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 .
Claim Status
Claims 18-21, 23-26, and 31-32 are rejected.
Claims 33-36 are withdrawn.
No claims are allowable.
Maintained 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.
Claims 18-27 and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Savage et al., (US 6,103,768 A, Aug. 15, 2000) (cited by applicant on IDS 02/17/2023) (hereinafter Savage) in view of De Saegher et al. (WO 2020/104645 A1, May 28, 2020) (cited by applicant on IDS 02/17/2023) (hereinafter De Saegher) further in view of Sawant et al., (WO 2020/016730 A1, Jan. 23, 2020) (hereinafter Sawant).
Savage discloses combination treatments whereby fatty acids are used to enhance or augment the activity of fungicides, bactericides, and biological control agents used to eradicate existing fungal and bacterial infections in plants (Abstract). The non-phytotoxic properties of fatty acids make them extremely useful for combinations with other disease control agents. Thus, fatty acids can be advantageously combined with other disease control chemicals such as antifungal or antibacterial agents (i.e., pesticidal active) (col 4, lines 48-53). Specifically exemplified is the use of fatty acid compounds in conjunction with formulations containing elemental sulfur which are widely used for preventative antifungal treatment (col 4, lines 53-56). Pelargonic acid and its salts or derivatives, in a concentration of about 0.25 to about 3% w/v, have excellent curative activity against established fungal infections of produce (Examples 2 through 5) (col 9, lines 42-45). Tank mixes of fatty acids can be prepared according to procedures which are well known to those skilled in the art. For example, a fatty acid spray oil can be prepared using a solvent solution or emulsion of the fatty acid (i.e., oil dispersion), a surfactant (i.e., at least one agrochemically acceptable excipient), and sufficient water to dilute the mixture to the desired concentration (i.e., a liquid). Salts of fatty acids are readily dispersible or soluble in water (col 8, lines 42-48). The composition may be an emulsified suspension of pelargonic acid (i.e., suspoemulsion) (i.e., liquid suspension) (col 14, line 27).
Savage differs from the instant claims insofar as not disclosing a choline salt of pelargonic acid and wherein the composition comprises particles in the size range of from 0.1 micron to 50 microns.
However, De Saegher discloses a composition comprising the choline salt of C8-C10 fatty acids, particularly, choline pelargonate (i.e., a choline salt of pelargonic acid), can be used as a fungicide by applying (e.g. spraying) the composition in an amount effective to inhibit the growth of one or more phytopathogenic fungi on plants or parts thereof (page 2, lines 8-12). The composition may further comprise other crop protection agents and/or pesticidal agents (page 11, lines 2-3). Examples of typical formulations comprising choline pelargonate, include water-soluble liquids (SL), emulsifiable concentrates (EC), emulsions in water (EW), suspension concentrates (SC, SE, FS, OD), water-dispersible granules (WG), granules (GR) and capsule concentrates (CS), as known to the skilled person (page 11, lines 4-9). The anti-fungal agent is present in an amount of 0.1% to 20% w/w of the total composition
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. Savage discloses wherein the fungicidal composition comprises pelargonic acid salts. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated choline pelargonate into the composition of Savage since they are known and effective fungicidal pelargonic acid salt as taught by DeSaegher.
The combined teachings of Savage and DeSaegher do not disclose wherein the composition comprises particles in the size range of from 0.1 micron to 50 microns.
However, Sawant discloses an agricultural composition for soil application comprising elemental sulphur, at least one amino acid, their polymers, salts or derivatives or mixtures thereof and at least one agrochemical excipient. The composition comprises particles in the size range of 0.1-20 microns and may be a water dispersible granular composition or liquid suspension (Abstract). Elemental sulphur is present in the range of 20-99%w/w of the total composition (Claim 1). The granule size of the composition is in the range of 0.1 -5mm (Claim 15). Suspensibility of the composition is at least 30% (Claim 16). Dispersibility of the composition is at least 30% (Claim 17). Viscosity of the composition is less than 2000cps (Claim 19). The composition when formulated at a specific particle size of 0.1-20 microns, made sulphur, nutrients and amino acids readily available for uptake by the plants and increase the overall yield (page 6, lines 2-4). The composition also exhibits superior physical characteristics such as suspensibility, dispersibility, flowability, wettability, stability and improved viscosity resulting in better pourability (page 6, lines 4-7). The agricultural composition may be in the form of aqueous suspension, suspo-emulsion, suspension concentrate, aqueous dispersion, water dispersible granules, seed dressings or emulsions for seed treatment, and combinations thereof page 10, lines 17-19).
