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  • PTAB · Jan 27, 2022 · CBM2018-00032 · APJ Meredith C Petravick · CBM · Rehearing

    The Board granted Patent Owner’s request for rehearing to authorize a request for Director rehearing of the final written decision.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “Given the particular circumstances of this proceeding, particularly that the Request for Rehearing was filed prior to the Supreme Court’s Arthrex decision, we construe Patent Owner’s Request for Rehearing as requesting authorization to file a Request for Rehearing by the Director of the Final Written Decision and grant this request. Patent Owner is authorized to file a Request for Rehearing by the Director of the Final Written Decision within 30 days of the date of this decision. See 37 C.F.R. §§ 42.5, 42.71(d).” slip op. at 3

    • Director reviewDirector review, grantedGranted

      “Given the particular circumstances of this proceeding, particularly that the Request for Rehearing was filed prior to the Supreme Court’s Arthrex decision, we construe Patent Owner’s Request for Rehearing as requesting authorization to file a Request for Rehearing by the Director of the Final Written Decision and grant this request. Patent Owner is authorized to file a Request for Rehearing by the Director of the Final Written Decision within 30 days of the date of this decision. See 37 C.F.R. §§ 42.5, 42.71(d).” slip op. at 3

    None
    Patents in suitUS 7,933,827
  • PTAB · Jan 27, 2022 · CBM2018-00030 · APJ Meredith C Petravick · CBM · Rehearing

    The Board granted Nasdaq’s rehearing request and authorized it to seek Director rehearing of the final written decision within 30 days.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “STANDARD A party requesting rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters it believes the Board misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision, we review the decision for an abuse of discretion. See generally 37 C.F.R. § 42.71 (b)–(d). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted).” slip op. at 2

    • Director reviewDirector review, grantedGranted

      “The United States Patent and Trademark Office subsequently implemented an interim procedure1 whereby review of a final written decision by the Director may be requested by a party to a post-grant review proceeding.” slip op. at 3

    None
    Patents in suitUS 7,921,051
  • PTAB · Jan 27, 2022 · CBM2018-00029 · APJ Meredith C Petravick · CBM · Rehearing

    The Board granted Nasdaq’s rehearing request and authorized it to seek Director rehearing of the final written decision within 30 days.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “Given the particular circumstances of this proceeding, particularly that the Request for Rehearing was filed prior to the Supreme Court’s Arthrex decision, we construe Patent Owner’s Request for Rehearing as requesting authorization to file a Request for Rehearing by the Director of the Final Written Decision and grant this request. Patent Owner is authorized to file a Request for Rehearing by the Director of the Final Written Decision within 30 days of the date of this decision. See 37 C.F.R. §§ 42.5, 42.71(d).” slip op. at 3

    None
    Patents in suitUS 7,747,506
  • PTAB · Jan 27, 2022 · CBM2018-00020 · APJ Meredith C Petravick · CBM · Rehearing

    The Board granted Patent Owner’s request for rehearing and authorized it to seek Director rehearing of the final written decision.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “STANDARD A party requesting rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters it believes the Board misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision, we review the decision for an abuse of discretion. See generally 37 C.F.R. § 42.71 (b)–(d). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted).” slip op. at 2

    • Director reviewDirector review, grantedGranted

      “Arthrex, Inc., 141 S. Ct. 1970 (2021). The Supreme Court held “that 35 U.S.C. § 6(c) is unenforceable as applied to the Director insofar as it prevents the Director from reviewing the decisions of the PTAB on his own. The Director may engage in such review and reach his own decision.” Arthrex, 141 S. Ct. at 1987. The Supreme Court “conclude[d] that the appropriate remedy is a remand to the Acting Director for him to decide whether to rehear the petition.” Id. The United States Patent and Trademark Office subsequently implemented an interim procedure1 whereby review of a final written decision by the Director may be requested by a party to a post-grant review proceeding.” slip op. at 3

    None
    Patents in suitUS 8,386,371
  • PTAB · Aug 6, 2021 · IPR2020-01133 · APJ Jo-Anne M Kokoski · IPR · Rehearing

