• Shenzhen Root Technology Co., Ltd. v. Willow Blossom Holdco LimitedAll claims unpatentable
  PTAB · Feb 18, 2026 · IPR2024-01296 · APJ Barry L Grossman · IPR · Final written decision

  Claims 1–46 are unpatentable as obvious under § 103 over the asserted combinations of Chang, Fang, Yuen, Khalil, Park, and Chen.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that before the effective filing date of the claimed invention a person of ordinary skill in the art (“POSITA”) “would have had at least a bachelor’s degree in mechanical engineering or a similar field and at least two years of experience designing human breast pump equipment” and that “[m]ore education could substitute for experience and vice versa.” Pet. 2 (citing Ex. 1003 ¶¶ 15–18). Mr. Bauer’s cited testimony supports Petitioner’s assertion.” slip op. at 16

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached

    “[parent application to the application that matured into the ’380 patent], the Examiner construed the term ‘self-contained, in-bra wearable device’ to mean ‘complete, or having all that is needed, in itself’ and is capable of being worn in a bra.” Pet. 3 (citing Ex. 1005, 2290) (emphasis omitted). According to Petitioner, “PO did not dispute this construction, and Petitioner applies it herein.” Id. Petitioner also states that “[o]ther terms of the Challenged Claims should receive their plain and ordinary meaning, and no formal claim constructions are necessary in this proceeding because ‘claim terms need only be construed to the extent necessary to resolve the controversy.’” Id. (citing Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011); Ex. 1003 ¶¶ 69–70). Again, because Patent Owner did not file a Response, we exercise our discretion and look to Patent Owner’s Preliminary Response. We note that in the Preliminary Response Patent Owner states that “[f]or purposes of this Preliminary Response, no claim terms require construction to resolve the prior art grounds raised in the Petition.” Prelim. Resp. 19. According to specific construction, any such terms should be accorded their plain and ordinary meaning in light of the specification.” Id. Construction is needed only for those terms “that are in controversy, and only to the extent necessary to resolve the controversy.” See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). There are no claim terms in controversy. Accordingly, we need not construe any terms for our analysis.” slip op. at 17

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable

    “Petitioner contends (Pet. 17) that a person of ordinary skill in the art “would have been motivated to implement Chang’s breast pump device as suggested by Fang” to achieve four benefits: (1) “to facilitate convenient cleaning and maintenance” (Pet. 19 (citing Ex, 1003 ¶ 102)); (2) “to facilitate more rapid assembly and disassembly (e.g., during use)” (id. at 20–21 (citing Ex. 1003 ¶ 105)); (3) “as a particularly effective and suitable option to generate negative” slip op. at 34

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

    “a breast pump device having “a diaphragm pump that generates negative air pressure.” Pet. 33; see also id. at 38. Petitioner explains Chang’s pump “generates suction by cyclical compression and decompression of a conduit or flex-tube, and expressly notes that other configurations were known and suitable.” Id. at 17 (citing Ex. 1007 ¶¶ 22, 25, 28, 68, 79, 84–86). Chang, however, does not mention, specifically, that Chang’s pump is a “diaphragm” pump. We note, however, that this claim clause does not state or require any specific type of pump. It merely requires a “pump.” Clause 1[e]/29[e], discussed below, however, does require a “diaphragm” pump. Petitioner here merely lays the foundation for this later clause by asserting that “Fang provides a straightforward suggestion of a diaphragm pump including a diaphragm housing component formed in a wall of the pump housing.” Id. at 18 (citing Ex. 1009 ¶¶ 24–25, Fig. 7; Ex. 1003 ¶ 97). Thus, Petitioner asserts, Fang teaches “an ‘air pump’ in pneumatic connection with the diaphragm that serves to generate negative air pressure,” and Chang teaches “the location of pump components (e.g., ‘motor’ [46]).” Pet. 33 (citing Ex. 1007 ¶¶ 72, 80, Fig, 6A; Ex. 1009 ¶¶ 19, 24). Petitioner then asserts that “the ‘air pump’ components of the combined device are positioned within the pump housing,” and the air pump is powered by Chang’s rechargeable battery. Id. (citing Ex. 1007 ¶¶ 72, 80).” slip op. at 34

