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
The amendment/argument filed 04/15/2026 is acknowledged and has been entered.
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 Claims 30-32, 36 and 38-39 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.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.
4. Claims 1, 3-6, 13-14 and 16 have been examined.
Grounds of Objection and Rejection Withdrawn
5. Unless specifically reiterated below, Applicant’s amendment and/or arguments have obviated or rendered moot the grounds of objection and rejection set forth in the previous Office action mailed 01/15/2026.
Grounds of Rejection Maintained
Claim Rejections - 35 USC § 103
6. 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.
7. 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.
8. Claims 1, 3-6, 13-14 and 16 remain 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.
Response to Arguments
Applicant’s arguments have been carefully considered but not found persuasive for the following reasons:
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
The Applicant only generally states nonobviousness, and lists case law, does not specifically point out any error of combination of the arts that the Examiner cited.
Therefore, the rejection is maintained for the reasons of record.
Conclusion
9. No claim is allowed.
10. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached on 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/YAN XIAO/Primary Examiner, Art Unit 1642
Prosecution Insights