- Fluidmaster, Inc. v. Danco, Inc.Some claims unpatentablePTAB · Dec 15, 2025 · IPR2024-00633 · APJ Meredith C Petravick · IPR · Final written decision
Claims 1, 7–15, 19, and 20 are unpatentable over Brown and Ho; claims 2–6 and 16–18 were not shown unpatentable on the asserted grounds.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“Brown’s adapter tube 23 (i.e., the extended portion) does not extend radially from a longitudinal axis of valve assembly 13 (i.e., the toilet fill valve). Ex. 1021, Fig. 1. Mr. Jobin testifies that a POSITA would not be motivated to move adapter tube 23 from a vertical position to a radial position because “a radial extended portion is directly counter to the stated goals of Brown (e.g., reducing noise caused by turbulence), at least insofar system.” Ex. 2013 ¶ 251; see Ex. 1021, 1:9–62. Patent Owner’s argument is persuasive. Petitioner’s analysis and Dr. Cameron’s testimony is conclusory and does not sufficiently explain why a POSITA would be motivated to make the proposed modification to Brown. For example, Petitioner does not sufficiently explain how such a modification would result in a more compact toilet fill valve system that could be adapted to fit in more toilet tank designs. Further, neither Petitioner nor Dr. Cameron sufficiently address Mr. Jobin’s testimony regarding Brown’s desire for a quieter toilet. See Pet. Reply 23; Ex. 1036 ¶ 84. Petitioner fails to meet its burden to show by a preponderance of the evidence that claim 2 is unpatentable over Brown and Ho.” slip op. at 35
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner
“description is an objective inquiry into the four corners of the specification from the perspective of a POSA. Using this test, the invention must be described in a manner sufficient to demonstrate that the inventor actually invented the claimed invention. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). “One shows that one is ‘in possession’ of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Written description is a question of fact judged as of the relevant filing date. Falko–Gunter Falkner v. Inglis, 448 F.3d 1357, 1363 (Fed. Cir. 2006). An ipsis verbis disclosure, however, is not necessary to satisfy the written description requirement. Vas–Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). The disclosure need only reasonably convey to a POSA that the inventor had possession of the subject matter in question, even if every nuance of the claims is not explicitly described in the specification. Id.; see Ariad, 598 F.3d at 1351. Patent Owner argues that the ’993 patent claims were “fully supported as of the filing date of at least the ’606 Application . . . March 11, 2004” because the ’606 Application discloses regulating water flow and a POSITA would know that appropriate devices for regulating water flow includes nonadjustable waterflow restrictors. PO Resp. 68; PO Sur-reply 28–30. Patent Owner’s argument is persuasive. The ’606 Application discloses: [W]hen the toilet fill valve 100 is open and water flows from the water inlet 103 to the water outlets 106 and into a toilet tank, an amount of water is also supplied to the bowl fill valve inlet 113 that flows through the bowl fill valve 109 and out the bowl fill valve outlet 116. By virtue of the manual setting of handle 119 valve 109 is regulated. In this manner, the flow of water is regulated so that enough water flows out of the bowl fill valve 109 to fill a toilet bowl without wasting any water down a drain. Ex. 1012, 47, ¶ 8 (emphasis added); see also Ex. 1001, 2:28–39. As can be seen from the passage above, the ’606 Application discloses regulating an amount of water supplied to a toilet bowl using a valve (i.e., a water flow regulator). Ex. 2013 ¶ 288.” slip op. at 48
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable
“1. Analysis of Claims 1–18 Schuster is available as prior art if the ’993 patent is only entitled to its January 27, 2014, filing date and not entitled to claim priority to earlier filing dates of the parent applications. On its face, the ’993 patent claims priority to a number of earlier parent applications, including Application No. 12/786,904 (the ’904 Application) filed May 25, 2010, and the Application code 63. Petitioner contends that the ’993 patent is not entitled to claim priority to the filing date of the earlier parent applications, and, thus, Schuster, a parent application of the ’993 patent, is available as prior art.15 Pet. 91–92. Petitioner alleges that the earlier parent applications, specifically Application No. 12/786,904 (the ’904 Application), do not provide written description support for the ’993 patent’s claim term “water flow regulator.” According to