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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/21/2026 has been entered.
Receipt of Applicants’ Arguments, Remarks and amended claims filed on 08/21/2026 is acknowledged.
Claims 1-6, 8-11 and 15-21 are pending.
Claims 7, 12-14 are cancelled.
Claims 1, 11, 18 and 21 have been amended.
Claims 1-6, 8-11 and 15-21 are pending and under examination in this application.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 06/30/2026, 08/16/2025 and 11/10/2022 are in compliance with the provisions of 37 CFR 1.98. Accordingly, the information disclosure statements have been considered by the examiner. Signed copies have been attached to this office action.
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, 8-11 and 15-21 are rejected under 35 U.S.C. 103 as being unpatentable over Cottrell et al. (US 2011/0144166 A1 hereinafter “Cottrell”) in view of Kellerby (WO 00/40084), Grubb (US Patent 3852416) and Sirinyan et al. (US 7,910,122 B2 hereinafter “Sirinyan”), and further in view of Horak et al., 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”).
Sirinyan is newly cited and applied in this Office Action; it was submitted by Applicant in the Information Disclosure Statement filed 06/30/2026 and considered of record. Sirinyan has a priority date of 06/29/2004, is entitled to that priority date under 35 U.S.C. 119, and issued 03/22/2011 — well before the 07/16/2021 effective filing date of the instant application. Sirinyan therefore qualifies as prior art under 35 U.S.C. 102(a)(1). Cottrell, Kellerby, Grubb, and Horak are relied upon as set forth in the prior Office Action (mailed 05/21/2026) for their teachings of: (i) a neonicotinoid together with a pyrethroid and an insect growth regulator (Cottrell, Abstract, ¶¶ 0011, 0014, 0058, 0074, 0081); (ii) deltamethrin as a suitable pyrethroid and an impregnated, injection-molded/extruded collar delivery format (Kellerby, p. 6:16-22, p. 12:12, p. 14:3-8); (iii) a solid pesticidal collar comprising a plasticized thermoplastic resin, including polyvinyl chloride, processed by extrusion or injection molding into a collar (Grubb, col. 1:34-44, col. 2:51-57, col. 3:7, col. 3:44-61); and (iv) in vivo efficacy of neonicotinoid/pyrethroid/methoprene collar formulations against fleas and ticks on dogs (Horak, pp. 3-5).
Summary of Prior Art:
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, ¶ 0007).
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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Grubb teaches a solid pesticidal collar comprising a solid pesticidal composition of a substantially non-volatile carbamate in a thermoplastic resin, characterized by being essentially dry and self-replenishing of carbamate particles on the surface of the composition (abstract), for the control of ectoparasites on animals in a manner that is nonirritating to the animal and provides long-lasting, continuous control, with the composition formed into a collar or a band for 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.
Sirinyan teaches active compound-containing moulded bodies for external use against parasites on animals (abstract).
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 ¶).
Claim 1 (as amended) recites, inter alia: “a filling agent which is polyvinyl chloride together with a plasticizer which is dioctyl adipate, and 0.1% w/w to about 8.0% w/w butylhydroxytoluene.” Claims 18 and 21 (as amended) recite substantially the same limitation.
Cottrell, Kellerby, Grubb, and Horak are relied upon as set forth in the prior Office Action (mailed 05/21/2026) for their teachings of: (i) a neonicotinoid together with a pyrethroid and an insect growth regulator (Cottrell, Abstract, ¶¶ 0011, 0014, 0058, 0074, 0081); (ii) deltamethrin as a suitable pyrethroid and an impregnated, injection-molded/extruded collar delivery format (Kellerby, p. 6:16-22, p. 12:12, p. 14:3-8); (iii) a solid pesticidal collar comprising a plasticized thermoplastic resin, including polyvinyl chloride, processed by extrusion or injection molding into a collar (Grubb, col. 1:34-44, col. 2:51-57, col. 3:7, col. 3:44-61); and (iv) in vivo efficacy of neonicotinoid/pyrethroid/methoprene collar formulations against fleas and ticks on dogs (Horak, pp. 3-5). Those mappings are not repeated in full here except as they bear on the newly amended limitations.
Regarding the filling agent “polyvinyl chloride” (claims 1, 18, 21): Grubb teaches that the resin of the solid pesticidal collar composition is polyvinyl chloride (Grubb, col. 3:7). Kellerby teaches that resins for the impregnated collar/tag device may be polyvinyl chloride (Kellerby, p. 14:8) and that resins may be thermoplastic (p. 13:36). Sirinyan independently and more specifically confirms polyvinyl chloride as the preferred matrix resin for ectoparasiticidal moulded bodies including neck collars: “According to the invention, preference is given to polyvinyl chloride, polypropylene, polyethylene and EPDM; very particular preference is given to polyvinyl chloride” (Sirinyan, col. 4, describing the polyvinyl resins for the invention), and every worked Example (1-4) uses PVC as the base resin of an insecticidal neck collar for dogs. This limitation is taught by the combined art.