    Granted Petitioner’s rehearing request and instituted review of claims 1–15 on all asserted grounds because the Petition showed a reasonable likelihood of unpatentability.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “Rehearing Request and conclude that we misapprehended the law of incorporation by reference when evaluating the grounds based on Ganesan- Publ’424, and that the Petition sets forth sufficient grounds and evidence to justify institution of trial.8 We, therefore, grant Petitioner’s Rehearing 8 Because our determination that we misapprehended the law of incorporation by reference is dispositive, we need not address Petitioner’s other arguments in the Rehearing Request. Request and institute an inter partes review of claims 1–15 of the ’103 patent on all the grounds asserted in the Petition.” slip op. at 3

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner

      “‘generally incorporates’ Ganesan-Prov’264, and did not ‘identif[y] with particularity’ any specific subject matter from Ganesan-Prov’264 . . . misapprehended the law of incorporation by reference in a way that is contrary to both Federal Circuit precedent and other Board decisions.” Req. Reh’g 10 (citing Dec. 18; Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed. Cir. 2000)). In particular, Petitioner argues that Advanced Display’s statement that “[t]o incorporate material by reference, the host document must identify with detailed particularity what specific material it incorporates and clearly indicate where that material is found in the various documents” (212 F.3d at 1282) does not mean that the host document must identify some specific subject matter or subpart of the incorporated document (such as by page/line). Rather, the quoted statement simply means that the host document must clearly identify what is being incorporated and where it can be found—even when the incorporation applies to the entire document.” slip op. at 5

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

      “with sufficient particularity such that the entirety of Ganesan-Prov’264 is incorporated therein, and Ganesan-Prov’264 forms a part of Ganesan- Publ’424 for purposes of anticipation. Ganesan-Prov’264 “relates generally to techniques for thermal control of microfluidic devices.” Ex. 1208, 2:29– 30. Ganesan-Prov’264 teaches that “heater/sensors in accordance with the invention may be integral with a microfluidic device or separate from a microfluidic device,” and “may be formed separately from the microfluidic device.” Id. at 12:16–21 (emphases added). Ganesan-Prov’264 further teaches that “one or more heater/sensors may be formed as part of a device configured to operatively receive a microfluidic device,” and “[t]he device may include one or more heater sensors positioned to be in thermal contact with portions of the operatively received microfluidic device.” Id. at 12:21– 26. Based on these teachings, Petitioner’s declarant, Dr. Mark Burns, testifies that “the heater array of Ganesan-Publ’424 may be formed integrally with the network-containing microfluidic substrate, or may be formed separately in a testing device into which the microfluidic substrate is placed or another part of the system.” Ex. 1101 ¶ 345 (citing Ex. 1109 ¶ 79; Ex. 1208, 12:20–25).” slip op. at 8

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner

      “to begin on April 11, 2022. Prelim. Resp. 45. We note, however, that the parties recently filed a Stipulation and Proposed Order to Extend Case Schedule, pushing the trial to December 2022, which the district court granted. Ex. 3001. Given the statutory deadlines, our latest possible date for issuance of a final written decision in this proceeding is in July, 2022, one year after we issue this decision instituting an inter partes review. 35 U.S.C. §§ 314(c), 316(a)(11); see also 37 C.F.R. § 42.100(c). Thus, our final written decision would issue at least four months before trial. “If the court’s trial date is earlier than the projected statutory deadline, the Board generally has weighed this fact in favor of exercising authority to deny institution under NHK.” Fintiv Order 9. We find that this factor weighs strongly against exercising discretion to deny institution.” slip op. at 12

    § 102 anticipationDiscretionary denial
    Patents in suitUS 8,415,103
  • Eis GmbH v. Novoluto GmbHRehearing granted
    PTAB · Sep 25, 2020 · IPR2020-00007 · APJ Susan L C Mitchell · IPR · Rehearing

