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 .
DETAILED ACTION
This action is FINAL.
Status of Claims
Claims 1-7, 9-30, and 34-36 are pending.
Claims 1-7, 9-18, and 34-36 are examined.
Claims 19-30 are withdrawn (see restriction below).
Priority
This application is filed 05/30/2023 and claims the benefit of domestic priority as below:
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Information Disclosure Statement
One IDS(s) received 05/30/2023 have been considered unless marked with a strikethrough. No additional IDS(s) is/are provided.
Response to Arguments
Applicant's arguments/amendments filed on 6/10/2026, and in the amendments, claims 1-7, 9, 11-18, and 34-36 are amended; and claim 8 is cancelled. No new matter has been added. With respect to the objection of claims has been fully considered and are persuasive. Therefore, the objection of claims has been withdrawn. The Applicant's arguments of the objection of drawings and the rejection of claims under 35 U.S.C 102 and 35 U.S.C 103 have been considered but are moot in view of the new ground of rejections for the amended claims 1-7, 9-18, and 34-36. The previous rejections of record are withdrawn in view of the amendment.
New Ground of Rejections
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because:
It is impossible to distinguish any differences between the vials labeled F1 through F15 vials in the Figure 1. For example, F3 is described as "clear" and F4 as "hazy," but they are indistinguishable in the image. Thus, the Figure 1 is not necessary for an understanding of the claimed invention. See 37 CFR 1.84(l) and (q).
Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Objections
Claim(s) 14-16 is/are objected to because of the following informalities:
Claim 14 is objected to because the phrase “one or more additional fungicide” should be “one or more additional fungicides”, and “is selected” should be “are selected” for consistency with claim 1.
Claim 15 is objected to because the phrase “one or more additional fungicide” should be “one or more additional fungicides” for consistency with claim 1.
Claim 16 is objected to because the phrase “one or more additional fungicide” should be “one or more additional fungicides”, and “is about” should be “are about” for consistency with claim 1.
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 1-7, 9-14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Cush et al. (US 9192159 B2, pub’d 11/24/2015) in view of Brown et al. (WO 2013/126948 A1, pub’d 09/06/2013).
With respect to the independent claim 1, the claim recites that a composition comprising at least one strobilurin fungicide, a polar aprotic solvent, a non-ionic emulsifier selected from the group consisting of polyoxyethylated aromatics, polyalkoxylated alkyl ethers and any combination thereof, optionally, one or more additional fungicides selected from the group consisting of triazoles, and at least one polyhydric alcohol compound, wherein the at least one polyhydric alcohol compound is at the amount of about 5% to about 50% by weight based on the total amount of the non-ionic emulsifier.
Cush teaches 1) a microemulsifiable, storage stable liquid agrochemical concentrate comprising azoxystrobin, which is a strobilurin fungicide; 2) suitable polar aprotic solvents, including DMSO; 3) non-ionic surfactants, including tristyrylphenol ethoxylates; 4) an emulsifier system capable of forming a microemulsion of azoxystrobin and propiconazole; and 5) propylene glycol as one of the suitable polyhydric alcohols (claim 1, column 4 lines 27-64, and column 6 lines 32-57). Cush further teaches that the proportions of azoxystrobin propiconazole, the solvent system, and the emulsifier system are selected so that a stable oil in water microemulsion forms spontaneously upon dilution, and the resulting compositions are storage stable, readily dispersible in water, biologically effective, and exhibit prolonged physical stability following dilution (column 3, lines 1-14 and 31-41).
Cush fails to teach the at least one polyhydric alcohol compound is at the amount of about 5% to about 50% by weight based on the total amount of the non-ionic emulsifier
Brown teaches that 1) an agrochemical emulsifiable concentrate (EC) formulation comprising a benzyl acetate based solvent system including ethoxylated tristyrylphenol (e.g., TERSPERSE® 2218) as a polyoxyethylated aromatic non-ionic emulsifier (claim 1, page 5 lines 21-30, and page 11 lines 21-32); and 2) the use of propylene glycol or DMSO as a co-solvent that is a polyhydric alcohol compound, (page 2 lines 10-15), and the ratio of benzyl acetate to the substantially water miscible co-solvent may range from 10:90 to 90:10 and, more preferably, 40:60 to 80:20 (claim 1 and 2). Brown further teaches that the benzyl acetate/co-solvent system can provide storage stable and dilution stable agrochemical formulations at relatively high activity ingredient loading (page 4 lines 6-10). Brown also teaches that benzyl acetate, when uses with a controlled amount of a polar, substantially water miscible co-solvent, can maintain active ingredient solubility in the concentrate and substantially reduce crystallization following dilution (page 4 lines 21-26).
