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 .
Applicants’ arguments, filed 05/26/2026, have been fully considered. Rejections and/or objections not reiterated from previous office action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112 – Indefiniteness
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 140 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 140 recites the broad recitation “wherein (i) the cyclodextrin is one or more, alpha -cyclodextrin […] beta cyclodextrin […] gamma-cyclodextrin […] each optionally alkylated with C1-C5 alkyl group and/or hydroxy-alkyl group”, and the claim also recites “and/or (ii) the cyclodextrin is a methyl-beta-cyclodextrin” which is the narrower statement of the range/limitation. It is unclear which group is controlling. For example, it is unclear if the cyclodextrin must have an methyl group as required by (ii), or if the alky group is merely optional ad recited by (i).
Claim 140 also recites “alpha -cyclodextrin: 6-member sugar ring molecule, beta cyclodextrin: 7-member sugar ring molecule, gamma-cyclodextrin: 8-member sugar ring molecule” (narrow recitation italicized; broader recitation bolded). Cyclodextrins are rings of glucopyranoside monomers, rather than any generic sugar, as evidenced at paragraph one of ACS (Cyclodextrin, ACS, 2015 [retrieved 08/10/2026], https://www.acs.org/molecule-of-the-week/archive/c/cyclodextrins.html).
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
For the purposes of examination groups (i) and (ii) will be interpreted as being recited in the alternative. Additionally, alpha-, beta- and gamma-cyclodextrin will be interpreted to be six, seven, or eight glucopyranosides rings, respectively, because that is how they are defined, as evidenced by ACS at paragraph one.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1) Claims 128, and 139-141 are rejected under 35 U.S.C. 103 as being unpatentable over Koren et al. (WO 2019/215645 A1, publication date 11/14/2019; cited in IDS).
Koren “relates to the use of cyclodextrins for increasing biological activity and improving retention and/or bioavailability of agrochemicals such as pesticides” [abstract]. In one example Koren discloses “Cyclodextrin complexation of tau-fluvalinate with CAVASOL® W7M was also performed by the co-precipitation method at pesticide-cyclodextrin weight % ratios of 1: 1 to 1:5 (i.e., the guest/host molecular structure is a complex of tau-fluvalinate and cyclodextrin at a weight ratio of 1:1 to 1:5; instant claim 139). It was prepared by dissolving both the pesticide and the cyclodextrin into acetone. After the reactions, the solvent was evaporated, and the dried cyclodextrin pesticide complex was obtained” (see para. 2 of Ex. 4, on page 87). Koren also discloses that “[t]he agrochemical compositions according to the invention, for example in the dosage forms which are conventional for liquid preparations, can be applied either as such or after previously having been diluted with water, that is to say for example as emulsions, suspensions, dispersions or solutions” [p. 33, para. 2]. Koren discloses “In some embodiments, the concentration of the pesticide in the composition is 10-50% by weight based on the total weight of the composition.” [p. 21, last paragraph]. Koren discloses the compositions may also comprise surfactants (i.e., additive) and pigments [p. 32, para. 8].
According to the instant specification at paragraph 75, CavasolTM W7M is methyl-beta-cyclodextrin (i.e., instant claim 140 (ii)).
The pigments of Koren suffice as a filler because the pigments are “a compound that is known and accepted in the art for use in the formation of compositions for agricultural or horticultural use” (see definition of filler at paragraph 32 of the instant specification).
The prior art does not anticipate the instant claims because it does not disclose all the limitations in one example or embodiment.
However, given the disclosure of each component individually, it would have been prima facie obvious for a person having ordinary skill in the art at, before the effective filling date of the claimed invention, to have selected and combined known components for their established functions with predictable results by following the teachings of Koren. MPEP 2143 and 2144.06(I).
"[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" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)). In the present case it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the emulsions of Koren to comprise the tau-fluvalinate/cyclodextrin complexes, and tau-fluvalinate, within the instantly claimed amounts through routine optimization. One would have been motivated to optimize the amount of tau-fluvalinate to find the optimal concomitant pesticidal effect of tau-fluvalinate. One would have had an expectation of success because Koren discloses pesticides should be present in amounts from 10-50% w/w of the compositions.
Additionally, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (See MPEP 2113.). In this case, the prior art product appears to be the same or obvious as claimed, despite not teaching the implicit emulsifying from an emulsifiable granule or powder steps, insofar as the compositions of Koren may be formulated as emulsions.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have to have formulated a water-in-oil emulsion comprising cyclodextrin/tau-fluvalinate complex, an additive, a filler and water. Wherein the complex and the tau-fluvalinate are present at the instantly claimed amounts. Wherein the cyclodextrin is methyl-beta-cyclodextrin.
