Patent Application 15107055 - Vermin Control Compositions

Title: Vermin Control Compositions

Application Information

Invention Title: Vermin Control Compositions
Application Number: 15107055
Submission Date: 2025-05-21T00:00:00.000Z
Effective Filing Date: 2016-06-21T00:00:00.000Z
Filing Date: 2016-06-21T00:00:00.000Z
National Class: 424
National Sub-Class: 084000
Examiner Employee Number: 86419
Art Unit: 1615
Tech Center: 1600

Rejection Summary

102 Rejections: 0
103 Rejections: 3

Cited Patents

The following patents were cited in the rejection:

Office Action Text

DETAILED ACTION
RESPONSE TO AMENDMENT
1. Receipt of Applicants’ amendments and arguments/remarks filed 1/31/2025 are acknowledged.

INFORMATION DISCLOSURE STATEMENT
2. No new Information Statement has been submitted for review.

WITHDRAWN REJECTIONS
3. Rejections not reiterated from previous Office Actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.

MAINTAINED REJECTIONS
Claim Rejections - 35 USC § 103
4. 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-4, 8, 16, 29 and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Agnew (US 2011/0257135), Prausnitz et al. “Skin Barrier and Transdermal Drug Delivery”, Banweer et al. “Development and Optimization of Transdermal System of Lisionopril dehydrate: Employing Permeation Enhancers”, and Herschler (US Patent 3,551, 554), Peterson et al. (5,296,222) and Bessette (US 2008/0269177).
Agnew (US 2011/0257135) (hereinafter Agnew) discloses topical pesticide formulations to kill pests such as mice and the formulations include cholecalciferol (vitamin D3) (i.e., toxicant) (abstract). Agnew discloses at least one carrier and the carrier or dermal penetrant may be any carrier that facilitates topical administration and delivery of the cholecalciferol transdermally (para 0013 and 0017). Preferably the carrier or one of the carriers is absolute alcohol, ethanol, n-methylpyrrolidone, or a glycol ether (para 0018). Agnew contemplates more than one carrier (see claim 4). The cholecalciferol (i.e., toxicant part i) is present from about 4 to 50 % (para 0015). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Agnew discloses delivery facilitating components that include aerosol propellants such as nitrogen as the propellant (para 0051). Agnew discloses liquid formulations (para 0019). Agnew discloses pest control and pets include rodents, mice rats, and rabbits (para 002). The fact that the composition is “for killing a target verminous animal selected from the group consisting of rodents, marsupials, leporids and mustelids” is regarded as “intended use” of the composition. It must be noted that the recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed.Cir. 1997) MPEP § 2111.02. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. The claim has been amended to recite “ wherein the amounts of the toxicant component and the alcohol and the sulfoxide components of the liquid carrier system that are present in the liquid composition are selected such that the lipid composition is formulated for killing the said target verminous animal by application to the skin thereof of a single dose amount of from about 0.1 ml up to 10 ml of the liquid composition, and such that the amount of the toxicant component that is present in that said single dose amount of the liquid composition is sufficient alone to kill the said target animal but is not substantially more than the fatal amount” and the Examiner respectfully submits that the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). While applicant intends for the amount of the carrier system to be such that it is effective to kill target verminous animals, it is not necessary that the prior art recognize this same purpose. Nonetheless the composition of Agnew is to provide for killing verminous animal by application to skin. Furthermore, the recitation of use of 0.1 ml to 10 ml is regarded as future intended use of the composition as it is the amount to be applied to skin which is given little patentable weight to a product claim. A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Agnew discloses the composition is administered in amounts from 0.5 to 3 ml (para 0025). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Agnew contemplates more than one carrier but does not specifically disclose the carrier system as recited in claim 1.
Prausnitz et al. “Skin Barrier and Transdermal Drug Delivery” (hereinafter Prausnitz et al.) disclose DMSO is an enhancer as well as ethanol and propylene glycol which all achieve increased drug solubility and partitioning. Because DMSO is a superb solvent, higher drug concentrations can be achieved than with other solvents, but it also expands the stratum corneum barrier, permitting increased drug uptake and possibly an increased rate of diffusion through the barrier. Incorporation of DMSO as a co-solvent with ethanol results in both increased drug solubility and partitioning (Fig. 124.6)
Prausnitz et al. does not disclose the amount of co-solvent (ethanol) and DMSO.
Banweer et al. “Development and Optimization of Transdermal System of Lisionopril dehydrate: Employing Permeation Enhancers” (hereinafter Banweer et al.) disclose DMSO/propylene glycol (PG) added as penetration enhancers and ratio of 70:30 DMSO/PG showed the best in vitro drug flux and possesses excellent physio-chemical properties at normal and accelerated temperature conditions (abstract). DMSO (e.g., a sulfoxide of part b and PG a propylene glycol of part a. 70% DMSO to 30 % PG overlaps with claim 1. ). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Banweer recognizes DMSO/PG ratio but not DMSO/ethanol.
