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 .
Restriction/Election
Applicant's election, without traverse, in the reply filed July 22, 2026 of Group I, claims 1 – 10, 12, and 17 - 22, directed to a recombinant acid molecule, a vector, a host cell, and a composition comprising a recombinant acid molecule.
Claims 13 – 15, and 23 - 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
The restriction requirement is still deemed proper and is therefore made FINAL.
The claims will be examined insofar as they read on the elected species.
Therefore, claims 1 – 10, 12, and 17 - 22 are under consideration to which the following grounds of rejection are applicable.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on February 2, 2026, and July 3, 2024 has been considered. An initialed copy of the IDS accompanies this Office Action.
Priority
The present application filed July 3, 2024, is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US2023/060036, filed January 3, 2023, which claims the benefit of Provisional Application 63/296,432, filed January 4, 2022.
Therefore, the earliest priority date is January 4, 2022.
Nonstatutory 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 1 – 10, 12, and 17 - 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 – 17 of published patent US 10071172 B2 (published September 11, 2018) (hereinafter referred to as ‘B2). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are wholly encompassed by, and significantly overlap in scope with claims 1, 25 – 26, and 28 - 46 of application 17/633,146.
Claims 13 – 17 of Patent ‘B2 is directed to a composition: a) an adeno-associated virus vector comprising a glucagon promoter operably linked to a nucleic acid sequence encoding Pdx1 and a nucleic acid sequence encoding MafA, wherein the vector does not encode Neurogenin 3 (Ngn3), and wherein the glucagon promoter a) consists of the nucleic acid sequence of SEQ ID NO: 1, or b) comprises the nucleic acid sequence of SEQ ID NO: 3; b) a buffer; and c) a contrast dye for endoscopic retrograde cholangiopancreatography.
Instantly recited claims 1 – 10, 12, and 17 are directed to a recombinant nucleic acid comprising a glucagon promoter operably linked to a nucleic acid molecule, a vector, a host cell, and a composition comprising a recombinant acid molecule. Specifically, claim 1 teaches that the glucagon promoter essentially consists of a nucleotide sequence of Seq ID No: 2. Seq ID No: 1 of ‘B2 is 1243 residues, whereas instantly recited Seq ID No: 2 is 592 residues, and Seq ID No: 2 has a 100% alignment score to Seq ID No: 1 of patent ‘B2.
Therefore, the instant application is in essence a “species” of the generic invention of patent ‘B2. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
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 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 – 2, 4 - 10, 12, and 17 - 22 are rejected under 35 U.S.C. 102 (a)(1)/(a)(2) as being anticipated by Gittes et al. (hereinafter referred to as “Gittes”) (US 20170087254 A1, published March 30, 2017). (This reference is listed in the IDS filed July 3, 2024).
Regarding claims 1 – 2, Gittes teaches a viral vector comprising a promoter operably linked to a nucleic acids encoding Pdx1 and a nucleic acid encoding MafA (Abstract). Gittes teaches Seq ID No: 2, which is a nucleic acid sequence of a human glucagon promoter (long) (Paragraph [0024]). Please note: Seq ID No: 2 has a 100% sequence alignment with instantly claimed Seq ID No: 1 (See Below).
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Regarding claim 4 – 7, Gittes teaches an adeno-associated virus vector comprising a promoter operably linked to a nucleic acids (Paragraph [0127]). Gittes teaches that the vector is an rAAV6 (Paragraph [0158]).
Regarding claim 8 – 10, and 12, Gittes teaches a vector, wherein a a host cell which can be cultured that contains a nucleic acid sequence encoding an adeno-associated virus (AAV) serotype 8 capsid protein (Paragraph [0142]). Gittes teaches that the glucagon promoters that can be used to express a heterologous protein in alpha cells (Paragraph [0003]). Specifically, Gittes teaches that the glucagon promoter drives expression of human PDX1 and human MAFA in human alpha cells (Paragraph [0014]).
Regarding claim 17, Gittes teaches teaches a viral vector comprising a promoter operably linked to a nucleic acids encoding Pdx1 and a nucleic acid encoding MafA (Abstract).
Regarding claims 18 – 22, Gittes teaches a composition comprising an adeno-associated virus vector comprising a promoter operably linked to a nucleic acid encoding Pdx1, and a contrast dye for endoscopic retrograde cholangiopancreatography (claim 15). Gittes teaches that the contrast dye is lopromid (claim 20).
Gittes meets all the limitations of the claims and, therefore, anticipates the claimed invention.
Conclusion
Claims 1 – 2, 4 – 10, 12, and 17 – 22 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYOMA SHUBHAM TIWARI whose telephone number is (571)272-2954. The examiner can normally be reached M-F 8:30 - 5:30 EST.
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/VYOMA SHUBHAM TIWARI/ Examiner, Art Unit 1634
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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