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 .
Claim Status
2. Claims 1-22 are under consideration in this Office Action.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on Dec. 17, 2025 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 Objections to Specification
4. The objection to the disclosure is withdrawn in view of Applicants amendment to the Specification.
Withdrawal of Rejections
5. The rejection of claims 1-22 under 35 U.S.C. 102(a)(2) as being anticipated by Hammill et al., is withdrawn in view of exception to the 102(a)(2) rejection.
6. The provisional nonstatutory double patenting rejection of claims 1, 3-4 and 21-22 as being unpatentable over claims 13-15 and 19-21 of copending Application No. 17/027,030 (reference application) is withdrawn in view of Applicants Terminal Disclaimer.
7. The provisional nonstatutory double patenting rejection of claim 1 as being unpatentable over claims 39, 66, 73 and 83 of copending Application No. 17/421,278 (reference application), now US Patent 12,421,519 is withdrawn in view of Applicants Terminal Disclaimer.
8. The nonstatutory double patenting rejection of claims 1, 3 and 12-13 as being unpatentable over claims 1, 9 and 11 of US Patent 12,391,624 (reference patent) is withdrawn in view of Applicants Terminal Disclaimer.
9. The nonstatutory double patenting rejection of claims 1, 3-4, 12-13 and 15 as being unpatentable over claims 1, and 3-8 of U.S. Patent No.11,993,778 is withdrawn in view of Applicants Terminal Disclaimer.
Maintained Grounds of Rejection
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
10. Claim 1, 11 and 20 are 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.
Claim 1 recites a method of increasing an amount of atmosphere derived nitrogen in a plant; however the metes and bounds for determining an increase are unclear. The claim does not recite a basis of comparison for which to determine whether an increase has occurred. Thus clarification is required to overcome the rejection.
Claim 11 recites the method decrease the amount of nitrogen; however the metes and bounds for determining an decrease are unclear. The claim does not recite a basis of comparison for which to determine whether a decrease has occurred. Thus clarification is required to overcome the rejection.
Claim 20 recites a method where the bacteria exhibits an increase in the amount of atmosphere derived nitrogen; however the metes and bounds for determining an increase are unclear. The claim does not recite a basis of comparison for which to determine whether an increase has occurred. Thus clarification is required to overcome the rejection.
Response to Arguments
11. Applicant's arguments filed Dec, 17, 2025 have been fully considered but they are not persuasive. Applicants response states that the increase is relative to the amount of atmosphere derived nitrogen in the plant before it was contacted with the genetically engineered bacterium; however the Office refers Applicants to the rejected claims. The rejected claims do not recite any comparison of increase (or decrease) based upon a plant not in contact with the genetically engineered bacterium. Therefore, it is suggested that the rejected claims clearly recite that the increase (or decrease) is compared to a plant without contact with the bacterium. Thus, the claimed rejection is maintained.
Double Patenting
12. 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.
13. Claims 1, 3-5,12-13 and 15 are provisionally rejected 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). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass a method providing atmospheric to a plant. Both sets of claims recite contacting or providing the plant with a genetically engineered non-intergeneric bacteria comprising NifA, glutaminase. 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. It is noted, that this application has recently been allowed, therefore this rejection will convert from a provisional rejection into a rejection.
Double Patenting
14. Claims 21-22 are provisionally rejected 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). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a composition comprising intergeneric Klebsiella variicola capable of fixing atmospheric nitrogen. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Double Patenting
15. Claims 1, 3 and 5 are provisionally rejected 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). 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 ; while the reference application recited remodeled nitrogen fixing non-intergeneric bacteria with at least one genetic variation of coding sequences for nitrogen fixation or assimilation contacted with crop plants. Both sets of claims recite the same nitrogen fixation or assimilation genes. 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
16. Claim 21 is provisionally rejected 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). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass a composition comprising genetically engineered or synthetic Klebsiella variicola, which will increase nitrogen fixation comprising a promoter sequence that is operably linked to the same recited nitrogen fixation coding sequences. Both sets of claims are comprised within a plant or seed. The subject of both sets of claims overlaps 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
17. 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
18. 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
19. 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
20. 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
21. 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
22. 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
23. 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
24. 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
25. Applicant's arguments filed Dec. 17, 2025 have been fully considered but they are not persuasive. Applicants argue 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: 67, 41, 42, 59, 60, 61, 62, or 63.
Contrary to Applicants arguments, copending application 17/258,024 is not patentably distinct because both sets of claims encompass a method providing atmospheric to a plant comprising contacting or providing the plant with a genetically engineered non-intergeneric bacteria comprising NifA, glutaminase. The application describe the same promoters, genes and nucleotide sequences identified by name or sequence identification number and does not exclude any instantly recited element.
Copending application 17/392,837 is not patentably distinct because both sets of claims encompass a method of increasing the amount of atmospheric derived nitrogen in a plant; comprising remodeled nitrogen fixing non-intergeneric bacteria with at least one genetic variation of coding sequences for nitrogen fixation or assimilation contacted with crop plants wherein both sets of claims recite the same nitrogen fixation or assimilation genes. The application 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.10,384,983 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.
With regard to instant claims 21-22, these claims are provisionally rejected over copending Application No. 17/287, 377, U.S. Patent No.10,919,814, and U.S. Patent No.10,934,226 because the rejected 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. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a composition comprising intergeneric Klebsiella variicola capable of fixing atmospheric nitrogen.
Therefore, applicants arguments are not persuasive and the rejections are maintained.
Pertinent Art
26. 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
27. No claims allowed.
28. 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.
29. 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 Dan Kolker, can be reached on 571-272-3181. 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