PTAB
Advanced fields
3 decisions · 466msnewest first
  • PTAB · Aug 3, 2026 · IPR2025-00283 · APJ Lilan Ren · IPR · Final written decision

    The Board cancelled claim 11 and granted substitute claims 14–16, finding Petitioner had not shown those claims unpatentable on any asserted ground.

    RulingsFinal written decision
    • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted

      “must determine whether the motion to amend meets the statutory and regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121. Lectrosonics, Paper 15 at 4. In that regard, Patent Owner bears the burden of persuasion to show that: (1) the amendment proposes a reasonable number of substitute claims; (2) the amendment responds to a ground of unpatentability involved in the trial; (3) the amendment does not seek to enlarge the scope of the claims of the patent or introduce new subject matter;” slip op. at 9

    • ExcludeMotion to exclude, deniedDenied

      “In this case, Patent Owner’s expert “Dr. Zhou signed the second declaration, stood behind its contents, and was available for cross-examination.” Paper 35, 4. Petitioner does not dispute this statement. Paper 39, 1. Petitioner does not identify any specific undue prejudice caused by Exhibit 2008. For example, Petitioner argues that “the failure to impress upon a witness that a statement is under oath goes to the heart of its reliability as evidence” and that “as the Board has recognized, hearsay is inherently unreliable” without specifying what statement in Exhibit 2008 lacks reliability. Paper 39, 4. Because Petitioner does not provide specific evidence of undue prejudice, we find Petitioner has suffered no such undue prejudice in this case. See Liquidia, 2021 WL 4860773 at *25. We therefore deny Petitioner’s Motion to Exclude on the basis of lack of authenticity. With regard to the assertion that Exhibit 2008 is hearsay, Petitioner objects to the exhibit because the testimony is based “on other informal and unpublished documents that are hearsay under FRE 802.” Paper 29, 1. Petitioner does not specify what such “informal and unpublished documents” are. See id. Federal Rule of Evidence 703 expressly states, “[a]n expert may base an opinion on fact or data in the case that the expert has been made aware of or personally observed.” The facts or data “need not be deny Petitioner’s Motion to Exclude on the basis of hearsay.” slip op. at 50

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable

      “Petitioner’s argument is unpersuasive. Paragraph 59 of the ’503 application describes formula 8-1 but does not support Petitioner’s argument that other unknown formulas may be included in the recited modified heavy chains. Ex. 2003 ¶ 59. Petitioner’s hypothesis that the recited heavy chains may (or may not) encompass unknown formulas is also inapposite to the written description inquiry before us — that is, whether the inventor was in possession of the subject matter recited in claims 14–16 based on the disclosure including formulas 8-1, 8-2, and 8-3. See PowerOasis, 522 F.3d at 1306.” slip op. at 14

