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  • PTAB · Oct 14, 2025 · IPR2024-00422 · APJ Scott B Howard · IPR · Final written decision

    The Board held claims 1–152 unpatentable based on the asserted obviousness grounds and struck Section II of Petitioner’s reply claim-construction brief.

    RulingsFinal written decision
    • BurdenFwd all claims unpatentableUnpatentable

      “Decision issues pursuant to 35 U.S.C. § 318(a). For the reasons that follow, we determine that Petitioner has shown by a preponderance of the evidence that the challenged claims are unpatentable.” slip op. at 2

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

      “1. “Contracted to Display a TV Ad Petitioner argues that the term means “contracted to display any form” slip op. at 14

    • Strike new argumentGranted

      “FURTHER ORDERED that Section II of Petitioner’s Reply Claim Construction Brief is stricken from the record; and” slip op. at 80

    Patent outcomesUS 7,861,260 unpatentable
    Claim constructioncites Phillips · KSR · Graham
    Patents in suitUS 7,861,260
  • PTAB · Oct 14, 2025 · IPR2025-00128 · APJ Scott B Howard · IPR · Final written decision

    The Board held claims 1–152 unpatentable based on obviousness grounds and struck Section II of Petitioner’s Reply Claim Construction Brief.

    RulingsFinal written decision
    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner

      “1. “Contracted to Display a TV Ad Petitioner argues that the term means “contracted to display any form” slip op. at 14

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

      “d) Conclusion Regarding Claim 1 For the reasons set forth above, Petitioner has demonstrated by a preponderance of the evidence that the subject matter of claim 1 would have been obvious over Baig, Costa, and Zwicky. 5. Analysis of Claims 2–5, 7–9, 12, 15, 17, 21, 22, 24, 26–28, 31, 32, 34, 37, 42, 44, 53, 54–58, 61, 62, 69, 71–80, 83, 84, 86–88, 91, 94, 96, 100, 101, 103, 106, 116–119, 122, 125, 128, 135, 137– 145, 147, 148, 151, and 152 Petitioner argues that the combination of Baig, Costa, and Zwicky teaches the limitations recited in claims 2–5, 7–9, 12, 15, 17, 21, 22, 24, 26–28, 31, 32, 34, 37, 42, 44, 53, 54–58, 61, 62, 69, 71–80, 83, 84, 86–88, 91, 94, 96, 100, 101, 103, 106, 116–119, 122, 125, 128, 135, 137–145, 147, 148, 151, and 152 and that a person having ordinary skill in the art would have combined the teachings with a reasonable expectation of success. Pet. 28–60; 422Pet. 29–51. Petitioner’s arguments are supported by citations to the prior art and the testimony of Mr. Lett. See Pet. 28–60; 422Pet. 29–51. We have reviewed Petitioner’s arguments and evidence, agree with them, and, therefore, adopt Petitioner’s arguments and evidence as our own. Patent Owner does not separately address those claims. See PO Resp.; 422PO Resp. Instead, Patent Owner only relies on the arguments discussed above for claim 1. See PO Resp. 13–16; 422PO Resp. 13–16. For the same reason as discussed above in Section II.D.4(b), we do not agree with Patent Owner’s arguments regarding the reason to combine the references. Accordingly, Petitioner has shown by a preponderance of the evidence” slip op. at 50

    • Strike new argumentNew argument disregardedGranted

      “F. Sua Sponte Striking Section II of Petitioner’s Reply Claim Construction Brief Our order allowing post-hearing claim construction briefing stated that “[t]he parties may not address any issues besides claim construction.” Paper 38, 1. Despite that order, Section II of Petitioner’s Reply Claim Construction Brief addresses obviousness under Patent Owner’s proposed construction. See Pet. Reply Post-hearing Br. 2–3 (Titled: “The Petition’s Obviousness Theory Renders Claims 121 and 146 Obvious Even Under Patent Owner’s Improper Construction.”). Because the section is in violation of our order, we sua sponte strike that section. See 37 C.F.R. § 42.12.” slip op. at 74

    Patent outcomesUS 7,861,260 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 7,861,260
  • PTAB · Oct 14, 2025 · IPR2024-00421 · APJ Scott B Howard · IPR · Final written decision

    The Board held claims 1–152 unpatentable over the asserted prior art and struck Section II of Petitioner’s reply claim construction brief.

