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 .
Response to Arguments
Applicant's arguments filed 6/8/2026 have been fully considered but they are not persuasive. The Examiner has re-weighed all the evidence of record.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn:
Claim objections to claims 15 and 24 are withdrawn in view of amendment.
112(b) rejections of claims 5, 7-9, 12, 15-17, and 22 are withdrawn in view of amendment.
112(d) rejections of claims 18-21 are withdrawn.
All 102 and 103 rejections are withdrawn in view of amendment.
The following rejections and/or objections are either reiterated or newly applied:
112(b) rejection of claim 1 is issued in view of amendment.
103 rejections have been issued for all claims in view of amendment.
The arguments in the response filed 6/8/2026 will be addressed below to the extent that they apply to the current rejections.
Intended Use
The 102 rejections over CN’383 have been withdrawn in view of amendment, however, Applicant’s arguments regarding intended use language are still applicable to the current rejections. The addition of language merely asserting that the composition is “configured for pouring onto external skin of cattle” does not impart any structural distinction that amounts to a functional limitation, nor does moving the intended use language from the preamble to the body of the claim transform it into a structural distinction. Applicant argues that the recitations of ectoparasites to be treated by the formulation and “cattle administration limitations” further define the claimed formulation. They do not. The application of the formulation to one species of ectoparasite over another species of ectoparasite has no bearing on the composition of the claimed formula. Furthermore, the claims are drawn to a product, not a method. Thus, a prior art structure which is capable of performing the claimed use will read on the instant limitations. For purposes of compact prosecution, the limitations drawn to specific intended uses will nonetheless be addressed with prior art.
103 Rejection over CN’383
Applicant argues the citation of overlapping ranges in the prior art does not establish the obviousness of the claimed formulation as a whole. This is not persuasive as the overlapping ranges cited in the prior art were not relied upon to establish obviousness the claimed formulation as a whole. Rather, the citation of overlapping ranges is to establish that the ranges and amounts of the claimed ingredients are known in the prior art. As explicitly stated in MPEP 2144.05, which discusses obviousness of similar and overlapping ranges and amounts, “[i]n the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.” Applicant further contends that “obviousness still requires a reason why a person of ordinary skill would have selected the claimed combination of ingredients … CN’383 does not teach or suggest the present claimed cattle pour-on formulation.” (As discussed above, the recitation of “cattle pour-on formulation” is an intended use that imparts no limiting, structural distinction. This will not be expounded upon further.) This is not persuasive as one does not need any teaching or suggestion to combine the teachings of a singular reference, since they are taught by the same reference. Moreover, many of the claimed limitations were addressed in a single embodiment of the cited reference (claim 7 of CN’383). CN’383 alone makes obvious the combination of ingredients claimed in the claim set addressed in the office action dated 4/3/2026, thus a person of ordinary skill could have followed the explicit teachings of CN’383 with a reasonable expectation of success.
Applicant also states that “the claimed formulation is not an arbitrary selection of known ingredients; it is a specifically configured animal pour-on formulation supported by the specification and efficacy data.” This is a mere conclusory statement without further explanation of why the cited data is significant. Applicant has not provided any evidence demonstrating the criticality of the selected ingredients, particularly with regard to those that are well-known in the art such as solvents and rheology modifiers. The selection of a known material based on its suitability for its intended use is prima facie obvious. MPEP 2144.07. The data in the instant Specification demonstrates that the composition is effective as an insecticide but does not establish the criticality of the selection nor amounts of any of the claimed ingredients.
103 Rejection over CN’383 in view of Fuchs, SASOL, WO’681, Cabot
To avoid redundancy, Applicant’s arguments regarding the separate 103 rejections in view of the secondary references listed above (Fuchs, SASOL, WO’681, and Cabot) will be addressed together. Applicant argues that the secondary references individually do not teach the amended indoxacarb pour-on formulation. This is not persuasive as none of the individual references were relied on for that purpose. Each reference was cited for teaching a specific component of the claimed formulation. Applicant further argues that none of the references provide teaching or motivation to make the requisite modifications to arrive at the claimed formulation. As discussed above, the selection of a known material based on its suitability for its intended use is prima facie obvious. No teaching or motivation is necessary.
With regard to SASOL, Applicant contends that the reliance on the suitability of a material as a pesticide carrier insufficient because the claimed invention is not merely the selection of a known solvent and “the claims require a specific combination of components and amounts”. Applicant has not provided any evidence demonstrating the criticality of the selected ingredients. Without evidence of criticality, the selection of a known material based on its suitability for its intended use is prima facie obvious. Applicant also states that “at most, the cited references show that the individual formulation components were known for different purposes in different contexts.” This is not persuasive. Fuchs, SASOL, WO’681, and CABOT each explicitly discuss the suitability of the components in the context of pest control (see Office Action dated 4/3/2026).
