- Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,236,318 - 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 - Syngenta Crop Protection AG v. Upl Ltd.All claims unpatentablePTAB · 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 · GrahamPatents in suitUS 11,445,727 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipationcites PhillipsPatents in suitUS 10,888,601 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipationcites PhillipsPatents in suitUS 10,888,601 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2022-01226 · 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 remaining 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
- ExcludeMotion to exclude, grantedMotion to exclude, deniedMixed
“challenged claims are thus anticipated, we do not reach the additional Grounds 2–7 proposed in the Petition. Furthermore, Petitioner’s Motion to Exclude Evidence is granted-in-part, denied-in-part and dismissed-in-part. Patent Owner’s Motion to Exclude Evidence is denied-in-part and dismissed-in-part.” slip op. at 92
Patent outcomesUS 10,888,601 unpatentable§ 102 anticipationcites PhillipsPatents in suitUS 10,888,601 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2022-01225 · APJ John G New · IPR · Final written decision
Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as anticipated by Dixon; the Board did not reach the remaining grounds.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Here, the claims are directed to methods of administering, i.e., using, a VEGF antagonist for an intended purpose of “treating an angiogenic eye disorder in a patient.” The Specification repeatedly characterizes the method as one for treating angiogenic eye disorders in patients. Apart from the preamble, the independent claims do not elsewhere recite or indicate any other use for the method steps comprising the administration of a VEGF antagonist. Thus, we determine that the preamble sets forth the essence of the invention—treating an angiogenic eye disorder in a patient. Additionally, we find that the preamble provides antecedent basis for claim terms “the patient” recited in the body of each independent claim, and “angiogenic eye disorders” recited in dependent claims 6, 7, 18, and 20. Indeed, without the preamble, it would be unclear to whom the doses of VEGF are administered. Thus, …in view of the evidence of record, namely, the claim language and the written description of the ’338 patent, we find that the preambles of method claims 1 and 14 are limiting insofar as they require “treating an angiogenic eye disorder in a patient.” Id. at 17–18 (citations omitted). We adopt this same reasoning here and find that the preamble of claim 1 reciting “[a] method for treating an angiogenic eye disorder in a patient” is limiting.” slip op. at 34
- 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.” slip op. at 37
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“If a claim limitation is directed to printed matter, the next step in 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 46
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A Person of Ordinary Skill in the Art Petitioner contends 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. 28. Petitioner asserts 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 28–29 (citing Ex. 1002 ¶¶ 27–29; Ex. 1003 ¶¶ 21–25). 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 level of skill in the art (see, e.g., Exs. 1006, 1020), we adopt Petitioner’s definition.” slip op. at 52
Patent outcomesUS 10,130,681 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 10,130,681 - Mylan Pharmaceuticals Inc. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Nov 9, 2022 · IPR2022-00298 · APJ Erica A Franklin · IPR · Final written decision
Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as anticipated by Dixon; the Board did not reach the other instituted grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Having considered the arguments and evidence, we maintain that Petitioners’ definition of one of ordinary skill in the art is reasonable and consistent with the ’338 patent and the prior art of record. On the other hand, we find Patent Owner’s definition to be inappropriately limited to those having “firsthand experience” regarding the diagnosis and treatment of angiogenic eye disorders, as explained by Dr. Do. See Ex. 2051 ¶ 28. While it may be that the claimed methods would be performed an ophthalmologist, a person having ordinary skill in the art need not be limited to those more appropriately considers that knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders, may be possessed by other professionals that are not ophthalmologists. Accordingly, we adopt Petitioners’ definition for purposes of this Decision.