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
Applicant’s election without traverse of claims 64 – 66 and 69 – 70 in the reply filed on April 16, 2026 is acknowledged.
Claims 51 – 63 and 67 – 68 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 16, 2026.
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 applicant regards as his invention.
Claims 64 and 65 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.
Regarding claim 64, the reference to a cancelled claim 1 renders the claim indefinite. However, for the sake of compact prosecution, claim 51 will be used as the proper referenced claim for examination.
Regarding claims 64 and 65, the phrase "e.g." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 64 and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Davidsohn et al. (W.O. Patent Application Publication No. 2017201527; cited on IDS, hereinafter Davidsohn).
Regarding claim 64, Davidsohn discloses gene therapy methods using genetic constructs processed from the original DNA (pp. 2 – 3, Bottom of page 2 to Top of page 3) into miRNA, shRNA, RNAi or mRNA (where the mRNA consists of a 5’ Cap and 3’ poly A or equivalent). Davidsohn does not explicitly state that the mRNA has 3’ UTR as in claim 51. However, Davidsohn further discloses a method of treating a mammal for obesity and type II diabetes (metabolic disorder) by administering a Sirt6 (p. 88, Claim 84) viral expression vector. The motivation to add a 3’ UTR to the mRNA construct is because it contains regulatory elements that control: how long the mRNA lasts in a cell, how efficiently it is translated into protein, and where it is localized.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mRNA vector of Davidsohn with a 3’ UTR in order to improve translation efficiency.
Regarding claim 69, Davidsohn discloses administering an effective amount of a vector (p. 3 “such as an AAV”, Bottom of page 3) or plurality of vectors expressing SIRT6 (p. 21; Table 2- Therapy group 15) to a subject.
Claims 65 and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Davidsohn in view of Zhong et al. (SIRT6 Protects Against Liver Fibrosis by Deacetylation and Suppression of SMAD3 in Hepatic Stellate Cells, Cellular and Molecular Gastroenterology and Hepatology, Volume 10, Issue 2, (2020); cited on IDS, hereinafter Zhong).
Regarding claims 65 and 66, Davidsohn teaches all of the elements of the current invention as stated above except administering the treatment to a subject with NAFLD.
However, Zhong provides the motivation for treating NASH, which progresses from NAFLD, by disclosing that SIRT6 protects against liver fibrosis. The aim of Zhong’s study was centered around the role (p. 341, Background) of hepatic SIRT6 in NASH.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the SIRT6 treatment of Davidsohn with the teaching from Zhong about SIRT6 treating liver fibrosis. Doing so would lead to a favorable outcome for treating NASH, according to Zhong.
Claim 70 is rejected under 35 U.S.C. 103 as being unpatentable over Davidsohn in view of Conway et al. (Non-viral Delivery of Zinc Finger Nuclease mRNA Enables Highly Efficient In Vivo Genome Editing of Multiple Therapeutic Gene Targets Molecular Therapy, 2019; 27, 866-877; hereinafter Conway).
Regarding claim 70, Davidsohn teaches all of the elements of the current invention as stated above except administering a single dose of an AAV followed by multiple administrations of the isolated nucleic acid molecule. However, Conway discloses repeat administration (Abstract) of ZFN mRNA-LNP after a single AAV donor dose. Conway further provides the motivation for utilizing this method by disclosing that this technique led to a significantly increased level of genome editing and transgene expression compared to a single dose.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the AAV administration method of Conway with the SIRT6 treatment protocol of Davidsohn. Doing so would increase transgene (SIRT6) expression in a subject, according to Conway.
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 64 – 66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 26, 27 and 48 – 51 of copending Application No. 19/502,457 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the two applications are directed to a method of treating a fibrotic disease or disorder with a vector encoding SIRT6.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER JACKSON III whose telephone number is (571)272-0247. The examiner can normally be reached M-F 9:00A - 5:00P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WALTER JACKSON III/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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