DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-15 are pending in the instant application and subject to examination herein.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. PCT/EP2023/063171, filed on 05/16/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/19/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 8 objected to because of the following informalities: The word “dispersible” is misspelled as “disperable”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation "the filler component" in “The pesticidal composition according to claim 1, wherein the filler component comprises less than 5% by weight of a diatomaceous earth material (eg, Celite™), or does not comprise diatomaceous earth material. There is insufficient antecedent basis for this limitation in the claim, because claim 1 does not claim any filler component that is not lactose (4-O-b-D-galactopyranosyl-a-D-glucopyranose), and a person of ordinary skill in the art would not understand how any portion of lactose, a known and specific organic substance, can also comprise an inorganic substance that is a diatomaceous earth material.
Further regarding claim 4, the phrase “eg, Celite™”, which is understood to represent "for example, Celite™", renders the claim indefinite because it is unclear whether the limitation following the phrase “eg” are part of the claimed invention. See MPEP § 2173.05(d). Furthermore, the use of a trade name (“Celite™”) in a claim as a limitation to identify or describe a particular material or product does not comply with the requirements of the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). See also Eli Lilly & Co. v. Apotex, Inc., 837 Fed. Appx. 780, 784-85, 2020 USPQ2d 11531 (Fed. Cir. 2020).
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.
Claims 1-4, 6 and 8-15 are unpatentable over Buchholz in view of Bayer, Knowles and Takabe.
Claims 1-4, 6 and 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over Buchholz (WO 2013/079564 A2)1 in view of Bayer (EP 2446742 A1)2, Knowles (Knowles, D. A., Chemistry and Technology of Agrochemical Formulations, Springer Science+Business Media, Dordrecht, The Nederlands, 2012) and Takabe (U.S. Patent No.9,808,000 B2)3.
Claim 1 is drawn to a pesticidal composition comprising spiropidion4 (25-35 wt%) and cyantraniliprole (15-25 wt%), and further comprising lactose5 (15-30 wt%) as a filler component.
Buchholtz discloses pesticidal mixtures comprising as active ingredient a mixture of component A and component B, wherein component A is a spiroheterocyclic pyrrolidine dione of the general formula (I) shown below, and component B is a compound selected from a Markush group that includes cyantraniliprole (page 1, lines 10-25 and page 2, lines 1-13):
PNG
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422
590
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Greyscale
(Buchholz’s Formula (I)).
Buchholtz specifically discloses spiropidion as exemplary compound “T1.055” (Table 1, page 9), and specifically discloses pesticide mixtures including spiropidion/T1.055 as a binary mixture of T1.055 with cyantraniliprole favored for treating various insects, including green peach aphid/Myzus persicae (page 29, lines 5-10, unnumbered table), two-spotted spider mite/Tetranychus urticae (page 30, lines 1-5, unnumbered table). The ratio of spiropidion/T1.055 to cyantraniliprole recommended by Buchholtz varies according to the pest to be treated, with preferred ratios of 3:1 to 1:3, respectively for green peach aphid, and 8:1 to 1:1 for two-spotted spider mite (pages 29 and 30, respectively). Buchholtz discloses that the pesticide combinations be formulated in any conventional form, by mixing the active ingredients with appropriate formulation inerts including diluents, solvents, fillers, surfactants, biocides and compounds that provide adjuvancy effects (page 49, lines 12-29). Buchholz particularly provides formulations to be applied in spraying forms, such as water dispersible concentrates, wettable powders and granules, including containing surfactants such as wetting and dispersing agents and other compounds that provide adjuvancy effects (page 49, lines 31-36). Buchholtz also includes compositions that preferably include an oil of vegetable or animal origin, or a mineral oil, in an amount generally from 0.01-10% based on the spray mixture (page 50, lines 1-5), and further recommends various surface active agents including anionic, cationic and non-ionic surfactants and includes pre-mixed oil/surfactant formulations (pages 50-51, bridging paragraph). Buchholz provides a general set of ranges for pesticide composition components, as follows (page 52, lines 4-8):
Active agent(s): 0.01-90%;
Surfactant(s): 0-20%;
10-99.99% solid or liquid formulation inerts and adjuvants.
