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
The instant application is a U.S. national phase of PCT/US2019/051951, filed on September 18, 2019 and has a provisional application 62/734335 with priority date September 21, 2018.
Applicant’s Amendment filed January 21, 2025 is acknowledged. Claims 1-63 and 78 are canceled. Claims 64, 71, and 83-84 are amended. Currently, claims 64-77 and 79-84 are pending and under examination.
The previous objection to the specification and 112(b) rejection in the non-final office action mailed November 6, 2024 are withdrawn due to Applicant’s amendment to the claims and specification filed January 21, 2025.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 64-75, 79-81, 83, and 84 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jarrett et al. (WO 98/08388, cited in PTO-892 mailed 11/6/2024, hereinafter “Jarrett”) in view of Hurst, et al. (JOURNAL OF BACTERIOLOGY, Apr. 2011, p. 1966–1980, cited in PTO-892 filed July 17, 2024, hereinafter “Hurst”).
Jarrett teaches Xenorhabdus nematophilus strains acting synergistically with Bacillus thuringiensis when applied as an oral insecticidal pesticide, against one or more species of insects belonging to the order Lepidoptera (abstract, claim 14). Jarrett teaches by acting synergistically with B. thuringiensis is meant that the combination of B. thuringiensis cellular material and X. bovienii is more effective than the sum of the effects of the pesticides used individually, which is pertinent to the limitations in claims 64 and 83-84 (pg. 10, lines 1-10). Jarrett teaches when used in conjunction with B.thuringiensis cells as an oral pesticide, the concentration of B. thuringiensis cellular material necessary to give 50% mortality in a P.brassicae when used alone is reduced by at least 80% when it is used in combination with the agent at a concentration sufficient to give 25% mortality when the agent is used alone which meets the limitation of claim 71 (pg. 10, lines 4-10). Jarrett teaches the agents used in the invention can be obtained, purified, or enriched from cells and cultures of the bacteria or mutants thereof (pg. 9, lines 17-20). Jarrett teaches in Examples 4 and 5 the synergistic activity of B. thuringiensis powder (derived from cultured B. thuringiensis) and X. nematophilus cells and supernatants against Pieris brassicae larvae was assessed and mortality was recorded after 2 and 4 days which meets the limitations of claims 64, 73, 75, 83, and 84 (pgs. 17-20). Further Jarrett teaches the compositions of the invention would be used to kill insects by spraying crops which meets the limitation of claims 81, 83, and 84 (pg. 6, lines 16-19).
Jarrett does not teach a Yersinia entomophaga strain that has 99.5% whole genome sequence identity to Y. entomophaga MH96 strain.
However, Hurst teaches the Y. entomophaga MH96 strain has a broad host range toxin complex active against insects (title). Hurst teaches filter-sterilized culture supernatants derived from Y. entomophaga MH96, grown at temperatures of 25°C or less, were able to cause mortality towards Plutella xylostella (Lepidoptera) and Costelytra zealandica (Coleoptera) larvae (abstract). Hurst teaches the bacterium Yersinia entomophaga MH96 was isolated from a diseased C. zealandica larva (pg. 1967, col. 1, para 3). Hurst teaches the main disease determinant of the Y. entomophaga MH96 strain is localized to a ~32kb pathogenicity island (PAI) (abstract). Several mutants of MH96 were created and tested for their effectiveness on the insects, which resulted in the TC knockout (which deletes the PAI from the genome) displayed no insecticidal activity (pg. 1972, Table 3). Hurst teaches further experiments were performed with the MH96 strain for insecticidal activity using sonicated filtrate (pure toxin) and culture supernatants (pg. 1973, Table 4). Hurst teaches the assays were carried out on a cabbage leaf disc assay which meets the limitation of plant or plant part recited in claims 64 and 80, and assessed at day 5 which meets the limitation of claim 75 (pg. 1970, col. 1, para 5-6). Hurst teaches phylogenetic analysis showed X. nematophilus TC protein XptD1 was similar to YenA2, the TCA-like genes in the PAI from MH96 (pg. 1970, col. 2, para 5). Hurst also teaches the LD50 of the TC from MH96 towards P. xylostella and C. zealandica larvae correlated with the relative efficacy of X. nematophilus XptA1 against Pieris rapae and Pieris brassicae (pg. 1976, col. 2, para 1).
Even though Jarrett and Hurst do not explicitly teach the mortality assessment was conducted on day 1 or day 3, the references encompass these days and thus meet the limitations of claims 72 and 74. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to utilize the method of combining two bacterial insecticidal strains (B. thuringiensis and X. nematophilus) to synergistically increase the insecticidal effects as taught by Jarrett, and replace X. nematophilus with the phylogenetically related species Y. entomophaga MH96 strain taught by Hurst with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to substitute the Y. entomophaga strains, specifically those having 99.5% identity to the MH96 strain, to advantageously increase the synergistic toxic effects on a broad host range as taught by Hurst. Further, one of ordinary skill in the art would have been motivated to utilize a known highly insecticidal bacteria such as B. thuringiensis with the Y. entomophaga MH96 strain taught by Hurst to overcome the ongoing problem of resistance to existing pesticides, or to expand the range of pests which can be controlled or the ways in which existing agents are used as taught by Jarrett (pg. 1, lines 12-16).
