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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 29, 2026 has been entered.
Claim Status
Claims 1-2, 7, 13-14, 16-17, 21, 27, 29, 33-38, 40-41 and 44-46 are pending.
Claims 12 and 20 are newly cancelled.
Claims 16-17, 33-38, 40-41 and 44-46 remain withdrawn as drawn to an unelected invention.
Claims 1-2, 7, 13 and 21 are newly amended.
Claims 1-2, 7, 13-14, 21, 27 and 29 are examined on the merits.
Response to Applicant Arguments – Indefiniteness
In response to Applicant’s arguments and amendments to the claims dated 01/29/2026 the indefiniteness rejections of record are withdrawn.
Response to Applicant Arguments – Enablement
In response to Applicant’s arguments and amendments to the claims dated 01/29/2026 the enablement rejections of record are withdrawn.
Claim Rejections - 35 USC § 112 (Indefiniteness)
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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “said first nucleic acid sequence comprises a sequence having at least 50% sequence identity to a nucleic acid sequence corresponding to a mautre sequence of a miRNA molecule” in part iv. of the claim, and the claim also recites “said first nucleic acid sequence exhibits 60-99.99% sequence identity with respect to a second nucleic acid sequence encoding a miRNA molecule egaged with an RNA-induced silencing complex (RISC)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 2, 7, 13-14, 21, 27 and 29 are rejected as depending on an indefinite claim and failing to limit the scope of the claim to definite subject matter.
In order to ensure compact prosecution the claim is interpreted to require only section i, and section iv. is not considered.
In claim 13, the recitation of “said miRNA molecule” renders the claim indefinite because there are two distinct recitations of miRNA molecules in claim 1, a first in the first line of the claim and a second in the second line of part i. Therefore, there are at least two different scopes of the claim, one where “said miRNA” in claim 13 further limits one miRNA molecule from claim 1 and a second where “said miRNA” in claim 13 further limits the other recitation from claim 1. As such claim 13 is rejected as indefinite and claims 27 and 29 are rejected for depending on an indefinite claim and failing to limit the scope of the claim to definite subject matter.
In order to ensure compact prosecution, “said miRNA molecule” in claim 13 is interpreted to refer to :=”a microRNA (miRNA) molecule” in line 1 of claim 1.
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.
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.
Applicant’s amendment to the claims filed on 01/29/2026 has necessitated this new ground of rejection. Specifically, the amendments to the claims to add limitations drawn to processing of nucleic acids and modifications of nucleic acid sequences. This amendment requires a new analysis to appropriately address these limitations. Accordingly, new art rejections are presented below.
Claims 1-2, 7, 13-14, 21, 27 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Maori, US 2020/0270604 with earliest priority date of September 19, 2017.
With respect to claim 1, Maori teaches methods of generating a microRNA (miRNA) having a silencing activity in a cell.
Specifically, Maori teaches methods of modifying a gene encoding or processed into a non-coding RNA molecule having no RNA silencing activity in a eukaryotic cell through the use of DNA editing agents to confer a silencing specificity onto the modified RNA molecule (Maori, Page 2, Paragraph 0013). Later, Maori teaches that the non-coding RNA molecule is processed into a miRNA (Maori, Page 9, Paragraph 0163).
Therefore, Maori teaches identifying a first nucleic acid sequence (gene encoding a non-coding RNA molecule) which is modified to generate a miRNA.
Additionally, Maori teaches that the first nucleic acid sequence is transcribable (Maori, Page 10, Paragraphs 0189-0190).
Maori, teaches that the first nucleic acid sequence does not have silencing activity and therefore is aberrantly processed as compared to the canonical processing of a second nucleic acid sequence encoding a miRNA molecule engaged with an RNA-induced silencing complex (RISC) (Maori, Page 2, Paragraph 0013).
Maori teaches modifying the first nucleic acid sequence to impart silencing activity by modifying it for processing into a miRNA (Maori, Page 2, Paragraph 0013; Maori, Page 10, Paragraph 0210). This concept is illustrated in paragraph 0081 on pages 4-5 of the specification and in Figure 12C.