  Patent outcomesUS 11,413,380 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,413,380
• GE Healthcare Ltd. v. The Johns Hopkins UniversityInstituted
  PTAB · Jan 14, 2026 · PGR2025-00059 · APJ Devon Zastrow Newman · PGR · Institution

  The Board instituted post-grant review of claims 1–4 on all four asserted grounds, finding a sufficient preliminary showing of obviousness and lack of enablement.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “V. CONCLUSION Petitioner has, at this stage, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1–4 of the ’233 patent is hereby instituted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 40

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not proffer a description of a POSA. See generally, Prelim. Resp. For the purposes of this decision, on the record at this time, we find that Petitioner’s definition appears consistent with the level of skill shown in the prior art references of record, and apply it herein. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). We invite the parties to further address the definition of a POSA during trial should they find it necessary.” slip op. at 7

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “In addition, the opinion stated in the Pomper Declaration that “the term of ‘low molecular weight’ is well accepted in the chemical arts” and the declarant “recognize[s] that low molecular weight compounds would have a molecular weight of typically from about 50 Daltons to about 1,500 Daltons” is offered by a co-inventor. We, as factfinder, have discretion to weigh the credibility of expert witnesses and to give each item of evidence such weight as appropriate. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”). In this case, we find that the published references on metabolites do not support the opinion. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d at 1368 (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”) US-121, of which Dr. Pomper is lead inventor, also uses the term “low molecular weight”—without further characterization of the term—and is uninformative as to the meaning of the term. See Ex. 1006, ¶ 12. In addition, Patent Owner’s definition does not appear to apply to all compounds claimed in US-121.5” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

    “limited to Patent Owner’s proposed “from about 50 Daltons to about 1,500 Daltons.” The cited evidence relied on in the Pomper Declaration to define “low molecular weight” as a term well accepted in the chemical arts relates to metabolomics and metabolites. See Ex. 1002, 169, (specifically, ¶ 17 of Dr. Pomper’s declaration). Patent Owner admits that Dr. Pomper’s testimony is about molecules that differ from the claimed imaging and radiotherapeutic agents targeting FAP-α, but argues that the testimony is still relevant for purposes of explanation. Prelim Resp. 21. While it may be relevant, the testimony is not persuasive in light of the Specification. We find the uncontested fact that several of the B moieties alone—without the A moiety or L linker—specifically identified in the ’233 patent fall outside of Patent Owner’s proposed definition persuasive, as we normally do not interpret claim terms in a way that excludes examples disclosed in the specification. See, e.g., Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1305 (Fed. Cir. 2007) (rejecting proposed claim interpretation that would exclude disclosed examples in the specification). The cases cited by Patent Owner supporting that a claim term may be construed to exclude embodiments where the prosecution history supports such construction are factually distinguishable from the instant case as they regard instances of specific prosecution history disclaimer, clear prosecution disavowal, or relate to a specific definition of the terms in the Specification for the term being construed. Here, “low molecular weight” is not defined in the Specification, but, as Petitioner argues (see Pet. 21–25) is characterized as “demonstrat[ing] faster pharmacokinetics and a higher specific signal within clinically convenient times after administration” and that it “can be synthesized in radiolabeled form more easily.” Ex.1001, 13:33–50, 14:56– 16:14, 17:9–20. We are persuaded by the testimony of Dr. Zeglis, Petitioner’s declarant, that compounds weighing over 1500 Da may share those same behaviors, along with certain identified B moieties disclosed as embodiments. See Ex. 1003 ¶ 83.” slip op. at 10

  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 12,115,233
• Fluidmaster, Inc. v. Danco, Inc.Some claims unpatentable
  PTAB · 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 · Graham
  Patents in suitUS 9,139,993
• Valve Corporation v. Ironburg Inventions Ltd.All claims unpatentable
  PTAB · 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 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 9,289,688
• Giesecke+devrient GmbH / Giesecke+devrient Currecy Technology GmbH et al. v. Lumenco, LLCSome claims unpatentable
  PTAB · 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 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,448,863
• Giesecke+devrient GmbH / Giesecke+devrient Currecy Technology GmbH et al. v. Lumenco, LLCAll claims unpatentable
  PTAB · Nov 19, 2025 · IPR2024-00838 · APJ Meredith C Petravick · IPR · Final written decision

  Claims 1–12 are unpatentable: claims 1 and 6 over Fuhse262, and the dependent claims over the additional asserted combinations.