Herschel (US Patent 3,551, 554) (hereinafter Herschler) states that compositions that contain relatively high amounts of DMSO (at least 50 %) by weight DMSO are preferable in that they have been shown to increase percutaneous penetration in a highly significant manner (abstract col. 5, lines 59-67). Claim 1 recites a method of enhancing penetration into and across an external membrane barrier of a human or animal subject which comprises topical administration to the external membrane such that the active agent produces the desired physiological effect amount of DMSO sufficient to enhance penetration to achieve desired physiological effect (claim 1). The DMSO is at least about 50 % by weight the composition (claim 2). Example 15 discloses propylene glycol and DMSO (i.e., a carrier system) which are present via the carrier system at amounts of roughly 50/50. Examples 32 and 33 disclose 80 % DMSO and 10 % ethanol. Example 71 is 70 % DMPS and 8 % ethanol. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the DMSO be present at amounts greater than 50 % (ranges that overlap) for the stated benefits of increasing percutaneous penetration. It would have further been obvious to one of ordinary skill in the art to substitute one known solvent (e.g., propylene glycol of Banweer) for another such as alcohols (e.g. ethanol) particularly in view that Agnew discloses these as art recognized equivalents. Herschler explicitly states “ in selecting the route of administration for a given agent, obviously the known toxicity, side effects and effectiveness for a given route of administration should be take into account” and “dosage forms for topical administration may include solutions (paints), nasal sprays, lotions, ointments (creams and gels), suppositories and the like. The solutions and nasal sprays may simply comprise the agent dissolved in DMSO, optionally, with an amount of water, glycerin or other diluent. For nasal sprays and other mucous membrane applications isotonic saline may be preferable as a diluent. The DMSO may be present in these forms in various concentrations, say from about 10 % to about 75 % by weight or higher” (col. 6, lines 42-58).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify Agnew to specifically include a dual carrier that comprises one dermal disruptant and solvent or dispersant as taught in by the combination of Prausnitz et al., Banweer et al, and Herschler et al. One would have been motivated to do so to arrive at a sufficient tissue penetrating system such that the drug penetrates mammalian tissue. Although of Prausnitz et al., Banweer et al, and Herschler et al are not directed to the intended use of “killing an animal”, specifically vermin, one would have a reasonable expectation of success that such tissue penetration systems would be combinable for use in killing vermin as taught in Agnew because Prausnitz et al., Banweer et al, and Herschler et al and Agnew are all directed to topical transdermal delivery systems using a combination of penetrating agents to arrive at sufficient transdermal penetration of the desired drug.
Regarding the use of DMSO and ethanol for permeation for animals, Peterson et al. (5,296,222) disclose permeation enhancers such as ethanol and DMSO and admixtures enhance permeation of biologically active agents by acting on the lipid matrix of the stratum carenum and enhance the permeation of biologically active agents (drugs) through the skin of an animal (col. 3, lines 15-38). Thus, application for permeation in animals would have been prima facie obvious to one of ordinary skill in the art. Furthermore, Bessette (US 2008/0269177) disclose pesticidal compositions which include rodenticides (para 0017) where these compositions typically comprise an inert carrier, in an amount in which the inert carrier can assist the instant active to be carried through a process or method of controlling pets. As such an amount of the inert carrier, the inventive pesticide compositions can comprise the inert carrier in an amount of from about 5 % to 99.9 % where the carrier may be liquid. Examples of liquid carriers include those such as ethanol, dimethylsulfoxide and a mixture thereof (para 0063). Thus, taken as a whole the combined teaches of the prior art suggest to one of ordinary skill in the art that skin penetrants (e.g., DMSO/ethanol) are useful to enhance the permeation of the desired drug which are applicable for use in rodenticide.
It would have been prima facie obvious to one of ordinary skill in the art to optimize the amounts of these known permeation enhancers (DMSO and ethanol combinations) for the stated purpose of penetration enhancement of drugs through the skin. Applicants’ state Banweer is delivering beneficial drugs transdermally to attain positive therapeutic effects however, Banweer et al concerns itself with penetrations enhancers which showed good drug flux which is applicable for use in the carriers of Agnew-(i.e., drug permeation). Additionally, Peterson et al. demonstrates enhanced permeation of active agents through skin of animals and that agents include DMSO and ethanol and combinations and Bessette recognizes rodenticide compositions containing carriers which may be liquid and composed of DMSO and ethanol in amounts anywhere from 5-99 .9 %. Taken as a whole the combined teachings suggest to one of ordinary skill in the art that skin penetrants (e.g., DMSO/ethanol) are useful to enhance the permeation of the desired drug which are applicable for use in rodenticide formulations.

