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“We agree with Patent Owner that Petitioner’s proposed POSA definition lacks specificity. That definition, if interpreted generically, could mean that a person may qualify as a POSA if they had, for example, a B.S. in mechanical engineering and only two years of experience designing or engineering any type of product in any field. That is too broad. We find that a POSA would have had the agreed-upon educational credentials—an undergraduate degree in mechanical engineering or a related engineering discipline. Ex. 1003 ¶ 35; Ex. 2024 ¶ 61. We find that a POSA would also have had 2–4 years of design or engineering experience related to products in the field of the invention, such devices. Ex. 1001, 1:16–54 (background of the invention). Such devices include, but are not necessarily limited to, hemostasis valves and catheters for minimally-invasive vascular surgeries. Id. And, consistent with the testimony of the parties’ experts, the POSA need not have had firsthand experience designing hemostasis valves. See, e.g., Ex. 1037 (Zalesky Tr.), 72:11–73:7 (testifying direct experience “designing” hemostasis valves or aspiration catheters is not necessary, but “general experience with vascular devices and procedures” is required); Ex. 2030 (Thornton Tr.), 180:13–19. Further, as Dr. Zalesky testified, the POSA’s experience related to developing such devices “could be as simple as bench testing and looking at clinical data.” Ex. 1037, 74:5–75:1. Lastly, a POSA would have had an understanding of such devices’ design requirements as determined by the needs of the physician, patient, and procedure, which understanding may be informed by work experience and/or study. Ex. 2030, 24:5–21.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“That does not, however, address the dispute about “flexibility.” On that issue, the argument and evidence at this stage tends to favor Patent Owner’s position that a “filament” as claimed is flexible. which include claim 1’s recitation of an “active tensioning mechanism” comprising the filament and the Specification’s description of a filament that can be both “loosened” and “tightened.” Prelim. Resp. 14–16 (citing, e.g., Ex. 1001, 9:36–37, 9:53–56 (teaching “the filament 150 is tightened” when the actuator buttons are released and “the filament 150 is loosened” when the buttons are pressed to open the valve)); see also Ex. 2025, 1288 (defining “tension” as to “tighten to a desired or appropriate degree”). These descriptions from the patent appear at this stage more consistent with the view that the filament is characteristically flexible, not rigid. So too, as we explained in related matters, the ’921 patent’s loop embodiments (where the filament forms one or more loops like depicted and described in Figures 6–7) require a flexible structure. See, e.g., Ex. 2032, 15–16 (explaining that the device would not work to constrict the tubular sidewall and lumen (analogous to the elongate member defining a lumen of the claims here) if the filament forming the loop(s) was inflexible); Ex. 1001, Figs. 6–7 (filament 150, with sub-filaments 150-A and 150-B). Although flexibility of the filament in the patent’s “bight” embodiments (e.g., as shown in Figures 8 and 9) is not manifestly clear, there is a dearth of evidence from Petitioner—either intrinsic or extrinsic to the patent— showing why a POSA would have understood the bights as embracing rigid structures. See Ex. 1001, Figs. 8–9 (similar to the loop embodiments, depicting structures 150-A and 150-B forming sub-filaments of the bight(s)). Moreover, as admitted by Petitioner’s expert, that a filament may be made from various materials described in the patent (e.g., synthetics or metals) does not, absent more information, lead to a conclusion that a filament is “rigid.” Ex. 2030, 125:2–126:4 (testifying “the relative stiffness or rigidity” slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“Based on the current record, we are unpersuaded that Schaffer describes a valve with a filament as claimed. If, as construed above (supra Section III.C), a filament requires flexibility, Petitioner has not demonstrated that Schaffer describes such a feature in its valves. Instead we agree with Patent Owner that Petitioner “implicitly admits” that Schaffer’s actuating members are rigid insofar as Petitioner argues those members would form gaps for fluid leakage around tools inserted through the central lumen when in use and compared to the use of a flexible string or wire (of Hartley or Eller). Prelim. Resp. 29 (citing Pet. 36). Moreover, we find Dr. Zalesky’s interpretation of Schaffer more plausible