• Bio-Rad Laboratories, Inc. v. California Institute Of TechnologyNo claims unpatentable
  PTAB · Mar 23, 2026 · IPR2024-01451 · APJ Tawen Chang · IPR · Final written decision

  Claims 1–19 were not shown unpatentable: Larson did not establish the claimed detection in a single sample volume, and the asserted obviousness combinations did not cure the deficiencies.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner states that, “[f]or purposes of this IPR proceeding, PO does not contest Petitioner’s description of qualifications for a person of ordinary skill in the art (POSA) set forth [above].” PO Resp. 23. In view of the above, and because Petitioner’s uncontested description of one of ordinary skill in the art is reasonable and consistent with the ’921 patent and the cited art, we adopt Petitioner’s definition of a POSA for purposes of this Decision, except that we replace the phrase “at least a year of experience in quantitative and/or dPCR and fluorescence-based analyte detection” with “around a year of experience in quantitative and/or dPCR and fluorescence-based analyte detection.” Pet. 9 (emphasis added).13” slip op. at 14

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

    “We begin with “the context in which a term is used in the asserted claim,” which can be “highly instructive.” Phillips, 415 F.3d at 1314. In this case, claim 1 recites that the claimed assay is “capable of unambiguously detecting the presence or absence of each of said at least M analytes, in any combination of presence or absence, in a single sample volume, . . . wherein the analytes are amplified in the single sample 15 In this regard, we note that Petitioner’s claim construction position is not predicated on the collection of droplets being reconstituted into its original, pre-partition form prior to amplification; rather, the droplets remain compartmentalized from each other in the PCR thermal cycling tube. Tr. 65:21–66:9 (Petitioner’s counsel explaining that the droplets do not combine in the PCR thermal cycling tube but, rather, are “suspended in an immiscible fluid and analyzed en masse”). indicates that the first instance of single sample volume, i.e., the single sample volume in which the presence or absence of each M analytes are to be detected, is the antecedent basis for the second instance of “single sample volume,” i.e., the single sample volume in which the analytes are amplified. Thus, as the parties appear to agree, the single sample volume in which amplification takes places must be the same single sample volume in which the presence or absence of analytes are to be detected. We are not persuaded that, when accorded its plain and ordinary meaning, a single sample volume divided into a collection of droplets would be considered the “same” single sample volume prior to its partition.” slip op. at 17

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “With respect to the limitation, “wherein the analytes are amplified in the single sample volume,” Petitioner asserts that “Larson discloses PCR assays that amplify target polynucleotide in a single sample volume, specifically a portion of the reaction mixture that is subsequently partitioned into droplets.” Pet. 31 (emphasis added). There is no dispute that the amplification of the analytes in Larson occurs in the droplets. Larson ¶¶ 6–7 (explaining that “[d]igital PCR (dPCR) is an alternative quantitation method in which dilute sample are divided into many separate reactions” and that “[t]he template is amplified in the droplet for detection”) (emphasis added). Because the claims require that amplification of the analytes be in the same sample volume in which the at least M analytes, in any combination of presence or absence, is unambiguously detected, and because the pre-partition single sample volume is not the same single sample volume as the collection of droplets after partition under our claim construction set forth above, we find Petitioner has not shown, by a preponderance of evidence, that claims 1–10 and 13–19 are anticipated by Larson.17 Tr. 68:12–69:14 (Petitioner’s counsel” slip op. at 27

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “Although we agree with Petitioner that Larson contemplates scenarios in which droplets may contain more than one target molecule and does not require the exclusion of such multiple occupancy droplets in all embodiments, we are nevertheless not persuaded Petitioner has shown, based on a preponderance of evidence, that Larson renders obvious an assay capable of unambiguously detecting, in such multiple occupancy droplets, the presence or absence of each of at least M analytes, in any combination of presence or absence, when M is greater than F and F is at least 2.” slip op. at 32

  Patent outcomesUS 11,827,921 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,827,921
• Samsung Display Co., Ltd. v. Pictiva Displays International Ltd.All claims unpatentable
  PTAB · Feb 9, 2026 · IPR2024-01095 · APJ Garth D Baer · IPR · Final written decision

