- Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentablePTAB · Sep 8, 2026 · IPR2025-00440 · APJ Tawen Chang · IPR · Final written decision
Claim 21 is unpatentable as obvious over Mizumura with either the ’498 PCT or McClymont; the Revised Contingent Motion to Amend proposing claim 22 is denied.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“overlap to a significant degree, i.e., a person with a Ph.D. in a discipline related to biological sciences and having had at least two years of work experience. However, the parties’ proposals differ slightly in the specific subjects in which a POSA would have had a doctoral degree, and whether the person’s work experience must have been directly related to horseshoe crab Factor C. As an initial matter, we find that a rigid requirement as to the subject of a POSA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 19; Ex. 1065, 99:14–100:3. with respect to the claims of the ’318 patent would have had a Ph.D. in molecular biology, biochemistry, or a related discipline, and about two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction The parties agree that “the terms in claim 21 can be afforded their plain and ordinary meaning for purposes of this proceeding” without further construction. Pet. 19–20; PO Resp. 11. Because express claim construction is not needed to resolve the issues in this case, we need not, and do not, construe expressly any claim term for purposes of this Decision. 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 14
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“Carrying Out the Invention section, that “[t]he Factor C of the present invention is a Factor C derived from a horseshoe crab,” and states later in the same section that “[e]xamples of the horseshoe crab include . . . Limulus polyphemus.” Ex. 1006, 40. However, none of the remaining portions of ’767 application cited by Patent Owner relate directly to L. polyphemus; instead, the remaining portions of ’767 application cited by Patent Owner are directed to other species, in particular the Japanese horseshoe crab T. tridentatus. Further, Patent Owner’s witness, Dr. Schaefer, conceded that the ’767 application does not contain Factor C sequence information for L. polyphemus. See, e.g., Ex. 1067, 44:25–45:23. Although “[n]o length requirement exists for a disclosure to adequately describe an invention,” Falko-Gunter, 448 F.3d at 1365–1366, we are persuaded that a POSA would not, based on the totality of the above disclosures, reasonably understand that the inventors were in possession of the claimed HEK-293 recombinant L. polyphemus Factor C protein, in view of the state of the art as of December 10, 2013. In this regard, we note that adequate written description of a biological molecule, such as a HEK293 recombinant L. polyphemus Factor C protein, requires “more than a mere statement that it is part of the invention and reference to a potential method for isolating it”; instead, what is required is “‘a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” The Regents of the” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Neither do we see Petitioner’s arguments regarding the December 10, 2013 priority date to be “mutually opposed” as Dr. Schaefer testified. Ex. 1067, 216:4– 24. Instead, we credit evidence of record, including Dr. Jain’s testimony and the February 22, 2018 Mizumura Declaration, that existence of the full sequence would permit a more complete analysis and that such an analysis would provide a POSA with a reasonable expectation that the claimed L. polyphemus recombinant protein would have a residual activity within the claimed range. See, e.g., Ex. 1029, 2–5; Ex. 1010, 48; Ex. 1065, 117:14– 130:24 (explaining that comparison of partial sequences in the Tokunaga 1991 publication showed “difference around the cleavage site” between T. tridentatus and L. polyphemus but comparison of the full sequence revealed that “the catalytic triad of histidine, serine, aspartate . . . to be more similar between Tachypleus and Limulus”). Patent Owner asserts that “Petitioner’s reliance on a statement made by Dr. Mizumura in a declaration submitted during prosecution of the ’767 Application fails to fill the gap in the analysis” regarding reasonable expectation of success, because the declaration “offers no evidence of the percentage of conserved amino acid substitutions that exist to support the conclusion that a POSA would have expected residual activity to be maintained between Tachypleus tridentatus and Limulus polyphemus” PO Resp. 47. However, as noted above, Dr. Mizumura provides an alignment of Factor C proteins from the two different species of horseshoe crab, determines that the similarity between the amino acid sequence is 99.5%, states that the amino acid residues that can undergo N-type sugar chain that L. polyphemus, like T. tridentatus, would also be less susceptible to inhibition by ions. Ex. 1029, 4–5. For the reasons discussed above, we also disagree with Patent Owner’s assertion that Petitioner’s reasonable expectation of success argument is “nothing more than conclusory assertions with no support.” PO Resp. 46. Rather, we find Petitioner has shown, by a preponderance of the evidence, that a POSA would have had reason to combine the teachings of Mizumura and the ’498 PCT, with a reasonable expectation of success in arriving at the Factor C protein recited in claim 21.” slip op. at 38
