• Snap Inc. v. You Map Inc.All claims unpatentable
  PTAB · Aug 31, 2023 · IPR2022-00568 · APJ Jason M Repko · IPR · Final written decision

  Claims 1–20 are unpatentable as obvious over Feldman and Jackson, or Feldman, Jackson, and Rush; the contingent motion to amend is granted.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “had a bachelor’s degree in electrical engineering, computer science, or a related field, plus two years’ work or research experience with location-based content delivery and/or visualization.” Pet. 5 (citing Ex. 1003 ¶¶ 19– experience and vice versa.” Id. Patent Owner does not contest Petitioner’s proposed level of ordinary skill in the art. See PO Resp.; Sur-reply. Patent Owner’s expert, Dr. Shamos, testifies that he “generally agree[s]” with Petitioner’s proposed articulation, and provides substantially the same expression of the level of ordinary skill in the art. Shamos Decl. ¶¶ 30–31. In this Decision, we apply Petitioner’s proposed definition.” slip op. at 6

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

    “Although Patent Owner appears to argue that applying the preference factors to a general score does not encompass weighting the general score’s components (see, e.g., id. at 10–12; Sur-reply 13–16), this is not reflected in Patent Owner’s proposed construction (PO Resp. 12). Patent Owner’s construction provides no limitation on how the preference factors are applied to a general score. See id. To the extent Patent Owner argues that the phrase “applied to,” as recited in the claim, excludes such component-based weighting, we disagree. Rather, the record better aligns with Petitioner’s argument that “applied to” involves a linear combination of values, which could be the values of the general score’s components. See Pet. 30–31. Petitioner’s position is supported by the plain language of the claim, the ’727 patent’s discussion of weighted aggregation, and Mr. William’s testimony—all of which indicate that weighting the component scores is encompassed by claim 1. As for the plain language, the claim does not define how the factors are “applied to” the general score. Rather, the claim only recites that they are. In the context of the claim, the preference factors are applied to the general score. Patent Owner does not dispute this. PO Resp. 12. Claim 1 further recites that the customized score is based on the application of the preference factors to the general score. Ex. 1001, 23:14–27. We note that the generate the combined ranking, which is then used for the recited selection. Beyond that, the claim does not specify how the two rankings are used or how the combined ranking must be generated. Thus, under the claim’s plain language, the customized score can be used to rank the posts and is based on the general score. Id.” slip op. at 11

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “adequately supported. We find that Mr. William’s declaration is adequately supported. This is not case where an expert “does not disclose the underlying facts or data on which the opinion is based.” See 37 C.F.R. § 42.65(a). Rather, Mr. Williams adequately supports his testimony about the second preference factor with reasoning based on Jackson’s teachings about how the social-network distance is used to weight the global score. See, e.g., Williams Decl. ¶ 133 (citing Ex. 1006, Fig. 4A, 16:23–25, 58–60). weighting criteria can be used together. Id. ¶¶ 147–149 (citing Ex. 1006, 3:57–44:22, 5:53–58, 9:54–67, 13:17–22, 17:47–67). Mr. Williams’s analysis relies on Jackson’s discussion of using multiple factors to score a post. Ex. 1006, 17:47–55, cited in Williams Decl. ¶ 147; see also Pet. 42–43; Reply 9. Mr. Williams also cites Jackson’s discussion of how social-network distance and geographic distance can be used together. Williams Decl. ¶ 147 (citing Ex. 1006, 3:57–4:22). We agree with Petitioner that Jackson adequately supports this part of Mr. Williams’s analysis. Reply 7–9. Specifically, Jackson discloses that a determination may use social-network distance to “modify the criteria” that it uses to provide posts to users. Ex. 1006, 3:66–4:1, cited in Williams Decl. ¶ 147. Jackson further explains how geographic distance can be used in addition to other criteria: “Transmitting the post to the second computing device may be dependent upon determining that the criteria is met and determining that the posting location is within the threshold distance.” Id. at 4:19–22 (emphasis added), cited in Williams Decl. ¶ 147. This is consistent with Jackson’s teaching that a post may be recommended based on several factors and for several reasons. Id. at 17:47–67, cited in Williams Decl. ¶ 147. Also, Jackson explains how the global score, which Petitioner mapped to the recited “general score,” is used to generate a post’s score: “[A] particular post’s global score . . . is multiplied by, divided by, or summed with a distance between” a user and the post’s author. Id. at 9:54–67, cited in Williams Decl. ¶ 148. Jackson weights a post’s global score against a position of the posts author in a social graph. Id. at 9:25–53. Mr. Williams testifies that it is obvious and conventional to generate the modified scores embodiment. Williams Decl. ¶ 144. This is supported by Jackson. In another example cited by Petitioner, Jackson multiplies a post’s global score by a geographic distance to generate a personal score. Id. at 21:60–22:5, cited in Pet. 37, 39, 43. Thus, Petitioner has shown Jackson teaches or suggests applying two different sets of preference factors to a post’s global score. Pet. 41 (citing Williams Decl. ¶ 144). We disagree with Patent Owner’s argument that neither Petitioner nor” slip op. at 31

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

    “We agree with Petitioner that Jackson adequately supports this part of Mr. Williams’s analysis. Reply 7–9. Specifically, Jackson discloses that a determination may use social-network distance to “modify the criteria” that it uses to provide posts to users. Ex. 1006, 3:66–4:1, cited in Williams Decl. ¶ 147. Jackson further explains how geographic distance can be used in addition to other criteria: “Transmitting the post to the second computing device may be dependent upon determining that the criteria is met and determining that the posting location is within the threshold distance.” Id. at 4:19–22 (emphasis added), cited in Williams Decl. ¶ 147. This is consistent with Jackson’s teaching that a post may be recommended based on several factors and for several reasons. Id. at 17:47–67, cited in Williams Decl. ¶ 147. Also, Jackson explains how the global score, which Petitioner mapped to the recited “general score,” is used to generate a post’s score: “[A] particular post’s global score . . . is multiplied by, divided by, or summed with a distance between” a user and the post’s author. Id. at 9:54–67, cited in Williams Decl. ¶ 148. Jackson weights a post’s global score against a position of the posts author in a social graph. Id. at 9:25–53. Mr. Williams testifies that it is obvious and conventional to generate the modified scores embodiment. Williams Decl. ¶ 144. This is supported by Jackson. In another example cited by Petitioner, Jackson multiplies a post’s global score by a geographic distance to generate a personal score. Id. at 21:60–22:5, cited in Pet. 37, 39, 43. Thus, Petitioner has shown Jackson teaches or suggests applying two different sets of preference factors to a post’s global score. Pet. 41 (citing Williams Decl. ¶ 144).” slip op. at 32

