- 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 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Jun 24, 2026 · PGR2025-00009 · APJ Susan L C Mitchell · PGR · Final written decision
Claims 1, 2, 6–14, and 16–29 are unpatentable based on written description, enablement, and obviousness grounds.
RulingsFinal written decision- Director reviewDirector review, deniedDenied
“Following institution, Patent Owner filed a Director Review Request (Paper 33), and Petitioner filed an Authorized Response (Paper 37), and the then-Acting Director issued a denial of the Director Review Request. Paper 40.” slip op. at 3
- Additional discoveryAdditional discovery, deniedDenied
“(Paper 46, “PO Resp.”), Petitioner filed a Reply to Patent Owner’s Response (Paper 71, “Pet. Reply”), and Patent Owner filed a Sur-reply (Paper 84, “PO Sur-reply”). Patent Owner filed a motion for additional discovery (Paper 62), Petitioner opposed the Motion for Discovery (Paper 63), and the Board denied the Motion for Discovery (Paper 77).” slip op. at 3
- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’035 patent.” slip op. at 53
Patent outcomesUS 12,123,035 unpatentable§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,123,035 - Imperative Care, Inc. v. Inari Medical, Inc.All claims unpatentablePTAB · Jan 16, 2026 · IPR2024-01157 · APJ Timothy G Majors · IPR · Final written decision
Claims 1–9 are unpatentable: the Board found them obvious over Schaffer with Hartley or Eller, though Schaffer alone did not anticipate and Hartley with Eller did not show claims 1–3, 5, 6, and 9.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“background for the POSA, but we agree with Patent Owner that Petitioner’s proposed POSA definition lacks some specificity concerning the POSA’s work experience. That definition, if interpreted generically, could mean that a person qualifies 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. 2008 ¶ 68. We also find that a POSA would 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, 1:21–57 (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. 1015 (Zalesky Tr.), 72:11–73:7 (testifying direct experience “designing”” slip op. at 13
- Expert testimonyPetitioner expert creditedOther
“Schaffer’s valve to include a single flexible string or wire that replaces the two U-shaped actuating members would have been seen by the POSA as potentially advantageous—giving further reason for the POSA to have made that change. Pet. 35–36. We credit Mr. Thornton’s testimony that a POSA would have understood that Schaffer’s U-shaped actuating members may into the lumen. Ex. 1003 ¶ 81. On the other hand, a POSA would have recognized that a single flexible string or wire that is looped completely around the exterior of the seal module/lumen would provide more uniform constriction and compression around the outer diameter of some commonlyused tools and including tools with diverse shapes and sizes. Ex. 1003 ¶¶ 80–88, 93–100. We observed this same reason for modifying the art at institution and, after considering the full trial record, our view has not changed. Inst. Dec. 37 (preliminarily finding that a POSA would have considered Hartley’s string or Eller’s wire “as providing expected benefits insofar as such a filament may more precisely and uniformly constrict a lumen against inserted tools of different sizes and shapes”). Patent Owner’s expert, Dr. Zalesky, does not disagree that a flexible string or wire would have carried this advantage. Ex. 2008 ¶ 75 (testifying a “filament changes shape dynamically, allowing for better adaptability to the contours of the valve lumen as it is constricted”);21 Ex. 1015 (Zalesky Tr.), 86:19–87:4 (testifying that POSAs in 2017 would have recognized that the “cinching” effect provided by a filament would have been more effective for large-bore catheters based on “simple mechanical engineering and physics”). And, at the oral hearing, Patent Owner agreed that using Hartley’s string in Schaffer would help eliminate potential fluid gaps; but Patent Owner qualified its answer that such a benefit would allegedly only have arisen if “the highly-compliant” seal member material in Schaffer was removed,” slip op. at 53
