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 is a national stage entry under 35 U.S.C. § 371 of PCT/US2022/019976 (filed 03/11/2022 ). Acknowledgement is made of Applicants’ claim for benefit of U.S. Provisional A pplication No. 63/160,415 (filed 03/12/2021 ). Claim Interpretation The following comments are made to establish broadest reasonable interpretation for the record. Regarding claims 10-13: These instant claims recite the term core promoter sequence ; t his term is interpreted as a nucleotide sequence comprising at least one recognition site required for the binding of polymerase ( e.g., a TATA box or a B recognition element ) . This interpretation is supported in the specification of the instant disclosure (pg. 5; par. 2). It is noted for the record a nucleic acid sequence comprising a core promoter sequence does not exclude a full-length promoter sequence , as the latter necessarily comprises the former. 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. Claim 42 is 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 42: This claim is drawn to a method of treating a subject in need thereof, comprising administering to the subject a polynucleotide comprising the promoter sequence of the instant application and a target nucleic acid sequence. The issue at hand concerns the term treating a subject in need thereof . The invention of the instant application is a promoter sequence; further, no claims recite a specific target for the target nucleic acid sequence. The limitation recited in line 5 of claim 42 specifies expression of the RNA, protein, or polypeptide encoded by the target nucleic acid sequence treats a disorder or disease. But what disorder or disease? Wha t, specifically, does the subject under discussion need ? As currently written, the metes and bounds of the instant claim are not clearly or precisely defined, rendering claim 42 indefinite. 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 . Claim s 1, 6, 8, 10-13, 20, 27, 29-30, 32-33, and 41-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-12 of U.S. Patent No. 11,674,154 ; as evidenced by Kaplan, et al. ( Semin Cell Dev Bio . 2016) . Although the claims at issue are not identical, they are not patentably distinct from each other . Please see the end of the Office action for all sequence alignments. Regarding claims 1, 6: Patented claims 4 and 8 of U.S. Patent No. 11,674,154 teach an rAAV comprising an intron comprising the sequence of SEQ ID NO: 37 ; as patented SEQ ID NO: 37 shares 100% sequence identity with instant SEQ ID NO: 1, this reads on the promoter-associated intronic sequence comprising a nucleic acid sequence having at least 95% sequence identity to SEQ ID NO: 1 limitation recited in claim 1, as well as the promoter-associated intronic sequence comprising the nucleic acid sequence of SEQ ID NO: 1 limitation recited in claim 6. Regarding claim 8: Patented claim 10 of U.S. Patent No. 11,674,154 teaches a nucleic acid comprising the sequence set forth in any one of SEQ ID NO: 26-28 . Patented SEQ ID NOs: 27 and 28 share 100% sequence identity to instant SEQ ID NO: 3; i.e., a CMV enhancer sequence . Thus, patented claim 8 reads on the polynucleotide comprising the promoter-associated intronic sequence of claim 1 and a nucleic acid sequence encoding an enhancer sequence limitation recited in claim 8. Regarding claims 10-13: Patented claims 4 and 8 of U.S. Patent No. 11,674,154 teach an rAAV comprising a chicken β-actin promoter or an intron comprising the sequence of SEQ ID NO: 37. It is set forth above patented SEQ ID NO s : 2 7 and 28 comprise a CMV enhancer sequence ; additionally, SEQ ID NOs: 27 and 28 share 100% sequence identity to instant SEQ ID NO: 1 in addition to instant SEQ ID NO: 3 . Thus, patented claims 4, 8, and 10 of U.S. Patent No. 11,674,154 teach a nucleic acid sequence comprising a CMV enhancer sequence and the promoter-associated intronic sequence of instant claim 1; it does not teach a promoter sequence comprising an enhancer sequence, the promoter-associated intronic sequence of claim 1 , and a nucleic acid sequence comprising a core promoter sequence . However, it would have been prima facie obvious to a person having ordinary skill in the art to have modified the rAAV comprising the sequence set forth in either of SEQ ID NOs: 27 or 28 to have included the chicken β-actin promoter in addition to the promoter-associated intronic sequence. This conclusion of obviousness is based on the ‘combining known alternatives rationale’; one would be motivated to combine the chicken β-actin promoter with the promoter-associated intronic sequence with the expectation of increasing transcription efficiency due to an additive effect of the two promoter elements. Additionally, one