  Patent outcomesUS 10,616,727 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 10,616,727
• Synthego Corporation v. Agilent Technologies, Inc.All claims unpatentable
  PTAB · May 17, 2023 · IPR2022-00403 · APJ Michael A Valek · IPR · Final written decision

  Claims 1–33 are unpatentable: claims 1–5, 8–21, and 24–33 are anticipated by Pioneer Hi-Bred; the remaining claims are obvious over the stated combinations.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “Patent Owner agrees that a POSA would have this educational level. Resp. 23. Patent Owner “also agrees that a POSA would have knowledge of prior art RNA based gene regulating technologies, but disagrees that the teachings of those technologies are relevant in the manner that Dr. Furneaux [and Petitioner] attempt[] to apply them” in the Petition’s grounds. Id. at 23– 24. We find the parties’ agreed understanding of the level of ordinary skill in the art to be supported by the record and apply that description in our analysis herein. To the extent the parties disagree regarding the application of a POSA’s general knowledge of nucleic acids and related prior art techniques to the Petition’s grounds, such disputes are addressed in our analysis below.” slip op. at 9

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

    “Independent claims 1 and 19 recite a guide RNA or crRNA molecule having “gRNA functionality comprising associating with a Cas protein and targeting the gRNA:Cas protein complex to the target sequence.” Ex. 1001, 257:42–44, 259:5–7. This claim language makes clear that the recited “gRNA functionality” requires a molecule that can: (1) associate with a Cas protein, and (2) target that complex to a target sequence in a polynucleotide. To the extent Petitioner suggests that a gRNA “need only bind to the Cas protein” to have “gRNA functionality,” we disagree because the claims additionally recite the above-quoted targeting functionality. See Reply 16 (emphasis added). At the same time, we agree with Petitioner that “a gRNA need not cleave the target DNA” to have the claimed “gRNA functionality.” Reply 16. The Specification defines “gRNA functionality” as “one or more functions of naturally occurring guide RNA, such as associating with a Cas protein, or a function performed by the guide RNA in association with a Cas protein” and lists various gRNA functions, e.g., “associating,” “targeting,” “binding,” “nicking,” and “cleaving,” that may be present “in certain embodiments” of the invention. Ex. 1001, 6:56–7:1. However, as noted above, the claims recite “gRNA functionality comprising” only the associating and targeting functions. Thus, while a molecule may have additional functions such as cleaving a target polynucleotide, it need only exhibit the recited “associating” and “targeting” functions to have the “gRNA functionality” in claims 1 and 19. Our determination that “gRNA functionality” requires the recited “associating” and “targeting” functions, but not additional, unrecited functions such as cleaving, is also consistent with the parties’ position that the claim language has its plain and ordinary meaning. See Pet. 17; Resp. 24. The parties do not dispute the construction of any other terms, nor do we discern that any further claim construction is necessary to resolve the issues in this proceeding. See Nidec Motor Corp. v. Zhongshan Broad OceanMotor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that it is only necessary to “construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 10

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

    “established that “anticipation does not require actual performance of suggestions in a disclosure.” Novo Nordisk Pharms., Inc. v. Bio-Tech. Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005); see also In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985). Moreover, the Petition need not assert that “gRNA functionality” is inherently disclosed because Petitioner has shown that Pioneer Hi-Bred’s expressly discloses this limitation. Pet. 25–26 (citing evidence). There is no additional requirement that this express disclosure be backed by test data in order for the reference to be anticipatory. See, e.g., Novo, 424 F.3d at 1355; Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326 (Fed. Cir. 2005) (“[P]roof of efficacy is not required in order for a reference to be enabled for purposes of anticipation.”).” slip op. at 22

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “Second, even if those sequences were truncated, the record does not support Patent Owner’s argument that a POSA would doubt that they have gRNA functionality. Patent Owner’s argument is premised on Dr. Marshall’s testimony that these sequences “are truncated to a point that would render them nonfunctional.” Ex. 2025 ¶ 200. But the references he cites do not support that position. See Ex. 2025 ¶ 202 (citing Ex. 1033 (“Fu”); Ex. 2044 (“Cencic”); and Ex. 2045 (“Mali”)). To the contrary, Fu evidences that “truncated gRNAs, with shorter regions of target complementarity <20 nucleotides in length” are functional and that truncation to 17 nt is beneficial. Ex. 1033, Abstr.; see also id. at 283 (“[W]e found that [truncated] gRNAs with 17 or 18 nucleotides of complementarity generally function efficiently at the intended target site and have improved specificities.”). Cencic and Mali likewise do not suggest that a 17 nt VT domain would lack gRNA functionality. See Ex. 2025 ¶ 202 (citing Cencic as showing “truncated gRNA tests showed that a guide sequence of only 16 nucleotides” abolished cleavage activity); Ex. 2045, Supp. Fig. 10 (“1-3 bp 5’ [gRNA] 11 Patent Owner asserts that Dr. Furneaux “adopted the definition of ‘truncated gRNAs’ as those with ‘regions of target complementarity <20 nucleotides in length” in paragraph 79 of his opening declaration. Sur-reply 8 n. 1. We disagree. The testimony in paragraph 79 refers to the particular results in Fu. See Ex. 1003 ¶ 78 (citing Ex. 1033). We see nothing there that suggests Dr. Furneaux agrees with Patent Owner’s position that any gRNA with a VT region of less than 20 nt is truncated. truncations are indeed well tolerated, but larger deletions lead to loss of activity”). Accordingly, we credit Dr. Furneaux’s testimony (see, e.g., Ex. 1003 ¶ 78, Ex. 1059 ¶¶ 73–75) over the competing testimony offered by Dr. Marshall on these points.” slip op. at 24

  Patent outcomesUS 10,900,034 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,900,034
• T-Mobile USA, Inc. v. Traxcell Technologies, LLCInstituted
  PTAB · May 24, 2022 · IPR2022-00669 · APJ Norman H Beamer · IPR · Institution

  The Board instituted IPR on claims 1–30 under all six §103 grounds and granted T-Mobile’s motion to join IPR2021-01552.

