DETAILED ACTION
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 .
Priority
The instant application filed on 05/11/2022 is a 371 of PCT/IB2020/061025 filed on 11/23/2020 and claims priority to CONC2019/0013425 filed on 11/28/2019. The certified copy of foreign priority is not in English; therefore, the effective filing date of the claimed invention is 11/23/2020.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Withdrawal of Rejections
The response and amendments filed on 10/02/2025 are acknowledged. Any previously applied minor objections and/or minor rejections (i.e., formal matters), not explicitly restated here for brevity, have been withdrawn necessitated by Applicant’s formality corrections and/or amendments. For the purposes of clarity of the record, the reasons for the Examiner’s withdrawal, and/or maintaining, if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner’s Response to Arguments section.
Briefly, the previous 35 U.S.C. 112(b) rejection for claim 1 pertaining to “Efficient Microorganism” and “Effective Microorganisms” has been withdrawn necessitated by Applicant’s arguments and submitted non-patent literature showing these terms are used interchangeably. The previous 35 U.S.C. 112(b) rejections for claims 8-9 have been withdrawn necessitated by Applicants amendments.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claims 2 and 4-5 are objected to because of the following informalities: “thuringi- ensis” in claim 2 should be “thuringiensis”; “sus- pension” in claim 4 should be “suspension”; and “Rho- dopseudomonas” should be “Rhodopseudomonas”. Appropriate correction is required. These are objection, not rejections, because these appear to be typographical errors.
Maintained and/or New Grounds of Rejection Necessitated by Amendments
Claim Rejections - 35 USC § 112(b), Indefiniteness
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-12 and 20-25 are rejected under 35 U.S.C. 112(b) 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.
Claims 1, 20, and 23 recite EMs, which according to the NPL of Higa (Beneficial and Effective Microorganisms for a Sustainable Agriculture and Environment, 1994) teaches that “EM consists of mixed cultures of beneficial and naturally-occurring microorganisms that can be applied as inoculants to increase the microbial diversity of soils and plants. Research has shown that the inoculation of EM cultures to the soil/plant ecosystem can improve soil quality, soil health, and the growth, yield, and quality of crops. EM contains selected species of microorganisms including predominant populations of lactic acid bacteria and yeasts, and smaller numbers of photosynthetic bacteria, actinomycetes and other types of organisms. All of these are mutually compatible with one another and can coexist in liquid culture” (see, e.g., Higa, “The Concept of Effective Microorganisms: Their Role and Application”, pg. 4). Based on the teachings of Higa, it is unclear what lactic acid bacteria, yeasts, photosynthetic bacteria species comprise EMs. Furthermore, Higa states “other types of organisms”, which can comprise any type of microorganism. Based on the teachings of Higa, it is unclear which microorganisms and included and excluded as EMs; therefore, the scope of the claimed invention cannot be ascertained. Moreover, one of ordinary skill in the art would not readily understand the metes and bounds of the claimed invention because EMs appear to be any microorganism, based on the Higa’s teachings.
Claims 21 and 24 recite “…wherein the sporulant entomopathogenic bacteria and entomopathogenic fungi have a humidity of up to 7%”; however, it is unclear how bacteria and fungi can have, or possess, a humidity. For the purposes of applying prior art, the Examiner has interpreted this to mean that the bacteria and fungi grow at a humidity of up to 7%.
Claim 25 recites “…wherein the sporulating entomopathogenic bacteria, entomopathogenic fungi, EMs, limonoid, and humic organic amendment are present in the following amounts:”; however, no amounts are listed. For the purposes of applying prior art, the Examiner has interpreted these amounts to be the same amounts that are recited in claims 7-11. Also the claim ends in a semi-colon and not a period. All claims must end in a period to clearly set forth the metes and bounds of the claim.
Claims 2-6, 9-10,12, and 19 are included in this rejection for depending on rejected independent claims 1 and 20 and failing to rectify the noted deficiencies.
Examiner’s Response to Arguments
Regarding Applicant’s arguments pertaining to the rejection of claim 1 for indefiniteness of what microorganisms are comprise “Effective Microorganisms” (EMs), this rejection has been maintained because Applicant has not provided sufficient evidence and/or arguments for what Higa defines as “other types of organisms”. Since the prior art of Higa teaches that EMs can include “other types of organisms”, the ordinary artisan would not readily understand what organisms are comprised within EMs and within the claimed composition, as a whole.
