• Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentable
  PTAB · Sep 8, 2026 · IPR2025-00440 · APJ Tawen Chang · IPR · Final written decision

  Claim 21 is unpatentable as obvious over Mizumura with either the ’498 PCT or McClymont; the Revised Contingent Motion to Amend proposing claim 22 is denied.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “overlap to a significant degree, i.e., a person with a Ph.D. in a discipline related to biological sciences and having had at least two years of work experience. However, the parties’ proposals differ slightly in the specific subjects in which a POSA would have had a doctoral degree, and whether the person’s work experience must have been directly related to horseshoe crab Factor C. As an initial matter, we find that a rigid requirement as to the subject of a POSA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 19; Ex. 1065, 99:14–100:3. with respect to the claims of the ’318 patent would have had a Ph.D. in molecular biology, biochemistry, or a related discipline, and about two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 13

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

    “C. Claim Construction The parties agree that “the terms in claim 21 can be afforded their plain and ordinary meaning for purposes of this proceeding” without further construction. Pet. 19–20; PO Resp. 11. Because express claim construction is not needed to resolve the issues in this case, we need not, and do not, construe expressly any claim term 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 14

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner

    “Carrying Out the Invention section, that “[t]he Factor C of the present invention is a Factor C derived from a horseshoe crab,” and states later in the same section that “[e]xamples of the horseshoe crab include . . . Limulus polyphemus.” Ex. 1006, 40. However, none of the remaining portions of ’767 application cited by Patent Owner relate directly to L. polyphemus; instead, the remaining portions of ’767 application cited by Patent Owner are directed to other species, in particular the Japanese horseshoe crab T. tridentatus. Further, Patent Owner’s witness, Dr. Schaefer, conceded that the ’767 application does not contain Factor C sequence information for L. polyphemus. See, e.g., Ex. 1067, 44:25–45:23. Although “[n]o length requirement exists for a disclosure to adequately describe an invention,” Falko-Gunter, 448 F.3d at 1365–1366, we are persuaded that a POSA would not, based on the totality of the above disclosures, reasonably understand that the inventors were in possession of the claimed HEK-293 recombinant L. polyphemus Factor C protein, in view of the state of the art as of December 10, 2013. In this regard, we note that adequate written description of a biological molecule, such as a HEK293 recombinant L. polyphemus Factor C protein, requires “more than a mere statement that it is part of the invention and reference to a potential method for isolating it”; instead, what is required is “‘a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” The Regents of the” slip op. at 21

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

    “Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Neither do we see Petitioner’s arguments regarding the December 10, 2013 priority date to be “mutually opposed” as Dr. Schaefer testified. Ex. 1067, 216:4– 24. Instead, we credit evidence of record, including Dr. Jain’s testimony and the February 22, 2018 Mizumura Declaration, that existence of the full sequence would permit a more complete analysis and that such an analysis would provide a POSA with a reasonable expectation that the claimed L. polyphemus recombinant protein would have a residual activity within the claimed range. See, e.g., Ex. 1029, 2–5; Ex. 1010, 48; Ex. 1065, 117:14– 130:24 (explaining that comparison of partial sequences in the Tokunaga 1991 publication showed “difference around the cleavage site” between T. tridentatus and L. polyphemus but comparison of the full sequence revealed that “the catalytic triad of histidine, serine, aspartate . . . to be more similar between Tachypleus and Limulus”). Patent Owner asserts that “Petitioner’s reliance on a statement made by Dr. Mizumura in a declaration submitted during prosecution of the ’767 Application fails to fill the gap in the analysis” regarding reasonable expectation of success, because the declaration “offers no evidence of the percentage of conserved amino acid substitutions that exist to support the conclusion that a POSA would have expected residual activity to be maintained between Tachypleus tridentatus and Limulus polyphemus” PO Resp. 47. However, as noted above, Dr. Mizumura provides an alignment of Factor C proteins from the two different species of horseshoe crab, determines that the similarity between the amino acid sequence is 99.5%, states that the amino acid residues that can undergo N-type sugar chain that L. polyphemus, like T. tridentatus, would also be less susceptible to inhibition by ions. Ex. 1029, 4–5. For the reasons discussed above, we also disagree with Patent Owner’s assertion that Petitioner’s reasonable expectation of success argument is “nothing more than conclusory assertions with no support.” PO Resp. 46. Rather, we find Petitioner has shown, by a preponderance of the evidence, that a POSA would have had reason to combine the teachings of Mizumura and the ’498 PCT, with a reasonable expectation of success in arriving at the Factor C protein recited in claim 21.” slip op. at 38

