- PTAB · Nov 19, 2025 · IPR2025-00948 · APJ Michael J Fitzpatrick · IPR · Institution
The Board instituted IPR on all claims 1–23, finding a reasonable likelihood that claim 11 would have been obvious over Herrstedt, Bös, and Herrington.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Institution of an inter partes review requires that “the information presented in the petition filed under section 311 and any response filed under section 313 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). Determining whether to institute has been delegated to the Board. See 37 C.F.R. § 42.4(a) (“The Board institutes the trial on behalf of the Director.”). Upon consideration of the Petition and the Preliminary Response, and for the reasons explained below, we determine that there is a reasonable likelihood that Petitioner would prevail with respect to at least one claim. Accordingly, we grant the Petition.” slip op. at 2
- Skill levelOther
“At this stage, we need not resolve the parties’ dispute with regard to the requisite level of skill in the art, as our analysis would be the same under either party’s definition of a POSA. We note, however, that Petitioner’s definition seems to be overly broad insofar as it would only require the POSA to be skilled in one of several broad fields, including “statistics” and “medical policy and decision making,” that do not directly relate to the claimed subject matter. At the same time, we do not agree with Patent Owner that the POSA needs specific clinical experience in the field of oncology. The claimed subject matter relates to the treatment of a side-effect associated with cancer therapy (CINV), and not the cancer itself. We also recognize that the prior art and the ’357 patent itself reflect the level of skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence of specific findings on the level of skill in the art does not give rise to reversible error where the prior art itself reflects an appropriate level and a need for testimony is not shown.”). We further find, based on the present record, that both parties’ experts are qualified to testify from the perspective of a POSA in this proceeding. See Ex. 1009 ¶¶ 1–7 (Dr. Peroutka’s qualifications); Ex. 2069 ¶¶ 8–15 (Dr. Navari’s qualifications); Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm'n, 22 F.4th 1369, 1377 (Fed. Cir. 2022) (“[T]o be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at a minimum possess ordinary skill in the art.”). Even if some specific experience with regard to the treatment” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“First, Petitioner proposes that “therapeutically effective amount” (recited in both independent claims) means: an amount sufficient to elicit the desired biological response. Pet. 9 (citing Ex. 1003, 8:13–15). The cited portion of the Specification clearly supports such a construction. Ex. 1003, 8:13–15 (“As used herein, ‘therapeutically effective amount’ refers to an amount sufficient to elicit the desired biological response.”). We adopt it. Second, Petitioner proposes that “the word if in claims 1 and 11 appears from context to mean ‘is’.” Id. (citing Ex parte Tanksley, 26 USPQ2d 1384, 1387 (BPAI 1991)). Both of the independent claims conclude with the following clause: “and said single dose of netupitant or pharmaceutically acceptable salt thereof if effective to treat said nausea and vomiting for said five consecutive days.” (Emphasis added). The word “if” cannot mean “is,” as Petitioner literally proposes. Pet. 9. However, we understand Petitioner to be arguing implicitly that (1) “if” was a typographical or other error in the independent claims and (2) “is” was intended in its place. Such is a reasonable position in the context of the challenged claims. On the instant record, with no argument to the contrary by Patent Owner, we construe claims 1 and 11 such that the word “is” was intended in lieu of the word “if” in the last clause of each claim. Cf. Canatex Completion Sols., Inc., v. Wellmatics, LLC, No. 2024-1466, 2025 WL 3153362, at *5 (Fed. Cir. Nov. 12, 2025) (“[W]e have ruled that a district court may correct obvious minor typographical and clerical errors in patents.”) (cleaned up; citations omitted)).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Third, Petitioner proposes a construction for “minimum effective dose of dexamethasone.” Pet. 10. That term appears nowhere in the challenged claims. Accordingly, we do not interpret the term.” slip op. at 11
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,943,515 - PTAB · Nov 19, 2025 · IPR2025-00945 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1–25 after finding a reasonable likelihood that claim 19 would have been obvious over MASCC and Hoffmann.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have the authority to determine whether to institute an inter partes review. 35 U.S.C. § 314; 37 C.F.R. §42.4(a). We may not institute an inter partes review “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon consideration of the Petition and the Preliminary Response, and for the reasons explained below, we determine that there is a reasonable likelihood that Petitioner would prevail with respect to at least one claim. Accordingly, we grant the Petition” slip op. at 2
- PTAB / AIA Trials › Real party in interest / privityOther
“Each party identifies itself as the sole real party in interest (RPI). Pet. 69; Paper 4, at 1. There is no dispute over RPIs in this proceeding. B. Related Matters” slip op. at 2
- Skill levelOther
