- Neogenomics Laboratories, Inc. v. Natera, Inc.Institution deniedPTAB · Jun 21, 2024 · IPR2024-00346 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution for claims 1–28 under § 325(d), finding the same or substantially the same art had been presented to the Office and no material examination error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential). “If a condition in the first part of the framework is satisfied and the petitioner fails to make a showing of material error, the Director generally will exercise discretion not to institute inter partes review.” Id. at 8–9. “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 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied
“III. CONCLUSION Because the same or substantially the same art previously were presented to the Office and Petitioner has not demonstrated that the examiner materially erred when considering the prior art, we exercise our discretion under § 325(d) and decline to institute inter partes review of the ’454 patent.10 IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied, and no trial is instituted.” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“erred when considering the multiplex-amplification limitation. See Advanced Bionics, 9 (“If reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.”). Under the asserted grounds, Petitioner relies on Forshew as the sole reference to teach this limitation, which is required in all challenged claims. Thus, we exercise our discretion under § 325(d) and decline to institute inter partes review of the ’454 patent.” slip op. at 13
§ 103 obviousnessDiscretionary denialPatents in suitUS 11,530,454 - Sandoz Inc. v. Acerta Pharma B.V.Institution deniedPTAB · Aug 7, 2023 · IPR2023-00478 · APJ Ulrike W Jenks · IPR · Institution
The Board denied institution of review of claims 8–12, 19, and 20 under § 325(d), finding the asserted art substantially the same as art previously presented and no material Office error.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“we agree with Patent Owner that, because Barf is nearly identical to Barf-PCT in its disclosure – Barf is “substantially the same art” as Barf-PCT, which was previously presented to the Office. Advanced Bionics, 8.” slip op. at 15
- PTAB / AIA Trials › Motions to amend / substitute claimsDenied
“for a certificate of correction is meritorious; instead, we are tasked with simply assessing whether there is a sufficient basis to support Patent Owner’s position. If so, it is up to the Director to decide whether to exercise the authority under § 255 and issue a certificate of correction. We have reviewed the arguments in the Motion and conclude that “there is a sufficient basis supporting Patent Owner’s position that the mistake may be correctable.” Honeywell, 939 F.3d at 1349. However, because as discussed above (see supra Section III), we deny institution here pursuant to our discretion under Section 325(d), we find that whether Barf is or is not prior art is immaterial to this proceeding and Patent Owner’s request and any certificate of correction here is moot. Therefore, we deny as moot the Motion for leave to file a Certificate of Correction.” slip op. at 22
Discretionary denialPatents in suitUS 10,272,083 - Ivantis, Inc. / Alcon Research, LLC et al. v. Sight Sciences, Inc.Institution deniedPTAB · Mar 27, 2023 · IPR2022-01533 · APJ Ulrike W Jenks · IPR · Institution
The Board denied institution of review of claims 1, 2, 5, 7, 8, 10, 11, 15, 18, 21, 23, 32, 33, 36, 38, 39, 41, 42, 46, 49, 52, 54, 63, 65, 68–70, 73, 77, …
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“(1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Id. at 8.” slip op. at 10
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Not reached
“6 Patent Owner presents an alternative basis for denying institution under 35 U.S.C. § 314(a) based on Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential) and the Director’s Memo re Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (“Vidal Memo”), at 4 (June 21, 2022). Prelim Resp. 76–81. Because we deny institution based on 35 U.S.C. § 325(d) need not separately reach a conclusion based on Fintiv in this decision.” slip op. at 9
Discretionary denialPatents in suitUS 8,287,482 - Ivantis, Inc. / Alcon Research, LLC et al. v. Sight Sciences, Inc.Institution deniedPTAB · Mar 27, 2023 · IPR2022-01530 · APJ Ulrike W Jenks · IPR · Institution
The Board denied institution of IPR for claims 1–3, 6–9, 12, 13, 15, and 17–20 under § 325(d), finding the art or arguments substantially similar to those previously considered and no material examiner error.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“4. Summary Considering the above Becton Dickson factors as they are incorporated into the two-part Advanced Bionic framework, we find that the factors weigh in favor of exercising our discretion and denying institution under § 325(d). The asserted art is either the same as, or cumulative to, the prior art that Examiner has already considered during prosecution of the ’742 patent and its parent application. Further, the arguments Petitioner Examiner during prosecution. Thus, we deny institution under § 325(d). III. CONCLUSION Because the same or substantially the same art previously were presented to the Office and Petitioner has not demonstrated that Examiner materially erred when considering the prior art, we exercise our discretion under § 325(d) and decline to institute inter partes review of the ’742 patent.” slip op. at 29
