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 .
Status of the Claims
Claims 1-18, 20-26 and 28-38 are pending in the present application.
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 1-2, 4, 6-16, 20, 26, 29, 32, 34 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Suchanek et al. (WO 2018/068774 A2) in view of Eiben et al. (WO 2016/050726 A1).
Regarding instant claim 1, Suchanek et al. teach a formulation comprising spores of the mycoparasitic fungus Pythium oligandrum M1, 79.77 wt.% olive oil, 0.96 wt.% vitamin E acetate and 16 wt.% precipitated silicone dioxide (Sident® 22 S), wherein the composition was stable for 6 months at a temperature of 25 °C (Example 12). This formulation comprises precipitated silicone dioxide in an amount that is outside the instantly claimed range.
Suchanek et al. also teach formulations comprising spores of the mycoparasitic fungus Pythium oligandrum M1, 6.5 wt.% precipitated silica (Sipernat® 22), and 92 wt.% paraffin oil or sunflower oil, wherein the compositions are stable for 24 months at a temperature of up to 25 °C (Examples 15-16). Examples 15-16 do not comprise an antioxidant, as instantly claimed.
Suchanek et al. do not explicitly disclose compositions comprising the fungal spores, at least 25 wt.% of at least one plant oil, at least 0.1 wt.% of at least one antioxidant, and between 1.5 and 7 wt.% of at least one rheology-modifying agent selected from fumed hydrophobic silica, fumed hydrophilic silica and precipitated silica.
Suchanek et al. teach a liquid biological antifungal product containing the Pythium oligandrum microorganism is characterized in that it contains a stabilized suspension of the Pythium oligandrum microorganism and contains 0.05 to 10.0 % weight culturing biomass of the Pythium oligandrum microorganism with content of cultivation medium, cell forms of this microorganism and substances produced by this microorganism, 79.77 to 99.95 % weight stabilizer, and the remainder, up to 100 % weight, at least of one modifying application substance from a group including filling, aroma and vitamin E (Claim 2). Suchanek et al. teach that the composition of liquid suspensions is compatible with a wide range of other substances which modify their utility properties or their applications in the form of antioxidant substances, natural activators and vitamins, for example silicon oxide as a filling, vitamin E acetate and other substances (pg. 5, ln. 11-14).
Eiben et al. teach a liquid composition comprising spores of a spore forming fungus, a polyether-modified trisiloxane and fumed silica or precipitated silica (Claim 1). Eiben et al. teach that fumed silica or precipitated silica is added in order to prevent sedimentation without influencing viability of the spores, providing long term stability when the formulation is at rest or in storage (pg. 5, ln. 3-7). Silica are also used as rheological control agents (pg. 5, ln. 15). Eiben et al. teach that the fumed silica is either hydrophilic or hydrophobic, and includes Aerosil 200 (pg. 5, ln. 19-22, 27 and 33; Examples 1-8). The silica concentration is between 0.1 to 9 wt.%, e.g. of 3 to 7 or 4 to 6 wt.% (pg. 6, ln. 8-18) and the spores include Isaria fumosorosea, in particular strains Apopka 97 and FE 9901 (pg. 13, ln. 20-22; pg. 14, ln. 2-3 and 10-11; Example 8; Claim 11).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare a liquid biological antifungal product according to Suchanek et al. comprising dormant oospores of the Pythium oligandrum M1 microorganism, 6.5 wt.% precipitated silica as an inorganic carrier, at least 79.77 wt.% plant oil as stabilizer, and 0.96 wt.% vitamin E acetate as modifying/application substance (i.e., antioxidant). A person of ordinary skill in the art would have been further motivated to prepare compositions comprising precipitated silica, wherein the concentration of precipitated silica is between 0.1 to 9 wt.%, such as 3 to 7 or 4 to 6 wt.%, as reasonably suggested by Suchanek et al. and Eiben et al. A person of ordinary skill in the art would have been able to determine the optimum workable concentration of fumed or precipitated silica within the ranges taught by Suchanek et al. and Eiben et al. in view of the teaching that silica prevents sedimentation providing long term stability when the formulation is at rest or in storage, and silica is used as rheological control agents.