2) Claims 128, 139-145 and 149 are rejected under 35 U.S.C. 103 as being unpatentable over Koren et al. (WO 2019/215645 A1, publication date 11/14/2019; cited in IDS) in view of Taranta et al. (US 2015/0056257 A1, publication date 02/26/2015).
Regarding instant claims 128, 139-141 and 149, Koren “relates to the use of cyclodextrins for increasing biological activity and improving retention and/or bioavailability of agrochemicals such as pesticides” [abstract]. In one example Koren discloses “Cyclodextrin complexation of tau-fluvalinate with CAVASOL® W7M was also performed by the co-precipitation method at pesticide-cyclodextrin weight % ratios of 1: 1 to 1:5 (i.e., the guest/host molecular structure is a complex of tau-fluvalinate and cyclodextrin at a weight ratio of 1:1 to 1:5; instant claim 139). It was prepared by dissolving both the pesticide and the cyclodextrin into acetone. After the reactions, the solvent was evaporated, and the dried cyclodextrin pesticide complex was obtained” (see para. 2 of Ex. 4, on page 87). Koren also discloses that “[t]he agrochemical compositions according to the invention, for example in the dosage forms which are conventional for liquid preparations, can be applied either as such or after previously having been diluted with water, that is to say for example as emulsions, suspensions, dispersions or solutions” [p. 33, para. 2]. Koren also desires a reduction in organic solvents because they are toxic to humans and the environment [p. 13, last paragraph, lines 4-6]. Finally, Koren discloses the compositions may comprise additional agrochemicals [p. 97, claim 16].
According to the instant specification at paragraph 75, CavasolTM W7M is methyl-beta-cyclodextrin (i.e., instant claim 140 (ii)).
Koren does not disclose an emulsifiable powder or granule.
Taranta “relates to emulsifiable granules containing a water-insoluble solvent, a
pesticide, which is dissolved in the water-insoluble solvent, a water-soluble polycarboxylate, and a water-soluble anionic surfactant” [abstract]. According to Taranta, conventional pesticide formulations, such as emulsion and suspension concentrates, present environmental and handling concerns and that “there is a need for a fast-emulsifiying solid crop protection formulation which has better handling characteristics and enhanced biological activity over conventional forms [emulsifiable concentrates], to satisfy both environmental concerns and provide an effective product for the farmer to use in an unsophisticated manner in the field. Object of the present invention was to overcome the above mentioned problems” [0002]. Taranta discloses specific pesticides include tau-fluvalinate [0102] and that the granules may also comprise a water soluble pesticide [0121]. Taranta teaches pesticides should be present in amounts from 1 to 25% w/w of the granules [0144]. Furthermore, “[t]he emulsifiable granules may comprise formulation auxiliaries. Suitable formulation auxiliaries are solid carriers or fillers […] solubilizers” (i.e., filler and additive) [0122]. Suitable water-insoluble solvents include oils of vegetable origin (i.e., vegetable oils; instant claim 149 at section c) [0024]. Finally, Taranta discloses an “emulsion obtainable by contacting water and the emulsifiable granules” [p. 10, claim 33].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the emulsions of tau-fluvalinate/cyclodextrin complexes of Koren with the emulsifiable granules of Taranta. One would have been motivated to make this combination because Taranta discloses that the emulsifiable granules advantageously address the environmental concerns associated with liquid formulations of pesticides, which is also desired by Koren. A skilled artisan would have been further motivated because Taranta teaches the emulsifiable granules have better handling characteristics over conventional forms, and may be used in an unsophisticated manner in the field. One would have had an expectation of success because Koren teaches emulsions are suitable for the solubilized tau-fluvalinate/cyclodextrin complex, while Taranta desires both tau-fluvalinate and a water-soluble pesticide. Taranta also welcomes the addition of solubilizers, which can read on the cyclodextrins of Koren. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
"[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" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)). In the present case it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the emulsifiable granules comprising the tau-fluvalinate/cyclodextrin complexes, and tau-fluvalinate, within the instantly claimed amounts through routine optimization. One would have been motivated to optimize the amount of tau-fluvalinate to find the optimal concomitant pesticidal effect of tau-fluvalinate. One would have had an expectation of success because Taranta desires water-soluble pesticides and suggests pesticides should be present in amounts from 1-25% w/w of the granules.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case the instantly claimed mass ratios of tau-fluvalinate to cyclodextrin (2:1 to 1:10 and 1:1 to 1:4; instant claims 139 and 139(a)) overlaps with the range of the prior art (1:1 to 1:5) and so a prima facie case of obviousness exists.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated an emulsion comprising a dried emulsifiable granule and water. Wherein the emulsifiable granules comprises a guest/host structure of tau-fluvalinate complexed with cyclodextrin and an agriculturally acceptable filler. Wherein the guest/host structure of tau-fluvalinate complexed with cyclodextrin is present within the instantly claimed range. Wherein the weight ratio of tau-fluvalinate to cyclodextrin is within the instantly claimed ranges (instant claims 139 and 149). Wherein the cyclodextrin is methyl-beta-cyclodextrin (instant claim 140(ii)). Wherein the tau-fluvalinate is present at the instantly claimed amount (instant claim 141(b)). Wherein the emulsifiable granule comprises vegetable oil (instant claim 149).