    RulingsFinal written decision
    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

      “d) Conclusion Regarding Claim 1 For the reasons set forth above, Petitioner has demonstrated by a” slip op. at 50

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

      “1. “Contracted to Display a TV Ad Petitioner argues that the term means “contracted to display any form” slip op. at 14

    • Strike new argumentGranted

      “F. Sua Sponte Striking Section II of Petitioner’s Reply Claim Construction Brief Our order allowing post-hearing claim construction briefing stated that “[t]he parties may not address any issues besides claim construction.” Paper 38, 1. Despite that order, Section II of Petitioner’s Reply Claim Construction Brief addresses obviousness under Patent Owner’s proposed construction. See Pet. Reply Post-hearing Br. 2–3 (Titled: “The Petition’s Obviousness Theory Renders Claims 121 and 146 Obvious Even Under Patent Owner’s Improper Construction.”). Because the section is in violation of our order, we sua sponte strike that section. See 37 C.F.R. § 42.12.” slip op. at 74

    Patent outcomesUS 7,861,260 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 7,861,260
  • PTAB · Nov 28, 2023 · IPR2023-00384 · APJ Kristen L Droesch · IPR · Final written decision

    Claims 9–12 are unpatentable under § 103 over Meyer, Zeff, Edlund, and Fisher; the Board did not reach the alternative ground adding Tittel.

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

      “1 Amazon.com, Inc., Amazon Web Services, Inc., and Amazon.com Services LLC, Inc. filed a motion for joinder and a petition in IPR2023-00384, which were granted. Accordingly, Amazon.com, Inc., Amazon Web Services, Inc., and Amazon.com Services LLC have been joined as a petitioner in this proceeding.” slip op. at 1

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

      “We do not agree with Patent Owner’s construction for “automatically with the BT computer system.” Under Phillips, the starting point for the analysis is the language of the claims themselves. See Phillips, 415 F.3d at 1314. Claim 9 recites “automatically with the BT computer system” and does not otherwise recite or require the acts recited in the claims that follow, such as “arranging for a third party computer system . . . to electronically tag a first computer of a first visitor visiting a website . . .” to be performed in whole or part by the BT computer system. Accordingly, based on the record evidence, we decline to adopt Patent Owner’s proposed construction for “automatically with the BT computer system.” As demonstrated in the analysis below, we need not further explicitly construe “automatically with the BT computer system” to resolve the controversy before us. See, e.g., Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 10

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

      “provide support for its construction, we do not agree that the proposed construction for “profile information” “derives directly from the specification of the ’615 Patent.” Patent Owner’s proposed construction has a broader in scope than the ’615 Patent Specification disclosures cited by Patent Owner as support. Without explanation, Patent Owner’s proposed property” and “demographic information about a visitor to a media property” (PO Resp. 7–8) (emphasis added), while the cited ’615 Patent Specification discloses that the “visitor’s profile “could be the observed behavior of the visitor on the media property, demographic information collected on the media property.” Ex. 1001, 3:37–44 (emphasis added); see also, e.g., Ex. 1001, 4:16–21, 4:64–67. In other words, without explanation, Patent Owner’s proposed construction for “profile information” encompasses the observed behavior, in general, of a media property visitor and the demographic information, in general, about a media property visitor, and is therefore broader than the cited ’615 Patent Specification, which more narrowly discloses the visitor’s observed behavior on the media property and the visitor’s demographic information collected on the media property. Patent Owner does not direct us to disclosure in the ’615 Patent Specification to support the full scope of Patent Owner’s proposed construction for “profile information.” In sum, based on the record evidence, we decline to adopt Patent Owner’s proposed construction for “profile information,” because the broad scope of the proposed construction is not supported by Patent Owner’s citations to the ’615 Patent Specification disclosure. Consistent with the cited ’615 Patent Specification disclosures, we instead construe “profile information” as “the observed behavior of the visitor on the media property, demographic information collected on the media property, or both.”8” slip op. at 11

    • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageNo construction neededDecided for petitioner

