• Beone Medicines USA, Inc. / Beigene, Ltd. v. Pharmacyclics LLCAll claims unpatentable
  PTAB · May 1, 2025 · PGR2024-00009 · APJ Sheridan K Snedden · PGR · Final written decision

  Claims 1–8, 12, and 20 are unpatentable for lack of written description under § 112(a); the Board did not reach the enablement, anticipation, or obviousness grounds.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986).” slip op. at 10

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

    “used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.200(b). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Moreover, “claim terms need only be construed ‘to the extent necessary to resolve the controversy.’” See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). The parties agree that the preamble of the claims should be limiting and that the terms “optionally substituted fused heterocyclic ring system” and “irreversible” BTKIs should be construed consistent with the definitions provided in the Specification. Pet. 42–45; see also id. at 42 (citing Ex. 1001, 19:57–20:7 (defining “optionally substituted” or “substituted”), 14:51–52 (defining “fused”), 15:66–16:21 (defining “heterocycle”), 14:36–44 (defining “ring” and “ring system”), 26:23–25 (defining “irreversible Btk inhibitor”); PO Resp. 26.” slip op. at 14

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

    “used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.200(b). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Moreover, “claim terms need only be construed ‘to the extent necessary to resolve the controversy.’” See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). The parties agree that the preamble of the claims should be limiting” slip op. at 14

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable

    “To satisfy written description for the claimed genus of iBTKIs, the Specification must describe either a representative number of members of the genus or structural features common to the members of the genus with enough precision that a POSA can visualize or recognize the members of the genus. See Ariad, 598 F.3d at 1350. Patent Owner concedes that the Specification does not describe a representative number of members of the genus, stating “this is a common structural features case.” Tr. 65:25–66:3. We, therefore, focus our analysis on whether the Specification adequately describes common structural features of the genus. We find that it does not.” slip op. at 30

  Patent outcomesUS 11,672,803 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 11,672,803
• Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.All claims unpatentable
  PTAB · 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 Phillips
  Patents in suitUS 11,007,201
• 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
• Guardant Health, Inc. v. University Of WashingtonAll claims unpatentable
  PTAB · Jan 11, 2024 · IPR2022-01158 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–28 are unpatentable because Eltoukhy anticipates them; the Board found they were not entitled to a priority date before Eltoukhy’s publication.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Level of Ordinary Skill in the Art In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). Furthermore, the prior art itself can reflect the appropriate level of ordinary skill in the art. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Here, Petitioner asserts that an ordinarily skilled artisan “would typically have an advanced degree, such as a Ph.D., with research experience in genomics, molecular biology, bioinformatics, or a related field, or could have less education but significant professional experience in one or more of these fields.” Pet. 8–9 (citing Ex. 1002 ¶ 38). Patent Owner states that for the purposes of this proceeding, it does not dispute Petitioner’s definition of the skill level. PO Resp. 2 (citing Ex. 2023 ¶¶ 21, 22). After reviewing the record, we adopt Petitioner’s definition as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention.” slip op. at 7

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionOther

    “1. “Sequence Reads” Petitioner argues that, for purposes of this Decision, no claim term needs specific construction beyond its plain and ordinary meaning. Pet. 10–11. Petitioner, however, seeks to provide context for understanding the scope of the term “sequence reads.” Specifically, Petitioner contends that “sequence reads” are produced by sequencing at least some of the tagged strands, whereas “consensus sequences” are generated by collapsing sequence reads. Id. at 11 (citing Ex. 1001, 4:45–47, 20:50–22:25, 23:29–57, 24:46–48, claim 1, claim 6). In the Decision to Institute, we agreed with Petitioner that “[t]he claims of the ’951 patent as well as the specification make clear that a ‘sequence read’ is different and distinct from a ‘consensus sequence.’” DI 7 (quoting Pet. 11). Patent Owner does not dispute Petitioner’s assertion. PO Resp. 12. Based on the complete record, we see no reason to change our determination of the scope of the term “sequence reads.”” slip op. at 8

