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 .
Status of the Application
1. Claims 1-27 are pending and subject to examination on the merits. Claims 1-27 are currently under examination.
Priority
2. Acknowledgment is made for the Applicant’s claim for domestic priority based on the US provisional application PRO 63/164,361 filed 22 March 2021.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on 05 February 2024, 23 April 2024, 16 May 2024, 01 October 2024, 07 January 2026, and 17 April 2026 have been considered by the examiner. See initialed and signed PTO/SB/08’s.
Election/Restrictions
4. Applicant’s election without traverse of Group I in the reply filed on 20 February 2026 is acknowledged.
Claim Objections
5. Claim 1 is objected to because of the following informalities: “at one or near one…” (line 5) should be “at or near the…” (line 5) to improve grammar. Appropriate correction is required.
6. Claim 2 is objected to because of the following informalities: “and any plurality and/or…” should be changed to “and a combination of…” to improve grammar. Appropriate correction is required.
7. Claim 10 is objected to because of the following informalities: “10^2” should be changed to “102” to properly denote scientific notation. Appropriate correction is required.
8. Claim 19 is objected to because of the following informalities: “Nitrogen, Phosphorus, Potassium…” should be changed to “nitrogen, phosphorus, potassium” to improve grammar. Appropriate correction is required.
Claim Rejections - 35 USC § 112a
9. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
10. Claim 8 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification fails to provide an enabling disclosure, because the specification does not provide evidence that the claimed biological materials (Strain 8619-G25 deposited with NRRL as B68109, Strain 8619-G50 deposited with NRRL as B68108, Strain 8619-G53 deposited with NRRL as B68107, Strain 8619-G88 deposited with NRRL as B68104, Strain 17899-G13 deposited with NRRL as B68110, Strain 55083-G14 deposited with NRRL as B68106, Strain 68890-G12 deposited with NRRL as B68103, Strain 77155-G3 deposited with NRRL as B68105, and Strain 77155-G46 deposited with NRRL as B68102) is : (1) known and readily available to the public; (2) reproducible from the written description; or, (3) deposited in compliance with the criteria set forth in 37 CFR 1.801-1.809.
The specification lacks complete deposit information for the strain identified as Strain 8619-G25 deposited with NRRL as B68109, Strain 8619-G50 deposited with NRRL as B68108, Strain 8619-G53 deposited with NRRL as B68107, Strain 8619-G88 deposited with NRRL as B68104, Strain 17899-G13 deposited with NRRL as B68110, Strain 55083-G14 deposited with NRRL as B68106, Strain 68890-G12 deposited with NRRL as B68103, Strain 77155-G3 deposited with NRRL as B68105, and Strain 77155-G46 deposited with NRRL as B68102 because it is not clear that the Strain 8619-G25 deposited with NRRL as B68109, Strain 8619-G50 deposited with NRRL as B68108, Strain 8619-G53 deposited with NRRL as B68107, Strain 8619-G88 deposited with NRRL as B68104, Strain 17899-G13 deposited with NRRL as B68110, Strain 55083-G14 deposited with NRRL as B68106, Strain 68890-G12 deposited with NRRL as B68103, Strain 77155-G3 deposited with NRRL as B68105, and Strain 77155-G46 deposited with NRRL as B68102 are known and publicly available or can be reproducibly isolated without undue experimentation, and because the invention of claim 8 uses the bacterial strains, a suitable deposit for patent purposes is required. Accordingly, filing of evidence of the reproducible production of the bacterial strains is necessary to practice the instant invention or filing of evidence of deposit is required. Without a publicly available deposit of the above bacterial strains, one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed. Exact replication of the bacterial strain is an unpredictable event. Applicants must comply with the criteria set forth in 37 CFR 1.801-1.809.
Since the deposit has already been made under the terms of the Budapest Treaty, an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific Strain 8619-G25 deposited with NRRL as B68109, Strain 8619-G50 deposited with NRRL as B68108, Strain 8619-G53 deposited with NRRL as B68107, Strain 8619-G88 deposited with NRRL as B68104, Strain 17899-G13 deposited with NRRL as B68110, Strain 55083-G14 deposited with NRRL as B68106, Strain 68890-G12 deposited with NRRL as B68103, Strain 77155-G3 deposited with NRRL as B68105, and Strain 77155-G46 deposited with NRRL as B68102 has been deposited under the Budapest Treaty, that said bacterial strains, will be irrevocably and without restriction or condition released to the public upon the issuance of a patent and that said bacterial strains, will be replaced should they ever become non-viable, would satisfy the deposit requirement made herein.
