- 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 - 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 - Integrated Dna Technologies, Inc. v. Tecan Genomics, Inc.No claims unpatentablePTAB · Apr 6, 2026 · IPR2025-00016 · APJ Zhenyu Yang · IPR · Final written decision
The Board found claims 1–3, 5–12, and 14–19 not shown unpatentable because Meyer did not disclose the claimed enrichment, which the obviousness grounds did not supply.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“for purposes of this Decision, we find a POSA would have had a Ph.D. in the field of chemistry, molecular biology, or biochemistry. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. Additionally, the POSA would have had knowledge of how those methods functioned. Id. at 12.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“As an initial matter, we acknowledge that the definition “to process so as to add or increase the proportion of a desirable ingredient” has two possible interpretations. In the first interpretation, “add or increase” shares the same object “the proportion of a desirable ingredient.” When the proportion of one ingredient goes higher, the proportion of at least another ingredient would necessarily go lower. Thus, the enrichment process under this interpretation results in a higher proportion of the desirable ingredient relative to other ingredients. Patent Owner adopts this interpretation. See PO Resp. 17 (“In the context of preparing a sequencing library, [Patent Owner] Tecan proposes that a nucleic acid sequence of interest is ‘enriched’ when the proportion of nucleic acid fragments containing the sequence of interest is increased relative to other nucleic acid fragments in the sample.”). According to Patent Owner, “amplifying the one or more oligonucleotide extension products . . . thereby enriching the nucleic acid sequence of interest, by generating amplified products comprising the enriched nucleic acid sequence of interest” in step (c) means “increas[ing] the proportion of the nucleic acid sequence of interest relative to the nucleic acid fragments in the solution not containing the sequence of interest by amplifying the oligonucleotide extension product and its complement.” Id. at 19–20. Under the second interpretation, the object for “add” is “a desirable ingredient,” whereas the object for “increase” is “the proportion of a desirable ingredient.” This interpretation is broader than the first one in that the result of the enrichment process not only encompasses a higher proportion of the desirable ingredient relative to other ingredients, but also more desirable ingredient in raw number.” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We agree with Dr. Sims. As explained above, the amplification step must result in at least some enrichment of the sequence of interest, even though it does not have to be the only cause. See supra Section II.C.2.b. Indeed, Petitioner acknowledges that “at least some of the enrichment must result from the recited steps.” Reply 12. Because Meyer’s enrichment for mRNA using the SMART protocol occurred before any recited steps of claim 1, we find it does not meet the claimed “enrichment” under our construction.” slip op. at 22
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“shown that Meyer discloses step (c) of claim 1, and Petitioner does not address that limitation in this ground, we find Petitioner has not met its burden to show that claims 8, 17, and 18 would have been obvious over Meyer. F. Alleged Obviousness over Meyer and Siebert Claim 2 depends from claim 1, and further recites “the nucleic acid fragment comprises genomic DNA.” Petitioner asserts that claim 2 would have been obvious over the combination of Meyer and Siebert. Pet. 62–65. Petitioner relies on Siebert for teaching the additional limitation recited in claim 2 only. Id. Because Petitioner has not shown that Meyer discloses step (c) of claim 1, and Petitioner does not rely on Siebert for teaching that limitation, we find Petitioner has not met its burden to show that claim 2 would have been obvious over the combination of Meyer and Siebert.” slip op. at 34