Buchholtz also discloses the result-effective determination of the efficacy of varying ratios and strengths of given binary combinations of active agents, wherein sunflower leaf discs are placed on agar in a 24-well microtiter plate and sprayed with a test solutions of the active agent combinations, and after drying, the leaf discs are infested with an aphid population of mixed ages and monitored for insect mortality (page 53, lines 14-17), including the specific combination of spiropidion/T1.055 with cyantraniliprole at varying total active agent and varying ratios between the agents (Table 63, page 57). Buchholtz similarly performs the result-effective determination of the efficacy of the combination of spiropidion with cyantraniliprole against two-spotted spider mite mortality using an assay of spraying the combination on bean-leaf discs on agar and infesting with the insects (page 58, lines 8-10 and Table 73, page 59).
Buchholtz does not disclose lactose as a specific component of a pesticide composition. However, a person of ordinary skill in the art would have a reasonable expectation of making and using a pesticide composition that includes Buchholtz’s combination of spiropidion/T1.055 with cyantraniliprole in the claimed ranges of instant claim 1, and further comprising lactose in the claimed range, because it was known in the art that including lactose as a component of a pesticidal composition increases the spectrum of the pests to be controlled by the composition and also accelerates the effect against the pests, per the disclosure of Bayer, and because the specific weight percent contents of the components of a pesticidal composition represent the adequate proportions and quantities of the ingredients for adequately dispersible and efficacious pesticides, and it was known in the art that the adequate proportions and quantities of pesticide composition ingredients are result-effective variables, and that the determination of these result-effective variables was known in the art, per the disclosures of Buchholz and Bayer, the teaching of Knowles and the disclosure of Takabe.
Bayer discloses pest control compositions comprising insecticidal or acaricidal active compounds and one or more activity enhancers from a group of monosaccharides and/or disaccharides (paragraph [0001]), with the specific group of disaccharides including lactose (paragraph [0004]), and Bayer discloses that lactose is particularly preferred from the group of disaccharides (paragraph [0030]). Bayer discloses that the activity enhancement effect of the sugar component in the pesticidal composition is that it increases the increases the spectrum of the pests to be controlled and also the effect against the pests occurs more quickly (paragraph [0017]). Bayer discloses that the sugar component of the compositions disclosed therein can be present in the broad concentration range of 0.001-95 wt% (paragraph [0027]). Bayer discloses an exemplary formulation, “Example 3”, wherein fipronil is the active agent, included at 12.5 wt%, lactose is included at 27 wt%, lignin sulfonate is included as a dispersant, alkylsulphonate naphthalene is included as a wetting agent, citric acid is included for chemical stabilization, and kaolin is included as a filler/carrier, and the components are blended with water, milled/grinded, and dried, granulated and sieved to prepare the composition as water dispersible granules (paragraph [0121]). Bayer discloses the evaluation of the composition for pesticidal efficacy by spraying an aqueous solution of the composition onto rice plants and monitoring the mortality of larva of Nidaparvata lugens on the rice plants, showing that the composition is 95% effective in killing the insect larva, whereas a comparable composition lacking the lactose component is only 55% effective (paragraph [0127], Table 1).
Knowles teaches a comprehensive review of agrochemicals, including their formulation (Chapter 3, pages 41-79), with particular review of water-dispersible granules (Chapter 4, pages 80-114). Knowles teaches that the main objectives of formulation of agrochemical products, including pesticides, are to provide the user with a convenient, safe product which will not deteriorate over a period of time, and to obtain the maximum activity inherent in the active ingredient, and further teaches that the main factors which need to be taken in account in the choice of a specific formulation include the following (page 42):
physico-chemical properties;
biological activity and mode of action;
method of application;
safety in use;
formulation costs;
market preference.