  RulingsInstitution decision

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

    “The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted unless the information presented in the petition and any preliminary response shows that “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” As elaborated below, we determine that Petitioner has established a reasonable likelihood that it would prevail with respect to at least one challenged claim, and we institute an inter partes review as to the challenged claims and grounds raised in the Petition. We also grant the Joinder Motion.” slip op. at 2

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

    “We are persuaded by Petitioner’s arguments. Because the Petition challenges the same claims on the same grounds using the same prior art, Kyocera factor (2) favors joinder. See Kyocera, IPR2013-00004, Paper 15 at 4. Indeed, the Board “routinely grants motions for joinder where the party seeking joinder introduces identical arguments and the same grounds raised in the existing proceeding.” Samsung Elecs. Co., Ltd. v. Raytheon Company, IPR2016-00962, Paper 12 at 9 (PTAB Aug. 24, 2016).” slip op. at 34

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Either proposal is consistent with the level of ordinary skill in the art reflected by the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). On this record, the level of ordinary skill is neither in dispute nor dispositive of any challenge. For purposes of this Decision, we apply Petitioner’s articulation.” slip op. at 10

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

    “Claim terms need only be construed to the extent necessary to resolve the controversy. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017). Petitioner states, “[n]o claim term requires express construction.” Pet. 11. Patent Owner states that it “considered the plain and ordinary meaning of each term of the ’196 patent as it would have been understood by one skilled in the art as of October 23, 2001.” Prelim. Resp. 3–4. For purposes of this Decision, we do not construe any claim terms.” slip op. at 10

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,918,196
• 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
• Hospira, Inc. v. Genentech, Inc.Rehearing granted
  PTAB · Oct 26, 2017 · IPR2017-00731 · APJ Zhenyu Yang · IPR · Rehearing

  The Board granted Hospira’s rehearing request and instituted review of claims 1–14 for obviousness over Baselga ’94 and Baselga ’96.

  RulingsRehearing decision

  • RehearingRehearing, grantedGranted

    “recites “in the absence of an anthracycline derivative.” In the Petition and the Preliminary Response, neither party proposed a construction for that term. Patent Owner, however, argues that “[e]ven if a person of ordinary skill would have chosen to combine an anti-ErbB2 antibody and a taxoid, there is no reason an ordinarily skilled artisan would have avoided anthracyclines as part of that treatment.” Prelim. Resp. 52 (emphasis added). In our Decision denying institution, we agreed with Patent Owner, stating that evidence of the record is “insufficient to suggest that an ordinary artisan would have avoided anthracyclines while pursuing the combination therapy with anti-ErbB2 antibody and a taxoid in a treatment regimen for humans.” Dec. 10 (emphasis added). In its Request for Rehearing, Petitioner contends that we erred in interpreting the limitation “in the absence of an anthracycline derivative” as requiring “avoidance” of an anthracycline derivative. Reh’g Req. 6. According to Petitioner, this term “is a negative limitation that is satisfied by anti-ErbB2 antibody–paclitaxel combinations that do not include an [anthracycline] derivative.” Id. at 5. After reconsidering the current record, we find Petitioner’s argument persuasive. In particular, because Baselga ’94 suggests a therapeutic composition consisting of an anti-ErbB2 antibody and paclitaxel, and does not suggest that doxorubicin must necessarily be included as part of the same treatment regimen, we are persuaded that the reference satisfies the limitation “in the absence of an anthracycline derivative.” Cf. Upsher-Smith Labs., Inc. v. Pamlab, L.L.C., 412 F.3d 1319, 1322 (Fed. Cir. 2005) (concluding the prior art anticipates a claim requiring a composition “essentially free of antioxidants,” because the prior art teaches “optional inclusion” of antioxidants, “despite no express teaching to exclude the antioxidants”).” slip op. at 17

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

    “In sum, Petitioner has presented sufficient evidence, for purposes of instituting trial, to show that in considering prior therapy received, an ordinary artisan would have been motivated to treat patients with ErbB2- overexpressing breast cancer by administering a combination of an anti- ErbB2 antibody and a taxoid, and “in the absence of an anthracycline derivative.”” slip op. at 18

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

    “Petitioner, however, points to other evidence to show that prior art teaches an ordinary artisan to combine an anti-ErbB2 antibody with a taxoid. Specifically, Petitioner refers to Baselga ʼ94 for teaching that, in mouse xenografts, “individual treatment with either anti-HER2 4D5 or paclitaxel alone resulted in 35% growth inhibition whereas the combination ‘resulted in a major antitumor activity with 93% inhibition of growth’ without increasing toxicity.” Id. at 45 (citing Ex. 1005 at 4). Similarly, Baselga ’96, citing Baselga ’94, teaches that “[i]n preclinical studies, both in vitro and in xenografts, rhuMAb HER2 markedly potentiated the antitumor effects of several chemotherapeutic agents, including … paclitaxel without increasing their toxicity.” Id. at 44 (quoting Ex. 1004, 15). Based on these teachings, we are persuaded that an ordinary artisan would have had a reason to treat HER2-positive breast cancer patients with a combination of rhuMAb HER2 and a taxoid.” slip op. at 12

