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  • PTAB · Sep 26, 2025 · IPR2025-00604 · APJ Ryan H Flax · IPR · Institution

    The Board instituted IPR on claims 1, 2, 7–24, 26–28, and 30–32 on all four 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

      “institute trial in an inter partes review. We may institute an inter partes review if the information presented in the petition filed under 35 U.S.C. § 311, and any preliminary response filed under § 313, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314. After reviewing the parties’ submissions in view of the existing record, we conclude that Petitioner demonstrates a reasonable likelihood it would prevail in showing that at least one challenged claim of the ’286 patent is unpatentable under the presented grounds. See Pet. Therefore, we grant institution of inter partes review. Our reasoning is discussed below. A.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “A POSA at the time of the alleged invention would have at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and two or more years of experience in the production of bispecific antibodies. (EX1002, ¶¶16-17.) Pet. 15. Patent Owner states, “[f]or purposes of the Preliminary Response, Patent Owner applies Petitioner’s proposed definition of a POSA.” Prelim. Resp. 10. At this point, we accept and use Petitioner’s proposed, and unopposed, definition of the ordinarily skilled artisan. It appears that Petitioner’s proposed definition comports with the level of skill in the art reflected in the prior art of record and the ’286 patent, itself. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C.” slip op. at 12

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningNo construction neededDecided for petitioner

      “The ’286 patent uses the term “heavy chain” or “heavy chains” repeatedly; however, we find no express definition of the term. See generally Ex. 1001. Rather, the ’286 patent uses the term “heavy chain” in relation to antibody structure in a way that suggests the term is standard and well known in the art. See, e.g., id. at 3:19–59 (Background). The parties’ briefing on the technology reinforces this fact. See Pet. 5–14 (“The basic structure of natural IgG comprises four protein chains—two identical heavy chains (shown in red) and two identical light chains (shown in blue)—which are arranged in a Y-shaped configuration: . . . (EX1013, 112-13; EX1002, ¶¶23-30.)”); Prelim. Resp. 3–4 (“Natural or wild type Igs have a particular structure made of two identical light (L) chains and two identical heavy (H) chains. See EX2008 at ¶ 23. Each Ig heavy chain consists of three constant domains (CH1, CH2, and CH3) and one variable domain (VH), which is also isotypes, or a functional derivative and/or fragment of these. In a preferred embodiment, Ig-like molecules are produced that are antibodies of the IgG isotype because IgG antibodies e.g. have a longer half life as compared to antibodies of other isotypes. Ex. 1001, 11:9–21. As noted above (see supra Section I.C), IgG antibodies’ heavy chains have three constant domains, but IgE and IgM have four. Thus, Patent Owner’s argument that heavy chain means one variable and three constant domains, and two differently-binding Fab arms, ignores embodiments of the invention. consistent with the definition of heavy chain in the ’286 Patent. See EX2008 at ¶ 24; EX1001 at 11:58–66.”). This is also how the ’286 patent generally uses the term. See Ex. 1001, 11:58–12:1. But, the Specification does not limit its embodiments to only IgG antibodies because it also describes that the invention may be “IgG1, IgG2, IgG3, IgG4, IgA, IgE, and IgM” type antibodies, and fragments. Ex. 1001, 11:9–21; see also supra n.10 (quoting the ’286 patent’s definition of antibody). Other embodiments would not necessarily have the heavy chains as argued by Patent Owner. There is no evidence of record that the ’286 patent’s claims or the Specification generally use or limit the term “heavy chains” (or “heavy chain”) in any way deviating from its ordinary and customary meaning in the art. Therefore, at this stage of the proceeding, we decline to expressly interpret this claim language. 2. Summary on Claim Construction At this stage of the proceeding, we expressly construe no claim terms and give each claim term the ordinary and customary meaning it would have had to the person of ordinary skill in the art as of the invention date. See Nidec Motor Corp., 868 F.3d at 1017. If either party intends to further argue claim construction at trial, they should do so in a clearly designated section of their briefing so as to expressly identify such arguments. See, e.g., 37 C.F.R. § 42.104(b)(3) (content of petition); see also Board’s Consolidated Trial Practice Guide (CTPG) at 46, 48–45 (Nov. 2019).12 Claim construction arguments should not be relegated to patentability arguments on the facts.” slip op. at 16

