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
Receipt of Remarks/Amendments filed on 04/03/2026 is acknowledged. Claims 1, 23-25, 32, 34-35, 38-41, 43, 46-48, and 50 are amended and claims 44-45 and 49 are canceled. Claims 1-43, 46-48, and 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 04/03/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner
Withdrawn Objections/Rejections
Claims 34 and 43 were objected to for informalities. Applicant’s amendments to these claims has overcome the objection and the objection is withdrawn.
Claims 39-43 and 46-50 were rejected under 35 U.S.C. 112(a) for scope of enablement. Applicant’s amendments to the claims have overcome the rejection and the rejection is withdrawn.
Claims 23-25, 32, 35-38, 43-45, and 50 were rejected under 35 U.S.C. 112(b) as being indefinite. Applicant’s amendments to these claims and cancellation of claims 44-45 have overcome the rejections and the rejections are withdrawn.
Claims 23-25 and 44-45 were rejected under 35 U.S.C. 112(d), as being of improper dependent form. Applicant’s amendments to claims 23-25 and cancellation of claims 44-45 have overcome the rejections and the rejections are withdrawn.
The following grounds of rejections are new and maintained, as necessitated by amendment:
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, 21, 27, and 34 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.
Claim 21 recites a pH of 7 to 10.5 which depends from claim 1 which recites a range of about 8 to 11. Since claim 21 depends from claim 1 it is unclear if 1) a pH of 7 reads on about 8, or 2) if a pH of 7 lacks antecedent basis.
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. Claim 36 is 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.
Claim 34 has been amended to depend on claim 30. Claim 30 defines wherein the agriculturally active compound is an acaricide, antimicrobial, fungicide, etc.. Claim 36 recites the exact same limitation, and ultimately depends on claim 30 given the new dependency of claim 34. As such, claim 36 fails to further limit the claims since it repeats a limitation already recited in a claim from which it depends.
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. Claims 1-3, 5-21, 23-43, 46-48, and 50 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, on record), 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 (on record), 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 include anionic and nonionic surfactants, specifically polymethyl methacrylate-polyethylene glycol graft copolymer ([0134]-[0138]; [0152]-[0156]; claims 35, claims 68-69), which read on the dispersant of claims 1 and 9-12. The concentration of such dispersants in the composition is 0.1-15% by weight based on the total weight of the composition ([0157]), which reads on the instantly claimed range of claim 5 and overlaps with the range of claim 6. 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. Moreover, De Oliveira provides a general teaching regarding the amount of lignosulfonate and dispersant to include, from which one of ordinary skill in the art could optimize the total amount of dispersants in the composition. 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 dispersion 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 or 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 claim 21. Regarding the pH of claim 1, the term “about” generally denotes a value within ± 10%. In the case of claim 1, a pH greater than “about 8” includes a pH of 7.2. Thus, the claimed range of about 8 to 11 overlaps with the range disclosed by the prior art. 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, the embodiment of De Oliveira having a pH of 7.5 falls within the instantly claimed range given the above considerations.
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 such as 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 and particle size of claim 1, nor a fungicide of claim 50.
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).
Roux also teaches the AI.15 enhancer {(E)-3-methyl-N′-(1-(naphthalen-2-yl) ethylidene) benzohydrazide} to differentially enhance the effect of triazole fungicides in addition to copper fungicides. Preferred triazole fungicides that are susceptible to enhancement include prothioconazole. The combination of the select fungicide and enhancer provides synergistic fungicidal activity against plant pathogenic fungi (col. 1-2, lines 64-9). Prothioconazole 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).
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]). The d50 is equivalent to the volume-weighted median particle size as defined in the instant claims and Richardson ([0052]).
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 combined with one or more other organic biocides and/or particulate sparingly soluble biocidal inorganic salts. These inorganic biocidal salts can be milled using the same procedures and 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. The AI.15 compound of Roux reads on the first active of claim 1.
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 taught by De Oliveira. The particle size afforded by the milling process of Richardson (i.e., a micron or less) reads on the particle size of claims 1 and 23-25 with sufficient specificity such that one of ordinary skill in the art would recognize the instantly claimed ranges from the teachings of Richardson. In any case, when the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
As such, the prior art teaches all the components of the instant formulation as defined in claims 1-3, 5-21, and 23-33. 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 also 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 meaning their combination would result in a synergistic effect for treating fungi and therefore improving crop growth. Additionally, the amount of the formulation 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 38-40 and 46, since the actives of the combined composition are effective in controlling and preventing fungal growth or protecting a crop from fungi. The combined composition comprises a fungicide, thus applying the combined composition also reads on applying a fungicide to the same plant, 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 diluting the formulation (i.e., the suspension concentrate) and adding an agriculturally active compound as recited in claim 42. It would have 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 the synergistic fungicidal activity, such synergy is expected if not inherent, as outlined above in the discussion of claim 35 above and claim 48 below.
