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 .
Status of Claims
Claims 1-50 are currently pending and are examined on the merits herein.
Priority
The instant application filed 10/20/2023, claims priority to Provisional Application No. 63/417,917, filed 10/20/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/03/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 34 and 43 are objected to because of the following informalities: The claims recite “the formulation claim 1” in their final line. This is assumed to be a typographical error which is meant to recite “the formulation of claim 1”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)-Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 39-43 and 46-50 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for controlling or preventing fungal growth in plants suffering or at risk of fungal infections, does not reasonably provide enablement for controlling or preventing fungal growth on any known “site” that has a fungal growth nor for protecting a crop from any known “pest”. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. §112, first paragraph, have been described In re Wands, 8 USPQ2d 1400(1988). They are:
1. The breadth of the claims;
2. The nature of the invention;
3. The state of the prior art;
4. The predictability or lack thereof in the art
5. The level of skill in the art;
6. The amount of direction or guidance present;
7. The presence or absence of working examples;
8. The quantity of experimentation needed.
The breadth of the claims
The breadth of the claims seems to encompass methods of controlling or preventing fungal growth on any known site with or at risk of a fungal infection as well as protecting crops from any known pest. The specification does not sufficiently describe methods of controlling or preventing fungal growth on any site other than a plant, part of a plant, a seed, soil where a plant is or will be growing, or soil where a seed has or will be sown. Furthermore, the specification does not sufficiently describe methods of protecting a crop from a pest other than fungal pathogens.
The nature of the invention
The nature of the invention as recited in the instant claims is a method of using an agricultural composition of the invention comprising applying said composition to a specific site.
The state of the prior art/ The predictability or lack thereof in the art
The vast majority of known fungal species are strict saprophytes; only very few species (less than 10% of identified fungi) can colonize plants. Phytopathogenic fungi represent an even smaller fraction of these plant colonizers. Commercial agriculture depends mainly on the application of chemical fungicides to protect crop plants against fungal pathogens by destroying and inhibiting their cells and spores (Intro of El-Baky, 2021). When a plant is infected, a fungicide cannot cure it. As an alternative, either a fungicide or an organic chemical will prevent disease by killing spores of fungi on plants and on the ground (Section 5.3, El-Baky). Given that phytopathogenic fungi are a small and specific sect of fungi, it is reasonable that methods targeting phytopathogenic fungi would be specific and distinct from method targeting non-phytopathogenic fungi, such as those in clinical settings. Also described in the prior art below are known excipients that are widely used in fungicide formulations for agricultural use. Examples include dispersants, anti-freeze agents, anti-foams, wetting agents and more. As such, it is clear from the prior art that a composition of the instant invention, which is formulated to contain such excipients, is used exclusively in agricultural settings. Thus, applying said formulation to any known site which is suffering or at risk of fungal growth would not be predictable or encouraged for sites other than those relating to agriculture. Given what is typical in the art, one would not be able to predicably treat a fungal infection on the skin, for instance, using the instantly claimed composition.
In the context of agriculture, U.S. farmers employ a range of pest management strategies to control weeds, insects, fungi, viruses, and bacteria. They till their soils, rotate their crops, scout their fields, and carefully consider factors such as plant density and planting dates. They also apply organic and synthetic pesticides (Dodson, 2025). For example, insecticides are used to control insect infestations. Most foliar applications need to be properly timed, otherwise they are not effective. Consequently, many farmers scout their fields to determine if/when insects are present. Fungicides are used to control pathogenic (disease-causing) organisms. Though these pesticides are often applied during the growing season to increase crop yields, they are also applied to prevent stored produce from spoiling (Dodson, 2025). Many methods are known for protecting a crop from a pest, however, each method requires different considerations meaning that a single method would not be a one-size fit all. As a result, the art of protecting a crop from pests is variable and dependent on the pest being treated.
