- PTAB · Dec 4, 2025 · IPR2025-01103 · APJ Brian P Murphy · IPR · Institution
The Board instituted IPR on claims 7–12 on all grounds, finding a reasonable likelihood that Lamkin and the asserted combinations render the claims obvious.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have jurisdiction under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Under § 314, the Board may not institute review on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). If the Board institutes a review, it unpatentability asserted for each claim.” 37 C.F.R. § 42.108(a). Upon consideration of the Petition, the Preliminary Response, and the evidence of record, for the reasons set forth below, we conclude the Petition demonstrates a reasonable likelihood that Petitioner would prevail in showing the unpatentability of at least one challenged claim in the ’101 patent. Accordingly, we institute an inter partes review of claims 7–12 of the ’101 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“(“POSITA”), various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citing Custom Accessories, Inc. v. Jeffrey- not exhaustive but are merely a guide to determining the level of ordinary skill in the art.” Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). There is uncontested evidence in the record before us that reflects the knowledge and experience of a POSITA. For purposes of this Decision, we adopt the Petition’s formulation of the level of ordinary skill in the art, which is consistent with the description in the ’101 patent, the prior art of record, and the testimony of Dr. Zadok.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other
“Petitioner contends that no claim terms need construction, but also contends that “claim interpretations on which this Petition depends are incorporated in and apparent from the prior art mapping analysis below.” Pet. 5. Patent Owner contends that Petitioner’s position contradicts the position Petitioner took in related district court litigation, particularly Petitioner’s district court constructions of means-plus-function limitations” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Fiechter (Ground 1B) in the manner claimed in the ’101 patent with a reasonable expectation of success, which we find sufficient to satisfy the reasonable likelihood standard on the present record. Pet. 42–45 (citing Ex. 1003 ¶¶ 360–362, 372–382). The Petition also offers several motivations to combine Lamkin and Ito (Ground 1C) in the manner claimed in the ’101 patent with a reasonable expectation of success, which we also find sufficient on the present record. Pet. 49–52 (citing Ex. 1003 ¶¶ 383–401). The Preliminary Response does not challenge the Petition’s asserted motivations to combine Lamkin-Fiechter or Lamkin-Ito. Prelim. Resp. generally. On the present record at this stage of the proceeding, we determine the Petition sufficiently supports a motivation to combine Lamkin-Fiechter and Lamkin-Ito with a reasonable expectation of success for the reasons articulated in the Petition and Dr. Zadok’s cited declaration paragraphs.” slip op. at 21
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,230,101 - PTAB · Nov 19, 2025 · IPR2025-00915 · APJ Arthur M Peslak · IPR · Institution
The Board instituted IPR on claims 1–30 on both asserted § 103 grounds, finding a reasonable likelihood that Petitioner would prevail.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“to determine whether or not to institute an inter partes review. Paper 12, 2–3. We, thus, have authority, acting on the designation of the Director, to determine whether to institute an inter partes review under 35 U.S.C. § 314(a). See 37 C.F.R § 42.4(a) (2024) (“The Board institutes the trial on behalf of the Director.”). Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the Petition shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Considering the Petition, the Preliminary Response, and all supporting evidence, we conclude that the information presented in the Petition establishes a reasonable likelihood that Petitioner would prevail in its challenge of at least one claim of the ’621 patent as unpatentable. Pursuant to 35 U.S.C. § 314, we hereby institute an inter partes review of all challenged claims of the ’621 patent on the grounds stated in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner, supported by Dr. Bajaj’s testimony (Ex. 1003 ¶¶ 24–27) submits that a person of ordinary skill in the art “would have been someone knowledgeable of and familiar with computer cluster systems and cluster computing techniques” in June 2006. Pet. 12. According to Petitioner, a person of ordinary skill in the art would have had a bachelor’s degree in computer science, computer engineering, electrical engineering, or an equivalent training, and approximately two years of experience working in the field of cluster computing or parallel processing and would be knowledgeable regarding high-level scientific computing languages. Additional work experience can substitute for specific educational background, and vice versa. Id. (citing Ex. 1003 ¶¶ 24–27). Patent Owner does not address Petitioner’s proposed level of ordinary skill in the art. See generally Prelim. Resp. For the purposes of this Decision, we adopt Petitioner’s undisputed level of ordinary skill in the art because it appears consistent with the problems address in the ’621 patent and the cited prior art. C. Claim Construction” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner “submit[s] that no claim term requires express construction.” Pet. 12–13. Patent Owner does not address claim construction in the Preliminary Response. We determine, at this stage of the proceeding, that we need not construe any claim terms to resolve the controversy before us. 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))).” slip op. at 11
