• Dr. Squatch, LLC v. The Procter & Gamble CompanyAll claims unpatentable
  PTAB · Jan 28, 2026 · IPR2024-01174 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–8 and 10–23 are unpatentable: the Board found claims 1–15 anticipated or obvious over the asserted grounds and claims 16–23 obvious over the Native combination.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedOther

    “argument that the prior art fails to enable a stable deodorant stick. Rather, we are persuaded by Petitioner that Lesniak sufficiently teaches compositions with the relevant ingredients and achieves stable compositions through the use of a second wax having a melting point of 73 to 90° C. Reply 6–7 (citing Ex. 1003, 1:39–54). For example, Lesniak’s compositions (nos. 8 and 11) that used such a second wax, namely CastorWax MP80, are disclosed as sufficiently stable. Ex. 1003, Table 2. Here, we further credit the testimony of Dr. Michniak-Kohn that Lesniak teaches how to make stable compositions by including a secondary wax, such as castor wax, with a sufficiently high melting point. Ex. 1003, 1:39-54, 5:23-32, Table 2. Both of the compositions (nos. 8 and 11) tested by Lesniak that had such a wax passed the stability tests. Id. Ex. 1086 ¶ 7; see also Reply 6 (“Lesniak overcame any stability issues, as it expressly discloses compositions that are ‘physically stable at high and low temperatures.’”) (citing Ex. 1003, 5:23–32).” slip op. at 22

  • Skill levelSkill level petitioner adoptedOther

    “Petitioner proposes that a person of ordinary skill in the art (“POSA” or “POSITA”) at the time of the invention “would have (1) at least a B.S. or equivalent degree; and (2) at least two years of experience in cosmetics formulations.” Pet. 17 (citing Ex. 1002 ¶¶ 27–29). Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications at this stage of the proceeding. PO Resp. 10. For this Decision, we adopt and apply Petitioner’s proposal above, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “Patent Owner asserts that the preamble of independent claim 1, 16, and 20 reciting “a deodorant stick” is limiting” as it provides antecedent basis for the recitation of “said deodorant stick being free of an aluminum salt” for each independent claim. PO Resp. 7–10. Patent Owner also points to dependent claims 6–9 as relying on the preamble reciting “a deodorant stick” as antecedent basis for claim elements. Id. at 9. We agree. Petitioner does not provide argument to the contrary. See, e.g., Pet. 19 (arguing that Lesniak discloses a deodorant stick in the form of an antiperspirant stick). We determine that no express construction of any claim term is necessary to determine whether to institute inter partes review. 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))). To the extent further discussion of the meaning any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 8

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

    “We find that the evidence of record fails to support Patent Owner’s argument that the prior art fails to enable a stable deodorant stick. Rather, we are persuaded by Petitioner that Lesniak sufficiently teaches compositions with the relevant ingredients and achieves stable compositions through the use of a second wax having a melting point of 73 to 90° C. Reply 6–7 (citing Ex. 1003, 1:39–54). For example, Lesniak’s compositions (nos. 8 and 11) that used such a second wax, namely CastorWax MP80, are disclosed as sufficiently stable. Ex. 1003, Table 2. Here, we further credit the testimony of Dr. Michniak-Kohn that Lesniak teaches how to make stable compositions by including a secondary wax, such as castor wax, with a sufficiently high melting point. Ex. 1003, 1:39-54, 5:23-32, Table 2. Both of the compositions (nos. 8 and 11) tested by Lesniak that had such a wax passed the stability tests. Id. Ex. 1086 ¶ 7; see also Reply 6 (“Lesniak overcame any stability issues, as it expressly discloses compositions that are ‘physically stable at high and low temperatures.’”) (citing Ex. 1003, 5:23–32). Having considered the parties’ positions and evidence of record, summarized above, we determine that Lesniak provides sufficient disclosure to enable a person of ordinary skill in the art to formulate deodorant stick within the parameters of claim 1. Therefore, for the reasons discussed above, we conclude that Petitioner has proved by a preponderance of evidence that Lesniak anticipates claim 1.” slip op. at 22

  Patent outcomesUS 11,497,706 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 11,497,706
• 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
• Advancell Pty Ltd.Instituted
  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
• Ascend Elements, Inc. v. Duesenfeld GmbHInstitution denied
  PTAB · Oct 10, 2025 · PGR2025-00037 · APJ Kevin W Cherry · PGR · Institution

  The Board denied institution of PGR on claims 1–14 because Petitioner did not show that any challenged claim was more likely than not unpatentable.

