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  • 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
  • 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
  • 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
  • PTAB · Oct 14, 2025 · PGR2025-00029 · APJ Kimberly Mcgraw · PGR · Institution

    The Board instituted PGR on claims 1–6 and 8–20 on all asserted grounds, finding it more likely than not that at least one challenged claim is unpatentable.

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

      “After reviewing the parties’ briefs and supporting evidence, we determine that Petitioner has sufficiently shown that Hassfjell-Hoff discloses each element of claim 1. As such, Petitioner’s argument and evidence as set forth above and further discussed below, sufficiently shows that it is more likely than not that claim 1 is anticipated by Hassfjell-Hoff, notwithstanding Patent Owner’s arguments, also addressed below.” slip op. at 16

    • Adverse judgmentAdverse judgmentOther

      “Here, Patentee Sciencons AS filed a statutory disclaimer of claim 7 of the ’603 patent. Ex. 2001. Based on our review of Exhibit 2001 and U.S. Patent and Trademark Office public records, we find that the disclaimer of claim 7 complies with the above-listed requirements of 37 C.F.R. § 1.321(a). Accordingly, we treat claim 7 as having never been part of the ’603 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, claim 7 is 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 1–6 and 8– 20, the remaining challenged claims that have not been disclaimed.” slip op. at 7

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

      “Sciencons AS also states that ARTBIO, Inc. is responsible for defending the ’603 patent in this proceeding and requests that ARTBIO, Inc. be included in the caption for this proceeding.2 Paper 4, 1; Paper 7, 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 proceeding of the ’603 patent. See Papers 3, 4, 7, 8. 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 ’603 patent and is responsible for defending the ’603 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

      “Petitioner contends that a person of ordinary skill in the art “would have had a bachelor’s degree in chemistry, chemical engineering, physics, nuclear chemistry, radiochemistry, or materials science, or a comparable field of study, plus approximately two to three years of professional experience with radioisotope generators, 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. 1017 ¶ 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.” slip op. at 10

    § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
    Patents in suitUS 12,125,603
  • PTAB · Sep 16, 2025 · IPR2025-00465 · APJ Timothy G Majors · IPR · Institution

    The Board instituted IPR on claims 1–18 because Petitioner showed a reasonable likelihood of proving claim 1 obvious over Gwozdz and Meezan.

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

      “A claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the relevant art. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) secondary considerations (i.e., objective indicia) of nonobviousness when presented.6 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). To show unpatentability based on a combination of teachings, “[a]n obviousness determination [also] requires finding both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” CRFD” slip op. at 7

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “[A POSA] would have been a pharmaceutical scientist, chemist, or biologist involved in the research and development of pharmaceutical formulations and/or delivery, and would have at least a Bachelor’s degree with at least 5 years of experience, or a Master’s, Ph.D. or Pharm.D. degree with several years of experience. In addition, a POSA would have had knowledge of benzodiazepine structure and function, and would further have knowledge and practical experience working with intranasal and transmembrane formulations, including knowledge of the physiology and anatomy of the nasal cavity, with relevant experience in developing intranasal formulations. Pet. 23–24; Ex. 1062 ¶ 20. Patent Owner “does not dispute” Petitioner’s POSA definition at this stage. Prelim. Resp. 18. We apply Petitioner’s proposed POSA definition for this Decision, which definition appears to be generally consistent with the cited prior art.” slip op. at 8

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

      “standard used in a civil action before the courts under 35 U.S.C. § 282(b), including construing claim language in accordance with its ordinary and customary meaning as understood by the POSA, in view of the patent’s specification and considering the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only expressly construe terms to the extent needed to resolve the controversy before us. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019).” slip op. at 8

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner

      “applicant, as part of the bargain with the public, must describe his or her invention so that the public will know what it is and that he or she has truly made the claimed invention.” AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1298 (Fed. Cir. 2014). “[T]he test for sufficiency [of the written description requirement] is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date sought.” Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (explaining that “the description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed”) (internal quotation marks omitted); see also id. at 1352 (“[A] description that merely renders the invention obvious does not satisfy the requirement.”).” slip op. at 25

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 11,241,414
  • PTAB · Sep 16, 2025 · IPR2025-00466 · APJ Timothy G Majors · IPR · Institution

    The Board instituted IPR on claims 1–27 because Petitioner showed a reasonable likelihood of prevailing on at least one claim, including claim 1 over Gwozdz and Meezan.

