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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 · Jan 27, 2025 · IPR2024-01098 · APJ Cynthia M Hardman · IPR · Institution

    The Board instituted IPR on all challenged claims 1–6 based on all asserted grounds, finding a reasonable likelihood that Kick anticipates or renders them obvious.

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

      “We have authority under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” After considering the briefing and cited evidence of record in view of this standard, we institute an inter partes review. The following preliminary findings of fact and conclusions of law are made solely to determine whether to institute review. Any final decision will be based on the full trial record.” slip op. at 2

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

      “challenged claims 1, 2, and 6 lack adequate written description support in the ’934 application as filed. See Pet. 10–11. The specification, figures, and claims as originally filed do not disclose any volume limitations. See Ex. 1004 (’934 prosecution history), 1–17. Instead, the volume limitations recited in the challenged claims find their first support in Figure 7, which was filed over one month after the ’934 application was originally filed. Compare id. at 1–17, with id. at 34–56. The addition of new matter during prosecution of a patent application is prohibited. See 35 U.S.C. § 132(a) (“No amendment shall introduce new matter into the disclosure of the invention.”); see also 37 C.F.R. § 1.121(f); Manual of Patent Examining Procedure (“MPEP”) § 608.04. Therefore, we agree with Petitioner that “the new matter improperly added during the prosecution of the ’934 application cannot be considered part of the disclosure of the original, April 19, 2010 application and/or relied upon for claiming priority in subsequent applications.” Pet. 9.” slip op. at 21

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

      “prosecution history), 34. We agree with Petitioner that “any claims in the subsequent applications that recite the new matter [are] entitled to, at the earliest, a priority date of February 25, 2020—the filing date of the ’195 application.” Pet. 10. As discussed above, challenged claims 1, 2, and 6 recite volume limitations that first find adequate support in Figure 7 of the ’195 application. Accordingly, on this record (and after consideration of Patent Owner’s arguments, discussed below), we determine that the priority date of the challenged claims is no earlier than the February 25, 2020, filing date of the ’195 application. Id. at 10–11. We agree with Petitioner that “Kick is prior art under 35 U.S.C. § 102(a)(1) with respect to the claims of the ’904 patent because it was published more than one year before the February 25, 2020, priority date of the challenged claims.” Pet. 16.” slip op. at 22

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

      “On this record, we find that the issues the parties raise regarding limitation [1z] are highly fact-intensive and implicate genuine issues of material fact that are more appropriately resolved on a fully-developed record. Accordingly, on this record we reserve judgment on these arguments, to allow the record to develop during trial.” slip op. at 30

    § 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 11,738,904
  • PTAB · Dec 18, 2024 · PGR2024-00035 · APJ Cynthia M Hardman · PGR · Institution

    The Board instituted PGR on all asserted grounds after finding the patent eligible for PGR and each challenged claim more likely than not unpatentable under at least one obviousness ground.

    RulingsInstitution decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level). However, we find some ambiguity in the last sentence of Petitioner’s proposal (“A POSITA could substitute additional education for industry experience and vice versa.”) because the reference to “additional education” is not tethered to relevant education. Accordingly, we modify the last sentence of Petitioner’s proposal to clarify that the additional education must be relevant. Thus, we restate that for purposes of this Decision, a person of ordinary skill in the art of the ’441 patent would have had: (i) an associate’s or bachelor’s degree in mechanical, industrial or manufacturing engineering and (ii) at least two to three years of practical experience with designing or manufacturing mechanical products such as food or beverage packaging. A POSITA could substitute additional relevant education for practical experience and vice versa. B. Post-Grant Review Eligibility As a threshold matter, we must determine whether Petitioner has” slip op. at 11

