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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 · Nov 20, 2025 · PGR2024-00034 · APJ Annette R Reimers · PGR · Final written decision

    Claims 1–19 are unpatentable: claims 1–19 as obvious over Unger and Smith, claim 18 also as obvious over Unger, Smith, and Hakansson, and claims 3–6, 8, 9, and 16 as indefinite.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “We note that the identification of a Ph.D. as an example of “more formal education” creates a vast range of education relative to a bachelor’s degree. Thus, we treat the identification of a Ph.D. just as it is—an example—and not a requirement. In this case, “more formal education” can be satisfied by a level of education less than a Ph.D (but greater than a bachelor’s degree). Based on our review of the record before us, we determine that Petitioner’s stated level of ordinary skill in the art is reasonable because it appears consistent with the evidence of record, including the asserted prior art. Accordingly, we adopt Petitioner’s definition, limited as discussed above, for the purposes of this Decision.” slip op. at 15

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

      “Petitioner contends that it “does not believe any terms need to be construed to resolve the prior art issues presented in this Petition.” Pet. 20 (citing Ex. 1002 ¶ 89). any claim language because doing so would have no effect on our analyses below of Petitioner’s asserted grounds and will not assist in resolving the present controversy between the parties. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 15

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

      “Petitioner argues that one of ordinary skill in the art would have found the proposed modification obvious for several reasons. Pet. 30. For instance, Petitioner argues that “Unger contains an express teaching, suggestion and/or motivation to incorporate an element such as Smith’s torsional spring into the lower and/or upper mount assemblies 308, 312 to facilitate attachment and detachment.” Id. Namely, Petitioner points to Unger’s disclosure that device mounts 308, 312 may be flexible or resilient so that device mounts 308, 312 may be bent to engage a portion of hearing protection device 108 and are then allowed to return to a normal state to secure communication device 104 to hearing protection device 108. Id. at 30–31 (quoting Ex. 1004, 6:20–37). Petitioner adds that one of ordinary skill in the art would have understood this disclosure “to teach that mount arms 308, 312 could be removable from housing 304 (e.g., as mount arm 312 is in Figure 6) and/or they could be designed to be ‘flexible’ or ‘resilient’ such that they can be manipulated,” and “that ‘resilient’ is defined as ‘bouncing or springing back into shape, position, etc. after being stretched, bent, or, esp., compressed.’” Id. at 31 (citing Ex. 1002 ¶ 117). Thus, according to Petitioner, this disclosure of Unger suggests using a torsion spring. Id. In addition, Petitioner asserts that one of ordinary skill in the art would have understood Unger’s disclosure to “suggest the use of a torsion designed to impart this functionality.” Pet. 30 (citing Ex. 1002 ¶ 118). Petitioner also asserts that one of ordinary skill in the art would have “understood that there were a limited number of ways to impart the referenced resilient or flexible ‘manipulation,’” and “would have been motivated to look to various known solutions to impart the suggested functionality, including the torsional spring mechanism of Smith that is used in a similar hearing protection device application for a similar purpose as Unger’s mounting arms (to apply a clamping force).” Id. at 32 (citing Ex. 1002 ¶¶ 120–121). Other reasons for combining the references set forth by Petitioner are the proposed modification: (1) “would have involved applying a known technique to a known device ready for improvement to yield predictable results” (Pet. 39–49 (citing Intel Corp. v. PACT XPP Schweiz AG, 61 F.4th 1373, 1380 (Fed. Cir. 2023); Ex. 1002 ¶ 131)), (2) would have constituted “combining prior art elements using known methods to achieve predictable results” (id. at 40 (citing KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007); Ex. 1002 ¶ 133)); and (3) would have been “the simple substitution of one known element (i.e., Smith’s torsion spring mechanism) into another (i.e., the connection point of Unger’s lower mount arm 308 and housing 304)” (id. at 40–41 (citing Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034, 1077 (Fed. Cir. 2016); Ex. 1002 ¶ 135)). Petitioner argues that one of ordinary skill in the art would have had a” slip op. at 22