As a possible means for completing the record, applicant may also submit a copy of the contract with the depository for deposit and maintenance of each deposit along with the necessary statements in order to meet the criteria set forth in 37 CFR 1.801-1.809.
Applicant’s attention is directed to In re Lundak, 773 F.2nd. 1216, 227 USPQ 90 (CAFC 1985) and 37 CRF 1.801-1.809 for further information concerning deposit practice.
Claim Rejections - 35 USC § 112b
11. 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.
12. Claims 10, 18, 20, and 27 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.
13. The term “about” in claim 10 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how confined substantially is, i.e. in an open or closed container or just in a container. To overcome this rejection, delete the word “about.”
14. Claim 18 recites the limitation "the formulation" in line 2. There is insufficient antecedent basis for this limitation in the claim.
15. The term “substantially” in claim 20 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how confined “substantially confined” is, i.e. in an open or closed container or just in a container. To overcome this rejection, delete the word “substantially.”
16. The term “substantially” in claim 27 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how equal “substantially equal” is. To overcome this rejection, delete the word “substantially.”
Claim Rejections - 35 USC § 103
17. 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.
18. 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.
19. Claims 1-6, 9-12, 14-20, and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Hwan et al (Park et al., 2014, KR1020140008903—cited on the IDS dated 05 February 2024) as evidenced by “Plant nutrients in the soil” (“Plant nutrients in the soil,” 1992, downloaded as a PDF from <https://www.dpi.nsw.gov.au/agriculture/soils/soil-testing-and-analysis/plant-nutrients> --cited herein) and Wang et al (Wang et al., 2018, PLOS Genetics—cited on the IDS dated 05 February 2024). Regarding claim 1, drawn to a synthetic composition comprising a plant element and a Paenibacillus bacterium, wherein said Paenibacillus is Paenibacillus polymyxa (claim 5) and Subgroup I (claim 6) with a 16S sequence 21 (claims 3-4), that is heterologously disposed to the plant element, wherein said plant element may be a seed/plant reproductive element (claims 12 and 17), leaf (claim 14), root (claim 15), whole plant (claim 16) wherein the Paenibacillus bacterium comprises an edit in one or more loci of its genome; wherein the edit is a deletion of at least one nucleotide, an insertion of at least one nucleotide, and/or a replacement of at least one nucleotide, at or near the GlnR Binding Site II, wherein the Paenibacillus bacterium displays an improved phenotype as compared to a Paenibacillus bacterium not comprising the edit, wherein the improved phenotype is increased acetylene reduction capability, improved biofilm formation, increased turbidity in culture, greater nitrogen fixation tolerance to oxygen levels, and any plurality and/or combination of the preceding, Park et al. teaches a Paenibacillus sp. fixated to potatoes with antimicrobial activity against phytophatogenic fungi and bacteria (abstract), where the Paenibacillus sp. may be a P. polymyxa (p. 2, claim 2) belonging to Subgroup I (See specification paragraph 0162) with a 16S sequence of SEQ ID NO: 21 (See Supplemental File: 20260508_124508_us-18-551-829a-21.rnpbm) and where the potato may be a seed (claims 9-10), whole plant (claim 9), or a root (p. 6, paragraph 8). Regarding claims 9 and 18, drawn to a formulation being a carrier, Park et al. teaches water as a carrier (Examples 2.1-2.2). Regarding claims 19 and 25-26, drawn to the utilization of a growth medium comprising soil in a pot, Park et al. teaches the utilization of soil, which “Plant nutrients in the soil” evidences contains nitrogen and phosphorus (p. 1) in a pot (Example 1). Regarding claim 10, drawn to a bacterium concentration of at least 102CFU/gram, Park et al. teaches a spore density of about 4x108 CFU/gram powder (Example 2.2). Regarding claim 11, drawn to an additional microbe, Park et al. teaches the formulation with S. aureus spores (Example 2.1). Regarding claim 27, drawn to the compositions in the soil with equal spacing, Park et al. teaches the even mixing of the spores into clay (Example 2.2).
Park et al. does not teach the deletion, insertion, and/or replacement of one or more nucleotides as an edit at the GlnR Binding Site II resulting in an improved phenotype of the edit containing Paenibacillus (claim 1), where said edit is GlnR Binding Site II inactivation (claim 2).
Wang et al. teaches mutational analysis of the GlnR Binding Site II to modulate nitrogenase activity, where GlnR Binding Site II inactivation resulted in a decrease in nifH transcription levels and associated nitrogenase activities (Fig. 6C and D).
