CTNF 18/273,716 CTNF 89177 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Election/Restrictions 08-25-02 Applicant’s election of Group II, claim 11 and new claims 25-43 , in the reply filed on 04/07/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 1-8, 13, 16-24 of Group I are cancelled. Claim Objections 07-29-01 AIA Claim 11 is objected to because of the following informalities: claim 11 is missing word “administering” in the beginning of the 7 th line before words “a vector” . Appropriate correction is required. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15-aia AIA Claim(s) 11, 25, 28-29 and 31 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Taylor et al (US 2006/0051369, March 2006) . Concerning claims 11 and 25 Taylor disclose a method of treating patients having hepatitis C infection by administering ADAR1 agonist (see paragraph [0053]), such ADAR1 can be expressed in a vector (see paragraph [0031]). HCV is well known in the art as an RNA virus (see paragraph [0015]). Concerning claim 28 Taylor disclose that ADAR1 is a human ADAR1 (see paragraph [0027]). Concerning claims 29 and 31 Taylor disclose that compositions for treatment can be delivered intravenously or intramuscular (see paragraph [0054]) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim (s) 11, 25-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al, above, as applied to claims 11, 25, 28-29 and 31, and in further view of Di Giorgio et al (Sci.Adv., June 2020, 6: 1-8), Jamieson et al (US 2017/0191057, July 2017), Mandel et al (WO 2019/071274, April 2019), Finkelstein et al (Journal of Lipid Research, 1978, vol.19: 289-303) and Fellner et al (Molecular and Cellular Pediatrics, 2016, 3:16, pages 1-5) . Teachings of Taylor are discussed above. Taylor further teach that RNA editing by ADAR1 can be used for controlling infections of DNA and RNA viruses (see paragraphs [0003-0005]). Taylor do not teach treatment of SARS-CoV-2 virus, or recombinant lentiviral vector for ADAR1 delivery, or administration by inhalation, or administration using cord blood CD34+ cells, or administration of full length ADAR1 protein of SEQ ID NO: 2 in a liposome. Di Giorgio teach that SARS-CoV-2 is susceptible to ADAR editing and ADAR can be effective in the virus treatment (see Abstract). Jamieson teach methods comprising administering to a subject cord blood CD34+ cells expressing ADAR1 (see paragraph [0006]), such cells might comprise lentiviral vector expressing ADAR1 (see paragraph [0007]). Mandel teach ADAR1 protein of SEQ ID NO: 72 (see pages 12-13), identical to instant SEQ ID NO: 2. Finkelstein teach liposomal delivery of enzymes (see page 289). Fellner teach delivery of protein therapeutics by inhalation (see Title, Abstract). It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to treat SARS-CoV-2 infection by delivery of ADAR1 through lentiviral vector using cord blood CD34+ cells or by inhalation of ADAR1 protein of SEQ ID NO: 2 in liposome based on teachings of Taylor, Di Giorgio, Jamieson, Mandel, Finkelstein and Fellner. One of the ordinary skill in the art would be motivated to do so, because Di Giorgio teach that that SARS-CoV-2 is susceptible to ADAR editing and suggest using ADAR as a therapeutic against the virus, same as Taylor suggests treatment of viruses with ADAR1. Jamieson teach effective methods of ADAR1 delivery, which can used for such virus treatment. Mandel teach the sequence of specific ADAR1 protein, identical to instantly claimed. Finkelstein and Fellner suggest specific ways of enzyme delivery, which can be used in virus treatment methods to deliver ADAR1 taught by Mandel . 07-21-aia AIA Claim (s) 11 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiden et al (PLOS ONE, 2014, volume 9, issue 10, e108476: 1-11) . Weiden teach that overexpression of ADAR1 in cells inhibits HIV-1 viral replication (see Abstract). Such overexpression was carried out by a vector expressing ADAR1 (see Transfection section on page 9). HIV-1 is a well known retrovirus (see Abstract). Weiden do not teach HIV-1 treatment of a subject by administering vector overexpressing ADAR1. It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to treat HIV-1 in subjects by administering vector overexpressing ADAR1 based on teachings of Weiden. One of the ordinary skill in the art would be motivated to do so because Weiden teach that ADAR1 inhibits viral replication in cells, making it obvious to try administering ADAR1 to HIV-1 infected subjects to inhibit viral replication in subjects therefore treating them . Double Patenting 08-33 AIA 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. 08-35 Claim s 11, 25-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-31 of copending Application No. 18/290,961 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims from ‘961 recite the same methods of treatment of RNA viral infections by administering vector expressing ADAR1, same as in instant claims . 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 EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5. 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. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at (571)272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637 Application/Control Number: 18/273,716 Page 2 Art Unit: 1637 Application/Control Number: 18/273,716 Page 3 Art Unit: 1637 Application/Control Number: 18/273,716 Page 4 Art Unit: 1637 Application/Control Number: 18/273,716 Page 5 Art Unit: 1637 Application/Control Number: 18/273,716 Page 6 Art Unit: 1637 Application/Control Number: 18/273,716 Page 7 Art Unit: 1637 Application/Control Number: 18/273,716 Page 8 Art Unit: 1637
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