Patent outcomesUS 10,876,108 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,876,108 - Integrated Dna Technologies, Inc. v. Tecan Genomics, Inc.No claims unpatentablePTAB · Apr 6, 2026 · IPR2025-00015 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1–3 and 5–22 were not shown unpatentable because Meyer does not disclose the claimed enrichment, and the other grounds rely on Meyer for that limitation.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“for purposes of this Decision, we find a POSA would have had a Ph.D. in the field of chemistry, molecular biology, or biochemistry. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. Additionally, the POSA would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned. Id. at 14. After institution, Patent Owner states that, for purposes of this proceeding, it adopts the Board’s definition of a POSA. PO Resp. 18. After reviewing the record developed during trial, we see no reason to change our finding on this issue. As we stated in the DI, our “definition of a POSA is consistent with the skill level reflected in the disclosures of the ’012 patent and prior art.” DI 14.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“to “enrich” means to “increase[] relative to the rest of the fragments.” Tr. 12:25–26. The panel asked: “In the starting material, there are three components, A, B, C, that say it’s 30 percent, 50 percent and 20 percent. You do PCR and it -- they all get amplified and the end result is still 30 percent, 50 percent, and 20 percent. Anything got enriched?” Id. at 12:18–21. Petitioner responded that “petitioner’s position is that in that situation, there is no enrichment.” Id. at 12:22–23. In other words, Petitioner does not disagree with Patent Owner that mere increase in the raw number is not enrichment. See also id. at 13:7–9 (“[W]e would agree that if it is truly unbiased amplification, that does not result in an increase in the proportion, and so that does not meet the plain meaning of enrich.”). We find the record, including the testimony from all three declarants, supports Patent Owner’s argument. See Sur-reply 1–5 (citing Ex. 1125, 283:1–6, 286:22–287:14; Ex. 1126, 170:18–171:1; Ex. 2037, 150:18–22, 173:15–17; Ex. 2038 ¶ 95), 8 (citing Ex. 1125, 271:10–15; Ex. 2037, 188:22–189:1). Thus, we adopt Patent Owner’s proposal that “a nucleic acid sequence of interest is ‘enriched’ when the proportion of nucleic acid fragments containing the sequence of interest is increased relative to other nucleic acid fragments in the sample.”9 See PO Resp. 19.” slip op. at 15
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We agree with Dr. Sims. As explained above, the amplification step must result in at least some enrichment of the sequence of interest, even though it does not have to be the only cause. See supra Section II.C.2.b. Indeed, Petitioner acknowledges that “at least some of the enrichment must result from the recited steps.” Reply 12. Because Meyer’s enrichment for mRNA using the SMART protocol occurred before any recited steps of claim 1, we find it does not meet the claimed “enrichment” under our construction.” slip op. at 27
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“F. Alleged Obviousness over Meyer and Siebert Claim 2 depends from claim 1, and further recites “the nucleic acid fragment comprises genomic DNA.” Petitioner asserts that claim 2 would have been obvious over the combination of Meyer and Siebert. Pet. 69–72. Petitioner relies on Siebert for teaching the additional limitation recited in claim 2 only. Id. Because Petitioner has not shown that Meyer discloses step (d) of claim 1, and Petitioner does not rely on Siebert for teaching that limitation, we find Petitioner has not met its burden to show that claim 2 would have been obvious over the combination of Meyer and Siebert. G. Alleged Obviousness over Meyer and Kelley Claim 9 depends from claim 1, and further recites “the barcode sequence is 12 nucleotides in length.” Petitioner asserts that claim 9 would have been obvious over the combination of Meyer and Kelley. Pet. 72–74. Petitioner relies on Kelley for teaching the additional limitation recited in claim 9 only. Id. Because Petitioner has not shown that Meyer discloses step (d) of claim 1, and Petitioner does not rely on Kelley for teaching that limitation, we find Petitioner has not met its burden to show that claim 9 would have been obvious over the combination of Meyer and Kelley. H. Alleged Obviousness over Meyer, Caruccio, and Bronner Each of claims 15 and 17–19 depends from claim 1. Claim 15 further recites “the second strand of the partial duplex adaptor is ligated to a 3′ end of the nucleic acid fragment.” Claim 17 recites “[t]he method of claim 1, further comprising performing bridge amplification of the annealed strand after step e).” Claim 18 further recites “the sequencing comprises use of four labeled reversible terminators.” And claim 19 further recites “the sequencing comprises semiconductor sequencing.” Petitioner asserts that claims 15 and 17–19 would have been obvious over the combination of Meyer, Caruccio, and Bronner. Pet. 75–80. Petitioner relies on Caruccio and Bronner for teaching the additional limitation recited in claims 15 and 17–19 only. Id. Because Petitioner has not shown that Meyer discloses step (d) of claim 1, and Petitioner does not rely on Caruccio and Bronner for teaching that limitation, we find Petitioner has not met its burden to show that claims 15 and 17–19 would have been obvious over the combination of Meyer, Caruccio, and Bronner.” slip op. at 38