Regarding claim 48, 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 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.
Regarding claim 50, it would have been obvious to modify the combined teachings of De Oliveira, Roux, and Richardson before the effective filing date of the claimed invention by using the prothioconazole of Roux in the combined method of De Oliveira, Roux, and Richardson to yield the instant invention. As discussed above, the combined composition of De Oliveira, Roux, and Richardson may be used in a method of applying a diluted composition to a plant, plant part, or seed which has or is at risk of a fungal infection. The method may be carried out in combination with additional agrochemicals via a tank mixing procedure as taught by De Oliveira. One of ordinary skill in the art would have been motivated to apply prothioconazole with the combined composition above in a method of protecting crops/plants from fungal infections since the prothioconazole is known to provide synergistic fungicidal activity when combined with the AI.15 enhancer of the combined composition, as taught by Roux. One of ordinary skill in the art would have had a reasonable expectation of success in using prothioconazole with the combined composition in a method of protecting crops from fungal pathogens since De Oliveira teaches combining fungicide compositions with additional fungicides in a tank-mix for co-application. Prothioconazole reads on the fungicide of claim 50.
Claim 1-21, 23-43, 46-48, and 50 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, 23-43, 46-48, and 50 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, (on record), 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 include xanthan gum ([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, but low enough that the material pours out or pumps easily (Section 2.3.2.2).
Thus, it would have been obvious to modify the combined composition of De Oliveira, Roux, and Richardson with the teachings of Hazra before the effective filing date of the claimed invention by providing a composition that comprises smectite clay and xanthan gum as reasonably suggested by Hazra, to yield the instant invention. One of ordinary skill in the art would have been motivated to use smectite clay and xanthan gum in the combined suspension concentrate of De Oliveira, Roux, and Richardson since the two together results in excellent long term suspension stability as taught by Hazra. One of ordinary skill in the art would have had a reasonable expectation of success in providing a composition comprising the smectite clay and xanthan gum of Hazra since the combined composition comprises a thickening agent already which may be xanthan gum as taught by De Oliveira, and the combined composition is a suspension concentrate which would benefit from smectite clay as taught by Hazra. The smectite clay reads on the inert filler as recited in instant claim 4.
The claim does not define the amount of inert filler to be included, however, the instant claim does recite an amount of the first active compound and the total amount of suspended material. As discussed above in regards to claim 2-3, Roux provides a general teaching for the amount of first active ingredient needed in the final diluted composition. As such, one of ordinary skill in the art would have optimized the amount of AI.15 (i.e., the first active ingredient) in the suspension concentrate depending on the amount of AI.15 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, one of ordinary skill in the art would have arrived at the instantly claimed amount of the first active in claim 4 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). Similarly, one of ordinary skill in the art would have arrived at the total amount of suspended material as defined in claim 4 depending on the desired viscosity and stability of the final composition as discussed by Hazra. It is well within the skills of the ordinary artisan to optimize the total amount of suspended material using no more than routine experimentation.
Claim 1-3, 5-43, 46-48, and 50 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, 23-43, 46-48, and 50 above, and further in view of G-Biosciences, The Protein Man’s Blog|A Discussion of Protein Research. Biological Buffers: pH Range and How to Prepare Them. Published 05/13/2014. (PTO-892), hereinafter the Protein Man.
The combined teachings of De Oliveira, Roux, and Richardson are discussed above.
As discussed above, De Oliveira teaches a pH adjuster or buffering agent such as organic or inorganic bases and/or organic or inorganic acids ([0159]; claim 30). The composition has a pH in the range of 5.0-7.5 ([0088]; [0146]; claim 70),
The combined teachings differ from that of the instant invention in that De Oliveira, Roux, nor Richardson disclose a phosphate or borate buffer as recited in claim 22.
The Protein Man teaches phosphate buffers for maintaining a pH range of 5.8 to 8.0. In order to achieve different pH values within this range 0.1M sodium phosphate monobasic and 0.1M sodium phosphate dibasic solutions are mixed in the proportions taught and adjusted to a final volume of 200ml using deionized water (page 3, final table).