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

    “Patent Owner argues that Exhibit 2029, which states that “breast cancers that overexpress p185 [i.e., HER2] will not respond well to Taxol,” teaches away from the claimed combination therapy. Prelim. Resp. 51 (citing Ex. 2029,5 1362). We are not persuaded on this record. In an obviousness inquiry, we must analyze the prior art as a whole, and not individually. See In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (explaining that the question is “whether there is something in the prior art as a whole to suggest the desirability, and thus the obviousness, of making the combination”). Other evidence of record shows paclitaxel had been approved for treating breast cancer (see, e.g., Ex. 1025, 10), demonstrates synergy of paclitaxel and an anti-ErbB2 antibody in human breast cancer xenografts (see, e.g., Ex. 1005, 4; Ex. 1004, 15), and suggests clinical trials of the combination therapy (see, e.g., Ex. 1005, 4; Ex. 1004, 15). Weighing all evidence of record, we are not persuaded that prior art as a whole teaches away from combining paclitaxel and an anti-ErbB2 antibody in treating HER2-positive cancers.” slip op. at 14

  Claim construction§ 103 obviousness
  Patents in suitUS 7,846,441
• Mylan Pharmaceuticals Inc. / Mylan Laboratories Limited v. Ucb Pharma GmbHNo claims unpatentable
  PTAB · Jul 19, 2017 · IPR2016-00517 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 3, 4, and 6–8 were held not unpatentable because Petitioner did not prove either obviousness ground by a preponderance of the evidence.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “For the purpose of this decision, we accept Petitioner’s undisputed contention that: [a] person of ordinary skill in the art would have a Ph.D. in chemistry, medicinal chemistry, pharmacology, or a related field, and at least one year of industrial exposure to drug discovery, drug design, and synthesis. In lieu of an advanced degree, the individual may have additional years of industry experience, including, for example, in drug discovery, drug synthesis, and structure-activity work. Pet. 6 (citing Ex. 1003 ¶ 20); see Prelim. Resp. 9; PO Resp. 6. Based on our review of the ’772 patent, the types of problems and solutions described in the ’772 patent and cited prior art, we adopt Petitioner’s definition of a person of ordinary skill in the art at the time of the claimed invention. We note that the applied prior art also reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

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

    “the broadest reasonable construction in light of the specification of the patent in which they appear. See Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard); 37 C.F.R. § 42.100(b). Under that standard, and absent any special definitions, we give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only those terms which are in controversy need to be construed, and only to the extent necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Petitioner submits that the “claims in the ʼ772 patent are presumed to take on their ordinary and customary meaning based on the broadest reasonable interpretation of the claim language.” Pet. 6. Patent Owner “does not dispute Petitioner’s position that no claim terms require construction, which the Board also accepted for purposes of institution.” PO Resp. 7 (citing Pet. 6; Inst. Dec. 7). In our Decision on Institution, we determined that “for purposes of this Decision, none of the terms in the challenged claims require express construction at this time.” Inst. Dec. 7. As in the Decision on Institution, we apply the broadest reasonable interpretation standard here, and see no reason to construe explicitly any claim term. B. Principles of Law” slip op. at 8

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

    “Petitioner, however, fails to point to any evidence that 5-HMT is metabolized through the CYP2D6 pathway, or that administering 5-HMT would have resulted in the same risks of drug interaction and adverse effects that Petitioner contends are the result of administering tolterodine. See Pet. 22–24 (describing alleged problems associated with tolterodine, not 5 HMT); Ex. 1003 ¶¶ 95–100 (Dr. Patterson’s testimony regarding the drawbacks of tolterodine). Indeed, such an argument appears to undermine Petitioner’s position, discussed in Section III.D.1 supra, that one of ordinary skill in the art would have selected 5-HMT as a lead compound over tolterodine to avoid the CYP2D6 metabolic pathway, and Dr. Patterson’s testimony that the prior art collectively “indicated to a skilled drug designer interested in overactive bladder treatment that 5-HMT would avoid the issues associated with dosing [] tolterodine.” Ex. 1003 ¶ 101. Petitioner’s argument also is contradicted by Dr. Patterson’s testimony that “5-HMT is not metabolized by both CYP2D6 and CYP3A4, but only by CYP3A4.” Id. ¶ 111; see also Ex. 1010, 289 (Postlind indicating that 5-HMT is not a CYP2D6 substrate).” slip op. at 25

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “Following our weighing of the experts’ testimony, we find that Dr. Roush’s testimony better addresses the issue at hand and we credit that testimony over Dr. Patterson’s testimony. Dr. Patterson opines generally that the “presence of two hydroxyl groups around the left most aromatic ring (shown above in blue) would have created a product likely to have decreased oral bioavailability compared to tolterodine because of its hydrophilicity and thus lower than acceptable lipophilicity” (Ex. 1003 ¶ 112), and that it “would [have been] a matter of routine experimentation” to confirm that 5-HMT could have significantly less bioavailability than its parent, tolterodine” (Ex. 1003 ¶ 115). Dr. Patterson, however, did not perform any experiments to confirm 5-HMT’s oral bioavailability, and cites to no further evidence to support his opinions. See Ex. 2022 ¶ 92; compare Brynne (Ex.1011) discussed supra § III.C.2. Dr. Roush, on the other hand, conducts an analysis of the compound under the “Rule of 5” to determine that “5-HMT does not meet a single factor, much less two, of the rule” thus teaching the skilled artisan “away from concluding that 5-HMT had an oral absorption problem.” PO Resp. 26– 27 (citing Ex. 2022 ¶¶ 56–58, 87, 92). At oral hearing, Patent Owner restated that the analysis under the Rule of 5 indicates that 5-HMT was “not even close to being a problem . . . for all four of these properties, 5-HMT says there’s no red flags; there’s no problem,” and that “Dr. Patterson admitted in his deposition, 5-HMT does not violate the Rule of Five.” Tr. 67:35–68:3; 68:17–21; see Ex. 2020 180:14–181:14.” slip op. at 31

