• Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCSome claims unpatentable
  PTAB · Dec 6, 2022 · IPR2021-00856 · APJ Ryan H Flax · IPR · Final written decision

  Claims 1–15 are unpatentable over the asserted §103 grounds; claims 17–23 were not shown unpatentable.

  RulingsFinal written decision

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed

    “persuasive and credit Dr. Kang’s testimony that Freedman’s ablating laser is incompatible with laser surgery on the lens or lens capsule during cataract surgery. Ex. 2087 ¶¶ 49–51, 79–82. This is because the ablating laser cannot pass through the cornea to reach the lens without destroying the cornea in the process. Id. ¶¶ 79, 82. In contrast, lasers used to cut internal tissues of the eye use laser photodisruption. Id. ¶ 80. Accordingly, we find that one of ordinary skill in the art would not have used Freedman’s system to perform surgery on the lens or lens capsule, as asserted by Petitioner.” slip op. at 76

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “exhibit provides no context or rationale for the award and, as discussed above, the Catalys product is composed of many components and systems not specifically covered by the challenged claims. Ex. 2043, 3. Patent Owner points also to a report dated June 28, 2012, as evidencing that this award was for the specific features of the Catalys product claimed, but this evidence lacks any identification of the author and the portion identifying features of the product appears to merely be listing features thereof rather identifying than any reason for the award. Ex. 2040. Additionally, the evidence of praise cited by Patent Owner is not specific to the subject matter of claim 1 (and its dependent claims) of the ’724 patent, but general praise for the FLACS system and laser-guided femtosecond laser procedures. See Ex. 2035; Ex. 2037; Ex. 2044; Ex. 2051. For these reasons, we are not persuaded by Patent Owner’s arguments or evidence on industry praise.” slip op. at 51

  Patent outcomesUS 8,500,724 mixed
  § 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,500,724
• Medtronic, Inc. And Medtronic Vascular, Inc. v. Teleflex Life Sciences LimitedSome claims unpatentable
  PTAB · Feb 23, 2022 · IPR2020-01343 · APJ James A Tartal · IPR · Final written decision

  Claims 52 and 53 are unpatentable as anticipated by Ressemann; the other challenged claims were not shown unpatentable because Itou is not prior art.

  RulingsFinal written decision

  • ExcludeMotion to exclude, deniedDenied

    “Documents are authenticated by evidence “sufficient to support a finding that the item is what the proponent claims it is.” Fed. R. Evid. 901(a); see Fox Factory v. SRAM, LLC, IPR2016-01876, Paper 59 at 63 (PTAB Apr. 2, 2018) (quoting same). “Authenticity is, therefore, not an especially high hurdle for a party to overcome.” Fox Factory, Paper 59 at 63 (citing United States v. Patterson, 277 F.3d 709, 713 (4th Cir. 2002)). We determine that Exhibit 2024 has been authenticated under the low bar required under Federal Rule of Evidence 901 based on the evidence provided by Petitioner. See Mot. Opp. 2–11. In addition, Petitioner’s arguments go to the weight of the evidence and not its admissibility. Accordingly, we deny Petitioner’s Motion to Exclude. We note, however, that even if we were to exclude Exhibit 2024, it would not change the outcome or our general analysis of this case.” slip op. at 13

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person of ordinary skill in the art at the time of the invention would have been either: (1) a medical doctor who would have had “(a) a medical degree; (b) completed a coronary intervention cardiologist;” or (2) an engineer who would have had “(a) an undergraduate degree in engineering, such as mechanical or biomedical engineering; and (b) at least three years of experience designing medical devices, including catheters or catheter-deployable devices.” Pet. 13–14. Additionally, Petitioner contends “[e]xtensive experience and technical training might substitute for education, and advanced degrees might substitute for experience.” Id. at 14. Further, according to Petitioner, a person of ordinary skill in the art “with a medical degree” and a person of ordinary skill in the art “with an engineering degree” may have had access to each other. Id. (citing Ex. 1005 ¶ 31; Ex. 1042 ¶¶ 18–19). Patent Owner does not dispute Petitioner’s proposed level of ordinary skill. PO Resp. 5. We adopt Petitioner’s proposed level of ordinary skill in the art as it is undisputed and consistent with the level of skill reflected in the prior art and the specification of the ’116 patent. 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)).” slip op. at 17

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached

    “Petitioner proposes the following constructions: (1) “substantially rigid” as “rigid enough to allow the device to be advanced within the guide catheter,” (2) “side opening” needs no construction and should be given its plain and ordinary meaning, (3) “lumen” as “the cavity of a tube,” and (4) “flexural modulus” as “[a] measure of resistance . . . to bending.” 7 Patent Owner argues that Dr. Hillstead does not meet the definition of a person of ordinary skill in the art because he lacks a four-year undergraduate degree in engineering. PO Resp. 5 n.1 (citing, e.g., Ex. 2137, 462:8–13). As noted above, however, it is undisputed that “[e]xtensive experience and technical training might substitute for education.” Pet. 14. Patent Owner does not address Dr. Hillstead’s significant professional experience, which we find sufficient to show he is qualified to opine on the issues in this proceeding from the perspective of a person of ordinary skill in the art. See Ex. 1043 (curriculum vitae of Dr. Hillstead). does not dispute at this stage of the proceeding Petitioner’s proposed construction of these terms. See generally PO Resp. In view of the issues we address below, we determine it is not necessary to address the express interpretation of any claim term. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017); Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”).” slip op. at 19