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

    “We disagree with Patent Owner’s proposed construction of the terms “paired sequence reads” and “unpaired sequence reads.” Even though the ’951 patent Specification discloses grouping sequence reads “sharing a unique set of SMI tags” into paired families,4 “[t]he written description part of the specification itself does not delimit the right to exclude. That is the function and purpose of claims.” Phillips, 415 F.3d at 1312 (“[T]he claims of a patent define the invention to which the patentee is entitled the right to exclude.”). Here, claim 1 explicitly defines the terms “paired sequence reads” and “unpaired sequence reads.” Indeed, in the context of paired versus unpaired sequence reads, claim 1 specifies that the complementarity is related to the “original parent polynucleotide molecule,” and not the duplex tags. For example, claim 1 recites that “each unpaired read represents a first tagged strand having no second differently tagged complementary strand derived from an original parent polynucleotide molecule represented among said sequence reads in said set of sequence reads.” Ex. 1001, 37:50–55 (emphasis added). Thus, the plain claim language contradicts Patent Owner’s argument” slip op. at 11

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

    “Claim 1 defines the terms “paired sequence reads” and “unpaired sequence reads” based on the complementarity of the target sequence strands derived from the “original parent polynucleotide molecule.” Ex. 1001, 37:46–55. As explained above, we reject Patent Owner’s contention that a sequence read is considered unpaired solely based on the complementarity of the SMI tags. See supra Section II.C.2. Due to the “errors introduced during sample preparation and sequencing” (Ex. 1029 ¶ 5), there are four outcomes when determining the complementarity of the sequence reads of two strands of SMI-linked target sequence: (1) the first SMI tag and the first strand target sequence are complementary to the second SMI tag and the second strand target sequence, respectively; (2) the first SMI tag is complementary to the second SMI tag but the first strand target sequence is not complementary to the second strand target sequence; (3) the first SMI tag is not complementary to the second SMI tag but the first strand target sequence is complementary to the second strand target sequence; and (4) the first SMI tag is not complementary to the second SMI tag, and the first strand target sequence is not complementary to the second strand target sequence. It is undisputed that Schmitt groups sequence reads into paired families based on the SMI tags, and Schmitt only considers sequences in which “information from both DNA strands was in perfect agreement.” Ex. 1029 ¶¶ 14, 96; PO Resp. 18. Thus, among the four outcomes, only scenario (1), in which both the SMI tags and the target sequences are complementary, represents a “paired sequence read,” which claim 1 defines as corresponding to “sequence reads generated from a first tagged strand and a second differently tagged complementary strand derived from an original parent polynucleotide molecule.” Ex. 1001, 37:46–50. Contrary to Patent Owner’s argument (see PO Resp. 26), in Schmitt,” slip op. at 18

  Patent outcomesUS 10,752,951 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 10,752,951
• Bausch & Lomb Incorporated v. Zeavision, LLCAll claims unpatentable
  PTAB · Apr 10, 2023 · IPR2022-00089 · APJ Tina E Hulse · IPR · Final written decision

  Claims 12–14, 16–21, 23, and 24 are unpatentable: Lang anticipates some claims, and the asserted Lang-based combinations render all challenged claims obvious.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In our Institution Decision, we adopted Petitioner’s definition (Dec. Inst. 6–7), which Patent Owner states that it “does not contest.” PO Resp. 17. Because the parties do not dispute the level of ordinary skill in the art, we adopt Petitioner’s definition as consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). Moreover, we find that Dr. Johnson and Dr. Dorey are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art. See Ex. 1024 ¶¶ 2–11, App’x A; Ex. 2001 ¶¶ 4–14, App’x A; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F. 4th 1369, 1376–77 (Fed. Cir. 2022) (“To offer expert testimony from the perspective of a skilled artisan in a patent case—like for claim construction, validity, or infringement—a witness must at least have ordinary skill in the art.”).” slip op. at 7

