DETAILED ACTION
This action is in reply to papers filed 6/17/2026.
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 .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20240309345A1, published 9/19/2014.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 6/17/2026 is acknowledged. Claims 15, 18, 22, 26-27,29, 37, 43, 45, 50, 53, 56, 68, 71 and 74 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 6/17/2026.
Claims 1-2, 7, 12 and 20 are pending and examined herein.
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 1-2, 7, 12 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-10, 12-14 and 18 of U.S. Patent No. 11434491. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
Instant claim 1 is drawn to a fusion protein comprising, from N-terminus to C-terminus, a DNA methyltransferase domain, a first XTEN linker, a nuclease-deficient RNA-guided endonuclease enzyme, a second XTEN linker, and a Krüppel associated box domain. Claim 20 is drawn to a cell comprising the fusion protein.
Claim 1 of U.S Patent ‘491 is drawn to a fusion protein comprising, from N-terminus to C-terminus: (i) a DNA methyltransferase domain, a nuclease-deficient RNA-guided DNA endonuclease enzyme, and a Krüppel associated box domain; or (ii) a Krüppel associated box domain, a nuclease-deficient RNA-guided DNA endonuclease enzyme, and a DNA methyltransferase domain. Dependent claim 5 states the nuclease-deficient RNA-guided DNA endonuclease enzyme is dCas9 and the DNA methyltransferase domain comprises a Dnmt3A protein and a Dnmt3L protein (a Dnmt3A-3L domain); wherein the dCas9 is covalently linked to the Dnmt3A-3L domain via an XTEN linker. Dependent claim 9 states that the wherein the nuclease-deficient RNA-guided DNA endonuclease enzyme is covalently linked to the Krüppel associated box domain via a peptide linker. Dependent claim 18 is drawn to a cell comprising the fusion protein.
It is clear that all the elements of the application claims are to be found in patent claims (as the application claims fully encompasses patent claims). The only difference between patent claims and instant claims is that the second linker (between the nuclease-deficient RNA-guided DNA endonuclease enzyme, and a Krüppel associated box domain) in instant claims is limited to an XTEN linker. However, the substitution of the generic peptide linker in the patent claims for an XTEN linker would have been prima facie obvious in view of Tan et al. (Nat Commun. 2019 Jan 25;10:439) who teach the 16 amino acid (aa) flexible linker (XTEN) has been identified as the best compromise between editing efficiency and specificity (Pg. 2, Col. 2, para. 4). Thus, for this purpose, the substitution of a generic peptide linker for the XTEN linker would have been prima facie obvious.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is allowed.
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/TITILAYO MOLOYE/ Primary Examiner, Art Unit 1632
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