DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group II in the reply filed on 12/01/2025 is acknowledged. The traversal is on the ground(s) that the composition prepared by the method of claim 45 is free of unbound serotonin receptor agonist and/or prodrug thereof is neither disclosed or suggested in Levite. This argument is found persuasive, however due to the amendment to the claims to include part (ii) of removing excess serotonin receptor agonist, this technical feature is not novel over the prior art. Weinstein et al. (US PgPub US2019/0240293) teach culturing immune cells with a serotonin receptor agonist to stimulate activation, and subsequently washing said cells, which would inherently meet the limitations of the amended claims, in particular part (ii). Therefore the restriction requirement is hereby maintained and made final.
Claims 33, 35-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/1/2025.
Applicants further elect without traverse the following species elections: white blood cells; 5HT1; pergolide; psilocybin; alkaline phosphatase; and cancer. After further consideration, the species election requirements are hereby withdrawn and all species will be examined.
Claims 45, 47-52 are pending and will be examined on the merits.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 45, 47-52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weinstein et al. (US PgPub US2019/0240293, published 8/8/2019).
The claims are directed to an in vitro method of contacting a composition comprising serotonin receptor-expressing cells with a serotonin receptor agonist thereby stimulating said cells, wherein said cells are either autologous cells obtained from said subject or allogeneic cells obtained from a donor, removing excess of said serotonin receptor agonist and diluting said composition.
Weinstein et al. (PgPub US2019/0240293) teach “the discovery that modulation of neurological signaling pathways can modulate an immune response and, e.g., can be used to modulate an anti-cancer immune response. Accordingly, therapeutic and pharmaceutical compositions (as well as veterinary compositions) comprising neuromodulating agents and related methods are disclosed herein for treatment of cancer. The invention also features methods of modulating an immune response or immune cell activities in a subject or in isolated immune cells” (see paragraph [0002]). Weinstein et al. disclose immune cells to include but are not limited to T lymphocytes (T cells), B lymphocytes (B cells), natural killer (NK) cells, macrophages, eosinophils, mast cells, dendritic cells and neutrophils. Weinstein et al. disclose neuromodulating agents can be divided into four major categories listed in several tables, in particular Weinstein et al. disclose the neuromodulating agent is a dopamine agonist listed in Tables 2A-2L. Table 2G lists serotonin agonists including pergolide, tryptamines, lysergamides, and phenethylamines and others listed in instant claim 50. Weinstein et al. teach examples of culturing immune cells to identify agents which stimulate activation and disclose “during the culture, the agent of interest identified as described in Example 1 or Example 2 is administered at various concentrations to the cells in culture” (see paragraph [0394] example 3). Weinstein et al. further discloses “at the end of the culture, supernatants or cells can be collected for further experiments ” (see paragraph [0389] example 3). The steps disclosed in example 3 include several washes with culture media or PBS and therefore would inherently be performing the instantly claimed step of “removing excess of said serotonin receptor agonist” and “diluting the composition”. Furthermore, Weinstein et al. discloses cell-based therapies (see paragraph [0232]) disclosing “The neuromodulating agent can be administered to the cell to effect an immune response (e.g., activation, polarization, antigen presentation, cytokine production, migration, proliferation, or differentiation) as described herein. Once the immune response is elicited, the cell can be administered to a subject” (see paragraph [0233]). Weinstein et al. teach each and every limitation of claims 45, 47-52.
Conclusion
Claims 45, 47-52 are rejected.
No Claim is allowed.
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/Meera Natarajan/Primary Examiner, Art Unit 1643