• Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. et al. v. Smart Mobile Technologies LLCSome claims unpatentable
  PTAB · Jan 23, 2024 · IPR2022-01248 · APJ Aaron W Moore · IPR · Final written decision

  Claims 14–21 and 23–26 are unpatentable under §103; claims 1–13 and 27–30 were not shown unpatentable because the asserted combinations failed to establish multiplexing.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “education.” Id. (citing Ex. 1003 ¶¶ 27–28). Patent Owner does not propose a level of ordinary skill and does not dispute Petitioner’s proposal. As Patent Owner does not dispute Petitioner’s characterization of the level of skill in the art, and because we find it generally consistent with the disclosures of the ’653 patent and the cited prior art, we adopt it. C.” slip op. at 10

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

    “Claim Construction Petitioner states that “no formal claim constructions are necessary in this proceeding.” Pet. 2. Patent Owner does seek an express construction of any claim term, and we thus conclude that we need not expressly construe any terms to resolve the issues before us. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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)). D.” slip op. at 10

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

    “d. Multiplexing Being “Well-Known” Petitioner additionally argues that multiplexing techniques were well- known. See Pet. 34; Pet. Reply 18. Even if that is correct, however, it is insufficient because Petitioner must show that it would have been obvious to modify Yegoshin to add multiplexing, and merely establishing that multiplexing was known in other contexts is insufficient to show how or why Yegoshin should be modified.” slip op. at 22

  • PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Granted

    “Patent Owner filed an opposition to the motion. See Paper 24. Patent Owner contends that the declaration is untimely and unfairly prejudicial because it circumvents our word count limitations and amounts to an additional brief because it analyzes claim construction and includes new cites to the record. See id. at 2–10. Having reviewed the parties’ positions, we grant the Motion. We note, however, that in view of the full record, and for the reasons below, our determination would not change even if we denied the motion. B.” slip op. at 9

  Patent outcomesUS 8,842,653 mixed
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,842,653
• Keysight Technologies, Inc. v. Centripetal Networks, Inc.Some claims unpatentable
  PTAB · Dec 15, 2023 · IPR2022-01097 · APJ Aaron W Moore · IPR · Final written decision

  Claims 1–3, 5–13, and 15–20 are unpatentable as obvious; claims 4 and 14 were not shown unpatentable because Sourcefire did not disclose the claimed responsive updating of an existing packet flow log entry.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not address this issue, and neither side argues that it might affect the patentability analysis or otherwise change the outcome. Thus, as 2 Sourcefire 3D System User Guide, Ver. 4.10, Mar. 16, 2011 (Ex. 1004). 3 U.S. Patent App. Pub. No. 2015/0207809 A1 (Ex. 1029). we did at institution, we apply Petitioner’s description of an ordinarily skilled artisan, as we find it consistent with the ’917 patent and the asserted prior art. B.” slip op. at 11

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

    “1. Threat Identifier and Threat Indicator Patent Owner identifies two terms that were construed in the ITC investigation involving the ’917 patent based on constructions agreed upon by the parties. PO Resp. 9. First, the parties in the ITC investigation agreed that “threat identifier” means “information that identifies one or more network threats.” Id. at 11 (citing Ex. 2004, 3). Second, the parties further agreed that “threat indicator” means “information that indicates a resource associated with a network threat,” “[f]or example, network addresses, ports, FQDNs, URLs, URIs, the type of threat, geographic information, anonymous proxies, actors, or the like.” Id. at 11–12 (citing Ex. 2004, 3). Patent Owner asserts that these constructions should be used in this proceeding. Id. at 12. Petitioner does not dispute these constructions, and we adopt them.4” slip op. at 12

  • ExcludeMotion to exclude, grantedGranted

    “Before we get to claim construction, we exclude Ex. 2018 as untimely because Patent Owner had the testimony before it filed the Response and was plainly aware of it, as it was alluded to in the Response. See PO Resp. 10; Mot. to Exclude Opp. 2 (admitting that the trial finished before the Response was filed and that Patent Owner filed other testimony excerpts with the Response). However, the exclusion is of little consequence because we find that the testimony would be devoid of probative value. Dr. Rubin is not a fact witness and has not been offered as an expert in this case. Patent Owner cites the testimony in an effort to show that Petitioner is taking inconsistent positions, but we fail to see how Petitioner’s conduct bears on the meaning of “flow” in the ’917 patent.” slip op. at 14