  Patent outcomesUS 11,236,318 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 11,236,318
• Interactive Communications International, Inc. v. Blackhawk Network Inc.All claims unpatentable
  PTAB · Jul 14, 2025 · IPR2024-00465 · APJ Bart A Gerstenblith · IPR · Final written decision

  Claims 1–24 are unpatentable: claims 1–10 and 12–24 as obvious over Szrek and Llach, and claim 11 as obvious over Szrek, Llach, and Gilmore.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “B. Level of Ordinary Skill in the Art Petitioner proposes that the level of ordinary skill in the art is an artisan with a working knowledge of POS activation systems and lottery systems that was gained through a mixture of training and work experience in the relevant field such as (i) having a Bachelor’s degree in computer science, computer communications, electrical engineering, or equivalent degree, coupled with at least three years of work experience; (ii) having a Master’s degree in computer science, computer communications, or electrical engineering, but having less work experience; or (iii) having no formal degree, but having experience in the relevant field of at least six years of work experience. Pet. 2–3 (citing Ex. 1003 ¶¶ 13–14).9 Patent Owner states that, “[f]or the purpose of this proceeding, Patent Owner adopts the Petition’s proposed definition of the level of ordinary skill in the art.” PO Resp. 19 (citing Pet. 2–3). We find that the parties’ agreed-upon level of ordinary skill in the art is consistent with the level of ordinary skill in the art reflected by the ’451 patent and the prior art of record. See Inst. Dec. 14; see Okajima v. 9 Petitioner proposes the same level of ordinary skill in the art that the Board adopted in PGR2020-00084 (Pet. 2–3 (citing Ex. 1008, 11)), and IPR2023- 01235 (see IPR2023-01235, Paper 34 at 12–13). Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978). Therefore, we adopt the parties’ agreed-upon level of ordinary skill in the art, as articulated above, in our consideration of the issues presently before us.” slip op. at 13

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

    “We need not construe “transaction processor” expressly because its meaning is not in dispute and its construction is not necessary to resolve the controversy before us.” slip op. at 16

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

    “On balance, we find that even with the alleged disadvantages identified by Patent Owner, one of ordinary skill in the art would have been motivated to modify Szrek with Llach’s third-party transaction processor because the advantage of having a “centralized intermediary” allows Szrek’s system to support different game providers, such as different lottery companies, which would reduce some implementation costs and allow the system to be more easily and cheaply extended. Pet. 47 (citing Ex. 1003 ¶ 181); see Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (“a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine”) (citing Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n.8 (Fed. Cir. 2000)); see also Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 795 (Fed. Cir. 2021) (stating the same). We acknowledge that the combination comes with some disadvantages, including “add[ed] delay, reduce[d] efficiency, and . . . implementation complexities by converting a simple, direct communication exchange into an exchange that traverses multiple systems.” PO Resp. 52 (citing Ex. 2052 ¶ 163). But, “[t]he fact that the motivating benefit comes at the expense of another benefit, however, should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another. Instead, the benefits, both lost and gained, should be weighed against one another.” Winner, 202 F.3d at 1349 n.8. Here, Szrek expressly teaches indirect communication as a possible implementation of its system and Petitioner’s combination—employing Llach’s third-party transaction processor as part of the indirect communication channel—offers the attractive benefit of allowing Szrek’s system to support different game providers, which would reduce some implementation costs even if it might increase other costs, e.g., by having to program certain components (e.g., the cash registers) differently. Specifically, we find that the ability to expand Szrek’s system to support different game providers provides advantages that outweigh the disadvantages discussed above in the circumstance where one desires a more robust and comprehensive system. See Pet. Reply 23 (noting three advantages of the combination— (1) “allow[ing] Szrek’s system to use ‘a centralized system for activating lottery tickets from different retailers and different locations,’” (2) “allow[ing] support for different game providers, such as different lottery companies,” “reduc[ing] implementation costs,” and (3) “allow[ing] Szrek’s system to ‘communicate with individual card” slip op. at 37