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateDecided for patent owner

      “In view of the evidence discussed above, we agree with Patent Owner that there is adequate written description support for a transparent container body such that a depression in the container base is “visible through at least a portion of the container body,” as recited in claims 9, 10, 15, and 16. Prelim. Resp. 9. Regarding Petitioner’s assertion that the ’441 patent does not disclose “a transparent/translucent liquid” (Pet. 7), we again disagree. As Patent Owner points out, “the ’441 Patent mentions beverages, such as ‘beer and soda,’ as liquids for which the claimed container would be suitable.” Prelim. Resp. 10 (quoting Ex. 1001, 1:25–27). Patent Owner demonstrates that a person of ordinary skill in the art “would have recognized that beer is typically see-through, or translucent.” Id. (citing Ex. 2012 (Till) ¶ 24 (discussing an inspection apparatus for bottles that “are filled with a transparent liquid (e.g. beer, table water, mineral water, wine etc.)”); Ex. 2013 (Schnuckle) ¶ 8 (noting “translucent to transparent liquids such as water, soda, juice, or the like”)). We agree with Patent Owner that the ’441 patent’s identification of “beer and soda as beverages the described and claimed container was intended to hold” provides adequate written description support “for having transparent or translucent liquids within the container.”12 Prelim. Resp. 10. For the reasons discussed above, on this record Petitioner has not demonstrated that claims 9, 10, 15, and 16 include subject matter having a November 10, 2023, priority date. Thus, Petitioner has not demonstrated that the ’441 patent is eligible for post-grant review under AIA § 3(n)(1)(A).” slip op. at 15

    • Expert testimonyPatent owner expert discountedDecided for petitioner

      “Patent Owner’s arguments are unavailing. As an initial matter, Mr. Kirkpatrick is opining about a design patent application, and Patent Owner has not established that Mr. Kirkpatrick possesses the education and experience of a designer of ordinary skill in the art of ornamental aspects of containers for storing liquids or solids. See Ex. 2001 ¶ 5 (implying that Mr. Kirkpatrick is a generalist whose experience with design patents is in preparing formal drawings of designs invented by others).17 For this reason alone, on this record we accord Mr. Kirkpatrick’s declaration little weight on the question of whether the ’195 parent application provides adequate written description support for originally-filed Figure 2 of the ’813 design application. See, e.g., Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022) (“To offer expert testimony from the perspective of a skilled artisan in a patent case . . . a witness must at least have ordinary skill in the art. Without that skill, the witness’ opinions are neither relevant nor reliable.”). Even if Mr. Kirkpatrick’s opinions were relevant, they would not change our conclusion regarding lack of adequate written description. Mr. Kirkpatrick attributes the differences between the drawings to “choices in drafting strategy of the respective illustrators,” such as how to use “contour lines to illustrate sloped surfaces” and how much detail to include for well-known features like pop-tops. See Ex. 2001 (Kirkpatrick Decl.) ¶¶ 19, 23–24, 28–32.18 These arguments are unavailing. First, there is no evidence of record indicating that the figures in the ’195 parent application and ’813 design application were created by different illustrators. Second, 17 Patent Owner also has not established that Mr. Kirkpatrick possesses the education and experience of a person of ordinary skill in the art of the ’441 patent, as we have defined it here. Supra Section II.A. 18 Mr. Kirkpatrick’s analysis of a photograph of a can submitted by the applicant during prosecution (see Ex. 2001 (Kirkpatrick Decl.) ¶¶ 25–32) is additionally unavailing because there is no evidence of record indicating that the patent illustrator(s) used this particular photograph or the depicted can to create the patent illustrations. we agree with Petitioner that even if different illustrators employ different drafting strategies, this “does not absolve Patent Owner’s responsibility not to add new matter.” Prelim. Reply 6.” slip op. at 28

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

      “Because the ’441 patent is eligible for post-grant review, we turn to an analysis of whether the Petition 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). C. Petitioner’s Grounds of Alleged Unpatentability As noted above in Section I.E, Petitioner asserts four different obviousness grounds. At this stage of the proceeding, Patent Owner does not address the merits of Petitioner’s obviousness grounds. See generally Prelim. Resp. For the reasons discussed below, we determine that Petitioner has demonstrated that it is more likely than not that the challenged claims are unpatentable based on the asserted grounds.” slip op. at 34

    Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · Graham
    Patents in suitUS 11,932,441
  • PTAB · Jun 11, 2024 · IPR2022-01602 · APJ Devon Zastrow Newman · IPR · Final written decision

    Claims 1–14 are unpatentable: claims 1–3 and 8–10 are anticipated by Weiman, and claims 4–7 and 11–14 are obvious over Weiman and Mozeleski; the revised motion to amend is denied.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Pet. 11 (citing Ex. 1002 (Drewry Decl.) ¶¶ 76–79). Patent Owner does not dispute Petitioner’s proposal. See generally Response. We adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the cited prior art and is undisputed on this record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 11

