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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 26 November 2025 has been entered.
Claim Status
Claims 23-25 are pending and examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 26 November 2025 is being considered by the Examiner.
Factual Summary
The claims are drawn to a DNA molecule comprising SEQ ID NO:2, transgenic plant products or biological samples comprising said DNA molecule. SEQ ID NO:2 is nearly identical to the DNA from the well-known MON89034 transgenic locus but for a 7bp deletion starting at position 2071. Table 1 of the specification makes clear that this site is 10bp 3’ of the 5’ genomic/transgenic junction site and still within a junction region and thus is unlikely to have any impact of the two expression cassettes within the MON89034 transgenic locus. It is noted that the examples within the instant specification say nothing about creating any deletion alleles, nor do they provide any statement or data regarding the function of the different disclosed deletion alleles. A multiple sequence alignment of the variable region of the 8 different reported deletion alleles is provide below. SEQ ID NO:2 has the shortest deletion, only 7bp. SEQ ID NOs: 30 and 31 are identical, so it unclear why they are listed as two different sequences. SEQ ID NOs: 26 and 27 have the largest deletions of greater than 60bp. All deletion sizes are reported relative to the full-length insert of MON89034 (instant SEQ ID NO:1). To reiterate, there is no statement or data provided to demonstrate that the claimed SEQ ID NO:2 is functionally any different or superior to any of the other deletion alleles set forth in SEQ ID NOs:26-30/31.
PNG
media_image1.png
286
524
media_image1.png
Greyscale
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Danilo et al 2018 (PLOS One 13:12 p. 1-14), De Framond et al (WO2010/077816), and further in view of Anderson et al (US 9428765 B2).
The claims are drawn to a DNA molecule comprising SEQ ID NO:2, transgenic plant products or biological samples comprising said DNA molecule. SEQ ID NO:2 is nearly identical to the DNA from the well-known MON89034 transgenic locus but for a 7bp deletion starting at position 2071. Instant, Table 1 of the specification makes clear that this site is 10bp 3’ of the 5’ genomic/transgenic junction site and still within a junction region and thus is unlikely to have any impact of the two expression cassettes within the MON89034 transgenic locus
Danilo et al teach creation of a landing pad in tomato that can be used for CRISPR/Cas-mediated insertion of transgenes of interest via homology-directed repair. The landing pad is created by targeted deletion of a region in dfr gene which results in a unique DNA segment that to be targeted.
Danilo et al do not teach to modify the MON89034 locus in maize to arrive at instant SEQ ID NO:2 or an obvious equivalent thereof.
De Framond et al teach corn plants comprising transgenic event 5307 which also comprises transgenes encoding insecticidal proteins. In Example 8, De Framond et al teach targeted modification of the 5307 event locus for insertion of transgenes including in the 5’ flanking sequence of the event.
Anderson et al teach corn plants comprising the MON89034 transgenic locus. They teach that this event was isolated from a population of at least about 23,000 independent transgenic events. They events were then screened for resistance to insect feeding and screened for an absence of undesirable phenotypic and agronomic traits (Example 1). The ability to reliably support expression of the insecticidal proteins and the fact that this line was chosen as the best event line out at least about 23,000 independent events supports the conclusion that the MON89034 is a ”landing pad,” and thus would have been seen as a high quality site in the maize genome to target for transgene integration. Further, given that lines having transgenic modifications at the MON89034 have already gone through regulatory, the MON89034 would be an even more attractive option for further targeted modification.
At the time of filing, it would have been prima facie obvious for a person of ordinary skill in the art to modify the 5’ flank (as taught by De Framond) of the MON89034 locus in maize which can then be used as a landing pad for subsequent integration of transgenes into a site that reliably supports expression of transgenes and has already been approved via many regulatory processes. After initial deletion of MON89034 to create a unique landing pad (as taught by Danilo) and said deletion being at the 5’ flanking sequence would leave a person of ordinary skill in the art at a locus very much like instant SEQ ID NO:2. Absent any evidence to the contrary, the position of The Office is that variants of the MON89034 locus having deletions present in the 5’ flanking sequence would have been obvious over the cited prior art including instant SEQ ID NO:2. Again, it is noted that there is no statement or data provided to demonstrate that the claimed SEQ ID NO:2 is functionally any different or superior to any of the other deletion alleles set forth in SEQ ID NOs:26-30/31. Additionally, the disclosed examples do not even discuss deletions of any kind.
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