Knowles teaches that water-dispersible granules, or dry flowables, as they are sometimes known, are a relatively new type of formulation and are being developed as safer and more commercially attractive alternatives to wettable powders and suspension concentrates. They are becoming more popular because of their convenience in packaging and use, being non-dusty, free-flowing granules which should disperse quickly when added to water in the spray tank (page 55). Knowles teaches that a typical water-dispersible granule formulation (per cent by weight) is as shown below (page 56):
Active ingredient: 50-90%;
Wetting agent: 1-5%;
Dispersing agent: 5-20%;
Disintegrating agent: 0-15%;
Soluble or insoluble filler: balance (100-total of other ingredients)%.
Knowles further teaches that surfactants fill the roles of wetting, dispersing, emulsifying and solubilizing in agrochemical products (page 57)., and that surfactants are classified into the groups of anionic, cationic, nonionic, and amphoteric (page 58). Knowles teaches that surfactants aid in solubilizing organic molecules (e.g., active agents) by micellization and improve wetting by lowering the contact angle of the pesticidal solution when it contacts a surface (page 61) and that low molecular weight surfactants are usually better wetting agents than high molecular weight surfactants the interfacial tension between the solution and the surface on which is spreads (page 63). Knowles teaches that surfactants which are used as dispersing agents have the ability to adsorb strongly onto a particle surface and provide a charged or steric barrier to reaggregation of particles, and that instead of being small molecules, which are necessary for rapid diffusion in the wetting process, dispersing agents tend to be much bigger molecules which provide as many anchoring points as possible onto the particle surface (page 64). Knowles teaches that the type of surfactant which will give the most efficient dispersing properties will also depend upon the nature (polarity) of the solid to be dispersed, and that as the majority of solid particles have a residual negative charge in water, the most commonly used surfactants are anionic or non-ionic, or mixtures of the two types. For wettable powder formulations, the most common dispersing agents are sodium lignosulphonates. For suspension concentrates, very good adsorption and stabilization are obtained using polyelectrolytes, such as sodium naphthalene sulphonate formaldehyde condensates (pages 64-65, bridging paragraph). Knowles teaches the result-effective determination of adequate content of dispersants and wetting agents, including the assay for particle aggregation below a critical threshold of dispersant and that particle size diminishes as dispersant is increased (page 104). Knowles teaches that wetting agents can accelerate the speed of dispersion of water-dispersible granule formulations with a concentration dependence on the content of the wetting agent (pages 109-110).
Takabe discloses water dispersible granules containing an active ingredient, a polyoxyalkylene alkyl ether phosphate, at least one anionic surfactant selected from a Markush group, and lactose (Abstract and paragraph [0001]). Takabe discloses that the content of the lactose in the formulation is usually from 10-98.8 wt% (Col. 6, line 65), that the granules may further comprise formulation adjuvants such as a carrier, pH adjuster and defoamer (Col. 7, lines 1-7). Takabe discloses exemplary formulations including clothianidin as active agent and lactose at varying content level with other ingredients (“Production Examples” 1-7, 9-12 and 15-18, Columns 10-12) and performs the result-effective determination of the dispersion of the granules in hard water after fresh preparation (Test Example 1, Cols. 12-13, bridging paragraph) and ageing (Test Example 2, Col. 13, lines 10-17) and the result-effective determination of friability, favoring good granule hardness, after fresh preparation (Test Example 3, Col. 13, lines 20-36) and after ageing (Test Example 4, Col. 13, lines 40-45).