Therefore, the state of the art for controlling or preventing fungal growth at a given site and for protecting crops from pests is unpredictable and requires various considerations. Although methods exist for treating fungal growth on skin or for protecting a crop from insects, there is no demonstration that a single composition would predictably control and prevent fungal growth on any site or protect a crop from any pest.
The level of one of ordinary skill
The level of skill would be moderate in order to carry out the method of applying an agricultural composition.
The amount of direction or guidance present/The presence or absence of working examples
The only guidance presented in the instant specification is for using one or more agriculturally active compounds, such as an acaricide, antimicrobial, fungicide, herbicide, insecticide, molluscicide, or nematocide, or a combination thereof, in a method of treating a site. Specifically, the method is a method for controlling or preventing fungal growth in crops. Crops which may be treated include those plagued by various pathogens including bacteria, viruses, fungal pathogens, mites, nematodes and more. However, there is no clear guidance described for any method apart from treating a plant at risk of a fungal pathogen. The only working example is Example 10 of the specification which investigates efficacy as a function of particle size. Example 10 was carried out using the suspension concentrate of the invention and 4 commercial fungicides. Tests were performed on 4 commercially important pathogenic fungi: Botrytis cinerea (on tomato plants), Zymoseptoria tritici (on wheat plants), Puccinia triticina (on wheat plants) and Phakopsora pachyrhizi (on soybean plants cultivar Siverka). The percentage of disease control and synergy for each treated plant and fungicide combination was measured. The ability of the instant composition to control or prevent fungal growth on non-agricultural sites or to protect crops from pests other than fungi is not described. Working examples that demonstrate such effects of the instant composition would be required.
The quantity of experimentation needed
Due to the unpredictability’s and vastness of treatment options for fungal infections and in crop protection (as discussed supra), and the lack of guidance in the instant specification, undue experimentation would be required. The art has not demonstrated a one-size fits all composition which could be used to treat fungal infections in plants and on skin nor has the art provided a method for protecting a crop from fungus using the same method as one used for insects. Given the many considerations in treating fungal infections and protecting crops, non-routine experimentation would be required to determine compositions and methods for applying a composition to any site or using it to protect crops from any pest. Because the instant specification only provides guidance for one example of controlling or preventing fungal growth in plants, and no examples of any other site or pest, undue experimentation would be required to practice the methods of claims 39-43 and 46-50.
Conclusion
Due to the non-routine of experimentation necessary to determine the specific methods of controlling or preventing fungal growth on all sites and protecting crops from all pests; the lack of direction/guidance presented in the specification regarding the specific requirements for the method; the unpredictability’s and considerations needed to develop such methods, as established by the state of the prior art; the breadth of the claims, undue experimentation would be required of a skilled artisan to make and/or use the claimed invention in its full scope.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-6, 14-15, 23-25, 27, and 34-37, and 43-45 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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 2-6, 14-15, 27, and 34 recite various weight percentages without reciting the basis for such percentages. It is unclear if weight percent is based on the total weight of the final composition or of a specific component. As such, the claims are indefinite.
Claims 23-25 recite a volume-weighted median particle size of the first active compound of “less than about” (15, 7, or 1) “microns”. Such a range includes a median particle size of zero. It is unclear how a particle could possess a median particle size of zero, therefore making the claims unclear. Additionally, parent claim 1 recites a volume-weighted median particle size of “from greater than 0.01 to 20 microns”. As such, there is no antecedent basis for a mean particle size below 0.01, which is included in the ranges of claims 23-25.
Claim 32 recites several species such as “Group 27 fungicide”, “Group U6 fungicide”, “Group 50 fungicide”, and “Group 29 fungicide”. Such “groups” are not a well-known species or groups of fungicides in the art and refer back to groups defined by the instant specification. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). See MPEP 2173.05(s).
