DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of the invention of Group I, in the reply filed on 11/20/2025 is acknowledged.
As the remaining of the claims have been amended to method of treating claims. Therefore, claims 1-3, 5-14 are pending and have been examined.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-3 and 5-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Delessard et al., Int. J. Mol. Sci. 2020, 21, 145 in view of Razavi et al., Nutrition and Cancer, 73:3, 514-522, published online 23 April 2020, and US2013/0295068 (‘068).
Delessard et al. teaches chemotherapeutic agents for treating cancer could cause spermatogenesis to be impaired (see page 2 of 23, second paragraph). Delessard et al. teaches DNA intercalating agents such as irinotecan, daunorubicin, doxorubicin, etoposide, and bleomycin, and antimetabolites such as methotrexate, cytarabine, that impact DNA biosynthesis, would be considered as risk for fertility. Most of the drugs listed (including cisplatin) in Table 1 are considered as moderate risk when exposed during childhood (see pages 2 and 3 of 23, Table 1).
Delessard et al. does not expressly teach the use of omega-3 fatty acid and antioxidants such as tocopherol in the method of reducing the risk of male infertility due to chemotherapeutic and/or radiotherapeutic treatment in a prepubertal subject.
Razavi et al. teaches omega-3 fatty acid treatment after bleomycin, etoposide and cisplatin treatment, improves spermatogenesis in rats (see the abstract). The combination of using EPA and DHA with the chemotherapeutic agents reduced the DNA damage significantly (see the abstract).
‘068 teaches the use of a composition comprising vitamin E, folic acid, and coenzyme-Q10 to enhanced the quality of sperms such as sperm count and sperm motility (see claims 14-15; [0008], [0009]).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ the herein claimed EPA and DHA, along with Coenzyme Q10, vitamin E, and folic acid, in a method of reducing the risk of male infertility due to chemotherapeutic and/or radiotherapeutic treatment in a prepubertal subject.
One of ordinary skill in the art would have been motivated to employ the herein claimed EPA and DHA, along with Coenzyme Q10, vitamin E, and folic acid, in a method of reducing the risk of male infertility due to chemotherapeutic and/or radiotherapeutic treatment in a prepubertal subject. The examiner notes that it is well-known in the art that chemotherapeutic agents such as cisplatin causing impaired spermatogenesis, especially when the patients were in their childhood and being exposed to the chemotherapeutic agents. Since the herein claimed agents, i.e., Omega-3 fatty acid like EPA and DHA, as well as the secondary agents such as Coenzyme Q10, vitamin E, and folic acid, are well-known to improves sperm counts (i.e., increasing spermatogenesis) and sperm quality, employing them concomitantly (in sequential, or co-administration manner) to produce the very same effect (e.g., increasing sperm quality and sperm count) is considered as prima facie obvious (See In re Kerkhoven 205 USPQ 1069 (CCPA 1980)).
No claims are allowed.
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/SAN MING R HUI/ Primary Examiner, Art Unit 1627