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  • PTAB · Nov 4, 2024 · IPR2023-00894 · APJ Robert A Pollock · IPR · Final written decision

    Claims 1–10 and 12–15 are unpatentable; claim 11 was not shown unpatentable. Substitute claims 16–25 and 27–30 are unpatentable over Mazur; claim 26 was not reached.

    RulingsFinal written decision
    • BurdenMixed

      “It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.’” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (quoting 35 U.S.C. § 312(a)(3)). Here, however, not until its Reply does Petitioner belatedly suggest that Ferrante’s disclosure of bone screws with self-tapping ends equally meets the limitation of claim 10 (with respect to the first member) as with claim 11 (with respect to the second member), and that both claims are obvious in light of “evidence” from Ferrante “that it was well known to equip bone screws with self-tapping ends.” Reply 26–27. We do not discern these arguments in the Petition, and consider them waived. See Netflix, Inc. v. DivX, LLC, 84 F.4th 1371,1377 (Fed. Cir. 2023) (“While the Board should not take an overly mechanistic view of a petition and decline to address an argument because the petitioner did not present it with ideal vigor and clarity, the Board should also not have to decode a petition to locate additional arguments beyond the ones clearly made.”). In sum, Petitioner’s error in failing to first address limitations of claim 10 in the Petition specific to the Cognet/Ferrante combination indicates a failure to meet the particularity requirements for what must be in the petition and cannot be left to be filled in on reply. See 35 U.S.C. § 312(a)(3); 37 C.F.R. §§ 42.22(a)(2) (requiring, among other things, “a detailed explanation of the significance of the evidence”), 42.104(b)(4)–(5) (requiring that petition “specify where each element of the claim is found in the prior art patents or printed publication relied upon” and, regarding submitted evidence, state “the relevance of the evidence to the challenge raised, including identifying specific portions of the evidence that support the challenge”). Microsoft, 2022 WL 989403, at *6. Accordingly, Petitioner has not shown persuasively that claim 11 would have been obvious in light of Cognet and Ferrante for the reasons set forth in the Petition. slip op. at 41

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “We also find persuasive Mr. Dominguez’s explanation that one of ordinary skill in the art would have understood “bore” as including stepped diameter holes, sometimes described as a bore having a counterbore. See generally Ex. 1018 ¶¶ 4–29; Reply 3–10. Three of Mr. Dominguez’s illustrative examples are reproduced in the annotated figures below. The above figures show Mr. Dominguez’s annotated illustrations from the Jackson (Ex. 1019, Fig. 3), Brånemark (Ex. 1021, Fig. 4), and Ray (Ex. 1025, Fig. 1) references as discussed at paragraphs 10, 12, and 13, respectively, of Mr. Dominguez’s Second Declaration. With reference to the above figures, Mr. Dominguez testifies that “Jackson describes a bone repair set screw in which ‘[t]he bore 27 comprises a first bore section 31, a second bore section 32,’ etc. delineated by shoulders 41, 42, etc. (Ex. 1019, 5:24– 43)” (Ex. 1018 ¶ 10); “Brånemark describes an osseous implantation device having body 1ʺ with first and second holding portions 21ʺ, 31ʺ and ‘an inner through bore with a first portion 4ʺ in the first holding portion and a second portion 5ʺ in the second holding portion.’” Ex. 1021, 4:44–46” (id. ¶ 12); and Ray discloses surgical calipers including “handle 12 having ‘stepped cylindrical bore 14,’” wherein “[c]ollar 20 of a shaft inserted in the bore ‘rests against a step of the bore 14’ (2:14–15)” (id. ¶ 13). Patent Owner responds that Mr. Dominguez’s examples “that allegedly show a single bore encompassing two or more stepped-diameter holes or a counterbore . . . . are specific to these references and divorced from the disclosures of the ’166 patent.” Sur-Reply 7. Insofar as the ’166 patent makes no mention of the term “bore” outside the claims, and Mr. Dominguez’s examples are all taken from the field of orthopedic surgery, we do not find this argument persuasive. Patent Owner further appears to contend that exemplary references to a “cylindrical stepped down bore” or a “stepped cylindrical bore” are too specific to be within the scope of the term “bore.” Sur-Reply 7–8. As these terms merely describe species within a larger genus, and Patent Owner presents no cogent reason to exclude them, we do not find this argument availing. Relatedly, we are also not persuaded by Patent Owner’s argument that “the prior art treats a ‘bore’ as an element that is distinct from a ‘counterbore.’” Id. at 8. Rather, we credit Mr. Dominguez’s testimony that “[a] counterbore is not a structure unto itself, a counterbore is part of a larger structure” as exemplified by numerous examples including Laps (Ex. 1028 ¶ 33 (sensor assembly wherein “bore 16 includes a counterbore 18”)); Martinez (Ex. 1029, 3:61 (surgical cutting instrument wherein “bore 56 has a counterbore 64”)); Zang (Ex. 1030, 2:49 (bone anchor having a “bore [that] includes a counterbore”)); Ledet (Ex. 1022, 29:3–5 (vertebral fixation plate having “through holes . . . . countersunk, or counterbored to accommodate the head of a bone screw”)); Seo (Ex. 1031, 3:45 (chair leg employing “counterbored bore 23”)); and Exner (Ex. 1032, 2:16 (extrusion press including “counterbored axial bore 6”)). Ex. 1018 ¶¶ 17–23. That a reference may refer to a figure as showing “bore 103” with “counterbore 105 . . . formed on one end” does not indicate that they are distinct structures as Patent Owner contends, but merely that the focus of each term is directed to the entire bore or to a particular aspect of the bore, i.e., its counterbore. See” slip op. at 22