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

      “i) Conclusion For the above reasons, we find, based on the record before us, that Petitioner establishes by a preponderance of the evidence that claim 1 would have been obvious over the combination of Unger and Smith. Patent Owner does not contend that any limitations in claim 1 are absent in the combination of Unger and Smith, or that claim 1 would not have been obvious over the combination of Unger and Smith, and therefore, has waived such arguments.8” slip op. at 28

    Patent outcomesUS 11,736,855 unpatentable
    Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham · Nautilus
    Patents in suitUS 11,736,855
  • PTAB · Nov 22, 2024 · PGR2024-00034 · APJ Patrick R Scanlon · PGR · Institution

    Instituted PGR on claims 1–19 and all asserted grounds after finding at least one claim more likely than not unpatentable.

    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. See 35 U.S.C. § 324 (2018); 37 C.F.R. § 42.4(a) (2022). To institute a post-grant review, we must determine that “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). For the reasons set forth below, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of at least one challenged claim. Accordingly, we institute a post-grant review of the challenged claims on the grounds set forth in the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “We note that the identification of a Ph.D. as an example of “more formal education” creates a vast range of education relative to a bachelor’s degree. Thus, we treat the identification of a Ph.D. just as it is—an example—and not a requirement. In this case, “more formal education” can be satisfied by a level of education less than a Ph.D (but greater than a bachelor’s degree). Based on our review of the record before us, we determine that Petitioner’s stated level of ordinary skill in the art is reasonable because it appears consistent with the evidence of record, definition, limited as discussed above, for the purposes of this Decision.” slip op. at 9

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

      “On the present record, we do not discern a need to construe explicitly any claim language because doing so would have no effect on our analyses below of Petitioner’s asserted grounds and will not assist in resolving the present controversy between the parties. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 10

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

      “would have understood Unger’s disclosure to “suggest the use of a torsion spring to facilitate attachment and detachment, because torsion springs are designed to impart this functionality.” Id. (citing Ex. 1002 ¶ 118). Petitioner also asserts that one of ordinary skill in the art would have “understood that there were a limited number of ways to impart the referenced resilient or flexible ‘manipulation,’” and “would have been motivated to look to various known solutions to impart the suggested functionality, including the torsional spring mechanism of Smith that is used in a similar hearing protection device application for a similar purpose as Unger’s mounting arms (to apply a clamping force).” Id. at 32 (citing Ex. 1002 ¶¶ 120–121).” slip op. at 17

    Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 11,736,855
  • PTAB · Sep 3, 2024 · IPR2023-00797 · APJ Stephen E Belisle · IPR · Remand

    The Board denied institution because Honda did not show a reasonable likelihood that claims 23, 24, 26, or 27 were obvious over either asserted combination.

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

      “review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2022). We may not institute an inter partes review “unless . . . 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). The “reasonable likelihood” standard is “a higher standard than mere notice pleading” but “lower than the ‘preponderance’ standard to prevail in a final written decision.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 at 13 (PTAB Dec. 20, 2019) (precedential). When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim. 37 C.F.R. § 42.108(a). Applying those standards, and upon consideration of the information presented in the Petition and Preliminary Response, we determine that Petitioner has not demonstrated a reasonable likelihood of prevailing with respect to any of challenged claims 23, 24, 26, and 27 of the ’302 patent. Accordingly, constrained by the record before us, we deny institution of an inter partes review of the ’302 patent.” slip op. at 2

