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 .
It is noted that Examiner for the present application has been changed. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Examiner Masudur Rahman.
Claim status
To expediting the prosecution, in this office action, examiner is pursuing the claims filed on 09/01/2023, in which applicant claims 1-16. Therefore, claims 1-16 are herein pending.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-6, drawn to method of obtaining a cell. in the reply filed on 19 February 2026 is acknowledged.
Claims 7-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-6 are under current examination.
Priority
This application was filed 09/01/2023 and is a 371 application of PCT/JP2022/008713 filed on 03/02/2022, which claims benefit to the foreign application JP2021-033658 filed on 03/03/2021.
Filing of a certified untranslated copy of the JP2021-033658, filed 09/01/2023 is acknowledged. MPEP 2304.01(c) states: Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action, 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Thus, the earliest possible priority for the instant application is 03/02/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/01/2023 and 05/29/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner and the signed and initialed PTO Forms 1449 are mailed with this action.
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.
Anticipated by Takeda et al.
Claim 1-5 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takeda et al., (US20080104723A1, cited in IDS filed 09/01/2023; hereinafter “Takeda”).
Regarding claims 1-4, Takeda describes a method of modifying a genome in a cell, said the cell comprises genomic DNA, wherein method comprising the steps of: A) providing a nucleic acid construct containing an LTR-type retrotransposon and a promoter; B) introducing said nucleic acid construct into said cell; C) culturing said cell for a predetermined period of time; and D) selecting a cell with a genome that has been modified by said nucleic acid construct. Takeda further states the following: that the aforementioned nucleic acid construct contains a foreign gene located in an operable manner in the aforementioned retrotransposon; that the aforementioned selection is achieved by the expression of said foreign gene; and that the aforementioned cell belongs to the same species as that of the natural host of the retrotransposon (claims 32, 35, 43 and 48). Takeda further states the nucleotide sequence to be introduced in the modifying genome preferably at least about 98% identity sequence identity to any one of the nucleotide sequences of the retrotransposons. [0285]-[0286].
Takeda states the following: that any sequence can serve as the retrotransposon sequence; that a variety of nucleic acid sequences can be inserted into the portion that is to be sandwiched by retrotransposon sequences; that when performing genome modification, not only a modification in the vicinity of the target, but also the effect of said modification is also attained, namely, that the modification can be inserted into the entire genome in an exhaustive manner or universal manner [0109], [0111], [0114], [0236].
Regarding claim 5, Takeda teaches that the nucleotide sequence to be newly introduce is identical to any one of the nucleotide sequences of the retrotransposons in the genomic DNA [0284].
Accordingly, Takeda anticipates the instant claims 1-5.
Anticipated by Masumoto et al.
Claim 1-6 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Masumoto et al., (JP2018191561A, attached the EPO translated copy; cited in IDS filed 09/01/2023; hereinafter “Masumoto”).
Regarding claims 1-6, Masumoto discloses a method of inserting foreign DNA into two or more sites of genomic DNA, said method comprising the insertion of a foreign DNA sequence into two or more copies of a nucleotide sequence of at least 200 bp contained in genomic double-stranded DNA wherein, in a host cell with two or more copies of said genomic double-stranded DNA containing said nucleotide sequence of at least 200 bp, (1) said genomic double-stranded DNA and (2) a donor DNA comprising both a nucleotide sequence homologous with said nucleotide sequence of at least 200 bp or a partial sequence thereof and a foreign DNA sequence are brought into contact with a nuclease that binds specifically to a selected target sequence within the nucleotide sequence of at least 200 bp and cleaves the DNA in said target sequence, thereby allowing homologous recombination between the nucleotide sequence of at least 200 bp in said genomic double-stranded DNA and the homologous sequence or partial sequence thereof contained in said donor DNA, and resulting in the insertion of the foreign DNA sequence into said two or more copies of the nucleotide sequence of at least 200 bp in the genomic double-stranded DNA, and the homologous nucleotide sequence has both sufficient sequence identity and length to bring about homologous recombination if the DNA in the target nucleotide sequence of at least 200 bp in the genomic DNA is cleaved. Masumoto further states that said nucleotide sequence of at least 200 bp is a retrotransposon (100% identity to the retrotransposons) (claims 1-2, and 11, [0018] of English translation copy). Moreover, Masumoto states that said donor DNA can also contain an optional marker gene for selecting a transformant wherein the foreign DNA has been inserted into the genome ([0049] of translated copy).
Accordingly, Masumoto anticipates the instant claims 1-6.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is (571)272-0196. The examiner can normally be reached M-F 8-5 (EST).
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, Christopher Babic can be reached on (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684
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