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Not reached
“A. Discretion Under 35 U.S.C. 325 (d) We first consider Patent Owner’s request that we deny institution7 under 35 U.S.C. § 325(d). Prelim. Resp. 9–52. Patent Owner contends that Petitioner’s alleged prior art was presented previously to Examiner during prosecution of the ’742 patent and its parent applications. Id. In the Patent Owner Response, Patent Owner provides a patent family tree, reproduced below. The patent family tree shows that “[t]he ’443 is a parent and the ’789 is a grandparent of the ’742” patent. Prelim. Resp. 8. Patent Owner argues that the same “Primary Examiner . . . examined all patents in this family. (See 7 Patent Owner presents an alternative basis for denying institution under 35 U.S.C. § 314(a) based on Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential) and the Director’s Memo re Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (“Vidal Memo”), at 4 (June 21, 2022). Prelim Resp. 76–81. Because we deny institution based on 35 U.S.C. § 325(d) need not separately reach a conclusion based on Fintiv in this decision.” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied
“III. CONCLUSION Because the same or substantially the same art previously were presented to the Office and Petitioner has not demonstrated that Examiner materially erred when considering the prior art, we exercise our discretion under § 325(d) and decline to institute inter partes review of the ’742 patent. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner’s request for an inter partes review, pursuant to 35 U.S.C. § 314(a), of claims 1–3, 6–9, 12, 13, 15, and 17–20 of the ’742 patent is denied, and no trial is instituted.” slip op. at 30
Discretionary denialPatents in suitUS 10,314,742 - Ivantis, Inc. / Alcon Research, LLC et al. v. Sight Sciences, Inc.Institution deniedPTAB · Mar 22, 2023 · IPR2022-01540 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution of IPR on claims 1–3 and 5–9 under § 325(d), finding substantially the same art had been presented and no material error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“review, “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.” Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced” slip op. at 5
Discretionary denialPatents in suitUS 9,486,361 - Ivantis, Inc. / Alcon Research, LLC et al. v. Sight Sciences, Inc.Institution deniedPTAB · Mar 21, 2023 · IPR2022-01529 · APJ Susan L C Mitchell · IPR · Institution
The Board denied institution of IPR on claims 1, 8, 11, 12, 21, 23, 24, 27, 42, 43, 46, 52, 54–59, 70, and 71 under § 325(d) because the art was previously considered or cumulative …
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“(1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics at 8.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied
“B. Summary Considering the above Becton Dickson factors as they are incorporated into the two-part Advanced Bionic framework, we find that the factors weigh in favor of exercising our discretion and denying institution under § 325(d). The asserted art is either the same as, or cumulative to, the prior art that Examiner has already considered during prosecution of the ’443 patent and its related applications, and Petitioner has not shown material error by the Office. Thus, we deny institution under § 325(d). Taking account of the information presented in the Petition, Preliminary Response, Reply, Sur-Reply, and the evidence of record, we exercise our discretion under § 325(d) and deny institution. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner’s request for an inter partes review, pursuant to 35 U.S.C. § 314(a), of claims 1, 8, 11, 12, 21, 23, 24, 27, 42, 43, 46, 52, 54–59, 70, and 71 of the ’443 patent is denied, and no trial is instituted.” slip op. at 20
Discretionary denialPatents in suitUS 9,370,443 - Guardant Health, Inc. v. University Of WashingtonInstitution deniedPTAB · Aug 1, 2022 · IPR2022-00449 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because the written-description priority arguments were substantially the same as those considered by the Office, and Petitioner did not show material error.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Based on this record, we find Petitioner’s arguments challenging written description support are the same or substantially the same as those considered by the examiner during the prosecution of the ’045 application. 4. Material Error Having found that the condition in the first part of the two-prong framework is satisfied, we next evaluate whether Petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, 8. Based on the current record, we determine Petitioner has not met its burden to show the examiner materially erred.” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Not reached
