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 Application
Receipt of Applicant’s Remarks and Amendments filed on 11/13/202 is acknowledged.
Claims 1-20 are pending.
Claims 1 and 18 are amended.
Claim 7 is canceled.
Claim 21 is new.
Claims 1-6 and 8-21 are pending and under examination in this application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6 and 8-21 are rejected under 35 U.S.C. 103 as being unpatentable over Cottrell et al. (US 2011/0144166 A1) hereinafter the reference is referred as Cottrell in view of Kellerby (WO 00/40084), (US Patent 3852416) hereinafter the reference is referred as Grubb and further in view of Efficacy of slow-release collar formulations of imidacloprid/flumethrin and deltamethrin and of spot-on formulations of fipronil/(s) - methoprene, dinotefuran/pyriproxyfen/permethrin and (s) –methoprene/amitraz/fipronil against Rhipicephalus sanguineus and Ctenocephalides felis on dogs (hereinafter the reference is referred as Horak).
Cottrell teaches spot-on topical insecticide formulation comprising a combination of a first pyrethroid insecticide effective for killing fleas, a second pyrethroid insecticide effective for killing ticks, and an insect growth regulator (IGR). The topical insecticide preparation can be packaged together or packaged so that the first and second pyrethroid insecticides are stored separately prior to administration of the insecticide preparation to the animal. The combination of the first and second pyrethroid insecticides with an insect growth regulator results in an insecticide preparation formulated to have enhanced insecticidal activity against fleas and ticks compared to the effectiveness of the first and second insecticides used alone. Furthermore, Cottrell discloses that the combination of the first and second pyrethroid insecticides with an insect growth regulator produces an insecticide preparation having enhanced insecticidal activity against fleas and ticks while advantageously minimizing the total amount of insecticide needed for its effectiveness (abstract).
Regarding claims 1-5, as noted above, Cottrell teaches an insecticide formulation comprising acetamiprid, dinotefuran (¶ 0011) (corresponding to neonicotinoid of instant component i)); bifenthrin, permethrin, cypermethrin, flumethrin, tau-fluvalinate, fenpropathrin, fenvalerate, flucythrinate (¶ 0058, page 5) (corresponding to pyrethroid of instant component i)); pyripoxyfen and methoprene (¶ 0014) (corresponding to insect growth regulator of instant component ii)); Polyvinylpyrrolidone-vinyl acetate copolymer (Table 2, page 9; Table 4, page 12) (corresponding to filling agent a plasticizer of instant component iii)).
Regarding claims 12-13, Cottrell teaches Polyvinylpyrrolidone-vinyl acetate copolymer PVP/VA (Table 2, page 9; Table 4, page 12) (corresponding to filling agent is a plastic resin of instant component iii)).
Regarding claim 15, in an embodiment, Cottrell teaches a method for controlling insect infestation comprising acetamiprid in a concentration range of 5% to 50 % (¶ 0081). Therefore, overlaps with instant neonicotinoid range of about 5 % to about 15 % w/w.
Regarding claim 16, in an embodiment, Cottrell teaches a method for controlling insect infestation comprising methoprene in a concentration range of 1 % to 2 % (¶ 0074), and pyriproxyfen in a concentration range of 0.5 % to 5 % (¶ 0081) (corresponding to the insect growth regulator of instant component ii). Therefore, overlaps with the instant insect growth regulator range of about 0.5 % to about 5 % w/w.
Regarding claims 18-20, in an embodiment, Cottrell teaches a method for controlling insect infestation in a dog and/or cat comprising administering acetamiprid, dinotefuran (¶ 0076) (corresponding to neonicotinoid of instant component i)); and permethrin (¶ 0076) (corresponding to pyrethroid of instant component i)); and pyripoxyfen and methoprene (¶ 0076) (corresponding to insect growth regulator of instant component ii)); and Polyvinylpyrrolidone-vinyl acetate copolymer PVP/VA (Table 2, page 9; Table 4, page 12) (corresponding to instant filling agent is a plasticizer). Therefore, the limitations of the method comprising i) a neonicotinoid optionally with a pyrethroid; ii) an insect growth regulator; and iii) a filling agent together with a plasticizer is taught.
Cottrell fails to specifically teach pyrethroid is deltamethrin.
Kellerby teaches a free-swinging, slow-release insecticidal tag (10) designed for attachment to the neck collar (30) of a domesticated animal for the prevention and treatment of tick and flea infestation, comprising at least one pyrethroid compound zeta-cypermethrin, in combination with piperonyl butoxide to produce a synergized insecticide (abstract). Furthermore, Kellerby discloses the synergized insecticide is then impregnated into a resin base polyvinyl chloride and then formed into an odorless sustained-release device in the shape of a tag or medallion, to be attached to the neck collar of the animal in such a manner so as to allow the tag to physically contact various parts of the animal’s body, and over the course of several months, it is particularly effective against all of the parasitic life stages of various domestic animal pests, for example, ticks and fleas (abstract).