  Claims 2, 4, 9–12, and 17 are unpatentable under § 103 because the prior-art combinations teach the claimed features and have adequate motivation and reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art Petitioner contends a person of ordinary skill in the art “would have had a Bachelor’s degree in chemistry, physics, or a comparable field of study, and at least three years of research or industrial experience with organic optoelectronic light-emitting devices.” Pet. 10. Further, “[a]n individual with additional education could have less research or industrial experience and vice versa.” Id. Patent Owner does not dispute Petitioner’s formulation. See generally PO Resp. We adopt Petitioner’s uncontested proposed definition because it is consistent with the disclosures of the asserted prior art. See, e.g., Ex. 1006, code (57); Ex. 1011, code (57).” slip op. at 7

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

    “electron-hopping dopant. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (“The prior art’s mere disclosure of more than one alternative does not constitute a teaching away from . . . alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed.”). As Petitioner explains, “Liq acts as an n-dopant in Ma,” which “increases ETL conductivity.” Pet. Reply 10. Patent Owner does not contest that Liq acts as an n-dopant in Ma. See Pet. Reply 30. Thus, Petitioner’s proposed combinations “substitute one known n-dopant for another to further the same goal of improving ETL conductivity.” Pet. Reply 10. Next, Patent Owner faults Petitioner for failing to show that using Ma’s Liq dopant in Diekmann’s/Suzuki’s ETL would result in lower diffusion or higher efficiencies as compared to Diekmann’s/Suzuki’s preferred n-dopants, which included cesium, barium, or lithium fluoride. PO Resp. 31–35; see PO Sur-reply 4–5. We disagree with Patent Owner’s argument because Petitioner does not need to show that Ma’s Liq n-dopant “was an improvement in a categorical sense” over Diekmann’s/Suzuki’s n-dopants, so long as Ma’s n-dopant was known and one skilled in the art would understand that implementing it had advantages. See Intel Corp. v. Pact XPP Schweiz AG, 61 F.4th 1373, 1381 (Fed. Cir. 2023) (quotation marks omitted); In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (“[O]ur case law does not require that a particular combination must be the preferred, or the most desirable, combination described in the prior art.”). Petitioner does not assert skilled artisans would have used Liq because it was a superior to Diekmann’s/Suzuki’s preferred dopants, but because doping ETLs with Liq had known benefits including lower driving voltage and enhanced power efficiency from enhanced carrier injection increased transport conductivity, as compared to an undoped device. Pet. 37 (citing Ex. 1010, 813). That other potentially suitable or even superior n-dopants were also known does not make Liq nonobvious. Given Liq’s benefits outlined above, Petitioner has articulated sufficient reasoning with rational underpinning to support the legal conclusion that its proffered combination of Ma’s known dopant in Diekmann’s/Suzuki’s device would have been obvious to one skilled in the art. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).” slip op. at 12

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

    “1. Whether Ma Qualifies as a Prior Art Printed Publication First, Patent Owner argues that Petitioner has not demonstrated that Ma was publicly accessible in August 2008 so as to qualify as prior art. PO 11 As Petitioner notes, the district court adopted a claim construction requiring only “one or more wavelengths” in the infrared-to-UV spectrum. PO Resp. 26 (citing Ex. 2031, 47–48). Resp. 16–24. We addressed this same issue in our Final Written Decision in IPR2024-01094. IPR2024-01094, Paper 42 at 9–13. As we explained there, Ma qualifies as prior art printed publication because the record evidence supports what Ma says on its face—that it was published online on August 29, 2008 by an Elsevier, an established publisher, in Synthetic Metals, which is a reputable journal. Id. For the same reason explained in IPR2024-01094, we agree with Petitioner that Ma qualifies as a prior art printed publication.” slip op. at 10

  Patent outcomesUS 11,828,425 unpatentable
  § 102 anticipation§ 103 obviousness
  Patents in suitUS 11,828,425
• Samsung Display Co., Ltd. v. Pictiva Displays International Ltd.Some claims unpatentable
  PTAB · Jan 22, 2026 · IPR2024-01094 · APJ Grace Karaffa Obermann · IPR · Final written decision