Finally, Applicant argues improper hindsight reconstruction. As for the assertion that the rejections are based on hindsight, as noted in MPEP 2145, any obviousness rejection is in a sense necessarily a reconstruction based on hindsight reasoning and is not improper if it takes into account only knowledge within the level of ordinary skill in the art at the time the claimed invention was made. Applicants have provided no evidence that the rejection is not based on knowledge available to those of ordinary skill in the art.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
New Rejections – 112(b)
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, part (b) recites “a paraffinic oil comprising a mixture of hydrotreated isoparaffinic hydrocarbons and naphthenic hydrocarbons in an amount ranging from about 87% to about 93% by weight”. This renders the claim indefinite as it is unclear if the recited range refers to the total amount of hydrotreated isoparaffinic hydrocarbons and naphthenic hydrocarbons in the paraffinic oil, or if the recited range refers to the amount of paraffinic oil in the composition. For purposes of compact prosecution, if the prior art teaches the recited values, it will be considered to meet the claim limitation.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 8-11, 13-14, and 16-22 are rejected under 35 U.S.C. 103 as being unpatentable over CN105010383A (hereinafter CN’383, published 11/4/2015, cited on the 7/1/2024 IDS), as evidenced Petry et al. (2017) and Cabot (2021, cited in the previous Office Action).
Regarding claims 1, 4, and 18-22, Examiner would like to reiterate that the recitations of “for controlling pests on cattle”, “configured for pouring onto external skin of cattle”, “pour-on formulation for horn flies or lice on cattle”, and recitations of selected species of ectoparasites are recitations of intended use. A prior art structure which is capable of performing the intended use meets the claim. As the composition taught by CN’383 is a suspension comprising the claimed ingredients [claim 7] that be applied by spraying [0129], it is therefore capable of pour-on application. Thus, the prior art composition meets the instant claim limitations. These recitations will be further addressed with prior art in a separate rejection below.
Regarding claims 1-4, 8-11, 13-14, and 16-22, CN’383 teaches an insecticidal composition comprising fipronil, indoxacarb, a solvent comprising mineral oil (reads on paraffinic oil), 0.1% to 5% of a defoamer (i.e. surfactant) comprising C8-C10 fatty alcohols (reads on oil-soluble, nonionic surfactant), and 0.2% to 5% of a thickener comprising gaseous silica, all amounts expressed in weight percentages [claim 7].
Regarding indoxacarb: CN’383 teaches that the fipronil and indoxacarb may be present in the amount of 30% by weight of the composition [claim 7]. CN’383 further teaches that, in one embodiment, the weight ratio of fipronil to indoxacarb may be 1:15 to 3.2:1 [claim 3]. Accordingly, the percentage weight of indoxacarb in the insecticidal composition taught by CN’383 is from 7.14% to 28.12% ((15/16) x 30 = 28.12%; (1/4.2) x 30 = 7.14%)). CN’383 also explicitly states that the indoxacarb may be present in the amount of 0.85% to 29.93% by weight of the total formulation [0019]. These ranges overlap with and make obvious the amounts of indoxacarb claimed in instant claims 1-3 and 22. MPEP 2144.05.
Regarding paraffinic oil: CN’383 does not explicitly state that mineral oil is a paraffinic oil comprising a mixture of hydrotreated isoparaffinic hydrocarbons and naphthenic hydrocarbons. However, as evidenced by Petry et al. (2017), mineral oil is a mixture of predominantly saturated hydrocarbons that includes straight-chain, branched (i.e. isoparaffins), and ring structures (i.e. naphthenic hydrocarbons) with carbon chain lengths greater than C16 [Abstract] (reads on instant claim 9). Mineral oils are manufactured from crude oils in various refining steps including catalytic hydrogenation (i.e. hydrotreating) [Introduction]. CN’383 teaches an embodiment of the insecticide wherein the solvent is present in the amount of 30.91% to 94.09% by weight (100 - 0.07 - 0.84 - 5 = 94.09; 100 - 29.16 - 29.92 - 10 = 30.91) [0042]. Since CN’383 teaches mineral/paraffinic oil as a suitable solvent, it would be obvious to include this solvent in the amount that solvents are taught to be suitable in. The disclosed range of 30.91% to 94.09% overlaps with and makes obvious the claimed ranges of instant claims 1, 8, and 22. MPEP 2144.05.
Regarding oil-soluble surfactant: C8-C10 fatty alcohols are oil-soluble, nonionic surfactants, thus the disclosure of 0.1% to 5% by weight of defoamer comprising C8-C10 fatty alcohols [claim 7] overlaps with and makes obvious the claimed ranges of instant claims 1, 10-11 and 22. MPEP 2144.05.