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

    “Ressemann. Pet. 23–31. Petitioner provides a detailed explanation of how it contends Ressemann discloses each of the limitations of claims 52 and 53. Id. In particular, Petitioner explains how Ressemann’s disclosures of the use of features including guide catheter 160, evacuation sheath assembly 100, intermediate shaft portion 120, distal shaft portion 130, lumen 140, and stent delivery system 194 correspond to the recited methods of claims 52 and 53. Id. Petitioner’s contentions are supported by Dr. Brecker and Dr. Hillstead. Ex. 1005 ¶¶ 164–174; Ex. 1042 ¶¶ 36–39, 58–62. Patent Owner does not dispute that claims 52 and 53 are anticipated by Ressemann. See generally PO Resp; PO Sur-reply; see also Pet. Reply 2 (Petitioner arguing that Patent Owner did not dispute that Ressemann anticipates claims 52 and 53). After reviewing the record, we find Petitioner shows by a preponderance of the evidence that Ressemann discloses each limitations (Pet. 23–31) as our own findings. Accordingly, Petitioner shows by a preponderance of the evidence that Ressemann anticipates claims 52 and 53 of the ’116 patent.” slip op. at 26

  Patent outcomesUS RE46,116 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-02139 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable.

  RulingsFinal written decision

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted

    “Petitioner Samsung Bioepis Co., Ltd. (“Bioepis”) timely submitted a Petition presenting substantially the same challenges as set forth in Pfizer’s Petition along with a request for joinder to IPR2017-01488. IPR2017- 02139. Paper 1. We granted Bioepis’s Petition and associated request for joinder to this case. IPR2017-02139, Paper 11, 6–7.” slip op. at 3

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “B. Person of Ordinary Skill in the Art The parties propose similar definitions of a person of ordinary skill for the ’213 patent. See Pet. 15–16; Prelim. Resp. 18; PO Resp. 18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 8. Petitioners do not contest this definition in its Reply and we find no reason to revise our earlier determination.” slip op. at 11

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

    “variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Prelim. Resp. 18–19; PO Resp. 19. Patent Owner correctly points out that this “construction comes directly from the definition provided in the ’213 patent.” Prelim. Resp. 19 (citing Ex. 1001, 11:32–38). Petitioners expressly adopt this construction in their Reply. Pet. Reply 5–6. We do not agree, however, that the claims demand a consensus of “all” human immunoglobulins in the literal sense. Indeed, Petitioners point out that “the ‘consensus’ sequence used for the patent variants was generated using the most common residue at each position identified in [Kabat 198711].” Pet. Reply 15 (citations omitted). And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner. 11 Kabat et al., Sequences of Proteins of Immunological Interest: Tabulation and Analysis of Amino Acid and Nucleic Acid Sequences of Precursors, V- Regions, C-Regions, J-Chain, T-Cell Receptor for Antigen, T-Cell Surface Antigens β2-Microglobulin, Major Histocompatibility Antigens, Thy-1 Complement, C-Reactive Protein, Thymopoietin, Post-Gamma Globulin, and α2-Macroblobulin, 41–175 (4th Ed. 1987). Ex. 1052. See PO Resp. 47. Moreover, in a parallel proceeding involving the same patent, Patent Owner did not dispute that the reference to “all sequences” in the patent, “refer[s] to all known sequences and there’s no dispute . . . that was really synonymous with Kabat 1987.” See IPR2017-01374 Paper 82, Tr. 15:4–16:4; see Ex. 1202 ¶ 157; Ex. 2105 ¶¶ 24–25; Ex. 2107 ¶¶ 18–19; Ex. 1198, 56:20–61:24; Ex. 1199, 27:14–28:13, 29:25–36:2, 57:1–58:6, 115:7–17, 165:17–169:9. Indeed, in a similar parallel proceeding, counsel for Patent Owner acknowledged that the term “all human immunoglobulins” refers to “all reasonably available[,] all known at the time of the invention.” IPR2017-01373, Paper 83, 47:21–48:5. Accordingly, we adopt the parties’ proposed construction, with a clarifying modification, specifically, “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure, as set forth in Kabat 1987.”” slip op. at 13

