Byondis B.V.

Patent Trials and Appeals Board

Feb 15, 2022

2021003458 (P.T.A.B. Feb. 15, 2022)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 16/456,177 06/28/2019 Willem DOKTER P1656US03/PB-064 1889 38427 7590 02/15/2022 Buscher Patent PLLC 7371 Atlas Walk Way #136 Gainesville, VA 20155 EXAMINER PUTTLITZ, KARL J ART UNIT PAPER NUMBER 1642 NOTIFICATION DATE DELIVERY MODE 02/15/2022 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): jls@buscherpatent.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte WILLEM DOKTER, PETER JOHANNES GOEDINGS, GIJSBERTUS FRANCISCUS MARIA VERHEIJDEN, and PATRICK HENRY BEUSKER ____________ Appeal 2021-003458 Application 16/456,177 Technology Center 1600 ____________ Before RYAN H. FLAX, DAVID COTTA, and CYNTYHIA M. HARDMAN, Administrative Patent Judges. FLAX, Administrative Patent Judge. DECISION ON APPEAL This is a decision under 35 U.S.C. § 134(a) involving claims directed to a method of treating bladder cancer in a human patient.1, 2 Claims 16-18 and 20-26 are on appeal as rejected under 35 U.S.C. § 103. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 “Appellant” herein refers to the “applicant” as defined by 37 C.F.R. § 1.42. Appellant identifies the Real Party-in-Interest as “Byondis B.V.” Appeal Br. 2. 2 Oral argument was heard on December 6, 2021, and a transcript of the hearing is a part of the record. Appeal 2021-003458 Application 16/456,177 2 STATEMENT OF THE CASE Dependent claim 22, which depends from independent claim 16, is illustrative and is reproduced below: 22. The method according to claim 16, wherein the compound of formula (I) is a compound of formula (II) Appeal Br. 16 (Claims Appendix). Independent claim 16 recites, in part, a “method of treating bladder cancer in a human patient, comprising administering to the patient a therapeutically effective amount of a compound,” which compound claim 22 specifically defines. See id. at 14. The Specification states that its described invention relates to duocarmycin-containing antibody-drug conjugates (ADCs) for use in the treatment of human solid tumours and haematological malignancies expressing human epidermal growth factor receptor 2 (HER2), in particular breast cancer, gastric cancer, bladder cancer, ovarian cancer, lung cancer, prostate cancer, pancreatic cancer, colorectal cancer, head and neck squamous cell cancer, osteosarcoma, and acute lymphoblastic leukaemia. Spec. 1:6-11. The Speciation identifies that trastuzumab (“Tmab,” herein), as recited in claim 22, is an anti-HER2 antibody. Id. at 12:6-13:3. Appeal 2021-003458 Application 16/456,177 3 The following rejections are appealed: Claims 16-18 and 20-25 stand rejected under 35 U.S.C. § 103(a) over Beusker,3 Alley,4 and Hussain.5 Final Action 3. Claim 26 stands rejected under 35 U.S.C. § 103(a) over Beusker, Alley, Hussain, Alavattam,6 and Persson.7 Id. at 7. DISCUSSION “[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). Regarding obviousness, “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “[I]f a technique has been used to improve one device [or method], and a person of ordinary skill in the art would recognize that it would improve similar device [or methods] in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” Id. at 417. 3 WO 2011/133039 A2, published Oct. 27, 2011 (“Beusker”). 4 US 2009/0010945 A1, published Jan. 8, 2009 (“Alley”). 5 Maha H.A. Hussain et al., Trastuzumab, Paclitaxel, Carboplatin, and Gemcitabine in Advanced Human Epidermal Growth Factor Receptor- 2/neu-Positive Urothelial Carcinoma: Results of a Multicenter Phase II National Cancer Institute Trial, 25(16) J. CLIN. ONCOLOGY 2218-24 (2007) (“Hussain”). 6 US 2013/0095172 A1, published Apr. 18, 2013 (“Alavattam”). 7 Mikael Persson et al., [177Lu]Pertuzumab: Experimental Therapy of HER- 2-Expressing Xenografts, 67(1) CANCER RES. 326-31 (2007) (“Persson”). Appeal 2021-003458 Application 16/456,177 4 However, [w]here claimed subject matter has been rejected as obvious in view of a combination of prior art references, a proper analysis under § 103 requires, inter alia, consideration of two factors: (1) whether the prior art would have suggested to those of ordinary skill in the art that they should make the claimed composition or device, or carry out the claimed process; and (2) whether the prior art would also have revealed that in so making or carrying out, those of ordinary skill would have a reasonable expectation of success. Both the suggestion and the reasonable expectation of success must be founded in the prior art, not in the applicant’s disclosure. In re Vaeck, 947 F.2d 488, 493 (Fed. Cir. 1991) (citation omitted). We review the Examiner’s determinations and Appellant’s arguments in view of these standards of law. The Examiner determines that Beusker teaches a conjugated compound as claimed, but