  RulingsInstitution decision

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

    “information presented in the petition filed under [35 U.S.C. §] 321 . . . demonstrates that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). For the reasons set forth below, we determine that Petitioner has failed to demonstrate that it is more likely than not that at least one of claims 1–14 of the ’463 patent is unpatentable. Accordingly, we deny institution of a postgrant review of claims 1–14 based on the grounds set forth in the Petition.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that one of ordinary skill in the art “would have had at least a Bachelor’s degree in electrical engineering, material science, chemical engineering, or an equivalent field, as well as at least 2 to 3 years of academic or industry experience in the recycling or processing of lithiumion batteries. Additional formal education focusing on processing of lithium batteries may substitute for practical experience and additional practical experience can substitute for less education.” Pet. 10–11. Patent Owner does not contest this definition of a person of skill in the art. See Prelim. Resp. 11. For purposes of this Decision, we adopt Petitioner’s assessment of the level of ordinary skill in the art, as, on the present record, it appears consistent with the ’463 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “distinct from “comminute[ion],” Petitioner offers only the testimony of its expert, Mr. Juzkow, who equates Tomioka’s “cutting” with “comminute[ion].” See Ex. 1003 ¶ 121. However, Mr. Juzkow provides insufficient reasoning to support his conclusion, particularly given the intrinsic and extrinsic evidence discussed above. In contrast, Patent Owner’s expert, Mr. Dantam, provides extensive reasoning, supported by citations to other evidence, to support his conclusion that Tomioka’s “dismantling” is not the claimed “comminution.” Thus, we give more weight to Mr. Dantam’s testimony than Mr. Juzkow’s testimony. Weighing this evidence all together, we find that Petitioner has failed to show that it is more likely than not that Tomioka’s teaches the claimed comminution under Petitioner’s first theory.” slip op. at 15

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundTeaching away not foundNot shown unpatentable

    “obvious. Pet. 34–35. However, we agree with Patent Owner that Petitioner has also failed to show that it is more likely than not that Tomioka renders this limitation obvious. See Prelim. Resp. 28–31. To begin with, Petitioner’s contentions lack sufficient reasoning explaining why a person of ordinary skill would have modified Tomioka in the manner proposed. “[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). Petitioner merely asserts that a person of ordinary skill in the art could use the roller system in place of the dismantling disclosed for the embodiments in Figures 19 and 20. On this record, we find this bare contention insufficient. actual disclosure of Tomioka. The rollers in Tomioka are used to separate the “battery body” from the “resin package enclosing the battery body,” and Tomioka specifically discloses that this technique is designed to “avoid damaging the battery body.” Ex. 1005 ¶¶ 25, 26, 29; Ex. 2011 ¶¶ 72–73. Thus, there is a significant difference between what Tomioka teaches and what Petitioner proposes to use the roller system to do. In addition, as Patent Owner points out, Tomioka specifically discloses there are risks associated with mechanically crushing battery packs, such as “risk of sparking due to residual voltage if the battery units are damaged in the process.” Ex. 1005 ¶ 5. Although we do not agree with Patent Owner that this amounts to a “teaching away,” see In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994), we do believe that this teaching suggests a trade off that should be weighed in determining whether to make the modification, see Medichem S.A. v. Rolabo S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). However, Petitioner has failed to account adequately, if at all, for this trade off. Thus, we find that Petitioner has failed to show that it is more likely than not that Tomioka accounts for the claimed “comminuting.”” slip op. at 15

  § 103 obviousness§ 112 disclosurecites Phillips · Graham · Nautilus
  Patents in suitUS 12,119,463
• Padagis US LLC v. Neurelis, Inc.Instituted
  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
• Padagis US LLC v. Neurelis, Inc.Instituted
  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
• Beone Medicines USA, Inc. / Beigene, Ltd. v. Pharmacyclics LLCAll claims unpatentable
  PTAB · May 1, 2025 · PGR2024-00009 · APJ Sheridan K Snedden · PGR · Final written decision