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

      “In brief summary, these limitations require one CH3 heavy chain to have a positive amino acid substituted in place of a neutral one, the other CH3 heavy chain to have a negative amino acid substituted in place of a neutral one, and that when the heavy chains are expressed by culturing the host cell these positive and negative amino acids interact and the antibody produced is a heterodimeric antibody. Petitioner asserts that Lazar expressly teaches engineering two CH3 domains so that, when expressed, they interact and form a heterodimeric CH3 interface by making neutral-to-positive and neutral-to-negative amino acid substitutions at known interacting residues on each CH3 domain, e.g., S364E (changing neutral serine to negative glutamic acid at residue 364) on one CH3 domain, and L368K (changing neutral leucine to positive lysine at residue 368) on the other CH3 domain; or T366D (swapping neutral threonine for negative aspartic acid at residue 366) on one CH3 domain and L351K (swapping neutral leucine for positive lysine at residue 351) on the other CH3 domain; that these residues were known in the art to be respective interfacing contact residues; that these modifications favor Fc heterodimerization; and that they result in a heterodimeric antibody (proof-of-concept shown by synthesizing and screening). Pet. 23–28 (citing Ex. 1001, 13:1–17, 17:67–18:3, 19:5–12; Ex. 1002 ¶¶ 111–119; Ex. 1004 ¶¶ 121, 183, 241 (Tables 1, 2); Ex. 1007, 8:9–10, 17:19–20 (Table 1); Ex. 1008, 244–36).” slip op. at 29

    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
    Patents in suitUS 9,358,286
  • PTAB · May 16, 2025 · IPR2024-01487 · APJ Julia Heaney · IPR · Institution

    The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claim 1 would have been obvious over Nakazawa and Glaug.

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

      “Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon consideration of the Petition in view of the record at this stage, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. We also determine that the arguments and evidence of record do not support discretionary denial of the Petition under 35 U.S.C. § 314(a). Accordingly, we grant institution of an inter partes review of all claims and all grounds asserted in the Petition.1” slip op. at 2

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

      “person of ordinary skill would modify either Nakazawa’s diffusion sheet or Glaug’s fluid acquisition system, but rather Petitioner argues “various layers in absorbent articles are invariably interchangeable.” Prelim. Resp. 41–42. Contrary to Patent Owner’s argument, as discussed above, Petitioner explains why and how a person of ordinary skill would modify Nakazawa’s diffusion sheet, and provides reasons for doing so. On this record, we find Petitioner’s reasoning sufficient.” slip op. at 24

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

      “Patent Owner further argues Nakazawa teaches away from Petitioner’s asserted modification in which Glaug’s lower non-perforated layer is added to Nakazawa’s diffusion sheet. Prelim. Resp. 42. Specifically, Patent Owner argues Nakazawa teaches that its embodiment in which the second absorbent material is wrapped in a hydrophilic sheet has the advantage of preventing leakage of super absorbent polymer (“SAP”) from the second absorbent material without impeding permeation of excretory fluid through the hydrophilic sheet. Id. at 43 (citing Ex. 1008 ¶ 85, Fig. 15). Patent Owner further relies on Petitioner’s argument that Nakazawa’s hydrophilic layer is analogous to the lower non-perforated layer in Glaug. Id. (citing Pet. 93–94). Therefore, Patent Owner argues, Nakazawa teaches that Glaug’s fluid acquisition system would impede permeation of fluid rather than promote it. Id. Patent Owner’s teaching away argument is unavailing based on the current record. Patent Owner improperly relies on Petitioner’s contention in its anticipation challenge based on Nakazawa, and characterizes it as an argument about Glaug. As further discussed in Section II.G below, Petitioner’s anticipation challenge is based on analogizing Nakazawa’s hydrophilic sheet to a core wrap feature identified in Patent Owner’s infringement contention in parallel district court litigation. See Pet. 92–93. Contrary to Patent Owner’s argument, Petitioner’s obviousness contention does not argue Nakazawa’s hydrophilic layer is analogous to Glaug’s nonperforated fibrous layer. Because Patent Owner is not properly characterizing Petitioner’s obviousness contention, Patent Owner’s teaching away argument is not persuasive.” slip op. at 24

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

      “Under Fintiv, we consider the following factors: 1. whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; 2. proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; 3. investment in the parallel proceeding by the court and the parties; 4. overlap between issues raised in the petition and in the parallel proceeding; 5. whether the petitioner and the defendant in the parallel proceeding are the same party; and 6. other circumstances that impact the Board’s exercise of discretion, including the merits. Fintiv at 5–6.” slip op. at 35

    Claim construction§ 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 9,308,138
  • PTAB · Mar 19, 2025 · IPR2023-01289 · APJ James A Tartal · IPR · Final written decision