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

    “Similarly, here, the Specification consistently states that the invention relates to oral formulations for protecting eye health and that the benefits of carotenoids, such as zeaxanthin and lutein, include the ability to absorb UV and blue light. See, e.g., Ex. 1001, Abstract (“Oral formulations for promoting eye health”), 4:25–31 (stating carotenoids such as zeaxanthin are “very good at absorbing ultraviolet (UV) and blue light”), 15:45–47 (“one object of this invention is to disclose multi-component orally-ingestible formulations for protecting eye health in mammals”). Like the preamble in Proveris, the preamble in claim 12 is the only reference in any of the independent claims to the allegedly inventive concept of protecting eye health from the harmful effects of blue light. Proveris, 739 F.3d at 1373. Moreover, the preamble of claim 12 recites: “A nutrient formulation for oral ingestion for protecting a user’s eyes from the harmful effect of blue light, the formulation comprising:.” Ex. 1001, 37:13–15. The body of claim from the group consisting of capsules, tablets, liquids, and powders for oral ingestion.” Ex. 1001, 37:22–24 (emphasis added). Similarly, claim 22, which depends from claim 12, relies on the preamble of claim 12 for antecedent basis for the limitation “wherein the user has macular degeneration and a lens-related disorder.” Id. at 38:21 (emphasis added). Thus, “the nutrient formulation” and “the user” in the claim body derives antecedent basis from the “nutrient formulation” and “user” that is “defined in greater detail in the preamble.” See Proveris, 739 F.3d at 1373. Accordingly, reading the patent as a whole, because the inventor clearly relied on both the preamble and the body of claim 12 to define the claimed invention, the preamble of claim 12 should be construed as limiting. See id.” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner

    “stereoisomers” should have its plain and ordinary meaning, and a person of ordinary skill in the art would understand this term to mean that the zeaxanthin that is present in the 3R-3R' stereoisomer form is “largely but not wholly free of meso-zeaxanthin stereoisomers.” Pet. 19 (citing Ex. 1024 ¶ 57, Ex. 1031, 3). Petitioner also contends the term “mixed tocopherols” should be construed to mean “a mixture of tocopherols such as alpha-, beta-, gamma-, and delta-tocopherols.” Pet. 22–24 (citing Ex. 1024 ¶¶ 65–66). Patent Owner does not address either of these claim terms in its Response. See generally PO Resp. Because there does not appear to be any dispute over the construction of these terms, we adopt Petitioner’s proposed constructions as they are consistent with the plain and ordinary meaning of the terms. See Wellman, terms need only be construed ‘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 11

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “2. Analysis Anticipation requires that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art omitted). “To establish inherency, the extrinsic evidence ‘must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.’” Id. (citation omitted). Moreover, to anticipate, a prior art reference must “disclose[] within the four corners of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim.” Net MoneyIN, Inc. v. Verisign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).” slip op. at 13

  Patent outcomesUS 10,307,384 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 10,307,384
• Ricetec, Inc. v. BASF SEAll claims unpatentable
  PTAB · Mar 8, 2023 · PGR2021-00114 · APJ Tina E Hulse · PGR · Final written decision

  Claims 1–17 are unpatentable: they lack written description support and are anticipated by Hinga; the Board also found the challenged dependent claims obvious over the listed combinations.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “As explained in our Institution Decision (Dec. Inst. 5–6), we do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner states a POSITA must have one to two years of postdoctoral research experience and Patent Owner’s definition requires at least five years of “research experience,” Patent Owner’s definition does not indicate a specific time for that research (i.e., it could include research during or after a doctoral program). Neither party addresses or contests the other party’s definition in their post-institution papers. See generally PO Resp.; Pet. Reply; PO Sur-reply. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). Moreover, we find that Dr. Shaner and Dr. Somers are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art, based on either party’s definition. See Ex. 1002 ¶¶ 4–15; Ex. 2036 ¶¶ 5–11, App’x A; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F. 4th 1369, 1376–77 (Fed. Cir. 2022) (“To offer expert testimony from the perspective of a skilled artisan in a patent case—like for claim construction, validity, or infringement—a witness must at least have ordinary skill in the art.”).” slip op. at 8