  Patent outcomesUS 7,985,772 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,985,772
• Mylan Pharmaceuticals Inc. / Mylan Laboratories Limited v. Ucb Pharma GmbHNo claims unpatentable
  PTAB · Jul 19, 2017 · IPR2016-01665 · APJ Michelle N Ankenbrand · IPR · Final written decision

  Claims 1–5 and 21–24 were not shown unpatentable under either § 103 ground because the petitioner did not establish the motivation and reasonable expectation of success needed to reach the claimed compounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “art. For the purpose of this decision, we accept Petitioner’s undisputed contention that: [a] person of ordinary skill in the art would have a Ph.D. in chemistry, medicinal chemistry, pharmacology, or a related field, and at least one year of industrial exposure to drug discovery, drug design, and synthesis. In lieu of an advanced degree, the individual may have additional years of industry experience, including, for example, in drug discovery, drug synthesis, and structure-activity work. Pet. 6 (citing Ex. 1003 ¶ 23); see Resp. 6. Based on our review of the ’650 patent, the types of problems and solutions described in the ’650 patent and cited prior art, we adopt Petitioner’s definition of a person of ordinary skill in the art at the time of the claimed invention. We note that the applied prior art also reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

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

    “the broadest reasonable construction in light of the specification of the patent in which they appear. See Cuozzo Speed Techs., LLC v. Lee, 136 S.Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard); 37 C.F.R. § 42.100(b). Under that standard, and absent any special definitions, we give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only those terms which are in controversy need to be construed, and only to the extent necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Petitioner submits that the “claims in the ʼ650 patent are presumed to take on their ordinary and customary meaning based on the broadest reasonable interpretation of the claim language.” Pet. 6. Patent Owner “does not dispute Petitioner’s position that no claim terms require construction, which the Board also accepted for purposes of institution.” Resp. 7 (citing Pet. 6; Inst. Dec. 7). In our Institution Decision, we determined that “no claim term requires express construction.” Inst. Dec. 7. After reviewing the entire record developed during trial, we affirm our determination from the Institution Decision that no claim term requires express construction to resolve the parties’ dispute.” slip op. at 8

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “Following our weighing of the experts’ testimony, we find that Dr. Roush’s testimony better addresses the issue at hand and we credit that testimony over Dr. Patterson’s testimony. Dr. Patterson opines generally that the “presence of two hydroxyl groups around the left most aromatic ring . . . would have created a product likely to have decreased oral bioavailability compared to tolterodine because of its hydrophilicity and thus lower than acceptable lipophilicity” (Ex. 1003 ¶ 112), and that it “would [have been] a matter of routine experimentation” to confirm that 5-HMT could have significantly less bioavailability than its parent, tolterodine” (Ex. 1003 ¶ 115). Dr. Patterson, however, did not perform any experiments to confirm 5-HMT’s oral bioavailability, and cites to no further evidence to support his opinions. See Ex. 2022 ¶ 92; compare Brynne (Ex. 1011) discussed supra § II.D.1. Dr. Roush, on the other hand, conducts an analysis of the compound under the “Rule of 5” to determine that “5-HMT does not meet a single factor, much less two, of the rule” thus teaching the skilled artisan “away from concluding that 5-HMT had an oral absorption problem.” Resp. 28–29 (citing Ex. 2022 ¶¶ 56–58, 87, 92). At oral hearing, Patent Owner restated that the analysis under the Rule of 5 indicates that 5-HMT was “not even close to being a problem . . . for all four of these properties, 5-HMT says there’s no red flags; there’s no problem,” and that “Dr. Patterson admitted in his deposition, 5-HMT does not violate the Rule of Five.” Tr. 67:35–68:3; 68:17–21; see Ex. 2020, 180:14–181:14. Regarding Petitioner’s reliance on the statement in Brynne that “[t]olterodine is tenfold more lipophilic than 5-HM[T], and consequently tolterodine penetrates membranes more rapidly,” Patent Owner does not appear to dispute the substance of that statement. Although such a statement illustrates a relative relationship between the lipophilicity of 5-HMT and tolterodine, it does not demonstrate that the lipophilicity of 5-HMT would have presented an absorption problem that would have led one of ordinary skill in the art to modify 5-HMT. Even if 5-HMT were considered by one of ordinary skill in the art to be less lipophilic than tolterodine, and thereby less rapidly absorbed, the record lacks sufficient evidence regarding the actual properties of 5-HMT for us to conclude that 5-HMT’s lipophilicity would have presented a bioavailability problem.21 For these reasons, Petitioner’s assertion that 5-HMT “may have bioavailability concerns” that would have prompted one of ordinary skill in the art to modify 5-HMT is unpersuasive. Reply 13.” slip op. at 31

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

    “On the complete record before us, we are unpersuaded that Petitioner carries its burden of demonstrating that 5-HMT has a bioavailability problem that would have motivated one of ordinary skill in the art to modify its structure. Regarding the lipophilicity profile of 5-HMT, Petitioner does not provide, or attempt to provide, any actual (as opposed to relative) data concerning the bioavailability of 5-HMT. Cf. supra § II.D.2 (Brynne comparing lipophilicity of tolterodine to lipophilicity of 5-HMT). Although data is not required, and although we do not find that absence of data alone to be fatal to Petitioner’s position on this issue, the absence of any data concerning the actual bioavailability of 5-HMT leaves Petitioner’s argument solely supported by expert testimony. We now turn to the contradictory statements of the parties’ experts. Following our weighing of the experts’ testimony, we find that Dr. Roush’s testimony better addresses the issue at hand and we credit that testimony over Dr. Patterson’s testimony. Dr. Patterson opines generally that the “presence of two hydroxyl groups around the left most aromatic ring . . . would have created a product likely to have decreased oral bioavailability compared to tolterodine because of its hydrophilicity and thus lower than acceptable lipophilicity” (Ex. 1003 ¶ 112), and that it “would [have been] a matter of routine experimentation” to confirm that 5-HMT could have significantly less bioavailability than its parent, tolterodine” (Ex. 1003 ¶ 115). Dr. Patterson, however, did not perform any experiments to confirm 5-HMT’s oral bioavailability, and cites to no further evidence to support his opinions. See Ex. 2022 ¶ 92; compare Brynne (Ex. 1011) discussed supra § II.D.1.” slip op. at 30

