• Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.Institution denied
  PTAB · Oct 3, 2025 · PGR2025-00032 · APJ Susan L C Mitchell · PGR · Institution

  The Board denied institution because Patent Owner disclaimed all challenged claims.

  RulingsInstitution decision

  • Adverse judgmentAdverse judgmentDenied

    “Section 42.207(e) states that “[n]o post-grant review will be instituted based on disclaimed claims.” 37 C.F.R. § 42.207(e). Because the Patent Owner has disclaimed all claims challenged by the grounds in this Petition, we determine that no trial will be instituted.” slip op. at 2

  None
  Patents in suitUS 12,115,166
• Formycon AG v. Regeneron Pharmaceuticals, Inc.Institution denied
  PTAB · Jun 2, 2025 · IPR2025-00233 · APJ Michael A Valek · IPR · Institution

  The Board denied institution under § 314(a) based on the Fintiv factors and denied joinder; it did not reach the merits of the asserted grounds.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivInstitution denied

    “B. The Fintiv Factors and Related Guidance The Board’s precedential decision in Fintiv outlines factors that balance considerations of system efficiency, fairness, and patent quality when a patent owner raises an argument for discretionary denial due to the advanced state of a parallel proceeding, such as the MDL proceeding here. Fintiv 5–6. These factors are: 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. Id. “[I]n evaluating the factors, the Board takes a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Id. at 6.” slip op. at 10

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

    “III. DISCRETION UNDER 35 U.S.C. § 314(A) We begin by addressing Patent Owner’s arguments for discretionary denial. As explained below, we find those arguments persuasive. Thus, we exercise discretion to deny institution of the Petition under 35 U.S.C. § 314(a) without reaching the merits of Petitioner’s asserted grounds of unpatentability.” slip op. at 8

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, deniedDenied

    “35 U.S.C. § 314(a) to deny institution of the Petition and deny the Joinder Motion.” slip op. at 2

  Discretionary denial
  Patents in suitUS 11,084,865
• Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.Institution denied
  PTAB · Jun 2, 2025 · IPR2025-00176 · APJ Michael A Valek · IPR · Institution

  The Board denied institution of IPR on all challenged claims under § 314(a), finding the Fintiv factors—particularly investment, overlap, and merits—weighed against review.

  RulingsInstitution decision

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

    “raised by this overlap, but given the circumstances, it does not effectively mitigate them. First, the disputed issues for Petitioner’s ODP defense are the same or substantially similar to those for the obviousness grounds in the Petition, but the Sotera stipulation does not prevent Petitioner from litigating those issues before both the district court (as part of its ODP defense) and here in the event an IPR is instituted.19 Second, the MDL proceeding 19 ODP or nonstatutory double patenting is, as the name implies, not premised on any statute. See, e.g., Ostuka Pharm. Co., Ltd. v. Sandoz, Inc., 678 F.3d 1280, 1297 (Fed. Cir. 2012) (“Nonstatutory double patenting is a judicially created doctrine grounded in public policy.”). Accordingly, it is not a ground Petitioner reasonably could have raised in this IPR. See 35 U.S.C. § 311(b) (inter partes review may be requested “only on a ground that could be raised under section 102 or 103”). includes other biosimilar applicant defendants who are similarly motivated to try to invalidate the ’865 patent claims, but who are not subject to any Sotera stipulation. Even if we institute review on Petitioner’s grounds here, those other defendants remain free to litigate the same grounds in the consolidated MDL proceeding. For these reasons and given the particular circumstances of this case, Petitioner’s Sotera stipulation does not sufficiently mitigate the risks of duplicated efforts or inconsistent decisions by making this IPR a “true alternative” to resolution of these issues by the district court. See Motorola Solutions, Inc. v. Stellar, LLC, IPR2024-01205, Paper 19, 3–4 (PTAB Mar. 28, 2005) (determining on Director Review that a Sotera stipulation did not ensure IPR would be a “true alternative” because Petitioner’s invalidity arguments “include combinations of the prior art asserted in these proceedings with unpublished system prior art, which Petitioner’s stipulation is not likely to moot” and thus the same or similar issues would remain in the parallel proceeding); SAP America, Inc. v. Cyandia, Inc., IPR2024-01496, Paper 13, 8–9 (PTAB Apr. 7, 2025) (similar).” slip op. at 19