  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 ʼ191 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, 1:27–42. The ʼ191 patent also discusses using lenses to create holograms. Id. at 2:6–21. Similarly, the prior art in this field, such as Fuhse262, relates to the use of lenses and mirrors to create hologram images for security purposes. Ex. 1006 ¶¶ 1–7. 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 of holograms and images using lenses and mirrors for the purpose of preventing counterfeiting of currency and other valuable products.” slip op. at 10

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “spot. Ex. 1006 ¶¶ 95–96, Fig. 10. Dr. Hesselink credibly testifies that while Fuhse262 depicts rays that form a light spot, the rays depicted are “chief rays” that depict only the center rays of light for each optical element. Ex. 1003 ¶¶ 178–179. Ambient light, however, reflects from the entire surface of the mirrors and forms reflected beams of light, not just the center rays aimed at the center point. Id. ¶ 178. According to Dr. Hesselink, the “chief ray” is representative of the larger bundle of rays that form the beams of light reflected off of the mirrors. See Id. ¶ 44. The volume of the voxel is set by the intersection of these beams and the center of the voxel is the point at which the center rays of each beam intersect. Id. ¶ 179. Although Dr. Lindstrand testifies “a POSITA would not have understood Fuhse262 to disclose creating a voxel” (Ex. 2004 ¶ 43), Dr. Lindstrand does not dispute Dr. Hesselink’s testimony that light would reflect off of the entire surface of Fuhse262’s mirrors and form reflected beams of light. See Ex. 2004 ¶¶ 42–58; Ex. 1055, 112:15–21 (“You also agree the ambient light would not just strike the center of the surface, it would strike the entire surface, correct? . . . THE WITNESS: I would say that that is a fair and accurate description.”) Dr. Hesselink’s testimony explaining that light beams would reflect off the entire surface of Fuhse262’s micromirrors and would create a voxel when they intersect with each other, provides sufficient support demonstrating how a POSITA would have understood Fuhse262’s disclosure of light rays being reflected off of mirrors and converging at a light spot shown in Figure 10. See Unification Techs. LLC v. Micron Tech. Inc., 2024 WL 3738401 at *7 (Fed. Cir. Aug. 9, 2024) (affirming the use of expert testimony to demonstrate how a skilled artisan would have understood a prior art reference’s disclosure as teaching a claim limitation).” slip op. at 18

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner

    “Petitioner contends that “no claim terms require express construction.” Pet. 15. “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 12

  • BurdenUnpatentable

    “off the entire surface of Fuhse262’s micromirrors and would create a voxel when they intersect with each other, provides sufficient support demonstrating how a POSITA would have understood Fuhse262’s disclosure of light rays being reflected off of mirrors and converging at a light spot shown in Figure 10. See Unification Techs. LLC v. Micron Tech. Inc., 2024 WL 3738401 at *7 (Fed. Cir. Aug. 9, 2024) (affirming the use of expert testimony to demonstrate how a skilled artisan would have understood a prior art reference’s disclosure as teaching a claim limitation). Patent Owner argues that light beams that intersect in an irregular or unintentional manner would not necessarily form a voxel, but does not explicitly show that Fuhse262’s light beams do, in fact, intersect in an irregular manner. PO Resp. 19. Petitioner has shown, as supported by Fuhse262’s disclosure, that Fuhse262’s mirrors are each oriented intentionally to point to a spot that allows them to create a light spot at the intended coordinates. See Pet. 27 (“In particular, Fuhse262 explains that ‘[t]he position of the mirror surfaces, i.e. the normal vector n, is to be determined in such a way that the light incident from a specified direction k ⃗ is reflected onto the focal point (x0, y0, z0) for all micromirrors 102 assigned to light spot 110.’”) (quoting Ex. 1006 ¶¶ 96–97). This disclosure, combined with Dr. Hesselink’s testimony that the intersection of light beams from the mirrors would create not just a spot but a voxel due to light reflecting off the entire surface of Fuhse262’s mirrors demonstrates that Fuhse262 teaches limitation 1b.5.” slip op. at 19