  • Expert testimonyDecided for petitioner

    “Before we get to claim construction, we exclude Ex. 2018 as untimely because Patent Owner had the testimony before it filed the Response and was plainly aware of it, as it was alluded to in the Response. See PO Resp. 10; Mot. to Exclude Opp. 2 (admitting that the trial finished before the Response was filed and that Patent Owner filed other testimony excerpts with the Response). However, the exclusion is of little consequence because we find that the testimony would be devoid of probative value. Dr. Rubin is not a fact witness and has not been offered as an expert in this case. Patent Owner cites the testimony in an effort to show that Petitioner is taking inconsistent positions, but we fail to see how Petitioner’s conduct bears on the meaning of “flow” in the ’917 patent.” slip op. at 14

  Patent outcomesUS 10,193,917 mixed
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 10,193,917
• 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
• Gaf Materials LLC v. Kirsch Research And Development, LLCAll claims unpatentable
  PTAB · May 24, 2022 · IPR2021-00192 · APJ Charles J Boudreau · IPR · Final written decision

  Claims 1–33 are unpatentable: claims 1, 8–12, and 19 are anticipated by Lou; the remaining claims are obvious over the stated Lou-based combinations.

  RulingsFinal written decision

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

    “patent. See Phillips, 415 F.3d at 1315–17. The term “extrusion lamination” does not appear anywhere in the ’482 patent outside of issued claim 1, but our understanding is supported by the prosecution history of the ’482 patent. Claim 1 as originally filed in the application that issued as the ’482 patent recited, in relevant part, “a reinforcing scrim of interwoven strands for supporting tensile forces in multiple directions; and at least one layer of thermoplastic material affixed to a side of the reinforcing scrim for providing a weather-resistant barrier.” Ex. 1002 (’482 patent prosecution history), 33. In response to a rejection of the claims as anticipated by U.S. Patent No. 5,523,357 to Peterson, describing a rubber mill calendering process, the applicant amended claim 1 to add the phrase “by extrusion lamination.” Id. at 71, 76. We find nothing to suggest that a person of ordinary skill in the art would have understood that amendment to add a requirement of an additional layer of thermoplastic material, separate and apart from the “at least one layer of thermoplastic material” already recited in the original claim, to serve as a binder between the scrim and the original layer of thermoplastic material. The applicant explained in remarks accompanying the amendment, “Peterson fails to disclose forming a thermoplastic layer over the reinforcing scrim by an extrusion lamination process.” Id. at 71 (italics, underlining, and capitalization omitted). We, thus, find that the added phrase specifies how the recited “thermoplastic material” must be “affixed” to “the side of the reinforcing scrim,” but does not alter the recited function of the thermoplastic material, namely, “for providing a weather-resistant barrier.” Although the applicant’s remarks further state that “[c]ontrarily [to the rubber mill calendering process of Peterson], the roofing underlayment of the present invention is formed by an extrusion lamination process which bonds the various layers together, including the pre-formed films, reinforcement scrim, and slip-resistant material” (id.), claim 1 does not recite “pre-formed films” or “slip-resistant material”; such additional layers are recited in dependent claims 5 (“metallized film”) and 2 (“layer of slip-resistant material”), respectively (Ex. 1001, 6:29, 6:37). Looking finally to the extrinsic evidence of record, including the testimony of the parties’ experts and other exhibits filed by the parties, we find no persuasive evidence to show that the recitation of extrusion lamination requires an additional layer in addition to the recited scrim and the at least one layer of thermoplastic material affixed to a side of the scrim. In that regard, notwithstanding Patent Owner’s contentions, we are not persuaded that “extrusion lamination” and “extrusion coating” are mutually exclusive. Rather, we credit Mr. Kaczkowski’s testimony that extrusion coating would also be considered “extrusion lamination” if, for example, it “results in the extrudate being permanently bonded to the substrate.” Ex. 2020, 28:17–20. While Patent Owner argues that Mr. Kaczkowski’s statement “is nothing more than restatement of the extrusion coating process,” and “[t]o think otherwise would require believing that ‘extrusion coating’ involves a thermoplastic layer that is extruded, and thus coated, onto a substrate with the result being that it is not permanently bonded, i.e., it will delaminate from the substrate” (PO Sur-reply 5), we disagree with Patent Owner’s further contentions that “[s]uch a product makes no sense” and “[u]nder Petitioner’s theories, the [prior art] would not work” (id.). Although there could indeed be extrusion coating processes that would result in coatings that are not permanently bonded, it does not follow that the cited prior art used such processes. Further, although a laminate may be affixed to substrate by an adhesive or other binder, we find no persuasive evidence in the record that the binder must be a separate layer from the laminate.” slip op. at 21