Claim 32 further recites “EBDC-like fungicide” which is indefinite. The term "like" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "EBDC-like" fungicides), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claim 35 recites the formulation of claim 1 being present in “an amount sufficient to enhance the biological effect of the agriculturally active compound, such that the total amount” of the active compound “is lower than would typically be required and/or recommended to provide the same biological effect in a composition that does not comprise the formulation of claim 1”. The phrase “lower than typically required and/or recommended” in the claim is a relative phrase which renders the claim indefinite. The term “lower than typically required and/or recommended” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 35 refers back to multiple claims (i.e., claim 34 and claim 1). It is unacceptable for a claim to reference two sets of claims to different features. See MPEP 608.01(n). As such, it is unclear what the claim is drawn to.
Claim 35-37 recite “the agriculturally active compound”, however, parent claim 34 does not recite an agriculturally active compound nor does claim 1, which it refers back to. As such, there is no antecedent basis for this limitation in the claim and it is unclear what the agriculturally active compound is.
Claim 38 recites the “composition of 34” instead of the “composition of claim 34”. As such, the dependency of the claim is unclear. For the sake of compact prosecution this will be interpreted as a topographical error that means to recited the “composition of claim 34”.
Claim 43 recites “adding an amount of the agriculturally active compound that is less than an amount” of the active compound that is “recommended for use in the absence of the formulation” of claim 1. The phrase “recommended for use” in the claim is a relative phrase which renders the claim indefinite. The term “recommended for use” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 44-45 recite a pH of “greater than about” (7.4 or 8). Parent claim 1 recites a pH of “from about 6 to 11”. As such, there is no antecedent basis for a pH above 11, which is included in the ranges of claims 44-45.
Claim 50 contains the trademark/trade names Imtrex, Balaya, Amistar, and Proline. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe several fungicide products which comprise different agriculturally active ingredients and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
1. Claims 23-25 and 44-45 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 23-25 recite a volume-weighted median particle size of the first active compound of “less than about” (15, 7, or 1) “microns”. Parent claim 1 recites a volume-weighted median particle size of “from greater than 0.01 to 20 microns”. Therefore, dependent claims 23-25 define a range that includes values outside the range of claim 1 (i.e., particle sizes below 0.01 microns). As such, claims 23-25 fail to further limit the size range of claim 1.
Claims 44-45 recite a pH of “greater than about” (7.4 or 8). Parent claim 1 recites a pH of “from about 6 to 11”. Therefore, dependent claims 44-45 define a range that includes values outside the range of claim 1 (i.e., pH above 11). As such, claims 44-45 fail to further limit the pH range of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Interpretation
Claim 4 recites wherein the formulation comprises less than 15 wt% of the first active and the formulation further comprises an inert filler, such that the total amount of suspended material in the formulation is at least 10 wt%. The inert filler nor its amount is defined by the claims or the instant specification. For the sake of compact prosecution the inert filler is being interpreted as a suspended material which is not a biologically active compound, which is present in any amount greater than 0 wt% such that the total amount of suspended material (inert filler and suspended actives combined) is at least 10 wt%.
Claim 16 recites wherein the freezing point depressant is a glycol, sugar, water soluble salt, or a combination thereof. Claim 17 recites wherein the sugar has a molecular weight of from 180 to 1,000 Daltons. Since parent claim 16 does not require a sugar and dependent claim 17 does not define that the formulation further comprises a sugar, the sugar is considered an optional ingredient. As such, the molecular weight of the sugar is also optional and will only be considered in the case where a sugar is present as the freezing point depressant. Similarly, claim 18, which depends from claim 16, defines species of the glycol, sugar, and salt. Such species will only be considered in the case where their respective genus is present as the freezing point depressant.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
1. Claim 1-3, 5-21, and 23-49 are rejected under 35 U.S.C. 103 as being unpatentable over De Oliveira, S.F., et al. (US 2024/0023557 A1, Filed 02/12/2021, PTO-892), hereinafter De Oliveira, in view of Roux, S., et al. (US 11,129,383 B2, 09/28/2021, IDS dated 05/03/2024), hereinafter Roux, and Richardson, W., et al. (US 2009/0143478 A1, 06/04/2009, IDS dated 05/03/2024), hereinafter Richardson, as evidenced by Green Agrochem, Calcium Lignosulfonate, Retrieved 10/20/25 (PTO-892), hereinafter Green Agrochem.