than Mr. Thornton’s on the question of whether a POSA would have regarded Schaffer’s actuating members as being substantially rigid structures. Ex. 2024 ¶¶ 92–100 (testifying, inter alia, that a POSA would have understood from Schaffer’s disclosure about making the actuator and actuating members from machining pre-existing amounts of metals and/or plastics, and further explaining that flexible parts would deform and be difficult to machine through conventional techniques); Ex. 1005 ¶¶ 81–82. Mr. Thornton testifies that Schaffer’s disclosed manufacturing techniques for the actuator/actuating members are only examples and “a [and flexible] flat wire or plastic tapes or ribbons.” Ex. 1003 ¶ 79. Such testimony invokes, at best, obviousness-based reasoning. This does not establish that Schaffer alone describes a filament sufficient to anticipate the claims. Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1296 (Fed. Cir. 2002) (explaining that the “test for novelty” requires “strict identity”); Jamesbury Corp. v. Litton Indus. Prods., Inc., 756 F.2d 1556, 1560 (Fed. Cir. 1985) (holding “anticipation is not shown by a prior art disclosure which is only ‘substantially the same’ as the claimed invention”), overruled on other grounds, A.C. Aukerman Co. v. R.L. Chaides Constr. Co., 960 F.2d 1020 (Fed. Cir. 1992) (en banc). Because we determine on this preliminary record that Schaffer does not describe a valve comprising a “filament” as claimed, Schaffer cannot anticipate the challenged claims.” slip op. at 26
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,844,921 - Padagis US LLC v. Neurelis, Inc.InstitutedPTAB · Sep 16, 2025 · IPR2025-00465 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–18 because Petitioner showed a reasonable likelihood of proving claim 1 obvious over Gwozdz and Meezan.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“A 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 at the time the invention was made to a person having ordinary skill in the relevant art. 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 ordinary skill in the art; and (4) secondary considerations (i.e., objective indicia) of nonobviousness when presented.6 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). To show unpatentability based on a combination of teachings, “[a]n obviousness determination [also] requires finding both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” CRFD” slip op. at 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“[A POSA] would have been a pharmaceutical scientist, chemist, or biologist involved in the research and development of pharmaceutical formulations and/or delivery, and would have at least a Bachelor’s degree with at least 5 years of experience, or a Master’s, Ph.D. or Pharm.D. degree with several years of experience. In addition, a POSA would have had knowledge of benzodiazepine structure and function, and would further have knowledge and practical experience working with intranasal and transmembrane formulations, including knowledge of the physiology and anatomy of the nasal cavity, with relevant experience in developing intranasal formulations. Pet. 23–24; Ex. 1062 ¶ 20. Patent Owner “does not dispute” Petitioner’s POSA definition at this stage. Prelim. Resp. 18. We apply Petitioner’s proposed POSA definition for this Decision, which definition appears to be generally consistent with the cited prior art.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“standard used in a civil action before the courts under 35 U.S.C. § 282(b), including construing claim language in accordance with its ordinary and customary meaning as understood by the POSA, in view of the patent’s specification and considering the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only expressly construe terms to the extent needed to resolve the controversy before us. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019).” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“applicant, as part of the bargain with the public, must describe his or her invention so that the public will know what it is and that he or she has truly made the claimed invention.” AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1298 (Fed. Cir. 2014). “[T]he test for sufficiency [of the written description requirement] is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date sought.” Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (explaining that “the description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed”) (internal quotation marks omitted); see also id. at 1352 (“[A] description that merely renders the invention obvious does not satisfy the requirement.”).” slip op. at 25