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

    “amount.” Pet. Reply 14. Patent Owner, however, argues that we erred in our construction because the Specification explicitly defines “effective amount” to mean “the amount of herbicide required to achieve at least about 65% phytotoxicity of conventional [i.e., wild, non-mutant] rice (e.g., red rice) in field applications.” PO Resp. 10 (quoting Ex. 1001, 6:34–37). Because the inventors served as their own lexicographers, Patent Owner asserts the Specification’s express definition controls. Id. at 10–11 (citing Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1380 (Fed. Cir. 2009) (“When a patentee explicitly defines a claim term in the patent specification, the patentee’s definition controls.”)). Nevertheless, Patent Owner acknowledges that the “less than 10% injury” language “is indeed a limitation of the ’346 Patent claims.” Id. at 11. Having considered the arguments and evidence presented at trial, we agree with Patent Owner that the inventors acted as their own lexicographer to define “effective amount” and that that definition governs its meaning. Phillips, 415 F.3d 1316 (“[O]ur cases recognize that the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.”). We, therefore, construe the term “effective amount” to mean “the amount of an herbicide required to achieve at least about 65% phytotoxicity of conventional rice (e.g., red rice) in field applications.” As explained further below, however, whether incorporated into the construction of “effective amount” or not, the claim language itself further requires that the “effective amount” encompass a specific range of amounts of herbicide (i.e., 14 g AI/Ha to 40 g AI/Ha of quizalofop) and cause “less than 10% injury” to the mutant rice. See Ex. 1001, claim 1.” slip op. at 10

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable

    “Mankin would derive the herbicide range suggested by Patent Owner and Dr. Somers from the “rules of thumb,” that range is much broader than the claimed range. Claim 1 recites that the effective amount is 14 g AI/Ha–40 g AI/Ha of quizalofop, but, according to Dr. Somers’s calculations from the Assure II herbicide label, a POSITA would understand the effective amount to be 19.25–154 (or 19.25–184.8) g AI/Ha. Ex. 2036 ¶ 54; PO Resp. 38. Patent Owner does not identify anything in the specification that would allow a POSITA to “immediately discern” the specific range limitations of the claims. See General Hospital, 888 F.3d at 1372. As the Federal Circuit has stated, “one cannot disclose a forest in the original application, and then pick a tree out of the forest and say here is my invention.” Purdue Pharma, 230 F.3d at 1326. Thus, we are not persuaded that the disclosure of a broad range of effective amounts via the Assure II herbicide label coupled with Dr. Somers’s undisclosed “rules of thumb” provide written description support for the narrower range limitations of the claims. Moreover, we agree with Petitioner that Patent Owner is impermissibly working backward from the claimed ranges to determine whether Dr. Somers’s “rules of thumb” can be used to re-create the claimed range from the herbicide label. Pet. Reply 15. That is not the test for written description. Written description “requires a statement of an invention, not an invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention.” Indivior UK Ltd. v. Dr. Reddy’s Labs. S.A., 18 F. 4th 1323, 1329 (Fed. Cir. 2021). Accordingly, we are not persuaded that Dr. Somers’s “rules of thumb” applied to the extrinsic herbicide label would be understood by a POSITA as a description in Mankin of the range limitation of the claims. Rather, as Dr. Somers concedes, his “rules of thumb” in conjunction with the herbicide label represent a starting point for a POSITA to test plants to determine what the effective amount range should be. See Ex. 2036 ¶ 53 (referring to a “dose response analysis” between 0.5x and 4x). But “a ‘mere wish or plan’ for obtaining the claimed invention is not sufficient.” See Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1351 (Fed. Cir. 2011).” slip op. at 30