5. Claims 1 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Agnew (US 2011/0257135), Agnew (US 2011/0257135), Prausnitz et al. “Skin Barrier and Transdermal Drug Delivery”, Banweer et al. “Development and Optimization of Transdermal System of Lisionopril dehydrate: Employing Permeation Enhancers”, Herschler (US Patent 3,551, 554), Peterson et al. (5,296,222) and Bessette (US 2008/0269177) as applied to claims 1, 3-4, 8, 16, 29 and 31-33 above, and further in view of Jones (US 8,142,801).
Agnew in view of Prausnitz, Banweer, and Williams have been discussed supra and do not explicitly disclose inclusion of pheromones or attractants. Jones (US 8,142,801) (hereinafter Jones) discloses pesticide compositions for pests such as mice that can further include feeding stimulants and attracts which include pheromones (col. 6, lines 51-65 and col. 17, lines 33-35). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to further include one or more pheromone or attractants as taught in Jones in in the pest control formulations of Agnew. One would have been motivated to do so for the stated function which is to serve as an attractant to the pests.

6. Claims 1 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Agnew (US 2011/0257135), Prausnitz et al. “Skin Barrier and Transdermal Drug Delivery”, Banweer et al. “Development and Optimization of Transdermal System of Lisionopril dehydrate: Employing Permeation Enhancers”, Herschler (US Patent 3,551, 554), Peterson et al. (5,296,222) and Bessette (US 2008/0269177) as applied to claims 1, 3-4, 8, 16, 29 and 31-33 above, and further in view of Atarashi et al. (US 2015/0173342).
The modified Agnew has been discussed supra and discloses propellant but does not disclose further comprising up to 10 % by weight one or more adjunct components of which these may be aerosol propellants.
Atarashi et al. (US 2015/0173342) (hereinafter Atarashi et al.) disclose the pest control agent may include, in addition to the active ingredient, other materials such as solvents, propellants or other ingredients (para 0048). A typical active ingredient:propellant for a liquefied gas is 10-90:90-10 (volume ratio) which overlaps with up to 10 % of the instant claims. The propellant can be 5 wt % (para 0066). It would have been prima facie obvious to one of ordinary skill in the art before the effective fling date of the instant invention to optimize the amount of adjuvant ingredients included in the pest control compositions such as the propellant. One would have been motivated to include the desired adjunct components for the desired properties such as perfume for desirable smell or propellant for expelling the pest control agent from the container.