Regarding the plasticizer “dioctyl adipate” (claims 1, 18, 21): Grubb and Kellerby teach phthalate-ester plasticizers (dioctyl phthalate, dimethyl phthalate, dihexyl phthalate) rather than an adipate ester. The application as filed, however, itself identifies dioctyl adipate as a known, art-recognized plasticizer for this type of formulation: paragraph [0055] of the specification discloses “the plasticizer is a member selected from the group consisting of” an extended Markush list of phthalate, phosphate, azelate, sebacate, and adipate esters, expressly including “di-2-ethylhexyl adipate, di-iso-octyl adipate, di-iso-nonyl adipate, di-iso-decyl adipate, benzyl butyl adipate, benzyl octyl adipate,... dioctyl adipate, and mixtures thereof.” This disclosure, presented in the same generic, background-recitation format used throughout the specification to describe known, conventional formulation components (see also ¶ 0054, listing “esters of adipic acid” generally among “suitable plasticizers”), constitutes Applicant's own admission that dioctyl adipate was, as of the effective filing date, a known and art-recognized plasticizer species for polymer-matrix pesticidal formulations of this kind. See MPEP § 2129 (admissions by the applicant may be used in a rejection under 35 U.S.C. 103). This admission is corroborated by Sirinyan, which independently confirms that adipic acid ester plasticizers (exemplified by di-n-butyl adipate, a homolog of dioctyl adipate) are suitable, effective plasticizers for PVC-based ectoparasiticidal collars, and further supplies an express motivation to prefer an adipate ester over the phthalate esters of Grubb/Kellerby: Sirinyan states that phthalate plasticizers conventionally used in such moulded bodies “are not entirely harmless toxicologically” and that “[i]t is therefore desirable to replace the said phthalates with environmentally compatible ingredients which are less toxic” (Sirinyan, Background of the Invention). A POSA, aware from Applicant's own disclosure that dioctyl adipate was a known member of the art-recognized adipate-ester plasticizer class, and motivated by Sirinyan's express teaching to substitute an adipate ester for the phthalate esters of Grubb/Kellerby, would have found it obvious to select dioctyl adipate as the plasticizer in the PVC collar matrix of the combined references, with a reasonable expectation of success. This is no more than the selection of a known compound, already disclosed by Applicant as suitable for this exact purpose, from among a finite number of identified, predictable options. KSR, 550 U.S. at 421; In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980).
Regarding “0.1% w/w to about 8.0% w/w butylhydroxytoluene” (claims 1, 18, 21): The application as filed likewise admits that butylhydroxytoluene (BHT) was a known, art-recognized antioxidant/stabilizer for this type of formulation, and admits the claimed concentration range for that very class of ingredient. Paragraph [0031] of the specification discloses that “the present disclosure provides stabilizers, preservative and/or antioxidants which can be... phenols, butylhydroxytoluene (BHT), butylhydroxyanisole, vitamin (tocopherols), and the like”; paragraph [0056] similarly discloses that “[s]uitable stabilizers are antioxidants and agents which protect resin from ultraviolet radiation and inadequate degradation during extrusion process,” further identifying “phenolic antioxidants... such as butylhydroxytoluene, butylhydroxyanisol, and the like” among the antioxidant agents suitable for that purpose. Both disclosures are presented in the same generic, background-recitation format used to describe conventional, art-known formulation components, and constitute Applicant's own admission that BHT was a known antioxidant/stabilizer for polymer-matrix pesticidal collar formulations as of the effective filing date. See MPEP § 2129. Moreover, the originally-filed claims confirm that this range was already associated with the very genus of preservative/stabilizer compounds that includes BHT: original claim 10 recited “a preservative,” original claim 11 recited that preservative as selected from a Markush group expressly including “butylated hydroxytoluene” (i.e., BHT), and paragraph [0030] of the specification discloses that “the preservative is present at a concentration of 0.1% w/w to about 8% w/w” — the identical range now recited in amended claim 1 for BHT specifically. Selecting BHT as the specific species from Applicant's own previously-disclosed genus of known antioxidant/stabilizer compounds, at the identical concentration range Applicant's own specification already associated with that genus, is not the discovery of a new or critical parameter; it is the obvious selection of one known, art-recognized member of a finite, already-disclosed group, at a range already disclosed for that group. In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) (selection of a known compound from a finite number of predictable options, each known to be useful for the intended purpose, is prima facie obvious). This admission is further corroborated by Sirinyan's independent teaching that PVC-collar moulded bodies conventionally include “stabilizers... [that are] antioxidants... which protect the collars... from undesirable breakdown during the processing, such as extruding.” Applicant has not presented evidence that the claimed range, or the selection of BHT specifically, produces results unexpected relative to the antioxidant species and loadings its own specification already discloses as suitable for this purpose.