Regarding instant claim 2, Suchanek et al. teach that the formulation comprises olive oil (Example 12). Suchanek et al. also teach that the stabilizer may be an oil, such as sunflower oil (Example 16; Claim 8).
Regarding instant claim 4, Suchanek et al. teach that the formulation comprises vitamin E acetate (i.e., tocopheryl acetate) (Example 12).
Regarding instant claim 6, Suchanek et al. teach the formulation comprises 0.96 wt.% vitamin E acetate (Example 12).
Regarding instant claim 7, Suchanek et al. do not include water in their composition.
Regarding instant claims 8-9, Suchanek et al. teach conidia of Pythium oligandrum M1 (Example 12).
Regarding instant claims 10-12, Suchanek et al. do not explicitly disclose fungal spores originating from the instantly claimed fungal species.
Eiben et al. teach that the spore forming fungus includes Isaria fumosorosea, in particular strains Apopka 97 and FE 9901 (pg. 13, ln. 20-22; pg. 14, ln. 2-3 and 10-11; Example 8; Claim 11).
Regarding instant claims 13-14, Eiben et al. teach that the spores are present in a concentration of between 1x105/ml and 2x1011/ml (Claim 9).
Regarding instant claims 15-16, Eiben et al. teach that a preferred polyether-modified trisiloxane includes Break-Thru S240 (pg. 4, ln. 21-28), wherein the polyether-modified trisiloxane fulfills the requirement of reducing surface tension even in high dilutions, and are viscous so that normally no thickening agent is necessary (pg. 4, ln. 30-34).
Regarding instant claim 20, Eiben et al. teach that the fumed silica is either hydrophilic or hydrophobic, and includes Aerosil 200 (pg. 5, ln. 19-22, 27 and 33; Examples 1-8).
Regarding instant claim 26, Suchanek et al. teach that the composition is antifungal (Example 12).
Regarding instant claim 29, Suchanek et al. teach that the oil comprises sunflower oil (Claim 8) and the silicon oxide comprises precipitated silica (Sident® 22 S; Example 12).
Regarding instant claims 32, 34 and 36, Suchanek et al. teach that the oil comprises sunflower oil (Claim 8); and Eiben et al. teach the spores include Isaria fumosorosea, in particular strains Apopka 97 and FE 9901 (pg. 13, ln. 20-22; pg. 14, ln. 2-3 and 10-11; Example 8; Claim 11). Eiben et al. teach that the fumed silica is either hydrophilic or hydrophobic, and includes Aerosil 200 (pg. 5, ln. 19-22, 27 and 33; Examples 1-8).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to prepare compositions comprising fungal spores originating from Isaria fumosorosea, sunflower oil, vitamin E acetate (i.e., tocopheryl acetate), and precipitated or fumed silica such as Sident® 22 S and Aerosil 200, as reasonably suggested by Suchanek et al. and Eiben et al.
Response to Arguments
Applicant's arguments filed 5 August 2025 have been fully considered but they are not persuasive. Applicant argues that in view of Examples 9 and 12 in Suchanek, a person skilled in the art would understand that the oospores of P. oligandrum are just as stable in sterile distilled water (Example 9) as they are in a formulation comprising, amongst other things, olive oil, Vitamin E and silicon dioxide (Example 12). The results do not demonstrate that the formulation of Example 12, which comprises olive oil, 16 wt.-% silicon dioxide and 0.96 wt.-% Vitamin E, has any influence on the stability of P. oligandrum spores.
The examiner respectfully argues that Suchanek et al. teach Examples 15-16 comprising oospores of P. oligandrum, 6.5 wt.% precipitated silica (Sipernat® 22), and 92 wt.% paraffin or sunflower oil, that resulted in longer stability of the product. The product was stable for 24 months at a temperature of up to 25 °C.
