- 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 - PTAB · Nov 10, 2025 · IPR2025-00878 · APJ Carl M Defranco · IPR · Institution
The Board instituted review of claims 1–3 and 11 after finding a reasonable likelihood that claim 1 is anticipated by Cleveland or obvious over Nakagawa.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“contentions, the cited portions of Cleveland, and the testimony of Clearwater’s expert), we find, preliminarily, that Cleveland discloses each claim element in the manner recited by claim 1. Thus, on the current record, Clearwater demonstrates a reasonable likelihood that challenged claim 1 is unpatentable as anticipated by Cleveland.” slip op. at 6
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner
“5 Clearwater argues that Cleveland qualifies as prior art under 35 U.S.C. § 102(e)(1) “based on both its provisional and non-provisional filing dates.” Pet. 17. In support, Clearwater asserts that Cleveland’s provisional (Ex. 1006) is “virtually identical” to Cleveland itself (id. at 18) and submits claim charts to demonstrate that the Cleveland provisional provides written support for: (1) at least claim 1 of Cleveland (id. at 18–21); and (2) the subject matter relied upon in Cleveland (id. at 21–40 (citing Ex. 1006 throughout)). Based on our review of the Cleveland provisional, as well as Clearwater’s claim charts, we are persuaded that the current record demonstrates that Cleveland is prior art to the challenged patent. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1381 (Fed. Cir. 2015).” slip op. at 4
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“satisfies each claim element as identified above in Section I.D, i.e., elements [1.pre]–[1.6]. See id. at 22–40. Clearwater also submits annotated Figure 3 of Cleveland, reproduced below, to further illustrate the specific laminate structure of Cleveland’s coffee cup. See id. at 39.” slip op. at 5
- Obviousness (§103) › Motivation to combine / reasonable expectation of successInstituted
“protective layers have “a coat weight of from 5 to 30 lbs/3000 ft2,” Clearwater submits the declaration of its expert, who explains that, because Nakagawa identifies the specific polymers and the thickness of the coat used for the plastic layers and one skilled in the art “would recognize that the disclosed polymers have a given density,” then “[w]ith these known parameters, the coat weight is easily calculated to be 23.04 lbs./ 3000 ft2 — falling squarely within the claimed range.” Pet. 53–54 (citing Ex. 1003 ¶¶ 132–133; Ex. 1008 ¶ 24; Ex. 1024, at 4). At this stage, we find that testimony credible and supported by the evidence presently of record. After reviewing the preliminary record (including Clearwater’s contentions, the cited portions of Nakagawa, and the testimony of Clearwater’s expert), we find, preliminarily, that Nakagawa discloses or otherwise suggests each claim element in the manner recited by claim 1. Thus, on the current record, Clearwater demonstrates a reasonable likelihood that challenged claim 1 is unpatentable as obvious over Nakagawa. We need not decide Clearwater’s challenge of the dependent claims based on Nakagawa alone nor its challenge of claims 1–3 based on Nakagawa and Tanner. Our analysis of these challenges, in our view, is best left for trial after full development of the record.” slip op. at 8
Claim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 8,637,126 - PTAB · Nov 3, 2025 · IPR2025-00827 · APJ Barry L Grossman · IPR · Institution
The Board instituted IPR on claims 1–5, 7–14, 16–19, 22–26, and 28–32, finding a reasonable likelihood that Renisch anticipates at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have considered Patent Owner’s arguments, but, on this record, are not persuaded. We recognize that Dr. Sonka provides a different opinion than Petitioner and Dr. Rosen. Dr. Sonka testifies that in his opinion “the distinctions between Renisch and claim 1 go beyond terminology.” Ex. 2014 ¶ 79. At this stage, in the absence of a full record, we need not record, it appears that Renisch discloses the elements of limitation [1(c)] at paragraphs 26–31, where it discloses obtaining a scanned 3D image of a fuller anatomy, i.e., a segmentation map, and then using a segmentation unit (76) to define the boundaries of anatomical structures of interest within that fuller anatomy, i.e., creating a plurality of segmentation masks, using a library, models, clustering, edge detection, region growing, neural networks, and/or an atlas of normal anatomical structures, and then identifying hot spots of interest within those anatomical structures of interest, and identifying organs with lesions and those without. Ex. 1005 ¶¶ 26–31. Based on the record before us and the specific disclosures in Renisch, as discussed in this Decision, we determine that Petitioner has met the “reasonable likelihood” standard necessary to institute an inter partes review proceeding. Although we address only Ground A and claims 1 and 10 herein for the purposes of institution, as noted above, we will address all asserted grounds and challenged claims in any final decision.” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We do not perceive a need to construe any claim limitation at this time. This, however, does not preclude the parties from arguing proposed constructions of the claims during trial. Indeed, the parties are hereby given notice that any disputed claim construction, in general, should be addressed at trial and, if so, should be addressed clearly in a designated section of briefing rather than relegated to arguments on the merits of patentability. Claim construction, if necessary, will be determined at the close of the evidentiary record and after any hearing. slip op. at 15
