- Imperative Care, Inc. v. Inari Medical, Inc.All claims unpatentablePTAB · Oct 6, 2026 · IPR2025-00728 · APJ Timothy G Majors · IPR · Final written decision
Claims 1–7, 9, 10, 15–18, and 20–24 are unpatentable as obvious over Schaffer with Hartley or Eller; claims 1–3, 5, 6, 9, 15–18, and 21–24 are also obvious over Hartley and Eller.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“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 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. 2033 ¶ 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, which involves endovascular devices and the surgical procedures that use such devices. Ex. 1001, 1:16–54 (background of the invention). Such devices include, but are not limited to, hemostasis valves and catheters for testimony of the parties’ experts, the POSA need not have had first-hand 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). 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.” Id. at 74:5–75:1. Lastly, a POSA would have understood such devices’ design requirements as determined by the needs of the physician, patient, and procedure, which understanding may be informed by work experience or study. Ex. 2030, 24:5–21.” slip op. at 12
- Expert testimonyPetitioner expert creditedPatent owner expert creditedMixed
“above (supra Section III.C), a filament requires flexibility, Petitioner has not demonstrated that Schaffer describes that feature in its valves. Instead, Patent Owner persuades us that Schaffer describes “rigid U-shaped actuating members—not a ‘filament.’” PO Resp. 23–24.13 We find Dr. Zalesky’s interpretation of Schaffer more credible than Mr. Thornton’s on the question of whether a POSA would have regarded Schaffer’s actuating members as being substantially rigid structures. Ex. 2033 ¶¶ 91–100 (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 person of ordinary skill in the art could have simply purchased pre-made [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.” slip op. at 28
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“Patent Owner cites intrinsic evidence in support of its interpretation, 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.” PO Resp. 14–17 (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 are more consistent with the view that the filament is characteristically flexible, not rigid. 10 We reached the same conclusion, based on substantially the same records, in the Institution Decision and the Final Written Decisions in the 1157, 156, and 289 IPRs. Inst. Dec. 14–18; Ex. 1042, 14–24; Ex. 1048, 16–23; Ex. 1049, 14–17 (noting the parties’ agreement at oral hearing that there was no additional argument or evidence about whether a filament requires flexibility that was not already addressed in related matters). After we construed the “filament” term to require flexibility at institution, Petitioner provided no further argument or evidence on this issue in its authorized trial briefing or at oral hearing. See generally Pet. Reply. 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 less 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. 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 is not clear from those . . . materials without knowing much more information”).” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We find that Petitioner has not shown, by a preponderance of the evidence, that Schaffer anticipates claim 1 or any of the other challenged claims, each of which requires at least one “filament.” We are unpersuaded above (supra Section III.C), a filament requires flexibility, Petitioner has not demonstrated that Schaffer describes that feature in its valves. Instead, Patent Owner persuades us that Schaffer describes “rigid U-shaped actuating members—not a ‘filament.’” PO Resp. 23–24.13 We find Dr. Zalesky’s interpretation of Schaffer more credible than Mr. Thornton’s on the question of whether a POSA would have regarded Schaffer’s actuating members as being substantially rigid structures. Ex. 2033 ¶¶ 91–100 (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 person of ordinary skill in the art could have simply purchased pre-made [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.” slip op. at 27
Patent outcomesUS 11,844,921 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,844,921 - Ajinomoto Co., Inc. v. Abtis Co., Ltd.No claims unpatentablePTAB · Aug 3, 2026 · IPR2025-00283 · APJ Lilan Ren · IPR · Final written decision
The Board cancelled claim 11 and granted substitute claims 14–16, finding Petitioner had not shown those claims unpatentable on any asserted ground.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted
“must determine whether the motion to amend meets the statutory and regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121. Lectrosonics, Paper 15 at 4. In that regard, Patent Owner bears the burden of persuasion to show that: (1) the amendment proposes a reasonable number of substitute claims; (2) the amendment responds to a ground of unpatentability involved in the trial; (3) the amendment does not seek to enlarge the scope of the claims of the patent or introduce new subject matter;” slip op. at 9
- ExcludeMotion to exclude, deniedDenied