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

    “lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient.” In our institution decision, we determined that this claim language “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” Dec. 10–12. Neither party disputes this interpretation. See PO Resp. 19; Pet. Reply 5–6. Consistent with claim 63’s express comparison between the immunogenicity of the claimed humanized antibody and that of its non-human parent, the Specification states that one object of the invention is to “to provide methods for the preparation of antibodies which are less antigenic in humans than non-human antibodies but have desired antigen binding and other characteristics and activities.” Ex. 1001, 4:24–28. The Specification similarly states that embodiments within the scope of the claims have “low immunogenicity,” or are designed to “minimize the potential immunogenicity of the resulting humanized antibody in the clinic.” Id. at 52:54–58, 61:56–61. Moreover, with reference to claim 63 in particular, Patent Owner points to the ’272 application as “explain[ing] that the purpose of humanizing antibodies using its consensus sequence approach is to reduce immunogenicity versus the non-human parent antibody. (Id., 6:24–30, 84:24–30.).” Prelim. Resp. 42 (citing Ex. 2032 (File History for U.S. Patent Application No. 07/715,272 (“the ’272 application”)); see also id. at 38 (indicating that the limitation is satisfied where “[o]nly 1 out of 885 patients experienced an immunogenic response . . . which was a substantial improvement over the murine 4D5 antibody”). In light of the above, we do not alter our prior determination that “[a] humanized antibody which lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient,” refers to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” slip op. at 14

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 6,407,213
• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-01488 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “B. Person of Ordinary Skill in the Art The parties propose similar definitions of a person of ordinary skill for the ’213 patent. See Pet. 15–16; Prelim. Resp. 18; PO Resp. 18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 8. Petitioners do not contest this definition in its Reply and we find no reason to revise our earlier determination.” slip op. at 11

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

    “variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Prelim. Resp. 18–19; PO Resp. 19. Patent Owner correctly points out that this “construction comes directly from the definition provided in the ’213 patent.” Prelim. Resp. 19 (citing Ex. 1001, 11:32–38). Petitioners expressly adopt this construction in their Reply. Pet. Reply 5–6. We do not agree, however, that the claims demand a consensus of “all” human immunoglobulins in the literal sense. Indeed, Petitioners point out that “the ‘consensus’ sequence used for the patent variants was generated using the most common residue at each position identified in [Kabat 198711].” Pet. Reply 15 (citations omitted). And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner.” slip op. at 13

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

    “humanized” (claims 1, 30, 62–64, 66, 79, 80); “and further comprising a Framework Region (FR) amino acid substitution at a site selected from the group consisting of” (claims 1, 30, 62, 63, 66, 79, and 80); “numbering system set forth in Kabat” (claims 1, 30, 62, 63, 66, 79, and 80); and “up to 3-fold more” (claim 65). Patent Owner does not dispute Petitioners’ proposed constructions, but asserts that “[n]o construction of those terms is necessary.” Prelim. Resp. 19; PO Resp. 19. On the present record, we agree with Patent Owner that the terms identified by Petitioners need not be construed to resolve the issues presently before us. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (instructing that claim terms need only be construed to the extent necessary to resolve the controversy). slip op. at 15

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner

    “substitutions, most being unrepresented in any ’272 embodiment.” Pet. Reply 8. We do not find Petitioners’ argument persuasive in light of Patent Owner’s evidence showing that the ’272 application discloses, inter alia, each of the framework substitutions recited in claims 12, 42, 60, 65, 71, 73– 74, and 79 (collectively, 66L, 71H, 73H, 78H, 93H), along with “a generalized scheme for humanizing any non-human antibody.” See PO Resp. 43–44 (citing Ex. 2032, 87–90, 93; Ex. 2041 ¶¶ 91–95).” slip op. at 19

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,407,213
• Celltrion, Inc. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-01374 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable because Kurrle and Queen 1990 were not prior art …

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “with respect to the ’213 patent. See Pet. 12–13; Prelim. Resp. 17–18; PO Resp. 17–18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 10–11. Petitioner does not contest this definition in its Reply and we find no reason to revise our earlier determination. We further note that the prior art itself demonstrates this level of 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 on 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)). C.” slip op. at 11

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

    “Patent Owner’s proposed construction derives from the ’213 patent’s definition of consensus sequence as “refer[ing] to an amino acid sequence which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Ex. 1001, 11:32–38. In the context of the patent as a whole, however, we do not understand the term to require a consensus of “all” human immunoglobulins in the literal sense because the embodiments in the patent were generated using the most common residue at each position identified in Kabat 1987.11 See id. at 10:34–63, 11:55–60; Ex. 2016 ¶¶ 25– 26. And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner. See PO Resp. 47. Moreover, at oral argument, Patent Owner did not contest Petitioner’s assertion that the reference to “all sequences” in the patent, “refer[s] to all known sequences and there’s no dispute . . . that was really synonymous with Kabat 1987.” Tr. 15:4–16:4.12 Accordingly, we adopt the parties proposed construction, with a clarifying modification, specifically, “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure, as set forth in Kabat 1987.”” slip op. at 13

