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  • PTAB · Jan 14, 2026 · PGR2025-00059 · APJ Devon Zastrow Newman · PGR · Institution

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

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

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

    • Skill levelSkill level petitioner adoptedDecided for petitioner

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

    • Expert testimonyPetitioner expert discountedDecided for patent owner

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

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

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

    Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 12,115,233
  • PTAB · Apr 8, 2025 · PGR2024-00054 · APJ Julia Heaney · PGR · Institution

    The Board instituted PGR on claims 1–17 and 22–28 and all asserted grounds, finding a sufficient likelihood that at least one challenged claim is unpatentable.

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

      “Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate 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) (2018). Upon consideration of the parties’ submissions and the evidence of record, we determine that Petitioner has demonstrated that it is more likely than not that at least one claim challenged in the Petition is unpatentable. Further, Patent Owner has not persuaded us that it is appropriate to exercise our discretion not to institute review. Accordingly, we institute a post-grant review of all claims and all grounds asserted in the Petition.1” slip op. at 2

    • Skill levelSkill level patent owner adoptedOther

      “On this record, we do not find Patent Owner’s proposed experience level of at least five years in measurement and analysis of coefficient of friction to be supported. As to the necessity of experience in textile engineering and fiber science, Patent Owner’s position, although not supported by declarant analysis of the factors listed above, is consistent with the disclosure of the ’854 patent, which describes features of a mesh layer in textile and fiber terms. See e.g., Ex. 1001, 10:17–11:14, 12:65–13:8, 14:20–24. On the whole, however, we do not discern on this record how specific experience in textile engineering and fiber science of a person of ordinary skill would materially alter the outcome at this stage of the proceeding. For purposes of this decision only, we apply Patent Owner’s proposed definition of a person of ordinary skill in the art, except for the requirement of five years of experience in measurement and analysis of coefficient of friction. The level of skill in the art remains an open issue in this proceeding. Further submissions by the parties may include argument and evidence that would assist in the resolution of this issue at the close of trial.” slip op. at 8

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

      “Petitioner contends “no formal claim construction is necessary in this proceeding.” Pet. 10; Reply 1, 4. Patent Owner contends the terms “mesh layer” and “coefficient of friction” require construction. Prelim. Resp. 14–16; Sur-reply 2–5. We have considered the parties’ arguments and discuss them below with regard to each of the terms Patent Owner contends should be construed. Because our determination that Petitioner demonstrates at least one challenged claim meets the threshold for institution (see SAS Inst., 138 S. Ct. at 1359–60) is not based on construing the term “mesh layer” or “coefficient of friction,” we determine we need not construe either claim term at this stage of the proceeding. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)). As further discussed below, we invite the parties to address claim construction at trial.” slip op. at 9

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

      “We agree with Petitioner that the ’854 patent specification does not include clear and explicit lexicography or a disclaimer that would support requiring “coefficient of friction” to be determined by a specific ASTM test method. The portion of the specification Patent Owner asserts as a definition of “coefficient of friction” (see Ex. 1001, 11:31–42) is a description of an embodiment; we find it does not express patentee intent to redefine the term. Further, the statement that “the coefficient of friction … may be determined using the … ASTM D1894 standard test method” (id. at 11:32–35) indicates that use of that specific test method is optional. Accordingly, in the absence of patentee lexicography or disavowal, we do not limit the scope of the term “coefficient of friction” to require that it be measured by a specific ASTM standard. Luminara Worldwide, LLC v. Liown Elecs. Co., 814 F.3d 1343, 1353 (Fed. Cir. 2016) (“Absent lexicography or disavowal, we do not depart from the plain meaning of the claims.”); In re Am. Acad. Of Sci. Tech Ctr., 367 F.3d 1359, 1369 (Fed. Cir. 2004) (“We have cautioned against reading limitations into a claim from the preferred embodiment described in the specification, even if it is the only embodiment described, absent clear disclaimer in the specification.”). We note that the ’854 patent specification sets forth a definition for the coefficient of friction between the surfaces of the mesh material and the slide surface. Ex. 1001, 4:38–46. As stated above, however, we do not expressly construe any claim term at this stage of the proceeding. Should the parties address the construction of “coefficient of friction” at trial, we will make a determination after the close of evidence and any hearing.” slip op. at 13

