• Cooler Masters Co., Ltd. v. Aavid Thermalloy LLCSome claims unpatentable
  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
• Neptune Generics, LLC v. Corcept Therapeutics, Inc.No claims unpatentable
  PTAB · Feb 10, 2020 · IPR2018-01494 · APJ David Cotta · IPR · Final written decision

  Claims 1–7 were not shown unpatentable under any asserted § 103 ground because the evidence did not establish the claimed serum-level testing and dose adjustment would have been obvious.

  RulingsFinal written decision

  • BurdenDecided for patent owner

    “In an inter partes review . . . , the petitioner shall have the burden of proving a proposition of unpatentability by a preponderance of the evidence.” 35 U.S.C. § 316(e); In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016). Petitioner has not met this burden here because the Petition does not clearly articulate why an optimization rationale would have led the skilled artisan to “adjust[] the daily dose of the patient to achieve mifepristone blood levels greater than 1300 ng/mL.” slip op. at 14

  • Skill levelSkill level petitioner adoptedOther

    “Petitioner contends that the person of ordinary skill in the art (“POSA”) would have: either a Pharm. D. or a Ph.D. in organic chemistry, pharmacy, pharmacology, or a related discipline; or a Bachelor’s or Master’s degree in organic chemistry or a related field with at least four years of experience relating to the study of pharmacokinetics or dosing of drugs, their detection and quantification, or their metabolism. Pet. 12. Patent Owner does not challenge Petitioner’s definition. Accordingly, we accept Petitioner’s definition, which is consistent with the level of skill reflected in the asserted prior art references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 9

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

    “Although the parties propose constructions for several claim terms (Pet. 12–15; PO Resp. 17–18), we determine that no explicit construction of any claim term is necessary to resolve this case. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 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))); 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’”).” slip op. at 10

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

    “Finally, Petitioner asserts that it would have been obvious that “the daily dosing of the patient could be adjusted to optimize mifepristone blood level, whatever level that might be.” Pet. 30. This argument is not persuasive for several reasons. First, Petitioner must do more than show that the ordinary artisan could have done what was claimed. Belden Inc. v. Berk–Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.”).” slip op. at 15

  Patent outcomesUS 8,921,348 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,921,348
• Lassen Therapeutics 1, Inc. v. Singapore Health Services Pte Ltd., And National University Of SignaporeInstitution denied
  PTAB · Feb 6, 2020 · PGR2019-00053 · APJ Jamie T Wisz · PGR · Institution

  The Board denied institution because Petitioner did not show it was more likely than not that claims 1–10 were unpatentable on any asserted ground.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied

    “review under 35 U.S.C. § 324 and 37 C.F.R. § 42.4(a). We may not institute a post-grant review unless “the information presented in the petition . . . , if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). Applying that standard, and upon consideration of the information presented in the Petition and the Preliminary Response, we determine that the information presented fails to demonstrate it is more likely than not that at least 1 of the challenged claims of the ’603 patent is unpatentable. Accordingly, we deny institution of post-grant review of claims 1–10 of the ’603 patent.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner states that, for purposes of the preliminary response only, it does not challenge Petitioner’s definition of a person of ordinary skill in the art. Prelim. Resp. 19. Based on the current record and for the purposes of this Decision, we adopt Petitioner’s proposed description of the person of ordinary skill in the art. Furthermore, we find that the prior art of record reflects 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).” slip op. at 7

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

    “We agree with Patent Owner that “Interleukin 11 receptor α (IL- 11Rα) antibody” should not be construed to include antibodies that bind to IL-11Rα of non-human species but not to the human version of this protein because such a construction does not comport with the language of claim 1, which is clearly directed to treating a human subject. See Pause Tech. v. TiVo, 419 F.3d 1326, 1331 (Fed. Cir. 2005) (rejecting interpretation of claim element that ignored “other language appearing later in the claim” in stating that ‘“[p]roper claim construction . . . demands interpretation of the entire claim in context, not a single element in isolation.’”) (citing Hockerson– Halberstadt, Inc. v. Converse Inc., 183 F.3d 1369, 1374 (Fed.Cir.1999)). Construing this term to include antibodies that bind solely to non-human IL- 11Rα would be inconsistent with a claim directed to treatment of a human. Accordingly, for purposes of this decision, we construe “Interleukin 11 receptor α (IL-11Rα) antibody” to mean “any natural or synthetic, monoclonal or polyclonal antibody made using any animal system including phage, or fragment or derivative thereof, that binds to human IL-11Rα.”” slip op. at 9

