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 .
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 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.
Priority
The instant application 18/550,876, filed 09/15/2023, is a 371 National Stage Entry of international patent application PCT/EP2022/057154, filed 03/18/2022, and claims foreign priority to European patent applications EP 21163830.9, EP 21163835.8, and EP 21163833.3, all filed 03/19/2021.
Status of Application and Claims
The preliminary amendment filed 09/15/2023 is acknowledged. Claims 3-11, 13 and 15 are amended. Claims 1-15 are currently pending and are examined on the merits herein.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/15/2023 and 06/27/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Claim Interpretation
Claim 5 recites that the butyl polyalkylene oxide block copolymer is “a butyl alcohol polyoxyethylene-polyoxypropylene block copolymer.” This is not a commonly recited name in the prior art, which typically recites such block copolymers as EO/PO block copolymers with a butyl base, as evidenced by “EO/PO Block Copolymers.” Stepan, available online 09/22/2020, accessed via WebArchive.org., https://www.stepan.com/content/dam/stepan-dot-com/webdam/website-product-documents/literature/agricultural-solutions/EOPO_Ag_RnDv2.pdf (p. 2 Toximul block copolymers). Claim 5’s recitation of “butyl alcohol polyethylene-polypropylene block copolymer” will be interpreted as interchangeable with any recitation of a copolymer propyleneoxide-ethyleneoxide (abbreviated as either EO/PO or PO/EO) block copolymer with a butyl or butanol base. Therefore, any recitation of a butyl PO/EO block copolymer will therefore read upon “a butyl alcohol polyoxyethylene-polyoxypropylene block copolymer.” This interpretation finds support in the instant specification which states that the term “butyl alcohol polyoxyethylene-polyoxypropylene block copolymer” is interchangeable with copolymer butanol PO (propylene oxide)/EO (ethylene oxide) (see instant specification p. 4 lines 4-7).
Claim 6 recites that the acrylic graft copolymer comprises a “methyacrylic acid backbone” (emphasis added). This is not a commonly recited name in the prior art, which typically recites such backbones as “methacrylic acid.” For evidence see the abstract of Liang, W. et al. (1999). Langmuir, 16(3), 1306-1310 (cited in PTO-892). Because it appears the term “methyacrylic” is being used to describe a methacrylic backbone on a graft copolymer, any recitation of a “methyacrylic” acid backbone will be interpreted to mean a “methacrylic” acid backbone.
Claim Objections
Claim 6 is objected to because of the following informalities: claim 6 recites a “methyacrylic acid backbone” (emphasis added). However, the claim should instead recite “methacrylic acid backbone” (emphasis added). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2, 6, 8, and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the claimed invention.
The specification discloses the broad genus of “acrylic graft copolymer,” and only defines one limitation about said acrylic graft copolymer (that it comprises a methacrylic acid backbone) with no further descriptors about the acrylic graft copolymer (see instant specification p. 3 lines 19-30 and p. 4 lines 16-17, as well as Table 3.1, 3.2 and 5). Claims 2 and 8 are directed to encompass any acrylic graft copolymer (absent any further descriptors), while claim 6 is directed to encompass any acrylic graft copolymer comprising a methacrylic acid backbone. The genus of “acrylic graft copolymer” is extremely broad and encompasses numerous variants of compounds, even when limited to comprising a methacrylic acid backbone; thus, the genus “acrylic graft copolymer” does not meet the 35 U.S.C. 112(a) written description provisions due to a lack of specific chemical structural information of the monomers and the polymers grafted within the acrylic graft copolymer. The specification provides no guidance as to determine specific acrylic graft copolymers, or even monomeric units or polymers comprising the graft copolymers, which fulfill the description. The specification provides insufficient written description to support the genus encompassed by the claim.
Additionally, the specification discloses one broad genus of “pesticidally active ingredient” to be added to the composition (p. 6 lines 26-27). This broad genus is also recited in claim 15. The genus of “pesticidally active ingredient” is extremely broad and encompasses numerous variants of compounds, and therefore does not meet the written description provisions due to a lack of specific chemical structural information based on what is appropriate to use in the composition. The specification provides no guidance as to determine specific pesticidally active agents which fulfill this description. The specification provides insufficient written description to support the genus encompassed by the claim.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
The skilled artisan cannot envision the detailed chemical structure of all acrylic graft copolymers appropriate for use in the aqueous suspension concentrate composition of the present invention. Similarly, the skilled artisan cannot envision the detailed chemical structure of all pesticidally active agents appropriate for use in the aqueous suspension concentrate composition of the present invention. Adequate written description requires more than a mere statement that it is part of the invention. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence. Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
The full breadth of claims 2, 6, and 8, fail to meet the written description provision of 35 USC § 112, first paragraph due to the extreme broadness and high variance of the genus “acrylic graft copolymer” without sufficient clarification in the specification. Furthermore, the full breadth of claim 15 does not meet the written description provision of 35 USC § 112, first paragraph, due to the extreme broadness and high variance of the genus “pesticidally active ingredient” without sufficient clarification in the specification. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC § 112 is severable from its enablement provision. (See page 1115.)