    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledNot shown unpatentable

      “These arguments in the Sur-Reply are unpersuasive to show a lack of enablement first and foremost because the arguments do not specifically provide evidence showing that any purported experimentation is undue. See Sur-Reply 2–8 (asserting, but without providing evidence under any specific Wands factors, that the examples and guidance in the specification do not extend to the broad scope of all antibodies); see Wands, 858 F.2d at 737. We again emphasize that the analysis of undue experimentation does not necessarily require every Wands factor to be explicitly addressed but the analysis must be based on “weighing many factual considerations” depending on the nature of the invention and underlying art. Cephalon, Inc. v. Watson Pharms., Inc., 707 F.3d 1330, 1336 (Fed. Cir. 2013). The assertion that the claim scope is broad alone does not suffice to show a lack of enablement based on the record before us. Moreover, as we note supra, Petitioner’s claim scope argument is based on the false premise that the scope of claims 14–16 is as broad as the claim term “antibody” without taking into account all other claim elements. For example, Petitioner does not disagree with Patent Owner’s statement that “[t]he ’675 Patent’s specification discloses the structural modification site, the chemistry used to modify that residue, and working examples demonstrating the modification” (Reply 2), but asserts only that “[t]he disclosure of SSFI that only binds to IgG1 Fc domains (SEQ ID NO:1) is . . . . inconsistent with the expansive scope of the claims.” Sur-Reply 5. Petitioner’s argument that the claims encompass proteins that lack a lysine reside at a 248 position improperly excludes from the claim language the “lysine residue at 248 position . . . [as] determined by the EU numbering system” that claims 14–16 require. As Dr. Zhou testifies, “each proposed lysine residue at position 248 (EU numbering) is covalently modified with a specific attachment with a terminal bio-orthogonal click-chemistry functional group. The specification describes targeted transfer of a chemical functional group to lysine 248” and when claims 14–16 are considered in their entirety, which includes all claim elements, “[a] POSA would understand the claim itself to limit the modified antibodies to those with lysine at position 248.” Ex. 2004 ¶ 48; Ex. 2008 ¶ 47. We also note that Patent Owner states “a POSA would understand that the phrase ‘one or more modified heavy chain’ encompasses antibodies within typical DAR distributions (i.e., fractional numbers) rather than requiring a distinct process for producing antibodies bearing modified heavy chains in exact integers.” Reply 2–3. Moreover, Patent Owner states that PepTalk Presentation demonstrates that “a POSA would understand antibody conjugation products to exist as mixtures rather than discrete whole number species” because PepTalk Presentation “presents DAR values as non-integer measurements, i.e. DARs of 1.8 and 1.9 reflecting such distributions.” Id. at 3 (citing Ex. 1007, 28). According to Patent Owner, “preparations having an average DAR of approximately 1.8 (commonly referred to in practice as ‘DAR2’) may reflect typical reaction distributions in which some antibodies contain two modified heavy chains while others contain fewer.” Id. at 3 (citing Ex. 2008 ¶ 46). Petitioner does not rebut these statements. See Sur-Reply 2–8. Based on the foregoing, the evidence before us does not show any” slip op. at 27

    Patent outcomesUS 11,896,675 not shown unpatentable
    § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · Nautilus
    Patents in suitUS 11,896,675
  • PTAB · Oct 6, 2025 · IPR2025-00585 · APJ Lilan Ren · IPR · Institution

    The Board denied institution on claims 1–6, 10–19 because claim 1’s scope is ambiguous and the petition did not show a reasonable likelihood of prevailing on any asserted obviousness ground.

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

      “review. See 35 U.S.C. § 314 (2024); 37 C.F.R. § 42.4(a) (2024). Institution of an inter partes review requires that “the information presented in the petition . . . and any response . . . 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). For the reasons set forth below, we determine that the scope of claim 1 is ambiguous and that there is not a reasonable likelihood that Petitioner will prevail with respect to at least one challenged claim, and we deny inter partes review.1” slip op. at 2

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

      “distinguishes and contrasts build material property from operational parameters. The diagnostic test passage therefore only describes a diagnostic test of the build material property but does not describe a subsequent diagnostic test to assess whether an operational parameter is suitable for the printer. Based solely on the diagnostic test passage and the prosecution history, a possible interpretation may be that the operational parameter determination in claim element 1b encompasses the diagnostic testing in claim element 1c. That is, “performing a diagnostic test to determine whether the operational parameter is suitable for the three-dimensional printer” in claim element 1c is subsumed as part of “determining an operational parameter of a fabrication process using the three-dimensional printer based upon the data, the operational parameter including at least one of a build platform temperature, a build volume temperature, an infill requirement, a rafting requirement, a support structure requirement, and a cooling requirement” in claim element 1b.” slip op. at 15

