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
1. Claims 1, 3, 5, and 7-9 are pending and under examination.
Claims 10-18, 21-23, and 26-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 02, 2025.
Claims 2, 4, 6, 19-20, 24-25, and 28-32 are cancelled.
Restrictions/Elections
2. The Office acknowledges receipt of Applicant’s restriction election filed October 02, 2025. Applicant elects Group I, claims 1, 3, 5, and 7-9, directed to a method of optimizing exogenously applied nitrogen use in a field by a population of crop plants, without traverse.
Claims 10-18, 21-23, and 26-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The requirement is deemed proper and is made FINAL.
Priority
3. This application is a 371 of International Application No. PCT/US2022/033408 filed June 14, 2022.
The Office acknowledges receipt of Applicant’s domestic priority documents Provisional Application No. 63/210,521 filed on June 15, 2021.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on January 04, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered to the extent of the English translations provided.
Claim Objections
5. Claims 1, 3, 5, and 7-9 are objected to because of the following:
Claim 1 contains syntactical and/or grammatical errors that obscure the intended recitation. It is recommended Applicant amend lns. 1-2 such that the phrase “by a population of corn plants” is deleted from its current placement and inserted between the phrases “nitrogen use” and “in a field”, if appropriate. It is recommended Applicant amend lns. 4-6 such that the phrase “to a field that comprises applied nitrogen fertilizer and a nitrogen stabilizer” is deleted from its current placement and inserted after the word “providing” in ln. 4, if appropriate.
Claim 7 contains a typographical and/or grammatical error; it is recommended Applicant amend “heat tolerant” to “heat-tolerant” if the word “heat” is meant to describe the plants’ tolerance to a temperature.
Dependent claims are included.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
6. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
7. Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The metes and bounds of claim 3 are indefinite because it is unclear if either the entire field is characterized by nitrogen run-offs or if the zones within the field are characterized by nitrogen run-offs. The presence of multiple reasonable interpretations renders the claim indefinite. If Applicant intends to recite zones that are characterized by nitrogen run-offs, it is suggested Applicant delete the phrase “that are characterized by nitrogen run-offs” from its current placement and insert it between “zones” and “within the field”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
8. 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.
9. Claims 1, 3, 5, and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Christensen et al. (US2021/0115463-A1, published 04/22/2021 (Applicant’s IDS)) in view of Gerecke et al. (US-2017/0217847-A1, published 08/03/2017 (Applicant’s IDS)).
Regarding claim 1, Christensen teaches a method of optimizing exogenously applied nitrogen use in a field by a population of corn plants, the plants comprising a heterologous polynucleotide (i.e., ZmM28 gene) that encodes a MADS-box polypeptide (i.e., AG099)[0004], [0009], [0020], [0073], [0147], the method comprising: a) providing crop plants wherein the expression of the heterologous polynucleotide increases one or more yield related agronomic parameters to a field that comprises applied nitrogen fertilizer[0009], [0013-0016], [0031-0033], [0073] (see: Examples); and b) increasing the nitrogen assimilation and/or nitrogen utilization rate during the crop plants growing season compared to a control population of plants not comprising the polynucleotide, thereby optimizing the exogenously applied nitrogen in the field[0073], [0242].
Christensen does not teach application of nitrogen to a field that comprises a nitrogen stabilizer.
However, Gerecke teaches controlling nutrient depletion from agricultural soils (Title) and application of nitrogen to a field that comprises a nitrogen stabilizer (Abstract)[0013-0021], [0036], [0110], [0112], [0115], [0162], [0193].
The combination of Christensen and Gerecke teaches a method of optimizing exogenously applied nitrogen use in a field by a population of corn plants, the plants containing a heterologous polynucleotide that encodes a MADS-box polypeptide, the method comprising: a) providing corn plants wherein the expression of the heterologous polynucleotide that encodes a MADS-box polypeptide increases one or more yield related agronomic parameters to a field that comprises applied nitrogen fertilizer and a nitrogen stabilizer; and b) increasing the nitrogen assimilation and/or nitrogen utilization rate during the corn plants growing season compared to a control population of plants not comprising the trait, thereby optimizing the exogenously applied nitrogen in the field.
