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 amendment filed 06/12/2026 is acknowledged and has been entered.
Claims 2, 5 and 17 have been amended.
3. Claims 1-20 are pending in the application. Claims 14-16 and 20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/19/2025.
4. Claims 1-13 and 17-19 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Grounds of Objection and Rejection Withdrawn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 03/12/2026.
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 1-13 and 17-19 remain rejected under 35 U.S.C. 103 as being unpatentable over Alraouji et al. (Molecular Carcinogenesis, 2020, 59:1041–1051) in view of Chung et al. (npj Breast Cancer, 2022, 8: 30, pages 1-10).
Claims 1-13 and 17-19 are herein drawn to a method of treating a breast cancer in a patient, wherein said method comprises administering a combination of an anti-interleukin-6 receptor antibody, a platinum-based antineoplastic drug, and a taxane, wherein said platinum-based antineoplastic drug is cisplatin or carboplatin, wherein said taxane is docetaxel, paclitaxel, or nab-paclitaxel, wherein said anti-interleukin-6 receptor antibody is tocilizumab.
Alraouji et al. teach that tocilizumab can suppress the prometastatic capacity of triple‐negative breast cancer (TNBC) cells and enhances the cytotoxic effect of cisplatin against these cells; see entire document, e.g., title, abstract. Alraouji et al. teach doses, schedules, and routes of administration of tocilizumab and cisplatin; see page 1047.
Alraouji et al. do not teach combination of tocilizumab with docetaxel for treating triple‐negative breast cancer (TNBC).
However, this deficiency is remedied by Chung et al.
Chung et al. teach that docetaxel synergizes with anti-IL-6R antibody (tocilizumab) in treating triple‐negative breast cancer (TNBC); see entire document, e.g., pages 4-5. Chung et al. teach doses, schedules, and routes of administration of tocilizumab and docetaxel; see first paragraph of right col. of page 8.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the references so as to treat triple‐negative breast cancer (TNBC) comprising a combination of tocilizumab, cisplatin and docetaxel treatment. One would have been motivated to do so because Alraouji et al. teach that tocilizumab enhances the cytotoxic effect of cisplatin in triple‐negative breast cancer (TNBC) treatment; Chung et al. teach that docetaxel synergizes with anti-IL-6R antibody (tocilizumab) in treating triple‐negative breast cancer (TNBC). 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 treat triple‐negative breast cancer (TNBC) comprising a combination of tocilizumab, cisplatin and docetaxel treatment, because tocilizumab enhances the cytotoxic effect of cisplatin and docetaxel in triple‐negative breast cancer (TNBC) treatment as taught by Alraouji et al. and Chung et al.
The Applicant’s arguments:
The specification demonstrates that administration of tocilizumab followed by cisplatin/docetaxel is a highly efficient neoadjuvant treatment for breast cancer. This combination is also a promising therapy for locally advanced TNBC patients with unprecedented responses, especially in patients with tumors bearing BRCA1/2 mutations. This was not to be expected based on the teachings of Alraouji et al. and Chung et al.
Evidence that the claimed invention is unexpectedly superior in one of a spectrum of common properties over the prior art can be enough to establish non-obviousness.
Response to Arguments
Applicant’s arguments have been carefully considered but not found persuasive for the following reasons:
The unexpected result is obtained with the combination of tocilizumab, cisplatin and docetaxel. However, the scope of the claims is broader than the combination of tocilizumab, cisplatin and docetaxel (e.g., any anti-interleukin-6 receptor antibody, any platinum-based antineoplastic drug, and a taxane). Therefore, applicant's argument is not commensurate with the scope of the claims.
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.
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/YAN XIAO/Primary Examiner, Art Unit 1642
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