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightMotivation foundDecided for petitioner

    “On balance, we find that even with the alleged disadvantages identified by Patent Owner, one of ordinary skill in the art would have been motivated to modify Szrek with Llach’s third-party transaction processor because the advantage of having a “centralized intermediary” allows Szrek’s system to support different game providers, such as different lottery companies, which would reduce some implementation costs and allow the system to be more easily and cheaply extended. Pet. 47 (citing Ex. 1003 ¶ 181); see Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (“a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine”) (citing Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n.8 (Fed. Cir. 2000)); see also Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 795 (Fed. Cir. 2021) (stating the same). We acknowledge that the combination comes with some disadvantages, including “add[ed] delay, reduce[d] efficiency, and . . . implementation complexities by converting a simple, direct communication exchange into an exchange that traverses multiple systems.” PO Resp. 52 (citing Ex. 2052 ¶ 163). But, “[t]he fact that the motivating benefit comes at the expense of another benefit, however, should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another. Instead, the benefits, both lost and gained, should be weighed against one another.” Winner, 202 F.3d at 1349 n.8. Here, Szrek expressly teaches indirect communication as a possible implementation of its system and Petitioner’s combination—employing Llach’s third-party transaction processor as part of the indirect communication channel—offers the attractive benefit of allowing Szrek’s system to support different game providers, which would reduce some implementation costs even if it might increase other costs, e.g., by having to program certain components (e.g., the cash registers) differently. Specifically, we find that the ability to expand Szrek’s system to support different game providers provides advantages that outweigh the disadvantages discussed above in the circumstance where one desires a more robust and comprehensive system. See Pet. Reply 23 (noting three advantages of the combination— (1) “allow[ing] Szrek’s system to use ‘a centralized system for activating lottery tickets from different retailers and different locations,’” (2) “allow[ing] support for different game providers, such as different lottery companies,” “reduc[ing] implementation costs,” and (3) “allow[ing] Szrek’s system to ‘communicate with individual card” slip op. at 37

  Patent outcomesUS 11,488,451 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,488,451
• Gene Company Pty Ltd v. The Trustees Of Columbia University In The City Of New YorkNo claims unpatentable
  PTAB · Jun 23, 2025 · IPR2024-00313 · APJ Tawen Chang · IPR · Final written decision

  Claims 1–54 were not shown unpatentable because Petitioner failed to establish a reasonable expectation of success for the proposed combinations; objective indicia also supported non-obviousness.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “As to the first issue, we agree with Patent Owner that defining the level of skill in view of the solution described in the patent risks improper hindsight. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) 18 (“[T]he level of skill in the art is a . . . lens through which . . . the Board views the prior art and the claimed invention,” which “prevents . . . factfinders from using their own insight or . . . hindsight[] to gauge obviousness.”). We therefore do not include “practical knowledge about . . . the deuterium isotope effect, including the patents and publications discussed [in the Petition],” as part of our definition of a person of ordinary skill in the art.” slip op. at 18

  • Expert testimonyPetitioner expert creditedMixed

    “person of ordinary skill in the art would employ” in an obviousness analysis, we give some weight to Dr. Guengerich’s testimony. KSR, 550 U.S. at 418; Plantronics, Inc. v. Aliph, Inc., 724 F.3d 1343, 1354 (Fed. Cir. 2013) (explaining that “motivation to combine may be found. . . in . . . the background knowledge, creativity, and common sense of the person of ordinary skill”). Nevertheless, even if we were to agree that an ordinarily skilled artisan would have seen the 1,5-shift in NRPE in Mata’s A2E biosynthetic pathway as a particularly desirable location for intervention, we are not persuaded that such a person would have been motivated to substitute C20 deuterated vitamin A for the vitamin A in Ortho Pharma’s composition and method, because Petitioner has not shown, by a preponderance of evidence, that such an artisan would have reasonably expected the substitution to retard the accumulation of A2E or to treat macular degeneration.” slip op. at 42