Patent outcomesUS 10,036,012 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,036,012 - Padagis US LLC v. Neurelis, Inc.InstitutedPTAB · Sep 16, 2025 · IPR2025-00466 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–27 because Petitioner showed a reasonable likelihood of prevailing on at least one claim, including claim 1 over Gwozdz and Meezan.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’786 patent’s challenged claims.1 We institute inter partes review on all challenged claims. SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018); 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”).” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“We find that Petitioner has made a threshold showing that the ’558 Provisional does not provide written description support for claim 1’s pharmaceutical solution consisting of each of the recited elements, including n-dodecyl beta-D-maltoside. It is true that “n-Dodecyl β-D-maltoside” can be found listed in the SIGMA Catalog. Ex. 1026, 316. But Dr. Donovan’s testimony helps put that listing in context. It is merely one among well over 100 ionic and non-ionic detergents listed in the cited six pages of the SIGMA Catalog. See 1026, 316–321; Ex. 1062 ¶ 50. When further considered in the context of paragraphs 150–152 of the ’558 Provisional, which generically suggest that “enhancer” compounds can be used in “some embodiments”—then introducing at least 15 classes of potential enhancers16 including “preferred” lysophospholipids and acyl carnitines—the listing of n-dodecyl beta-D-maltoside among at least 150 biological detergents in the SIGMA Catalog is even more remote. Moreover, although satisfaction of the written description requirement is not limited to what is exemplified in a priority application, none of the ’558 Provisional’s examples use any “enhancer,” much less any detergent, any alkyl glycoside, or n-dodecyl beta-D maltoside in particular. The 16 The ’558 Provisional suggests that whether “a given compound” will function as an “enhancer” in a formulation requires testing. Ex. 1008 ¶ 150 (indicating “an in vivo or good model test” may “determin[e] whether the uptake of the drug is enhanced to a clinically significant degree”). ethanol. See Ex. 1008 ¶¶ 172–174 (Examples 1 and 2). In short, we find no sufficient disclosure of “blaze marks” in the ’558 Provisional that point to the inventors’ possession of a pharmaceutical solution that includes n-dodecyl beta-D-maltoside as claimed. Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1326–27 (Fed. Cir. 2000) (analogizing an application’s generic disclosures to a forest of unmarked trees and explaining that, “to satisfy the written description requirement,” there must be “blaze marks directing the skilled artisan to that tree [within the forest that represents the claimed invention]” in the application).” slip op. at 28
- PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for patent owner
“and applying collateral estoppel to vacate a claim construction in an underlying IPR). In an IPR, “a party seeking to invoke collateral estoppel must show: ‘(1) the issue is identical to one decided in the first action; (2) the issue was actually litigated in the first action; (3) resolution of the issue was essential to a final judgment in the first action; and (4) [the party against whom collateral estoppel is being asserted] had a full and fair opportunity to litigate the issue in the first action.’” Google LLC v. Hammond Development Int’l, Inc., 54 F.4th 1377, 1381 (Fed. Cir. 2022) (quoting In re Freeman, 30 F.3d 1459, 1465 (Fed. Cir. 1994)) (alteration in original).14 “It is [also] well established that patent claims need not be identical for collateral estoppel to apply.” Id. at 1381. Instead, “collateral estoppel requires the issues of patentability be identical.” Id. If “the differences between the unadjudicated patent claims and adjudicated patent claims do not materially alter the question of invalidity, collateral estoppel applies.” Ohio Willow Wood Co. v. Alps South, LLC, 735 F.3d 1333, 1342–43 (Fed. Cir. 2013) (affirming application of collateral estoppel where claims adjudicated as obvious required a “polymeric” gel whereas similar, unadjudicated claims required a “block copolymer” gel). “Collateral estoppel also applies to common issues in actions involving different but related patents.” Mycogen Plant Sci., Inc. v. Monsanto Co., 252 F.3d 1306, 1310 (Fed. Cir. 2001), vacated on other grounds, 353 U.S. 1109 (2002).” slip op. at 22
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artReference not prior artMixed