Regarding Applicant’s arguments pertaining to claims 8 and 9, as previously discussed, these rejections have been withdrawn.
Maintained and/or New Grounds of Rejection Necessitated by Amendments
Claim Rejections - 35 USC § 103, Obviousness
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-8, 11, 20, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Hellwege (WO 2013/110591; Date of Publication: August 1, 2013 – previously cited) and Blasiak (WO 2018/129016; Date of Publication: July 12, 2018 – previously cited).
Hellwege’s general disclosure relates to “active compound combinations and
compositions for reducing the damage of plants and plant parts as well as losses in harvested fruits or vegetables caused by insects, nematodes or phytopathogens and which have fungicidal
or nematicidal or insecticidal activity including any combination of the three activities, in
particular within a composition, which comprises (A) Fluopyram, (B) a sporeforming bacterium
of the genera Bacillus, selected from Bacillus firmus, Bacillus cereus, Bacillus pumilis, Bacillus
amyloliquefaciens, Bacillus subtilis strain GB03, Bacillus subtilis strain QST713, and (C) at least
one biological control agent, in particular bacteria, fungi or yeasts, protozoa, viruses,
entomopathogenic nematodes, inoculants, botanicals and products produced by microorganisms
including proteins or secondary metabolite” (see, e.g., Hellwege, abstract).
Regarding claims 1, 2, 20, and 23 pertaining to the sporulant entomopathogenic bacteria,
Hellwege teaches that the spore-forming bacteria used within the composition can be Bacillus
thuringiensis or Bacillus papillae (see, e.g., Hellwege, pg. 6, lines 19 & 21).
Regarding claims 1, 3, 20, and 23 pertaining to the entomopathogenic fungi, Hellwege teaches that the fungi used within the composition can be Beauveria bassiana, Lecanicillium lecanii, Metarhizium anisopliae, Paecilomyces lilacinus, or Paecilomyces fumosoroseus (see, e.g., Hellwege, pg. 7, lines 10, 15-17, and 21-22).
Regarding claims 1, 5, 20, and 23 pertaining to efficient microorganisms (EMs), Hellwege
teaches that S. cerevisiae can be used as a biological control agent (see, e.g., Hellwege, abstract & pg. 15, lines 11-12).
Regarding claims 1, 6, 20, and 23 pertaining to the limonoid, Hellwege teaches that the
composition can include botanicals or plant extracts, including Azadirachtin (neem) (see, e.g., Hellwege, pg. 9, line 5).
Regarding claims 1 and 23 pertaining to the liquid suspension, Hellwege teaches liquid carriers for the formulation, such as water, alcohols, organic solvents, or oils (see, e.g., Hellwege, pg. 61, lines 22 & 27).
Regarding claims 7-8, 11, and 22 pertaining to the viable colony counts for the sporulant entomopathogenic bacteria, the entomopathogenic fungi, and the EMs, Hellwege teaches that microorganisms are present in an amount ranging from about 1x101 to about 1x1012 CFU/g, wherein some embodiments have microorganisms ranging from 1x104 to about 1x1012 CFU/g (see, e.g., Hellwege, pg. 56).
However, Hellwege does not teach: a humic organic amendment (claims 1, 4, 20, and 23); or wherein the sporulant entomopathogenic bacteria and entomopathogenic fungi have a humidity of up to 7% (claims 21 and 24).
Blasiak’s general disclosure relates to the use of isolated Bacillus strains in compositions to enhance crop growth and yield (see, e.g., Blasiak, abstract).
Regarding claims 1, 4, 20, and 23 pertaining to the humic organic amendment, Blasiak teaches the use of humic acids and fulvic acids within the composition (see, e.g., Blasiak, pg. 12).
Regarding claims 21 and 24 pertaining to the humidity, Blasiak teaches inoculant compositions comprising bacterial and fungal microorganisms (see, e.g., Blasiak, pgs. 8-10), wherein the microorganisms are kept at a relative humidity of “0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95%, or more” (see, e.g., Blasiak, pg. 51) (see, e.g., MPEP 2144.05(I)).