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

      “Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’786 patent’s challenged claims.1 We institute inter partes review on all challenged claims. SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018); 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”).” slip op. at 2

    • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

      “We find that Petitioner has made a threshold showing that the ’558 Provisional does not provide written description support for claim 1’s pharmaceutical solution consisting of each of the recited elements, including n-dodecyl beta-D-maltoside. It is true that “n-Dodecyl β-D-maltoside” can be found listed in the SIGMA Catalog. Ex. 1026, 316. But Dr. Donovan’s testimony helps put that listing in context. It is merely one among well over 100 ionic and non-ionic detergents listed in the cited six pages of the SIGMA Catalog. See 1026, 316–321; Ex. 1062 ¶ 50. When further considered in the context of paragraphs 150–152 of the ’558 Provisional, which generically suggest that “enhancer” compounds can be used in “some embodiments”—then introducing at least 15 classes of potential enhancers16 including “preferred” lysophospholipids and acyl carnitines—the listing of n-dodecyl beta-D-maltoside among at least 150 biological detergents in the SIGMA Catalog is even more remote. Moreover, although satisfaction of the written description requirement is not limited to what is exemplified in a priority application, none of the ’558 Provisional’s examples use any “enhancer,” much less any detergent, any alkyl glycoside, or n-dodecyl beta-D maltoside in particular. The 16 The ’558 Provisional suggests that whether “a given compound” will function as an “enhancer” in a formulation requires testing. Ex. 1008 ¶ 150 (indicating “an in vivo or good model test” may “determin[e] whether the uptake of the drug is enhanced to a clinically significant degree”). ethanol. See Ex. 1008 ¶¶ 172–174 (Examples 1 and 2). In short, we find no sufficient disclosure of “blaze marks” in the ’558 Provisional that point to the inventors’ possession of a pharmaceutical solution that includes n-dodecyl beta-D-maltoside as claimed. Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1326–27 (Fed. Cir. 2000) (analogizing an application’s generic disclosures to a forest of unmarked trees and explaining that, “to satisfy the written description requirement,” there must be “blaze marks directing the skilled artisan to that tree [within the forest that represents the claimed invention]” in the application).” slip op. at 28

    • PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for patent owner

      “and applying collateral estoppel to vacate a claim construction in an underlying IPR). In an IPR, “a party seeking to invoke collateral estoppel must show: ‘(1) the issue is identical to one decided in the first action; (2) the issue was actually litigated in the first action; (3) resolution of the issue was essential to a final judgment in the first action; and (4) [the party against whom collateral estoppel is being asserted] had a full and fair opportunity to litigate the issue in the first action.’” Google LLC v. Hammond Development Int’l, Inc., 54 F.4th 1377, 1381 (Fed. Cir. 2022) (quoting In re Freeman, 30 F.3d 1459, 1465 (Fed. Cir. 1994)) (alteration in original).14 “It is [also] well established that patent claims need not be identical for collateral estoppel to apply.” Id. at 1381. Instead, “collateral estoppel requires the issues of patentability be identical.” Id. If “the differences between the unadjudicated patent claims and adjudicated patent claims do not materially alter the question of invalidity, collateral estoppel applies.” Ohio Willow Wood Co. v. Alps South, LLC, 735 F.3d 1333, 1342–43 (Fed. Cir. 2013) (affirming application of collateral estoppel where claims adjudicated as obvious required a “polymeric” gel whereas similar, unadjudicated claims required a “block copolymer” gel). “Collateral estoppel also applies to common issues in actions involving different but related patents.” Mycogen Plant Sci., Inc. v. Monsanto Co., 252 F.3d 1306, 1310 (Fed. Cir. 2001), vacated on other grounds, 353 U.S. 1109 (2002).” slip op. at 22

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artReference not prior artMixed