  Claims 1–8, 12, and 20 are unpatentable for lack of written description under § 112(a); the Board did not reach the enablement, anticipation, or obviousness grounds.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986).” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.200(b). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Moreover, “claim terms need only be construed ‘to the extent necessary to resolve the controversy.’” See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). The parties agree that the preamble of the claims should be limiting and that the terms “optionally substituted fused heterocyclic ring system” and “irreversible” BTKIs should be construed consistent with the definitions provided in the Specification. Pet. 42–45; see also id. at 42 (citing Ex. 1001, 19:57–20:7 (defining “optionally substituted” or “substituted”), 14:51–52 (defining “fused”), 15:66–16:21 (defining “heterocycle”), 14:36–44 (defining “ring” and “ring system”), 26:23–25 (defining “irreversible Btk inhibitor”); PO Resp. 26.” slip op. at 14

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

    “used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.200(b). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Moreover, “claim terms need only be construed ‘to the extent necessary to resolve the controversy.’” See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). The parties agree that the preamble of the claims should be limiting” slip op. at 14

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable

    “To satisfy written description for the claimed genus of iBTKIs, the Specification must describe either a representative number of members of the genus or structural features common to the members of the genus with enough precision that a POSA can visualize or recognize the members of the genus. See Ariad, 598 F.3d at 1350. Patent Owner concedes that the Specification does not describe a representative number of members of the genus, stating “this is a common structural features case.” Tr. 65:25–66:3. We, therefore, focus our analysis on whether the Specification adequately describes common structural features of the genus. We find that it does not.” slip op. at 30

  Patent outcomesUS 11,672,803 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 11,672,803
• Innoscience (Zhuhai) Technology Company, Ltd / Innoscience America, Inc. v. Efficient Power Conversion CorporationAll claims unpatentable
  PTAB · Mar 18, 2025 · IPR2023-01381 · APJ Jon B Tornquist · IPR · Final written decision

  Claims 1–3 and 7–9 are unpatentable as obvious over Uemoto and Smith; the motion to amend is granted, and proposed substitute claims 13 and 14 are not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In order to determine whether an invention would have been obvious at the time the application was filed, we consider the level of ordinary skill in the pertinent art. Graham, 383 U.S. at 17. In assessing the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (quotation omitted). Petitioner contends a person of ordinary skill in the art “would have possessed at least a four-year degree in electrical engineering, chemical engineering, physics, or material science, or a closely related field, and at least two years of experience in semiconductor device design or fabrication, including the processing of semiconductor materials, analysis of device operation, or the development of new device topologies.” Pet. 5–6. Petitioner contends “[a]dditional education could substitute for professional experience and vice versa.” Id. at 6. Patent Owner contends that a person of ordinary skill in the art would have had “at least a four-year degree in electrical engineering, physics, material science, or a closely related field, and three years of professional work experience in the epitaxial growth, design, and fabrication of semiconductor electronic devices, including those of GaN.” PO Resp. 7 (citing Ex. 2009 ¶ 82). Upon review of the evidence of record and the parties’ arguments, we adopt Petitioner’s definition of the person of ordinary skill in the art as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (holding that the prior art itself can reflect the appropriate level of ordinary skill in the art). We note, however, that the conclusions reached in this Decision would be the same under either proposed definition of the ordinarily skilled artisan. See Ex. 2009 ¶ 83 (Dr. Schubert testifying that his opinions would be the same under either proposed definition); Ex. 1033 ¶ 9 (Dr. Shealy testifying that the differences in proposed definitions of the ordinarily skilled artisan “would not change the outcome of the invalidity analysis in any material manner”); PO Resp. 7; Pet. Reply 1.” slip op. at 9