Wang et al. does not expressly teach an improved phenotype resulting from GlnR Binding Site II inactivation in claims 1 and 2. However, according to MPEP 2112, the inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 103. The inactivation of the GlnR Binding Site II of Wang et al. is the same as the edit recited in the claims. As such, it is the examiner’s position that the Paenibacillus with the edit resulting in GlnR Binding Site II would have any of the improved phenotypes recited by the claims. Since the Office does not have the facilities for examining and comparing applicant’s mutant with the mutant of the prior art, the burden is on the applicant to show a novel or unobvious difference between the recited product and the recited product of the prior art (i.e., that the mutant of the prior art does not possess the same phenotype of the recited mutant). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Therefore, it 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 combine the teachings of Hwan et al., as evidenced by “Plant nutrients in the soil,” and Wang et al. to add Paenibacillus bacterium to plants to control plant diseases as taught by Hwan et al. One would be motivated to combine these teachings to arrive at the instant claims to control plant diseases with Paenibacillus to improve shelf life and increase yields, as taught by Hwan et al. (p. 3, paragraph 5). There would be reasonable expectation of success, yielding no surprising results when combining the teachings of Hwan et al., as evidenced by “Plant nutrients in the soil,” and Wang et al. to add a mutant Paenibacillus bacterium to plants to control plant diseases, since Hwan et al. teaches the beneficial addition of the Paenibacillus bacterium to growing potatoes.
20. Claims 7 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Hwan et al (Park et al., 2014, KR1020140008903—cited on the IDS dated 05 February 2024) as evidenced by “Plant nutrients in the soil” (“Plant nutrients in the soil,” 1992, downloaded as a PDF from <https://www.dpi.nsw.gov.au/agriculture/soils/soil-testing-and-analysis/plant-nutrients> --cited herein) and Wang et al (Wang et al., 2018, PLOS Genetics—cited on the IDS dated 05 February 2024) as applied to claims 1-6, 9-12, 14-20, and 25-27 above, and further in view of Grady et al (Grady et al., 2016, Microb Cell Fact—cited herein).
The teachings of Park et al. as evidenced by “Plant nutrients in the soil” and Wang et al. are discussed above and incorporated into the instant rejection.
Park et al. as evidenced by “Plant nutrients in the soil” and Wang et al. does not teach the utilization of a Subgroup II Paenibacillus bacterium (claim 7), a monocot (claim 22), a C3 monocot (claim 23), or a C4 monocot (claim 24).
Regarding the utilization of a subgroup II Paenibacillus, Grady et al. teaches the utilization of Paenibacillus graminis, an exemplary subgroup II bacterium (See the specification at paragraph 163) for phosphorus solubilization, which can promote plant growth (abstract and p. 6, column 1, paragraph 1). Regarding a monocot plant, Grady et al. teaches that the genus Paenibacillus contains many species which are known to promote the growth of plants including maize and rice, exemplary C3 and C4 monocots (See Specification paragraph 17)
Therefore, it 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 combine the teachings of Park et al. as evidenced by “Plant nutrients in the soil,” Wang et al., and Grady et al. to apply mutant Paenibacillus to C3 and C4 monocots to promote crop growth as taught by Grady et al (abstract). One would be motivated to combine these teachings to arrive at the instant claims to promote protection against insect herbivores and phytopathogens, including bacteria, fungi, nematodes, and viruses as taught by Grady et al (abstract). There would be reasonable expectation of success, yielding no surprising results when combining the teachings of Park et al. as evidenced by “Plant nutrients in the soil,” Wang et al., and Grady et al. to apply mutant Paenibacillus to C3 and C4 monocots, since Park et al. teaches the addition of Paenibacillus to multiple parts of a plant.
Double Patenting
21. 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.
22. Claim 1-2, 5-7, 9-17, 19-20, 25, and 26 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 4-6, 9-11, 17-18, and 23-25 of copending Application No. 19/154,686 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘686 claims would necessarily anticipate the instant claims.