      “system.” Under Phillips, the starting point for the analysis is the language of the claims themselves. See Phillips, 415 F.3d at 1314. The language of claim 9 does not include limitations precluding the later occurring transfer of any profile information as a result of tagging the first computer of a first visitor visiting a first website. See Ex. 1001, 14:7–40. We also agree with Petitioner’s arguments that the language of claim 9, by use of the transitional phrase “comprising,” does not preclude the occurrence of “transferring to the third party computer system any profile information” after the step of “arranging for a third party computer system . . . to electronically tag a first computer of a first visitor visiting a first website, which occurs “at a first time.” See id. We also do not agree with Patent Owner’s arguments that the ’615 Patent Specification supports its construction. Although Patent Owner directs attention to the ’615 Patent Specification disclosures that the BT computer company stores a visitor’s collected profile information and does not transfer it to the second media property, but asks the second media property to tag the visitor or arrange for a tag to be placed (see PO Resp. 10; Ex. 1001, 9:47–54), and further discloses that the BT company has no economic incentive to transfer profile information to the second media property (see PO Resp. 11; Ex. 1001, 9:54–65), these disclosures do not provide sufficient support for Patent Owner’s requirement that “arranging for a third party computer system . . . to electronically tag a first computer of a first visitor visiting a first website” must not result in transfer of visitor profile information to the third party computer system. See PO Resp. 10–11.” slip op. at 16

    Patent outcomesUS 9,830,615 unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 9,830,615
  • 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
  • PTAB · Oct 25, 2022 · IPR2020-00021 · APJ Scott B Howard · IPR · Rehearing

    On rehearing, the Board held claims 1–10 unpatentable as obvious: claims 1–3, 5, and 7 over AAPA and Frezzolini; claims 4, 6, and 8–10 over AAPA, Frezzolini, and Iwamura.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “Updated Guidance. See Opp. Reh’g 4–8. Instead, Patent Owner argues that we correctly determined in the Final Written Decision that AAPA was the foundation or starting point of the ground. Id. However, the language that we relied upon from the Guidance Memo in the Final Written Decision has been deleted from the Updated Guidance. Compare Guidance Memo 6 (directing the PTAB to determine if the applicant admitted prior art is the foundation or starting point), with Updated Guidance (language omitted). Although we properly followed the Guidance Memo in the Final Written follow the clear and unambiguous requirements of the Updated Guidance. Moreover, Patent Owner does not direct us to any Federal Circuit case law that suggests using the foundation or starting point test of the Guidance Memo. See Opp. Reh’g 4–8. Although the Qualcomm panel was aware of the Guidance Memo (see 24 F.4th at 1373), the Federal Circuit neither discussed the test set out in the Guidance Memo, nor directed that the PTAB apply the foundation or starting point test. See 24 F.4th 1367.” slip op. at 22

    • Skill levelSkill level petitioner adoptedOther

      “Petitioner argues—supported by the testimony of Dr. Wood—that a person having ordinary skill in the art (“PHOSITA”) “would have had a bachelor’s degree in mechanical engineering, electrical engineering, or a similar discipline and at least two years of design experience with photovoltaic systems.” Pet. 20 (emphasis added) (citing Ex. 1011 ¶¶ 18– 22). In the Institution Decision, we adopted Petitioner’s description of a person having ordinary skill in the art, “except that we delete[d] the qualifier ‘at least’ to eliminate vagueness as to the amount of practical experience.” Inst. Dec. 15–16. Patent Owner does not address that determination. See PO Resp. Accordingly, for the reasons given in the Institution Decision, we adopt Petitioner’s proposed level of ordinary skill, except that we delete the qualifier “at least” to eliminate vagueness as to the amount of practical experience. See Inst. Dec. 16. Therefore, a person having ordinary skill in the art would have had a bachelor’s degree in mechanical engineering, electrical engineering, or a similar discipline and two years of design experience with photovoltaic systems.” slip op. at 10