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

    “the “reinforcing scrim of interwoven strands” recited in claim 1 and Lou’s polypropylene polymer 2 to the recited “thermoplastic material.” Id. at 22– 23. Petitioner further contends that Lou discloses “affixing the thermoplastic material by extrusion lamination,” citing Lou’s disclosures that “[e]xtruder 20 supplies polypropylene polymer 2 through a slit orifice to deposit a thin continuous coating on the surface of sheet 1” and that coated sheet 3 is pressed by a calendaring nip formed by heated and unheated rolls. Id. at 23 (quoting Ex. 1005, 2:34–44) (citing Ex. 1003 ¶ 19; Ex. 1005, 2:45– 49).” slip op. at 34

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

    “Having considered the parties’ respective arguments, we find that Petitioner’s contentions are supported by the evidence of record, and we find that Petitioner has articulated sufficient reasoning with rational underpinnings (including support both from the cited prior art and from Mr. Kaczkowski’s testimony) to combine the relevant teachings of Lou and Goodacre. We disagree with Patent Owner’s suggestion it is insufficient that Mr. Kaczkowski opined that a person of ordinary skill would have evaluated the proposed combination based on the combined teachings of the asserted references. As the Supreme Court has explained, When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103. KSR, 550 U.S. at 421. Patent Owner does not dispute Goodacre’s teachings or that combining those teachings with Lou would increase the tensile strength of Lou’s underlayment, but appears instead only to fault Mr. Kaczkowski for not determining whether those solutions would be less expensive than other alternatives. Such arguments are not persuasive. Although, as cited above, Petitioner alleges in the Petition that a skilled artisan would have recognized cross-lamination as “a simpler, less costly way to manufacture a nonwoven reinforcing scrim . . . consistent with Lou” (Pet. 37), we find that is only one among several reasons identified by Petitioner and Mr. Kaczkowski for the combination (see, e.g., id. at 34–35 (additionally identifying increased tensile strength as a well-known benefit of orienting polyolefin fabric)), each of which is independently persuasive.” slip op. at 53

  • ExcludeMotion to exclude, grantedGranted

    “Motion to Exclude. Federal Rule of Evidence 801 defines “hearsay” as a “a statement that: (1) the declarant does not make while testifying in the current trial or hearing; and (2) a party offers in evidence to prove the truth of the matter asserted in the statement.” Fed. R. Evid. 801(c). We agree with Petitioner that Patent Owner is offering Dr. Reitman’s testimony for its truth. As Petitioner points out, Dr. Reitman’s testimony is presented in the Patent Owner Response in alleged support of Patent Owner’s argument. See Reply Mot. Excl. 1 (citing PO Resp. 22 (“Maureen Reitman recognized that ‘extrusion coating’ and ‘extrusion lamination’ were two different processes”; “[A]s Ds. [sic] Reitman recognized, a POSITA would understand ‘extrusion coating’ to be different than ‘extrusion lamination.’”)). Further, Rule 802 provides that hearsay is not admissible unless a federal statute, the Federal Rules of Evidence, or other rules prescribed by the Supreme Court provide otherwise. Fed. R. Evid. 802. We agree with Petitioner that no exception or exclusion applies in this case. Mot. Excl. 1. Although, as Patent Owner contends, Federal Rule of Evidence 703 provides that “[a]n expert may base an opinion on facts or data in the case that the expert has been made aware of or personally observed,” and that “[i]f experts in the particular field would reasonably rely on those kinds of facts or data in forming an opinion on the subject, they need not be admissible for the opinion to be admitted,” we are not persuaded that opinions of others offered in litigation are the sort of “facts or data” that experts in the field of roofing underlayments would reasonably rely on in forming their own opinions.” slip op. at 64

  Patent outcomesUS 6,308,482 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,308,482
• 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

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.