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 This application was filed June 28, 2022, and is a 371 application of PCT/IB2020/001079 filed on December 28, 2020, which claims benefit to the provisional application 62/954,448 filed on December 28, 2019. Election/Restrictions Applicant’s election without traverse of Group I (claims 1-12, 14, 26-28, 30-32 and 38), drawn to an immune cell that comprises an expressed immune cell activator polypeptide comprising an intracellular signal transduction domain, a transmembrane domain, and an extracellular label domain, wherein the immune cell secretes one or more polypeptide effector molecules), and species: 1.) Immunomodulator - PD-I; 2.) Immune cell - T cell, 3.) Tumor- mesothelioma ; 4.) Tumor cell - mesothelial cell; 5.) Cell surface protein of the tumor cell- mesothelin; 6.) Additional biochemical activity of the bi specific polypeptide - extending the half-life of the bispecific polypeptide in vivo in the reply filed on Sept. 2 nd , 2025, is acknowledged. Claim s 7, 30, 69-70, 73-77, and 81-83 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention , there being no allowable generic or linking claim.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 9/2/2025 . Claim Status In the response filed Sept. 2, 2025, Applicant has amended claims 1-4, 7-8, 26, 63-65, 75-77, canceled claims 13-25, 32-62, 66-68, 71-72, 78-80 and filed new claims 81-83. Claims 1-12, 26-28, 30-31, 63-65, 69-70, 73-77, and 81-83 are pending. Claims 7, 30, 69-70, 73-77, and 81-83 are withdrawn and the election was made without traverse in the reply filed on 9/2/2025. Currently, Claims 1- 6, 8- 12, 26-28, 3 1, and 63-65 are under examination in this application. Information Disclosure Statement 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. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 6 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 64 recites : “The immune cell of claim 64 , wherein the wherein the additional biochemical activities or biological functions comprise: specific binding of a fluorophore, extending the half-life of the bi specific polypeptide in vivo , increasing the affinity of the bi-specific polypeptide, and modulating an immune response mediated by a Fc domain”. In the instant case, the immune cell of the dependent claim 64 is not further limit ing . Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. In the interest of compact prosecution, the claim 64 will be interpreted as being dependent on claim 63 which is also directed to additional biochemical activities or biological functions. 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. Claim s 1 , 31 , and 63- 65 are rejected under 35 U.S.C. 102 (a)(1) FILLIN "Insert either \“(a)(1)\” or \“(a)(2)\” or both. If paragraph (a)(2) of 35 U.S.C. 102 is applicable, use form paragraph 7.15.01.aia, 7.15.02.aia or 7.15.03.aia where applicable." \d "[ 2 ]" as being anticipated by Karches , Clara H., et al. (Clinical Cancer Research 25.19: 5890-5900, published Oct. 2019) . Regarding claim 1, and 31, Karches discloses a immune cell (i.e. T cell) that comprises an expressed immune cell activator polypeptide comprising an intracellular signal transduction domain (i.e. CD3ζ), a transmembrane domain (i.e. CD28) , and an extracellular label domain (i.e. EGFRvIII ), wherein the label domain comprises a structurally inert domain derived from human mesothelin extracellular domain (ECD) (i.e. MSLN) (see e.g. abstract, fig. 1- 4 , supp fig. 1, and pages 2,4, and 6-7) . Further, Karches discloses that the immune cell is capable of specifically binding to a bispecific polypeptide (i.e. 2+2 antibody, BiAb , anti EGFRvIII x anti EpCAM BiAb )(see e.g. page 4) , comprising ( i ) a label-binding domain comprising a single chain polypeptide (i.e. mesothelin IgG) (see e.g. page 8, fig. 4) and (ii) a cell surface protein-binding domain comprising a single chain polypeptide that binds to a cell surface protein receptor of a target cell (e.g. EpCAM tumor cells) (see e.g. supp fig. 1 and 2, page 7-8 ). Regarding claim 63 -64 , Karches discloses wherein the bispecific polypeptide further comprises one or more domains that provide additional biochemical activities or biological functions , corresponding to the claim limitation of modulating an immune response mediated by a F c domain (see e.g. page 7-8, and 9, fig. 1) . Regarding claim 65, Karches discloses wherein the bispecific polypeptide comprises additional cell surface protein-binding domains comprising a single chain polypeptide domains that bind to different cell surface receptors of different cells (e.g. a T-cell and a Tumor cell)(see e.g. page 2, 6-7, supp. Fig. 