      “We agree that at least one portion of Gwozdz is not prior art. To establish that the cited disclosures in Gwozdz are prior art, Petitioner must show support for those disclosures in the Gwozdz Provisional. In re Riggs, 131 F.4th 1377, 1384 (Fed. Cir. 2025) (explaining that “the portion of the application relied on . . . as prior art must be supported by the provisional application”). Petitioner did not establish that Gwozdz’s disclosure of “penetration enhancers” finds support in the Gwozdz Provisional. Pet. 22. Conversely, Patent Owner shows that the phrase is absent in the Gwozdz Provisional. Prelim. Resp. 37.20 Based on this record, we determine that Gwozdz’s mention of “penetration enhancers” is not prior art to the 19 Patent Owner argues this “penetration enhancers” disclosure in Gwozdz is not prior art regardless which of the disputed priority dates (March 28, 2008, or March 27, 2009) one accords to the challenged claims. Prelim. Resp. 33. 20 We also agree that collateral estoppel does not bar Patent Owner from challenging Gwozdz’s prior-art status in this case. Patent Owner’s apparent concession that Gwozdz was prior art during the 451 IPR does not equate to the issue being actually litigated. Prelim. Resp. 34–35; Ex. 1040, 14 (“Patent Owner does not contest that Gwozdz is entitled to this filing date” of the Gwozdz Provisional). Purdue, 767 F. App’x at 922 (determining “[t]he priority date for the Joshi reference . . . cannot be determined based on collateral estoppel” where patentee could have argued, but did not in fact argue, Joshi’s prior-art status in an earlier matter).” slip op. at 35

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 11,793,786
  • PTAB · Sep 16, 2025 · IPR2025-00464 · APJ Annette R Reimers · IPR · Institution

    The Board instituted IPR on claims 1–22, finding a reasonable likelihood that claim 1 would have been obvious over Gwozdz and Meezan.

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

      “3. Conclusion For the reasons discussed above and based on the present record, we find that Petitioner has made an adequate threshold showing that the issues presented in this Petition are substantially the same as the issues the Board previously considered in IPR2019-00451 and that Gwozdz’s effective date is March 28, 2008. We therefore determine that Petitioner has shown that it is reasonably likely to prevail in establishing that at least claim 1 would have been obvious over Gwozdz and Meezan. IV. CONCLUSION Petitioner has shown a reasonable likelihood that it will prevail in establishing the unpatentability of at least one of the claims challenged in the Petition. We institute trial on all challenged claims under the grounds raised in the Petition. PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed.” slip op. at 21

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “[A POSA] would have been a pharmaceutical scientist, chemist, or biologist involved in the research and development of pharmaceutical formulations and/or delivery, and would have at least a Bachelor’s degree with at least 5 years of experience, or a Master’s, Ph.D. or Pharm.D. degree with several years of experience. In addition, a POSA would have had knowledge of benzodiazepine structure and function, and would further have knowledge and practical experience working with intranasal and transmembrane formulations, including knowledge of the physiology and anatomy of the nasal cavity, with relevant experience in developing intranasal formulations. Pet. 23; Ex. 1062 ¶ 20. Patent Owner “does not dispute” Petitioner’s POSA definition at this stage. Prelim. Resp. 16. We apply Petitioner’s proposed POSA definition for this Decision, which definition appears to be generally consistent with the cited prior art.” slip op. at 6

    • PTAB / AIA Trials › §315(e) estoppelMixed

      “As the Board’s decision in the 451 IPR explicitly found written description inadequate for the “alkyl glycoside” limitation in the ’558 Provisional, which is the same issue raised here for the ’546 patent, Petitioner has shown that issue was actually litigated and decided in the 451 IPR. Where the same issue is actually litigated and decided as part of a final adjudication in an earlier action, the test for invoking collateral estoppel in a later action is met. On this record and for the reasons above, we are persuaded that collateral estoppel bars Patent Owner from arguing the challenged claims are entitled to the priority date of the ’558 Provisional.” slip op. at 14

