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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 29 June 2026 is acknowledged. The traversal is on the ground(s) that the claims of group II depend from Group I and inherently overlap in between the groups. Searching would necessarily identify art relevant to the detection nucleic acids of claims 8-9 since the incorporate the DNA molecule of claim 5. This is not found persuasive, because as written, there is no requirement that the nucleic acid molecule adapted for detection comprises any portion of the DNA molecule of claim 5. It simply could detect a part of the sequence that is 5’ or 3’ to SEQ ID NO:20 in whatever context SEQ ID NO:20 happens to be in. Note that there is no limitation in claim 5 which requires that the SEQ ID NO:20 needs to be present in a specific context. This means that the structure of claims 8-9 is essentially unlimited. If the claims are required specifically comprise a fragment of the complement of SEQ ID NO:20, then it would be limited as Applicant is arguing, but as written, it is not limited as such.
The requirement is still deemed proper and is therefore made FINAL.
Claims 8-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 29 June 2026.
Applicant’s election of SEQ ID NO:20 in the reply filed on 29 June 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Status
Claims 5-9 are pending.
Claims 8-9 are withdrawn from consideration.
Claims 5-7 are examined on the merits.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diehn et al (US8575434), and further in view of Cui et al (US 9540655), Finnigan et al (2016, Genes, Genomes, Genetics 6:2147-2156), and Čermák (US 2020/0407754).
The claims are drawn to DNA molecules, processed transgenic maize products, and biological samples comprising SEQ ID NO:20. Note that seeds removed from the cob could be considered both processed products and biological samples.
Diehn et al teach DNA that make up and maize plants and plant parts comprising Maize event DP-004114-3. Maize event DP-004114-3 differs instant SEQ ID NO:20 only by the absence of the CgRRS, which is a 27 bp insertion that introduces another Cas endonuclease site close to the 3’ insertion junction that matches a Cas endonuclease site close to the 5’ insertion junction. This allows for excising the event locus with a single gRNA/Cas complex.
Cui et al teach it is desirable to excise polynucleotide sequence from a transgenic event using a zinc finger nuclease to remove polynucleotide consisting of a gene expression cassette, from chromosomally integrated transgenic event, where the polynucleotide removed can be a selectable marker, whereupon excision and removal of a polynucleotide sequence the modified transgenic event can be retargeted by the insertion of a polynucleotide sequence. The excision of a polynucleotide sequence and subsequent retargeting of the modified transgenic event provides advantages such as re-use of a selectable marker or the ability to overcome unintended changes to the plant transcriptome which results from the expression of specific genes (column 16, lines 1-16).
Finnigan et al teach a method of excising any genomic locus of interest in yeast; a unique target sequence plus a PAM is integrated upstream and downstream of the locus of interest, and a gene cassette expressing Cas9 and one expressing a single sgRNA matching the target sequence are introduced into the genome, resulting in the excising on the locus of interest (pg 2149, right column, paragraph 2). Finnigan et al teach that the target sequence should not have a counterpart in the genome of the target organism (pg 2149, right column, paragraph 2). Finnigan et al teach that flanking any number of selected genes with the same unique target sequence expression of just a single sgRNA initiates Cas9-mediated removal and scarless replacement and excision of these targeted genes (page 2151, right column, paragraph 4). Finnigan et al teach that the method allows repeated targeting of any given locus (paragraph spanning pg 2153-2154). Finnigan et al teach that the method could be applied to any organism in which CRISPR cas9 methodology is being used (abstract).
Čermák teaches a method for insertion of up to at least a 42 base pair sequence into a plant genome at a desired region (examples 1, 2) using a donor plasmid comprising 600-800 bp regions flanking the insertion sequence, where the 600-800 bp regions match the genomic sequence flanking the desired insertion site (paragraph 265). The method uses nucleic acids encoding Cas nucleases and a construct encoding a guide RNA complementary to the sequences adjacent to the insertion site, thus targeting the insertion to the desired site (paragraph 267-269). Čermák teaches ways to increase the proportion of desired editing events (paragraph 271-272) and that the method can be used in any plant, including soybean and maize (paragraph 217).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the maize plants comprising event DP-004114-3, taught by Diehn et al, to enable deletion of the event using single sgRNA and the CRISPR Cas system, as taught by Finnigan et al in yeast. One of ordinary skill in the art would have been motivated to do so because Cui et al suggest excising all or a portion of the transgenic insert and/or flanking sequences of event DP-004114-3, then targeting another insert to the chromosomal site of event DP-004114-3 (column 4, line 52, to column 5, line 10). Having Cas target sites at approximately the 5’ and 3’ junctions would allow Cui et al’s suggested excision of the transgenic event insert.
One of ordinary skill in the art would then adapt Čermák’s method of inserting DNA sequences into a genomic site of interest to introduce the CgRRS close to the 3’ junction of a maize plant with the event. The exact placement is a mere design choice, and one of ordinary skill in the art could thus reasonably choose to place it a similar distance from the event as the 5’ targeting sequence is. Accordingly, claims 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diehn et al, and further in view of Cui et al, Finnigan et al, and Čermák.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R KEOGH whose telephone number is (571)272-2960. The examiner can normally be reached M-Th 7-4:30, half day on Fridays.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
Prosecution Insights