“At this stage, we need not resolve the parties’ dispute with regard to the requisite level of skill in the art, as our analysis would be the same under either party’s definition of a POSA. We note, however, that Petitioner’s definition seems to be overly broad insofar as it would only require the POSA to be skilled in one of several broad fields, including “statistics” and “medical policy and decision making,” that do not directly relate to the claimed subject matter. At the same time, we do not agree with Patent Owner that the POSA needs specific clinical experience in the field of oncology. The claimed subject matter relates to the treatment of a side-effect associated with cancer therapy (CINV), and not the cancer itself. We also recognize that the prior art and the ’826 patent itself reflect the level of skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence of specific findings on the level of skill in the art does not give rise to reversible error where the prior art itself reflects an appropriate level and a need for testimony is not shown.”). We further find, based on the present record, that both parties’ experts are qualified to testify from the perspective of a POSA in this proceeding. See Ex. 1009 ¶¶ 1–7 (Dr. Peroutka’s qualifications); Ex. 2067 ¶¶ 8–15 (Dr. Navari’s qualifications); Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm'n, 22 F.4th 1369, 1377 (Fed. Cir. 2022) (“[T]o be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at a minimum possess ordinary skill in the art.”). Even if some specific experience with regard to the treatment of CINV is required, Dr. Peroutka appears to have published in that field. See, e.g., Ex. 1020 at 10, (publication 16: article on “Combination antiemetics” in Cancer Treatment Reports); id. at 11 (publication 37: article on “Neurotransmitter receptor binding studies predict antiemetic efficacy and side effects” in Cancer Treatment Reports); id. at 13 (publication 51: article on “Chemotherapeutic agents do not interact with neurotransmitter receptors” in Cancer Chemotherapy and Pharmacology). B. Claim Construction” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionNo construction neededOther
“First, Petitioner proposes that “therapeutically effective amount” (recited in both independent claims) means: an amount sufficient to elicit the desired biological response. Pet. 9 (citing Ex. 1001, 7:55–57). The cited portion of the Specification clearly supports such a construction. Ex. 1001, 7:55–57 (“As used herein, ‘therapeutically effective amount’ refers to an amount sufficient to elicit the desired biological response.”). We adopt it. Second, Petitioner proposes a construction for “minimum effective dose of dexamethasone.” Pet. 9. That term appears nowhere in the challenged claims. Accordingly, we do not interpret the term. Finally, Petitioner proposes construing the following language appearing in claim 1: “administering to said patient on day one netupitant or a pharmaceutically acceptable salt thereof, in a therapeutically effective amount which enters the systemic circulation, crosses the blood brain barrier and occupies at least 70% of neurokinin-1 (NK1) receptors in the striatum seventy-two hours after said administration.” Pet. 9–10 (emphasis added). Specifically, Petitioner proposes that the italicized language, as introduced by the word “which,” denotes inherent properties (and not further limitations) resulting from the administering of the drug in a therapeutically effective amount. Id. On the instant record, with no argument to the contrary by Patent Owner, we agree with Petitioner. However, we do not explicitly address claim 1 below. Instead, the focus of our institution analysis is independent claim 19. We do not perceive a need to construe expressly any other claim term of the ’826 patent for purposes of determining whether to institute trial. C. Summary of Asserted References” slip op. at 13
Claim construction§ 103 obviousnesscites GrahamPatents in suitUS 8,623,826 - PTAB · Nov 19, 2025 · IPR2025-00947 · APJ Christopher G Paulraj · IPR · Institution
The Board instituted review of all challenged claims and grounds, finding a reasonable likelihood that claim 1 would have been obvious over Herrstedt and Bös.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denialDenied
“II. DISCUSSION A. Discretionary Denial Patent Owner filed a request for discretionary denial of institution. Paper 8. Petitioner opposed. Paper 9. The Acting Director denied the discretionary denial request. Paper 12 (September 19, 2025). Accordingly, we proceed with our analysis of the merits of Petitioner’s patentability” slip op. at 8
- Skill levelOther
“At this stage, we need not resolve the parties’ dispute with regard to the requisite level of skill in the art, as our analysis would be the same under either party’s definition of a POSA. We note, however, that Petitioner’s definition seems to be overly broad insofar as it would only require the POSA to be skilled in one of several broad fields, including “statistics” and “medical policy and decision making,” that do not directly relate to the claimed subject matter. At the same time, we do not agree with Patent Owner that the POSA needs specific clinical experience in the field of oncology. The claimed subject matter relates to the treatment of a side-effect associated with cancer therapy (CINV), and not the cancer itself. We also recognize that the prior art and the ’357 patent itself reflect the level of skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence of specific findings on the level of skill in the art does not give rise to reversible error where the prior art itself reflects an appropriate level and a need for testimony is not shown.”).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2019). This standard requires that we construe claims “in accordance with the ordinary and customary meaning of such claim[s] as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Petitioner contends no terms need to be construed to find the claims unpatentable in view of the prior art. Pet. 9. Patent Owner also contends that no claim construction is necessary to resolve the parties’ disputes. Prelim Resp. 14. At this stage, we do not perceive a need to construe expressly any claim terms of the ’357 patent for purposes of determining whether to institute trial.