The instant claims in their broadest are drawn to a synthetic composition comprising a plant element and a Paenibacillus bacterium, wherein said Paenibacillus is Paenibacillus polymyxa (claim 5), Subgroup I (claim 6), and Subgroup II (claim 7), that is heterologously disposed to the plant element, wherein said plant element may be a seed/plant reproductive element (claims 12 and 17), leaf (claim 14), root (claim 15), whole plant (claim 16) wherein the Paenibacillus bacterium comprises an edit in one or more loci of its genome; wherein the edit is a deletion of at least one nucleotide, an insertion of at least one nucleotide, and/or a replacement of at least one nucleotide, at or near the GlnR Binding Site II, wherein the Paenibacillus bacterium displays an improved phenotype as compared to a Paenibacillus bacterium not comprising the edit, wherein the improved phenotype is increased acetylene reduction capability, improved biofilm formation, increased turbidity in culture, greater nitrogen fixation tolerance to oxygen levels, and any plurality and/or combination of the preceding, and a bacterium concentration of at least 102CFU/gram, Park et al. teaches a spore density of about 4x108 CFU/gram powder (claim 10).
The ‘686 claims in their broadest are drawn to a synthetic composition comprising a plant element and a Paenibacillus bacterium that is heterologously disposed to the plant element, wherein the Paenibacillus bacterium comprises an edit in one or more loci of its genome; wherein the edit is a deletion of at least one nucleotide, an insertion of at least one nucleotide, and/or a replacement of at least one nucleotide, at or near one or more of the following genomic loci: glnR, GlnR Binding Site I, GlnR Binding Site II, nrgA, orf1, cueR, and/or any combination or plurality of edit(s) at any one or more of said genomic loci; wherein the Paenibacillus polymyxa bacterium, Subgroup I, or Subgroup II, displays an improved phenotype as compared to a Paenibacillus bacterium not comprising said edit, wherein the improved phenotype is selected from the group consisting of: increased acetylene reduction capability, improved biofilm formation, increased turbidity in culture, greater nitrogen fixation tolerance to oxygen levels, and any plurality and/or combination of the preceding; wherein the synthetic composition further comprises a formulation component and/or an agricultural composition; wherein the formulation component is selected from the group consisting of: a compound that improves the stability of the microbe, a preservative, a carrier, a surfactant, an anti-complex agent, and any combination thereof; and wherein the Paenibacillus bacterium is present at a concentration of at least about 10^2 CFU/mL in a liquid formulation, or at least about 10^2 CFU/gram in a non-liquid formulation, with an additional microbe, wherein the plant element is a seed, leaf, root, reproductive element, and/or whole plant, and wherein the seed comprises a transgene.
Thus, the difference between the claims in the ‘686 claim set recites 6 possible modification sites, including the GlnR binding site II. This however would still anticpate the instant claims because the ‘686 claims still include the GlnR binding Site II locus with a limited amount of other alternatives.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
23. Claims 1-4 and 9-26 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 and 20-22 of copending Application No. 19/109,302 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘686 claims would necessarily anticipate the instant claims.
The instant claims in their broadest are drawn to a synthetic composition comprising a plant element and a Paenibacillus bacterium, wherein said Paenibacillus is Paenibacillus polymyxa (claim 5), Subgroup I (claim 6), and Subgroup II (claim 7), that is heterologously disposed to the plant element, wherein said plant element may be a seed/plant reproductive element (claims 12 and 17), leaf (claim 14), root (claim 15), whole plant (claim 16), or a seed with a transgene, wherein the Paenibacillus bacterium comprises an edit in one or more loci of its genome; wherein the edit is a deletion of at least one nucleotide, an insertion of at least one nucleotide, and/or a replacement of at least one nucleotide, at or near the GlnR Binding Site II, wherein the Paenibacillus bacterium displays an improved phenotype as compared to a Paenibacillus bacterium not comprising the edit, wherein the improved phenotype is increased acetylene reduction capability, improved biofilm formation, increased turbidity in culture, greater nitrogen fixation tolerance to oxygen levels, and any plurality and/or combination of the preceding, and a bacterium concentration of at least 102CFU/gram, Park et al. teaches a spore density of about 4x108 CFU/gram powder (claim 10), wherein , the formulation is soil with nitrogen and phosphorus, and the synthetic composition is at zero degrees Celsius.