    Claims 1–33 are unpatentable as obvious over Collinge; the Board did not reach the anticipation grounds based on Collinge or the grounds based on Fiske.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner asserts that a person of ordinary skill in the art would have had “the equivalent of an undergraduate degree in electrical and computer engineering (or a related field) and approximately two years of work experience in the field of secure payment system,” and that “[a]dditional education in the field could be substituted for industry experience, and vice versa.” PO Resp. 4. Patent Owner does not suggest that its proposed level of ordinary skill materially differs from the level of skill proposed by Petitioner. See id. We find, on the current record, that the ’171 patent and the cited prior art references reflect the appropriate level of skill at the time of the claimed invention and that the level of appropriate skill reflected in these references and in the ’171 patent is consistent with the definition of a person of ordinary skill in the art proposed by Petitioner. Accordingly, we adopt Petitioner’s proposed level of ordinary skill. We would have reached the same conclusions in this Decision had we adopted Patent Owner’s proposed level of ordinary skill in the art.” slip op. at 14

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

      “In light of the lack of any dispute over the Second Construction, a construction we find consistent with the ordinary and customary meaning of the claim language, we need not resolve whether the claim language also encompasses Petitioner’s First Construction. Moreover, as explained below, we find Collinge renders obvious the subject matter of the limitation under either construction. See infra Section III.D.5. For the foregoing reasons, we find that an express construction of any claim term is not necessary for purposes of this Decision. 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 16

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

      “We disagree with Patent Owner’s arguments because here Petitioner is not relying on some other disclosure to fill a missing limitation absent from Collinge, but is instead relying only on Collinge and the knowledge a person of ordinary skill in the art would possess when appreciating the teachings of Collinge. Petitioner is not suggesting Collinge needed to be modified to add the use of an APDU, but, rather, that Collinge’s disclosure already contemplated it based on the well-known background of the art. Petitioner shows by a preponderance of the evidence that “the Collinge Provisionals state the disclosures therein are intended to be used in a ‘standard’ PayPass transaction,” and that a person of ordinary skill in the art would have considered “the PayPass Specification (and EMV Specifications, with which the PayPass Specification complies) when reading Collinge.” Pet. Reply 8 (citing Ex. 1009, 8, 14–15, 22–23; Ex. 1050 ¶ 22). in a “standard” PayPass transaction and that a person of ordinary skill in the art would have known, at a minimum, that it would have been obvious from Collinge that the “first set of data” (i.e., the encrypted payload in Collinge) would have been “usable” by the application of Collinge “to formulate an application protocol data unit response,” as required by limitation [1.C]. Petitioner further demonstrates how Collinge discloses that the “first set of data” was “useable by the application to formulate” an APDU response in addressing limitation [1.E–3], which specifically requires “generating a response.” See Pet. Reply 11 (explaining that “[d]etails of how [the encrypted payload] is used to formulate an APDU response are explained where that is separately claimed”); see also id. (citing Pet. 48–50 (addressing limitation [1.E-3])).” slip op. at 36

    Patent outcomesUS 10,032,171 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,032,171
  • PTAB · Nov 1, 2024 · IPR2023-01035 · APJ Tina E Hulse · IPR · Final written decision

    The Board granted cancellation of claims 1–6, 8–10, and 22–28, and denied substitute claims 29–44 because Wright ’451 rendered them obvious.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends that a person of ordinary skill in the art at the time of the invention (“POSA” or “POSITA”) would have had “a bachelor’s degree and two or more years of experience or a master’s degree in organic synthesis or chemical engineering, with education substituting for experience and vice versa.” Pet. 15 (citing Ex. 1002 ¶ 16). Patent Owner took no position on the level of ordinary skill in the art in its Preliminary Response. Prelim. Resp. 8. In our Institution Decision, we adopted Petitioner’s definition. Dec. Inst. 6–7. In its Motion to Amend, Patent Owner states that it accepts the Board’s definition for purposes of this proceeding. MTA 24. We, therefore, see no reason to disturb our definition of the level of ordinary skill in the art as it appears to be consistent with the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 8

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

      “Although neither party expressly proposes a construction for the term “conversion,” the parties appear to differ in their interpretations of that term. Petitioner interprets “conversion” to mean the percent conversion of the 1- alcohol. See Pet. Opp. RMTA 6–7 (interpreting “conversion” as percentage of remaining 1-alcohol); Ex. 1040, 109:2–11. Patent Owner, on the other hand, interprets “conversion” to mean the total percentage of alkenes that have been produced. Ex. 2010 ¶ 123 (interpreting “conversion” as percentage of total alkenes). During oral argument, counsel for Patent Owner conceded that “conversion can mean either.” Tr. 27:18–28:13. Without the benefit of briefing by the parties, we decline to expressly construe the term “conversion,” as our Decision would be the same under either interpretation, as discussed further below. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (finding only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy). Moreover, we do not find it necessary to expressly construe any other claim terms for purposes of this Decision. Id.” slip op. at 10

