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  • PTAB · Nov 4, 2025 · IPR2025-00718 · APJ Zhenyu Yang · IPR · Institution

    The Board instituted IPR on all challenged claims, claims 1–4 and 6–26, on all asserted grounds because Petitioner showed a reasonable likelihood of prevailing on at least one claim.

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

      “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.” 35 U.S.C. § 314(a). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). We institute inter” slip op. at 2

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

      “On the current record, it is unclear to what extent, if at all, the alleged “scientific basis for the invention” describes adding bromine to coal. Written description requires more than that the disclosure renders the claimed subject matter obvious. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1571–72 (Fed. Cir. 1997) (“The question is not whether a claimed invention is an obvious variant of that which is disclosed in the specification. Rather, a prior application itself must describe an invention.”); PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306 (Fed. Cir. 2008) (“Entitlement to a filing date does not extend to subject matter which is not disclosed, but would be obvious over what is expressly disclosed.”).” slip op. at 18

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

      “The standard for public accessibility is one of “reasonable diligence,” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016), to locate the information by “interested members of the relevant public.” Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1569 (Fed. Cir. it was ‘disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.’” Blue Calypso, 815 F.3d at 1348 (quoting Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545 F.3d 1340, 1350 (Fed. Cir. 2008)). Patent Owner argues that “Petitioners rely on their paid technical expert’s largely uncorroborated fact testimony regarding a conference that took place twenty years ago.” Prelim. Resp. 27. Patent Owner asserts that “Petitioners have not corroborated the number of people in attendance at this track during the relevant time, nor whether those people were skilled in the art.” Id. Thus, Patent Owner concludes that “Petitioners have not provided sufficient evidence that Sjostrom was disseminated or otherwise made available to . . . persons interested and ordinarily skilled in the subject matter or art.” Id. (quotation marks omitted). We are not persuaded by Patent Owner’s argument. Petitioner relies on the testimony of Dr. Niksa, who attended and delivered a presentation at the 2005 EUEC. Ex. 1002 ¶¶ 125, 242–251; Ex. 1030, 3, 7, 23, 32, 106–118; Ex. 1031. Dr. Niksa testifies that there were over 800 attendees. Ex. 1002 ¶ 250. Other evidence corroborates Dr. Niksa’s testimony. Ex. 1030, 103–118 (list of attendees); Ex. 1031. Petitioner’s evidence does not indicate that attendance of the 2005 EUEC was restricted, and the evidence indicates that the CD appears to have been disseminated without any apparent restriction or expectation of confidentiality. Ex. 1002 ¶¶ 243, 244, 248; Ex. 1010; Ex. 1030, 103–118; Ex. 1031; GoPro, 908 F.3d at 694–95. reasonable likelihood that Sjostrom was publicly available, and thus, qualifies as printed publications. See Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 28 (PTAB Dec. 20, 2019) (Paper 29) (precedential).” slip op. at 28

    § 102 anticipation§ 112 disclosurecites Phillips
    Patents in suitUS 10,926,218
  • PTAB · Oct 14, 2025 · IPR2025-00688 · APJ Avelyn M Ross · IPR · Institution

    The Board instituted IPR on claims 1–18 on all asserted grounds, finding a reasonable likelihood that Petitioner would prevail on at least one challenged claim.

    RulingsInstitution decision
    • PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner

      “The mere existence of some relationship between a petitioner and another entity, however, is not sufficient to place that petitioner in privity with that entity. Google LLC v. DDC Technology, LLC, IPR2023-00707, Paper 27 at 37 (PTAB Oct. 25, 2023). Instead, that relationship must be related to an earlier lawsuit and be “sufficiently close that it can be fairly said that the petitioner had a full and fair opportunity to litigate the validity of the patent in that lawsuit” or the evidence must show “the petitioner is simply serving as a proxy to allow another party to litigate the patent validity question that the other party raised in an earlier-filed litigation.” WesternGeco, 889 F.3d at 1319.” slip op. at 10