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Herrstedt taught the use of aprepitant as an NK1 receptor antagonist that could be combined with dexamethasone and palonosetron to treat emesis. Nonetheless, based on Bös’s identification of netupitant (compound Ib) as a “potent and selective” NK1 antagonist with “valuable therapeutic properties,” the present record supports Petitioner’s argument that the POSA would have been motivated to replace aprepitant with netupitant in the combination therapy. Ex, 1014, 14:31–34. Bös indicates that the compounds disclosed therein have utility in the treatment of emesis, and that neutpitant in particular “is a potent antagonist of NK1 induced behaviors in Gerbil and blocks emesis in Ferrets and suncus murinus with similar potency.” Id. at 19:26–30. Bös further indicates that netupitant has a high affinity for the NK1 receptor and a prolonged half-life. Id. at 18:44–48, 19:31–38. In view of these properties, we find a POSA would have had good reason to consider netupitant as a potential replacement for aprepitant in the treatment of CINV.” slip op. at 28
Claim construction§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 9,186,357 - PTAB · Nov 19, 2025 · IPR2025-00946 · APJ Christopher G Paulraj · IPR · Institution
The Board instituted inter partes review on all challenged claims and grounds after finding a reasonable likelihood that claims 2 and 4 would have been obvious over Herrstedt and Bös.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314; 37 C.F.R. §42.4(a). We may not institute an inter partes review “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a).” slip op. at 2
- PTAB / AIA Trials › Discretionary denialNot reached
“II. DISCUSSION A. Discretionary Denial Patent Owner filed a request for discretionary denial of institution. Paper 8. Petitioner opposed. Paper 9. The Acting Director denied the discretionary denial request. Paper 12 (September 19, 2025). Accordingly, we proceed with our analysis of the merits of Petitioner’s patentability challenges and do not address the discretionary denial arguments presented by the parties.” slip op. at 8
- Skill levelOther
“At this stage, we need not resolve the parties’ dispute with regard to the requisite level of skill in the art, as our analysis would be the same under either party’s definition of a POSA. We note, however, that Petitioner’s definition seems to be overly broad insofar as it would only require the POSA to be skilled in one of several broad fields, including “statistics” and “medical policy and decision making,” that do not directly relate to the Owner that the POSA needs specific clinical experience in the field of oncology. The claimed subject matter relates to the treatment of a side-effect associated with cancer therapy (CINV), and not the cancer itself. We also recognize that the prior art and the ’357 patent itself reflect the level of skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence of specific findings on the level of skill in the art does not give rise to reversible error where the prior art itself reflects an appropriate level and a need for testimony is not shown.”). We further find, based on the present record, that both parties’ experts are qualified to testify from the perspective of a POSA in this proceeding. See Ex. 1009 ¶¶ 1–7 (Dr. Peroutka’s qualifications); Ex. 2068 ¶¶ 8–15 (Dr. Navari’s qualifications); Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm'n, 22 F.4th 1369, 1377 (Fed. Cir. 2022) (“[T]o be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at a minimum possess ordinary skill in the art.”). Even if some specific experience with regard to the treatment of CINV is required, Dr. Peroutka appears to have published in that field. See, e.g., Ex. 1020 at 10, (publication 16: article on “Combination antiemetics” in Cancer Treatment Reports); id. at 11 (publication 37: article on “Neurotransmitter receptor binding studies predict antiemetic efficacy and side effects” in Cancer Treatment Reports); id. at 13 (publication 51: article on “Chemotherapeutic agents do not interact with neurotransmitter receptors” in Cancer Chemotherapy and Pharmacology).” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“that could be combined with dexamethasone and/or palonosetron to treat emesis. Nonetheless, based on Bös’s identification of netupitant (compound Ib) as a “potent and selective” NK1 antagonist with “valuable therapeutic properties,” the present record supports Petitioner’s argument that the POSA would have been motivated to replace aprepitant with netupitant in the compounds disclosed therein have utility in the treatment of emesis, and that neutpitant in particular “is a potent antagonist of NK1 induced behaviors in Gerbil and blocks emesis in Ferrets and suncus murinus with similar potency.” Id. at 19:26–30. Bös further indicates that netupitant has a high affinity for the NK1 receptor and a prolonged half-life. Id. at 18:44–48, 19:31–38. In view of these properties, we find a POSA would have had good reason to consider netupitant as a potential replacement for aprepitant in the treatment of CINV. Bös also teaches that the daily dosage can be adjusted between 10 to 1000 mg per person, or above that upper limit when necessary, and that the effective amount can be fitted to the individual requirements in each particular case. Id. at 42:5–11. As with palonosetron, given the significant half-life of netupitant, and its administration via the circulatory system, we find that a POSA would also have been motivated to adjust the dose of netupitant to an amount that induces “blood levels” effective to treat CINV.” slip op. at 28
§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 9,186,357 - MPL Brands NV, Inc. v. Buzzballz, LLCAll claims unpatentablePTAB · Nov 17, 2025 · PGR2024-00035 · APJ Cynthia M Hardman · PGR · Final written decision
Claims 1–20 are unpatentable as obvious over the cited prior art, based on the Board’s findings across the four asserted grounds.