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“that issue, after considering the full record developed through trial, we agree with Patent Owner that a “filament” as claimed is flexible. On balance, the evidence supports Patent Owner’s interpretation. Patent Owner cites the claim language, including the recitation that “the filament circumferentially constricts the lumen to create a seal,” which Dr. Zalesky opines a POSA would have understood as implying a flexible structure. PO Resp. 25–26; Ex. 2008 ¶¶ 71–76 (testifying, inter alia, that “[t]o ‘circumferentially constrict,’ the filament must be flexible and extend circumferentially about the lumen” such that “the filament will adapt to the shape of the lumen as the lumen is constricted and thus ‘circumferentially constrict’ the lumen as recited in Claim 1”).12 The Specification also describes the filament as being selectively “tightened” and “loosened” about the elongate member. Ex. 1001, 9:37–40, 9:55–59 (teaching “the filament 150 is tightened” when the actuator is released and “the filament 150 is loosened” when the actuator is pressed to open the valve)). Dr. Zalesky opines that a POSA would have understood the patent’s description of” slip op. at 18
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“challenge fails on this record whether the clearer prosecution drawings in Exhibit 1008 are considered in the analysis of anticipation by Schaffer, or not. Whether those prosecution drawings are considered “extrinsic evidence” to Schaffer (as argued by Patent Owner) or publicly-available “intrinsic evidence” with respect to Schaffer (as Petitioner argues) does not change our Decision on Ground 1. Opp. 10–11; Mot. Reply, 3–5. Patent Owner’s motion is, therefore, moot as to Ground 1.” slip op. at 72
Patent outcomesUS 11,697,011 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,697,011 - Omega Liner Company, Inc. v. Buergofol GmbHAll claims unpatentablePTAB · Mar 14, 2025 · IPR2023-01372 · APJ Grace Karaffa Obermann · IPR · Final written decision
Claims 1, 3–7, and 10–13 are unpatentable as obvious over Hummel and Schuhmann or Hummel and Nagai; anticipation by Hummel alone was not shown.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner, in the Petition, proposes that a person of ordinary skill in the art “would have at least a bachelor’s degree in Polymer Science and Engineering, Material Science and Engineering, or a related engineering field, combined with at least three years of experience in the formulation, manufacturing, and end-use performance of polymeric film and sheet products.” Pet. 3 (citing Ex. 1003 ¶ 23). Petitioner further states that “[a]lternatively, one skilled in the art could be a person with at least seven years of experience in the formulation, manufacturing, and end-use performance of polymeric film and sheet products, without possessing a bachelor’s degree in a related scientific or engineering discipline.” Id. In the Response, Patent Owner states that it “adopts Petitioner’s description of” the hypothetical person of ordinary skill in the art. Resp. 11 (citing Ex. 2001 ¶ 11). We apply Petitioner’s unopposed definition because it is consistent with disclosures in the ’882 patent, the asserted prior art, and the declaration testimony of Dr. MacLean. See Ex. 1001, code (57) (Abstract), 1:10–2:49 (background of the claimed invention); Ex. 1005, code (57) (Abstract), 1 (description of field and background of Hummel’s” slip op. at 9
- ExcludeMotion to exclude, deniedDenied
“The Board regularly denies as moot motions to exclude evidence that is not relied upon in a final written decision. See, e.g., Foursquare Labs, Inc., v. BoardActive Corp., IPR2023-00919, Paper 29 at 84 (PTAB Nov. 27, 2024); Neurocrine Biosciences, Inc., v. Spruce Biosciences, Inc., PGR2021- 00088, Paper 64 at 12, 20, 21, 23 (PTAB Nov. 26, 2024). Patent Owner does not persuade us that a deviation from this general practice is warranted in this case––the reason given by Patent Owner, involving concerns stemming from appellate review, would apply to all cases. We do not rely on Exhibit 1047–1049, 1051, 1060, 1061, 1070, or 1071 in this decision, therefore, we deny Patent Owner’s Motion to Exclude as moot. B. Petitioner’s Motion to Exclude Exhibit 2001 (Paper 52) Petitioner moves to exclude paragraphs 13–25, 29–40, 42–43, 48–49, 56–61, and 66–75 of Exhibit 2001, which is the declaration of Dr. Brant. Paper 52. In Petitioner’s view, Dr. Brant’s “declaration is replete with inadmissible hearsay, improper legal conclusions, and testimony unsupported by reliable methods or personal knowledge.” Id. at 1. made available for cross-examination pursuant to routine discovery in our forum. Petitioner’s objections otherwise go primarily to the weight that should be accorded to Dr. Brant’s testimony, without raising any persuasive arguments for its exclusion. See generally id. (Petitioner’s arguments). Accordingly, we deny Petitioner’s Motion to Exclude Exhibit 2001. C. Petitioner’s Motion to Exclude Exhibit 2003 (Paper 53) Petitioner moves to exclude certain