Patent outcomesUS 11,236,318 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,236,318 - Avanos Medical, Inc. v. Stratus Medical, LLCAll claims unpatentablePTAB · Mar 5, 2026 · IPR2024-01212 · APJ Arthur M Peslak · IPR · Final written decision
Claims 1–29 are unpatentable because Petitioner showed by a preponderance of the evidence that the asserted prior-art combinations rendered them obvious under §103.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” KSR, 550 U.S. at 417. In this case, we must determine whether one of ordinary skill in the art would recognize that applying the teachings of Fitz and Lee of deploying multiple filaments to increase and control the ablation volume to Racz’s distal tip would improve Racz’s device in the same way. For us to resolve this question in Petitioner’s favor, Petitioner must provide “some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” Id. at 418 (citing In re Kahn, 441 F.3d at 988). However, bodily incorporation, i.e., “an actual physical substitution of” Lee’s filaments into Racz is not required. See In re Mouttet, 686 F.3d 1322, 1332 (Fed. Cir. 2012) (“It is well-established that a determination of obviousness based on teachings from multiple references does not require an actual, physical substitution of elements.”); In re Nievelt, 482 F.2d 965, 968 (CCPA 1973) (“Combining the teachings of references does not involve an ability to combine their specific structures.”).” slip op. at 30
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“11. Balancing the Graham Factors After weighing all the evidence submitted by the parties in light of the Graham factors, we determine Petitioner has demonstrated by a preponderance of the evidence that the claims 1, 3–10, 18–26, 28, and 29 would have been obvious over Racz, Fitz, and Lee. As discussed above, Petitioner’s evidence establishes that the combination of Racz, Fitz, and Lee teaches every limitation of claims 1, 3–10, 18–26, 28, and 29 and that an ordinarily skilled artisan would have been motivated to combine Racz, Fitz, and Lee with a reasonable expectation of success. Further, as discussed above, Patent Owner’s evidence of secondary considerations is entitled to little, if any, weight because Patent Owner fails to establish nexus. Consequently, after considering all the evidence in the record both for and against patentability, we determine that Petitioner has shown by a preponderance of the evidence that claims 1, 3–10, 18–26, 28, and 29 would have been obvious over Racz, Fitz, and Lee. E. Ground B: Obviousness in view of Racz, Fitz, Lee and Young ’965 Petitioner contends that claims 1–10, 18–26, and 28–29 are also obvious over Racz, Fitz, Lee, and Young ’965. Pet. 62–67. Patent Owner argues that Young ’965 does not cure the alleged deficiencies in Ground 1, is directed to tumor ablation not neurotomy, would require a substantial redesign of Racz’s modified device, and there is no motivation to combine. PO Resp. 59–60. We start with a brief overview of Young ’965 and address the parties’” slip op. at 78
- ExcludeMotion to exclude, deniedDenied
“Accordingly, both Motions are dismissed as moot.” slip op. at 94
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A. Level of Ordinary Skill in the Art In determining the level of skill in the art, we consider the type of” slip op. at 12
Patent outcomesUS 10,925,664 unpatentable§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,925,664 - 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 - The Boeing Company v. The Regents Of The University Of CaliforniaNo claims unpatentablePTAB · Oct 2, 2025 · IPR2024-00761 · APJ Alyssa A Finamore · IPR · Final written decision
The Board held claims 1–24 not unpatentable because the asserted references did not show the glass element propagating a modified stress wave to generate tensile stress at the interface.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Petitioner asserts that a person of ordinary skill in the art (“POSITA”) at the time of the invention of the ’684 patent “would have had an M.S. in Mechanical Engineering or a related field, and at least five years of experience using laser systems to characterize and test mechanical behavior in materials” and that “[m]ore education may supplement practical experience or vice versa.” Pet. 5 (citing Ex. 1003 ¶ 38). Patent Owner” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Decided for patent owner