Taranta discloses the filler may be ammonium sulfate [0123], as per instant claim 142 at section b.
Regarding instant claims 143-145, Taranta discloses the composition may comprise effervescent agents [0122] and that suitable effervescent is a combination hydrogen carbonate and an organic acid such as citric acid and sodium hydrogen carbonate (i.e., CAS:144-55-8; sodium bicarbonate) [0127], as per instant claim 143 at section C (effervescent system comprises acid and base) and instant claim 144 at section b. Taranta also discloses the granules may comprise surfactants and dispersants [0122]. “Suitable surfactants are surface-active compounds, such as anionic, cationic, nonionic and amphoteric surfactants, polyelectrolytes, and mixtures thereof. Such surfactants can be used as emulsifier, [or] dispersant” [0128]. Taranta discloses that suitable surfactants include lignin sulfonates (i.e., instant claim 145 at section a) [0129].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07. In the present case, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have selected the citric acid/sodium bicarbonate system and the lignine sulfonate surfactants of Taranta as the effervescent and dispersing agent desired by Taranta, respectively. One would have been motivated and had an expectation of success because Taranta discloses citric acid/sodium bicarbonate is a suitable effervescent system. Additionally, Taranta discloses surfactants may serve as dispersing agent and that lignine sulfonates are suitable surfactants for the emulsifiable granules.
3) Claim 146 is rejected under 35 U.S.C. 103 as being unpatentable over Koren et al. (WO 2019/215645 A1, publication date 11/14/2019) in view of Taranta et al. (US 2015/0056257 A1, publication date 02/26/2015) as applied to claims 128, 139-145 and 149 above, and further in view of UA ‘068 (UA 120068 C2, publication date 09/25/2019; citing English machine translation).
Koren and Taranta, which are taught above, differ from the instant claims insofar as they do not teach a linear dodecyl benzene sulfonate in 2-ethylhexanol. Taranta desires “sulfonates of dodecyl- and tridecylbenzenes” [0036 & 0129] such as calcium dodecylbenzene sulfonate [0189].
UA ‘068 discloses a fungicidal composition [abstract] preferably in the form of a wettable powder [p 5, para. 8 (middle of page)]. UA ‘068 discloses anionic surfactants which may be used as dispersants [p. 3, penultimate paragraph]. According to UA ‘068 particularly suitable anionic surfactants include linear dodecylbenzenesulfonates in 2-ethylhexanol [p. 4, para. 2].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07. In the present case, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have selected the linear dodecylbenzene sulfonate in 2-ethylhexanol of UA ‘068 because UA ‘068 discloses it is a suitable dodecylbenzene sulfonate for solid biocidal formulations.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to formulated a granule, as taught by Koren and Taranta to further comprise a linear dodecyl benzene sulfonate in 2-ethylhexanol.
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 128, and 139-146 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,127,559 B2 in view of Koren et al. (WO 2019/215645 A1, publication date 11/14/2019; cited in IDS) in view of Taranta et al. (US 2015/0056257 A1, publication date 02/26/2015).
The conflicting claims of ‘559 disclose a quest host molecular structure of cyclodextrin and folpet at a weight ratio of 1:2 folpet to cyclodextrin [claim 3]. “[W]herein the guest/host inclusion complex comprises guest folpet and host methylated β-cyclodextrin in weight ratio of 1:2” [claim 4].
The conflicting claims do not disclose an emulsion and tau-fluvalinate.