- BurdenDecided for petitioner
“Compliance with the Particularity Requirements of 35 U.S.C. § 312(a)(3) Patent Owner asserts that the Petition fails to meet the particularity requirements of 35 U.S.C. § 312(a)(3). Prelim. Resp. 18–26. According to Patent Owner, “Petitioner’s excessive internal cross-referencing impermissibly forces the Board and Patent Owner to piece together scattered portions of the Petition (and exhibits).” Id. at 26. Patent Owner concludes that “the Petition fails to adequately map the references to the claim elements with particularity.” Id. We disagree. Using claims 1 and 10 as an example, Petitioner asserts: Claim 10 recites a “system for automatically processing 3D images” that is substantively identical to the “method for automatically processing 3D images” recited in claim 1, addressed above. Whereas claim 1 (the method claim) recites a series of steps, each performed “by a processor,” claim 10 (the system claim) recites a “processor” with stored instructions that perform the same steps recited in claim 1. Similarly, dependent claims 11–14, 16, and 26 are substantively identical to dependent claims 2–5, 7, and 19. Pet. 41–42. Claims 1 and 10 contain similar elements and limitations. Petitioner’s reference, for example, in the Petition’s analysis of claim 10, back to the analysis of claim 1 concerning nearly identical elements and limitations (id. at 42) is a matter of efficiency and is sufficiently clear for us to determine the basis for Petitioner’s challenges. We determine that the Petition does not violate the statutory requirement for particularity.” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“We have considered Patent Owner’s arguments, but, on this record, are not persuaded. We recognize that Dr. Sonka provides a different opinion than Petitioner and Dr. Rosen. Dr. Sonka testifies that in his opinion “the distinctions between Renisch and claim 1 go beyond terminology.” Ex. 2014 ¶ 79. At this stage, in the absence of a full record, we need not record, it appears that Renisch discloses the elements of limitation [1(c)] at paragraphs 26–31, where it discloses obtaining a scanned 3D image of a fuller anatomy, i.e., a segmentation map, and then using a segmentation unit (76) to define the boundaries of anatomical structures of interest within that fuller anatomy, i.e., creating a plurality of segmentation masks, using a library, models, clustering, edge detection, region growing, neural networks, and/or an atlas of normal anatomical structures, and then identifying hot spots of interest within those anatomical structures of interest, and identifying organs with lesions and those without. Ex. 1005 ¶¶ 26–31. Based on the record before us and the specific disclosures in Renisch, as discussed in this Decision, we determine that Petitioner has met the “reasonable likelihood” standard necessary to institute an inter partes review proceeding. Although we address only Ground A and claims 1 and 10 herein for the purposes of institution, as noted above, we will address all asserted grounds and challenged claims in any final decision.” slip op. at 20
Claim construction§ 102 anticipationDiscretionary denialcites PhillipsPatents in suitUS 11,941,817 - PTAB · Oct 24, 2025 · IPR2025-00524 · APJ John G New · IPR · Institution
The Board instituted inter partes review of claims 1–20 on all grounds in the Petition.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314, the Board “may not authorize an inter partes review to be instituted unless … the information presented in the petition … and any response … shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons we explain below, we institute inter partes review of claims 1–20 of the ’118 patent.” slip op. at 2
Nonecites Phillips · KSRPatents in suitUS 12,015,118 - PTAB · Oct 16, 2025 · IPR2025-00776 · APJ John G New · IPR · Institution
Instituted review of claims 9, 11, 32–58, 60–62, and 64–67 on all remaining petition grounds, after finding a reasonable likelihood that claim 9 is unpatentable over Thomas and Faucette.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“For the reasons set forth below, we determine that Petitioner has demonstrated that there is a reasonable likelihood that at least one of claims 9, 11, 32–58, 60–62, and 64–67 of the ’802 patent is unpatentable, and we on the Grounds set forth in the Petition.” slip op. at 2
- Settled expectationsOther
