• Stryker Corporation / Wright Medical Technology, Inc v. Osteomed LLCSome claims unpatentable
  PTAB · May 4, 2026 · IPR2021-01452 · APJ Sheridan K Snedden · IPR · Remand

  On remand, claims 6, 8, 9, 13, and 19 are unpatentable; claims 2–5, 11, 12, 17, and 18 were not shown unpatentable over Slater or Slater and Weaver.

  RulingsRemand decision

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

    “Accordingly, for the same reasons expressed by our previous decision addressing claim 8 of the ’085 patent, and the court’s analysis in Stryker, we conclude that Slater does not anticipate claims 2–5, 11, 12, 17, and 18 of the ’716 patent because Slater deliberately describes a variable angle hole that lacks a single predetermined angle—that is, Slater describes a transfixation screw hole that does not have a central axis defining the trajectory.” slip op. at 14

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

    “In its Petition, Petitioner contends that Weaver discloses the limitations in claim 6 and that it would have been obvious to add Weaver’s features to Slater’s plate to provide a more secure fixation between the screws and the plate. Pet. 36–39; Ex. 1002 ¶¶ 188–196. Specifically, Petitioner contends that configuring Slater’s transfixation screw hole (claim 6) or at least one of Slater’s attachment points (claim 8) as a threaded screw hole to lockably engage the head of a locking screw would have been an obvious design choice “because locking screws ‘provide a high resistance to shear or torsional forces’ and reduce the incidence of screw loosening.” Pet. 39 (quoting Ex. 1009, 1:57–58); Ex. 1009, 1:46–48; Ex. 1002 ¶¶ 191– 196. Petitioner otherwise relies on its anticipation analysis for claim 1 discussed above. Pet. 36.” slip op. at 18

  Patent outcomesUS 9,763,716 mixed
  § 102 anticipation§ 103 obviousness
  Patents in suitUS 9,763,716
• Stryker Corporation / Wright Medical Technology, Inc. v. Osteomed LLCSome claims unpatentable
  PTAB · May 4, 2026 · IPR2021-01450 · APJ Sheridan K Snedden · IPR · Remand

  On remand, claims 6, 8–10, 14, and 17 are unpatentable; claims 2–5, 12, and 13 were not shown unpatentable, based on anticipation by Slater and obviousness over Slater and Weaver.

  RulingsRemand decision

  • RemandMixed

    “Appeals for the Federal Circuit. The court issued its decision in Stryker Corp. v. OsteoMed LLC, No. 2023-1925, 2025 WL 2814019 (Fed. Cir. Oct. 3, 2025) (“Stryker”) (Paper 49),1 affirming-in-part, reversing-in-part, vacating and remanding-in-part our Final Written Decision (Paper 46) for further proceedings. In its opinion, the Federal Circuit reversed our finding of no anticipation as to independent claims 1 and 11 of U.S. Patent No. 8,529,608 B2 (“the ’608 patent,” Ex. 1001), and vacated and remanded for further proceedings to evaluate whether dependent claims 2–6, 8–10, 12–14, and 17 (the “Remanded Claims”) are similarly unpatentable in view of Petitioner’s challenges relying on the Slater reference. Stryker, slip op. at 14–15. We have jurisdiction under 35 U.S.C. § 6. We issue this Final Written Decision on Remand pursuant to 35 U.S.C. §§ 144, 318 and 37 C.F.R. § 42.73 in an inter partes review involving Stryker Corporation and Wright Medical Technology, Inc. (collectively, “Petitioner”) and OsteoMed LLC (“Patent Owner”). For the reasons discussed below, after considering the entirety of the record in light of the Federal Circuit’s directives in Stryker, we find by a preponderance of the evidence that claims 6, 8–10, 14, and 17 are unpatentable. We also conclude that Petitioner has not demonstrated, by a preponderance of the evidence, that claims 2–5, 12, and 13 are unpatentable.” slip op. at 2