Claims 11-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification, while being enabling for protection against a broad spectrum of nematode pests and diseases, does not reasonably provide enablement for prevention of nematicidal or fungicidal damage in a plant. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).[1]
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Formal, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention, relative skill level, and breadth of the claims
The instant invention is directed to methods of using an aqueous suspension concentrate composition containing cyclobutrifluram to reduce or prevent nematicidal or fungicidal damage in a plant (emphasis added).
The complex nature of the claims is greatly exacerbated by the breath of the claims. The claims encompass broad ways that an aqueous suspension concentrate composition containing cyclobutrifluram prevents nematicidal or fungicidal damage to a plant. The relative skill of those in the art is high, that of an MD or PhD.
The state and predictability of the art
The state of the art recognizes that cyclobutrifluram provides broad spectrum control of nematodes and key fungal diseases, particularly soil-borne diseases. As illustrative of the state of the art, the examiner cites Anon.; "Syngenta announces TYMIRIUM technology brand"; 07 May 2020; pp.1-2; URL:https:/Awww.syngenta.com/en/company/media/syngenta-news/year/2020/syngenta-announces-tymirium-tm-technology-brand (cited in IDS).
The lack of significant guidance from the specification or the prior art with regard to preventing nematicidal or fungicidal damage in a plant makes practicing the scope of the invention unpredictable. Since the instant specification provides no limiting definition of the term “prevention”, the examiner will adopt the broadest reasonable interpretation for it. The Merriam-Webster’s Online Dictionary defines “prevent” as “to keep from happening or existing”, i.e., to completely eradicate.
The claims are thus very broad insofar as they recite prevention of nematicidal or fungicidal damage in a plant, i.e., the complete eradication of the same. While such “prevention” might theoretically be possible under strictly controlled laboratory conditions, as a practical matter it is nearly impossible to achieve in the “real world;” complications such as infection by any nematodes or fungi besides the nematodes and/or key fungi/soil-borne diseases controlled by cyclobutrifluram, failure of the concentrate composition to properly adhere to the seeds, plant or locus of the plant being treated for protection, and/or development of nematicidal or fungicidal population immunity is always a risk.
The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for preventing nematicidal or fungicidal damage in a plant. The specification only states that cyclobutrifluram provides protection against a broad spectrum of nematode pests and diseases across major crops and geographies (instant specification p. 1 lines 9-15). This guidance fails to address the complete eradication of all nematocidal or fungicidal damage in a plant. Due to the limited guidance in the art surrounding preventing all nematocidal or fungicidal damage in a plant, one of ordinary skill would undergo undue experimentation in deducing which nematocidal and fungicidal damage can be eradicated by the instantly claimed cyclobutrifluram suspension concentrate, at what effective concentrations, etc.
There are no provided working examples of the specification directed towards preventing nematicidal or fungicidal damage in a plant. The principles, preferred embodiments, and modes of operation described in the specification fail to enable prevention of nematicidal or fungicidal damage in a plant.
The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed method of applying the aqueous suspension concentrate composition to a seed, plant, or locus of a plant could be predictably used to prevent nematicidal or fungicidal damage in a plant as inferred by the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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.
Claim 6 recites the limitation “the acrylic graft copolymer” in reference to the aqueous composition according to claim 3. However, claim 3 does not recite an acrylic graft copolymer, nor does claim 1 (which claim 3 is dependent upon). Therefore, there is insufficient antecedent basis for this limitation in the claims upon which claim 6 depends. For the purposes of compact prosecution, claim 6 will be interpreted as being dependent upon claim 2, which introduces the acrylic graft copolymer limitation.
Claim Rejections - 35 USC § 103
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 1-6 and 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over CN-111990405-A (Shao, Y. et al) published 11/27/2020 (cited, with machine translation, in PTO-892) in view of US 6,559,156 B1 (Dimitrova, G.) published 05/06/2003 (cited in PTO-892), “EO/PO Block Copolymers.” Stepan, available online 09/22/2020, accessed via WebArchive.org., https://www.stepan.com/content/dam/stepan-dot-com/webdam/website-product-documents/literature/agricultural-solutions/EOPO_Ag_RnDv2.pdf (cited in PTO-892), and WO 2021/055316 A1 (Ponasik, J. A. et al) published 03/25/2021, qualifies as prior art under 102(a)(2) based on filing date of 09/15/2020 (cited in PTO-892), as evidenced by Anon.; “Toximul 8315” 01 June 2015; pp. 1-2 https:/www.stepan.com/content/dam/stepan-dot-com/webdan/website-product-documents/product-bulletins/surfactants/TOXIMUL8315.pdf (cited in IDS, hereinafter “Toximul 8315 specification sheet”) and Liang, W. et al. (1999). Langmuir, 16(3), 1306-1310 (cited in PTO-892).
