• JSR Corporation / JSR Life Sciences, LLC v. Cytiva Bioprocess R&D ABSome claims unpatentable
  PTAB · May 18, 2023 · IPR2022-00044 · APJ Ulrike W Jenks · IPR · Final written decision

  Claims 1–3, 5–7, 10–16, 18–20, and 23–30 are unpatentable as obvious; claims 4 and 17 were not shown unpatentable because the art did not establish expected Fab binding.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Level of Ordinary Skill in the Art In determining the level of skill in the art, we consider the 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); Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). Petitioner asserts that a person of ordinary skill in the art would have had (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; (2) several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and (3) an understanding of the various factors involved in purifying proteins using chromatography.[] Such a person would have had multiple years of experience with affinity ligand design and protein purification. Pet. 9–10 (citing Ex. 1002 ¶¶ 13–14). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill. See generally PO Resp. Because Petitioner’s proposed definition is unopposed and appears consistent with the Specification and art of record, we apply it here.” slip op. at 12

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

    “Petitioner contends that based on Patent Owner’s implicit construction in the district court litigation “that the term ‘the ligand comprising at least two polypeptides’ refers to a multimeric ligand (such as a tetramer) comprised of multiple polypeptides, each of which is a monomer.” Pet. 15 (citing Ex. 1020 ¶¶ 41, 50, 58, 62, 74, 87).” slip op. at 13

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable

    “knowledge that any one of the five SPA IgG binding domains are known to bind IgG and can function as a ligand for the purification of antibodies. Linhult and Abrahmsén both expressly suggest that the glycine codon at position 29 can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Ex. 1004, 2; Ex. 1005, 2:32–37. Here, the SPA IgG binding domains comprise a short list of 5 members: E, D, A, B, or C. Of these 5 members, the glycine at position 29 in domain B has already been mutated to an alanine to create a domain Z which has been shown to retain IgG binding activity. Ex. 1004, 6 (Fig. 3). Figure 1A of Linhult is reproduced below. Linhult’s Figure 1A, reproduced above, shows the amino acid alignments of the Z, Z(F30A) and the five homologous domains (E, D, A, B, and C). The three boxes show the α-helices. Ex. 1004, 2; Ex. 1005, Fig. 2. Here, Linhult and Abrahmsén show that the IgG binding domains of SPA – E, D, A, B, and C share many structural similarities. See Ex. 1004, 2 (Fig. 1(a) (reproduced above)); Ex. 1005, 3:25–35. As discussed in our Institution Decision (Dec. 30–31), there are a finite number—five (5)—SPA IgG binding domains and each possesses the dipeptide sequence Asp-Gly known to a be a target for alkaline protein degradation. Therefore, the solution of mutating the glycine at position 29 for an alanine to remove the alkaline sensitive sequence is not a product of innovation, but of ordinary skill and common sense. See Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364-65 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). It is well established that [s]tructural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties. In re Deuel, 51 F.3d 1552, 1558 (Fed. Cir. 1995).” slip op. at 37

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

    “Neither claim 1 nor claim 14 recite a need to bind the Fab region of an antibody or that the target molecule is Fab. All that is required by these claims is that they adsorb a target molecule and that you can elute the target molecule from the matrix. The target molecule, therefore, can reasonably encompass IgG. Petitioner’s articulated rationale is that there was an expectation that the composition binds antibodies, including monoclonal antibodies, and therefore, would be useful in a process of for isolating antibodies. Petitioner contends that: A POSA would have also reasonably expected such a combination to achieve a process for isolating one or more target compounds using the recited affinity chromatography matrix given the well-known fact that each individual SPA domain, including the C domain, has affinity for antibodies (Ex. 1004, [1]) as well as Abrahmsén’s confirmation that a G29A mutation on SPA “would not interfere with folding [of SPA] or binding to [antibodies]” (Ex. 1005, 5:13-16). (Ex. 1002 ¶131.) Pet. 25; Reply 8 (“‘A POSA would not have been motivated only by Fab-binding ability, as even Dr. Bracewell agreed that ‘a POSA would have understood that it was desirable to purify monoclonal antibodies for therapeutic use in 2006.’(Ex. 1057, 75:17-76:4, 113:23-114:11, 157:24- 158:9; Ex. 1061 ¶29)”). The law does not require that the teachings of the reference be combined for the reason or advantage contemplated by the inventor, as long as some suggestion to combine the elements is provided by the prior art as a whole. In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992); In re Kronig, 539 F.2d 1300, 1304 (CCPA 1976); see In re Kemps, 97 F.3d 1427, 1430” slip op. at 44

  Patent outcomesUS 10,343,142 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,343,142
• JSR Corporation / JSR Life Sciences, LLC v. Cytiva Bioprocess R&D ABSome claims unpatentable
  PTAB · May 18, 2023 · IPR2022-00041 · APJ Ulrike W Jenks · IPR · Final written decision