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

    “Accordingly, for the same reasons expressed by our previous decision addressing claim 8 of the ’085 patent, and the court’s analysis in Stryker, we conclude that Slater does not anticipate claims 2–5, 12, and 13 of the ’608 patent because Slater deliberately describes a variable angle hole that lacks a single predetermined angle—that is, Slater describes a transfixation screw hole that does not have a central axis defining the trajectory.” slip op. at 13

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

    “limitations in claim 6 and that it would have been obvious to add Weaver’s features to Slater’s plate to provide a more secure fixation between the screws and the plate. Pet. 37–39; Ex. 1002 ¶¶ 161–169. Specifically, Petitioner contends that configuring Slater’s transfixation screw hole (claim 6) or at least one of Slater’s attachment points (claim 8) as a threaded screw hole to lockably engage the head of a locking screw would have been an obvious design choice “because locking screws ‘provide a high resistance to shear or torsional forces’ and reduce the incidence of screw loosening.” Pet. 39 (quoting Ex. 1009, 1:57–58); Ex. 1009, 1:46–48; Ex. 1002 ¶¶ 162– 163. Petitioner otherwise relies on its anticipation analysis for claim 1 discussed above. Pet. 37. Patent Owner raised no separate argument regarding the patentability of claims 6 and 8, instead relying solely on its argument that Slater does not anticipate independent claim 1, on which claims 6 and 8 depend. PO Resp. 46; Reply 4 (“Patent Owner does not challenge the combination of Slater and Weaver for claims 6 and 8.”). We have reviewed Petitioner’s arguments and evidence as to the undisputed limitations of claims 6 and 8 and find that Petitioner establishes that the combination of Slater and Weaver discloses all of the limitations of claims 6 and 8, and that one of ordinary skill in the art would have been motivated to combine Slater and Weaver for the reasons provided by Petitioner. We adopt Petitioner’s arguments and evidence as to these limitations as our own. See Pet. 37–39.” slip op. at 19

  Patent outcomesUS 8,529,608 mixed
  § 102 anticipation§ 103 obviousness
  Patents in suitUS 8,529,608
• Stryker Corporation / Wright Medical Technology, Inc. v. Osteomed LLCSome claims unpatentable
  PTAB · May 4, 2026 · IPR2021-01451 · APJ Sheridan K Snedden · IPR · Remand

  On remand, claims 6, 8, 9, and 13 were held unpatentable; claims 2–5, 11, and 12 were not shown unpatentable because Slater lacks the claimed central axis.

  RulingsRemand decision

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableUnpatentableMixed

    “addressing the ’085 patent and by the court’s analysis in Stryker, we conclude that Slater does not anticipate claims 2–5, 11, and 12 of the ’776 patent because Slater deliberately describes a variable angle hole that lacks a single predetermined angle—that is, Slater describes a transfixation screw hole that does not have a central axis defining the trajectory.” slip op. at 13

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

    “In its Petition, Petitioner contends that Weaver discloses the limitations in claim 6 and that it would have been obvious to add Weaver’s features to Slater’s plate to provide a more secure fixation between the screws and the plate. Pet. 36–39; Ex. 1002 ¶¶ 169–74. Specifically, Petitioner contends that configuring Slater’s transfixation screw hole (claim 6) or at least one of Slater’s attachment points (claim 8) as a threaded screw hole to lockably engage the head of a locking screw would have been an obvious design choice “because locking screws ‘provide a high resistance to shear or torsional forces’ and reduce the incidence of screw loosening.” Pet. 39 (quoting Ex. 1009, 1:57–58); Ex. 1009, 1:46–48; Ex. 1002 ¶¶ 169– 74. Petitioner otherwise relies on its anticipation analysis for claim 1 discussed above. Pet. 36.” slip op. at 17

