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 19 August 2024. Claims 2, 3, 15, and 16 have been amended. Claim 5 has been cancelled. Claim 21 is newly added. Claims 1, 8, and 10-12, and the non-elected species in claims 2, 3, 5, and 7 have been withdrawn. Claims 2-4, 6, 7, 9, 13-17, and 21 are currently pending and under examination.
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 Rejection:
The rejection of claims 2-7, 9, and 13-17 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35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement, is withdrawn.
The rejection of claims 15 and 16 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn.
Maintenance/Modification of 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, 6, 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, 6, 7, and 9, Siepe et al. teach a method of protecting a plant 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 (Abs.; p. 14, line 11-13; p. 44, line 9-13; p. 47, line 43 to p. 48, line 9), the Paenibacillus including Paenibacillus terrae (p. 19, line 15-18). 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 may include Paenibacillus terrae, it would have been obvious to one of ordinary skill in the art to utilize Paenibacillus terrae as the Paenibacillus in the composition utilized in the method.
Siepe et al. do not teach that the Paenibacillus terrae strain is specifically Paenibacillus terrae strain NRRL B-67615. However, Siepe et al. teach Paenibacillus terrae, which is likewise usable for application to an animal pest, a plant, seed, or growth soil for protection against animal pests, including Lepidopteran pests.
No other properties of claimed Paenibacillus terrae strain NRRL B-67615 are recited in the instant disclosure. As such, it is highly likely that the Paenibacillus terrae strain of Siepe et al. is identical to the instantly recited strain. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicant’s composition differs and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicant. Even if the strain of Siepe et al. is not identical to the instantly claimed strain, any differences between the prior art strain and the claimed strain would likely be small and would not result in a patentable distinction.
Further, it would have been obvious to one of ordinary skill in the art from the teachings of Siepe et al. to provide and utilize an alternative Paenibacillus terrae species. The use of alternative species Paenibacillus terrae strain NRRL B-67615 amounts to the simple substitution of one known Paenibacillus terrae species for another, and would have been expected to predictably and successfully provide such a species for protecting plants from animal pest damage.
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.
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
With regard to Siepe et al., Applicant urges that Siepe does not teach that the Paenibacillus terrae strains are insecticidal, and Applicant has determined via sequencing analysis of the Paenibacillus terrae strains in Siepe and the strain as claimed, that these strains are not genetically identical.
Applicant’s arguments have been fully considered, but have not been found persuasive.
With regard to Applicant’s argument that that Siepe does not teach that the Paenibacillus terrae strains are insecticidal, it is clear from the teachings of Siepe et al. that the composition comprising Paenibacillus terrae is insecticidal (see for example, p. 44, line 9-13; p. 47, line 43 to p. 48, line 9).
With regard to Applicant’s argument that Applicant has determined via sequencing analysis of the Paenibacillus terrae strains in Siepe and the strain as claimed, that these strains are not genetically identical; it is noted that this evidence of genetic difference has not been presented with the response. As such, a determination as to the persuasiveness of this evidence cannot be made. It is suggested that the sequence comparisons be presented as evidence.
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.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Celik et al. (Effects of Indole-3-Acetic Acid on Hemocytes of Achoria grisella Fabr. (Lepidoptera: Pyralidae), J. Entomol. Res. Soc., (2017), 19(2): 83-93), in view of Kim et al. (Paenibacillus terrae AY-38 resistance against Botrytis cinerea in Solanum lycopersicum L. plants through deference hormones regulation, Journal of Plant Interactions (2017), Vol. 12, No. 1, pp. 244-253).
With regard to claim 21, Celik et al. teach that indole-3-acetic acid (IAA) applied to Achoria grisella larvae, which is an animal pest, in amounts including 2, 10, 50 and 100 ppm exhibits detrimental effects on A. grisella (Abs.). IAA is a natural auxin the positively affects plant growth, and adversely impacts insects (p. 83, Introduction, Para. 1).
However, Celik et al. do not teach that a composition consisting of a biologically pure culture of a Paenibacillus terrae strain and a carrier is applied to the animal pest.
Kim et al. teach the application of a composition consisting of a pure culture of Paenibacillus terrae AY-38 in culture medium, which is a carrier, to a plant to improve plant growth, including counteracting pathogenic B. cinerea infections, where the Paenibacillus terrae AY-38 secretes significant amounts of IAA, including 109.57 ± 3.2 µg/mL (109.57 ± 3.2 ppm) (Abs.; p. 245, Right Col., Antagonism of AY-38 against Botrytis cinerea on tomato fruits).
It would have been obvious to one of ordinary skill in the art to combine the teachings of Celik et al. and Kim et al., because both teach that IAA improves plant growth. The application of a composition consisting of a culture medium containing Paenibacillus terrae AY-38, which secretes amounts of IAA including 109.57 ± 3.2 µg/mL, is known in the art as taught by Kim et al. The application of a composition consisting of culture medium containing Paenibacillus terrae AY-38 to provide about 100 ppm IAA as taught by Kim et al., would have been expected to predictably improve the method of Celik et al., by not only providing an effective amount of IAA to have a detrimental effect on A. grisella, but also advantageously providing additionally protection against pathogenic B. cinerea infections, thus further enhancing plant health and growth.
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 extension fee 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 date of this final action.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653