Regarding claims 7-8, 11, 22, and 25’s concentrations of sporulant entomopathogenic bacteria, entomopathogenic fungi, and the EMs, MPEP 2144.05 states that “Generally, differences in concentrations or temperatures will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claims are disclosure in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. Those working in the biological and/or pharmaceutical arts would understand that the adjustments of particular conventional working conditions (e.g., concentration or amount of a compound) is deemed a matter of judicious selection and routine optimization, which is within the purview of the skilled artisan. For example, the disclosure of Hellwege states “numerous variations and additions to the various embodiments suggested herein, which do not depart from the instant invention, will be apparent to those skilled in the art in light of the instant disclosure” (see, e.g., Hellwege, pg. 3). Moreover, Hellwege states “Those skilled in the art will understand how to select an effective amount/concentration using routine dose-response experiments” (see, e.g., Hellwege, pg. 4). This is motivation for someone of ordinary skill in the art to practice or test the parameter widely to find those that are functional or optimal which then would be inclusive or cover the steps as instantly claimed. Absent any teaching of criticality by the Applicant concerning concentration, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are results effective variable which can be met as a matter of routine optimization.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Hellwege’s composition comprising a sporulant entomopathogenic bacteria, an entomopathogenic fungi, S. cerevisiae, and Azadirachtin, in combination with humic acids and fulvic acids, as taught by Blasiak. One would have been motivated to do so because Blasiak teaches that humic and fulvic acids can be used as stabilizing compounds to enhance the survival and/or stability of a microorganism in an inoculant composition (see, e.g., Blasiak, pgs. 8 & 11). Based on the teachings of Hellwege and Blasiak, it would have been obvious to produce a biocontrol composition comprising a sporulant entomopathogenic bacteria, an entomopathogenic fungi, S. cerevisiae, Azadirachtin, humic acids, and fulvic acids in order to stabilize the entomopathogenic bacteria and fungi within the composition. Furthermore, production of a biocontrol control composition that includes humic and fulvic acid would have been advantageous or beneficial for Hellwege’s purpose of producing a composition that controls insects, nematodes, or phytopathogens on plants, plant parts, harvested fruits, or vegetables (see, e.g., Hellwege, abstract). One would have expected success because Hellwege and Blasiak both teach the production of a composition comprising entomopathogenic bacteria and fungi for the protection of plants.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hellwege and Blasiak as applied to claims 1-8, 11, 20, and 22-23 above, and further in view of Song (CN 106032342; Date of Publication: October 19, 2016 – previously cited).
The teachings of Hellwege and Blasiak, herein referred to as modified-Hellwege-Blasiak, are discussed above as it pertains to a composition comprising sporulant entomopathogenic bacteria, entomopathogenic fungi, a limonoid, EMs, and a humic organic agent in a liquid suspension.
However, modified-Hellwege-Blasiak does not teach: wherein the HAC compounds have a concentration between 85 and 90 g/L and the FAC compounds have a concentration between and to 13 g/L (claim 9).
Song’s general disclosure relates to a fertilizer composition comprising humic acids in order to improve soil urease activity, improve nitrogen condition, accelerate conversion of organic matter, improve catalase activity, and protect the normal activities of soil microbes (see, e.g., Song, English translation, “Summary of the Invention”, pg. 2).
Regarding claim 9 pertaining to the concentration of humic and fulvic acid, Song teaches the concentration of humic acid is 75-90 g/L (see, e.g., Song, English translation, “Summary of the Invention, pg. 2) and the concentration of fulvic acid is 15 g/L (see, e.g., Song, English translation, “Embodiment 4”, pg. 5) (see, e.g., MPEP 2144.05(I)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce modified-Hellwege-Blasiak’s composition comprising a sporulant entomopathogenic bacteria, an entomopathogenic fungi, S. cerevisiae, and Azadirachtin, in combination with humic acid and fulvic acid at a concentration of 75-90 g/L and 15g/L, respectively, as taught by Song. One would have been motivated to do so because Song teaches that humic acid and fulvic acid at a concentration of 75-90 g/L and 15 g/L, respectively, can promote fertilizer efficiency that results in a higher rate of nutrient release, and activates urase, invertase, phosphatase, and catalase within the soil to strengthen soil fertility and improve fertilizer efficiency (see, e.g., Song, English translation, pg. 4). Therefore, based on the teachings of modified-Hellwege-Blasiak and Song, it would have been obvious to include humic acid and fulvic acid at their respective concentrations within the biocontrol composition comprising a sporulant entomopathogenic bacteria, an entomopathogenic fungi, S. cerevisiae, and Azadirachtin, in order to promote soil fertilizing and fertilizer efficiency when applied to plants/crops within an agricultural setting. Furthermore, producing a biocontrol composition comprising humic and fulvic acid at their respective concentrations would have been advantageous or beneficial for modified-Hellwege-Blasiak’s purpose of protecting crops to enhance crop growth/yield. One would have expected success because modified-Hellwege-Blasiak and Song both teach a composition for protecting and/or enhancing plant growth.