Petitioner, “water flow regulator” encompasses both adjustable devices for restricting the flow of water (i.e., valves) and fixed devices for restricting the flow of water (i.e., restrictors). Pet. 15. Petitioner contends that the ’904 Application does not provide support for water flow restrictors and, thus, does not provide support for the broader claim term water flow regulators. Id. at 14–15, 91–92. Petitioner argues that only adjustable water flow devices (i.e., valves) are supported by the ’904 Application. Id. Petitioner, thus, asserts that earliest effective filing date of the ’993 patent’s claims is the filing date of its application, January 27, 2014. Id. at 92. To be entitled to claim the benefit of an earlier filing date under 35 U.S.C. § 120 each application in the priority chain must comply with the written description requirement of 35 U.S.C. § 112(a). See Hollmer v. 14 The parties do not dispute that the ’993 patent and the earlier parent applications, including the ’904 Application and the ’606 Application, have the same pertinent portions of their specifications. See PO Resp. 71, n.16; Ex. 1004 ¶ 324. 15 Schuster issued on January 31, 2012, from Application No. 12/786,904, filed on May 25, 2010. Ex. 1029, code (21), (22), (45). Schuster, thus, issued more than one year prior to January 27, 2014.” slip op. at 46
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentable
“2. Analysis of Claims 19 and 20 Claim 19 depends from claim 14 and additionally recites, “wherein the waterflow regulator comprises an adjustable water flow regulator that is configured to adjust the flow rate of the second portion of the water based at least in part on a setting of the adjustable water flow regulator.” Ex. 1001, 12:16–20. Claim 20 depends from claim 14 and recites the same additional limitation. Id. at 12:21–24. Claims 19 and 20, thus, require the water flow regulator to be an adjustable water flow regulator. Petitioner indicates that the earlier parent applications provide written description support for an adjustable water flow regulator. Pet. 91 (“[T]he ’904 application specification makes it clear that the adjustability of the bowl fill valve is a desirable and essential feature of the invention”); PO Surreply 28. Accordingly, Petitioner fails to meet its burden to show, by a preponderance of the evidence, that claims 19 and 20 are unpatentable over Schuster.” slip op. at 50
Patent outcomesUS 9,139,993 mixed§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 9,139,993 - PTAB · Dec 10, 2025 · PGR2025-00054 · APJ Ryan H Flax · PGR · Institution
The Board instituted PGR on claims 1–16 on all four grounds, finding at least one claim more likely than not unpatentable based on obviousness, indefiniteness, or lack of written description.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“institute trial in a post-grant review. We institute a post-grant review only if the information presented in the petition filed under 35 U.S.C. § 321, if unrebutted, shows that it is more likely than not that at least one claim challenged in the petition is unpatentable. 35 U.S.C. § 324. On the existing record, we conclude that Petitioner demonstrates it is more likely than not that Petitioner would prevail in showing that at least one challenged claim of the ’781 patent is unpatentable under a presented ground. See generally Pet. Therefore, we grant institution of post-grant review. Our reasoning is discussed below.” slip op. at 2
- PTAB / AIA Trials › Real party in interest / privityDecided for petitioner
“STANDING Petitioner states that it certifies that: (1) the ’781 patent is available for post grant review because its earliest claimed effective filing date is October 9, 2018, and the patent issued less than nine months ago, on December 3, 2024; and (2) Petitioner is not barred or estopped from requesting a post grant review on the grounds in this petition. Pet. 5. This is sufficient. See 35 U.S.C. § 100(note)(A)–(B), § 321; 37 C.F.R. § 42.204(a). Patent Owner does not contest standing. See generally Prelim. Resp. B. REAL PARTIES-IN-INTEREST Petitioner states that “[t]he real parties-in-interest are Petitioner Straumann USA, LLC and its affiliates Institut Straumann AG and JJGC Indústria e Comércio de Materiais Dentários S.A.” Pet. 3. Patent Owner raises no objection and itself identifies “Smart Denture Conversions, LLC is the real party-in-interest.” Paper 4, 2; see generally Prelim. Resp. C.” slip op. at 3
- Skill levelSkill level petitioner adoptedDecided for petitioner