Thus claims 64-75, 79-81, 83, and 84 are obvious over Jarrett in view of Hurst.
Claims 76, 77, and 82 are rejected under 35 U.S.C. 103 as being unpatentable over Jarrett and Hurst as applied to claims 64-75, 79-81, 83, and 84 above, and further in view of Oppert, et al. (WO 2009/067487 A2, cited in PTO-892 filed July 17, 2024, hereinafter “Oppert”).
Neither prior art explicitly teaches the combinatorial effect of the two insecticides being measured after 5 days post treatment. Nor Jarrett or Hurst explicitly teach the insecticides are applied to plant foliage.
However, Oppert teaches a novel cadherin peptide that enhances the toxicity of Cry proteins derived from B. thuringiensis (abstract). Oppert teaches the cadherin peptide is derived from Tenebrio molitor larvae and has synergistic characteristics of a binary toxin potentiating Cry3 and Cry1 toxins against coleopterans and lepidopteran species (pg. 1, para 1). Oppert teaches the Cry toxins and cadherin peptide were co-administered on susceptible and Bt-resistant Pectinophora gossypiella and assessed for the larval mortality (pg. 29, para 77, pg. 30, para 79). Oppert teaches the susceptible P. gossypiella larval mortality was assessed at days 7, 10, 17, and 21 and showed significant increase in mortality at day 17 and 21 (Figure 7). For the Bt-resistant P. gossypiella, the combinatorial effect of the Cry1A toxin and cadherin peptide significantly increased mortality on days 7, 10, 17, 21, and 28 (Figure 8). Oppert teaches the composition would typically be applied onto the foliage of the plant by conventional methods such as spraying which meets the limitation of claim 82 (pg. 5, para 8).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to combine the methods of a composition comprising B. thuringiensis taught by Jarret with the Y. entomophaga taught by Hurst, and conduct the experimentation methods taught by Oppert with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to test the effectiveness of the composition by employing the analysis method of assessing the combined effects of the composition and compare to the insecticidal effects of the individual components over a series of days ranging from 1-9 days post treatment as taught by the prior art. In the case where the claimed ranges (such as the days post-treatment) overlap or lie inside ranges disclosed by the prior art is a prima facie case of obviousness (See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further it would have been obvious to one of ordinary skill in the art to apply the composition to the foliage of the plant by conventional methods as taught by Oppert.
Thus, claims 76, 77, and 82 are obvious over Jarrett and Hurst in view of Oppert.
Response to Arguments
Applicant's arguments filed January 21, 2025 have been fully considered but they are not persuasive.
Regarding remarks directed to the 103 rejections, Applicant argues the outstanding rejections are improper because the proposed modifications require an impermissible change to the underlying principle of operation—replacement of Jarrett's "novel strains of Xenorhabdus" with "a Yersinia entomophaga pesticide.""If the proposed modification or combination of the prior art would change the principle of operation of the prior art invention being modified, then the teachings of the references are not sufficient to render the claims prima facie obvious." MPEP 2143.01. Applicant argues Jarrett is founded upon "novel strains of Xenorhabdus" and "novel pesticidal agents which can be isolated from Xenorhabdus spp." Replacing those strains/toxins with the recited Yersinia entomophaga pesticide would eviscerate Jarrett's entire teaching and would clearly constitute an impermissible change the principle of operation underlying Jarrett's compositions/methods. Such modifications cannot support a rejection under 35 U.S.C. 103. Applicant also argues one of ordinary skill in the art would never have been motivated to make the proposed modifications. If one of ordinary skill in the art had wanted to make use of Hurst's Yersinia entomophaga in the compositions/methods of Jarrett, he/she would not have replaced Jarrett's "novel strains of Xenorhabdus," which are the heart of Jarrett's disclosure, but rather the Bacillus thuringiensis. Such a change would not anticipate the presently claimed method and would not render the presently claimed methods obvious.
In response to applicant's argument that the incorporation of the Y. entomophaga strain taught by Hurst would be an impermissible change of the underlying principle of operation in the method taught by Jarrett, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, Jarrett teaches the synergistic effects of B. thuringiensis and the novel Xenorhabdus strain, wherein the combination produces enhanced insecticidal effects. Hurst teaches a novel Y. entomophaga strain that has insecticidal effects. It would have been prima facie obvious to one of ordinary skill in the art to combine this novel insecticidal Y. entomophaga strain with the well-known insecticidal B. thuringiensis to create a composition with enhanced insecticidal effects that are greater than the individual strains’ effects alone, thus the 103 rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 JESSICA EDWARDS whose telephone number is (571)270-0938. The examiner can normally be reached M-F 8am-5pm EST.
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/JESSICA EDWARDS/
Examiner
Art Unit 1657
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657