Claims 10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hellwege, Blasiak, and Song as applied to claims 1-9, 11, 20, and 22-23 above, and further in view of Quaranta (US 2018/0237434; Date of Publication: August 23, 2018 – previously cited).
The teachings of Hellwege, Blasiak, and Song, herein referred to as modified-Hellwege-Blasiak-Song, are discussed above as it pertains to a composition comprising sporulant entomopathogenic bacteria, entomopathogenic fungi, a limonoid, EMs, and a humic organic agent in a liquid suspension.
However, modified-Hellwege-Blasiak-Song does not teach: wherein the humic organic amendment in a liquid suspension further comprises a mineral compound in a concentration between 55 and 65 g/L (claim 10); or wherein the mineral compound is water-soluble potassium (K2O) (claim 19).
Quaranta’s general disclosure relates to agrochemical compositions for “combating, preventing, infestation of plants, harvested food crops, seeds or non-living materials by phytopathogenic microorganisms, in particular fungi” (see, e.g., Quaranta, abstract).
Regarding claims 10 and 19 pertaining to the water-soluble potassium, Quaranta teaches potassium oxide (i.e., K2O), wherein this nutrient is the most preferred plant nutrient, and present at an amount of “5% to 50% by weight, preferably of 10% to 25% by weight or of 15% to 20% by weight (see, e.g., Quaranta, [0226]). One of ordinary skill in the art would readily recognize that depending on the starting concentration of potassium oxide, the composition can encompass a concentration of potassium oxide between 55 and 65 g/L.
Regarding claim 10’s density of concentration of potassium oxide, MPEP 2144.05 states that “Generally, differences in concentrations or temperatures will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claims are disclosure in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. Those working in the biological and/or pharmaceutical arts would understand that the adjustments of particular conventional working conditions (e.g., concentration or amount of a compound) is deemed a matter of judicious selection and routine optimization, which is within the purview of the skilled artisan. For example, the disclosure of Hellwege states “numerous variations and additions to the various embodiments suggested herein, which do not depart from the instant invention, will be apparent to those skilled in the art in light of the instant disclosure” (see, e.g., Hellwege, pg. 3) Moreover, Hellwege states “Those skilled in the art will understand how to select an effective amount/concentration using routine dose-response experiments” (see, e.g., Hellwege, pg. 4). Additionally, Quaranta teaches a wide range of plant nutrient percentages, which opens up the ability for one of ordinary skill in the art to test this parameter widely in order to find the optimal working concentration of potassium oxide, especially since potassium oxide is the most preferred nutrient (see, e.g., Quaranta, [0226]). Therefore, one of ordinary skill in the art would understand that manipulation of the concentration of potassium oxide can affect the amount of nutrient available within the composition, which can affect plant health during administration of the entomopathogenic agents. Furthermore, this is motivation for someone of ordinary skill in the art to practice or test the parameter widely to find those that are functional or optimal which then would be inclusive or cover the steps as instantly claimed. Absent any teaching of criticality by the Applicant concerning concentration, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are results effective variable which can be met as a matter of routine optimization.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce modified-Hellwege-Blasiak-Song’s composition comprising a sporulant entomopathogenic bacteria, an entomopathogenic fungi, S. cerevisiae, Azadirachtin, humic acid, and fulvic acid in combination with K2O, as taught by Quaranta. One would have been motivated to do so because Quaranta teaches that K2O is the most preferred plant nutrient (see, e.g., Quaranta, [0226]). Therefore, based on the teachings of modified-Hellwege-Blasiak-Song and Quaranta, it would have been obvious to produce a biocontrol composition comprising a sporulant entomopathogenic bacteria, an entomopathogenic fungi, S. cerevisiae, Azadirachtin, humic acid, and fulvic acid in combination with K2O because modified-Hellwege-Blasiak-Song and Quaranta both teach that humic acid, fulvic acid, and K2O are soil nutrients (see, e.g., Song, English translation, pg. 4 & Quaranta, [0226]). Furthermore, production of a biocontrol composition comprising a sporulant entomopathogenic bacteria, an entomopathogenic fungi, S. cerevisiae, Azadirachtin, humic acid, and fulvic acid in combination with K2O would have been advantageous or beneficial for modified-Hellwege-Blasiak-Song’s purpose of producing a composition for protecting and/or enhancing plant growth. One would have expected success because modified-Hellwege-Blasiak-Song and Quaranta both teach compositions for protecting plants and/or enhancing plant growth.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Hellwege and Blasiak as applied to claims 1-8, 11, 20, and 22-23 above, and further in view of Rao (US 2006/0099233; Date of Publication: May 11, 2006 – previously cited).