  Discretionary denial
  Patents in suitUS 11,084,865
• Cipla Limited v. Gilead Sciences, Inc.Institution denied
  PTAB · May 15, 2025 · IPR2025-00033 · APJ Susan L C Mitchell · IPR · Institution

  The Board denied institution of IPR on claims 1–13 under § 314(a), finding the Fintiv factors favored denial and the petition did not present compelling merits.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied

    “We determine that this factor weighs heavily in favor of exercising discretion to deny the Petition. The trial date in the district court litigation is scheduled for October 6, 2025. See Prelim. Resp. 16 (citing Ex. 2010). This date is at least six months before our projected statutory deadline should we go forward in this case. Patent Owner points out that this trial date is nine months later than the median time to trial in the District of Delaware, and in Patent Owner’s view, the parties are on track to satisfy the current schedule. Id. at 16–17 (citing Ex. 2011).” slip op. at 9

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

    “1 Patent Owner also asserts that the Petition should be denied under 35 U.S.C. § 325(d), but we need not reach this issue because we are exercising discretion under Section 314(a) to deny the Petition. See Prelim. Resp. 2–3.” slip op. at 2

  Discretionary denial
  Patents in suitUS 11,744,802
• Aardevo North America, LLC v. Agventure B.V.Institution denied
  PTAB · May 1, 2025 · IPR2025-00136 · APJ Jeffrey N Fredman · IPR · Institution

  Institution of inter partes review was denied for claims 1–10 because Petitioner did not establish a reasonable likelihood of prevailing on any asserted ground.

  RulingsInstitution decision

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

    “Accordingly, we find that on the current record Petitioner has not shown that it has a reasonable likelihood that it would prevail on these obviousness grounds. XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5. XIII. CONCLUSION After reviewing the information presented in the Petition and the Preliminary Response, we determine that, based on the evidence of record, Petitioner has not established a reasonable likelihood that claims 1–10 of the ’841 patent are unpatentable. XIV. ORDER Accordingly, it is ORDERED that, pursuant to 35 U.S.C. § 314(a), institution of an inter partes review of all challenged claims on all grounds presented in the Petition is denied.” slip op. at 35

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable

    “However, neither Petitioner nor Dr. Jansky provide specific data on the record before us showing the actual measured homozygosity of either of the inbred lines, US-W 5309 and US-W 5315. And Phumichai experimentally demonstrates that Dr. Jansky’s assumption that theoretical heterozygosity reduction of 50% per generation is not necessarily accurate, stating the “observed average percentage of reduction of heterozygosity per generation (38.4% or 38.5%) was lower than the theoretically expected value of 50%.” Ex. 1005, 982. Indeed, Phumichai disclosed that the “SOPH [Section-based observed percentage of heterozygosity] decreased steadily from the original 100% in 99H2–1 (S0) to the family means of 62.4% in 3H2 (S1), 37.9% in 3H3 (S2).” Id. at 981. That is, Phumichai experimentally shows that in an S2 generation of a potato line, the heterozygosity was 37.9%, resulting in homozygosity of about 62.1%, below the 75% theoretically expected and the 75% required by claim 1 of the ’841 patent. Therefore, the evidence of record does not show that the S2 generation of potato lines in Jong necessarily satisfies the homozygosity recitation in claim 1 of the ’841 patent, and so cannot establish on the record before us that Jong inherently teaches this limitation.” slip op. at 15

  • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedNot shown unpatentableNot shown unpatentable

