DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The TrackOne Request filed September 12, 2025 was granted October 31, 2025. Therefore, this application is accorded special status.
Election/Restrictions
Applicant’s election without traverse of Group II (claims 93-103 and newly added claims 104-110) in the reply filed on February 3, 2026 is acknowledged. Applicants also canceled non-elected claims 82-92. Therefore, claims 93-110 are pending in this application, and are under examination.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
It is noted that color drawings are present in this application, but Applicants have not filed a Petition to Accept Color Drawings and have not paid the associated fee. In addition, the specification does not contain the statement regarding the color drawings, as described above.
Specification
The disclosure is objected to because of the following informalities:
The Tables at paragraphs [0129]-[0132], [0137], and [0181] are not numbered.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at paragraph [0230]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the terms BIOBRICK® at paragraphs [0231], [0232], [0234], and [0235], PHUSION® at paragraph [0231], and GIBSON ASSEMBLY® at paragraph [0231], which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
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.
Claims 93-95 and 104-110 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.
At claim 93, line 8, it is not clear how the DNA binding polypeptide binds to the heterologous promoter sequence. Is the direct binding a covalent binding? For indirect binding, what proximity can the polypeptide be in order to provide transcriptional control?
Claims 94-95 and 104-110 depend from claim 93, and are therefore included in this rejection.
Double Patenting
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.
Claims 93, 106, and 108 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 12, and 14 of U.S. Patent No. 9,957,509.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘509 patent claims a bacterial nitrogen reduction expression system comprising an operon comprising a plurality of coding sequences associated with nitrogen fixation and the instant application claims a cell comprising a bacterial nitrogen reduction expression system comprising an operon comprising a plurality of coding sequences associated with nitrogen fixation.
Regarding claim 93, the ‘509 patent claims a bacterial nitrogen reduction expression system comprising an operon comprising a plurality of coding sequences associated with nitrogen fixation, a heterologous promoter region, and a heterologous transcriptional controller sequence encoding a protein that binds directly or indirectly to the heterologous promoter region.
Regarding claim 106, the ‘509 patent claims that the genes associated with nitrogen fixation are selected from nifJ, nifH, nifD, nifK, nifY, nifE, nifN, nifU, nifS, nifV, nifW, nifZ, nifM, nifB, and nifQ.
Regarding claim 108, the ‘509 patent claims that the transcriptional controller does not regulate the genes collectively associated with nitrogen fixation under native regulation.
The ‘509 patent does not claim a cell comprising the nitrogen reduction expression system.
However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate the nitrogen reduction system of the ‘509 patent into a cell according to the instant application because this will allow a practitioner to control nitrogen fixation in plant cells via use of the cells and expression of the nitrogen reduction expression system.
Claims 94-105, 107, and 109-11- are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 12, and 14 of U.S. Patent No. 9,957,509, as applied to claims 93, 106, and 108 above, and in view of Martinez-Argudo et al. (186(3) Journal of Bacteriology 601-610, (2004)).
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘509 patent claims a bacterial nitrogen reduction expression system comprising an operon comprising a plurality of coding sequences associated with nitrogen fixation and the instant application claims a cell comprising a bacterial nitrogen reduction expression system comprising an operon comprising a plurality of coding sequences associated with nitrogen fixation.
Regarding claim 96, the ‘509 patent claims a bacterial nitrogen reduction expression system comprising an operon comprising a plurality of coding sequences associated with nitrogen fixation, a heterologous promoter region, and a heterologous transcriptional controller sequence encoding a protein that binds directly or indirectly to the heterologous promoter region.
Regarding claim 97, the ‘509 patent claims that the genes associated with nitrogen fixation are selected from nifJ, nifH, nifD, nifK, nifY, nifE, nifN, nifU, nifS, nifV, nifW, nifZ, nifM, nifB, and nifQ.
Regarding claim 99, the ‘509 patent claims that the transcriptional controller does not regulate the genes collectively associated with nitrogen fixation under native regulation.
The ’509 patent does not claim that the cell is a prokaryotic Klebsiella cell. The ‘509 patent does not claim that nifL is omitted from the nif gene cluster. The ‘509 patent does not claim constitutive expression. The ‘509 patent does not claim that the sequence-specific DNA binding polypeptide is a sigma factor.