RulingsFinal written decision- Skill levelOther
“II. ANALYSIS A. Level of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art” slip op. at 12
- Expert testimonyPatent owner expert discountedDecided for patent owner
“person or designer of ordinary skill in the art. See Reply 7; Ex. 2001 ¶ 5. Patent Owner asserts that Mr. Kirkpatrick’s testimony is nevertheless relevant because it “informs the opinion of expert witnesses who do qualify as POSITAs” (i.e., Dr. Rojas). PO Resp. 4–5. But the level of ordinary skill in the art as defined here does not mention patents or patent drawings, and Patent Owner has not explained why or in what capacity a person of ordinary skill in the art would have consulted with a patent illustrator.15 For these reasons, we accord no weight to Mr. Kirkpatrick’s opinions on how a person of ordinary skill in the art would have viewed the figures. See” slip op. at 26
- BurdenFwd all claims unpatentableUnpatentable
“Petitioner has the burden of proving unpatentability of the challenged claims by a preponderance of the evidence. 35 U.S.C. § 326(e). Having reviewed the parties’ arguments and cited evidence, for the reasons we discuss below, we find that Petitioner has demonstrated by a preponderance of the evidence that claims 1–20 are unpatentable as obvious over the cited prior art.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“For the above reasons, and after considering Patent Owner’s” slip op. at 47
Patent outcomesUS 11,932,441 unpatentable§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,932,441 - PTAB · Nov 13, 2025 · IPR2025-00805 · APJ Eric C Jeschke · IPR · Institution
The Board instituted IPR on claims 1–24 and all asserted grounds, finding a reasonable likelihood that Petitioner would prevail on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. See 35 U.S.C. § 314; 37 C.F.R. § 42.4(a) (2024) (“The Board institutes the trial on behalf of the Director.”). Inter partes review may not be instituted “unless . . . the information presented in the petition . . . 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. Upon consideration of the evidence and arguments in the record, for the reasons below, we determine that the information presented shows a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims. We thus institute inter partes review on all challenged claims on all asserted grounds. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63, 369–70 (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
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“C. Patent Owner’s Arguments Under 35 U.S.C. § 325(d) In the Preliminary Response, Patent Owner contends that Petitioner’s unpatentability arguments presented in this proceeding were previously considered by the USPTO. See Prelim. Resp. 31–33. In her decision referring this matter to the Board, then-Acting Director Stewart rejected that argument. See Paper 20 at 2–3 (discussing why “Petitioner provides persuasive reasoning, supported by evidence, that discretionary denial under 35 U.S.C. § 325(d) is not appropriate”); see also Prelim. Resp. 31–33 (referring to and citing Patent Owner’s Discretionary Denial Brief (Paper 8)). We need not and do not address this issue further.” slip op. at 15
- Skill levelSkill level petitioner adoptedDecided for petitioner
“For purposes of this Decision, we adopt the definition of the level of ordinary skill in the art proposed by Petitioner. As to the inclusion of physics in Petitioner’s definition, Dr. Singhose (a professor of mechanical engineering) testifies as to why undergraduate mechanical engineering degree holders would have the requisite knowledge here, but does not testify that undergraduate physics degree holders would not. See Singhose Decl. ¶¶ 2, 27, 28. In addition, Patent Owner and Dr. Singhose require “a four-year degree in mechanical engineering or a closely related field,” but fail to identify what fields are “closely related.” See Prelim. Resp. 11; Singhose Decl. ¶ 27. Based on the Morse Declaration, we are persuaded at this stage that a hypothetical undergraduate physics degree holder would have adequate knowledge for one of ordinary skill in the art of the invention here. See Morse Decl. ¶ 31. As to the requisite years of experience proposed in the definitions— three for Petitioner versus “at least one” for Patent Owner—we note that Patent Owner’s definition is broader than, but includes, Petitioner’s definition. Moreover, for both the inclusion of physics and the years of experience issues, Patent Owner acknowledges that the arguments in the Preliminary Response “are not impacted based on which definition is applied.” Prelim. Resp. 12 (citing Singhose Decl. ¶¶ 30–34). Further, Patent Owner does not argue at this stage that Petitioner’s proposal for the level of ordinary skill leads to an improper understanding of how a skilled artisan would understand either the challenged patent or the prior art.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“B. Claim Construction In inter partes reviews, the Board interprets claim language using the same claim construction standard that would be used in a civil action under 35 U.S.C. § 282(b), as described in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). See 37 C.F.R. § 42.100(b). Under that standard, we generally give claim terms their ordinary and customary meaning, as would be understood by a person of ordinary skill in the art at the time of the invention, in light of the language of the claims, the specification, and the prosecution history. See Phillips, 415 F.3d at 1313–14. Although extrinsic evidence, when available, may also be useful when construing claim terms under this standard, extrinsic evidence should be considered in the context of the intrinsic evidence. See id. at 1317–19. Petitioner does not propose express constructions for any claim terms. Pet. 12. Patent Owner also does not propose any express constructions. See Prelim. Resp. 12. On the current record, we need not construe explicitly any claim terms. 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)). As discussed below, however, the parties dispute the meaning of “gaseous fuel.” We address this issue below in the analysis of the challenge to claims 1–3, 5–9, and 18 based on Nakafushi and Olmr.” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 10,393,034 - Recor Medical, Inc. / Otsuka Medical Devices Co., Ltd. v. Medtronic Ireland Manufacturing Unlimited Co.Some claims unpatentablePTAB · Nov 3, 2025 · IPR2022-00431 · APJ Eric C Jeschke · IPR · Remand
On remand, claims 1–3 and 8–12 are unpatentable over the instituted grounds; claim 4 was not shown unpatentable.