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner subsequently proposed an alternative definition, as a person having “[a] Bachelor’s Degree in biomedical and/or mechanical engineering or similar training and . . . at least three years of experience with implant devices used for internal fixation of bones.” POR 5 (citing Ex. 2012 ¶¶ 32–33). According to Patent Owner, “[t]his hypothetical person would be capable of performing various design tasks and would understand the basic mechanical features and operation of orthopaedic implant devices [and] have an appreciation for orthopaedic fusion techniques and the medical issues and concerns faced by a doctor/surgeon charged when performing operations to implant orthopaedic devices.” Id. Despite some differences in wording, Patent Owner asserts (and Petitioner does not contest) that any “distinction between the parties’ proposed definitions of a POSITA does not affect the arguments set forth herein.” Id. (citing Ex. 2012 ¶ 34). Consistent with this view, we find the parties’ constructions equally applicable in light of the prior art of record and the disclosure of the ’166 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). We adopt, for convenience, Petitioner’s definition, but our analysis does not change depending on which of the two articulations are applied here. H.” slip op. at 12

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

      “one of ordinary skill in the art would understand that “bore,” as used in the context of claims 1 and 12, encompasses a multi-diameter passage, and in particular, one having stepped longitudinal cross sections such as that shown in Cognet’s Figure 1. See generally DI 11–13. For the reasons that follow, we conclude that one of ordinary skill in the art would have understood “bore” as such. Relying on the testimony of Mr. Dominguez, Petitioner initially proposed a construction of “bore” as “a usually cylindrical hole made by or as if by the turning or twisting movement of a tool.” Pet. 16 (citing Ex. 1002 ¶ 58). Petitioner’s proposal relied on Mr. Dominguez’s testimony that “[a] bore is a cylindrical hole made by the spinning rotation of a twist drill cutting tool. It is typically made by removing material from a solid or hollow object, similar to a tunnel or orifice.” Ex. 1002 ¶ 58. Pointing to its annotation of Cognet’s Figure 1, above, Patent Owner argued that that the term “bore” excludes a tunnel made by “two adjacent bores.” See Prelim. Resp. 21–25. In view of the then-available evidence, we provisionally construed “bore” as a hole or passage made by or as if by the turning or twisting movement of a tool such that its interior walls have cylindrical lateral cross-sections, and which do not exclude holes or passages having tapered or stepped longitudinal cross-sections. DI 13.” slip op. at 19

    Patent outcomesUS 11,298,166 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
    Patents in suitUS 11,298,166
  • PTAB · Jul 5, 2023 · PGR2022-00023 · APJ Robert A Pollock · PGR · Final written decision