Thus, it would have been obvious to modify the combined composition of De Oliveira, Roux, and Richardson before the effective filing date of the claimed invention by using a phosphate buffer as the buffering agent to yield the instantly claimed invention. It would have been prima facie obvious to use a phosphate buffer since it is capable of buffering a solution within the pH range of 5.8 to 8.0 as taught by the Protein Man and De Oliveira teaches the use of buffering agents to generate a pH in the range of 5.0 to 7.5. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In this case, a phosphate buffer is recognized for its suitability to maintain a pH within the range of 5.8 and 8.0, which encompasses a majority of the preferred pH range taught by De Oliveira and overlaps with the pH range of instant claim 1. One of ordinary skill in the art would have had a reasonable expectation of success in using a phosphate buffer as the buffering agent in the combined suspension concentrate given that De Oliveira generally teaches a buffer and the Protein Man teaches methods of adjusting pH using a phosphate buffer.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-43, 46-48, and 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 40, 44, and 49-51 of copending Application No. 18/384,266 in view of De Oliveira. The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of De Oliveira.
The copending claims recite a water-dispersible granule, comprising particles of a first agriculturally active compound having the same structure as defined in instant claim 1; a dispersant; wherein the particles of the first active compound have a volume-weighted median particle size ranging from greater than 0.01 microns to 20 microns (Copending claim 1). Copending claim 40 further recites a composition comprising: the water-dispersible granule of claim 1; and an additional agriculturally active compound. The composition of claim 40 further comprises water (Copending claim 44). Such a composition would lead to the water-dispersible granules being dispersed in water which reads on an aqueous suspension as instantly claimed. The copending claims define a method of using the composition of claim 40, comprising applying it to a plant, part of a plant, a seed, soil where a plant is or will be growing, or soil where a seed has been or will be sown as well as a method for controlling or preventing fungal growth comprising combining the composition of claim 40 with water to form a fine particle suspension comprising particles of the first agriculturally active compound; and applying the fine particle suspension to a site that has a fungal growth or is at risk of developing fungal growth (Copending claims 49-51), which reads on the instantly claimed methods.
The copending claims differ from the instant claims in that the copending claims do not recite a freezing point depressant or a buffer/partially neutralized base.
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). De Oliveira teaches propylene glycol as an antifreezing agent ([0168]-[0170]; claims 42-44) as well as a pH adjuster or buffering agent such as organic or inorganic bases and/or organic or inorganic acids ([0159]; claim 30). The composition has a pH in the range of 5.0-7.5 ([0088]; [0146]; claim 70), which overlaps with the instantly claimed pH that defines a lower range of about 8.
It would have been obvious to combine the composition of the copending claims with that of De Oliveira since both compositions are used in methods for treating fungal growth in plants and the antifreeze and buffering agents of De Oliveira are known and effective additives for aqueous suspensions used in such methods. “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). Thus, one of ordinary skill in the art would reasonably combine such agents into the fine particle suspension of the copending claims to yield the instantly claimed composition and methods.
This is a provisional nonstatutory double patenting rejection.
Claims 1-43, 46-48, and 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 24, and 30-31 of copending Application No. 18/391,459 in view of De Oliveira. The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of De Oliveira.
The copending claims recite a composition, comprising a compound having the same structure as defined in instant claim 1; a lipophilic solvent; a first dispersant; and a rheology modifier (Copending claim 1). The compound is present in the form of particles having a volume-weighted median particle size ranging from greater than 0.01 microns to 20 microns (Copending claim 3). The copending claims recite an agricultural composition, comprising water and/or a lipophilic solvent and the composition of claim 1, as well as a method for controlling or preventing fungal growth comprising: diluting the composition of claim 1 with water and/or a lipophilic solvent to form a diluted mixture; and applying the diluted mixture to a site that has a fungal growth or that is at risk of developing a fungal growth (Copending claims 24 and 31). The copending claims further define a method of using the agricultural composition of claim 24, applying the agricultural composition to a plant, a part of a plant, a seed, soil where a plant is or will be growing, or soil where a seed has been or will be sown (copending claim 30). As such, the composition of copending claim 1 with water as defined in copending claim 24 reads on an aqueous suspension of the instant invention, while the methods of using such a composition read on the methods of using the instant composition.
The copending claims differ from the instant claims in that the copending claims do not recite a freezing point depressant or a buffer/partially neutralized base.