skilled in the art would have a reasonable expectation of success in doing so, as patented claims 4 and 8 teach the chicken β-actin promoter and the promoter-associated intronic sequence as functional equivalents. Thus, the modified rAAV as set forth above reads on the promoter sequence comprising a nucleic acid sequence comprising an enhancer sequence, a nucleic acid sequence comprising a core promoter sequence, and the promoter-associated intronic sequence of claim 1 limitation recited in claim 10, the wherein the nucleic acid sequence comprising the core promoter sequence is: (a) operably linked at its 5' end to the 3' end of the enhancer sequence; and (b) operably linked at its 3' end to the 5' end of the promoter-associated intronic sequence limitation recited in claim 11, the wherein (i) the enhancer sequence is a CMV enhancer sequence; and/or (ii) the core promoter sequence is a chicken β-actin core promoter sequence limitation recited in claim 12, as well as the wherein (i) the CMV enhancer sequence comprises a nucleic acid sequence having at least 95% identity to SEQ ID NO: 3 limitation recited in claim 13. Regarding claim 20: Patented claim 10 of U.S. Patent No. 11,674,154 teaches a nucleic acid comprising the sequence set forth in any one of SEQ ID NO: 26-28 . Patented SEQ ID NOs: 27 and 28 share 96% sequence identity with instant SEQ ID NO: 6; thus, patented claim 10 reads on the promoter sequence comprising a nucleic acid sequence having at least 95% identity to SEQ ID NO: 6 limitation recited in claim 20. Regarding claim s 27 , 29-30 : Patented claim 1 teaches an rAAV comprising an isolated nucleic acid comprising a transgene comprising a promoter operably linked to a nucleic acid sequence encoding an activin receptor type-1 (ACVR1) protein ; patented claim 5 teaches an rAAV comprising a nucleic acid that encodes an artificial miRNA (ami-RNA) and a nucleic acid that encodes ACVR1, wherein the ami-RNA and the transgene are operably linked to the promoter (patented claim 7). This reads on the wherein the promoter sequence is operably linked to a target nucleic acid sequence limitation recited in claim 27 . T he mRNA encoding the ACVR1 protein of patented claim 1 reads on the wherein the target nucleic acid sequence encodes an RNA limitation recited in claim 29, as well as the wherein (b) the target nucleic acid sequence encodes an mRNA that is translated to a protein or polypeptide limitation recited in claim 30. The ami-RNA of patented claim 5 reads on the wherein the target nucleic acid sequence encodes an RNA limitation recited in claim 29, as well as the wherein (a) the RNA is a miRNA limitation recited in claim 30. Regarding claims 32-33, 41- 42, 44- 45 : It is set forth above the claims of U.S. Patent No. 11,674,154 teaches a polynucleotide comprising the promoter sequence of the instant claims and a target nucleic acid sequence ; the patented claims do not teach the remaining limitations recited in the instant claims. However , the specification of U.S. Patent No. 11,674,154 teaches a method of treating a subject having or suspected of having fibrodysplasia ossificans progressive (col. 3; par. 9), w herein the rAAV of the disclosure is administered to the subject in a physiologically acceptable carrier (col. 28; par. 3). This reads on: the delivery vehicle comprising the polynucleotide of claim 8 limitation recited in claim 32, the wherein the delivery vehicle is an adeno-associated viral (AAV) vector limitation recited in claim 33; the method of expressing an RNA, protein, or polypeptide in a subject, the method comprising administering to the subject an effective amount of a delivery vehicle comprising a polynucleotide comprising a promoter sequence of claim 10 and a target nucleic acid sequence encoding the RNA, protein, or polypeptide, wherein the promoter sequence is operably linked to the target nucleic acid sequence limitation recited in claim 41; the method of treating a subject in need thereof, the method comprising administering to the subject an effective amount of a delivery vehicle comprising a polynucleotide comprising a promoter sequence of claim 10 and a target nucleic acid sequence encoding an RNA, protein, or polypeptide, wherein the promoter sequence is operably linked to the target nucleic acid sequence, and wherein expression of the RNA, protein, or polypeptide treats a disease or disorder limitation recited in claim 42; the wherein the delivery vehicle is a vector limitation recited in claim 44; and the wherein the vector is an AAV vector limitation recited in claim 45. It has been held that a claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use . See Pfizer , 518 F.3d at 1363; Geneva , 349 F.3d at 1385-86, and Sun