DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office Action is in response to the paper filed 23 June 2026. Claim 6 has been cancelled. Claims 1, 8, and 10-12, and the non-elected species in claims 2, 3, and 7 remain withdrawn. Claims 2-4, 6, 7, 9, and 13-17 are currently pending and under examination.
In view of the elected species of a biologically pure culture of Paenibacillus terrae strains NRRL B-67615, B-67306, and B-67304 being deemed to be free of the art, the species of a cell free preparation of a biologically pure culture of Paenibacillus terrae strains NRRL B-67615, B-67306, or B-67304, is rejoined and hereafter examined.
The present application is a 35 U.S.C. §371 national phase entry of International Application No. PCT/US2019/051638, filed September 18, 2019, which claims the benefit under 35 U.S.C. § 119 of U.S. Provisional Patent Application No. 62/734057, filed September 20, 2018.
Withdrawal of Objections/Rejections:
The objection to claim 6, is withdrawn.
The rejection of claims 2-4, 7, 9, and 13-17 under 35 U.S.C. 103 as being unpatentable over Siepe et al., in view of Beau et al., is withdrawn.
New Rejections Necessitated by Amendment:
Claim Rejections - 35 USC § 103
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.
Claims 2-4, 7, 9, and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Siepe et al., (WO 2017/137353; Published Aug. 17, 2017 – Previously Presented).
With regard to claims 2, 3, 7, and 9, Siepe et al. teach a method of protecting a plant from pathogens and infection, including from pathogenic fungi and bacteria, and from an animal pest including an insect, by applying to the animal pest, the plant, its seed, or growth soil, an insecticidally effective amount of a composition comprising a biologically pure culture of Paenibacillus or a cell-free extract or metabolites thereof (Abs.; p. 9, line 1 to p. 10, line 8; p. 14, line 11-13; p. 34, line 10-20; p. 44, line 9-13; p. 47, line 43 to p. 48, line 9; claim 1), the Paenibacillus including Paenibacillus terrae (p. 19, line 15-18; claim 2).
The plant or seed including cereals such as wheat and rice, fruits, and vegetables, which are a “useful plant” as defined by Applicant (see Spec. para. 56-57; “useful plants” as used in the present context refers to crop plants which are employed as plants for obtaining foodstuffs, feedstuffs, fuels or for industrial purposes”), wherein the plant is protected from phytopathogenic insects or pests, including lepidopteran pests, including Agrotis spp., Alabama argillacea, Anticarsia spp., Bupalus piniarius, Capua reticulana, Cheimatobia brumata, Choristoneura fumiferana, Dendrolimus pini, Diaphania nitidalis, Earias insulana, Feltia spp., Galleria mellonella, Heliothis spp., Lymantria spp., Mamestra brassicae, Pectinophora gossypiella, Phyllocnistis citrella, Pieris spp., Pseudoplusia includens, Spodoptera spp., Tortrix viridana, Trichoplusia spp. (p. 40, line 36 to p. 41, line 31). As Siepe et al. expressly teach that the Paenibacillus includes Paenibacillus terrae, and that the active component includes a cell-free extract or metabolites thereof, it would have been obvious to one of ordinary skill in the art to utilize a cell-free extract of Paenibacillus terrae as the cell-free preparation in the composition utilized in the method.
Paenibacillus spp., including Paenibacillus terrae, desirably produces fungicidal metabolites, including fusaricidins (p. 24, line 10-19; p. 27, line 9-13). As such, a cell-free extract as taught by Siepe et al. includes fungicidal metabolites, including fusaricidins. Applicant defines “cell-free preparation” as follows: “[t]he term ‘cell-free preparation’ refers to a biologically pure culture or fermentation broth from which cells have been removed or substantially removed through means well known to those of skill in the art” (Specification, Para. 42). Applicant further indicates that fusaricidins are substances produced by the claimed Paenibacillus species in culture (Specification, Para. 5, 32). The cell-free preparation as claimed is not narrowly defined and no specific components appear to be required to be present. As Applicant indicates that the claimed Paenibacillus species produce fusaricidins, and as the claimed and taught methods both protect plants from the same pests, the cell-free preparation as taught by Siepe et al. is deemed to be structurally the same as that claimed for use in the method.
With regard to claim 4, Siepe et al. teach that the plant to be treated, and therefore the seeds of said plant, have been modified, including my mutagenesis or genetic engineering (p. 35, line 8-17), which indicates that the seed is a transgenic seed.
With regard to claim 13, Siepe et al. teach that the composition further comprises a metabolite of the Paenibacillus terrae (p. 19, line 15-18), wherein metabolites are a fermentation product.
With regard to claim 14, Siepe et al. teach that the composition is a liquid formulation (p. 48, line 28-30).
With regard to claim 15, Siepe et al. teach that the composition is applied as a seed treatment at about 1x103 to 5x1016 CFU/seed (p. 55, line 3642), wherein the composition is applied as a liquid formulation (p. 48, line 28-30). While it is not specifically taught that the composition comprises at least about 1x104 CFU/mL of the liquid formulation, it would have been routine for an ordinary artisan to determine the appropriate amount of the composition to apply based on the type of plant, the location, the climate, and the pest to be treated. Additionally, please also note that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer v. Apotex, 480 F.3d at 1368. The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)). Accordingly, it would have been obvious to optimize the amount of the Paenibacillus terrae in the liquid composition, including to at least about 1x104 CFU/mL, to result in the application of an effective amount of the composition based on factors including the type of plant, the location, the climate, and the pest to be treated, when practicing the method as taught by Siepe et al. and Beau et al.
With regard to claim 16, Siepe et al. teach that the composition further comprises
an agriculturally acceptable carrier (p. 48, line 22-24; p. 54, line 1-8), or a stabilizer (p. 51, line 9-14).
With regard to claim 17, Siepe et al. teach that the composition is applied at about 1x1012 to 5x1014 CFU per hectare (p. 55, line 20-31), which is fully encompassed within about 1x104 to about 1x1014 CFU per hectare.
Response to Arguments
Applicant indicates that the amendments place the claims in condition for allowance.
Applicant’s arguments have been fully considered, but have not been found persuasive. As discussed in the modified rejection above, the rejoined species of “a cell-free preparation” is not allowable.
It is noted that removal of the now-examined species of “a cell-free preparation thereof” from independent claims 2 and 3 would place the claims in condition for allowance, as indicated by Examiner in the interview of 19 December 2025.
Conclusion
No claims are allowable.
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 JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