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that “[a] person of ordinary skill in the art [“POSITA”] would have at least a bachelor’s degree in chemical engineering, mechanical engineering, or a related field of study with at least two years of experience implementing pollution control in power generation plants for natural gas, coal, and/or industrial waste incineration.” Pet. 11 (citing Ex. 1002 ¶¶ 48–51). Patent Owner does not dispute the level of ordinary skill in the art. See generally Prelim Resp. For purposes of this Decision, we adopt Petitioner’s proposed definition of a person of ordinary skill in the art because it is consistent with the skill level reflected in the disclosures of the ’370 patent and prior art. See Okajima, 261 F.3d at 1355 (the prior art may reflect an appropriate level of skill in the art).” slip op. at 12

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

      “Petitioner “do[es] not, at this time, contend that any term requires construction,” and instead, states that “[a]ll terms have been accorded their plain and ordinary meaning.” Pet. 10 (citing Ex. 1002 ¶¶ 212–215). Patent Owner does not propose any constructions at this time. See generally Prelim. Resp. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term expressly.” slip op. at 13

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateDecided for petitioner

      “We are not persuaded by this argument. The Federal Circuit has instructed that [e]ntitlement to a filing date does not extend to subject matter which is not disclosed, but would be obvious over what is expressly disclosed. It extends only to that which is disclosed. While the meaning of terms, phrases, or diagrams in a disclosure is to be explained or interpreted from the vantage point of one skilled in the art, all the limitations must appear in the specification. The question is not whether a claimed invention is an obvious variant of that which is disclosed in the specification. Rather, a prior application itself must describe an invention, and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought. Lockwood, 107 F.3d at 1571–72. Here, what “a POSITA would understand,” without disclosure in the specification, is insufficient to show written-description support. Prelim. Resp. 24. Thus, on this record, and for purposes of institution, Patent Owner has not shown that the Provisional Application provides sufficient support for adding the claimed genus to the coal. 3. Summary In sum, on this record, Patent Owner has not shown that either the Provisional Application or the Pre-2018 Applications provide sufficient written-description support for the challenged claims. As a result, we determine that the ’370 patent cannot claim priority to the Provisional Application. Thus, all asserted prior art qualifies as prior art.” slip op. at 25

    Claim construction§ 102 anticipation§ 112 disclosurecites Phillips
    Patents in suitUS 10,933,370
  • PTAB · Oct 9, 2025 · IPR2025-00425 · APJ Kristina M Kalan · IPR · Institution

    The Board instituted IPR on all challenged claims and all asserted grounds, finding a reasonable likelihood that Petitioner would prevail on at least one claim.

    RulingsInstitution decision
    • PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner

      “After reviewing the evidence of record, we are persuaded the instant Petition is not time-barred as to the Chem-Mod Purchasers. Generic indemnity agreements are insufficient, without more, to establish privity. 9 Petitioner asserts that the supply agreements between the Chem-Mod Purchasers and Chem-Mod expired in 2021. For the reasons discussed herein, we determine that the language of these agreements does not establish privity. In the event Patent Owner maintains its argument that the Chem-Mod Purchasers are in privity with Chem-Mod, the parties should address the legal impact, if any, of the expiration of these agreements on Patent Owner’s arguments. WesternGeco LLC, 889 F.3d at 1321 (a “contractual and fairly standard customer-manufacturer relationship regarding the accused product” does not suggest, “without more, that the parties were litigating . . . [an] IPR[] as proxies for the other.”). The only relationship alleged to exist between Chem-Mod, its affiliates, and the Chem-Mod Purchasers is that of a supplier-customer relationship. As part of that relationship, the parties entered into supply agreements that included an indemnification provision for the purchased products. Exs. 2037–2042 (discussed at Sur-reply 7–8). We acknowledge, but disagree with, Patent Owner’s argument that the terms of the indemnity “specifically targeted” the activities at the “heart of the alleged infringement.” Sur-reply 7–8. Rather, the indemnification language in these agreements appears to be standard and typical of supply agreements. See Ex. 2037, 26;10 Ex. 2038, 10–12; Ex, 2039, 10–12; Ex. 2040, 10–12; Ex. 2041, 10–12; Ex. 2042, 24–27. Such language, without more, “does not amount to a sufficiently-close relationship to warrant finding . . . privity.” WesternGeco LLC, 889 F.3d at 1321–22.” slip op. at 11

    • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

      “Patent Owner does not point to any record evidence that suggests the parties to the Delaware Action adequately represented the Chem-Mod Purchasers’ interests or that the Chem-Mod Purchasers controlled, directed, or funded the Delaware Action. See generally Prelim. Resp.; Sur-reply. Nor does Patent Owner suggest that the indemnified Petitioners are acting as a proxy for Chem-Mod and its affiliates in this case. Thus, the relationship with Chem-Mod, its affiliates, and the indemnified Petitioners was not “sufficiently close that it can be fairly said petitioner had a full and fair opportunity to litigate the validity of the patent in that lawsuit.” Google, IPR2023-00707, Paper 27 at 37. In sum, Petitioner bears the burden of demonstrating compliance with 35 U.S.C. § 312(a)(2) and § 315(b), but the current record does not provide sufficient reason to doubt Petitioner’s assertion that Chem-Mod was not “funding this petition, advising on strategy for this petition, or exercising any control over Petitioner’s decision to file the petition (or the arguments included therein).” Pet. 2; see also Reply 1–2. Indeed, the current record supports that the relationship between Chem-Mod and the Chem-Mod Purchasers was a standard supplier/customer relationship. Exs. 2037–2042. The evidence does not support that Chem- Mod negotiated a license on behalf of the Chem-Mod Purchasers or that the Chem-Mod Purchasers owned power plants that were at issue in the Delaware Litigation. Ex. 2009, 91; Ex. 2010, 107. Therefore, on this record, we determine that the relationship between Chem-Mod and the Chem-Mod Purchasers does not support that the Petition is time-barred.” slip op. at 15

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “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). Furthermore, the prior art itself can reflect the appropriate level of ordinary skill in the art. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Petitioner asserts that a person of ordinary skill in the art (“POSITA”) “would have at least a bachelor’s degree in chemical engineering, mechanical engineering, or a related field of study with at least two years of experience implementing pollution control in power generation plants for natural gas, coal, and/or industrial waste incineration.” Pet. 12 (citing Ex. 1002 ¶¶ 48–51). Patent Owner does not dispute the level of ordinary skill in the art. See generally Prelim Resp. For purposes of this Decision, we adopt Petitioner’s proposed definition of a POSITA because it is consistent with the skill level reflected in the disclosures of the ’225 patent and prior art. See Okajima, 261 F.3d at 1355 (the prior art may reflect an appropriate level of skill in the art).” slip op. at 19

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

      “Petitioner discusses the term “pyrolysis char” and states that, for the purposes of the Petition, it adopts and applies the Delaware court’s construction that “allow[s] for the pyrolysis char to be created within the combustor, so long as it is then present (and combusted) with the coal and the bromine compound.” Pet. 11–12 (citing Ex. 1071). Patent Owner does not appear to propose any express claim constructions. See generally Prelim. Resp. 7. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term expressly.” slip op. at 20

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
    Patents in suitUS 10,589,225
  • PTAB · Oct 6, 2025 · IPR2025-00423 · APJ Zhenyu Yang · IPR · Institution

    The Board instituted IPR on claims 1–4 and 6–29 on all asserted grounds, finding a reasonable likelihood of unpatentability based on the asserted obviousness and anticipation challenges.

    RulingsInstitution decision
    • PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner

      “After reviewing the evidence of record, we are persuaded the instant Petition is not time-barred as to the Chem-Mod Purchasers. Generic indemnity agreements are insufficient, without more, to establish privity. WesternGeco LLC, 889 F.3d at 1321 (“a contractual and fairly standard customer-manufacturer relationship regarding the accused product” does not suggest, “without more, that the parties were litigating . . . [an] IPR[] as proxies for the other.”). The only relationship alleged to exist between Chem-Mod, its affiliates, and the Chem-Mod Purchasers is that of a supplier-customer relationship. As part of that relationship, the parties entered into supply agreements that included an indemnification provision for the purchased products. Exs. 2037–2042 (discussed at Sur-reply 7–8).” slip op. at 12

    • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

      “In sum, Petitioners bear the burden of demonstrating compliance with 35 U.S.C. § 312(a)(2) and § 315(b), but the current record does not provide sufficient reason to doubt Petitioners’ assertion that Chem-Mod was not “funding this petition, advising on strategy for this petition, or exercising any control over Petitioners’ decision to file the petition (or the arguments included therein).” Pet. 2; see also Reply 2. Indeed, the current record supports that the relationship between Chem-Mod and the Chem-Mod Purchasers was a standard supplier/customer relationship. Exs. 2037–2042. The evidence does not support that Chem-Mod negotiated a license on behalf of the Chem-Mod Purchasers or that the Chem-Mod purchasers owned power plants that were at issue in the Delaware Litigation. Ex. 2009, 91; Ex. 2010, 107. Therefore, on this record, we determine that the relationship between Chem-Mod and the Chem-Mod Purchasers does not support that the Petition is time-barred.” slip op. at 16

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

      “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.” 35 U.S.C. § 314(a).” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “engineering, mechanical engineering, or a related field of study with at least two years of experience implementing pollution control in power generation plants for natural gas, coal, and/or industrial waste incineration.” Pet. 11–12 (citing Ex. 1002 ¶¶ 48–51). Patent Owner does not dispute the level of ordinary skill in the art. See generally Prelim Resp. For purposes of this Decision, we adopt Petitioners’ proposed definition of a POSITA because it is consistent with the skill level reflected in the disclosures of the ’430 patent and prior art. See Okajima, 261 F.3d at 1355 (the prior art may reflect an appropriate level of skill in the art).” slip op. at 21

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
    Patents in suitUS 10,668,430
  • PTAB · Sep 26, 2025 · IPR2025-00605 · APJ Tawen Chang · IPR · Institution

    The Board instituted IPR on claims 1–7 and all petitioned grounds, finding a reasonable likelihood that claim 1 is anticipated by Desjarlais or Moore or obvious over Lazar alone.

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

      “SAS, 138 S. Ct. at 1356. Thus, because we determine, based on the arguments and evidence on the present record, that there is a reasonable likelihood Petitioner would prevail with respect to claim 1, we institute an inter partes review of all challenged claims under each Ground presented in the Petition. Id.; see also 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). III. CONCLUSION For the reasons provided above, we find that Petitioner has demonstrated a reasonable likelihood of showing at trial that at least one of the challenged claims of the ’859 patent is unpatentable under at least one ground. Accordingly, we institute inter partes review of all challenged claims based on all the Grounds presented in the Petition.” slip op. at 49

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

      “As Petitioner points out, the cited disclosure in the ’935 provisional does not “mention[] positions 364 and 368 together as a pair of positions for potential mutations on two chains.” Pet. 28 (citing Ex. 1002 ¶¶ 109–19). Although Patent Owner is correct that examples or actual reduction to practice are not required for adequate written description and “[a] specification may . . . contain a written description of a broadly claimed 34 invention without describing all species that [the] claim encompasses,” Prelim. Resp. 15 (quoting Ariad Pharms., 598 F.3d at 1352 and Cordis Corp. v. Medtronic AVE Inc., 339 F.3d 1352, 1365 (Fed. Cir. 2003)), the ’935 provisional must still “reasonably convey[] to those skilled in the art that the inventor[s] had possession of the claimed subject matter” as of the relevant date. Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 127 F.4th 896, 914 (Fed. Cir. 2025); Ariad, 598 F.3d at 1351. In this case, Table A of the ’935 provisional discloses a list of CH3 domain interface residues and identifies, for each interface residue in heavy chain A, the contacting residue in the corresponding chain B. Ex. 1030, 17, Table A. Table A does not, however, describe any particular substitutions or pairs of substitutions that should be made to the CH3 domains. See, e.g., Pet. 28 (citing Ex. 1002 ¶¶ 109–119). Table 7 of the ’935 provisional does identify specific amino acid substitutions in CH3 domains, including substitutions resulting in a positively charged residue at position 364 (e.g., S364K) and a negatively charged residue (e.g., L368D) at position 368. Ex. 1030, 52, Table 7. Patent Owner argues that this table “discloses specific positions for ‘identification of novel charge pair mutants.’” Prelim. Resp. 13 (citing Ex. 2010 ¶ 48). As Petitioner points out, however, while Example 13 of the ’935 provisional relates to identification of novel charge pair mutants, Table 7 itself was only a “first step” in this identification process. Ex. 1030, 51:6–17. In this step, “many interface contact residues in the IgG CH3 domain were scanned one by one or in groups for substitutions that would result in repulsion of 35 identical heavy chains” so that identified substitutions can then be used to generate antibodies “by engineering matched pairs of CH3 residues in one or more IgG heavy chains – CH3 regions” in follow up experiments. Id. Accordingly, Table 7 does not appear to describe heterodimer combinations, such as those that would result from a pairing of chains with different substitutions. Pet. 29–30 (citing, e.g., Ex. 1002 ¶¶ 111–118). As Petitioner further points out, the follow up experiments testing the matched pairs of CH3 residues did not include paired substitutions at positions 364 and 368. Id. at 29–31. Patent Owner points to disclosure in the ’935 provisional describing, as a distinguishing feature of its invention, the substitution of non-charged or neutral amino acids in wildtype CH3 with charged residues, which according to the ’935 provisional has the “advantage that at least one additional charge-charge interaction in the CH3 interface is created.” Prelim. Resp. 12 (citing, e.g., Ex. 2010 ¶¶ 42–48). For the same reasons discussed above, Petitioner has sufficiently established, for purposes of institution, that such disclosure would not reasonably convey to an ordinarily skilled artisan that the inventors had possession of the entire genus of heterodimeric antibodies comprising CH3 domains wherein a non-charged amino acid is replaced with a charged residue so as to create an additional charge-charge interaction in the CH3 interface. In this regard, we also note that “a description that merely renders the invention obvious does not satisfy the [written description] requirement.” Ariad, 598 F.3d at 1352.” slip op. at 34

