METHOD OF PRODUCING AN IMMUNE CELL THAT RESPONDS TO A CANCER-ASSOCIATED ANTIGEN

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 . Priority The instant application was filed 1st August 2024, which claims priority from provisional application 63/517262, filed 2nd August 2023. Election/Restrictions Applicants’ election without traverse of Group I, claims 1-14, drawn to a method of producing an immune cell that responds to a cancer-associated antigen in the reply filed on 2nd of September 2026 is acknowledged. Claims 15-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on the 2nd of September 2026. Information Disclosure Statement The information disclosure statement (IDS) submitted on 1st of August 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. It is noted that Applicants have not filed an information disclosure statement under §l.97(c). Applicant is reminded of 37 CFR §1.56, which details Applicant's duty to disclose all information known to be material to patentability. Specification The use of the terms “Matrigel” (p. 28), TrypLE (p. 32-33), “GlutaMAX”(p. 34), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Claim Rejections - 35 USC § 102 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 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. (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 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nakazawa, Tsutomu, et al. (International Journal of Molecular Sciences 23.21: 12992, published 2022, hereinafter as “Nakazawa”). Regarding claim 1, 3, and 8, Nakazawa discloses a method of producing an immune cell (i.e. a dendritic cell) that responds to a cancer-associated antigen (e.g. CCNB1, i.e. Cyclin B1), the method comprising stimulating an immune cell with an antigen contained in a pluripotent stem cell (see e.g. sec. 2.2-2.3, 5.6 and fig. 4 and 8). Regarding claim 2 and 9, Nakazawa discloses wherein the immune cell is included in a mononuclear cell (see e.g. page 10). Regarding claim 4, 5, and 10, Nakazawa discloses five freeze-thaw cycles plus sonication (see e.g. sec. 5.4.3, p. 10-11) corresponding to the claim limitation of lysing the pluripotent stem cell to obtain the antigen, wherein the antigen is a lysate of a pluripotent stem cell, and wherein at least part of the pluripotent stem cell is a lysate of a pluripotent stem cell. Regarding claim 6 and 11, Nakazawa discloses wherein the stimulated immune cell responds to a panel of tumor-associated antigens (e.g. PSMA family members, EPCAM, PSAP, and CCNB1/cyclin B1) corresponding to a plurality of types of cancer-associated antigens (see e.g. sec. 2.2, fig. 4). Regarding claim 7 and 12, Nakazawa discloses wherein the stimulated immune cell is IFN-γ positive (see e.g. sec. 2.3 and 5.7, p. 6, fig. 8). Thus, Nakazawa anticipates the instant claims. Claims 1, 3-8, and 10-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kooreman, et al. (US11298380 B2 published 2022, hereinafter as “Kooreman”). Regarding claim 1, 3, and 8, Kooreman discloses a vaccination method that administer pluripotent stem cells to a patient to boost the immune response, corresponding to the claim limitation of method of producing an immune cell (i.e. T-cell, B-cell, dendritic cells, and mature APC from blood)(Example 1, col. 16, fig. 3) that responds to a cancer-associated antigen (i.e. tuman-associated antigen, TAA or TSA, e.g. EPCAM)(Example 1, col. 13) comprising stimulating an immune cell with an antigen contained in a pluripotent stem cell (see e.g. claim 1, Example 1, figs. 1-2). Regarding claim 4, 5, and 10, Kooreman discloses lysing the pluripotent stem cell to obtain the antigen wherein the antigen is a lysate of a pluripotent stem cell, and wherein at least part of the pluripotent stem cell is a lysate of a pluripotent stem cell (e.g. ELISPOT assay)(see e.g. Example 1, fig. 4, col. 20). Regarding claim 6 and 11, Kooreman discloses wherein the stimulated immune cell responds to a plurality of types of cancer-associated antigens. (e.g. EPCAM) (see e.g. col. 13-16, Example 1). Regarding claim 7 and 12, Kooreman discloses wherein the stimulated immune cell is IFN-γ positive (see e.g. col. 20). Regarding claim 13, as stated supra, Kooreman discloses a method of amplifying (i.e. boost or enhance) a response of an immune cell to a cancer-associated antigen, the method comprising stimulating an immune cell with an antigen contained in a pluripotent stem cell (see e.g. col. 13-16, Example 1, claims 1, 9 and 14, fig. 3-5, 8). Regarding claim 14, as stated supra, Kooreman discloses a method of amplifying (i.e. boost or enhance) a response of an immune cell to a cancer-associated antigen, the method comprising stimulating an immune cell with at least part of a pluripotent stem cell (see e.g. col. 13-16Example 1, claims 1, 9 and 14, fig. 3-5, 8). Thus, Kooreman anticipates the instant claims. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPHINE GONZALES whose telephone number is (571)272-1794. The examiner can normally be reached M-Th: 10AM - 5:00PM (EST). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. Josephine Gonzales PhD Examiner Art Unit 1638 /JOSEPHINE GONZALES/Examiner, Art Unit 1638 /Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638