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable

    “We agree with Patent Owner that Petitioner appears to have overlooked the ’603 patent Specification’s disclosure of anti-IL-11Rα antibodies. Specifically, the ’603 patent lists “monoclonal antibody clone 025 (Sino Biological), clone EPR5446 (Abcam), clone 473143 (R & D Systems), clones 8E2 and 8E4 described in US 2014/0219919 A1 [Edwards] and the monoclonal antibodies described in Blanc et al (J. Immunol Methods. 2000 Jul. 31; 241(1–2); 43–59).” Ex. 1001, 18:41–46; Ex. 1003 ¶ 176.6 Edwards, which Petitioner relies on for its obviousness and anticipation grounds, is directed to antibodies “that bind to IL-11Rα and neutralize IL-11 signaling.” Ex. 1008 ¶ 13. Table 1 of Edwards lists clones 8E2 and 8E4 and sixty-three other antibodies (including variants of 8E2) as “exemplary IL-11Rα-binding proteins.” Id. ¶ 362. Table 1 of Edwards also includes the sequence ID numbers for the heavy and light chains of the variable regions of each of these sixty-five clones and the amino acid sequences for each are disclosed in the sequence listing. Id. ¶ 362, p. 46– 104.7” slip op. at 12

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 10,106,603
• Trans Ova Genetics, LC v. Xy, LLCNo claims unpatentable
  PTAB · Jun 26, 2019 · IPR2018-00250 · APJ David Cotta · IPR · Final written decision

  Claims 1–16 were not proven unpatentable because Petitioner failed to establish that Lu, relied on in every asserted obviousness ground, was prior art.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference not prior artNot shown unpatentable

    “Inc. v. Apotex Inc., 754 F.3d 952, 968 (Fed. Cir. 2014); In re Katz, 687 F.2d 450, 454 (Fed. Cir. 1982). “The question of whether a reference is a work of others for the purposes of § 102(a) is, like that of inventorship, a question of law based on underlying facts.” Allergan, 754 F.3d at 969 (citing Ethicon, Inc. v. U.S. Surgical Corp., 135 F.3d 1456, 1460 (Fed. Cir. 1998)). In determining whether a reference is the work of the named inventor(s), the inquiry focuses on whether the relevant content of the reference – which includes “the design, trial, and analysis of results” – was solely the work of the inventor(s). See Allergan, 754 F.3d at 969; Riverwood Int’l Corp. v. R.A. Jones & Co., 324 F.3d 1346, 1356 (Fed. Cir. 2003) (“What is significant is not merely the differences in the listed inventors, but whether the portions of the reference relied on as prior art, and the subject matter of the claims in question, represent the work of a common inventive entity.”).” slip op. at 14

  • Expert testimonyPatent owner expert creditedOther

    “9 We acknowledge that Mr. Miles, as a former board member of XY, as well as XY’s long-time patent counsel and the filer of the ’769 priority provisional applications, may have some interest in the outcome of this IPR and that Mr. Miles is being compensated by XY for time spent relating to his testimony. Ex. 2003 ¶¶ 4–7; Ex. 1033, 21:7–14, 158:8–22. However, we note that Mr. Miles’ testimony was under oath and subject to cross-examination. We find Mr. Miles’ testimony to be credible as to the facts for which it is cited herein.” slip op. at 10