Regarding the “greater than 90% for at least 180 days” efficacy limitation (claims 1, 18, 21): As discussed above, Sirinyan's own PVC/adipate-ester collars — the identical delivery platform now claimed — independently achieve greater than 90% efficacy against fleas (Ctenocephalides felis) and ticks (Ixodes ricinus, Ixodes holocyclus) over a period of five to six months when administered as neck collars (Sirinyan, Activity Experiments, Examples A-C). This closely corroborates and strengthens the rationale, already set forth with respect to Kellerby's “several months” sustained-release teaching and Horak's in vivo data, that the claimed efficacy/duration limitation is the predictable, expected performance of a neonicotinoid/pyrethroid/IGR combination delivered from a PVC/adipate-ester collar matrix, rather than an unexpected result. See Response to Arguments, Argument C, above.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to formulate an insecticide composition comprising (i) a neonicotinoid together with a pyrethroid, (ii) an insect growth regulator (methoprene), and (iii) a filling agent which is polyvinyl chloride together with a plasticizer which is dioctyl adipate and an antioxidant stabilizer such as butylhydroxytoluene, and to impregnate and mold that formulation into a collar releasing an effective amount of the actives to protect an animal against fleas and ticks with an efficacy of greater than 90% for at least 180 days, for the following reasons: Cottrell and Horak establish the active-ingredient combination and its efficacy in a collar context; Kellerby and Grubb establish the impregnated, injection-molded/extruded PVC collar format and manufacturing techniques; and Sirinyan supplies both an express, self-contained motivation to select an adipate-ester plasticizer over the phthalate esters of Grubb/Kellerby (to reduce toxicity) and confirms that a PVC/adipate-ester collar platform achieves the claimed efficacy and duration. Each reference is applied for what it fairly discloses, and the combination of familiar elements according to known methods yields no more than predictable results. KSR, 550 U.S. at 416.
Claim 18 (method claim) contains substantially similar efficacy and duration language.
Regarding claims 2-5, 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 claim 6, Kellerby teaches deltamethrin (page 12, line 12) (corresponding to the pyrethroid of instant component i).
Regarding claims 8-11, these claims (directed to a lubricant and a preservative, respectively, selected from Markush groups not including butylhydroxytoluene as amended) stand rejected as set forth in the prior Office Action over Kellerby (p. 15:15-17, lubricants; p. 15:19-20, preservatives) and Grubb (col. 3:26-27, 3:40-41), which teachings are unaffected by the amendments and are incorporated herein by reference.
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. 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 is taught.
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.
Regarding claim 17, in an embodiment, Kellerby teaches about 10 % zeta-cypermethrin (page 12, lines 2-3). Therefore, it overlaps with instant pyrethroid range of about 0.5 % to about 10 % w/w.
Regarding claims 1, 8-11, 18, 21, Grubb teaches a solid pesticidal composition comprising an effective amount of 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.
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.
Examiner clarifies prima facie obviousness and motivation to combine:
It would have been prima facie obvious to a person of ordinary skill in the art (PHOSITA) before the effective filing date of the claimed invention to formulate an insecticide composition comprising (i) a neonicotinoid optionally together with a pyrethroid; (ii) an IGR; and (iii) a filling agent together with a plasticizer, as taught by Cottrell and Horak, and to incorporate that formulation into a wearable collar using the impregnation, compounding, and molding techniques taught by Kellerby and Grubb, for the following reasons.
First, Cottrell establishes that the particular combination of neonicotinoid actives (acetamiprid, dinotefuran), pyrethroid actives, and IGR (methoprene) is an effective and known insecticide combination, and identifies PVP/VA as a compatible excipient class. The active ingredient selection from Cottrell is independent of Cottrell's choice of spot-on delivery. A PHOSITA understands that the identity of active ingredients in a pesticidal formulation can be decoupled from the delivery vehicle: the same active classes that kill fleas and ticks in a spot-on can be incorporated into a collar matrix to achieve sustained, extended-release efficacy. There is no technical barrier to this transfer; the active ingredients, once selected, are incorporated into the polymer matrix at the time of manufacture, where molecular mobility is restricted and the stability concerns Cottrell identifies for liquid concentrates do not apply.