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

    “compensated GaN layer above the barrier layer, and a gate contact above the compensated GaN layer.” Ex. 1001, 5:12–18. Petitioner contends the term “compensated” indicates that the step of compensating the GaN layer has already occurred, such that the term “compensated GaN layer” should be construed as a “‘[d]oped GaN layer formed with a step to passivate its impurities’ which is a ‘product-by-process’ limitation.”5 Pet. 12–14. And, because compensation with hydrogen was the “critical step” distinguishing the claims from the prior art, and because hydrogenation in as-grown III-nitride materials had been well known for over a decade by 2009, Petitioner contends “compensated” “cannot be interpreted as mere hydrogen presence in as-grown material, a well-known property of doped GaN.” Id. at 15. Patent Owner contends “compensated GaN material” should be construed as “a semiconductor GaN gate material in which one type of impurity (for example, donor) cancels the electrical effects of the other type of impurity (for example, acceptor).” PO Resp. 11 (citing Ex. 2009 ¶ 92) (emphasis added). Patent Owner contends this construction is consistent with the IEEE dictionary, which defines “compensated semiconductor” as 5 Given that product-by-process steps in a device claim are not entitled to patentable weight, Petitioner contends “the prior art only need show a material with passivated impurities to show unpatentability, not the step to achieve it.” Pet. 15–16. “[a] semiconductor in which one type of impurity or imperfection (for example, donor) partially cancels the electric effects of the other type of impurity or imperfection (for example, acceptor).” PO Resp. 14 (quoting Ex. 2004). Patent Owner contends its construction is also consistent with the written description of the ’294 patent, which explains that a compensated GaN material is part of the gate and includes a p-type impurity that imparts an electrical effect (i.e., conductivity), as well as a second impurity, e.g., hydrogen, that partially cancels the electrical effect of the p-type impurity, rendering the layer semi-insulating. Id. at 14–15 (citing Ex. 1001, 3:10–13, 3:43–45). On this record, we construe “compensated GaN layer” as “a GaN layer in which one type of impurity (for example, donor) partially cancels the electric effects of the other type of impurity (for example, acceptor).” This is consistent with the disclosures of the ’294 patent, the IEEE dictionary definition, and the construction ultimately adopted by the ITC. Ex. 2004, 3; Ex. 1049, 16–17 (ITC construing “compensated GaN layer” to mean “a GaN layer in which one type of impurity partially cancels the electrical effects of another type of impurity”); Ex. 1001, 3:43–45 (explaining that the compensated GaN layer of the ’294 patent is formed through the “passivation of a p-type impurity using hydrogen”). For the reasons set forth below, however, we decline to construe “compensated GaN layer” as a product-by-process claim term (as asserted by Petitioner), or to limit the compensated GaN layer to a gate material (as asserted by Patent Owner).” slip op. at 11

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

    “There are two exceptions to the general rule that we apply the ordinary and customary meaning of a claim term: (1) when a patentee sets out a definition and acts as his own lexicographer, or (2) when the patentee disavows the full scope of a claim term either in the specification or during prosecution. See Thorner, 669 F.3d at 1365. The standards for lexicography and disclaimer, however, are “exacting.” Id. at 1366. There is no argument that the patentees acted as their own lexicographer to redefine the term “compensated GaN layer.” With respect to disavowal, a “patentee may demonstrate intent to deviate from the ordinary and accustomed meaning of a claim term by including in the specification expressions of manifest exclusion or restriction, representing a clear disavowal of claim scope.” Thorner, 669 F.3d at 1366 (quoting Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002)). As noted by Patent Owner, the title of the ’294 patent is, in part, “Compensated Gate MISFET” and much of the discussion of the ’294 patent is of a compensated GaN layer that is directly below the gate contact and above a barrier layer and operates in conjunction with the gate contact to control the on/off state of the transistor. PO Resp. 12–14. We are presented with insufficient argument or evidence to conclude, however, that these disclosures rise to the level of a disclaimer. For example, although the title of the ’294 patent is directed to a “Compensated Gate MISFET,” claim 1 is more broadly directed to “[a] column III Nitride transistor.” Ex. 1001, 5:12, code (54). Nor are we directed to an expression or statement of manifest exclusion in the ’294 patent that would serve to disclaim any “compensated GaN layer” that is not directly below the gate and/or that does not function in concert with the gate electrode to control the on/off state of the transistor. See Thorner, 669 F.3d at 1366. With respect to the stated goals of the invention, as noted by Patent Owner, one of the primary purposes of the compensated GaN layer of the ’294 patent is to reduce gate leakage and gate capacitance. Ex. 1001, 2:13– 19, 3:18–21 (“[U]sing a compensated semiconductor layer 38 leads to low gate leakage during device operation.”). We cannot use the goals of the invention, however, to rewrite the claims or insert terms that are not present. See Thorner, 669 F.3d at 1366. Moreover, the prior art of record indicates that a compensated GaN layer that is below the gate contact and above a barrier layer, but not part of the active gate structure, may also “decrease the leakage current between the gate and the drain.” Ex. 1006 ¶¶ 44 (“Even when a positive bias of 5 V or higher is applied to the gate electrode, no significant gate-leakage current is observed.”), 61. As such, evidence of record suggests that a person of ordinary skill in the art would have understood that one of the primary goals disclosed in the ’294 patent is achieved regardless of whether the compensated GaN layer is part of the gate, or simply in close vicinity to the gate. In view of the foregoing, we are not persuaded that the written description of the ’294 patent indicates that the “compensated GaN layer” must be part of the gate structure.” slip op. at 17