“Patent Owner also filed a Request with the Acting Director of the USPTO seeking discretionary denial of institution of inter partes review (Paper 6, the “Request”). Petitioner subsequently filed a brief opposing Patent Owner’s Request (Paper 8). On September 3, 2025, the Acting Director denied Patent Owner’s Request for discretionary denial of institution of inter partes review and referred the case to the panel for an institution decision on the merits (Paper 11).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill would have an M.D. or a Ph.D. degree in virology, immunology, and vaccinology, and at least 3 years of experience in one or more of the research, design, development, and testing of antiviral vaccines. Pet. 17. Petitioner asserts that a person of ordinary skill may be part of a multidisciplinary team having such experience. Id. (citing Ex. 1002 ¶ 81). Patent Owner does not dispute the level of skill asserted by Petitioner.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party requests construction of any claim terms. Petitioner asserts that all claim terms should be given their ordinary and customary meaning, and Patent Owner does not disagree. See Pet. 17. Accordingly, we find, for the purposes of this Decision, that no terms of the challenged claims requires construction beyond the ordinary and customary meaning of the terms, as understood by a person of ordinary skill in the art at the time of the invention. Phillips, 415 F.3d at 1312–13; see also Vivid Techs., Inc. v. construes claims only to the extent necessary to resolve a dispute).” slip op. at 10
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 11,730,802 - PTAB · Oct 14, 2025 · IPR2025-00685 · APJ John G New · IPR · Institution
The Board instituted IPR on claims 1–23 and all petitioned grounds, finding a reasonable likelihood that the claims are obvious over Wei and Liu.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Summary Based upon the record as presently developed, we conclude that Petitioner has met its burden of showing a reasonable likelihood of showing at trial that at least claim 1 of the ’370 patent is obvious over the cited prior art. Because we determine that Petitioner has demonstrated a reasonable likelihood of success at trial in showing that at least one claim is unpatentable on at least one of the stated Grounds, we institute inter partes review of all challenged claims of the ’370 patent, based on all of the remaining grounds identified in the Petition. See 37 C.F.R. § 42.208(a); SAS Inst., Inc. v. Iancu, 584 U.S. 357, 371 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”).” slip op. at 44
- Skill levelSkill level board ownOther
“appears to be generally consistent with the level of skill presented in the cited prior art. See generally, e.g., Exs. 1005–1008; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself may reflect an appropriate level of skill in the art). However, at this point we reject the portion of Petitioner’s proposed definition that includes having “access to other individuals with that knowledge and experience,” as not reflecting the individual level of skill of a given skilled artisan. See, e.g., Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986) (holding that “[t]he person of ordinary skill is a hypothetical person who is presumed to be aware of all the pertinent prior art. The actual inventor’s skill is not determinative”) (emphasis added, footnotes omitted). Consequently, and for the purposes of this Decision, we adopt Petitioner’s proposed definition as defining a person of ordinary skill in the art as a person who would have had “a Ph.D. in immunology, molecular biology, cellular biology, or a similar field, or an M.D. with similar experience, and would further have had at least five years of experience with antibodies and antibody engineering.”” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningOther
“Petitioner states that no term of the challenged claims requires construction to resolve the challenges in this Petition. Pet. 32. Patent Owner does not contest Petitioner’s assertion. See generally Prelim. Resp. We find, for the purposes of this Decision, that no terms of the challenged claims require construction beyond the ordinary and customary meaning of the terms, as understood by a person of ordinary skill in the art at the time of the invention. Phillips, 415 F.3d at 1312–13.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“We find, based upon the present record and for the purposes of this Decision, that Petitioner has sufficiently established that a person of ordinary skill in the art would have been motivated to combine the teachings of Wei and Liu to determine the activity and suitability of Liu’s humanized anti- EGFR antibodies in an ADC. We acknowledge that Liu is silent regarding the pH selectivity or tissue preference of its binding affinity, but Patent Owner points to no prior art reference that would have informed a skilled artisan upon this point or that would have discouraged a person of ordinary skill in the art from combining the references. See fn.7, supra. And, even if a skilled artisan might have recognized that Liu’s humanized cetuximab might have been potentially problematic if it failed to show pH-selective activity like Wei’s Y104D, the mere fact that some disadvantage may come with an advantage when combining prior art does not foreclose their combination under § 103. Medichem, S.A. v. Rolabo S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). In the instance of Liu’s humanized anti-EGFR antibody, a person of ordinary skill in the art would have recognized that its advantages (enhanced activity against tumor cells compared to chimeric cetuximab, thus requiring smaller dosages) could balance or outweigh its possible disadvantages (e.g., possible activity against non-tumor cells). Furthermore, it is in the nature of scientific research to continue to try new substitutions in drug therapy, even if a promising candidate has been discovered. As the Supreme Court stated in KSR: When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. 550 U.S. at 421.” slip op. at 39
Claim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,792,370
Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.