  Claims 1–3, 5–7, 10–16, 18–20, and 23–30 are unpatentable as obvious; claims 4 and 17 were not shown unpatentable because the art did not establish expected Fab binding.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that a person of ordinary skill in the art would have had (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; (2) several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and (3) an understanding of the various factors involved in purifying proteins using chromatography.[] Such a person would have had multiple years of experience with affinity ligand design and protein purification. Pet. 9–10 (citing Ex. 1002 ¶¶ 13–14). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill. See generally PO Resp. Because Petitioner’s proposed definition is unopposed and appears consistent with the Specification and art of record, we apply it here.” slip op. at 13

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

    “According to the Specification, “the present invention . . . relates to a multimeric chromatography ligand (also denoted a ‘multimer’) comprised of at least two Domain C units, or a functional fragments or variants thereof.” Ex. 1001, 7:27–30. The Specification additionally recites that a multimer containing only domain C units can, however, include linkers. Id. 7:39–41. In addition, the Specification describes that “the multimer comprises one or more additional units, which are different from Domain C.” Id. 7: 44–45. Based on these disclosures in the Specification, a multimer is composed of at least two or more monomers. Because Petitioner’s construction is consistent with the ’142 patent’s express construction of the term, and because Patent Owner agrees with Petitioner’s construction, we apply it here.” slip op. at 14

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

    “knowledge that any one of the five SPA IgG binding domains are known to bind IgG and can function as a ligand for the purification of antibodies. Linhult and Abrahmsén both expressly suggest that the glycine codon at position 29 can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Ex. 1004, 2; Ex. 1005, 2:32–37. Here, the SPA IgG binding domains comprise a short list of 5 members: E, D, A, B, or C. Of these 5 members, the glycine at position 29 in domain B has already been mutated to an alanine to create a domain Z which has been shown to retain IgG binding activity. Ex. 1004, 6 (Fig. 3). Figure 1A of Linhult is reproduced below. Linhult’s Figure 1A, reproduced above, shows the amino acid alignments of the Z, Z(F30A) and the five homologous domains (E, D, A, B, and C). The three boxes show the α-helices. Ex. 1004, 2; Ex. 1005, Fig. 2. Here, Linhult and Abrahmsén show that the IgG binding domains of SPA – E, D, A, B, and C share many structural similarities. See Ex. 1004, 2 (Fig. 1(a) (reproduced above)); Ex. 1005, 3:25–35. As discussed in our Institution Decision (Dec. 30–31), there are a finite number—five (5)—SPA IgG binding domains and each possesses the dipeptide sequence Asp-Gly known to a be a target for alkaline protein degradation. Therefore, the solution of mutating the glycine at position 29 for an alanine to remove the alkaline sensitive sequence is not a product of innovation, but of ordinary skill and common sense. See Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364-65 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). It is well established that” slip op. at 37

  • Obviousness (§103) › KSR rationalesUnpatentable

    “Here, the teachings of Linhult, Abrahmsén, and Hober suggest mutating the glycine at position 29 for an alanine in any one of the IgG binding domains of E, D, A, B, or C of SPA in order to avoid protein degradation. Ex. 1004, 2; Ex. 1005, 5:4–9. We, therefore, agree with Petitioner that the art expressly suggests that the glycine codon can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Pet. 23 (citing Ex. 1002 ¶¶ 99–111). Attaching any one of SPA mutated IgG binding domains E D A B or C to a matrix using “known ligand-construction methods to yield a predictable result[] (e.g., the claimed affinity chromatography matrix)” would have been obvious. Pet. 25 (citing Ex. 1002 ¶ 130). As the Federal Circuit has explained, “[w]here a skilled artisan merely pursues ‘known options’ from ‘a finite number of identified, predictable solutions,’ the resulting invention is obvious under Section 103.” In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1070 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). Accordingly, we agree with Petitioner that the combination of Linhult Abrahmsén, and Hober expressly suggests mutating the glycine codon for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Pet. 23 (citing Ex. 1002 ¶¶ 99–111). We also agree that the cited art teaches using these mutant SPA domains in column chromatography for the isolation of antibodies.” slip op. at 36

  Patent outcomesUS 10,343,142 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,343,142
• JSR Corporation / JSR Life Sciences, LLC v. Cytiva Bioprocess R&D ABSome claims unpatentable
  PTAB · May 18, 2023 · IPR2022-00045 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–10, 12–14, 16–28, 30–32, and 34–37 are unpatentable as obvious; claims 11 and 29 were not shown unpatentable because the art did not establish expected Fab binding.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that a person of ordinary skill in the art would have had (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; (2) several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and (3) an understanding of the various factors involved in purifying proteins using chromatography.[] Such a person would have had multiple years of experience with affinity ligand design and protein purification. Pet. 9–10 (citing Ex. 1002 ¶¶ 13–14). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill. See generally PO Resp. Because Petitioner’s proposed definition is unopposed and appears consistent with the Specification and art of record, we apply it here. C.” slip op. at 12

