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 1, 3-4 and 11-15 are pending.
Claims 2 and 5-10 are canceled.
Claims 1, 3-4 and 11-15 are examined in the instant application.
All previous rejections not set forth below have been withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendments
6. Objections withdrawn from action:
The drawing objections are withdrawn.
The specification objections are withdrawn.
The claim objections are withdrawn.
Rejections withdrawn from action:
The rejection for claims 1 and 3-7, under 101 is withdrawn in view of amendment, because the claims require generating, backcrossing, and selecting a ZmNPF6.8 knockout.
The rejection for claims 1-10, under 112(a) Written Description is withdrawn in view of amendment, because the Applicant limited the claims to SEQ ID NO: 1-3.
The rejection for claims 1-10, under 112(a) Enablement is withdrawn in view of amendment, because the Applicant limited the claims to SEQ ID NO: 1-3.
The rejection for claims 3, 6, and 8, under 112(b) is withdrawn in view of amendment, because Applicant removed “homology” and “strong” making the claims definite.
The rejection for claim 1, under 102 is withdrawn in view of amendment, because Jia does not disclose on generating a ZmNPF6.8 knockout to decrease nitrogen uptake.
The rejection for claims 1 and 3-7, under 102 is withdrawn in view of amendment, because Allen does not specifically disclose on generating a ZmNPF6.8 knockout to decrease nitrogen uptake.
The 103 has been added in light of the claim amendments.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-4, and 11-15, are rejected under 35 U.S.C. 103 as being unpatentable over Allen et al., (US 20160010101 A1 (previously cited)).
In regard to claims 1 and 14, Allen teaches ZmNRT1.3 (Zea mays nitrate transporter 1) protein encoded by SEQ ID NO: 2 having 100% sequence identity to Applicants SEQ ID NO: 1, (see alignment in Office action dated 06/24/2025). Allen teaches that ZmNRT1.3 (ZmNPF6.8) are low-affinity nitrate transporters, (see paragraphs [0017 and [0019], and example 3). Allen teaches on modulating nitrogen uptake, (see paragraph [0013]), specifically on making mutant plants with reduced activity and selecting a mutant plant with the gene knocked out “[m]utations that impact gene expression or that interfere with the function (enhanced nitrogen utilization activity) of the encoded protein are well known in the art. Insertional mutations in gene exons usually result in null-mutants. Mutations in conserved residues are particularly effective in inhibiting the activity of the encoded protein. Conserved residues of plant nitrate uptake-associated polypeptides suitable for mutagenesis with the goal to eliminate nitrate uptake-associated activity have been described” (i.e. decreasing nitrogen uptake) in Z. mays using ZmNRT1.3 gene, (see paragraph [0208]).
Allen teaches a “methods for decreasing or eliminating the expression of endogenous genes in plants are also known in the art and can be similarly applied to the instant disclosure. These methods include other forms of mutagenesis, such as ethyl methanesulfonate-induced mutagenesis, deletion mutagenesis, and fast neutron deletion mutagenesis used in a reverse genetics sense (with PCR) to identify plant lines in which the endogenous gene has been deleted.” (i.e. generating a knockout of ZmNRT1.3 (ZmNPF6.8)), (see paragraphs [0207]).
Allen teaches “[m]ethods for modulating drought tolerance in plants are also a feature of the disclosure, as are plants produced by such methods. For example, a method of modulating drought tolerance comprises: (a) selecting at least one low-affinity nitrate transporter gene to impact, thereby providing at least one desired low-affinity nitrate transporter gene; (b) introducing a mutant form of the at least one desired low-affinity nitrate transporter gene into the plant and (c) expressing the mutant form, thereby modulating drought tolerance in the plant. In certain embodiments, the mutant gene is introduced by Agrobacterium-mediated transfer, electroporation, micro-projectile bombardment, a sexual cross or the like” (i.e. backcrossing, selecting a Zea mays plant with said gene knocked out). Further regarding claim 14, Allen teaches the “genotype is the F1 of two purebred genetic lines, parents A and B, derived from the cross of two known maize inbreds, A188 and B73”, (see paragraph [0276]), which reads on the parent plant being B73.
Overall, Allen suggest on modulating ZmNRT1.3 (ZmNPF6.8) low-affinity nitrate transporters to decrease nitrate uptake within the plant to modulate drought tolerance.
Allen does not specifically teach an example on decreasing nitrogen uptake by generating a ZmNPF8.6 knock out.
Allen does suggest on making mutant plants with reduced activity and selecting a mutant plant with the gene knocked out “[m]utations that impact gene expression or that interfere with the function (enhanced nitrogen utilization activity) of the encoded protein are well known in the art. Insertional mutations in gene exons usually result in null-mutants. Mutations in conserved residues are particularly effective in inhibiting the activity of the encoded protein. Conserved residues of plant nitrate uptake-associated polypeptides suitable for mutagenesis with the goal to eliminate nitrate uptake-associated activity have been described” (i.e. decreasing nitrogen uptake) in Z. mays using ZmNRT1.3 gene, (see paragraph [0208]).
Given that Allen specifically suggest that one skilled in the art would want to decrease or eliminate the expression of said sequence, would have been obvious for one skilled in the art knowing that one should also knock out ZmNRT1.3 (ZmNPF6.8) low-affinity nitrate transporters to decrease nitrate uptake within the plant. Additionally, since Allen is teaching on the exact same gene.