The teachings of Hellwege and Blasiak, herein referred to as modified-Hellwege-Blasiak, are discussed above as it pertains to a composition comprising sporulant entomopathogenic bacteria, entomopathogenic fungi, a limonoid, EMs, and a humic organic agent in a liquid suspension.
However, modified-Hellwege-Blasiak does not teach: wherein Azadirachtin is in a solution between 0.1 and 10%, with a density of 1.012 g/mL (claim 12).
Rao’s general disclosure relates to “improved granular formulation of neem seed extract containing azadirachtins having enhanced storage stability and the ability for gradual release of azadirachtins” (see, e.g., Rao, abstract).
Regarding claim 12 pertaining to the percent of azadirachtin, Rao teaches 0.1% azadirachtin (see, e.g., Rao, [0089]). Moreover, Rao teaches within Formulation 1, a density of azadirachtin equal to 0.08 g/mL azadirachtin (i.e., 1.22 g neem seed extract in 15 mL water) (see, e.g., Rao, [0089]).
Regarding claim 12’s density of azadirachtin, MPEP 2144.05 states that “Generally, differences in concentrations or temperatures will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claims are disclosure in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. Those working in the biological and/or pharmaceutical arts would understand that the adjustments of particular conventional working conditions (e.g., concentration or amount of a compound) is deemed a matter of judicious selection and routine optimization, which is within the purview of the skilled artisan. For example, the disclosure of Hellwege states “numerous variations and additions to the various embodiments suggested herein, which do not depart from the instant invention, will be apparent to those skilled in the art in light of the instant disclosure” (see, e.g., Hellwege, pg. 3) Moreover, Hellwege states “Those skilled in the art will understand how to select an effective amount/concentration using routine dose-response experiments” (see, e.g., Hellwege, pg. 4). Additionally, Rao teaches that the azadirachtin granular formulation is able to stabilize the azadirachtin (see, e.g., Rao, [0036]), therefore, one of ordinary skill in the art would understand that manipulation of the density of azadirachtin could affect the stability of the compound. This is motivation for someone of ordinary skill in the art to practice or test the parameter widely to find those that are functional or optimal which then would be inclusive or cover the steps as instantly claimed. Absent any teaching of criticality by the Applicant concerning concentration, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are results effective variable which can be met as a matter of routine optimization.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce modified-Hellwege-Blasiak’s composition comprising a sporulant entomopathogenic bacteria, an entomopathogenic fungi, S. cerevisiae, and Azadirachtin, wherein the amount of Azadirachtin in the solution is 0.1%, as taught by Rao. One would have been motivated to do so because Rao teaches that Azadirachtin at 0.1% is capable of being encapsulated into granules and still maintain enhanced storage stability and gradual release to a plant’s rhizosphere (see, e.g., Rao, abstract & Examples 3-5). Moreover, Rao teaches that Azadirachtins have been “tested against more than 400 insects and found to be active as an antifeedant, insect growth regulation, ovicidal, and the like, thereby reducing insect population unlike neurotic insecticides” (see, e.g., Rao, [0004]). Therefore, based on the teachings of modified-Hellwege-Blasiak and Rao, it would have been obvious to produce a composition comprising a sporulant entomopathogenic bacteria, an entomopathogenic fungi, S. cerevisiae, and Azadirachtin, wherein the amount of Azadirachtin in the solution is 0.1%. Furthermore, production of a composition comprising a sporulant entomopathogenic bacteria, an entomopathogenic fungi, S. cerevisiae, and Azadirachtin, wherein the amount of Azadirachtin in the solution is 0.1% would have been advantageous or beneficial for modified-Hellwege-Blasiak’s purpose of protecting crops to enhance crop growth/yield. One would have expected success because modified-Hellwege-Blasiak and Rao both teach a composition for protecting and/or enhancing plant growth.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Hellwege (WO 2013/110591; Date of Publication: August 1, 2013 – previously cited) and Blasiak (WO 2018/129016; Date of Publication: July 12, 2018 – previously cited) as applied to claims 1-12 and 20-25 above, and further in view of Song (CN 106032342; Date of Publication: October 19, 2016 – previously cited) and Rao (US 2006/0099233; Date of Publication: May 11, 2006 – previously cited).