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

    “support, the ligand capable of binding the one or more target compound(s) and comprising at least two polypeptides.” Ex. 1001, 15:46–49; 17:28–31. Petitioner argues that “‘the ligand comprising at least two polypeptides’ refers to a multimeric ligand (such as a tetramer) comprised of multiple polypeptides, each of which is a monomer.” Pet. 19–20 (citing Ex. 1002 ¶¶ 43–45). Petitioner argues that this construction is consistent with Patent Owner’s implicit construction in the Delaware litigation between the parties. Id. Patent Owner does not challenge Petitioner’s claim construction. See generally PO Resp. According to the Specification, “the present invention . . . relates to a multimeric chromatography ligand (also denoted a ‘multimer’) comprised of at least two domain C units, or a functional fragments [sic] or variants thereof.” Ex. 1001, 7:35–38. The Specification additionally recites that a multimer containing only domain C units can, however, include linkers. Id. at 7:39–41. In addition, the Specification describes that “the multimer comprises one or more additional units, which are different from Domain C.” Id. at 7:52–53. Based on these disclosures in the Specification, a multimer is composed of at least two or more monomers. Because Petitioner’s construction is consistent with the ’007 patent’s express construction of the term, we apply that construction for the purposes of this decision.” slip op. at 13

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

    “Petitioner’s articulated obviousness ground is premised on the knowledge that any one of the five SPA IgG binding domains are known to bind IgG and can function as a ligand for the purification of antibodies. Linhult and Abrahmsén both expressly suggest that the glycine codon at position 29 can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Ex. 1004, 2; Ex. 1005, 2:32–37. Here, the SPA IgG binding domains comprise a short list of 5 members: E, D, A, B, or C. Of these 5 members, the glycine at position 29 in domain B has already been mutated to an alanine to create a domain Z which has been shown to retain IgG binding activity. Ex. 1004, 6 (Fig. 3). Figure 1A of Linhult is reproduced below. Linhult’s Figure 1A, reproduced above, shows the amino acid alignments of the Z, Z(F30A) and the five homologous domains (E, D, A, B, and C). The three boxes show the α-helices. Ex. 1004, 2; Ex. 1005, Fig. 2. Here, Linhult and Abrahmsén show that the IgG binding domains of SPA – E, D, A, B, or C share many structural similarities. See Ex. 1004, 2 (Fig. 1(a) (reproduced above)); Ex. 1005, 3:25–35. As discussed in our Institution Decision (Dec. 30–31), there are a finite number – five (5) – SPA IgG binding domains and each possesses the dipeptide sequence Asp-Gly known to a be a target for alkaline protein degradation. Therefore, the solution of mutating the glycine at position 29 for an alanine to remove the alkaline sensitive sequence is not a product of innovation but of ordinary skill and common sense. See Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364-65 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). It is well established that” slip op. at 38

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

    “(c) No Teaching Away We are also not persuaded by Patent Owner’s contention that the art teaches away from the G29A substitution because it interferes with Fab binding. See PO Resp. 39–42; Sur-reply 9; Ex. 2009 at 2; Ex. 2010 at 25; Ex. 2012 at 25–26; Ex. 2029 at 7. None of claims 1, 2, or 20 recite a need to bind the Fab region of an antibody or that the target molecule is Fab. All that is required by these claims is that they adsorb a target molecule and that you can elute the target molecule from the matrix. The target molecule, therefore, can reasonably encompass IgG.” slip op. at 44

  Patent outcomesUS 10,875,007 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,875,007
• JSR Corporation / JSR Life Sciences, LLC v. Cytiva Bioprocess R&D ABSome claims unpatentable
  PTAB · May 18, 2023 · IPR2022-00042 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–10, 12–14, 16–28, 30–32, and 34–37 are unpatentable as obvious; claims 11 and 29 were not shown unpatentable because Fab binding was not predictable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “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); Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). Petitioner asserts that a person of ordinary skill in the art would have had (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; (2) several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and (3) an understanding of the various factors involved in purifying proteins using chromatography.[] Such a person would have had multiple years of experience with affinity ligand design and protein purification. Pet. 9–10 (citing Ex. 1002 ¶¶ 13–14). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill. See generally PO Resp. Because Petitioner’s proposed definition is unopposed and appears consistent with the Specification and art of record, we apply it here. C.” slip op. at 12

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

    “According to the Specification, “the present invention . . . relates to a multimeric chromatography ligand (also denoted a ‘multimer’) comprised of at least two domain C units, or a functional fragments [sic] or variants thereof.” Ex. 1001, 7:35–38. The Specification additionally recites that a multimer containing only domain C units can, however, include linkers. Id. at 7:39–41. In addition, the Specification describes that “the multimer comprises one or more additional units, which are different from Domain C.” Id. at 7:52–53. Based on these disclosures in the Specification, a multimer is composed of at least two or more monomers. Because Petitioner’s construction is consistent with the ’007 patent’s express construction of the term, we apply that construction for the purposes of this decision. Having considered the parties’ positions and evidence of record, we determine that the express construction of any other claim term is unnecessary to resolve the disputed issues in this matter. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). To the extent further discussion of the meaning of any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 14