    “Owner is telling. Petitioner does not refute Patent Owner’s evidence of objective indicia. On the current record, the objective indicia evidence is compelling. As to long felt need, Patent Owner cited evidence on record before the Examiner that showed a persistent need recognized by ordinarily skilled artisans. In re Gershon, 372 F.2d 535, 538 (CCPA 1967). For example, Dr. Huang states “This research is the breakthrough we have been waiting for since nearly a century . . . This is crucial for the potato breeding worldwide.” Ex. 2009, 687. There is no evidence that this long-felt need was satisfied by another before Appellant’s invention. See Newell Companies, Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988) (“[O]nce another supplied the key element, there was no long-felt need or, indeed, a problem to be solved . . . .”). Lastly, Dr. Lindhout explains that this invention satisfies the long-felt need, stating “I have discovered, and disclosed in the present application for patent, how a fertile homozygote in” slip op. at 33

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

    “XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5.” slip op. at 35

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 11,140,841
• Solus Advanced Materials Co., Ltd. v. SK Nexilis Co., Ltd.Institution denied
  PTAB · Apr 25, 2025 · IPR2024-01462 · APJ Jo-Anne M Kokoski · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–8 were unpatentable under the asserted obviousness grounds.

  RulingsInstitution decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “experience working on the development of materials or components for electronic devices such as batteries.” Pet. 2. Petitioner further contends that “[a]dditional education, such as a graduate degree, could compensate for less work experience, and additional work experience could compensate for less formal education.” Id. Patent Owner states that, “[f]or purposes of this Preliminary Response, Patent Owner applies Petitioner’s level of skill for a person of ordinary skill in the art.” Prelim. Resp. 4. For purposes of this Decision, we adopt Petitioner’s undisputed proposed definition because it appears to be consistent with the cited prior art and the disclosure of the ’014 patent. 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 neededOther

    “customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” 37 C.F.R. § 42.100(b). Under this standard, claim terms are generally given their plain and ordinary meaning as would have been understood by a person of ordinary skill in the art at the time of the invention and in the context of the entire patent disclosure. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). Only those terms in controversy need to be construed, and only to the extent necessary to resolve the controversy. Realtime Data LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019). in this proceeding.” Pet. 3. Patent Owner contends that “[t]he Board need not construe any term in order to determine that institution should be denied.” Prelim. Resp. 4. Based on the record before us, we determine that no claim term requires express construction for purposes of this Decision. See Realtime Data, 912 F.3d at 1375.” slip op. at 8

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

    “For these reasons, we are not persuaded that Petitioner sufficiently establishes that a POSITA would have been motivated to modify Hanafusa in light of Dobashi with a reasonable expectation of success as Petitioner contends. Accordingly, we determine that Petitioner fails to demonstrate a reasonable likelihood of prevailing in its assertion that the subject matter of claim 1, and claims 4 and 8 that depend therefrom, would have been obvious over the combined teachings of Hanafusa and Dobashi.” slip op. at 18

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

    “Petitioner also focuses on Hanafusa’s teaching that all known methods can be used to make a rough surface low-profile, and Dobashi’s teaching that RSm can be used as an indicator for judgment of the surface, to support its contention that a POSITA would have been motivated to apply Dobashi’s RSm to further achieve Hanafusa’s purpose, without explaining how and why that would be the case. In particular, neither Petitioner nor Dr. Josefowicz adequately explain why a POSITA looking for ways to make Hanafusa’s surface roughness low-profile would look to methods to achieve as the period of waviness, RSm can also be used as an indicator for judgment of the surface.” Ex. 1005, 2:66–3:1, 6:23–26. Dobashi explains that waviness is “an indicator for determining whether the fine pattern forming performance is good or bad,” and “[t]he surface has small waviness and is smooth when RSm is large, and the surface has large waviness and is rough when RSm is small.” Id. at 3:1–3, 6:27–29. Dobashi also teaches that surface roughness Rzjis is used as a low-profile indicator. Ex. 1005, 2:66– 3:1. Dobashi, therefore, teaches that RSm is an indicator of surface waviness, which Dobashi explains is different than surface roughness. Id. at 2:66–3:3, 6:23–29. Given these teachings in Dobashi, neither Petitioner nor Dr. Josefowicz sufficiently explains how or why a POSITA would have been motivated to implement Dobashi’s RSm values to make Hanafusa’s surface roughness low-profile. See Pet. 10–12; Ex. 1003 ¶¶ 46–52.” slip op. at 14

