DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 5, 2026 has been entered.
Claim Amendment
3. The amendment filed May 5, 2026 has been entered. Claims 1 and 11 have been amended. Claim 20 is cancelled. Claims 1-19 and 21-22 are under consideration in this Office Action.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on May 5, 2026 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawal of Rejections
5. The rejection of claim 1, 11 and 20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of Applicants amendments and cancellation of claims.
6. The provisional rejection of claims 1, 3-5,12-13 and 15 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 18, 24-27, 39, and 167-170 of copending Application No. 17/258,024 (reference application) is withdrawn in view of Applicants Terminal Disclaimer.
7. The provisional rejection of claims 21-22 on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 16, and 24 of copending Application No. 17/287,377 (reference application) is withdrawn in view of Applicants amendment and arguments.
8. The provisional rejection of claims 1, 3 and 5 on the ground of nonstatutory double patenting as being unpatentable over claims 9 and 24-25 of copending Application No. 17/392,837 (reference application) is withdrawn in view of Applicants amendment and arguments.
9. The provisional rejection of claim on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 50 of copending Application No. 17/792,670 (reference application) is withdrawn in view of Applicants amendment and arguments.
Maintained Grounds of Rejection
Double Patenting
10. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Double Patenting
11. Claims 1, 3-5 and 8-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 144-145, 153, 156, and 159-160 of copending Application No. 18/345,783 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass a method of increasing the amount of atmospheric derived nitrogen in a plant. Both sets of claims recite contacting or exposing the plant with a genetically engineered diazotrophic bacteria comprising NifA. Additionally the dependent claims recite overlapping subject matter making them patentably indistinct. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Double Patenting
12. Claims 1 and 3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 64, 68, 74 and 76 of copending Application No. 18/607,210 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass a method of increasing the amount of atmospheric derived nitrogen or increasing nitrogen fixation activity. Both sets of claims comprise the same genes for regulating nitrogen fixation or assimilation and a microbe or bacteria having genetic modifications in a plant. Additionally the dependent claims recite overlapping subject matter making them patentably indistinct. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Double Patenting
13. Claims 1, 3-5 and 11-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7, 9-10 and 13-14 of US Patent 11,739,032 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to methods of increasing nitrogen fixation in a plant, said method comprising exposing said plant to a plurality of engineered, non-intergeneric diazotrophs, wherein said engineered, non-intergeneric diazotrophs comprise at least one genetic variation within one or more genes for regulating nitrogen fixation or assimilation, said genetic variation comprising genetic material that originates from an organism of the same genus as said engineered, non-intergeneric diazotrophs. Both sets of claims comprise engineered, non-intergeneric diazotrophs are bacteria and genes for regulating nitrogen fixation or assimilation alters the activity or expression of a gene selected from the group consisting of NifA, NifL, NifH GlnE, AmtB, ntrB, ntrC, polynucleotide encoding glutamine synthetase, glnA, glnB, glnK, drat, polynucleotide encoding glutaminase, and glnD. Additionally the dependent claims recite overlapping subject matter making them patentably indistinct.
Double Patenting
14. Claims 1, 3-4, 12-13 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 13 and 15 of U.S. Patent No.10,384,983. Although the claims at issue are not identical, they are not patentably distinct from each other. Both sets of claims are drawn to a method of increasing an amount of atmospheric derived nitrogen in a corn plant comprising exposing or contacting a corn plant to genetically engineered diazotrophs comprising a GlnE. The instant claim also recites the GlnE and the same strains. Additionally both sets of claims recite overlapping subject matter making them patentably indistinct.
Double Patenting
15. Claims 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,975,817. Although the claims at issue are not identical, they are not patentably distinct from each other. Both sets of claims are drawn to a method of increasing the amount of atmospheric derived nitrogen in a corn plant, comprising: exposing said corn plant in said field to a plurality of engineered diazotrophic bacteria, said plurality of engineered diazotrophic bacteria comprising a nitrogen fixation genetic regulatory network, having increased expression or activity of NifA, and wherein the genetic material of said plurality of engineered diazotrophic bacteria consists essentially of genetic material from bacteria of the genus of said plurality of engineered diazotrophic bacteria. Therefore, the claims recite overlapping subject matter making them patentably indistinct.
