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. Claim Status Claim s 1-52 are cancelled. Claim s 53-72 as filed o n 19 October 2023 are pending and under examination. 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 53-57, 59-60, 62-6 4 , and 65-72 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. Regarding claim 53, the claims recites 9 to 16 amino acid substitutions in the framework regions of the VH domain of SEQ ID NO: 1 and 9 to 20 amino acid substitutions in the VL domain of SEQ ID NO: 2. The framework regions of SEQ ID NO: 1 and 2 are not defined making the metes and bounds of this limitation of the claim indefinite. Claims 5 4 -57, 59-60, 62-6 4 , and 66-72 inherit the limitation without providing correction and are also rejected for being indefinite. Claim 64 is unclear what of the listed sequence combinations are required by the claim and several of the sequences only specific the VH or the VL. Appropriate correction is required. Examiner believes the FR regions to be as follows based on Figures 1A and 1B and the CDR sequences : FR1 amino acids 1 to 23, FR2 amino acids 34 to 49, FR3 amino acids 56 to 87, and FR4 amino acids 97 to 106, all in reference to SEQ ID NO: 2; and FR1 amino acids 1 to 30, FR2 amino acids 36 to 49, FR3 amino acids 66 to 97, and FR4 amino acids 103 to 113, all in reference to SEQ ID NO: 1. Applicant should provide the amino acids of all framework sequences to provide exact metes and bounds for the substitutions that can be made. Regarding claim 65, the claim requires a nucleic acid sequence of those listed, SEQ ID NO: 33 and 41-42 are an amino acid sequence making the metes and bounds indefinite. Regarding claims 53 and 54, the claims incorrectly incorporate sequences by using “SEQ ID NO:1” and “SEQ ID NO:2” without spaces between the colon and sequence number and use of “SEQ ID NOs:” in claim 54 and not “SEQ ID NO:”. Appropriate correction is required to “SEQ ID NO: 1”, “SEQ ID NO: 2”, and “SEQ ID NO:” where needed. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer . Claims 53-54, 56 - 57 , 59- 60, 63 , and 66- 7 0 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 42-61 of copending Application No. 18556172 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Instant SEQ ID NO: 1 and 2 match SEQ ID NO: 1 and 2 of the reference application. Regarding claim s 53-54 and 56-57 , t he reference application recites the a CAR comprising a VH of at least 95% identity with SEQ ID NO: 1 and a VL of at least 95% identity of SEQ ID NO: 2 which would recite the VH and VL including substitutions in the framework regions required by instant claim 42 (claims 42-43) . The CAR T of the reference claims would comprise an scFv which is a fragment as required by claims 53-54 and 56. Regarding claims 59-60, t he referenced application recites a TM of CD28 and CD8, and costimulatory domains of CD28, 4-1BB, OX40 , iCOS, CD27, CD80, and CD70 (claim 45). Regarding claim 62, by teaching the antibody sequence of instant claim 53 it teaches the humanized antibody of instant claim 62. Regarding claim 63, the reference application recite a nucleic acid encoding the CAR (claim 52). Regarding claims 66-67, the reference application recites an NK cell comprising the CAR of the claims (claims 50-52). Regarding claims 68-70, the reference application recites a pharmaceutical composition comprising a plurality of claims and a method of treating cancer by using the CAR of the claims (claims 59-61). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 53, 62, and 71-72 p rovisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 42-61 of copending Application No. 18556172 (reference application) in view of Steentoft et. al. Glycobiology. 28(9):656-669. (2018) (PTO-892) and Prendergast et. al. MABS. 9(4):615-627. (2017) (PTO-892). The recitations of the reference application from the previous rejection are incorporated here in full. The reference application recites a CAR T cell that binds S T n which comprises an ScFv which is the humanized anti-STn fragment of the claims. The reference application does not teach the use of antibody conjugates or a method of detecting the presence of STn using the antibody fragment of the instant claims. These deficiencies are filled by Steentoft and Prendergast . Steentoft teaches the ScFv comprises the VH and VL of an antibody with binding specificity (Figure 1). Prendergast teaches anti-STn antibodies for use in antibody drug conjugates for use in treating cancer to provide drug targeting that can differentiate between normal and malignant tumor cells (abstract). Prendergast further teaches the use of immunohistochemistry (IHC) to characterize neoplastic cells (page 617 in col 2 in final par and page 618 in col 1 entire column and col 2 in lines 1-7 and page 623 in col 2 in par 2 ). Regarding the kit of claim 72, Prendergast teaches commercial antibodies that were used in binding STn including B72.3 (Figure 2) used in combination with ELISA and flow cytometry (page 617 in col 1 in lines 4-13) and the conjugation of B72.3 to indium-111 which is an approved diagnostic by the FDA and the use of this antibody conjugate in a clinical trial where the antibody conjugate would be an antibody conjugate with a means for detecting the amount of antibody bound to STn by PET (page 621 in col 2 in par 1). It would have been obvious at the time the application was filed to one of skill in the art that the scFv of the CAR of the reference application was an antibody fragment capable of binding STn and capable of being used in antibody drug conjugates and IHC for use in characterization of cancer cells and drug delivery of cancer cells as taught by Steentoft and Prendergast . One of skill in the art would have been motivated to use the anti-STn antibody fragment of the reference application in additional applications to provide for alternative methods of treatment and for use in IHC. There would have been a motivation to one of skill in the art to explore other applications for treatment and diagnosis as this provides additional financial gain from the developed antibody fragment and alternative therapies for treatment of patients. There would have been a reasonable expectation of success as IHC and antibody-drug conjugates are both areas of the art with a high amount of knowledge in the art and the reference application and the art both teach STn as a target of inte rest in both applications. This is a provisional nonstatutory double patenting rejection. Allowable Subject Matter Claims 58 and 61 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT FRANCESCA EDGINGTON-GIORDANO whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-8232 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon - Fri 8:00 - 5:00 . 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. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /F.E./ Examiner, Art Unit 1643 /Meera Natarajan/ Primary Examiner, Art Unit 1643