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · Graham
    Patents in suitUS 11,998,854
  • PTAB · Jan 24, 2024 · IPR2023-01184 · APJ Julia Heaney · IPR · Institution

    The Board instituted IPR on claims 1–19 and all petition grounds, finding a reasonable likelihood that claims 1, 2–4, 6–8, 15–16, and 18–19 are unpatentable.

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

      “Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). Upon consideration of the Petition and the evidence of record, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of all claims and all grounds asserted in the Petition.1” slip op. at 2

    • Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateOther

      “Although Petitioner has asserted the absence of specific supporting disclosure for claims 1, 15, and 18 from the ’780, ’317, and ’977 applications and the ’155, ’587, ’601, ’977, and ’753 provisional applications, the burden to show an effective filing date (or dates) of the challenged claims prior to April 22, 2010 falls on Patent Owner here because Petitioner has asserted prior art references with earlier effective dates. In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1376 (Fed. Cir. 2016) (In an inter partes review, “a patentee bears the burden of establishing that its claimed invention is entitled to an earlier priority date than an asserted prior art reference.”). An earlier effective filing date is not presumed because, as shown in the above figure, the ’783 application is a continuation-in-part to each of the ’780, ’317, and ’977 applications that have filing dates earlier than April 22, 2010. See PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1305 (Fed. Cir. 2008) (“When neither the PTO nor the Board has previously considered priority, there is simply no reason to presume that claims in a [continuation-in-part] application are entitled to the effective filing date of an earlier filed application.”). On this record, and in the absence of the development of any contrary argument, we find that Petitioner has demonstrated sufficiently for institution that each of the asserted references are prior art to the challenged claims. The parties will have an opportunity to present their positions on the issue of the effective filing date of the challenged claims further during trial.” slip op. at 11

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

      “of Kronberg, discloses or suggests all of the elements of claim 6. Pet. 28–34 (citing Ex. 1002 ¶¶ 107–148). More particularly, Petitioner argues that Adest discloses the limitations of claims 6, but to the extent there is a dispute that Adest discloses the “watchdog unit” limitation [6A], a person of ordinary skill in the art would have been motivated to combine the watchdog apparatus taught by Kronberg with the solar power system taught by Adest to monitor communications between signal mechanism 420 and power modules 405 of Adest. Id. at 32 (citing Ex. 1002 ¶ 127). Petitioner further argues that the watchdog taught by Kronberg was a well-known technique for detecting malfunctions at the time of the invention, and would have been one of a number of solutions for detecting the absence of a periodic signal. Id. (citing Ex. 1002 ¶¶ 128–129; Ex. 1009, 1269). Petitioner further argues that Kronberg “suggests that its watchdog apparatus is to be used to provide ‘automatic shutdown of critical devices in case of failure,’” consistent with Adest’s objective of shutting down a power generating facility when a transmitter fails to send a communication because of, for example, a fire or theft of a photovoltaic module. Id. at 32–33 (citing Ex. 1006, 1:12–15; Ex. 1005, 7:6–12).” slip op. at 19

    • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for patent owner

      “The limitation “means to poll the central controller to determine if an interruption of the communication is transient” presumptively invokes 35 U.S.C. § 112 ¶ 6. Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1348 (Fed. Cir. 2015) (en banc in relevant part). Claims subject to 35 U.S.C. § 112 ¶ 6 are construed in a “two-step process,” whereby we “first identify the claimed function,” and then “determine what structure, if any, disclosed in the specification corresponds to the claimed function.” Id. at 1351. Accordingly, our rules require that the Petition “identify the specific portions of the specification that describe the structure, material, or acts corresponding to each claimed function.” 37 C.F.R. § 42.104(b)(3). Further, “the corresponding structure for a § 112 ¶ 6 claim for a computer-implemented function is the algorithm disclosed in the specification” Aristocrat Techs. Austl. Pty Ltd. v. Int’l Game Tech., 521 F.3d 1328, 1333 (Fed. Cir. 2008) (quoting Harris Corp. v. Ericsson Inc., 417 F.3d 1241, 1249 (Fed. Cir. 2005)). Federal Circuit precedent requires disclosure of an algorithm in the specification for any computer-implemented function beyond “basic functions of a microprocessor.” See EON Corp. IP Holdings, LLC v. AT&T Mobility LLC, 785 F.3d 616, 623 (Fed. Cir. 2015) (“A microprocessor or general purpose computer lends sufficient structure only to basic functions of a microprocessor. All other computer implemented functions require disclosure of an algorithm.”). Petitioner does not identify any portion of the ’218 patent specification that describes corresponding structure for performing the claimed function of “poll[ing] the central controller to determine if an interruption of the communication is transient.” See Pet. 39. Accordingly, Petitioner has not identified sufficient corresponding structure for performing the function of this presumptive means-plus-function limitation.” slip op. at 22

    Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 8,823,218
  • PTAB · Oct 13, 2023 · PGR2023-00022 · APJ Devon Zastrow Newman · PGR · Institution

    The Board instituted PGR on claims 1–33 under all petition grounds, finding it more likely than not that at least one claim lacks written description and enablement.

    RulingsInstitution decision
    • Skill levelSkill level board ownOther

      “Based on the information presented, we agree with Patent Owner that the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (prior art itself can reflect the appropriate level of ordinary skill in the art). We do not find it necessary to define the level of skill in the art at the time of the invention at this time. However, for purposes of deciding whether to institute trial, we find that Dr. Silverstone is qualified to provide helpful opinion testimony on the issues regarding which we cite his testimony in this decision. See Ex. 1003 ¶¶ 6–15.” slip op. at 7

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

      “Based on the above, we agree with Patent Owner that many of the arguments raised by the Examiner are highly similar to the challenges in this proceeding, particularly the written description challenge. However, some arguments differ. For instance, Petitioner’s enablement argument identifies that, contrary to Applicant’s statement during prosecution reproduced above, amino acids and protein structure outside the disclosed AAD-12 motif can also affect the activity of the claimed dioxygenases to degrade phenoxy auxin and pyridyloxy auxin. See Ex. 1003 ¶¶ 42–50, 79 (Dr. Silverstone describing the mechanics of protein binding and explaining why the ’055 patent disclosure fails to provide sufficient information to the skilled artisan to know which amino acids could be changed while retaining the ability to enzymatically degrade both phenoxy and pyridyloxy auxin herbicides). See also Pet. 27–34 (asserting, e.g., 85% homology to AAD-12 motif alone is insufficient to predict enzymatic degradation activity). While the Examiner’s rejections regarded the disclosure corresponding to the ability to degrade herbicides, the Examiner plainly relied on Applicant’s statements that the AAD-12 motif’s structure alone was responsible when deciding to withdraw the rejection. Ex. 1002, 355. The Examiner did not have the additional testimony supplied by the Silverstone declaration explaining otherwise. See Ex. 1003 ¶¶ 42–50, 79. Petitioner, through Dr. Silverstone, also addresses the effort the skilled artisan would have needed to undertake to determine what proteins outside of the AAD-12 motif would affect the ability of homologues to enzymatically degrade the recited herbicides, and provides evidence for consideration regarding the lack of a clear link between the AAD-12 motif and the ability to enzymatically degrade both phenoxy and pyridyloxy auxin herbicides. Ex. 1003, 347. Therefore, the arguments are not entirely overlapping. And while these issues do in part overlap with Petitioner’s arguments pertaining to enablement, we agree with Petitioner that the Examiner did not complete a written Wands analysis. Although we conclude that the arguments are not entirely overlapping, we proceed to the second step in the analysis, for completeness.” slip op. at 13