“At this point, we find little meaningful difference between the two proposed definitions. In fact, neither does Patent Owner’s witness, Mr. Leinsing, who states that his “opinions would not change under either definition.” Ex. 2011 ¶ 42. And, as set forth above, Patent Owner asserts that, for the sake of its present arguments, it matters not which of the two proposed definitions we use for this proceeding. Prelim. Resp. 21. Thus, at this stage, we accept and use Petitioner’s proposed definition of the ordinarily skilled artisan, which, unlike Patent Owner’s, does not implicate reliance on the knowledge of people other than the individual ordinarily skilled artisan. Petitioner’s definition appears to comport with the level of skill in the art reflected in the prior art of record and the ’781 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he prior art itself [may] reflect[] an appropriate level” of ordinary skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). This issue may be further developed at trial by the parties, if desired. C.” slip op. at 19
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“same claim construction standard that is used to construe patent claims in a civil action in federal district court thus, by default, we give claim terms their ordinary and customary meaning, which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” 37 C.F.R. § 42.200(b); Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner indicates that None of the claim terms of claims 1–16 need to be construed to determine the patentability issues presented in this petition. The petition applies the ordinary meaning of the claim language as it would be understood by a POSA after reading the ’781 patent. Ex. 1002, ¶130. Petitioner will propose a construction if Patent Owner argues or the Board determines that one is required for any term. Pet. 31 (citing Ex. 1002). And, Patent Owner presents no express position on claim construction at this point. See generally Prelim. Resp. At this stage of the proceeding, we do not expressly construe any claim terms; however, this position is preliminary and we may change it based on the fully developed record at trial.8 D.” slip op. at 19
Claim construction§ 103 obviousness§ 112 disclosurecites GrahamPatents in suitUS 12,156,781 - Valve Corporation v. Ironburg Inventions Ltd.All claims unpatentablePTAB · Dec 2, 2025 · IPR2017-00858 · APJ Mitchell G Weatherly · IPR · Remand
On remand, the Board held claims 18, 19, 21, 26, and 29 unpatentable as obvious over Burns and LaCelle; collateral estoppel also rendered those claims unpatentable.
RulingsRemand decision- Skill levelSkill level board ownDecided for petitioner
“understanding of a person of ordinary skill in the art at the time of the invention. Graham, 383 U.S. at 17. Valve contends that the ordinarily skilled artisan would have: a bachelor’s degree in an industrial design or engineering field, and approximately two years of relevant experience, for example. Alternatively, the same or an equivalent level of skill in the art could be obtained by end users or hobbyists who have substantial experience modifying or creating customized game controllers that include features to better suit their needs, even without any college education. Pet. 10 (citing Ex. 1009 ¶ 11). Ironburg, without expressly defining the level of ordinary skill, contends that a college degree of the type identified by Valve is not required. See Supp. PO Resp. 4–6. Ironburg notes that the level of ordinary skill is “relatively low” and the technology involved “is simple and straightforward.” Id. at 4 (citing Ex. 2016 ¶ 21). Ironburg’s contentions regarding the level of ordinary skill are consistent with Valve’s position, id. at 6, which we apply in our analysis. D. Whether Claims 18, 19, 21, 26, and 29 Are “Patentably Distinct” from” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“Ex. 1001, 10:65–11:3. In IPR2016-00948, in which we addressed similar claim limitations in a related patent, U.S. Patent 8,641,525 (Ex. 1038, the “’525 patent”),12 we found that “thickness” as used in claims such as claims 18 and 19 refers to “the dimension of the elongate member perpendicular to 12 Claims 10 and 11 of the ’525 patent contain the limitations directed to the thickness of the elongate member that substantially parallel the limitations introduced in claims 18 and 19 respectively. Compare Ex. 1038, 5:13–16, with Ex. 1001, 10:65–11:3. the surface of the elongate member (i.e., also the direction of displacement when the user activates the control function).” Ex. 1058, 10–11; Ex. 1055, 13; Ex. 1056. We interpret “thickness” the same way in this proceeding.13” slip op. at 16