paragraphs of Exhibit 2003, which is the declaration of Dr. Schleicher, a named co-inventor of the ’882 patent. Paper 53. We do not rely on Dr. Schleicher’s declaration in this decision. Accordingly, we deny Petitioner’s Motion to Exclude Exhibit 2003 as moot. D. Petitioner’s Motion to Exclude Exhibit 2004 (Paper 54) Petitioner moves to exclude paragraphs 6–59 of Exhibit 2004, which is the declaration of Dr. Boutrid, another named co-inventor of the ’882 patent. Paper 54. In Petitioner’s view, Dr. Boutrid’s declaration “is riddled with inadmissible evidence, including hearsay, double hearsay, and testimony lacking personal knowledge. Much of the declaration relies on out-of-court statements from unidentified customers and unidentified UV-curable resin manufacturers, none of whom are identified or made available for examination.” Id. at 1. Much of the testimony about which Petitioner’s objects pertains to customer complaints about Patent Owner’s products, and whether maleic anhydride was included in the curable resin used by the customers, which form no part of this decision. See, e.g., id. at 4–7. We can take account of Petitioner’s objections, including Petitioner’s view that parts of Dr. Boutrid’s testimony are based on impermissible hearsay and unsound the record for appeal. Accordingly, we deny Petitioner’s Motion to Exclude Exhibit 2004.” slip op. at 51
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We agree with Patent Owner that Petitioner relies on a list of optional additives set forth in Hummel––a list that Hummel provides without any guidance as to why any particular additive would have been selected to serve any purpose, specifically in relation to the relevant layer (e). See Ex. 1005, 11:18–26 (relevant disclosure in Hummel). In other words, Hummel’s disclosure does not teach, with anticipatory specificity, a multilayer film in which a migrating compound is selected specifically for addition to layer (e). Although the lack of a specific example is not necessarily fatal to this anticipation ground, we cannot properly find that Hummel anticipates claim 1 absent some disclosure that “clearly and unequivocally” teaches the claimed subject matter “or direct[s] those skilled in the art to the” claimed” slip op. at 29
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“These are attorney arguments, unsupported by evidence, except for a single citation to Schuhmann’s “sticky” products. Id. (citing Ex. 1007, 17). Because that sole citation to evidence is inadequate to support Patent Owner’s arguments about the understanding of an ordinarily skilled artisan, we agree with Petitioner that these conclusory arguments are “baselessly” advanced by Patent Owner. Reply 3. the particular problem with which the inventor is involved.” In re Clay, 966 F.2d 656, 659 (Fed. Cir. 1992). Schuhmann’s release films are “reasonably pertinent” to a problem addressed in the ’882 patent, namely, providing a “release effect against adhesive substances such as resins.” Ex. 1001, 2:56– 57. So too is Hummel, which relates to removal of an inner tubular layer, “after the resin has cured,” without “tearing or seizing” during the process of removal. Ex. 1005, 7, 23. On this record, an ordinarily skilled artisan would have been aware of both references and would have taken account of their combined disclosures.” slip op. at 37
Patent outcomesUS 9,657,882 unpatentable§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,657,882 - PTAB · Jan 13, 2025 · IPR2024-00183 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–6, 10, 11, 13–20, 22, 23, and 26–33 because the asserted combinations of ICMSF, Hughes, and Price showed a reasonable likelihood that at least one claim was obvious.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“314. An inter partes review may not be instituted unless “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Further, a decision to institute may not do so on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); 37 C.F.R. § 42.108(a). After considering the evidence and arguments presented in the Petition, we determine that Petitioner demonstrates a reasonable likelihood of prevailing in showing that at least one of the challenged claims of the ’584 patent is unpatentable. Accordingly, we institute an inter partes review as to the challenged claims of the ’584 patent on the grounds of unpatentability set forth in the Petition. A.