“We agree that at least one portion of Gwozdz is not prior art. To establish that the cited disclosures in Gwozdz are prior art, Petitioner must show support for those disclosures in the Gwozdz Provisional. In re Riggs, 131 F.4th 1377, 1384 (Fed. Cir. 2025) (explaining that “the portion of the application relied on . . . as prior art must be supported by the provisional application”). Petitioner did not establish that Gwozdz’s disclosure of “penetration enhancers” finds support in the Gwozdz Provisional. Pet. 22. Conversely, Patent Owner shows that the phrase is absent in the Gwozdz Provisional. Prelim. Resp. 37.20 Based on this record, we determine that Gwozdz’s mention of “penetration enhancers” is not prior art to the 19 Patent Owner argues this “penetration enhancers” disclosure in Gwozdz is not prior art regardless which of the disputed priority dates (March 28, 2008, or March 27, 2009) one accords to the challenged claims. Prelim. Resp. 33. 20 We also agree that collateral estoppel does not bar Patent Owner from challenging Gwozdz’s prior-art status in this case. Patent Owner’s apparent concession that Gwozdz was prior art during the 451 IPR does not equate to the issue being actually litigated. Prelim. Resp. 34–35; Ex. 1040, 14 (“Patent Owner does not contest that Gwozdz is entitled to this filing date” of the Gwozdz Provisional). Purdue, 767 F. App’x at 922 (determining “[t]he priority date for the Joshi reference . . . cannot be determined based on collateral estoppel” where patentee could have argued, but did not in fact argue, Joshi’s prior-art status in an earlier matter).” slip op. at 35
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,793,786 - Padagis US LLC v. Neurelis, Inc.InstitutedPTAB · Sep 16, 2025 · IPR2025-00464 · APJ Annette R Reimers · IPR · Institution
The Board instituted IPR on claims 1–22, finding a reasonable likelihood that claim 1 would have been obvious over Gwozdz and Meezan.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“3. Conclusion For the reasons discussed above and based on the present record, we find that Petitioner has made an adequate threshold showing that the issues presented in this Petition are substantially the same as the issues the Board previously considered in IPR2019-00451 and that Gwozdz’s effective date is March 28, 2008. We therefore determine that Petitioner has shown that it is reasonably likely to prevail in establishing that at least claim 1 would have been obvious over Gwozdz and Meezan. IV. CONCLUSION Petitioner has shown a reasonable likelihood that it will prevail in establishing the unpatentability of at least one of the claims challenged in the Petition. We institute trial on all challenged claims under the grounds raised in the Petition. PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed.” slip op. at 21
- Skill levelSkill level petitioner adoptedDecided for petitioner
“[A POSA] would have been a pharmaceutical scientist, chemist, or biologist involved in the research and development of pharmaceutical formulations and/or delivery, and would have at least a Bachelor’s degree with at least 5 years of experience, or a Master’s, Ph.D. or Pharm.D. degree with several years of experience. In addition, a POSA would have had knowledge of benzodiazepine structure and function, and would further have knowledge and practical experience working with intranasal and transmembrane formulations, including knowledge of the physiology and anatomy of the nasal cavity, with relevant experience in developing intranasal formulations. Pet. 23; Ex. 1062 ¶ 20. Patent Owner “does not dispute” Petitioner’s POSA definition at this stage. Prelim. Resp. 16. We apply Petitioner’s proposed POSA definition for this Decision, which definition appears to be generally consistent with the cited prior art.” slip op. at 6
- PTAB / AIA Trials › §315(e) estoppelMixed
“As the Board’s decision in the 451 IPR explicitly found written description inadequate for the “alkyl glycoside” limitation in the ’558 Provisional, which is the same issue raised here for the ’546 patent, Petitioner has shown that issue was actually litigated and decided in the 451 IPR. Where the same issue is actually litigated and decided as part of a final adjudication in an earlier action, the test for invoking collateral estoppel in a later action is met. On this record and for the reasons above, we are persuaded that collateral estoppel bars Patent Owner from arguing the challenged claims are entitled to the priority date of the ’558 Provisional.” slip op. at 14
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedMixed
“We agree that at least one portion of Gwozdz is not prior art. To establish that the cited disclosures in Gwozdz are prior art, Petitioner must show support for those disclosures in the Gwozdz Provisional. In re Riggs, 131 F.4th 1377, 1384 (Fed. Cir. 2025) (explaining that “the portion of the application relied on . . . as prior art must be supported by the provisional application”). Petitioner did not establish that Gwozdz’s disclosure of “penetration enhancers” finds support in the Gwozdz Provisional. Pet. 22. Conversely, Patent Owner shows that the phrase is absent in the Gwozdz 9 Patent Owner argues that as the ’546 Patent claims priority to the ’439 Application, the “penetration enhancers” disclosure in Gwozdz is not prior art because Gwozdz and the ’439 Application were filed on the same day (March 27, 2009). Prelim. Resp. 21–22. 10 Patent Owner argues that the passage in Gwozdz concerning “penetration enhancers” is relevant solely to “a pharmaceutical composition for injection,” not for intranasal administration as required by the ’546 Patent. Prelim. Resp. 22. First, as noted above, based on the record presented, we determine that Gwozdz’s mention of “penetration enhancers” is not prior art to the challenged claims. Second, we disagree, however, that Gwozdz’s non-prior art mention of penetration enhancers is relevant solely to a pharmaceutical composition for injection as argued by Patent Owner. Gwozdz discloses that “[the] pharmaceutical compositions of the present invention” can be administered by a number of “nonlimiting” routes including intranasal administration. See Ex. 1009, 9:2–11. Provisional. Prelim. Resp. 20–21. Based on this record, we determine that Gwozdz’s mention of “penetration enhancers” is not prior art to the challenged claims. The phrase cannot, therefore, be used to establish a motivation to combine the asserted references.” slip op. at 18
§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,895,546 - Qiagen Sciences, LLC v. Tecan Genomics, Inc.Adverse judgmentPTAB · Aug 12, 2025 · IPR2025-00027 · APJ Deborah Katz · IPR · Adverse judgment
The Board granted the parties’ joint motion for adverse judgment against Patent Owner after it disclaimed the entire patent term, and terminated the instituted inter partes review.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“17.) Previously, on July 11, 2025, Patent Owner filed a disclaimer disclaiming the entire term of the ’241 patent. (See Ex. 2020.) Because there is no term left for any claim of the ’241 patent, we determine it is appropriate to terminate the inter partes review and enter judgment against Patent Owner. ORDER Accordingly, it is: ORDERED that the parties’ joint motion for adverse judgment is granted; and” slip op. at 2
NonePatents in suitUS 11,725,241 - Integrated Dna Technologies, Inc. v. Tecan Genomics, Inc.Adverse judgmentPTAB · Aug 11, 2025 · IPR2024-01502 · APJ James A Worth · IPR · Adverse judgment
The Board granted the joint motion for adverse judgment after Patent Owner disclaimed claims 1–3, 5–11, and 14–17, and terminated the inter partes review.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“Section 42.73 provides that “[a] party may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include: (2) Cancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” 37 C.F.R. § 42.73(b)(2). We agree that adverse judgment and termination are appropriate in view of the disclaimer because no challenged claim remains.” slip op. at 2
NonePatents in suitUS 9,546,399 - Encube Ethicals PTV. Ltd. v. Dermavant Sciences GmbHAdverse judgmentPTAB · Mar 7, 2025 · IPR2024-00834 · APJ Tawen Chang · IPR · Adverse judgment
The Board entered adverse judgment against Patent Owner on all challenged claims, 1–4, 6–10, 16, 18, 21, and 22, following their disclaimer.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“Terminate Proceeding and Parties’ Joint Motion for Entry of Adverse Judgment (collectively “Motion”). The parties jointly request that the Board enter adverse judgment in light of the disclaimer filed by Patent Owner disclaiming all challenged claims. Mot. 1 (citing 37 C.F.R. § 42.73(b)(2)). The Motion attaches as an exhibit a disclaimer under 37 C.F.R. § 1.321(a), filed January 28, 2025, of claims 1–4, 6–10, 16, 18, 21, and 22 of the ’088 patent, which constitute all of the claims challenged in the inter partes review. Ex. 2001; Paper 1, 3.” slip op. at 2
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Denied
“Accordingly, we grant the Parties’ Joint Motion for Entry of Adverse Judgment. This Adverse Judgment is sufficient to dispose of this proceeding and Patent Owner’s Motion to Terminate is denied as moot.1” slip op. at 3
NonePatents in suitUS 11,590,088 - Fusion Orthopedics, LLC v. Extremity Medical, LLCSome claims unpatentablePTAB · Nov 4, 2024 · IPR2023-00894 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–10 and 12–15 are unpatentable; claim 11 was not shown unpatentable. Substitute claims 16–25 and 27–30 are unpatentable over Mazur; claim 26 was not reached.
