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. Claims 1-20 are pending and under consideration. Claim Objections Claims 1 and 16 are objected to because of the following informalities: Claims 1 and 16 incorporate Table 2 from the specification. MPEP 2173.05 (s) indicates where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant's convenience. Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) . " Table 2 is not so large that it would be impractical to define the invention without referring to the table as a whole. Furthermore, reference to Table 2 results in duplicate recitations, as the limitations of claim 1(a), 1(b), 16(a)(i)(1), and 16(a)(i)(2) are also within Table 2. Appropriate correction is required. . Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp . Claim s 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-18 of copending Application No. 18381215 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons . The instant and copending claims are each drawn to nucleic acid molecule encoding a chimeric antigen receptor (CAR) comprising an anti-CD19 binding domain, a transmembrane domain, a costimulatory, and an intracellular signaling domain . The sequence limitations for the anti-CD19 binding domain are identical in both sets of claims. Both sets of claims encompass the same transmembrane, costimulatory, and intracellular signaling domain s. Both sets of claims encompass a vector comprising the nucleic acid molecule, a modified cell comprising the vector, a composition comprising the modified cell, and a method treating a disease associated with expression of CD19 comprising administering the modified cell. I n instances where the same transmembrane, costimulatory, and intracellular signaling domains are recited, the instant and copending claims differ only by the recitation in the instant claims of a second polynucleotide compris ing a nucleic acid encoding a polypeptide that enhances an immune cell function . Thus , each product and method of the instant claims is a species of the generic products and methods of the copending claims. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claims 3 , 7 , and 18 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. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitations “ a chemokine, a chemokine receptor, a cytokine, a cytokine receptor ” in part (a), and the claim also recites specific cytokines, receptors, and chemokines in parts (b) and (c) which are the narrower statement s of the limitation s . Regarding claim 7, part (a) recites the broad limitation of unlimited mutation at one of several positions and part (b) recites specific amino acid substitutions at those same pos iti ons, which are the narrower statements of the limitations. Claim 18(c) recites the broad recitations “ a chemokine, a chemokine receptor, a cytokine, a cytokine receptor ” and the claim also recites specific cytokines, receptors, and chemokines, which are the narrower statements of the limitations. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, because the specification, while being enabling for a vector comprising a first polynucleotide encoding a CAR comprising a single chain antibody or a single chain antibody fragment comprising an anti-CD19 binding domain having any of 12 disclosed and recited sets of six CDRs , each set derived from a single antibody isolate , and a second polynucleotide encoding IL-18, does not reasonably provide enablement for the full range of vector constructs recited in the claims . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. The enabled scope is limited with respect to both the first and second polynucleotides recited in claim s 1 and 16 . The anti-CD 19 binding component is recited in claim 1(c) and 16(a)(3) to comprise “ a light chain variable domain comprising a light chain complementary determining region 1 (LC CDR1), a light chain complementary determining region 2 (LC CDR2), and a light chain complementary determining region 3 (LC CDR3) disclosed in Table 2; and a heavy chain variable domain comprising a heavy chain complementary determining region 1 (HC CDR1), a heavy chain complementary determining region 2 (HC CDR2), and a heavy chain complementary determining region 3 (HC CDR3) disclosed in Table 2 ” . Table 2 lists sets of six heavy and light chain CDRs for each of 12 antibody isolates. The language of claim s 1 and 16 does not require that any set of 3 CDRs from a given chain be paired with the 3 CDRs from the corresponding heavy or light chain from the same isolate. For example, the claim encompasses an antibody comprising the light chain CDRs from isolate P1 and the heavy chain CDRs from P2. Given that the various antibodies were independently isolated , they bind different epitopes, and the corresponding CDR sequences display sequence diversity, it is not predictable that the pairing of CDRs from different antibodies will form a functional antibody. The specification does not disclose any attempt to test heterologous pairings of CDRs as encompassed by the claims. The second polynucleotide in claim 1 is recited to compris e “ a nucleic acid encoding a polypeptide that enhances an immune cell function ”. The breadth of this limitation is