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art at the time of the invention (POSA/POSITA), “would most likely have an advanced degree in microbiology, food science, or animal science and at least two years of work experience but may alternatively have a bachelor’s degree in those areas and at least four years of experience with validation methodologies.” Pet. 11. (citing Ex. 1041 ¶¶ 22–24). Petitioner further contends that a person of ordinary skill in the art would have had “a working knowledge of microbiology,” “would have been involved in developing sampling and testing methodologies for analysis of food products (“validation methodologies”),” and “would have been familiar with relevant scientific literature and industry regulations, directives, and guidelines relating to validation methodologies.” Id.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We agree with Patent Owner that the term “lots” does not require construction because on the current record, there is no controversy over the meaning of the term, and neither Petitioner nor Patent Owner identify any way that claim construction impacts the decision. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“This definition requires that a “validation” determines that “a particular sample tests negative.” The initial definition sentence makes no mention of “cleared for release” as necessary for “validation.” Rather, the definition only refers to “cleared for release” in the more limited situation where a particular composite sample “tests negative all single-unit production lot samples,” and even then, the “cleared for release” is a separate step that occurs after the samples are “validated.”” slip op. at 21
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 7,534,584 - PTAB · Aug 22, 2024 · IPR2024-00521 · APJ Cynthia M Hardman · IPR · Institution
The Board instituted IPR on all grounds challenging claims 13 and 29, finding a reasonable likelihood that both claims would be shown unpatentable as obvious.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Denied
“the prior art asserted in Petition 3 at the time it filed Petition 1, and had in hand both Patent Owner’s preliminary response to Petition 1 and the Board’s institution decision on Petition 1. See, e.g., Pet. 9; Prelim. Resp. 7–8. Nevertheless, we find that factors 2 and 3, considered in combination with factor 1, do not favor discretionary denial. See Code200, Paper 18, 5 (“General Plastic factor 1 must be read in conjunction with factors 2 and 3.”). We agree with Petitioner that the grounds and arguments presented by Petition 3 are not informed by the Board decisions or Patent Owner arguments in the first two IPRs. Petitioner’s arguments are unchanged as to the overlapping claim elements found in claim 1, from which challenged claims 13 and 29 depend. As to those overlapping elements, Petitioner repeats without substantive modification the mapping from Ground 1 of Petition 1 and is using neither the Petition 1 POPR [Patent Owner Preliminary Response] nor the institution decision to modify arguments that were previously unsuccessful, nor shifting its prior art arguments for this petition. Pet. 11. Stated differently, we find no “road-mapping” concerns or “shifts in the prior art asserted and the related arguments” in the later petition, like those found in General Plastic. See General Plastic at 17.” slip op. at 15
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). Petitioner ultimately bears the burden of persuasion to prove unpatentability of each challenged claim by a preponderance of the evidence. 35 U.S.C. § 316(e). This burden never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). The Board may authorize an inter partes review if we determine that the information presented in the Petition and Patent Owner’s Preliminary Response shows a reasonable likelihood that Petitioner will prevail with respect to at least one of the challenged claims. 35 U.S.C. § 314(a).” slip op. at 19
- Skill levelSkill level petitioner adoptedDecided for petitioner
“a Bachelor of Science degree in biomedical engineering, or a similar field, such as electrical, or software, or computer engineering, and two years of industry experience or research working with medical devices and systems for measuring biomedical signals. Such systems might include those for determining levels of blood analytes, such as glucose, in a 9 See infra Section III.B. 10 Patent Owner does not presently assert any objective indicia of nonobviousness. See generally Prelim. Resp. 11 For purposes of this Decision, we apply a priority date in the 2009–2010 timeframe. See supra page 3 n.1. On the present record, it does not appear that the level of ordinary skill changed during this timeframe. patient and transmitting indications of such levels to a receiving device for reporting the measurements. Additional education, such as a Master’s degree could substitute for the industry experience, or vice versa. Pet. 23 (citing Ex. 1208 (Gross Decl.) ¶ 51).” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Having reviewed the arguments and evidence of record, we determine that no construction of any claim term is needed to decide whether to institute this Petition. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Any final written decision entered in this case may include express claim constructions, or may include discussion of claim scope that differs from that provided in our analysis below. Any final claim constructions will be based on the full trial record. Should the parties argue for any specific claim interpretations at trial, they should do so in a separately designated section of their briefing to highlight their proposed claim interpretations. See, e.g., Consolidated Trial Practice Guide (Nov. 21, 2019), 44–49.12 Claim construction arguments should not be merely asserted within arguments over the merits of patentability challenges.” slip op. at 23
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,298,056 - Sanofi Pasteur Inc. / SK Chemicals Co., Ltd. et al. v. Pfizer Inc.All claims unpatentablePTAB · Jun 10, 2024 · IPR2018-00187 · APJ Jeffrey N Fredman · IPR · Remand
On remand, the Board found proposed substitute claims 48 and 49 unpatentable as obvious over GSK-711, Merck-086, and Hausdorff, and denied the motion to amend as to those claims.
RulingsRemand decision- RemandOther
“I. INTRODUCTION This case was remanded to the Board by the United States Court of Appeals for the Federal Circuit with instructions that we address the patentability of Patent Owner’s proposed substitute claims 48 and 49 to U.S. Patent No. 9,492,559 B2 (Ex. 1001, “the ’559 patent”). Pfizer Inc. v. Sanofi Pasteur Inc., 94 F.4th 1341 (Fed. Cir. 2024); see Paper 15 (Patent Owner’s Motion to Amend, “Mot. Amend.”). The Court stated that: we affirm in toto the Board’s decision at issue in Appeals 2019- 1875 and 2019-1876. We further affirm the Board’s decisions at issue in Appeals 2019-1871, 2019-1873, and 2019-2224 as to claims 1–45 and proposed substitute claims 46, 47, and 50–52. Claims 1–45 are therefore unpatentable. But we vacate the Board’s denials of Pfizer’s motions to amend in those decisions as to proposed substitute claims 48 and 49 and remand for further proceedings consistent with this opinion. Pfizer, 94 F.4th at 1354.3 We therefore limit our analysis to proposed substitute claims 48 and 49 (the “Challenged Claims”) of the ’559 patent. For the reasons discussed herein, we determine that Petitioner has shown, by a preponderance of the evidence, that the Challenged Claims are unpatentable. 3 The same issues on remand in IPR2018-00187 remain for IPR2017-02131 and IPR2017-02132, and all three of these pending cases are addressed together in both the Federal Circuit’s Decision from which these proceedings are remanded, and in this consolidated Final Decision, because the issues presented are substantively identical. See Pfizer, 94 F.4th 1341, 1350–54. We generally cite to the record of the IPR2018-00187 proceeding, as it is representative, and will specifically note when we cite to the record in either of the IPR2017-02131 or IPR2017-02132 proceedings.” slip op. at 2
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied
“V. CONCLUSION We conclude on remand that Petitioner has shown by a preponderance of the evidence that proposed substitute claims 48 and 49 are unpatentable as obvious over the combination of GSK-711, Merck-086, and Hausdorff, in view of the knowledge of the ordinary artisan. Motion to Amend Outcome19 Claim(s) Original Claims Cancelled by Amendment Substitute Claims Proposed in the Amendment 48, 49 Substitute Claims: Motion to Amend Granted Substitute Claims: Motion to Amend Denied 48, 49” slip op. at 33
- Skill levelSkill level petitioner adoptedDecided for petitioner
“12 Petitioner states that the person of ordinary skill in the art at the time of the invention “would have had a Ph.D. or equivalent degree in chemistry, immunology, or other biological sciences or an MD and at least 2 years of experience in glycoconjugate vaccine research and development, or would objective indicia of obviousness or non-obviousness.13 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). In that regard, an obviousness analysis “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR, 550 U.S. at 418. In KSR, the Supreme Court also stated that an invention may be found obvious if trying a course of conduct would have been obvious to a person having ordinary skill: 