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “We find persuasive, and credit, Mr. Drewry’s testimony that (1) a POSITA would have appreciated that the proposed modification to replace Weiman’s screw/socket with Waugh’s angled version provides benefits including “avoiding selected muscular and abdominal anatomical structures,” and (2) such “benefits would have been desirable for certain applications, such as those where the patient’s anatomy dictates that OLIF would provide the patient with the best medical outcome.” Ex. 1044 (Drewry Second Supp. Decl.) ¶¶ 23–26; see also Ex. 1043 (Waugh), ¶¶ 54, 87–90 (describing use of angled screw holes to, e.g., “receive a fastener via a surgical pathway” and configured “to penetrate endplate tissue of a vertebral body”). We find the weight of evidence supports Petitioner’s articulation of a POSITA’s understanding of how to use angles to avoid anatomical features” slip op. at 61

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

      “Petitioner asserts that no terms require construction “because they are shown to be anticipated and/or obvious regardless of construction.” Pet. 12. Patent Owner did not propose any terms for construction. See generally Response. We determine that no claim terms require express construction to render this Decision.” slip op. at 18

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

      “j. Conclusion on Claim 1 For the above reasons, we determine that Petitioner has shown by a preponderance of the evidence that Weiman discloses each and every limitation of claim 1, and therefore anticipates claim 1.” slip op. at 28

    Patent outcomesUS 9,956,087 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 9,956,087
  • PTAB · Feb 22, 2024 · PGR2022-00055 · APJ Sean P O’Hanlon · PGR · Final written decision

    Claims 1–4 and 10–13 are unpatentable under § 101; claims 1–4 and 11–13 are also unpatentable as obvious over Pirovolou, Panchal, and Budiman, and claim 10 over those references plus Downton.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “The level of ordinary skill in the art is “a prism or lens” through which we view the prior art and the claimed invention. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). The person of ordinary skill in the art is a hypothetical person presumed to have known the relevant art at the time of the invention. In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). In determining the level of ordinary skill in the art, we may consider certain factors, including: “(1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field.” Best Med. Int’l, Inc. v. Elekta Inc., 46 F.4th 1346, 1353 (Fed. Cir. 2022) (citations omitted). “The patent’s purpose can also be informative.” Id. (citation omitted).” slip op. at 9

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

      “The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (alteration in original) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Neither party presents arguments for the express construction of any term, instead interpreting the claim terms according to their ordinary and customary meaning. Pet. 18; PO Resp. 29. For purposes of this Decision, and based on the record before us, we determine that no construction of any term is necessary. slip op. at 10

    • Patent Eligibility (§101) › Alice/Mayo step one — 'directed to'Step1 directed to exceptionUnpatentable

      “information (recitations 1.3, 1.8), using received information to generate a set of possible drilling paths (recitation 1.4), removing certain ones of the generated possible paths (recitations 1.5–1.6), selecting a desired one of the generated paths (recitation 1.7), and updating a plan to include the selected path (recitation 1.9). This collection and manipulation of data is similar to the data collection and management concepts that were held to be patent ineligible in previous cases. See Content Extraction & Transmission LLC v. Wells Fargo Bank, 776 F.3d 1343, 1345, 1347 (Fed. Cir. 2014); In re TLI Commc’ns LLC Patent Litig., 823 F.3d 607, 610, 613 (Fed. Cir. 2016); Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1351–54 (Fed. Cir. 2016). Although the claim enumerates the type of information (i.e., BHA location, target path, and possible convergence paths) that is acquired and analyzed, the Federal Circuit has explained that the mere selection and manipulation of particular information by itself does not make an abstract concept any less abstract. Elec. Power Grp., 830 F.3d at 1353; Dig. Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1351 (Fed. Cir. 2014).” slip op. at 20

    • Patent Eligibility (§101) › Alice/Mayo step two — inventive conceptStep2 no inventive conceptUnpatentable