  Claims 1, 2, 6, and 8–14 are unpatentable as obvious over Ma; claims 3 and 4 were not shown unpatentable over Werner.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends: A person of ordinary skill in the art (“POSA”) at the time of the alleged invention of the ’223 patent would have had a university degree in chemistry and additional expertise or a second university degree in the field of electrical engineering, particularly optoelectronics, or alternatively a university degree in electrical engineering and additional expertise or a second university degree in the field of chemistry. The person of ordinary skill in the art has spent several years studying the structure and function of organic optoelectronic components, in particular OLEDs, and has detailed knowledge of the chemical structure of light-emitting organic layers and the transport of charge carriers to these layers. In this respect, the person of ordinary skill in the art works at the interface between electrical engineering/physics (charge carrier transport and light emission processes in optoelectronic components) and chemistry, in particular organic chemistry (materials and layer stack combinations suitable). Pet. 14 (citing Ex. 1003 ¶¶ 46–47). Patent Owner does not dispute Petitioner’s contention. See generally Resp. Neither party indicates that the result would change depending on the definition selected. We adopt Petitioner’s uncontested proposed definition, because it is consistent with the disclosures of the asserted prior art references. See Ex. 1005, (code 57); Ex. 1007, 8107 (abstracts of the references asserted in the patentability challenges).” slip op. at 8

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

    “history pertaining to the patent.” 37 C.F.R. § 42.100(b). Under that standard, claim terms generally are given their plain and ordinary meaning as would have been understood by the ordinarily skilled artisan at the time of the invention and within the context of the entire patent disclosure. See Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). We construe claim terms only as relevant to the parties’ contentions and only to the extent necessary to resolve the issues in dispute. See 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). Neither party indicates that an express construction for any claim term is necessary to resolve the disputes at hand. Pet. 15; see generally Resp. On this record, we determine that no claim term requires express construction for purposes of this Decision. In our analysis of the challenges, however, we discuss the meaning of the terms “metal complex” and “central metal atom,” which appear in claim 1 (Ex. 1001, 19:19–20) to the extent necessary to resolve Patent Owner’s contention that Petitioner fails to establish that Ma invalidates claim 1. See Resp. 53, 56–58.” slip op. at 9

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

    “Whether Ma qualifies as a “printed publication” involves an inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public. In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). A reference is considered “publicly accessible” upon a satisfactory showing that the document has been “disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence[] can locate it.” Kyocera Wireless Corp. v. ITC, 545 F.3d 1340, 1350 (Fed. Cir. 2008); see Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 10– 11 (PTAB Dec. 20, 2019) (precedential).” slip op. at 10

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

    “Based on the information presented, we find Petitioner has the better position. Patent Owner admits that joint vaporization means “two materials vaporize together.” Reply 21 (quoting Resp. 54). As Petitioner argues, “This is what Ma discloses.” Id. We agree with Petitioner that Ma describes a “two-component” electron transport layer having a “thickness with one value.” Id.; see Ex. 1007, 811 (reporting a “co-deposited” application of “BPhen:LiQ” that is “50 nm thick”). Ma’s disclosure, thereby, strongly “indicates that the two components were vaporized together––as opposed to creating a ‘macroscopically homogenous form’” prepared by sequentially vaporizing the individual components as Patent Owner “hypothesizes.” Reply 21 (citing Ex. 1020 ¶¶ 42–44; Ex. 2041 ¶¶ 155–157); see Resp. 54– 55; see also Ex. 1007, 811 (Ma’s description of its device fabrication, appearing in the third paragraph of the experiments section). Petitioner further advances evidence that “[p]reparing a layer that is ‘macroscopically homogeneous’ but potentially microscopically heterogeneous,” as Patent Owner postulates, “would introduce excessive variability and render the data noncomparable and unreliable, thus undermining the experiment’s purpose.” Reply 21 (citing Ex. 1020 ¶ 44); see Resp. 54–55. Patent Owner presents no counterargument or evidence that is persuasive to undercut Petitioner’s reasoning or evidence on that point. See Sur-reply 19–22. Petitioner also argues that an ordinarily skilled artisan would have recognized “that vaporizing materials together would best achieve Ma’s objective of assessing the current density using different Liq doping percentages.” Reply 22 (citing Ex. 1007, 811; Ex. 1020 ¶ 51). Here again, Petitioner’s evidence on point stands uncontested. See Sur-reply 19–22 (declining to contest that point). On this record, therefore, we agree with Petitioner that, as to the relevant disclosure in Ma, “the most natural interpretation of ‘co-deposition’ for forming a layer, particularly when there is nothing to indicate that the materials” are “vaporized sequentially,” is that the materials are co-deposited by joint vaporization. Reply 22 (citing Ex. 1020 ¶ 46–51). We further agree that, “[u]nder a preponderance standard, Ma’s disclosures are sufficient to render joint vaporization at least obvious.” Id. For the above reasons, we determine that Petitioner demonstrates by a preponderance of the evidence that Ma discloses joint vaporization as required by the challenged claims.” slip op. at 15

