DETAILED CORRESPONDENCE
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1, 4, 8, 11-14, 17, and 396-400 are pending in the application.
Applicant’s amendment to the claims, filed April 21, 2026 is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Applicant’s remarks filed April 21, 2026 in response to the non-final rejection filed January 22, 2026 have been fully considered.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in a prior Office action.
Restriction/Election
In response to a requirement for restriction/election mailed June 6, 2024, applicant elected without traverse the invention of Group I, corresponding to pending claims 1, 4, 8, 11-14, 17, and 396-400, and the species of S661T in the reply filed August 5, 2024.
All pending claims are drawn to the elected invention and are being examined on the merits.
Priority
This application is filed under 35 U.S.C. 371 as a national stage of international application PCT/US2019/044480, filed on July 31, 2019, which claims domestic priority under 35 U.S.C. 119(e) to U.S. provisional application numbers 62/712,809, 62/751,421, 62/775,865, 62/822,639, and 62/873,031, filed on July 31, 2018, October 26, 2018, December 5, 2018, March 22, 2019, and July 11, 2019, respectively.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a), except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosures of the prior-filed applications, U.S. provisional application numbers 62/712,809, 62/751,421, and 62/775,865 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) for claims 1, 4, 8, 11-14, 17, and 396-400 of this application. For example, the provisional application numbers 62/712,809, 62/751,421, and 62/775,865 fail to provide descriptive support for all recited mutations in claim 1. Claims 1, 4, 8, 11-14, 17, and 396-400 have an effective filing date of March 22, 2019.
Claim Objections
The objections to claims 1, 396, 398, and 400 are withdrawn in view of the amendment to claim 1 to recite “comprising the amino acid sequence of a human adenosine deaminase acting on RNA 2 (hADAR2) protein with the exception E488Q and M383L mutations,” and the amendments to claims 396, 398, and 400 to insert “or” between “exosomes,” and “microvesicles.”
Claims 1, 17, 396, 398, and 400 are objected to because of the following informalities:
Claim 1 is objected to in the recitation of “with the exception E488Q and M383L mutations” and in the interest of improving claim form and grammar, it is suggested that the noted phrase be amended to recite (with markings to show changes made) “with the exception of E488Q and M383L mutations.”
Claim 1 is also objected to in the recitation of “wherein the amino acid numbering of the mutation positions corresponds to the amino acid sequence of the hADAR2 protein.” One of skill in the art would recognize that the recited amino acid positions correspond to the catalytic domain of hADAR2 (see, e.g., Supplementary Text and Figures, obtained from https://www.nature.com/articles/nsmb.3203#Sec21., 2016, 14 pages, particularly Supplementary table 1; cited on Form PTO filed September 5, 2024) and in the interest of improving claim form, it is suggested that the noted phrase be amended to recite (with markings to show changes made) “wherein the amino acid numbering catalytic domain of the hADAR2 protein.”
Claim 17 is objected to in the recitation of “or a nucleotide sequence” in parts a) and c) and in the interest of improving claim form, it is suggested that the noted phrase be amended to recite (with markings to show changes made) “or a polynucleotide comprising a nucleotide sequence.”
Claims 396, 398, and 400 are objected to in the recitation of “it” and in the interest of improving claim form, it is suggested that “it” be amended to recite “the pharmaceutical composition.”
Claim Rejections - 35 USC § 112(b)
The rejection of claims 1, 4, 8, 11-14, 17, and 396-400 under 35 U.S.C. 112(b) is withdrawn in view of the amendment to claim 1 to recite “comprising the amino acid sequence of a human adenosine deaminase acting on RNA 2 (hADAR2) protein with the exception E488Q and M383L mutations,” and the amendment to claim 399 to recite “the system of claim 17.”
Claims 397 and 398 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 397 (claim 398 dependent therefrom) recites the limitation “the composition of claim 4.” There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 112(a)
The new matter rejection of claims 1, 4, 8, 11-14, 17, and 396-400 under 35 U.S.C. 112(a) is withdrawn in view of the amendment to claim 1.