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “In our Institution Decision, we preliminarily construed the preamble of claim 28 as limiting. Inst. Dec. 30–31. Petitioner did not take issue with our construction, or dispute Patent Owner’s construction of the preambles of claims 1 and 29 as also limiting. After consideration of the full trial record, we maintain our construction of the preamble of claim 28 as limiting for the reasons set forth in our Institution Decision. For similar reasons and the reasons set forth in Patent Owner’s Response, we further construe the preambles of claims 1 and 29 as limiting. See PO Resp. 12–14. We further determine that we do not need to construe any other claim term in order to resolve the controversy between the parties. 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 26

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would be understood by a person of ordinary skill in the art, at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id.” slip op. at 25

  Patent outcomesUS RE47,045 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
• Interactive Communications International, Inc. v. Blackhawk Network Inc.No claims unpatentable
  PTAB · Feb 6, 2025 · IPR2023-01235 · APJ Bart A Gerstenblith · IPR · Final written decision

  Claims 1–6 were not shown unpatentable under either obviousness ground because Szrek did not disclose a pre-printed lottery ticket without lottery numbers associated at customer purchase.

  RulingsFinal written decision

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

    “real party in interest. Prelim. Resp. 1–2, 32–34. In the Institution Decision, we stated: To the extent Patent Owner seeks to pursue its argument that Linq3 is a real party of interest to Petitioner, even though no time bar under 35 U.S.C. § 315(b) has been asserted, Patent Owner may raise the issue of real party in interest again in its Patent Owner Response and the parties may brief and argue the issue during trial. Inst. Dec. 11. In its Patent Owner Response, Patent Owner did not raise the issue of challenging Petitioner’s identified real party in interest. See generally PO Resp. Thus, we need not address this issue further because we find that Patent Owner has waived any challenge to Petitioner’s identification of the real parties in interest in this proceeding. See Paper 12 (Scheduling Order), 9 (“Patent Owner is cautioned that any arguments not raised in the response may be deemed waived.”).” slip op. at 5

  • Skill levelSkill level petitioner adoptedDecided for patent owner

    “B. Level of Ordinary Skill in the Art Petitioner proposes that the level of ordinary skill in the art is an artisan with a working knowledge of POS activation systems and lottery systems that was gained through a mixture of training and work experience in the relevant field such as (i) having a Bachelor’s degree in computer science, computer communications, electrical engineering, or equivalent degree, coupled with at least three years of work experience; (ii) having a Master’s degree in computer science, computer communications, or electrical engineering, but having less work experience; or (iii) having no formal degree, but having experience in the relevant field of at least six years of work experience. Pet. 2–3 (citing Ex. 1003 ¶ 13).5 Patent Owner states that, “[f]or the purpose of this proceeding, Patent Owner adopts the Petition’s proposed definition of the level of ordinary skill in the art.” PO Resp. 19. 5 Petitioner proposes the same level of ordinary skill in the art that the Board adopted in PGR2020-00084. Pet. 2–3 (citing Ex. 1008, 11). We find that the parties’ agreed-upon level of ordinary skill in the art is consistent with the level of ordinary skill in the art reflected by the ’135 patent and the prior art of record. See Inst. Dec. 14; see Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978). Therefore, we adopt the parties’ agreed-upon level of ordinary skill in the art, as articulated above, in our consideration of the issues presently before us.” slip op. at 12

  • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed patent owner constructionDisclaimer foundDecided for patent owner

    “Following the block quote from Yacenda, the applicant then stated, “[b]ased on the foregoing, Yacenda’s system is directly opposite of the instant claims, as the instant claims require a ‘pre-printed lottery ticket’ which has no lottery numbers associated with it at the time of customer purchase.’” Ex. 1002, 76. This statement is clear and unmistakable. It (1) specifically states that “the instant claims require” and (2) then states what the claims require—a “‘pre-printed lottery ticket’ which has no lottery numbers associated with it at the time of customer purchase.” We fail to see how the applicant could have been more clear in stating a requirement of the Challenged Claims. And, by doing so, the applicant narrowed the scope of what would otherwise be encompassed in the meaning of “pre-printed lottery ticket” and therefore what would otherwise be encompassed in the scope of the Challenged Claims—a lottery ticket which has lottery numbers associated with it at the time of customer purchase.” slip op. at 27