The teachings of Hellwege and Blasiak, herein referred to as modified-Hellwege-Blasiak, are discussed above as it pertains to a composition comprising sporulant entomopathogenic bacteria, entomopathogenic fungi, a limonoid, EMs, and a humic organic agent in a liquid suspension.
Regarding claim 25 pertaining to the viable colony counts for the sporulant entomopathogenic bacteria, the entomopathogenic fungi, and the EMs, Hellwege teaches that microorganisms are present in an amount ranging from about 1x101 to about 1x1012 CFU/g, wherein some embodiments have microorganisms ranging from 1x104 to about 1x1012 CFU/g (see, e.g., Hellwege, pg. 56).
However, modified-Hellwege-Blasiak does not teach: the amount of the limonoid and humic organic amendment (claim 25).
Song’s general disclosure is discussed above.
Regarding claim 25 pertaining to the concentration of humic organic amendment, Song teaches the concentration of humic acid is 75-90 g/L (see, e.g., Song, English translation, “Summary of the Invention, pg. 2) and the concentration of fulvic acid is 15 g/L (see, e.g., Song, English translation, “Embodiment 4”, pg. 5) (see, e.g., MPEP 2144.05(I)).
Rao’s general disclosure is discussed above.
Regarding claim 25 pertaining to the percent of azadirachtin, Rao teaches 0.1% azadirachtin (see, e.g., Rao, [0089]). Moreover, Rao teaches within Formulation 1, a density of azadirachtin equal to 0.08 g/mL azadirachtin (i.e., 1.22 g neem seed extract in 15 mL water) (see, e.g., Rao, [0089]).
Regarding claim 25’s density of azadirachtin, MPEP 2144.05 states that “Generally, differences in concentrations or temperatures will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claims are disclosure in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. Those working in the biological and/or pharmaceutical arts would understand that the adjustments of particular conventional working conditions (e.g., concentration or amount of a compound) is deemed a matter of judicious selection and routine optimization, which is within the purview of the skilled artisan. For example, the disclosure of Hellwege states “numerous variations and additions to the various embodiments suggested herein, which do not depart from the instant invention, will be apparent to those skilled in the art in light of the instant disclosure” (see, e.g., Hellwege, pg. 3) Moreover, Hellwege states “Those skilled in the art will understand how to select an effective amount/concentration using routine dose-response experiments” (see, e.g., Hellwege, pg. 4). Additionally, Rao teaches that the azadirachtin granular formulation is able to stabilize the azadirachtin (see, e.g., Rao, [0036]), therefore, one of ordinary skill in the art would understand that manipulation of the density of azadirachtin could affect the stability of the compound. This is motivation for someone of ordinary skill in the art to practice or test the parameter widely to find those that are functional or optimal which then would be inclusive or cover the steps as instantly claimed. Absent any teaching of criticality by the Applicant concerning concentration, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are results effective variable which can be met as a matter of routine optimization.