      “removing illogical options as the “pruning” step, rather than both of the “removing” steps as asserted by Patent Owner. See Ex. 1001, 6:21–34, 6:42–43, 6:50. The two “removing” steps noted by Patent Owner reduce the number of cost considerations that the computer must perform (by increasing the number of other comparisons (regarding illogical options and rule violations)), but do not change the way in which the computer performs the cost analyses. And, as explained above, neither the “removing” steps nor any other recitation alters the way in which drilling is performed. Moreover, as also noted above, the “removing” steps relied upon by Patent Owner are part of the abstract idea itself and, therefore, cannot evidence an inventive concept. See Berkheimer v. HP Inc., 890 F.3d 1369, 1374 (Fed. Cir. 2018) (Moore, J., concurring); BSG Tech LLC v. BuySeasons, Inc., 899 F.3d 1281, 1290–91 (Fed. Cir. 2018). As noted above, the additional elements of the processor and memory are recited at a high level of generality, i.e., as a generic processor performing a generic computer function of processing data. The ’454 patent also describes the processor and memory as generic computer components. See Ex. 1001, 4:50–5:29. The claim includes the additional recitations of a memory and processor to send a control signal. A memory for storing data and a processor for processing data and sending signals are well‐understood, routine, and conventional computer components, which in this claim are recited at a high level of generality and perform generic computer functions (e.g., storing, processing, and transmitting information). See Ex. 1003 ¶¶ 104–105 (citing Ex. 1006 ¶ 22, Fig. 2, code (57)). Generic computer components performing generic computer functions, alone, do not amount to significantly more than the abstract idea, as the Supreme Court has explained that “the mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.” Alice, 573 U.S. at 223. Viewing the limitations in combination also fails to amount to significantly more than the abstract idea. The claimed system seeks to use a processor and memory to generate possible convergence paths, remove certain ones of the generated possible paths, select a desired one of the generated paths, update a plan to include the selected path, and send a signal, but these functions reflect ordinary usage typically performed by a generic computer, as would be recognized by those of ordinary skill in the field of mining. See, e.g., Ex. 1006 ¶ 22, code (57). The claim here does not invoke any of the considerations that courts have identified as providing significantly more than an exception; the combination of elements is no more than the sum of their parts. Additionally, as the Federal Circuit has explained, claims that do not include a requirement for performing “claimed functions of [data] gathering, analyzing, and [transmitting] by use of anything [other than] conventional, generic technology” fail to provide an inventive concept. Elec. Power Grp., 830 F.3d at 1356. Accordingly, on this record, Petitioner sufficiently shows that the claim as a whole does not amount to significantly more than the recited exception.” slip op. at 29

    Patent outcomesUS 11,170,454 unpatentable
    Claim construction§ 101 eligibility§ 102 anticipation§ 103 obviousnesscites Alice · Mayo · Bilski · Electric Power · KSR · Graham
    Patents in suitUS 11,170,454
  • PTAB · Oct 31, 2023 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Final written decision

    The Board cancelled claims 1–17 and denied substitute claims 18–30 for lack of written-description support; it did not reach the remaining grounds against the substitute claims.

    RulingsFinal written decision
    • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part

      “For the reasons discussed below, on the full trial record, we find that Patent Owner has not carried its burden of showing by a preponderance of the evidence that the proposed substitute claims introduce no new matter relative to the original disclosure. 35 U.S.C. § 326(d)(3); 37 C.F.R. § 42.221(d)(1); see also Paper 58, 2 (Patent Owner acknowledging that it “bears the burden to meet the regulatory and statutory requirements” for a motion to amend, including demonstrating that the substitute claims do not “introduce new matter”). Importantly, we note that Patent Owner fails to explain how the material cited in the claim chart supports the claims. See Mot. 15–16. Instead, Patent Owner provides only a claim chart with bare citations, leaving it to the panel to discern how the cited material supports the claim limitations. See id. Patent Owner’s failure to explain the citations constitutes a fatal error, as we have reviewed the passages cited by Patent Owner and are unable to discern where support is found for several of the substitute claim limitations. Where, as here, “the Board is unable to determine how the specification and drawings support the proposed substitute claims, the motion to amend may be denied.” Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019) (“TPG”),6 71.” slip op. at 15

