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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) is acknowledged. As such, the effective filing date of Claims 4-6, 9, and 15-16 is 08/11/2021.
Status of the Claims
Amendments dated 11/13/2025 have been entered.
Claims 15-16 are newly added.
Claims 4-6, 9, and 15-16 are pending.
Claims 4-6, 9, and 15-16 are examined herein.
The objection to the Drawings is withdrawn in view of Applicant’s amendments to the Drawings.
The objections to Claims 4 and 9 are withdrawn in view of Applicant’s amendments to the claims.
All previous claim rejections of record are rendered moot in light of Applicant’s amendments to the claims.
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.
---The following are new rejections made in view of Applicant’s amendments to the claims dated 11/13/2025---
Claims 4-6 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Su et al. (Journal of experimental botany 69.21 (2018): 5177-5189) in view of Shi et al. (Journal of experimental botany 69.21 (2018): 5177-5189), taken with evidence from the instant specification.
When looking at the broadest reasonable interpretation of Claims 4-6, it is unclear what structure the new claim limitation “field-grown” imparts on the modified maize plant recited in Claim 4. When looking at currently amended Claim 4, the only limitations that impart structure on the modified maize plant are the limitations drawn to disrupting or inhibiting the expression of nf-ya3 encoding a protein that has the sequence of SEQ ID NO: 1 in maize plant cells that are comprised within the modified maize plant. When examining Claim 4, it is unclear what the actual structural difference would be between a modified maize plant that has been grown in a greenhouse or laboratory setting comprising maize plant cells modified by disrupting or inhibiting expression of nf-ya3 encoding a protein that has the sequence of SEQ ID NO: 1 and a modified maize plant that has been grown in a field or test plot setting comprising maize plant cells modified by disrupting or inhibiting expression of nf-ya3 encoding a protein that has the sequence of SEQ ID NO: 1, because the claimed structural components of the plants would seemingly be identical (i.e., the plants grown in either scenario would be identical). For purposes of compact prosecution and searches in the prior art, Examiner will assume that a modified maize plant that has been grown in a greenhouse or laboratory has some sort of structural difference relative to the instantly claimed modified maize plant that has been grown in a field or test plot. Despite this determination, Examiner invites Applicant to provide evidence that such a difference does exist for the instantly claimed modified maize plant.
Regarding Claims 4-6, Su et al. (herein referred to as Su ) teaches Zmnf-ya3 knockout mutant maize plants derived from immature zygotic embryos from maize inbred line Yu658, wherein the expression of Zmnf-ya3 in maize plants was inhibited using the CRISPR–Cas9 (clustered regularly interspaced short palindromic repeats–CRISPR-associated protein 9)-mediated mutagenesis system. The immature maize embryos were infected by Agrobacterium for agro-transformation of the CRISPR Cas9 editing cassette to inhibit the expression of Zmnf-ya3, wherein embryos were sub-cultured until the formation of transformed calli, which were harvested and then regenerated for three 2 week subculture steps in pre-regeneration medium (dark), regeneration medium I (dark), and regeneration medium II (light) at 28 °C, respectively. The mutant maize plant Zmnf-ya3 was obtained from T2 plant lines, and plants without any sequence editing were selected as the wild type (WT) (pg. 5178, right column, first full paragraph). Su also teaches that Zmnf-ya3 mutant maize plants under long day (LD) conditions flowered later than WT maize plants under long day conditions (pg. 5810, left column, Results, first paragraph). Su also teaches that Zmnf-ya3 mutants had differences in drought and heat tolerance under LD conditions relative to WT maize plants (pg. 5810, left column, Results, second paragraph bridging to right column). The disclosure of Su puts one of ordinary skill in the art on notice that inhibiting the expression of Zmnf-ya3 in maize plants has agro-economically important results in regard to altering or changing agro-economically important phenotypes (flowering time, drought stress tolerance, heat stress tolerance) in modified maize plants. Su teaches that the modified maize plants already comprising the mutation to Zmnf-ya3 were regenerated from immature embryos to calli to F2 plants lines (pg. 5178, left column, Materials and Methods, first paragraph) that were subsequently grown in growth chambers (pg. 5179, right column, Experimental treatments, first and second paragraph).