  Claim construction§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 11,346,014
• Solus Advanced Materials Co., Ltd. v. SK Nexilis Co., Ltd.Institution denied
  PTAB · Apr 23, 2025 · IPR2024-01461 · APJ Jo-Anne M Kokoski · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–10 were unpatentable over either asserted § 103 ground.

  RulingsInstitution decision

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

    “Institution of an inter partes review is authorized by statute when “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 (2018); see also 37 C.F.R. § 42.4 (2023). For the reasons discussed below, we deny the Petition and do not institute an inter partes review.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “II. ANALYSIS A. Level of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art (“POSITA”) “would have had at least an undergraduate degree in materials science, chemical engineering, electrical engineering, or related field, or equivalent knowledge, training, or experience, with at least two years of experience working on the development of materials or components for electronic devices such as batteries.” Pet. 4. Petitioner further contends that “[a]dditional education, such as a graduate degree, could compensate for less 7 We refer to the page numbers added by Petitioner to the bottom-center of the page. formal education.” Id. (citing Ex. 1003 ¶ 10). Patent Owner states that, “[f]or purposes of this Preliminary Response, Patent Owner applies Petitioner’s level of skill for a person of ordinary skill in the art.” Prelim. Resp. 4. For purposes of this Decision, we adopt Petitioner’s undisputed proposed definition because it appears to be consistent with the cited prior art and the disclosure of the ’689 patent. 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, 163–64 (Fed. Cir. 1985))).” slip op. at 10

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “We are not persuaded, on this record, that Petitioner adequately establishes that Khatibi discloses a CTE in the claimed range of 16 to 22 µm/(m·°C.). Petitioner’s argument that Khatibi’s reported values meet this claim limitation are based solely on Dr. Randall’s testimony that Khatibi’s measurement method would produce results that would not significantly differ from results determined using the claimed method. See Pet. 16–18 (citing Ex. 1003 ¶¶ 56–60). Dr. Randall’s testimony, however, is largely conclusory and unsupported by adequate explanation and/or objective evidence. For example, Dr. Randall does not provide adequate explanation or objective evidence to support his opinion that Khatibi’s use of a laser speckle based dilatometer instead of the claimed thermomechanical analyzer “is unlikely to significantly impact the CTE value” because “variations in equipment and a heating speed of 5° C/min would not significantly alter the results.” Ex. 1003 ¶ 58. In particular, Dr. Randall neither explains what constitutes a “significant” impact on CTE, nor provides objective evidence to support his contention that equipment variations and heating differences would not “significantly alter” the resulting measurements. And although Dr. Randall opines that “the heating rate (5°C per minute) is typical for certain devices” such as a thermomechanical analyzer or dilatometer, and “[t]ypically, these devices use temperature ramp rates between 2°C and 20°C per minutes, so the ‘5° C./min’ recited in [1d] is common and should not drastically affect the measurement results,” Dr. Randall fails to point us to any evidence showing that these temperatures are “typical” or that the claimed heating rate is “common.” Id. ¶ 59 (emphases added). to little weight. See 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”); Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 12 at 5 (PTAB Feb. 10, 2023) (finding that “the Board was correct in giving little weight to Petitioner’s expert because the expert declaration merely offered conclusory assertions without underlying factual support”); Upjohn Co. v. Mova Pharm. Corp., 225 F.3d 1306, 1311 (Fed. Cir. 2000) (“Lack of factual support for expert opinion to factual determinations, however, may render the testimony of little probative value in a validity determination.” (quoting Ashland Oil, Inc. v. Delta Resins and Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985))); see also In re Ethicon, Inc., 844 F.3d 1344, 1348, 1352 (Fed. Cir. 2017) (concluding that the Board properly gave “little weight” to conclusory expert testimony of objective indicia). Because Petitioner offers Dr. Randall’s testimony to supply a limitation missing from the prior art, namely, the CTE measurement method, and we give Dr. Randall’s unsupported and conclusory testimony little weight, we are not persuaded that Petitioner establishes a reasonable likelihood of showing that Khatibi discloses limitation [1d].” slip op. at 17