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“2. Whether the Combined Teachings of Burns and LaCelle Describe All Elements of Claims 18, 19, 21, 26, and 29 Valve argues that it is “undisputed that all elements of base claim 1 are taught by the combination of Burns in view of LaCelle.” Valve Remand Br. 21 (citing Pet. 33–38; Ex. 1009 ¶¶ 23–25, 27–29). Ironburg disagrees, responding that “neither Burns nor LaCelle discloses the first control with an elongate member having a second surface arranged to be non-parallel with the back, outer surface of case.” Ironburg Remand Br. 20. Ironburg’s argument appears to rest on the issue of whether LaCelle describes its underside items as a control. We have already found that LaCelle’s underside items are controls as explained above. However, even if LaCelle did not disclose that its underside items were controls, Valve relies upon Burns as describing this aspect of claim 1. Valve Supp. Reply 9–10. Either way, Valve persuades us that the Burns and LaCelle, when combined as Valve suggests, teach every element of claim 1. In Parts II.D.1–4 above, we have also analyzed the parties’ arguments and supporting evidence on the issues of whether Burns describes the limitations introduced in each of claims 18, 19, 21, 26, and 29. For the reasons expressed above, Valve persuades us that Burns and LaCelle, when combined as Valve suggests, teach every element of dependent claims 18, 19, 21, 26, and 29. We have already concluded that Valve has proven that an ordinarily skilled artisan would have been motivated to combine teachings of Burns and LaCelle to arrive at the invention of claim 1, and those motivations also suffice for dependent claims 18, 19, 21, 26, and 29, all of which introduce limitations that we find to be described by Burns. Accordingly, we find that Valve has proven by a preponderance of evidence that the combined teachings of Burns and LaCelle render claims 18, 19, 21, 26, and 29 unpatentable as obvious.” slip op. at 25
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“On the first issue, we find that LaCelle’s underside items would have been understood by an ordinarily skilled artisan as a “control.” LaCelle describes the article illustrated in all its figures as a “game controller.” Ex. 1005, code (57). Dr. Rempel testifies that even if an ordinarily skilled artisan “were not 100% certain that the identified features on the back of the . . . LaCelle . . . controller[] are functional controls, their location and appearance certainly suggests functional back controls to one of ordinary skill in the art (even if another interpretation were also possible).” Ex. 1019 ¶ 12. The Federal Circuit has instructed us that we erred by failing to consider Dr. Rempel’s testimony supporting Valve’s Supplement Reply. Valve II, at 16. Dr. Rempel’s testimony is consistent with the manner in which LaCelle graphically depicts the items on the underside of its game controller, and we credit that testimony as being persuasive. Additionally, as we explain below, we do not find that Valve must prove that LaCelle describes its underside items as a control to support its position that an ordinarily skilled artisan would have been motivated to apply the curved shape of LaCelle’s underside items to the surface of Burns’s elongate members. On the second issue, we find that LaCelle undisputedly describes its items on the underside of the controller as being curved. On the third issue, the probative value of Valve’s Supplemental Reply argument and supporting evidence, the Federal Circuit held that we ignored important testimony establishing that an ordinarily skilled artisan “‘would have combined LaCelle and Burns’ and ‘would recognize that the predictable result of the combination — a back paddle having an end that is curved like that of LaCelle — could have better coupling with the user’s finger.’” Id., at 17–18 (quoting Ex. 1019 ¶ 39 with added emphasis). The Federal Circuit also refocused our obviousness inquiry on “whether a person of ordinary skill in the art would have been motivated to combine Burns and LaCelle, not whether the combination would with absolute certainty result in the desired outcome.” Id. at 18. Dr. Rempel’s testimony cited by the Federal Circuit establishes that an ordinarily skilled artisan would have been motivated to apply the curved shape of LaCelle’s underside items to Burns’s elongate members. Our original Remand Decision failed to consider that testimony, and the Federal Circuit has identified that failure as error. Valve II, at 17. The argument proffered by Ironburg to rebut Dr. Rempel’s testimony is not supported by evidence. See Ironburg Remand Br. 23–24 (citing our Remand Decision but failing to cite evidence in support of Ironburg’s proffered argument).” slip op. at 24
Patent outcomesUS 9,289,688 unpatentableClaim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 9,289,688 - PTAB · Nov 21, 2025 · IPR2025-00956 · APJ Ryan H Flax · IPR · Institution
