DETAILED ACTION
RE: Gregory et al.
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s reply filed on 9/23/2025 is acknowledged. New claims 99-102 have been added. Claims 79-94 and 99-102 are pending. Claims 1-78 and 95-98 are canceled. Claims 85 and 90 have been amended.
3. Claims 79-94 and 99-102 are under examination.
Rejections Withdrawn
4. All rejections in the office action mailed on 6/23/2025 except the one maintained below are withdrawn in view of applicant’s amendments.
Rejections Maintained
Claim Rejections - 35 USC § 103
5. 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, 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.
6. Claims 79-94 and new claims 99-102 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Gomis et al. (WO 2013/153458A2, pub. date: 10/17/2013, IDS filed on 6/21/2023), in view of Payandeh et al. (Asian Pac J Cancer Prev, 2015, 16(12): 4863-4867).
Regarding claims 79, 85, 90 and new claim 99, Gomis et al. discloses a method comprising i) quantifying the expression level of the c-MAF gene in a tumor sample of a subject having triple negative breast cancer, ii) comparing the expression level obtained in step i) with a reference value, wherein an increased level of the c-MAF gene expression compared to the reference level indicates poor bone-metastasis-free survival (Fig. 4,[0042], [00110] and claim 2), or poor disease-free survival ([0336]), metastasis free survival ([0041]).
Gomis et al. teaches an in vitro method or designing a customized therapy for a subject suffering triple negative (including basal-like) breast cancer (TNBC) or, alternatively ER+ breast cancer, which comprises
i) quantifying the c-MAF gene amplification or translocation in a sample of
said subject and
ii) comparing the gene amplification or translocation obtained in i) with a
reference value,
wherein if the c-MAF gene amplification is increased with respect to said reference value, then administering to the subject a therapeutic drug that prevents, inhibits and treats bone metastasis, and if the expression level or c-MAF gene amplification is not increased with respect to said reference value, then said subject is not susceptible to receive a therapy aiming to prevent and/or treat bone metastasis (claim 10, [0212]).
Gomis et al. does not teach that if the expression level or c-MAF gene amplification in the subject is not increased with respect to said reference value, then treat said subject with tamoxifen. However, these deficiencies are made up for in the teachings of Payandeh et al.
Regarding claims 79, 83, 84, 90, 92, 94, and new claims 99-100, and 102, Payandeh et al. teaches treating triple negative breast cancer (TNBC) with tamoxifen plus radiation (abstract).
Regarding claims 80, 86 and 91, Payandeh et al. teaches that the age of the patients includes 60-69 (Table 1). These patients would be postmenopausal.
Regarding claim 81, Payandeh teaches that treatment with combination of tamoxifen plus radiation increases the OS and reduces the mortality rate (abstract).
Regarding claims 82, 88, 93, and new claim 101, tamoxifen is known to inhibit the binding of estrogen to estrogen receptor.
Regarding claims 85, 87 and 89, Payandeh et al. teaches treating patients having bone metastasis with tamoxifen plus radiation (Table 1).
It would have been prima facie obvious to one of ordinary skill in the art to have treated the breast cancer patients whose c-MAF expression level or gene amplification is not increased with respect to the reference value with tamoxifen and radiation in view of Payandeh et al. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Payandeh teaches that treatment of triple negative breast cancer patients with combination of tamoxifen plus radiation increases the OS and reduces the mortality rate (abstract).
Applicant’s Arguments
The response states that the Examiner acknowledged that "Gomis et al. does not teach that if the expression level or c-MAF gene amplification in the subject is not increased with respect to said reference value, then treat said subject with tamoxifen."
Furthermore, Payandeh does not rectify the deficiencies of Gomis. While Payandeh teaches treating triple negative breast cancer with tamoxifen, Payandeh does not mention c-MAF at all. Payandeh cannot cure the deficiencies of Gomis, if Payandeh itself does not even mention c-MAF, let alone the quantification of c-MAF. Therefore, a person of skill in the art would not have been motivated to combine Gomis and Payandeh, nor would the person of skill in the art been able to arrive at the claimed methods after such a combination.
Response to Arguments
Applicant’s arguments have been carefully considered but are not persuasive.
Gomis et al. teaches that if the c-MAF gene amplification is increased with respect to a reference value, then administering to the subject a therapeutic drug that prevents, inhibits and treats bone metastasis, and if the expression level or c-MAF gene amplification is not increased with respect to said reference value, then said subject is not susceptible to receive a therapy aiming to prevent and/or treat bone metastasis (claim 10, [0212]) (emphasis added). In summary, for TNBC patients having increased c-MAF gene amplification, Gomis et al. teaches treating them with a therapeutic drug that prevents, inhibits and treats bone metastasis. For TNBC patients having not increased c-MAF gene amplification, Gomis et al. only teaches that they are not susceptible to a therapeutic drug that prevents, inhibits and treats bone metastasis. Gomis et al. does not specifically teach how to treat TNBC patients having not increased c-MAF gene amplification. There is indeed a need to treat such patients. One of ordinary skill in the art would have been motivated to find a treatment which is not a therapeutic drug that prevents, inhibits and treats bone metastasis.
Payandeh et al. teaches treating patients having triple negative breast cancer (TNBC) with tamoxifen plus radiation. Of 70 patients, 23 patients had metastasis including 8 patients having bone metastasis (abstract and page 4864). Payandeh et al. teaches that treatment for TNBC patients with combination of tamoxifen plus radiation increases the OS and reduces mortality rate (page 4866, last para).
It would have been prima facie obvious to one of ordinary skill in the art to have treated the TNBC patients whose c-MAF expression level or gene amplification is not increased with respect to the reference value with tamoxifen and radiation in view of Payandeh et al. One of ordinary skill in the art would have been motivated to do so because Gomis et al. identified these patients as not being susceptible to a therapeutic drug that prevents, inhibits and treats bone metastasis and there is a need to treat these patients, and Payandeh teaches that tamoxifen plus radiation were effective in treating TNBC patients (majority of the them have no bone metastasis). One of ordinary skill in the art would have had a reasonable expectation of success because Payandeh teaches that tamoxifen plus radiation were effective in treating TNBC (majority of the them have no bone metastasis) and increased the OS and reduces the mortality rate (abstract).
New Grounds of Objection
Claim Objections
7. New claims 99-102 are objected to as the last step of the method (administering ) does not correlate with the preamble (identification).
Conclusion
8. No claims are allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG SANG whose telephone number is (571)272-8145. The examiner can normally be reached on Monday-Friday 8am-5pm.
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/HONG SANG/Primary Examiner, Art Unit 1643