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 .
Status of the Claims
Claims 1-6 are currently pending.
Election/Restrictions
During a telephone conversation with Amy Schmid on 6/9/2026 a provisional election was made without traverse to prosecute the Species of a mental symptom, claims 1-3 and 5-6. Affirmation of this election must be made by applicant in replying to this Office action. Claim 4 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3 and 5-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 1 (line 3), 5 (line 2), and 6 (line 2) recite “(accession number: FERM BP-11331)”. It is unclear what the parenthetical information is conveying. Further, parenthesis is reserved for reference characters and information within parenthesis has no effect on the scope of the claims. See MPEP 608.01(m). Applicant is advised to remove the parenthesis.
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 1-3 and 5-6 are rejected 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.).
The instant claims recite a method for improving a female menopausal symptom, comprising administering a lactobacillus strain that is Lactobacillus gasseri CP2305 strain (accession number: FERM BP-11331), a processed product of the lactobacillus strain, or an extract thereof to a subject in need thereof.
Sawada teaches a method for activating vagus nerve in a subject (para 0059), comprising administering an agent to the subject, wherein the agent is Lactobacillus gasseri strain CP2305 (FERM BP-11331) (para 0034), the agent is orally administered (para 0061), the agent is used for a food or drink product (para 0008, 0010-0013, 0066), and the agent is effective for sleep improvement (para 0014), as it is thought that the activation of vagal afferent nerve is involved in the improvement of insomnia and quality of sleeping (para 0026).
Sawada does not teach the claimed subject in need thereof (claim 1).
However, Sawada does teach the method is for improving insomnia and quality of sleeping comprises the administration of Lactobacillus gasseri strain CP2305 (FERM BP-11331). HHP teaches insomnia is attributed to menopause (p.7 para 3), and disrupted sleep is a common complaint during perimenopause (p.9 para 2).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to administer Lactobacillus gasseri strain CP2305 (FERM BP-11331) to women going through menopause, since HHP discloses that insomnia is attributed to menopause, and Sawada discloses that the administration of Lactobacillus gasseri strain CP2305 (FERM BP-11331) improves insomnia and quality of sleeping. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to administer Lactobacillus gasseri strain CP2305 (FERM BP-11331) to women going through menopause with a reasonable expectation of success.
Conclusion
No claims are allowed.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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