De Oliveira teaches compositions comprising a copper-based fungicide and a polyelectrolyte (abstract). The composition is preferably a suspension concentrate (SC), specifically an aqueous suspension concentrate ([0090];[0229]; [0513]; claim 71). The term “suspension concentrate” refers to a suspension of solid particles in a liquid intended for dilution with water prior to use ([0043]). The composition of De Oliveira provides a stable aqueous suspension comprising a high concentration of a copper-based fungicide up to about 30% (w/w), with improved fungicidal activity and/or effective control of plant health compared to commercially available formulations of said copper-based fungicide ([0256]).
Regarding the dispersant, De Oliveira teaches calcium lignosulfonate as the polyanion polyelectrolyte at a concentration of 2% to 3% by weight based on the total weight of the composition ([0107]-[0108]; claims 8-9). Calcium lignosulfonate is used in the art as a dispersing agent and has a molecular weight in the range of 40,000 to 65,000 Da as evidenced by Green Agrochem. As such, calcium lignosulfonate reads on the dispersant of claims 1, 7-10, and 12-13. Explicit dispersants are also taught, which may include anionic and nonionic surfactants ([0134]-[0138]; [0152]-[0153]; claims 35, claims 68-69), thereby reading on the dispersant of claims 1 and 9-11. The concentration of such a dispersant in the composition is 0.1-15% by weight based on the total weight of the composition ([0157]). Regarding the total amount of dispersant, one of ordinary skill in the art could have recognized which compounds in the formulation act as dispersants and optimize the total amount of dispersants through no more than routine experimentation. De Oliveira provides a general teaching regarding the amount of dispersant to include, which one of ordinary skill in the art could use as guidance in the optimization process. As such, one of ordinary skill in the art would have arrived at the instantly claimed range of claims 5 and 6 through no more than routine experimentation depending on the desired properties of the final product. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
De Oliveira teaches propylene glycol as an antifreezing agent ([0168]-[0170]; claims 42-44), which reads on the freezing point depressant of claims 1, 16, and 18-19. As discussed above, the limitation of claim 17 is met by default when the freezing point depressant is propylene glycol. The concentration of the antifreezing agent in the composition is 1-10% by weight based on the total weight of the composition ([0171]; claim 45), which falls within the range of claims 14 and overlaps with the range of claim 15. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. Regarding claim 20, the propylene glycol of the prior art inherently possesses the recited properties as evidenced by the instant specification. Propylene glycol is used as the freezing point depressant in the instant invention (Examples 1 and 7 of instant specification) meaning it must have the same properties as the freezing point depressant as instantly claimed. "Products of identical chemical composition cannot have mutually exclusive properties." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
De Oliveira further teaches a pH adjuster or buffering agent such as organic or inorganic bases and/or organic or inorganic acids ([0159]; claim 30), which read on the buffer and base of claim 1. The composition has a pH in the range of 5.0-7.5 ([0088]; [0146]; claim 70), which overlaps with the pH of claims 1, 21, and 44. Regarding claim 45, the term “about” generally denotes a value within ± 10% of the recited amount. In the case of claim 45, a pH greater than “about 8” includes a pH range of greater than 7.2. Thus, the range of the prior art also overlaps with the instantly claimed range of claim 45. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding the additional ingredients of claims 26-28, De Oliveira teaches that the composition may comprise viscosity modifiers in the form of rheology modifiers and thickeners ([0187]-[0192]; claim 30), surfactants at a total concentration of 2-5% by weight of the total composition ([0181]; claim 53), and antifoaming agents [0165]-[0167]; claim 39).
The copper-based fungicide of De Oliveira is selected from the group consisting of copper oxychloride, copper hydroxide, copper sulfate, and any combination thereof ([0123]; claim 4), all of which read on the agriculturally active compound of claims 29-33.