  • Prior constructionDecided for patent owner

    “We previously stated that the language of claim 63, “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” IPR2017-01488, Paper 27 at 10–12. Patent Owner does not dispute this interpretation. See PO Resp. 19. Petitioner argues that the recited reduction in immunogenicity is both an inherent aspect of the claimed humanized antibodies, and “the stated goal of all humanization projects, including that of Queen 1990 and Kurrle.” Pet. Reply, 28, 43. Petitioner also contends that the term is not a claim limitation and “simply a statement of the intended result of the claimed compositions,” but, nevertheless, states: “For the purpose of the present petition only, Petitioner will assume that the preambles are limiting.” Pet. 13 n.3. On balance, we see no need to alter our prior determination that “[a] humanized antibody which lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient,” refers to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody. Nevertheless, to the extent Petitioner is correct that the preambles should be accorded no weight, such a determination would not alter the outcome of this proceeding.” slip op. at 15

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner

    “The ’213 patent issued from application number 08/146,206 (“the ’206 application”), which is an application that entered the national stage on November 17, 1993, from a PCT application filed on June 15, 1992. Ex. 1001, (21), (22), (86). The ’206 application is also a continuation-in-part of the ’272 application, filed on June 14, 1991. Id. at (63). Kurrle was published on December 19, 1990 (Ex. 1071, (43)), and Queen 1990 was published on July 26, 1990 (Ex. 1050, (43)), both of which predate the earliest possible priority date, June 14, 1991, shown on the face of the ’213 patent. Accordingly, Petitioner has satisfied its initial burden of showing that Kurrle and Queen 1990, on their face, qualify as prior art to the challenged claims. We next consider whether Patent Owner has antedated these references.” slip op. at 18

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,407,213
• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, IncSome claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-01489 · APJ Zhenyu Yang · IPR · Final written decision

  The Board held claims 1, 2, 4, 12, 25, 29–31, 33, 42, 60, 62–64, 66, 67, 69, 71, 73, 74, 78, 80, and 81 unpatentable as obvious; claims 65, 72, 75–77, and 79 were not …

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Level of Ordinary Skill in the Art In the Decision to Institute, we found the parties’ proposed definitions of a person of ordinary skill for the ’213 patent are similar. Dec. 7 (citing Pet. 16; Prelim. Resp. 17). We adopted Patent Owner’s proposed definition that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Id. During trial, Patent Owner points out that Petitioner’s proposed definition “encompasses persons without advanced degrees but who have ‘knowledge gained through 4–5 years of work experience.’” PO Resp. 17. A person of ordinary skill in the art is a hypothetical person who is presumed to know the relevant prior art. Custom Accessories, Inc. v. Jeffrey–Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). The artisan may gain such knowledge through either formal education or extensive work experience. Thus, we do not discern an appreciable difference in the parties’ respective definitions of the level of ordinary skill in the art, and any perceived distinction does not impact our Decision. Having considered the complete record developed at trial, we see no reason to change our assessment.” slip op. at 9

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

    “In the Decision to Institute, we agreed with Patent Owner that the ’213 patent expressly defined “consensus human variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Dec. 9–10; Ex. 1501, 11:32–38. During trial, the parties did not argue otherwise, and we see no reason to change our position as to claim construction. See PO 17–18; Reply 5. We, however, clarify that “all” in the consensus of “all human immunoglobulins” is not in the literal sense. In fact, Patent Owner does not appear to argue otherwise.7 Dr. Wilson, the expert witness for Patent 7 In a parallel proceeding involving the same patent, counsel for Patent Owner acknowledged that the term “all human immunoglobulins” refers to Owner, testified that the consensus sequence of the ’213 patent was “derived from ‘all’ known antibody sequences of any particular subclass or subunit structure.” Ex. 2041 ¶ 210 (emphasis added); see also PO Resp. 52 (arguing the same); Ex. 1698, 59:22–60:1 (Dr. Carter testifying that the consensus sequence, as defined in the ’213 patent, “only describes what was known at that time or it’s only available sequences at that -- at that time”); Ex. 1699, 35:9–16 (Dr. Presta explaining that the consensus sequence of the ’213 patent had the most common residue at every position “for the sequences that were available”). And evidence of record shows that at the priority date of the ’213 patent, the sequences that were listed in Kabat 1987 “were the sequences available.” Ex. 1699, 35:9–20; see also Ex. 2016 ¶ 25 (Kabat 1987 “collected known sequence data of antibodies”); Ex. 1698, 60:13–25 (Dr. Carter explaining the consensus sequence was derived from Kabat 1987, which is what was available at the time of the ’213 patent); Ex. 1699, 27:19–25 (Dr. Presta stating that “Elvin Kabat had taken all known human/mouse/rabbit antibody sequences, published them in a government publication, and that there were human subgroups of sequences within the heavy and the light chains”).” slip op. at 11

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

    “For the purpose of this Decision, we see no need to expressly construe any other claim terms. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating claim terms need only be construed to the extent necessary to resolve the controversy).” slip op. at 13