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

      “adequately describes a heterodimeric antibody comprising the recited charged residues at the recited positions of the CH3 domains, i.e., “a positively charged amino residue at position 364” at a first CH3 domain and “a negatively charged amino acid residue at position 368” of the second CH3 domain. Having considered the evidence of record at this preliminary stage of the proceeding, and for the reasons set forth below, we are persuaded that Petitioner has shown sufficiently, for purposes of institution, that the ’935 provisional does not provide adequate written description support for claim 1 of the ’859 patent and that, accordingly, Desjarlais and Moore qualify as prior art to that claim. As Petitioner points out, the cited disclosure in the ’935 provisional does not “mention[] positions 364 and 368 together as a pair of positions for potential mutations on two chains.” Pet. 28 (citing Ex. 1002 ¶¶ 109–19). Although Patent Owner is correct that examples or actual reduction to practice are not required for adequate written description and “[a] specification may . . . contain a written description of a broadly claimed 34 invention without describing all species that [the] claim encompasses,” Prelim. Resp. 15 (quoting Ariad Pharms., 598 F.3d at 1352 and Cordis Corp. v. Medtronic AVE Inc., 339 F.3d 1352, 1365 (Fed. Cir. 2003)), the ’935 provisional must still “reasonably convey[] to those skilled in the art that the inventor[s] had possession of the claimed subject matter” as of the relevant date. Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 127 F.4th 896, 914 (Fed. Cir. 2025); Ariad, 598 F.3d at 1351.” slip op. at 34

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

      “The ’859 patent does not provide an explicit definition of “immunoglobulin class.” Nevertheless, we do not construe that term to require “two heavy chains with four domains, VH, CH1, CH2, and CH3, and two Fab arms.” As an initial matter, the Specification teaches that antibodies include, 16 e.g., IgE and IgM — which have an additional CH4 domain in their heavy chains — as well as functional derivatives and/or fragments of known antibody isotypes. Ex. 1001, 11:44–48. Patent Owner’s proposed construction, which limits antibodies to those having two Fab arms and “two heavy chains with four domains, VH, CH1, CH2, and CH3,” excludes these embodiments and cannot be correct. Moreover, the ’859 patent defines antibody as containing “one or more domains” that bind an epitope on an antigen. Ex. 1001, 11:39–44. Thus, an antibody does not require two Fab arms as in a native immunoglobulin molecule.12 The ’859 patent also describes a preferred embodiment as “Ig-like molecules.” Id. at 11:49–52. Thus, we look to the definition of “Ig-like molecule” in the ’859 patent, i.e., “a proteinaceous molecule that possesses at least one immunoglobulin (Ig) domain,” to inform our understanding of the phrase “immunoglobulin class of proteins.” Ex. 1001, 11:4–6. Accordingly, we further construe “immunoglobulin class of proteins” to mean proteinaceous molecules comprising at least one domain that is derived from or shares sequence homology with an immunoglobulin domain.” slip op. at 16

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 11,926,859
  • PTAB · Dec 16, 2024 · IPR2024-01014 · APJ Zhenyu Yang · IPR · Institution

    The Board instituted inter partes review of claims 1–8 on all asserted grounds, finding a reasonable likelihood that Barbour would render the challenged claims unpatentable.