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Regarding claim 6, Kellerby teaches deltamethrin (page 12, line 12) (corresponding to the pyrethroid of instant component i)).
Regarding claims 8-9, Kellerby teaches other materials for example, lubricants (page 15, line 30) and polyesters of polyols, polycarboxylic acids, adipic acids which can function as lubricants (page 15, lines 15-17). Therefore, the limitation of lubricants is a member selected from the group consisting of esters thereof is taught.
Regarding claims 10-11, Kellerby teaches synthetic and natural elastomers (e.g., rubber obtained from hevea brasiliensis), epoxidized soybean oil, epoxidized linseed oil, epoxidized tall oils (page 15, lines 19-20). Therefore, the limitation of preservatives are taught.
Regarding claims 12-13, Kellerby teaches resins may be thermoplastic (page 13, line 36), polyvinyl chloride (page 14, line 8), polybutadiene styrene-butadiene copolymer (SBR) (page 14, line 13), acrylonitrile-butadiene copolymer, polyurethane, polyvinyl chloride (claim 12).
Regarding claim 14, Kellerby teaches examples of plasticizers are phthalates, dioctyl phthalate, dimethyl phthalate, dihexyl phthalate, di (2-ethylhexyl) isophthalate (page 15, lines 1-15).
Regarding claim 17, in an embodiment, Kellerby teaches about 10 % zeta-cypermethrin (page 12, lines 2-3). Therefore, overlaps with instant pyrethroid range of about 0.5 % to about 10 % w/w.
Grubb teaches solid the subject matter and scope of pet collar comprising a solid pesticidal composition, substantially non-volatile carbamate, thermoplastic resin characterized by being essentially dry and self-replenishing of carbamate particles on the surface of the composition (abstract) and for the control of ectoparasites on animals which is nonirritating to the animal, that is long lasting, continuous control, formation into a collar or band attachment to the collar (column 1, lines 34-44). Grubb teaches use of carbamates as the active insecticides. However, it would have been obvious to a person having ordinary skill in the art to use an alternative insecticide in place of the carbamates to fabricate the pet collar.
Regarding claims 1, 8-14, 18, 21, Grub teaches a solid pesticidal composition comprising a mixture of effective amount of a solid, a plasticized solid thermoplastic resin (column 2, lines 51-57), wherein the resin is polyvinyl chloride (column 3, line 7), dioctyl phthalate (column 3, line 22), epoxidized soybean oils (column 3, line 26-27) corresponding to preservative; low molecular weight polyethylene are examples of lubricants which can be used (column 3, line 40-41); wherein the preparation of a mixture of a solid, plasticized solid thermoplastic resin is processed into a fused product, e.g., a collar or a band (column 3, line 60-61); Moreover, Grubb teaches in formulating the solid pesticidal compositions, various ingredients are mixed and conveniently processed by means of known techniques of dry blend extrusion or injection molding to form a solid fused product in whatever shape is desired, wherein the product can be extruded or molded in an elongated rectangular shape, punched with holes and have a buckle attached for use as an animal collar for dogs and cats (column 3, line 44-53), and in Examples 1 -7, fabrication of dog collars with polyvinyl chloride, dioctyl phthalate, epoxidized soybean oil and carbamate as the insecticide.
Horak teaches several chemicals, or combinations of chemicals, with acaricidal or insecticidal properties and are safe for treatment of domestic dogs and cats, that have been formulated for application either orally, parenterally, topically or as medicated collars, lasting for serval weeks to months (page 2, left column, last ¶).
Regarding claims 1-6, 15-21, Horak teaches pet collar comprising neonicotinoid imidacloprid 10% and pyrethroid flumethrin 4.5 % and methoprene 5.8 % (page 3 & 4, ¶ Methods: study 1 -2) and immediate efficacies were similar on the imidacloprid/flumethrin, deltamethrin, fipronil/(s)-methoprene and
dinotefuran/pyriproxyfen/permethrin treated groups of dogs (78.3%, 86.5% 89.1% and 79.9%) (page 5, right column, ¶ 1). Therefore, the limitation of a pet collar comprising neonicotinoid together with pyrethroid and an insect growth regulator methoprene are safely used, known and taught in prior art.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the insecticide composition comprising a i) a neonicotinoid optionally together with pyrethroid, ii) an insect growth regulator, and iii) a filling agent together with a plasticizer as taught by Cottrell, Horak in view of Kellerby and incorporate the formulation into a wearable tag or medallion in the form of a collar as taught by Kellerby and Grubb. One would have been motivated to do so because the combined teachings of Cottrell, Kellerby in view Grubb and further in view of Horak of discloses compositions and methods for preventing and treating of tick and flea infestation on a domesticated animal.