Shao teaches a nematicidal agricultural composition containing fluopyram and cyclobutrifluram wherein the mass ratio of fluopyram to cyclobutrifluram in the agricultural composition is 5:1-1:5 (claims 1 and 2). Shao teaches the composition is formulated in an agriculturally acceptable formulation, with components including adjuvants or carriers to assist the efficacy of the fluopyram and cyclobutrifluram (claim 3). Shao exemplifies the use of a 400 g/L fluopyram-cyclobutrifluram suspension, wherein the mass ratio of fluopyram to cyclobutrifluram is 5:1, and demonstrates its improved efficacy against Meloidogyne incognita inoculated on root seedlings compared to a suspension of fluopyram alone and a suspension of cyclobutrifluram alone ([0023]-[0030]). The Examiner calculates the concentration of cyclobutrifluram in the exemplified 400 g/L suspension to be roughly 67 g/L in the suspension when in a mass ratio of 5 fluopyram to 1 cyclobutrifluram. Shao also exemplifies the use of a similar preparation of fluopyram-cyclobutrifluram in controlling peanut root knot nematodes ([0036]-[0039]).
Shao teaches that, in order to fully exert the efficacy of the active ingredients in the pesticide, they can be prepared in a formulation that is convenient for application; the dosage form can include suspensions, and when forming said dosage form the ordinarily skilled artisan will know that, in addition to using the pesticide containing nematicidal active ingredients, a variety of adjuvants are needed, such as one or more of a dispersion medium, a dispersant, an emulsifier, a wetting agent, a thickener, defoaming agent, antifreeze agent, disintegrant, binder, filler, carrier, and the like ([0015]). This addition of adjuvants, particularly defoaming agent, antifreeze agent, thickener, and carrier, read on instant claims 9 and 10.
Shao teaches the nematicidal agricultural composition can be applied in various ways, including seed soaking; soil-borne nematodes are preferentially controlled by soil treatment such as seed soaking and seed coating ([0016]).
Shao differs from the instantly claimed invention in that it fails to teach the cyclobutrifluram is present in an aqueous suspension concentrate composition, which includes 1-30 g/L of a sulfosuccinate wetting agent, 5-50 g/L of a butyl polyalkylene oxide block copolymer, and 2.5-35 g/L of a sodium lignosulfonate, as recited in instant claim 1. Shao fails to teach the composition further comprises 1-55 g/L of an acrylic graft copolymer, as recited in instant claim 2, and that the acrylic graft copolymer comprises a methacrylic acid backbone, as recited in instant claim 6. Shao fails to teach that the butyl polyalkylene oxide block copolymer is a butyl alcohol polyoxyethylene-polyoxypropylene block copolymer, as recited in instant claim 5. Additionally, Shao fails to teach that said composition comprises 100 to 600 g/L of cyclobutrifluram, or 200 to 500 g/L of cyclobutrifluram, as recited in instant claims 3 and 4. Shao fails to teach the specific concentration ranges for cyclobutrifluram, sulfosuccinate wetting agent, butyl polyalkylene oxide block copolymer, sodium lignosulfonate, and acrylic graft copolymer, as recited in instant claim 8. Shao also fails to teach that the composition further comprises from 5 to 120 g/L of a pigment as recited in instant claim 7.
Because Shao doesn’t teach the full composition of claim 1, Shao also differs from the instantly claimed invention in that it fails to teach a method of reducing or preventing nematicidal or fungicidal damage in a plant comprising applying a composition according to claim 1 to either the seed of a plant, or to the plant or to the locus thereof, wherein the plant is selected from a long list which includes peanut, as recited in instant claims 11-12 and 13-14, respectively. Also due to the fact that Shao doesn’t teach this method, Shao also doesn’t teach the method applying to the seed wherein the composition comprises a further pesticidally active ingredient, as recited in instant claim 15.