    Granted EIS GMBH’s rehearing request and instituted IPR of claims 1–3, 5, 7, 8, 11, 14, 15, 17–21, and 23–26 on all asserted grounds.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “We find that Dr. Prisco’s testimony is a reasonable interpretation of how Taylor works if the bellows are bidirectional, and the bellows are expanded and contracted when the suction cup is sealingly engaged. Figure 3 of Taylor shown above appears to support Dr. Prisco’s testimony that the bellows may be expanded or contracted from the initial position shown in Figure 3 and does not appear to show any valve or second opening in the bellows to provide unidirectional flow as Dr. Jensen, Patent Owner’s declarant, asserts. Also, as Petitioner asserts, Taylor indicates that a squeeze ball may be substituted for the bellows expressly indicating a device with a bidirectional flow. Although Patent Owner raises valid arguments concerning a common definition of bellows indicating unidirectional flow and provides testimony from Dr. Jensen reasonably supporting such a position, these dueling positions create a genuine issue of material fact that we weigh in favor of Petitioner on institution. See 37 C.F.R. 42.108(c).” slip op. at 18

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

      “We conclude from a review of Fang and Taylor that they are not substantially the same art nor is Petitioner making substantially the same argument as was presented the Office during prosecution of the ’061 Patent based on Fang. We find that the way in which Fang and Taylor work appear to be materially different. Fang appears to apply only suction to the skin whereas Taylor, with the sealingly connected suction cup, appears to apply a cyclical vacuum that Dr. Prisco testifies meets the claim limitations requiring generation of a pattern of negative and positive pressures, modulated with respect to a reference pressure. Ex. 1002 ¶¶ 62–64, 75. Thus Taylor appears to teach the claim element Patent Owner argued during prosecution was missing from Fang. Also, in applying factors (b) and (d) of Becton, Dickinson, because of such differences noted above, we find that Taylor is not cumulative of Fang, which was considered and applied by the Office during prosecution of the ’061 Patent. 4. Conclusion Thus, we find that Taylor and Fang are not substantially the same art, nor were substantially the same arguments based on these references presented in the Petition and during prosecution of the ’061 Patent, respectively. As discussed above, because Petitioner primarily relies on Taylor in all four grounds for teaching the modulation of positive and negative pressures with respect to a reference pressure as required by all of the challenged claims, we also find that, overall, the same or substantially the same art was not previously presented to the Office nor were the same or substantially the same arguments previously presented to the Office. Therefore, we do not need to reach the application of the remaining Becton, Dickenson factors relating to whether the Petitioner has demonstrated a material error by the Office. Thus, we decline to exercise our discretion under § 325(d) to deny institution of an inter partes review here.” slip op. at 12

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

      “how Taylor works if the bellows are bidirectional, and the bellows are expanded and contracted when the suction cup is sealingly engaged. Figure 3 of Taylor shown above appears to support Dr. Prisco’s testimony that the bellows may be expanded or contracted from the initial position shown in Figure 3 and does not appear to show any valve or second opening in the bellows to provide unidirectional flow as Dr. Jensen, Patent Owner’s declarant, asserts. Also, as Petitioner asserts, Taylor indicates that a squeeze ball may be substituted for the bellows expressly indicating a device with a bidirectional flow. Although Patent Owner raises valid arguments concerning a common definition of bellows indicating unidirectional flow and provides testimony from Dr. Jensen reasonably supporting such a position, these dueling positions create a genuine issue of material fact that we weigh in favor of Petitioner on institution. See 37 C.F.R. 42.108(c).” slip op. at 18

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

      “We find that Dr. Prisco’s testimony is a reasonable interpretation of how Taylor works if the bellows are bidirectional, and the bellows are expanded and contracted when the suction cup is sealingly engaged. Figure 3 of Taylor shown above appears to support Dr. Prisco’s testimony that the bellows may be expanded or contracted from the initial position shown in Figure 3 and does not appear to show any valve or second opening in the bellows to provide unidirectional flow as Dr. Jensen, Patent Owner’s declarant, asserts. Also, as Petitioner asserts, Taylor indicates that a squeeze ball may be substituted for the bellows expressly indicating a device with a bidirectional flow. Although Patent Owner raises valid arguments concerning a common definition of bellows indicating unidirectional flow and provides testimony from Dr. Jensen reasonably supporting such a position, these dueling positions create a genuine issue of material fact that we weigh in favor of Petitioner on institution. See 37 C.F.R. 42.108(c).” slip op. at 18