One of ordinary skill in the art would have found it obvious to use the insecticide acetamiprid, dinotefuran (neonicotinoid) with an optionally pyrethroid in combination with an insect growth regulator (IGR) methoprene or any other species thereof because, the combination can be effective to kill fleas, flea eggs, flea larvae, ticks, tick eggs, tick larvae and tick nymphs and the selection of the combination of insecticides and IGRs produces an insecticide having high insecticidal activity while allowing for a lower total amount of insecticide to be applied to the animal, compared to the effectiveness and amount required of the individual insecticides when used alone to achieve the same kill rate as taught by Cottrell (¶ 0007) and Horak in view of Kellerby (page 6, lines 27). Therefore, regarding claims 15-17, it would have been obvious to a person having ordinary skill in the art (PHOSITA) to optimize the amount of the neonicotinoid, IGR, and pyrethroid to the effective concentration desired. One of ordinary skill in the art would have been motivated to incorporate the effective insecticide formulation into a resin base to achieve a longer duration of slow release over an extended period of time, for example over several months and further improve the ease of use, treatment and prevention of flea and tick infestation in dogs and cats through various methods, by incorporating the formulation into (1) neck collars having a releasable insecticide composition, (2) topically applied in the form of “spot-on” shampoos, aerosols, dips, sprays, and powders and (3) as an orally administered insecticide composition as taught by Kellerby and Grubb. Therefore, the insecticide formulation and its components of a neonicotinoid, pyrethroid, insect growth regulator, filling agent together with a plasticizer, methods of preventing and treating flea and tick infestation and incorporating the formulation into neck collars having a releasable impregnated insecticide composition for fleas and ticks are well known in the prior art of record.
It is obvious to combine prior art elements according to the known methods to yield predictable results. Please see MPEP 2141 (III)(A)-(G).
Response to Amendments/Arguments
Applicants argue that: the invention is drawn to a molded collar, where the insecticides are mixed and impregnated into a solid matrix and Cotrell’s formulation differs and teaches away from an impregnated collar formulation.
Examiner very respectfully disagrees. The subject matter of instant invention is a formulation, device or pet collar useful for repelling and killing arthropods pests or ectoparasites, and the formulation comprises a mixture of insecticides comprising neonicotinoid together with a pyrethroid, and an insect growth regulator methoprene formulated/molded into a collar. Cottrell teaches a combination of insecticides and insect growth regulator methoprene that are identical to instant invention. Moreover, the claim does not say it cannot be stored separately and mixed together prior to administration. It just merely says “together”, and thus Examiner interprets that these two component to mean “mixed together” as taught by Cottrell. Therefore, the limitations of all the components prior to amended claim 1 are taught. The requirement of “wherein the formulation is impregnated and molded into a collar” will be addressed by the teachings Grubb and the motivation to combine the synergistic insecticides are taught by Horak (see rejections above).
Kellerby teaches a “free-swinging, slow-release insecticidal tag/collar” for the prevention and treatment of tick and flea infestation, comprising pyrethroid compound in combination with piperonyl butoxide to produce a synergized insecticide (abstract). Applicant is hung up on the term “free-swinging” collar as something that is totally different from instant invention. Examiner would like to clarify the term “free-swinging”. By “free-swinging” as that term is used, it is meant that the tag is allowed substantially unfettered freedom of movement in all directions, and additionally, the term “slow-release” is meant that the insecticide is released from the tag over a period of several months, and furthermore, the term “neck tag or medallion” is meant to be in any shaped object that is capable of being attached, either directly or indirectly, to the neck collar of a domestic animal (page 11, lines 15-28). Kellerby further disclose neck collars having a releasable impregnated insecticide composition are well known. Generally, the neck collar, also commonly referred to as a flea collar, is comprised of some type of plasticized thermoplastic polymer that is extruded, coextruded or injection molded, or compounded with an insecticide, typically an organophosphate or carbamate compound (page 6, lines 16-22), and the insecticide composition of the present invention is preferably releasably impregnated into a resin base, wherein the impregnation can be accomplished by any number of suitable means, such as, but not limited to co extrusion, compounding, or blending. Preferably, the resin base is capable of allowing the insecticide composition to be slowly released from the resin base over an extended period of time, such as several months. Preferably, the impregnated resin base is substantially odorless. The impregnated resin base is then formed by suitable means, such as injection molding or profile extrusion and stamping processes, into a desired shape such as, but not limited to a tag or medallion. Therefore, Kellerby in view of Grubb suggests the limitation of claims 1 and 21 “wherein the formulation is impregnated and molded into a collar”, and thus the limitation is taught.
A prima facie case is properly established and it would have been obvious to combine prior art references in order to arrive at the present instant claims to reasonable have expectation of success.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDRE MACH whose telephone number is (571)272-2755. The examiner can normally be reached 0800 - 1700 M-F.
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/ANDRE MACH/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615