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

      “2. Analysis A patent claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which said claimed invention pertains. See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations, including (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of skill in the art; and (4) objective evidence of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). Objective evidence of nonobviousness may include” slip op. at 13

    • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedDecided for petitioner

      “We are not persuaded. “[A]ny superior property must be unexpected to be considered as evidence of non-obviousness.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). We must, therefore, first consider what results were expected to determine what a POSA would have considered to be unexpected. Id. As seen by the table below, Wright ’451’s disclosure fully encompasses the temperature ranges and purported unexpected results recited by substitute claim 29 and shown in Table 2 of the ’048 Patent: Reference Reaction Calcination Conversion Regioselectivity Rate13 Temperature Temperature Wright ’451 about 220 °C about 200 °C greater than about 90% to to about to 600 °C about 95% about 99% 440 °C Substitute 240 °C to about 420 °C at least 95% to about Claim 29” slip op. at 23

    Patent outcomesUS 10,995,048 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR
    Patents in suitUS 10,995,048
  • PTAB · Sep 20, 2024 · PGR2024-00018 · APJ Kevin W Cherry · PGR · Institution

    The Board instituted PGR on claims 1–15 and all petitioned grounds, finding a reasonable likelihood that claims 1–3, 6, and 10 are obvious over ElMasry.

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

      “Under 35 U.S.C. § 324(a), a post-grant review may be instituted only if “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Post-grant review is available for patents that issue from applications that at one point contained at least one claim with an effective filing date on or after March 16, 2013. See Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), §§ 3(n)(1), 6(f)(2)(A). After considering the briefing and the evidence of record, for the reasons set forth below, we determine that Petitioner has shown that the ’947 patent is eligible for post-grant review, and has shown it is more likely than not that at least one challenged claim of the ’947 patent is unpatentable under § 324(a). Accordingly, we institute a post-grant review of the challenged claims of the ’947 patent.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends that a person of ordinary skill in the art “would have a B.S. degree in Electrical Engineering, Physics, Chemistry, or an equivalent field, and at least 2-3 years of academic or industry experience in engineering related to optical sorting systems.” Pet. 17 (citing Ex. 1009 ¶ 21). Patent Owner did not file a Preliminary Response to the Petition and, therefore, at this point, does not contest Petitioner’s definition for one of ordinary skill in the art. Petitioner’s proposed definition appears to be consistent with the disclosure of the ’947 patent, and we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that the prior art itself may “reflect[] an appropriate level” of ordinary skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 11

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

      “Having considered the record, we determine that no express claim construction is necessary for any claim terms for the purposes of rendering a decision to institute trial. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (holding that only claim terms in controversy need to be construed, and only to the extent necessary to resolve the controversy (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). At this stage, we find it unnecessary to resolve whether “electronic control unit” and “processing module” should be construed as mean plus function limitations under § 112(f), because it is possible to address the obviousness grounds presented whether or not these limitations are so construed, and even if the claims were indefinite in the manner Petitioner contends. See Intel Corp. v. Qualcomm Inc., 21 F.4th 801, 813 (Fed. Cir. 2021) (noting indefiniteness of a means-plus-function limitation does not always render it impossible to adjudicate a prior-art challenge). We direct the parties to address the construction of these claim terms and Petitioner’s interpretation during trial.” slip op. at 13

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

      “We have reviewed Petitioner evidence and citations and, on the current record, we find that Petitioner has shown that it is more likely than not that ElMasry teaches all the limitations of claim 1, without need for any modification. Thus, we find that Petitioner has shown that it is more likely than not that claim 1 would have been unpatentable as obvious over ElMasry.” slip op. at 20

    Claim construction§ 103 obviousness§ 112 disclosure
    Patents in suitUS 11,666,947
  • PTAB · Sep 10, 2024 · IPR2024-00563 · APJ Zhenyu Yang · IPR · Institution

    The Board instituted IPR on claims 1, 12, and 28 because Petitioner showed a reasonable likelihood of prevailing on obviousness over Gil, Norden, Dean, Alphagan, and Federal Register.