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

      “Petitioner persuades us that the ’418 Application lacks adequate written description support for the formulation limitations of proposed substitute claim 18 [limitations 18a–8c]. As outlined by Petitioner and its declarants, the ’418 Application, including the Abstract, Field of the Invention, Summary of the Invention, and Detailed Description of the Invention sections, uniformly focuses on phosphate prodrugs of levodopa and carbidopa. See, e.g., Ex. 1004 (Sloan Decl.) ¶¶ 38–55, 64–69; Ex. 1003 (LeWitt Decl.) ¶¶ 89–97; Ex. 1047 (Forrest Decl.) ¶¶ 40–74, 80–92; Opp. 6– 10; Pet. 23–26, 49–55. We agree with Petitioner that “nothing in the specification suggests that the invention includes methods of subcutaneous infusion with anything other than the carbidopa prodrugs and L-dopa prodrugs of Formulas (I) and (II), respectively, or teaches how to get sufficient amounts of either L-dopa or carbidopa into solution, or achieve particular L-dopa plasma levels, without those particular prodrugs.” Pet. 27. Petitioner persuades us that the ’418 Application fails to contain “[so] much as a single generic sentence, anywhere in the application, suggesting the inventors possessed the claimed formulations.” Sur-reply 3. Additionally, the ’418 Application contains no example teaching administration of an aqueous formulation comprising carbidopa itself with levodopa itself or one of the three claimed levodopa prodrugs, let alone one that is suitable for continuous subcutaneous administration. See Ex. 1047 (Forrest Decl.) ¶¶ 61–72, 82–92. Patent Owner is correct that to establish written description support, neither “an actual reduction to practice,” nor a verbatim recitation of the claims is required. Sur-reply 4. Nevertheless, “[a]lthough examples are not always required to satisfy the written description requirement, the lack of any disclosure of examples may be considered when determining whether the claimed invention is adequately described.” Bos. Sci. Corp. v. Johnson & Johnson, 647 F.3d 1353, 1364 (Fed. Cir. 2011). Here, the lack of an actual reduction to practice or verbatim description of a formulation that falls within the scope of the claims is relevant, because we also see no other description or material in the ’418 Application that suggests the claimed methods extend to continuous subcutaneous administration of a composition comprising levodopa or one of the three claimed levodopa prodrugs, together with carbidopa, in an aqueous carrier.” slip op. at 28

    • ExcludeMotion to exclude, deniedDenied

      “All of the exhibits that are the subject of Patent Owner’s motion to exclude relate to the prior-art status and/or authenticity of Yacoby-Zeevi and ancillary related documents underlying Petitioner’s prior art-based challenges to the proposed substitute claims. See generally MTE. Because we deny Patent Owner’s request to enter proposed substitute claims 18–30 based on lack of written description support and do not reach Petitioner’s prior-art based challenges to the patentability of these claims, we do not rely on Exhibits 1005, 1007, 1040–1044, 1046, or 1048–1050 in this Decision. Accordingly we dismiss Patent Owner’s Motion to Exclude as moot.” slip op. at 49

    • Strike new argumentNew argument consideredDenied

      “On the other hand, Petitioner shows that Patent Owner took positions in its Motion to Amend that it only later sought to support with technical declarations. For example, in the Motion to Amend, Patent Owner elected to assert “that levodopa and carbidopa could be ‘interchanged’ in a formulation with their prodrugs, and that a skilled artisan could ‘perform a pharmacokinetic analysis to predict steady state levodopa plasma levels’ using the ‘parent compounds’ based on Example 24.” MTS 2 (citing Mot. 12–13). Patent Owner, however, “chose to forgo any expert support” on these issues at the time it filed its Motion to Amend, and instead waited until the Reply to submit technical declarations in support of these arguments. Id. We agree with Petitioner that although Patent Owner “was not required to anticipate the arguments that [Petitioner] would make in its Opposition” to the Motion to Amend, if Patent Owner “wanted to provide expert testimony to support the positions it actually took” in that Motion, “the TPG required [Patent Owner] to do so at that time, instead of waiting until [Petitioner] had limited ability to respond.” Id. at 5. Accordingly, we agree with Petitioner that in this respect at least some portions of Patent Owner’s Declarations are untimely, because it is “improper for a reply to present new evidence (including new expert testimony) that could have been presented in a prior filing.” TPG 74. Nevertheless, an order striking arguments and evidence in their entirety is an “exceptional remedy,” particularly under the circumstances here, where some portions of the Declarations are proper, while other portions are untimely. TPG 80. Moreover, “there is a strong public policy for making all information filed in an administrative proceeding available to the public.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012- 00010, Paper 59 at 40 (PTAB Feb. 24, 2014). Under the facts of this case, Patent Owner was permitted to file evidence to respond to Petitioner’s unpatentability claims, but also belatedly supported positions it made in earlier attorney argument. Petitioner’s Motion to Strike, however, challenges all of Patent Owner’s evidence, without acknowledging that some portions constitute proper reply. Although “[t]he Board is not required to attempt to sort proper from improper portions of the reply” (TPG 74, emphasis added), under the circumstances here, we agree with Patent Owner that Petitioner’s lack of specificity as to what it seeks to strike is fatal to Petitioner’s motion. Accordingly, we decline to strike the Declarations in their entirety as untimely.” slip op. at 46

