Prosecution Insights
Last updated: July 17, 2026
Application No. 16/851,360

RNA-Guided Transcriptional Regulation

Final Rejection §103§DP
Filed
Apr 17, 2020
Priority
Jun 04, 2013 — provisional 61/830,787 +3 more
Examiner
GROOMS, TIFFANY NICOLE
Art Unit
1637
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
President and Fellows of Harvard College
OA Round
6 (Final)
59%
Grant Probability
Moderate
7-8
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 59% of resolved cases
59%
Career Allowance Rate
107 granted / 180 resolved
-0.6% vs TC avg
Strong +46% interview lift
Without
With
+45.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
47 currently pending
Career history
227
Total Applications
across all art units

Statute-Specific Performance

§101
2.0%
-38.0% vs TC avg
§103
51.1%
+11.1% vs TC avg
§102
6.1%
-33.9% vs TC avg
§112
7.5%
-32.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 180 resolved cases

Office Action

§103 §DP
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 . Application Status The Amendments and Remarks filed 23 February 2026 are acknowledged and have been entered. Claims 41-43 and 45-57 are pending and being examined on the merits. Priority The instant application is a CON of application 16/851,360 filed 04/17/2020, which is a CON of application 16/441,209 filed 06/14/2019, which is a CON of application 14/319,530 filed 06/30/2014, which is a CON of PCT US2014/040868 filed on 06/04/2014, which claims priority to US provisional 61/830,787 filed 06/04/2013. Claim Rejections - 35 USC § 103 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 41-43 and 45-57 are rejected under 35 U.S.C. 103 as being unpatentable over Doudna et al. (US20140068797 A1, 01/28/2013, cited on the information disclosure statement filed 04/20/2020). This rejection is modified to clarify the motivation and reasonable expectation of success in view of Applicant’s arguments, does not constitute a new ground of rejection, and continues to rely on the same references, findings, and combination set forth in the prior Office Action. Regarding claim 41, Doudna teaches a method of modulating transcription of a target cell, comprised of providing a cell with a guide RNA that is complementary to the target nucleic acid sequences on genomic DNA or exogenous DNA, and the null Cas9 protein (same as Cas9 having inactive nuclease domain) [136,137, 0163, 0409-0410, 0775]. Doudna teaches that a guide RNA is also referred to a "DNA-targeting RNA" [0130]. Doudna teaches that the DNA-targeting RNA comprises an additional segment at either the 5' or 3' end that comprises a modification or sequence that provides for a binding site for proteins (e.g., proteins that act on DNA, including transcriptional activators, transcriptional repressors, DNA methyltransferases, DNA demethylases, histone acetyltransferases, histone deacetylases, and the like); thereby teaching where the guide RNA is connected to a transcriptional regulator [0133, 0385, 0425, 0443]. Additionally, Doudna teaches that the increase of transcription can be due to fusion partners between dCas9 and transcription activator proteins [0415-0419]; thereby teaching that fusion partners outside of a dCas9/ DNA-targeting RNA complex can be used to modulate transcriptional expression. While Doudna does not teach that the guide RNA is directly tethered to the transcriptional regulator, it would have been obvious to one ordinary skilled in the art before the effective filing date of the claimed invention to modify the DNA-targeting RNA such that the proteins (e.g., proteins that act on DNA, including transcriptional activators, transcriptional repressors, DNA methyltransferases, DNA demethylases, histone acetyltransferases, histone deacetylases, and the like) are tethered to the guide RNA via the binding site as taught by Doudna rather than employing the non-covalent recruitment mechanism taught by Doudna. Doudna teaches that the 5’ or 3’ end of the DNA-targeting RNA comprises an additional segment upon which a transcriptional activator or repressor can bind. Therefore, a skilled artisan would be motivated and have a reasonable expectation of success to use the binding site on the DNA-targeting RNA to directly tether the transcriptional modulator to the guide RNA because direct tethering represents a predictable design variation that would ensure association of the transcriptional regulator with the guide RNA. One of ordinary skill in the art would have had a reasonable expectation of success because Doudna already teaches localization of transcriptional regulators through guide-RNA-associated recruitment and further teaches transcriptional modulation through localization of transcriptional activators and repressors to target DNA. Direct tethering merely substitutes one known localization strategy for another known localization strategy while preserving the same intended function, namely localization of a transcriptional regulator to a target nucleic acid through the dCas9/guide RNA targeting complex. Regarding claim 42, Doudna teaches that a subject method involves introducing into a host cell (or a population of host cells) one or more nucleic acids comprising nucleotide sequences encoding a DNA-targeting RNA and/or a variant Cas9 site-directed polypeptide, thereby teaching the introduction of a plurality of guide RNAs with a nuclease null Cas9 [0469, 0422]. Regarding claim 43, Doudna teaches a CRISPRi system that can be used to repress multiple target genes simultaneously and uses a catalytically dead Cas9, lacking endonuclease activity, co-expressed with a guide RNA, to generate a DNA recognition complex that can