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “We do not find Mr. Hutton’s testimony particularly helpful. First, we have addressed the points raised by his testimony in our discussion above because they are largely the same as the arguments raised in Petitioner’s Reply. Second, we find his testimony entitled to very little weight because he applies an incorrect understanding of the caselaw, which mirrors Petitioner’s incorrect and arguably misleading quotations of the Federal Circuit’s decision in Quest. In particular, in paragraph 5, Mr. Hutton states the following as his understanding of the law as it applies to prosecution disclaimer: “I also understand that in order to disclaim embodiments within the specification, the statements should have some indication that the applicant intended to surrender embodiments from the specification.” Ex. 1038 ¶ 5 (emphasis added). This then leads Mr. Hutton to state: “[t]hus, in my opinion, a [person of ordinary skill in the art] would not view applicant’s statements as a disclaimer, because the applicant never stated that they intended to surrender multiple embodiments described in the specification.” Id. ¶ 13 (emphasis added). As we explained above in responding to a similar argument by Petitioner, the caselaw does not require an applicant to expressly state whether a disclaimer excludes particular embodiments of the subject specification when disclaiming claim scope during prosecution. See Quest, 924 F.3d at 1229. And, as noted above, counsel for Petitioner agreed that such a statement explicitly disclaiming particular embodiments is not required. Tr. 12:18–13:17. Third, although we have considered Mr. Hutton’s testimony, we find it “less significant than the intrinsic record in determining the legally operative meaning of” “pre-printed lottery ticket.” Phillips, 415 F.3d at 1317. In particular, we are cognizant of the Federal Circuit’s guidance that we “should discount any expert testimony that is clearly at odds with the claim construction mandated by . . . the prosecution history.” Id. at 1318 (internal quotation omitted). In this instance, for the reasons explained above, we find that Mr. Hutton’s testimony is clearly at odds with the applicant’s arguments during prosecution and that his testimony is based on a misunderstanding of what is required by the governing caselaw for prosecution history disclaimer.” slip op. at 43

  Patent outcomesUS 9,865,135 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,865,135
• Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.All claims unpatentable
  PTAB · 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 Phillips
  Patents in suitUS 10,849,908
• Syngenta Crop Protection AG v. Upl Ltd.All claims unpatentable
  PTAB · Jul 26, 2024 · PGR2023-00017 · APJ Zhenyu Yang · PGR · Final written decision

  Claims 1–10 are unpatentable: claims 1, 3–5, 7, 9, and 10 are anticipated by Godoy; claims 1–10 are anticipated by Tobler; other grounds were not reached.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “record (Ex. 1022, Attachments 5, 6) and the ResearchGate page (id., Attachments 7–10), to further support her opinion that the Godoy report was publicly available before November 4, 2016. Id. ¶¶ 31–38, 42–48. She testifies that “ResearchGate contains many search features which would allow an interested POSA to find the Godoy report, e.g., key word searching.” Id. ¶ 48. Dr. Jacobsen, who has personally used the service, agrees that in ResearchGate, “you can start to search for publications using keywords and things like that, authors.” Ex. 1043, 66:1–67:10. For these reasons, we again find Dr. Hall-Ellis’s testimony credible.” slip op. at 32

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

    “record (Ex. 1022, Attachments 5, 6) and the ResearchGate page (id., Attachments 7–10), to further support her opinion that the Godoy report was publicly available before November 4, 2016. Id. ¶¶ 31–38, 42–48. She testifies that “ResearchGate contains many search features which would allow an interested POSA to find the Godoy report, e.g., key word searching.” Id. ¶ 48. Dr. Jacobsen, who has personally used the service, agrees that in ResearchGate, “you can start to search for publications using keywords and things like that, authors.” Ex. 1043, 66:1–67:10. For these reasons, we again find Dr. Hall-Ellis’s testimony credible.” slip op. at 32

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

    “several lists, Petitioner has met its burden in showing that an ordinarily skilled artisan would at once envisage the fungicidal combination of claim 1 from its disclosure. Accordingly, Tobler anticipates claim 1. We address Patent Owner’s arguments below.” slip op. at 44