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

      “We find Patent Owner’s arguments persuasive, and the above testimony of its technical expert, Mr. Alberth, even more so. Based on the foregoing and the record before us, we find Petitioner fails to sufficiently show that the ’586 Provisional lacks written description support for the feature of a transmitter configured to form and transmit, in response to a received request, “the probing signal with a code sequence modulated in the frequency domain,” as recited in independent claim 23. Although not its burden, we find Patent Owner sufficiently evidences that the disclosure of the ’586 Provisional would have reasonably conveyed to skilled artisans that the inventor possessed the features of the subject limitation. 5. Conclusion For the reasons expressed above, and based on the record before us, we determine Petitioner has not sufficiently shown that Koo is prior art to the Challenged Claims. Accordingly, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing that any of the Challenged Claims is unpatentable as obvious over the combination of 802.16a-2003, 802.16-2001, and Koo.” slip op. at 21

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

      “But in doing so, Petitioner ignores the context in which the skilled artisan would have read Kitroser: where IEEE, the governing body issuing the Call for Contributions, itself explicitly questioned “if [implementing 802.16a in a mobile systems environment] is technically feasible and, if so, at what level” (Ex. 2007, 1 (emphasis added)), and where, as noted above, Kitroser provides no explanation, support, or other commentary for its “no changes” statements, and admits such statements are “subject to change in form and content after further study” and subject to amendment and withdrawal entirely (Ex. 1007, 1–4 (emphasis added)). Based on the foregoing, although Petitioner may have identified a “reason” that the skilled artisan allegedly would have combined 802.16a with Kitroser, we are not persuaded that it is a rational reason, i.e., a reason sufficiently shown to have a rational underpinning at the time of the invention of the Challenged Claims. See KSR, 550 U.S. at 418 (To support the legal conclusion of obviousness, “there must be some articulated reasoning with some rational underpinning” for combining elements in the manner claimed. (quoting In re Kahn, 441 F.3d at 988)).” slip op. at 29

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citation omitted). The level of ordinary skill in the art also may be reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Neither party argues that the outcome of this case would differ based on our adoption of any particular definition of the level of ordinary skill in the art. Considering the subject matter of the ’302 patent, the background technical field, the prior art, and Petitioner’s proposed and unopposed definition of the skilled artisan, we apply the level of skill set forth above, which is consistent with the testimony of Dr. Buehrer (Ex. 1003 ¶ 23), except that we omit the two instances of “at least” to remove the unbounded nature of the definition.” slip op. at 13

    § 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 10,771,302
  • PTAB · Jul 31, 2024 · PGR2023-00016 · APJ Stephen E Belisle · PGR · Final written decision

    Claims 1–3, 5, 7–10, 12, 14–17, and 19 are unpatentable based on lack of written description, indefiniteness, anticipation, and obviousness.

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

      “B. Claims 1–20 of the ’705 Patent Petitioner argues that claims 1–20 of the ’705 patent have an effective” slip op. at 19

    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
    • Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteUnpatentable
    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
    Patent outcomesUS 11,297,705 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · Nautilus
    Patents in suitUS 11,297,705
  • 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 · 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 · Sep 11, 2023 · IPR2023-00457 · APJ James P Calve · IPR · Institution

    The Board denied institution because Netskope did not show a reasonable likelihood that claims 1–9 were unpatentable on any of its four §103 grounds.

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

      “review. See 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2022) (“The Board institutes the trial on behalf of the Director.”). An inter partes review may not be instituted “unless . . . 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). Upon consideration of the evidence and arguments in the record, we determine that the information presented does not show a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims. We therefore deny institution of an inter partes review.” slip op. at 2

    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “The parties substantially agree on the level of ordinary skill in the art and differ mainly in the level of experience required for different levels of education. We consider Patent Owner’s proposed level of ordinary skill to be slightly more consistent with the ’968 patent and the asserted prior art, and we apply it in our obviousness analysis below. We note, however, that our decision would be the same under either party’s proposed definition of the level of ordinary skill in the art.” slip op. at 8

