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 .
DETAILED ACTION
Claims 1-40 are pending.
Election/Restrictions
Applicant’s election of Group I, claims 1-17, in the reply filed on 11/13/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 18-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/13/2025.
Claims 1-17 are examined herein.
Claim Objections
Claim 4 is objected to because of the following informalities: “Bacillus firmus strain I-1582” is inconsistent with Bacillus firmus I-1582 recited in claim 1.
Appropriate correction is required.
Claim 9 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claim 9 has not been further treated on the merits.
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 2-8, 14, and 17 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 2 recites “wherein the mutant comprises a biologically pure culture of a Bacillus firmus strain NRRL B-67003, a Bacillus firmus strain NRRL B-67518 or a mutant having all the identifying characteristics of one or more of the strains and improved indole acetic acid production compared to one or more of the strains.” It is unclear whether the limitation “one or more of the strains” refers only to Bacillus firmus strain NRRL B-67003 and a Bacillus firmus strain NRRL B-67518 or whether this limitation refers to Bacillus firmus strain NRRL B-67003, Bacillus firmus strain NRRL B-67518, and Bacillus firmus I-1582.
Claim 4 recites the limitation “wherein the mutant strain has a genome sequence with greater than about 90% sequence identity to Bacillus firmus strain I-1582.” Claim 6 recites the limitation “wherein the mutant strain has a genome sequence with greater than about 90% sequence identity to Bacillus firmus I-1582, Bacillus firmus strain NRRL B-67003 or Bacillus firmus strain NRRL B-67518.” For both of these claims, it is unclear what the reference genome sequence is because the genome sequence of each recited strain is not disclosed in the specification.
Claim 8 recites the limitation "the mutant strain" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 8 depends from claim 2. Claim 2 recites at least two different mutant strains, including B. firmus strain NRRL B-67003 and B. firmus strain NRRL B-67518.
Claim 14 recites the limitation "the strain" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites “The composition of claim 13 comprising at least about 1 × 106 CFU of the strain/g freeze-dried powder or spray-dried powder.” However, claim 14 ultimately depends from claim 10, which is drawn to a composition comprising a fermentation product of Bacillus firmus strain NRRL B-67003, Bacillus firmus strain NRRL B-67518, or a mutant of one or more of the strains. Claim 10 does not require that the composition comprises the bacteria, only a fermentation product of the bacteria. Therefore, the metes and bounds of claim 14 are undefined since it is unclear whether the composition comprises the fermentation product, the bacteria, or both the fermentation product and the bacteria. Furthermore, claim 14 is drafted such that the sentence is incomplete: “The composition of claim 13 comprising…” For example, the claim does not recite “The composition of claim 13, wherein the composition comprises at least about 1 × 106 CFU of the strain/g freeze-dried powder or spray-dried powder.
Claim 17 is indefinite because the claim recites the composition of claim 15 or 16 comprising at least about 2 × 109 CFU of the strain/mL of the liquid formulation. There is a lack of antecedent basis for “the strain” since claim 17 ultimately depends from claim 10, which recites at least two different strains. Furthermore, it is unclear whether the composition comprises the fermentation product, the bacteria (CFU), or bacteria and the fermentation product. Claim 17 is also drafted as an incomplete sentence.
Claims 3 and 5-8 are indefinite for depending from a rejected base claim and not rectifying the source of indefiniteness.
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.
Claims 2-3, 6-8, and 10-17 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claims 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.
It is apparent that Bacillus firmus strain NRRL B-67003 and Bacillus firmus strain NRRL B-67518 are required to practice the claimed invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the Bacillus firmus strain NRRL B-67003 and Bacillus firmus strain NRRL B-67518.
It is noted that Applicants have deposited Bacillus firmus strain NRRL B-67003 and Bacillus firmus strain NRRL B-67518 but there is no indication as to public availability. See specification [0082] and [0081], respectively. There is no repeatable method set forth in the specification by which the public could obtain the strains.
This rejection will be withdrawn if a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, is made that clearly indicates that all restrictions imposed by the depositor on the availability to the public of the deposited material (Bacillus firmus strain NRRL B-67003 and Bacillus firmus strain NRRL B-67518 at the National Center for Agricultural Utilization Research, a Budapest Treaty depository) will be irrevocably removed upon the granting of the patent. See 37 C.F.R. 1.808; MPEP 2404.01. In the alternative, Applicant may convincingly show that there indeed exists a repeatable method to obtain the strain.