  • ExcludeMotion to exclude, deniedMixed

    “Exclude. Paragraph 12 of the Miles Declaration reads as follows: “Also[,] in the late 1990s, XY had a collaborative research agreement with a bull stud called Cogent in the United Kingdom.” Ex. 2003 ¶ 12.11 This statement is not itself hearsay because it was asserted by Mr. Miles while testifying in this proceeding, i.e., “at the current trial.” See Fed. R. Evid. 801(c). Petitioner contends that paragraph 12 is inadmissible because it is based, at least in part, on statements contained in Exhibits 2001 and 2002. We are not persuaded by this argument because paragraph 12 does not rely on Exhibits 2001 and 2002. See Ex. 2003 ¶ 12; Ex. 1033, 59:22–62:18 (Mr. Miles’ testimony on basis and meaning of paragraph 12 of his declaration). Petitioner also argues that paragraph 12 should be excluded as improper opinion testimony because it is based on Exhibits 2001 and 2002, to which, according to Petitioner, Mr. Miles is not competent to testify. Mot. 13–14. We are not persuaded by Petitioner’s argument because, as discussed, paragraph 12 does not rely on Exhibits 2001 and 2002.” slip op. at 22

  Patent outcomesUS 8,652,769 not shown unpatentable
  § 102 anticipation
  Patents in suitUS 8,652,769
• 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
• Envirologix Inc. v. Ionian Technologies, Inc.Rehearing denied
  PTAB · Oct 11, 2018 · IPR2018-00406 · APJ Ulrike W Jenks · IPR · Rehearing

  The Board denied EnviroLogix’s rehearing request, leaving institution denied because Ehses did not show a reasonable likelihood of proving any challenged claim anticipated.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “modified by specifically identifying all matters the party believes were misapprehended or overlooked, and the place where each matter was addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is” slip op. at 2

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “anticipation by inherency requires that any missing material must be recognized by the POSITA as necessarily present. Decision 20 (citing In re Robertson, 169 F.3d 743 (Fed. Cir. 1999)). In the Petition, Petitioner contends that Ehses discloses amplification of a target in real time based on Ehses’s teaching that “the increase in fluorescence intensity was monitored” and Dr. Edwards’ opinion that “[d]yes that bind DNA, like TO-PRO-1, generate a fluorescent signal upon binding that is detected in” real time. Pet. 21 (citing Ehses 175; Ex. 1008 (Edwards Decl.) ¶ 49).” slip op. at 3

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableNot shown unpatentable

    “anticipation by inherency requires that any missing material must be recognized by the POSITA as necessarily present. Decision 20 (citing In re Robertson, 169 F.3d 743 (Fed. Cir. 1999)). In the Petition, Petitioner contends that Ehses discloses amplification of a target in real time based on Ehses’s teaching that “the increase in fluorescence intensity was monitored” and Dr. Edwards’ opinion that “[d]yes that bind DNA, like TO-PRO-1, generate a fluorescent signal upon binding that is detected in” real time. Pet. 21 (citing Ehses 175; Ex. 1008 (Edwards Decl.) ¶ 49).” slip op. at 3

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityNot reached

    “zero when fluorescence begins to increase and continues during the reaction. Req. Reh’g 12. Petitioner has not challenged our determination that Ehses Dissertation fails to qualify as prior art, nor otherwise explained why the Ehses Dissertation reflects the understanding of those of ordinary skill at the relevant time. See Decision 15 (“Petitioner has [not] made a threshold showing that the Ehses Dissertation was sufficiently publicly accessible to qualify as a ‘printed publication’ under § 102(b)”). Moreover, Petitioners did not previously rely upon any teachings of Ehses Dissertation, particularly Figure 3.4, to support an inherency argument for Ehses anticipation grounds in the Petition. A request for rehearing is not an opportunity for the requestor to present new arguments or evidence. Accordingly, we are not persuaded by Petitioner’s assertion that we overlooked or misapprehended Petitioner’s anticipation arguments in light of the newly cited disclosure of the Ehses Dissertation.” slip op. at 6

  § 102 anticipation
  Patents in suitUS 9,562,264
• Envirologix Inc. v. Ionian Technologies, Inc.Rehearing denied
  PTAB · Oct 11, 2018 · IPR2018-00405 · APJ Christopher G Paulraj · IPR · Rehearing