  • RemandOther

    “Appeals for the Federal Circuit. The court issued its decision in Stryker Corp. v. OsteoMed LLC, No. 2023-1925, 2025 WL 2814019 (Fed. Cir. Oct. 3, 2025) (“Stryker”) (Paper 49),1 affirming-in-part, reversing-in-part, vacating and remanding-in-part our Final Written Decision (Paper 46, “FWD”) for further proceedings. In its opinion, the Federal Circuit reversed our finding of no anticipation as to independent claims 1 and 10 of U.S. Patent 9,351,776 B2 (“the ’776 patent,” Ex. 1001), and vacated and remanded for further proceedings to evaluate whether dependent claims 2–6 and 8, 9 and 11–13 (the “Remanded Claims”) are unpatentable in view of Petitioner’s challenges relying on the Slater reference. Stryker, slip op. 14– 15.” slip op. at 2

  Patent outcomesUS 9,351,776 mixed
  § 102 anticipation§ 103 obviousness
  Patents in suitUS 9,351,776
• Stryker Corporation / Wright Medical Technology, Inc. v. Osteomed LLCSome claims unpatentable
  PTAB · Mar 15, 2023 · IPR2021-01453 · APJ Richard H Marschall · IPR · Final written decision

  Claims 1–7 are unpatentable: Slater anticipates claims 1–3, 6, and 7, and Slater with Weaver renders claims 4 and 5 obvious; claims 8 and 9 remain patentable.

  RulingsFinal written decision

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “summarized above, we determine that Patent Owner has the better position. First, we agree with Patent Owner that Petitioner’s reliance on the new declaration from Dr. Holmes goes beyond the bounds of permissible argument and evidence in reply. See PO Sur-reply 11–14. The 23-page declaration goes into detail as to how a surgeon would use Falkner’s plate when spanning two bones. See Ex. 1028 ¶¶ 20–36. While some of these opinions are certainly responsive to Patent Owner’s arguments and the testimony of Mr. Sommers, much if not all of the material could have been included with the Petition. Falkner contains readily apparent shortcomings when it comes to its two-bone embodiment because it devotes only a sentence, and no figures, to this possibility. See Ex. 1006 ¶ 21. Petitioner should have foreseen the potential shortcomings of Falkner as an anticipatory reference and included a declaration from Dr. Holmes with the Petition. See Consolidated Trial Practice Guide (Nov. 2019) (“CTPG”), 73 (“Petitioner may not submit new evidence or argument in reply that it could have presented earlier, e.g. to make out a prima facie case of unpatentability.”), 74–75 (“It is also improper for a reply to present new evidence (including new expert testimony) that could have been presented in a prior filing.”). Without the supporting testimony of Dr. Holmes, Petitioner’s arguments in its Reply lack adequate support and Patent Owner’s arguments in its Response are largely unrebutted.” slip op. at 51

  • Strike new argumentNew argument disregardedDecided for patent owner

    “summarized above, we determine that Patent Owner has the better position. First, we agree with Patent Owner that Petitioner’s reliance on the new declaration from Dr. Holmes goes beyond the bounds of permissible argument and evidence in reply. See PO Sur-reply 11–14. The 23-page declaration goes into detail as to how a surgeon would use Falkner’s plate when spanning two bones. See Ex. 1028 ¶¶ 20–36. While some of these opinions are certainly responsive to Patent Owner’s arguments and the testimony of Mr. Sommers, much if not all of the material could have been included with the Petition. Falkner contains readily apparent shortcomings when it comes to its two-bone embodiment because it devotes only a sentence, and no figures, to this possibility. See Ex. 1006 ¶ 21. Petitioner should have foreseen the potential shortcomings of Falkner as an anticipatory reference and included a declaration from Dr. Holmes with the Petition. See Consolidated Trial Practice Guide (Nov. 2019) (“CTPG”), 73 (“Petitioner may not submit new evidence or argument in reply that it could have presented earlier, e.g. to make out a prima facie case of unpatentability.”), 74–75 (“It is also improper for a reply to present new evidence (including new expert testimony) that could have been presented in a prior filing.”). Without the supporting testimony of Dr. Holmes, Petitioner’s arguments in its Reply lack adequate support and Patent Owner’s arguments in its Response are largely unrebutted.” slip op. at 51