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. Id. at 421. “KSR affirmed the logical inverse of this statement by stating that § 103 bars patentability unless ‘the improvement is more than the predictable use of prior art elements according to their established have an M.S. degree and at least 4 years of relevant experience.” Pet. 26 (citing Ex. 1005 ¶ 77). Patent Owner “does not dispute Sanofi’s proposed level of skill for the person having ordinary skill in the art.” PO Response 8. We agree with the parties regarding the level of ordinary skill in the art. In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). We also note that the applied prior art reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). 13 Neither Petitioner nor Patent Owner presents evidence on the fourth Graham factor.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“II. ANALYSIS A. Claim Interpretation As discussed in the Final Written Decision, and left undisturbed by the Federal Circuit Decision, upon review of the parties’ arguments and the evidence before us, we maintain our conclusion that the claim term “immunogenic,” as it is used in the ’559 patent and recited by proposed substitute claims 46, 48, and 49, requires that a functional antibody be elicited against each immunogen contained in the respective composition. Paper 61, 7–9. Consequently, for proposed substitute claims 48 and 49, the term “immunogenic” requires that functional antibodies be elicited against each immunogen specifically recited and required.” slip op. at 9
Patent outcomesUS 9,492,559 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,492,559 - Sanofi Pasteur Inc. / SK Chemicals Co., Ltd. et al. v. Pfizer Inc.All claims unpatentablePTAB · Jun 10, 2024 · IPR2017-02131 · APJ Jeffrey N Fredman · IPR · Remand
On remand, the Board denied the motion to amend proposed substitute claims 48 and 49, finding them obvious over GSK-711, Merck-086, and Hausdorff in view of ordinary skill.
RulingsRemand decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“II. ANALYSIS A. Claim Interpretation As discussed in the Final Written Decision, and left undisturbed by the Federal Circuit Decision, upon review of the parties’ arguments and the evidence before us, we maintain our conclusion that the claim term “immunogenic,” as it is used in the ’559 patent and recited by proposed substitute claims 46, 48, and 49, requires that a functional antibody be elicited against each immunogen contained in the respective composition. Paper 61, 7–9. Consequently, for proposed substitute claims 48 and 49, the term “immunogenic” requires that functional antibodies be elicited against each immunogen specifically recited and required.” slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“12 Petitioner states that the person of ordinary skill in the art at the time of the invention “would have had a Ph.D. or equivalent degree in chemistry, immunology, or other biological sciences or an MD and at least 2 years of experience in glycoconjugate vaccine research and development, or would objective indicia of obviousness or non-obviousness.13 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“of success in obtaining a 2-log increase, we find Table 3 of Hausdorff shows that a composition with thirteen of the fourteen serotypes that were required by proposed substitute claim 46, conjugated with CRM197, produced an immune response with more than a 2-log increase above baseline serum IgG levels in New Zealand White Rabbits after administration of the two equal doses with or without the aluminum salt adjuvant. Ex. 2027 ¶ 231, Table 3. Thus, we find there would have been a reasonable expectation of success in the inclusion of serotypes 22F, 33F, 8, 10A, 11A, 12F, and 15B in Hausdorff’s pneumococcal vaccine composition while retaining the 2-log increased immune response of the thirteen serotypes and also retaining a 2- log increase in the immune response to the added serotypes. We note that Patent Owner does not identify any particularized evidence drawn to the seven serotypes recited in the challenged claims showing any expected difference in the behavior of these serotypes from the fourteen serotypes already included in the Hausdorff composition.” slip op. at 26
Patent outcomesUS 9,492,559 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,492,559 - Sanofi Pasteur Inc. / SK Chemicals Co., Ltd. et al. v. Pfizer Inc.All claims unpatentablePTAB · Jun 10, 2024 · IPR2017-02132 · APJ Jeffrey N Fredman · IPR · Remand
On remand, the Board denied the motion to amend because proposed substitute claims 48 and 49 were obvious over GSK-711, Merck-086, and Hausdorff.