    The Board held claims 2, 3, 5, 14, 26, 27, and 30 unpatentable for lack of written description, but did not find claims 1, 6, and 25 unpatentable.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for patent owner

      “We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology and cancer biology, which would encompass the blood cancers recited by Patent Owner. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). We find that Dr. Gordon and Dr. Sharman are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art, based on either party’s definition. Ex. 1020, ¶¶ 8– 19; Ex. 2008, ¶¶ 11–24.” slip op. at 7

    • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

      “We find Dr. Sharman’s statements and deposition testimony have substantially greater credibility than Dr. Gordon’s statements and deposition testimony based on Dr. Sharman’s significantly greater relevant experience in treatment and study of hematological cancers using chemotherapeutic agents and based on Dr. Sharman’s superior recollection and more complete analysis of the record found in the ’942 patent. In particular, we found Dr. Gordon’s statement that no example “includes” every element of claim 1 factually incorrect as contradicted by at least Figure 2 of the ’942 patent where the ordinary understanding of includes to mean encompasses is used. See Ex. 1020 ¶ 131. Ebit Sys. Am., LLC v. Thales Visonix, Inc., 881 F.3d 1354, 1358 (Fed. Cir. 2018) (“The PTAB [i]s entitled to weigh the credibility of the witnesses ....”).” slip op. at 16

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

      “The parties do not identify any issue relating to the preamble that needs to be addressed to resolve the sole written description challenge and the parties do not dispute that the transitional term “comprising” is “inclusive or open-ended and does not exclude additional, unrecited elements or method steps.” Georgia-Pacific Corp. v. US. Gypsum Co., 195 F.3d 1322, 1327 (Fed. Cir. 1999). We therefore find that there are no terms that need claim construction. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 8

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateWritten description inadequateMixed

      “We find that Figure 2 of the ’942 patent and the associated example provide literal and express descriptive support for claim 1 of the ’942 patent. As descriptive support for claim 1, the ’942 patent teaches treatment of leukemia or lymphoma, including chronic lymphocytic leukemia and small lymphocytic lymphoma (Ex. 1001, 16:21–22), by orally administering the Bcl-2 inhibitor GDC-0199 (Ex. 1001, 17:16) in escalating doses of 50 mg per day during a first week and 100 mg per day during a second week (Ex. 1001, Figure 2). Claim 1 of the ’942 patent, as written, does not exclude performance of the complete combination therapy shown in Figure 2. Rather, the reasonable understanding of the term “comprising” in claim 1 encompasses monotherapy with GDC-0199 alone and combination therapy with obinutuzumab. Both embodiments are described in the Specification. As Patent Owner points out, the ’942 Specification is replete with disclosures to administer GDC-0199 by itself to a patient, stating” slip op. at 16

    Patent outcomesUS 10,993,942 mixed
    Claim construction§ 112 disclosure
    Patents in suitUS 10,993,942
  • PTAB · Feb 9, 2023 · IPR2021-01324 · APJ Cynthia M Hardman · IPR · Final written decision

    Claims 1, 2, and 7–17 are unpatentable under §102 or §103; claims 3–6 and 18–20 were not shown unpatentable.

    RulingsFinal written decision
    • Expert testimonyPetitioner expert discountedDecided for patent owner

      “in Table 1 and the formulations of Potta claim 21 (i.e., ‘from about 0.1% w/w to about 15% w/w epinephrine or a salt thereof’), because such formulations would elicit the desired biological or medicinal response.” Ex. 1002 ¶ 272. Dr. Weinstein provides an essentially identical opinion. Ex. 1003 ¶ 286. Neither declarant supports their opinion with any explanation as to why the Potta formulations would provide the claimed plasma epinephrine concentration or elicit a biological or medicinal response. Accordingly, we do not credit these opinions, and determine that Petitioner has not met its burden to establish that Potta inherently anticipates claim 3. See n re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”).” slip op. at 29

