DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment and response filed on 1/15/2026 have been received and entered into the case. Claims 1-5, 7, 11, and 14-21 have been canceled. Claims 6, 8-10 and 12-13 are currently pending, Claims 8-10 and 12 have been withdrawn, and Claims 6 and 13 are pending and have been considered on the merits, insofar as they read on the elected species of Lactobacillus gasseri CP2305 strain (accession number: FERM BP-11331). All arguments have been fully considered.
Withdrawn Rejections
Rejections of Claims 6 and 13 under 35 U.S.C. 103 as being unpatentable over Nishida et al (Journal of Functional Foods. 2017;36:112-121. Cited on IDS) in view of Kluk (https://drjustinekluk.com/notebook/acne-and-the-menstrual-cycle/. 2018;1-2.) and Bagatin et al (An Bras Dermatol. 2019;94(1):62-75.) are withdrawn in view of applicant’s amendments.
Claim Objections
Claim 13 is objected to because of the following informalities: the recitation of “the premenstrual” on line 1 is suggested to read “the at least one premenstrual” to be consistent with claim 6. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
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.
Claims 6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Samuelsson et al (US 7,312,067 B2; 12/25/2007.).
The instant claims recite a method for regulating a female hormone secretion, comprising: administering Lactobacillus gasseri CP2305 strain accession number: FERM BP-11331 or a composition comprising the Lactobacillus gasseri CP2305 strain accession number: FERM BP-11331 to a woman, wherein the woman has menstrual cycles, and the woman has at least one premenstrual symptom selected from the group consisting of apathy, anger, and an increase in leucorrhea, to regulate the female hormone secretion of the woman.
Samuelsson teaches a method for treating bacterial vaginosis comprising administering Lactobacillus gasseri (col.4 line 1, col.5 line 45-50) to women (col.9 line 15), wherein the administration started during the first menstrual discharge (col.8 line 66-67). Samuelsson teaches during menstruation, women often have complaints of increased vaginal discharge (increased leucorrhea) and irritation, a condition called bacterial vaginosis, and is the most common condition associated with irritation and increased amount of odorous vaginal discharge (col.2 line 13-17).
Samuelsson does not teach the claimed Lactobacillus gasseri strain (claim 6).
However, Samuelsson does teach Lactobacillus gasseri is useful for treating bacterial vaginosis, symptoms include increased amount of odorous vaginal discharge. The reference strain would have rendered the claimed strain obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the clear, close relationship between the strains as evidenced by their belonging to the same species as well as its ability to improve leucorrhea.
Limitations of “for regulating a female hormone secretion” and “to regulate the female hormone secretion of the woman” in claim 6 do not recite any additional active method steps, but simply states a characterization or conclusion of the results of process step positively recited (e.g. analyzing). Therefore, these limitations are not considered to further limit the method defined by the claim and has not been given weight in construing the claims.
Response to Arguments
Applicant argues that cited references do not teach or suggest “the woman has at least one premenstrual symptom selected from the group consisting of apathy, anger and an increase in leucorrhea” as recited in the amended claims 6 and 13. However, these arguments are moot in light of the new rejections above in view of applicant’s amendments.
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 extension fee 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 LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached on (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759