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

      “partes review, “the Director 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. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential). “If a condition in the first part of the framework 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.” Id. at 8–9. “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9.” slip op. at 17

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

      “the District of New Jersey is more than three years, argues that “a trial may not be held until 2026—well after a FWD would be expected in this proceeding.” Pet. 15 (citing Ex. 1027, 2); Reply 8. Based on this evidence of the median time to trial in the district, we find factor 2 weighs in favor of institution. See Fintiv Memo 3 (“[W]hen considering the proximity of the district court’s trial date to the date when the PTAB final written decision will be due, the PTAB will consider the median time from filing to disposition of the civil trial for the district in which the parallel litigation resides.”)” slip op. at 22

    • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingOther

      “guidance as to the meaning of particular claim terms.” Phillips, 415 F.3d 1314. Claim 1 is directed to “[a] method for reducing eye redness in a human subject having ocular hyperemia.” The preamble is limiting because (1) it provides the antecedent bases for “said human” and “said reduction of eye redness” recited in the body of the claim; and (2) “it is a statement of the intentional purpose for which the method must be performed.” See Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1341–43 (Fed. Cir. 2021). The preamble, however, does not require that eye redness is actually reduced. Id. Nor does the body of the claim recite any efficacy requirement.” slip op. at 24

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITADecided for petitioner

      “In claim construction, “the claims themselves provide substantial guidance as to the meaning of particular claim terms.” Phillips, 415 F.3d 1314. Claim 1 is directed to “[a] method for reducing eye redness in a human subject having ocular hyperemia.” The preamble is limiting because (1) it provides the antecedent bases for “said human” and “said reduction of eye redness” recited in the body of the claim; and (2) “it is a statement of the intentional purpose for which the method must be performed.” See Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1341–43 (Fed. Cir. 2021). The preamble, however, does not require that eye redness is actually reduced. Id. Nor does the body of the claim recite any efficacy requirement.” slip op. at 24

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips
    Patents in suitUS 11,596,600
  • PTAB · Jun 21, 2024 · IPR2024-00346 · APJ Zhenyu Yang · IPR · Institution

    The Board denied institution for claims 1–28 under § 325(d), finding the same or substantially the same art had been presented to the Office and no material examination error was shown.

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

      “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. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential). “If a condition in the first part of the framework 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.” Id. at 8–9. “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9.” slip op. at 6

    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied

      “III. CONCLUSION Because the same or substantially the same art previously were presented to the Office and Petitioner has not demonstrated that the examiner materially erred when considering the prior art, we exercise our discretion under § 325(d) and decline to institute inter partes review of the ’454 patent.10 IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied, and no trial is instituted.” slip op. at 18

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

      “erred when considering the multiplex-amplification limitation. See Advanced Bionics, 9 (“If reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.”). Under the asserted grounds, Petitioner relies on Forshew as the sole reference to teach this limitation, which is required in all challenged claims. Thus, we exercise our discretion under § 325(d) and decline to institute inter partes review of the ’454 patent.” slip op. at 13

    § 103 obviousnessDiscretionary denial
    Patents in suitUS 11,530,454
  • PTAB · Jun 14, 2024 · IPR2023-00442 · APJ John G New · IPR · Final written decision

    Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as obvious over Dixon because Dixon anticipates them.

    RulingsFinal written decision
    • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner

      “We adopt the same reasoning here, and conclude that the evidence of record and the Specification of the ’681 patent support construing the preamble’s recitation of a “method for treating a patient with an angiogenic eye disorder” as meaning administering a compound, i.e., the recited VEGF antagonist, to a patient for the purpose of improving or providing a beneficial effect in their angiogenic eye disorder. We find that, as in Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, although the claims “encompass a clinical result, they do not require such a result.” (emphasis added). 8 F.4th 1331, 1343 (Fed. Cir. 2021). We consequently reject Patent Owner’s proposed construction that the language of the preamble reciting a “method for treating an angiogenic eye disorder” requires not only an intent to treat, but, additionally, a high degree of efficacy on par with monthly Lucentis. See PO Resp. 9–10.” slip op. at 17