Applicant’s invention is unpatentable over the disclosure of Buchholz in view of the disclosures of Bayer and Takabe and the teaching of Knowles, because a person of ordinary skill in the art, at the effective time of filing, would have a reasonable expectation of success in formulating a pesticidal composition comprising spiropidion and cyantraniliprole as a binary active agent combination, and further comprising lactose, in the claimed ranges of the ingredients, because it was known in the art that a combination of spiropidion and cyantraniliprole is effective in controlling insect pests in a pesticidal composition, per the disclosure of Buchholz, and it was known in the art that pesticidal compositions are enhanced by the inclusion of lactose in the formulation, per the disclosure of Bayer, and because the specific weight percent contents of the components of a pesticidal composition represent the adequate proportions and quantities of the ingredients for adequately dispersible and efficacious pesticides, and it was known in the art that the adequate proportions and quantities of pesticide composition ingredients are result-effective variables, and the determination of these result-effective variables was known in the art, per the disclosures of Buchholz and Bayer, the teaching of Knowles and the disclosure of Takabe.
Thus, the invention was prima facie obvious at the time of filing.
Claims 2-3 further limit the ranges of wt% for the active agents and lactose in the pesticidal composition, and are met by the rejection above because these wt% ranges are result-effective variables and their determination was known in the prior art, as discussed above.
Claim 4 further limits claim 1 to the content of an additional filler, specifically to <5 wt% diatomaceous earth, but does not require that this additional filler is present in the composition, and is therefore met by the rejection above.
Claim 6 further limits claim 1 to wherein the composition further comprises one or more additional ingredients selected from a Markush group that includes wetting agents, biocides, stabilizers and pigments. As discussed in the rejection above, Bayer discloses and exemplifies the formulation of a pesticidal composition comprising alkylsulphonate naphthalene as wetting agent.
Claim 8 further limits claim 1 to wherein the composition is formulated as water dispersible granules. Buchholz discloses that combination pesticide compositions disclosed therein may be employed in any conventional formulation, including water dispersible granule (page 49), and as discussed above, both Bayer and Takabe exemplify pesticidal compositions formulated with lactose as water dispersible granules, and Knowles teaches the value and typical compositional profile of water dispersible granules and the result-effective determination of adequate dispersant and wetting agent content in this class of formulations.
Claim 9 further limits claim 1 to wherein the composition is an aqueous composition comprising the composition. As discussed above, Buchholz, Bayer, Takabe and Knowles all address the formulation of water dispersible granules, and a person of ordinary skill in the art would at once recognize that water dispersible granules are intended for dispersion in water, and thus will be diluted in water for application. Notably, as discussed above, Takabe performed result-effective dispersion tests for the exemplified formulations, by dispersing them in hard water.
Claim 10 further limits claim 9 to wherein the adjuvant is selected from a Markush group; however, claim 10 does not require that the adjuvant is present in the composition, and is therefore met by the rejection of claim 9 discussed above.
Claim 11 further limits claim 1 to a method of combating and controlling pests which comprises applying a composition according to claim 1 to a pest, to a locus of a pest, or to a crop of a useful plant susceptible to attack by a pest. Buchholz discloses a method of controlling insects, acarines, nematodes or molluscs which comprises applying to a pest, to a locus of a pest, or to a plant susceptible to attack by a pest a combination of components A and B; seeds comprising a mixture of components A and B; and a method comprising coating a seed with a mixture of the components A and B disclosed therein (page 30, lines 5-9), wherein as discussed above, spiropidion is exemplified with cyantraniliprole. Additionally, as discussed above, Buchholz exemplifies the insecticidal property of the combination of spiropidion with cyantraniliprole on plant parts for killing insects, and Bayer exemplifies, for a lactose-containing formulation of water dispersible granules, the insecticidal property of the composition upon application to rice plants.
Claim 12 further limits claim 11 to wherein the pest to be combatted or controlled is selected from a Markush group of biological orders including Homoptera (which includes aphids) and Thysanoptera (thrips). Claim 13 further limits claim 12 to wherein the pest is selected from a Markush group that includes aphids and thrips. Buchholz discloses that the combination pesticidal compositions disclosed therein are useful to control infestations of insect pests of both the Hemiptera (Homoptera) and Thysanoptera orders (page 31, lines 23-24), and as discussed above Buchholz exemplifies the control of aphids with the combination of spiropidion and cyantraniliprole. Additionally, Bayer discloses that lactose-comprising pesticidal compositions are useful against various species of the Homoptera order, including Aphis spp. (paragraph [0067]) and against various species of the Thysanoptera order, including Thrips spp. (paragraph [0075]).