Koren “relates to the use of cyclodextrins for increasing biological activity and improving retention and/or bioavailability of agrochemicals such as pesticides” [abstract]. Suitable pesticides include folpet [p. 23, last paragraph] and tau fluvalinate [p. 42, first paragraph]. Koren also discloses that “[t]he agrochemical compositions according to the invention, for example in the dosage forms which are conventional for liquid preparations, can be applied either as such or after previously having been diluted with water, that is to say for example as emulsions” [p. 33, para. 2].
Koren does not disclose emulsifiable granules.
Taranta “relates to emulsifiable granules containing a water-insoluble solvent, a pesticide, which is dissolved in the water-insoluble solvent, a water-soluble polycarboxylate, and a water-soluble anionic surfactant” [abstract]. According to Taranta “[c]rop protection agents are formulated in solid or liquid compositions, usually in the form of a concentrate for ease of handling and transportation, which is diluted with water by the user before application. Liquid formulations in the form of emulsifiable concentrates contain a very high proportion of organic solvent (often up to 80 percent) which are increasingly coming under scrutiny for their effect on the environment; emulsion concentrates have a higher water content but still contain organic solvents. […] Thus there is a need for a fast-emulsifiying solid crop protection formulation which has better handling characteristics and enhanced biological activity over conventional forms, to satisfy both environmental concerns and provide an effective, product for the farmer to use in an unsophisticated manner in the field. Object of the present intention was to overcome the above mentioned problems” [0002]. Taranta discloses specific pesticides include tau-fluvalinate [0102] and that the granules may also comprise a water soluble pesticide [0121]. Taranta teaches pesticides should be present in amounts from 1 to 25% w/w of the granules [0144]. Furthermore, “[t]he emulsifiable granules may comprise formulation auxiliaries. Suitable formulation auxiliaries are solid carriers or fillers […] solubilizers” [0122]. Suitable water-insoluble solvents include oils of vegetable origin (i.e., vegetable oils; instant claim 149 at section c) [0024]. Finally, Taranta discloses a “sprayable emulsion obtainable by contacting water and the emulsifiable granules” [p. 10, claim 33].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have simply substituted the folpet of the conflicting claims with the tau-fluvalinate of Koren because Koren discloses they are both suitable for complexing with cyclodextrin. The skilled artisan would have been motivated to have substituted the tau-fluvalinate of Koren in place of the folpet of the conflicting claims for active agent with a reasonable expectation of success. The simple substitution of one known element in place of another in order to achieve predictable results is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the emulsions of tau-fluvalinate/cyclodextrin complexes taught by the conflicting claims and Koren with the emulsifiable granules of Taranta. One would have been motivated to make this combination because Taranta discloses that the emulsifiable granules address the environmental concerns associated with liquid formulations of pesticides. A skilled artisan would have been further motivated because Taranta also teaches the emulsifiable granules have better handling characteristics over conventional forms, and may be used in an unsophisticated manner in the field. One would have had an expectation of success because Koren discloses emulsions are suitable for the solubilized tau-fluvalinate/cyclodextrin complex, while Taranta desires both tau-fluvalinate and a water-soluble pesticide. Taranta also welcomes the addition of solubilizers, which can read on the cyclodextrins of the conflicting claims. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
"[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" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)). In the present case it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the emulsifiable granules comprising the tau-fluvalinate/cyclodextrin complexes, and tau-fluvalinate, within the instantly claimed amounts through routine optimization. One would have been motivated to optimize the amount of tau-fluvalinate to find the optimal concomitant pesticidal effect of tau-fluvalinate. One would have had an expectation of success because Taranta desires water-soluble pesticides and suggests pesticides should be present in amounts from 1-25% w/w of the granules.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated an emulsion comprising a dried emulsifiable granule and water. Wherein the emulsifiable granules comprises a guest/host structure of tau-fluvalinate complexed with cyclodextrin and an agriculturally acceptable filler. Wherein the guest/host structure of tau-fluvalinate complexed with cyclodextrin is present within the instantly claimed range.
Response to Arguments
1) On page 16 of their Remarks, Applicant argues that the simple substitution of tau-fluvalinate in place of folpet in the non-statutory double patenting rejection was misplaced. According to applicant “To formulate a chemical compound, the relevant considerations are the chemical and physical properties of the chemical compound, not the intended use of the chemical compound. By the Examiner's logic, all pesticides may be formulated the same way because they all function as pesticides. This logic is clearly erroneous, and it is improper to allege that folpet may be substituted with tau-fluvalinate because "Koren disclosed they are suitable for the same purpose."
