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 .
DETAILED ACTION
1. The Office acknowledges the receipt of Applicant’s Request for Continued Examination filed March 19, 2025. Claims 159, 162, 163, 165-167 and 169-178 are pending. Claims 172-178 are withdrawn. Claims 159, 162, 163, 165-167 and 169-171 are examined.
All previous rejections not set forth below have been withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Applicant’s has priority benefit of Provisional Application No. 62/942715, filed December 2, 2019.
Claim Objections
2. Claim 159 is objected to because of the following: in line 4, a comma should be inserted before the term “wherein”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
3. Claims 165-167 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.
In claim 165, the recitation of “the engineered circular guide RNA hybridized to the target RNA sequence” lacks antecedence. Claim 159 is directed to a circular guidance RNA comprising two components: (i) a targeting domain and ii) an additional secondary structure. The “hybridization” language in claim 159 describes the function of the targeting domain. Claim 165 implies that the circular guide RNA of claim 159 also comprises the target RNA sequence. Does Applicant intend for claim 165 to comprise at least three components?
In claim 165, the metes and bounds of “configured to recruit an RNA editing entity” are unclear. It is unclear how an engineered circular guide RNA structurally differs from a “configured” engineered circular guide RNA. How does one skilled in the art distinguish an unconfigured circular guide RNA from a configured circular guide RNA?
In claim 165, it is unclear what “recruit” constitutes. This term in not defined in Applicant’s disclosure. It is unclear how one skilled in the art can objectively determine that an RNA editing entity is recruited.
Dependent claims 166 and 167 are included.
Clarification and/or correction is required.
Claim Rejections - 35 USC § 112(a)
4. Claims 165-167 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The recitation of “configured to recruit an RNA editing entity” lacks adequate written description for the following reasons. With regard to the recitation of “configured”, there is inadequate written description with regard to the structural configuration of the engineered circular guide RNA in a manner that would recruit an RNA editing entity. There is no disclosure as to what circular guide RNA configuration, when hybridized to the target RNA sequence, would recruit which corresponding RNA editing entity. This configuration and RNA editing entity appear to be specific, however, the configuration and the RNA editing entity are not recited in the claims. There is no disclosure as to the structure of the RNA editing entity, e.g., whether it is a nucleotide sequence, enzyme, chemical compound, etc.
Accordingly, for the above reasons, the recitation of “configured to recruit an RNA editing entity” lacks adequate written description as commensurate in scope with the claims.
Claim Rejections - 35 USC § 102
5. Claims 159, 160, 162, 163, 165-167 and 169-171 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Zhang et al. (US Pub. No. 20190359971 (A)).
With regard to claim 159, Zhang teaches an engineered circular guide RNA [0373] for editing a nucleotide in a target RNA sequence, wherein the engineered circular guide RNA comprises a targeting domain that forms a secondary structure comprising a mismatch between the targeting domain and the target RNA sequence upon hybridization ([0435], [0072]), wherein the mismatch is created by positioning guanosine or cytosine opposite adenosine (converted to an iosine) present in the target RNA sequence ([0232], 0233]) and at least one additional secondary structure comprising one or more stem loops upon hybridization to a target RNA sequence [0020]. With regard to claim 162, the targeting domain forms a plurality of loops of 6-12 nucleotides created 30-40 base pairs apart, wherein the mismatch is located within the 30-40 base pair region (Fig. 43A, [0155]). With regard to claim 163, the targeting domain comprises a sequence length of 25 nucleotides or more in length [0059]. With regard to claim 165, ADAR enzyme (adenosine deaminase acting on RNA) is the RNA editing entity that edits the target RNA sequence [0232]. With regard to claim 166, the editing of the target RNA sequence results in at least a partial knockdown of the edited RNA sequence [0215]. With regard to claim 167, the editing of the target RNA sequence results in a sense codon read as a stop codon [0868]. With regard to claims 170-171, Zhang teaches a liposome delivery vehicle and diluent ([0623]-[0624]).
Accordingly, the claimed invention is anticipated by the prior art.
Conclusion
6. No claim is allowed. 7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG T BUI whose telephone number is (571)272-0793. The examiner can normally be reached M-F 8am-5pm.
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/PHUONG T BUI/Primary Examiner, Art Unit 1663
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