It would have been first obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce modified-Hellwege-Blasiak’s composition comprising a sporulant entomopathogenic bacteria, an entomopathogenic fungi, S. cerevisiae, and Azadirachtin, in combination with humic acid and fulvic acid at a concentration of 75-90 g/L and 15g/L, respectively, as taught by Song. One would have been motivated to do so because Song teaches that humic acid and fulvic acid at a concentration of 75-90 g/L and 15 g/L, respectively, can promote fertilizer efficiency that results in a higher rate of nutrient release, and activates urase, invertase, phosphatase, and catalase within the soil to strengthen soil fertility and improve fertilizer efficiency (see, e.g., Song, English translation, pg. 4). Therefore, based on the teachings of modified-Hellwege-Blasiak and Song, it would have been obvious to include humic acid and fulvic acid at their respective concentrations within the biocontrol composition comprising a sporulant entomopathogenic bacteria, an entomopathogenic fungi, S. cerevisiae, and Azadirachtin, in order to promote soil fertilizing and fertilizer efficiency when applied to plants/crops within an agricultural setting. Furthermore, producing a biocontrol composition comprising humic and fulvic acid at their respective concentrations would have been advantageous or beneficial for modified-Hellwege-Blasiak’s purpose of protecting crops to enhance crop growth/yield. One would have expected success because modified-Hellwege-Blasiak and Song both teach a composition for protecting and/or enhancing plant growth.
It would have been secondly obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce modified-Hellwege-Blasiak’s composition comprising a sporulant entomopathogenic bacteria, an entomopathogenic fungi, S. cerevisiae, and Azadirachtin, wherein the amount of Azadirachtin in the solution is 0.1%, as taught by Rao. One would have been motivated to do so because Rao teaches that Azadirachtin at 0.1% is capable of being encapsulated into granules and still maintain enhanced storage stability and gradual release to a plant’s rhizosphere (see, e.g., Rao, abstract & Examples 3-5). Moreover, Rao teaches that Azadirachtins have been “tested against more than 400 insects and found to be active as an antifeedant, insect growth regulation, ovicidal, and the like, thereby reducing insect population unlike neurotic insecticides” (see, e.g., Rao, [0004]). Therefore, based on the teachings of modified-Hellwege-Blasiak and Rao, it would have been obvious to produce a composition comprising a sporulant entomopathogenic bacteria, an entomopathogenic fungi, S. cerevisiae, and Azadirachtin, wherein the amount of Azadirachtin in the solution is 0.1%. Furthermore, production of a composition comprising a sporulant entomopathogenic bacteria, an entomopathogenic fungi, S. cerevisiae, and Azadirachtin, wherein the amount of Azadirachtin in the solution is 0.1% would have been advantageous or beneficial for modified-Hellwege-Blasiak’s purpose of protecting crops to enhance crop growth/yield. One would have expected success because modified-Hellwege-Blasiak and Rao both teach a composition for protecting and/or enhancing plant growth.
Examiner’s Response to Arguments
Applicant's arguments filed 10/02/2025 have been fully considered but they are not persuasive.
Regarding Applicant’s argument pertaining to the teachings of Hellwege and Blasiak (remarks, pages 6-8), these arguments are not persuasive for multiple reasons. First, as discussed above, Hellwege was used to teach a composition comprising sporulant entomopathogenic bacteria, entomopathogenic fungi, EMs, a limonoid, and a liquid suspension. Blasiak, as discussed above, was solely used to teach a humic organic amendment. Therefore, one of ordinary skill in the art would have been motivated to combine the teachings of Hellwege and Blasiak because Blasiak teaches humic and fulvic acids can be used as stabilizing compounds to enhance the survival and/or stability of a microorganism in an inoculant composition (see, e.g., Blasiak, pgs. 8 & 11). Secondly, in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Hellwege and Blasiak are analogous art because they both teach compositions comprising entomopathogenic bacteria and fungi for the protection of plants. Thirdly, regarding Applicant’s arguments pertaining to Blasiak’s definition of an inoculant, this is not persuasive because Blasiak uses the transitional phrase “comprising” which is “inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (see, e.g., MPEP 2111.03); therefore, the microorganisms taught by Hellwege can be included in the teachings of Blasiak since the microorganisms comprised within Blasiak’s inoculant is open-ended.