    • ExcludeMotion to exclude, deniedDenied

      “As the moving party, Petitioner bears the burden of establishing that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). Having considered the arguments and evidence of record, we determine that Petitioner has not met its burden of proof. We agree with Patent Owner that “[n]o bright line rule prohibits the consideration of post-priority date evidence,” and that such evidence is permissible in certain contexts. Opp. 2–3. On this record we do not find that there is sufficient cause to exclude the challenged exhibits, because any consideration by the Board of these exhibits has taken into account their alleged post-priority date status. Thus, we do not find that maintaining the exhibits in this proceeding results in any unfair prejudice to Petitioner, or that the exhibits have confused the issues before us. Accordingly, we deny Petitioner’s motion to exclude.” slip op. at 73

    • Skill levelOther

      “II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8

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

      “For the above reasons, on the full trial record we determine that” slip op. at 26

    Patent outcomesUS 10,682,414 mixed
    § 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,682,414
  • PTAB · Jun 4, 2020 · IPR2019-00337 · APJ Linda E Horner · IPR · Final written decision

    Claims 9, 10, and 13 were held unpatentable as obvious; claims 11 and 12 were not shown unpatentable.

    RulingsFinal written decision
    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedReference is prior artDecided for petitioner

      “The existence of a published abstract that would have allowed one skilled in the art exercising reasonable diligence to locate the foreign patent application and the fact that the application was classified and indexed in the patent office, were central to the Wyer court’s conclusion that the application was “publicly accessible.”” slip op. at 35

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

      “inherency, then the assertions of obviousness are mere conclusory statements. We are unable to recognize any proffered reasoning underlying the assertions of obviousness. “[Challenges] on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). As yet another possible alternative, Petitioner may be basing its case on improper hindsight by relying on and quoting the Specification of the ’240 patent in its obviousness analysis. See Pet. 27. That, too, is unpersuasive. Regardless as to its theory of the case, we determine that Petitioner has failed to explain sufficiently why the claimed heat pipe having a configuration of two plates having bonded together circumferential edge lips would have been obvious. Accordingly, Petitioner has not shown by a preponderance of the evidence that claim 12 is unpatentable over Morikawa alone.” slip op. at 55

    • ExcludeMotion to exclude, deniedMixed

      “as not relevant under FRE 104 on the grounds that Petitioner failed “to introduce sufficient proof that Exhibit 1004 was publicly accessible such that it qualifies as a prior art printed publication under United States law.” Paper 46, 3; see also id. at 4 (citing Fed. R. Evid. 104, 401). As set forth in section II.D, above, the evidence of record leads us to an entirely different conclusion regarding Nakamura’s prior art status. Because Petitioner persuades us that Nakamura qualifies as a prior art printed publication as of the earliest possible effective filing date of the challenged claims of the ’240 patent, we deny Patent Owner’s request on its merits.” slip op. at 82

    Patent outcomesUS 7,066,240 mixed
    § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 7,066,240
  • PTAB · Jun 4, 2020 · IPR2019-00144 · APJ Linda E Horner · IPR · Final written decision

    Claims 9–12 were not shown unpatentable; claim 13 was shown unpatentable as obvious over Nakamura and Takahashi.

    RulingsFinal written decision
    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

      “The existence of a published abstract that would have allowed one skilled in the art exercising reasonable diligence to locate the foreign patent application and the fact that the application was classified and indexed in the patent office, were central to the Wyer court’s conclusion that the application was “publicly accessible.”” slip op. at 36

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

      “made using related processes, however, says nothing about why one of ordinary skill in the art would combine them in a manner that renders the claimed subject matter obvious. See Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1368 (Fed. Cir. 2012) (quoting Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 n.3 (Fed. Cir. 2008) (“We must still be careful not to allow hindsight reconstruction of references to reach the claimed invention without any explanation as to how or why the references would be combined to produce the claimed invention.”)). Petitioner’s argument that the references are “similar and analogous” is not adequate reasoning, by itself, to support a conclusion of obviousness.” slip op. at 54

    • ExcludeMotion to exclude, deniedMixed

      “as not relevant under FRE 104 on the grounds that Petitioner failed “to introduce sufficient proof that Exhibit 1004 was publicly accessible such that it qualifies as a prior art printed publication under United States law.” Paper 46, 3; see also id. at 4 (citing Fed. R. Evid. 104, 401). As set forth in section II.D, above, the evidence of record leads us to an entirely different conclusion regarding Nakamura’s prior art status. Because Petitioner persuades us that Nakamura qualifies as a prior art printed publication as of the earliest possible effective filing date of the challenged claims of the ’240 patent, we deny Patent Owner’s request on its merits.” slip op. at 73

    Patent outcomesUS 7,066,240 mixed
    § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 7,066,240
  • 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
  • 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
  • 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
  • PTAB · Jan 8, 2018 · IPR2016-01434 · APJ Michael W Kim · IPR · Final written decision

    Claims 11–13 and 15–20 are unpatentable as obvious; claim 14 was not shown unpatentable because the cited personal notes were not “content contributed.”