However, Su does not explicitly teach the limitation of Claims 4-5, wherein the modified maize plant is “field-grown” or the limitations of Claims 15-16, wherein the modified maize plant is an elite variety.
Regarding Claims 4-5, Shi et al. (herein referred to as Shi) teaches the genomic modification of maize plants using CRISPR-Cas9 gene editing (pg. 213, left column, Experimental procedures, Plasmids and reagents used for plant transformation; right column, Maize transformation), and the subsequent growth of the modified plants in field trial conditions in small plots with various levels of drought stress while others were managed for optimum yield/nonstress conditions— for the purpose of evaluating the yield performance of the modified maize plants under abiotic stress conditions (pg. 214, left column, Maize hybrid yield testing). Shi also teaches that growing genetically modified maize plants under field conditions is well known and routine in the art (pg. 213, first full paragraph). Regarding Claims 15-16, Shi teaches that the genetic modifications were performed in the PH184C inbred maize line, which is defined as an “elite Non-Stiff Stalk (NSS) proprietary inbred” (elite variety) as evidenced by Weers et al. (2024; Field Crops Research 317 (2024): 10952; pg. 2, left column, Materials and Methods, 2.1, second sentence).
Based on the agro-economically important results from inhibiting expression of Zmnf-ya3 in maize disclosed by Su and the teachings of Shi which show scaling the growth of genetically modified maize plant from a laboratory/greenhouse setting to field conditions, one of ordinary skill in the art would have been motivated to take the Zmnf-ya3 maize mutant plants disclosed by Su and grow the Zmnf-ya3 mutant plants under a variety of environmental conditions (including drought stress conditions) in field test plots, as taught by Shi. Additionally, based on the disclosure of Shi, one of ordinary skill in the art would have been motivated to create Zmnf-ya3 maize mutant plants in an elite maize variety rather than the inbred maize variety taught by Su because it would be routine and well known in the art to perform genome modifications in an elite maize variety that is subsequently grown in field conditions.
Furthermore, based on the above teaching, it would have been obvious for one of ordinary skill in the art at the time of the effective filing date of the claimed invention to inhibit the expression of Zmnf-ya3 in a maize plant as taught by Su in a variety of field condition test plots, as taught by Shi, wherein one of ordinary skill in the art would reasonably expect the Zmnf-ya3 mutant plant grown in field conditions to have increased nitrogen use efficiency (Claim 4) and increased biomass (Claims 5 and 6), by virtue of the instant specification (paragraphs bridging pgs. 24-25; Figure 6c, Fig. 17). The CRISPR-Cas9 mediated mutagenesis system that targeted the Zmnf-ya3 gene in maize plants taught by Su would be reasonably expected to inhibit (“knock out”) the expression of Zmnf-ya3 in the mutant maize plants (as evidenced by the experimental results of Su; pg. 5180, left column, Results, first sentence), wherein the modified maize plants would be expected to be grown in test plots under variable field conditions, as made obvious by Shi. The evidence of the specification shows that the inhibition of expression of maize nf-ya3 in maize plants grown in variable growth conditions caused the recited effects of increased grain biomass and nitrogen utilization efficiency (Fig. 6c; paragraph bridging pgs. 18-19). As such, and without evidence to the contrary, it is reasonable to conclude that the inhibition of expression of maize nf-ya3 in maize taught by Su would inherently produce the recited properties when grown in variable field conditions made obvious by Shi. The Applicant is reminded that the discovery of a new property does not render a claimed invention patentable, specifically, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer" (See MPEP 2112). The rationale to support a conclusion that the claims would have been obvious is that all the claimed elements were known in the prior art, and one of ordinary skill could have combined these elements as claimed with no change to their respective functions. Thus the combination yielding predictable results would have been expected by a skilled artisan. Therefore, for all the reasons above, the claimed invention is prima facie obvious.
