- Apotex Inc. / Apotex Corp. v. Auspex Pharmaceuticals, Inc.Institution deniedPTAB · Mar 9, 2022 · IPR2021-01507 · APJ Grace Karaffa Obermann · IPR · Institution
The Board denied institution of review of claims 1–3 under § 325(d), finding the petition relied on substantially the same art or arguments previously presented and did not show material Examiner error.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Becton, Dickinson factors (a), (b), and (d) relate to whether the art or arguments presented in the Petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, Paper 6 at 10. Factors (c), (e), and (f) “relate to whether the petitioner has demonstrated a material error by the Office” in its prior consideration of the prior art or arguments. Id. In general, only if the same, or substantially the same, art or arguments previously were presented to the Office, do we turn to whether Petitioner has established a material error. Id. “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9.” slip op. at 24
Discretionary denialPatents in suitUS 8,524,733 - Hospira, Inc. v. Genentech, Inc.Institution deniedPTAB · Jul 27, 2017 · IPR2017-00739 · APJ Robert A Pollock · IPR · Institution
The Board denied institution on claims 1–11 and 14–17 under § 325(d), finding the priority issue and Nabholtz ground had been considered during prosecution.
RulingsInstitution decision- BurdenDecided for patent owner
“Prelim. Resp. 10–11; see also id. 11, n.3 (arguing that Applicant demonstrated support for a three-part combination comprising a “further therapeutic agent”). Having considered the Specification of the ’649 Application and the arguments raised during prosecution, as discussed section II(B), above, Petitioner has not presented any further evidence in this proceeding that would persuade us to reach a conclusion different from the Examiner’s position that the challenged claims are adequately disclosed in the priority document.” slip op. at 14
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateDecided for patent owner
“established priority for those claims based upon the parent application’s specific disclosure of using growth inhibitory agents as part of the present invention. (Ex. 1119-5 at 179 (citing Ex. 1121 at 20 (16:11- 24), 39 (35:6-14), 41 (37:9-18).) Based upon that disclosure, the examiner agreed that the claims reciting a combination with “a further growth inhibitory agent” were supported by, and thus entitled to priority to, the parent applications. (Ex. 1119-5 at 41; id. at 292-93; Ex. 1119- 6 at 245.) Prelim. Resp. 10–11; see also id. 11, n.3 (arguing that Applicant demonstrated support for a three-part combination comprising a “further therapeutic agent”). Having considered the Specification of the ’649 Application and the arguments raised during prosecution, as discussed section II(B), above, Petitioner has not presented any further evidence in this proceeding that would persuade us to reach a conclusion different from the Examiner’s position that the challenged claims are adequately disclosed in the priority document.” slip op. at 14
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledDecided for patent owner
“combination are needed to demonstrate that they can be usefully combined,’” flatly contradicts Patent Owner’s position that the ’649 Application and ’346 Provisional Application adequately disclose the claimed invention. Pet. 17–18 (citing Ex. 1119-5, 308–09). We do not find Petitioner’s argument persuasive. As an initial matter, Petition fails to address the “Wands” factors in its enablement analysis. See In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).” slip op. at 15
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“As discussed in section II(B), above, the Examiner considered fully the written description and enablement issues underlying Applicant’s claim to priority in allowing the claims to issue, and Petitioner has not presented new evidence or arguments that would convince us that the Examiner’s determination was unreasonable. The Examiner’s decision to withdraw the rejection under 35 U.S.C. § 102(b) over Nabholtz was expressly predicated on that priority determination, which removed Nabholtz as prior art. In Ground I of this Petition, Petitioner also asserts that the claims are unpatentable under § 102(b) over Nabholtz, thus raising “the same or substantially the same prior art or arguments previously [] presented to the Office” as contemplated under 35 U.S.C. § 325(d). Under the circumstances of this case, we exercise our discretion under § 325(d) and decline to institute inter partes review based on Ground I.” slip op. at 18
§ 102 anticipation§ 112 disclosureDiscretionary denialPatents in suitUS 7,892,549 - Hospira, Inc. v. Genentech, Inc.Institution deniedPTAB · Jul 27, 2017 · IPR2017-00731 · APJ Zhenyu Yang · IPR · Institution
Institution was denied for claims 1–14: the Baselga ’97 and Baselga ’94 ground was denied under § 325(d), and the Baselga ’96 and Baselga ’94 ground did not meet the reasonable-likelihood threshold.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“In this case, in an office action dated December 7, 1999, the examiner rejected the then-pending claims as anticipated by Baselga ’97. Ex. 1011, vol. 1, 379. In response, the applicant attempted to distinguish over the reference. Id. at 398. The applicant later submitted a declaration by the inventor under 37 C.F.R. §1.131, together with certain evidence, to antedate Baselga ’97. Ex. 1011, vol. 2, 37, 118–47. In an office action dated January 9, 2001, the examiner found that neither the argument nor the declaration was persuasive. Id. at 213–14. As a result, the examiner continued to reject the claims as unpatentable over Baselga ’97. Id. at 212–14. In response, the applicant submitted another declaration by the inventor under 37 C.F.R. §1.131, accompanied by additional evidence, to antedate Baselga ’97. Id. at 230–31, 237–312. Thereafter, the examiner withdrew the rejection based on Baselga ’97, stating that “[t]he declaration filed on 5/07/2001 under 37 CFR 1.131 is sufficient to overcome the Baselga (1997).” Id. at 324. Petitioner does not present additional evidence or persuasive arguments in this proceeding for us to reach a different conclusion with respect to Baselga ’97. Under these circumstances, we exercise our discretion under § 325(d) and decline to institute inter partes review based on the combination of Baselga ’97 and Baselga ’94.” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“in the absence of an anthracycline derivative.” To account for this limitation, Petitioner argues that (1) the cardiotoxicity of anthracycline derivatives was well known in the prior art; (2) both preclinical and clinical studies employed the combination of an anti-ErbB2 antibody “with paclitaxel or anthracycline, not together;” and (3) Baselga ʼ94 shows that the combination with paclitaxel was superior to the combination with doxorubicin, an anthracycline derivative. Pet. 45–46. Patent Owner counters that Petitioner has not shown an ordinary artisan would have avoided anthracyclines when pursuing the combination therapy of anti- ErbB2 antibody with a taxoid. Prelim. Resp. 52. We agree with Patent Owner. Petitioner is correct that cardiotoxicity of anthracyclines was well known at the time of the ’441 patent invention. See, e.g., Ex. 1033. Yet, Petitioner concedes that “[a]nthracyclines were and remain common first-line chemotherapies for breast cancer.” Pet. 13. Thus, cardiotoxicity does not appear to have motivated an ordinary artisan to avoid anthracyclines in treating breast cancer. slip op. at 9
- BurdenInstitution denied
“We acknowledge that Baselga ’94 teaches a pre-clinical study using mice that combined anti-ErbB2 antibody with either paclitaxel or an anthracycline, but not the anti-ErbB2 antibody with both paclitaxel and an anthracycline. Without additional credible evidence5 or persuasive argument, however, this fact 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. As a result, based on the current record, we conclude Petitioner has 5 In the concurrently issued decision to institute trial in IPR2017-00737, we conclude that Petitioner has made a sufficient showing regarding the limitation “in the absence of an anthracycline derivative.” IPR2017-00737, Paper 17, 21–23. There, we take into consideration the disclosures of Baselga ’97 and a second prior-art reference. Id. We also find the testimony of Dr. Litton on this issue persuasive. Id. The record in the present proceeding, however, is different. As explained above, Baselga ’97 was removed from consideration as prior art for the two-drug combination treatment recited in the claims of the ’441 patent during prosecution and, as we do not revisit the antedating issue here, it is not part of our analysis. Also, the second prior art reference in IPR2017-00737 is not of record in this proceeding and Petitioner does not present persuasive expert testimony on this issue. not established a reasonable likelihood it would prevail in showing that any challenged claim would have been obvious over the teachings of Baselga ’96 and Baselga ’94.” slip op. at 10
Discretionary denialPatents in suitUS 7,846,441 - Mylan Pharmaceuticals Inc. v. Research Corporation Technologies, Inc.Institution deniedPTAB · Oct 24, 2016 · IPR2016-01248 · APJ Jacqueline Wright Bonilla · IPR · Institution
The Board denied institution on all challenged claims under § 325(d), because Mylan presented the same prior art and arguments it had previously presented.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“Institution of an inter partes review is subject to the Board’s discretion. See 37 C.F.R. § 42.108(b). By statute, “[i]n determining whether to institute or order a proceeding under this chapter, chapter 30, or chapter 31, the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” 35 U.S.C. § 325(d). For the reasons discussed above, the current Petition presents the same prior art and arguments previously presented by the same Petitioner in IPR2016-01101. Accordingly, we exercise our discretion to deny institution of inter partes review in this case under 35 U.S.C. § 325(d).” slip op. at 3
Discretionary denial - PTAB · Jan 7, 2016 · IPR2015-01492 · APJ Tina E Hulse · IPR · Institution
The Board denied institution on claims 1–26 under § 325(d) because the petition repeated the prior art and arguments in IPR2015-00865, in which Panacea was also a party.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“B. Discussion The Petition is substantively identical to the petition in the 865 IPR. In the Petition, Panacea admits this fact, stating that it “recognizes that the instant Petition presents the same prior art and arguments that have been presented to the Office in the petition in Case IPR2015-00865.” Pet. 8. At the time Panacea filed this Petition, the petition in the 865 IPR was pending before us. The 865 IPR petition was filed collectively by eighteen different entities, including Panacea. 865 IPR, Paper 10, 1. In the Patent Owner Preliminary Response in the 865 IPR, Patent Owner asserted that the collective Petitioner failed to identify all of the real parties-in-interest, as required by 35 U.S.C. § 312(a)(2), and argued that the petition should be denied. 865 IPR, Paper 17, 5–22.” slip op. at 6
Discretionary denialPatents in suitUS 8,569,325 - PTAB · Jan 7, 2016 · IPR2015-01496 · APJ Erica A Franklin · IPR · Institution
The Board denied institution of IPR for claims 1–27 under § 325(d), because the petition presented the same art and arguments in a pending IPR involving the same patent.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“In determining whether to institute or order a proceeding under this chapter, chapter 30, or chapter 31,2 the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office. Because the Petition presents the same prior art and arguments to challenge the same claims of the ’703 patent that were previously presented in IPR ’864, and because Panacea is also a petitioner in that instituted proceeding, we determine, under the current circumstances, that our judicial resources are best spent elsewhere. See Heckler v. Chaney, 470 U.S. 821, 831 (1985) (stating that when deciding whether to take action in a particular matter, an agency must determine whether its resources are best spent on one matter or another). Thus, we find it is appropriate to exercise our discretion under § 325(d) to deny institution of an inter partes review for any of the challenged claims.” slip op. at 6
Discretionary denialPatents in suitUS 8,404,703
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.