DETAILED ACTION
Applicants claim amendments/arguments in the response filed 5/8/2026 are acknowledged and entered into the record.
Accordingly Claims 33, 35-44 have been previously withdrawn. Claims 45, 47-52 and newly added claims 53-55 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 Maintained - 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, 47-55 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.
Response to Arguments
Applicant's argue in the response filed 5/8/2026 that because Weinstein does not explicitly require washing the treated cells before administration, and washing is not necessarily required for administration, the Examiner’s argument asserting inherency is improper. Applicants further argue “a wash for analytical purposes (e.g. removing unbound antibody for an ELISA assay), as disclosed in Weinstein, does not inherently ensure that the residual concentration of the serotonin receptor agonist is below a ‘therapeutically unsafe level’ for human administration.” Applicants argue new claims 53-55 define that the stimulated cells obtained after the removing step exhibit enhanced therapeutic function, including overcoming IDO related effects and at least 2-fold greater cytolytic activity compared to unstimulated cells and highlight the unexpected findings shown in the instant specification. These arguments have been considered but not found to be persuasive.
Applicant’s arguments are not commensurate in scope with the instant claims. The instant claims are drawn to an in vitro method comprising (i) contacting cells with an agonist, thereby stimulating said cells, (ii) removing excess agonist, and (iii) optionally diluting the composition obtained. The instant claims do not recite a limitation involving immediate administration of said cells. Therefore, the disclosure of Weinstein et al. meets the limitations of the instant claims. Furthermore, paragraph [0288] of Weinstein et al. discloses activated NK cells having increased lytic function or are cytotoxic, capable of performing ADCC, and can be assessed by measuring secretion of cytolytic granules. Example 3 of Weinstein et al. also discloses “wells in which the compound of interest induces an amount of interferon gamma as measured by optical density that is greater than 2-fold higher than the unstimulated cell control are identified as being able to induce T cell activation.” The teachings of Weinstein et al. meet the limitations of the instant claims and therefore the rejection of record is maintained.
Conclusion
Claims 45, 47-55 are rejected.
No Claim is allowed.
THIS ACTION IS MADE FINAL. 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.
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/Meera Natarajan/Primary Examiner, Art Unit 1643
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