DETAILED ACTION
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 .
Summary
Receipt of the Preliminary Amendment dated October 22, 2025 is acknowledged.
Claims 1, 3-16, and 19-20 are pending in this application.
Claims 1, 4-6, and 19-20 have been amended.
Claims 2 and 17-18 have been cancelled.
All pending claims are under examination in this application.
Withdrawn Rejections
Claim Rejections - 35 USC § 112
The rejection of claims 1, 3-16, and 19-20 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for alleviating or treating sleep disorder, does not reasonably provide enablement for prevent sleep disorder has been withdrawn in view of the amendments to the claims to remove the term “preventing”.
The rejection of Claims 4-6 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention because the claims depend from cancelled claim 2 has been withdrawn in view of the amendment to the claims to change the dependency from 2 to 3.
Claim Rejections - 35 USC § 102
The rejection of claims 1, 3-6, 12-13, 15-16, and 19-20 under 35 U.S.C. 102(a)(1) as being anticipated by Altaf et al. (US 2025/0114411) has been withdrawn in view of the submission of the interim copy of foreign priority document 10-2021-0015295.
The rejection of claims 1, 3-6, 12-13, 15-16, and 19-20 under 35 U.S.C. 102(a)(1) as being anticipated by Altaf et al. (US 2023/0355689) has been withdrawn in view of the submission of the interim copy of foreign priority document 10-2021-0015295.
Newly Applied Rejections
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 15-16, and 19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Moiseyenko et al. (US 2024/0066074).
Moiseyenko discloses probiotic treatments for neurodegenerative disorders and/or one or more symptoms of neurodegenerative disorders. Symptoms include sleep disruption (paragraph 0011). The method of treatment comprises administering a composition including Prevotella histicola (paragraph 0012). The compositions include a component of the isolated microbial organism. Such components may include, for example, bacterial outer membrane vesicles, bacterial capsules, bacterial cell wall, bacterial cell envelope, or other components of bacteria (paragraph 0041).
Moiseyenko discloses oral administration of the composition (paragraph 0043).
Regarding claim 15, the composition can be formulated as a pharmaceutical composition, nutraceutical composition, or a probiotic composition (paragraph 0043).
Regarding claim 16, nutraceutical compositions include food stuffs (paragraph 0107).
Regarding claim 19, according to Example 1, Prevotella histicola was obtained and cultured.
Moiseyenka, therefore, anticipates the rejected claims.
Claim Objections
Claims 3-14 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art is that of Moiseyanka, as discussed above. Moisenyanka discloses sleep disturbances, as they relate to a neurological disorder, such as Parkinson’s. There is no disclosure of any specific sleep disorders as recited in claims 3-11. Moiseyanka additionally does not disclose extracellular vesicles.
Conclusion
Due to the new grounds of rejection presented in this office action, this action is made Non-Final.
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/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
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