RulingsRemand decision- RemandOther
“Federal Circuit (Paper 33), which vacated the original Final Written Decision and remanded the proceeding to the Board. See ReCor Med., Inc. v. Medtronic Ir. Mfg. Unlimited Co., No. 2023-2251, 2025 WL 944511 (Fed. Cir. Mar. 27, 2025) (“the Appeal Decision” or “Appeal Dec.”); see also Paper 41 (copy of the Appeal Decision). The Federal Circuit’s mandate issued on May 5, 2025. See Paper 40. We have jurisdiction under 35 U.S.C. § 6, and we issue this Final Written Decision on Remand under 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons below, on the complete record, we conclude that Petitioner has proven, by a preponderance of the evidence, the unpatentability of claims 1–3 and 8–12 of the challenged patent, and we conclude that Petitioner has not proven, by a preponderance of the evidence, the unpatentability of claim 4.” slip op. at 2
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedNot shown unpatentable
“and Petitioner’s rebuttal evidence. Objective evidence of nonobviousness, when present, must be considered as part of an obviousness inquiry. Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012). Notwithstanding what the teachings of the prior art would have suggested to one of ordinary skill in the art, the totality of the evidence submitted, including objective evidence of nonobviousness, may lead to a conclusion that one or more of the challenged claims would not have been obvious to one of ordinary skill in the art. In re Piasecki, 745 F.2d 1468, 1471–72 (Fed. Cir. 1984).” slip op. at 50
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed
“1. Claims 1–3 and 8–11 Because the obviousness ground based on Levin and Acker is dispositive as to challenged claims 1–3 and 8–11, we need not reach this additional ground as to those claims. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 371 (2018) (holding that a petitioner “is entitled to a final written decision addressing all of the claims it has challenged”); Boston Sci. Scimed, analysis in the appeal to the Federal Circuit. See Appeal Dec. *1–*2 (summarizing grounds at issue on appeal and not discussing anticipation based on Acker). Inc. v. Cook Grp. Inc., 809 F. App’x 984, 990 (Fed. Cir. 2020) (nonprecedential) (stating that the “Board need not address issues that are not necessary to the resolution of the proceeding,” such as “alternative arguments with respect to claims [the Board] found unpatentable on other grounds”); SK Hynix Inc. v. Netlist, Inc., IPR2017-00692, Paper 25 at 40 (PTAB July 5, 2018) (determining all challenged claims to be unpatentable and not addressing additional grounds). 2. Dependent Claim 4 As to dependent claim 4, in the context of this ground, Petitioner relies on Acker as to the additional limitations in claim 4 in the same manner as relied on in the context of the ground based on Levin and Acker. See Pet. 73 (“The combination teaches this element for the same reasons described in [the obviousness ground based on Levin and Acker], claim 4, with the exception that [one of ordinary skill in the art] would have been motivated based on his or her knowledge of prior renal denervation work, as noted above.”). Thus, for the same reasons discussed above (see § II.C.3.c), we determine, based on the complete record, that Petitioner has not demonstrated by a preponderance of the evidence that claim 4 would have been obvious based on Acker and the knowledge of one of ordinary skill in the art. G. Asserted Obviousness of Claim 12 Based on Acker, the Knowledge of a Person of Ordinary Skill in the Art, and Yock Petitioner asserts that claim 12, which depends from independent claim 1, would have been obvious based on Acker, the knowledge of one of ordinary skill in the art, and Yock. Pet. 12, 75; Pet. Reply 35–36. Patent Owner provides arguments addressing this ground. PO Resp. 57–60; PO” slip op. at 75
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“1. Independent Claim 1 Petitioner contends that Acker discloses each limitation of claim 1. Pet. 61–63; Pet. Reply 35. In the “Overview of the Ground” section, Petitioner references its proposed construction of the phrase “configured to” and states that “it is proper to consider whether the prior art is ‘capable of’ performing the recited functions, as opposed to requiring that a designer of a prior art device have actually conceived of the recited functional language.” Pet. 61. Petitioner continues: “If the PTAB agrees that this is the proper approach to claim construction, then Acker also anticipates the claims challenged in this ground.” Id. For the reasons below, we determine, based on the complete record, that Petitioner has not demonstrated by a preponderance of the evidence that claim 1 is anticipated by Acker. As to element 1d, which includes the phrase “configured to,”16 Petitioner states that Acker is capable of being used to target renal neural fibers outside of the blood vessel to thermally induce modulation of target neural fibers while protecting non-target tissue in the blood vessel wall from thermal injury for the reasons discussed under claim 1, limitation [1d] and in the section entitled “Reasonable Expectation of Success”, beginning on page 37 [of the Petition]. Pet. 62–63 (citing Daft Pet. Decl. ¶ 179) (first bracketed text added by Petitioner). Patent Owner argues that, in the context of this asserted ground based” slip op. at 71