Dimitrova teaches an aqueous suspension concentrate formulation that contains high proportions of the fungicide pyrimethanil (Col. 1 lines 6-12). Dimitrova teaches formulations which include 50-80 % w/v of active ingredient pyrimethanil, 0.2 to 5% w/v of a polyoxyethylene-polyoxyproplyene block copolymer surfactant and 0.2 to 5% w/v of naphthalene formaldehyde condensate surfactant do not solidify when milled and exhibit low propensity to crystallize when stored for long periods (Abstract; Col. 2 lines 17-19). As evidenced by the instant specification, polyoxyethylene-polyoxyproplyene can be abbreviated as “PO/EO” (see instant specification p. 4 lines 4-7). Dimitrova teaches the use of a variety of components in its formulations (Col. 2 lines 4-8). Dimitrova teaches the use of “Atlox 4913,” a polymethyl methacrylate-polyethylene glycol graft copolymer, which acts as a dispersant in most of the exemplified formulations (Col. 2 lines 12-13; Col. 2 lines 55-56; Table 1 Formulation numbers 1-12, 14, and 16-24). As evidenced by Liang, “Atlox 4913” consists of poly(methyl-methacrylate) methacrylic acid backbone and polyethlene oxide side chains (Abstract); therefore, “Atlox 4913” reads on an acrylic graft copolymer comprising a methacrylic acid backbone, and reads on the limitation of claim 6 (see Claim Interpretation section supra). Dimitrova teaches the use of “Polyfon H,” a sodium lignosulfonate, as a dispersant in formulation 23 (Col. 2 line 22; Table 1 Formulation number 23). Dimitrova teaches the use of “Aerosol OT/S,” a dioctyl sodium sulfosuccinate, as a wetter in formulation 12 (Col. 2 lines 38-39). Dimitrova teaches that the formulations which include the PO/EO block copolymer, antifoam adjuvant, “Atlox 4913,” and either “Polyfon H” or “Aerosol OT/S” exhibit no milling problems (Col. 2 lines 55-56; Table 1 Formulation numbers 23 and 12).
Stepan teaches that TOXIMUL 8315 is a butyl-based ethylene oxide/propylene oxide (EO/PO) block copolymer which can be used as a dispersant, emulsifier and wetting agent in water-based formulation types in agricultural solutions (p. 1; p. 2 Properties, “Toximul 8315”). Stepan teaches TOXIMUL 8315 is used in suspension concentrate formulations types (p. 3 “TOXIMUL 8315”). As evidenced by the Toximul 8315 specification sheet, TOXIMUL 8315 is a butyl polyalkylene oxide block copolymer (p. 1); therefore, TOXIMUL 8315 reads on a butyl polyalkylene oxide block copolymer, more specifically a butyl PO/EO block copolymer, which reads on the limitation of claim 5 (see Claim Interpretation section supra).
Ponasik teaches suspending active ingredients into suspension allows for improved distribution of active ingredients over crops during many delivery systems (p. 80 [0230]). Ponasik teaches exemplary component ranges for water-based suspension concentrates (p. 81 “Exemplary Component Ranges for Suspension Concentrates”). Ponasik teaches common components within suspension concentrates (wherein water serves as the continuous phase) are present at the following concentrations: 5-20 g/L for wetting agents or co-dispersants (used to facilitate milling process) and 20-60 g/L for dispersants (used to assist in dispersing active ingredients in the concentrate and/or on dilution in water) (p. 81 [0231]).
Regarding the aqueous suspension concentrate composition comprising, in addition to cyclobutrifluram and the adjuvants taught by Shao, a sulfosuccinate wetting agent, butyl polyalkylene oxide block copolymer, sodium lignosulfonate, and acrylic graft copolymer (as recited, with concentration ranges, collectively in instant claims 1-2, 5-6 and 8), it would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the instantly claimed invention, to: (1) formulate the suspension of Shao (containing the nematicidal ingredients and adjuvants) into an aqueous suspension concentrate formulation; (2) add the ingredients dioctyl sodium sulfosuccinate “Aerosol OT/S,” butyl polyalkylene oxide block copolymer “TOXIMUL 8315” (which is a butyl-based EO/PO block copolymer, and reads on instant claim 5), sodium lignosulphonate “Polyfon H,” and polymethyl methacrylate-polyethylene glycol graft copolymer “Atlox 4913” (which has a methacrylic acid backbone, and reads on instant claim 6), and; (3) perform routine optimization on the amount of each added ingredient, and arrive at the instantly claimed invention.
The ordinarily skilled artisan would have been motivated to perform modification (1) because Shao teaches its nematicidal actives are effective in a suspension formulation, in combination with adjuvants such as antifreeze, antifoaming, and thickening agents, for application to plants affected by nematodes, and Dimitrova teaches its aqueous suspension concentrate to be an agricultural formulation exhibiting a lack of milling problems when comprising adjuvants and high proportions of fungicide. The ordinarily skilled artisan would have thus been motivated to formulate an aqueous suspension concentrate, like Dimitrova’s, comprising the nematicidal actives and adjuvants of Shao to allow for incorporation of high proportions of active agents cyclobutrifluram and fluopyram without causing milling problems. The ordinarily skilled artisan would have a reasonable expectation of success doing so based on the fact that Shao teaches its agricultural actives are used in a suspension formulation, and an aqueous suspension concentrate is a suspension formulation.