1, page 23 of PDF) . Thus, Karches et al . anticipates the instant claims. Claims 1 -6 , 8 -12 , 26-28, 31, and 63-6 5 are rejected under 35 U.S.C. 102(a)(1) FILLIN "Insert either \“(a)(1)\” or \“(a)(2)\” or both. If paragraph (a)(2) of 35 U.S.C. 102 is applicable, use form paragraph 7.15.01.aia, 7.15.02.aia or 7.15.03.aia where applicable." \d "[ 2 ]" as being anticipated by B rogdon et al., (US20 19 / 0000944A1; published Jan. 201 9 ). Regarding claim 1, B rogdon discloses a n immune cell (i.e. immune effector cell, e.g. T cell) (see e.g. para. 239 -240 , 351 , 393 , claim 1 ) that comprises an expressed immune cell activator polypeptide comprising an intracellular signal transduction domain ( i.e. CD3ζ) (e.g. para. 241, 281, 305, 416 , claim 1 ) , a transmembrane domain (i.e. CD28) (see e.g. 284 , claim 1 ) , and an extracellular label domain, wherein the label domain comprises a structurally inert domain derived from human mesothelin extracellular domain (ECD)(i.e. MSLN)(see e.g. claim 57, para. 77-78, claim 1 ). Further, Brogdon discloses that the immune cell is capable of specifically binding to a bispecific polypeptide (see e.g. para. 121, 224-227, 487 ), comprising ( i ) a label-binding domain comprising a single chain polypeptide and (ii) a cell surface protein-binding domain comprising a single chain polypeptide that binds to a cell surface protein receptor of a target cell (e.g. a first Ig variable domain of a scFv , which has binding specificity for mesothelin) (see e.g. para. 121, 224-227, 434 ). Regarding claim 2 and 5 , B r o gdon discloses comprising an extracellular chimeric polypeptide (see e.g. para. 112-113) , wherein the extracellular chimeric polypeptide comprises a binding domain of a VHH antibody (i.e. camelid VHH domains)(see e.g. para. 117, 119-120) or a single chain variable fragment and a the label domain ( i. e. antigen-recognition domain)(e.g. scFv )(see e.g. para. 113, 117, 434) . Regarding claim 3 -4 and 6 , Brogdon discloses wherein the immune cell secretes one or more polypeptide effector molecules (see e.g. para. 114) , wherein the polypeptide effector molecule comprises an antibody that specifically binds to one or more immunomodulators , where the immunomodulator is PD-1 (i.e. PD1)(see e.g. para. 246, 271, 273-276 , 382 and 416 ). Regarding claim 8, as stated supra, Brogdon discloses wherein an immune cell that comprises a nucleic acid vector (see e.g. para. 280-294) comprising (a) a promoter region effective for transcription in the immune cell (see e.g. para. 161-169, 279, 292-301 and 303; table 1) ; (b) a polynucleotide encoding an amino acid sequence of the immune cell activator polypeptide (see e.g. para. 82-89, 121, 124 449, table 1, 6 , claims 39-69 ) , comprising an intracellular signal transduction domain (i.e. CD3ζ)(e.g. para. 241, 281, 305, 416, claim 1), a transmembrane domain (i.e. CD28)(see e.g. 284, claim 1), and an extracellular label domain, wherein the label domain comprises a structurally inert domain derived from human mesothelin extracellular domain (ECD)(i.e. MSLN)(see e.g. claim 57, para. 77-78, claim 1). Further, Brogdon discloses that the immune cell is capable of specifically binding to a bispecific polypeptide (see e.g. para. 121, 224-227, 487), comprising ( i ) a label-binding domain comprising a single chain polypeptide and (ii) a cell surface protein-binding domain comprising a single chain polypeptide that binds to a cell surface protein receptor of a target cell (e.g. a first Ig variable domain of a scFv , which has binding specificity for mesothelin)(see e.g. para. 121, 224-227, 422, 434) (c) a terminator region effective for ending transcription in the immune cell (see e.g. para. 115, 118, 171, and 174) . Regarding claim 9, which further comprises a second nucleic acid vector (see e.g. para. 255-273) comprising (a) a promoter region effective for transcription in the immune cell (see e.g. para. 292, 297-300) ; (b) a polynucleotide encoding an amino acid sequence of one or more secreted polypeptide effector molecules (see e.g. para. 273, 600) ; (c) a terminator region effective for ending transcription in the immune cell (see e.g. para. 115, 118, 171, and 174). Regarding claims 10, 26, and 28, as stated supra, Brogdon discloses wherein the nucleic acid vector further comprises a polynucleotide encoding an amino acid sequence of a polypeptide effector molecule comprising an antibody or a binding fragment thereof that specifically binds to one or more immunomodulators wherein the immunomodulator is PD-1, wherein the immune cell secretes one or more polypeptide effector molecules (see e.g. para. 114, 246, 271, 273-276, 382 and 416). Regarding