“Both parties maintain that no claim term needs to be construed. Pet. 4 (citing Ex. 1003 ¶ 40); PO Resp. 20. Patent Owner, however, provides an express construction for limitation [1.d] of independent claim 1 and the similar limitation of independent claim 13, namely limitation [13.c]. PO Resp. 20 (citing Ex. 2011 ¶ 25). To resolve the controversy before us, we determine that these limitations require express construction. 1. “the glass element is configured to propagate and modify a stress wave to the coating/substrate interface to generate a tensile stress between the substrate and the coating” (limitation [1.d]) and “propagating and modifying a stress wave through the glass element to the coating/substrate interface to generate a tensile force between the substrate and the coating” (limitation [13.c]) Patent Owner argues these limitations mean “changing the profile of the laser generated compressive wave and propagating the wave profile as modified to the free surface of the coating, which upon reflection from the free surface as a tension wave generates a tensile stress at the coating/substrate interface.” PO Resp. 20 (citing Ex. 2011 ¶ 25). Petitioner does not refute this proposed construction and, during the oral argument, Petitioner confirmed it agrees with the proposed construction. Tr. 8:16–9:12. We so no reason to depart from the parties agreed-upon construction of limitations [1.d] and [13.c]. Accordingly, for purposes of this Final Written Decision, we adopt the parties’ construction of limitations [1.d] and [13.c].” slip op. at 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“a shock in the compression wave in the fused silica substrate. Even if we were to agree with Petitioner that Wang-Dissertation’s fused silica substrate modifies the compression waveform, we would not be persuaded that the fused silica substrate propagates the modified wave to the free surface of the coating, which upon reflection from the free surface as a tension wave generates a tensile stress at the coating/substrate interface, as limitation [1.d] requires. In view of the presence of tension-wave-1 in Wang-Dissertation’s experiments, we find Petitioner has not demonstrated persuasively that the fused silica substrate propagates a modified stress wave to the free surface of the coating to generate a tensile stress at the coating/substrate interface. Also, we find credible Dr. Gupta’s unrebutted testimony that any modified compression wave would attenuate in the substrate and not propagate to the free surface coating or generate a tensile stress at the coating/substrate interface. Ex. 2011 ¶¶ 93–98. Petitioner does not dispute that the experiments in Wang-Dissertation include tension-wave-1. See Ex. 1005, 65 (“The experimental picture is complicated somewhat by the presence of a tensile wave, reflected from the back of the confining layer.”). Nor does Petitioner dispute that Wang-Dissertation discloses that the tension-wave-1 propagates faster than the compression-wave-1 and eventually overtakes compression-wave-1. See id. at 65–66 (“Being tensile, it propagates faster that the peak compressive stress, and faster than the low stress tail of the main pulse. It eventually overtakes the compressive pulse and linear dissipative mechanisms govern the final thickness of the shock.”). Rather, Petitioner relies on Dr. Wang’s testimony regarding the timing of the waves through the sample and argues that tension-wave-1 does not overtake compression-wave-1 in the fused silica substrate. Pet. Reply 17 (citing Ex. 1038 ¶ 5). Dr. Wang testifies that the peak stress from tension-wave-1 is about 2 ns behind the peak of compression-wave-1 and will not reach the interface before the reflected tensile peak of compression-wave-1 reaches the interface in 0.3 ns. Ex. 1038 ¶ 5. However, as Dr. Gupta persuasively explains, the delay between tension-wave-1 and compression-wave-1 depends on the properties of the confining layer, and Wang-Dissertation acknowledges that these properties are not well controlled. Ex. 2011 ¶ 54; see also Ex. 1005, 65 (“The surface properties of that confining layer are not well controlled.”).” slip op. at 19
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“claimed subject matter. Pet. 35–38; Pet. Reply 23–24. In doing so, Petitioner continues to rely on Wang-Dissertation to disclose limitation [1.d] of independent claim 1 and limitation [13.c] of independent claim 13. Pet. 35–38; Pet. Reply 23–24. Petitioner does not put forth any further obviousness rationale in this ground based on Wang-Dissertation for teaching these limitations. For the same reasons discussed in sections II.C.2–3, Petitioner has not persuaded us that Wang-Dissertation teaches or suggests limitations [1.d] and [13.c]. Thus, Petitioner has not shown, by a preponderance of the evidence, that Wang-Dissertation renders obvious the subject matter set forth in claims 4, 6, 9, 15, 17, 20, 23, and 24, which depend from independent claims 1 and 13.” slip op. at 24
Patent outcomesUS 7,487,684 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 7,487,684 - Nintendo Co., Ltd. / Nintendo Of America Inc. v. American GNC CorporationAll claims unpatentablePTAB · Aug 20, 2025 · IPR2024-00668 · APJ Lisa L Tsang · IPR · Final written decision
Claims 1 and 4 are unpatentable as obvious over Smith, Chan, and Bernstein (claim 1), Smith, Chan, Bernstein, Irwin, and Merhav (claim 4), and Tingleff, Chan, and Bernstein (claims 1 and 4).