It would have been obvious to a PHOSITA at the time of the invention to modify the solvent system of cush by employing the benzyl acetate/co-solvent system taught by Brown and by selecting propylene glycol form Brown’s identified water miscible co-solvent. A skilled artisan would have been motivated to modify Cush’s azoxystrobin containing microemulsifiable concentrate by incorporating Brown’s benzyl acetate solvent system because Cush teaches selecting solvents and emulsifiers to obtain a storage stable concentrate that forms a stable microemulsion upon dilution, while Brown teaches that controlled amount of benzyl acetate improves active ingredient loading, storage and dilution stability, and resistance to crystallization in analogous agrochemical concentrate. Therefore, Brown’s teaching would have suggested using benzyl acetate in Cush’s formulation to address the same solubility and stability concerns, with a reasonable expectation of success because Cush permits suitable solvent selection and Brown shows benzyl acetate’s effectiveness in comparable formulation. (see MPEP 2143)
Combination teachings fail to teach the at least one polyhydric alcohol compound is at the amount of about 5% to about 50% by weight based on the total amount of the non-ionic emulsifier.
However, a skilled artisan should seek to improve haze resistance, crystallization resistance, and emulsion stability in an azoxystrobin containing agrochemical concentrate, would have had reason to adjust the identities and relative amounts of conventional formulation components, including a polyhydric alcohol and a nonionic emulsifier, through ordinary formulation screening. Therefore, seeking an operable and stable composition would have had reason to screen claimed relative amounts through routine experimentation. Determining a workable range under such circumstance may be obvious as routine optimization. (see MPEP 2143, 2144 and 2145) The claimed concentration represents a routine optimization process, rather than a critical issue or an unexpected result, is clearly shown in the instant specification. For example, in example 2, Soprophor CY/8 is fixed at 126.10g while propylene glycol is varied to provide PG/emulsifier ratios of 0%, 1.75%, 3.50%, 5.04%, 6.97%, 8.27%, 9.77%, 11.26% and 13.01%. The formulations at 0% through 3.50% become hazy, while those at 5.04% through 13.01% remained transparent under the reported conditions. Example 1 separately tests 0g, 14.1g and 94g of propylene glycol relative to 126.1g of Soprophor CY/8, corresponding to approximately 0%, 11.18%, and 74.54%. The specification states that propylene glycol could resolve haze, but that excessive propylene glycol could cause sedimentation. Accordingly, the specification provides a graduated test series only through 13.01%, followed by a separate high level test at approximately 74.54%. It does not systematically test the interval between 13.01% and 74.54%, and it provides no evidence that 50% is a critical upper boundary. Therefore, the 50% limit appears to define a broad operable formulation window rather than a boundary associated with a distinct or unexpected effect. (see MPEP 2144.05 and 716.02(d)) Moreover, example 3 further tests that nonionic emulsifier at a nominal PG/emulsifier ratio of approximately 11.4%, and the results varied materially with emulsifier identity, and only certain emulsifiers produced favorable stability. Thus, Example 3 confirms that the claimed types of emulsifiers do not function uniformly and that, even at a low concentration of 5%, different emulsifiers can yield substantially different results. Unexpected results evidence must be commensurate in scope with the claims and must provide a reasonable basis for concluding that the asserted effect occurs throughout the claimed range and genus. (see MPEP 716.02(a), 716.02(b), and 716.02(d))
Cush and Brown provide a reason to combine the claimed formulation components, and to adjust their amount to obtain solubilization, spontaneous emulsification, storage stability, dilution stability, and crystallization resistance. Although the Cush and Brown do not teach the claimed concentration as a result effective variable, a person of ordinary skill would have had reason and a reasonable expectation of success to identity an operable ratio though routine screening of a finite set of conventional formulation parameters. Therefore, for these reasons, claim 1 have been obvious.
With respect to claims 2-4, the claims recite that the list of polar aprotic solvents in claim 2, specific polar aprotic solvents are benzyl acetate, acetophenone and any combination thereof in claim 3, and the polar aprotic solvent is benzyl acetate in claim 4.
Cush teaches suitable polar aprotic solvents, including DMSO (column 6 lines 32-57), as required in claim 2.
Cush fails to teach the use of benzyl acetate as the polar aprotic solvent.
Brown teaches that an agrochemical emulsifiable concentrate (EC) formulation comprising a benzyl acetate based solvent system including ethoxylated tristyrylphenol (e.g., TERSPERSE® 2218) as a polyoxyethylated aromatic non-ionic emulsifier (claim 1, page 5 lines 21-30, and page 11 lines 21-32). Brown further teaches the use of glycol glycol or DMSO as a co-solvent that is a polyhydric alcohol compound, (page 2 lines 10-15). Accordingly, Brown teaches benzyl acetate as a solvent serving the same functional purpose to Cush.
With respect to claim 5, the claims recite that the non-ionic emulsifier is selected from the family consisting of tristyrylphenol ethoxylates.
Cush teaches non-ionic surfactants, including tristyrylphenol ethoxylates (claim 1, column 4 lines 27-64, and column 6 lines 32-57).
With respect to claims 6-7, the claims recite the non-ionic emulsifier, and its amount in the composition as about 1 % to about 20% by weight and about 8% to about 15% by weight, based on the total weight of the composition.
Cush teaches formulation containing tristyrylphenol ethoxylate at 8.5%, 9.0%, 11.0% and 11.1% by weight of the formulation. (Table 1)
Therefore, claims 6-7 are obvious based on the overlapping ranges (MPEP 2144.05).