Therefore, prior to the effective filing date it would have been prima facie obvious to one of ordinary skill in the art to modify the teachings of Allen because one skilled in the art would just preform the suggested method of inhibiting ZmNRT1.3 (ZmNPF6.8) low-affinity nitrate transporters.
One would have a reasonable expectation of success in this approach because Allen specifically suggest that one skilled in the art would want to decrease or eliminate the expression of said sequence. Consequently, based on the teachings of Allen, one would reasonably expect reduce the nitrogen uptake of Z. mays by knocking out ZmNRT1.3 (ZmNPF6.8).
In regard to claim 3, Allen teaches expressing SEQ ID NO: 4 which has 100% sequence identity to Applicants SEQ ID NO: 3 (coding region nucleotide sequence), (see alignment in Office action dated 06/24/2025 and Applicants specification paragraph [0012]).
• In regard to claim 4, Allen teaches 100% sequence identity for both the amino acid (SEQ ID NO: 1) and coding sequence (SEQ ID NO: 3). While Allen omits the specific UTR and intron sequences of the gene, it is routine in the art to arrive to the genomic sequence (SEQ ID NO: 2) once the protein and coding for the ZmNRT1.3 (ZmNPF6.8) gene are known. Because these sequence encode the identical protein and are obvious over the prior art.
In regard to claim 11, Allen references a method of transposon tagging which included using MU insertions (i.e. Mutator transposon insertion), (see paragraphs [0205]). Specifically, mentions using transposon tagging to “reduce or eliminate the nitrate uptake-associated activity of one or more nitrate uptake-associated polypeptide”, (see paragraph [0202]). Furthermore, references the Trait Utility System for Corn (TUSC), as described in Bensen et al., (1995) Plant Cell 7:75-84, is a system developed by Pioneer Hi-Bred International for identifying and characterizing Mutator (Mu) transposable element insertions in selected maize genes, (see paragraphs [0205]).
In regard to claim 12, Allen teaches “methods for decreasing or eliminating the expression of endogenous genes in plants are also known in the art and can be similarly applied to the instant disclosure. These methods include other forms of mutagenesis, such as ethyl methanesulfonate-induced mutagenesis, deletion mutagenesis, and fast neutron deletion mutagenesis used in a reverse genetics sense (with PCR) to identify plant lines in which the endogenous gene has been deleted.” (i.e. knockout is produced by targeted deletion of said gene), (see paragraphs [0207]).
In regard to claim 13, since the gene is known in the art and Allen teaches inhibiting said gene, the location (181,884,791 Chromosome 5) does not matter since the whole gene is knocked out.
In regard to claim 15, Allen teaches producing a “the planting of 15 transgene positive seeds”… “ZmNRT1.1 and ZmNRT1.3 were over-expressed in transgenic maize plants” (i.e. producing a seed from the selected plant and propagating a maize line comprising said gene), (see paragraphs [0267] and [0268]).
Response to Arguments
Applicant’s argues that 1) Allen does not teach decreasing nitrogen uptake of Zea mays, but overexpression and is teaching away, 2) Allen does not teach backcrossing and selection steps, and 3) Allen does not teach a knock out, see page 31, filed September 15, 2025, with respect to the rejection(s) of claim(s) 1, 3-4, 11-12, and 14-15 have been fully considered and are not persuasive.
In regard to arguments 1) and 3) that Allen teaches away from the instant application, because it teaches overexpression of said gene and not decreasing. A fuller reading of the art teaches that one would want to produce mutant plants with reduced activity, specifically selecting a mutant plant with the gene knocked out “[m]utations that impact gene expression or that interfere with the function (enhanced nitrogen utilization activity) of the encoded protein are well known in the art. Insertional mutations in gene exons usually result in null-mutants. Mutations in conserved residues are particularly effective in inhibiting the activity of the encoded protein. Conserved residues of plant nitrate uptake-associated polypeptides suitable for mutagenesis with the goal to eliminate nitrate uptake-associated activity have been described” (i.e. decreasing nitrogen uptake) in Z. mays using ZmNRT1.3 gene, (see paragraph [0208]). Allen does not specifically teach that when SEQ ID NO: 1 is inhibited you get decreased nitrogen uptake. However, Allen shows that when SEQ ID NO: 1 is overexpressed you get increased nitrate uptake, (see paragraph [0264]), so that one of ordinary skill in the art would reasonably expect that inhibiting expression of SEQ ID NO: 1 would get decreased uptake. This is evidence that if Allen claims doing then exact same thing as Applicant then one could expect to get the result Applicant is claiming.
Moreover, Applicant’s arguments are not commensurate in scope with what is claimed. Namely, the claims are not directed to selecting for plants with decreased nitrogen uptake. The claims are directed to selecting plants with decreased zmNPF6.8 expression which is exactly what Allen suggests doing.
In regard to argument 2) A fuller reading of Allen teaches how one would sexually cross plant with the mutant gene (i.e. ZmNPF6.8 knock out), “ (c) expressing the mutant form, thereby modulating drought tolerance in the plant. In certain embodiments, the mutant gene is introduced by Agrobacterium-mediated transfer, electroporation, micro-projectile bombardment, a sexual cross or the like” (i.e. backcrossing and selecting a Zea mays plant with said gene knocked out). The steps are interpreted as backcrossing and selecting a plant with said gene. Additionally, Applicant is reminded that this is a 103 rejection and that it is a combination of teachings that render the claim obvious. Therefore, the arguments are unpersuasive and the rejection is maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/C.J.O./Examiner, Art Unit 1663
/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
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