  Patent outcomesUS 8,558,223 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 8,558,223
• Samsung Display Co., Ltd. v. Pictiva Displays International Ltd.All claims unpatentable
  PTAB · Jan 22, 2026 · IPR2024-01093 · APJ Grace Karaffa Obermann · IPR · Final written decision

  Claims 1–16 are unpatentable: claims 1–13 and 15–16 on anticipation and obviousness grounds, and claim 14 on obviousness over Choulis.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A person of ordinary skill in the art (“POSITA”) at the time of the alleged invention of the ’164 patent would have had a Bachelor’s degree in chemistry, physics, or a comparable field of study, and at least three years of research or industrial experience with organic optoelectronic light-emitting devices. An individual with additional education could have less research or industrial experience and vice versa. Pet. 12. Patent Owner repeatedly refers to “a POSITA” without addressing the definition of that term or contesting Petitioner’s proposed definition. See Resp. 1, 2 n.1, 3, 8, 9, 15–21, 23, 26, 29, 32–33, 35, 37, 38, 40, 41, 44–49, 51–57, 61, 62 (bare references to “a POSITA”). Neither party indicates that the ultimate result on patentability would change depending on the definition selected. We adopt Petitioner’s proposed definition, which is not contested, because it is consistent with the disclosures of the asserted prior art. See Ex. 1004, (code 57); Ex. 1006, code (57); Ex. 1008, code (57); Ex. 1009, code (57) (abstracts of the references asserted in the patentability challenges).” slip op. at 7

  • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageDisclaimer not foundTerm construed board ownDecided for petitioner

    “because no information raised during the trial phase of this review changes the calculus: First and foremost, the plain terms of claim 1 include no language from which we reasonably can impose limits on the phrase “matrix material” as urged by Patent Owner. In addition, the specification includes no special definition of that phrase that supports importing Patent Owner’s proposed narrowing limitation into the claim. Furthermore, we are directed to no disclaimer of claim scope during patent prosecution that would support Patent Owner’s twice-rejected argument that the phrase “matrix material” in claim 1 excludes embedded dopants and dispersed agglomerations. And the extrinsic evidence advanced by Patent Owner during this review is ineffective to override the clear interpretation of “matrix material” that is established by the intrinsic evidence. Reply 1–7.10” slip op. at 8