  Patent outcomesUS 10,901,191 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,901,191
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 17, 2025 · IPR2024-00648 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–30 are unpatentable: claims 1–2, 4–7, 9–12, 14–17, and 19–30 are anticipated by the MSI-H Study Record; claims 3, 8, 13, and 18 are obvious over the cited combinations.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

    “We agree with Patent Owner that the phrase “in response to” in claim 1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having cancer to determine that the patient’s cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 10

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference is prior artDecided for petitioner

    “Patent Owner does not direct us to evidence that it attempted to file any patent application before the publication date of the MSI-H clinical study and was denied an earlier filing date. Contrary to Patent Owner’s argument that it could not file a patent application without results from the MSI-H clinical study, we note that the inventors filed a provisional patent application on November 13, 2014, which, although also filed more than a year after the publication of the MSI-H clinical study, disclosed no clinical results or data. Ex. 1001, cover; Ex. 1030, 1. After considering the parties’ arguments, we are not persuaded by Patent Owner’s assertion that the inventors could not have filed an earlier application to at least attempt to secure a priority date before the MSI-H clinical study was publicly available. an earlier filing date. Instead, we are persuaded by Petitioner’s argument that because the MSI-H clinical study was published before the inventors filed an application to protect their patent rights the MSI-H clinical study is prior art for the information it discloses. Accordingly, we proceed to analyze Petitioner’s contentions in Ground 1.” slip op. at 24

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

    “the genus disclosed in the MSI Study Record and does not argue or provide evidence to show that one of ordinary skill in the art could have envisaged each species within that genus. PO Resp. 11–14. We are not persuaded that either the size of the genus in the MSI Study Record or whether one of ordinary skill in the art would have been able to envisage every species within it is dispositive of whether the MSI Study Record anticipates claim 1, where one of ordinary skill in the art would have known that specific cancers recited in claim 1 would be included in the MSI Study Record. As Petitioner argues, claim 1 requires that “a patient…selected from the group consisting of [the listed cancers]” be tested and treated. Pet. Reply 10 (emphasis original). Claim 1 does not require that the patient have each and every one of the sixteen listed cancers to anticipate the claim. Rather, claim 1 requires testing a sample from “a patient” with one of the recited types of cancer and treating the patient. See Brown v. 3M, 265 F.3d 1349, 1351 (Fed. Cir. 2001) (“When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art.”).” slip op. at 31

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “In contrast, the testimony of Patent Owner’s witness, Dr. Goldberg, supports Petitioner’s argument of the knowledge in the art at the time, wherein Dr. Goldberg testifies that “[w]hile many clinical oncologists were aware that patients with Lynch Syndrome had a defect in DNA mismatch repair, they associated MSI testing with young onset colorectal and endometrial cancer and patients with a family history of colorectal and/or endometrial cancer.” Ex. 2090 ¶ 79. Similarly, during his deposition, Dr. Goldberg also agreed that endometrial, gastric, and small-bowel cancers would come to mind when he saw a reference to MSI-high non-colorectal cancer. See Ex. 1243, 115:5–116:22 (Q. And so does endometrial cancer come to mind when you see reference to MSI-high non-colorectal cancers? . . . A. Yes. Q. As . . . a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does gastric cancer come to mind? . . . A. comes to mind. So the answer is yes. Q. As a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does small bowel cancer come to mind? . . . A. Yes.”). Patent Owner does not direct us to other evidence contradicting Petitioner’s argument that MSI-H was known to occur in endometrial, small bowel, and gastric cancer. Pet. 18.” slip op. at 30

