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 .
Priority
Acknowledgment is made of applicant’s claim for priority based on a provisional application filed as 63/209,881 on 06/11/2021.
All claims are given the priority date of 06/11/2021.
Application Status
Receipt is acknowledged of amendment, filed 07/09/2024. Claims 1, 2, 8-11, 13, 20, 28, 29, 31, 39, 41, 42, 44, 50, 52, 57, 72, 73, 78, 80, 82, 91 and 107 are currently pending.
Election/Restriction
Applicant’s election of Group I, drawn to claims 1, 2, 8-11, 13, 20, 28, 29, 31, 39, 41, 42, 44, 50, 52, 57, 72, 73, 78 and 80, in the reply filed on 08/03/2026 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Claims 82, 91 and 107 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 08/03/2026.
Claims 1, 2, 8-11, 13, 20, 28, 29, 31, 39, 41, 42, 44, 50, 52, 57, 72, 73, 78 and 80 are currently under examination.
Information Disclosure Statement
Receipt of acknowledgment of the information disclosure statements filed on 07/09/2024 and 08/04/2026 have been received and all references have been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code; at para [00582]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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 –
(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 8-11, 13, 20, 28, 29, 31, 39, 41, 42, 44, 50, 52, 57, 72, 73, 78 and 80 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Liu et al (WO 2018/165629 A1).
Regarding claims 1, 2 and 8, Liu teaches the fusion protein comprising, from 5’ to 3’: a cytidine deaminase domain, BE3; a linker; a nCas9 protein; a linker; UDG; UdgX; a linker; PolK; Rev1; and NLS (Page 136, Paragraph 1 bridging Page 137, Paragraph 1).
Regarding claims 9-11, Liu teaches the UBP domain used in the fusion protein is UdgX identified as SEQ ID NO: 49 which comprises 100% identity to instant SEQ ID NO: 49 (Page 68, Paragraph 2; See Appendix I).
Regarding claim 13, Liu teaches the fusion protein comprising, from 5’ to 3’: a cytidine deaminase domain, BE3; a linker; a nCas9 protein; a linker; UDG; UdgX; a linker; PolK; Rev1; and NLS (Page 136, Paragraph 1 bridging Page 137, Paragraph 1).
Regarding claim 20, Liu teaches the BE3 sequence with the fusion protein of SEQ ID NO: 117 which is 100% identical to instant SEQ ID NO: 93 (Page 136, Paragraph 1 bridging Page 137, Paragraph 1; See Appendix II).
Regarding claims 28, 29 and 31, Liu teaches the nCas9 sequence within the fusion protein sequence of SEQ ID NO: 117 which is 81% identical to instant SEQ ID NO: 21 (Page 136, Paragraph 1 bridging Page 137, Paragraph 1; See Appendix III).
Regarding claim 39, Liu teaches the linker sequence between the BE3 sequence and the nCas9 sequence within the fusion protein sequence of SEQ ID NO: 117 which is 100% identical to instant SEQ ID NO: 102 (Page 136, Paragraph 1 bridging Page 137, Paragraph 1; See Appendix IV).
Regarding claims 41 and 42, Liu teaches the fusion protein comprising, from 5’ to 3’: a cytidine deaminase domain, BE3; a linker; a nCas9 protein; a linker; UDG; UdgX; a linker; PolK; Rev1; and NLS (Page 136, Paragraph 1 bridging Page 137, Paragraph 1).
Regarding claim 44, Liu teaches the fusion protein can be configured to comprise the structure: NH2-[NAP]-[cytidine deaminase]-[UBP]-[napDNAbp]-COOH [00229].
Regarding claims 50 and 52, Liu teaches the fusion protein comprising, from 5’ to 3’: a cytidine deaminase domain, BE3; a linker; a nCas9 protein; a linker; UDG; UdgX; a linker; PolK; Rev1; and NLS (Page 136, Paragraph 1 bridging Page 137, Paragraph 1). Liu teaches the sequence of the NLS as SEQ ID NO: 41 which is 100% identical to instant SEQ ID NO: 41 (Page 136, Paragraph 1 bridging Page 137, Paragraph 1; See Appendix V).
Regarding claims 57 and 80, Liu teaches a pharmaceutical composition comprising the fusion protein and gRNA complex [00256].
Regarding claims 72, 73 and 78, Liu teaches a kit comprising the nucleic acid construct encoding the fusion protein and gRNA backbone [00267]. Liu teaches base editing of HEK2, RNF2, and FANCF in HEK293 cells using the BE3_UdGX_polymerase fusion proteins [00284-00285].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ROSE LIPPOLIS whose telephone number is (703)756-5450. The examiner can normally be reached Monday-Friday, 8:00am to 5:00pm EST.
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 A 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.
/ALEXANDRA ROSE LIPPOLIS/Examiner, Art Unit 1637
/CELINE X QIAN/Primary Examiner, Art Unit 1637
Prosecution Insights