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denial
    Patents in suitUS 9,849,061
  • Eis GmbH v. Novoluto GmbHRehearing granted
    PTAB · Jun 17, 2020 · IPR2019-01302 · APJ John E Schneider · IPR · Rehearing

    Granted rehearing and instituted inter partes review of claims 1–30 on all asserted grounds, finding a reasonable likelihood that claim 1 is unpatentable over Guan, Lee, and Hovland.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “decision should be modified. 37 C.F.R. § 42.71(d). The party must identify specifically all matters we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision on a petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). “An abuse of discretion occurs if the decision (1) is clearly unreasonable, arbitrary, or fanciful; (2) is based on an erroneous conclusion of law; (3) rests on clearly erroneous fact findings; or (4) involves a record that contains no evidence on which the Board could rationally base its decision.” Redline Detection, LLC v. Star Envirotech, Inc., 811 F.3d 435, 442 (Fed. Cir. 2015). With this in mind, we address the arguments presented by Petitioner in turn.” slip op. at 3

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

      “Request for Rehearing and conclude there are genuine issues of material fact about the teachings of Guan that warrant institution and resolution at trial.” slip op. at 2

    • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

      “Patent Owner contends that Guan is non-analogous art in that it is not related to stimulation of the clitoris. Prelim. Resp. 59. Patent Owner also contends that there is no motivation to combine the teachings of Lee and Guan. Id. at 60–63. Patent Owner argues that one skilled in the art would not consider using the indirect stimulator of Guan in the dildo of Lee as it would require a modification of Lee beyond a simple substitution of elements. Id.” slip op. at 5

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

      “Petitioner has also provided a reasonable motivation to combine the teachings of Lee and Guan. Lee comprises a dildo with an extension which directly stimulates the clitoris, a body part. Ex. 1006, Fig. 1; Ex. 1002, ¶¶ 72, 134–137. Guan discloses an apparatus, which indirectly stimulates a body part. Ex. 1007, 3; Ex. 1002 ¶ 137. Given the teaching in the art of the problems with direct stimulation versus indirect stimulation, we agree on this record with Dr. Prisco that one skilled in the art would have had a reason to substitute the indirect stimulation device of Guan for the direct intensive and is best decided on a full record. Cf. Monark Knitting Mach, Corp. v. Sulzer Morat GmbH, 139 F.3d 877, 886 (Fed. Cir. 1998) (determining that issues of fact concerning secondary considerations precluded grant of summary judgment) reasonable expectation of success. Ex. 1002 ¶¶ 132–137.” slip op. at 6

    § 103 obviousness
    Patents in suitUS 9,937,097
  • PTAB · Jul 23, 2019 · IPR2017-02158 · APJ Christopher G Paulraj · IPR · Rehearing

    The Board accepted Patent Owners’ rehearing request as timely but denied rehearing, finding no overlooked or misapprehended issue requiring modification of the final written decision.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “layer is being removed (i.e., Example 1). Id. at 2–3. We are not persuaded that we misapprehended or overlooked the evidence of record regarding whether Baumgärtel requires the use of pigments for rejuvenation. As we noted in our Final Written Decision, Example 1 of Baumgärtel does not mention the use of any pigments yet discusses the removal of the yellowed/damaged surface layer of white siding using a composition containing 99% dichloromethane. Paper 29, 42. Although the amendment in the Proposed Substitute Claims required both color and luster to be restored, it did not otherwise modify our construction of “rejuvenating,” which encompasses either “remov[ing] or transform[ing] the chalky surface that develops on vinyl siding that is exposed to sunlight and other environmental conditions.” Id. at 15 (emphasis added). The teaching in Baumgärtel’s Example 1 of removing the surface layer using a 99% dichloromethane solution satisfies our construction of “rejuvenating.” We, therefore, did not misapprehend or overlook Patent Owners’ evidence and arguments in determining that Example 1 of Baumgärtel anticipates the Proposed Substitute Claims.” slip op. at 7

