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 .
Detailed Action
Claims 46, and 49 - 56 are currently pending in the instant application.
Restriction/Election
Applicants’ election without traverse , in the reply filed September 4, 2026 of Group V, claims 46, drawn to a method of preparing a dosage form
Applicant has canceled claims 1 – 45, and 47 – 48 in the response filed on September 4, 2026. Applicant has added claims 49 – 56 by Applicants’ amendment filed on September 4, 2026.
The restriction requirement is still deemed proper and is therefore made FINAL.
Therefore, claims 46, and 49 - 56 are under consideration to which the following grounds of rejection are applicable.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on October 28, 2024, and October 10, 2025 has been considered. An initiated copy of the IDS accompanies this Office Action.
Priority
The present application filed October 28, 2024, is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US2023/066350, filed April 28, 2023, which claims the benefit of Provisional Application 63/336,635, filed April 29, 2022.
Therefore, the earliest priority date is April 29, 2022.
Provisional 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 46, and 49 - 56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims copending Application No. 18/003980, as per claims filed on 12/24/2025 and hereinafter referred to as ‘980. 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 115- 126 of the copending application.
Claims 115 of the copending application teaches A composition comprising: (i) the polynucleotide encoding the human Ins protein of claim 1 and (ii) a polynucleotide comprising a nucleic acid encoding a human glucokinase (Gck) protein, wherein the nucleic acid encoding the human Gck protein comprises a sequence at least 85%, 90%, 95%,96%, 97%,98%, 99%, or 100% identical to any one of:SEQ ID NOs: 61-80 and 162, or any combination thereof.
Claim 119 of the copending application teaches the composition of claim 118, wherein the human Ins protein comprises the amino acid sequence of any of amino acids 25-110 of SEQ ID NO: 41, amino acids 25-110 of SEQ ID NO: 144, amino acids 25-110 of SEQ ID NO: 145, SEQ ID NO: 41, SEQ ID NO: 144, or SEQ ID NO: 145.
Claim 123 of the copending application teaches that the composition of claim 122, wherein the AAV capsid serotype of the rAAV particle and/or the second rAAV particle is selected from AAV1, AAV2, AAV3, AAV4,AAV5, AAV6, AAV7, AAV8, AAVRH8, AAVrh9, AAV9, AAVrh10, AAV10,AAVRH10, AAV11, or AAV12.
Claim 46 of the instant invention is directed to a method of preparing a dosage form comprising combining:(a) a first composition comprising a first recombinant AAV (rAAV) particle comprising a first AAV vector genome comprising an insulin expression cassette comprising a first promoter operably linked to a polynucleotide encoding a human insulin (hlns) protein, wherein the insulin expression cassette is flanked by inverted terminal repeats (ITRs); andb) a second composition comprising a second recombinant AAV (rAAV) particle comprising a second AAV vector genome comprising a glucokinase expression cassette comprising a second promoter operably linked to a polynucleotide encoding a human glucokinase (hGck) protein, wherein the glucokinase expression cassette is flanked by inverted terminal repeats (ITRs);wherein each composition is in an amount sufficient to provide a vector ratio selected from the group consisting of 1:0.25-0.75, 1:1.75-2.25, and 1:3.75-4.25.
Claim 51 teaches that the method of claim 46, wherein the hIns protein comprises the amino acid sequence of any one of amino acids 25-110 of SEQ ID NO: 41, amino acids 25-110 of SEQ ID NO:144, amino acids 25-110 of SEQ ID NO: 145, SEQ ID NO: 41, SEQ ID NO: 144, or SEQ ID NO: 145.
The ‘980 applications claims compositions, but double-patenting rejections of claims to a method of use based on a claimed composition are proper. This rejection is necessitated by the decision of the Court of Appeals for the Federal Circuit in Pfizer Inc. v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001, at page 1008 (March 2008), which indicates that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application and that the preclusion of such a double patenting rejection under 35 USC 121 does not apply where the present application is other than a divisional application of the patent application containing such patentably indistinct claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejection - 35 USC § 112(b)
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 applicant regards as his invention.
Claims 46, and 49 – 56 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.
Claim 46 is indefinite for the recitation of “each composition is in an amount sufficient to provide a vector ratio selected from the group consisting of 1:0.25-0.75, 1:1.75-2.25, and 1:3.75-4.25” in lines 11 – 12. It is unclear which composition corresponds to which part of the ratio, i.e. whether the ratio is first composition: second composition, or second composition: first composition. Thus, the metes and bounds of the claim cannot be determined.
Claim 49 – 56 are indefinite insofar as they ultimately depend from claim 46.
Claim Rejection - 35 USC § 103
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 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.
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 46 and 49 - 56 are rejected under 35 U.S.C. 103 as being unpatentable over Gupta et al. (hereinafter referred to as “Gupta”) (WO/2022/006551, published January 6, 2022), as evidenced by Chavez et al. (US 10584328 B2, published March 10, 2020). (Please note: Gupta is listed in the IDS filed November 28, 2024).
Regarding claim 46, Gupta teaches administering to the subject a plurality of rAAV particles comprising a first rAAV particle comprising an expression cassette comprising a polynucleotide encoding human insulin and a second rAAV particle comprising an expression cassette comprising a polynucleotide encoding human Gck (Paragraph [0025]) (interpreted as preparing a dosage form) Gupta teaches that the regulatory element (i.e. promoter and modified nucleic acid sequence(s) are inserted between the two ITRs (Paragraph [0183]).
Regarding claim 46 (in part), and 49, Gupta does not specifically exemplify that that each composition is in an amount sufficient to provide a vector ratio. However, one of ordinary skill in the would know the how much of each vector to use to yield the desired vector, as evidenced by Chavez et al. Chavez et al. teaches that a plurality of eukaryotic cells are transfected with the first vector and the second vector at a vector ratio of the first vector to the second vector of about 1:50 (claim 20).
MPEP 2144 states that: “The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992); see also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings); Ex parte Clapp, 227 USPQ 972 (Bd. Pat. App. & Inter. 1985) (examiner must present convincing line of reasoning supporting rejection); and Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993) (reliance on logic and sound scientific reasoning).”
Regarding claim 50, Gupta teaches that the encoded human Gck protein comprises the amino acid sequence of SEQ ID NO: 82 (Paragraph [0234]).
Regarding claim 51, Gupta teaches that the hIns protein comprises amino acids 25-110 of SEQ ID NO: 145 (Paragraph [0233]).
Regarding claim 52, Gupta teaches that the polynucleotide encoding a human insulin (Ins) protein comprises a nucleotide sequence encoding a signal peptide (Paragraph [0010]).
Regarding claim 53 – 56, Gupta teaches that AAV serotype is AAV1 (Paragraph [0023]).
Conclusion
Claims 46, and 49 – 56 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria Leavitt can be reached on (571) 272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VYOMA SHUBHAM TIWARI/ Examiner, Art Unit 1634
/MARIA G LEAVITT/ Supervisory Patent Examiner, Art Unit 1634
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