RulingsFinal written decision- BurdenMixed
“It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.’” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (quoting 35 U.S.C. § 312(a)(3)). Here, however, not until its Reply does Petitioner belatedly suggest that Ferrante’s disclosure of bone screws with self-tapping ends equally meets the limitation of claim 10 (with respect to the first member) as with claim 11 (with respect to the second member), and that both claims are obvious in light of “evidence” from Ferrante “that it was well known to equip bone screws with self-tapping ends.” Reply 26–27. We do not discern these arguments in the Petition, and consider them waived. See Netflix, Inc. v. DivX, LLC, 84 F.4th 1371,1377 (Fed. Cir. 2023) (“While the Board should not take an overly mechanistic view of a petition and decline to address an argument because the petitioner did not present it with ideal vigor and clarity, the Board should also not have to decode a petition to locate additional arguments beyond the ones clearly made.”). In sum, Petitioner’s error in failing to first address limitations of claim 10 in the Petition specific to the Cognet/Ferrante combination indicates a failure to meet the particularity requirements for what must be in the petition and cannot be left to be filled in on reply. See 35 U.S.C. § 312(a)(3); 37 C.F.R. §§ 42.22(a)(2) (requiring, among other things, “a detailed explanation of the significance of the evidence”), 42.104(b)(4)–(5) (requiring that petition “specify where each element of the claim is found in the prior art patents or printed publication relied upon” and, regarding submitted evidence, state “the relevance of the evidence to the challenge raised, including identifying specific portions of the evidence that support the challenge”). Microsoft, 2022 WL 989403, at *6. Accordingly, Petitioner has not shown persuasively that claim 11 would have been obvious in light of Cognet and Ferrante for the reasons set forth in the Petition. slip op. at 41
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We also find persuasive Mr. Dominguez’s explanation that one of ordinary skill in the art would have understood “bore” as including stepped diameter holes, sometimes described as a bore having a counterbore. See generally Ex. 1018 ¶¶ 4–29; Reply 3–10. Three of Mr. Dominguez’s illustrative examples are reproduced in the annotated figures below. The above figures show Mr. Dominguez’s annotated illustrations from the Jackson (Ex. 1019, Fig. 3), Brånemark (Ex. 1021, Fig. 4), and Ray (Ex. 1025, Fig. 1) references as discussed at paragraphs 10, 12, and 13, respectively, of Mr. Dominguez’s Second Declaration. With reference to the above figures, Mr. Dominguez testifies that “Jackson describes a bone repair set screw in which ‘[t]he bore 27 comprises a first bore section 31, a second bore section 32,’ etc. delineated by shoulders 41, 42, etc. (Ex. 1019, 5:24– 43)” (Ex. 1018 ¶ 10); “Brånemark describes an osseous implantation device having body 1ʺ with first and second holding portions 21ʺ, 31ʺ and ‘an inner through bore with a first portion 4ʺ in the first holding portion and a second portion 5ʺ in the second holding portion.’” Ex. 1021, 4:44–46” (id. ¶ 12); and Ray discloses surgical calipers including “handle 12 having ‘stepped cylindrical bore 14,’” wherein “[c]ollar 20 of a shaft inserted in the bore ‘rests against a step of the bore 14’ (2:14–15)” (id. ¶ 13). Patent Owner responds that Mr. Dominguez’s examples “that allegedly show a single bore encompassing two or more stepped-diameter holes or a counterbore . . . . are specific to these references and divorced from the disclosures of the ’166 patent.” Sur-Reply 7. Insofar as the ’166 patent makes no mention of the term “bore” outside the claims, and Mr. Dominguez’s examples are all taken from the field of orthopedic surgery, we do not find this argument persuasive. Patent Owner further appears to contend that exemplary references to a “cylindrical stepped down bore” or a “stepped cylindrical bore” are too specific to be within the scope of the term “bore.” Sur-Reply 7–8. As these terms merely describe species within a larger genus, and Patent Owner presents no cogent reason to exclude them, we do not find