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). De Oliveira teaches propylene glycol as an antifreezing agent ([0168]-[0170]; claims 42-44) as well as a pH adjuster or buffering agent such as organic or inorganic bases and/or organic or inorganic acids ([0159]; claim 30). The composition has a pH in the range of 5.0-7.5 ([0088]; [0146]; claim 70), which overlaps with the instantly claimed pH that defines a lower range of about 8.
It would have been obvious to combine the composition of the copending claims with that of De Oliveira since both compositions are used in methods for treating fungal growth in plants and the antifreeze and buffering agents of De Oliveira are known and effective additives for aqueous suspensions used in such methods. “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). Thus, one of ordinary skill in the art would reasonably combine such agents into the composition of the copending claims in water to yield the instantly claimed composition and methods.
This is a provisional nonstatutory double patenting rejection.
Claims 1-43, 46-48, and 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/384,286 in view of Richardson. The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Richardson.
The copending claims recite a method for inhibiting a fungal infection in a seed or plant at risk thereof, comprising contacting the seed or plant with a fungicide comprising azoxystrobin, difenoconazole, chlorothalonil, tebuconazole, folpet, prothioconazole, fluxapyroxad, metconazole, mefentrifluconazole, pydiflumetofen, benzovindiflupyr, fenpicoxamid, cyazofamid, pyraclostrobin, or a combination thereof; and the apyrase inhibitor (E)-3-methyl-N'-(1-(naphthalen-2-yl) ethylidene)benzohydrazide (copending claim 1). As such, the copending claims render a composition used in such a method obvious.
The copending claims differ from the instant claims in that the copending claims do not define the composition of the method as an aqueous suspension also comprising a dispersant, a freezing point depressant, and a buffer, wherein particles of the first active compound have a specific size.
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 of any particle, the rainfastness of any particle, and the 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]). 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]). Examples of classes of compounds that have fungicidal activity and meet the solubility (and optionally also the crystallinity and melting point) requirements include azoxystrobin, chlorothalonil, ([0065]), difenoconazole, tebuconazole ([0067]). Chlorothalonil is a prime example ([0065]). Generally, the processes produce slurries or suspensions of particulate biocidal material. Richardson further teaches include dissolvable buffering agents ([0072]), specifically teaching milling formulations of chlorothalonil in water wherein the concentrate generated has a pH of 8.0 and 7.3 (Examples 1-2).
It would have been obvious to combine the composition made obvious by the copending claims with the composition of Richardson to provide the active agents of the copending claims in an aqueous suspension as taught by Richardson, wherein particles of the suspension have particle size of a micron or less. One of ordinary skill in the art would have been motivated to produces such a suspension since biocides with small particle size may be used at lower effective doses as taught by Richardson. Furthermore, it would have been obvious to provide the milled biocides in an aqueous suspension comprising dispersants, antifreeze agents, buffering agents, and other preferred excipients, since such components are known and effective in the art of formulating fungicides as taught by Richardson. Generally, the combination of prior art elements according to known methods to yield predictable results is considered prima facie obvious. One of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of the copending claims and Richardson since both teach compositions comprising many of the same fungicides. A method of using the combined composition in the method of the copending claims further reads on the instantly claimed methods.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 04/03/2026 have been fully considered but they are not persuasive:
(1) Applicant argues that claims 2-6, 14-15, 27, and 34 are not indefinite, stating that “the formulation comprises from 0.5 wt% to about 60 wt% of the first active compound” is equivalent to the weight of the first active compound being from 0.5 wt% to about 60 wt% of the weight of the claimed formulation.
Examiner respectfully disagrees, as a formulation comprising from 0.5 wt% to about 60 wt% of the first active compound could be based on the weight of the dispersant or based on the weight of the aqueous carrier. It is not a given that such weight percents are based on the total weight of the formulation unless explicitly recited. For that reason, the claims are indefinite.
(2) Applicant argues against the 103 rejection over De Oliveira, Roux, and Richardson. Specifically, Applicant asserts that one of skill in the art would not look to formulate compound 1 in water because the compound is water sensitive. Applicant points to Example 6 of the instant specification for support, further stating that neither Roux no De Oliveira teach or suggest the problem of water sensitivity of the compound. As such, Applicant asserts that one of skill in the art would not be motivated to combine Roux’s hydrolytically sensitive molecule with De Oliveira’s aqueous compositions with any expectation of success.