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

    “Petitioner’s articulated obviousness ground is premised on the knowledge that any one of the five SPA IgG binding domains are known to bind IgG and can function as a ligand for the purification of antibodies. Linhult and Abrahmsén both expressly suggest that the glycine codon at position 29 can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Ex. 1004, 2; Ex. 1005, 2:32–37. Here, the SPA IgG binding domains comprise a short list of 5 members: E, D, A, B, or C. Of these 5 members, the glycine at position 29 in domain B has already been mutated to an alanine to create a domain Z which has been shown to retain IgG binding activity. Ex. 1004, 6 (Fig. 3). Figure 1A of Linhult is reproduced below. Linhult’s Figure 1A, reproduced above, shows the amino acid alignments of the Z, Z(F30A) and the five homologous domains (E, D, A, B, and C). The three boxes show the α-helices. Ex. 1004, 2; Ex. 1005, Fig. 2. Here, Linhult and Abrahmsén show that the IgG binding domains of SPA – E, D, A, B, or C share many structural similarities. See Ex. 1004, 2 (Fig. 1(a) (reproduced above)); Ex. 1005, 3:25–35. As discussed in our Institution Decision (Dec. 30–31), there are a finite number – five (5) – SPA IgG binding domains and each possesses the dipeptide sequence Asp-Gly known to a be a target for alkaline protein degradation. Therefore, the solution of mutating the glycine at position 29 for an alanine to remove the alkaline sensitive sequence is not a product of innovation but of ordinary skill and common sense. See Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364-65 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). It is well established that [s]tructural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties. In re Deuel, 51 F.3d 1552, 1558 (Fed. Cir. 1995).” slip op. at 38

  Patent outcomesUS 10,875,007 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,875,007
• Tide International (USA), Inc. v. Upl Na Inc.Some claims unpatentable
  PTAB · Jan 4, 2022 · IPR2020-01113 · APJ Michael A Valek · IPR · Final written decision

  Claims 1–4 are unpatentable as obvious over Misselbrook, CN ’588, and JP ’902; claims 7–12 were not shown unpatentable because the grounds did not establish motivation to add a disintegrating agent.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “relevant to determining the level of ordinary skill in the art include the type of problems encountered in the art and prior art solutions to those problems. See Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696–97 (Fed. Cir. 1983). The prior art itself may also reflect an appropriate level of skill. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for patent owner

    “We also adopt the parties’ position that the preamble of claims 1 and 7 is not limiting beyond the term “granule.” Claims 1 and 7 each recite “[a] chemically stable dry flow, low compact, dust free soluble phosphoramidothioate granule consisting of” the set of ingredients recited in body of those claims. Ex. 1001, 7:44–45, 8:19–20. While the wherein clause describing the dimensions of “said granule” relies on “granule” in the preamble for antecedent basis, none of the other preamble language appears to be necessary to breathe life and meaning into the claim, and the claim body recites a structurally complete invention. See Catalina Marketing Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (explaining that a preamble is limiting if it is “necessary to give live, meaning, and vitality to the claim,” but “is not limiting where a patentee defines a structurally complete invention in the claim body”) (internal quotations omitted). Thus, we agree with the parties, and the district court in the related litigation, that the preamble language other than “granule” is not limiting.” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner

    “Moreover, we agree that the transitional phrase “consisting of” in claims 1 and 7 creates a “very strong presumption that the claim element is ‘closed’ and therefore exclude[s] any elements, steps, or ingredients not specified in the claim.” Pet. 5; Resp. 12 (both quoting Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350, 1358 (Fed. Cir. 2016)). Neither party seeks to overcome that presumption, nor do we see any basis for doing so based on the record before us. Accordingly, we construe the challenged claims to be limited to granule compositions containing only those ingredients recited in the claims. There are no other terms that need to be construed to resolve the issues presented in this proceeding. Therefore, we do not construe any additional terms. See, e.g., Nidec Motor Corp. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 11

  • Expert testimonyPetitioner expert creditedPatent owner expert creditedMixed

    “demonstrating that the “general conditions” regarding the use of these ingredients in such compositions was known. In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012) (noting that any overlap between the claimed and disclosed ranges serves to disclose the “general conditions” of the claim). “Such overlap itself provides sufficient motivation to optimize the ranges.” Id. Moreover, we credit Mr. Geigle’s testimony that a POSITA would have understood because the concentration of acephate was increased the concentration of the other ingredients would necessarily decrease and that a POSITA would have been able optimize these amounts using standard techniques and testing. Ex. 1003 ¶¶ 85–113. Thus, Petitioner has demonstrated that these ingredient concentrations are result-effective variables that would have been obvious to optimize through routine experimentation.” slip op. at 24

  Patent outcomesUS 7,473,685 mixed
  Claim construction§ 103 obviousnesscites Graham
  Patents in suitUS 7,473,685
• Syngenta Crop Protection AG v. FMC CorporationSome claims unpatentable
  PTAB · Aug 31, 2021 · PGR2020-00028 · APJ Cynthia M Hardman · PGR · Final written decision