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “While the parties use slightly different language, we are unable to discern any substantive differences between the proffered levels of skill and basic qualifications of a person of ordinary skill in the art. Accordingly, we adopt Dr. Papakonstantinou’s articulation of the level of ordinary skill as our own, if for no other reason then for its conciseness, with the understanding that the differences between the proffered levels of ordinary skill are limited and inconsequential in our analysis.” slip op. at 23

    • Expert testimonyPetitioner expert creditedPatent owner expert creditedDecided for patent owner

      “above-identified single statement in the specification, which uses permissible language such as “can be” and “does not need to be,” is sufficient to justify Patent Owner’s assertions, which for all practical purposes, is a disavowal of claim scope. See Home Diagnostics, Inc. v. LifeScan, Inc., 381 F.3d 1352, 1358 (Fed. Cir. 2004) (“Absent a clear disavowal in the specification or the prosecution history, the patentee is entitled to the full scope of its claim language.”) We also credit the testimony of Dr. Almeroth over that of Dr. Papakonstantinou, because, among other reasons, Dr. Almeroth supports his testimony with relevant citations to the specification, while Dr. Papakonstantinou largely repeats that which is set forth in the Patent Owner Response, without further analysis. graphical fields that allow the input of administrative information without programming” are advantageous over “cumbersome programming performed in the past.” Ex. 2002 ¶¶ 44, 47. We treat this argument as subsumed within Patent Owner’s argument that the specification disparages prior art systems that require HTML programming to perform administrative tasks.” slip op. at 16

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

      “224, 232 encompasses a “link to content.” In application, however, “what is a wireless LAN?” 224, 232 is actually two separate components: (1) the underlying technical set of computer instructions that, upon clicking the link associated with “what is a wireless LAN?” 232, transports a user to a web page associated with “what is a wireless LAN?” 232; and (2) the words “what is a wireless LAN?” 224 itself displayed on the computer display, but separate from the technical set of computer instructions set forth in (1). In this example, (1) is “link to content, but not itself ‘content,’” however, (2) is itself “content.” More precisely, when we now consider “what is a wireless LAN?” 224, 232 in relation to the aforementioned construction of “content” as “electronic data embodying information for an individual or individuals,” it becomes clear that “what is a wireless LAN?” 224, 232 is both “links to content” and “content.” Specifically, component (1) of “what is a wireless LAN?” 232 is “links to content,” but not “content” itself, because the underlying technical set of computer instructions is not “electronic data embodying information for an individual or individuals,” but for a computer. By contrast, component (2) of “what is a wireless LAN?” 224 is “content,” as it is clearly “electronic data embodying information for an individual or individuals,” in that the words “what is a wireless LAN?” are intended to convey information to an individual. So, as a practical matter, we discern that every disclosure of a “link to content” that includes “electronic data embodying information for an individual or individuals” (i.e., any information associated with a “link” that is separate from a generic indication of the “link” itself), is “content.” See also Ex. 3001, 6–16 (providing further analysis concerning construction, which we expressly incorporate herein). Accordingly, we determine that a proper construction of “content” is “electronic data embodying information for an individual or individuals,” and excluding “links to content,” but not excluding “content” associated with the “links to content.”” slip op. at 10

    • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageTerm construed petitioner constructionDecided for petitioner