In response to this argument, it is noted that Roux teaches its compositions in the form of dispersions, solutions, suspensions, aerosols and powder, which comprise the fungicide, enhancer, and a phytologically-acceptable inert carrier. The most widely used carrier is water (col. 13, lines 54-58). There is no reason why one of ordinary skill in the art would be discouraged from adding the enhancers of Roux into an aqueous suspension of De Oliveira since suspensions comprising water as a carrier are encouraged by Roux. Regarding Applicant’s showing of the instantly claimed compound being water sensitive, Example 6 analyzes chemical stability as a function of pH, with rapid degradation only occurring under mildly acidic conditions of pH 4.5. A pH of 4.5 falls outside of the pH range taught in the composition of De Oliveira (i.e., 5-7.5). Applicant also disregards that the suspension concentrate of De Oliveira comprises other ingredients as claimed and is not just the active in water. As discussed above, the suspensions of De Oliveira are formulated with various additional components, specifically a polyanion dispersant, and every other component recited in instant claim 1. If Applicant is claiming that the enhancer of Roux could not reasonably be added into the suspension concentrate of De Oliveira, which comprises every additional component of claim 1, then Applicant is characterizing their own composition as unstable. Lastly, as Applicant points out, the prior art does not teach the problem of water sensitivity in the compound as claimed. For this very reason, one of ordinary skill in the art would not look at the disclosures of De Oliveira and Roux and be discouraged from adding the instantly claimed compound into an aqueous formulation, since these disclosures in and of themselves do not teach water sensitivity as an issue. Applicant’s showing of “water sensitivity” in the specification is not something that would have been available to one of ordinary skill in the art at the time of effective filing, and therefore is not taken into consideration in the obviousness analysis.
(3) Applicant further argues that none of the references teach or suggest the pH range recited in claim 1 as amended. Applicant argues that pH is a logarithmic scale and therefore De Oliveira does not teach any pH overlapping with the pH range of about 8 to 11 as recited in claim 1. Moreover, the difference in pH recited in claim 1 provides for surprising superior stability of the compound as demonstrated by Example 7, wherein “Compound 1 is chemically unstable at neutral or acidic pH, but is stable at pH 8”.
First, Examiner maintains that a pH of about 8 reads on a pH of 7.5. While pH is technically derived on a logarithmic scale, pH is not typically reported by its hydronium ion concentration, rather it is reported by pH units which range from 0 to 14. As such a 10% difference would not be calculated by the ordinary artisan based on hydronium ion concentration, rather it would be calculated based on conventional pH units.
Further regarding the meaning of “about”, it is stated in the instant specification that “the numerical parameters set forth are approximations that may depend on the desired properties sought” (Detailed Description, para. 2). Looking at Example 6 of the instant specification, which defines chemical stability as a function of pH, it can be observed that acceptable stability is achieved at a pH of 7.4 and not at a pH of 4.5. Thus, a pH of “about 8” as claimed can be characterized as an “approximation depending on the desired properties sought”, which includes a pH of 7.4 as shown in Example 6. The claimed pH of about 8 at least refers to a pH of 7.4 since this pH is shown to achieve desired properties in the instant specification. De Olivera teaches pH 7.5 which reads on such an interpretation. Regarding Example 7, long term chemical stability is analyzed for a pH of 6, 7, and 8. The results indicate that across the different temperatures, compositions at pHs 6 and 7 actually have the same if not higher amount of Compound 1 remaining after 1 month. After 9 months at 38oC, pH 6 and pH 7 are still retaining approximately 90% of Compound 1 which does not appear significantly different from the amounts retained in pH 8 formulations, especially given that these values contain some degree of error since several of the amounts reported are above 100% and in pH 8 compositions, the amount of compound 1 is increasing from month 1 to month 9, which could only be explained by measurement error. Additionally, Example 7 does not provide any experimental data for a pH between 7 and 8, meaning that there is no understanding of where a pH range of about 8 starts if “about 8” is an approximation depending on the desired properties sought. Moreover, the pH of 7.5 taught by De Oliveira falls between pH 7 and pH 8, for which there is no data. Lastly, no data is presented for any pH above 8, meaning the evidence is not commensurate in scope with the instantly claimed pH range which goes up to pH 11.
It is also of note that claim 21 recites a pH of 7 to 10.5 which depends from claim 1. Such a range very clearly overlaps with the pH range of De Oliveira (i.e., 5-7.5), with 7.5 falling inside a range of 7 to 10.5. Since claim 21 depends from claim 1, which recites a range of about 8 to 11, then 1) a pH of 7 must read on about 8 or 2) a pH of 7 lacks antecedent basis.
Conclusion
No claims 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.
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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