Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
2. The election filed without traverse on 09/30/2025 in response to the Office Action of 07/31/2025 is acknowledged and has been entered.
Applicant has elected Group I, claims 1, 3-6, 13-14 and 16, drawn to a method of treating a HER2 positive cancer in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a combination therapy comprising tucatinib, trastuzumab and an oxaliplatin-based chemotherapy.
Additionally, Applicant has elected mFOLFOX7 as species of oxaliplatin-based chemotherapy, colorectal cancer as species of cancer.
Upon review and reconsideration, the other cancer of claim 6 will be rejoined with colorectal cancer for examination.
3. Claims 1, 3-6, 13-14, 16, 30-32, 36 and 38-39 are pending in the application. Claims 30-32, 36 and 38-39 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/30/2025.
Claims 1, 3-6, 13-14 and 16 are currently under prosecution.
Priority
Applicant’s claim under 35 U.S.C. §§ 119(e) and/or 365(c) for benefit of the earlier filing date of applications, is acknowledged.
6. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 103
7. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
8. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
9. Claims 1, 3-6, 13-14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Peterson et al. (WO 2018201016, published on 01 November 2018, IDS) in view of Desai et al. (US 20190184031, published on 06/20/2019).
Claims 1, 3-6, 13-14 and 16 are herein drawn to a method of treating a HER2 positive cancer in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a combination therapy comprising tucatinib, trastuzumab and an oxaliplatin-based chemotherapy, wherein the oxaliplatin-based chemotherapy comprises oxaliplatin, leucovorin, and fluorouracil administered as an mFOLFOX7 regimen.
Peterson et al. teach a method of treating HER2 positive cancer comprising an
anti-HER2 antibody (e.g., trastuzumab) and tucatinib, the method further comprising a chemotherapeutic agent (e.g., fluorouracil); see entire document, e.g., claims 1-68, Examples 1-6).
Peterson et al. teach wherein the cancer is an unresectable locally advanced cancer or a metastatic cancer; see claim 7.
Peterson et al. teach wherein the cancer is selected from the group consisting of colorectal cancer, esophageal cancer, gastric cancer, cholangiocarcinoma, non-small cell lung cancer, bladder cancer, biliary cancer, breast cancer, and a combination thereof; see claim 6.
Peterson et al. do not teach treating colorectal cancer using mFOLFOX7 regimen.
However, this deficiency is remedied by Desai et al.
Desai et al. teach a method of treating a colorectal cancer using FOLFOX regimen (e.g., mFOLFOX7); see entire document, e.g., abstract, [0270].
Thus, one of ordinary skill in the art would have a reasonable expectation of success that by combining the teachings of the references so as to combine tucatinib, trastuzumab and mFOLFOX7 regimen for treating colorectal cancer, because it is prima facie obvious to combine two therapeutic agents, each of which is taught by the prior art to be useful for the same purpose, in order to form a combination that is to be used for the very same purpose. The idea of combining the first and second therapeutic agents to form a third flows logically from having the first and second been individually taught in the prior art. See In re Kerkhoven, 205 USPQ 1069 (CCPA 1980); see M.P.E.P. § 2144.06. In this case, tucatinib, trastuzumab and mFOLFOX7 regimen for treating colorectal cancer are taught by the prior arts.
Conclusion
10. No claim is allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN XIAO whose telephone number is (571)270-3578. The examiner can normally be reached M-F 8-5 EST.
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/YAN XIAO/Primary Examiner, Art Unit 1642
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