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “To be probative, Patent Owner must prove there is a nexus between the presented evidence and the merits of the claimed invention. See Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988). A rebuttable presumption of nexus applies when the “patentee shows that the asserted evidence is tied to a specific product and that the product ‘is the invention disclosed and claimed.’” Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019) (quoting Demaco, 851 F.2d at 1392). “That is, presuming nexus is appropriate ‘when the patentee shows that the asserted objective evidence is tied to a specific product and that product embodies the claimed features, and is coextensive with them.’” Id. (quoting Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1072 (Fed. Cir. 2018)). If the praise is not limited to the features of the claimed invention, the patent owner may still prove nexus “by showing that the evidence of secondary considerations is the ‘direct result of the unique characteristics of the claimed invention.’” Id. at 1373–74 (quoting In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996)). Patent Owner contends that the compensated gate of the ’294 patent “was a breakthrough invention and resulted in the first commercially viable enhancement-mode GaN transistor.” PO Resp. 60 (citing Ex. 2009 ¶¶ 192– 193, 197; Ex. 2021). Patent Owner further contends that this achievement required the counter-intuitive use of a compensated gate material in the gate structure, and represented “a technological leap that laid the foundation for viable enhancement-mode GaN transistors.” Id. at 61–62. For this achievement, Patent Owner contends the inventor, Dr. Alex Lidow, received the 2015 SEMI Award. Id. at 60 (citing Ex. 2021). Upon review of Patent Owner’s evidence and the parties’ arguments, we find that Patent Owner’s objective indicia evidence is entitled to little, if any, weight. The evidence of praise relied upon by Patent Owner is not clearly linked to the claimed invention or any particular product having each of the claimed features of the ’294 patent. Ex. 2021. For example, the 2015 SEMI award was provided to Dr. Lidow “for commercialization of GaN power devices.” Id. An article explaining the award indicates that “high cost” previously “limited [the] commercial success” of GaN technologies, but Dr. Lidow was able to overcome these issues, “from resolving packaging limitations to establishing a low-cost supply chain,” “through persistence.” Id. This praise is not demonstrably linked to the claimed invention or any particular device, and does not mention the use of a compensated gate, or any other relevant feature recited in the claims. In view of the foregoing, we determine that Patent Owner’s objective evidence of non-obviousness is entitled to little, if any, weight.” slip op. at 20

  Patent outcomesUS 8,350,294 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,350,294
• Novartis Pharmaceuticals Corporation v. Regents Of The University Of Michigan And University Of South FloridaAll claims unpatentable
  PTAB · Mar 5, 2025 · IPR2023-01346 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 10, 11, and 18 are unpatentable because Hickey anticipates each claim; the Board did not reach the alternative Almarsson grounds.

