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 8/31/2026 have been received and entered into the case. Claim 2 has been canceled, Claims 7-16 have been added. Claims 1 and 3-16 are pending, Claims 4 and 9-16 are withdrawn, and Claims 1, 3 and 5-8 have been considered on the merits, insofar as they read on the elected species of a mental symptom. All arguments have been fully considered.
Withdrawn Rejections
Rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in view of applicant’s amendments.
Rejections of Claims 1-3 and 5-6 under 35 U.S.C. 103 as being unpatentable over Sawada et al (US 2012/0009163 A1; 1/12/2012.) in view of HHP (Harvard Health Publishing. 2017;1-12.) are withdrawn in view of applicant’s amendments.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112:
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3 and 5-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventors or a joint inventor, or for pre-AIA the inventor(s), before the effective filing date of the application, had possession of the claimed invention.
The purpose of the written description requirement is to ensure that the invention had possession, as of the filing date of the application, of the specific subject matter later claimed by him or her. A patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention. Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, no that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention."
Claim 1 recites a method for improving a female menopausal symptom, comprising administering a lactobacillus strain that is Lactobacillus gasseri CP2305 strain having accession number: FERM BP-11331, a processed product of the lactobacillus strain, or an extract thereof to a subject in need thereof, wherein the female menopausal symptom is a mental symptom and/or a physical symptom, and wherein the mental symptom is at least one selected from the group consisting of anger, irritability, and depression, and wherein the physical symptom is at least one selected from the group consisting of getting chilled, headache, dizziness, nausea, fatigue, stiff shoulders, lower back pain, and pain in a limb.
The limitation of “a processed product of the lactobacillus strain, or an extract thereof” encompass a wide array of processed products and/or extracts. The instant specification fails to identify an active ingredient that improves a female menopausal symptom including anger, irritability, depression, getting chilled, headache, dizziness, nausea, fatigue, stiff shoulders, lower back pain, and pain in a limb. It is well-known in the art that processed products and extracts are made by removing compounds using a solvent, and that different solvents extract distinct chemical compounds based on polarity, boiling point, solubility, and selectivity, resulting in vastly different processed products and extracts. The instant specification discloses examples of solvents used for extraction (para 0043). However, extraction conditions and specific processed products and extracts are not disclosed. In addition, the instant specification fails to disclose and/or provides support for administering a processed product of the lactobacillus strain, or an extract thereof to a subject in need thereof, for improving a female menopausal symptom including anger, irritability, depression, getting chilled, headache, dizziness, nausea, fatigue, stiff shoulders, lower back pain, and pain in a limb. Since the relationship between specific ingredients and the claimed function is not clearly established, claim 1 fails the written description requirement. Moreover, the specification neither describes the complete structure of a representative number of species, nor describes a representative number of species in terms of partial structure and relevant identifying characteristics. Absent of such teachings and guidance as to the structure and function of the claimed processed products and/or extracts, the specification does not describe the claimed processed products and/or extracts in such full, clear, concise and exact terms so as to indicate that applicant had possession of the claimed processed products and/or extracts at the time of filing of the present application. Thus, the written description requirement has not been satisfied.
Response to Arguments
Applicant argues that cited references fail to teach or suggest administering Lactobacillus gasseri CP2305 strain having accession number: FERM BP-11331 to a subject in need thereof to treat at least one mental symptom selected from the group consisting of anger, irritability, and depression as recited in amended claim 1. However, these arguments are moot since those rejections are withdrawn 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
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