RulingsFinal written decision- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“partes review may not be instituted if the petition requesting the proceeding is filed more than 1 year after the date on which the petitioner, real party in interest, or privy of the petitioner is served with a complaint alleging infringement of the patent.” 35 U.S.C. § 315(b) (emphasis added). Accordingly, a petition for inter partes review may be considered only if, among other things, it “identifies all real parties in interest,” and no real party in interest was served with a complaint alleging infringement of the challenged patent more than one year before the petition was filed. 35 U.S.C. § 312(a)(2). “[T]he IPR petitioner bears the burden of persuasion to demonstrate that its petitions are not time-barred under § 315(b) based on a complaint served on a real party in interest more than a year earlier.” Worlds Inc. v. Bungie, Inc., 903 F.3d 1237, 1242 (Fed. Cir. 2018). However, “an IPR petitioner’s initial identification of the real parties in interest should be accepted unless and until disputed by a patent owner,” who, in turn, “must produce some evidence that tends to show that a particular third party should be named a real party in interest.” Id. at 1242, 1244 (footnote omitted).” slip op. at 8
- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner
“Based on the arguments and evidence of record, we determine that Patent Owner has not produced sufficient evidence to support a finding that STMicro should be named a real party in interest to this proceeding. At best, Patent Owner’s evidence and arguments establish only that Patent Owner previously filed a complaint against STMicro, asserting that STMicro infringed patents related to the ’648 patent (see generally Ex. 2012); and that Patent Owner served a subpoena to compel STMicro to testify and produce documents in Patent Owner’s infringement suit against Petitioner (see generally Ex. 2014). The record before us does not demonstrate a relationship between Petitioner and STMicro sufficient to show that STMicro is a real party in interest. See Worlds, 903 F.3d at 1242, 1244 (“[A]n IPR petitioner’s initial identification of the real parties in interest should be accepted unless and until disputed by a patent owner,” who, in turn, “must produce some evidence that tends to show that a particular third party should be named a real party in interest.” (footnote omitted)).” slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 5 (citing Ex. 1002 ¶¶ 12–14). Patent Owner counters that the skilled artisan would have had “at least a ‘Master’s Degree in Electrical or Electronics Engineering, and approximately five years of relevant experience in the development of control systems for inertial navigation, MEMS semiconductor processing, and analog circuit design.’” PO Resp. 18 (citing Ex. 2019 ¶ 57). We adopt Petitioner’s articulation of the level of ordinary skill in the art, which is consistent with our review and understanding of the technology and descriptions in the ’648 patent and prior art of record, and we apply it in our obviousness evaluations below. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). We note, however, that we would reach the same conclusions applying either Petitioner’s or Patent Owner’s definition of the level of skill in the art.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“We find unavailing Petitioner’s reliance on Catalina to support its claim construction position. See Reply 2. In particular, although Petitioner contends the body of the claims “define[s] a structurally complete invention,” Petitioner does not explain how the claims additionally “use[] the preamble only to state a purpose or intended use for the invention,” as Catalina further requires. See Catalina, 289 F.3d at 808 (“a preamble is not limiting ‘where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention” (emphasis added)). In this regard, we discern no reason to interpret “[a] micro inertial measurement unit” as reciting only a purpose or intended use because the term, on its face, uses “micro inertial measurement” as an adjective that conveys further structural details of the unit. Accordingly, on the complete record, and for the reasons set forth in our Institution Decision, we maintain our construction that “[a] micro inertial measurement unit” recited in the preamble is limiting and requires a micro-sized inertial measurement unit, and that the structures recited in the limitations of the claims are limited to structures implemented as MEMS devices. Dec. 21–24.” slip op. at 14
Patent outcomesUS 6,671,648 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 6,671,648 - Nintendo Co., Ltd. / Nintendo Of America Inc. v. American GNC CorporationAll claims unpatentablePTAB · Aug 20, 2025 · IPR2024-00667 · APJ Jennifer S Bisk · IPR · Final written decision
Claims 1 and 3 are unpatentable under § 103 over Fujiyoshi, Kumar, Cox, and Townsend, and independently over Mitamura and Townsend.
