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 .
Election/Restrictions
Applicant’s election of Group I (claims 1-14) in the reply filed on 03June2026 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Claims 22-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups of invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03June2026.
Status of the Claims
The amendments and arguments filed 03June2026 are acknowledged and have been fully considered. Claims 15-21 are canceled. Claims 1-14 and 22-31 are pending. Claims 6, 26, and 29 are currently amended. Claim 12 was previously presented. Claims 1-5, 7-11, 13-14, 22-25, 27-28, 30-31 are original. Claims 22-31 are withdrawn.
Claims 1-14 are examined on the merits herein.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) [US provisional 63278790 filed 12November2021] and 35 U.S.C. 365(c) [national stage of PCT/US2022/049494 filed 10November2022] is acknowledged. Claims 1-14 have an effective filing date of 12November2021.
Claim Objections
Claims 1, 2, 4, 5, 6, 8, 9, 11, 12, 13 are objected to because of the following informalities: these claims all recite abbreviations without first defining them within the claim (dCas, GP41, GB1, sfGFP, VP64, TAL should all be written in long form with the abbreviation afterwards in parenthesis or the abbreviations should be otherwise defined in the claims (such as by saying that it has a particular sequence, as is suggested within the below indefiniteness rejection). 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.
Claims 2, 5, 6, 9, 12, and 13 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.
These claims are indefinite because they recite a broad, function reference to GP41, VP64, TAL, and/or dead Cas9 (“dCas9”) then recite a narrow, structural reference to a particular sequence. It is not clear to which these claims are limited (the broad recitation or the narrow one), making these claims indefinite.
Please amend these claims to recite something like “GP41 comprising the sequence SEQ ID NO: 2”, “GP4 comprising the sequence SEQ ID NO: 1”, “VP64 comprising the sequence SEQ ID NO: 4”, “TAL comprising the sequence SEQ ID NO: 34”, and “dCas9 comprising the sequence SEQ ID NO: 5”.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over BOERSMA et al. (“Multi-color single-molecule imaging uncovers extensive heterogeneity in mRNA decoding” 2019 CELL 178:458-472; of record IDS 03June2026) and TANENBAUM et al. (“A protein tagging system for signal amplification in gene expression and fluorescence imaging” 2014 CELL 159(3):635-646; of record IDS 03June2026).
These claims are directed toward a transcriptional activator system which may comprise a nucleotide sequence that encodes, or the amino acids encoded thereby, a dead Cas9 (“dCas9”) fused to a binding polypeptide comprising an amino acid GP41 binding sequence, a llama GP41 nanobody (optionally five or more copies of that GP41 nanobody), and a VP64 or TAL activator domain (wherein the nanobody may comprise the activator domain), and a sgRNA sequence. These systems may also comprise a ”GB1” or “sfGFP” solubilizing domain/tag.
While not stated in these claims, please note that the specification calls these claimed transcriptional activator systems “MoonTag” systems.
BOERSMA et al. teach what is called the “MoonTag” system (which BOERSMA et al. describe as a variation of the “SunTag” system taught by TANENBAUM et al.). “SunTag” systems utilize VP64 activator domains, “GB1” or “sfGFP” solubilizing domains, and may be utilized with a dead Cas (“dCas”) and sgRNA sequences for imaging or to modify gene expression (TANENBAUM et al. at the bottom of page 3, pages 8-9, page 12). The “MoonTag” system differs from “SunTag” by comprising llama GP41 which binds to a GP41 binding sequence (BOERSMA et al. at the right column on page 460). [relevant to claims 1-6 and 8-13] BOERSMA et al. teach “MoonTag” systems utilizing 4, 12, and 24 copies of GP41 binding sequence (at the right column on page 460). [relevant to claims 7 and 14]
The reason the “MoonTag” system taught by BOERSMA et al. is not being applied as an anticipatory reference is because BOERSMA et al. appears to describe using “MoonTag” for imaging (i.e., BOERSMA et al. does not appear to teach utilizing “MoonTag” with a dCas and sgRNA).
TANENBAUM et al. teach using “SunTag” with a dCas and sgRNA for modulating gene expression and, in that way, supplements the deficiency of BOERSMA et al.
Absent evidence to the contrary, and because TANENBAUM et al. explain that these transcriptional activator systems may be utilized with a dCas and sgRNA to, for example, desirably modulate gene expression; the Office believes that it would have been obvious to a person with ordinary skill in the art at the time this application was filed (a “POSA”) to apply the “MoonTag” systems taught by BOERSMA et al. with a dCas and sgRNA to, for example, desirably modulate gene expression. Combining BOERSMA et al. and TANENBAUM et al. to arrive at the presently claimed subject matter appears to have been no more than “combining prior art elements according to known methods to yield predictable results” (MPEP § 2143(I)(A)); “applying a known technique to a known method/product ready for improvement to yield predictable results” (MPEP § 2143(I)(D)); or, at the very least, “obvious to try” with a reasonable expectation of success and the motivation of desirably modulating gene expression (MPEP § 2143(I)(E)).
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 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19, 34, 38-39, 43, 63, 78, 82, 83, 87 of copending Application No. 18862329 (published as US20250304983, Attny. Dkt. No. 09531-0505US1). Although the claims at issue are not identical, they are not patentably distinct from each other.
The transcriptional activators of this application’s claims 1-14 (what Applicant calls “MoonTag” systems) appear to be the same transcriptional activators within claims 19, 34, 38-39, 43, 63, 78, 82, 83, 87 of 18862329 with systems comprising a dead Cas9 (“dCas9”) fused to a binding polypeptide comprising an amino acid GP41 binding sequence, a llama GP41 nanobody, and a VP64 or TAL activator domain (wherein the nanobody may comprise the activator domain), a sgRNA sequence, and optionally a ”GB1” or “sfGFP” solubilizing domain/tag.
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 Rebecca STEPHENS whose telephone number is (571)272-0070. The examiner can normally be reached Monday through Friday 8:30-4:30.
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/REBECCA STEPHENS/Examiner, Art Unit 1663
/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
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