  The Board denied rehearing and maintained its denial of institution, finding no reasonable likelihood that Ehses anticipated any challenged claim.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “II. DISCUSSION A party requesting rehearing has the burden to show a decision should be modified by specifically identifying all matters the party believes were misapprehended or overlooked, and the place where each matter was addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is” slip op. at 2

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “In order to meet the claim requirements, however, Petitioner must first show that Ehses performed real-time detection in an assay that also omits the initial denaturation step. See Decision 11; see Prelim. Resp. 11 (“the petition provides no comparison of the reaction conditions disclosed in Ehses to the reaction conditions recited in the claims”). But Ehses does not teach omitting the denaturation step as part of its Standard and Nicking protocols. See Ehses 175 (2.1.2 Standard SDA and 2.1.3 Nicking SDA). Rather, in a single sentence, Ehses mentions the omission of a denaturation step only in comparison to the experimental protocols in which a denaturation step is expressly included, but even then cautions that such an omission tends to result in undesirable side reactions. Ehses 177. Thus, contrary to Petitioner’s arguments, we do not find that Ehses teaches real-time detection of target DNA within 10 minutes was necessarily performed using the TO-PRO-1 dye when “omitting the initial denaturation step.” Id.” slip op. at 4

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

    “We remain unpersuaded by this argument. As discussed in our Decision, anticipation by inherency requires that any missing material must be recognized by the POSITA as necessarily present. Decision 19 (citing In re Robertson, 169 F.3d 743 (Fed. Cir. 1999)). In the Petition, Petitioner contends that Ehses discloses amplification of a target in real time based on Ehses’s teaching that “the increase in fluorescence intensity was monitored” and Dr. Edwards’ opinion that “[d]yes that bind DNA, like TO-PRO-1, generate a fluorescent signal upon binding that is detected in” real time. Pet. 21 (citing Ehses 175; Ex. 1008 (Edwards Decl.) ¶ 82). In order to meet the claim requirements, however, Petitioner must first show that Ehses performed real-time detection in an assay that also omits the initial denaturation step. See Decision 11; see Prelim. Resp. 11 (“the petition provides no comparison of the reaction conditions disclosed in Ehses to the reaction conditions recited in the claims”). But Ehses does not teach omitting the denaturation step as part of its Standard and Nicking protocols. See Ehses 175 (2.1.2 Standard SDA and 2.1.3 Nicking SDA). Rather, in a single sentence, Ehses mentions the omission of a denaturation step only in comparison to the experimental protocols in which a denaturation step is expressly included, but even then cautions that such an omission tends to result in undesirable side reactions. Ehses 177. Thus, contrary to Petitioner’s arguments, we do not find that Ehses teaches real-time detection of target DNA within 10 minutes was necessarily performed using the TO-PRO-1 dye when “omitting the initial denaturation step.” Id.” slip op. at 3

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedDecided for patent owner

    “2 Although not established as prior art, the Ehses Dissertation indicates that TO- PRO-1 fluoresces in the presence of double stranded DNA, whereas SYBR Gold detects both double and single-stranded products. See Ex. 1004, 37. zero when fluorescence begins to increase and continues during the reaction. Req. Reh’g 12. Petitioner has not challenged our determination that Ehses Dissertation fails to qualify as prior art, nor otherwise explained why the Ehses Dissertation reflects the understanding of those of ordinary skill at the relevant time. See Decision 15 (“Petitioner has [not] made a threshold showing that the Ehses Dissertation was sufficiently publicly accessible to qualify as a ‘printed publication’ under § 102(b)”). Moreover, Petitioners did not previously rely upon any teachings of Ehses Dissertation, particularly Figure 3.4, to support an inherency argument for Ehses anticipation grounds in the Petition. A request for rehearing is not an opportunity for the requestor to present new arguments or evidence. Accordingly, we are not persuaded by Petitioner’s assertion that we overlooked or misapprehended Petitioner’s anticipation arguments in light of the newly cited disclosure of the Ehses Dissertation.” slip op. at 5