    § 112 disclosure
    Patents in suitUS 11,091,507
  • 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 · Mar 13, 2023 · PGR2022-00055 · APJ Sean P O’Hanlon · PGR · Institution

    The Board instituted PGR on claims 1–4 and 10–13, finding the petition showed a reasonable likelihood of prevailing on § 101 and § 103 grounds.

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

      “We have authority to determine whether to institute a post-grant review. 35 U.S.C. § 324(c) (2018); 37 C.F.R. § 42.4(a). Institution of postgrant review is authorized by statute only when “the information presented in the petition . . . , if such information is not rebutted, 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). “When instituting post-grant 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.” 37 C.F.R. § 42.208(a)). Having considered the arguments and evidence presented by Petitioner and Patent Owner, we determine that Petitioner has demonstrated that it is more likely than not that it will prevail with respect to at least one challenged claim. Accordingly, we institute post-grant review of the challenged claims of the ’454 patent.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner does not contest Petitioner’s definition or offer a definition of its own. See generally Prelim. Resp. Based on the arguments presented and the cited references, we find Petitioner’s definition of the level of ordinary skill reasonable and, for purposes of this Decision, adopt it as our own.” slip op. at 10

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

      “The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (alteration in original) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Neither party presents arguments for the express construction of any term, instead interpreting the claim terms according to their ordinary and customary meaning. Pet. 18; Prelim. Resp. 15. For purposes of this Decision, and based on the record before us, we determine that no construction of any term is necessary. We note that this determination does not preclude the parties from arguing their proposed constructions of the claims during trial. Indeed, the parties are hereby given notice that claim construction, in general, is an issue to be addressed at trial. A final determination as to claim construction will be made at the close of the proceeding, after any hearing, based on all the evidence of record. slip op. at 11

    • Patent Eligibility (§101) › Alice/Mayo step one — 'directed to'Step1 directed to exceptionInstituted

      “Claim 1 recites a system that performs the steps of receiving information (recitations 1.3, 1.8), using received information to generate a set of possible drilling paths (recitation 1.4), removing certain ones of the generated possible paths (recitations 1.5–1.6), selecting a desired one of the generated paths (recitation 1.7), and updating a plan to include the selected path (recitation 1.9). This collection and manipulation of data is similar to the data collection and management concepts that were held to be patent ineligible in previous cases. See Content Extraction & Transmission LLC v. Wells Fargo Bank, 776 F.3d 1343, 1345, 1347 (Fed. Cir. 2014); In re TLI Commc’ns LLC Patent Litig., 823 F.3d 607, 610, 613 (Fed. Cir. 2016); Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1351–54 (Fed. Cir. 2016). Although the claim enumerates the type of information (i.e., BHA location, target path, and possible convergence paths) that is acquired and analyzed, the Federal Circuit has explained that the mere selection and manipulation of particular information by itself does not make an abstract concept any less abstract. Elec. Power Grp., 830 F.3d at 1353; Dig. Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1351 (Fed. Cir. 2014). Accordingly, on this record, Petitioner sufficiently shows that the claim recites an abstract idea that falls within the grouping of mental processes. See Elec. Power Grp., 830 F.3d at 1355.” slip op. at 19

    Claim construction§ 101 eligibility§ 102 anticipation§ 103 obviousnesscites Alice · Mayo · Bilski · Electric Power · KSR · Graham
    Patents in suitUS 11,170,454
  • PTAB · Feb 8, 2023 · IPR2022-01335 · APJ Arthur M Peslak · IPR · Institution

    The Board instituted IPR on claims 19, 20, and 37–52 based on the §103 combination of Hardin and Salmre, finding a reasonable likelihood of prevailing.