barely narrowed in claim 2, which recites that t he polypeptide that enhances an immune cell function, or a functional derivative thereof is selected from the group consisting of a cytokine, an interferon, a chemokine, an antibody or antibody fragment, a checkpoint inhibitor antagonist, a dominant negative receptor, a switch receptor, and a combination thereof. Claim 3 similarly limits the polypeptide that enhances an immune cell function to “ a chemokine, a chemokine receptor, a cytokine, a cytokine receptor ” in part (a) or one of several specific cytokines, receptors, and chemokines in parts (b) and (c) . The corresponding limitation in claim 16(b) is “ a nucleic acid encoding Interleukin-18 (IL-18), and/or Interleukin-18 receptor (IL-18R) ”. The specification discloses data only for constructs in which the polypeptide that enhances an immune cell function is IL-18. The specification teaches that “ Armoring the novel CD19 CAR T cells with IL-18: (1) enhanced the expression of the CD19 CAR; (2) reduced their expansion in the absence of stimulation; (3) enhanced their tumor clearance efficacy; (4) stimulated the CD19 CAR T cells contraction after tumor clearance; (5) enhanced or maintained a high percentage of CD4 + CD19 CAR T cells in treated animals; and (6) reduced side effects (e.g., weight loss). Generally, co-expressing the novel CD19 CARs with IL-18 reduced systemic CAR-induced toxicity (e.g., weight loss) and tumor relapse or remission. ” The specification asserts that several immune modulators increase the efficacy of engineered CAR T cells ([0089][0195] in publication US 20240226154 A9). While this might well turn out to be generally true, no supporting data are presently disclosed. Furthermore, i t would be expected, a priori , that the net effect s of different construct s would vary depending on the activity of the proposed immune modulator. In fact, the specification acknowledges that not all known immune modulators can enhance the effectiveness (enhanced tumor clearance and low toxicity) and persistence of CAR T cells in vivo [0089]. Therefore, it would not be predictable that any other cytokine, chemokine, or receptor would have the same beneficial effects as IL-18. In the absence of data showing the effects of a ny construct comprising a chemokine, chemokine receptor, cytokine, or cytokine receptor other than IL-18 , the specification does teach one of skill in the art how to use any such constructs . Claims 1- 15 and 17- 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The second polynucleotide in claim 1 is recited to compris e “ a nucleic acid encoding a polypeptide that enhances an immune cell function ”. Thus, claim 1 asserts possession of all polypeptides having the function of enhancing immune cell function. The breadth of this limitation is barely narrowed in claim 2, which recites categories of polypeptides named for their general functions: a cytokine, an interferon, a chemokine, an antibody or antibody fragment, a checkpoint inhibitor antagonist, a dominant negative receptor, a switch receptor, and a combination thereof. Many polypeptides fitting these functional categories are known in the art. Claim 2 encompasses them all, as well as any polypeptides that may be discovered in the future. Claim 3 (a) similarly encompasses all known and yet to be discovered chemokine s, chemokine receptor s , c ytokine s , and cytokine receptor s. Where specific polypeptides are named, one of skill in the art could readily envision structures that would possess the required functions. The skilled artisan cannot, however, envision the structure of all polypeptides having the function of enhancing immune cell function or of all known and yet to be discovered cytokine s , chemokine s , antibod ies , checkpoint inhibitor antagonist s , dominant negative receptor s , or switch receptor s. Although the specification contemplates specific chemokine s, c ytokine s , and receptor s which are recited in the dependent claims , such disclosures are not representative of the entire claimed genus. Also, even though one of skill in the art might envision polypeptides that enhance immune cell function that are not specifically contemplated in the specification, the generic teaching of the specification at most render s such molecules obvious. One shows that one is “in possession” of the invention by describing the invention , with all its claimed limitations, not that which makes it obvious. Lockwood v. American Airlines, Inc ., 107 F.3d 1505, 41 USPQ2d 1961 at 1966. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT DANIEL C GAMETT , Ph.D., whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-1853 . The examiner can normally be reached on FILLIN "Work schedule?" \* MERGEFORMAT M-W 9:00 am-5:30pm, EST . Please note the examiner’s part-time schedule . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration t ool. To schedule an interview, a pplicant 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, FILLIN "SPE Name?" \* MERGEFORMAT Joanne Hama can be reached on FILLIN "SPE Phone?" \* MERGEFORMAT 5712722911 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. FILLIN "Value?" \* MERGEFORMAT /DANIEL C GAMETT/ Primary Examiner Art Unit 1647