  Claims 1–3, 9–13, and 21–30 are unpatentable for lack of enablement; claims 9–13 also lack written description. Petitioner did not prove anticipation or obviousness of claims 1–7 and 22–31.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In determining the level of skill in the art, we consider factors including the type of problems encountered in the art, prior art solutions to those problems, and the sophistication of the technology. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). Because Petitioner’s proposed definition is consistent with the prior art of record and the sophistication of the technology demonstrated by the record, we apply it here.5” slip op. at 10

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

    “Based on the complete record developed at trial, we determine that to resolve the disputes herein, we do not need to expressly construe any claim term. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that construction is needed only for disputed terms, and only as necessary to resolve the controversy).” slip op. at 11

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “We find that Dr. Dayan’s testimony on these points lacks sufficient supporting analysis. In opining that the tested substituents are representative of the steric and electrostatic properties across the claimed substituents, Dr. Dayan merely compares the properties of the tested substituents to each other. See, e.g., id. ¶¶ 52–56. He does not expressly compare them to the properties of the many remaining, untested substituents within the scope of the claims. See id.; see also Reply 14 (“At best, [Dr.] Dayan testified that the positive activity . . . at each substituent” suggests that the position is involved in herbicidal activity, “not that the tested compounds were sufficient to provide any reasonable expectation of success as to the billions of structurally diverse compounds covered” by the claims.). And although Dr. Dayan acknowledges that several tested compounds showed no herbicidal activity, he does not expressly explain how he took these compounds into account in nevertheless concluding that an ordinarily skilled artisan would expect at least some activity across all claimed substituents. See, e.g., Ex. 2011 ¶¶ 54–56 (noting exceptions to herbicidal activity). As one example, Dr. Dayan acknowledges the lack of activity shown in the data for substituents larger than hydrogen at the R6 position, but does not explain the impact of that data on the remaining claimed substituents. See id. ¶ 54 (Dr. Dayan noting that activity is “not as favored by larger alkyl groups” at R6, but nevertheless concluding that “one would expect at least some herbicidal activity” across all claimed R6 substituents). In contrast, Dr. Hunt compares the size and properties of the R6 substituents that showed no activity with the size and properties of other claimed but untested R6 substituents. Ex. 1003 ¶¶ 163, 166–68; Ex. 1029 ¶¶ 37, 38. This comparison indicates that the majority of R6 substituents are larger than the tested substituents, such that the vast majority of the claimed compounds (i.e., those with compounds having R6 substituents larger than those tested), could have no herbicidal activity. Ex. 1003 ¶ 167; Ex. 1029 ¶¶ 12, 37, 38. Thus, we find that the data in the Specification regarding at least position R6 gives a person of ordinary skill in the art reason to doubt that substantially all compounds within the full scope of claim 1 of the ’202 patent would exhibit herbicidal activity. Ex. 1003 ¶ 163; Ex. 1029 ¶¶ 11, 12, 38; In re Surrey, 370 F.2d 349, 355 (CCPA 1966) (“[W]here the applicant seeks to obtain a monopoly in exchange for his disclosure of a group of compounds there should be a disclosure which gives a reasonable assurance that all, or substantially all of them are useful.”).” slip op. at 29

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable

    “We find that the need for iterative QSAR modeling, together with the sheer number of candidate compositions that must be synthesized (each of which would take at least a week to make) for both the modeling and herbicide testing, weighs against enablement, especially in light of the limited guidance in the Specification and the general unpredictability in the art. 3. Conclusion In sum, it is undisputed that claim 1 covers at least a billion compounds. The art is unpredictable, and the Specification indicates that not all of the compounds falling within claim 1 are effective herbicides. See, e.g., Pet. 22 (listing compounds that showed no herbicidal activity). Although the level of ordinary skill in the art is relatively high and the field is mature, Petitioner establishes by a preponderance of the evidence that the ’202 patent does not provide sufficient meaningful guidance or working examples across the full scope of claim 1 to allow a person of ordinary skill in the art to determine which other compounds across the full scope of the claim have herbicidal activity without undue experimentation.” slip op. at 45

  Patent outcomesUS 10,294,202 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR
  Patents in suitUS 10,294,202
• Douglas Dynamics, L.L.C. / Douglas Dynamics, Inc. v. Meyer Products LLCSome claims unpatentable
  PTAB · Mar 1, 2017 · IPR2015-01839 · APJ Jacqueline T Harlow · IPR · Final written decision

  Claims 1, 2, 4–7, 28–31, 36, 38, 39, 43, and 44 are unpatentable under § 103(a); claims 8, 32, 33, and 48–54 were not shown unpatentable.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageTerm construed board ownDecided for patent owner

    “The disclosure of the ’829 patent is expressly addressed to the problem of, and a solution for, unreliable and vulnerable electrical connections caused by splicing auxiliary lights into OEM headlight wiring. The Background of the Invention explains that “[t]raditionally, the auxiliary lights were spliced into the existing wiring for the headlights of the vehicle.” slip op. at 11