Maori teaches that these modified nucleic acid sequences can then be processed into small RNAs that are engaged with the RISC and have silencing activity in the cell (Maori, Page 9, Paragraph 0167). Specifically, Maori teaches that the first nucleic acid molecule can be modified into a miRNA (Maori, Page 9, Paragraph 0163) and further that miRNAs become incorporated as a single-stranded RNA into the RISC (Maori, Page 9, Paragraph 0167).
Finally, Maori teaches that these modifications are introduced through the use of a DNA editing agent including a gRNA and a donor oligonucleotide (Maori, Page 13, Paragraphs 0244-0245; Maori, Page 14, Paragraph 0258).
With respect to claim 1, Maori does not explicitly teach a first nucleic acid sequence which exhibits 60-99.99% sequence identity with respect to a second nucleic acid sequence encoding a miRNA molecule engaged with RISC.
Given the teachings of Maori it would have been obvious at the time of filing to modify the method of Maori to use first nucleic acids which have at least 60% sequence identity to a nucleic acid sequence encoding a miRNA molecule engaged with RISC. This would have been obvious because those sequences with higher levels of identity to the target sequence; a miRNA engaged with RISC and having silencing activity, would require fewer modifications to confer the silencing activity and therefore would be easier to add this characteristic to.
This would have been motivating to the ordinary artisan because it would allow for an easier and more efficient methods of conferring silencing activity to the first nucleic acid molecules. As such claim 1 is rejected as obvious under Maori.
With respect to claim 2, Maori teaches all of the limitations of claim 1 taught above, see above.
Further, Maori teaches modifying the nucleic acid sequences allows for processing into small RNAs that are engaged with the RISC and have silencing activity in the cell (Maori, Page 9, Paragraph 0167). Specifically, Maori teaches that the first nucleic acid molecule can be modified into a miRNA (Maori, Page 9, Paragraph 0163) and further that miRNAs become incorporated as a single-stranded RNA into the RISC (Maori, Page 9, Paragraph 0167). Therefore, Maori teaches canonical processing of said RNA molecule.
With respect to claim 7, Maori teaches all of the limitations of claim 1 taught above, see above.
Further, Maori teaches multiple sequence alignment to determine sequence complementarity or identity and further that the processing is effected by Dicer nucleases (Maori, Page 11, Paragraph 0208; Maori, Page 9, Paragraphs 0164-0166).
With respect to claim 13, Maori teaches all of the limitations of claim 1 taught above, see above.
Further, Maori teaches redirecting a silencing activity of a non-coding RNA (RNA silencing molecule) towards a non-natural target of the non-coding RNA (Maori, Page 11, Paragraph 0196).
With respect to claim 14, Maori teaches all of the limitations of claim 1 taught above, see above.
With respect to claim 21, Maori teaches all of the limitations of claim 1 taught above, see above.
Further, Maori teaches that the DNA editing agent is a Crispr Associated nuclease (Cas9) (Maori, Page 13, Paragraph 0245).
With respect to claim 27, Maori teaches all of the limitations of claim 13 taught above, see above.
Further, Maori teaches that the target RNA molecule is an exogenous target RNA (Maori, Page 11, Paragraph 0204).
With respect to claim 29, Maori teaches all of the limitations of claim 13 taught above, see above.
Further, Maori teaches said cell is a eukaryotic cell (Maori, Abstract).
With respect to claims 2, 7, 13-14, 21, 27 and 29 Maori does not explicitly teach a first nucleic acid sequence which is homologous to a miRNA molecule.
Given the teachings of Maori it would have been obvious at the time of filing to modify the method of Maori to use first nucleic acids which are homologous to a miRNA molecule. This would have been obvious because those sequences with higher levels of identity to a second nucleic acid sequence encoding a miRNA molecule, would require fewer modifications to confer the silencing activity and therefore would be easier to add this characteristic to. Those sequence with homology to miRNA but which are not processed into miRNAs would require the least modification to produce a molecule capable of processing into miRNAs.
This would have been motivating to the ordinary artisan because it would allow for an easier and more efficient methods of conferring silencing activity to the first nucleic acid molecules. As such claims 2, 7, 13-14, 21, 27 and 29 are rejected as obvious under Maori.
Conclusion
All examined claims are rejected.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN JAMES SULLIVAN whose telephone number is (571)272-0561. The examiner can normally be reached 7:30 to 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on (571)270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN JAMES SULLIVAN/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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