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledNot shown unpatentable

    “We are not persuaded. Given the state of the art in 2017, and the known availability of the G2096S seeds at that time, we find the ’346 patent specification enables the claims. The ’346 patent specification clearly describes the G2096S mutant ACCase rice and its use in the claimed method for treating rice. See, e.g., Ex. 1001, 2:37–45, 57:51–61. Contrary to Petitioner’s assertion, the ’346 patent specification has not omitted the G2096S herbicide tolerant rice. Rather, the ’346 patent specification expressly identifies the G2096S mutant rice that possesses the phenotype of tolerance to the effective amounts of herbicides, and describes the method for treating that mutant rice with those effective amounts. See, e.g., id. at 8:8–12; 57:51–61. Thus, we are not persuaded that we erred in relying on Hinga’s seed deposits to determine that Petitioner has failed to meet its burden to prove that the ’346 patent specification fails to enable the challenged claims. Cf. Wands, 858 F.2d at 736 (stating “[n]o deposit is necessary if the biological organisms can be obtained from readily available sources.”).” slip op. at 46

  Patent outcomesUS 11,096,346 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 11,096,346
• Ricetec, Inc. v. BASF SEAll claims unpatentable
  PTAB · Mar 8, 2023 · PGR2021-00113 · APJ Tina E Hulse · PGR · Final written decision

  Claims 1–15 are unpatentable: they lack written-description support, and claims 1–3, 7, and 11–15 are anticipated by Hinga or Hinga2013.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “As explained in our Institution Decision (Dec. Inst. 6–7), we do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner states a POSITA must have one to two years of postdoctoral research experience and Patent Owner’s definition requires at least five years of “research experience,” Patent Owner’s definition does not indicate a specific time for that research (i.e., it could include research during or after a doctoral program). Neither party addresses or contests the other party’s definition in their post-institution papers. See generally PO Resp.; Pet. Reply; PO Sur-reply. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). Moreover, we find that Dr. Shaner and Dr. Somers are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art, based on either party’s definition. See Ex. 1002 ¶¶ 5–15; Ex. 2036 ¶¶ 5–11, App’x A; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F. 4th 1369, 1376–77 (Fed. Cir. 2022) (“To offer expert testimony from the perspective of a skilled artisan in a patent case—like for claim construction, validity, or infringement—a witness must at least have ordinary skill in the art.”).” slip op. at 8

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

    “Having considered the arguments and evidence presented at trial, we agree with Patent Owner that the inventors acted as their own lexicographer to define “effective amount” and that that definition governs its meaning. Phillips, 415 F.3d 1316 (“[O]ur cases recognize that the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.”). We, therefore, construe the term “effective amount” to mean “the amount of an herbicide required to achieve at least about 65% phytotoxicity of conventional rice (e.g., red rice) in field applications.” As explained further below, however, whether incorporated into the construction of “effective amount” or not, the claim language itself further requires that the “effective amount” encompass a specific range of amounts of herbicide and cause “less than 10%” injury to the mutant rice. See Ex. 1001, claim 1. We determine it is unnecessary to expressly construe any other claim terms for purposes of this Decision. See Wellman, 642 F.3d at 1361.” slip op. at 11

