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 23-25 are pending and examined on the merits.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 6 March 2026, 11 March 2026, 23 April 2026, 29 April 2026, 4 May 2026, 17 June 2026 are 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.
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Response to Interview Summary
As indicated in their interview summary contained in the response filed 22 June 2026, Applicant filed a Request for Continuing Examination after allowance submitted with an IDS. Applicant clearly thought that these references in the IDS were potentially important to patentability otherwise they simply would have paid their issue fee. Among these references were three office actions for related cases that contained obviousness rejections. Upon reading these rejections, the Examiner determined that such rejections should be raised against the instant claims. When Applicant withdraws a case from issue and requests continuing examination, new rejections are always a possibility, so it unclear to the Examiner why Applicant continues to state in the interview, interview summary, and arguments that the obviousness rejection of record uses references that were previously submitted via IDS. Especially, given that Applicant states, “Applicant acknowledges that prosecution was properly reopened following the Request for Continued Examination,” on page 10 of their remarks filed 22 June 2026. Applicant further acknowledges that the Examiner suggested that evidence be provided to demonstrate a functional difference of advantage of SEQ ID NO:2 compared to the other disclosed deletion alleles (see Factual Summary above) be provided to overcome the obviousness rejection of record. No such data are of record, nor has any been
submitted in the response filed 22 June 2026.
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 remain 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. The 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 approval, 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.
Response to Arguments - Claim Rejections - 35 USC § 103
Applicant's arguments filed 22 June 2026 have been fully considered but they are not persuasive.
Many of Applicant’s arguments do not amount to more than piecemeal analysis. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Additionally, Applicant’s position appears to be that instant claims are not obvious, because there is nothing in the prior art that would directly lead a person of ordinary skill in the art to arrive at SEQ ID NO:2.
This is not persuasive. There is not 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 MON89034 transgenic locus of Anderson 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 Anderson 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. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
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