“In this case, Patent Owner’s expert “Dr. Zhou signed the second declaration, stood behind its contents, and was available for cross-examination.” Paper 35, 4. Petitioner does not dispute this statement. Paper 39, 1. Petitioner does not identify any specific undue prejudice caused by Exhibit 2008. For example, Petitioner argues that “the failure to impress upon a witness that a statement is under oath goes to the heart of its reliability as evidence” and that “as the Board has recognized, hearsay is inherently unreliable” without specifying what statement in Exhibit 2008 lacks reliability. Paper 39, 4. Because Petitioner does not provide specific evidence of undue prejudice, we find Petitioner has suffered no such undue prejudice in this case. See Liquidia, 2021 WL 4860773 at *25. We therefore deny Petitioner’s Motion to Exclude on the basis of lack of authenticity. With regard to the assertion that Exhibit 2008 is hearsay, Petitioner objects to the exhibit because the testimony is based “on other informal and unpublished documents that are hearsay under FRE 802.” Paper 29, 1. Petitioner does not specify what such “informal and unpublished documents” are. See id. Federal Rule of Evidence 703 expressly states, “[a]n expert may base an opinion on fact or data in the case that the expert has been made aware of or personally observed.” The facts or data “need not be deny Petitioner’s Motion to Exclude on the basis of hearsay.” slip op. at 50
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable
“Petitioner’s argument is unpersuasive. Paragraph 59 of the ’503 application describes formula 8-1 but does not support Petitioner’s argument that other unknown formulas may be included in the recited modified heavy chains. Ex. 2003 ¶ 59. Petitioner’s hypothesis that the recited heavy chains may (or may not) encompass unknown formulas is also inapposite to the written description inquiry before us — that is, whether the inventor was in possession of the subject matter recited in claims 14–16 based on the disclosure including formulas 8-1, 8-2, and 8-3. See PowerOasis, 522 F.3d at 1306.” slip op. at 14
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledNot shown unpatentable
“These arguments in the Sur-Reply are unpersuasive to show a lack of enablement first and foremost because the arguments do not specifically provide evidence showing that any purported experimentation is undue. See Sur-Reply 2–8 (asserting, but without providing evidence under any specific Wands factors, that the examples and guidance in the specification do not extend to the broad scope of all antibodies); see Wands, 858 F.2d at 737. We again emphasize that the analysis of undue experimentation does not necessarily require every Wands factor to be explicitly addressed but the analysis must be based on “weighing many factual considerations” depending on the nature of the invention and underlying art. Cephalon, Inc. v. Watson Pharms., Inc., 707 F.3d 1330, 1336 (Fed. Cir. 2013). The assertion that the claim scope is broad alone does not suffice to show a lack of enablement based on the record before us. Moreover, as we note supra, Petitioner’s claim scope argument is based on the false premise that the scope of claims 14–16 is as broad as the claim term “antibody” without taking into account all other claim elements. For example, Petitioner does not disagree with Patent Owner’s statement that “[t]he ’675 Patent’s specification discloses the structural modification site, the chemistry used to modify that residue, and working examples demonstrating the modification” (Reply 2), but asserts only that “[t]he disclosure of SSFI that only binds to IgG1 Fc domains (SEQ ID NO:1) is . . . . inconsistent with the expansive scope of the claims.” Sur-Reply 5. Petitioner’s argument that the claims encompass proteins that lack a lysine reside at a 248 position improperly excludes from the claim language the “lysine residue at 248 position . . . [as] determined by the EU numbering system” that claims 14–16 require. As Dr. Zhou testifies, “each proposed lysine residue at position 248 (EU numbering) is covalently modified with a specific attachment with a terminal bio-orthogonal click-chemistry functional group. The specification describes targeted transfer of a chemical functional group to lysine 248” and when claims 14–16 are considered in their entirety, which includes all claim elements, “[a] POSA would understand the claim itself to limit the modified antibodies to those with lysine at position 248.” Ex. 2004 ¶ 48; Ex. 2008 ¶ 47. We also note that Patent Owner states “a POSA would understand that the phrase ‘one or more modified heavy chain’ encompasses antibodies within typical DAR distributions (i.e., fractional numbers) rather than requiring a distinct process for producing antibodies bearing modified heavy chains in exact integers.” Reply 2–3. Moreover, Patent Owner states that PepTalk Presentation demonstrates that “a POSA would understand antibody conjugation products to exist as mixtures rather than discrete whole number species” because PepTalk Presentation “presents DAR values as non-integer measurements, i.e. DARs of 1.8 and 1.9 reflecting such distributions.” Id. at 3 (citing Ex. 1007, 28). According to Patent Owner, “preparations having an average DAR of approximately 1.8 (commonly referred to in practice as ‘DAR2’) may reflect typical reaction distributions in which some antibodies contain two modified heavy chains while others contain fewer.” Id. at 3 (citing Ex. 2008 ¶ 46). Petitioner does not rebut these statements. See Sur-Reply 2–8. Based on the foregoing, the evidence before us does not show any” slip op. at 27