The ordinarily skilled artisan would have been motivated to perform modification (2) because (a) dioctyl sodium sulfosuccinate “Aerosol OT/S” is a wetting agent which, when formulated in Dimitrova’s aqueous suspension concentrate, results in a composition with desirable milling effects, (b) “TOXIMUL 8315” is a butyl EO/PO block copolymer surfactant and wetting agent used in agricultural suspension concentrates, and Dimitrova teaches that the use of EO/PO block copolymer surfactant in its aqueous suspension concentrate allows for improved milling effects and prevents storage problems, (c) sodium lignosulfonate “Polyfon H” is a dispersant which, when formulated in Dimitrova’s aqueous suspension concentrate, results in a composition with desirable milling effects, and (d) the acrylic graft copolymer “Atlox 4913” is a dispersant which, when formulated in Dimitrova’s aqueous suspension concentrate, results in a composition with desirable milling effects; the ordinarily skilled artisan would seek to include these ingredients into the aqueous suspension concentrate containing Shao’s nematicidal actives in order to harness the desirable effects of each wetting agent and dispersant for the resulting aqueous suspension concentrate. The ordinarily skilled artisan would find a reasonable expectation of success performing modification (2) based on the fact that Shao teaches the ordinarily skilled artisan will know that adjuvants, particularly wetting agents and dispersants, are necessary in the formulation, and Dimitrova and Stepan collectively teach that the adjuvants “Aerosol OT/S,” “TOXIMUL 8315,” “Polyfon H,” and “Atlox 4913” are wetting agents and dispersants successfully used in aqueous suspension concentrate formulations.
The ordinarily skilled artisan would have then performed modification (3) in order to perform routine optimization on the amounts of wetting agent and dispersants being added to the aqueous suspension concentrate composition, for the purpose of optimizing the milling and dispersion properties of the resulting suspension concentrate composition, and arrive at the instantly claimed amount limitations for sulfosuccinate wetting agent, butyl polyalkylene oxide block copolymer, sodium lignosulfonate, and acrylic graft copolymer claims in instant claims 1, 2, and 8. Dimitrova establishes the purpose of “Aerosol OT/S” and EO/PO block copolymer are to be wetting agents in the aqueous suspension concentrate, and the purpose of “Polyfon H” and “Atlox 4913” are to be dispersants in the aqueous suspension concentrate, and demonstrates that each ingredient’s presence in a suspension concentrate composition improves milling effects. Additionally, Ponasik establishes that the amounts of wetting agent and dispersant in a suspension concentrate composition are important, by stating that typical amounts for each of the wetting agent and dispersant are within 5-20 g/L and 20-60 g/L, respectively, in order to facilitate improved milling effects and dispersion of active ingredients. Therefore, the teachings of Dimitrova and Ponasik establish that the amounts of wetting agents and dispersants in an aqueous suspension concentrate composition are results-effective variables, with the observable results being improved wettability, milling, and dispersion properties when used together in a suspension concentrate composition. Ponasik teaches a finite range of concentrations for wetting agent and dispersant in an aqueous suspension concentrate composition with which the ordinarily skilled artisan can perform routine optimization with a reasonable expectation of success, in order to optimize the wettability and dispersion properties of the resulting composition. Ponasik’s taught concentration ranges for wetting agent and dispersant overlap, and thus render obvious, the claimed amount ranges for sulfosuccinate wetting agent, butyl poylalkylene oxide block copolymer, sodium lignosulfonate, and acrylic graft copolymer recited in instant claims 1, 2 and 8. Additionally, "where 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). See MPEP 2144.05 (I) and (II) for discussions on overlapping ranges and optimization within prior art conditions through routine experimentation.
Regarding the concentration of cyclobutrifluram, as recited in claims 3, 4 and 8 (wherein the composition comprises 100 to 600 g/L, 200 to 500 g/L, or 150-550 g/L of cyclobutrifluram, respectively), it would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the instantly claimed invention, to perform routine optimization on the amount of cyclobutrifluram in the agricultural composition when incorporating Shao’s fluopyram and cyclobutrifluram into an aqueous suspension concentrate rendered obvious by the collective teachings, for the purpose of optimizing nematicidal activity of the resulting composition, and arrive at the instantly claimed concentration range for cyclobutrifluram. Shao exemplifies the use of a 5:1 ratio of fluopyram to cyclobutrifluram in a 400 g/L suspension for nematicidal activity. Shao establishes that the amounts of fluopyram and cyclobutrifluram in the suspension are results-effective variables, with the observable result being the nematicidal activity against nematodes. Shao also teaches that the ratio of fluopyram to cyclobutrifluram can be anywhere from 5:1 to 1:5. When in a 400 g/L nematicidal suspension, this is equivalent to a range of roughly 67-335 g/L for both fluopyram and cyclobutrifluram, depending on the ratios between the two. Thus, Shao teaches a finite range of concentrations for cyclobutrifluram in a suspension composition (67-335 g/L) with which the ordinarily skilled artisan can perform routine optimization with a reasonable expectation of success, in order to optimize the nematicidal activity when combining the two ingredients into the aqueous suspension concentrate rendered obvious by the collective teachings. Shao’s taught concentration range for cyclobutrifluram overlaps, and thus renders obvious, the claimed amount ranges for cyclobutrifluram recited in instant claims 3, 4 and 8. Additionally, "[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). See MPEP 2144.05 (I) and (II) for discussions on overlapping ranges and optimization within prior art conditions through routine experimentation.