  Patent outcomesUS 11,643,462 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,643,462
• Giesecke+devrient GmbH / Giesecke+devrient Currency Technology GmbH et al. v. Lumenco, LLCAll claims unpatentable
  PTAB · Nov 17, 2025 · IPR2024-00836 · APJ Nabeel U Khan · IPR · Final written decision

  Claims 1, 6–14, 28, and 32–39 are unpatentable as obvious over the asserted combinations of Fuhse262, Fuhse925, Jordan, and Fuhse172.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “ways: the first is the inclusion of “or a similar field” when describing the education level of a POSITA, and second is the inclusion of “with diffusive light” when describing the experience level of a POSITA. We decline to include either of these additional requirements in the definition of the level of ordinary skill. As to the first difference, Patent Owner does not explain what aspects of computer science would make it a field similar to the others listed, nor what additional engineering coursework would suffice. See Ex. 2004 ¶ 25. Nor does Patent Owner explain, generally, what makes a field “similar” to the ones listed or how to make that determination. We determine that Patent uncertainty into the definition and, therefore, do not adopt it. As to the second difference, Patent Owner proposes that the level of skill include two years’ experience with “diffusive light micro-optic security features.” The ʼ294 patent, however, does not mention “diffusive light.” Instead, the challenge claims and the written description of the ʼ294 patent use the term “ambient light.” See, e.g., Ex. 1001, Abstract, 20:50, 59. Ambient light, such as sunlight, includes both parallel and diffuse light. See Ex. 1055, 97:21–98:8; Ex. 1006 ¶ 54 (describing the use of sunlight or ceiling light). The ʼ294 patent mentions ambient light in an ordinary manner without discussing any distinctions between parallel light and diffuse light or giving any significance to the nature of diffuse light and its effects on the invention. We, therefore, adopt Petitioner’s definition of level of ordinary skill except that we find that the phrase “at least” in Petitioner’s proposed definition creates a vague, open-ended upper bound for the level of ordinary skill, and we therefore do not adopt that aspect of the proposal.” slip op. at 11

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “references expressly teach but what they would have suggested to one of ordinary skill in the art at the time the invention was made”) (quoting In re Lamberti, 545 F.2d 747, 750 (CCPA 1976)) (emphasis added); Syntex (U.S.A.) LLC v. Apotex, Inc., 407 F.3d 1371, 1380 (Fed. Cir. 2005) (“What a reference teaches a person of ordinary skill is not . . . limited to what a reference specifically ‘talks about’ or what is specifically ‘mentioned’ or ‘written’ in the reference.”). Here, Petitioner has established that Fuhse262 discloses mirrors that reflect light rays converging at a light spot. Ex. 1006 ¶¶ 95–96, Fig. 10. Dr. Hesselink credibly testifies that while Fuhse262 depicts rays that form a light spot, the rays depicted are “chief rays” that depict only the center rays of light for each optical element. Ex. 1003 ¶¶ 169–170. Ambient light, however, reflects from the entire surface of the mirrors and forms reflected beams of light, not just the center rays aimed at the center point. Id. ¶ 170. According to Dr. Hesselink, the “chief ray” is representative of the larger bundle of rays that form the beams of light reflected off of the mirrors. See Id. ¶ 44. The volume of the voxel is set by the intersection of these beams and the center of the voxel is the point at which the center rays of each beam intersect. Id. ¶ 171. Although Dr. Lindstrand testifies a POSITA would not have understood Fuhse262 to disclose creating a voxel (Ex. 2004 ¶ 43), Dr. Lindstrand does not dispute Dr. Hesselink’s testimony that light would reflect off of the entire surface of Fuhse262’s mirrors and form reflected beams of light. See Ex. 2004 ¶¶ 42– 58; Ex. 1055, 112:15–21 (“You also agree the ambient light would not just strike the center of the surface, it would strike the entire surface, correct? . . . THE WITNESS: I would say that that is a fair and accurate description.”) would reflect off the entire surface of Fuhse262’s micromirrors and would create a voxel when they intersect with each other, provides sufficient support demonstrating how a person of ordinary skill in the art would have understood Fuhse262’s disclosure of light rays being reflected off of mirrors and converging at a light spot shown in Figure 10. See Unification Techs. LLC v. Micron Tech. Inc., 2024 WL 3738401 at *7 (Fed. Cir. Aug. 9, 2024) (affirming the use of expert testimony to demonstrate how a skilled artisan would have understood a prior art reference’s disclosure as teaching a claim limitation).” slip op. at 28