The level of ordinary skill in the plant biotechnology art is high as demonstrated by Christensen and Gerecke. It would have been prima facie obvious to one of ordinary skill in the art before the instant effective filing date to modify the teachings of Christensen with the teachings of Gerecke to apply nitrogen to a field that comprises a nitrogen stabilizer. One of ordinary skill in the art would have been motivated to do so because Gerecke suggests that applying a nitrogen stabilizer to a field increases the nitrogen available to plant roots and minimizes the leaching of loss of nutrients into surface and subsurface ground waters (Abstract). In addition to improving the availability of nitrogen for promoting crop growth, reducing run-off of applied nitrogen into the environment also reduces the incidence and environmental impacts of nitrogen fertilizers. Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention with a reasonable expectation of success and without any surprising or unexpected results.
Regarding claim 3, the combined teachings of Christensen and Gerecke are as discussed above.
Christensen does not teach wherein the corn plants are planted in one or more zones within the field that are characterized by nitrogen run-offs.
However, Gerecke teaches wherein the corn plants are planted in one or more zones within the field that are characterized by nitrogen run-offs (Abstract).
Regarding claim 5, in addition to the teachings discussed above, Christensen teaches wherein the applied nitrogen is used more effectively by the crop plants as measured by increase in stalk and/or leaf nitrogen content and/or increase in shoot and/or root biomass[0242].
Regarding claim 7, the combined teachings of Christensen and Gerecke are as discussed above. Further regarding "wherein the crop plants are heat tolerant," the 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 method new to the discoverer. Thus, the claiming of a new use, new function, or previously unknown property, which is inherently present in the prior art method, does not necessarily make the limitation novel. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established (MPEP 2112.01(I)).
Regarding claim 8, in addition to the teachings discussed above, Christensen teaches wherein the plants are corn plants that comprise event DP202216-6[0002], [0004], [0021-0025], [0073].
Regarding claim 9, in addition to the teachings discussed above, Christensen teaches the method wherein the applied nitrogen is about 5% to about 50% less than an application rate[0073].
Christensen does not teach wherein an application rate of about 50lbs to about 400lbs of nitrogen per acre compared to a normal field not comprising the crop plants having the polynucleotide.
However, Gerecke teaches wherein an application rate of about 50lbs to about 400lbs of nitrogen per acre compared to a normal field not comprising the crop plants having the polynucleotide[0026], [0087]. It would have been obvious to one of ordinary skill in the art at the time the invention was made to apply about 5% to about 50% less nitrogen than an application rate of about 50lbs to about 400lbs of nitrogen per acre compared to a normal field not comprising the crop plants having the polynucleotide, since discovering the optimum or workable ranges involves only routine skill in the art wherein the general conditions of the claim are disclosed in the prior art.
Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention with a reasonable expectation of success and without any surprising or unexpected results.
10. Claims 1, 3, 5, and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (Proceedings of the National Academy of Sciences. 2019; 116(47):23850-23858 (U)) in view of Gerecke et al. (US-2017/0217847-A1, published 08/03/2017 (Applicant’s IDS)).
Regarding claim 1, Wu teaches a method of optimizing exogenously applied nitrogen use in a field by a population of corn plants, the plants comprising a heterologous polynucleotide (i.e., ZMM28 gene) that encodes a MADS-box polypeptide (Abstract; p. 23851, full paragraphs 2-4), the method comprising: a) providing crop plants wherein the expression of the heterologous polynucleotide increases one or more yield related agronomic parameters to a hydroponic growth chamber that comprises applied nitrogen fertilizer (Abstract; p. 23852, full paragraphs 1-5; p. 23853, full paragraph 1); and b) increasing the nitrogen assimilation and/or nitrogen utilization rate during the crop plants growing season compared to a control population of plants not comprising the polynucleotide, thereby optimizing the exogenously applied nitrogen (p. 23852, “Extended and Increased zmm28 Expression Increases N Uptake and Assimilation.”).
Wu does not teach application of nitrogen to a field or a nitrogen stabilizer.
