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 .
Claim Status
Claims 16-23 are pending and examined on the merits.
Factual Summary
The claims are drawn to a DNA molecule comprising SEQ ID NO:2, transgenic plants, plant products, and methods of using the products comprising said DNA molecule. SEQ ID NO:2 is nearly identical to the DNA from the well-known MON87701 transgenic locus but for a 7bp deletion near the 5’ insertion junction of the MON87701 event. Given the small deletion’s location, it is unlikely to have any impact of the two expression cassettes within the MON87701 transgenic locus.
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.
Claim(s) 16-23 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 Gao et al (US 8049071 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 MON87701 transgenic locus but for a 7bp deletion starting at position 2071. Instant, Table 1 of the specification makes clear that this site is basically at the 5’ genomic/transgenic junction site and thus is unlikely to have any impact of the expression cassettes within the MON87701 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 MON87701 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.
Gao et al teach soybean plants comprising the MON87701 transgenic locus. They teach that this event was isolated from a population of about 100 independent transgenic events, 42 of which were found to be single-copy and carried forward to F1 generation (Column 19-20). One hundred and fifteen of the F1 plants were screened for screened for insect resistance (Column 20). Southern blot analysis found what was later called the MON87701 locus to be free of vector backbone and the glyphosate resistance gene (Column 20). The ability to reliably support expression of the insecticidal proteins and the fact that this line was chosen as the best event line as being free of vector backbone support the idea that the MON87701 is a ”landing pad,” and thus would have been seen as a high quality site in the soybean genome to target for transgene integration. Further, given that lines having transgenic modifications at the MON87701 locus have already gone through regulatory approval, the MON87701 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 MON87701 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 MON87701 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 MON87701 locus having a deletion present in the 5’ flanking sequence would have been obvious over the cited prior art including instant SEQ ID NO:2.
There is no requirement that the absolute structural identity to be accounted for to render a claim obvious. This position is supported by the MPEP. Additionally, the position is supported by one of the inventors of the instant claims Dr. Michael Kock. MPEP 2144.05 (I.) state, “Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with prior art but are merely close. Titanium Metal Corp of America v. Banner 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)” This is analogous to the instant scenario as while SEQ ID NO:2 is not identical to the MON87701 transgenic locus of Gao et al, the structures are so similar that they are obvious variants of one another, especially given that the deletion is not a region of the locus that is known to not comprise either a gene or an expression control sequence. In fact, there is an argument to be made that that the claims should be rejected over Gao et al as single reference obviousness rejection. The writings of Inventor Kock support such a position which states, “as genome editing is considered part of the toolkit of the person skilled in the art, establishing an obvious variation (eg a different knock-out mutation for the same gene) should not satisfy the inventive step requirement solely because it has been made by an NGT (new genomic technique).” Left column of page 332 of Kim et al 2024 (GRUR International 73:4, p. 323-339).
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.
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/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
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