Detailed action
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1, 2 and 9 are amended.
Claims 1-2, 5-6, 9, 15-18, 20, 24, 26 and 42-44 are pending and examined.
Claim Rejections - 35 USC § 112
Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 5-6, 9, 15-18, 20, 24, 26 and 42-44 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This rejection has been modified from the rejection of claims 1-2, 5-6, 9, 15-18, 20, 24, 26 and 42-44 as applied in the Non-Final Rejection filed 11/10/2026 in response to amendments made by Applicant.
Applicant claims a modified corn plant comprising a mutant allele of the endogenous GA20 oxidase_5 (GA20ox5) wherein the mutant allele produces an RNA molecule comprising an antisense sequence complimentary to at least part of the sense strand of the GA20ox5 gene causing suppression of the endogenous GA20ox5 locus wherein an embodiment of the mutant allele comprises: (a) a genome modification of a deletion of at least a portion of the transcription termination sequence of the SAMT gene and the entire intergenic region between the ZmSAMT and GA20ox5 genes or (b) a deletion of at least a portion of the GA20ox5 gene and the entire intergenic region between the GA20ox5 and SAMT genes wherein the endogenous GA20ox5 gene shares at least 95% identity to nucleotides 399-2871 of SEQ ID NO: 9 and the endogenous ZmSAMT gene shares at least 95% identity to nucleotides 297-5026 of SEQ ID NO: 10 (claim 1).
Claim 2 specifies that the mutant allele includes deletion of at least a portion of the transcription termination sequence of the ZmSAMT gene and at least a portion of the endogenous GA20ox5 gene and the entire intergenic region between the two.
Claim 5 requires that the mutant allele of claim 1 comprises the endogenous SAMT gene promoter or portion thereof operably linked to a transcribable DNA sequence encoding an RNA molecule that is at least 95% complementary to all or part of the endogenous GA20ox5 gene.
Claim 6 specifies that the transcribable DNA sequence of claim 5 is at least 95% complementary to (a) a portion of an RNA transcript sequence encoded by the GA20ox5 gene, (b and c) at least 15 nucleotides of a Markush group of sequences.
Claim 9 requires that the modification of claim 1 further deletes at least: (i) a portion of the transcription termination sequence of the GA20ox5 gene or (ii) one or both of the transcription termination sequences of the GA20ox5 and SAMT genes.
Claim 15 requires that the mutant allele of claim 1 produces an RNA molecule comprising an antisense sequence that is at least 95% complementary to an RNA transcript sequence or a portion thereof encoded by the endogenous GA20ox5 gene.
Claim 16 and 17 require the RNA transcript sequence is at least 95% identical to at least 15 consecutive nucleotides of a Markush group of sequences.
Claim 18 requires that the antisense sequence of the RNA molecule of claim 1 is at least 95% complementary to at least 15 consecutive nucleotides of a Markush group of sequences.
Claim 20 requires that the genome modification of claim 1 results in the production of an RNA molecule comprising an antisense sequence from a genomic region selected from any exon, portion of any intron or portion of any UTR of the GA20ox5 locus.
Claim 24 requires that the sense RNA transcript of claim 1 encoded by the mutant allele of the GA20ox5 gene is truncated compared to a wild-type allele of the GA20ox5 gene.
Claim 26 requires that the genome modification of claim 1 comprises at least two non-contiguous deletions.
Claim 42 requires that the corn plant of claim 1 is homozygous for the mutant allele at the GA20ox5 locus.
Claim 43 requires that the corn plant of claim 1 is heterozygous for the mutant allele at the GA20ox5 locus.
An embodiment of claim 44 requires that the corn plant of claim 1 has a shorter plant height or improved lodging resistance relative to an unmodified plant.
Applicant describes a corn plant wherein a portion of a maize GA20ox5 and/or SAMT in addition to the intergenic region between the genes was deleted by transformation with one of three vector constructs (Tables 3-5). Applicant describes three vector constructs and their targets, each of which comprises at least a portion of both a GA20ox5 and SAMT gene (Table 3). Applicant describes deletion edits in R0 and R1 corn plants, each of which encompasses a portion of both the GA20ox5 and SAMT gene (Table 5). Applicant describes plants comprising the deletions comprising a reduction in height (Tables 6 and 7). Applicant describes the structures of each gene and intergenic region in Table 2. Applicant does not describe the genus of plants as broadly claimed. Applicant has not described a representative number of a corn plant comprising a of genome modification wherein the mutant allele encompasses the entire GA20ox5 gene being deleted or other embodiments wherein the portion deleted may not effectively produce an antisense sequence capable of downregulating GA20ox5.