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

      “Anticipation by or Obviousness over Barbour Petitioner asserts that Barbour anticipates and/or renders obvious all challenged claims. Pet. 6, 41–67. Patent Owner does not dispute these assertions. Barbour is the published 2004 application and shares the same disclosure as the ’378 patent. Based on this record, we find Petitioner’s arguments on anticipation and/or obviousness persuasive. Thus, we determine Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of the challenged claims. We institute inter partes review of all challenged claims on all of the grounds in the Petition.” slip op. at 21

    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledDecided for petitioner

      “4. Summary In sum, based on the current record, and for purposes of this Decision, Petitioner has shown sufficiently that the disclosure of the 2004 application, by itself, fails to enable POSAs to practice the challenged claims without undue experimentation. In addition, Patent Owner has not shown that TC1507 was “known and readily available to the public” as of the filing date of the 2004 application. Therefore, the 2004 application does not enable the challenged claims, and the challenged claims are not entitled to the 2004 priority date. The earliest possible priority date for the challenged claims is, thus, July 6, 2007, which is the filing date of the 2007 application.” slip op. at 18

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

      “4. Summary In sum, based on the current record, and for purposes of this Decision, Petitioner has shown sufficiently that the disclosure of the 2004 application, by itself, fails to enable POSAs to practice the challenged claims without undue experimentation. In addition, Patent Owner has not shown that TC1507 was “known and readily available to the public” as of the filing date of the 2004 application. Therefore, the 2004 application does not enable the challenged claims, and the challenged claims are not entitled to the 2004 priority date. The earliest possible priority date for the challenged claims is, thus, July 6, 2007, which is the filing date of the 2007 application.” slip op. at 18

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference is prior artPrinted publication establishedDecided for petitioner

      “Thus, the critical issue is not, as Patent Owner asserts, whether “the same application can be simultaneously enabling and not enabling.” Id. at 32. It is whether TC1507 was “known and readily available” to the public at the relevant time. As explained above, for the priority determination, the relevant time is April 30, 2004, the filing date of the 2004 application. Patent Owner has not produced or pointed to any evidence to show TC1507 corn “readily available” to the public without restrictions as of the filing date of the 2004 application. On the other hand, for prior-art status determination, the relevant time is February 16, 2006, the publication date of Barbour. Petitioner has presented sufficient evidence, which Patent Owner does not challenge, to show that, by 2006, corn harvested from TC1507 plants was “commercially available following the 2003, 2004, and 2005 growing seasons” and “[s]uch corn was sold as a commodity—without any contractual restrictions” Pet. 52 (citing Ex. 1007 ¶ 134). As a result, based on the current record, we find Petitioner has established sufficiently that, as of its publication date in February 2006, Barbour is prior art that would have enabled practice of the subject matter encompassed by the challenged claims.” slip op. at 20

    § 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips
    Patents in suitUS 8,901,378
  • 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 · Aug 17, 2023 · PGR2023-00020 · APJ Jeffrey N Fredman · PGR · Institution

    Instituted PGR on claims 22 and 25–31; the Board found a reasonable likelihood of success on anticipation over Zhang and obviousness grounds for claim 22.

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

      “Feb. 13, 2020) (“Advanced Bionics”) (precedential), we further apply the following two-step framework in determining whether discretionary denial under § 325(d) is appropriate: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Becton, Dickinson Factors (a), (b), and (d) relate to the first step, and Becton, Dickinson Factors (c), (e), and (f) relate to the second step. Id. Only if the same or substantially the same art or arguments were previously presented to the Office do we then consider whether petitioner has demonstrated error. Advanced Bionics, at 8–10. “If the petitioner fails to show that the Office erred, the Director may exercise [her] discretion not to institute inter partes review.” Id. at 8–9 (“If a condition in the first part of the framework [i.e., substantially same art or arguments] is satisfied and the petitioner fails to make a showing of material error, the Director generally will exercise discretion not to institute inter partes review.”). “At bottom, this [§ 325(d)] framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9. An “example of a material error” could be “misapprehending or overlooking specific teachings of the relevant prior art where those teachings impact patentability of the challenged claims.” Id. at 8 n.9” slip op. at 13