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

    “second surfaces of the electrolytic copper foil ranges from 3 to 92.” Ex. 1001, 13:62–63. Petitioner contends that “Kim teaches that the electrolytic copper foil (e.g., untreated or treated copper foil) having Rz less than 2 µm is advantageous toward battery efficiency and performance,” and, similarly, Griesi describes the use of untreated electrolytic copper foil with an Rz value less than 2 µm in printed circuit boards that are compatible with secondary batteries. Pet. 58–59 (citing Ex. 1012, claim 2, ¶¶ 13, 25, 27; Ex. 1003 ¶ 157). In particular, Petitioner notes that Griesi’s Figure 3.16 describes an “Rz value of 1.2 µm.” Id. at 59 (citing Ex. 1015, 53–54; Ex. 1003 ¶ 158). Petitioner asserts that “Dr. Randall explains that a POSITA would have also recognized another surface roughness-related parameter, Rpc, in Griesi as a potentially useful parameter that can be optimized to further enhance uniformity or generally improve Kim’s copper foil surface, for example, to prevent wrinkles or achieve other advantageous effects.” Id. (citing Ex. 1003 ¶ 159). Although Dr. Randall demonstrates that Griesi’s Pc (or Rpc) value is 19.2 over a 4 mm sampling length (Ex. 1003 ¶ 155), Petitioner does not contend that Griesi addresses this value, or indicates any benefit that might be derived from its use. Instead, Griesi’s Pc value appears to be an incidental finding, which is not discussed or analyzed in the reference. See incidental, unexamined finding would lead a POSITA to import Griesi’s Pc value into Kim’s copper foil, absent a hindsight desire to reconstruct the claimed invention. As such, Petitioner’s arguments with respect to Kim and Griesi are not persuasive. See Cheese Sys. Inc. v. Tetra Pak Cheese and Powder Sys., Inc., 725 F.3d 1341, 1352 (Fed. Cir. 2013) (“Obviousness cannot be based on the hindsight combination of components selectively culled from the prior art to fit the parameters of the patented invention.” (internal quotations marks omitted)). Thus, we are not persuaded, on this record, that the combined disclosures of Kim and Griesi teach all of the elements of limitation [1g].” slip op. at 23

  § 103 obviousnesscites Phillips
  Patents in suitUS 10,811,689
• Solus Advanced Materials Co, Ltd. v. SK Nexilis Co., Ltd.Institution denied
  PTAB · Apr 22, 2025 · IPR2024-01460 · APJ Jon B Tornquist · IPR · Institution

  The Board denied institution of review of claims 1–11 because the Fintiv factors, including the early trial date and close merits case, favored discretionary denial.

  RulingsInstitution decision

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

    “whether to institute an inter partes review. Applying the standard set forth in 35 U.S.C. § 314(a), we may not institute an inter partes review unless the information presented in the petition “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Institution of inter partes review, however, is discretionary. See Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“[T]he PTO is permitted, but never compelled, to institute an IPR proceeding.”). For the reasons stated below, we exercise our discretion not to institute an inter partes review. A. Real Parties-in-Interest” slip op. at 2

  • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied

    “Board’s projected statutory deadline to issue a final written decision. Fintiv, Paper 11 at 9. “If the court’s trial date is at or around the same time as the projected statutory deadline . . . the decision whether to institute will likely implicate other factors.” Id. Conversely, “[i]f the court’s trial date is earlier than the projected statutory deadline,” this has generally weighed “in favor of exercising authority to deny institution.” Id.” slip op. at 15