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that one of ordinary skill in the art would have “at least a bachelor’s degree in engineering with at least two years of experience in the field, such as experience with the design of surgical implants, or a clinical practitioner with a medical degree and at least two years of experience as an orthopedic surgeon.” Pet. 10 (citing Ex. 1002 ¶¶ 35–39). Patent Owner does not dispute Petitioner’s proposal. See PO Resp. 20. We adopt Petitioner’s asserted level of ordinary skill because it is consistent with the problems identified and solutions provided in the ’085 patent and the prior art.” slip op. at 9

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

    “Having considered the parties’ positions and evidence of record, we determine that we need not expressly construe any claim term to resolve any of the challenges we consider in this Decision. 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 10

  Patent outcomesUS 10,245,085 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,245,085
• 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
• Neste Oil Oyj v. Reg Synthetic Fuels, LLCSome claims unpatentable
  PTAB · Jul 26, 2017 · IPR2013-00578 · APJ Christopher L Crumbley · IPR · Remand

  Claims 1, 3, 4, and 8 are unpatentable as anticipated by Craig; claims 2 and 5 are not proven unpatentable because Dindi is not prior art.

  RulingsRemand decision

  • RemandDecided for patent owner

    “To remove Dindi as a prior art reference, the record must establish either: (1) a conception and reduction to practice before the filing date of Dindi; or (2) a conception before the filing date of the Dindi patent combined with diligence and reduction to practice after that date. See Taurus IP, LLC v. DaimlerChrysler Corp., 726 F.3d 1306, 1323 (Fed. Cir. 2013). The Federal Circuit held that the record before us establishes, with sufficient corroboration, that Mr. Abhari conceived of the invention of claims 2 and 5 of the ’804 patent on April 29, 2008. REG Synthetic Fuels, 841 F.3d at 963. It is undisputed that Dindi was filed on June 13, 2008, and that Mr. Abhari filed on December 4, 2008 the application that issued as the ’804 patent. Dindi is not prior art—and, therefore, Neste’s ground of unpatentability fails—if either: (1) Mr. Abhari actually reduced to practice the invention of claims 2 and 5 between April 29 and June 13, 2008, or (2) Mr. Abhari exercised reasonably continuous diligence between June 13 and December 4, 2008, when the invention was constructively reduced to practice by filing of a patent application. Because, as set forth below, we find sufficient evidence of actual reduction to practice, we do not address Mr. Abhari’s alleged diligence.” slip op. at 5

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedNot shown unpatentableNot shown unpatentable

    “To remove Dindi as a prior art reference, the record must establish either: (1) a conception and reduction to practice before the filing date of Dindi; or (2) a conception before the filing date of the Dindi patent combined with diligence and reduction to practice after that date. See Taurus IP, LLC v. DaimlerChrysler Corp., 726 F.3d 1306, 1323 (Fed. Cir. 2013). The Federal Circuit held that the record before us establishes, with sufficient corroboration, that Mr. Abhari conceived of the invention of claims 2 and 5 of the ’804 patent on April 29, 2008. REG Synthetic Fuels, 841 F.3d at 963. It is undisputed that Dindi was filed on June 13, 2008, and that Mr. Abhari filed on December 4, 2008 the application that issued as the ’804 patent. Dindi is not prior art—and, therefore, Neste’s ground of unpatentability fails—if either: (1) Mr. Abhari actually reduced to practice the invention of claims 2 and 5 between April 29 and June 13, 2008, or (2) Mr. Abhari exercised reasonably continuous diligence between June 13 and December 4, 2008, when the invention was constructively reduced to practice by filing of a patent application. Because, as set forth below, we find sufficient evidence of actual reduction to practice, we do not address Mr. Abhari’s alleged diligence.” slip op. at 5