With respect to claims 9-11, the claims recite the selection and amount of strobilurin fungicide in the composition.
Cush teaches that azoxystrobin is present in the concentration in an amount of 0.1% to 25% by weight, preferably 0.1% to 15% by weight. (claim 4).
Accordingly, the claimed ranges overlap with, or are fully encompassed by, the ranges disclosure in Cush. (see MPEP 2144.05)
With respect to claims 12-13, the claims recite that the polar aprotic solvent, including benzyl acetate, is present in an amount of about 40 % to about 70 % by weight, based on the total weight of the composition.
Brown teaches the primary solvent system comprises benzyl acetate used on its own (page 4, lines 32-33). Brown further teaches that emulsifiable concentration formulations in which benzyl acetate constitutes the principal solvent component of the formulation, optionally in combination with a substantially water-immiscible solvent, and discloses that the benzyl acetate is preferably used with the substantially water-immiscible co-solvent in a mixing ratio range of from 10: 90 to 90: 10, more preferably in the mixing ratio range of from 40:60 to 80:20, as the primary solvent system (column 3 lines 33-38).
Accordingly, the claimed ranges overlap with, or are fully encompassed by, the ranges disclosure in Brown. (see MPEP 2144.05)
With respect to claims 14 and 16, the claims recite one or more additional fungicides selected from triazoles, including propiconazole, and their amounts (i.e., about 1%-30%) based on the total weight of the composition.
Cush teaches propiconazole, which is one of the triazole fungicides recited in claim 14, and teaches that propiconazole is present in an amount of about 0.1% - about 25% by weight. (column 3 line 63-67)
Accordingly, the claimed ranges overlap with, or are fully encompassed by, the ranges disclosure in Cush. (see MPEP 2144.05)
Claim(s) 15, 17, 18, and 34-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cush et al. (US 9192159 B2, pub’d 11/24/2015) and Brown et al. (WO 2013/126948 A1, pub’d 09/06/2013) as applied to claim 1 above, and further in view of Bristow et al. (US 2016/0249616 A1, pub’s 09/01/2016).
With respect to claims 15 and 17, the claims recite one or more additional fungicides selected from triazoles, including prothioconazole, and their amounts (i.e., about 1%-30%) based on the total weight of the composition.
As discussed above, Cush teaches the azoxystrobin containing liquid formulation, nonionic emulsifier system, and polyhydric alcohol formulation components. Brown teaches benzyl acetate as the principal solvent.
The combination of Cush and Brown fails to teach prothioconazole and its amount in the formulation.
Bristow teaches a composition comprises Picoxystrobin as a strobilurin fungicide, N-methylpyrrolidone as a polar aprotic solvent, tristyrylphenol ethoxylates as a polyoxyethylated aromatic non-ionic emulsifier, cypoconazole as an optional additional triazole fungicide as prothioconazole, and propylene glycol as a polyhydric alcohol compound (paragraph [0005], and paragraph [0098]),
A person of ordinary skill in the art would have been select Bristow’s prothioconazole as an alternative known triazole fungicide for use in Cush’s azoxystrobin containing formulation because Cush teaches combining azoxystrobin with a triazole fungicide, and Bristow identifies prothioconazole as a suitable member of that fungicide class. Therefore, Bristow teaching would have suggested substituting prothioconazole for Cush’s propiconazole to provide another known strobilurin-triazole fungicide combination in agrochemical composition.
With respect to claims 18, and 34-36, the claims recite the composition wherein the ratio between the polar aprotic solvent and the at least one polyhydric alcohol compound is about 8: 1 to about 350: 1 in claim 18, and the specific numerical compositions comprising defined amounts of (1) a strobilurin fungicides including azoxystrobin; (2) a polar aprotic solvent including benzyl acetates; (3) a non-ionic emulsifier selected from polyoxyethylated aromatics, polyalkoxylated alkyl ethers; (4) an optional triazole fungicide including prothioconazole; (5) a polyhydric alcohol compound (e.g., propylene glycol) in claim 34-36.
The combination teachings of Cush, Brown and Bristow fail to teach the specific ratio of the polar aprotic solvent and polyhydric alcohol, and overall composition.
However, for the same reasons discussed with respect to claim 1, a skilled artisan would have had reason to combine these known components and adjust their relative amounts through routine formulating screening. Therefore, Claims 18, and 34-36 are result effective variables routinely adjusted to balance solubility, stability, and emulsification performance. Selecting specific component and values within disclosed workable ranges to produce a stable formulation would have constituted routine optimization.
Optimization of result effective variable, such as component elements, and concentration, thorough routine experimentation does not confer patentability. (see MPEP 2144.05) Furthermore, where the claimed workable elements and concentration ranges constitutes choosing from prior arts, the claimed subject matter is obvious, and yielded predictable results.
Conclusion
Claims 1-7, 9-18, and 34-36 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SEONG JONG KIM whose telephone number is (571)272-6918. The examiner can normally be reached 7:00am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A. Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEONG JONG KIM/Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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