The composition may comprise an additional bioactive ingredient, also termed additional agrochemical, such as a growth regulator, a bio-stimulant, a fungicide, a herbicide, an insecticide, an acaricide, a molluscicide, a miticide, a rodenticide; and/or an bactericide ([0198]).
De Oliveira teaches a particle size distribution (d50) in the composition of below 5 microns ([0149]). This is achieved by a milling or grinding process in the production method ([0554]; [0561]-[0565]; claim 88).
De Oliveira further teaches methods of preventing, reducing and/or eliminating the presence of a phytopathogen on a plant or on one or more plant parts, comprising applying a combination or composition of the present invention to said plant or plant part (abstract). Specifically, a diluted aqueous composition is used to contact said plant or plant part ([0439]). Prior to use, the composition of De Oliveira is dissolved, dispersed, or diluted in water, to provide an aqueous composition comprising between 0.001 and 10 w/v % of the copper-based fungicide ([0456]). The composition is preferably diluted 2-5000 times, preferably about 200 times, with an aqueous solvent, preferably water, prior to contacting a plant, plant part or soil with the composition ([0457]). The composition or delivery system may be tank mixed with an additional agrochemical or applied sequentially with the additional agrochemical. In some embodiments the composition or delivery system is applied simultaneously with the additional agrochemical ([0550]).
The teachings of De Oliveira differ from that of the instant invention in that De Oliveira does not teach a first active having the structure of claim 1.
Roux teaches compositions and methods of treating plants infected with fungal pathogens by contacting an infected plant or plant at risk of infection with a fungicidal composition comprising an fungicide selected from copper compound such as copper octanoate or copper hydroxide, an enhancer selected from apyrase inhibitors such as (E)-3-methyl-N-(1-(naphthalen-2-yl) ethylidene) benzohydrazide and, optionally, a phytologically-acceptable inert carrier (abstract). Apyrase inhibitors such as AI.15 {(E)-3-methyl-N′-(1-(naphthalen-2-yl) ethylidene) benzohydrazide} differentially enhance the effect of copper and triazole fungicides against plant pathogenic fungi. Preferred fungicides that are susceptible to enhancement include copper octanoate and copper hydroxide. The combination of the select fungicide and enhancer provides synergistic fungicidal activity against plant pathogenic fungi (col. 1-2, lines 64-9). Copper hydroxide and (E)-3-methyl-N′-(1-(naphthalen-2-yl) ethylidene) benzohydrazide are specifically claimed in combination for a method of treating a plant or seed infected by or at risk of infection of a plant fungal pathogen (claim 1). The apyrase inhibitors can be provided at 0.01-10% weight to weight in a final composition. When provided in liquid form, the apyrase inhibitors can be provided at 0.01-10% volume to volume in a final diluted composition. The skilled artisan will recognize that the formulation of the fungicide and the apyrase inhibitor can be provided in a concentrate that can be diluted prior to use, or can be provided in a diluted form ready for treatment (col. 6, lines 25-39).
Richardson discloses a method of milling substantially insoluble solid organic biocides to form a micron or sub-micron product having a narrow particle size distribution. The milled product can be used in foliar applications at a lower effective dosage than prior art formulations (abstract). The method produces stable aqueous dispersions of the organic biocide. For foliar treatment, the composition is generally combined with water to provide a stable suspension having the desired concentration, and this stable suspension is then broadcast onto the crops, as is known in the art. ([0115]).
The protection provided by a biocide depends on having a particle of the biocide within a particular area or volume of the substrate to be protected. The longevity, rainfastness, and suspendability of any particle are all functions of the particle diameter ([0058]). Small particles have the advantages of enhanced bioactivity due to the greater allowable coverage (number of particles) and tenacity associated with smaller particles, as opposed to larger particles of the same organic biocide. Enhanced bioactivity allows the use of less biocide in an application ([0053]). Reduced dosage results in lower cost, less pesticide residue on harvested crops, and mitigation of environmental impact ([0008]).