  • ExcludeNot reached

    “As noted above, the Federal Circuit vacated our decision on Neste’s Motion to Exclude as to Exhibits 2012, 2013, 2057, and 2062, for further consideration of the hearsay objections in light of the decision on appeal, “because [they] may be relevant for diligence and reduction to practice.” REG Synthetic Fuels, 841 F.3d at 965. Upon review, however, we have determined that we need not rely on any of the exhibits in question to reach our decision in REG’s favor. For this reason, Neste’s objections to the exhibits are moot, as we would have found against Neste on the merits regardless of the outcome of the Motion.” slip op. at 19

  Patent outcomesUS 8,231,804 mixed
  § 102 anticipation
  Patents in suitUS 8,231,804
• Oxford Nanopore Technologies Ltd. v. University Of Washington And Uab Research FoundationSome claims unpatentable
  PTAB · Feb 26, 2016 · IPR2014-00513 · APJ Francisco C Prats · IPR · Final written decision

  Claim 10 is unpatentable as obvious over the ’782 patent and Butler; anticipation of claim 10 by Butler and claims 17–18 by the Wong Poster or Wong Abstract was not shown.

  RulingsFinal written decision

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

    “substances, including ions. Ex. 1001, 8:45–49. Nonetheless, to detect an analyte, claim 1, from which claim 10 depends, requires its practitioner to compare (1) a first measured ion current obtained from the first liquid medium suspected of containing the analyte, with (2) a second measured ion current, obtained “without an analyte present,” that is, a known control containing no analyte. Id. at 103:42. As claim 1 states, the presence of the analyte is indicated by a reduction in the first measured ion current of 5% or more for at least 1.0 microsecond, as compared to the second measured ion current level without an analyte present. Id. at 103:40–44. Thus, as Patent Owner contends (PO Resp. 3–4), if the ions forming the first and second measured ion currents were considered “analytes,” the comparison required by claim 1, and its dependent claim 10, could not be performed, because removing the current-forming ions to prepare a sample “without an analyte present” (as recited in claim 1) would make it impossible to measure the ion current necessary to perform the required comparison. This conclusion is consistent with Examples 2, 3, and 6 of the ’550 patent, each of which is described as comparing ion current blockades “with and without [a]nalyte” (Ex. 1001, 41:55, 42:27, 45:49), yet each of which uses an ion-containing buffer including potassium and chloride ions to generate the measured current (id. at 41:15–16 (describing all ion conductance experiments as being performed in 1M KCl, 10 mM Hepes/KOH buffered at pH 8)). Accordingly, we conclude that, consistent with the Specification of the ’550 patent, the broadest reasonable interpretation of the term “analytes” in claim 10 encompasses only those substances detectable by measuring a reduction in ion current of 5% or more for at least 1.0 microsecond, as compared to an ion current level for the Msp without an analyte present, and does not encompass the ions forming the measured ion current, or other buffer components present in the liquid media used in the analyte detection process.” slip op. at 11

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “As discussed above, we agree with Patent Owner that the term “analytes” in claim 10 does not encompass the ions that produce the ion current that is measured in the claimed process. Petitioner does not dispute 9 Declaration of Steven A. Benner, Ph.D. (Declaration executed Dec. 5, 2014) (Ex. 2003; “Benner Declaration” or “Benner Decl.”). Patent Owner’s contention that the potassium ions in Butler’s experiments form the ion current that Butler measured. See Reply 1–6. Moreover, we discern no error in Patent Owner’s assertion, and supporting testimony of its witness, Dr. Benner, that Butler’s system is essentially identical to the system described in Examples 2, 3, and 6 of the ’550 patent, all of which use the potassium ions to generate the measured ion current. Accordingly, we agree with Patent Owner that the term “analytes” in claim 10 does not encompass the potassium ions in Butler’s experiments. Because Petitioner relies on the potassium ions in Butler’s experiments, along with the DNA in those experiments, as corresponding to the plurality of different analytes required by claim 10 (see Pet. 29), we agree with Patent Owner that Petitioner has not shown that Butler describes a process which includes all of the features of claim 10. We conclude, therefore, that Petitioner has not shown by a preponderance of the evidence that Butler anticipates claim 10 of the ’550 patent.” slip op. at 13