The Board instituted IPR on claims 1–12 under all asserted grounds, finding a reasonable likelihood that at least one claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“institute trial in an inter partes review. We institute an inter partes review only if the information presented in the petition filed under 35 U.S.C. § 311, and any preliminary response filed under § 313, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314. After reviewing the parties’ submissions in view of the existing record, we conclude that Petitioner demonstrates a reasonable likelihood it would prevail in showing that at least one challenged claim of the ’992 patent is unpatentable under the presented grounds. See Pet. Therefore, we grant institution of inter partes review. Our reasoning is discussed below. A.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“These two proposed definitions of the ordinarily skilled artisan share many consistencies, for example, the types of degrees and experience such a person would have had, but differ in the number of years of experience. Petitioner proposes the ordinarily skilled artisan would have had at least five years of experience and Patent Owner proposes at least three years (which would necessarily include five years, too). Patent Owner also proposes that the ordinarily skilled artisan would have consulted a dentist, oral surgeon, prosthodontist, or periodontist with experience in dental implants and prosthetics. At this point, we find little meaningful difference between the two proposed definitions. In fact, neither does Patent Owner’s witness, Mr. Leinsing, who states that his “opinions would not change under either definition.” Ex. 2011 ¶ 40. Thus, at this stage, we accept and use Petitioner’s proposed definition of the ordinarily skilled artisan, which, unlike Patent Owner’s, does not implicate reliance on the knowledge of people other than the individual ordinarily skilled artisan. Petitioner’s definition appears to comport with the level of skill in the art reflected in the prior art of record and the ’992 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). This parties may further developed this issue at trial, if desired. C.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The Board interprets claim terms in an inter partes review using the same claim construction standard that is used to construe patent claims in a civil action in federal district court. 37 C.F.R. § 42.100(b). In construing claims, district courts and the Board here, by default, give claim terms their ordinary and customary meaning, which is “the meaning that the term would have to 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) (en banc).” slip op. at 14
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“Here, the first claim limitation at issue is broad, i.e., different thread pattern/profile between a definite and a temporary screw, and the Specification’s and priority applications’ disclosure is narrow and specific, asymmetric buttress style threads in a temporary screw and symmetrical threads in a definite screw (are different). Any apparent predictability in or maturity of the relevant field here must be contrasted with the fact that the Specification, considering the ’992 patent itself or any of the identified priority applications, never once even discusses the (claimed) concept of specifically differing the thread style between a temporary and a definitive screw. Any differences in thread style are not called out by the disclosure, but are described and can be discerned only in relation to the respective threads’ functionality, i.e., Fig. 75’s temporary screw 190 has buttress-style threading so it can be pulled out rather than unscrewed from the abutment; Fig. 9’s definitive screw 75 has male threads that fill the female threads of the abutment 8 for a secure permanent engagement. Ex. 1001, 15:23–30, 21:25–44, 23:3–36; Ex. 1012, 97–98, Figs. 9, 75. And, although it is possible for a single disclosed species to provide written description support for a claimed genus, “a sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350; see also Synthes USA, LLC v. Spinal Kinetics, Inc., 734 F.3d 1332, 1344 (Fed. Cir. 2013). That does not appear to be the case here—the present record does not support that the described asymmetrical buttress, serrated style of different temporary screw threading (relative to that of the definitive screw and regardless of the direction of the threads for rotation) is sufficiently representative of the genus’s “different” thread patterns/profiles. See, e.g., Ex. 1006 (a buttress style thread does not function the same as a buttress reverse or 75º joint profile or rounded, or trapezoidal thread).” slip op. at 30