RulingsFinal written decision- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerNot time barredDecided for petitioner
“other things, it “identifies all real parties in interest.” 35 U.S.C. § 312(a)(2). “[T]he IPR petitioner bears the burden of persuasion to demonstrate that its petitions are not time-barred under § 315(b) based on a complaint served on a real party in interest more than a year earlier.” Worlds Inc. v. Bungie, Inc., 903 F.3d 1237, 1242 (Fed. Cir. 2018). However, “an IPR petitioner’s initial identification of the real parties in interest should be accepted unless and until disputed by a patent owner,” who, in turn, “must produce some evidence that tends to show that a particular third party should be named a real party in interest.” Id. at 1242, 1244 (footnote omitted). Whether a non-party is a real party in interest is a “highly fact-” slip op. at 11
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have possessed a bachelor’s degree in electrical engineering or similar degree, with two to three years of practical experience designing and/or implementing systems that include sensors for measuring movement, such as acceleration and rotational position. . . . A skilled artisan could also have had more formal education and less practical experience, or vice versa. Pet. 5 (citing Ex. 1002 ¶¶ 12–14). Patent Owner states that “[a] person of ordinary skill in the art with respect to the ’122 Patent would have at least a five years of relevant experience in the development of control systems for inertial navigation, MEMS semiconductor processing, and analog circuit design.” PO Resp. 18 (citing Ex. 2019 ¶ 57). We adopt Petitioner’s articulation of the level of ordinary skill in the art, which is consistent with our review and understanding of the technology and descriptions in the ’122 patent and prior art of record, and we apply it in our obviousness evaluations below. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). We note, however, that we would reach the same conclusions applying either Petitioner’s or Patent Owner’s definition of the level of skill in the art.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“that 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). In this context, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art in question at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (citations omitted) (en banc). “The Board is required to construe ‘only those terms ... that are in controversy, and only to the extent necessary to resolve the controversy.’” Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng'g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Neither party argues that any claim term requires construction. Pet. 6; PO Resp. 18. Accordingly, we do not explicitly construe any term.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“Record evidence supports Petitioner’s contentions that a skilled artisan would have had reason to look to Kumar for further implementation details of a circuit that performs functions like those performed by Fujiyoshi. See Pet 24–26. For example, Dr. Young testifies that a person of ordinary skill in the art would have recognized that Kumar discloses the details, at a granular level, of Fujiyoshi’s capacitive sensing systems and would have looked to Kumar for understanding of how to implement Fujiyoshi’s system. Ex. 1002 ¶ 145. Patent Owner does not point to persuasive evidence to rebut this opinion. Moreover, Petitioner cites to Kumar, not only for an explicit disclosure of capacitive pickoff signals, but also for its disclosure of both DC bias and AC carrier signals and recognizing the applicability of an AC carrier pickoffs that operates without DC bias. Pet. 24–26 (citing Ex. 1005 3:65–4:2, 6:29–36). We credit Dr. Young’s testimony on this issue and agree with Petitioner that a person of ordinary skill in the art, looking at Fujiyoshi’s description of capacitive sensing systems, would be motivated to look to Kumar for its more detailed teachings of the implementation details of such systems and would combine these details to arrive at limitation 1(a). We determine that Petitioner has shown, by a preponderance of the evidence, that one of ordinary skill in the art would have been motivated to combine Fujiyoshi and Kumar in the manner argued by Petitioner.” slip op. at 37