Therefore, Suchanek et al. teach compositions that are stable for 6 months as well as compositions that are stable for up to 24 months. A person of ordinary skill in the art would have been motivated to prepare compositions according to Suchanek et al. with the reasonable expectation that the products will be stable for at least 6 months and up to 24 months.
Applicant also argues that the present claims are directed to an improved formulation for improving the stability of fungal spores. The claimed liquid agricultural formulation, as recited in claim 1, comprises “fungal spores, at least 25 wt.-% of at least one plant oil, at least 0.1 wt.-% of at least one antioxidant and between 1.5 wt.-% and 7 wt.-% of at least one rheology-modifying agent, wherein the at least one rheology modifying agent is selected from the group consisting of fumed hydrophobic silica, fumed hydrophilic silica and precipitated silica.” Examples 2, 4 and 5 of the present application clearly demonstrate that the specifically claimed composition improves fungal spore viability.
Examples 2 and 4 demonstrate that a plant oil formulation comprising both an antioxidant and a rheology-modifying agent unexpectedly allows for improved conidial viability when compared to the plant oil alone, the plant oil comprising just the antioxidant, or the plant oil comprising just the rheology-modifying agent.
Examples 2 and 5 demonstrate that a plant oil formulation comprising both an antioxidant and a rheology-modifying agent allows for improved conidial viability when compared to the plant oil alone, or the plant oil comprising just the antioxidant.
Applicant asserts that the present application therefore demonstrates that the combination of at least one antioxidant and at least one rheology-modifying agent at a concentration of between 1.5 wt.-% and 7 wt.-% in a plant oil has an unexpected, synergistic technical effect of improving conidial viability when compared to formulations comprising either an antioxidant or a rheology-modifying agent alone.
The examiner respectfully argues that Suchanek et al. teach that in Examples 11-12 the numbers of viable oospores did not fall below 90% of the initial value for a minimum of 6 months at a temperature of 25 °C, and Examples 15-16 the numbers of viable oospores did not fall below 90% of the initial value for up to 24 months at a temperature of 25 °C. Therefore, formulations according to Suchanek et al. comprising fungal spores, at least one plant oil, at least one rheology-modifying agent, and optionally at least one antioxidant, were stable for 6 to 24 months. Thus, the stability of the compositions according to the instant invention for 8 weeks is not surprising and unexpected.
Applicant further argues that there is no need to add a further rheology-modifying agent to the formulation of Example 12 of Suchanek, or replace the rheology-modifying agent of Example 12 of Suchanek. Eiben does not provide any teaching or motivation to the skilled person to replace the 16% of silicon oxide used in Example 12 of Suchanek with the fumed or precipitated silica disclosed in Eiben.
The examiner respectfully argues that Suchanek et al. teach formulations comprising a precipitated silica (Sident® 22 S or Sipernat® 22). Eiben et al. teach that fumed silica or precipitated silica is added in order to prevent sedimentation without influencing viability of the spores, providing long term stability when the formulation is at rest or in storage (pg. 5, ln. 3-7). It would have been obvious to one of ordinary skill in the art at the time of the instant invention to substitute fumed silica and precipitated silica according to Eiben et al. as a functional equivalent to the precipitated silica taught by Suchanek et al. The Supreme Court in KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. One such rationale includes the simple substitution of one known element for another to obtain predictable results. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. See MPEP 2143.
Claims 3, 5, 23-25, 28, 30-31, 33, 35 and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Suchanek et al. (WO 2018/068774 A2) in view of Eiben et al. (WO 2016/050726 A1) as applied to claims 1-2, 4, 6-16, 20, 26, 29, 32, 34 and 36 above, further in view of Park et al. (WO 2014/193162 A1).
The teachings of Suchanek et al. and Eiben et al. are discussed above.
Regarding instant claim 3, 23-25 and 28, Suchanek et al. and Eiben et al. do not explicitly disclose soybean oil.