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

      “We adopt Petitioner’s proposed construction of the claim terms “initial dose,” “secondary dose,” and “tertiary dose.” Petitioner proposes adoption of the definitions expressly set forth in the Specification of the ’681 patent, viz., that the initial dose is the dose “administered at the beginning of the treatment regimen,” and is followed by the secondary doses that are “administered after the initial dose,” and the tertiary doses are “administered after the secondary doses” and may be distinguished from the secondary doses “in terms of frequency of administration.” Ex. 1001, col. 3, ll. 36–44. Patent Owner does not expressly dispute Petitioner’s construction, other than to argue that, by 2011, a person of ordinary skill in the art would have understood “initial” and “secondary” doses to correspond to loading doses and “tertiary” doses to correspond to maintenance doses. PO Resp. 13 (citing Ex. 2056 ¶ 66; Ex. 2349, 6–11. Patent Owner contends that the purpose (and expected effect) of loading doses was to achieve visual acuity gains and retina drying, and the goal of less frequent maintenance doses was to maintain the efficacy achieved with loading doses. Id. at 14 (citing Ex. 2056 ¶ 66). As we have explained above, we do not find persuasive Patent Owner’s argument that the definition of these terms requires a high, or otherwise defined, degree of efficacy. As we stated in the -00881 and -01225 Decisions: Based on those express definitions in the Specification, we do not find cause to construe the terms differently. In particular, we do not find that the Specification requires the “tertiary doses” to maintain any efficacy gain achieved after the initial and secondary doses, or that the term suggests any specific level of efficacy. The Specification unequivocally states that “[t]he terms ‘initial dose,’ ‘secondary doses,’ and ‘tertiary doses,’ refer to the temporal sequence of administration of the VEGF antagonist.”” slip op. at 18

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner

      “If a claim limitation is directed to printed matter, the second step of the Praxair analysis is to determine whether the printed matter is functionally related to its “substrate.” Praxair, 890 F.3d at 1032. Printed matter that is functionally related to its substrate is given patentable weight. Id. (citing DiStefano, 808 F.3d at 850). However, “[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” Id. (quoting In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004)). More specifically, printed matter is functionally related to its substrate when the language changes not mere thoughts or outcomes, but provides action steps that the method requires. See C R Bard Inc. v. AngioDynamics, Inc., 979 F.3d 1372, 1381 (Fed. Cir. 2020) (holding that the test for printed matter is whether it “merely informs people of the claimed information, or whether it instead interacts with the other elements of the claim to … cause a specific action in a claimed process.”); see also Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) (stating that language “is only a statement of purpose and intended result” where its “expression does not result in a manipulative difference in the steps of the claim”) (emphasis added).” slip op. at 21

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “A Person of Ordinary Skill in the Art Petitioner notes that the Petitioner in the ’00881 IPR proposed that a person of ordinary skill in the art would have: (1) knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders; and (2) the ability to understand results and findings presented or published by others in the field. Pet. 17–18 (quoting -00881 IPR, Paper 94 at 9–10). Furthermore, it was asserted that such a person would typically have an advanced degree, such as an M.D. or Ph.D. (or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field), with practical academic or medical experience in (i) developing treatments for angiogenic eye disorders, including through the use of VEGF antagonists, or (ii) treating of same, including through the use of VEGF antagonists. Id. at 18 (citing -00881 IPR Paper 94 at 10). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. In the -01225 IPR, we adopted the same definition of a person of ordinary skill in the art for the challenged claims of the ’681 patent, concluding that that definition was consistent with the level of skill in the art. See -01225 IPR, Paper 96 at 52–53. Having previously adopted this definition of the level of skill in the art for the claims of the ’681 patent, we do so again in the present proceeding.” slip op. at 25

    Patent outcomesUS 10,130,681 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,130,681
  • PTAB · May 31, 2024 · IPR2024-00235 · APJ Carl M Defranco · IPR · Institution

    The Board instituted IPR on claims 1–6, 8, 10, and 14–16 based on a reasonable likelihood that claims 1 and 14 are anticipated by Young and obvious over Young and Norrie.

    RulingsInstitution decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Provisur proposes that one of ordinary skill in the art typically would have had: (1) a bachelor’s degree (or equivalent) in mechanical engineering (or a similar field) and at least two years of experience working as an engineer (or similar role) on food processing and/or packaging systems (or in a similar field); or (2) at least seven years of experience working as an engineer (or similar role) on food processing and/or packaging systems (or in a similar field). Pet. 12. Weber does not contest Provisur’s framing of the level of ordinary skill in the art. Because Provisur’s proposed definition is consistent with the level of skill described in the ’321 patent and the prior art of record, we adopt it here for purposes of institution.” slip op. at 5