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,241,414 - Padagis US LLC v. Neurelis, Inc.InstitutedPTAB · Sep 16, 2025 · IPR2025-00466 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–27 because Petitioner showed a reasonable likelihood of prevailing on at least one claim, including claim 1 over Gwozdz and Meezan.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’786 patent’s challenged claims.1 We institute inter partes review on all challenged claims. SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018); 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”).” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“We find that Petitioner has made a threshold showing that the ’558 Provisional does not provide written description support for claim 1’s pharmaceutical solution consisting of each of the recited elements, including n-dodecyl beta-D-maltoside. It is true that “n-Dodecyl β-D-maltoside” can be found listed in the SIGMA Catalog. Ex. 1026, 316. But Dr. Donovan’s testimony helps put that listing in context. It is merely one among well over 100 ionic and non-ionic detergents listed in the cited six pages of the SIGMA Catalog. See 1026, 316–321; Ex. 1062 ¶ 50. When further considered in the context of paragraphs 150–152 of the ’558 Provisional, which generically suggest that “enhancer” compounds can be used in “some embodiments”—then introducing at least 15 classes of potential enhancers16 including “preferred” lysophospholipids and acyl carnitines—the listing of n-dodecyl beta-D-maltoside among at least 150 biological detergents in the SIGMA Catalog is even more remote. Moreover, although satisfaction of the written description requirement is not limited to what is exemplified in a priority application, none of the ’558 Provisional’s examples use any “enhancer,” much less any detergent, any alkyl glycoside, or n-dodecyl beta-D maltoside in particular. The 16 The ’558 Provisional suggests that whether “a given compound” will function as an “enhancer” in a formulation requires testing. Ex. 1008 ¶ 150 (indicating “an in vivo or good model test” may “determin[e] whether the uptake of the drug is enhanced to a clinically significant degree”). ethanol. See Ex. 1008 ¶¶ 172–174 (Examples 1 and 2). In short, we find no sufficient disclosure of “blaze marks” in the ’558 Provisional that point to the inventors’ possession of a pharmaceutical solution that includes n-dodecyl beta-D-maltoside as claimed. Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1326–27 (Fed. Cir. 2000) (analogizing an application’s generic disclosures to a forest of unmarked trees and explaining that, “to satisfy the written description requirement,” there must be “blaze marks directing the skilled artisan to that tree [within the forest that represents the claimed invention]” in the application).” slip op. at 28
- PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for patent owner
“and applying collateral estoppel to vacate a claim construction in an underlying IPR). In an IPR, “a party seeking to invoke collateral estoppel must show: ‘(1) the issue is identical to one decided in the first action; (2) the issue was actually litigated in the first action; (3) resolution of the issue was essential to a final judgment in the first action; and (4) [the party against whom collateral estoppel is being asserted] had a full and fair opportunity to litigate the issue in the first action.’” Google LLC v. Hammond Development Int’l, Inc., 54 F.4th 1377, 1381 (Fed. Cir. 2022) (quoting In re Freeman, 30 F.3d 1459, 1465 (Fed. Cir. 1994)) (alteration in original).14 “It is [also] well established that patent claims need not be identical for collateral estoppel to apply.” Id. at 1381. Instead, “collateral estoppel requires the issues of patentability be identical.” Id. If “the differences between the unadjudicated patent claims and adjudicated patent claims do not materially alter the question of invalidity, collateral estoppel applies.” Ohio Willow Wood Co. v. Alps South, LLC, 735 F.3d 1333, 1342–43 (Fed. Cir. 2013) (affirming application of collateral estoppel where claims adjudicated as obvious required a “polymeric” gel whereas similar, unadjudicated claims required a “block copolymer” gel). “Collateral estoppel also applies to common issues in actions involving different but related patents.” Mycogen Plant Sci., Inc. v. Monsanto Co., 252 F.3d 1306, 1310 (Fed. Cir. 2001), vacated on other grounds, 353 U.S. 1109 (2002).” slip op. at 22
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artReference not prior artMixed
