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 .
Priority
Acknowledgment is made of applicant’s claim for priority based on a foreign application filed as GB 2003814.7 on 03/16/2020.
All claims are given the priority date of 03/16/2020.
Application Status
Receipt is acknowledged of amendment, filed 02/20/2026. Claims 1-28 are currently pending.
Election/Restriction
Applicant’s election without traverse of Group I, claims 1-12, 15, 18-25 and 27 in the reply filed on 02/20/2026 is acknowledged.
Claims 13, 14, 16, 17, 26 and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 02/20/2026.
Claims 1-12, 15, 18-25 and 27 are currently under examination.
Information Disclosure Statement
Receipt of acknowledgment of the information disclosure statement filed on 09/20/2022 has been received and all references have been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “CRISPR-cas editing” wherein “CRISPR” is an abbreviation. All abbreviations must be spelled out in the first instance with the abbreviation placed in parenthesis next to the term, such as “Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) cas editing”.
Appropriate correction is required.
Claims 4-12, 18-25 and 27 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claims. See MPEP § 608.01(n). Accordingly, the claims have not been further treated on the merits.
Therefore, only claims 1-3 will be further treated on the merits.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a process without significantly more. The claim(s) recite(s) a method of selecting one or more guide RNA sequences for use in CRISPR-Cas editing of a nucleic acid sequence.
Regarding claim 1, this claim recites at least one step, thus the claim is to a process, which is one of the statuary categories of the invention. However, the claim requires the step of identifying a plurality of guide RNA sequences. The step of identifying a plurality of guide RNA sequences falls into the category of “mental process”. Thus, the limitation in the step falls into the “mental process” grouping of abstract ideas and therefore, recites a judicial exception. This judicial exception is not integrated into a practical application because the claim recites an abstract idea.
Claim 1 recites additional steps, such as determining the frequency of editing outcomes for each of the plurality of guide RNA sequences; and selecting one or more guide RNA sequences for which the frequency of the most abundant editing outcome is determined to be at least 2-fold greater than the frequency of the second most abundant editing outcome. As such, these steps are merely data gathering steps after the mental process of selecting a plurality of guide RNA sequences without any limitations or steps of why and/or how the plurality of guide RNA sequences are selected, which do not add additional elements that are considered significantly more than the judicial exception. Accordingly, the additional limitations do not integrate the recited judicial exception into a practical application and the claim is directed to judicial exception.
When consider the claim as a whole, the judicial exception is not integrated into a practical application based on the analysis as discussed above. Therefore, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by of Rohatgi et al (WO 2019/232494 A2).
Regarding claims 1-3, Rohatgi teaches a plurality of modified cells can
be produced by contacting a plurality of cells with a subset of gRNAs generated by the
aforementioned methods for selecting a subset of guide RNAs (gRNAs) able to generate a
desired genotype in a target region of a genome, in combination with a targeted endonuclease, such as a Cas protein, and optionally a donor polynucleotide [0111 and 0114]. Rohatgi teaches the computer system is used to produce a probability distribution of editing outcomes, the input can be a sequence, wherein the sequence can be a sequence flanking a cut in a genome sequence by a targeted endonuclease, a sequence of a guide RNA, a sequence of a donor polynucleotide, a sequence of a desired editing outcome, or any combination thereof [0125]. Rohatgi teaches the computer system can comprise a computer readable medium for identifying a set of guide RNAs able to produce a desired genomic outcome in a genome in a sequence flanking the targeted endonuclease mediated cut [0115]. Rohatgi teaches that the editing outcome for the most abundant editing outcome is 55% whereas the editing outcome for the second most abundant editing outcome is 20% (Pages 60 and 61, Figs. 7A and 7B).
Conclusion
No claims are allowed.
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/ALEXANDRA ROSE LIPPOLIS/Examiner, Art Unit 1637
/CELINE X QIAN/Primary Examiner, Art Unit 1637
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