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 on 12/19/2025 in response to the Office Action of 11/19/2025 is acknowledged and has been entered.
Applicant has elected Group I, claims 1-13 and 17-19, 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.
Because applicant did not distinctly and specifically point out any supposed errors in the restriction requirement, the election has been treated as an election without traverse. See MPEP 818.03(a).
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 Claims 14-16 and 20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Claims 1-13 and 17-19 are currently under prosecution.
Claim Rejections - 35 USC § 112
5. The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
6. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
7. Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 5 recites the limitation "a dose of said taxane of steps (2) and (3)" in lines 8-9. There is insufficient antecedent basis for this limitation in the claim.
8. 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 § 102
9. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
10. Claims 1-3, 8-13 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen et al. (WO 2021257503, published on 23 December 2021).
Claims 1-3, 8-13 and 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.
Nguyen et al. teach a method of treating breast cancer in a subject comprises administering a taxane (e.g., nab-paclitaxel or paclitaxel) and more chemotherapeutic agents, wherein the chemotherapeutic agents include platinum-based chemotherapeutic agents include (carboplatin or cisplatin) and interleukin 6 (IL-6) blockers (e.g., tocilizumab); see entire document, e.g., abstract, page 16-lines 6-10, page 17-line 1, page 19-line 5.
For claim 3, Nguyen et al. teach the pharmaceutical composition is administered to a human subject; see page 28-lines 34-35.
For claim 8, Nguyen et al. teach 125 mg/m2 nab-paclitaxel; see claim 9.
For claims 9-10, Nguyen et al. teach breast cancers is triple-negative breast cancer (TNBC); see abstract, page 1-line-10 and page 1-lines 22-23.
For claim 11, Nguyen et al. teach administering intravenously for nab-paclitaxel; see page 2-line 33-34.
Claim Rejections - 35 USC § 103
11. 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.
12. 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.
13. Claims 1-13 and 17-19 are 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.
Conclusion
14. No claim is allowed.
15. 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