  Patent outcomesUS 6,858,650 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,858,650
• Mylan Pharmaceuticals Inc. / Mylan Laboratories Limited v. Ucb Pharma GmbHNo claims unpatentable
  PTAB · Jul 19, 2017 · IPR2016-01636 · APJ Michelle N Ankenbrand · IPR · Final written decision

  Claims 1–5 and 21–24 were not shown unpatentable under either § 103 ground because the evidence did not establish a reason to make the claimed modifications with a reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “art. For the purpose of this decision, we accept Petitioner’s undisputed contention that: [a] person of ordinary skill in the art would have a Ph.D. in chemistry, medicinal chemistry, pharmacology, or a related field, and at least one year of industrial exposure to drug discovery, drug design, and synthesis. In lieu of an advanced degree, the individual may have additional years of industry experience, including, for example, in drug discovery, drug synthesis, and structure-activity work. Pet. 6 (citing Ex. 1003 ¶ 23); see Resp. 6. Based on our review of the ’650 patent, the types of problems and solutions described in the ’650 patent and cited prior art, we adopt Petitioner’s definition of a person of ordinary skill in the art at the time of the claimed invention. We note that the applied prior art also reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

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

    “the broadest reasonable construction in light of the specification of the patent in which they appear. See Cuozzo Speed Techs., LLC v. Lee, 136 S.Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard); 37 C.F.R. § 42.100(b). Under that standard, and absent any special definitions, we give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only those terms which are in controversy need to be construed, and only to the extent necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Petitioner submits that the “claims in the ʼ650 patent are presumed to take on their ordinary and customary meaning based on the broadest reasonable interpretation of the claim language.” Pet. 6. Patent Owner “does not dispute Petitioner’s position that no claim terms require construction, which the Board also accepted for purposes of institution.” Resp. 7 (citing Pet. 6; Inst. Dec. 7). In our Institution Decision, we determined that “no claim term requires express construction.” Inst. Dec. 7. After reviewing the entire record developed during trial, we affirm our determination from the Institution Decision that no claim term requires express construction to resolve the parties’ dispute.” slip op. at 8

  • BurdenNot shown unpatentable

    “II. DISCUSSION Petitioner bears the burden of proving unpatentability of the challenged claims, and that burden never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner must establish the facts supporting its challenge by a preponderance of the evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). Below, we explain why Petitioner has not met its burden with respect to the challenged claims.” slip op. at 7

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

    “On the complete record before us, we are unpersuaded that Petitioner carries its burden of demonstrating that 5-HMT has a bioavailability problem that would have motivated one of ordinary skill in the art to modify its structure. Regarding the lipophilicity profile of 5-HMT, Petitioner does not provide, or attempt to provide, any actual (as opposed to relative) data concerning the bioavailability of 5-HMT. Cf. supra § II.D.2 (Brynne comparing lipophilicity of tolterodine to lipophilicity of 5-HMT). Although data is not required, and although we do not find that absence of data alone to be fatal to Petitioner’s position on this issue, the absence of any data concerning the actual bioavailability of 5-HMT leaves Petitioner’s argument solely supported by expert testimony. We now turn to the contradictory statements of the parties’ experts. Following our weighing of the experts’ testimony, we find that Dr. Roush’s testimony better addresses the issue at hand and we credit that testimony over Dr. Patterson’s testimony. Dr. Patterson opines generally that the “presence of two hydroxyl groups around the left most aromatic ring . . . would have created a product likely to have decreased oral bioavailability compared to tolterodine because of its hydrophilicity and thus lower than acceptable lipophilicity” (Ex. 1003 ¶ 112), and that it “would [have been] a matter of routine experimentation” to confirm that 5-HMT could have significantly less bioavailability than its parent, tolterodine” (Ex. 1003 ¶ 115). Dr. Patterson, however, did not perform any experiments to confirm 5-HMT’s oral bioavailability, and cites to no further evidence to support his opinions. See Ex. 2022 ¶ 92; compare Brynne (Ex. 1011) discussed supra § II.D.1.” slip op. at 30

  Patent outcomesUS 6,858,650 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,858,650
• Mylan Pharmaceuticals Inc. / Mylan Laboratories Limited et al. v. Ucb Pharma GmbHNo claims unpatentable
  PTAB · Jul 19, 2017 · IPR2016-01596 · APJ Michelle N Ankenbrand · IPR · Final written decision

  Claims 1–5 and 21–24 were not shown unpatentable under either § 103 ground because the evidence did not establish a reason to make the claimed modifications with a reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “art. For the purpose of this decision, we accept Petitioner’s undisputed contention that: [a] person of ordinary skill in the art would have a Ph.D. in chemistry, medicinal chemistry, pharmacology, or a related field, and at least one year of industrial exposure to drug discovery, drug design, and synthesis. In lieu of an advanced degree, the individual may have additional years of industry experience, including, for example, in drug discovery, drug synthesis, and structure-activity work. Pet. 6 (citing Ex. 1003 ¶ 23); see Resp. 6. Based on our review of the ’650 patent, the types of problems and solutions described in the ’650 patent and cited prior art, we adopt Petitioner’s definition of a person of ordinary skill in the art at the time of the claimed invention. We note that the applied prior art also reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