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

      “Under 37 C.F.R. § 42.5(c)(3), “[a] late action will be excused on a showing of good cause or upon a Board decision that consideration on the merits would be in the interests of justice.” 37 C.F.R. § 42.5(c)(3) (emphasis added). Patent Owners have presented evidence tending to show that their counsel believed that the Request for Rehearing was timely filed on May 8, 2019. See Exs. 2011–2013. It does not appear, however, that they attached any document with their filing before clicking the submit button on PTAB E2E. In this regard, we note that the email generated by the PTAB E2E system and sent to counsel of record on May 8, 2019 clearly stated “THERE WERE NO DOCUMENTS SUBMITTED WITH THIS REQUEST.” Ex. 3001. Patent Owners have not explained why they did not take immediate action after receiving that email to determine whether the Request for Rehearing was actually filed.1 Indeed, Patent Owners remained” slip op. at 4

    • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingDecided for petitioner

      “http://www.uspto.gov/ip/boards/bpai/prps.jsp#heading-5 (emphasis added). 2 We are also not persuaded that the filing of a Notice of Appeal (Paper 33) by Patent Owners divested the Board of jurisdiction to decide the merits of the Request for Rehearing. The Federal Circuit’s decision in In re Graves, 69 F.3d 1147 (Fed. Cir. 1995), is instructive on this point. There, the applicant had filed a notice of appeal to the Federal Circuit after the Board entered its initial decision but before the Board’s decision on a request for reconsideration. Id. at 1150. Because the notice of appeal was filed too late if based on the initial decision, the court determined that the Board’s initial” slip op. at 5

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

      “misapprehended evidence and arguments showing that Dr. Storey’s experiment was not based on Example 1 of Baumgärtel, and thus insufficient for Petitioners to meet their burden of showing inherent anticipation. Ex. 2010, 4–6. But, as set forth in our Final Written Decision, we fully considered the evidence of record and determined that the experiments conducted by Dr. Storey further support a finding of inherent anticipation by Baumgärtel. Paper 29, 43 (citing Ex. 1022 ¶¶ 12–36). We recognized that the 99.5% pure dichloromethane used by Dr. Storey for his experiments did not include the 1% of additional ingredients identified in Example 1, but took into account Dr. Storey’s unrebutted testimony that those additional ingredients in such small proportions would not have materially affected the rejuvenation characteristics of dichloromethane. Id. at 43–44 (citing Ex. 1005 ¶¶ 81–82). As we noted, Patent Owners did not cross-examine Dr. Storey as to his declaration testimony in this proceeding; nor did Patent Owners’ expert Dr. Grulke address these points in his own declaration. Id. at 44. Thus, we are not persuaded that we misapprehended or overlooked the cited testimony of Dr. Storey regarding inherent anticipation.” slip op. at 7

    § 102 anticipation
    Patents in suitUS 6,669,991
  • 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 · May 2, 2016 · IPR2015-01340 · APJ Rama G Elluru · IPR · Rehearing

    The Board granted Mylan’s rehearing request and instituted IPR of claims 1, 2, 4, 6-22, 25-30, 32-37, and 39-42.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “II. ANALYSIS When rehearing a decision on institution, the Board reviews the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). The applicable standard for a request for rehearing is set forth in 37 C.F.R. § 42.71(d), which provides in relevant part: A party dissatisfied with a decision may file a single request for rehearing without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. We grant Petitioner’s request for rehearing and institute an inter partes review of claims 1, 2, 4, 6–22, 25–30, 32–37, and 39–42 of the ’186 patent for the reasons provided in the concurrently issued Decision on Institution. Paper 16.” slip op. at 2

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

      “References Basis Claims challenged Ashworth I, Villhauer, Raag and, 1, 2, 4, 6–11, 25–28, § 103(a) Hanessian 32–35, 39, and 40 Ashworth I, Villhauer, Raag, 12–16, 29, 30, 36, 37, Hanessian, Bachovchin, and § 103(a) 41, and 42 GLUCOPHAGE Label Ashworth I, Villhauer, Raag, Hanessian, Bachovchin and, § 103(a) 12, 17, 18, and 22 XENICAL Label Ashworth I, Villhauer, Raag, Hanessian, Bachovchin, and § 103(a) 12, 19, 20, and 21” slip op. at 2

    None
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