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
This Non-Final Office Action is responsive to the communication received 10/28/2022.
Claims 1-20 are pending.
Claims 1-20 are under examination in this Office Action.
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.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception, an abstract idea, without significantly more. Claims 2-20 depend directly or indirectly from claim 1.
The claim 1 limitations directed to mental processes are (e) selecting for edited cells comprising the integrated plasmid by screening for the desired phenotype or genotype.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim recites additional elements that consist of well understood, routine, conventional activity already engaged in by the scientific community.
The claim 1 limitations directed to well understood, routine, conventional activity already engaged in by the scientific community are (a) designing and synthesizing an editing cassette comprising a large donor DNA sequence, wherein the editing cassette further comprises a gRNA comprising homology to a target sequence in the cells; (b) inserting the editing cassette into a plasmid backbone resulting in an editing plasmid; (c) transforming the population of cells with editing plasmid; (d) allowing editing to take place in the population of cells to produce edited cells, wherein editing comprises integrating the editing plasmid into genomes of the population of cells. Liu et al. (4/2020) The CRISPER Journal volume 3 pages 97 to 108 (hereinafter known as "Liu") teaches (a) designing and synthesizing an editing cassette comprising a large donor DNA sequence, wherein the editing cassette further comprises a gRNA comprising homology to a target sequence in the cells; (b) inserting the editing cassette into a plasmid backbone resulting in an editing plasmid; (c) transforming the population of cells with editing plasmid; (d) allowing editing to take place in the population of cells to produce edited cells, wherein editing comprises integrating the editing plasmid into genomes of the population of cells (see entire document especially pages 98 to 102).
Claim Rejections - 35 USC § 102
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.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al. (4/2020) The CRISPER Journal volume 3 pages 97 to 108 (hereinafter known as "Liu").
With regards to claims 1-20, Liu teaches:
a) as in claims 1-20, a method for insertion of large DNA sequences into a population of cells and identifying cells with a desired phenotype or genotype comprising the steps of: (a) designing and synthesizing an editing cassette comprising a large donor DNA sequence, wherein the editing cassette further comprises a gRNA comprising homology to a target sequence in the cells; (b) inserting the editing cassette into a plasmid backbone resulting in an editing plasmid; (c) transforming the population of cells with editing plasmid; (d) allowing editing to take place in the population of cells to produce edited cells, wherein editing comprises integrating the editing plasmid into genomes of the population of cells; and (e) selecting for edited cells comprising the integrated plasmid by screening for the desired phenotype or genotype; wherein the editing cassette or the plasmid backbone further comprises a coding sequence for a nuclease and one or more promoters driving transcription of the coding sequence for the nuclease; wherein the nuclease is MAD7; wherein the target sequence is a neutral integration site in the genomes of the cells; wherein the editing cassette further comprises a barcode sequence corresponding to the large donor DNA sequence; wherein the editing cassette further comprises a selectable marker sequence and one or more promoters driving transcription of the editing cassette and/or the selectable marker sequence, and wherein the method further comprises a selection step between the transforming and allowing steps; wherein the editing cassette further comprises an amplification priming site at a 3′ end of the editing cassette; wherein the plasmid backbone further comprises a selectable marker sequence and one or more promoters driving transcription of the selectable marker sequence, and wherein the method further comprises a selection step between the transforming and allowing steps; wherein the plasmid backbone further comprises a barcode sequence corresponding to the plasmid backbone; wherein the large donor DNA sequence is from 500 bp to 50 Kb in length; wherein the large donor DNA sequence comprises one or more endogenous genes; wherein the editing cassette or the plasmid backbone further comprises a landing pad; further comprising: (i) transforming the edited cells with a vector carrying an additional large donor DNA sequence, wherein the vector carrying the additional large donor DNA sequence further comprises a coding sequence for a recombinase or a meganuclease under control of an inducible promoter; (ii) inducing expression of the recombinase or meganuclease to insert the additional large donor DNA sequence into the landing pad; and (iii) screening for cells comprising the desired phenotype or genotype; wherein the vector carrying the additional large donor DNA sequence further comprise a selectable marker and the method further comprises a selection step between the transforming and inducing steps; wherein the vector carrying the additional large donor DNA sequence is another editing plasmid; wherein the cells are microbial cells; wherein the cells are bacterial cells; wherein the cells are Escherichia coli cells; wherein the cells are mammalian cells (see entire document especially pages 98 to 102).
Thus, Liu anticipates the present claims.
Conclusion
No claim is allowed.
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/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684