  § 102 anticipation
  Patents in suitUS 9,562,263
• Acrux DDS Pty Ltd. / Acrux Limited et al. v. Kaken Pharmaceutical Co., Ltd. And Valeant Pharmaceuticals International, Inc.All claims unpatentable
  PTAB · Jun 6, 2018 · IPR2017-00190 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1 and 2 are unpatentable under § 103 over the Kaken Abstracts combined with JP ’639, the ’367 patent, or Hay.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “what is required to establish a prior reduction to practice by the United States Court of Appeals for the Federal Circuit (“Federal Circuit”) is instructive. 437 F.3d 1157 (Fed. Cir. 2006). The Federal Circuit sets forth the following three criteria for Patent Owner to establish an actual reduction to practice: (1) construction of an embodiment or performance of a method that met all the limitations of the claim; (2) a determination that the invention would work for its intended purpose; and (3) sufficient evidence to corroborate inventor testimony regarding these events. Id. at 1169; see also In re NTP, Inc., 654 F.3d 1279, 1291 (Fed. Cir. 2011) (“Sufficiency of corroboration is determined by using a ‘rule of reason’ analysis, under which all pertinent evidence is examined when determining the credibility of an inventor’s testimony.”) (quoting Medichem, 437 F.3d at 1170). The Federal Circuit provides the following further clarity on what is required to be corroborated. For purposes of conceptual clarity, as well as clarity of language, it should be noted that no similar condition of “corroboration” is imposed on an inventor’s notebook, or indeed on any documentary or physical evidence, as a condition for its serving as evidence of reduction to practice. Of course, the credibility (and therefore the corroborative value) of an inventor’s notebook may vary. Nevertheless, a notebook, unlike the oral testimony of an inventor, may be weighed, for whatever it is worth, in the final determination of reduction to practice. However, in a case involving reduction to practice, an unwitnessed notebook is insufficient on its own to support a claim of reduction to practice. Once properly admitted into evidence, documentary and physical evidence is assigned probative value and collectively weighed to determine whether reduction to practice has been achieved. This is what is meant by the maxim that documentary and physical evidence to not require “corroboration.”” slip op. at 20

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

    “the combination of the teaching of the nail lacquer references and the Kaken Abstracts, namely, the difficulty of treating tinea unguium because of the lack of ability of antifungal agents to penetrate the keratinuous layers of the nail. Pet. 43. Relying on testimony by Dr. Walters, Petitioner states that “[a] person of ordinary skill in the art would have been motivated to improve the compositions and topical application method of JP’639 using potent azole antifungal compounds that are effective against the microorganisms that cause onychomycosis and that are not inactivated by keratin.” Pet. 43–44; Ex. 1005 ¶ 131. Dr. Walters makes similar statements with regard to the ’367 patent and Hay, for instance, relying on Hay’s statement that “cures of onychomycosis are possible after topical therapy” and may result from topical therapy alone. See Pet. 48 (stating “a person of ordinary skill in the art would have been motivated to treat onychomycosis with topical therapy, and would have been motivated to find the best antifungal agent for such topical therapy”); Ex. 1005 ¶ 138; Pet. 52 (same regarding combination with Hay); Ex. 1005 ¶ 145.” slip op. at 38

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

    “For objective evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention.” In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (quotation and emphasis omitted). In evaluating the import of Patent Owner’s secondary considerations evidence on whether the challenged claims would have been obvious, we apply a presumption of nexus between the secondary considerations and the challenged claims when the Patent Owner “shows that the asserted objective evidence is tied to a specific product and that product ‘is the invention disclosed and claimed in the patent.’” WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1329 (Fed. Cir. 2016) (citation omitted). That presumption, however, is rebuttable. Id. (1) presumption of nexus and scope of challenged claims Here, we determine that Patent Owner is entitled to a presumption of a nexus between secondary considerations relating to Jublia® and the subject matter of the challenged claims because Patent Owner has shown that the secondary considerations are tied to a specific product, Jublia®, that is covered by challenged claims 1 and 2. See PO Resp. 60; Ex. 1043, 1. We find, however, that Petitioner has rebutted the presumption of nexus as discussed below. slip op. at 42

  • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsDecided for petitioner

    “Patent Owner’s evidence, however, links the alleged unexpected results for topical use of efinaconazole with the unclaimed feature of being a monotherapy where nail management, such as debridement, is not required. See Ex. 1001, 17:33–18:32 (claims 1 and 2 employ the open transitional term “comprises”). Petitioner also provides evidence that we credit that Jublia®’s efficacy was only incremental over that of Penlac®. See Reply 20; Ex. 1504, 4 (FDA stating concerning efinaconazole solution for the treatment of onychomycosis that preliminary efficacy analysis “claims to show a primary efficacy response rate of about 16%, which is similar to at least one currently approved therapy” and “[a]pproximately 85% of subjects would fail to respond to your proposed treatment”); Ex. 1510 ¶ 72 (stating Jublia®’s clinical trials involved patients with less severe nail involvement than Penlac® and also utilized other topical antifungals for tinea pedis indicating “a higher efficacy rate for Jublia® could have reasonably been expected simply based on these study design differences”); see also Ex. 1510 ¶ 69 (stating “Jublia® is only indicated for patients having mild to moderate cases of onychomycosis, i.e. ‘patients 18 years and older (18 to 70 years of age) with 20% to 50% clinical involvement of the target toenail, without dermatophytomas or lunula (matrix) involvement’”). We conclude that Patent Owner’s evidence of unexpected results is weak and insufficient to support the nonobviousness of the challenged claims.” slip op. at 47

  Patent outcomesUS 7,214,506 unpatentable
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,214,506
• Hospira, Inc. v. Genentech, Inc.All claims unpatentable
  PTAB · Mar 9, 2018 · IPR2016-01771 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–5 are unpatentable as obvious over Kabbinavar and over the 2000 Press Release; anticipation by Kabbinavar was not established.

  RulingsFinal written decision

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

    “summarized above, we conclude that Kabbinavar fails to disclose “assessing the patient for gastrointestinal perforation” as required by the challenged claims. In making this determination, we note that Kabbinavar expressly states that the patients enrolled in the disclosed study underwent regular “baseline tumor assessments [that] included a chest x-ray, abdominal and pelvis computed tomography [(“CT”)] scans.” Ex. 1005 at 3–4. We are not, however, persuaded by Petitioner’s argument that “Kabbinavar teaches that the subjects receiving bevacizumab underwent regular CT scans that the Skilled Artisan would have understood (1) were performed to determine whether the subjects were experiencing any GI injury including GI perforation and (2) would have detected signs of GI perforation.” Reply 12 (citing Ex. 1025 ¶¶ 26–29; Ex. 1026, 39:6–16) (emphasis added). Rather, we find that Kabbinavar expressly discloses that the CT scans were performed for the purposes of tumor assessment, and not for assessing the patient for GI perforation. While it is undisputed that CT scans of the abdominal and pelvis, such as those performed in Kabbinavar, are capable of detecting GI perforation (Ex. 1025 ¶ 26; Ex. 1026, 39:6–16; Ex. 1022; Ex. 1023; Ex. 1027, 55:1–57:4), the evidence of record supports a finding that a person of ordinary skill in the art looking for a GI perforation would have performed different steps that are not necessarily taken in cases where GI perforation is not suspected, such as in the case of performing baseline tumor assessments (or tumor staging). Here, we credit the testimony of Dr. Levy, Professor of Radiology at Georgetown University Medical Center, who testified that, where a patient is suspected to have GI perforation, a radiologist would use particular contrast agents and would use a setting known as a “lung window,” a setting that is better suited to detect the presence of free air and to more easily identify the location of the perforation. Ex. 2012 ¶¶ 24–35. In contrast, the record fails to establish that the same or equivalent steps would necessarily be used where a radiologist was performing baseline tumor assessments. See Reply 14–17; Ex. 1026, 53:8–60:17. Accordingly, based on the evidence of record, we conclude that the use of a CT scan in the manner disclosed in Kabbinavar would not have necessarily confirmed the presence or absence of GI perforation. That is, while a CT scan is capable of assessing a patient for GI perforation, Petitioner failed to show that the patients discussed in Kabbinavar necessarily underwent an evaluation to determine if those patients had GI perforation. As such, we find that Kabbinavar fails to explicitly or inherently disclose the requirement for “assessing the patient for gastrointestinal perforation.”” slip op. at 13