The ‘302 claims in their broadest are drawn to a synthetic composition comprising a plant element and a Paenibacillus bacterium that is heterologously disposed to the plant element, wherein the Paenibacillus bacterium comprises an edit in one or more loci of its genome; wherein the edit is a deletion of at least one nucleotide, an insertion of at least one nucleotide, and/or a replacement of at least one nucleotide, at or near one or more of the following genomic loci: glnR, GlnR Binding Site I, GlnR Binding Site II, nrgA, orf1, cueR, and/or any combination or plurality of edit(s) at any one or more of said genomic loci; wherein the Paenibacillus polymyxa bacterium, Subgroup I, or Subgroup II, displays an improved phenotype as compared to a Paenibacillus bacterium not comprising said edit, wherein the improved phenotype is selected from the group consisting of: increased acetylene reduction capability, improved biofilm formation, increased turbidity in culture, greater nitrogen fixation tolerance to oxygen levels, and any plurality and/or combination of the preceding; wherein the synthetic composition further comprises a formulation component and/or an agricultural composition; wherein the formulation component is selected from the group consisting of: a compound that improves the stability of the microbe, a preservative, a carrier, a surfactant, an anti-complex agent, and any combination thereof; and wherein the Paenibacillus bacterium is present at a concentration of at least about 10^2 CFU/mL in a liquid formulation, or at least about 10^2 CFU/gram in a non-liquid formulation, with an additional microbe, wherein the plant element is a seed, leaf, root, reproductive element, and/or whole plant, and wherein the seed comprises a transgene, wherein, the formulation is soil with nitrogen and phosphorus, and the synthetic composition is at zero degrees Celsius..
It is notable that the SEQ ID NOs: 1-66 of the instant application and the ‘302 claim set are identical. Thus, the difference between the claims in the ‘302 claim set recites 6 possible modification sites, including the GlnR binding site II. This however would still anticpate the instant claims because the ‘302 claims still include the GlnR binding Site II locus with a limited amount of other alternatives.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
24. Claim 1-2, 10-21, and 25 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-18 and 20-22 of copending Application No. 19/123,017 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘686 claims would necessarily anticipate the instant claims.
The instant claims in their broadest are drawn to a synthetic composition comprising a plant element and a Paenibacillus bacterium, wherein said Paenibacillus is Paenibacillus polymyxa (claim 5), Subgroup I (claim 6), and Subgroup II (claim 7), that is heterologously disposed to the plant element, wherein said plant element may be a seed/plant reproductive element (claims 12 and 17), leaf (claim 14), root (claim 15), whole plant (claim 16) wherein the Paenibacillus bacterium comprises an edit in one or more loci of its genome; wherein the edit is a deletion of at least one nucleotide, an insertion of at least one nucleotide, and/or a replacement of at least one nucleotide, at or near the GlnR Binding Site II, wherein the Paenibacillus bacterium displays an improved phenotype as compared to a Paenibacillus bacterium not comprising the edit, wherein the improved phenotype is increased acetylene reduction capability, improved biofilm formation, increased turbidity in culture, greater nitrogen fixation tolerance to oxygen levels, and any plurality and/or combination of the preceding, and a bacterium concentration of at least 102CFU/gram, Park et al. teaches a spore density of about 4x108 CFU/gram powder (claim 10).
The ‘017 claims in their broadest are drawn to a synthetic composition comprising a plant element and a Paenibacillus bacterium that is heterologously disposed to the plant element, wherein the Paenibacillus bacterium comprises an edit in one or more loci of its genome; wherein the edit is a deletion of at least one nucleotide, an insertion of at least one nucleotide, and/or a replacement of at least one nucleotide, at or near one or more of the following genomic loci: glnR, GlnR Binding Site I, GlnR Binding Site II, nrgA, orf1, cueR, and/or any combination or plurality of edit(s) at any one or more of said genomic loci; wherein the Paenibacillus polymyxa bacterium, Subgroup I, or Subgroup II, displays an improved phenotype as compared to a Paenibacillus bacterium not comprising said edit, wherein the improved phenotype is selected from the group consisting of: increased acetylene reduction capability, improved biofilm formation, increased turbidity in culture, greater nitrogen fixation tolerance to oxygen levels, and any plurality and/or combination of the preceding; wherein the synthetic composition further comprises a formulation component and/or an agricultural composition; wherein the formulation component is selected from the group consisting of: a compound that improves the stability of the microbe, a preservative, a carrier, a surfactant, an anti-complex agent, and any combination thereof; and wherein the Paenibacillus bacterium is present at a concentration of at least about 10^2 CFU/mL in a liquid formulation, or at least about 10^2 CFU/gram in a non-liquid formulation, with an additional microbe, wherein the plant element is a seed, leaf, root, reproductive element, and/or whole plant, and wherein the seed comprises a transgene.
Thus, the difference between the claims in the ‘686 claim set recites 6 possible modification sites, including the GlnR binding site II. This however would still anticpate the instant claims because the ‘017 claims still include the GlnR binding Site II locus with a limited amount of other alternatives.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
25. Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
26. All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CIARA A MCKNIGHT whose telephone number is (703)756-4791. The examiner can normally be reached M-F 8:00am-4:30pm.
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/CIARA A MCKNIGHT/Examiner, Art Unit 1656
/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656
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