Regarding claims 94-95 and 102-103, Martinez-Argudo discloses the NifL-NifA system that allows bacteria to fix atmospheric nitrogen to ammonia (page 601, column 1, second paragraph). Martinez-Argudo discloses that NifL homologues are found in the prokaryotic Klebsiella species (page 602, column 1, first paragraph). Martinez-Argudo discloses that NifL can inhibit nifA activity (page 604, column 1, final paragraph).
Regarding claim 96, Martinez-Argudo disclose that NifL modulates and controls nifA (page 601, column 2, first two paragraphs).
Regarding claims 98 and 107, Martinez-Argudo discloses that the nifLA promoter is active under conditions of nitrogen excess, which is interpreted as constitutive expression.
Regarding claims 100-101 and 109-110, Martinez-Argudo discloses that transcription is dependent on a sigma factor 54, which is a Group I sigma factor (page 601, paragraph bridging columns 1 and 2).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to delete or omit nifL from the nif gene cluster of the ‘509 patent because, as disclosed by Martinez-Argudo, nifL can inhibit other genes (nifA) of the nif gene cluster. One of ordinary skill in the art would have been motivated to delete or omit nifL from the nif gene cluster in order to prevent inhibition of the nitrogen fixing capability of the Klebsiella cell of the ‘509 patent. Further, it would have been obvious to one of ordinary skill in the art at the time the invention was made to include the sigma 54 transcription factor of Martinez-Argudo in the nitrogen fixing gene cluster of the ‘509 patent because this provides for an efficient method of initiating transcription of the genes of the nif gene cluster.
Claims 93-110 are are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-42 of copending Application No. 18/978,750 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘750 application claims a bacterial nitrogen reduction expression system comprising an operon comprising a plurality of coding sequences associated with nitrogen fixation and the instant application claims a cell comprising a bacterial nitrogen reduction expression system comprising an operon comprising a plurality of coding sequences associated with nitrogen fixation.
Regarding claim 93, the ‘750 application claims a bacterial nitrogen reduction expression system comprising an operon comprising a plurality of coding sequences associated with nitrogen fixation, a heterologous promoter region, and a heterologous transcriptional controller sequence encoding a protein that binds directly or indirectly to the heterologous promoter region. The ‘750 application claims a cell comprising the nitrogen reduction expression system.
Regarding claims 94 and 102, the ‘750 application claims that the cell is a prokaryotic cell.
Regarding claims 95 and103, the ‘750 application claims that the cell is a Klebsiella cell.
Regarding claims 96 and 105, the ‘750 application claims that nifL is omitted from the nif gene cluster.
Regarding claims 97 and 106, the ‘750 application claims that the genes associated with nitrogen fixation are selected from nifJ, nifH, nifD, nifK, nifY, nifE, nifN, nifU, nifS, nifV, nifW, nifZ, nifM, nifB, and nifQ.
Regarding claims 98 and 107, the ‘750 application claims that the regulatory sequences causes constitutive expression of the sequences.
Regarding claims 99 and 108, the ‘750 application claims the sequence-specific DNA binding polypeptide does not regulate nif gene cluster under native regulation.
Regarding claims 100 and 109, the ’750 application claims that the sequence-specific DNA binding polypeptide is a sigma factor.
Regarding claims 101 and 110, the ‘750 application claims that the sequence-specific DNA binding polypeptide is a Group I sigma factor.
Therefore, the claims are not deemed to be patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Merrick et al. (185 Molecular Genetics and Genomics 75-81 (1982) disclose that the nifL gen of the Klebsiella pneumoniae nitrogen fixation (nif) gene cluster is a nif-specific repressor (abstract). Merrick et al. disclose that mutations in the nifL gene results in altered regulation and reduction in repression of nitrogenase synthesis (abstract).
Lan et al. (207 Archives of Microbiology 253, 1-10 (2025) is a post-filing reference that modification of the nifL-nifA operon of Klebsiella oxytoca improves nitrogen fixing efficiency in plants (abstract). Lan et al. disclose that nifL inhibits the transcriptional activity of nifA.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANCY J LEITH whose telephone number is (313)446-4874. The examiner can normally be reached Monday - Thursday 8:00 AM - 6:30 PM.
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NANCY J. LEITH
Primary Examiner
Art Unit 1636
/NANCY J LEITH/Primary Examiner, Art Unit 1636