Pharmaceutical Industries v. Eli Lilly and Co ., 611 F. 3d 1381, 1387 (CAFC 2010). See MPEP 804(II)(B)(1) . Therefore, U.S. Patent No. 11,674,154 renders obvious the use of a polynucleotide comprising the promoter sequence of the instant claims and a target nucleic acid sequence in a method of administration to a subject. Regarding claim 43: Following the above discussion, as evidenced by Kaplan, et al., the Activin A cytokine acts as a key regulator of the immune system in mammals which can exhibit both pro- and anti-inflammatory properties depending upon the cellular and temporal context (pg. 33; par. 3.4); as ACVR1 is the receptor for Activin A, restoring wild-type ACVR1 function via administration of the rAAV of patented claim 1 necessarily induces an immune response in a subject to which it is administered . Thus, U.S. Patent No. 11,674,154 renders obvious the method of inducing an immune response in a subject, the method comprising administering to the subject an effective amount of a delivery vehicle comprising a polynucleotide comprising a promoter sequence of claim 10 and a target nucleic acid sequence encoding an RNA, protein, or polypeptide, wherein the promoter sequence is operably linked to the target nucleic acid sequence, and wherein expression of the RNA, protein, or polypeptide elicits an immune response limitation recited in claim 43. Claim s 36 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,674,154 , in view of Gorfien, et al. (US 2009/0280533) ; as evidenced by Kaplan, et al. ( Semin Cell Dev Bio . 2016) . Gorfien, et al. teaches a cell culture medium formulation that supports the in vitro cultivation of mammalian cells (Abstract). Regarding claim s 36, 38: It is set forth above the claims of U.S. Patent No. 11,674,154 teach a polynucleotide comprising the promoter sequence of the instant claims and a target nucleic acid sequence; the patented claims do not teach the limitations recited in instant claim 38. Gorfien, et al. teaches a method for the production of recombinant proteins from mammalian cells, the method comprising obtaining a mammalian cell that has been genetically engineered to produce a polypeptide and cultivating the mammalian cell under conditions favoring the expression of the polypeptide, wherein the polypeptide is subsequently isolated from the cells and/or the used culture medium (par. 0172); this reads on the limitations recited in claim 38. It would have been prima facie obvious to a person having ordinary skill in the art to have used the polynucleotide comprising the promoter sequence and target nucleic acid sequence taught by U.S. Patent No. 11,674,154 in the method of Gorfien, et al. This conclusion of obviousness is based on the ‘teaching, suggestion, or motivation rationale’. One would be motivated to do so for the production of recombinant wild-type ACVR1 protein ; recombinant protein production is useful to those skilled in the art for use in a wide variety of assays, e.g., in vitro studies investigating the role of ACVR1 in the BMP pathway (as evidenced by Kaplan, et al.; Abstract), drug development screens. Further, i t has been held that a claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use ( See Pfizer , 518 F.3d at 1363; Geneva , 349 F.3d at 1385-86, and Sun Pharmaceutical Industries v. Eli Lilly and Co ., 611 F. 3d 1381, 1387 (CAFC 2010) ; s ee MPEP 804(II)(B)(1) ) ; as U.S. Patent No. 11,674,154 discloses a method for obtaining the rAAV of the disclosure comprising culturing a host cell transfected with the rAAV (col. 25, par. 4; col. 26, par. 4), one would have a reasonable expectation of success in doing so, as using the polynucleotide of U.S. Patent No. 11,674,154 is clearly within the scope of the disclosure. Therefore, U.S. Patent No. 11,674,154 renders obvious the limitations recited in instant claims 36 and 38. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT GINA PRONZATI whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-5725 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Friday 9:00a - 5:00p ET . 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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. /GINA PRONZATI/ Examiner, Art Unit 1633 /ALLISON M FOX/ Primary Examiner, Art Unit 1633 SEQUENCE ALIGNMENTS RE: U.S. Patent No. 11,674,154 Query (instant SEQ ID NO: 1) vs. Subject (patented SEQ ID NO: 37) Query (instant SEQ ID NO: 1) vs. Subject (patented SEQ ID NO: 27) Query (instant SEQ ID NO: 1) vs. Subject (patented SEQ ID NO: 28) Query (instant SEQ ID NO: 3) vs. Subject (patented SEQ ID NO: 27) Query (instant SEQ ID NO: 3) vs. Subject (patented SEQ ID NO: 28) Query (instant SEQ ID NO: 6) vs. Subject (patented SEQ ID NO: 27) Query (instant SEQ ID NO: 6) vs. Subject (patented SEQ ID NO: 28)