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

    “As an initial matter, we observe that whether or not the preamble term “light circuit” is limiting has little bearing on the ultimate disposition of this inter partes review, as it is undisputed that Douglas has identified, for each asserted ground of unpatentability, disclosure of a light circuit. See PO Resp. 11–12. Furthermore, we agree with Douglas that “light circuit” does not connote any structure beyond that explicitly recited in the body of the claims. Indeed, it is unclear that either Meyer or Mr. Ricca disputes such conclusion. For example, Meyer states in its Patent Owner Response that” slip op. at 18

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner

    “As a general rule, the words “a” or “an” in a patent claim carry the meaning of “one or more.” Baldwin Graphic Sys., Inc. v. Siebert, Inc., 512 F.3d 1338, 1342–43 (Fed. Cir. 2008). That rule is particularly applicable 15 where, as here, those words are used in combination with the open-ended antecedent “comprising.” See, e.g., Abtox, Inc. v. Exitron Corp., 122 F.3d 1019, 1023 (Fed. Cir. 1997). “An exception to the general rule that ‘a’ or ‘an’ means more than one only arises where the language of the claims themselves, the specification, or the prosecution history necessitate a departure from the rule.” Baldwin Graphic, 512 F.3d at 1342–43. We discern no such exception here. First, Meyer has not identified, and we do not discern, any requirement in the language of the claims to support the conclusion that the recited “an auxiliary light connector to connect an auxiliary light” must be a single auxiliary light connector.” slip op. at 15

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

    “As set forth above, Möller explicitly teaches the incorporation of microprocessors and microcontrollers to improve relay-circuitry-based vehicle electronics systems. Ex. 1006, 4:41–48. Contemporaneous prior art 33 references, including Gould and COP8, disclose advantages obtained through the incorporation of microprocessors and microcontrollers into relay circuitry for controlling end devices, further underscoring that an ordinarily skilled artisan would have sought to modify the relay circuitry of Knepel with the microprocessors and microcontrollers of Möller. See Ex. 1010, 9, 11; Ex. 1011, 14. Moreover, Dr. Neuhalfen testifies, without challenge, that it was well-known at the time of invention of the ’829 patent to use microprocessors to control original vehicle lights, as well as auxiliary lights, and identifies numerous advantages that the proposed combination would afford. Ex. 1014 ¶ 59. Indeed, Meyer’s expert, Mr. Ricca, agrees that it would not have been difficult for an ordinarily skilled artisan to supplement the circuit of Knepel to provide microprocessor control of the relays in that circuit. Ex. 1033, 182:6–11. In view of the teachings of Möller itself, and the contemporaneous prior art, as well as the testimony of Dr. Neuhalfen and Mr. Ricca, we find that a person of ordinary skill in the art at the time of the invention would have recognized the value of using known elements, i.e., microprocessors and microcontrollers, as taught by Möller, to improve the relay circuitry for controlling original vehicle lights and auxiliary lights of Knepel. We likewise find that a person of ordinary skill in the art would have appreciated that the microprocessors of Möller could be incorporated into, i.e., used to supplement, the relay circuitry of Knepel. See KSR, 550 U.S. at 418 (an obviousness analysis “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account” slip op. at 33

  Patent outcomesUS 6,265,829 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,265,829
• Pharmacosmos A/S v. Luitpold Pharmaceuticals, Inc.Some claims unpatentable
  PTAB · Jan 4, 2017 · IPR2015-01490 · APJ Lora M Green · IPR · Final written decision

  Claims 1–3, 10–15, 23, 25, 27, 30, and 41–43 are unpatentable; claims 17 and 47 were not shown unpatentable; claims 28 and 29 were cancelled.

  RulingsFinal written decision

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

    “based on the complex as a whole, rather than just the carbohydrate component, as Fishbane related to iron dextran complexes. Reply 10. We agree with Petitioner that the language of the term “substantially non-immunogenic carbohydrate component” itself only requires an assessment of the immunogenicity of the carbohydrate component, and disagree with Patent Owner that the claims require an assessment of the immunogenicity of the iron carbohydrate complex as a whole. In that regard, we note that the Specification of the ’702 patent supports our construction that the “substantially non-immunogenic carbohydrate component” is limited to the carbohydrate component as opposed to the iron carbohydrate complex as a whole. Specifically, the Specification teaches in the background section that previously available iron dextran products suffered from a “high incidence of anaphylactoid reactions . . . believed to be caused by the formation of antibodies to the dextran moiety,” while “[o]ther parenteral iron products (e.g., iron sucrose and iron gluconate) do not contain the dextran moiety, and the incidence of anaphylaxis with these products is markedly lower.” Ex. 1001, 1:53–57; see also id. at 11:3‒4 (“non-immunogenic carbohydrate component; no cross reactivity with anti-dextran antibodies”). Moreover, the language of independent claim 1 itself does not require a non-immunogenic complex, but only specifies that the “iron carbohydrate complex has a substantially non-immunogenic carbohydrate component.” Moreover, we decline to limit the term “substantially non- immunogenic carbohydrate complex” to require an incidence level of lower than 0.6%. Rather, what is supported by the claim language and the Specification is a low risk such that the incidence of adverse events of the carbohydrate complex is lower than dextran. See, e.g., Tr. 53‒54 (counsel for Patent Owner acknowledging that Fishbane was not incorporated by reference, and that it was only cited as a “see generally”).” slip op. at 10