Response to Arguments
Applicant’s Remarks on pgs. 8-9 in the reply filed on 11/13/2025 are acknowledged but do not overcome these new rejections for the reasons given in the 35 U.S.C. §103 rejections above. It is noted that this is a new rejection necessitated by the new claim amendments.
Closest Prior Art
Claim 9 appears to be free of the prior art. The closest prior art in regard to Claim 9 can be found in Su et al. (Journal of experimental botany 69.21 (2018): 5177-5189) and Shin et al. (US 2013/0139280 A1, published 05/30/2013).
Su et al. teaches a method of CRISPR-Cas9- mediated mutagenesis to inhibit the expression of Zmnf-ya3 in maize plants. Su et al. also teaches Zmnf-ya3 knockout mutant maize plants, wherein the expression of Zmnf-ya3 in maize plants was inhibited using the CRISPR–Cas9 (clustered regularly interspaced short palindromic repeats–CRISPR-associated protein 9)-mediated mutagenesis system. The immature maize embryos were infected by Agrobacterium for agro-transformation of the CRISPR Cas9 editing cassette to inhibit the expression of Zmnf-ya3, wherein embryos were subcultured until the formation of transformed calli, which were harvested and then regenerated for three 2 week subculture steps in pre-regeneration medium (dark), regeneration medium I (dark), and regeneration medium II (light) at 28 °C, respectively. The mutant maize plant Zmnf-ya3 was obtained from T2 plant lines, and plants without any sequence editing were selected as the wild type (WT) (pg. 5178, right column, first full paragraph).
Shin et al. teaches SEQ ID NO: 543, a Zea mays HD8-like protein (pg. 62, Table J), that has 100% sequence identity to instant SEQ ID NO: 2 encoding an hb75 protein from Zea mays (See instant Specification, Table 4, pg. 37). Shin further teaches a plant, plant cell, or plant part, including seeds, obtained by the method of claim 109, wherein said plant, plant cell, or plant part comprises a recombinant nucleic acid encoding a HD8-like polypeptide (Claim 120), wherein the present claims teaches a method for enhancing yield-related traits in a plant relative to a control plant, comprising modulating expression in a plant of a nucleic acid encoding: an HD8-like polypeptide (Claim 109), wherein said nucleic acid encodes any one of the polypeptides listed in one of Tables A1, A2, A3, F, or J (Claim 116), wherein said enhanced yield-related traits comprise increased yield and/or increased early vigor relative to a control plant, and wherein said increased yield preferably comprises increased biomass and/or increased seed yield relative to a control plant (Claim 111). Shin further defines “modulating” to include any change of the expression of the inventive nucleic acid sequences or encoded proteins, which leads to increased yield and/or increased growth of the plants, wherein the expression can increase from zero (absence of, or immeasurable expression) to a certain amount, or can decrease from a certain amount to immeasurable small amounts or zero (pg. 11, paragraph 0132). Shin also defines the terms “yield" of a plant and "plant yield" to mean vegetative biomass such as root and/or shoot biomass, to reproductive organs, and/or to propagules such as seeds of that plant (pg. 16, paragraph 0181).
However, neither Su et al., Shin et al., nor the prior art teach or provide any motivation to inhibit both a Zea mays nf-ya3 protein and a Zea mays HD8-like protein in a method for engineering a modified maize plant, much less a modified maize plant comprising the inhibition of both Zmnf-ya3 and Zea mays HD8-like protein, wherein the modified maize plant exhibits an increase in Nitrogen (N) uptake, increased biomass, an increased harvest index, an increased Total nitrogen utilization (NUtE), or an increased grain yield (total Grain NUtE), relative to an unmodified parent maize plant.
Conclusion
Claims 4-6 and 15-16 are rejected.
Claims 9 is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY L. MCWILLIAMS whose telephone number is (703)756-4704. The examiner can normally be reached M-F 08:00-17:30.
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/KELSEY L MCWILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663