Richardson teaches a method of preparing an organic biocide product having a d50 equal to or less than about 1 micron ([0029]). Particle size as defined in Richardson is the mean weight average particle diameter, which is equivalent to the mean volume average particle diameter, also known as d50. The dxx is the diameter where "xx" is the percent of the volume of the solid material that has an average diameter smaller than the stated diameter. Smaller sizes are beneficially determined by, for example, a dynamic light scattering method ([0052]). Thus, d50 is equivalent to the volume-weighted median particle size as defined in the instant claims.
The milling of the organic biocides is advantageously performed in the presence of an aqueous medium containing surfactants and/or dispersants, such as those known in the art. ([0088]). Other adjuvants, such as: fillers including biocidal fillers such as zinc oxide and non-biocidal fillers such as silica; stabilizer/dispersants; typical viscosity modifiers/stabilizers; typical anti-foaming agents; antifreeze such as propylene glycol; chelators and the like, can be added to the water before or during milling ([0089]). Suitable surface active agents include anionics such as lignosulfonates and more ([0090]). The particulate organic biocide is, in many embodiments, combined with one or more other organic biocides and/or particulate sparingly soluble biocidal inorganic salts. These inorganic biocidal salts can be milled, for example, using the same procedures and importantly the same milling media described for the organic pesticides. For instance, particulate copper(I) oxide is useful and is readily milled by such a process. Preferred inorganic copper salts include copper hydroxides; copper carbonates; basic (or "alkaline") copper carbonates; basic copper sulfates and more ([0102]-[0104]).
First, it would have been obvious to combine the compositions of De Oliveira and Roux before the effective filing date of the claimed invention by adding the (E)-3-methyl-N′-(1-(naphthalen-2-yl) ethylidene) benzohydrazide (hereinafter AI.15) of Roux into the suspension concentrate composition of De Oliveira to yield the instantly claimed composition. One of ordinary skill in the art would have been motivated to add the AI.15 of Roux into the composition of De Oliveira since such a compound is known to act as an enhancer for copper fungicides and De Oliveira teaches a composition comprising copper fungicides. Thus, one of ordinary skill in the art would expect the addition of AI.15 to enhance the fungicidal effect of De Oliveira’s composition and increase its effectiveness in its method of preventing, reducing and/or eliminating the presence of a phytopathogen on a plant. Additionally, “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Both De Oliveira and Roux teach copper fungicide compositions for treating plants at risk or suffering from fungal infections. One of ordinary skill in the art would have had a reasonable expectation of success in combining the compositions of De Oliveira and Roux since the composition of De Oliveira welcomes additional bioactive agents and Roux teaches that the enhancers are formulated with a copper fungicide and any phytologically-acceptable carrier.
