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
This is a response to Applicant’s communication filed on September 2, 2025. Application No. 17/926,424, is a 371 of PCT/JP2021/017946, filed May 11, 2021, and claims foreign priority to Japanese application No. JAPAN 2020-088810, filed May 21, 2020. In an amendment filed September 2, 2025, Applicant cancelled claims 2-4. Claims 1 and 5-7 pending.
Rejection Withdrawn
The rejection of claims 1 and 5-7 under 35 U.S.C. 102(a)(1) as being anticipated by Uchiyama et al., U.S. Patent No. 6,716,424, is withdrawn in view of Applicant’s September 2, 2025, Amendment & Remarks.
New Rejection Necessitated by Applicant’s September 2, 2025, Amendment
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.
The factual inquiries 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.
Claims 1 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Uchiyama et al., U.S. Patent No. 6,716,424 B1 (previously cited in the withdrawn 102(a)(1), rejection above), in view of Lephart et al., US2006/0122262 A1. As stated in the previous 35 U.S.C. 102(a)(1) rejection, Uchiyama discloses a method for improving the quality of life (QOL) of a 40-year-old or older postmenopausal woman (without menopausal disorder), comprising administering a composition comprising equols to said woman, in an effective amount for improving QOL of said woman. See Uchiyama et al., Abstract; see Id., Background Art, Col. 1, ln. 18 – Col. 3., ln. 36, for improved symptoms; see also Id., Col. 12, ln. 1 – Col. 15, ln. 5, Examples 1-9, Best Mode for Carrying Out the Invention, for composition dosage and food products; see also Id., claim 8, for the same. The difference between the prior art and present invention is/are the specific improvements of both physical and mental symptoms as in the amended claims.
Lephart teaches that equol binds and blocks the hormonal action of DHT and sequesters it from the androgen receptor, thus altering growth and physiological hormone responses that are regulated by androgens. See Lephart et al., USPG ‘262 publc’n, Abstract. Furthermore, physiological and pathophysiological conditions mediated by androgen include, and not limited to, benign prostatic hyperplasia, female pattern alopecia, facial and body hair, acne, excessive secretion of sebum from sebaceous gland, skin appearance, anti-aging, anti-photoaging, skin faultlessness, skin pigment deposition, Alzheimer’s disease, emotional abnormality and psychological unhealthiness, depression, anxiety Tourette’s syndrome, Kennedy syndrome, congenital defects in synthesis and metabolism of steroidal hormone including androgen, obesity abnormal body weight, abnormal lipid and cholesterol levels, overproduction of lipids, lipid breakdown, suppression of insulin resistance, hypertension, thyroid function and cardiovascular disease. See Id., claims 23 and 31. Thus, all the elements of the present invention were known in the art at the time of the invention.
It would have been obvious to the ordinary artisan at the time of the invention to combine the teachings of Uchiyama and Lephart in a method comprising administering eqouls for improving the QOL of a 40-year-old or older postmenopausal woman (without menopausal disorder) to also improve conditions mediated by androgen as taught specifically by Lephart. All the elements of the of the prior art operate in substantially the same way alone as they would together. The present invention combines these prior art elements according to known methods to yield predictable results.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached Monday - Friday, 9:00 a.m. -5:00 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY R ROZOF/Primary Examiner, Art Unit
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