Patent outcomesUS 6,508,122 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 6,508,122 - Lululemon USA Inc. v. Nike, Inc.All claims unpatentablePTAB · Aug 6, 2025 · IPR2024-00460 · APJ Ken B Barrett · IPR · Final written decision
Claims 1–21 are unpatentable: claims 1–21 under Nishida grounds and claims 11 and 21 also over Nishida with Zuckerman; Zuckerman-only grounds fail for lack of a surrounding structure.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that: A hypothetical person of ordinary skill in the art (“POSA”) would have had at least a bachelor’s degree in textile engineering, mechanical engineering, or similar technical degree and at least 3 years of experience working with knitted textiles for use in fabric-based articles, including apparel such as footwear. Ex.1003, ¶¶34-37. For individuals with different educational backgrounds, a person could still be of ordinary skill in the art provided that person’s additional experience compensates for any differences in that person’s education as stated above. Id., ¶37. Pet. 14–15. Patent Owner states that, “[f]or purposes of this proceeding, Nike applies lululemon’s proposed level of skill in the art.” PO Resp. 13. Petitioner’s definition is consistent with the level of ordinary skill reflected in the prior art references of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (recognizing that the prior art itself may reflect an appropriate level of skill in the art). For purposes of this decision, we apply Petitioner’s definition of the person of ordinary skill in the art.” slip op. at 9
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Id. at 99:12–25. Dr. Brookstein stated during his deposition that he has “49 years of experience of teaching textile engineering.” Id. at 97:6–8. We credit Dr. Brookstein’s testimony over that of Dr. Pastore’s because it is consistent with the reference and based on decades of experience in the textile field. Nishida’s claim 1 states that, “during the production of the material web (1), [shoe patterns] . . . are produced by . . . a textile production method within the material web.” Ex. 1005, 9. We find that Nishida’s claim language discloses the recited, “simultaneously knitting a textile element with a surrounding textile structure.”” slip op. at 22
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“We find the District Court’s reasoning persuasive, and we, like the District Court, decline to adopt Petitioner’s overly broad proposed construction. However, for purposes of deciding the dispositive fact issue before us, we need not determine the precise boundaries of “surrounding textile structure,” for example whether it completely or mostly encircles the textile element, and if “mostly,” what percentage of encircling is required. See Pet. Reply 2 (Petitioner characterizing Patent Owner’s position as “mostly” means over 50%); id. at 4 (Petitioner impliedly arguing that the “surrounding” need not be complete, i.e., 100%); PO Sur-reply 3–4 (Patent Owner arguing that “Zuckerman’s textile structures . . . each abut only about 25% of the periphery of Zuckerman’s blank.”). We find that a person of ordinary skill in the art would not understand the portion of Zuckerman’s strip 13 in purple to surround the green blank 11 (textile element) under any reasonable construction of “surrounding textile structure.” Dr. Pastore testifies that “Zuckerman discloses two separate textile structures adjacent the blank—one on each side . . . they abut only two sides of Zuckerman’s blank, with each structure abutting only about a quarter of the blank’s periphery,” and opines that “a POSITA would not have understood these two separate structures, designated by purple in the figure above, to be a textile structure ‘surrounding’ the blank [shown in green].” Ex. 2003 ¶ 54. We find Dr. Pastore’s tesimony credible as it is consistent with Zuckerman’s Figure and with the plain and ordinary meaning of “surrounding” and with the Specification of the ’749 patent (particularly Figure 9). Dr. Brookstein’s testimony, on the other hand, is based on Petitioner’s overly broad proposed construction—that any part of a textile area that is not a textile element is “surrounding textile structure”—” slip op. at 44
Patent outcomesUS 8,266,749 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,266,749
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.