“Specifically, Petitioner argues that the ’785 application lacks written description support for “converting” or “attaching” tags to “circulating DNA molecules,” as recited in independent claims 1 and 20. Id. at 17–30. Patent Owner argues that we should deny institution under § 325(d) “because the Office already found that the specification provides § 112 support for tagging circulating DNA.” Prelim. Resp. 10. For the reasons explained below, we find Patent Owner’s arguments persuasive.5 5 As another basis for its priority arguments, Petitioner contends that the ’785 application does not enable methods for “converting” or “attaching” tags to “circulating DNA molecules.” Pet. 30. Patent Owner asserts that “[t]he Petition gives enablement only cursory treatment.” Prelim. Resp. 36. We agree with Patent Owner. Petitioner disposes of the entire enablement argument in a single seven-line paragraph. See Pet. 30. It provides no meaningful analyses of the factors set forth in In re Wands, 858 F.2d 731,” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied
“III. CONCLUSION Petitioner’s anticipation and obviousness grounds rest on the priority date of the challenged claims. Because we decline to reconsider Petitioner’s challenge of priority date based on lack of written description support, we exercise our discretion under § 325(d) and decline to institute inter partes review of the ’699 patent. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied.” slip op. at 18
§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,689,699 - Passage Bio, Inc. v. The Trustees Of The University Of Pennsylvania And Regenxbio, Inc.Institution deniedPTAB · Oct 6, 2021 · PGR2021-00073 · APJ Zhenyu Yang · PGR · Institution
The Board denied institution of PGR on claims 1–15, finding the § 112 arguments substantially repeated prosecution arguments without material Office error and exercising discretion under § 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Under § 325(d), in determining whether to institute a post-grant review, “the Director may take into account whether, and reject the petition 1 U.S. Patent No. 7,906,111 B2, issued March 15, 2011 (Ex. 1019, “the ’111 patent”). The ’111 patent is in the same family as the challenged ’441 patent. See infra, Section II.A.1. 2 Petitioner contends that “[w]hile Petitioner discusses the ’111 prior art patent, other printed publications – all within the ’441 patent’s family – are also prior art because they published more than one-year prior to October 2, 2018.” Pet. 73 n.14. 6 or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6, 8 (PTAB Feb. 13, 2020) (precedential). When analyzing the second prong, “[i]f reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.” Id. at 9. “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id.” slip op. at 6
- Other 314aInstitution denied discretionary otherDenied
“Petitioner further asserts that the challenged claims lack utility. Pet. 68–72. Institution of post-grant review is discretionary. See 35 U.S.C. § 324(a); see also SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1356 (2018) (“[Section] 314(a) invests the Director with discretion on the question whether to institute review . . . .” (emphasis omitted)); Harmonic Inc. v. Avid Tech, Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (explaining that under § 314(a), “the PTO is permitted, but never compelled, to institute an IPR proceeding”).6 6 Even though SAS and Harmonic address inter partes reviews, we see no reason to interpret the statute governing post-grant reviews differently. 26 In exercising that discretion, we are guided by the statutory requirement, in promulgating regulations for post-grant review, to consider the effect of any regulations on “the efficient administration of the Office [and] the ability of the Office to timely complete proceedings,” 35 U.S.C. § 326(b), as well as the requirement to construe our rules to “secure the just, speedy, and inexpensive resolution of every proceeding,” 37 C.F.R. § 42.1(b). Under the Office Guidance, “if the PTAB institutes a trial, the PTAB will institute on all challenges raised in the petition.” Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018).7 Here, we determine that 35 U.S.C. § 325(d) is sufficiently implicated that instituting review on all grounds would undermine the statutory purpose of 35 U.S.C. § 325(d). Accordingly, we deny the entire Petition. SAS Q&A’s, Part D, Effect of SAS on Future Challenges that Could Be Denied for Statutory Reasons, answer to Question D1 (June 5, 2018).8” slip op. at 26
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAOther
“As an initial matter, we agree with Patent Owner that “the only functional requirement of the claims is the ability to form a functional 19 capsid.” Sur-reply 8; see also Pet. 21 (proposing that we construe the term “AAV capsid protein” to mean “a protein that can form an AAV capsid”). More importantly, contrary to Petitioner’s contention, the examiner, during the prosecution of the ’218 application and priority applications, specifically considered the formation of the capsid. See, e.g., Ex. 1002, 5172 (“[T]he lack of characterization of the capsid protein at the time of filing means one could not know which of the 736 amino acids or 2208 nucleotides could be modified without affecting the ability to form a ‘capsid’ protein.”); Ex. 1011, 1374, 2198 (“The specification teaches only SEQ ID NO: 123 and does not provide those variable amino acids nor any fragments such that a person of skill in the art would recognize those amino acids that are related by 95% to SEQ ID NO: 123 and have capsid formation and function.”); Ex. 2023, 11 (“[T]he specification teaches only that SEQ ID NO: 123 is essential to form a capsid.”).” slip op. at 19
Claim constructionDiscretionary denialPatents in suitUS 10,695,441 - 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
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.