The only structures described are specific deletions encompassing the entire interspecific space between the GA20ox5 gene and SAMT gene and portions of each the GA20ox5 gene and SAMT gene (Tables 6 and 7). Given the breadth of the genera encompassed by the claims, the described species are not sufficiently representative. It is not clear how, for example, the entirety of the GA20ox5 sequence could be deleted while still resulting in production of an antisense sequence that downregulates GA20ox5. Applicant has not set forth the requisite structure-function relationship for the genus of a deletion of any portion, including the entirety of the GA20ox5 gene wherein said structure is necessary and sufficient to produce an antisense sequence complementary to the GA20ox5 gene. The only structures provided by Applicant encompass deletions of a portion of the GA20ox5 gene. Dependent claims 2, 5-6, 9, 15-18, 20, 24, 26 and 42-44 do not narrow the scope of the claimed invention such that one of ordinary skill in the art would recognize Applicant to have been in possession of the full scope of the claimed invention.
Applicant’s arguments regarding rejection under 35 USC 112(a)
Applicant's arguments filed 2/9/2026 have been fully considered but they are not persuasive.
Applicant argues on pages 7-8 of the Remarks filed 2/9/2026 that the claims are fully supported by the Specification because the claims have been amended to require that the entire intergenic region between the GA20ox5 and ZmSAMT genes be deleted and at least a portion of the GA20ox5 gene. Applicant argues that one of ordinary skill in the art would have recognized Applicant to have been in full possession of the scope of the claimed invention because the Specification provides in paragraph 162 that deletion of the intergenic region will bring the oppositely oriented ZmSAMT gene promoter in closer proximity to the GA20ox5 gene such that the ZmSAMT gene promoter can drive the expression of an antisense RNA transcript that reads through at least a portion of the GA20ox5 gene. Applicant notes that Table 2 provides annotations of genomic sequence elements of the gene regions which one of ordinary skill in the art could use to predict effective modifications according to the claims.
This argument has been fully considered but it is not persuasive. While it is acknowledged that one of ordinary skill in the art would be able to determine how to effectively delete a portion of the ZmSAMT such that the transcription termination sequence is sufficiently disrupted in order to allow for the antisense sequence of the Ga20ox5 to be produced, the scope of the claims encompasses deletion of the entirety of the Ga20ox5 gene because it is drawn to at least a portion. It is also acknowledged that one of ordinary skill in the art would recognize that a deletion of any portion of the Ga20ox5 would not be necessary given that the production of the antisense sequence is reliant on the presence of the Ga20ox5 coding region to be used as a template. Therefore, if Applicant wishes for a portion of the Ga20ox5 sequence to be deleted, Applicant may consider drawing the scope of the claim to require a minimum portion of the Ga20ox5 to be maintained such that an effective antisense sequence would be produced to downregulate Ga20ox5.
Closest Prior Art
The closest prior art is Allen (US20180051295), which teaches a corn plant comprising a recombinant DNA construct comprising a transcribable DNA sequence encoding a non-coding RNA molecule, wherein the non-coding RNA molecule comprises a targeting sequence encoding an endogenous GA20 oxidase protein in a monocot wherein the nucleotide is selected from a Markush group of sequences including SEQ ID NO: 9 (Claim 136). Allen teaches that protein SEQ ID NO: 9 is encoded by SEQ ID NO: 7 (Table 1). Instant SEQ ID NO: 5 shares 100% identity with several 15nt regions with SEQ ID NO: 7 taught by Allen. The prior art does not teach a sequence with at least 90% identity to nucleotides 1-3180 of instant SEQ ID NO: 9 nor a sequence with at least 90% identity to nucleotides 1-5331 of instant SEQ ID NO: 10.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 DAVID R BYRNES whose telephone number is (571)270-3935. The examiner can normally be reached 9:00 - 5:00 M-F.
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, Bratislav Stankovic can be reached at (571) 270-0305. 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.
/DAVID R BYRNES/Examiner, Art Unit 1662
Prosecution Insights