      “We agree with Petitioner. We are persuaded that “administrative interface” is broader than the “administrative page” mentioned in the specification, in that an “administrative interface” may encompass 9 While discussing “graphical user interface” during oral argument, Patent Owner stated that it was not disclaiming claim scope. Tr. 47:20–22 (“We’re not arguing that the claim terms have been disclaimed in some phrase.”). something other than an “administrative page.” We are also persuaded that the specification’s disclosure of a non-limiting embodiment, that of a highlyautomated and browser-based “administrative page,” does not require that a proper construction of “administrative interface” include “graphical user interface.” As admitted by Patent Owner, these pages are “example[s]” only, and, at best, merely “impl[y]” the presence of a “graphical user interface.” See PO Resp. 8–9 (citing Ex. 1002, 16:39–44; Ex. 2002 ¶ 40). We are persuaded that an “implied example” does not belong in a proper construction of a claim term. Indeed, Petitioner asserts that Patent Owner’s factual premise, concerning the above “implied example,” is flawed, as the specification’s “reference to automation and a browser provides no basis for restricting the claimed ‘administrative interface’ to a graphical user interface.” Pet. Reply 5–6 (citing Ex. 1033 ¶ 15) (Dr. Almeroth testifies that “automation of computer systems does not require a graphical user interface.”). More specifically, Dr. Almeroth identifies other automated “interfaces” in the specification, such as “a networked cash register, bar code scanner or electronic product code reader” (Ex. 1002, 13:8–15, 14:51–52) that do not require a “graphical user interface.” Ex. 1033 ¶ 14. We agree with Dr. Almeroth’s analysis of the specification. Dr. Almeroth asserts further, and we agree, again, that “[o]ne of ordinary skill would understand that that cash register could be connected to a server that is accessible only via a command line interface, and that administrators could use command-line tools . . . to group content on that server.” Ex. 1033 ¶ 14. Patent Owner cites In re Abbott Diabetes Care, Inc., 696 F.3d 1142, 1149–1150 (Fed. Cir. 2012) for its finding of an implicit definition of a” slip op. at 13

    Patent outcomesUS 7,516,177 mixed
    Claim construction§ 103 obviousnesscites KSR
    Patents in suitUS 7,516,177
  • PTAB · Sep 1, 2015 · CBM2014-00088 · APJ William V Saindon · CBM · Final written decision

    Claims 1, 2, 16, 18, 22, 25, 26, 29, 36, 38–43, 50, 51, 55, 62, and 63 are unpatentable as anticipated by Campbell; the remaining instituted claims were not shown unpatentable.

    RulingsFinal written decision
    • ExcludeMotion to exclude, deniedDecided for petitioner

      “B. Patent Owner’s Motion to Exclude Patent Owner moves to exclude Exhibits 1062–1065, filed by Petitioner on April 7, 2015, over two months after Petitioner filed its Reply and 22 days before oral hearing. PO Mot. Excl. 2–3. Petitioner characterizes its submission as “supplemental information” and “apologizes for its oversight” of the “minor procedural defect” of not seeking authorization to file a motion for supplemental information. Pet. Opp. Mot. Excl. 2. We dismiss as moot Patent Owner’s Motion to Exclude because we hereby order the expungement of Exhibits 1062–1065 for being filed without prior authorization.” slip op. at 8

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

      “before (Jack Henry CBM, Paper 17, 9–10).6 PO Resp. 21–22. Patent Owner notes that, if we do not adopt that construction, it will “abide by the Board’s decision.” Id. at 21. We decline to adopt the district court construction, a construction previously considered and not adopted, in the absence of arguments explaining why we should adopt that construction, and in the presence of a statement that Patent Owner will abide by our construction should we not choose to adopt that construction. Upon consideration of the record before us, we maintain that the broadest reasonable interpretation of “subsystem identification information” is “information that identifies a subsystem.”” slip op. at 11

