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 April 14, 2026. 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 14, 2026, has been entered.
Rejection Maintained
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.
The rejection of claims 1 and 5-7 under 35 U.S.C. 103 as being unpatentable over Uchiyama et al., U.S. Patent No. 6,716,424 B1, in view of Lephart et al., US2006/0122262 A1, is maintained for reasons made of record. Applicant has amended the claims to a smaller set of conditions improved by the administration of equols, which, notably, were previously claimed (and rejected over the prior art) and argues that the prior art fails to disclose these specific conditions or even suggest improvements in these conditions. Applicant’s argument has been fully considered and is not persuasive.
Applicant argues that the improvement in the narrowed list of conditions, now claimed, are not specifically disclosed in the prior art or even suggested, and therefore not obvious over the teaching of the prior art. The claims are now drawn to improving QOL of a 40-year-old or older postmenopausal woman by administering equols. The improvements in QOL are now limited to improving: (1) bronchitis, (2) autonomic nerve balance, (3) hearing loss and (4) intestinal regulation. Notably, none of these conditions are specifically defined in the disclosure of the present invention.
In this case, the generally claimed improvements are specifically disclosed in the prior art or suggested. Claim 24 of Lephart teaches the following physiological and pathophysiological conditions “improved” (as claimed by the present invention): excessive secretion of sebum from sebaceous glands (i.e., bronchitis); anti-aging, emotions, and mental health, depression (i.e., autonomic nerve balance and hearing loss); obesity, body weight, lipid and cholesterol levels, lipogenesis, lipolysis, etc. (i.e., intestinal regulation). Accordingly, the all elements as presently claimed are disclosed in the prior art.
As stated in November 14,, 2025, Final Office action, 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 equols 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. Again, 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.
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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