Regarding the amount of the first active compound (AI.15) as recited in claims 2-3, Roux teaches an amount of 0.01-10% by weight or volume in a final diluted composition. De Oliveira teaches suspension concentrates which are diluted prior to use, preferably 2-5000 times with water. As such, one of ordinary skill in the art would have optimized the amount of enhancer (AI.15) in the suspension concentrate of De Oliveira depending on the amount of enhancer desired in the final diluted product for use. Given the guidance from Roux on the optimal amount of enhancer to be present in the final diluted composition, and the guidance from De Oliveira on dilution, one of ordinary skill in the art would have arrived at the instantly claimed amounts of claims 2 and 3 through no more than routine experimentation. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding the particle size of the first active ingredient, the combined composition of De Oliveira and Roux contains a copper fungicide and AI.15 in an aqueous suspension. De Oliveira teaches a milling step in the production method that provides the suspended particles with a d50 of below 5 microns. It would have been obvious to produce the combined composition in the same manner as the composition of De Oliveira with the only difference being a step of adding AI.15 to give the composition made obvious above. As a result of this combination, all of the suspended particles in the mixed solution would undergo the milling process of De Oliveira. Thus, the AI.15 particles would also be milled to a particle size (d50) of less than 5 microns. Particle size as defined by “d50” reads on the volume-weighted median particle size as instantly claimed as evidenced by Richardson. Thus, a d50 of less than 5 microns falls within the range of claims 23-24 and overlaps with the range of instant claims 1 and 25. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
Additionally, it would have been obvious to modify the combined teachings of De Oliveira and Roux with those of Richardson by milling the combined composition according to the method of Richardson to give the suspended particles a d50 of a micron or less, further yielding the instantly claimed invention. One of ordinary skill in the art would have been motivated to perform the milling process of Richardson on the combined composition of De Oliveira and Roux since the milling process of Richardson provides stable aqueous dispersions comprising organic biocide particles with a d50 equal to or less than about 1 micron. Particles of this size enhance bioactivity and reduce the amount of active needed in the composition, resulting in lower cost, less pesticide residue on harvested crops, and mitigation of environmental impact as taught by Richardson. One of ordinary skill in the art would have had a reasonable expectation of success in performing the milling process of Richardson on the combined composition of De Oliveira and Roux since De Oliveira already teaches a milling step and a d50 of below 5 microns. Additionally, the milling process of Richardson is performed in the presence of an aqueous medium containing surfactants and/or dispersants; viscosity modifiers/stabilizers; anti-foaming agents; antifreeze and more. Such components are all found in the combined composition. Lastly, Richardson teaches that the particulate organic biocides may be combined with inorganic salts such as the copper fungicides of De Oliveira. The particle size afforded by the milling process of Richardson (i.e., a micron or less) further reads on the particle size of claims 1 and 23-25.
As such, the prior art teaches all the components of the instant formulation as defined in claims 1-3, 5-21, 23-33, and 44-45. Therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
Regarding the agricultural composition of claim 34, De Oliveira and Roux both teach diluting their respective compositions with water prior to use. Thus, it would have been obvious to do the same with the combined composition of De Oliveira, Roux, and Richardson, since the combined composition is a suspension concentrate. De Oliveira teaches diluting the suspension concentrate around 200 times with water until an aqueous composition comprising between 0.001 and 10 w/v % of the copper-based fungicide is provided. It is well within the skills of the ordinary artisan to optimize the amount of suspension concentrate in the diluted agricultural composition for use, depending on the bioactivity/amount of actives desired in the final product. The amount of concentrate in the final diluted composition depends simply on the amount of water added. As such, one of ordinary skill in the art would have arrived at the instantly claimed amount of suspension concentrate through no more than routine experimentation. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 35, De Oliveira teaches a composition with improved fungicidal activity compared to commercially available formulations of said copper-based fungicide. Roux teaches that AI.15 (i.e., the first active ingredient) acts as an enhancer for copper fungicides and Richardson teaches that a particle size of 1 micron or less allows for a lower effective dose than prior art formulations. Thus, the combined agricultural composition, which combines the teachings of De Oliveira, Roux, and Richardson, would reasonably allow the copper fungicide (i.e., the agriculturally active compound) to be incorporated in the composition at amounts lower than would typically be required in order to achieve the same biological effect as a composition which does not have the instant formulation. Additionally, the amount of the formulation of claim 1 (i.e., the combined suspension concentrate) present in the agricultural composition of claim 34 is made obvious above. In the case where the composition made obvious by the prior art is identical to the composition claimed, the composition must necessarily have the characteristics claimed as an inherent property. In other words, since the amount of the suspension concentrate present in the agricultural composition is made obvious above, that amount is inherently able to achieve the effects described in claim 35. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
The combined composition of De Oliveira, Roux, and Richardson comprises copper fungicides as the agriculturally active ingredient, thereby reading on claims 36-37.