claim 11 -12, and 27 , Brogdon discloses wherein the immune cell activator polypeptide further comprises a binding domain of a VHH antibody (see e.g. para. 117, 119-120, 208, 212, 259, 262-266) . Regarding claim 31 , as stated supra, which is T cell or natural killer cell (see e.g. para. 622). Regarding claim 63 -6 4 , Brogdon discloses wherein the bispecific polypeptide further comprises one or more domains that provide additional biochemical activities or biological functions , such as specific binding of a fluorophore (e.g. GFP) (see e.g. para. 294, 303, 434) . Regarding claim 65, Brogdon discloses wherein the bispecific polypeptide comprises additional cell surface protein-binding domains comprising a single chain polypeptide domains that bind to different cell surface receptors of the same cell (i.e. one domain for scFv for mesothelin and another for an antigen other than mesothelin e.g. FAP)(see e.g. para. 226-229). Thus, Brogdon et al . anticipates the instant claims. Claim Rejections - 35 USC § 103 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. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 63- 64 are rejected under 35 U.S.C. 103 as being unpatentable over Brogdon et al., (US2019/0000944A1; published Jan. 2019), as applied above to claims 1-6, 8-12, 26-28, 31, and 63-64, and in further view of Davé , Emma, et al. ( MAbs . Vol. 8. No. 7. Taylor & Francis, published 201 6 , hereinafter as “Dave” ), and Karches , Clara H., et al. (Clinical Cancer Research 25.19: 5890-5900, published Oct. 2019) . The teachings of Brogdon et al ., apply here as indicated above. Regarding claim 63- 64, Brogdon discloses an anti-cancer effect (biological effect)(i.e. additional biochemical activities or biological functions) which can be manifested by various means (see e.g. para. 126, Example 4). Brogdon does not explicitly state extending the half-life of the bi-specific polypeptide in vivo . However, the prior art of Dave discloses wherein the bispecific polypeptide (i.e. bispecific antibody Fab- dsFv ) further comprises one or more domains (e.g. variable fragment ( Fv ) domain of a humanized albumin-binding antibody was fused to the C-termini of Fab constant domains, such that the VL and VH domains were individually connected to the Cκ and CH1 domains by peptide linkers ) that provide additional biochemical activities or biological functions comprising extending the half-life of the bispecific polypeptide in vivo (see e.g. abstract, fig. 1, table 2, pages 1329, 1331-1332 ). Accordingly, it would have been obvious to one of ordinary skill in the art to combine the bi-specific polypeptide as taught by Brogdon with the bi-specific polypeptide as taught by Dave in a method of extending the half-life of the bi-specific polypeptide in vivo because Dave discloses that there is a need for antigen-binding therapeutics with enhanced serum half-life (see e.g. page 1329). Further, Dave discloses that while short serum half-life’s may be irrelevant or advantageous in some applications, it invokes impractical dosing regimens in the treatment of chronic disorders , and thus extending serum half-life has become increasingly important (see page 1319). Thus, a person of ordinary skill in the art would have had a reasonable expectation of success because both Brogdon and Dave disclose bi-specific polypeptides that u tilize Fab, VH, CH1 domains and variable fragment ( Fv ) domains , as discussed above. Thus, person of ordinary skill in the art would have been able to use the additional domains such as those taught by Dave in combination with the bispecific polypeptide as taught by Brogdon to obtain predictable results with a reasonable expectation of success. Additionally , the prior art of Karches discloses that the bi-specific polypeptide (i.e. BiAb ) may be engineered for half-lives according to the needs, and that the concentration could then be adjusted to maintain T cell efficacy (see e.g. page 11). Furthermore, an artisan of ordinary skill in the art of bi-specific antibodies has good reason to pursue the known options within his or her technical grasp ( KSR International Co. v. Teleflex Inc. , 82 USPQ2d 1385 (US 2007). Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT JOSEPHINE GONZALES whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-1794 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-Th: 9AM - 5:00PM (EST) . 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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. FILLIN "Examiner Stamp" \* MERGEFORMAT JOSEPHINE GONZALES Examiner Art Unit 1631 /JOSEPHINE GONZALES/ Examiner, Art Unit 1631 /JAMES D SCHULTZ/ Supervisory Patent Examiner, Art Unit 1631