- Xencor, Inc. v. Merus N.V.InstitutedPTAB · 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 PhillipsPatents in suitUS 9,358,286 - PTAB · Aug 12, 2025 · IPR2025-00405 · APJ Debra L Dennett · IPR · Institution
The Board instituted IPR on claims 1–6 and 12–26 because Petitioner showed a reasonable likelihood of prevailing on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review under 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2025). The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless the Director determines . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least [one] of the claims challenged in the petition.” For the reasons set forth below, upon considering the Petition, Preliminary Response, and the evidence of record as presently developed, we determine that Petitioner has established a reasonable likelihood of prevailing with respect to at least one challenged claim. Accordingly, we grant the Petition and institute an inter partes review.” slip op. at 2
- BurdenNot reached
“3. Analysis On the preliminary record, we agree with Patent Owner that Petitioner fails to demonstrate that it meets the threshold showing under 35 U.S.C. § 314(a) for institution of trial with respect to Grounds 4C, 5C, and 6C.” slip op. at 91
Nonecites Phillips · KSR · GrahamPatents in suitUS 11,769,910 - Solus Advanced Materials Co., Ltd. v. SK Nexilis Co., Ltd.Institution deniedPTAB · May 19, 2025 · IPR2025-00005 · APJ John G New · IPR · Institution
The Board denied institution on all grounds, finding no reasonable likelihood that claims 1–4 were obvious because Petitioner did not show a reasonable expectation of success in combining the cited references.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“Analysis The burden of proving the unpatentability of the challenged claims rests with (and is borne at all times by) Petitioner. 35 U.S.C. §§ 314(a), 316(e); see also In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016). To satisfy this burden, Petitioner must “articulate specific reasoning, based on evidence of record, to support the legal conclusion of obviousness”; “mere conclusory statements” will not suffice. Magnum Tools, 829 F.3d at 1380. Indeed, “[i]t is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.’” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (quoting 35 U.S.C. § 312(a)(3)). Furthermore, “[a]n obviousness determination requires finding that a person of ordinary skill in the art would have been motivated to combine or modify the teachings in the prior art and would have had a reasonable expectation of success in doing so.” See Regents of the Univ. of Cal. v. Broad Inst., Inc., 903 F.3d 1286, 1291 (Fed. Cir. 2018). We have consistently denied institution of inter partes review in cases in which the petitioner fails to meet its burden of demonstrating a reasonable likelihood of success at trial with respect to the latter requirement. See NJOY, LLC v. JUUL Labs., Inc., IPR2024-00536, Paper 17 (PTAB Aug. 12, 2024) (denying institution where petitioner did not show a reasonable expectation of success in combining the asserted references); see also Honeywell Int’l Inc. v. DSM IP Assets, B.V., IPR2024-00493, Paper 7 (PTAB Aug. 21, 2024). We conclude that, in this instance, Petitioner fails to meet its burden of showing that a person of ordinary skill in the art would have had a reasonable expectation of success in combining the references.” slip op. at 32
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“As an initial matter, we note that, of the 44 specimens tested by Ye, as revealed in Ye’s Table II, only a single specimen, specimen 15, meets the required TC ratios recited in challenged claim 1 of the ’541 patent. Furthermore, none of the references cited by Petitioner teach, or even remotely suggest, the four requisite TC ratios recited by challenged claim 1. We find Petitioner’s argument that a person of ordinary skill in the art would have been motivated to exclusively select Ye’s sample 15, out of the remaining 43, to which to apply the teachings of Hara and Otsuka concerning the requisite tensile strength and weight deviation ranges in the hope of arriving at the claimed invention, is implausible. Indeed, only the ’541 patent, among all of the evidence of record, that actually mentions the required texture coefficient ratios recited in challenged claim 1. Petitioner provides no convincing argument as to why a skilled artisan would have selected sample 15 for combination with Hara and Otsuka. Rather, Petitioner’s argument appears to be based upon impermissible hindsight reconstruction. However: Any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from applicant's disclosure, such a reconstruction is proper. In re McLaughlin, 443 F.2d 1392, 1395 (C.C.P.A. 1971). Accordingly, Petitioner’s failure to suggest a reason as to why a person of ordinary skill in the art would have been motivated to select that single specimen, without knowledge of the specific TC ratios disclosed by the ’541 patent argues against Petitioner’s contention that the claims are obvious.” slip op. at 47
- PTAB / AIA Trials › Discretionary denialNot reached
“Discretionary Denial of Institution under 35 U.S.C. §§ 314(a) and 325(d) Because we deny institution of inter partes review on the merits, we do not reach the parties’ arguments in this respect.” slip op. at 58
§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 9,457,541 - 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 · GrahamPatents in suitUS 9,308,138 - Solus Advanced Materials Co, Ltd. v. SK Nexilis Co., Ltd.Institution deniedPTAB · 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 · GrahamPatents in suitUS 10,480,090 - Mastercard Incorporated And Mastercard International Incorporated v. Ov Loop, Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,032,171 - Penumbra, Inc. v. Rapidpulse, Inc.InstitutedPTAB · Feb 21, 2025 · IPR2024-01261 · APJ Jamie T Wisz · IPR · Institution