Regarding the method of reducing or preventing nematicidal or fungicidal damage in a plant recited in instant claims 11-15 (wherein the composition of claim 1 is applied to the seed of a plant, or the plant or locus thereof, wherein the plant is chosen from a group including peanut, and wherein the composition comprises a further pesticidally active ingredient), it would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the instantly claimed invention, to apply the resulting aqueous suspension concentrate rendered obvious by the collective teachings to the seeds of a peanut plant using seed soaking or seed coating, and arrive at the instantly claimed invention. It is noted that a seed is interpreted broadly to be a plant, and therefore, when applying the composition to a seed, both claims 11 and 13 are satisfied by the method. The ordinarily skilled artisan would have been motivated to do so because Shao teaches its combination of cyclobutrifluram and fluopyram (interpreted as a further pesticidally active agent) is effective in controlling peanut root knot nematodes, and that soil-borne nematodes are preferentially controlled by soil treatment such as seed soaking and seed coating. Therefore, the ordinarily skilled artisan would be motivated to use the composition rendered obvious by the collective teachings by applying the aqueous suspension concentrate to seeds of peanut plant in order to control and reduce damage caused by soil-borne root knot nematodes affecting peanut plants. The ordinarily skilled artisan would have a reasonable expectation of success applying the composition rendered obvious by the collective teachings to peanut seeds in order to reduce damage from root knot nematodes because Shao teaches this combination of nematicidal actives cyclobutrifluram and fluopyram to be effective against peanut root knot nematodes.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over CN-111990405-A (Shao, Y. et al) published 11/27/2020 (cited, with machine translation, in PTO-892) in view of US 6,559,156 B1 (Dimitrova, G.) published 05/06/2003 (cited in PTO-892), “EO/PO Block Copolymers.” Stepan, available online 09/22/2020, accessed via WebArchive.org., https://www.stepan.com/content/dam/stepan-dot-com/webdam/website-product-documents/literature/agricultural-solutions/EOPO_Ag_RnDv2.pdf (cited in PTO-892), and WO 2021/055316 A1 (Ponasik, J. A. et al) published 03/25/2021, qualifies as prior art under 102(a)(2) based on filing date of 09/15/2020 (cited in PTO-892), with evidence from Anon.; “Toximul 8315” 01 June 2015; pp. 1-2 https:/www.stepan.com/content/dam/stepan-dot-com/webdan/website-product-documents/product-bulletins/surfactants/TOXIMUL8315.pdf (cited in IDS, hereinafter “Toximul 8315 specification sheet”) and Liang, W. et al. (1999). Langmuir, 16(3), 1306-1310 (cited in PTO-892), as applied to claims 1-6 and 8-15 above, and further in view of “FD&C Blue 1 Powder Technical Data Sheet” Spectra Colors Corporation, 02/03/2014, https://spectracolors.com/wp-content/uploads/2017/04/5.FC_.0010P0-TDS.pdf (cited in PTO-892).
The teachings of Shao, Dimitrova, Stepan, and Ponasik, and evidence from Toximul 8315 specification sheet and Liang, as they pertain to instant claims 1-6 and 8-15, are addressed supra. Additionally, Ponasik teaches its formulations may include colorants, for instance in order to provide product identification and anti-counterfeiting, to identify specific products for health and safety reasons, and to reveal where an otherwise largely transparent formulation has been applied, for instance to ensure complete coverage with minimal duplicative coverage; one of ordinary skill will recognize that there are several agriculturally acceptable colorants available, with a representative example being FD&C Blue No.1 (p. 76 [0223]).
The collective teachings differ from the instantly claimed invention in that they fail to teach the composition further comprises 5 to 120 g/L of a pigment, as recited in instant claim 7.
Spectra Colors Corporation teaches that FD&C Blue 1 powder is soluble in water at 20 g/100 mL at 28 ºC (p. 1 “Solubility”). This is equivalent to 200 g/L.