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

    “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. KSR, 550 U.S. at 421. Here, Queen 1989 recognizes the need to substitute framework residues in order to “reduce immunogenicity while retaining high binding affinity.” See Ex. 1534, 3. Thus, even if Queen 1990 is not available as prior art, we find that an ordinary artisan would have identified the candidates for substitution, as recited in claims 12, 42, 60, 71, 73, and 74. Indeed, Dr. Wilson testified that he performed a “good analysis” and identified 19 amino acid positions in the light chain and 19 in the heavy chain, including 66L (recited in claims 12 and 42), 73H (recited in claim 71), 78H (recited in claims 60 and 73), 93H (recited in claim 74). Ex. 1697, 242:4–6; Ex. 2041 ¶ 186, Appendix 1. Claims 12, 66, 67, 71, 73, 74, and 78” slip op. at 22

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,407,213
• Celltrion, Inc. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-01373 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1, 2, 4, 12, 25, 29–31, 33, 42, 60, 62–64, 66, 67, 69, 71, 73, 74, 78, 80, and 81 are unpatentable; claims 65, 72, 75–77, and 79 are not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedOther

    “Level of Ordinary Skill in the Art In the Decision to Institute, we found the parties’ proposed definitions of a person of ordinary skill for the ’213 patent are similar. Dec. 10 (citing Pet. 12; Prelim. Resp. 17). We adopted Patent Owner’s proposed definition that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Id. at 10–11. During trial, the parties did not dispute this finding. Having considered the complete record developed at trial, we see no reason to change our assessment. We further note that, in this case, the prior art itself demonstrates the level of 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)).” slip op. at 10

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

    “In the Decision to Institute, we agreed with Patent Owner that the ’213 patent expressly defined “consensus human variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Dec. 7; Ex. 1001, 11:32–38. During trial, the parties did not argue otherwise, and we see no reason to change our position as to claim construction. We, however, clarify that “all” in the consensus of “all human immunoglobulins” is not in the literal sense. Indeed, counsel for Patent Owner acknowledged that the term refers to “all reasonably available[,] all known at the time of the invention.” Tr. 47:21–48:5. Dr. Wilson, the expert witness for Patent Owner, testified that the consensus sequence of the ’213 patent was “derived from ‘all’ known antibody sequences of any particular subclass or subunit structure.” Ex. 2041 ¶ 207 (emphasis added); see also PO Resp. 52 (arguing the same); Ex. 1140, 59:22–60:1 (Dr. Carter testifying that the consensus sequence, as defined in the ’213 patent, “only describes what was known at that time or it’s only available sequences at that -- at that time”); Ex. 1142, 35:9–16 (Dr. Presta explaining that the consensus sequence of the ’213 patent had the most common residue at every position “for the sequences that were available”). And evidence of record shows that at the priority date of the ’213 patent, the sequences that were listed in Kabat 1987 “were the sequences available.” Ex. 1142, 35:9–20; see also Ex. 2016 ¶ 25 (Kabat 1987 “collected known sequence data of antibodies”); Ex. 1140, 60:13–25 (Dr. Carter explaining the consensus sequence was derived from Kabat 1987, which is what was available at the time of the ’213 patent); Ex. 1142, 27:19–25 (Dr. Presta stating that “Elvin Kabat had taken all known human/mouse/rabbit antibody sequences, published them in a government publication, and that there were human subgroups of sequences within the heavy and the light chains”). Thus, although we reiterate our previous construction of “consensus” slip op. at 11

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

    “For the purpose of this Decision, we see no need to expressly construe any other claim terms. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating claim terms need only be construed to the extent necessary to resolve the controversy).” slip op. at 13

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

    “combination of Queen 1989 and the PDB database, together with the knowledge of an ordinary artisan, teaches or suggests each limitation of claims 12, 63, 66, 67, 71, 73, 74, and 78, and that a person of ordinary skill in the art would have had a reason to combine the references, and would have had a reasonable expectation of producing humanized antibodies with the substitutions and properties recited in those claims. We further determine that evidence of secondary considerations is not sufficient to outweigh the strong evidence of obviousness associated with the other Graham factors. As a result, we conclude that Petitioner has established by a preponderance of the evidence that claims 12, 63, 66, 67, 71, 73, 74, and 78 are unpatentable over Queen 1989 and the PDB database.” slip op. at 37

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,407,213
• Merck Sharp & Dohme Corp. v. Wyeth LLCSome claims unpatentable
  PTAB · Jun 8, 2018 · IPR2017-00380 · APJ Erica A Franklin · IPR · Final written decision

  Claims 1–6, 10, 11, 14, 17, 19, and 20 are unpatentable as obvious over Prevenar and Chiron; claim 18 was not shown unpatentable.