Instituted IPR of claims 1–20 on all petitioned grounds after finding a reasonable likelihood that the challenged claims would have been obvious over the cited combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), the Board “may not authorize an inter partes review to be instituted unless . . . 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.” After considering the Petition, the Preliminary Response, and the evidence of record, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing with respect to at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of claims 1–20 of the ’402 patent, based on all of the grounds identified in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner, relying on the testimony of Mr. Brown, contends that a person of ordinary skill in the art (“POSA” or “POSITA”) as of the relevant date would be either: (1) a person with a B.S. in engineering or an equivalent field, with two-four years of academic or industry experience in aspiration embolectomy and thrombectomy or comparable industry experience who would, where appropriate, work or consult with others, including a physician, to develop embolectomy or thrombectomy devices; or (2) an interventional neurosurgeon with at least three years of experience developing and/or using medical devices in embolectomy or thrombectomy procedures, and who would, where appropriate, work or consult with others, including an engineer, to develop such a medical device. Pet. 11 (citing Ex. 1005 ¶ 48). Petitioner also contends that, “[a] person with less education but more relevant practical experience, or more relevant education but less practical experience, may also meet this standard.” Id. Patent Owner states that for purposes of its Preliminary Response, it accepts Petitioner’s proposed definition of POSA, but “reserves the right to propose its own description of a POSA if the Board institutes review.” Prelim. Resp. 8 n.3. For purposes of this Decision, we adopt Petitioner’s characterization because it is consistent with the level of skill in the art at the time of the invention as reflected by the ’402 patent and the cited 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”” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Petitioner provides a proposed construction for the term “[limited/limiting] to a positive amount of exit flow” recited in claims 3, 4, 13, and 15, as “the maximum permitted amount of positive exit flow in the distal direction, including no exit flow.” Pet. 15–16. Patent Owner asserts that “Petitioner’s proposed construction of ‘a positive amount of exit flow’ as ‘including no exit flow’ is plainly wrong.” Prelim. Resp. 9 (citing Pet. 15–16). Patent Owner also asserts that to the extent Petitioner “view[s] the claim term ‘flow in and out’ as encompassing only flow in or no flow at all, that would be plainly wrong too.” Id. Having evaluated the arguments and evidence before us on this record, we determine that construction of “[limited/limiting] to a positive amount of exit flow” is not necessary for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)). Turning to a different claim term, we note that neither party provided an explicit construction for the limitation in claim 1 of “control[ling] fluid address the proper claim construction for this term and to specifically discuss what is encompassed by “flow . . . out from the distal end.” We note that in the related cases (IPR2021-01466 and IPR2022-00608), we construed the term, “forward flow” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters of fluid.” Ex. 2007, 15; Ex. 2011, 13–14. Upon review of the parties’ arguments and the evidence of record, we determine that no terms require express construction for purposes of this Decision. See Nidec Motor Corp, 868 F.3d at 1017.” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted
“c) Analysis On the current record, we are persuaded that Petitioner has demonstrated a reasonable likelihood that the subject matter of claim 1 would have been obvious over the combined disclosures of Yang and Mullins. First, Patent Owner asserts that Yang does not disclose the limitation of “a controller . . . to control fluid flow in and out from the distal end.” Prelim. Resp. 21– 32. On the current record, we agree with Patent Owner that introducing a positive pressure pulse such as through the water hammer effect does not necessarily mean that there will be an overall distal end. See Ex. 2001 ¶¶ 53–54; Ex. 2005 ¶ 60; Ex. 2007, 51 n.12. This is especially true if an overall vacuum state is maintained in the catheter. See Ex. 2001 ¶ 56; Ex. 2007, 43; Ex. 2010, 125:11–18. Further, on the current record, we credit the testimony of Patent Owner’s declarant, Mr. Culbert, that to have flow out of the catheter’s distal end when it is in a patient, the pressure in the catheter needs to exceed mean arterial pressure. See Ex. 2001 ¶ 59; Ex. 2010, 126:15–21. Therefore, on the current record, we agree with Patent Owner that Yang may not explicitly disclose flow out from the distal end of the catheter. Whether Yang alone renders this limitation obvious may be explored further on a full trial record; however, because this limitation appears to be taught by Mullins and Petitioner has shown on this record that a POSA would have been motivated to combine the disclosures of Yang and Mullins, we are sufficiently persuaded that Petitioner has met its burden to show a reasonable likelihood that this limitation is rendered obvious by the combined disclosures of Yang and Mullins.” slip op. at 18
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,406,402 - Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.All claims unpatentablePTAB · Nov 27, 2024 · PGR2022-00025 · APJ Susan L C Mitchell · PGR · Final written decision
Claims 1–19 are unpatentable because the ’201 patent lacks written description support for the claimed genus of CRF1 receptor antagonists under § 112(a).