RulingsRemand decision- RemandOther
“in which it: (1) affirmed our Final Written Decisions to the extent that claims 1–45 of the ’559 patent and proposed substitute claims 46, 47, and 50–52 were found unpatentable and (2) vacated our Final Written Decisions as to proposed substitute claims 48 and 49 of the ’559 patent and remanded for further proceedings consistent with its decision. Pfizer, 94 F.4th at 1354. The Federal Circuit determined that we abused our discretion because “[i]t does not appear that the Board considered whether, once incorporated, it would have been reasonably expected that the compositions exhibit the claimed 2-log IgG increase across all serotypes5 recited in proposed claims 48 and 49.” Id. at 1353. The Federal Circuit explained that it “is hornbook law that administrative agencies must provide a ‘reasoned basis’ for their actions that is sufficient to permit meaningful judicial review.” Id. The Federal Circuit therefore remanded for the Board to address whether the record provided sufficient evidence to support an obviousness finding for the 2-log IgG increase required by proposed substitute claims 48 and 49 of the ’559 patent. Id. at 1352–53. On May 15, 2024, we conducted a conference call with the parties where the parties agreed that no further briefing or evidence was necessary to address the remand. Paper 83.” slip op. at 4
- Skill levelSkill level board ownDecided for petitioner
“12 Petitioner states that the person of ordinary skill in the art at the time of the invention “would have had a Ph.D. or equivalent degree in chemistry, immunology, or other biological sciences or an MD and at least 2 years of experience in glycoconjugate vaccine research and development, or would objective indicia of obviousness or non-obviousness.13 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“II. ANALYSIS A. Claim Interpretation As discussed in the Final Written Decision, and left undisturbed by the Federal Circuit Decision, upon review of the parties’ arguments and the evidence before us, we maintain our conclusion that the claim term “immunogenic,” as it is used in the ’559 patent and recited by proposed substitute claims 46, 48, and 49, requires that a functional antibody be elicited against each immunogen contained in the respective composition. Paper 61, 7–9. Consequently, for proposed substitute claims 48 and 49, the term “immunogenic” requires that functional antibodies be elicited against each immunogen specifically recited and required.” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“(1) Prior Art Teaches the Disputed Claim Limitation We agree with Petitioner that the asserted prior art teaches the claim limitations. We find Merck-086 teaches “a multivalent immunogenic composition having 15 distinct polysaccharide-protein conjugates. Each conjugate consists of a capsular polysaccharide prepared from a different serotype of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F or 33F) conjugated to a carrier protein, preferably CRM197.” Ex. 1008 ¶ 2; see also 02131 Ex. 1006, 1:7–11. That is, Merck-086 teaches a multivalent composition that lacks one of the capsular polysaccharides required by proposed substitute claim 48, i.e., serotype 15B, and that lacks the capsular polysaccharides of serotypes 12F, 10A, 11A, and 8 required by proposed substitute claim 49. We find GSK-711 teaches “the multivalent pneumococcal vaccine of the invention will be selected from the following serotypes 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15[B], 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F.” Ex. 1007, 7:1–3; see also 02131 Ex. 1007, 8:29–31. GSK 2008 also teaches conjugation of polysaccharides to the carrier protein CRM197. See Ex. 1007, 10:4–6; see also 02131 Ex. 1007, 10:12–15.” slip op. at 23
Patent outcomesUS 9,492,559 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,492,559
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.