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedMixed

      “We agree that at least one portion of Gwozdz is not prior art. To establish that the cited disclosures in Gwozdz are prior art, Petitioner must show support for those disclosures in the Gwozdz Provisional. In re Riggs, 131 F.4th 1377, 1384 (Fed. Cir. 2025) (explaining that “the portion of the application relied on . . . as prior art must be supported by the provisional application”). Petitioner did not establish that Gwozdz’s disclosure of “penetration enhancers” finds support in the Gwozdz Provisional. Pet. 22. Conversely, Patent Owner shows that the phrase is absent in the Gwozdz 9 Patent Owner argues that as the ’546 Patent claims priority to the ’439 Application, the “penetration enhancers” disclosure in Gwozdz is not prior art because Gwozdz and the ’439 Application were filed on the same day (March 27, 2009). Prelim. Resp. 21–22. 10 Patent Owner argues that the passage in Gwozdz concerning “penetration enhancers” is relevant solely to “a pharmaceutical composition for injection,” not for intranasal administration as required by the ’546 Patent. Prelim. Resp. 22. First, as noted above, based on the record presented, we determine that Gwozdz’s mention of “penetration enhancers” is not prior art to the challenged claims. Second, we disagree, however, that Gwozdz’s non-prior art mention of penetration enhancers is relevant solely to a pharmaceutical composition for injection as argued by Patent Owner. Gwozdz discloses that “[the] pharmaceutical compositions of the present invention” can be administered by a number of “nonlimiting” routes including intranasal administration. See Ex. 1009, 9:2–11. Provisional. Prelim. Resp. 20–21. Based on this record, we determine that Gwozdz’s mention of “penetration enhancers” is not prior art to the challenged claims. The phrase cannot, therefore, be used to establish a motivation to combine the asserted references.” slip op. at 18

    § 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 8,895,546
  • PTAB · Mar 27, 2025 · IPR2024-01451 · APJ Erica A Franklin · IPR · Institution

    The Board instituted review of claims 1–19 on all petition grounds, finding a reasonable likelihood that claim 1 would have been obvious over Larson alone.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied

      “of whether we exercise our discretion to deny institution under 35 U.S.C. § 314(a). Rather, when considering the Fintiv factors, we “take[] a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Fintiv at 6. Here, factors one and six are neutral, factors two and three weigh against discretionary denial, and factors four and five favor denial. We assign less weight to the existence of an overlap in asserted claims and prior art, in view of there being no trial date scheduled in the District Court case and no persuasive evidence that the court’s trial date would be expected to be significantly before the due date of our Final Written Decision. Therefore, after weighing all of the factors, we determine that the facts in this case that weigh against exercising discretion outweigh the facts that favor exercising discretion. Accordingly, we decline to exercise our discretion to deny institution under § 314(a).” slip op. at 13

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “At this stage in the proceeding, Patent Owner does not dispute Petitioner’s description of the person of ordinary skill in the art. Prelim. Resp. 27. In view of this, 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 for purposes of this Decision. We note, however, that the open-ended language “at least” expands the range of experience indefinitely with no upper bound. Therefore, we do not apply this aspect of Petitioner’s formulation.” slip op. at 14

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

      “We determine that there is no need to expressly construe any claim term to determine whether to institute an inter partes review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 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))). To the extent that any discussion regarding the scope of a claim term is relevant to our decision, we address that issue in our analysis of the asserted grounds of unpatentability.” slip op. at 15

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner

      “Owner that Petitioner has not demonstrated sufficiently in the Petition, for purposes of institution, that all of the portions of Saxonov relied upon in the Petition are prior art. In particular, we determine that Petitioner has not established that the disputed portions of Saxonov are entitled to claim the benefit of the ’013 provisional filing date because Petitioner has failed to satisfy the second condition for this benefit, i.e., by showing that the provisional application provides sufficient support for certain subject matter in Saxonov relied upon for prior art purposes in the Petition.” slip op. at 28

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · Graham
    Patents in suitUS 11,827,921
  • PTAB · Jan 23, 2025 · IPR2024-01094 · APJ Grace Karaffa Obermann · IPR · Institution

    Instituted review of claims 1–4, 6, and 8–14 on all asserted grounds; Petitioner showed a reasonable likelihood that claim 1 is obvious over Ma.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

      “We apply a two-part framework when assessing whether to exercise our discretion to deny a petition under Section 325(d). First, we consider whether the same or substantially the same prior art or arguments previously were presented to the Office. Second, if either condition is satisfied, we assess whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of the challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019- 01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) (setting forth twopart framework that guides the Board’s decision whether to exercise its discretion to deny review under Section 325(d)).” slip op. at 7