Savage discloses compositions containing elemental sulfur used to eradicate existing fungal and bacterial infections in plants and formulated as a suspension. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the composition of Savage comprising particles in the size range of from 0.1 micron to 20 microns since compositions formulated at a specific particle size of 0.1-20 microns make sulfur, nutrients and amino acids readily available for uptake by the plants and increase the overall yield as taught by Sawant.
Regarding the limitation of claim 18 reciting an elemental sulphur in the range of 10% w/w to 95% w/w of the total composition, as discussed above, Sawant teaches that elemental sulphur is present in the range of 20-99% w/w of the total composition. Accordingly, it would have been obvious to formulate the composition of Savage comprising elemental sulphur in the range of 20-99% w/w of the total composition, since this is a known and effective amount of elemental sulfur for agricultural compositions as taught by Sawant.
Regarding the limitation of claim 18 reciting choline salt of pelargonic acid in the range of 0.01% w/w to 50% w/w of the total composition, as discussed above, Savage teaches that pelargonic acid and its salts or derivatives, in a concentration of about 0.25 to about 3% w/v, have excellent curative activity against established fungal infections. De Saegher teaches that choline pelargonate (i.e., a choline salt of pelargonic acid), can be used as a fungicide by applying (e.g. spraying) the composition in an amount effective to inhibit the growth of one or more phytopathogenic fungi. Accordingly, one of ordinary skill in the art would have arrived at the claimed amount of choline pelargonate (i.e., a choline salt of pelargonic acid) through routine experimentation to formulate the amount effective to inhibit the growth of phytopathogenic fungi as taught by De Saegher.
Regarding claim 21, as discussed above, Savage discloses antifungal compositions comprising pelargonic acid and its salts. Accordingly, it would have been obvious to formulate the composition of Savage in the form of water dispersible granules (i.e., a solid) since water dispersible granules are a typical formulation of antifungal compositions comprising choline pelargonate (i.e., a choline salt of pelargonic acid) as taught by De Saegher.
Regarding claims 22 and 23, it would have been obvious to formulate the water dispersible granules as taught by Savage in view of De Saegher wherein suspensibility and dispersibility of the composition is at least 30% since this is a known and effective level of suspensibility and dispersibility for water dispersible granules of agricultural formulations as taught by Sawant.
Regarding claims 24 and 25, it would have been obvious to formulate the water dispersible granules as taught by Savage in view of De Saegher in the size range of from 0.1 mm to 5 mm since this is a known and effective size for water dispersible granules of agricultural formulations as taught by Sawant. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
Regarding the limitations of claim 26 reciting the form of a flowable concentrate and combination of capsulated suspension and suspension concentrate (ZC), as discussed above, Savage discloses antifungal liquid compositions comprising pelargonic acid and its salts with elemental sulphur for use on plants. Accordingly, it would have been obvious to formulate the composition of Savage as suspension concentrates (SC, SE, FS, OD) (i.e., flowable concentrates) and capsule concentrates (CS) since these are known and effective liquid formulations of antifungal compositions comprising choline pelargonate (i.e., a choline salt of pelargonic acid) as taught by De Saegher. In regards to the formulation of a combination of capsulated suspension and suspension concentrate (ZC), since De Saegher discloses the use of suspension concentrates and capsule concentrates individually, the use of the individual species in combination would have been obvious since it is prima facie obvious to combine two compositions, each of which is taught by De Saegher to be useful for the same purpose, in order to form a third composition to be used for the very same purpose; the idea for combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06.
Regarding the limitation of claim 26 reciting the form of a seed dressing, as discussed above, Savage discloses antifungal liquid compositions comprising pelargonic acid and its salts with elemental sulphur for use on plants. Accordingly, it would have been obvious to formulate the composition of Savage as a seed dressing since this is a known and effective formulation for agricultural compositions as taught by Sawant.
Regarding claim 27, as discussed above, Savage discloses antifungal suspensions comprising pelargonic acid and its salts with elemental sulphur for use on plants. Accordingly, it would have been obvious to formulate the composition of Savage having a viscosity of less than 2000 cps since this is a known and effective viscosity for agricultural suspensions as taught by Sawant.