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

      “review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a) (2018). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition, Preliminary Response, and the evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 22 and 25–31 of the ’817 patent.” slip op. at 2

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

      “We find that on the present record, the evidence more likely than not supports Petitioner’s claim interpretation which is based on the express definition of the term “patient” in the ’817 patent specification. That express definition states: “‘Patient’ and ‘subject’ are used interchangeably herein and include, but not limited to, primates such as humans, canines, porcine, ungulates, rodents, poultry, and avian.” Ex. 1001, 32:65–67.” slip op. at 8

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundInstituted

      “We appreciate Patent Owner’s point that for a reference to anticipate without disclosing the relevant feature of the claimed invention, it is required that the “missing characteristic is necessarily present . . . in the single anticipating reference.” Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003). In this case, Zhang demonstrates that ganaxolone continues to improve status epilepticus in rats for 5+ hours, supporting the inherency position. Moreover, the ’817 patent’s Specification shows that 10 and 20 mg/kg ganaxolone doses that bracket the 12 and 15 mg/kg ganaxolone doses tested by Zhang, result in improved 24-hour survival relative to lower doses. See Ex. 1001, Fig. 4; Ex. 1009, 21 ¶ 117. This evidence further supports Petitioner’s inherency position because it shows that doses bracketing those recited in Zhang provide continued improvement to patients for periods exceeding 8 hours. “Extrinsic evidence can be used to demonstrate what is ‘necessarily present’ in a prior art embodiment even if the extrinsic evidence is not itself prior art.” Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322, 1329 (Fed. Cir. 2020). As to the issue of whether Zhang’s teaching to treat with multiple doses also teaches “improvement to the patient after administration for more than 8 hours” as required by claim 22, on this record we find that Petitioner’s position is more persuasive. Claim 22 does not distinguish between a single administration event or multiple administrations, and therefore is reasonably interpreted as broadly open to both single administration and multiple administrations. This understanding is consistent with the ’817 patent, which teaches that “[g]anaxolone or a pharmaceutically acceptable salt thereof can be administered, e.g., once daily, twice daily, three times daily, or four times daily.” Ex. 1001, 8:35–37. Zhang teaches “[d]osing schedules in which the substituted β-cyclodextrin-ganaxolone injectable formulation is injected every 1 hr, 2 hrs, 4 hrs, 6 hrs, 8 hrs, 12 hrs, or 24 hours are included herein.” Ex. 1009, 13 ¶ 74. We agree with Petitioner that, on this record, Zhang directly demonstrates that where doses are administered every 1, 2, or 4 hours, the ganaxolone would have been expected to necessarily result in improvement in status epilepticus treatment over more than 8 hours based on the five hour efficacy results reported in Zhang. See Ex. 1009, 25 ¶ 135.9” slip op. at 27

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips
    Patents in suitUS 11,395,817
  • PTAB · Jul 31, 2023 · PGR2023-00017 · APJ Zhenyu Yang · PGR · Institution

    Instituted PGR on claims 1–10 and all asserted grounds because the Board found it more likely than not that Tobler anticipates and renders obvious at least claim 1.

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

      “We review the Petition under 35 U.S.C. § 324, which provides that a post-grant review may not be instituted 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). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 324(a). Accordingly, we institute a post-grant review of all challenged claims based on all grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PTAB Consolidated Trial Practice Guide (“Practice Guide”),1 5–6 (Nov. 2019).” slip op. at 2

    • Other 314aInstitution denied discretionary otherDenied

      “We disagree. It is unclear which aspect of the Petition that Patent Owner takes issue with. If it is the “multitudinous grounds” presented in the Petition, Patent Owner points to no authority that permits us to deny institution merely because a petition presents numerous grounds. In any event, on the facts of this case, we do not view eight grounds asserted in the Petition to be excessive.6 To the extent Patent Owner urges that we should deny institution because Petitioner’s grounds are “futil[e],” we understand that to be an argument on the merits, and not related to our discretion. See Prelim. 6 The Petition presents five grounds. See generally Pet. We agree with Patent Owner, however, the ground based on Tobler, in fact, encompasses three grounds, and the ground based on De Oliveira, in fact, encompasses two grounds. See Prelim. Resp. 2. Resp. 45. As explained below, we find Petitioner has established that it is more likely than not that claims 1–10 of the ’727 patent are unpatentable over Tobler. See infra Section II.D.2. Because the grounds based on Tobler apply to all challenged claims,7 at least these grounds are not, as Patent Owner asserts, futile. Thus, we decline to exercise discretion to deny the Petition under § 324(a).” slip op. at 6