De Oliveira teaches methods of preventing, reducing and/or eliminating the presence of a phytopathogen on a plant or on one or more plant parts, comprising applying a combination or composition of the present invention to said plant or plant part. Roux similarly teaches a method of treating a plant or seed infected by or at risk of infection of a plant fungal pathogen. Thus, it would have been obvious to one of ordinary skill in the art to use the combined composition of De Oliveira, Roux, and Richardson in a method comprising diluting the combined suspension concentrate to give the diluted agricultural composition above, and applying the diluted composition to a plant, plant part, or seed which has or is at risk of a fungal infection as taught by both De Oliveira and Roux. Such a method reads on the method of instant claims 38 as well as the method of instant claims 39-40 and 46 since the actives of the combined composition are effective in controlling and preventing fungal growth or protecting a crop from a pest (i.e., fungi). The combined composition comprises a fungicide, thus, applying the combined composition also reads on applying a fungicide or pesticide to the same site, as recited in claims 41 and 47.
Regarding claims 42-43, it is discussed above that De Oliveira teaches tank mixing the composition with an additional agrochemical. Such as step reads on wherein diluting the formulation (i.e., the suspension concentrate) comprises adding an agriculturally active compound as recited in claim 42. It would have therefore been obvious to do the same in the method of applying the combined composition of De Oliveira, Roux, and Richardson since the use of a known technique to improve similar methods or products in the same way is considered prima facie obvious. See MPEP 2143. Regarding adding a lesser amount of agriculturally active compound than is recommended for use in the absence of the suspension concentrate, it would have been obvious to one of ordinary skill in the art to add less of the additional agrochemical than is typically needed, as outlined above in the discussion of claim 35.
Regarding claims 48 and 49, the combined composition of De Oliveira, Roux, and Richardson comprises a copper fungicide and AI.15. AI.15 is an enhancer of the copper fungicide as taught by Roux. Thus, a method of applying the combined composition would result in a synergistic effect between the enhancer and the pesticide/fungicide. Furthermore, since the composition made obvious by the prior art is identical to the composition claimed, the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
Claim 1-21 and 23-49 are rejected under 35 U.S.C. 103 as being unpatentable over De Oliveira, Roux, and Richardson as applied to claims 1-3, 5-21, and 23-49 above, and further in view of Hazra, D., et al. (2019). Role of pesticide formulations for sustainable crop protection and environment management: A review. J Pharmacogn Phytochem. 8(2):686-693, (PTO-892), hereinafter Hazra.
The combined teachings of De Oliveira, Roux, and Richardson are discussed above.
As discussed above, De Oliveira teaches a thickening agent. Thickening agents are selected from agar, alginic acid, alginate, carrageenan, gellan gum, xanthan gum, succinoglycan gum, guar gum, acetylated distarch adipate, acetylated oxidised starch, arabinogalactan, ethyl cellulose, methyl cellulose, locust bean gum, starch sodium octenylsuccinate, and triethyl citrate ([0189]; claim 59).
The combined teachings differ from that of the instant invention in that De Oliveira, Roux, nor Richardson explicitly teach a formulation comprising an inert filler as recited in claim 4.
Hazra teaches the role of pesticide formulations in sustainable crop protection and environmental management (title). Suspension Concentrates (SC) or Aqueous flowables (AF) are concentrated 40% to 70% w/w suspensions of micronized active pesticide in water. Prior to spraying on target areas, aqueous flowables are diluted with water in a spray tank to achieve the minimum effective pesticide concentration. AFs must be formulated for low viscosity and good fluidity so that transfer to the spray tank is easy and complete. Since the active ingredients in AFs are insoluble, good suspension stability is essential. If the suspension settles and leaves sediment at the bottom of the container, the application of the pesticide may be too weak to be effective. Also, disposal of the residue in the container becomes a problem. A combination of smectite clay (aka bentonite) and xanthan gum works synergistically to provide excellent long term suspension stability at low viscosity and at low cost. Developing a flowable is a balancing act between the need to keep the viscosity high enough that particles do not sink rapidly,