This argument is not persuasive. It was never the Examiner’s position that all pesticides may be formulated the same way because they all function as pesticides. Additionally, the Examiner respectfully notes that such a conclusion does not necessarily flow from the logic of the referenced rejection in the Office Action mailed 02/24/2026. To clarify, the conflicting claims recite quest host molecular structure of cyclodextrin and folpet at a weight ratio of 1:2 folpet to cyclodextrin (see US 12,127,559 B2 at [claim 3]). Koren, on the other hand, “relates to the use of cyclodextrins for increasing biological activity and improving retention and/or bioavailability of agrochemicals such as pesticides” (see Koren at [abstract]). Koren further discloses that suitable pesticides include folpet (see Koren [p. 23, last paragraph]) and tau fluvalinate (see Koren at [p. 42, first paragraph]). In other words Koren discloses that both folpet and tau-fluvalinate a suitable to be complexed with cyclodextrin, meaning both folpet and tau-fluvalinate have the requisite chemical and physical properties to complex with cyclodextrin. As such, the Examiner relies on Koren because Koren discloses active agents useful for agrochemical formulations that can be complexed with cyclodextrin to improve retention and bioavailability.
2) On page 16 of their Remarks, Applicant argues that “person would not be motivated to formulate the tau-fluvalinate-pesticidal complex into the water-emulsifiable granules disclosed in Wirth, because the water emulsifiable granules of Wirth was taught for formulating "agrochemical active compounds".
This argument is moot in view of the new rejections set forth above.
3) On pages 16 and 17 of their Remarks, Applicant argues the combination of Koren and Wirth is unfounded because “Wirth taught specific criteria for choosing "agrochemical active compounds" that may be used, namely the agrochemical must be a solid with a melting point above 20°C or a liquid a room temperature (see claim 1 of Wirth). The Examiner has provided no comment on whether the alleged tau-fluvalinate-
pesticidal complex would meet these criteria.”
This argument is moot in view of the new rejections set forth above.
4) On page 18 of the Remark, Applicant argues that once complexed with cyclodextrin, the previously water insoluble tau-fluvalinate becomes soluble and so “The logical use of a now water-soluble tau-fluvalinate-cyclodextrin complex would be to prepare an aqueous single-phase product, such as an aqueous solution.”
This argument is not persuasive. In the second paragraph on page 33, Koren discloses “[t]he agrochemical compositions according to the invention, for example in the dosage forms which are conventional for liquid preparations, can be applied either as such or after previously having been diluted with water, that is to say for example as emulsions, suspensions, dispersions or solutions.” That is to say, Koren discloses the cyclodextrin-pesticide complex compositions may be applied as emulsions.
Furthermore, arguments presented by applicant cannot take the place of evidence in the record. See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984); In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) ("An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness."). See MPEP § 716.01(c). In the present case, the argument that the logical formulation of a tau-fluvalinate/cyclodextrin complex is an aqueous solution cannot take the place of evidence demonstrating that an aqueous solution is the only possible formulation.
Therefore, considering Koren explicitly discloses emulsions it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated a tau-fluvalinate/cyclodextrin complex as an emulsion.
5) On page 18 of their Remarks, Applicant argue that there is not motivation to combine the tau-fluvalinate-cyclodextrin complex as an emulsifiable powder/granule.
This argument is not persuasive. As stated above, a skilled artisan would have been motivated to combined the tau-fluvalinate/cyclodextrin complex with an emulsifiable granule because Taranta teaches the emulsifiable granules have better handling characteristics over conventional forms (e.g., formulations of Koren), and may be used in an unsophisticated manner in the field (i.e., easy to use).
6) On pages 19 and 20 of their Remarks, Applicant asserts the claimed composition provides unexpectedly increased biological efficacy compared to previously known oil-in-water composition emulsions formed and/or compositions from tau-fluvalinate non-solid comprising a non-solubilized hydrophobic solidified tau-fluvalinate. Applicant cites Figures 1-3 of the instant specification for support.
This argument is not persuasive. Overcoming a rejection based on unexpected results requires the combination of three different elements: (i) the results must fairly compare with the prior art, (ii) the results must truly be unexpected and (iii) the claims must be commensurate in scope. MPEP §716.02. The burden rests with Applicant to establish results are unexpected and significant. MPEP §716.02(b). Applicant's showing of allegedly unexpected results does not satisfy any of these requirements.
