DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The amendment filed November 6, 2025 has been received and entered. The text of those sections of Title 35, U.S. Code, not included in this action can be found in a prior Office action. Any rejection set forth in a previous Office action that is not specifically set forth below is withdrawn.
3. Claims 1, 2, 4-7, and 9-11 are pending.
Election/Restrictions
4. In the reply filed on July 24, 2025, applicant elected Group I, now claims 1, 2, 4-7, 9, and 10, without traverse.
5. Claim 11 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
6. Claims 1, 2, 4-7, 9, and 10 are examined on the merits.
Claim Rejections - 35 USC § 112
Claims 1, 2, 4, 5, and 10 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
7. Claim 1 is indefinite because lines 8-9 of the claim states that the elution is performed using water and methanol but then states that the solvent ratio of the elution solvents is “water to ethanol”. It appears that “ethanol” should read “methanol.” However, clarification and/or correction is needed.
8. Claims 5 and 10 are indefinite because the antecedent basis for “the Pleurotus eryngii” is unclear. The parent claims recite “Pleurotus eryngii” numerous times; thus, it is unclear which recitation is intended to provide the antecedent basis for this limitation in claims 5 and 10.
Claim Rejections - 35 USC § 101
9. Claims 1, 2, 4-7, 9, and 10are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more for the reasons set forth in the previous Office action.
All of applicant’s arguments regarding this ground of rejection have been fully considered but are not persuasive. Applicant argues:
Independent claims 1 and 6 as amended recite that the fraction of Pleurotus eryngii is a methanol fraction obtained through a two-step ethanol/methanol chromatography process in a specific manner as recited in the claims. Such process imparts structural and functional changes (e.g., by providing purified serotonin-modulating components), which possess markedly different characteristics than the naturally occurring Pleurotus eryngii. The activity of the methanol fraction is shown in Examples 2-5 provided in the specification, which demonstrate serotonin receptor binding inhibitory activity, activation of signaling mediated by serotonin receptors by selectively binding to serotonin receptors, and antidepressant efficacy of fraction of Pleurotus eryngii extract as evidenced by the forced swimming test.
However, applicant has not provided any specific evidence to support the assertion that the extraction and fractionation method as claimed produces any structural or functional changes in comparison with the closest occurring natural counterpart. The extraction, fractionation, and column purification steps claimed by applicant would serve to the separate and partition portions and compounds from the mushroom. However, this does not necessarily result in any structural changes to the compounds themselves. The solvent extraction and column purification steps only serve to partition and concentrate the molecules that are naturally in the mushroom. Thus, the closest occurring natural counterpart is the fraction itself because this is only a mixture of naturally occurring compounds in the mushroom. Therefore, the comparison of the claimed fraction to the mushroom itself is not considered to be persuasive because the mushroom is not the closest occurring counterpart.
10. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655