specifically interfere with transcriptional elongation, RNA polymerase binding, or transcription factor binding [0726]. Doudna teaches that CRISPRi can be used to repress multiple target genes simultaneously [0726]. Regarding claim 45, Doudna teaches introducing into a cell (or a population of cells) one or more nucleic acids comprising nucleotide sequences encoding a site-directed modifying polypeptide ( e.g., a naturally occurring Cas9; a modified, i.e., mutated or variant, Cas9; a chimeric Cas9; etc.). [0276, 0329]. Regarding claim 46-47, Doudna teaches that suitable hosts include human cells [324-328]. Regarding claims 48-50 and 52-54, Doudna teaches that the DNA-targeting RNA" or "DNA targeting RNA polynucleotide" (also referred to herein as a "guide RNA" or "gRNA") can have a length of from about 12 nucleotides to about 100 nucleotides [0130, 0428]. Regarding claim 51, Doudna teaches the target DNA may be, for example, naked DNA in vitro, chromosomal DNA in cells in vitro, chromosomal DNA in cells in vivo, etc.[0254]. Regarding claim 55, the teaching of Doudna are discussed above as applied to claims 42 and 43. Regarding claims 56-57, Doudna teaches where the DNA-targeting RNAs can be differently recognized by dCas9 proteins from different bacteria, such as S. pyogenes [0445]. Response to Arguments Applicant's arguments filed 14 August 2025 have been fully considered but they are not persuasive. Applicant argues that Doudna teaches only modulation of transcription through binding of the dCas9/guide RNA complex itself and does not teach modulation using a transcriptional regulator associated with the guide RNA. The argument is not persuasive. Doudna expressly teaches that a DNA-targeting RNA may comprise a sequence that provides a binding site for proteins acting on DNA, including transcriptional activators and transcriptional repressors. See paragraphs [0133], [0385], [0425], and [0443]. Doudna additionally teaches embodiments employing transcriptional activators associated with the dCas9 targeting system. See paragraphs [0415]-[0419]. Accordingly, Doudna does not merely teach steric repression through dCas9 binding but expressly contemplates localization of transcriptional regulators to target DNA through the CRISPR targeting system to include a DNA-targeting RNA. Applicant argues that Doudna fails to expressly disclose a guide RNA directly tethered to a transcriptional regulator. The Examiner agrees that Doudna does not expressly disclose direct tethering. However, obviousness does not require that every claim limitation be expressly disclosed in a single reference. As discussed in the rejection, Doudna teaches guide RNAs comprising protein recruitment sequences and specifically identifies transcriptional activators and transcriptional repressors as proteins that may be recruited through such sequences. Doudna further teaches transcriptional modulation through localization of such regulators to target DNA. A person of ordinary skill in the art would have recognized direct tethering as a predictable alternative to non-covalent recruitment because both approaches achieve the same objective of localizing the transcriptional regulator to the guide RNA/dCas9 complex. The claimed direct tether therefore represents an obvious design choice and predictable variation of Doudna’s recruitment strategy. Applicant argues that a person of ordinary skill in the art would understand Doudna’s disclosed binding site to bind the active DNA-binding site of the transcriptional regulator, thereby preventing the regulator from activating or repressing transcription. The argument is not persuasive. Doudna contains no teaching that the disclosed protein-binding site must interact with a functional DNA-binding surface of the recruited protein or otherwise abolish the activity of the recruited protein. To the contrary, Doudna identifies transcriptional activators and transcriptional repressors as examples of proteins that may be associated with the guide RNA through such binding sites, which would have suggested to a person of ordinary skill in the art that the recruited proteins remain capable of performing their intended biological functions. Applicant has not provided objective evidence demonstrating that a person of ordinary skill in the art would have expected recruitment of a transcriptional regulator through a guide-RNA-associated binding site to render the regulator nonfunctional. Applicants have provided only arguments of counsel, and arguments of counsel cannot take the place of factually supported objective evidence. See, e.g., In re Huang, 100 F.3d 135,139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). Applicant argues that Doudna provides no reasonable expectation of success for using a guide RNA-associated transcriptional regulator to modulate expression of a target nucleic acid. The argument is not persuasive. Doudna expressly teaches transcriptional modulation through localization of proteins to target DNA using the CRISPR targeting system. Doudna further teaches guide RNAs containing sequences for recruiting transcriptional activators and repressors. A person of ordinary skill in the art would reasonably expect that directly tethering such regulators to the guide RNA would maintain or improve localization of the regulator to the target nucleic acid while preserving the intended transcriptional regulatory function. Direct tethering merely substitutes one known localization mechanism for another known localization mechanism while preserving the same intended result. Such predictable modification would have carried a reasonable expectation of success. 