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

      “Because Petitioner has shown that it is more likely than not that Petitioner will prevail in showing that at least one claim lacks sufficient written description and is not enabled, we conclude the challenged claims are eligible for post-grant review. V. CONCLUSION After considering the evidence and arguments presently before us, we determine Petitioner has shown it is more likely than not that at least one challenged claim of the ’055 patent lacks written description and is unpatentable. Accordingly, we institute a post-grant review. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a), a post-grant review of claims 1–33 of the ’055 patent is instituted with respect to all grounds set forth in the Petition; and” slip op. at 57

    • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther

      “85% identity as “highly identical” in this field and that the “conserved motif residues comprise ‘the active site that is essential for catalytic activity.’” Prelim. Resp. 31 (citing Ex. 1001, 11:1–6)). However, on the record before us, we are unpersuaded that this is sufficient because the Specification lacks disclosure supporting that a polypeptide of, for example, 86% identity to SEQ ID NO: 2 would retain the ability to degrade herbicides if the 5 amino acids in the general formula of HX109D(X)111-134 T(X)136-261H(X)263-272R, and the required chain lengths are present. In this regard we are persuaded by the testimony of Dr. Silverstone (Ex. 1003 ¶¶ 48–93) regarding the limitations of the disclosure of the ’055 patent and the lack of information supporting the skilled artisan in understanding that the inventor possessed the entire claimed genus (e.g., lack of example at lower end of sequence identity and lack of information to assist the skilled artisan in predicting whether an α-ketoglutarate-dependent dioxygenase would interact with or degrade either phenoxy auxin herbicides and/or pyridyloxy auxin herbicides). Dr. Silverstone testifies, and we are persuaded on this record, that the skilled artisan would not have read the guidance in the disclosure and understood that the inventors possessed the ability to design a modified SEQ ID NO: 2 at the 85% identity level that retained the function of degrading the recited herbicides, let alone the full scope of the claimed genus. Id. Patent Owner argues that Dr. Silverstone’s testimony that conserved amino acids of the AAD-12 motif are present in other α- ketoglutarate-dependent dioxygenases but do not have the claimed dual activity (Ex. 1003 ¶ 48) is misplaced because it “ignores that the location and spacing of those residues in other αKG-dependent dioxygenases differ from those in the AAD-12 motif.” Prelim. Resp. 38. However, Patent Owner offers no evidence that supports its argument. Id. It is thus unpersuasive.” slip op. at 36

    § 112 disclosureDiscretionary denial
    Patents in suitUS 11,371,055
  • PTAB · Feb 14, 2023 · IPR2022-01417 · APJ Jeffrey W Abraham · IPR · Institution

    The Board instituted inter partes review of claims 1–27 on all asserted grounds, finding a reasonable likelihood that Nook-015 anticipates claims 1, 2, and 5–12.

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

      “review. 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2022). The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless the Director determines . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons set forth below, we determine the information presented in the Petition establishes a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims. Accordingly, we institute an inter partes review.” slip op. at 2