Park et al. teach a composition comprising spores of Paecilomyces lilacinus (a.k.a., Purpureocillium lilacinum), a vegetable oil (i.e., soybean oil) and an antioxidant (Example 8; Figure 4).
Regarding instant claims 5, 28, 30-31, 33, 35 and 37-38, Suchanek et al. and Eiben et al. do not explicitly disclose that the antioxidant comprises butylhydroxytoluol (BHT).
Park et al. teach the antioxidant is tertiary butyl hydroquinone (TBHQ), butyl hydroxyl toluene (BHT), butylated hydroxyanisole (BHA), propyl gallate (PG), vitamin C vitamin C, vitamin E, lecithin or iron oxide (pg. 5, ln. 40-42). Park et al. confirmed the stability improvement effect of the active spores using various antioxidants, it was confirmed that the active spores with the addition of antioxidants maintained the spore survival rate of 88% or more even after 210 days (Fig. 4; Example 8).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare compositions according to Suchanek et al. and Eiben et al. wherein the plant oil is soybean oil and the antioxidant is BHT, as reasonably suggested by Park et al. Such would have been obvious because Park et al. teach that soybean oil and BHT are suitable oils and antioxidants for compositions comprising active spores produced from Paecilomyces lilacinus (a.k.a., Purpureocillium lilacinum), wherein the compositions are stabilized for 210 days. Thus, replacing the oil and antioxidants of Suchanek et al. and Eiben et al. with soybean oil and BHT according to Park et al. is a simple substitution of one known element for another with a reasonable expectation of success.
Response to Arguments
Applicant argues that Park does not remedy the aforementioned deficiencies in the teachings of Suchanek or Suchanek and Eiben.
Therefore, the examiner’s arguments above are repeated herein.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Suchanek et al. (WO 2018/068774 A2) in view of Eiben et al. (WO 2016/050726 A1) as applied to claims 1-2, 4, 6-16, 20, 26, 29, 32, 34 and 36 above, further in view of Zhang et al. (CN 106 614 562 A).
The teachings of Suchanek et al. and Eiben et al. are discussed above.
Regarding instant claims 17-18, Suchanek et al. and Eiben et al. do not explicitly disclose an emulsifier selected from the group consisting of ethoxylated sorbitan esters, ethoxylated sorbitan monooleate, ethoxylated sorbitan monolaurate, ethoxylated sorbitol esters, ethoxylated sorbitol tetraoleate-laurate, and ethoxylated castor oils.
Zhang et al. teach compositions comprising 0.5-5 wt.% conidiospores of Hirsutella citriformis, 0.1-1 wt.% antioxidant, 0.1-1 wt.% surfactant, 0.05-0.2 wt.% UV filter and a vegetable oil to 100 wt.%. The antioxidant is for example vitamin C or vitamin E, and the vegetable oil is peanut oil, olive oil or corn oil (Abstract; Embodiments 1-3). Zhang et al. teach that the surfactant includes ethoxylated castor oil (claim 2). Zhang et al. further teach that the beneficial effects of the composition include improved survival rate of spore, good stability, convenient use, low production costs, etc. (pg. 2).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare compositions according to Suchanek et al. and Eiben et al. wherein the composition comprises an emulsifier, such as ethoxylated castor oil, as reasonably taught by Zhang et al. Such would have been obvious because Zhang et al. teach formulations comprising fungal spores, a vegetable oil, emulsifiers, antioxidants, etc., wherein the beneficial effects of the composition include improved survival rate of spore, good stability, convenient use, low production costs, etc.
Response to Arguments
Applicant argues that Zhang does not remedy the aforementioned deficiencies in the teachings of Suchanek or Suchanek and Eiben.
Therefore, the examiner’s arguments above are repeated herein.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nathan W Schlientz whose telephone number is (571)272-9924. The examiner can normally be reached 10:00 AM to 6:00 PM, Monday through Friday.
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/N.W.S/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616