Second, Kellerby independently teaches the impregnated collar as a known delivery vehicle, provides the manufacturing process (co-extrusion, compounding, injection molding, page 14 lines 3–8), and specifically identifies deltamethrin as a suitable pyrethroid (page 12, line 12). Kellerby expressly acknowledges that flea collars comprised of plasticized thermoplastic polymer impregnated with insecticide are well known (page 6, lines 16–22), providing the skilled artisan with a ready-made format into which Cottrell's actives can be incorporated.
Third, Grubb confirms the collar format, demonstrates sustained-release delivery of pesticidal compositions in extruded or injection-molded thermoplastic collars, and shows that the insecticide identity is substitutable within the matrix (column 3, lines 44–61). Horak demonstrates that the neonicotinoid/pyrethroid/methoprene combination is effective and safe when delivered in a collar format over multiple months in vivo, providing a reasonable expectation of success.
One of ordinary skill in the art would therefore have been motivated to: (a) select Cottrell's identified active ingredients (neonicotinoid, pyrethroid, methoprene) and excipients; (b) substitute deltamethrin as the pyrethroid, as taught by Kellerby (page 12, line 12) and demonstrated in Horak's deltamethrin collar arm; (c) incorporate the combined formulation into Kellerby's and Grubb's known impregnated thermoplastic collar format using known molding and extrusion techniques; and (d) optimize the active ingredient concentrations within the ranges taught by Cottrell and Kellerby to achieve target efficacy and release duration, which is routine formulation experimentation. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416–417 (2007).
Regarding claim 21 specifically: Claim 21 recites a neonicotinoid that is acetamiprid or dinotefuran together with deltamethrin as the pyrethroid, methoprene as the IGR, a filling agent and plasticizer, wherein the formulation is impregnated and molded into a collar, with >90% efficacy for at least 180 days. Each of these limitations is taught by the combination: Cottrell teaches acetamiprid and dinotefuran (¶ 0011), methoprene (¶ 0014), and filling agent/plasticizer (PVP/VA, Table 2); Kellerby teaches deltamethrin (page 12, line 12) and the impregnated/molded collar format (page 14, lines 3–8); Grubb teaches the molded thermoplastic pesticidal collar (column 3, lines 44–61); and the >90%/180-day efficacy limitation is a result-effective variable that does not confer patentability, as discussed under Argument 2 below. A PHOSITA would have had a reasonable expectation of success in combining these known elements to produce a functional collar.
It is obvious to combine prior art elements according to known methods to yield predictable results. MPEP § 2141(III)(A)–(G).
Response to Arguments
Applicant's arguments filed 08/21/2026 have been fully considered. To the extent the arguments are directed to the motivation to combine Cottrell, Kellerby, Grubb, and Horak as applied in the prior Final Office Action, they are addressed above. To the extent the arguments are directed to the newly added limitations of claims 1, 18, and 21 (filling agent which is polyvinyl chloride, plasticizer which is dioctyl adipate, and 0.1% w/w to about 8.0% w/w butylhydroxytoluene), those limitations are newly addressed above in view of Sirinyan, entered for the first time in this Office Action.
ARGUMENT 1: Applicant argues that a POSA would not have been motivated to incorporate a three-active spot-on composition into a collar matrix because the prior art (Grubb, Horak) already discloses stable one- and two-active collar formats, citing Ex parte Hansen, Appeal 2019-001796 (PTAB Nov. 14, 2019), for the proposition that a POSA is not motivated to modify a structure that already solves the stated problem.
This argument is not persuasive:
First, Hansen is distinguishable on its facts. In Hansen, the base reference's simpler woven structure already achieved the identical stated goal (softness/comfort against skin) that the proposed laminate modification was offered to achieve; the modification supplied no additional benefit beyond what the base reference already provided, so the PTAB found the modification purely redundant. Here, by contrast, the addition of a third active class — an insect growth regulator — to a neonicotinoid/pyrethroid combination supplies a distinct and independently recognized benefit that one- and two-active formats do not provide: broader-spectrum control across additional life stages of the target parasites (ovicidal/larvicidal activity via the IGR, in addition to adulticidal activity via the neonicotinoid and pyrethroid). Cottrell expressly teaches that combining a neonicotinoid or pyrethroid actives with an insect growth regulator “results in an insecticide preparation formulated to have enhanced insecticidal activity against fleas and ticks... while advantageously minimizing the total amount of insecticide needed for its effectiveness” (Cottrell, Abstract; ¶ 0007). A POSA seeking this recognized, independent benefit would have reason to add the third active even though narrower-spectrum one- and two-active collars were already commercially known; unlike Hansen, the modification here is additive, not redundant.