Claim 14 further limits the method of claim 11 to wherein the plant is selected from (i) cotton, or (ii) fruit and vegetables. Buchholz discloses that the binary pesticidal compositions disclosed therein can be applied to “useful plants” including grape vines, fruits including apples and many others, and vegetables such as cabbages, carrots and many others (page 32, lines 1-14).
Claim 15 further limits the method of claim 11 to wherein the composition is to the soil of the crop of the useful plant by drip, drenching or injection. Buchholz discloses that the amount of a combination of the invention to be applied, will depend on various factors, such as the compounds employed; the subject of the treatment, such as, for example plants, soil or seeds; the type of treatment, such as, for example spraying, dusting or seed dressing; the purpose of the treatment, such as, for example prophylactic or therapeutic; the type of pest to be controlled or the application time (page 45, lines 23-27). Bayer discloses that lactose-comprising pesticidal compositions disclosed therein can be applied by drench, drip and spray liquors (paragraph [0084]).
Applicant’s invention is unpatentable over the disclosure of Buchholz in view of the disclosure of Bayer, the teaching of Knowles, and the disclosure of Takabe, because a person of ordinary skill in the art, at the effective time of filing, would have a reasonable expectation of success in would have a reasonable expectation of success in formulating a pesticidal composition of water dispersible granules comprising spiropidion and cyantraniliprole as a binary active agent combination , and further comprising lactose, in the claimed ranges of the ingredients, and using such a composition for the control of pests including aphids and thrips on “useful plants” including fruits and vegetables, for the following reasons:
it was known in the art that a combination of spiropidion and cyantraniliprole is effective in controlling insect pests, including aphids and thrips, in a pesticidal composition such as water dispersible granules, including on fruit and vegetable plants, per the disclosure of Buchholz;
it was known in the art that pesticidal compositions, including water soluble granule formulations, are enhanced by the inclusion of lactose in the formulation, per the disclosure of Bayer;
it was known in the art that water dispersible granules are an advantageous agrochemical formulation, per the teaching of Knowles;
the specific weight percent contents of the components of a pesticidal composition, including a water dispersible granule formulation represent the adequate proportions and quantities of the ingredients for adequately dispersible and efficacious pesticides, and it was known in the art that the adequate proportions and quantities of pesticide composition ingredients are result-effective variables, and the determination of these result-effective variables was known in the art, including for water dispersible granule formulations, per the disclosures of Buchholz and Bayer, the teaching of Knowles and the disclosure of Takabe;
Thus, the invention was prima facie obvious at the time of writing.
Allowable Subject Matter
Claims 5 and 7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Prior art does not teach or reasonably suggest, alone or in combination, a pesticidal composition comprising spiropidion, cyantraniliprole and lactose and further comprising a buffer and/or an additional (third) insecticidal active ingredient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to W. JUSTIN YOUNGBLOOD whose telephone number is (703)756-5979. The examiner can normally be reached on Monday-Thursday from 8am to 5pm. The examiner can also be reached on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren, can be reached at telephone number (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/W.J.Y./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 Cited in Applicant’s Information Disclosure Statement dated 11/19/2024.
2 Cited in Applicant’s Information Disclosure Statement dated 11/19/2024.
3 Cited in Applicant’s Information Disclosure Statement dated 11/19/2024.
4 [3-(4-chloro-2,6-dimethylphenyl)-8-methoxy-1-methyl-2-oxo-1,8-diazaspiro[4.5]dec-3-en-4-yl] ethyl carbonate
5 4-O-b-D-galactopyranosyl-a-D-glucopyranose.
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