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner

      “In Sotera Wireless, Inc. v. Massimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential), the Board declined to exercise its discretion to deny review under Fintiv where the patent owner stipulated “if IPR is instituted, they will not pursue in the District Court Litigation any ground raised or that could have been reasonably raised in an IPR.” Sotera Wireless, Paper 12 at 18. Importantly, moreover, on June 21, 2022, the Director of the United States Patent and Trademark Office issued a Memorandum setting forth an “Interim Procedure for Discretionary Denials in AIA Post Grant Proceedings with Parallel District Court Litigation” (“Guidance Memo”).6 The Guidance Memo states that “[c]onsistent with Sotera Wireless, Inc., the PTAB will not discretionarily deny institution in view of parallel district court litigation where a petitioner presents a stipulation not to pursue in a parallel proceeding the same grounds or any grounds that could have reasonably been raised before the PTAB.” Guidance Memo 3 (footnote and emphasis omitted).” slip op. at 10

    • 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 argument. See generally Prelim. Resp. Neither party indicates that the result on institution would change depending on the definition selected. Accordingly, for the sole purpose of deciding whether to institute review, we adopt Petitioner’s uncontested proposed definition, because, on this record, it is consistent with the disclosures of the asserted prior art. See Ex. 1005, (code 57); Ex. 1007, 8107 (abstracts of the references asserted in the patentability challenges).” slip op. at 11

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

      “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 7 Following the parties’ convention, when citing Exhibit 1007, we refer to original page numbers, not page numbers added by Petitioner. 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 our decision whether to institute review. Pet. 15; see generally Prelim. Resp. On this record, we determine that no claim term requires express construction for purposes of this Decision.” slip op. at 12

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · Graham
    Patents in suitUS 8,558,223
  • PTAB · Jan 23, 2025 · IPR2024-01093 · APJ Grace Karaffa Obermann · IPR · Institution

    The Board instituted IPR of claims 1–16 on all petition grounds, finding a reasonable likelihood that claim 1 is anticipated by Choulis.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

      “We apply a two-part framework when assessing whether to exercise our discretion to deny a petition under Section 325(d). First, we consider whether the same or substantially the same prior art or arguments previously were presented to the Office. Second, if either condition is satisfied, we assess whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of the challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019- 01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) (setting forth twopart framework that guides the Board’s decision whether to exercise its discretion to deny review under Section 325(d)).” slip op. at 7

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner

      “Importantly, moreover, on June 21, 2022, the Director of the United States Patent and Trademark Office issued a Memorandum setting forth an “Interim Procedure for Discretionary Denials in AIA Post Grant Proceedings with Parallel District Court Litigation” (“Guidance Memo”).8 The Guidance Memo states that “[c]onsistent with Sotera Wireless, Inc., the PTAB will not discretionarily deny institution in view of parallel district court litigation where a petitioner presents a stipulation not to pursue in a parallel proceeding the same grounds or any grounds that could have reasonably been raised before the PTAB.” Guidance Memo 3 (footnote and emphasis omitted).” slip op. at 9

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends: 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 does not dispute Petitioner’s argument. See generally Prelim. Resp. Neither party indicates that the result on institution would change depending on the definition selected. Accordingly, for the sole purpose of deciding whether to institute review, we adopt Petitioner’s uncontested proposed definition, because, on this record, 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 10

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

      “to the meaning of particular claim terms.”). Claim 1 recites first, second, and third matrix materials but, aside from reciting relationships between the LUMOs and HOMOs of the matrix material, does not require any particular composition or any particular amount for any of the three matrix materials. Ex. 1001, 9:4–22. Nor does claim 1 recite that any of the matrix materials must be present in a continuous phase. Id. Claim 1 does recite that the organic functional layer, which includes the three matrix materials, is doped with at least one emitter material. Id. at 9:21–22. On this record, no words in claim 1 limit a “matrix material” to the meaning advanced by Patent Owner.” slip op. at 24

    Claim construction§ 102 anticipationDiscretionary denialcites Phillips · Graham
    Patents in suitUS 8,723,164
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