Second, KSR does not require that the base reference be deficient before a POSA is motivated to modify it; it requires only an articulated reason, supported by rational underpinning, to make the combination. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Cottrell's own teaching of enhanced, broader-spectrum insecticidal activity from the three-active combination supplies that reason independent of whether narrower alternatives already existed in the market.
ARGUMENT 2: Applicant argues that Horak's comparative figures show that the three-active spot-on formulation (dinotefuran/pyriproxyfen/permethrin) exhibited the steepest performance decay among all tested treatments, and that this data teaches away from combining three actives in a collar.
This argument is not persuasive:
Horak's decay data concerns liquid spot-on formulations, in which active release is governed by percutaneous absorption, sebum partitioning, grooming-related loss, and environmental washout — mechanisms that are physically and chemically distinct from the diffusion-controlled release of actives from a solid, impregnated thermoplastic matrix such as the claimed collar. A POSA would not extrapolate the decay kinetics of an evaporating/absorbing topical liquid to a mechanistically distinct solid-matrix delivery vehicle. Sirinyan's own long-duration in vivo data confirms this distinction: solid PVC-based moulded collars formulated with adipic acid ester plasticizers (in place of phthalate plasticizers) achieve greater than 90% efficacy against fleas (Ctenocephalides felis) and ticks (Ixodes ricinus, Ixodes holocyclus) over a period of five to six months (Sirinyan, Examples A-C; col. relating to “Activity Experiments”), even where the actives are only two in number — demonstrating that the solid-matrix collar platform does not exhibit the accelerated decay Horak observed for liquid spot-on treatments. A reference does not teach away merely because a different formulation type performs differently; teaching away requires that the reference criticize, discredit, or discourage the claimed solution itself. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Horak says nothing about, and does not criticize, three-active solid-matrix collars.
ARGUMENT 3: Applicant argues that the claimed collar's greater-than-90% efficacy for at least 180 days represents an unexpected result relative to the one- and two-active collars of the prior art (Scalibor, Seresto), rebutting any prima facie case of obviousness.
This argument is not persuasive:
Unexpected results must be compared against the closest prior art, not against a general commercial benchmark. In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). Sirinyan — now the closest prior art for the claimed delivery platform — discloses a structurally analogous solid PVC collar plasticized with an adipic acid ester (di-n-butyl adipate), which already achieves greater than 90% efficacy against fleas and ticks over five to six months (i.e., approximately 150-180+ days) using only two actives (imidacloprid and flumethrin). See Sirinyan, Examples 1-4 and Activity Experiments A-C. Because the identical delivery platform already known in the art (PVC matrix plus adipate-ester plasticizer) demonstrates comparably high, comparably durable efficacy, Applicant's showing that a three-active version of the same platform also achieves greater than 90% efficacy for at least 180 days is not unexpected — it is consistent with, and predictable from, the performance already demonstrated by the closest prior art delivery vehicle. Applicant has not provided a side-by-side comparative showing against Sirinyan's PVC/adipate-ester collar platform specifically, as required to establish unexpected results relative to the closest prior art. In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984). Additionally, Applicant's own specification undercuts the unexpected-results showing: the working examples (Table A, Table B, Product 3-CC) that achieve the claimed efficacy are formulated entirely from ingredient species and concentration ranges (PVC filling agent, dioctyl adipate plasticizer, BHT stabilizer at 0.50% w/w) that the specification itself discloses, at ¶¶ 0030, 0031, 0054-0056 and original claim 11, as members of known, conventional Markush genera — not as a newly-discovered critical combination. Applicant's own efficacy data (¶¶ 0087-0088, FIGS. 1-2) further shows performance declining over the course of the study (e.g., Formulation 4 falling to 88% control by Day 280), consistent with the ordinary, expected decay behavior of a sustained-release collar rather than an unexpectedly superior, non-declining result.
ARGUMENT 4: Applicant argues that written description support for the amendments exists at paragraphs [0030]-[0031], [0052], [0055], and Examples 1-3 of the application as filed, and that no new matter has been added.
The Examiner does not dispute this. Compliance with 35 U.S.C. § 112(a) is acknowledged and is not at issue in the rejections above, which are made solely under 35 U.S.C. § 103. Written description compliance does not bear on obviousness. In re Baird, 16 F.3d 380, 382 (Fed. Cir. 1994).
Applicant's arguments have been fully considered and are found to be unpersuasive.
Conclusion
No claims are allowed.
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/ANDRE MACH/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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