  RulingsFinal written decision

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

    “Based on the record as a whole, we determine that the Specification sets forth with reasonable clarity, deliberateness, and precision the definition of the term “polysaccharide,” as accurately represented by Petitioner, and acknowledged by Patent Owner. With respect to the phrase “polysaccharide-protein conjugates,” the Specification does not provide a” slip op. at 9

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

    “similarly precise definition. However, the Specification generally describes such conjugates in a manner that is consistent with the plain and ordinary meaning of the phrase. For example, the Specification explains that polysaccharides are “chemically activated (e.g., via reductive amination) to make the saccharides capable of reacting with the carrier protein.” Ex. 1001, 17:35–37. The Specification also explains that “[c]arrier proteins should be amenable to standard conjugation procedures.” Id. at 17:47–50. In particular, the Specification states, “[t]he chemical activation of the polysaccharides and subsequent conjugation to the carrier protein (i.e., a polysaccharide-protein conjugate) are achieved by conventional means.” Id. at 17:43–45. Moreover, as Patent Owner asserts, the Specification describes the polysaccharide-protein conjugates as an example of an “immunogenic composition.” Ex. 1001, 1:29–30. In light of those Specification descriptions, we determine that the broadest reasonable construction of the claim phrase “polysaccharide-protein conjugates” refers to an immunogenic composition resulting from reacting any antigenic saccharide element (or antigenic unit) commonly used in the immunologic and bacterial vaccine arts, including, but not limited to, a saccharide, an oligosaccharide, a polysaccharide, a liposaccharide, a lipo-oligosaccharide, a lipopolysaccharide, a glycosylate, a glycoconjugate, and the like with a carrier protein that is amenable to standard conjugation procedures.” slip op. at 10

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “In the Institution Decision, we adopted Patent Owner’s description of the level of ordinary skill at that stage in the proceeding because it included a requirement for experience relating to polysaccharide-protein conjugates. Dec. Inst. 13. Based on the record as a whole, we determine that a declarant having significant experience relating to protein-silicone oil interactions also offers useful information relating to the subject matter of the challenged claims. Thus, we also recognize those having ordinary skill in the art relating to silicone-induced interactions/aggregation in pharmaceuticals. Thus, we adopt Patent Owner’s description of one having ordinary skill in the art of formulating polysaccharide-protein conjugate immunogenic compositions. Further, we describe one having ordinary skill in the art of silicone-induced interactions/aggregation in pharmaceuticals as either (a) a Ph.D. degree in the pharmaceutical sciences, physical chemistry or protein chemistry, at least two years of work experience involving researching silicone-induced interactions/aggregation in pharmaceuticals, or (b) a Master’s degree in the pharmaceutical sciences, physical chemistry or protein chemistry, at least four years of work experience involving researching silicone-induced interactions/aggregation in pharmaceuticals.” slip op. at 15

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “inadequately supported by the testimony of Drs. Morefield (Ex. 2121) and Thomson (Ex. 2124). The portions of the declarations of Drs. Morefield and Thomson relied upon by the Patent Owner do not refer to any evidence to support their opinions that a histidine buffer would not be a beneficial addition to the Prevenar formulation. Rather, those discussions sound of unsubstantiated theoretical concerns, and are speculative at best. At worst, certain of those theories has been refuted in the art. For example, Petitioner directs us to the testimony of one of its declarants, Dr. HogenEsch, who has a Ph.D. in Pathology and Immunology. Reply 13–16. Dr. HogenEsch explains persuasively that, contrary to the speculation of Drs. Morefield and Thomson, “histidine buffer had specifically been reported . . . not to interact with aluminum adjuvant through ligand exchange.” Ex. 1122 ¶ 43. In support of this testimony, Dr. HogenEsch quotes a disclosure from US Patent No. 6,251,678 B17 explaining that, although phosphate-containing buffers are generally not preferred because they may interact with aluminum adjuvants, “the non interaction of histidine . . . buffers with aluminum adjuvant was demonstrated by zeta potential measurements of the surface charge of the aluminum adjuvant.” Id. (quoting Ex. 1109, 3:24–30). We find that the unsupported testimony offered by Patent Owner’s declarants to be outweighed by rebuttal testimony from Dr. HogenEsch and the express disclosures by Chiron relied upon by Petitioner. Generally, as Petitioner and Dr. Kalonia note, Chiron teaches that buffers are a standard component of vaccines. Pet. 40; Ex. 1009 ¶ 128 (citing Ex. 1011, 1:6–7). More specifically, as Petitioner asserts, Chiron teaches that adding histidine buffer to aluminum-adjuvanted pneumococcal CRM197 conjugate formulations comprising a sodium salt is advantageously biocompatible and” slip op. at 23

  Patent outcomesUS 8,562,999 mixed
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,562,999
• Merck Sharp & Dohme Corp. v. Wyeth LLCSome claims unpatentable
  PTAB · Jun 8, 2018 · IPR2017-00378 · APJ Erica A Franklin · IPR · Final written decision

  Claims 1–6, 10, 11, 14, 17, 19, and 20 are unpatentable as obvious over Chiron, Smith, and Elan; claim 17 is also unpatentable with Peña. Claim 18 was not shown unpatentable.