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

      “review, we “may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. 7 The cases Patent Owner cites do not support its argument on discretionary denial under § 324(a). See Prelim. Resp. 45–46. In those cases, the Board exercised discretion to deny institution because the petitions only met the threshold requirement for institution with regard to a small percentage of the challenged claims. See Chevron Oronite Co. LLC v. Infineum USA L.P., IPR2018-00923, Paper 9, 11 (PTAB Nov. 7, 2018) (stating “instituting a trial with respect to all twenty claims based on evidence and arguments directed to dependent claims 3 and 4 is not an efficient use of the Board’s time and resources”); Deeper, UAB v. Vexilar, Inc., IPR2018-01310, Paper 7, 2 (PTAB Jan. 24, 2019) (denying institution because the petitioner only “demonstrated a reasonable likelihood of prevailing with respect to only two of twenty-three challenged claims as to only one of four asserted grounds of unpatentability”). MED-EL Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential). The parties agree that, during prosecution, the relevant disclosure in Tobler was before the Examiner in U.S. Patent Application Publication 2010/0216640, which was cited in an Information Disclosure Statement (“IDS”). Pet. 12; Prelim. Resp. 46. In other words, the first prong of the Advanced Bionics analysis is satisfied. Thus, we must determine whether Petitioner has shown a material error by the Office. We find Petitioner has met its burden on this issue.” slip op. at 7

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

      “The parties agree that, for purposes of this Decision, all claim terms should be given their plain and ordinary meaning. Pet. 18; Prelim. Resp. 13. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to address the construction of any claim term.” slip op. at 9

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips
    Patents in suitUS 11,445,727
  • PTAB · Jul 12, 2023 · IPR2023-00451 · APJ Michael A Valek · IPR · Institution

    The Board instituted IPR on claims 1–23 based on all petition grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

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

      “On the current record, we determine that the Petition demonstrates “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). Accordingly, we institute an inter partes review.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “would have had a medical or an engineering degree and would have had experience with surgical instruments and implants used for spinal joint fusion, including [sacroiliac (“SI”)] joint fusion.” Pet. 7 (citing Ex. 1002 ¶ 15). At this stage, we find Petitioner’s description of the level of ordinary skill in the art to be sufficiently supported by the record and apply it for purposes of this Decision. slip op. at 8

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

      “Petitioner submits that the parties have submitted joint claim construction in the Florida litigation, and asserts that “[t]he grounds set forth in this [P]etition render the challenged claims obvious under either party’s construction.” Pet. 8 (citing Ex. 1002 ¶ 34; Ex. 1017). Nevertheless, Petitioner urges that “express construction is not necessary.” Id. at 7. At this stage of the proceeding and for purposes of instituting trial, we determine that there are no terms that require express construction. See” slip op. at 8

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

      “We agree with Petitioner. Figures 30, 32A and 32B in the Specification depict a working channel with tangs 180a and 180b. See Ex. 1001, Figs. 30, 32A–B. These figures and all of the related description in the Specification describing a working channel with tangs appear in the Parent (Ex. 1006, Figs. 30, 32A–B, 3:17–21, 6:47–54, 15:25–51), but not in the Grandparent. See also Ex. 1002 ¶¶ 42–43 (explaining the same). Accordingly, based on the current record, we find that the Grandparent application does not provide sufficient written description for the limitations requiring that the working channel have tangs in the independent claims. See Ex. 1001, 42:7 (limitation 1.b.4 “at least one tang on a distal end”), 43:9–11 (limitation 10.b.2 “two bilateral blunt tangs on a distal end”), 44:31–32 the challenged claims are not entitled to the benefit of the Grandparent’s filing date.” slip op. at 9

    Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 11,083,511
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