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“preamble of method claims 1 and 14, i.e., “[a] method for treating an angiogenic eye disorder in a patient” is limiting. Although we agree with Petitioners that the preamble sets forth “‘a statement of purpose or intended’ use for the claimed dosing regimen,” see Pet. 17, that does not the end our inquiry. As noted in the Institution Decision, the Federal Circuit has explained that its case law does not support a “binary distinction between statements of mere intended purpose on the one hand and limiting preambles on the other.” Eli Lilly and Company v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1340 (Fed. Cir. 2021). Rather, as the Federal Circuit reiterated, “there is no ‘litmus test’ for determining whether a preamble is limiting.” Id. (citing Bicon, Inc. v. Straumann Co., 441 F.3d 945, 952 (Fed. Cir. 2006) and Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)). As the Court instructed, we consider whether to treat a preamble as a claim limitation based upon “the facts [in this] case in light of the claim as a whole and the invention described in the patent.” Id. (quoting Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 831 (Fed. Cir. 2003)).” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“or that the administered doses are “therapeutically effective” separately or cumulatively. Instead, the claimed method focuses on treating an angiogenic eye disorder with a specific compound, i.e., a VEGF antagonist, based on a specific temporal regimen, i.e., sequentially administering an initial dose, followed by a prescribed time frame for secondary and tertiary dose(s). As discussed above, we determined that the preamble limits the claims in terms of requiring the doses of VEGF antagonist administered to be for the purpose of treating an angiogenic eye disorder in a patient. We find that the intrinsic evidence supports finding that it is the administration of the VEGF antagonist to such patient for the purpose of providing an improvement of or beneficial effect on their angiogenic eye disorder that satisfies the “treating” portion of the preamble.” slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“arguments and the evidence, we find that the Specification expressly defines the terms “initial dose,” “secondary doses,” and “tertiary doses.” The Specification states, refer to the temporal sequence of administration of the VEGF antagonist. Thus, the “initial dose” is the dose which is administered at the beginning of the treatment regimen (also referred to as the “baseline dose”); the “secondary doses” are the doses which are administered after the initial dose; and the “tertiary doses” are the doses which are administered after the secondary doses. Ex. 1001, 3:31–38 (emphasis added). 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,” and that “the ‘tertiary doses’ are the doses which are administered after the secondary doses.” Ex. 1001, 3:31–38 (emphasis added). Patent Owner has not directed us to any portion of the Specification or other persuasive evidence that supports adding an efficacy requirement to that definition.” slip op. at 24
Patent outcomesUS 9,254,338 unpatentableClaim construction§ 102 anticipationcites Phillips · GrahamPatents in suitUS 9,254,338 - Mylan Pharmaceuticals Inc. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Nov 9, 2022 · IPR2022-00258 · APJ Erica A Franklin · IPR · Final written decision
Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as anticipated by Dixon; the Board did not reach the other grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Having considered the arguments and evidence, we maintain that Petitioners’ definition of one of ordinary skill in the art is reasonable and consistent with the ’338 patent and the prior art of record. On the other hand, we find Patent Owner’s definition to be inappropriately limited to those having “firsthand experience” regarding the diagnosis and treatment of angiogenic eye disorders, as explained by Dr. Do. See Ex. 2051 ¶ 28. While it may be that the claimed methods would be performed an ophthalmologist, a person having ordinary skill in the art need not be limited to those more appropriately considers that knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders, may be possessed by other professionals that are not ophthalmologists. Accordingly, we adopt Petitioners’ definition for purposes of this Decision.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“preamble of method claims 1 and 14, i.e., “[a] method for treating an angiogenic eye disorder in a patient” is limiting. Although we agree with Petitioners that the preamble sets forth “‘a statement of purpose or intended’ use for the claimed dosing regimen,” see Pet. 17, that does not the end our inquiry. As noted in the Institution Decision, the Federal Circuit has explained that its case law does not support a “binary distinction between statements of mere intended purpose on the one hand and limiting preambles on the other.” Eli Lilly and Company v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1340 (Fed. Cir. 2021). Rather, as the Federal Circuit reiterated, “there is no ‘litmus test’ for determining whether a preamble is limiting.” Id. (citing Bicon, Inc. v. Straumann Co., 441 F.3d 945, 952 (Fed. Cir. 2006) and Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)). As the Court instructed, we consider whether to treat a preamble as a claim limitation based upon “the facts [in this] case in light of the claim as a whole and the invention described in the patent.” Id. (quoting Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 831 (Fed. Cir. 2003)). Here, the claims are directed to methods of administering, i.e., using, a VEGF antagonist for an intended purpose of “treating an angiogenic eye disorder in a patient.” See Claims 1 and 14, Ex. 1001, 23:2–3; 24:3–4. The