“We agree that at least one portion of Gwozdz is not prior art. To establish that the cited disclosures in Gwozdz are prior art, Petitioner must show support for those disclosures in the Gwozdz Provisional. In re Riggs, 131 F.4th 1377, 1384 (Fed. Cir. 2025) (explaining that “the portion of the application relied on . . . as prior art must be supported by the provisional application”). Petitioner did not establish that Gwozdz’s disclosure of “penetration enhancers” finds support in the Gwozdz Provisional. Pet. 22. Conversely, Patent Owner shows that the phrase is absent in the Gwozdz Provisional. Prelim. Resp. 37.20 Based on this record, we determine that Gwozdz’s mention of “penetration enhancers” is not prior art to the 19 Patent Owner argues this “penetration enhancers” disclosure in Gwozdz is not prior art regardless which of the disputed priority dates (March 28, 2008, or March 27, 2009) one accords to the challenged claims. Prelim. Resp. 33. 20 We also agree that collateral estoppel does not bar Patent Owner from challenging Gwozdz’s prior-art status in this case. Patent Owner’s apparent concession that Gwozdz was prior art during the 451 IPR does not equate to the issue being actually litigated. Prelim. Resp. 34–35; Ex. 1040, 14 (“Patent Owner does not contest that Gwozdz is entitled to this filing date” of the Gwozdz Provisional). Purdue, 767 F. App’x at 922 (determining “[t]he priority date for the Joshi reference . . . cannot be determined based on collateral estoppel” where patentee could have argued, but did not in fact argue, Joshi’s prior-art status in an earlier matter).” slip op. at 35
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,793,786 - Padagis US LLC v. Neurelis, Inc.InstitutedPTAB · Sep 16, 2025 · IPR2025-00464 · APJ Annette R Reimers · IPR · Institution
The Board instituted IPR on claims 1–22, finding a reasonable likelihood that claim 1 would have been obvious over Gwozdz and Meezan.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“3. Conclusion For the reasons discussed above and based on the present record, we find that Petitioner has made an adequate threshold showing that the issues presented in this Petition are substantially the same as the issues the Board previously considered in IPR2019-00451 and that Gwozdz’s effective date is March 28, 2008. We therefore determine that Petitioner has shown that it is reasonably likely to prevail in establishing that at least claim 1 would have been obvious over Gwozdz and Meezan. IV. CONCLUSION Petitioner has shown a reasonable likelihood that it will prevail in establishing the unpatentability of at least one of the claims challenged in the Petition. We institute trial on all challenged claims under the grounds raised in the Petition. PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed.” slip op. at 21
- Skill levelSkill level petitioner adoptedDecided for petitioner
“[A POSA] would have been a pharmaceutical scientist, chemist, or biologist involved in the research and development of pharmaceutical formulations and/or delivery, and would have at least a Bachelor’s degree with at least 5 years of experience, or a Master’s, Ph.D. or Pharm.D. degree with several years of experience. In addition, a POSA would have had knowledge of benzodiazepine structure and function, and would further have knowledge and practical experience working with intranasal and transmembrane formulations, including knowledge of the physiology and anatomy of the nasal cavity, with relevant experience in developing intranasal formulations. Pet. 23; Ex. 1062 ¶ 20. Patent Owner “does not dispute” Petitioner’s POSA definition at this stage. Prelim. Resp. 16. We apply Petitioner’s proposed POSA definition for this Decision, which definition appears to be generally consistent with the cited prior art.” slip op. at 6
- PTAB / AIA Trials › §315(e) estoppelMixed
“As the Board’s decision in the 451 IPR explicitly found written description inadequate for the “alkyl glycoside” limitation in the ’558 Provisional, which is the same issue raised here for the ’546 patent, Petitioner has shown that issue was actually litigated and decided in the 451 IPR. Where the same issue is actually litigated and decided as part of a final adjudication in an earlier action, the test for invoking collateral estoppel in a later action is met. On this record and for the reasons above, we are persuaded that collateral estoppel bars Patent Owner from arguing the challenged claims are entitled to the priority date of the ’558 Provisional.” slip op. at 14
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedMixed