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 Langi, 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 §§ 706.02(1)(1) - 706.02(1)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-l.isp. Claims 41-43 and 45-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 5, 8-9, 12-14, and 22 of U.S. Patent No. 8993233 (cited on the information disclosure statement filed 04/20/2020) in view of Doudna (US20140068797 A1, 01/28/2013, cited on the information disclosure statement filed 04/20/2020). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claimed invention is obvious over the claims of the patent. The patented claims all the limitations of the instant claims except, wherein the guide RNA or plurality of guide RNAs is tethered, fused, connected or joined to the transcriptional regulator, wherein the cell is a human cell and wherein the guide RNA is about 100 nucleotides. The teachings of Doudna are discussed above. It would have been obvious to one ordinary skilled in the art before the effective filing date of the claimed invention to modify the patented claims to include the use of a guide RNA as claimed that is 100 nucleotides in length and wherein it is fused to a transcriptional regulator. One of ordinary skill would be motivated to make the modification given’s Doudna teachings that transcription can be modulated with the use of more than one DNA targeting RNA that is up to 100 nucleotides and that can be fused to a transcriptional activator or repressor. One of ordinary skill would have a reasonable expectation of success as the both the patented claims and Doudna teach methods of modulation gene expression. For additional limitations of the instant claims, see the additional teachings of the patented claims. To the extent that there are limitations that are not provided for by the patented claims, the teachings of Doudna are discussed above. It would have been obvious to have modified the subject matter of the patented claims to arrive at the subject matter of the instant claims for substantially the same reasons as discussed above in view of the teachings of Doudna. Claims 41-43 and 45-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-28 of U.S. Patent No. 8999641 (cited on the information disclosure statement filed 04/20/2020) in view of Doudna (US20140068797 A1, 01/28/2013, cited on the information disclosure statement filed 04/20/2020). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claimed invention is obvious over the claims of the patent. The patented claims all the limitations of the instant claims except, wherein the guide RNA or plurality of guide RNAs is tethered, fused, connected or joined to the transcriptional regulator, wherein the cell is a human cell and wherein the guide RNA is about 100 nucleotides. The teachings of Doudna are discussed above. It would have been obvious to one ordinary skilled in the art before the effective filing date of the claimed invention to modify the patented claims to include the use of a guide RNA as claimed that is 100 nucleotides in length and wherein it is fused to a transcriptional regulator. One of ordinary skill would be motivated to make the modification given’s Doudna teachings that transcription can be modulated with the use of more than one DNA targeting RNA that is up to 100 nucleotides and that can be fused to a transcriptional activator or repressor. One of ordinary skill would have a reasonable expectation of success as the both the patented claims and Doudna teach methods of modulation gene expression. For additional limitations of the instant claims, see the additional teachings of the patented claims. To the extent that there are limitations that are not provided for by the patented claims, the teachings of Doudna are discussed above. It would have been obvious to have modified the subject matter of the patented claims to arrive at the subject matter of the instant claims for substantially the same reasons as discussed above in view of the teachings of Doudna. Claim 41-43 and 45-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 8932814B2 (cited on the information disclosure statement filed 04/20/2020) in view of Doudna (US20140068797 A1, 01/28/2013, cited on the information disclosure statement filed 04/20/2020). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claimed invention is obvious over the claims of the patent. The patented claims all the limitations of the instant claims except, wherein the guide RNA or plurality of guide RNAs is tethered, fused, connected or joined to the transcriptional regulator, wherein the cell is a human cell and wherein the guide RNA is about 100 nucleotides. The teachings of Doudna are discussed above. It would have been obvious to one ordinary skilled in the art before the effective filing date of the claimed invention to modify the patented claims to the use of a guide RNA as claimed that is 100 nucleotides in length and wherein it is fused to a transcriptional regulator. One of ordinary skill would be motivated to make the modification given’s Doudna teachings that transcription can be modulated with the use of more than one DNA targeting RNA that is up to 100 nucleotides and that can be fused to a transcriptional activator or repressor. One of ordinary skill would have a reasonable expectation of success as the both the patented claims and Doudna teach methods of modulation gene expression. For additional limitations of the instant claims, see the additional teachings of the patented claims. To the extent that there are limitations that are not provided for by the patented claims, the teachings of Doudna are discussed above. It would have been obvious to have modified the subject matter of the patented claims to arrive at the subject matter of the instant claims for substantially the same reasons as discussed above in view of the teachings of Doudna. Claims 41-43 and 45-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 8871445 (cited on the information disclosure statement filed 04/20/2020) in view of Doudna (US20140068797 A1, 01/28/2013, cited on the information disclosure statement filed 04/20/2020). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claimed invention is obvious over the claims of the patent. The patented claims all the limitations of the instant claims except, wherein the guide RNA or plurality of guide RNAs is tethered, fused, connected or joined to the transcriptional regulator, wherein the cell is a human cell and wherein the guide RNA is about 100 nucleotides. The teachings of Doudna are discussed above. It would have been obvious to one ordinary skilled in the art before the effective filing date of the claimed invention to modify the patented claims to include the use of a guide RNA as claimed that is 100 nucleotides in length and wherein it is fused to a transcriptional regulator. One of ordinary skill would be motivated to make the modification given’s Doudna teachings that transcription can be modulated with the use of more than one DNA targeting RNA that is up to 100 nucleotides and that can be fused to a transcriptional activator or repressor. One of ordinary skill would have a reasonable expectation of success as the both the patented claims and Doudna teach methods of modulation gene expression. For additional limitations of the instant claims, see the additional teachings of the patented claims. To the extent that there are limitations that are not provided for by the patented claims, the teachings of Doudna are discussed above. It would have been obvious to have modified the subject matter of the patented claims to arrive at the subject matter of the instant claims for substantially the same reasons as discussed above in view of the teachings of Doudna. Claims 41-43 and 45-57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 25 of copending Application No. 14/681510 in view of Doudna (US20140068797 A1, 01/28/2013, cited on the information disclosure statement filed 04/20/2020). The instant application and the copending applicant have a common assignee. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claimed invention is obvious over the claims of the copending Application. The copending Application claims all the limitations of the instant claims except, wherein the guide RNA or plurality of guide RNAs is tethered, fused, connected or joined to the transcriptional regulator, wherein the cell is a human cell and wherein the guide RNA is about 100 nucleotides. The teachings of Doudna are discussed above. It would have been obvious to one ordinary skilled in the art before the effective filing date of the claimed invention to modify the copending Application claims to include the use of a guide RNA as claimed that is 100 nucleotides in length and wherein it is fused to a transcriptional regulator. One of ordinary skill would be motivated to make the modification given’s Doudna teachings that transcription can be modulated with the use of more than one DNA targeting RNA that is up to 100 nucleotides and that can be fused to a transcriptional activator or repressor. One or ordinary skill would have a reasonable expectation of success as the both the patented claims and Doudna teach methods of modulation gene expression. For additional limitations of the instant claims, see the additional teachings of the patented claims. To the extent that there are limitations that are not provided for by the patented claims, the teachings of Doudna are discussed above. It would have been obvious to have modified the subject matter of the patented claims to arrive at the subject matter of the instant claims for substantially the same reasons as discussed above in view of the teachings of Doudna. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 41-43 and 45-57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over allowed claims 17-26 of U.S. Patent 11535863B2 in view of Doudna (US20140068797 A1, 01/28/2013, cited on the information disclosure statement filed 04/20/2020). The instant application and the copending applicant have a common assignee. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claimed invention is obvious over the claims of the patent. The patented claims all the limitations of the instant claims except, wherein the guide RNA or plurality of guide RNAs is tethered, fused, connected or joined to the transcriptional regulator, wherein the cell is a human cell and wherein the guide RNA is about 100 nucleotides. The teachings of Doudna are discussed above. It would have been obvious to one ordinary skilled in the art before the effective filing date of the claimed invention to modify the patented claims to include the use of a guide RNA as claimed that is 100 nucleotides in length and wherein it is fused to a transcriptional regulator. One of ordinary skill would be motivated to make the modification given’s Doudna teachings that transcription can be modulated with the use of more than one DNA targeting RNA that is up to 100 nucleotides and that can be fused to a transcriptional activator or repressor. One of ordinary skill would have a reasonable expectation of success as the both the patented claims and Doudna teach methods of modulation gene expression. For additional limitations of the instant claims, see the additional teachings of the patented claims. To the extent that there are limitations that are not provided for by the patented claims, the teachings of Doudna are discussed above. It would have been obvious to have modified the subject matter of the patented claims to arrive at the subject matter of the instant claims for substantially the same reasons as discussed above in view of the teachings of Doudna. Claims 41-43 and 45-57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 13-14, and 25-33 of copending Application No. 14/319,530 in view of Doudna (US20140068797 A1, 01/28/2013, cited on the information disclosure statement filed 04/20/2020). The instant application and the copending applicant have a common assignee. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claimed invention is obvious over the claims of the copending Application. The copending Application claims all the limitations of the instant claims except, wherein the guide RNA or plurality of guide RNAs is tethered, fused, connected or joined to the transcriptional regulator, and wherein the Cas nuclease is a null Cas nuclease. The teachings of Doudna are discussed above. It would have been obvious to one ordinary skilled in the art before the effective filing date of the claimed invention to modify the copending Application claims where the guide RNA as claimed is fused to a transcriptional regulator and wherein the Cas is a null Cas nuclease. One of ordinary skill would be motivated to make the modification given’s Doudna teachings that transcription can be modulated with the use of more than one DNA targeting RNA that is up to 100 nucleotides and that can be fused to a transcriptional activator or repressor. One or ordinary skill would have a reasonable expectation of success as the both the patented claims and Doudna teach methods of modulation gene expression. For additional limitations of the instant claims, see the additional teachings of the patented claims. To the extent that there are limitations that are not provided for by the patented claims, the teachings of Doudna are discussed above. It would have been obvious to have modified the subject matter of the patented claims to arrive at the subject matter of the instant claims for substantially the same reasons as discussed above in view of the teachings of Doudna. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 41-43 and 45-57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of US Patent 11981917 B2 in view of Doudna (US20140068797 A1, 01/28/2013, cited on the information disclosure statement filed 04/20/2020). The instant application and the copending applicant have a common assignee. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claimed invention is obvious over the claims of the patent. The patent claims all the limitations of the instant claims except, wherein the guide RNA or plurality of guide RNAs is tethered, fused, connected or joined to a transcriptional regulator. The teachings of Doudna are discussed above. It would have been obvious to one ordinary skilled in the art before the effective filing date of the claimed invention to modify the patent where a guide RNA is fused to a transcriptional regulator. One of ordinary skill would be motivated to make the modification given’s Doudna teachings that transcription can be modulated with the use of more than one DNA targeting RNA that is up to 100 nucleotides and that can be fused to a transcriptional activator or repressor. One or ordinary skill would have a reasonable expectation of success as the both the patented claims and Doudna teach methods of modulation gene expression. For additional limitations of the instant claims, see the additional teachings of the patented claims. To the extent that there are limitations that are not provided for by the patented claims, the teachings of Doudna are discussed above. It would have been obvious to have modified the subject matter of the patented claims to arrive at the subject matter of the instant claims for substantially the same reasons as discussed above in view of the teachings of Doudna. Response to Arguments Applicants argue that the patented or application claims are not obvious over Doudna and therefore, they are patentably distinct from the present claims. Applicants’ arguments have been considered and found not persuasive for the same reasons discussed above. Therefore, all nonstatutory double patenting rejections are maintained. Conclusion No claims are allowed. THIS ACTION IS MADE FINAL. 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 TIFFANY N GROOMS whose telephone number is (571)272-3771. The examiner can normally be reached M-F 830-530. 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 Dunston can be reached on 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. /TIFFANY NICOLE GROOMS/Examiner, Art Unit 1637
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Prosecution Timeline

Show 10 earlier events
Jun 17, 2024
Non-Final Rejection mailed — §103, §DP
Dec 16, 2024
Response Filed
Feb 24, 2025
Final Rejection mailed — §103, §DP
Aug 14, 2025
Request for Continued Examination
Aug 15, 2025
Response after Non-Final Action
Aug 26, 2025
Non-Final Rejection mailed — §103, §DP
Feb 23, 2026
Response Filed
Jun 23, 2026
Final Rejection mailed — §103, §DP (current)

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Prosecution Projections

7-8
Expected OA Rounds
59%
Grant Probability
99%
With Interview (+45.8%)
3y 6m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 180 resolved cases by this examiner. Grant probability derived from career allowance rate.

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