Regarding claims 29 and 30, it would have been obvious to formulate the antifungal suspension composition (i.e., liquid suspension) of Savage wherein suspensibility and dispersibility of the composition is at least 30% since this is a known and effective level of suspensibility and dispersibility for liquid suspensions of agricultural formulations as taught by Sawant.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Savage et al., (US 6,103,768 A, Aug. 15, 2000) (cited by applicant on IDS 02/17/2023) (hereinafter Savage) in view of De Saegher et al. (WO 2020/104645 A1, May 28, 2020) (cited by applicant on IDS 02/17/2023) (hereinafter De Saegher) further in view of Sawant et al., (WO 2020/016730 A1, Jan. 23, 2020) (hereinafter Sawant) and further in view of Okafo et al., (Preliminary Studies On The Suspending Properties Of Sida Acuta Gum In Paracetamol Suspension, June 01, 2017) (hereinafter Okafo).
As discussed above, Savage, De Saegher, and Sawant make obvious the limitations of claims 18 and 26 but do not teach wherein the composition has pourability of less than 5% residue.
However, Okafo teaches that suspensions that are formulated well should have some desirable physical properties and that an increase in the viscosity of the dispersion medium, results in reduction in the rate of settling of the dispersed particles but the viscosity should not be excessively high to avoid retardation of pourability (page 303, bottom paragraph). Further, an increase in viscosity also decreases pourability. One of the qualities of a good suspension is that of pourability from the container. Therefore a balance should be struck between increase in viscosity and good pourability (page 310, Viscosity of the paracetamol suspensions).
As discussed above, Savage discloses antifungal suspensions comprising pelargonic acid and its salts with elemental sulphur. Accordingly, one of ordinary skill in the art would have arrived at the suspension of Savage having pourability of less than 5% residue through routine experimentation in order to strike a balance between increase in viscosity and good pourability since good pourability is a desirable physical property of suspensions as taught by Okafo.
Response to Applicant’s Arguments
Applicant argues that Savage's examples show not all fatty acids can be combined with sulfur and used for antifungal treatment without damaging the treated plant, specifically, that teach greatest amount of leaf injury was observed for a combination of sulfur with potassium oleate and a combination of sulfur with potassium cocoate showed the least damage, therefore, the person of ordinary skill in the art would conclude combinations of cocoate salts with sulfur, would be the best starting point when seeking to improve on the teachings of Savage.
Applicant’s arguments have been fully considered and are found to be persuasive. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. See MPEP 2123. As discussed above, Savage teaches the use of fatty acid compounds, such as salts of pelargonic acid, in conjunction with formulations containing elemental sulfur which are widely used for preventative antifungal treatment. Savage does not teach wherein a combination of pelargonic acid salts and elemental sulfur cause damage to leaves. Thus, one of ordinary skill in the art would have reasonably expected that a combination of pelargonic acid salts and elemental sulfur would be used for preventative antifungal treatment with a reasonable expectation of success.
Additionally, the prior art does not need to point to a single lead compound (i.e., cocoate salts with sulfur) for further development because such restrictive view is rejected in KSR. See Ex. 11 of MPEP 2143(I)(B).
Applicant argues that given the Examples of Savage, the person of ordinary skill in the art would conclude that mixtures of fatty acids would be less likely to injure leaves when combined with sulfur, or alternatively would select the most prevalent fatty acid in cocoate, lauric acid but would not test pelargonic acid because it is not a component of cocoate.
Applicant’s arguments have been fully considered and are found to be persuasive. As discussed above, the prior art does not need to point to a single lead compound (i.e., cocoate salts with sulfur) for further development. Savage disclosing that a combination of sulfur with potassium cocoate showed the least damage when compared to a combination of sulfur with potassium oleate in one example does not make it less obvious that a combination of pelargonic acid salts and elemental sulfur would be used for preventative antifungal treatment.
Applicant argues that in Table 2, upon comparing treatment T1 (Sulphur 55% + Choline pelargonate 5% water dispersible granule (WDG)) with T4 (Sulphur 80% WDG) and T5 (Choline pelargonate 5% WDG) applied at same dosage, it was noted that treatment T1 demonstrated control of 81% whereas treatment T4 and T5 demonstrated 51% and 40% control against powdery mildew, whereas the expected % control was 70.6% calculated by Colby's method. And further in Table 3, on comparing treatment T2 (Sulphur 20% + Choline pelargonate 35% water dispersible granules) and T3 (Sulphur 20% + Choline pelargonate 35% liquid suspension) applied at 5000gm/ha with T4 (Sulphur 80% WDG) and T5 (Choline pelargonate 40% WDG) it was observed that treatment T2 and T3 demonstrated 91% and 90% control respectively against powdery mildew whereas T5 demonstrated 69% control and T4 depicted 61% control against the fungal disease. The expected increase as per Colby's method for T2 and T3 was 87.91%, which is an unexpected synergistic result.