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

      “Petitioner argues that all claim terms should be construed according to their ordinary and customary meaning at the time of the invention. Pet. 20. Patent Owner argues that two terms require explicit constructions: “the power line modem” and “the data signal coupler.” PO Resp. 20–22. Patent Owner’s proposed claim constructions limit the “power line modem” and the “data signal coupler” to DC power lines. PO Resp. 20–22. However, during the Oral Hearing, Patent Owner agreed that, consistent with the plain and ordinary meaning, the other limitations of the claims require that the components operate on DC power lines. Tr. 37:5–23. As discussed in more detail below, Petitioner’s combination of prior art references uses DC power lines. Accordingly, no express construction is needed to resolve any dispute in this proceeding. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 11

    • Strike new argumentNew argument disregardedDecided for petitioner

      “of the background knowledge possessed by a person of ordinary skill in the art.” Guidance Memo 6–7; Updated Guidance 4–5. Although Patent Owner had the opportunity to make such an argument in the Sur-reply when addressing the Guidance Memo (and by implication, the identical language of Updated Guidance), Patent Owner chose not to do so and, accordingly, forfeited the argument. See Paper 9, 7. Although Patent Owner raised the argument at the oral hearing,17 that is not enough to preserve the argument as no new arguments can by made during the Oral Hearing. See CTPG at 85– 86 (“During an oral hearing, a party . . . may only present arguments relied upon in the papers previously submitted.”); Dell, 818 F.3d at 1301 (“[T]he Board denied Acceleron its procedural rights by relying in its decision on a factual assertion introduced into the proceeding only at oral argument, after Acceleron could meaningfully respond.”). Just as a movant may not make a new argument in a request for rehearing, a party opposing such a request cannot raise new arguments that it did not make before. See Apple Inc. v. Taction Tech., Inc., IPR2022-00057, Paper 15 at 4 (“A request for rehearing is not an opportunity . . . to present new arguments.”) (Denying Request for Rehearing). Accordingly, because Patent Owner did not argue that the limitations taught by the AAPA were not known in the prior art in its Patent Owner Response or Sur-reply, that argument is forfeited and cannot be considered on rehearing.” slip op. at 24

    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,922,048
  • Ingenico Inc. v. Ioengine, LLCSome claims unpatentable
    PTAB · Sep 21, 2020 · IPR2019-00929 · APJ Elizabeth M Roesel · IPR · Final written decision

    Claims 55, 57–63, 67–72, 74, 77, 78, 81–87, 89, 92–98, 100, 103, 104, 106–112, 116–121, 123, and 126–129 are unpatentable; the remaining challenged claims were not shown unpatentable.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “the Board’s adopted definition of a POSITA. PO Resp. 3; Ex. 2139 ¶¶ 12, 13. Both parties’ experts state, however, that their opinions would not change based upon which party’s definition of a POSITA is adopted. Ex. 2139 ¶ 13; Ex. 2110, 240:24–241:6.” slip op. at 14

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

      “For these reasons, we find that Petitioner has shown by a” slip op. at 40

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

      “meet claims 74, 89, 100, and 123 because Davis “does not have two different devices on the client side.” PO Resp. 63–64. Patent Owner’s argument does not persuasively rebut Petitioner’s obviousness case, which relies on Iida, not Davis, to teach two devices on the client side—Iida’s digital camera 12 (a portable device) and terminal 14. Pet. 13–16, 60; Ex. 1003 ¶ 57, Figs. 1A, 1B. Furthermore, in Petitioner’s combination, a digital certificate is substituted for Iida’s user ID and password. Pet. 61. Patent Owner does not dispute Petitioner’s contention that Iida discloses transmitting a user ID and password stored in memory 48 of camera 12 to image server 18 through terminal 14. Id. at 43–44 (addressing claim 71; citing Ex. 1003 ¶¶ 110, 113). Accordingly, Petitioner persuades us that the combination of Iida and Davis discloses the limitations of claims 74, 89, 100, and 123 (and claims 71, 86, 97, and 120 from which they depend).” slip op. at 89

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

      “First, Patent Owner has not argued that the licensed products are coextensive with the claims of the ’703 Patent, accordingly, there is no presumption of a nexus. See Lectrosonics, Paper 33 at 33.” slip op. at 94

    Patent outcomesUS 9,774,703 mixed
    § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 9,774,703
  • 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
  • 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
  • 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
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