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

      “Provisur asserts that the claim terms should be construed “according to their plain and ordinary meanings as understood by [one of ordinary skill in the art] in view of the specification and prosecution history” and that “[n]o terms require an explicit construction to resolve the unpatentability 4 US 5,514,032, issued May 7, 1996 (Ex. 1004, “Young”). 5 US 4,979,269, issued Dec. 25, 1990 (Ex. 1005, “Norrie”). 6 US 6,929,540 B2, issued Aug. 16, 2005 (Ex. 1006, “Johnson”). 7 US 6,198,834 B1, issued Mar. 6, 2001 (Ex. 1007, “Belk”). controversy between the parties here.” Pet. 13. Weber appears to agree, its counsel stating in the parallel Missouri action that “most of [Weber’s] patent claims are plain and ordinary . . . [t]hey’re not difficult or complex claims or claim terms.” Ex. 1028, 5. There being no dispute, we need not expressly construe any claim terms at this stage, because we can decide the threshold question of institution without further construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (approving Board decision not to construe claim language where the construction is not material to the dispute).” slip op. at 5

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

      “Weber requests that we deny institution under 35 U.S.C. § 314(a) due to the advanced state of the parallel Missouri action. See Prelim. Resp. 6– 17. Provisur disputes that discretionary denial is warranted (Pet. 73–77), but nonetheless submits a Sotera stipulation (Ex. 1029) in an effort to resolve the issue.8 In light of Provisur’s Sotera stipulation, we will not discretionarily deny institution under § 314(a). See Director Memorandum, Interim Procedure for Discretionary Denials in AIA-Post Grant Proceedings With Parallel District Court Litigation, U.S. PATENT AND TRADEMARK OFFICE (June 21, 2022), at 3, 7.” slip op. at 6

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

      “We disagree with Weber’s position, at least on the current record. Instead, we find that Provisur presents sufficient evidence that Young anticipates all elements of independent claims 1 and 14, including the disputed limitation requiring “automatic determination of the thickness of the fat cover.” In particular, Young’s imaging system 190 includes multiple cameras, including top plan camera 196, end view camera 197, and fat line camera 198, as well as controller 172 and real-time image processor 194. Ex. 1004, 17:34–59, 18:46–56, Figs. 2, 13. As described by Young, top plan camera 196 is primarily used to obtain “physical dimensions and characteristics” of the meat product, end view camera 197 is primarily used to determine the “height” of meat product and “to create a clear delineation along the top edge of the end” of the meat product, whereas fat line camera 198 is primarily used to determine the fat/lean separation line of the meat product. See id. at 17:59–18:39. Those disclosures by Young clearly contemplate determining specific dimensions of the meat product, and not simply identifying the fat/lean separation line, as Weber suggests. See Prelim. Resp. 19. To determine the “thickness” of the fat cover, Young’s imaging system has image processing routine 240, which “generates a fat/lean separation line and an edge line . . . representing the outer surface of the pork side proximate the fat/lean line” and uses those lines to calculate “the height, width, and length of the [meat product].” Ex. 1004, 23:12–25, 24:10–22. As part of routine 240, controller 172 uses that information to set the cutting profile of knife assembly 100 “so that the assembly follows a fixed distance from the separation line to provide the optimum fat cover for the loin.” Id. at 18:35–39 (emphasis added). Notably, according to Young, the “fixed distance” represents the “desired” thickness of fat that remains on the meat, after cutting, and “sufficiently keeps the loin from drying out, but doesn’t make the loin look too fat.” Id. at 20:60–66; see also id. at 10:39–42 (“Through control of the knife blade along several axes, assembly 100 preferably produces an optimum separation between loin and belly, with a desired fat covering left on the loin.” (emphasis added)). Young’s disclosure that image processing routine 240 determines a “fixed distance” from the loin/fat separation line at which to cut the meat product undoubtedly corresponds to the claimed “determination of the thickness of the fat cover . . . in a contactless manner.” See Ex. 1003 ¶¶ 104–112. Indeed, Young discloses specific dimensions for the desired optimum fat cover to remain on the meat—“a fixed distance (preferably 0.1 inch) from the fat/lean separation line 6.” Ex. 1004, 20:55–63.” slip op. at 8

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denial
    Patents in suitUS 8,529,321
  • PTAB · Apr 16, 2024 · IPR2023-01397 · APJ John G New · IPR · Institution

    The Board denied institution on all grounds because Dexcom did not show a reasonable likelihood that claims 1–4, 8, 9, and 11–27 were unpatentable.

