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 1-2, 4-5, and 8-40 are pending. Claims 18-40 are withdrawn. Claims 3 and 6-7 are cancelled. Claims 1-2, 4-5, and 8-17 are under examination on their merits.
Response to Arguments
Applicant's arguments filed 6/23/2026 have been fully considered but they are not persuasive.
Applicant requests rejoinder of withdrawn claims 18-40 (Arguments, paragraph 1 on page 9).
In response, until all claims to the elected product are found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Here, the elected product claims are not allowable, so the withdrawn claims are not rejoined at this time.
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.
(New Rejection Necessitated by Amendment) Claims 2, 4-5, 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 strain comprises a mutant of the Bacillus firmus strain NRRL B-67003 or a Bacillus firmus strain NRRL B-67518 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 I-1582.” It is unclear what the reference genome sequence is because the genome sequence of each recited strain is not disclosed in the specification.
Claim 4 recites the limitation "the mutant strain" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 4 depends from claim 1. Claim 1 recites at least two different mutant strains, including B. firmus strain NRRL B-67003 and B. firmus strain NRRL B-67518.
Claim 5 recites the limitation "the mutant strain" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 5 ultimately depends from claim 1. Claim 1 recites at least two different mutant strains, including B. firmus strain NRRL B-67003 and B. firmus strain NRRL B-67518.
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 1. Claim 1 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 Bacillus firmus" 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 strain of Bacillus firmus strain NRRL B-67003 or Bacillus firmus strain NRRL B-67518. 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.
Claim 17 is indefinite because the claim recites the composition of claim 15 wherein the liquid formulation comprises at least about 2 × 109 CFU of the Bacillus firmus strain/mL of the liquid formulation. There is a lack of antecedent basis for “the Bacillus firmus” 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 5 is indefinite for depending from a rejected base claim and not rectifying the source of indefiniteness.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
(New Rejection Necessitated by Amendment) Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 fails to include all the limitations of the claim upon which it depends. Claim 2 recites the mutant strain comprises a mutant of the Bacillus firmus strain NRRL B-67003 or a Bacillus firmus strain NRRL B-6718 and improved indole acetic acid production compared to one or more of the strains. However, claim 2 depends from claim 1, which recites the mutant comprises a biologically pure culture of a Bacillus firmus strain NRRL B-67003 or a Bacillus firmus strain NRRL B-67518. In other words, claim 1 requires the mutant strain comprises Bacillus firmus strain NRRL B-67003 or Bacillus firmus strain NRRL B-67518, whereas claim 2 recites the mutant strain comprises a mutant of Bacillus firmus strain NRRL B-67003 or Bacillus firmus strain NRRL B-67518.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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.
(New Rejection Necessitated by Amendment) Claims 1-2, 4-5, and 8-17 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 2 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.
Claims 2 and 10 recite a genus of a mutant strain of Bacillus firmus strains NRRL B-67003 and NRRL B-67518. Additionally, claim 2 requires the mutant strain comprises improved indole acetic acid production.
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); cited in the Non-Final Action mailed on 12/23/2025) 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; cited in the Non-Final Action mailed on 12/23/2025). Although Idris et al. (Molecular plant-microbe interactions 20.6 (2007): 619-626; cited in the Non-Final Action mailed on 12/23/2025) 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.
In summary, although the prior art teaches that Bacillus firmus strains are beneficial for plants because of their ability to stimulate plant growth, 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 mutant strains of Bacillus firmus NRRL B-67003 and NRRL B-67518 because of the following reasons: no mutants of NRRL B-67003 and NRRL B-67518 are disclosed, 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at (571)272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CANDICE LEE SWIFT/Examiner, Art Unit 1657
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
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