  • Skill levelOther

    “We do not find a significant different between the requirements for the ordinary artisan proposed by Petitioner and Patent Owner. We agree with Petitioner (Pet. 14) that the best evidence of the level of skill in the art are the references themselves, see Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001), and, thus, we need not explicitly adopt either Petitioner’s or Patent Owner’s characterization of the level of skill in the art. Moreover, we note that the result of the analysis regarding the patentability of the claims would be the same under the requirements for the ordinary artisan proposed by either Petitioner or Patent Owner.” slip op. at 12

  • Expert testimonyPetitioner expert creditedDecided for petitioner
  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableInherency foundUnpatentable

    “Petition (Pet. 22–27), we find that Petitioner has demonstrated by a preponderance of the evidence that Geisser teaches all the limitations of claim 1, either inherently or explicitly. That is, we agree with Petitioner that Geisser teaches a method of treating a disease characterized by an iron deficiency, specifically iron deficiency anemia (Pet. 23; Ex. 1003, Abstract, 1:4‒7, 2:4‒7, 9:30‒31). We further agree that Geisser teaches a method of administering an iron carbohydrate complex, that is, iron carboxymaltose, in a single dosage form of at least 0.6 grams of elemental iron, as Geisser teaches administering iron carbohydrate complexes as a single dose of 500‒ 1000 mg of iron. Pet. 23 (citing Ex. 1003, 1:26‒4:1, 8:7-10, 10:14‒17). In that regard, we credit the testimony of Dr. Linhardt that Geiser discloses iron carboxymaltose, and that Geisser describes a general synthetic method that is nearly identical to the method described in the ʼ702 patent. Ex. 1005 ¶¶ 8‒10, 13. In addition, as Geisser teaches one of the iron carbohydrate complexes explicitly recited by claim 1, that is, iron carboxymaltose, it would inherently meet the limitation that the carbohydrate component is substantially non-immunogenic and would have substantially no cross-reactivity with anti-dextran antibodies. In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (“Products of identical chemical composition can not have mutually exclusive properties.”). The teachings of Geisser support that finding, as Geisser specifically teaches that the complexes have low toxicity and a reduced danger of anaphylactic shock. Pet. 23 (citing Ex. 1003, 1:26‒ 2:1, 8:7‒10); see also Ex. 1001, 12:12‒14 (noting that as “[t]he iron carboxymaltose complex (e.g., VIT-45) generally does not contain dextran and [it] does not react with dextran antibodies.”).” slip op. at 18

  Patent outcomesUS 7,754,702 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,754,702
• Dermira, Inc. v. Purepharm, Inc.Some claims unpatentable
  PTAB · Dec 27, 2016 · IPR2015-01594 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–3 and 5–8 are unpatentable as anticipated by Hays or obvious over the listed combinations; claim 4 was not shown unpatentable for lack of a reason to add another sweating therapy.

  RulingsFinal written decision

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

    “In interpreting claim terms, the claims themselves provide substantial guidance. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Here, claim 1, from which claims 2–8 depend, recites the dosed amount of glycopyrrolate in solution as “an amount ranging from 3.0 wt. % to 4 wt. %.” Because claim 1 describes the dosed amount by the strength/concentration, it supports our conclusion that term “dosed amount” is not limited by the volume of the glycopyrrolate solution.” slip op. at 6

  • BurdenMixed

    “Petitioner may well be correct that preferring a non-anticholinergic does not necessarily exclude administering “another oral and/or topical therapy for reduction of sweating,” as required by challenged claim 4. Petitioner, however, does not point to any credible evidence or otherwise explain why an ordinary artisan would have chosen another therapy to reduce sweating to be administered in combination with glycopyrrolate. Without some articulated reasoning with rational underpinning as to why an ordinary artisan would have added a second therapeutic for reducing sweating to the transdermal patch of Bodor, which uses the anticholinergic to eliminate the formation of an aqueous layer between the delivery system and the skin to enhance the penetration of the transdermal drug being delivered, Petitioner has not met its burden of demonstrating that claim 4 20 would have been obvious over the combination of Bobrove and Bodor. See KSR, 550 U.S. at 418.” slip op. at 20