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

    “person of ordinary skill in the art would have had adequate reason to assess patients with colorectal cancer receiving bevacizumab in combination with chemotherapeutic agents, such as the patients disclosed in Kabbinavar and the 2000 Press Release, for GI perforation. In reaching this conclusion, we credit the testimony of Dr. Neugut that the standard of care and the knowledge of a person of ordinary skill in the art would have guided a physician to assess patients receiving bevacizumab for GI perforation. Ex. 1002 ¶¶ 92–108; Ex. 1025 ¶¶ 35–40. We are persuaded that such an assessment necessarily begins with evaluating patients for symptoms of GI perforation, such as nausea and abdominal pain, and in the event of a showing of such signs, a physician would have assessed the patient for GI perforation. Id. at ¶¶ 92–94. Guiding that physician would have been the knowledge that GI cancers and systemic chemotherapy each were known to be causally related to GI perforation. Pet. 48; Ex. 1002 ¶¶ 91, 96-99; Ex. 1025 ¶ 39; Ex. 1027, 64:1–24; Ex. 1026, 95:18–96:17; Ex. 1007, 9 (“ask if the patient has recently received chemotherapy as this may cause perforation by weakening the bowel wall at a site of tumor.”). The physician would have known that GI perforation was associated with a high rate of death, and thus the physician would have been particularly concerned with a life-threatening complication such as GI perforation. Pet. 47; Ex. 1002 ¶ 90; Ex. 1007, 11. The physician would have also known that chemotherapy promotes GI injury by killing tumor cells and effectively eroding away the tumor as well as by killing epithelial cells that line the gut wall. Pet. 48; Reply 23; Ex. 1002 ¶¶ 98–101; Ex. 1025 ¶ 39; Ex. 1009, 5; Ex. 1010, 3; Ex. 1013, 2. Finally, the physician would have known that the protein VEGF promotes GI injury repair and that a VEGF-neutralizing antibody, such as bevacizumab, could impair the ability of VEGF to promote GI injury repair and thus potentially exacerbate GI tissue injury caused by chemotherapy. Reply 23; Ex. 1002 ¶ 82; Ex. 1025 ¶ 39; Ex. 1008, 3, 8–9.” slip op. at 20

  • Obviousness (§103) › Objective indicia / secondary considerationsNot reached

    “We further note that secondary consideration have not been asserted in this case.” slip op. at 21

  Patent outcomesUS 7,622,115 unpatentable
  § 102 anticipation§ 103 obviousnesscites Phillips
  Patents in suitUS 7,622,115
• Par Pharmaceutical, Inc. / Breckenridge Pharmaceutical, Inc. et al. v. Novartis AGNo claims unpatentable
  PTAB · Jan 11, 2018 · IPR2016-00084 · APJ Christopher L Crumbley · IPR · Final written decision

  Claims 1–3 and 8–10 were not proven unpatentable because the proposed obviousness analysis did not show that the choices leading to everolimus were finite, small, or easily traversed.

  RulingsFinal written decision

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

    “The facts of the case at hand provide a stark contrast. As we have found above, while the prior art recognized rapamycin as a promising immunosuppressant, it was only one among many possible lead compounds. Furthermore, the prior art shows that chemists were pursuing a number of avenues to increase solubility, including making derivatives but also other approaches such as formulation techniques or prodrugs. And most tellingly, in contrast to Bristol-Myers Squibb where the experts agreed on the type and location of the potential substituents, here the experts diverge significantly. As discussed above, we credit the testimony of Novartis’ experts over Par’s, and find that the options of substituent and substituent position would not have been as narrow as those proposed by Par. In sum, we find that the person of ordinary skill in the art at the time the invention was made would have been faced with a large number of decision points along the lead compound analysis proposed by Par. The number of potential compounds encompassed by this decision tree is unclear, but would be far larger than the three compounds Dr. Jorgensen discusses. Only by making the “right” choice at each step would the skilled artisan arrive at everolimus, the compound of claim 10 and the basis of Par’s obviousness challenge. In light of these facts, we cannot conclude that the options faced would have been—in the words of the Federal Circuit—finite, small, or easily traversed. We, therefore, cannot conclude that the compound of claim 10, and by extension, the compounds of claims 1–3, would have been obvious to one of skill in the art as of October 1992.” slip op. at 35