Regarding Applicant’s argument pertaining to the teachings of Hellwege as it pertains to the viable colony counts for the sporulant entomopathogenic bacteria, the entomopathogenic fungi, and the EMs (remarks, pages 8-9), as previously discussed above, Hellwege teaches that microorganisms are present in an amount ranging from about 1x1011 to about 1x1012 CFU/g, wherein some embodiments have microorganisms ranging from 1x104 to about 1x1012 CFU/g (see, e.g., Hellwege, pg. 56). The microorganism ranges taught by Hellwege comprise the claims microorganism concentrations; therefore, claims 7-8 and 11 are prima facie obvious in view of Hellwege (see, e.g., MPEP 2144.05(I)).
Regarding Applicant’s arguments pertaining to the teachings of Song (remarks, page 9), this argument is not persuasive for multiple reasons. First, Song is analogous art to Hellwege and Blasiak, and the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Modified-Hellwege-Blasiak both teach compositions comprising entomopathogenic bacteria and fungi for the protection of plants. Moreover, Song teaches humic acids and fulvic acids within compositions as stabilizing compounds to enhance the survival and/or stability of a microorganism in an inoculant composition (see, e.g., Blasiak, pgs. 8 & 11). Moreover, Song teaches humic acid and fulvic acid compositions (see, e.g., Song, English Translation, abstract). Therefore, modified-Hellwege-Blasiak and Song are analogous art. Secondly, Song teaches that the concentration of humic acid is 75-90 g/L (see, e.g., Song, English translation, “Summary of the Invention, pg. 2) and the concentration of fulvic acid is 15 g/L (see, e.g., Song, English translation, “Embodiment 4”, pg. 5) (see, e.g., MPEP 2144.05(I)). Therefore, based on these teachings, claim 9 is prima facie obvious in view of modified-Hellwege-Blasiak and Song.
Regarding Applicant’s arguments pertaining to the teachings of Quaranta (remarks, pages 10-12), these arguments are not persuasive for multiple reasons. First, Quaranta is analogous art to modified-Hellwege-Blasiak because both Quaranta and modified-Hellwege-Blasiak teach compositions for protecting plants and/or enhancing plant growth. Secondly, regarding Applicant’s argument that Quaranta does not teach a composition suspended in a liquid, this argument is not persuasive because Quaranta was not used to teach this limitation. Instead, as previously discussed, modified-Hellwege-Blasiak teaches liquid carriers for the formulation, such as water, alcohols, organic solvents, or oils (see, e.g., Hellwege, pg. 61, lines 22 & 27). Thirdly, regarding Applicant’s arguments pertaining to the concentration of potassium oxide, as discussed above, this concentration can be met as a matter of routine optimization. Moreover, Quaranta teaches a wide range of plant nutrient percentages, which opens up the ability for one of ordinary skill in the art to test this parameter widely in order to find the optimal working concentration of potassium oxide, especially since potassium oxide is the most preferred nutrient (see, e.g., Quaranta, [0226]). Therefore, this is motivation for one of ordinary skill in the art to test the parameter widely in order to obtain an optimal concentration of potassium oxide.
Regarding Applicant’s arguments pertaining to the teachings of Rao (remarks, pages 12-13), this argument is not persuasive for multiple reasons. First, Rao is analogous art to modified-Hellwege-Blasiak because both Rao and modified-Hellwege-Blasiak teach compositions for protecting and/or enhancing plant growth. Moreover, modified-Hellwege-Blasiak teach teaches that the composition can include botanicals or plant extracts, including Azadirachtin (neem) (see, e.g., Hellwege, pg. 9, line 5), and Rao teaches compositions comprising limonoids, such as azadirachtins (see, e.g., Rao, [0004]). Secondly, regarding Applicant’s argument pertaining to the azadirachtin as part of the biological control composition, this argument is not persuasive because modified-Hellwege-Blasiak already teaches that the biological control composition comprises Azadirachtin. Rao was used to merely teach the concentration of azadirachtin, which can be met as a matter of routine optimization.
Regarding Applicant’s secondary considerations, it is recommended that Applicant provide these data as an affidavit under 37 CFR 1.132.
Conclusion
Claims 1-12 and 19-25 are rejected.
No claims are allowed.
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.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE IANNUZO whose telephone number is (703)756-5559. The examiner can normally be reached Mon - Fri: 8:30-6:00 EST.
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/NATALIE IANNUZO/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653