Claims 1-8 and 10-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
Claim 1 is drawn to a composition comprising a biologically pure culture of a mutant of Bacillus firmus I-1582 having improved indole acetic acid production and improved ability to promote plant growth compared to Bacillus firmus I-152.
Claims 2 and 10 recite a genus of a mutant having all the identifying characteristics of one or more of the Bacillus firmus strains NRRL B-67003 and NRRL B-67518. The broadest reasonable interpretation of “identifying characteristics” in view of the specification and dependent claims are the following: greater than about 90% sequence identity to Bacillus firmus strain NRRL B-67003 or Bacillus firmus strain NRRL B-67518, enhanced indole acetic acid production compared to Bacillus firmus strain NRRL B-67003 or Bacillus firmus strain NRRL B-67518, enhanced ability to promote/enhance plant growth compared to Bacillus firmus I-1582, Bacillus firmus strain NRRL B-67003 or Bacillus firmus strain NRRL B-67518, ability to increase plant yield relative to Bacillus firmus I-1582, Bacillus firmus strain NRRL B-67003 or Bacillus firmus strain NRRL B-67518, and a nematode control ability at least comparable to parent strain I-1582.
Although the strains NRRL B-67003 and NRRL B-67518 are disclosed in the specification (e.g. Table 3 on page 24), no other species are disclosed with all of the identifying characteristics listed above. No mutants of NRRL B-67003 or NRRL B-67518 are disclosed. The specification discloses that the strains NRRL B-67003 and NRRL B-67518 are produced by random mutagenesis and/or genome shuffling of Bacillus firmus I-1582 (see specification [0087] and [00100]).
The strains NRRL B-67003 and NRRL B-67518 are never genetically characterized, so the genetic differences (structure) between the mutants and their parent strain that are responsible for the identifying characteristics of the mutant strains (e.g. improved indole-3-acetic acid production) are not disclosed within the specification.
The prior art does not teach any species of the claimed genus. Mutants of Bacillus firmus I-1582 are known in the art (see for example, the abstract of US 6,406,690 and paragraph 41 of WO 2013/152353 A1), but they are uncharacterized with respect to indole-3-acetic acid production. Mutants of NRRL B-67003 or NRRL B-67518 were unknown in the prior art as of the effective filing date of the claimed invention.
Indole-3-acetic acid is a phytohormone produced by bacteria such as Bacillus firmus that enhances plant growth. For example, Datta (Plant and Soil 69, 365-373 (1982)) teaches a super strain of Bacillus firmus (NCIM-2636) that produces the phytohormone indole-3-acetic acid and also solubilizes inorganic phosphate (Summary). Bacillus firmus NARS1 is also known to increase plant growth (Abstract of Khan et al. "Plant growth promoting effect of Bacillus firmus strain NARS1 isolated from Central Himalayan region of India on Cicer arientnum at low temperature." (2007): 1179-1181). Although Idris et al. (Molecular plant-microbe interactions 20.6 (2007): 619-626) teaches putative genes involved in indole-3-acetic acid metabolism in Bacillus amyloliquefaciens FZB42 (Abstract), the genes responsible for indole-3-acetic acid in Bacillus firmus I-1582 are not known.
Bacillus strains are also known to produce a toxin that kills nematodes (Terefe et al., Journal of invertebrate pathology 100.2 (2009): 94-99; page 94, Introduction, right column, paragraph 1). Furthermore, Terefe teaches that Bacillus firmus kills nematodes (Terefe page 94, right column, paragraph 2). Hagan et al. (Plant Health Progress 16.4 (2015): 151-157) teaches that Bacillus firmus I-1582 in particular is a nematicide (Abstract, left column, paragraph 1).
In summary, although the prior art teaches that Bacillus firmus strains are beneficial for plants because of their ability to stimulate plant growth and kill nematodes, the genes responsible for indole-3-acetic acid (phytohormone) and toxin production in Bacillus firmus I-1582 are not taught by the prior art.
The person of ordinary skill in the art would not have recognized that the inventors had possession of the claimed genus of mutants because of the following reasons: only two species are disclosed (NRRL B-67003 and NRRL B-67518), there are no species taught by the prior art, there is no structure-function correlation disclosed, and the person of ordinary skill in the art would have been unable to predict and visualize the structures of all the species within the claimed genus based on the state of the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CANDICE LEE SWIFT whose telephone number is (571)272-0177. The examiner can normally be reached M-F 8:00 AM-4:30 PM (Eastern).
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/CANDICE LEE SWIFT/Examiner, Art Unit 1657
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
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