  RulingsFinal written decision

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

    “For a functionally-defined genus, “the written description requirement [can be met] when the art has established a correlation between structure and function.” Ariad, 598 F.3d at 1350. Here, the challenge claims recite two types of functional limitations. First, independent claim 10 requires the coformer to have a second chemical functionality, which is defined as being complementary to the first chemical functionality via non-covalent hydrogen bonding. That is, the co-former’s second chemical functionality must be complementary to either a carboxamide, carbonyl, or amine functionality of an API via non-covalent hydrogen bonding. Second, the non-covalent hydrogen bonding between the first chemical functionality of the API and the second chemical functionality of the co-former must result in the formation of supramolecular synthons.” slip op. at 21

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artDecided for petitioner

    “We therefore find that the parent ’956 application lacks written description support for the challenged claims, and thus, on the record before us, we determine that the effective filing date of the challenged claims is February 13, 2014, the filing date the ’344 patent. Thus, the references relied upon by Petitioner (Hickey, Almarsson, and Martindale) qualify as prior art to the ’344 patent. Pet. 33, 45.” slip op. at 26

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

    “III. ANALYSIS A. Principles of Law To anticipate a claim under 35 U.S.C. § 102, “a single prior art reference must expressly or inherently disclose each claim limitation.” Finisar Corp. v. DirecTV Group, Inc., 523 F.3d 1323, 1334 (Fed. Cir. 2008). Accordingly, “‘the dispositive question regarding anticipation [i]s whether one skilled in the art would reasonably understand or infer from the [prior art reference’s] teaching’ that every claim element was disclosed in that single reference.” Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1368 (Fed. Cir. 2003) (quoting In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991)).” slip op. at 26

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Pet. 7–8. “Patent Owners do not contest the level of ordinary skill in the art set forth in the Petition.” PO Resp. 11. Because Petitioner’s unopposed definition is consistent with the ’344 patent and the prior art of record, we adopt that definition. See Okajima v. Bourdeau, 261 F.3d 1350, 1354–55 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579–80 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 8

  Patent outcomesUS 10,633,344 unpatentable
  § 102 anticipation§ 112 disclosurecites KSR · Graham
  Patents in suitUS 10,633,344
• Ovid Therapeutics Inc. v. Marinus Pharmaceuticals, Inc.Institution denied
  PTAB · Sep 20, 2024 · IPR2024-00726 · APJ Erica A Franklin · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–21 were unpatentable under any of the three asserted obviousness grounds.

  RulingsInstitution decision

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

    “Based upon our review of the arguments and an examination of the claim language itself, the written description, and the prosecution history, we determine that the record supports finding that the entire “wherein” clause recited in independent claim 1 is limiting. This clause recites, wherein the effective amount of ganaxolone is administered as an intravenous bolus plus continuous infusion to produce and maintain a ganaxolone plasma concentration of about 500 ng/ml to about 1000 ng/ml for about 8 hours to about 12 hours.” slip op. at 10

  • Skill levelOther

    “Petitioner asserts that a person of ordinary skill in the art (“POSA”) at the time the application for the ’100 patent was filed “would have had a medical degree or a Ph.D. in pharmacology or fields related to the development of pharmaceuticals and would have been familiar with the PK [pharmacokinetics] and PD [pharmacodynamics] of pharmaceuticals.” Pet. 18. Additionally, Petitioner asserts “[a] POSA also would have had several years of experience as a practicing neurologist treating patients who suffer from seizure disorders, including SE, and/or several years of experience in researching treatments for such seizure disorders.” Id. (citing Ex. 1002 ¶ 50). According to Patent Owner, a person of ordinary skill in the art at the time the application for the ’100 patent was filed, “would have had a medical degree, or a Ph.D. in pharmacology or other field related to the development of pharmaceuticals, or equivalent degree, and several years of with Refractory Status Epilepticus, Poster Abstract F53, 37 J. CLIN. NEUROPHYSIOLOGY 332 (July 2020) (Ex. 1009, “Husain 2020”). experience as a practicing neurologist treating patients who suffer from seizure disorders including status epilepticus and/or several years of experience in researching treatments for such seizure disorders.” Prelim. Resp. 17–18 (citing Ex. 2011 ¶ 44). We note that the parties’ proposed definitions are largely similar, except that Patent Owner additionally recognizes “an equivalent degree” as an alternative to a medical degree or Ph.D. in pharmacology or other field related to the development of pharmaceuticals. Compare Pet. 18 with Prelim. Resp. 17–18. We do not need to resolve this issue as our findings and conclusion in this Decision would be the same under either proposed definition.” slip op. at 7