Double Patenting
16. Claims 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21 and 24 and 15 of U.S. Patent No.10,934,226. Although the claims at issue are not identical, they are not patentably distinct from each other. Both sets of claims are drawn to a engineered non-intergeneric diazotroph genetically engineered bacterium comprising a nitrogen fixation or nitrogen assimilation coding sequence, and a plant seed. Therefore, both sets of claims recite overlapping subject matter making them patentably indistinct.
Double Patenting
17. Claims 1 and 3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, and 7 of U.S. Patent No. 10,556,839. Although the claims at issue are not identical, they are not patentably distinct from each other. Both sets of claims are drawn to a method of increasing an amount of atmospheric derived nitrogen in a corn plant in a field, the method comprising: exposing a corn plant in a field to a plurality of engineered diazotrophs comprising at least one genetic variation introduced in a nitrogen fixation genetic regulatory network that increases expression or activity of nifH, and a promoter. Therefore, the claims recite overlapping subject matter making them patentably indistinct.
Double Patenting
18. Claims 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No.10,919,814. Although the claims at issue are not identical, they are not patentably distinct from each other. Both sets of claims are drawn to a composition comprising: an engineered diazotroph comprising at least one genetic variation introduced in a nitrogen fixation genetic regulatory network, whereby the engineered diazotroph comprises increased expression or activity of nifH, increased expression or activity of nifA, and a plant seed, where the plant is corn or wheat. Therefore, both sets of claims recite overlapping subject matter making them patentably indistinct.
Response to Arguments
19. Applicant's arguments filed May 5, 2026 have been fully considered but they are not persuasive. Applicants urge that none of the rejected applications or patents
teach a method of increasing an amount of atmosphere derived nitrogen in a plant,
said method comprising contacting said plant with a genetically engineered bacterium, wherein said genetically engineered bacterium comprises (a) a nitrogen fixation or nitrogen assimilation coding sequence, operably linked to (b) an inserted infC promoter, wherein the inserted infC promoter comprises a nucleotide sequence having at least 90% sequence identity to the sequence set forth in SEQ ID NO: 41, 42, 59, 60, 61, 62, 63 or 67.
Claims 144-145, 153, 156, and 159-160 of copending Application No. 18/345,783 (reference application). The claims at issue are not identical, because the reference application recites a method of increasing the amount of atmospheric derived nitrogen in a plant in a field, the method comprising: exposing the plant in the field to a plurality of engineered diazotrophic bacteria, thereby increasing an amount of atmospheric derived nitrogen within the plant that is exposed to the plurality of engineered diazotrophic bacteria relative to a plant that is exposed to a same amount of a second plurality of a non-engineered diazotrophic bacteria that are the same species as the plurality of engineered diazotrophic bacteria; wherein the plurality of engineered diazotrophic bacteria comprises at least one genetic variation introduced into a nitrogen fixation genetic regulatory network that results in one or more of: increased expression or activity of NifA or decreased expression or activity of NifL, wherein at least one genetic variation introduced into the nitrogen fixation genetic regulatory network comprises insertion of a heterologous sequence found within a genome of a bacterium of the genus of the plurality of engineered diazotrophic bacteria; and
wherein nitrogen fixation activity of the plurality of engineered diazotrophic bacteria in non-nitrogen-limiting conditions is greater than nitrogen fixation activity, in similar non-nitrogen-limiting conditions, of a same amount of the second plurality of non-engineered diazotrophic bacteria. Therefore, both sets of claims encompass a method of increasing the amount of atmospheric derived nitrogen in a plant. Both sets of claims recite contacting or exposing the plant with a genetically engineered diazotrophic bacteria comprising NifA. Therefore, the claims recite overlapping subject matter making them patentably indistinct.
Although the claims are not identical, copending Application No. 18/607,210 is not patentably distinct because it provides a wild type microbe with nitrogen fixing activity, wherein the wild type microbe contains one or more genes for regulating nitrogen fixation or assimilation; introducing one or more targeted genetic variations within one or more of the genes for regulating nitrogen fixation or assimilation to produce a genetically modified microbe having increased nitrogen fixation activity and decreased fitness compared to the wild type microbe; introducing one or more targeted genetic variations into one or more genes in a glutamine conversion pathway of the genetically modified microbe to improve the fitness of the genetically modified microbe, wherein such that the a resulting genetically modified microbe has increased nitrogen fixation activity and similar OF increased fitness at least the same fitness of the wild type microbe as compared to the wild type microbe under the same growing conditions.