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

    “Petition under 35 U.S.C. § 325(d) because the same or substantially the same art and arguments were before the Examiner during prosecution and Petitioner’s has not demonstrated that the Examiner erred in a material manner when allowing the claims. Pet. 17–18. Given our discretionary denial of the Petition in view of the Fintiv factors, we do not address Petitioner’s further arguments with respect to § 325(d).” slip op. at 32

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner applies Petitioner’s recited level of ordinary skill in the art for purposes of its Preliminary Response. Prelim. Resp. 4. Upon review of the parties’ arguments and the prior art of record, we adopt Petitioner’s unopposed definition of the ordinarily skilled artisan for purposes of this decision as it appears consistent with the disclosures of the ’090 patent and the prior art of record. C. Claim Construction” slip op. at 9

  § 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 10,480,090
• Honeywell International Inc. v. DSM IP Assets B.V.Institution denied
  PTAB · Aug 21, 2024 · IPR2024-00493 · APJ Erica A Franklin · IPR · Institution

  The Board denied institution because Honeywell did not show a reasonable likelihood that claims 1–9 were unpatentable over any of its three obviousness combinations.

  RulingsInstitution decision

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

    “Accordingly, we determine that Petitioner has not shown a reasonable likelihood of prevailing in its obviousness challenge of independent claim 1 or dependent claims 2–9 over the combination of Simmelink and Section 73.1015.” slip op. at 23

  • Skill levelOther

    “PHOSITA) at the time of the ’532 patent “would have had at least a Bachelor’s degree in the field of chemistry, chemical engineering, polymer chemistry, or materials science and at least three years of relevant work experience in the field of high strength fibers.” Pet. 8 (citing Ex. 1003 ¶ 18). Petitioner adds that individuals with different educational backgrounds could still be of ordinary skill in the art if they have “additional experience [that] compensates for a deficit in their education and experience stated above.” Id. According to Patent Owner, a person or ordinary skill in the art, would have (i) a bachelor’s degree in chemistry, polymer chemistry, materials science, chemical engineering, or biomedical engineering and (ii) three years of experience in designing and manufacturing gel-spun UHMWPE yarns. At this level of skill, a PHOSITA would have a detailed understanding of the information provided in the Technology Background, Section II, supra, including (i) the differences between linear HDPE and UHMWPE, (ii) the history underlying Section 73.1015 and the early failures of the 1960s-era blue, melt-extruded polyethylene sutures, (iii) why the molecular orientation of polyethylene molecules leads to strong yarns in the special case of gel-spun UHMWPE, and (iv) the challenges associated with coloring gel-spun UHMWPE yarns, especially for end-use medical applications. Prelim. Resp. 33–34. We note that the parties’ proposed definitions are largely similar, except that Patent Owner additionally recognizes a Bachelor’s degree in biomedical engineering and requires experience in designing and manufacturing gel-spun UHMWPE yarns. In any event, we do not need to the same under either proposed definition.” slip op. at 6

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

    “a skilled artisan would have understood that the “gel spinning” process recited in the claims requires the use of a solvent during the spinning process. Indeed, the Specification describes this term, as follows: Gel spinning is understood to include at least the steps of spinning filaments from a solution of ultra-high molecular weight polyethylene in a spin solvent; cooling the filament obtained to form a gel filament removing at least partly the spin solvent from the gel filament; removing at least partly the spin solvent from the gel filament; and drawing the filament in at least one drawing step before during or after removing spin solvent. Ex. 1001, 2:31–37. We recognize the inventor’s lexicography as dispositive with respect to the meaning of the term “gel spinning.” See Phillips v. AWHCorp., 415 F.3d 1303, 1316 (Fed. Cir. 2005); SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1343–44 (Fed. Cir.” slip op. at 8