  RulingsFinal written decision

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

    “claim term “polysaccharide” is set forth in the Specification. Pet. 37–42. In particular, the Specification defines “polysaccharide” as including “any antigenic saccharide element (or antigenic unit) commonly used in the immunologic and bacterial vaccine arts, including, but not limited to, a ‘saccharide’, an ‘oligosaccharide’, a ‘polysaccharide’, a ‘liposaccharide’, a ‘lipo-oligosaccharide (LOS)’, a ‘lipopolysaccharide (LPS)’, a ‘glycosylate’, a ‘glycoconjugate’ and the like.” Ex. 1001, 16:32–38. Patent Owner similarly acknowledges that the term “polysaccharide” is expressly defined in the Specification. PO Resp. 11.” slip op. at 7

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

    “In light of those Specification descriptions, we determine that the broadest reasonable construction of the claim phrase “polysaccharide-protein conjugates” refers to an immunogenic composition resulting from reacting any antigenic saccharide element (or antigenic unit) commonly used in the immunologic and bacterial vaccine arts, including, but not limited to, a saccharide, an oligosaccharide, a polysaccharide, a liposaccharide, a lipo-oligosaccharide, a lipopolysaccharide, a glycosylate, a glycoconjugate, and the like with a carrier protein that is amenable to standard conjugation procedures. Although we recognize that the claimed invention is directed toward an immunogenic composition, we also note that the claims do not recite any specific level of immunogenicity for the composition. The Specification explains that the invention “broadly relates to novel formulations which stabilize and inhibit precipitation of immunogenic compositions.” Ex. 1001, 2:53–55. The Specification describes aggregation as an indicator of physical/thermal stability of the immunogenic composition. Id. at 2:7–8. Breakdown of the composition to an undesired form (e.g., an aggregate) lowers the total concentration of the product. Id. at 1:43–46. Insofar as Patent Owner asserts that the claims require “measuring antigenicity to determine the extent of the loss of antigenicity due to silicone-induced aggregation,” as in Example 4 of the Specification, PO Resp. 14, we disagree. Although Example 4 discusses total antigenicity (and loss), the claims do not require the formulation to retain a particular degree of immunogenicity. Instead, the claims are directed to a formulation comprising a polysaccharide-protein conjugate, i.e., an “immunogen,” see, e.g., Ex. 1001, 14:19–23, wherein the formulation inhibits aggregation6 induced by the siliconized container means. The presence of a polysaccharide-protein conjugate confers the immunogenic element of the claim. While performing an immunoassay to measure loss of antigenicity, as in Example 4, may provide information regarding whether silicone-induced aggregation has occurred, such an assay is not required to meet the “protein-polysaccharide conjugate” element of the claim. Moreover, as explained in each example described in the Specification, the occurrence of aggregation/precipitation may be detected upon visual inspection. See, e.g., Ex. 1001, 27:6–11 (discussing visual inspection for precipitation).” slip op. at 10

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “In the Institution Decision, we adopted Patent Owner’s description of the level of ordinary skill at that stage in the proceeding because it included a requirement for experience relating to polysaccharide-protein conjugates. Dec. Inst. 12–13. Based on the record as a whole, we determine that a declarant having significant experience relating to protein-silicone oil interactions also offers useful information relating to the subject matter of the challenged claims. Thus, we also recognize those having ordinary skill in the art relating to silicone-induced interactions/aggregation in pharmaceuticals. Thus, we adopt Patent Owner’s description of one having ordinary skill in the art of formulating polysaccharide-protein conjugate immunogenic compositions. Further, we describe one having ordinary skill in the art of silicone-induced interactions/aggregation in pharmaceuticals as either (a) a Ph.D. degree in the pharmaceutical sciences, physical chemistry or protein chemistry, at least two years of work experience involving researching silicone-induced interactions/aggregation in pharmaceuticals, or (b) a Master’s degree in the pharmaceutical sciences, physical chemistry or protein chemistry, at least four years of work experience involving researching silicone-induced interactions/aggregation in pharmaceuticals. We also note that the applied prior art reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). We recognize each of Petitioner’s and Patent Owner’s declarants as qualified to provide the offered opinions on the level of skill and the knowledge of a person of ordinary skill in the art at the time of the invention with respect to formulating polysaccharide-protein conjugates and/or silicone-induced interactions/aggregation in pharmaceuticals. The relative weight that we assign such testimony, however, is subject to additional factors. See, e.g., Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,763 (Aug. 14, 2012) (“Opinions expressed without disclosing the underlying facts or data may be given little or no weight.”).” slip op. at 15

