DETAILED ACTION
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 .
Claims 46-73 are still at issue and are present for examination.
Election/Restrictions
Applicant's election of the invention of Group 1, claims 46-50, 59-64 and 73, to a polypeptide comprising an ADAR2 catalytic domain at least 95% identical to SEQ ID NO:2 and having an E488 mutation and a N406 mutation, in the paper of 10/23/2025, 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)).
It is noted that the previous office action requested and election of species of a tethering protein, referencing claims 53, 58 and 67, and applicants have made no such election.
Claims 51-58, 65-72 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609 A(1) states, "the list may not be incorporated into the specification but must be submitted in a separate paper."
Applicants filing of information disclosure statements on 3/7/2023, 4/10/2023 and 4/15/2023 are acknowledged and have been considered.
Claim Objections
Claim 73 is objected to because of the following informalities:
Claim 73 recites “polynucleotide encoding for the engineered polypeptide”, which should be “polynucleotide encoding
Appropriate correction and/or comment is required.
Specification
The disclosure is objected to because of the following informalities:
Applicants specification is objected to because applicants specification comprises Nucleotide and/or Amino Acids Disclosures Requiring a "Sequence Listing".
Applicants attention is directed to 37 CFR 1.821(a) which presents a definition for "nucleotide and/or amino acid sequences." This definition sets forth limits, in terms of numbers of amino acids and/or numbers of nucleotides, at or above which compliance with the sequence rules is required. Nucleotide and/or amino acid sequences as used in 37 CFR 1.821 through 37 CFR 1.825 are interpreted to mean an unbranched sequence of four or more amino acids or an unbranched sequence of ten or more nucleotides.
Specifically applicants specification at Figures 1A, 3B, 7, 9A, 12A lists nucleotide sequences which require a sequence identifier and are to be included in applicants sequence listing as per 37 CFR 1.821 through 37 CFR 1.825. Further each of the sequences in the figures require a sequence identifier either in the figure itself or in the description of the figure.
Appropriate correction is required.
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.
Claim 46-50, 59-64 and 73 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.
Claims 46 (claims 47-50 dependent on), 59 (claims 60-64 dependent on) and 73 are indefinite in the recitations E488X1 and N496X2 absent a reference sequence. While the claims requires a certain identity to SEQ ID NO:2, it is unclear if E488X1 and B496X2 are relative to SEQ ID NO:2 or some other reference sequence.
Closest Prior Art
WO 2018/161032 A1 discloses an engineered polypeptide comprising an ADAR2 catalytic domain that comprises a sequence that is at least 100% identical to SEQ ID NO: 2 from amino acid 316 to amino acid 697 of SEQ ID NO: 2.
WO 2019/104094 A2 discloses a method for modifying a target site within a DNA-RNA hybrid molecule comprising contacting the hybrid molecule with an ADAR2 protein comprising an E488Q mutation.
Katrekar et al., (Nature Methods, Vol 16, No. 3, pp 239-242, March 2019) teach the ADAR2 hyperactive mutant E488Q and that the equivalent ADAR1 mutant shows the highest A>G edits.
Remarks
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G HUTSON whose telephone number is (571)272-0930. The examiner can normally be reached 6-3 EST Mon-Fri.
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, Robert Mondesi can be reached at (408) 918-7584. 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.
rgh
1/16/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652