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

      “benefit of the filing date of an earlier filed application only if the disclosure of the earlier application provides support for the claims of the later application, as required by 35 U.S.C. § 112.” PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306 (Fed. Cir. 2008); see also Research Corps. Techs. v. Microsoft Corp., 627 F.3d 859, 871–72 (Fed. Cir. 2010) (holding that claims of the later-filed application, which were not limited to a “blue noise mask,” were “not entitled to claim the benefit of their parent applications’ filing dates”); ICU Med., Inc. v. Alaris Med. Sys., 558 F.3d 1368, 1377–78 (Fed. Cir. 2009) (holding that “spikeless” claims “added years later during prosecution” were not supported by the specification which “describe[d] only medical valves with spikes”); Tronzo v. Biomet, Inc., 156 F.3d 1154, 1158–60 (Fed. Cir. 1998) (holding the generic shaped cup claims of the later-filed child application were not entitled to the filing date of the parent application that “disclosed only a trapezoidal cup and nothing more”). “To satisfy the written description requirement the disclosure of the prior application must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, [the inventor] was in possession of the invention.” PowerOasis, 522 F.3d at 1306 (emphasis omitted; alteration in original). The sufficiency of written description support is based on “an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc).” slip op. at 20

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends that a person of ordinary skill in the art in the field in the relevant time frame would have had “(1) at least a bachelor’s degree in Mechanical Engineering, Computer Engineering, Chemical Engineering, Materials Science, or a related field, and (2) at least two years of research or industry experience in 3D printing or materials used for 3D printing.” Pet. 5 (citing Ex. 1003 ¶ 20). Petitioner also contends that “[a]dditional experience could substitute for a formal degree or formal training (and vice versa).” Id. (citing the same). Patent Owner contends that an ordinarily skilled artisan “would have had a bachelor’s degree in Mechanical Engineering, Computer Engineering, Electrical Engineering, Chemical Engineering, Materials Science, or a comparable field and at least two years of experience related to 3D printing, with additional experience potentially being a substitute for a formal degree or training (and vice versa).” Prelim. Resp. 12. For purposes of this decision, we adopt Petitioner’s definition of the level of ordinary skill in the art as it appears unopposed and consistent with the disclosures of the ’464 patent and the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9

    Claim construction§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 11,167,464
  • PTAB · Aug 8, 2025 · IPR2025-00283 · APJ Lilan Ren · IPR · Institution

    The Board instituted IPR on claim 11, finding a reasonable likelihood it would be shown unpatentable under § 102 over CA959 and under § 103 over the listed combinations.

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

      “In this case, claim 11, as it is currently written, depends from claim 1 and therefore requires that all of the limitations of claim 1, including the negative limitation of claim element 1.d, have written description support in negative limitation must be supported through an “express disclaimer or independent lexicography in the written description.” Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1323 (Fed. Cir. 2003). The parties agree that “the applications underlying the ’675 Patent are entirely silent regarding terminal aldehyde groups.” Pet. 17; see Prelim Resp. 9–10. Patent Owner’s argument that these underlying applications reasonably convey possession to a POSA does not cite to evidence in the record as support. See Prelim Resp. 9. Patent Owner argues that the specific structures recited in claim element 11.a “necessarily exclude[] the terminal groups contained in the negative limitation” (id. at 9–10) but does not sufficiently explain why there is the requisite “express disclaimer or independent lexicography” (Omega Eng’g, 334 F.3d at 1323) to exclude only these particular terminal functional groups but not others. Although the scope of claim 11 is limited to those structures specifically recited, the record before us does not sufficiently show why the inclusion of these structures in element 11.a excludes only the particular terminal functional groups in the negative limitation but not others. We preliminarily determine, based on the record before us, that Petitioner has adequately established that the provisional application does not provide written description support for claim 11 as it is currently written. Accordingly, at this stage of the proceeding, Petitioner has sufficiently 11 We note that Patent Owner represents that, “[t]o the extent the Board is inclined to hold that current Claim 11 is not adequately supported by the specification due to the negative limitation recited in disclaimed Claim 1, Patent Owner intends to amend Claim 11 into independent form and remove the reference to the negative limitation.” Prelim. Resp. 11 n.4. 2023, which is the filing date of the application that issued as the ’675 patent, for purposes of institution.” slip op. at 14