angiogenic eye disorders in patients. See, e.g., id. at 1:18–20, 63–66, 2:23– 27; 3:19–20; 5:11–13. Apart from the preamble, the independent claims do not elsewhere recite or indicate any other use for the method steps comprising the administration of a VEGF antagonist. Thus, we determine that the preamble sets forth the essence of the invention—treating an angiogenic eye disorder in a patient. As the Federal Circuit explained in Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339 (Fed. Cir. 2003), “preamble language will limit the claim if it recites not merely a context in which the invention may be used, but the essence of the invention without which performance of the recited steps is nothing but an academic exercise,” and that this principle frequently holds true for method claims. Id. at 1345 (citing Griffin v. Bertina, 285 F.3d 1029, 1033 (Fed. Cir. 2002)). We find that such is the case here. Additionally, we find that the preamble provides antecedent basis for claim terms “the patient” recited in the body of each independent claim, and “angiogenic eye disorders” recited in dependent claims 6, 7, 18, and 20. Indeed, without the preamble, it would be unclear to whom the doses of VEGF are administered. Thus, in view of Federal Circuit case law regarding statements of intended purpose in claims directed to method of using compositions, and in view of the evidence of record, namely, the claim language and the written description of the ’338 patent, we find that the preambles of method claims 1 and 14 are limiting insofar as they require “treating an angiogenic eye disorder in a patient.”” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We begin by noting that the claims do not recite any dosage amounts or that the administered doses are “therapeutically effective” separately or cumulatively. Instead, the claimed method focuses on treating an angiogenic eye disorder with a specific compound, i.e., a VEGF antagonist, based on a specific temporal regimen, i.e., sequentially administering an initial dose, followed by a prescribed time frame for secondary and tertiary dose(s). As discussed above, we determined that the preamble limits the claims in terms of requiring the doses of VEGF antagonist administered to be for the purpose of treating an angiogenic eye disorder in a patient. We find that the intrinsic evidence supports finding that it is the administration of the VEGF antagonist to such patient for the purpose of providing an improvement of or beneficial effect on their angiogenic eye disorder that satisfies the “treating” portion of the preamble. regarding the “Amount of VEGF Antagonist Administered.” See Ex. 1001, 6:29–7:14. In that discussion, the Specification explains, The amount of VEGF antagonist administered to the patient in each dose is, in most cases, a therapeutically effective amount. As used herein, the phrase “therapeutically effective amount” means a dose of VEGF antagonist that results in a detectable improvement in one or more symptoms or indicia of an angiogenic eye disorder, or a dose of VEGF antagonist that inhibits, prevents, lessens or delays the progression of an angiogenic eye disorder. Id. at 6:48–55 (emphasis added). That description, along with the absence of the phrase “therapeutically effective” in the claims,11 signals for us the inventors’ intention to not limit the claims to the administration of doses that ultimately prove to be therapeutically effective in a given patient. Instead, the Specification describes administration of VEGF antagonist doses for treating angiogenic eye disorder in a manner that encompasses doses that result in disclosed improvements and benefits, referred to as “therapeutically effective amounts,” and doses that do not. Indeed, as guidance, the Specification discloses that “a therapeutically effective amount can be from about 0.05 mg to about 5 mg,” without any guarantee that any particular dosage regimen administered within that range of dosage amounts will necessarily be “therapeutically effective,” and without limiting the treatment methods based upon such results. Ex. 1001, 6:55–58 (emphasis added).” slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“arguments and the evidence, we find that the Specification expressly defines the terms “initial dose,” “secondary doses,” and “tertiary doses.” The Specification states, refer to the temporal sequence of administration of the VEGF antagonist. Thus, the “initial dose” is the dose which is administered at the beginning of the treatment regimen (also referred to as the “baseline dose”); the “secondary doses” are the doses which are administered after the initial dose; and the “tertiary doses” are the doses which are administered after the secondary doses. Ex. 1001, 3:31–38 (emphasis added). 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,” and that “the ‘tertiary doses’ are the doses which are administered after the secondary doses.” Ex. 1001, 3:31–38 (emphasis added). Patent Owner has not directed us to any portion of the Specification or other persuasive evidence that supports adding an efficacy requirement to that definition.” slip op. at 24
Patent outcomesUS 9,254,338 unpatentableClaim construction§ 102 anticipationcites Phillips · GrahamPatents in suitUS 9,254,338
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