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

      “B. Claim Interpretation We interpret claims “using the same claim construction standard that would be used to construe the claims in a civil action [held] under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b). Under this standard, we construe a claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. We construe the claims only to the extent necessary to determine whether to institute inter partes review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017). The parties agree that no claim constructions are needed. Pet. 21; Prelim. Resp. 15. Having considered the record, we determine that no express claim construction is necessary to reach our decision.” slip op. at 9

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

      “3. Motivation to Combine Petitioner contends that a skilled artisan would have been motivated to combine Jordan and FortiGate because FortiGate analyzes content in real-time and downloads new or updated virus definitions to identify suspicious network traffic, and this capability would improve Jordan’s complementary system, which generates and updates rules for malware detection. Pet. 25.” slip op. at 12

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR
    Patents in suitUS 9,231,968
  • PTAB · Aug 4, 2023 · PGR2023-00016 · APJ Stephen E Belisle · PGR · Institution

    The Board instituted PGR on claims 1–3, 5, 7–10, 12, 14–17, and 19 based on a reasonable likelihood that the claims are unpatentable across the petition’s grounds.

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

      “review. 35 U.S.C. § 324(c); 37 C.F.R. § 42.4(a) (2022). We may not institute a post-grant review “unless . . . 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). Applying those standards, and upon consideration of the information presented in the Petition and Preliminary Response, we determine that Petitioner has established that it is more likely than not that at least one claim of the ’705 patent is unpatentable. Accordingly, we institute a post-grant review as to all challenged claims of the ’705 patent on all grounds raised in the Petition.” slip op. at 2

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

      “pertinence of Bruning, in particular, or of any reference Patent Owner asserts is substantially similar to Evanicky, Lee, Doheny and Van Winkle or of the asserted combinations thereof, and did not issue a rejection based on their disclosures or combined teachings, and that this constitutes Examiner error. See Pet. 5–6, 10–11. Indeed, in the Final Written Decision in PGR2022-00009, the Board determined that Bruning anticipates independent claims 1, 8 and 15 and many other dependent claims of the parent ’341 patent, which claims are substantially similar to the challenged claims in this case involving the child ’705 patent. Ex. 1032, 52–68. Also, as discussed below in Section V, we determine that Petitioner has established that it is more likely than not that claims 1–3, 5, 7–10, 12, 14–17, and 19 of the ’705 patent are unpatentable. We also find the Examiner’s error here is further compounded by not having identified that the claims of the ’705 patent are not entitled to claim priority to any of the filing dates of any of its ancestor applications, and thus, not having searched for and considered a substantial pool of prior art. See supra Sections III.B, III.C. Accordingly, Becton, Dickinson factor (e) weighs against exercising discretion to deny institution under § 325(d).” slip op. at 37

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

      “Pet. 11–15), we determine that the ’215 provisional (and other Pre-AIA Applications) does not provide sufficient written description support to reasonably convey to the skilled artisan that, as of the filing date of the ’215 provisional, the inventors had possession of the limitation “wherein the switch is electrically connected between the DC voltage output and at least one of the first operating LED circuit or the at least one additional LED circuit,” as recited in claim 1. See Ariad Pharm., 598 F.3d at 1351. Accordingly, on this record, we are persuaded that the ’215 provisional lacks sufficient written description support for the inventions recited in claims 1–20 of the ’705 patent. Thus, on this record, claims 1–20 of the ’705 patent are not entitled to priority and, for purposes of institution, do not receive an effective filing date as early as that of the ’597 PCT (i.e., 2010) or any other Pre-AIA Application.” slip op. at 24

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

      “h) Conclusion At this stage of the proceeding and based on the record before us, we are persuaded that Petitioner’s cited evidence sufficiently supports Petitioner’s contention that independent claim 15 is unpatentable as anticipated by Bruning. Accordingly, at this stage of the proceeding, we are persuaded that Petitioner has shown that it is more likely than not that independent claim 15 is anticipated by Bruning.” slip op. at 74

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · Graham · Nautilus
    Patents in suitUS 11,297,705
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