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “We credit Dr. Kalonia’s testimony that a skilled artisan would have used a siliconized container to store Chiron’s formulation with persuasive weight, as that testimony is supported by Smith’s disclosure, as discussed above. On the other hand, we find that Patent Owner’s assertions and the related opinions by its declarants, e.g., Drs. Morefield (Ex. 2120) and Thomson (Ex. 2123), that a person of ordinary skill would not have found it obvious to use siliconized containers to store Chiron’s formulations are inadequately supported. For example, Patent Owner relies upon Dr. Morefield’s testimony that a siliconized container would not have been used in Chiron’s Example 8 because (a) the example involved a saccharide stability study, and introducing a siliconized container would have injected an unknown parameter into the experiment, and (b) the data demonstrates that the formulation was highly unstable. PO Resp. 25 (citing Ex. 2120 ¶¶ 36–42). However, Dr. Morefield has not provided any evidence to suggest that a siliconized container represented an “unknown” parameter. Rather, as evidenced by Smith and Elan, it was a known parameter, with a known solution. Nor has Dr. Morefield accurately characterized the data disclosed in Chiron’s Example 8 as demonstrating Chiron’s formulation was “highly unstable.” Chiron expressly concludes from the data in Example 8 that “[f]ree saccharide levels are thus stable for at least 1 month at 2–8°C, before and after packaging,” and that stability issues arose for two formulations, MenW125 and Men Y, only “[u]nder thermal stress conditions.” Ex. 1011, 16:3–6.” slip op. at 27

  Patent outcomesUS 8,562,999 mixed
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,562,999
• Celanese International Corporation v. Daicel CorporationSome claims unpatentable
  PTAB · May 3, 2018 · IPR2017-00163 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1 and 3–14 are unpatentable under the stated § 103 grounds; claim 2 was not shown unpatentable because the cited level-control teaching did not establish its claimed flow-rate limitation.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “definition is off-base and inappropriate for this proceeding.” Id. We disagree. As an initial matter, challenged claim 1 includes multiple steps other than the “condensation step” and the “separation and recycling step.” Thus, we decline to discount Patent Owner’s proposed definition of the ordinary skill level merely because it includes experience with an anhydrous process. More importantly, it is undisputed that acetic anhydride, like acetic acid, is produced through carbonylation processes. See, e.g., Ex. 1005, 3:26–50; Ex. 1027, 116–17. In our view, an ordinary artisan having production experience for acetic anhydride falls squarely within Petitioner’s definition: one with a working knowledge of carbonylation processes.” slip op. at 10

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

    “In the Decision to Institute, we agreed with Petitioner and construed the term “buffering function” to mean “ability to temporarily retain.” Dec. 6–7. We also stated that there was no need to construe any other term expressly. Id. at 7. During trial, Patent Owner does not dispute these determinations. PO Resp. 3. Having considered the complete record developed at trial, we see no reason to change our interpretation of the claims.” slip op. at 8

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

    “Petitioner argues, and we agree, an ordinary artisan would have known that such fluctuating flow rates in a carbonylation process are economically disadvantageous. Pet. 27 (citing Ex. 1002 ¶¶ 80, 81). Indeed, Ochiai teaches “[w]hile a steady state of dry acetic acid product has been maintained from the distillation system per methanol feed rate, process inefficiency in the form of variable liquid levels and flow rates of the 26 intermediate process streams is economically disadvantageous.” Ex. 1009, 2:31–36. Patent Owner contends that an ordinary artisan would have understood the process inefficiencies referred to in Ochiai as limited to those in the reaction and flash evaporation steps, and not including inefficiencies in the decanter or in the condensation and separation steps. See id. at 35 (citing Ex. 2006 ¶¶ 120–122). We are not persuaded. As explained above, even though Ochiai focuses on the reactor and flasher, an ordinary artisan would have understood that the flow rates downstream of the flasher, including the overhead stream exiting the light ends column and into the decanter, would also fluctuate. See supra 18–19. Ochiai teaches it is important to “reduce variability of the flow rates of the intermediate streams relative to the methanol feed rate so as to improve process efficiency.” Ex. 1009, 4:5–9. Dr. Bhise testified, and we agree, that relative to the methanol feed, the overhead stream exiting the light ends column and into the decanter is an intermediate stream. See Ex. 1050, 136:10–15. As a result, an ordinary artisan would have understood that Ochiai suggests reducing the fluctuation of the overhead stream to improve process efficiency.” slip op. at 26

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

    “controlling the amount in the decanter, as evinced by its “repeated strong statements regarding the critical importance of concentration in an acetic acid production process.” PO Resp. 30–32. A reference teaches away “when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken” by the inventor. In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). A reference may not teach away even if a particular solution is not the preferred solution or is inferior to another solution. In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004). In this case, despite pointing out that level control may not detect, or at least not detect in a timely fashion, some undesirable conditions in the process, Hallinan describes level control “works reasonably well in ensuring quality control.” Ex. 1011, 6:11–16. Thus, we do not find the focus on concentration in the invention of Hallinan amounts to teaching away because it “does not criticize, discredit, or otherwise discourage” the use of level control. See In re Fulton, 391 F.3d at 1201; see also In re Mouttet, 686 F.3d 1322, 1334 (Fed. Cir. 2012) (explaining “just because better alternatives exist in the prior art does not mean that an inferior combination is inapt for obviousness purposes”). In sum, we agree with Petitioner that Hallinan teaches level controlling the decanter based on the fluctuating incoming flow rate, as recited in the wherein clause of claim 1. See Pet. 24–27.” slip op. at 24

  Patent outcomesUS 8,940,932 mixed
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,940,932

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.