this argument availing. Relatedly, we are also not persuaded by Patent Owner’s argument that “the prior art treats a ‘bore’ as an element that is distinct from a ‘counterbore.’” Id. at 8. Rather, we credit Mr. Dominguez’s testimony that “[a] counterbore is not a structure unto itself, a counterbore is part of a larger structure” as exemplified by numerous examples including Laps (Ex. 1028 ¶ 33 (sensor assembly wherein “bore 16 includes a counterbore 18”)); Martinez (Ex. 1029, 3:61 (surgical cutting instrument wherein “bore 56 has a counterbore 64”)); Zang (Ex. 1030, 2:49 (bone anchor having a “bore [that] includes a counterbore”)); Ledet (Ex. 1022, 29:3–5 (vertebral fixation plate having “through holes . . . . countersunk, or counterbored to accommodate the head of a bone screw”)); Seo (Ex. 1031, 3:45 (chair leg employing “counterbored bore 23”)); and Exner (Ex. 1032, 2:16 (extrusion press including “counterbored axial bore 6”)). Ex. 1018 ¶¶ 17–23. That a reference may refer to a figure as showing “bore 103” with “counterbore 105 . . . formed on one end” does not indicate that they are distinct structures as Patent Owner contends, but merely that the focus of each term is directed to the entire bore or to a particular aspect of the bore, i.e., its counterbore. See” slip op. at 22
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner subsequently proposed an alternative definition, as a person having “[a] Bachelor’s Degree in biomedical and/or mechanical engineering or similar training and . . . at least three years of experience with implant devices used for internal fixation of bones.” POR 5 (citing Ex. 2012 ¶¶ 32–33). According to Patent Owner, “[t]his hypothetical person would be capable of performing various design tasks and would understand the basic mechanical features and operation of orthopaedic implant devices [and] have an appreciation for orthopaedic fusion techniques and the medical issues and concerns faced by a doctor/surgeon charged when performing operations to implant orthopaedic devices.” Id. Despite some differences in wording, Patent Owner asserts (and Petitioner does not contest) that any “distinction between the parties’ proposed definitions of a POSITA does not affect the arguments set forth herein.” Id. (citing Ex. 2012 ¶ 34). Consistent with this view, we find the parties’ constructions equally applicable in light of the prior art of record and the disclosure of the ’166 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). We adopt, for convenience, Petitioner’s definition, but our analysis does not change depending on which of the two articulations are applied here. H.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“one of ordinary skill in the art would understand that “bore,” as used in the context of claims 1 and 12, encompasses a multi-diameter passage, and in particular, one having stepped longitudinal cross sections such as that shown in Cognet’s Figure 1. See generally DI 11–13. For the reasons that follow, we conclude that one of ordinary skill in the art would have understood “bore” as such. Relying on the testimony of Mr. Dominguez, Petitioner initially proposed a construction of “bore” as “a usually cylindrical hole made by or as if by the turning or twisting movement of a tool.” Pet. 16 (citing Ex. 1002 ¶ 58). Petitioner’s proposal relied on Mr. Dominguez’s testimony that “[a] bore is a cylindrical hole made by the spinning rotation of a twist drill cutting tool. It is typically made by removing material from a solid or hollow object, similar to a tunnel or orifice.” Ex. 1002 ¶ 58. Pointing to its annotation of Cognet’s Figure 1, above, Patent Owner argued that that the term “bore” excludes a tunnel made by “two adjacent bores.” See Prelim. Resp. 21–25. In view of the then-available evidence, we provisionally construed “bore” as a hole or passage made by or as if by the turning or twisting movement of a tool such that its interior walls have cylindrical lateral cross-sections, and which do not exclude holes or passages having tapered or stepped longitudinal cross-sections. DI 13.” slip op. at 19
Patent outcomesUS 11,298,166 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,298,166
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.