“We agree that at least one portion of Gwozdz is not prior art. To establish that the cited disclosures in Gwozdz are prior art, Petitioner must show support for those disclosures in the Gwozdz Provisional. In re Riggs, 131 F.4th 1377, 1384 (Fed. Cir. 2025) (explaining that “the portion of the application relied on . . . as prior art must be supported by the provisional application”). Petitioner did not establish that Gwozdz’s disclosure of “penetration enhancers” finds support in the Gwozdz Provisional. Pet. 22. Conversely, Patent Owner shows that the phrase is absent in the Gwozdz 9 Patent Owner argues that as the ’546 Patent claims priority to the ’439 Application, the “penetration enhancers” disclosure in Gwozdz is not prior art because Gwozdz and the ’439 Application were filed on the same day (March 27, 2009). Prelim. Resp. 21–22. 10 Patent Owner argues that the passage in Gwozdz concerning “penetration enhancers” is relevant solely to “a pharmaceutical composition for injection,” not for intranasal administration as required by the ’546 Patent. Prelim. Resp. 22. First, as noted above, based on the record presented, we determine that Gwozdz’s mention of “penetration enhancers” is not prior art to the challenged claims. Second, we disagree, however, that Gwozdz’s non-prior art mention of penetration enhancers is relevant solely to a pharmaceutical composition for injection as argued by Patent Owner. Gwozdz discloses that “[the] pharmaceutical compositions of the present invention” can be administered by a number of “nonlimiting” routes including intranasal administration. See Ex. 1009, 9:2–11. Provisional. Prelim. Resp. 20–21. Based on this record, we determine that Gwozdz’s mention of “penetration enhancers” is not prior art to the challenged claims. The phrase cannot, therefore, be used to establish a motivation to combine the asserted references.” slip op. at 18
§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,895,546 - CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.InstitutedPTAB · Aug 14, 2025 · IPR2025-00505 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted inter partes review of claims 1–15 on all grounds, finding a reasonable likelihood that the claims would have been shown obvious over the asserted prior art.
RulingsInstitution decision- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner
“However, Patent Owner has not shown that circumstances exist that would require dismissal of the proceeding as barred under § 315(b) if the unnamed party were added as a real party in interest. Patent Owner has also not alleged any discovery abuse at this time. We determine that we need not address whether Cipla is an unnamed RPI at this stage. The parties may further address this issue during the trial portion of the proceedings. As the Board explained in SharkNinja, it “better serves the interest of cost and efficiency” when the Board does not engage in the “extensive analysis” required to determine whether a party is an unnamed RPI if the result of that analysis has no material impact on the proceeding. SharkNinja v. iRobot Corp., IPR2020-00734, Paper 11 at 19–20 (PTAB Oct. 6, 2020) (precedential). Here, it is undisputed that Petitioner could have named Cipla as an RPI in its Petition without triggering a statutory bar or estoppel under 35 U.S.C. § 315.” slip op. at 5
- Skill levelSkill level petitioner adoptedOther
“Patent Owner states it disagrees with Petitioner’s “definition of a POSA but assumes their definition for purposes of the arguments presented herein.” Prelim. Resp. 6. At this stage in the proceeding, we find that Petitioner’s analysis reasonably establishes a level of ordinary skill in the art as it directly relates to those deciding treatments based on the prior art references. The level of ordinary skill in the art usually is evidenced by the prior art references themselves. See, e.g., Ex. 1003, 1817, author list. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995).” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“Thus, the ’552 patent teaches that patients may or may not receive some therapeutic benefit from the treatment and also recognizes that any therapeutic benefit may result in prolonging life, but not necessarily result in complete remission of the pancreatic tumor. This understanding is consistent with Dr. Ratain’s testimony that “[t]reating a patient is always with the attempt or intent to cause a therapeutic improvement of the patient, which, in the case of metastatic pancreatic cancer, could be reduced tumor growth or increased overall survival in the patient.” Ex. 1002 ¶ 50. We are unpersuaded, however, by Dr. Ratain’s statement equating “treatment with a saline control” with the claimed “treating metastatic adenocarcinoma,” because the claim is addressing a disease condition whereas the example in