(i) Applicant has not compared the efficacy of the claimed composition to the closest prior art. The closest prior art is an aqueous solution of tau-fluvalinate with CA V ASOL® W7M at pesticide-cyclodextrin weight % ratios of 1: 1 to 1:5 and is disclosed by Koren on page 87 as Example 4. See MPEP 716.02(e).
(ii) Where the unexpected properties of a claimed invention are not shown to have a significance equal to or greater than the expected properties, the evidence of unexpected properties may not be sufficient to rebut the evidence of obviousness. In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) (MPEP 716.02(c)).
In regard to Figure 1, the Examiner respectfully emphasizes that the instant claims are drawn to an emulsion. As such, the comparison disclosed in the instant specification is a comparison between the instantly claimed emulsion of Tau-CD directly after formation and an emulsion of Tau-CD after a month of storage.
In the present case, the improved efficacy of the Tau-CD EG (tau-fluvalinate/cyclodextrin complex emulsifiable granule) as compared to the Tau-CD EW (tau-fluvalinate/cyclodextrin complex aqueous emulsion) would have been expected by a skilled artisan in view of the prior art because the comparative example of Tau-CD EW was stored for approximately 1 month. A skilled artisan would have understood that the complex of Tau-CD does not exhibit irreversible binding. For example, see for example, Villaverde et al. (J. Agric. Food Chem. 2006, 54, 4766-4772). Villaverde relates to complexes of beta cyclodextrin and an herbicide [abstract] and discloses cyclodextrins “have the tendency to form inclusion complexes by reversibly incorporating a nonpolar compound into their hydrophobic central cavities” [p. 4766, col. 1, lines 4-6]. Accordingly, a skilled artisan would have understood that over time, as tau-fluvalinate disassociates and re-associates with the cyclodextrin, some amount of the tau-fluvalinate would precipitate due to its low solubility in water. As a result a skilled artisan would have expected less available solubilized tau-fluvalinate in the emulsion after a month as compared to the emulsion directly after formulation.
In regard to Figures 2 and 3, the improved efficacy of emulsion comprising the Tau-CD complexes as compared to the emulsions comprising non-solubilized tau-fluvalinate (Maverik 240EW) would have been expected in view of the prior art. Koren discloses solutions comprising Tau-CD complexes have improved pesticidal efficacy as compared to compositions of tau-fluvalinate without cyclodextrin (Maverik) (see Tables 3 and 4 on page 88). Koren additionally discloses agrochemical compositions disclosed therein “can be applied either as such or after previously having been diluted with water, that is to say for example as emulsions” [p. 33, para. 2]. As such, as skilled artisan would have expected emulsions comprising Tau-CD complexes, as taught by Koren, to have improved biological activity (i.e., improved efficacy) as compared to compositions of tau-fluvalinate without cyclodextrin (Maverik).
(iii) The "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support" (see MPEP 716.02(d) quoting In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)). In the present case the claims are not commensurate in scope with the objective evidence because the claims do not recite a concentration of Tau-CD complex in the emulsion. The recitation of 20-95% of guest host structure in the emulsifiable granule does not limit the amount of Tau-CD present in the claimed emulsion. This is important because the Figure 1 demonstrates that that the emulsifiable granules only demonstrate statistically significant results at concentrations of 200 ppm (see overlapping error bars in FIG. 1 for 400ppm). Furthermore, the broad recitation of cyclodextrin is not reasonably represented by the narrow demonstration of CA V ASOL® W7M (methyl-beta-cyclodextrin). See for example, Flaherty et al. (Chemosphere, 2013, v. 91, p. 912–920) which discloses different cyclodextrin derivatives have different binding constants (see abstract and Table 2 on page 917). Finally, the independent claim does not recited a ratio of tau-fluvalinate to cyclodextrin which impacts pesticidal efficacy, e.g., LD50 (see Koren at pages 88-90, Tables 36).
7) On pages 19 and 20 of their Remarks, Applicant asserts the claimed composition provides unexpected stability. Applicant cites Figures 1-3 of the instant specification for support.
This argument is not persuasive. A mere conclusion that Applicant’s device exhibits unexpected results is not enough to show nonobviousness. Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). See MPEP 716.02. In the present case, Applicant has not provided evidence to support the allegedly unexpected stability of the instantly claimed emulsions.
8) On page 22 of their Remarks, Applicant argues that the deficiencies of Koren cannot be remedied with Wirth.
This argument is moot in view of the new rejections set forth above.
Conclusion
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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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