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

    “the broadest reasonable construction in light of the specification of the patent in which they appear. See Cuozzo Speed Techs., LLC v. Lee, 136 S.Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard); 37 C.F.R. § 42.100(b). Under that standard, and absent any special definitions, we give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only those terms which are in controversy need to be construed, and only to the extent necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Petitioner submits that the “claims in the ʼ650 patent are presumed to take on their ordinary and customary meaning based on the broadest reasonable interpretation of the claim language.” Pet. 6. Patent Owner “does not dispute Petitioner’s position that no claim terms require construction, which the Board also accepted for purposes of institution.” Resp. 7 (citing Pet. 6; Inst. Dec. 7). In our Institution Decision, we determined that “no claim term requires express construction.” Inst. Dec. 7. After reviewing the entire record developed during trial, we affirm our determination from the Institution Decision that no claim term requires express construction to resolve the parties’ dispute.” slip op. at 8

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “Following our weighing of the experts’ testimony, we find that Dr. Roush’s testimony better addresses the issue at hand and we credit that testimony over Dr. Patterson’s testimony. Dr. Patterson opines generally that the “presence of two hydroxyl groups around the left most aromatic ring . . . would have created a product likely to have decreased oral bioavailability compared to tolterodine because of its hydrophilicity and thus lower than acceptable lipophilicity” (Ex. 1003 ¶ 112), and that it “would [have been] a matter of routine experimentation” to confirm that 5-HMT could have significantly less bioavailability than its parent, tolterodine” (Ex. 1003 ¶ 115). Dr. Patterson, however, did not perform any experiments to confirm 5-HMT’s oral bioavailability, and cites to no further evidence to support his opinions. See Ex. 2022 ¶ 92; compare Brynne (Ex. 1011) discussed supra § II.D.1. Dr. Roush, on the other hand, conducts an analysis of the compound under the “Rule of 5” to determine that “5-HMT does not meet a single factor, much less two, of the rule” thus teaching the skilled artisan “away from concluding that 5-HMT had an oral absorption problem.” Resp. 28–29 (citing Ex. 2022 ¶¶ 56–58, 87, 92). At oral hearing, Patent Owner restated that the analysis under the Rule of 5 indicates that 5-HMT was “not even close to being a problem . . . for all four of these properties, 5-HMT says there’s no red flags; there’s no problem,” and that “Dr. Patterson admitted in his deposition, 5-HMT does not violate the Rule of Five.” Tr. 67:35–68:3; 68:17–21; see Ex. 2020, 180:14–181:14. Regarding Petitioner’s reliance on the statement in Brynne that “[t]olterodine is tenfold more lipophilic than 5-HM[T], and consequently tolterodine penetrates membranes more rapidly,” Patent Owner does not appear to dispute the substance of that statement. Although such a statement illustrates a relative relationship between the lipophilicity of 5-HMT and tolterodine, it does not demonstrate that the lipophilicity of 5-HMT would have presented an absorption problem that would have led one of ordinary skill in the art to modify 5-HMT. Even if 5-HMT were considered by one of ordinary skill in the art to be less lipophilic than tolterodine, and thereby less rapidly absorbed, the record lacks sufficient evidence regarding the actual properties of 5-HMT for us to conclude that 5-HMT’s lipophilicity would have presented a bioavailability problem.21 For these reasons, Petitioner’s assertion that 5-HMT “may have bioavailability concerns” that would have prompted one of ordinary skill in the art to modify 5-HMT is unpersuasive. Reply 13.” slip op. at 31

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

    “On the complete record before us, we are unpersuaded that Petitioner carries its burden of demonstrating that 5-HMT has a bioavailability problem that would have motivated one of ordinary skill in the art to modify its structure. Regarding the lipophilicity profile of 5-HMT, Petitioner does not provide, or attempt to provide, any actual (as opposed to relative) data concerning the bioavailability of 5-HMT. Cf. supra § II.D.2 (Brynne comparing lipophilicity of tolterodine to lipophilicity of 5-HMT). Although data is not required, and although we do not find that absence of data alone to be fatal to Petitioner’s position on this issue, the absence of any data concerning the actual bioavailability of 5-HMT leaves Petitioner’s argument solely supported by expert testimony. We now turn to the contradictory statements of the parties’ experts. Following our weighing of the experts’ testimony, we find that Dr. Roush’s testimony better addresses the issue at hand and we credit that testimony over Dr. Patterson’s testimony. Dr. Patterson opines generally that the “presence of two hydroxyl groups around the left most aromatic ring . . . would have created a product likely to have decreased oral bioavailability compared to tolterodine because of its hydrophilicity and thus lower than acceptable lipophilicity” (Ex. 1003 ¶ 112), and that it “would [have been] a matter of routine experimentation” to confirm that 5-HMT could have significantly less bioavailability than its parent, tolterodine” (Ex. 1003 ¶ 115). Dr. Patterson, however, did not perform any experiments to confirm 5-HMT’s oral bioavailability, and cites to no further evidence to support his opinions. See Ex. 2022 ¶ 92; compare Brynne (Ex. 1011) discussed supra § II.D.1.” slip op. at 30

  Patent outcomesUS 6,858,650 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,858,650
• Blue Coat Systems, Inc. v. Finjan, Inc.Rehearing granted
  PTAB · Jul 18, 2017 · IPR2016-01444 · APJ Patrick M Boucher · IPR · Rehearing

  Granted Blue Coat’s rehearing request and instituted review of claims 1, 4–6, 9, 12–14, 17, 24, 35, and 37; the petition showed a reasonable likelihood of prevailing on the asserted § 103 grounds.