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

      “on behalf of the Director.”). Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the Petition shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Considering the Petition, the arguments presented in the Preliminary Response, as well as all supporting evidence, we conclude that the information presented in the Petition establishes that there is a reasonable likelihood that Petitioner would prevail in its challenge of at least one claim of the ’447 patent as unpatentable. Pursuant to 35 U.S.C. § 314, we hereby institute an inter partes review of all Challenged Claims of the ’447 patent on the ground stated in the Petition.” slip op. at 3

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

      “(1) Petitioner asserts that substantially the same two claim limitations lack written description support in the ’094 application and U.S. Patent Application No. 13/856,392 (“the ’392 application”) (compare Pet. 23–29, with IPR2022-01333, Paper 4 (petition) at 23–28); (2) Petitioner asserts that because these limitations lack written description support in the ’094 and ’392 applications, the Challenged Claims are not entitled to the priority date of either of these applications and, therefore, Hardin ’665 (the pre-issuance publication of the ’094 application) is available as prior art to the Challenged Claims (compare Pet. 1, 2, 28–29, with IPR2022-01333, Paper 4 at 1, 2, 28–29);” slip op. at 15

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

      “(3) Petitioner asserts that the same combination of references— Hardin ’665 and Salmre—would have rendered the subject matter of the claims challenged in each petition obvious to one of ordinary skill in the art at the time of the invention (compare Pet. 29–64, with IPR2022-01333, Paper 4 at 29–66); (4) Petitioner asserts the same reasons with rational underpinning as to why one of ordinary skill in the art would have been motivated to combine the teachings of Hardin ’665 and Salmre as proposed with a reasonable expectation of success (compare Pet. 65–71, with IPR2022-01333, Paper 4 at 66–71);” slip op. at 15

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

      “that we should exercise our discretion to deny institution pursuant to 35 U.S.C. § 314(a) and Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential) (compare Prelim. Resp. 61–66, with IPR2022-01333, Paper 9 at 61–66);” slip op. at 16

    Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips
    Patents in suitUS 10,984,447
  • PTAB · Feb 8, 2023 · IPR2022-01334 · APJ Arthur M Peslak · IPR · Institution

    The Board instituted review of claims 18 and 21–36 on the Hardin and Salmre obviousness ground, finding a reasonable likelihood of success.

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

      “on behalf of the Director.”). Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the Petition shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Considering the Petition, the arguments presented in the Preliminary Response, as well as all supporting evidence, we conclude that the information presented in the Petition establishes that there is a reasonable likelihood that Petitioner would prevail in its challenge of at least one claim of the ’447 patent as unpatentable. Pursuant to 35 U.S.C. § 314, we hereby institute an inter partes review of all Challenged Claims of the ’447 patent on the ground stated in the Petition.” slip op. at 3

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

      “lack written description support in the ’094 application and U.S. Patent Application No. 13/856,392 (“the ’392 application”) (compare Pet. 23–28, with IPR2022-01333, Paper 4 (petition) at 23–28); (2) Petitioner asserts that because these limitations lack written description support in the ’094 and ’392 applications, the Challenged Claims are not entitled to the priority date of either of these applications and, therefore, Hardin ’665 (the pre-issuance publication of the ’094 application) is available as prior art to the Challenged Claims (compare Pet. 1, 2, 28–29, with IPR2022-01333, Paper 4 at 1, 2, 28–29);” slip op. at 14

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

      “Hardin ’665 and Salmre—would have rendered the subject matter of the claims challenged in each petition obvious to one of ordinary skill in the art at the time of the invention (compare Pet. 29–62, with IPR2022-01333, Paper 4 at 29–66); (4) Petitioner asserts the same reasons with rational underpinning as to why one of ordinary skill in the art would have been motivated to combine the teachings of Hardin ’665 and Salmre as proposed with a reasonable expectation of success (compare Pet. 59–65, with IPR2022-01333, Paper 4 at 66–71);” slip op. at 15

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

      “that we should exercise our discretion to deny institution pursuant to 35 U.S.C. § 314(a) and Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential) (compare Prelim. Resp. 61–66, with IPR2022-01333, Paper 9 at 61–66);” slip op. at 15

    Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips
    Patents in suitUS 10,984,447
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