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

      “In this case, claim 11, as it is currently written, depends from claim 1 and therefore requires that all of the limitations of claim 1, including the negative limitation of claim element 1.d, have written description support in negative limitation must be supported through an “express disclaimer or independent lexicography in the written description.” Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1323 (Fed. Cir. 2003). The parties agree that “the applications underlying the ’675 Patent are entirely silent regarding terminal aldehyde groups.” Pet. 17; see Prelim Resp. 9–10. Patent Owner’s argument that these underlying applications reasonably convey possession to a POSA does not cite to evidence in the record as support. See Prelim Resp. 9. Patent Owner argues that the specific structures recited in claim element 11.a “necessarily exclude[] the terminal groups contained in the negative limitation” (id. at 9–10) but does not sufficiently explain why there is the requisite “express disclaimer or independent lexicography” (Omega Eng’g, 334 F.3d at 1323) to exclude only these particular terminal functional groups but not others. Although the scope of claim 11 is limited to those structures specifically recited, the record before us does not sufficiently show why the inclusion of these structures in element 11.a excludes only the particular terminal functional groups in the negative limitation but not others. We preliminarily determine, based on the record before us, that Petitioner has adequately established that the provisional application does not provide written description support for claim 11 as it is currently written. Accordingly, at this stage of the proceeding, Petitioner has sufficiently 11 We note that Patent Owner represents that, “[t]o the extent the Board is inclined to hold that current Claim 11 is not adequately supported by the specification due to the negative limitation recited in disclaimed Claim 1, Patent Owner intends to amend Claim 11 into independent form and remove the reference to the negative limitation.” Prelim. Resp. 11 n.4. 2023, which is the filing date of the application that issued as the ’675 patent, for purposes of institution.” slip op. at 14

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Reference is prior artInstituted

      “1. CA959 The parties agree that CA959 is entitled to the same priority date as the provisional application, filed on March 8, 2019. Pet. 22; Prelim. Resp. 5. The parties agree that CA959 and ’675 patent contain essentially identical disclosures. Pet. 16; see Prelim. Resp. 9. 2. Analysis of Ground 1 At this stage of the proceeding, Patent Owner does not address Petitioner’s specific contentions with respect to the limitations of claim 11 (Pet. 31–34, 37). See generally Prelim. Resp. Based on our determination supra that claim 11 of the ’675 patent is entitled to the January 16, 2023 priority date and based on our review and consideration of the current record with regard to the alleged anticipation by CA959, we determine that Petitioner has sufficiently shown that CA959 discloses all elements of claim 11 for purposes of institution. See Pet. 31–34, 37 (and evidence cited therein). Based on the reasons provided supra, we determine that the information presented in the Petition demonstrates a reasonable likelihood of showing that claim 11 is anticipated under 35 U.S.C. § 102 by CA959.” slip op. at 16

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

      “Patent Owner does not cite any authority stating that in a proper obviousness analysis under 35 U.S.C. § 103, there is a bright line test for the frequency at which the phrase “motivation to combine” (or similar phrases) is repeated in the petition and/or testimony. Patent Owner’s argument regarding the purportedly low frequency in which Petitioner and/or Dr. Tumey uses such phrases (see Prelim. Resp. 12) does not rebut Petitioner’s testimonial and other evidence in support of Petitioner’s arguments regarding motivation. For example, Dr. Tumey testifies that as of 2019, “there was an expectation that site-specific conjugation would decrease off-target toxicity and improve the pharmacokinetic properties of the ADC, and thus there was a clear motivation in the art to pursue technologies that allowed site-specific conjugation.” Ex. 1002 ¶ 60. Dr. Tumey cites as support Exhibit 1027, which is an article titled “Antibody-Drug Conjugate-Based Therapeutics: State of the Science” in the Journal of the National Cancer Institute. Ex. 1002 ¶ 60 (citing Ex. 1027, pg. 538); Ex. 1027.” slip op. at 21

    § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 11,896,675

Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.