RulingsFinal written decision- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“[A] sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. at 1350 (citing Regents, 119 F.3d at 1568–69). Moreover, “an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials.” Id. (citing Regents, 119 F.3d at 1568 (quoting Fiers, 984 F.2d at 1171)). Furthermore, “functional claim language can meet the written description requirement when the art has established a correlation between structure and function.” Id. (citing Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed. Cir. 2002) (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001))). “[M]erely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” Id.” slip op. at 42
- Skill levelSkill level petitioner adoptedDecided for petitioner
“According to Petitioner, a person of ordinary skill in the relevant art (“POSA”) “would have a medical degree or a Ph.D. in a field related to endocrinology, and would have knowledge of hormone regulation and disorders, as well as knowledge of the treatment regimens employed to treat such disorders . . . [and] would also have at least three years of experience conducting research concerning endocrine disorders, including CAH or other adrenal disorders.” Pet. 26–27 (citing Ex. 1005 ¶ 34 (Dr. Carey Declaration)). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. Because Petitioner’s definition of a person of skill in the art appears commensurate with the level of skill reflected in the asserted art in this case as well as the ’201 patent itself, see, e.g., Exs. 1024, 1025, 2003, 2004, 2005, we apply Petitioner’s proposed level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating prior art itself can reflect the appropriate level of ordinary skill in the art). C.” slip op. at 22
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“For these reasons, we do not find persuasive the testimony of Patent Owner’s expert, Dr. Dobs, that: By describing adjustments of dosing protocols to achieve an A4 reduction from baseline, and describing this use of tildacerfont as just one embodiment of the claimed use of the entire well-known, well-characterized, and discrete class, the specification reasonably conveyed to a POSA that the invention extended to the particularly claimed use of the entire recited class. Ex. 2014 ¶ 82. On the contrary, far from being a “well-known, well-characterized, and discrete class” the prior art teaches a heterogeneous assembly of different classes of small molecule CRF1 receptor antagonists (Type I, Type II, and “atypical”) displaying a very considerable variety of structures, both in terms of the core pharmacophore (e.g., monocyclic, bicyclic, tricyclic, phenolic, cyclohexyl amide, etc.) as well as in the various side groups. Moreover, the challenged claims recite only “a CRF1 receptor antagonist or a pharmaceutically acceptable salt thereof,” the scope of which also encompasses the much larger (and, according to Williams) much more effective large-molecule (peptide) CRF1 receptor antagonists, about which the Specification is entirely silent. See Ex. 1029, Abstr., 1065. Furthermore, despite Dr. Dobs’ testimony that “[t]he [prior art] references explain the typical CRF1 antagonist consists of a core nitrogen heterocycle with an aryl substituent adjacent to the core nitrogen atom and a branched alkyl group attached at the opposite end of the core,” Dr. Dobs also acknowledged that the “atypical CRF1 receptors depicted in Figures 11 and 12 of Williams had different structures, and lacked the nitrogen heterocyclic core.” Ex. 1042, 127:9–14, 130:13–131:16; see also Ex. 2014 ¶ 83. Additionally, Petitioner’s expert, Dr. Cutler, testified, by way of example, in his Reply Declaration that two of the ‘“first-generation CRF1 antagonists’ identified in Figure 1 of the Williams article do not fall within the Figure 2 structure Dr. Dobs relies upon.” Ex. 1047 ¶ 93. Indeed, with respect to the alleged core pharmacophore that Dr. Dobs” slip op. at 54
- ExcludeMotion to exclude, deniedMixed
“with chemical terminology”; “could not answer questions regarding the chemical structures in the prior art articles”; “did not know whether CRF1 receptor antagonists contained the structural features she deemed ‘essential’ in her Declaration”; and “agreed that tildacerfont has structurally unique features” (see Ex. 1042, 52–53, 125–126, 126–128, 128–130) goes to the weight that we assign to such testimony, but we do not find that such testimony, in light of Dr. Dobs’ extensive qualifications as an endocrinologist set forth above, deems Dr. Dobs unqualified to testify concerning the written description issue in this proceeding. For these reasons explained above, Petitioner’s Motion to Exclude Dr. Dobs’ written description opinions in paragraphs 20 and 75–87 of Exhibit 2014 is denied.” slip op. at 11
Patent outcomesUS 11,007,201 unpatentable§ 112 disclosurecites PhillipsPatents in suitUS 11,007,201 - Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.All claims unpatentablePTAB · Nov 26, 2024 · PGR2021-00088 · APJ John G New · PGR · Final written decision
Claims 1–25 are unpatentable because the ’908 patent lacks written description support under § 112(a); the Board did not reach Grounds 1–3 or 5.