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · GrahamPatents in suitUS 11,937,992 - Giesecke+devrient GmbH / Giesecke+devrient Currecy Technology GmbH et al. v. Lumenco, LLCSome claims unpatentablePTAB · Nov 21, 2025 · IPR2024-00839 · APJ Meredith C Petravick · IPR · Final written decision
Claims 1, 2, 5, 6, and 12–20 are unpatentable as obvious; claims 3, 4, and 7–11 were not shown unpatentable because the asserted combinations did not establish random mirror selection.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We adopt Petitioner’s proposed definition of a POSITA because Petitioner’s definition is consistent with the types of problems encountered in the art, the prior art solutions to those problems, and the sophistication of the technology. For example, the ʼ863 patent provides, as relevant background, a discussion of anti-counterfeiting devices made up of arrays of lenses used to display unique images, placed on currency and labels for retail products. Ex. 1001, 1:31–43. The ʼ863 patent also discusses using lenses to create holograms. Id. at 2:7–20. Similarly, the prior art in this field, such as Fuhse847, relates to the use of lenses and mirrors to create hologram images for security purposes. Ex. 1022, 1–8. These descriptions demonstrate, consistent with Petitioner’s proposed definition, that a POSITA would need an educational background to understand optics, lenses, and mirrors along with professional experience with optical security features to understand the creation holograms and images using lenses and mirrors for the purpose of preventing counterfeiting of currency and other valuable products. Patent Owner’s proposed definition differs from Petitioner’s in that it includes “or a similar field” when describing the education level of a POSITA and it includes “with diffusive light” when describing the experience level of a POSITA. As to the first difference, the addition of “similar field” introduces vagueness and unnecessary uncertainty into the definition. Patent Owner does not explain what aspects of computer science would make it a field similar to the others listed, or what additional engineering coursework would suffice to make a person a POSITA. See Ex. 2001 ¶ 25. Nor does Patent Owner explain, generally, what makes a field “similar” to the ones listed or how to make that determination. As to the second difference, the addition of “with diffusive light”” slip op. at 10
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Patent Owner did not move to exclude Dr. Hesselink’s testimony. See 37 C.F.R. § 42.62; Pet. Reply 25 (arguing that Patent Owner waived its ability to challenge Dr. Hesselink’s qualification.). At the hearing, Patent Owner explained that its argument that Dr. Hesselink is not a POSITA “goes to [the] weight” of Dr. Hesselink’s testimony. Tr. 37:8. In any event, Patent Owner’s argument is based on its proposed definition of a POSITA, which we do not adopt. We, therefore, are not persuaded that Dr. Hesselink testimony should be given little or no weight.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends that “no claim terms require express construction.” Pet. 11. Patent Owner agrees “that the terms do not require construction for purposes of evaluating the Petition.” PO Resp. 13. We do not need to construe any terms explicitly to reach our decision on institution. 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)); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (approving Board decision not to construe claim language where construction is not material to the dispute).” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“teaches the preamble and all of the limitations of claim 1. Pet. 12–34. Petitioner contends that it would have been obvious to a POSITA to automate the computations for designing micro mirror arrays in Fuhse847 with Rich’s teaching of a processor running software. Id. at 14–17. Patent Owner does not specifically dispute Petitioner’s contentions regarding the preamble, limitations 1b–1e, and the motivation to combine Fuhse847 and Rich. See generally PO Resp. We have reviewed Petitioner’s contentions and supporting evidence and are persuaded that the combination of Fuhse847 and Rich teaches the preamble and undisputed limitations 1b–1e, and that one of ordinary skill in the art would have been motivated to combine Fuhse847 and Rich in the manner set forth in the Petition.” slip op. at 17
Patent outcomesUS 11,448,863 mixedClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,448,863 - 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
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.