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable

    “labels is akin to relying on literature that clearly provides, on its face, the missing disclosure, as in Falkner. Id. On the contrary, Patent Owner’s argument makes clear that the herbicide labels, by themselves, are insufficient to describe the claimed range limitation. Specifically, because the label ranges do not align with the claimed ranges, Dr. Somers had to make additional assumptions and inferences to support Patent Owner’s written description argument. For example, to calculate the potential effective amount range of herbicides, Dr. Somers applied several different “rules of thumb,” none of which are disclosed in the Mankin specification. See Ex. 2036 ¶¶ 34, 54. According to Dr. Somers, to determine the effective amount for a plant with an unknown response to an herbicide, a POSITA “would naturally test the lowest label (1X) rate of the herbicide, along with a few rates below (starting at about half-X) and above the 1X rate (up to 4X) of the herbicide, to determine the effective dose for this ‘uncharacterized’ plant.” Id. ¶ 34. Dr. Somers refers to this as a “dose response analysis.” Id. ¶ 53. In other words, to determine what the actual effective amount of herbicides should be, Dr. Somers explains that a POSITA would have to test the plants at these “rule of thumb” amounts to determine the effective range. Id. ¶ 34. Given the additional assumptions and inferences that must be made to the herbicide labels to arrive at the range limitations, we are not persuaded that relying on the extrinsic herbicide labels for written description support is proper in this case. That said, even if we were to allow Patent Owner to rely on the herbicide labels and the “rules of thumb” for determining the effective herbicide dose, Patent Owner admits that the ranges calculated from the herbicide labels are broader than the range limitations of the claims. See PO Resp. 39. As Petitioner notes, however, the Mankin Application does not provide any guidance as to whether the effective amount range of herbicide would include a 0.5x dose, a 2x dose, or the 4x dose, such that a POSITA could immediately discern the claimed range from the herbicide label.17 Pet. Reply 16.” slip op. at 30

  • Expert testimonyPatent owner expert discountedDecided for petitioner

    “Dr. Somers, however, relies on the label for Fusilade II, which is a different fluazifop-P-butyl herbicide with a different range of 52.98–103.96 g AI/Ha, which—not surprisingly—aligns more closely with the claimed range of at least 56–150 g AI/Ha. Ex. 2036 ¶ 52. We note that Fusilade II does not appear to be one of the listed herbicides in Table 1, whereas Fusilade DX is. Ex. 2034 ¶ 219 (listing “Fusilade, Fusilade 2000, Fusilade DX, ICI-A 00009, ICI-A 00005, SL-236, IH-773B, TF-1169, and Fusion” as examples of synonyms and trade names for fluazifop-P-butyl). Regardless, that the dose range differs for the same herbicide calls into question the credibility of Dr. Somers’s assertion that a person of ordinary skill in the art would have been able to discern the claimed range limitation by simply looking at the EPA-approved herbicide labels (and applying his “rules of thumb”).18, 19” slip op. at 33

  Patent outcomesUS 11,096,345 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 11,096,345
• Rimfrost As. v. Aker Biomarine Antarctic As.All claims unpatentable
  PTAB · Mar 6, 2020 · IPR2018-01730 · APJ John E Schneider · IPR · Final written decision

  Claims 1–20 are unpatentable across the stated anticipation and obviousness grounds; the contingent motion to amend with substitute claims 21–29 is denied because those claims are obvious.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “At institution, we preliminarily adopted Petitioner’s definition of an ordinarily skilled artisan, and determined that the prior art itself was sufficient to demonstrate the level of ordinary skill in the art at the time of the invention. Inst. Dec. 8. We note that Patent Owner states that it “accepts [Petitioner’s] definition of a POSITA.” PO Resp. 15. Accordingly, for this Decision, we adopt Petitioner’s definition, while maintaining that the prior art demonstrates the appropriate level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect appropriate level of ordinary skill in art). Moreover, we have reviewed the credentials of Drs. Tallon and Hoem, and consider each of them to be qualified to provide their opinion on the level of skill and the knowledge of a person of ordinary skill in the art at the time of the invention.” slip op. at 10