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

      “With a full record, we find that the preponderance of the evidence supports Petitioner’s position. Campbell does not state that only the image is encrypted. Instead, Campbell states that “information [is] encrypted . . . to provide security for the images transported.” Ex. 1019, 5:55–58 (emphasis added). Thus, Campbell uses the terms information and image to refer to different collections of data. Earlier in that column, Campbell also explains what it means by “information,” and it is clear that this information is not just images but rather includes “information [that] accompan[ies] those images.” Id. at 5:25–26 (emphasis added). For example, the information identifies the “sending institution,” “receiving institution,” and “the disposition of the check.” Id. at 5:26–31. As we discussed in a prior claim construction of this term, we are persuaded that information identifying the sending institution is a SSID. See Jack Henry CBM, Paper 37, 8–11. Thus, when this information is encrypted, it is an encrypted SSID, as required by claim 1. See also Ex. 1003 ¶¶ 64–65, 78–84, 91 (Petitioner’s Declarant, Dr. Knox, testifying that the encrypted information in Campbell identifies the receiving institution). Patent Owner argues that Campbell discloses that the controller may be configured to handle encrypted information, which means that it “does not necessarily encrypt subsystem information” and that encryption is not “necessarily always . . . accomplished.” PO Resp. 32–34.14 Patent Owner does not provide an explanation as to how this, even if true, would preclude anticipation: Campbell would still disclose encrypted SSIDs if it disclosed the encryption as a capability but not a necessity of the system. Kalman v. Kimberly-Clark Corp., 713 F.2d 760, 772 (Fed. Cir. 1983) (“The law of anticipation does not require that the reference ‘teach’ what the subject patent teaches. . . . . [I]t is only necessary that the claims under attack, as construed by the court, ‘read on’ something disclosed in the reference, i.e., all limitations of the claim are found in the reference, or ‘fully met’ by it”); see also Pet. Reply 5–6 (arguing that there is no requirement that the prior 14 Later in its Response, Patent Owner argues that, although Campbell may “encrypt the name of th[e] bank,” Campbell does not “encrypt[] identification information that identifies a particular subsystem of the . . . Bank.” PO Resp. 48–49. Thus, Patent Owner appears to recognize that in fact Campbell discloses encrypting the name of the bank (while disputing that the name is sufficient to be a SSID). art mandate the use of a disclosed feature). Notwithstanding, we disagree that Campbell only occasionally encrypts SSIDs, for the reasons explained in the prior paragraph. Reviewing the record before us, we are persuaded that Campbell discloses transmitting an encrypted SSID.” slip op. at 17

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “relay network over a telecommunications company network. Ex. 1002, 12:50–61. Patent Owner’s Declarant, Mr. Ginsberg, acknowledges that Campbell describes transmission of signals over a public switched telephone network, but states that “the ‘central offices’ are not described as being remote from the receiving bank.” Ex. 2004 ¶ 22. Mr. Ginsberg appears to be discussing the portion of Campbell where it describes the signals 16 “Wide Area Network (WAN)[:] A data communications network that covers geographically separated areas, typically containing cities. Thus a WAN is usually composed of Local Area Networks (LAN) interconnected by other communications links hired from a PTT or other common carrier.” Focal Dictionary of Telecommunications (1999) available at http://search.credoreference.com/content/entry/bhfidt/wide_area_network_w an/0 (Ex. 3002). produced by the sending bank being transmitted on network access lines 22 to reach telephone network 10 and, more specifically, that “[t]he signals received by the network on line 22 may be transmitted through the network 10 via . . . one or more central offices to the check image processing node 12.” Ex. 1019, 3:17–43. Mr. Ginsberg does not explain how this passage supports his conclusion. Whether the “central offices” (not relied on by Petitioner for this claim) are remote to the sending bank has no bearing, which we can see, on whether Campbell describes a WAN. Campbell describes transmission of information between the sending bank and the node over a public switched telephone network; it is that communication that Petitioner asserts occurs over a WAN. See Pet. Reply 11–12; Pet. 30–31. A public switched telephone network covers geographically distinct locations. One of ordinary skill in the art would understand that transmitting information over such a network generally involves the sender and receiver being in different locations; likewise, the system of Campbell makes little sense if the banks and the node are all in the same location.17 Accordingly, Mr. Ginsberg’s testimony on this point is unpersuasive. On the other hand, Petitioner’s Declarant, Dr. Knox, explains how the Campbell system uses a public switched telephone network and a frame relay network, which Dr. Knox testifies is a type of WAN. Ex. 1003 ¶ 158. This testimony is persuasive, under its own reasoning and because, as” slip op. at 21

    Patent outcomesUS 6,032,137 mixed
    Claim construction§ 102 anticipation
    Patents in suitUS 6,032,137
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