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

    “(citing Ex. 1009, 1821). Hays instructs that glycopyrrolate solutions should be carefully applied while avoiding the mouth, nose, and eyes. Id. (citing Ex. 1009, 1798, 1809). For example, it discloses applying a cotton applicator dipped in the glycopyrrolate solution to the skin while holding the hair up out the way to treat patients with gustatory sweating in the hairline. Id. at 31 (citing Ex. 1009, 1819). Dr. Guy testifies that an ordinary artisan would have understood the cotton applicator in Hays “as being any of a cotton ball, a cotton pad, a cotton swab, or having a cotton component as a part of a larger applicator.” Ex. 1003 ¶ 72. According to Hays, glycopyrrolate in concentrations of 0.5%, 1.0%, and up to 4% provided effective control of gustatory sweating with no significant side effects. Pet. 29 (citing Ex. 1009, 1819). Thus, we agree with Petitioner that Hays discloses each and every limitation of claim 1.” slip op. at 11

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundMotivation not foundMixed

    “Bobrove specifically teaches applying a “roll on” glycopyrrolate solution. Ex. 1008, 6:26–27, 6:36–37. It, however, also generally teaches that glycopyrrolate is administered topically. Id. at 4:1. Thus, one of ordinary skill in the art would have had a reason to look for other means to apply glycopyrrolate. As Dr. Guy testifies, “[t]here are a limited number of ways to topically deliver a drug to a patient’s skin.” Ex. 1003 ¶ 16. In addition, Bobrove suggests to avoid the eyes, nose, and mouth during the topical administration. Ex. 1008, 5:37–39. Given these considerations, Bodor provides an effective alternative: a cotton cloth to absorb the drug and rub it on the skin. Ex. 1030, 15:39–54; see also Ex. 1003 ¶ 17 (explaining that, at the time of the invention, an ordinary artisan would have known that use of medicated pads “allowed for topical application of a solution, for example to a subject’s face, while excluding application to sensitive areas such as the eyes or mucous membranes”). Thus, we conclude Petitioner has shown, by a preponderance of the evidence, that an ordinary artisan would have had a reason to combine the teachings of Bobrove and Bodor. In sum, Petitioner has shown, by a preponderance of the evidence, that an ordinary artisan would have had a reason to combine the teachings of Bobrove and Bodor, and that the combination teaches each and every limitation of claims 1 and 2. Claims 4, 5, and 8” slip op. at 19

  Patent outcomesUS 8,252,316 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 8,252,316
• Dermira, Inc. v. Purepharm, Inc.Some claims unpatentable
  PTAB · Dec 27, 2016 · IPR2015-01593 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–3 and 5–10 are unpatentable as anticipated by Hays or obvious over the stated combinations; claim 4 was not shown unpatentable for lack of a reason to add another sweating therapy.

  RulingsFinal written decision

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

    “In interpreting claim terms, the claims themselves provide substantial guidance. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Here, the challenged claims recite the dosed amount of glycopyrrolate in solution as “an amount ranging from 1.0 wt. % to 6 wt. %” (claim 1); “an amount ranging from 2.0 wt. % to 6.0 wt. %” (claim 9); and “an amount ranging from 2.0 wt. % to 4.0 wt. %” (claim 10). Because the claims describe the dosed amount by the strength/concentration, they support our conclusion that term “dosed amount” is not limited by the volume of the glycopyrrolate solution.” slip op. at 6

  • Skill levelSkill level board ownOther

    “The parties disagree over the level of ordinary skill.8 See Pet. 17–18; PO Resp. 3; Reply 9. For purposes of this Decision, we do not need to resolve this dispute because the prior art itself reflects an appropriate skill level. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 16

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “not qualify as one of ordinary skill in the art because he is not a clinician, physician, or pharmacist. PO Resp. 3–4. We disagree with Patent Owner on this issue. All asserted references relate to topical administration of pharmaceutical compositions. See, e.g., Ex. 1008, 4:1; Ex. 1010, 2:35–38; Ex. 1030, 3:60–61. In addition, the challenged ’524 patent relates to the topical delivery of glycopyrrolate to reduce excessive sweating and minimize side effects. Ex. 1001, Abstract, 1:13–21. Dr. Guy has over 30 years of experience in fields including topical drug delivery, transdermal” slip op. at 16

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

    “water base and a vanishing cream base in 0.5 to 1% concentration. It completely controls gustatory sweating for several days or more.” Pet. 30 (citing Ex. 1009, 1821). Hays instructs that glycopyrrolate solutions should be carefully applied while avoiding the mouth, nose, and eyes. Id. at 31 (citing Ex. 1009, 1798, 1809). For example, it discloses applying a cotton applicator dipped in the glycopyrrolate solution to the skin while holding the hair up out the way to treat patients with gustatory sweating in the hairline. Id. (citing Ex. 1009, 1819). Dr. Guy testifies that an ordinary artisan would have understood the cotton applicator in Hays “as being any of a cotton ball, a cotton pad, a cotton swab, or having a cotton component as a part of a larger applicator.” Ex. 1003 ¶ 90. According to Hays, glycopyrrolate in concentrations of 0.5%, 1.0%, and up to 4% provided effective control of gustatory sweating with no significant side effects. Pet. 31 (citing Ex. 1009, 1819). Thus, we agree with Petitioner that Hays discloses each and every limitation of claim 1.” slip op. at 11

  Patent outcomesUS 8,679,524 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 8,679,524

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.