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

    “agree with Patent Owner that Petitioner has not shown sufficiently for institution that the claimed invention would have been obvious over the combined teachings of During and NCT03350035. As discussed above, in Section II.B., we have determined that the “wherein” clause of independent claim 1 is liming. In other words, the claim requires that the effective amount of ganaxolone is administered as an IV bolus plus continuous infusion and that such administration produces and maintains a ganaxolone plasma concentration of about 500 to 1000 ng/ml for about 8 to 12 hours. With respect to the recited plasma concentration limitation, Petitioner has alleged only that it is met inherently. Dr. Sankar has only offered the same conclusory position in his declaration. See Ex. 1002 ¶¶ 113, 115. While “inherency may supply a missing claim limitation in an obviousness analysis,” this doctrine “must be carefully circumscribed in the context of obviousness.” PAR Pharmaceutical, Inc. v. TWI Pharmaceuticals, Inc., 773 F.3d 1186, 1194–1195 (Fed. Cir. 2014). As the Federal Circuit has explained: The mere fact that a certain thing may result from a given set of circumstances is not sufficient. If, however, the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient. Id. at 1195 (quoting In re Oelrich, 666 F.2d, 578, 581 (C.C.P.A. 1981). Here, Petitioner and Dr. Sankar have not explained or demonstrated why or how the natural result of administering the dosages in During according to the method disclosed in NCT03350035 would produce and maintain a ganaxolone plasma concentration of about 500 to 1000 ng/ml for about 8 to 12 hours. This deficit is more pronounced in view of the Specification disclosure of a Phase 2 Open-Label Dose Range Study that exemplifies how some ganaxolone dosages that suppressed SE did not produce and maintain ganaxolone plasma concentrations ≥ 500 ng/ml for about 8 to 12 hours. See Ex. 1001, Fig 15; see also Ex. 1001, 55:13–56:30. Thus, because Petitioner relies on inherency for the plasma concentration limitation without providing evidence that such inherency exists, Petitioner has failed to establish sufficiently for institution that During and NCT03350035 teach or suggest each limitation of the claim 1. Accordingly, we determine that Petitioner has not shown a reasonable” slip op. at 17

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

    “agree with Patent Owner that Petitioner has not shown sufficiently for institution that the claimed invention would have been obvious over the combined teachings of During and NCT03350035. As discussed above, in Section II.B., we have determined that the “wherein” clause of independent claim 1 is liming. In other words, the claim requires that the effective amount of ganaxolone is administered as an IV bolus plus continuous infusion and that such administration produces and maintains a ganaxolone plasma concentration of about 500 to 1000 ng/ml for about 8 to 12 hours. With respect to the recited plasma concentration limitation, Petitioner has alleged only that it is met inherently. Dr. Sankar has only offered the same conclusory position in his declaration. See Ex. 1002 ¶¶ 113, 115. While “inherency may supply a missing claim limitation in an obviousness analysis,” this doctrine “must be carefully circumscribed in the context of obviousness.” PAR Pharmaceutical, Inc. v. TWI Pharmaceuticals, Inc., 773 F.3d 1186, 1194–1195 (Fed. Cir. 2014). As the Federal Circuit has explained: The mere fact that a certain thing may result from a given set of circumstances is not sufficient. If, however, the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient. Id. at 1195 (quoting In re Oelrich, 666 F.2d, 578, 581 (C.C.P.A. 1981). Here, Petitioner and Dr. Sankar have not explained or demonstrated why or how the natural result of administering the dosages in During according to the method disclosed in NCT03350035 would produce and maintain a ganaxolone plasma concentration of about 500 to 1000 ng/ml for about 8 to 12 hours. This deficit is more pronounced in view of the Specification disclosure of a Phase 2 Open-Label Dose Range Study that exemplifies how some ganaxolone dosages that suppressed SE did not produce and maintain ganaxolone plasma concentrations ≥ 500 ng/ml for about 8 to 12 hours. See Ex. 1001, Fig 15; see also Ex. 1001, 55:13–56:30. Thus, because Petitioner relies on inherency for the plasma concentration limitation without providing evidence that such inherency exists, Petitioner has failed to establish sufficiently for institution that During and NCT03350035 teach or suggest each limitation of the claim 1.” slip op. at 17

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 11,110,100

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.