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “Petitioner argues that “no claim terms require express construction to resolve the challenges here.” Pet. 13. Patent Owner “agree[s] that the terms Resp. 13–14. Having reviewed the record and the arguments before us, we determine that no claim terms require express construction to resolve the dispute between the parties.” slip op. at 13

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

    “As to Petitioner’s more general allegations regarding motivation to combine the embodiments of Fuhse262 and reasonable expectation of success, we agree with Petitioner for the reasons provided in the Petition and summarized above. Specifically, we agree with Petitioner that Fuhse262 concave mirrors and lenses with embodiments that use micromirrors. See Ex. 1006 ¶ 83 (“In order to still obtain a higher resolution in the produced light-spot image with an unchanged high floating height, the large mirrors or lenses used in the previous exemplary embodiments are each replaced by a plurality of smaller micromirrors or microprisms, which together have essentially the same optical effect as the original optical element.”). We also agree that the embodiments of Fuhse262 build on each other and often refer back to each other. For example, Fuhse262 expressly refers back to “previous exemplary embodiments” when explaining that micromirrors may replace other optical elements in the various embodiments. Ex. 1006 ¶ 83. Fuhse262’s Figures 8(a) through 8(d) build on each successive example, adding and modifying the configuration of mirrors disclosed in the previous figure. See Id. ¶¶ 88, 94 (explaining that Figure 8(b) is based on Figure 8(a) but shows mirrors arranged in checkerboard-like manner and Figures 8(c) and 8(d) further modify the configuration with every “fourth field” and “ninth field” respectively being assigned to specific light spots.) Fuhse262 also explains that Figure 9 is a sectional view of Figure 8 and that Figure 10 illustrates the “calculation of the flat mirror surfaces of the micromirrors” of Figures 8 and 9. Id. ¶¶ 91, 95. For the aforementioned reasons, we determine that Petitioner has demonstrated, by a preponderance of the evidence, that a person of ordinary skill would have been motivated to combine the teachings of the relied upon embodiments of Fuhse262.” slip op. at 18

  Patent outcomesUS 10,189,294 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 10,189,294
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 6, 2025 · IPR2024-00623 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–7 are unpatentable: claims 1–3 and 5–7 are anticipated by the MSI-H Study Record, and claim 4 is obvious over the MSI-H Study Record and other cited references.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “On balance, we find Petitioner’s evidence more persuasive of what one of ordinary skill in the art would have understood from the MSI-H Study Record. We find Dr. Neugut’s and Dr. Oberstein’s testimony, and Dr. Lonberg’s lack of clear testimony to the contrary, persuasive as to this issue. In addition, we are not persuaded by the case law cited by Patent Owner regarding inherent anticipation. See PO Resp. 6–7. Rather, we agree with Petitioner that the correct inquiry is whether the skilled artisan would have understood that all limitations are disclosed in the prior art. See Pet. 34–35; Pet. Reply 12–13. In light of the cited testimony, we are persuaded that Petitioner has met its burden of proving that a skilled artisan would reasonably have understood or inferred that the limitation for a patient having received a prior cancer therapy drug to treat the tumor was disclosed in the MSI-Study Record. Petitioner demonstrates what one of ordinary skill in the art would have understood from the MSI-H Study Record, not what it inherently discloses. Contra PO Resp. 6–9.” slip op. at 22