Applicant’s arguments have been fully considered and are found to be persuasive. It is unclear how the results of the Colby formula in the instant application can be relied upon to show synergy when the formulations being compared have different percentages of active ingredients. As noted on page 6, lines 7-10 of the instant specification, the instantly claimed invention relies on a percentage of sulphur in the total composition, in addition to the percentage of pelargonic acid present in the total composition. T1 comprises a combination of sulphur and choline pelargonate in a water dispersible granule. T2 and T3 comprise a combination of sulphur and choline pelargonate in a suspension. T4 comprises only sulphur in a water dispersible granule, and T5 comprises only choline pelargonate in a water dispersible granule. Table 2 shows that the sulphur in T1 and T4 was present in the water dispersible granules at the same dosage, however, the WDG of T1 comprises sulphur in 55% and the WDG in T4 comprises sulphur in 80%. Table 3 shows that WDG of T2 comprises sulphur in 20% and choline pelargonate in 35% and the liquid suspension of T3 comprises sulphur in 20% and choline pelargonate in 35%. However, WDG T4 comprises sulphur in 80% and WDG T5 comprises choline pelargonate in 40%. Thus, the unexpected results cannot be determined because it is unclear if the results are due to the combination of sulfur and choline pelargonate or due to the high amounts present in the comparative examples.
Additionally, the claimed subject matter must be compared with the closest prior art to be effective to rebut a prima facie case of obviousness. See MPEP 716.02(e). Applicant has not shown comparison of the instantly claimed invention and the closest prior art. As discussed above, Savage teaches that a combination of sulfur and fatty acids is pesticidally effective. Thus, Savage appears to be the closest prior art and Applicant has not shown that the results of the combination of sulfur and choline pelargonate as instantly claimed would be unexpected when compared to the compositions of Savage.
Furthermore, purely arguendo, even if Applicant’s showing was probative of unexpected results, claim 1 would not be commensurate in scope with the showing. Claim 18 recites an elemental sulphur in the range of 1% w/w to 95% w/w and choline salt of pelargonic acid in the range of 0.01% w/w to 50% w/w of the total composition. However, the exemplary compositions shown in Tables 2 and 3 used to demonstrate the unexpected synergy comprise sulphur in a percentage from 20-55% and choline pelargonate in a range of 2.5-40%. As discussed above, Savage teaches that pelargonic acid and its salts or derivatives, in a concentration of about 0.25 to about 3% w/v, have excellent curative activity against established fungal infections of produce and that a mixture of components can be sufficiently active so that application of the composition enables utilization of reduced amounts of each of the active ingredients while still providing effective activity (col 10, lines 60-65). Thus, because the prior art teaches that pelargonic acid must be present in a specific amount to be effective and that combining active ingredients alters the amount of active ingredients necessary for effective activity, one of ordinary skill in the art would not reasonably expect any and all amounts of the compounds to result in a pesticidal effect and synergy outside of the range provided in the Applicant’s data.
Applicant argues that contrary to what Savage reports, at Examples 12-13, Tables 17-18, the present combination of sulfur and choline pelargonate caused no crop phytotoxicity and improved yield (Qtl/ha, quintal/hectare, 100 kg/hectare) over using sulfur or choline pelargonate alone.
Applicant’s arguments have been fully considered and are found to be persuasive. The examples of Savage do not teach that the combination of sulfur and choline pelargonate caused crop phytotoxicity and decreased yield. Thus, it is unclear how Savage reports that the combination of sulfur and choline pelargonate caused crop phytotoxicity and decreased yield.
Applicant argues that Sawant and Okafo do not remedy the deficiencies of Savage and De Saegher.
Applicant’s arguments have been fully considered and are found to be persuasive. The Examiner submits that Applicant’s argument with regards to Savage and De Saegher is addressed above and is unpersuasive. Therefore, these rejections are maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Samantha J Knight whose telephone number is (571)270-3760. The examiner can normally be reached Monday - Friday 8:30 am to 5:00 pm ET.
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/S.J.K./ Examiner, Art Unit 1614
/TRACY LIU/ Primary Examiner, Art Unit 1614