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “We find that Petitioner establishes by a preponderance of the evidence that Choulis anticipates claim 13. We agree with Petitioner, in that regard, that Choulis explicitly teaches “using spin-coating as a method for depositing materials, which involves a simultaneous application process” as required by claim 13. Reply 16 (citing Pet. 40–41; Ex. 1044 ¶ 45).16 We 15 Petitioner raises Djobo as a background reference supporting that Choulis anticipates deposition of PVK by evaporation. Pet. 41. Patent Owner counters that Djobo, to the contrary, shows that Choulis does not teach deposition of PVK by evaporation. Resp. 48. In other words, both parties cite Djobo in connection with the ground based on anticipation by Choulis. Against that backdrop, we determine that Patent Owner waives any argument that Petitioner improperly cites Djobo as a background reference in support of the anticipation challenge, which is based on Choulis alone. Resp. 48 (nowhere asserting that the challenge is deficient on that basis). That waiver arises because no argument, in that regard, is raised in Patent Owner’s Response see Inst. Dec. 34 (“The Board shall deemed waived any issue not raised by Patent Owner in a timely response to the Petition . . . .”). 16 Patent Owner’s statement that “spin coating tends to cause phase separation” is not developed adequately on this record and, therefore, is further agree with Petitioner that Patent Owner “has not contested this point.” Resp. 48. “Therefore, there is no genuine dispute regarding the unpatentability of claim 13,” although Patent Owner raises “arguments concerning evaporation, which is a distinct process from spin-coating” relevant to the additional limitations of claim 14. Reply 16. We determine that Petitioner establishes by a preponderance of the evidence that Choulis anticipates claim 13. Patent Owner, however, has the better position on whether Choulis anticipates claim 14, which “includes the requirement of applying matrix materials via evaporation coating.” Reply 16. Petitioner seems to abandon that challenge in the Reply by raising arguments that appear, on this record, to bear exclusively on whether the subject matter of claim 14 would have been obvious over Choulis.17 Id. at 16–17. Those arguments are insufficient to counter Patent Owner’s reasons why Choulis does not anticipate the “evaporation coating” limitation of claim 14. Compare id., with Resp. 48. On this record, therefore, we determine that Petitioner does not establish by a preponderance of the evidence that Choulis anticipates claim 14. unpersuasive to persuade us “that Choulis does not have three matrix materials.” Sur-reply 15. That argument runs counter to Choulis’s explicit, intrinsic disclosures, which illustrate (Ex. 1004, Fig. 4) and describe (id. ¶ 30) an organic light emitting layer composed of three matrix materials. See Pet. 24–25 (citing Ex. 1004, Fig. 4, ¶ 30); see also Ex. 1003 ¶¶ 85–88 (persuasive declaration testimony of Dr. Holmes, cited at Pet. 24–25). 17 There is some confusion on this point, given that both parties sometimes collapse, into a single argument, whether Choulis anticipates or renders obvious claim 1. Compare Resp. 48, with Reply 16–17.” slip op. at 35

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

    “On this record, therefore, we determine that Choulis, at minimum, suggests that a person of ordinary skill in the art at the time of the invention would have recognized PMMA as a suitable alternative to PVK in Choulis’s Figure 4 embodiment, notwithstanding any differences raised by Patent Owner. Ex. 1004 ¶ 44. Patent Owner’s argument that no disclosure in Choulis suggests that an ordinarily skilled artisan “would have found it desirable to use PMMA in place of PVK in Choulis’s devices” misses the mark, where Choulis includes both PMMA and PVK in lists of materials suitable for use as host or matrix materials. Resp. 38; Ex. 1004 ¶ 44. “Our caselaw is clear. It’s not necessary to show that a combination is ‘the best option, only that it is a suitable option.’” Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 800 (Fed. Cir. 2021). Even if Choulis does not expressly disclose substituting PMMA for PVK in the Figure 4 embodiment, “an ordinarily skilled artisan would have found it obvious to make that substitution.” Reply 10 (citing Pet. 31 (citing Ex. 1003 ¶ 100; Ex. 1044 ¶ 23)). The suggestion for that substitution is set forth unambiguously in Choulis’s listing of both “PVK” and “PMMA” as materials suitable for use as a first “host” material in Choulis’s organic functional layer; that is, “the light emitting layer” that is “described above” in Figure 4. Ex. 1004 ¶ 44. ii. Alternative Reasoning for Replacing PVK with PMMA Patent Owner counterargues that using PPMA in place of PVK would have been understood to “upset the hole and electron balance,” as well as “affect hole-charge recombination,” and “degrade the performance of the resulting OLED system.” Resp. 37. Petitioner responds with evidence that “it would have been a routine task for” an ordinarily skilled artisan “to optimize the composition of each component within the light-emitting layer to achieve the desired charge balance.” Reply 11 (citing Ex. 1004 ¶ 24). Petitioner’s response brings to light a second reason why an ordinarily” slip op. at 40

  Patent outcomesUS 8,723,164 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,723,164
• Samsung Display Co., Ltd. v. Pictiva Displays International Ltd.All claims unpatentable
  PTAB · Jan 22, 2026 · IPR2024-01095 · APJ Garth D Baer · IPR · Final written decision