  • Skill levelSkill level board ownDecided for petitioner

    “In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’974 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy.” slip op. at 9

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

  Patent outcomesUS 11,325,974 unpatentable
  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,325,974
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 4, 2025 · IPR2024-00624 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–4, 6–10, and 12–15 are unpatentable, principally because the MSI-H Study Record anticipates them.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “Pet. 12 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Thus, Petitioner and Patent Owner characterize one of ordinary skill in the art differently. Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects.” slip op. at 8

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 11–12; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe 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)). We construe” slip op. at 7

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

    “record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’975 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not inherently anticipate where it failed to mention specific vitamin deficiencies, instead merely inviting further experimentation to find associations with metabolic perturbations). requirement, efficacy is inherent in carrying out the claim steps,” referring to a claimed method of treating or preventing stroke, which was held to be anticipated by the publication of a proposed study. 677 F.3d at 1381. Patent Owner attempts to distinguish the size and apparent surety of the study in Montgomery from the MSR. PO Resp. 15. But because we find that the MSR teaches performing the steps recited in claim 1 for the purpose of determining and treating MSI-H cancer, we are persuaded that the MSR inherently discloses the results of selection of patients and administration of the drug treatment recited in those steps. See Bristol-Myers, 246 F.3d at 1376. Whether or not the MSR could have provided results or was sufficient for full regulatory approval does not change that the MSR teaches Patent Owner’s claimed steps. We have no reason to doubt that the disclosure in the MSR of the steps recited in claim 1 produces the efficacy element required in claim 1, whether or not this efficacy was disclosed in the MSR or was known when it was published. See Mehl/Biophile, 192 F.3d at 1366 (“Where, as here, the result is a necessary consequence of what was deliberately intended, it is of no import that the article’s authors did not appreciate the results.”).” slip op. at 21

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “use that does not qualify as prior art. PO Resp. 18–25. Patent Owner argues that an inventor can be granted latitude to experiment in the public eye until her invention is ready for patenting. Id. at 18 (citing Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 64 (1998). According to Patent Owner, the experimental use negation applies to the MSR under a 13-factor analysis provided in Allen Engineering Corp. v. Bartell Industries, Inc., 299 F.3d 1336, 1353 (Fed. Cir. 2002). PO Resp. 19–25. For example, Patent Owner argues that to establish that treatment of MSI-H cancers was effective, the inventors had to test treatment in humans, there being no animal models, and had to publish the MSR on the government website under federal law. Id. at 20–22. Patent Owner argues further that the inventors had control over the MSI-H clinical study and that the field of cancer treatment was highly unpredictable, among other facts. Id. at 21. Patent Owner argues that “[a]t the time of the MSR’s posting, the claimed invention was not, nor could it have been, ready for patenting. The clinical study that ultimately collected the data reported in the patent specification and supporting the patent claims had not and could not have commenced before the MSR was posted.” Id. at 23. sometimes said that an inventor acquires an undue advantage over the public by delaying to take out a patent, inasmuch as he thereby preserves the monopoly to himself for a longer period than is allowed by the policy of the law,” but held that “when the delay is occasioned by a bona fide effort to bring his invention to perfection, or to ascertain whether it will answer the purpose intended,” the experiment use exception can preserve the inventor’s rights. City of Elizabeth v. Am. Nicholson Pavement Co., 97 U.S. 126, 137 (1877). Because we are not persuaded that Patent Owner could not have filed an earlier application, we are not persuaded that the experimental use doctrine is properly applied in this case. Given that clinical trial protocols published on the ClinicalTrials.gov website have been successfully asserted as prior art in other cases, we are not persuaded by Patent Owner’s arguments that the MSR is not available as prior art against the challenged claims. See, e.g., Salix Pharms., Ltd. v. Norwich Pharms. Inc., 98 F.4th 1056, 1061 (Fed. Cir.), cert. denied, 145 S. Ct. 567 (2024), and cert. denied, 145 S. Ct. 983 (2024).” slip op. at 24

  Patent outcomesUS 11,325,975 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,325,975

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.