Patent outcomesUS 8,845,629 mixed§ 102 anticipation§ 103 obviousnesscites Phillips · KSRPatents in suitUS 8,845,629 - PTAB · Oct 23, 2025 · IPR2025-00989 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on all challenged claims based on the asserted grounds, finding a reasonable likelihood of success on the Schaffer-Hartley and Schaffer-Eller combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’291 patent’s challenged claims. We institute inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018); 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). Findings and conclusions at this stage are preliminary and based on the current record. Any final decision will be based on a full trial record.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“We agree with Patent Owner that Petitioner’s proposed POSA definition lacks specificity. That definition, if interpreted generically, could mean that a person may qualify as a POSA if they had, for example, a B.S. in mechanical engineering and only two years of experience designing or engineering any type of product in any field. That is too broad. We find that a POSA would have had the agreed-upon educational credentials—an undergraduate degree in mechanical engineering or a related engineering discipline. Ex. 1003 ¶ 36; Ex. 2001 ¶ 73. We find that a POSA would also have had 2–4 years of design or engineering experience related to products in the field of the invention, which involves endovascular devices and the surgical procedures that use such devices. Ex. 1001, 1:24–60 (background of the invention). Such devices include, but are not necessarily limited to, hemostasis valves and catheters for minimally-invasive vascular surgeries. Id. And, consistent with the testimony of the parties’ experts, the POSA need not have had firsthand experience designing hemostasis valves. See, e.g., Ex. 1029 (Zalesky Tr.), 72:11–73:7 (testifying direct experience “designing” hemostasis valves or aspiration catheters is not necessary, but “general experience with vascular devices and procedures” is required); Ex. 2006 (Thornton Tr.), 180:13–19. Further, as Dr. Zalesky testified, the POSA’s experience related to developing such devices “could be as simple as bench testing and looking at clinical data.” Ex. 1029, 74:5–75:1. Lastly, a POSA would have had an” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“As noted above, the challenged claims require a “filament formed in a loop around the tubular sidewall” where, when a portion of the filament is pulled away from the loop, the loop’s diameter reduces, thereby reducing the diameter of the lumen formed by the tubular sidewall to seal the valve. See supra Section II.D. Every embodiment in the ’291 patent where the filament is described as forming a “loop” in the manner claimed involves a filament that is necessarily flexible. See, e.g., Ex. 1001, 13:17–29, Figs. 6–7. The valve would not work if the looped filament were somehow inflexible— pulling an end of the filament would not change the diameter of the loop, and the valve would not seal. Ex. 2001 ¶ 65 (testifying “a loop in a rigid component would necessarily be fixed in size” and the “inherent property of flexibility is essential to the loop structure of the claims”); Ex. 1023, 16–17” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We are unpersuaded that Schaffer describes a valve with a filament as claimed. If, as construed above (supra Section III.C), the filament requires flexibility, Petitioner has not demonstrated that Schaffer describes such a feature in its valves. Instead, we agree with Patent Owner that a POSA would more likely understand Schaffer’s two U-shaped actuating members as being rigid features. Prelim. Resp. 33–36. We agree with Patent Owner that Petitioner implicitly admits that Schaffer’s actuating members are rigid leakage around tools inserted through the central lumen when in use and compared to the use of a flexible string or wire (of Hartley or Eller). Prelim. Resp. 34 (citing Pet. 51). We also find Dr. Zalesky’s interpretation of Schaffer more plausible than Mr. Thornton’s on the question of whether a POSA would have regarded Schaffer’s actuating members as being rigid structures. Ex. 2001 ¶¶ 78–85 (testifying, inter alia, that a POSA would have understood from Schaffer’s disclosure about making the actuator and actuating members from machining pre-existing amounts of metals and/or plastics, and further explaining that flexible parts would deform and be difficult to machine through conventional techniques); Ex. 1005 ¶¶ 81–82. Mr. Thornton opines that Schaffer’s disclosed manufacturing techniques for the actuator/actuating members are only examples and “a person of ordinary skill in the art could have simply purchased pre-made [flexible] flat wire or plastic tapes or ribbons.” Ex. 1003 ¶ 96. Such opinion invokes, at best, obviousness-based reasoning. This does not establish that Schaffer alone describes a filament sufficient to anticipate the claims. Furthermore, Mr. Thornton’s opinion that a POSA “would have understood that Schaffer’s U-shaped actuating members would have preferably been formed from a thin, flexible material” finds no support in Schaffer itself. Ex. 1003 ¶ 95. This opinion is also at odds with his testimony in related cases about an alleged formation of gaps with Schaffer’s actuating members, which suggested those members had a set “size” and lacked flexibility. See IPR2025-01157 (Ex. 1003 ¶ 81 (testifying a POSA “would have recognized that Hartley’s flexible string may better seal the valve than Schaffer’s metallic/plastic actuating members” because, “if a tool did not fit the size of” slip op. at 31
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,865,291 - PTAB · Oct 14, 2025 · IPR2025-00747 · APJ Richard H Marschall · IPR · Institution
The Board denied institution because Buttiker was not prior art, so Petitioner did not show a reasonable likelihood that claims 5, 6, 9, or 10 were unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“establish a reasonable likelihood of proving that any of the challenged claims would have been obvious because all of the challenges rely on Buttiker for specific limitations, and Buttiker is not prior art to the challenged claims of the ’271 patent. Accordingly, Petitioner has not shown” slip op. at 16
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner
“When claiming the benefit of priority to a provisional application, the provisional application must provide written description support for the claims in question. See 35 U.S.C. § 119(e) (referring to “an invention 10 Petitioner does not dispute Patent Owner’s arguments on this point in its Preliminary Reply. See Prelim. Reply 2–4. disclosed in the manner provided by section 112(a)”); see also New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290, 1294 (Fed. Cir. 2002) (“[T]o be afforded the priority date of the provisional application, . . . the written description of the provisional must adequately support the claims of the non-provisional application.”). Patent Owner argues that the ’688 provisional application supports claims 5, 6, 9, and 10 of the ’271 patent because they describe the method of controlling the pumps and thermal modulators to achieve selected temperatures upstream of the brewing chamber and creating a resulting solvent used to infuse a solute, creating an infused beverage. See Prelim. Sur-reply 3–4 (citing Prelim. Resp. 16–18, 35–37; Ex. 1012, 12–15). Patent Owner also refers to Figure 2 of the ’688 provisional application, which discloses the device that performs the method described in the application. See id. at 4–5. With one exception that we address immediately below, Petitioner does not contest these assertions or argue that the ’688 provisional application fails to disclose the subject matter claimed in claims 5, 6, 9, and 10 of the ’271 patent. See Pet. 18–20; Prelim. Reply 2–4. Based on our review of the record, the ’688 provisional application provides adequate written description support for the challenged claims of the ’271 patent.11 See Ex. 1012, 11–15 (describing Figure 2 of the ’688 provisional application and related methods), Fig. 2.” slip op. at 12
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference not prior artPrinted publication establishedDecided for patent owner
“only qualify as prior art under section 102(a)(1) because section 102(a)(2) does not apply to purely foreign patent publications like Buttiker. See 35 U.S.C. § 102(a)(2) (describing scope of prior art as including “a patent issued under section 151” (addressing issued U.S. patents) and “an application for patent published or deemed published under section 122(b)” (addressing published U.S. applications)); MPEP § 2152 (“The documents upon which a prior art rejection under 35 U.S.C. 102(a)(2) may be based are U.S. patent documents only.”).10 Under section 102(a)(1), Buttiker may be prior art if it “was patented [or] described in a printed publication . . . before the effective filing date of the claimed invention.” 35 U.S.C. § 102(a)(1). Buttiker published after the ’688 provisional application was filed, but before the other applications to which the ’271 patent claims priority were filed. See Ex. 1010, 1; Ex. 1001, code (60). Accordingly, whether the ’271 patent claims at issue here have adequate support in the ’688 provisional application determines whether Buttiker is prior art to those claims because Buttiker’s publication predates later applications to which the ’271 patent claims priority.” slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateDecided for patent owner
“When claiming the benefit of priority to a provisional application, the provisional application must provide written description support for the claims in question. See 35 U.S.C. § 119(e) (referring to “an invention 10 Petitioner does not dispute Patent Owner’s arguments on this point in its Preliminary Reply. See Prelim. Reply 2–4. disclosed in the manner provided by section 112(a)”); see also New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290, 1294 (Fed. Cir. 2002) (“[T]o be afforded the priority date of the provisional application, . . . the written description of the provisional must adequately support the claims of the non-provisional application.”). Patent Owner argues that the ’688 provisional application supports claims 5, 6, 9, and 10 of the ’271 patent because they describe the method of controlling the pumps and thermal modulators to achieve selected temperatures upstream of the brewing chamber and creating a resulting solvent used to infuse a solute, creating an infused beverage. See Prelim. Sur-reply 3–4 (citing Prelim. Resp. 16–18, 35–37; Ex. 1012, 12–15). Patent Owner also refers to Figure 2 of the ’688 provisional application, which discloses the device that performs the method described in the application. See id. at 4–5. With one exception that we address immediately below, Petitioner does not contest these assertions or argue that the ’688 provisional application fails to disclose the subject matter claimed in claims 5, 6, 9, and 10 of the ’271 patent. See Pet. 18–20; Prelim. Reply 2–4. Based on our review of the record, the ’688 provisional application provides adequate written description support for the challenged claims of the ’271 patent.11 See Ex. 1012, 11–15 (describing Figure 2 of the ’688 provisional application and related methods), Fig. 2.” slip op. at 12
§ 102 anticipation§ 103 obviousness§ 112 disclosurePatents in suitUS 11,957,271 - PTAB · Oct 10, 2025 · IPR2025-00728 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on all challenged claims and all five grounds, finding a reasonable likelihood of success based on at least one claim, including claim 1 over Hartley and Eller.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’921 patent’s challenged claims.1 We institute inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018); 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). Findings and conclusions at this stage are preliminary and based on the current record. Any final decision will be based on a full trial record.