RulingsFinal written decision- ExcludeMotion to exclude, deniedMixed
“To the extent that Dr. Dobs has admitted that she is “not comfortable with chemical terminology”; “could not answer questions regarding the chemical structures in the prior art articles”; “did not know whether CRF1 receptor antagonists contained the structural features she deemed ‘essential’ in her Declaration”; and “agreed that tildacerfont has structurally unique features” (see Ex. 1038, 52–53, 125–126, 126–128, 128–130), we will weigh her testimony regarding those matters accordingly. However, for the reasons explained above, Petitioner’s Motion to Exclude Dr. Dobs’ written description opinions in paragraphs 19 and 80–91 of Exhibit 2014 is denied.” slip op. at 10
- Strike new argumentOther
“Analysis Patent Owner’s Exhibits 2020–2026 play no part in our reasoning and were not relied upon by the Board in reaching our Decision. Petitioner’s Motion to strike Exhibits 2020–2026 is therefore dismissed as moot.” slip op. at 23
- Skill levelSkill level petitioner adoptedDecided for petitioner
“typically possess a medical degree or a Ph.D. in a field related to endocrinology, and would have knowledge of hormone regulation and disorders, as well as knowledge of the treatment regimens employed to treat such disorders. Pet. 60 (citing Ex. 1005 ¶ 34). Petitioner argues that such a person of ordinary skill would also have at least three years of experience conducting research concerning endocrine disorders, including CAH or other adrenal disorders. Id. Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. Because we find Petitioner’s definition to be consistent with the demonstrable level of skill in the art (see, e.g., Exs. 1009, 1025, 2003, 2004, 2005), and in the absence of a different proposed definition of the level of skill in the art by Patent Owner, we adopt Petitioner’s definition.” slip op. at 26
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“For these reasons, we do not find persuasive the testimony of Patent Owner’s expert, Dr. Dobs, that: By describing adjustments of dosing protocols to achieve at least a 10% reduction from baseline, and describing this use of tildacerfont as just one embodiment of the claimed use of the entire well-known, well-characterized, and discrete class, the specification reasonably conveyed to a POSA that the invention extended to the particularly claimed use of the entire recited class. Ex. 2014 ¶ 87. On the contrary, far from being a “well-known, well-characterized, and discrete class” the prior art teaches a heterogeneous assembly of different classes of small molecule CRF1 receptor antagonists (Type I, Type II, and “atypical”) displaying a very considerable variety of structures, both in terms of the core pharmacophore (e.g., monocyclic, bicyclic, tricyclic, phenolic, cyclohexyl amide, etc.) as well as in the various side groups. Moreover, the challenged claims recite only “a CRF1 receptor antagonist or a pharmaceutically acceptable salt thereof,” the scope of which also encompasses the much larger (and, according to Williams) much more effective large-molecule (peptide) CRF1 receptor antagonists, about which the Specification is entirely silent. See Ex. 1029, Abstr., 1065.” slip op. at 56
Patent outcomesUS 10,849,908 unpatentable§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,849,908 - Cimbria Srl v. 3u Vision SrlInstitutedPTAB · 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 disclosurePatents in suitUS 11,666,947
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.