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 .
Status of the Claims
This Office Action is in response to Applicant's Restriction Requirement remarks filed on December 5, 2025. Claim(s) 1, 2, and 4-12 are pending. Claim(s) 5-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant's election of Group I drawn to a method for extending lifespan and/or delaying aging in a subject comprising administering to the subject an effective amount of about 1-10 mg/kg of (24S)-3ß-hydroxy-5a-stigmastan-6-one without traverse of the restriction requirement in the reply is acknowledged. The requirement is deemed proper and is therefore made FINAL. Claim(s) 1, 2, and 4 are examined herein insofar as they read on the elected invention.
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 (i.e., changing from AIA to pre-AIA ) 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, 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.
Claims 1, 2, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (US PG PUB 2014/0370131).
Kim teaches the natural extract, Plumula nelumbinis, has excellent brain neuron-protecting activity [0071], has excellent reactive oxygen species (ROS) scavenging activity and antioxidant activity [0072]; is derived from a natural material, and thus is safe to the human body [0073].
Kim teaches a method for preparing a composition for the protection of brain neurons including the steps of: (a) preparing Plumula nelumbinis; (b) adding methanol to the Plumula nelumbinis to form a mixture; (c) sonicating the mixture; (d) isolating and purifying a methanol fraction from the sonicated mixture; (e) adding ethyl acetate to the isolated and purified methanol fraction; and (f) isolating and purifying an ethyl acetate fraction from the mixture of step (e) [0044].
Kim teaches the general dosage of the pharmaceutical composition to be 0.001-1000 mg/kg for adults [0034].
Kim teaches brain neuron protecting activity of the EtOAc layer of Plumula nelumbinis is associated with ROS scavenging activity (FIG. 5; [0056]).
Kim does not specifically teach the compound (24S)-3ß-hydroxy-5a-stigmastan-6-one of the instant claims.
The applicant’s specification explicitly states that PN6 was extracted and purified from Plumula nelumbinis (PN) in accordance with the procedures described in the section of "Materials and Methods". The identity of the purified PN6 (i.e., (24S)-3ß-hydroxy-5a-stigmastan-6-one) was confirmed by NMR proton spectroscopy [0093].
Kim teaches standard laboratory techniques, such as solvent extraction, for isolating and purifying fractions from a botanical mixture.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have known that purified extracts of Plumula nelumbinis may be employed as a method of protecting brain neuronal activity, reducing reactive oxygen species (ROS) scavenging activity due to the high antioxidant activity as taught by Kim, thereby extending lifespan and increasing vitality. It is a well-established practice in the pharmaceutical arts to analyze known medicinal compounds to identify the active component(s). This allows for standardized dosing, the removal of toxic or inactive plant material, and the creation of more concentrated therapeutic formulations. Given that Kim confirms Plumula nelumbinis treats said ailments, a POSITA would have had reasonable expectation of success that one or more chemical components within Plumula nelumbinis possesses the therapeutic property. Absent secondary considerations, the isolation of (24S)-3ß-hydroxy-5a-stigmastan-6-one involves routine and conventional purification methods known in the art.
Examiner notes that the limitations “activator of mammalian SIRT1 or nicotinamide adenine dinucleotide (NAD+)” (claim 6) are considered properties inherent in the disclosed active agent. "Products of identical chemical composition cannot have mutual exclusive properties." Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Conclusion
Claims 1, 2, and 4 are not allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-32800-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1627
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