However, Gerecke teaches controlling nutrient depletion from agricultural soils (Title) and application of nitrogen to a field that comprises a nitrogen stabilizer (Abstract)[0013-0021], [0036], [0110], [0112], [0115], [0162], [0193].
The combination of Wu and Gerecke teaches a method of optimizing exogenously applied nitrogen use in a field by a population of corn plants, the plants containing a heterologous polynucleotide that encodes a MADS-box polypeptide, the method comprising: a) providing corn plants wherein the expression of the heterologous polynucleotide that encodes a MADS-box polypeptide increases one or more yield related agronomic parameters to a field that comprises applied nitrogen fertilizer and a nitrogen stabilizer; and b) increasing the nitrogen assimilation and/or nitrogen utilization rate during the corn plants growing season compared to a control population of plants not comprising the trait, thereby optimizing the exogenously applied nitrogen in the field.
The level of ordinary skill in the plant biotechnology art is high as demonstrated by Wu and Gerecke. It would have been prima facie obvious to one of ordinary skill in the art before the instant effective filing date to modify the teachings of Wu with the teachings of Gerecke to apply nitrogen to a field that comprises a nitrogen stabilizer. One of ordinary skill in the art would have been motivated to do so because Gerecke suggests that applying a nitrogen stabilizer to a field increases the nitrogen available to plant roots and minimizes the leaching of loss of nutrients into surface and subsurface ground waters (Abstract). In addition to improving the availability of nitrogen for promoting crop growth, reducing run-off of applied nitrogen into the environment also reduces the incidence and environmental impacts of nitrogen fertilizers. Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention with a reasonable expectation of success and without any surprising or unexpected results.
Regarding claim 3, the combined teachings of Wu and Gerecke are as discussed above.
Wu does not teach wherein the corn plants are planted in one or more zones within the field that are characterized by nitrogen run-offs.
However, Gerecke teaches wherein the corn plants are planted in one or more zones within the field that are characterized by nitrogen run-offs (Abstract).
Regarding claim 5, in addition to the teachings discussed above, Wu teaches wherein the applied nitrogen is used more effectively by the crop plants as measured by increase in stalk and/or leaf nitrogen content and/or increase in shoot and/or root biomass (p. 23852, “Extended and Increased zmm28 Expression Results in Maize Plants with Altered Agronomic Traits.”; p. 23852, “Extended and Increased zmm28 Expression Increases N Uptake and Assimilation.”).
Regarding claim 7, the combined teachings of Wu and Gerecke are as discussed above. Further regarding "wherein the crop plants are heat tolerant," the 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 method new to the discoverer. Thus, the claiming of a new use, new function, or previously unknown property, which is inherently present in the prior art method, does not necessarily make the limitation novel. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established (MPEP 2112.01(I)).
Regarding claim 8, in addition to the teachings discussed above, Wu teaches wherein the plants are corn plants that comprise event DP202216-6 (p. 23851, “Transgenic Event Selection.”; p. 23852, full paragraphs 1-5).
Regarding claim 9, the combined teachings of Wu and Gerecke are as discussed above.
Wu does not teach a method wherein the applied nitrogen is about 5% to about 50% less than an application rate of about 50lbs to about 400lbs of nitrogen per acre compared to a normal field not comprising the crop plants having the polynucleotide.
However, Gerecke teaches an application rate of about 50lbs to about 400lbs of nitrogen per acre compared to a normal field not comprising the crop plants having the polynucleotide[0026], [0087]. It would have been obvious to one of ordinary skill in the art at the time the invention was made to apply about 5% to about 50% less nitrogen than an application rate of about 50lbs to about 400lbs of nitrogen per acre compared to a normal field not comprising the crop plants having the polynucleotide, since discovering the optimum or workable ranges involves only routine skill in the art wherein the general conditions of the claim are disclosed in the prior art.
Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention with a reasonable expectation of success and without any surprising or unexpected results.
Conclusion
11. No claim is allowed.
Examiner’s Contact Information
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEQUANTARIUS JAVON SPEED whose telephone number is (703)756-4779. The examiner can normally be reached M-F; 9AM-5PM ET.
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/DEQUANTARIUS JAVON SPEED/Junior Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663