Patent outcomesUS 11,896,675 not shown unpatentable§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · NautilusPatents in suitUS 11,896,675 - Imperative Care, Inc. v. Inari Medical, Inc.All claims unpatentablePTAB · Jun 9, 2026 · IPR2025-00289 · APJ Timothy G Majors · IPR · Final written decision
Claims 1–15 are unpatentable: claims 1–15 under Grounds 2 and 3, and claim 10 under Ground 4; Ground 1 did not establish unpatentability.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“We have construed the “filament” term in multiple related proceedings and agreed with Patent Owner that the claimed filament requires flexibility. See Ex. 1050 (Final Written Decision in 156 IPR); IPR2024-01157, Paper 35 (Final Written Decision) at 15–24. Specifically, we determined that the evidence supports Patent Owner’s position that “a POSA would have understood the plain and ordinary meaning of the claimed ‘filament’ as a flexible length of material (e.g., one or more string(s), wire(s), tape(s)).” See, e.g., Ex. 1050, 23. We maintain that construction in this Decision for the reasons given by Patent Owner (see PO Resp. 24–32; PO Sur-reply 6–8), we disagree with Petitioner’s argument to the contrary (Pet. Reply 27–31), and we incorporate our analysis concerning the meaning of the filament term from the related proceedings identified above, which applies equally here.13 Ex. 1050 (Final Written Decision in 156 IPR); IPR2024-01157, Paper 35 (Final Written Decision) at 15–24. The parties agreed at the oral hearing that there is no additional argument or evidence 13 Although the ’005 patent is not directly related to the patents at issue in the 1157 and 156 IPRs, the ’519 Application that the ’005 patent purports to incorporate for providing all relevant disclosures about the filament term is a parent application to the challenged patents in the 1157 and 156 IPRs (see supra n.3). SightSound Techs., LLC v. Apple Inc., 809 F.3d 1307, 1316 (Fed. Cir. 2015) (“Where multiple patents derive from the same parent application and share many common terms, we must interpret the claims consistently across all asserted patents.”) (internal quotation marks omitted). We also construed the filament term consistently in other ongoing proceedings on related patents. See, e.g., Ex. 1045 (Institution Decision in the 728 IPR), 12–18; Ex. 1046 (Institution Decision in the 989 IPR), 13–21. already addressed in those related matters. Tr. 6:13–23, 23:19–26.” slip op. at 16
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner contends that the person of ordinary skill in the art (“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). Although Patent Owner states that it “disagrees” with Petitioner’s POSA definition, Patent Owner nevertheless applies that definition in this case. PO Resp. 32–33; see Tr. 22:23–23:5 (Patent Owner is “not disputing” Petitioner’s definition, asserting the definition “doesn’t make any difference in this case”).” slip op. at 13
- Expert testimonyPatent owner expert creditedPetitioner expert creditedMixed
“We credit Dr. Zalesky’s interpretation of Schaffer on whether the POSA would have understood Schaffer as describing rigid actuating members. Dr. Zalesky testifies, for example, that a POSA would have understood from Schaffer’s disclosures about the actuating members being “machined” from metal or plastic, that such actuating members would be rigid. Ex. 2026 ¶ 101 (explaining “machining is a manufacturing process in which the desired part . . . is created using the controlled removal of bulk material” to produce a “rigid material”); Ex. 1005 ¶ 82 (“The actuating member 55 and the actuating button 261 is machined from aluminum” and “[i]n another example, the actuating member 55 and the actuating button 261 are machined from plastic”); Ex. 2026 ¶¶ 102–103 (testifying the disclosed valve assembly technique in Schaffer (Ex. 1005 ¶ 83) also indicates that “rigid” actuating members are used). Mr. Thornton opines (without citation to any persuasive supporting disclosure) that a POSA “would have understood that Schaffer’s U-shaped actuating members would have preferably been formed from a thin, flexible material.” Ex. 1003 ¶ 113. But, at deposition, Mr. Thornton conceded that machined plastics and aluminum, like disclosed in Schaffer, are rigid. Ex. 2005, 168:2–6 (“Q. And you said that plastic that would be machined would be rigid, correct? A. I think that’s a fair statement.”). Although Mr. Thornton opines that Schaffer’s actuating members would “preferably”” slip op. at 29
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableUnpatentableMixed
“For the reasons above, Petitioner has not established that the claimed “filament” is disclosed in the combination of Garrison and Schaffer and, thus, Petitioner has not shown by a preponderance of the evidence that claim 1 would have been obvious over Garrison and Schaffer. Petitioner’s challenge to independent claim 10 (and the claims that depend from claim 1 and claim 10) fails for similar reasons. Each of the challenged claims requires a “filament” and, given our construction of that term and our findings above that Schaffer does not teach or suggest the claimed filament, Petitioner has not proved by a preponderance of the” slip op. at 31