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

    “28 Because Petitioner has shown that asserted prior art references anticipate claims 1 and 3–10, we do not address whether these claims would have been obvious over De Oliveira, either alone or in view of Wiglesworth, Tobler, and Godoy. 29 Having determined that Petitioner has shown all challenged claims are unpatentable under other grounds, we do not address this obvious ground. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1359 (2018) (holding a petitioner “is entitled to a final written decision addressing all of the claims it has challenged”); Bos. Sci. Scimed, Inc. v. Cook Grp. Inc., 809 F. App’x 984, 990 (Fed. Cir. 2020) (recognizing that the “Board need not address issues that are not necessary to the resolution of the proceeding” and, thus, agreeing that the Board has “discretion to decline to decide additional instituted grounds once the petitioner has prevailed on all its challenged claims”).” slip op. at 81

  Patent outcomesUS 11,445,727 unpatentable
  § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 11,445,727
• Samsung Bioepis Co. Ltd. v. Regeneron Pharmaceuticals, Inc.All claims unpatentable
  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
• Netflix, Inc. v. Divx, LLCNo claims unpatentable
  PTAB · Feb 22, 2024 · IPR2020-00558 · APJ Iftikhar Ahmed · IPR · Remand

  The majority determined claims 1–24 were not shown unpatentable over Chen, Lindahl, and Hurst; the dissent would have found them obvious.

  RulingsRemand decision

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

    “We determine Patent Owner’s reading of the claim limitation is the better one. The limitation begins with the verb “locating,” and it therefore makes sense that the clause would recite what is located (i.e., encryption information) and where it is located (i.e., within the requested portions of the selected stream of protected video). In other words, it is reasonable that the second and third clauses of the limitation both modify the first clause (for example, as could perhaps be expressed through the use of commas as “locating encryption information, that identifies encrypted portions of frames of video, within the requested portions of the selected stream of protected video”).10 On the other hand, Petitioner’s reading of the limitation, 10 In general, we recognize that the use of commas to set off phrases in claim drafting is not consistent. We included commas above to illustrate Patent Owner’s understanding of the claim limitation. allowing only the second clause to modify the first, while not unreasonable, makes less sense. That is, the encrypted information identifies the encrypted portions of frames, which in turn are within the requested portions of the selected stream of protected video. Reading the claim in its entirety, the encrypted portions of frames would be understood to be located within the requested portions of the stream; it does not seem necessary for the claim to expressly recite that aspect. For example, the very next limitation— limitation [m] of claim 1—refers to “each encrypted portion of the frames of video” but does not expressly recite “within the requested portions of the selected stream.” Ex. 1001, 27:58–60. Thus, when limitation [l] recites “within the requested portions of the selected stream,” it seems more likely that the clause refers to where that encrypted information is located rather than simply to indicate the obvious location of the encrypted portion of the frames of video. We therefore view Patent Owner’s reading of the claim language as the better one.” slip op. at 13

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

    “I am persuaded that the Petition demonstrates that one of ordinary skill in the art would have had a motivation to combine Chen, Lindahl, and Hurst, as asserted by Petitioner. As the Federal Circuit found, the Petition pointed to and relied upon the portions in Chen describing pre-Chen art, without scalability or FEC features that were part of what Chen describes as aspects of its own inventive system. Netflix, slip op. at 9–10 (citing Pet. 17– 19, 69–70). I agree with Petitioner that “Chen-924 teaches several embodiments that adaptively stream alternative representations of a video using partially encrypted container files.” Pet. 20 (citing Ex. 1010, 14:41– 15:60). I determine that Chen-924 provides support for the rationale provided in the Petition, and that one of ordinary skill in the art would have been motivated to combine Chen and Lindahl in view of the disclosure of Chen-924. As discussed above, the Petition does not rely solely on privacy concerns and improvements to efficiency as its motivation to combine the references. See Pet. 18–19 (specifying piracy concerns, improvements to the efficiency of adaptive streaming, optimization of the balance between bitrate and bandwidth, and improvements to the end-user experience with fast startup and seek). With respect to whether one of ordinary skill in the art would have” slip op. at 52