  RulingsRehearing decision

  • RehearingRehearing, grantedGranted

    “reexamination proceeding. Of particular relevance, the reexamination concluded with a Reexamination Certificate issued on November 28, 2016, including a claim for the benefit of the November 8, 1996 filing date of U.S. Provisional Appl. No. 60/030,639 (“the ’639 provisional application”). Ex. 3006 at [60]. In denying the Petition, the Prior Decision noted that “Petitioner has taken no steps to explain or respond to the effect of these developments on its argument.” Dec. 7. This remains true. Nevertheless, we agree with Petitioner that our Prior Decision gave insufficient consideration to the Petition’s assertion that “U.S. Patent No. 7,613,926 [(“the ’926 patent”), i.e., an intermediate patent in the priority chain of the ’086 patent] fails to claim priority to the ’639 provisional application and instead the earliest priority document cited in the ’926 patent is [the ’194 patent].” Pet. 5 (citing Ex. 1012, col. 1, ll. 8–32); see Req. Reh’g 4–5, 6 n.4, 7–9. For a claim of a patent to be entitled to the effective filing date of an earlier filed application, each application in the priority chain must refer to the earlier filed application. Encyclopaedia Britannica, Inc. v. Alpine Elecs. of Am., Inc., 609 F.3d 1345, 1350–52 (Fed. Cir. 2010). Accordingly, we grant Petitioner’s Rehearing Request and proceed to the merits of the Petition.” slip op. at 8

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

    “a formally defined safety policy” and allows checking “with certainty, that the proof is valid and hence the foreign code is safe to execute.” Ex. 1004, 107. Thus, Petitioner argues that one of ordinary skill in the art would reasonably understand Necula to teach that its proof-carrying code adds to the foreign code, consistent with the construction of “append” that we apply herein, and Petitioner articulates sufficient reasoning with rational underpinning to apply that teaching to Swimmer’s representation of DSP data. See Pet. 46–49. This is not an instance, for example, in which Petitioner relies on a characterization of the problem provided by the patent to derive its reasoning. Cf., e.g., Mintz v. Dietz & Watson, Inc., 679 F.3d 1372 (Fed. Cir. 2012). Indeed, Patent Owner’s contention that “the storage of the DSP in a database is one of the key features that distinguishes the ‘086 Patent over the prior art” dilutes the strength of its argument. The contrary positions of the parties’ declarants in their testimonial evidence creates a genuine issue of material fact, which we resolve in the light most favorable to Petitioner for purposes of this Decision. 37 C.F.R. § 42.108(c). Accordingly, we conclude that Petitioner has made a sufficient showing also with respect to these elements, and that Petitioner demonstrates a reasonable likelihood of prevailing on its challenge of claims 1 and 9. See infra Section II.E.10 (discussing limits in our weighing of Patent Owner’s Secondary Considerations evidence in this Preliminary Proceeding).” slip op. at 21

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

    “be considered under 35 U.S.C. § 312 because Petitioner has failed to name all real parties in interest, as required by the statute.” Prelim. Resp. 9. The parties agree that, on June 12, 2016, Symantec Corporation (“Symantec”) announced that it was acquiring Petitioner. Pet. 13; Prelim. Resp. 9. The Petition discloses that “[t]he transaction is expected to close in the third quarter of 2016,” and that “[a]s of the filing date of this petition the transaction has not been executed.” Pet. 13. The Petition further represents that “Symantec has not controlled or had the ability to control the filing of this petition, whether through funding or strategy.” Id. As noted above, Petitioner expressly identified Symantec as a real party in interest before any decision on institution of an inter partes review was made. Paper 8, 2. Patent Owner contends that “Symantec had control over the filing of the Petition during the period between the announcement of the acquisition and the closing of the acquisition,” which it asserts occurred on August 1, 2016. Prelim. Resp. 9. Patent Owner also contends that it “understands from the underlying litigation that ‘Blue Coat Systems, Inc.’ no longer exists 1 A petition to accept an unintentionally delayed claim of priority for the ’926 patent, claiming the benefit of U.S. Patent Appl. No. 08/790,097 which was filed January 29, 1997, was dismissed by the Office on June 13, 2017. Exs. 1027, 3007. A renewed petition was filed on June 16, 2017. Ex. 3008. At this time, the Office has not ruled on the renewed petition, and that pending petition accordingly does not affect our determination of the challenged claims’ effective filing date for purposes of this Decision. as an entity, or at least goes by ‘Blue Coat Systems LLC’ for at least the last two months.” Id. at 10. We have reviewed the evidence provided by Patent Owner and find it insufficient to support Patent Owner’s allegation that Petitioner has failed to comply with 35 U.S.C. § 312(a) or 37 C.F.R. § 42.8(a)(3). That evidence is, at best, suggestive regarding an issue that is not jurisdictional. Lumentum Holdings, Inc. v. Capella Photonics, Inc., Case IPR2015-00739, slip op. (PTAB Mar. 4, 2016) (Paper 38) (precedential).” slip op. at 9

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

    “1. “Downloadable” Every challenged independent claim recites a “Downloadable,” and Petitioner contends that “[t]he broadest reasonable interpretation of the term ‘downloadable’ includes ‘an executable application program, which is downloaded from a source computer and run on a destination computer.’” Pet. 15. Petitioner’s proposed construction parallels a statement made in the Specification of the ’194 patent. Ex. 1012, col. 1, ll. 44–47. Patent Owner “does not dispute” this proposed construction, which we adopt for purposes of this Decision. Prelim. Resp. 5. 2. “database” Challenged independent claim 42 recites “a database of Downloadable security profiles.” Petitioner contends that “[t]he broadest reasonable interpretation of the term ‘database’ includes ‘a collection of interrelated data organized according to a database schema to serve one or more applications.’” Pet. 15. Patent Owner also “does not dispute” this proposed construction, but argues that “the practical import of Petitioner’s proposed construction for the term ‘database,’ is that log files, such as Swimmer’s audit trail, do not fall within the scope of the claims.” Prelim. Resp. 5–6. That is, Patent Owner contends that “logging functionality is distinct from storing in a database, which allows DSP to be efficiently retrieved from the database,” as compared with the “record-keeping” functionality of an “event log.” Id. at 7. Patent Owner’s argument was considered by the panel in IPR2015- 01892, which concluded that, “[t]o the extent that construction would exclude a log file consisting of an ‘unstructured collection of data on a computer,’ . . . [an] unstructured log file would not be a database,” but the construction does not “necessarily exclude[] all log files from being databases.” 1892 Dec. 16 (emphasis in original). We agree with the reasoning expressed in the Final Written Decision of IPR2015-01892. Id. at 12–17. For purposes of this Decision, we adopt Petitioner’s proposed construction.” slip op. at 10

  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
  Patents in suitUS 8,079,086

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.