Claim Rejections - 35 USC § 102
Claims 1, 4, 8, 11-14, 17, and 396-400 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhang et al. (U.S. 2021/0163944 A1; with priority to January 21, 2019; cited on Form PTO-892 filed January 22, 2026; hereafter “Zhang”).
As amended, claim 1 is drawn to an engineered protein having cytidine deaminase activity and comprising the amino acid sequence of a human adenosine deaminase acting on RNA 2 (hADAR2) protein with the exception E488Q and M383L mutations and one or more of the mutations selected from the group consisting of: V351G, S486A, T375S, S370C, P462A, N597I, L332I, I398V, K350I, D619G, S661T, S582T, V440I, S495N, and K418E, wherein the amino acid numbering of the mutation positions corresponds to the amino acid sequence of the hADAR2 protein.
Regarding claim 1, Zhang teaches a human ADAR2 with the mutations E488Q, M383L, and D619G (pp. 77-78, paragraph [0650]).
Regarding claims 4, 8, 11, 13, 17, 397, and 399, Zhang teaches a system comprising the modified ADAR or a nucleotide sequence encoding the modified ADAR, a catalytically inactive Cas13 protein or a nucleotide sequence encoding the catalytically inactive Cas13 protein, and a guide sequence capable of hybridizing with a target RNA sequence (pp. 81-82, paragraph [0681]).
Regarding claims 12, 14, 396, 398, and 400, Zhang teaches the system is a vector system for expression (paragraph [0681]) and teaches the components of the system are delivered to a cell via lipid nanoparticles (paragraph [0689]).
Therefore, Zhang anticipates claims 1, 4, 8, 11-14, 17, and 396-400 as written.
RESPONSE TO REMARKS: Applicant argues the provisional application 62/775,865 provides descriptive support for the M383L mutation and given that the effective filing date of the provisional application 62/775,865 is December 5, 2018, Zhang is not available as prior art.
Applicant’s argument is not found persuasive. The provisional application 62/775,865 does not provide descriptive support for all mutations recited in claim 1, e.g., D619G. Thus, Zhang is available as prior art under 35 U.S.C. 102(a)(2) and for reasons stated above anticipates claims 1, 4, 8, 11-14, 17, and 396-400 as written.
Claims 1, 4, 8, 11-14, 17, and 396-400 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhang et al. (US 2022/0177863 A1; with priority to March 18, 2019; cited on the attached Form PTO-892; hereafter “Zhang-2”).
Regarding claim 1, Zhang-2 teaches a human ADAR2 catalytic domain with the mutations E488Q, M383L, and V351G (p. 16, column 1, middle).
Regarding claims 4, 8, 11, 13, 17, 397, and 399, Zhang-2 teaches a system comprising the modified ADAR or a nucleotide sequence encoding the modified ADAR, a catalytically inactive Cas13 protein or a nucleotide sequence encoding the catalytically inactive Cas13 protein, and a guide sequence capable of hybridizing with a target RNA sequence (p. 20, paragraph [0163]).
Regarding claims 12, 14, 396, 398, and 400, Zhang-2 teaches the system is a vector system for expression (p. 20, paragraph [0163]) and teaches the components of the system are delivered to a cell via lipid nanoparticles (p. 21, paragraph [0171]).
Therefore, Zhang-2 anticipates claims 1, 4, 8, 11-14, 17, and 396-400 as written.
Conclusion
Status of the claims:
Claims 1, 4, 8, 11-14, 17, and 396-400 are pending.
Claims 1, 4, 8, 11-14, 17, and 396-400 are rejected.
No claim is in condition for allowance.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID J STEADMAN whose telephone number is (571)272-0942. The examiner can normally be reached Monday to Friday, 7:30 AM to 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MANJUNATH N. RAO can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/David Steadman/Primary Examiner, Art Unit 1656
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