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“6. Printed Publication Status of Petitioner’s Asserted Prior Art The Federal Circuit instructs that “[t]o qualify as a printed publication, a reference ‘must have been sufficiently accessible to the public interested in the art.’” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (citing In re Cronyn, 890 F. 3d 1158, 1160 (Fed. Cir. 1989)). “A reference will be considered publicly accessible if it was ‘disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” Id. (citing Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545 F. 3d 1340, 1350 (Fed. Cir. 2008)). Further, the question of whether a document qualifies as a “printed publication” for the purposes of 35 U.S.C. § 102 “involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to a member of the public.” Medtronic, Inc. v. Barry, 891 F.3d 1368, 1380 (Fed. Cir. 2018) (citing In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004)). At this stage of the proceeding, Petitioner “must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018- 01039, Paper 29, 13 (PTAB Dec. 20, 2019) (precedential). The reasonable likelihood standard “is lower than the ‘preponderance’ standard to prevail in in a final written decision.” Id.” slip op. at 16
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,563,621 - 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 12, 2025 · IPR2025-00914 · APJ Brian P Murphy · IPR · Institution
The Board instituted IPR on claims 1–19 because the petition showed a reasonable likelihood that Menon combined with Trefethen, RS6000, and POEref rendered them obvious.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Under § 314, the Board may not institute review on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 584 U.S. 357, 371 (2018). If the Board institutes a review, it will institute “on all of the challenged claims and on all grounds of unpatentability asserted for each claim.” 37 C.F.R. § 42.108(a). Upon consideration of the Petition, the Preliminary Response, and the evidence of record, for the reasons set forth below, we conclude the Petition demonstrates a reasonable likelihood that Petitioner would prevail in showing the unpatentability of at least one challenged claim in the ’679 patent. Accordingly, we institute an inter partes review of claims 1–19 of the ’679 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citing Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986)). “These factors are not exhaustive but are merely a guide to determining the level of ordinary skill in the art.” Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). There is uncontested evidence in the record before us that reflects the knowledge and experience of a POSITA. For purposes of this Decision, we adopt the Petition’s formulation of the level of ordinary skill in the art, which is consistent with the description in the ’679 patent, the prior art of record, and the testimony of Dr. Bajaj.” slip op. at 10
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“The Petition first asserts that Menon and Trefethen are analogous prior art because they pertain to the same “field of cluster computing” as the ’679 patent and “are reasonably pertinent to the problem of the ’679 patent, namely, executing a single program on multiple nodes.” Pet. 22 (citing Ex. 1001, 1:14–15; Ex. 1003 ¶¶ 129–133; Ex. 1005, 2; Ex. 1006, Abstract). The Petition points out that Menon expressly cites and builds on the MultiMATLAB system taught by Trefethen. Id. (citing Ex. 1005, 1–2); see also Ex. 1003 ¶ 70 (“Menon builds on the teaching of Trefethen”). The Petition also contends that: Accordingly, Menon and Trefethen together represent a combination of prior art elements according to known methods (executing MATLAB code on a multiprocessor system) to yield the predictable result discussed in both papers: the MultiMATLAB system executing MATLAB in parallel to perform mathematical calculations. Pet. 23–24 (citing Ex. 1003 ¶ 134; Ex. 1005, Abstract; Ex. 1006, 2–7). The Petition further contends that a POSITA would have found it predictable to combine Trefethen with Menon with a reasonable expectation of success “because researchers had a strong desire to parallelize MATLAB.” Id. (citing Ex. 1003 ¶ 137; Ex. 1005, 2; Ex. 1006, 11–12).” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“RS6000, and POEref in the manner claimed in the ’679 patent with a reasonable expectation of success, which we find sufficient on the present record.” slip op. at 17
§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 12,021,679 - 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 10, 2025 · IPR2025-00916 · APJ Karl D Easthom · IPR · Institution
The Board instituted IPR of claims 1–20 on all petitioned grounds, finding a reasonable likelihood that Petitioner would prevail on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“determine whether to institute an inter partes review under 35 U.S.C. § 314(a). See 37 C.F.R § 42.4(a) (2024) (“The Board institutes the trial on behalf of the Director.”).1 Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the Petition shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.”” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“publication, a reference ‘must have been sufficiently accessible to the public interested in the art.” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (quoting In re Cronyn, 890 F. 3d 1158, 1160 (Fed. Cir. 1989)). “A reference will be considered publicly accessible if it was ‘disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.’” Id. (quoting Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545 F. 3d 1340, 1350 (Fed. Cir. 2008)). Further, the question of whether a document qualifies as a “printed publication” for the purposes of 35 U.S.C. § 102 “involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to a member of the” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“ordinarily skilled artisan would have been motivated to combine Menon, Trefethen, RS6000, and MPIref with a reasonable expectation of success. Id. at 23–28. Petitioner also maps the prior art to the limitations of claim 1. Id. at 27–67. Patent Owner does not address motivation to combine or the mapping. See generally Prelim. Resp.” slip op. at 26
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A person of ordinary skill in the art (“POSITA”) in June 2006 would have been someone knowledgeable of and familiar with computer cluster systems and cluster computing techniques available at the time. Such a POSITA would have a bachelor’s degree in computer science, computer engineering, electrical engineering, or an equivalent training, and approximately two years of experience working in the field of cluster computing or parallel processing and would be knowledgeable regarding high-level scientific computing languages. Additional work experience can substitute for specific educational background, and vice versa.” slip op. at 9
§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,811,582
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.