RESPONSE TO ARGUMENTS
7. Applicant’s arguments have been fully considered and are not found persuasive for the reasons below.
Applicant argues "and wherein the amounts of the toxicant component and the alcohol and the sulfoxide components of the liquid carrier system that are present in the liquid composition are selected within the respective above-defined ranges for each thereof such that the liquid composition is formulated such that it is effective to kill the said selected target verminous animal by application to the skin thereof of a single dose amount of from 0.1 ml up to 10 ml of the liquid composition, and such that the amount of the toxicant component that is present in that said single dose amount of the liquid composition is sufficient alone to kill the said selected target animal but is not substantially more than that fatal amount thereof" - is a physical, compositional - and thus "structural" - limiting feature of the liquid composition that is the subject of the claim.
Applicants argue that the previously added final clause of the claim is now defined more clearly as a true, physical composition and structural feature further defining the physical make-up of the composition itself.
In response, Applicants focus on the amendment that “wherein the amounts of toxicant component and the alcohol and the sulfoxide component of the liquid carrier system that are present in the liquid composition are selected within the respective above-defined ranges for teach thereof such that the liquid composition is formulated such that it is effective to kill the said target venomous animal by application to the skin thereof a single dose amount of from 0.1 ml up to 10 ml of liquid composition”. The prior art need not recognize this same purpose and result. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006).
Applicants argue that Agnew teaches nothing about relative amounts of each of two carriers in such a dose.
In response, this argument is not found persuasive because applicants are arguing the rejections individually when the relative amounts of each of the carriers has been addressed by the combined teaches as discussed supra. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicants argue that Prausntz does not teach or suggest Applicant’s recited final clause limiting the amount of toxicant present .Applicants argue skin of vermin and skin of humans are not equivalent or similar.
Oviousness does not require absolute predictability of success. “Obviousness does not require absolute predictability of success.” Id. at 903, 7 USPQ2d at 1681.
Applicants repeat the argument that Banweer disclose 3 % pf PG and 7 % of DMSO based on the total liquid carrier system itself.
In response, the amounts were addressed by the combined teachings of Banweer, Herschel, Peterson et al. and Bassette. Applicant is not claiming an amount of overall carrier system in the composition. Banweer was not solely relied upon to show the ratio. The combined teachings of Prausnitz et al., Banweer et al, and Herschler et al. address the DMSO/ethanol and claimed ratio. While Examples 32 and 33 of Herschler disclose 80 % DMSO and 10 % ethanol and the claim is 70 % DMSO, Herschel disclose amounts of DMSO of at least 50 % for increased percutaneous penetration and that even if Example 71 is a ointment, Herschler explicitly states “ in selecting the route of administration for a given agent, obviously the known toxicity, side effects and effectiveness for a given route of administration should be take into account’ and “dosage forms for topical administration may include solutions (paints), nasal sprays, lotions, ointments (creams and gels), suppositories and the like. The solutions and nasal sprays may simply comprise the agent dissolved in DMSO, optionally, with an amount of water, glycerin or other diluent. For nasal sprays and other mucous membrane applications isotonic saline may be preferable as a diluent. The DMSO may be present in these forms in various concentrations, say from about 10 % to about 75 % by weight or higher (col. 6, lines 42-58). Thus, the DMSO is not limited to the 80 % of the Example, nor is it limited to just ointments as it states that solutions may also include the concentrations from 10 % to 75 %, an amount that explicitly overlaps the claimed amounts of 40 % to 70 % DMSO.
Herschler does not suggest Applicant’s recited final clause limiting the amount of toxicant present and does not relate to killing verminous animal.
Peterson discloses nothing specific about any particular combinations of penetration enhancers and no working examples of the same. Bassette disclose nothing specific about any particular combinations of penetration enhancers and no working examples and does not relate to the killing of verminous animal species.
In response, Peterson was relied upon to show that DMSO enhances permeability of drugs and permeation and Bessette disclose carries that assist the active to be carried through a process of controlling pests which include those such as ethanol, DMSO and mixtures which are present in overlapping amounts. Thus, taken as whole the combined teaching of the prior art suggest to one of ordinary skill in the art. The ”killing verminous animal species” is still regarded as intended use that the composition is to be used for.

Applicants have amended claim 1 to recite:

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Applicants focus on the amendment that “wherein the amounts of toxicant component and the alcohol and the sulfoxide component of the liquid carrier system that are present in the liquid composition are selected within the respective above-defined ranges for teach thereof such that the liquid composition is formulated such that it is effective to kill the said target venomous animal by application to the skin thereof a single dose amount of from 0.1 ml up to 10 ml of liquid composition”. The prior art need not recognize this same result. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006).

CONCLUSION
6. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
CORRESPONDENCE
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAH AL-AWADI/ Primary Examiner, Art Unit 1615