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“We agree with Patent Owner that Petitioner’s proposed POSA definition lacks specificity. That definition, if interpreted generically, could mean that a person may qualify as a POSA if they had, for example, a B.S. in mechanical engineering and only two years of experience designing or engineering any type of product in any field. That is too broad. We find that a POSA would have had the agreed-upon educational credentials—an undergraduate degree in mechanical engineering or a related engineering discipline. Ex. 1003 ¶ 35; Ex. 2024 ¶ 61. We find that a POSA would also have had 2–4 years of design or engineering experience related to products in the field of the invention, such devices. Ex. 1001, 1:16–54 (background of the invention). Such devices include, but are not necessarily limited to, hemostasis valves and catheters for minimally-invasive vascular surgeries. Id. And, consistent with the testimony of the parties’ experts, the POSA need not have had firsthand experience designing hemostasis valves. See, e.g., Ex. 1037 (Zalesky Tr.), 72:11–73:7 (testifying direct experience “designing” hemostasis valves or aspiration catheters is not necessary, but “general experience with vascular devices and procedures” is required); Ex. 2030 (Thornton Tr.), 180:13–19. Further, as Dr. Zalesky testified, the POSA’s experience related to developing such devices “could be as simple as bench testing and looking at clinical data.” Ex. 1037, 74:5–75:1. Lastly, a POSA would have had an understanding of such devices’ design requirements as determined by the needs of the physician, patient, and procedure, which understanding may be informed by work experience and/or study. Ex. 2030, 24:5–21.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“That does not, however, address the dispute about “flexibility.” On that issue, the argument and evidence at this stage tends to favor Patent Owner’s position that a “filament” as claimed is flexible. which include claim 1’s recitation of an “active tensioning mechanism” comprising the filament and the Specification’s description of a filament that can be both “loosened” and “tightened.” Prelim. Resp. 14–16 (citing, e.g., Ex. 1001, 9:36–37, 9:53–56 (teaching “the filament 150 is tightened” when the actuator buttons are released and “the filament 150 is loosened” when the buttons are pressed to open the valve)); see also Ex. 2025, 1288 (defining “tension” as to “tighten to a desired or appropriate degree”). These descriptions from the patent appear at this stage more consistent with the view that the filament is characteristically flexible, not rigid. So too, as we explained in related matters, the ’921 patent’s loop embodiments (where the filament forms one or more loops like depicted and described in Figures 6–7) require a flexible structure. See, e.g., Ex. 2032, 15–16 (explaining that the device would not work to constrict the tubular sidewall and lumen (analogous to the elongate member defining a lumen of the claims here) if the filament forming the loop(s) was inflexible); Ex. 1001, Figs. 6–7 (filament 150, with sub-filaments 150-A and 150-B). Although flexibility of the filament in the patent’s “bight” embodiments (e.g., as shown in Figures 8 and 9) is not manifestly clear, there is a dearth of evidence from Petitioner—either intrinsic or extrinsic to the patent— showing why a POSA would have understood the bights as embracing rigid structures. See Ex. 1001, Figs. 8–9 (similar to the loop embodiments, depicting structures 150-A and 150-B forming sub-filaments of the bight(s)). Moreover, as admitted by Petitioner’s expert, that a filament may be made from various materials described in the patent (e.g., synthetics or metals) does not, absent more information, lead to a conclusion that a filament is “rigid.” Ex. 2030, 125:2–126:4 (testifying “the relative stiffness or rigidity” slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“Based on the current record, we are unpersuaded that Schaffer describes a valve with a filament as claimed. If, as construed above (supra Section III.C), a filament requires flexibility, Petitioner has not demonstrated that Schaffer describes such a feature in its valves. Instead we agree with Patent Owner that Petitioner “implicitly admits” that Schaffer’s actuating members are rigid insofar as Petitioner argues those members would form gaps for fluid leakage around tools inserted through the central lumen when in use and compared to the use of a flexible string or wire (of Hartley or Eller). Prelim. Resp. 29 (citing Pet. 36). Moreover, we find Dr. Zalesky’s interpretation of Schaffer more plausible than Mr. Thornton’s on the question of whether a POSA would have regarded Schaffer’s actuating members as being substantially rigid structures. Ex. 2024 ¶¶ 92–100 (testifying, inter alia, that a POSA would have understood from Schaffer’s disclosure about making the actuator and actuating members from machining pre-existing amounts of metals and/or plastics, and further explaining that flexible parts would deform and be difficult to machine through conventional techniques); Ex. 1005 ¶¶ 81–82. Mr. Thornton testifies that Schaffer’s disclosed manufacturing techniques for the actuator/actuating members are only examples and “a [and flexible] flat wire or plastic tapes or ribbons.” Ex. 1003 ¶ 79. Such testimony invokes, at best, obviousness-based reasoning. This does not establish that Schaffer alone describes a filament sufficient to anticipate the claims. Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1296 (Fed. Cir. 2002) (explaining that the “test for novelty” requires “strict identity”); Jamesbury Corp. v. Litton Indus. Prods., Inc., 756 F.2d 1556, 1560 (Fed. Cir. 1985) (holding “anticipation is not shown by a prior art disclosure which is only ‘substantially the same’ as the claimed invention”), overruled on other grounds, A.C. Aukerman Co. v. R.L. Chaides Constr. Co., 960 F.2d 1020 (Fed. Cir. 1992) (en banc). Because we determine on this preliminary record that Schaffer does not describe a valve comprising a “filament” as claimed, Schaffer cannot anticipate the challenged claims.” slip op. at 26
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,844,921
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.