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

      “proceeding, we agree with Petitioner that the ’236 patent is not entitled to the 2014 priority date of the original application. Whether the Specification complies with the written description requirement calls for a comparison of the scope of the claim with the scope of the description to determine whether the inventor has demonstrated possession of the claimed invention. See Ariad, 598 F.3d 1336 at 1353; Power Oasis, 522 F.3d 1299, 1306. The independent claims of the ’236 patent each require (1) a load detection sensor “configured to detect presence of a vehicle battery” and (2) a reverse polarity sensor “configured to detect polarity of a vehicle battery.” Ex. 1001, 5:16–27 (claim 1), 6:7–22 (claim 13), 6:65–7:13 (claim 18), 8:1– 15 (claim 23). The Specification of the ’236 patent does not expressly disclose both a load detection sensor and reverse polarity sensor configured to perform the recited functions. Instead, the Specification identifies a single circuit, the “automatic detection module,” that “can automatically detect[] whether the load is detected” and “whether the electrode is connected with the automobile storage battery reversely.” Ex. 1001, 2:51–54. We are persuaded by Petitioner’s arguments that the disclosure of a single circuit capable of performing two functions does not demonstrate the inventors had possession of an invention that requires two separate sensors configured to perform separate functions as recited in the claims. See Ariad, 598 F.3d 1336 at 1352 (“[A] description that merely renders the invention obvious does not satisfy the [written description] requirement.”); Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000) (holding that “the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue,” but that “one skilled in the art, reading the original disclosure, must immediately discern the limitation at issue in the claims”); cf. PIN/NIP, Inc. v. Platte Chem. Co., 304 F.3d 1235, 1248 (Fed. Cir. 2002) (finding a claim for a method involving sequential application of two chemicals was invalid for lack of adequate written description where the specification indicated that the invention was a method of applying a “composition” containing the two chemicals). For all of the foregoing reasons, based on the present record, we agree with Petitioner that the Specification of the ’236 patent does not provide adequate written description support for distinct “load detection” and “reverse polarity” sensors, and, therefore, the challenged claims are not entitled to a priority date earlier than April 21, 2021, the filing date of the ʼ236 patent.” slip op. at 12

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

      “A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” Verdegaal Bros. Inc., v. Union Oil Co., 814 F.2d 628, 631 (Fed. Cir. 1987); see also Finisar Corp. v. DirecTV Group, Inc., 523 F.3d 1 US 9,007,015 B1, issued Apr. 14, 2015 (Ex. 1004). 2 US 9,245,888 B2, issued Jan. 26, 2016 (Ex. 1010). 3 US 10,60,024 B2, issued Mar. 31, 2020 (Ex. 1005). 1323, 1334 (Fed. Cir. 2008) (to anticipate a patent claim under 35 U.S.C. § 102, “a single prior art reference must expressly or inherently disclose each claim limitation”). Moreover, “[b]ecause the hallmark of anticipation is prior invention, the prior art reference—in order to anticipate under 35 U.S.C. § 102—must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements ‘arranged as in the claim.’” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)). Whether a reference anticipates is assessed from the perspective of one of ordinary skill in the art. See Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1368 (Fed. Cir. 2003) (“‘[T]he 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.” (alterations in original) (quoting In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991))). Additionally, “[u]nder the principles of inherency, if the prior art necessarily functions in accordance with, or includes, the claimed limitations, it anticipates.” MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999) (citation omitted); In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349–50 (Fed. Cir. 2002). slip op. at 6

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

      “C. Claim Construction In an inter partes review, we construe claim terms according to the standard set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–17 (Fed. Cir. 2005) (en banc). 37 C.F.R. § 42.100(b). Under Phillips, claim terms are afforded “their ordinary and customary meaning.” Phillips, 415 F.3d at 1312. “[T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” Id. at 1313. “Importantly, the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.” Id.” slip op. at 10

    Claim construction§ 102 anticipation§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 11,104,236
  • PTAB · Nov 14, 2022 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Institution

    The Board instituted PGR on claims 1–17 based on all asserted grounds, finding the petition showed they more likely than not lacked written description support and enablement.