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

    “Claim 1 describes gel spinning as the manner by which the filaments comprised in the claimed colored multi-filament yarn are obtained. This, on its face, is a product-by-process claim element because it describes the filament structure being obtained in a particular way, i.e., by gel spinning. See Kamstrup A/S v. Axioma Metering UAB, 43 F.4th 1374, 1382 (Fed. Cir. 2022) (agreeing with the Board that “cast in one piece” is a product-by-process claim element as it describes the structure being cast “in a particular way”). For this element to be limiting, it must impart “structural and functional differences” that distinguish the claimed product from the prior art. See Amgen Inc. v. F. Hoffman-La Roche Ltd, 580 F.3d 1340, 1365–67 (Fed. Cir. 2009). Patent Owner argues persuasively that gel spinning imparts structural and functional differences to the claimed product because the process “creates overlap between polyethylene molecules within the UHMWPE filaments that maximizes the intermolecular Van der Waals interactions, resulting in highly crystalline filaments with high tensile strength.” Prelim. Resp. 38, 22 (citing Ex. 1014, 62–66). According to Patent Owner, “the structure of the gel spun UHMWPE is substantially different from other types of UHMWPE such as compression-molded and ram-extruded UHMWPE used to make joint replacements and other orthopedic implants.” Id. at 38.” slip op. at 9

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,280,532
• Nexus Pharmaceuticals, LLC v. Exela Pharma Sciences, LLCInstitution denied
  PTAB · Aug 8, 2024 · PGR2024-00016 · APJ Ulrike W Jenks · PGR · Institution

  The Board denied institution of PGR on claims 1–30 under § 325(d), finding substantially the same art or arguments had been presented to the Office and no material error was shown.

  RulingsInstitution decision

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

    “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 exercise discretion to deny institution under § 325(d). Accordingly, we do not institute a post-grant review of the challenged claims of the ’370 patent.” slip op. at 2

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

    “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.”3 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). We consider several non-exclusive factors as set forth in Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 (Dec. 15, 2017) (precedential as to § III.C.5, first paragraph) (“Becton, Dickinson”), which “provide useful insight into how to apply the 3 The Board institutes trial on behalf of the Director. 37 C.F.R. § 42.4(a). framework” under § 325(d). Advanced Bionics, 9. These non-exclusive factors include: (a) the similarities and material differences between the asserted art and the prior art involved during examination; (b) the cumulative nature of the asserted art and the prior art evaluated during examination; (c) the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection; (d) the extent of the overlap between the arguments made during examination and the manner in which Petitioner relies on the prior art or Patent Owner distinguishes the prior art; (e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art; and (f) the extent to which additional evidence and facts presented in the Petition warrant reconsideration of the prior art or arguments. Becton, Dickinson, 17–18 (formatting added). “If, after review of factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office, then factors (c), (e), and (f) relate to whether the petitioner has demonstrated a material error by the Office.” Advanced Bionics, 10.” slip op. at 10

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person of ordinary skill in the art: would have had an advanced degree like a Ph.D. or equivalent in chemistry, biochemistry, pharmaceutics, pharmacy, or a related pharmaceutical field, with at least two years of experience in pharmaceutical formulation development, analysis, optimization and manufacturing, including experiences with processes and techniques for minimizing impurities in, and improving the stability of, pharmaceutical drug products during manufacture and storage. Pet. 27 (citing Ex. 1003 ¶ 24). Petitioner also states that one of ordinary skill in the art “may also have lesser levels of education but more years of experience” and “[a] multi-disciplinary team consisting of individuals with different skills and experience could also suffice.” Id. Patent Owner argues that: A person of ordinary skill in the art has attained a Pharm. D., or M.S. or Ph.D. in chemistry, chemical engineering, or a related field; has three or more years of experience in developing aqueous drug formulations; and has access to other scientists to collaborate and consult with on, for example, characterizing the drug formulation, manufacture of the drug formulation, and clinical use and effect of the drug formulation.” slip op. at 7

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

    “Because this Decision declining to institute trial does not necessitate the application of any express claim construction, we need not construe any terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe 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 8

  Claim constructionDiscretionary denial
  Patents in suitUS 11,642,370

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.