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

      “We do not find Petitioner’s argument persuasive. Figure 29 is a “cross-sectional view,… of the insertion device” disclosed by Raymond. Ex. 1110 ¶ 55. Another view of base 122 is depicted in Raymond’s Figure 18, a detail of which is reproduced below: Detail of Figure 18 of Raymond showing base 122 As depicted in Figure 18, base 122 of Raymond’s device comprises a circular disk, with an annular ring on the proximal side. This view is consistent with the cross-sectional view of base 122 in Raymond’s Figure 29, reproduced below: Detail of Raymond’s Figure 29 depicting a cross-sectional view of base 122 The annular ring of base 122, as depicted in Raymond’s Figures 18 and 29 thus comprises, at most, a single recess encircling base 122 beneath the annular ring at the periphery of the base. As such, it neither teaches nor suggests “a plurality of recesses disposed on a periphery of the on-body electronics unit housing, wherein the plurality of recesses comprises a first recess in a spaced relation to a second recess,” as required by challenged claim 1 of the ’335 patent. Petitioner’s argument that Figures 20 and 30 of Raymond depict” slip op. at 29

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

      “Detail of Raymond’s Figure 29 depicting a cross-sectional view of base 122 The annular ring of base 122, as depicted in Raymond’s Figures 18 and 29 thus comprises, at most, a single recess encircling base 122 beneath the annular ring at the periphery of the base. As such, it neither teaches nor suggests “a plurality of recesses disposed on a periphery of the on-body electronics unit housing, wherein the plurality of recesses comprises a first recess in a spaced relation to a second recess,” as required by challenged claim 1 of the ’335 patent. Petitioner’s argument that Figures 20 and 30 of Raymond depict plural recesses in Raymond’s base 122 is based upon a false premise. See Pet. 37–38. The depiction of base 122 in these Figures is entirely consistent with the depiction of base 122 in Raymond’s Figure 18 as having an annular ring with a single recess situated beneath its rim. With respect to Petitioner’s argument that it would have been an obvious design choice to implement two spaced-apart plural recesses on the housing (see Pet. 38), neither Petitioner nor its Declarant, Dr. Fletcher, adduces any evidence beyond that conclusory statement. Id. at 38 (citing Ex. 1103 ¶ 70; Ex. 1110, Figs. 18, 25–27); Ex. 1003, 77. Petitioner makes no persuasive argument as to why a skilled artisan would substitute multiple recesses for a single annular ring, which seemingly serves the purpose of allowing base 122 to be held in position by base-retaining arms 1226. To the contrary, substituting multiple recesses in base 122 to engage retaining arms 1226, and ensuring that each retaining arm 1226 suitably engages each recess, would seem only to add needless complexity to the design, without producing a substantial benefit or improvement.” slip op. at 30

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

      “Turner’s rotation-resisting recesses 77 are not located on the periphery of its body 20. Instead, they are disclosed as being located upon the upper surface of body 20, between its central axis and its edge, and are configured to receive rotation-resisting protrusions 71 of insertion device 70. This placement of rotation-resisting recesses 77 is depicted in Figure 9 of Turner, which is reproduced again below: Figure 9 of Turner is a perspective, exploded view of its fluid delivery system including body 20 and rotation-restricting recesses 77 We therefore find that Turner does not teach or suggest the limitation of challenged claim 1 (and all claims by their dependency) reciting “an on body electronics unit housing comprising a plurality of recesses disposed on a periphery of the on body electronics unit housing.” We further conclude that Petitioner provides no persuasive reason why a person of ordinary skill in the art would have been motivated to alter the location of Turner’s rotation-resisting recesses 77 from the upper surface to the circumferential periphery of body 20, because Turner and the ’335 patent teach that their respective recesses serve different functions. Turner teaches that:” slip op. at 47

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached

      “Because we deny institution of inter partes review on the merits, we need not reach the parties’ arguments with respect to whether we should exercise our discretion and deny institution of inter partes review under Section 325(d). As we conclude in Sections IV.B.2.d and IV.C.2.c above, Petitioner has failed to meet its burden of showing a reasonable likelihood of demonstrating at trial that the challenged claims are unpatentable over the combination of Thomas and Raymond, or of Thomas, Raymond, and Turner. That remains true even if, arguendo, the Examiner materially erred in concluding that Thomas is not prior art to the ’335 patent, an issue upon 13 Thomas et al. (US 2010/0198034 A1, August 5, 2010) (“Thomas ’034”), Ex. 2101. 14 The publication date of the Thomas reference that is a basis of Grounds 1 and 2 in this inter partes review is August 12, 2010, one week after the publication of Thomas ’034. which we express no view. We consequently deny as moot Patent Owner’s request that we exercise our discretion under Section 325(d).” slip op. at 51

    § 103 obviousnessDiscretionary denialcites Phillips · Graham
    Patents in suitUS 11,266,335
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