It would have been prima facie obvious for a person having ordinarily skill in the art, before the effective filing date of the claimed invention, to add FD&C Blue No.1 to the aqueous suspension concentrate rendered obvious by the collective teachings, and arrive at the instantly claimed invention. Additionally, it would have been prima facie obvious for a person having ordinarily skill in the art, before the effective filing date of the claimed invention, to perform routine optimization on the amount of said added FD&C Blue No.1, and arrive at the instantly claimed concentration range for pigment. The ordinarily skilled artisan would have been motivated to add FD&C Blue No.1 to the aqueous suspension concentrate used to treat seeds against nematicidal infection in order to provide product identification and anti-counterfeiting, to identify specific products for health and safety reasons, and to reveal where an otherwise largely transparent formulation has been applied. The ordinarily skilled artisan would find a reasonable expectation of success using FD&C Blue No.1 in the aqueous suspension concentrate composition because Ponasik teaches that FD&C Blue No. 1 is a well-known agriculturally acceptable colorant. The ordinarily skilled artisan would have also performed routine optimization on the amount of FD&C Blue No. 1 added to the aqueous suspension concentrate composition in order to optimize the effects of the colorant on the color of the composition. A finite concentration range for the amount of colorant FD&C Blue No. 1 is taught by Spectra Colors Coropration, which teaches that the solubility/saturation point of the composition is 200 g/L in water (which is the base of the aqueous suspension concentrate composition). Thus, the ordinarily skilled artisan has a finite concentration range (0-200 g/L) with which routine optimization of the amount of dissolved FD&C Blue No. 1 in the aqueous suspension concentrate is reasonable. The ordinarily skilled artisan would have a reasonable expectation of success working within this concentration range to perform routine optimization because FD&C Blue No. 1 is a well-known agriculturally acceptable colorant that is soluble in the aqueous suspension concentrate’s base (water) up to 200 g/L. The finite concentration range of 0-200 g/L for FD&C Blue No. 1 encompasses, and thus renders obvious, the claimed amount range for pigment recited in instant claim 7. Additionally, "[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). See MPEP 2144.05 (I) and (II).
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 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of copending Application No. 18/551,255 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because App’255 claims an aqueous suspension concentrate composition comprising (i) cyclobutrifluram, (ii) 25 to 126 g/L of a vegetable oil, (iii) 25-125 g/L of an ethoxylated fatty alcohol, (v) 1-30 g/L of a sulfosuccinate wetting agent, (vi) 5-50 g/L of a butyl polyalkylene oxide block copolymer, and (vii) 2.5 to 35 g/L of a sodium lignosulfonate (claims 1 and 10). These emboldened limitations are exactly the limitations of instant claim 1, and because of the inclusion of adjuvant species of vegetable oil and ethoxylated fatty alcohol, the further limitation of instant claim 10 (comprising one or more adjuvants or carriers) is also read upon. Thus, claim 10 of App’255 anticipates instant claims 1 and 10.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7, and 10-15 of copending Application No. 18/551,255 in view of US 6,559,156 B1 (Dimitrova, G.) published 05/06/2003 (cited in PTO-892) and “EO/PO Block Copolymers.” Stepan, available online 09/22/2020, accessed via WebArchive.org., https://www.stepan.com/content/dam/stepan-dot-com/webdam/website-product-documents/literature/agricultural-solutions/EOPO_Ag_RnDv2.pdf (cited in PTO-892), as evidenced by Anon.; “Toximul 8315” 01 June 2015; pp. 1-2 https:/www.stepan.com/content/dam/stepan-dot-com/webdan/website-product-documents/product-bulletins/surfactants/TOXIMUL8315.pdf (cited in IDS, hereinafter “Toximul 8315 specification sheet”) and Liang, W. et al. (1999). Langmuir, 16(3), 1306-1310 (cited in PTO-892).
The anticipation of instant claims 1 and 10 by App’255’s claim 10 is addressed in the single-reference NSDP rejection supra. Additionally, App’255 also claims the aqueous suspension concentrate composition comprises 100 to 300 gram / liter of cyclobutrifluram (claim 2). This range overlaps and renders obvious the instantly claimed ranges for cyclobutrifluram in instant claims 3 and 4, as well as the range claimed for cyclobutrifluram in instant claim 8. App’255 also claims the aqueous composition further comprises (iv) 20 to 120 gram/liter of a pigment (claim 7); this range overlaps, and renders obvious, the range for pigment recited in instant claim 7. App’255 further claims the aqueous composition comprises (viii) 1 to 55 gram / liter of an acrylic graft copolymer (claim 11). This reads on the acrylic graft copolymer and its amount limitations recited in instant claims 2 and 8. When taken into combination, claims 1, 10 and 11 of App’255 recite all ingredients with overlapping concentration ranges compared to those recited in instant claim 8, thus rendering the entirety of claim 8 obvious. Finally, App’255 claims a method of reducing or preventing nematicidal or fungicidal damage in a plant comprising applying a composition according to claim 1 to the seed of a plant, wherein the plant is selected from barley, brassica head and stem vegetables, bean, carrot, chickpea, corn, cotton, cowpea, curcurbits, drybeans, field peas, garden beans, garlic, lentils, lettuce, millet, oat, onion, peanut, peas, potato, rice, rye, sorghum, soybean, sugarbeet, sunflower, triticale, canola, oil seed rape seed, sweet corn, and wheat, and wherein the composition comprises a further pesticidally active ingredient (claims 12-15). These claims, when taken in combination with claims 1 and 10, render obvious the method of instant claims 11-15.