Patent outcomesUS 11,554,005 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,554,005 - 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 · Nov 19, 2025 · PGR2025-00053 · APJ Susan L C Mitchell · PGR · Institution
The Board instituted PGR on claims 1–3 and 5–15, finding written-description and enablement challenges more likely than not to succeed, but not the obviousness challenge.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition and the cited evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 1–3 and 5– 15 of the ’773 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’773 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Pet. 7. We have adjusted the claims challenged to only those that remain in effect following Patent Owner’s disclaimer. See Ex. 2003. 3 US 7,767,429 B2, issued Aug. 3, 2010 (the “’429 patent”; Ex. 1005). 4 Chao et al., Structure of Human Hyaluronidase-1, a Hyaluronan Hydrolyzing Enzyme Involved in Tumor Growth and Angiogenesis, 46 Biochemistry 6911–6920 (2007) (Ex. 1006). Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not have expertise specifically in hyaluronidases. See Pet. 16–17. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. At this stage of the proceeding and on the record before us now, we apply Petitioner’s proposed POSA level, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner
“refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 47:8–22 (emphasis added). On this record, however, we find that the definition of “modified PH20 polypeptide” permits amino acid replacements in the PH20 polypeptide but only “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:13–15. Indeed, while some of the language in the above paragraph is permissive in nature, i.e.., describing the number of amino acid replacements a modified PH20 polypeptide “can have” or “[t]ypically . . . contains” or the other modifications the polypeptide “can include,” the phrase “so long as” is not. See Ex. 1001, 47:8–22. This distinction demonstrates that hyaluronidase activity is not an optional feature of a non-limiting example, but a requirement of the “modified PH20 polypeptide” defined and claimed in the ’773 patent. See Alynylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (explaining that the “contrast” between “non-limiting terms” and more definitive statements may indicate that the latter is definitional).” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“We determine that we need not expressly construe any other claim terms for the purpose of deciding whether to institute post-grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 14
Claim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 12,195,773 - PTAB · Nov 19, 2025 · PGR2025-00050 · APJ Susan L C Mitchell · PGR · Institution
The Board instituted PGR on claims 1–3 and 6–10 because Petitioner showed they were more likely than not to lack written-description support and enablement.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition and the cited evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 1–3 and 6– 10 of the ’791 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’791 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not have expertise specifically in hyaluronidases. See Pet. 20. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. At this stage of the proceeding and on the record before us now, we apply Petitioner’s proposed POSA level, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner
“refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 47:4–18 (emphasis added). On this record, we find that the definition of “modified PH20 polypeptide” permits amino acid replacements in the PH20 polypeptide but only “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:9–11. Indeed, while some of the language in the above paragraph is permissive in nature, i.e.., describing the number of amino acid replacements a modified PH20 polypeptide “can have” or “[t]ypically . . . contains” or the other modifications the polypeptide “can include,” the phrase “so long as” is not. See Ex. 1001, 47:4–18. This distinction demonstrates that hyaluronidase activity is not an optional feature, but a requirement of the “modified PH20 polypeptide” defined and claimed in the ’791 patent. See Alynylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (explaining that the “contrast” between “non-limiting terms” and more definitive statements may indicate that the latter is definitional). Thus, the evidence of record shows the ’791 patent recognizes a broad understanding of a “modified PH20 polypeptide” as encompassing PH20 sequences from a variety of different mammalian species, with or without precursor or signal sequences, with or without post-translational modifications, and with up to 150 amino acid replacements. The express definition of “modified PH20 polypeptide” in the ’791 patent permits up to 150 amino acid replacements but only “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:9–11. That is, the provided definition of “modified PH20 polypeptide” in the ’791 patent expressly requires some hyaluronidase activity. On the current record, we therefore adopt the definition for “modified PH20 polypeptide” as recited in the ’791 patent to encompass polypeptides with some hyaluronidase activity. We determine that we need not expressly construe any other claim terms for the purpose of deciding whether to institute post-grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateInstituted
“As we noted, on the current record claim 1 is reasonably interpreted to encompass PH20 polypeptides with some hyaluronidase activity. But even if we were to find that immunization using PH20 polypeptide as a contraceptive antigen serves to satisfy the utility requirement for the instant claims, there is a similar concern as to whether modified PH20 polypeptides with significant differences from the native protein as encompassed by claim 1 would maintain the antigenic determinants necessary to function as contraceptives. See Ex. 1003 ¶ 122. That the modified PH20 polypeptides would be homogenous in function is contradicted both by evidence in the ’791 patent itself and by Dr. Hecht and Dr. Parker. The ’791 patent discloses synthesis of 6,753 single amino acid mutations in residues 1‒447 of SEQ ID NO: 3. See Ex. 1001, 199:15–200:34. The ’791 patent teaches that just under 10% of these mutations, i.e. over 600, “exhibit activity that is increased compared to wildtype.” Id. at 233:1–2. Appendix A of Dr. Hecht’s Declaration shows 3,380 of these mutations were inactive, or 57.13%. See Ex. 1003, Appendix A-1, 171. Thus, the ’791 patent evidences that even when only a single mutation is made in the PH20 polypeptide, that single mutation is more likely than not to alter the structure in such a way as to inactivate the hyaluronidase activity found in the native PH20 polypeptide. On this record, Dr. Hecht persuasively demonstrates that when the full scope of claim 1 is addressed, which includes not just single mutations in the PH20 polypeptide, but also multiple mutations, there is no expectation of structural homogeneity, stating that “[i]ntroducing multiple amino acid changes simultaneously . . . could prevent the folding of sequences into secondary structures and structural motifs and can destabilize those structures if they do form.” Ex. 1003 ¶ 59. Dr. Hecht notes that claim 1 allows “up to 21 changes, with each additional change (except at position 309) being to any of 19 alternative amino acids. But the up to 21 changes also can be at any of 433 different positions.” Id. ¶ 129. Dr. Park calculates that the number of distinct polypeptides that meet the claimed criteria “is extremely large by all accounts, ranging from 1049 to 1060 distinct polypeptides.” See Ex. 1004 ¶ 161. Dr. Hecht characterizes the number of possible mutations as “astronomical in size.” Ex. 1003 ¶ 134.” slip op. at 20
Claim construction§ 112 disclosurePatents in suitUS 12,077,791 - PTAB · Nov 13, 2025 · PGR2025-00042 · APJ Susan L C Mitchell · PGR · Institution
The Board instituted PGR on claims 1, 2, 5, and 7–33, finding likely written-description and enablement failures; it found the obviousness showing insufficient.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“XII. CONCLUSION Petitioner has, at this stage of the proceedings, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. XIII. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1, 2, 5, and 7–33 of the ’618 patent is hereby granted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 46
- Skill levelSkill level petitioner adoptedOther
“Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’618 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not have expertise specifically in hyaluronidases. See Pet. 15–16. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. At this stage of the proceeding and on the record before us now, we apply Petitioner’s proposed POSA level, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“On this record, however, we find that the entire text quoted above is part of the definition of “modified PH20 polypeptide” because it continues to detail specific elements required including a requirement that replacements in the PH20 polypeptide are permitted “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:2–4; see Ex. 2001 ¶¶ 48, 67 (stating a “patent’s definition controls”). Indeed, while some of the language in the definitional paragraph is permissive in nature, i.e.., describing the number of amino acid replacements a modified PH20 polypeptide “can have” or “[t]ypically . . . contains” or the other modifications the polypeptide “can include,” the phrase “so long as” is not. See Ex. 1001, 47:1–11. This distinction demonstrates that hyaluronidase activity is not an optional feature of a non-limiting example as Patent Owner posits, but a requirement of the “modified PH20 polypeptide” defined and claimed in the ’618 patent. See Alynylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (explaining that the “contrast” between “non-limiting terms” and more definitive statements may indicate that the latter is definitional). Moreover, Dr. Triggs-Raine recognizes the “therapeutic use of hyaluronidases” and notes that “different hyaluronidases were known to have different functions and substrates.” Ex. 2001 ¶¶ 29, 113.6 That is, Dr. Triggs-Raine recognizes hyaluronidase activity as the primary utility for the modified PH20 polypeptides recited in claim 1.” slip op. at 13