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

      “For the reasons explained below, we find that Petitioner has met the threshold showing for post-grant review of claims 1–17 with respect to the first challenge (written description support for the claimed genus). On that basis, we institute post-grant review of all challenged claims. See SAS Institute Inc. v. Iancu, 138 S. Ct. 1348, 1358 (2018); 37 C.F.R. § 42.208(a) (“When instituting post-grant review, the Board will authorize the review to proceed on all of the challenged claims . . . .”). We address this challenge first, then provide the parties guidance on Petitioner’s second written description challenge (support for carbidopa itself).” slip op. at 19

    • Skill levelSkill level board ownOther

      “Ex. 1006, 1 (citations omitted). Accordingly, when considering the ’507 patent’s purpose, the type of problems encountered in the art, and prior art solutions to those problems, it is clear that with respect to levodopa/carbidopa treatments for Parkinson’s Disease, the pharmaceutical formulation and its resulting pharmacokinetics and patient experience are intertwined, thus supporting a requirement that a person of ordinary skill in the art have knowledge or experience in each of these areas. See, e.g., Indivior Inc. v. Dr. Reddy’s Labs., S.A., 930 F.3d 1325, 1345 (Fed. Cir. 2019) (finding no clear error in district court’s compromise measure of level of ordinary skill in the art as a team comprising different skill sets). In view of the above considerations, we preliminarily find that a person of ordinary skill in the art would be a member of a team that includes person(s) with (a) a Ph.D. in a field related to the development of pharmaceuticals (for example, pharmacology, pharmacokinetics, pharmaceutics, pharmaceutical chemistry, organic chemistry, biochemistry, molecular biology, medicinal chemistry, formulation development, or a related field), or equivalent degree, and 2–4 years of experience in the analysis of pharmacokinetic data, pharmaceutical formulation development, and/or drug discovery or development, or a B.S. or M.S. degree in a field related to the development of pharmaceuticals, or equivalent degree, and 4–6 years of experience in the analysis of pharmacokinetic data, pharmaceutical formulation development, and/or drug discovery or development, and (b) a medical degree or equivalent degree with experience in treating patients with Parkinson’s disease. In subsequent briefing, should the parties propose any differences from the team approach articulated above, they should support their proposal and address the impact, if any, of the differences on the pertinent disputes in this proceeding. Any final determination on the level of ordinary skill in the art will be made on the full trial record.” slip op. at 15

    • Expert testimonyPetitioner expert creditedOther

      “Additionally, based on their statements of qualifications and curricula vitae, for purposes of this Decision we find Drs. LeWitt and Sloan qualified to provide technical opinions from the perspective of a person of ordinary skill in the art. Ex. 1003 ¶¶ 1–10, pp. 87–119 (Dr. LeWitt’s statement of qualifications and curriculum vitae); Ex. 1004 ¶¶ 1–11, pp. 45–71 (Dr. Sloan’s statement of qualifications).” slip op. at 16

    • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

      “We agree with the parties that the express definition provided during prosecution should be adopted. See, e.g., Biotec Biologische Naturverpackungen GmbH v. Biocorp, Inc., 249 F.3d 1341, 1346–47 (Fed. Cir. 2001) (construing claims in accordance with definition provided in declarations submitted during prosecution). Accordingly, we preliminarily construe the term “a compound comprising levodopa” in accordance with the full definition Dr. Okun provided during prosecution, i.e., “any molecule with a levodopa core moiety including levodopa itself, as well as prodrugs, salts, and hydrates of levodopa.”” slip op. at 17

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · Graham
    Patents in suitUS 11,091,507
  • PTAB · Aug 15, 2022 · IPR2022-00381 · APJ Julia Heaney · IPR · Institution

    The Board instituted IPR on claims 1–10 and 12–18 on all asserted grounds, finding a reasonable likelihood that the claims are unpatentable as obvious.

