- PTAB · Nov 19, 2025 · IPR2025-00949 · APJ Michael J Fitzpatrick · IPR · Institution
The Board instituted inter partes review of all 23 claims after finding a reasonable likelihood that Azurity would show claim 1 obvious over Herrstedt and Bös.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“legal requirement for a reasonable expectation of success. Petitioner must show that a POSA would have had a reasonable expectation of success in combining the prior art teachings in the manner claimed. See Life Techs. Inc. v. Clontech Labs. Inc., 224 F.3d 1320, 1326 (Fed. Cir. 2000) (“Reasonable expectation of success is assessed from the perspective of the person of ordinary skill in the art. That the inventors were ultimately successful is irrelevant to whether one of ordinary skill in the art, at the time the invention was made, would have reasonably expected success.”). Thus, Petitioner must show that a POSA would have had a reasonable expectation of success in modifying Herrstedt’s combination therapy for treating CINV by substituting netupitant for aprepitant and “inducing in [the patient] therapeutically effective blood levels of palonosetron and netupitant in a combination regimen with dexamethasone,” as recited in claim 1. Framed properly, the record evidence shows adequate support for a reasonable expectation of success. The POSA would need only substitute one known NK1 antagonist for another, and the record supports that she would know how to dose it. See Ex. 1014, 42:5–11 (Bös teaching a dosing range for netupitant); see also Ex. 1009 ¶¶736–737 (opining as to dosing and reasonable expectation of success). In fact, Patent Owner does not identify any obstacle a POSA might encounter in carrying out the proposed modification. Prelim. Resp. 26–28. Rather, Patent Owner disputes that a POSA would attempt to carry out the proposed modification because she would not have expected the netupitant to prevent CIN. However, as discussed above, the prior art taught treating CINV with aprepitant, a known NK1 antagonist. Netupitant was another known NK1 antagonist. The Petition demonstrates sufficiently, at least for institution purposes, both a reason to combine the prior art and a reasonable expectation of success.” slip op. at 21
- 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” slip op. at 9
- Expert testimonyPetitioner expert creditedOther
“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. 2070 ¶¶ 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), 11 (publication 37: article on “Neurotransmitter receptor binding studies predict antiemetic efficacy and side effects” in Cancer Treatment Reports), 13 (publication 51: article on “Chemotherapeutic agents do not interact with neurotransmitter receptors” in Cancer Chemotherapy and Pharmacology).” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionTerm construed board ownOther
“First, Petitioner proposes that “complete response” (recited in the preamble of independent claim 2 and the bodies of dependent claims 8 and 18) means: no emetic episodes, no rescue medication.” Pet. 10 (citing Ex. 1004, 18:9–12). The cited portion of the Specification supports such a construction. Ex. 1004, 18:9–12 (“The primary efficacy endpoint was the complete response rate (defined as no emetic episodes, no rescue medication) within 120 hours after the start of the highly emetogenic chemotherapy administration.”). On the instant record, with no argument to the contrary by Patent Owner, we adopt it. Second, Petitioner proposes that “independently effective” (recited in dependent claims 12, 18, and 23) means “protection against nausea and vomiting for five consecutive days, regardless of whether other drugs are administered.” Pet. 10 (citing Ex. 1007, 329; Ex. 1009 ¶785). Dr. Peroutka states that “that the ’297 patent specification does not define or otherwise disclose what is meant by ‘independently effective.’” Ex. 1009 ¶785. However, according to Dr. Peroutka, its meaning is evident from the prosecution history. Id. (citing Ex. 1007, 329). On the instant record, with no argument to the contrary by Patent Owner, we agree that “independently effective” means protection against something regardless of whether other drugs are administered. However, we do not agree that the protection is limited to being “against nausea and vomiting for five consecutive days.” Rather, other claim terms provide context for “independently effective.” See Ex. 1004, 22:22–25 (“12. The method of claim 1, wherein said blood levels of netupitant are independently effective to prevent acute and delayed nausea and vomiting in a subject receiving highly emetogenic cancer chemotherapy. (Emphasis added)), 23:1–3 (“23. The method of claim 3, wherein said blood levels of netupitant are independently effective to prevent nausea in a subject receiving highly emetogenic cancer chemotherapy. (Emphasis added)). Third, Petitioner proposes that “inducing in said subject therapeutically effective blood levels” (recited in all three independent claims) means “administering therapeutically-effective amounts that reach the target receptors in the central nervous system (CNS) via the circulatory system—as would be necessary for orally- or intravenously-administered drugs.” Pet. 10. As support, Petitioner relies on testimony from Dr. Peroutka, interpretation of the prosecution history, and the ’297 patent. Id. (citing Ex. 1009 ¶¶729–732; Ex. 1008, 120, 165–167; Ex. 1004, 7:54–60). The text of the ’297 patent is the best source as to the meaning of its claims. See Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (“The specification is . . . the primary basis for construing the claims.”); Metabolite Labs., Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1360 (Fed. Cir. 2004) (“In most cases, the best source for discerning the proper context of claim terms is the patent specification wherein the patent applicant describes the invention.”). And, the most relevant portion of what Petitioner cites from the ’297 patent states: “As used herein, ‘therapeutically effective amount’ refers to an amount sufficient to elicit the desired biological response.” Ex. 1004, 7:54–56.8 On the instant record, with no input from Patent Owner, we construe “inducing in said subject therapeutically effective blood levels” to mean “inducing in said subject blood levels sufficient to elicit the desired biological response.”” slip op. at 10
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,828,297 - 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 - Inari Agriculture, Inc. v. Corteva Agriscience LLCNo claims unpatentablePTAB · Nov 18, 2025 · IPR2024-01014 · APJ Zhenyu Yang · IPR · Final written decision
Petitioner did not show claims 1–8 unpatentable because they are entitled to the 2004 priority date, making Barbour unavailable as prior art.
RulingsFinal written decision- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Entitled to earlier dateDecided for patent owner
“For a claim to a biological material, the enablement requirement of § 112, first paragraph, does not require such assured access to a microorganism deposit as of the filing date; what is required is assurance of access (to the microorganism culture by the public upon issuance of a patent on the application) prior to or during the pendency of the application, so that, upon issuance of a U. S. patent on the application, the public will, in fact, receive something in return for the patent grant. Feldman, 517 F.2d at 1355. Patent Owner has persuaded us that such exception not only applies to a deposit, but also extends to a biological material known and readily available. See 52 Fed. Reg. 34080, 34081. In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art.” slip op. at 15
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner
“In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art. Because all of Petitioner’s challenges rely on Barbour (Pet. 6), all those challenges fail.” slip op. at 15
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable
“In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art. Because all of Petitioner’s challenges rely on Barbour (Pet. 6), all those challenges fail.” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“would understand that the term “‘flanked by’ permits overlap between the expression cassette and the DNA sequence it is flanked by.” Pet. 24–26. Patent Owner does not propose any claim construction. PO Resp. 6–7. On this record and for purposes of this Decision, we see no need to expressly construe any claim term.” slip op. at 9
Patent outcomesUS 8,901,378 not shown unpatentableClaim construction§ 102 anticipation§ 112 disclosurecites PhillipsPatents in suitUS 8,901,378 - 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
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.