  • Skill levelSkill level petitioner adoptedOther

    “Par contends, supported by the testimony of Dr. Jorgensen, that a person of ordinary skill in the art at the time of the invention would generally have a Ph.D. in organic chemistry or medicinal chemistry or physical chemistry or a related field, or a Masters or Bachelor degree in chemistry or a related field and at least three years’ experience in drug discovery and design. Pet. 16 (citing Ex. 1003 ¶ 45). Novartis’ experts, with insubstantial exceptions, agree with Dr. Jorgensen’s recitation. Ex. 2092 ¶ 22 (Klibanov); Ex. 2093 ¶¶ 47–48 (Roush). We adopt the level of skill recited by the parties for purposes of our analysis herein.” slip op. at 13

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “Based on our review of the entirety of the record, we cannot conclude, as Par contends, that the C40 hydroxyl group would be the obvious, optimal, or preferred location for substitutions to rapamycin. Dr. Jorgensen’s testimony to that effect is premised on his assertion that a person of ordinary skill in the art would have first narrowed the group of possible substitution positions to the C10, C28, or C40, because those are the hydroxyl groups of rapamycin. Ex. 1003 ¶ 142 (“person of ordinary skill in the art would have focused on hydroxyl groups on rapamycin as initial targets for modification.”). This statement, however, is based only on Dr. Jorgensen’s statement that the reactions of hydroxyl groups are “among the most fundamental and elementary reactions taught in beginning organic chemistry courses.” Id. Dr. Jorgensen provides no objective, documentary evidence that would indicate that starting with hydroxyl groups was an accepted rule followed by medicinal chemists in the field. To the contrary, Dr. Roush testifies that Dr. Jorgensen’s focus on rapamycin’s hydroxyl groups is inconsistent with the prior art as a whole, and provides multiple citations to the documentary evidence in the record supporting his testimony. Ex. 2093 ¶¶ 197, 206–216 (citing prior art modifications at the C9, C26, C27, C28, and C32 positions). For example, Ondeyka14 discloses demethylation of the methoxy group at rapamycin’s C29 position, while Caulfield15 discloses oxime substitutions at C32.16 We have weighed the testimony of Drs. Jorgensen and Roush on this point, and find Dr. Roush’s to be the more credible. While we agree with Par that a person of ordinary skill in the art would have considered rapamycin’s C40 position as a candidate for substitution, that site must be evaluated as one potential substitution site among many that were being modified in the field at the time of the invention.” slip op. at 24

  • Obviousness (§103) › Objective indicia / secondary considerationsNot reached

    “obviousness challenge. In light of these facts, we cannot conclude that the options faced would have been—in the words of the Federal Circuit—finite, small, or easily traversed. We, therefore, cannot conclude that the compound of claim 10, and by extension, the compounds of claims 1–3, would have been obvious to one of skill in the art as of October 1992. With respect to the second ground of unpatentability, pertaining to the method of treatment claims 8 and 9, Par’s obviousness arguments are premised on the conclusion that everolimus would have been obvious. See Pet. 48–51 (“claims 8 and 9 would have been obvious to a person of ordinary skill in the art in view of the art that makes the 40-O-2- hydroxyethyl-rapamycin derivative obvious”). As we conclude that everolimus has not been shown to be obvious, we reach the same conclusion as to the methods of claims 8 and 9. The addition of Hughes to the ground of unpatentability does not provide any of the teachings we found lacking from the art asserted in the first ground of unpatentability. As we have concluded that Par’s articulated lead compound analysis is insufficient to establish the obviousness of any of the challenged claims, we need not reach, and do not evaluate, the objective indicia of obviousness submitted by Novartis. PO Resp. 60–68.” slip op. at 36

  Patent outcomesUS 5,665,772 not shown unpatentable
  § 103 obviousness
  Patents in suitUS 5,665,772

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.