  • Strike new argumentNew argument disregardedDecided for petitioner

    “I agree with Petitioner that Patent Owner’s Remand Brief, specifically pages 1–7, attempt to address aspects of claim 1 for the first time on remand. I also agree that Patent Owner’s arguments attempt to recharacterize limitations [j] and [k] to raise issues that Patent Owner did not raise previously, in contravention of our Order that issues raised needed support from “where those issues were raised in previous briefings by the parties.” Paper 56, 2. I have addressed whether scalability and FEC are integral to how Chen operates above, as well as whether the Petition relies on those aspects, supra. The questions about how Chen operates and what portions of Chen are asserted in the ground of unpatentability were previously raised, but now are being considered or reconsidered, based on the Federal Circuit’s decision. In Patent Owner’s Remand Brief, pages 1–7, the citations to argument previously raised do not support the arguments now presented by Patent Owner on remand. As such, I determine Patent Owner’s new arguments fall outside the scope of remand, and I dismiss these arguments seeking to distinguish limitations [j] and [k] from the cited prior art combination.24” slip op. at 62

  • ExcludeMotion to exclude, grantedMixed

    “7 Patent Owner’s Brief on Remand recognizes that there are two arguments Patent Owner raised in its Patent Owner Response that were not addressed in the Final Written Decision. See PO Remand Br. 1 (citing PO Resp. 24–37 (the construction of “locating encrypted information . . . within requested portions”), 38–58 (referring to Patent Owner’s “common keys” argument)). 8 The Final Decision also addressed Petitioner’s Motion to Exclude (Paper 42). See Final Dec. 28–37 (granting-in-part, denying-in-part, and dismissing-in-part Petitioner’s Motion). Our determinations on that Motion were part of Petitioner’s appeal to the Federal Circuit. See Paper 52. Because the Federal Circuit did not address this aspect of the Final Written Decision and the Federal Circuit’s decision does not impact our previous rulings on the Motion, we maintain those rulings here. Additionally, on remand, Petitioner requested authorization to file a motion for sanctions, which we held in abeyance until the parties’ briefing on remand was complete. See Ex. 3003, 1. Petitioner requests sanctions because of the impropriety of Patent Owner’s remand brief, including new claim construction arguments for limitations [1j] and [1k], and prejudice to Petitioner. Id. at 3, 5. Although we reserved further consideration of Petitioner’s request, we expanded both the time and pages allowed for Petitioner’s responsive brief, and also allowed Petitioner to address any related issues in its responsive brief. Id. at 1. Having considered the parties’ briefing on remand, and given that we do not reach the claim construction arguments that Petitioner objected to in its request for authorization to file a motion for sanctions, we deny Petitioner’s request.” slip op. at 5

  Patent outcomesUS 10,225,588 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,225,588
• Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jan 9, 2024 · IPR2023-00566 · APJ John G New · IPR · Final written decision

  Claims 1–9, 34–39, 41–43, and 45 are unpatentable as anticipated by Dixon; the Board did not reach the other grounds.

  RulingsFinal written decision

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

    “inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “Owner and its experts proposed claim construction of “effectively treating” as meaning “noninferior,” “statistically noninferior,” or “comparable.” Pet. Reply 4. Petitioner asserts that Patent Owner, and its expert, Dr. Do, advance the proposed construction of “effectively treating, ” with no explanation for what that means, or how it comports with the challenged dependent claims that recite visual acuity limitations ranging from losing less than 15 letters to gaining more than 15 letters. Id. at 4–5.” slip op. at 32

  • ExcludeMotion to exclude, grantedMotion to exclude, deniedMixed

    “inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24

  Patent outcomesUS 10,888,601 unpatentable
  Claim construction§ 102 anticipationcites Phillips
  Patents in suitUS 10,888,601
• Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jan 9, 2024 · IPR2023-00533 · APJ John G New · IPR · Final written decision

  Claims 1–9, 34–39, 41–43, and 45 are unpatentable as anticipated by Dixon; the Board did not reach the other grounds.

  RulingsFinal written decision

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

    “inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “Id. at 18. The similar language of the challenged claims of the ’601 patent, and our reasoning in the related -00881 Decision, compel the same conclusion here, i.e., that the preamble is limiting upon the claims.” slip op. at 43

  • ExcludeMotion to exclude, grantedMotion to exclude, deniedMixed

    “inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24

  Patent outcomesUS 10,888,601 unpatentable
  Claim construction§ 102 anticipationcites Phillips
  Patents in suitUS 10,888,601

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.