  Claims 2, 4, 9–12, and 17 are unpatentable under § 103 over the Diekmann- and Suzuki-based combinations with the respective secondary references.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “had a Bachelor’s degree in chemistry, physics, or a comparable field of study, and at least three years of research or industrial experience with organic optoelectronic light-emitting devices.” Pet. 10. Further, “[a]n individual with additional education could have less research or industrial experience and vice versa.” Id. Patent Owner does not dispute Petitioner’s formulation. See generally PO Resp. We adopt Petitioner’s uncontested proposed definition because it is consistent with the disclosures of the asserted prior art. See, e.g., Ex. 1006, code (57); Ex. 1011, code (57).” slip op. at 7

  • BurdenUnpatentable

    “III. OBVIOUSNESS ANALYSIS Petitioner contends that claims 2, 4, 9–12, and 17 are unpatentable under 35 U.S.C. § 103. For the reasons explained below, we find that Petitioner has shown by a preponderance of evidence that these claims are unpatentable over the asserted prior art.” slip op. at 7

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

    “Resp. 16–24. We addressed this same issue in our Final Written Decision in IPR2024-01094. IPR2024-01094, Paper 42 at 9–13. As we explained there, Ma qualifies as prior art printed publication because the record evidence supports what Ma says on its face—that it was published online on August 29, 2008 by an Elsevier, an established publisher, in Synthetic Metals, which is a reputable journal. Id. For the same reason explained in IPR2024-01094, we agree with Petitioner that Ma qualifies as a prior art printed publication.” slip op. at 11

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

    “additional feature in claims 2 and 12, Patent Owner raises a number of challenges to Petitioner’s asserted rationale for combining Ma. See PO Resp. 27–47. First, Patent Owner asserts that skilled artisans would not have used Ma’s Liq dopant in Diekmann/Suzuki because both employ electron-donor dopants that operate differently from Liq’s electron-hopping dopant. Id. at 28–31. We disagree with Patent Owner’s argument because it highlights a difference in the references’ dopants without identifying any incompatibility. Even if Diekmann and Suzuki teach electron-donor type ndopants as Patent Owner asserts, neither precludes or disparages Ma’s electron-hopping dopant. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (“The prior art’s mere disclosure of more than one alternative does not constitute a teaching away from . . . alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed.”). As Petitioner explains, “Liq acts as an n-dopant in Ma,” which “increases ETL conductivity.” Pet. Reply 10. Patent Owner does not contest that Liq acts as an n-dopant in Ma. See Pet. Reply 30. Thus, Petitioner’s proposed combinations “substitute one known n-dopant for another to further the same goal of improving ETL conductivity.” Pet. Reply 10. Next, Patent Owner faults Petitioner for failing to show that using Ma’s Liq dopant in Diekmann’s/Suzuki’s ETL would result in lower diffusion or higher efficiencies as compared to Diekmann’s/Suzuki’s preferred n-dopants, which included cesium, barium, or lithium fluoride. PO Resp. 31–35; see PO Sur-reply 4–5. We disagree with Patent Owner’s argument because Petitioner does not need to show that Ma’s Liq n-dopant “was an improvement in a categorical sense” over Diekmann’s/Suzuki’s n-dopants, so long as Ma’s n-dopant was known and one skilled in the art would understand that implementing it had advantages. See Intel Corp. v. Pact XPP Schweiz AG, 61 F.4th 1373, 1381 (Fed. Cir. 2023) (quotation marks omitted); In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (“[O]ur case law does not require that a particular combination must be the preferred, or the most desirable, combination described in the prior art.”). Petitioner does not assert skilled artisans would have used Liq because it was a superior to Diekmann’s/Suzuki’s preferred dopants, but because doping ETLs with Liq had known benefits including lower driving voltage and enhanced power efficiency from enhanced carrier injection increased transport conductivity, as compared to an undoped device. Pet. 37 (citing Ex. 1010, 813). That other potentially suitable or even superior n-dopants were also known does not make Liq nonobvious. Given Liq’s benefits outlined above, Petitioner has articulated sufficient reasoning with rational underpinning to support the legal conclusion that its proffered combination of Ma’s known dopant in Diekmann’s/Suzuki’s device would have been obvious to one skilled in the art. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).” slip op. at 11

  Patent outcomesUS 11,828,425 unpatentable
  § 102 anticipation§ 103 obviousness
  Patents in suitUS 11,828,425
• 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
• 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
• Advancell Pty Ltd. v. Sciencons As And Artbio, Inc.Instituted
  PTAB · Nov 6, 2025 · PGR2025-00040 · APJ Kimberly Mcgraw · PGR · Institution

  The Board instituted PGR on claims 1–9, 11–33, and 35–38 on all petition grounds, finding it more likely than not that Hassfjell-Hoff anticipates at least claim 1.