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

    “Such broadening usages as ‘about’ must be given reasonable scope; they must be viewed by the decision maker as they would be understood by persons experienced in the field of the invention. Although it is rarely feasible to attach a precise limit to ‘about,’ the usage can usually be understood in light of the technology embodied in the invention.” Modine Mfg. Co. v. U.S. Int’l Trade Comm’n, 75 F.3d 1545, 1554 (Fed. Cir. 1996). After considering the parties’ arguments and reviewing the Specification of the ’765 patent, we conclude that Petitioner’s proposed construction is consistent with the intrinsic evidence. Although the ’765 patent does not explicitly address the issue of “about,” the meaning of the term can be discerned from a careful reading of the Specification. Example 8 of the ’765 patent reports the analysis of phospholipid available Krill product. Ex. 1001, col. 31, l, 46–col. 32, l. 42. Table 22, reproduced above, reports the calculated values for the various phospholipids in values to a tenth of a percent. Id. at col. 32, ll. 18–38. In the discussion of the table, the values are rounded to the nearest whole number, not the nearest tenth. Id. at col. 32, ll. 11–15. This is consistent with the approach advanced by Petitioner. IPR2018-00295, Paper 35, 12.3 Similarly here, we find that although the Specification does not explicitly define the term “about,” its meaning may be discerned from the manner by which the Specification refers to reported values for phospholipid profiles of krill oil. Ex. 1001, 32:18–44 (Table 22). In the discussion of the lipids reported in Table 22, the values are rounded to the nearest whole number, not the nearest tenth. Id. at 32:47–52. This is more consistent with the approach advanced by Petitioner than by Patent Owner. Thus, as determined in that Final Written Decision, and for the reasons set forth therein, “the term ‘greater than about 5% w/w’ shall be construed to mean ‘greater than 4.5% w/w.’” IPR2018-00295, Paper 35, 13.” slip op. at 12

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “We have considered the arguments of the parties and the evidence of record and conclude that claims 5 and 6 are not anticipated by Catchpole. While we agree with Petitioner that Catchpole teaches compositions that can Catchpole discloses a krill oil composition having that amount of acylalkyphospholipids. Catchpole teaches a method of separating lipid materials from a feed material. Ex. 1009, 4. The feed material used in Catchpole may be derived from “terrestrial animals, marine animals, terrestrial plants, marine plants, or micro-organisms such as microalgae, yeast and bacteria. Preferably the feed material is derived from sheep, goat, pig, mouse, water buffalo, camel, yak, horse, donkey, llama, bovine or human.” Id. at 7. Catchpole does not specifically disclose a Krill extract that contains greater than 10% acylalkyphospholipids. The only specific disclosure of the acylalkyphospholipid content of krill oil is in Table 16 discussed above, which discloses an acylalkyphospholipid content of 4.8%, less than the 6% and 7% recited in claims 5 and 6. Based on the foregoing we conclude that claims 5 and 6 are not anticipated by Catchpole. E. Ground 2 - Obviousness Based on Catchpole Combined with Sampalis” slip op. at 17

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

    “have been fully and fairly tried in a previous action and adversely resolved against a party-opponent.” Ohio Willow Wood Co. v. Alps South, LLC, 735 F.3d 1333, 1342 (Fed. Cir. 2013) (citing Pharmacia & Upjohn Co. v. Mylan Pharm., Inc., 170 F.3d 1373, 1379 (Fed Cir. 1999)). “It is well established that collateral estoppel, also known as issue preclusion, applies in the administrative context.” MaxLinear, Inc. v. CF CRESPE LLC, 880 F.3d 1373, 1376 (Fed. Cir. 2018) (citations omitted); Webpower, Inc. v. WAG (Final Written Decision). The application of collateral estoppel is not limited to patent claims that are identical. Ohio Willow Wood, 735 F.3d at 1342. “Rather, it is the identity of the issues that were litigated that determines whether collateral estoppel should apply. . . . If the differences between the unadjudicated patent claims and the adjudicated patent claims do not materially alter the question of invalidity, collateral estoppel applies.” Id. As our reviewing court has explained, collateral estoppel precludes a party from relitigating an issue if: (1) prior action presents an identical issue; (2) the prior action actually litigated and adjudged that issue; (3) the judgment in that prior action necessarily required determination of the identical issue; and (4) the prior action featured full representation of the estopped party. VirnetX Inc. v. Apple, Inc., 909 F.3d 1375, 1377 (Fed. Cir. 2018) (quoting Stephen Slesinger, Inc. v. Disney Enters., Inc., 702 F.3d 640, 644 (Fed. Cir. 2012)).” slip op. at 21

  Patent outcomesUS 9,072,752 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 9,072,752

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.