notes that the reference “does not explicitly teach treatment of HER2 positive bladder cancer,” per the claimed method. Final Action 4-5 (citing Beusker 140-141, 185, 201, 218). The Examiner cites Alley as teaching preparing a modified antibody to control conjugation points. Id. at 5 (citing Alley ¶¶ 13, 240-249). The Examiner cites Hussain as teaching the use of Tmab to treat urothelial (bladder) cancer and specifically HER2 positive IHC3+ patients, in its disclosure of administering Tmab with paclitaxel (and also with carboplatin and gemcitabine, which Examiner does not note). Id. at 5 (citing Hussain 2219, 2222); see also id. at 6-7 (Examiner responding to Appellant’s arguments over Hussain). Appellant argues that the rejection is in error for two reasons: (1) Hussain did not disclose successful use of Tmab to treat HER2 positive bladder cancer, as claimed; and (2) the rejection ignores a prior art disclosure subsequent to Hussain, i.e., Wendling, which states that Hussain’s Appeal 2021-003458 Application 16/456,177 5 professed hope for such a use for Tmab was unfounded and that Tmab was not an effective treatment for bladder cancer. Appeal Br. 4-5. For the reasons below, we are persuaded by Appellant’s arguments. The Examiner relies on Hussain for teaching using a composition, that was arguably disclosed in the prior art, for the specifically claimed purpose of treating bladder cancer. Final Action 5-7. However, Hussain is inconclusive about whether Tmab is an effective bladder cancer treatment because it does not use Tmab in isolation, but rather in a cocktail of drugs also including paclitaxel, carboplatin, and gemcitabine. Hussain 2218. Although the claims are fashioned as “comprising” claims, meaning they are open to including steps in addition those expressly recited, the fact that Hussain does not teach a therapeutic impact of Tmab, individually, on bladder cancer adds uncertainty as to whether it is Tmab or some other component of the therapeutic cocktail that may be useful. Id. Further, Hussain itself expresses uncertainty as to whether Tmab (or the entire cocktail) is effective in treating bladder cancer and states that “[d]etermining the true contribution of trastuzumab requires a randomized trial,” and calls the use of Tmab for such a purpose, at best, merely “feasible.” Id. at 2218, 2222-23. In response to the Examiner’s position on Hussain, Appellant submitted Wendling,8 which is a subsequent report on “a multicenter, randomized phase II trial” using Tmab as HER2-positive bladder cancer therapy. Appeal Br. 8-10. Wendling disclosed that Tmab was not effective for treating bladder cancer, making “no difference” when used as such a 8 Patrice Wendling, Trastuzumab Role May be Limited in HER2-Positive Bladder Cancer, MDedge, Hematology & Oncology (2012) (“Wendling”). Appeal 2021-003458 Application 16/456,177 6 therapy, that “[p]atients treated with trastuzumab did not have improved quality of life scores,” and that “it is unclear whether a trastuzumab combination should be proposed for patients . . . .” Wendling 1-3 (Wendling’s pages are not numbered, thus, we cite its pages as they appear sequentially). We find that even if Hussain may have promoted some hope that Tmab could be used as a bladder cancer therapy, Wendling cast strong doubt on that proposition. The record does not reflect that the Examiner gave Wendling any consideration. See generally Final Action; Answer. We are persuaded by Appellant’s arguments that the rejection fails to establish a motivation to use the claimed Tmab-drug conjugate in the claimed method and also that there would have been significant uncertainty that such a use would be effective. “While absolute certainty is not necessary to establish a reasonable expectation of success, there can be little better evidence negating an expectation of success than actual reports of failure.” Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1354 (Fed. Cir. 2003). We find that Wendling’s reported failure of Tmab calls into question any potential motivation to use the composition to treat bladder cancer and that the record lacks evidence of a reasonable expectation of success for that claimed purpose. As for the second obviousness rejection, the Examiner relies on Hussain in the same way as for the first rejection, discussed above. Therefore, for the same reasons, we are persuaded by Appellant’s arguments. For the reasons set forth above, we find that the Examiner has failed to present a prima facie case for obviousness. Therefore, we reverse the Examiner’s obviousness rejections. Appeal 2021-003458 Application 16/456,177 7 DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 16-18, 20-25 103(a) Beusker, Alley, Hussain 16-18, 20-25 26 103(a) Beusker, Alley, Hussain, Alavattam, Persson 26 Overall Outcome: 16-18, 20-26 REVERSED