  RulingsInstitution decision

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

    “Under 35 U.S.C. § 324(a), a post-grant review may be instituted only if “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Post-grant review is available for patents that issue from applications that at one point contained at least one claim with an effective filing date on or after March 16, 2013. See Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), §§ 3(n)(1), 6(f)(2)(A). After considering the briefing and the evidence of record, for the reasons set forth below, we determine that Petitioner has shown that the ’437 patent is eligible for post-grant review and that it is more likely than not that at least one challenged claim of the ’437 patent is unpatentable under § 324(a). Accordingly, we institute a post-grant review of all challenged claims of the ’437 patent.” slip op. at 2

  • Adverse judgmentAdverse judgmentOther

    “Here, Patentee Sciencons AS filed a statutory disclaimer of claims 10 and 34 of the ’437 patent. Ex. 2001; Prelim. Resp. 43. Based on our review of Exhibit 2001 and the Office’s public records, we find that the disclaimer of claims 10 and 34 complies with the above-listed requirements of 37 C.F.R. § 1.321(a). Accordingly, we treat claims 10 and 34 as having never been part of the ’437 patent. See Vectra Fitness, Inc. v. TNWK Corp., 162 F.3d 1379, 1383 (Fed. Cir. 1998) (“This court has interpreted the term ‘considered as part of the original patent’ in [35 U.S.C.] § 253 to mean that the patent is treated as though the disclaimed claims never existed.”). Because post-grant review cannot be instituted based on disclaimed claims, claims 10 and 34 are outside the scope of this proceeding. 37 C.F.R. § 42.207(e) (“No post-grant review will be instituted based on disclaimed claims.”); General Elec. Co. v. United Techs. Corp., IPR2017-00491, Paper 9 (PTAB July 6, 2017) (precedential) (denying institution in view of a statutory disclaimer of all the challenged claims). Thus, we confine our analysis in this Decision to claims 1–9, 11–33, and 35– 38, the remaining challenged claims that have not been disclaimed.” slip op. at 6

  • PTAB / AIA Trials › Real party in interest / privityGranted

    “Sciencons AS also states that ARTBIO, Inc. is responsible for defending the ’437 patent in this proceeding and requests that ARTBIO, Inc. be included in the caption for this proceeding.2 Paper 4, 1. ARTBIO, Inc. has signed powers of attorney appointing the same practitioners that were appointed by Sciencons AS to transact all business associated with the instant post-grant review review of the ’437 patent. See Paper 3. To date, no objection has been raised to Patent Owner’s request. Given Sciencons AS’s representation that ARTBIO, Inc. is currently the exclusive licensee of the ’437 patent and is responsible for defending the ’437 patent, we grant Sciencons AS’s unopposed request that ARTBIO, Inc. be included in the caption. For convenience we refer to Sciencons AS and the purported exclusive licensee ARTBIO, Inc. collectively as “Patent Owner.” As stated supra, to the extent any party disputes ARTBIO, Inc.’s right to participate in this proceeding or to be included in the caption, the party shall request authorization to brief the issue within 10 business days of this Decision.” slip op. at 3

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “nuclear chemistry, radiochemistry, or materials science, or a comparable field of study, plus approximately two to three years of professional experience with radioisotope generators, radiopharmaceutical chemistry, nuclear medicine, or other relevant industry experience” and that “[a]dditional graduate education could substitute for professional experience, and significant experience in the field could substitute for formal education.” Pet. 2–3 (citing Ex. 1002 ¶ 33; Ex. 1019 ¶ 27). At this stage of the proceeding, Patent Owner does not dispute Petitioner’s proposed definition nor provide a proposed definition of its own. See generally Prelim. Resp. For the purposes of this Decision, we adopt Petitioner’s undisputed proposed definition of a POSITA.” slip op. at 10

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 12,249,437
• 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.