Thus, both sets of claims comprise the same genes for regulating nitrogen fixation or assimilation and a microbe or bacteria having genetic modifications in a plant. Therefore, the claims recite overlapping subject matter making them patentably indistinct.
U.S. Patent No. 9,975,817, although the claims at issue are not identical, they are not patentably distinct from each other. The patented claims are drawn to a method of increasing the amount of atmospheric derived nitrogen in a corn plant, comprising: exposing said corn plant in said field to a plurality of engineered diazotrophic bacteria, said plurality of engineered diazotrophic bacteria comprising a nitrogen fixation genetic regulatory network, having increased expression or activity of NifA, and wherein the genetic material of said plurality of engineered diazotrophic bacteria consists essentially of genetic material from bacteria of the genus of said plurality of engineered diazotrophic bacteria. Thus, the claims recite overlapping subject matter making them patentably indistinct.
U.S. Patent No.10,384,983 is not patentably distinct from each other because both sets of claims are drawn to a method of increasing an amount of atmospheric derived nitrogen in a corn plant comprising exposing or contacting a corn plant to genetically engineered diazotrophs comprising a GlnE comprising the same strains. The patent describe the same promoters, genes and nucleotide sequences identified by name or sequence identification number and does not exclude any instantly recited element.
U.S. Patent No. 10,556,839 is not patentably distinct because both sets of claims are drawn to a method of increasing an amount of atmospheric derived nitrogen in a corn plant in a field, the method comprising: exposing a corn plant in a field to a plurality of engineered diazotrophs comprising at least one genetic variation introduced in a nitrogen fixation genetic regulatory network that increases expression or activity of nifH, and a promoter. The patent describe the same promoters, genes and nucleotide sequences identified by name or sequence identification number and does not exclude any instantly recited element.
U.S. Patent No.10,919,814 is not patentably distinct from the instantly rejected claims. Both sets of claims are drawn to a composition comprising: an engineered diazotroph comprising at least one genetic variation introduced in a nitrogen fixation genetic regulatory network, whereby the engineered diazotroph comprises increased expression or activity of nifH, increased expression or activity of nifA, and a plant seed, where the plant is corn or wheat. Accordingly, both sets of claims recite overlapping subject matter making them patentably indistinct.
The claims of U.S. Patent No.10,934,226 are not identical, and are not patentably distinct from the instantly recited claims. Both sets of claims recite an engineered, non-intergeneric diazotroph having increased nitrogen fixation activity as compared to an unmodified organism of the same species as said engineered, non-intergeneric diazotroph, wherein said engineered, non-intergeneric diazotroph comprises a genetic variation within one or more genes for regulating nitrogen fixation or assimilation, said genetic variation comprising genetic material that originates from at least one organism of the same species as said engineered, non-intergeneric diazotroph, which is overlapping subject matter making them patentably indistinct.
US Patent 11,739,032, although the claims at issue are not identical, the claims are not patentably distinct from each other. Both sets of claims comprise engineered, non-intergeneric diazotrophs are bacteria and genes for regulating nitrogen fixation or assimilation alters the activity or expression of a gene selected from the group consisting of NifA, NifL, NifH GlnE, AmtB, ntrB, ntrC, polynucleotide encoding glutamine synthetase, glnA, glnB, glnK, drat, polynucleotide encoding glutaminase, and glnD. Thus the overlapping subject matter making them patentably indistinct.
Therefore, applicants arguments are not persuasive and the rejections are maintained.
Pertinent Art
20. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. See WO2017011602, WO9305154, 20150128670, 10,384,983, 11,993,778, 11,565,979, 9,975,817, 10,934,226, 10,556,839 and 11,739,032.
Conclusion
21. No claims allowed.
22. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JA-NA A HINES whose telephone number is (571)272-0859. The examiner can normally be reached Monday thru Thursday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Peter Paras, can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANA A HINES/Primary Examiner, Art Unit 1645
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