App’255 differs from the instantly claimed invention in that it fails to claim that the that the butyl polyalkylene oxide block copolymer is a butyl alcohol polyoxyethylene-polyoxypropylene block copolymer, as recited in instant claim 5. Additionally, App’255 fails to claim the acrylic graft copolymer comprises a methyacrylic acid backbone, as recited in instant claim 6. Finally, App’255 fails to claim the aqueous suspension concentrate composition further comprises one or more additional ingredients selected from an anti-freeze agent, an anti-foam agent, a thickening agent, a biocide (preservative), a buffering agent, and/or a stabilizer, as recited in instant claim 9.
Dimitrova teaches an aqueous suspension concentrate formulation that contains high proportions of the fungicide pyrimethanil (Col. 1 lines 6-12). Dimitrova teaches formulations which include 50-80 % w/v of active ingredient pyrimethanil, 0.2 to 5% w/v of a polyoxyethylene-polyoxyproplyene block copolymer surfactant and 0.2 to 5% w/v of naphthalene formaldehyde condensate surfactant do not solidify when milled and exhibit low propensity to crystallize when stored for long periods (Abstract; Col. 2 lines 17-19). As evidenced by the instant specification, polyoxyethylene-polyoxyproplyene can be abbreviated as “PO/EO” (see instant specification p. 4 lines 4-7). Dimitrova teaches the use of a variety of components in its formulations (Col. 2 lines 4-8). Dimitrova teaches the use of “Atlox 4913,” a polymethyl methacrylate-polyethylene glycol graft copolymer, which acts as a dispersant in most of the exemplified formulations (Col. 2 lines 12-13; Col. 2 lines 55-56; Table 1 Formulation numbers 1-12, 14, and 16-24). As evidenced by Liang, “Atlox 4913” consists of poly(methyl-methacrylate) methacrylic acid backbone and polyethlene oxide side chains (Abstract); therefore, “Atlox 4913” reads on an acrylic graft copolymer comprising a methacrylic acid backbone, and reads on the limitation of claim 6 (see Claim Interpretation section supra). Dimitrova teaches that the formulations which include the PO/EO block copolymer, antifoam adjuvant, and “Atlox 4913” exhibit no milling problems (Col. 2 lines 55-56; Table 1 Formulation numbers 23 and 12).
Stepan teaches that TOXIMUL 8315 is a butyl-based ethylene oxide/propylene oxide (EO/PO) block copolymer which can be used as a dispersant, emulsifier and wetting agent in water-based formulation types in agricultural solutions (p. 1; p. 2 Properties, “Toximul 8315”). Stepan teaches TOXIMUL 8315 is used in suspension concentrate formulations types (p. 3 “TOXIMUL 8315”). As evidenced by the Toximul 8315 specification sheet, TOXIMUL 8315 is a butyl polyalkylene oxide block copolymer (p. 1); therefore, TOXIMUL 8315 reads on a butyl polyalkylene oxide block copolymer, more specifically a butyl PO/EO block copolymer, which reads on the limitation of claim 5 (see Claim Interpretation section supra).
It would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the instantly claimed invention, to use the ingredients (1) “TOXIMUL 8315” (which is a butyl-based EO/PO block copolymer, and reads on instant claim 5) as the butyl polyalkylene oxide block copolymer, (2) “Atlox 4913” (which has a methacrylic acid backbone, and reads on instant claim 6), as the as the acrylic graft copolymer, (3) an antifoam agent, in the aqueous suspension concentrate composition of App’255 and arrive at the instantly claimed invention. The ordinarily skilled artisan would have been motivated to do so because (1) “TOXIMUL 8315” is a butyl EO/PO block copolymer surfactant and wetting agent used in agricultural suspension concentrates, (2) the acrylic graft copolymer “Atlox 4913” is a dispersant which, when formulated in Dimitrova’s aqueous suspension concentrate, results in a composition with desirable milling effects, and (3) antifoam is used in Dimitrova’s aqueous suspension concentrate resulting in a composition with desirable milling effects and no documented foaming issues. The ordinarily skilled artisan would seek to include these ingredients into the aqueous suspension concentrate of App’255 in order to harness the desirable effects of the wetting agent, dispersant and antifoam agent for the resulting aqueous suspension concentrate. The ordinarily skilled artisan would find a reasonable expectation of success using these ingredients based on the fact that App’255 teaches an aqueous suspension concentrate composition comprising an agricultural active ingredient, and Dimitrova and Stepan collectively teach that the adjuvants “TOXIMUL 8315,” “Atlox 4913” and antifoam are adjuvants successfully used in aqueous suspension concentrate formulations.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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/SOPHIA MARIE TAYLOR/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616
[1] As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is “undue”, not “experimentation”.
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