- Disclosure Requirements (§112) › Written description (Ariad)Instituted
“Every patent must describe an invention. It is part of the quid pro quo of a patent.” Ariad, 598 F.3d at 1345. Ariad explains that for generic claims the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus. Id. at 1349. Ariad explains “that 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. at 1350. Ariad also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. . . . But merely 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 21
Claim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 12,037,618 - 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 14, 2025 · IPR2025-00685 · APJ John G New · IPR · Institution
The Board instituted IPR on claims 1–23 and all petitioned grounds, finding a reasonable likelihood that the claims are obvious over Wei and Liu.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Summary Based upon the record as presently developed, we conclude that Petitioner has met its burden of showing a reasonable likelihood of showing at trial that at least claim 1 of the ’370 patent is obvious over the cited prior art. Because we determine that Petitioner has demonstrated a reasonable likelihood of success at trial in showing that at least one claim is unpatentable on at least one of the stated Grounds, we institute inter partes review of all challenged claims of the ’370 patent, based on all of the remaining grounds identified in the Petition. See 37 C.F.R. § 42.208(a); SAS Inst., Inc. v. Iancu, 584 U.S. 357, 371 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”).” slip op. at 44
- Skill levelSkill level board ownOther
“appears to be generally consistent with the level of skill presented in the cited prior art. See generally, e.g., Exs. 1005–1008; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself may reflect an appropriate level of skill in the art). However, at this point we reject the portion of Petitioner’s proposed definition that includes having “access to other individuals with that knowledge and experience,” as not reflecting the individual level of skill of a given skilled artisan. See, e.g., Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986) (holding that “[t]he person of ordinary skill is a hypothetical person who is presumed to be aware of all the pertinent prior art. The actual inventor’s skill is not determinative”) (emphasis added, footnotes omitted). Consequently, and for the purposes of this Decision, we adopt Petitioner’s proposed definition as defining a person of ordinary skill in the art as a person who would have had “a Ph.D. in immunology, molecular biology, cellular biology, or a similar field, or an M.D. with similar experience, and would further have had at least five years of experience with antibodies and antibody engineering.”” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningOther
“Petitioner states that no term of the challenged claims requires construction to resolve the challenges in this Petition. Pet. 32. Patent Owner does not contest Petitioner’s assertion. See generally Prelim. Resp. We find, for the purposes of this Decision, that no terms of the challenged claims require 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.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“We find, based upon the present record and for the purposes of this Decision, that Petitioner has sufficiently established that a person of ordinary skill in the art would have been motivated to combine the teachings of Wei and Liu to determine the activity and suitability of Liu’s humanized anti- EGFR antibodies in an ADC. We acknowledge that Liu is silent regarding the pH selectivity or tissue preference of its binding affinity, but Patent Owner points to no prior art reference that would have informed a skilled artisan upon this point or that would have discouraged a person of ordinary skill in the art from combining the references. See fn.7, supra. And, even if a skilled artisan might have recognized that Liu’s humanized cetuximab might have been potentially problematic if it failed to show pH-selective activity like Wei’s Y104D, the mere fact that some disadvantage may come with an advantage when combining prior art does not foreclose their combination under § 103. Medichem, S.A. v. Rolabo S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). In the instance of Liu’s humanized anti-EGFR antibody, a person of ordinary skill in the art would have recognized that its advantages (enhanced activity against tumor cells compared to chimeric cetuximab, thus requiring smaller dosages) could balance or outweigh its possible disadvantages (e.g., possible activity against non-tumor cells). Furthermore, it is in the nature of scientific research to continue to try new substitutions in drug therapy, even if a promising candidate has been discovered. As the Supreme Court stated in KSR: When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. 550 U.S. at 421.” slip op. at 39
Claim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,792,370
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.