Figure 6A is clearly providing a control, without any expectation of therapeutic benefit. See id. ¶ 55. We are not persuaded, on this record, that because Patent Owner did not include the phrase “therapeutically effective amount” in the claims, the claims solely relate to “administering” the antineoplastic therapies without any resulting therapeutic benefit. Rather, on this record, we agree with Patent Owner that the ordinary understanding of a claim reciting a “method of treating metastatic adenocarcinoma of the pancreas” that comprises “administering an antineoplastic therapy to the patient” in order “to treat the metastatic adenocarcinoma of the pancreas” is that the “treatment” would have more than a de minimis therapeutic benefit or efficacy for the patient being treated. To the extent that Patent Owner’s position would require some” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“While we are aware that hindsight bias may plague determinations of obviousness, Graham, 383 U.S. at 36, we are also mindful that the Supreme Court has clearly stated that the “combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR, 550 U.S. at 416. The evidence of record shows the prior art provides specific reasons to replace irinotecan with liposomal irinotecan in the treatment of pancreatic cancer, including improved sustained release, local bioactivation, increased efficacy, and reduced side effects. Ex. 1006, 9; Ex. 1008, 921; Ex. 1002 ¶¶ 91, 238, 239. These specific reasons, as supported by Dr. Ratain, provide specific support for the obviousness of modifying the Conroy Protocol for patients with toxicity to substitute a 60 mg/m2 dose of liposomal irinotecan for irinotecan, particularly in patients with the particular UGT1A1 allele identified by Bayever. Ex. 1006, 3.” slip op. at 37
Claim construction§ 103 obviousnesscites KSRPatents in suitUS 11,344,552 - PTAB · Jun 18, 2025 · IPR2025-00289 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–15 under all four asserted §103 grounds because the petition showed a reasonable likelihood of prevailing on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’005 patent’s challenged claims. In a separate decision, the Acting Director denied Patent Owner’s request for discretionary denial. Paper 9. We institute inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018); 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“(“POSA”) in August 2018 “would have had an undergraduate degree in mechanical engineering or a related engineering discipline and 2–4 years of catheter design experience.” Pet. 17 (citing Ex. 1003 ¶ 35). Patent Owner provides no alternative definition of the POSA’s qualifications and, instead, applies Petitioner’s definition in its Preliminary Response. Prelim. Resp. 26. We apply Petitioner’s proposed POSA level for this Decision, which level appears to be reasonable and consistent with the cited prior art.” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“disclosure about filament features) includes the same disclosures concerning “loop” and “bight” embodiments as in the patent challenged in the 1157 IPR. Ex. 1017 ¶¶ 64–69, Figs. 6–9. And claim 1 of the ’005 patent encompasses, but is not limited to, filaments that form a loop. Thus, similar to our preliminary decision in the 1157 IPR, we decline at this time to construe the filament of claim 1 of the ’005 patent as limited to a “flexible” filament.13” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Petitioner contends a POSA would have been motivated to use Schaffer’s hemostasis valve in Garrison’s aspiration system for several reasons. Pet. 35–37. For example, Petitioner contends that Garrison discloses that adjustable-opening valves may be used, that Schaffer suggests its valve may be used with interventional catheters of the type described in Garrison, and that a skilled artisan would have recognized that Schaffer’s valve, with its features biasing the valve to a closed position, could simplify operation of Garrison’s system by avoiding a need to manually close/seal the valve during procedures. Id. (citing Ex. 1003 ¶¶ 95–99). We find that Petitioner’s contentions are supported by the cited teachings in the references and the testimony of Mr. Thornton. Petitioner’s evidence is sufficient at this stage and we determine that Petitioner is reasonably likely to prevail in showing that at least claim 1 would have been obvious over Garrison and Schaffer. Below we explain why Patent Owner’s counterargument does not undermine Petitioner’s showing on this record.” slip op. at 29
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,554,005
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.