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

      “Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). Upon consideration of the Petition, the Preliminary Response, and the evidence of record, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of all claims and all grounds asserted in the Petition.1” slip op. at 2

    • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther

      “Having reviewed the disclosures of the ’626 provisional application relied upon by Patent Owner, we do not agree that they would convey to a person of ordinary skill in the art that Mr. Niester had possession of using 222 or 282 nm wavelengths to disinfect human or animal skin. While they refer to human activity such as travel, surgery, and food preparation, the disclosures do not refer to disinfecting skin. Rather, they refer to sterilizing things in the presence of humans, such as surfaces and air, but not human or animal skin itself. Therefore, we determine that Petitioner has satisfied its initial burden of production on the effective-filing-date issue by identifying the absence of specific supporting disclosure for claim 1 from the ’626 provisional application. See Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d 1375, 1379–1380 (Fed. Cir. 2015) (discussing burden framework in inter partes review). Based on this record, we find that Petitioner has demonstrated a reasonable likelihood that it will prevail in establishing that challenged claims 1–10 are not entitled to an effective filing date earlier than the filing date of the PCT application. The parties will have an opportunity to develop their positions on the issue of the effective filing date of claims 1–10 during trial.” slip op. at 10

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

      “Having considered the evidence and arguments presented by both parties on the present record, we are persuaded Petitioner sufficiently shows that Eckhardt and Sosnin teach or suggest all of the limitations in claim 1, and sufficiently explains how a person of ordinary skill in the art would have used Eckhardt’s teaching of narrow spectrum light in the range of 220 to 310 nm to disinfect skin, with Sosnin’s implementation of excimer lasers including 222 and 282 nm to kill bacteria, to arrive at the method of claim 1 with a reasonable expectation of success. We disagree with Patent Owner’s argument that Eckhardt teaches away from the use of UV light on skin because it is based on a mischaracterization of Eckhardt, which does not teach bandages as a way to provide cover from direct UV light, but rather, compensates for application of UV light through a bandage by controlling the UV light intensity. Indeed, Eckhardt’s embodiment that Petitioner relies upon is titled “UV- Transmissive Bandage” and explains how to choose bandage materials that transmit UV-C light. See Ex. 1004 ¶¶ 69–72. We also disagree, on this record, with Patent Owner’s argument that Sosnin would dissuade a person of ordinary skill from using 222 or 282 nm wavelengths to disinfect skin . Although Patent Owner is correct that Sosnin refers to the need for additional testing before using its technology outside of a laboratory (Prelim. Resp. 31), Mr. Lawal directs us to evidence supporting his testimony that it was general knowledge in the art at the time of the invention that even though UV light poses safety risks to human skin, UV-C light of 222 nm on bare skin for disinfection was relatively safe. Ex. 1003 ¶¶ 88–91 (citing Exs. 1013, 1015, 1016, 1017). Patent Owner presents only attorney argument in response to Mr. Lawal’s testimony and supporting evidence. We invite the parties to continue to develop this issue during trial.” slip op. at 17

    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

      “We disagree with Patent Owner’s argument that Eckhardt teaches away from the use of UV light on skin because it is based on a mischaracterization of Eckhardt, which does not teach bandages as a way to provide cover from direct UV light, but rather, compensates for application of UV light through a bandage by controlling the UV light intensity. Indeed, Eckhardt’s embodiment that Petitioner relies upon is titled “UV- Transmissive Bandage” and explains how to choose bandage materials that transmit UV-C light. See Ex. 1004 ¶¶ 69–72. We also disagree, on this record, with Patent Owner’s argument that Sosnin would dissuade a person of ordinary skill from using 222 or 282 nm wavelengths to disinfect skin . Although Patent Owner is correct that Sosnin refers to the need for additional testing before using its technology outside of a laboratory (Prelim. Resp. 31), Mr. Lawal directs us to evidence supporting his testimony that it was general knowledge in the art at the time of the invention that even though UV light poses safety risks to human skin, UV-C light of 222 nm on bare skin for disinfection was relatively safe. Ex. 1003 ¶¶ 88–91 (citing Exs. 1013, 1015, 1016, 1017). Patent Owner presents only attorney argument in response to Mr. Lawal’s testimony and supporting evidence. We invite the parties to continue to develop this issue during trial.” slip op. at 17

    § 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · Graham
    Patents in suitUS 9,700,642

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.