  • Strike new argumentNew argument disregardedDecided for patent owner

    “As provided in 37 C.F.R. § 42.23(b), a “reply may only respond to arguments raised in the corresponding opposition or patent owner response.” Thus, “a reply that raises a new issue or belatedly presents evidence will not be considered and may be returned.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,767 (Aug. 14, 2012). One indication that a new issue has been raised in a reply is where a petitioner submits “new evidence necessary to make out a prima facie case” of unpatentability of an original claim. Id. In contrast, where evidence submitted in support of a reply responded only to contentions presented in a Patent Owner response, and was not relied upon or necessary to the prima facie case of unpatentability, our reviewing court found no abuse of discretion by the Board in admitting the reply evidence. Belden Inc. v Berk-Tek LLC, 805 F.3d 1064, 1077–79 (Fed. Cir. 2015). Here, Petitioner contends that, in advancing its new contentions, its Reply merely responds to Patent Owner’s argument that the only substance in Butler’s liquid media that would be considered an analyte is the single stranded DNA tested by Butler. Reply 5, n.3; see also id. at 4 (citing Ex. 2003 ¶ 17 (Benner Decl.)). It might be true that Patent Owner’s Response argued that the DNA tested by Butler was the only analyte encompassed by claim 10. The basis for that argument, however, was Patent Owner’s response to contentions and evidence raised by Petitioner in its Petition. Specifically, Patent Owner responded that the potassium ions identified in the Petition as the second analyte were not reasonably considered “analytes” under the broadest reasonable construction of claim 10 consistent with the Specification. See PO Resp. 2–9. In its Reply, Petitioner now raises an entirely novel theory of unpatentability, a theory Patent Owner would not have addressed in its Response, as it was not raised in the Petition. We are not persuaded that presenting this novel theory of unpatentability, distinct from that originally presented in its Petition, truly responds to Patent Owner’s arguments about the reasonableness of considering potassium ions “analytes” as that term is used in claim 10. Rather, because the Reply presents new evidence in an effort to raise a new theory of anticipation, we conclude that the Reply exceeds its proper scope. See Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,767 (Aug. 14, 2012).” slip op. at 15

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable

    “To show that Butler anticipates claim 10, Petitioner must show that Butler discloses “every limitation of the claimed invention, either explicitly or inherently.” In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). Petitioner contends that, in addition to the dA50 molecules Butler tested, Butler also discloses two types of contaminants in its experiments that would be considered “analytes”: (1) divalent and trivalent ions, and (2) less than full-length oligonucleotides. Reply 5. Petitioner has not shown sufficiently that Butler explicitly or inherently discloses that those substances were present in the DNA experiments cited by Petitioner. As to the alleged divalent and trivalent ion impurities, Butler states only that “[i]f these hypothetical contaminant molecules are present in the dA50 aliquots that we add to the cis compartment, then we would observe the correlation between increased blockade rate and the presence of dA50.” Ex. 1003, 107 (emphasis added). Butler’s hypothetical guess at potential causes of ion current blockades does not equate to an explicit disclosure of the presence of those contaminants in its experiments. Moreover, because Butler’s disclosure, at best, suggests that such contaminants might possibly have been present, Butler does not inherently disclose the presence of those contaminants. See Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (“The very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question.”) (emphasis added); In re Oelrich, 666 F.2d 578, 581 (CCPA 1981) (“Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.”).” slip op. at 17

  Patent outcomesUS 8,673,550 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,673,550

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.