Regarding fumed silicon oxide: As evidenced by Cabot, gaseous silica (i.e. fumed silica) is synthetic, amorphous silicon oxide [pg. 3 - What is Fumed Silica?]. Thus, the disclosure of 0.2% to 5% of thickener (i.e. rheology modifier) comprising gaseous silica overlaps with and makes obvious the claimed ranges of instant claims 1, 13-14, 16-17, and 22. MPEP 2144.05.
Claims 1, 4, 12, 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over CN105010383A (hereinafter CN’383, published 11/4/2015, cited on the 7/1/2024 IDS), as evidenced by Petry et al. (2017) and Cabot (2021, cited in the previous Office Action), as applied to claims 1 and 22 above, and further in view of Guerino et al. (US 2016/0008370 A1, published 1/14/2016), and further evidenced by Safic Alcan, Fumed Silica (published 4/26/2026).
The following rejections of claims 1, 4, and 18-22 will address only the recitations relating to intended use. The analysis of the structural limitations that have been previously made obvious will not be repeated herein.
Regarding claims 1, 4, and 18-22, Guerino is directed to the use of indoxacarb formulations for control of ectoparasites (reads on instant claim 4) on a domestic animal [Abstract]. The formulation of Guerino comprises of about 5% to 50% indoxacarb by weight [claim 1] and a veterinarily acceptable carrier including ingredients such as solvents, crystallization inhibitors, surfactants, oils, and tackifiers [0036]. The formulation may be an emulsion wherein the oil phase comprises of paraffin oil [0073-74]. The formulation may also include a non-ionic surfactant such as polyoxyethylene alkyl ether [0069] and a viscosity-increasing substance (i.e. rheology modifier) such as colloidal silica (reads on fumed silica) [0076]. As evidenced by Safic Alcan, fumed silica may be referred to as colloidal silicon dioxide in major pharmacopoeias used in pharmaceutical manufacturing, and is considered an established, well-known excipient [pg. 7, Applications in pharmaceuticals].
Guerino teaches that any appropriate domestic animal, including cattle (reads on instant claim 1), may be treated with the indoxacarb formulation [0048]. The formulation of Guerino is characterized as a “pour-on” formulation [0041] (reads on instant claims 1 and 22) that is applied to a localized region of skin on the animal [0040] (reads on instant claims 1 and 18). Guerino teaches that the indoxacarb diffuses beyond the localized region of topical application to provide ectoparasitic control over the entire or a significant portion of the animal’s body [0042] (reads on instant claim 18). Guerino further teaches that the formulation and method of treatment is suitable for control of ectoparasites including ticks [0021], mites [0020], lice [0022], fleas [0023], and horn flies [0019] (reads on instant claims 19-22). Based on the teachings of Guerino, a skilled artisan would recognize that the composition taught by CN’383 could be administered topically to cattle and be effective at controlling the disclosed species of ectoparasites, as both compositions are capable of pour-on administration and comprise the same active ingredients.
Regarding claim 12, CN’383 teaches that the insecticidal composition may include a defoamer comprising C8-C10 fatty alcohols [claim 7]. CN’383 does not explicitly describe C8-C10 fatty alcohols as nonionic surfactants, however, a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. MPEP 2112.01. CN’383 further teaches that insecticidal composition may comprise of nonionic surfactants [0048].
CN’383 does not explicitly teach polyoxyethylene alkyl ether. Guerino teaches polyoxyethylene alkyl ether as a suitable nonionic surfactant for a pour-on pesticidal indoxacarb formulation [0069]. The selection of a known material based on its suitability for its intended use is prima facie obvious. MPEP 2144.07. Thus, it would be obvious to modify the teachings of CN’383 with that of Guerino and select polyoxyethylene alkyl ether as a nonionic surfactant for inclusion in the composition taught by CN’383 to arrive at the instantly claimed invention.
Furthermore, Guerino teaches that poloxyethylene alkyl ethers may serve an additional function in an insecticidal composition as a crystallization inhibitor [0044]. As previously discussed, a skilled artisan armed with the teachings of Guerino would recognize that the composition made obvious by CN’383 could be adapted for other applications, such as the instantly claimed pour-on formulation for treating ectoparasites on cattle. Guerino teaches that the inclusion of a crystallization inhibitor in the insecticidal formulation minimizes precipitation of indoxacarb crystals on an animal’s hairs and helps prevents a sticky appearance after application [0043]. Thus, one of ordinary skill would be motivated to include a crystallization inhibitor such as polyoxyethylene alkyl ether in the formulation in order to adapt the composition for wider commercial applications, such as veterinary use, and improve the formulation’s persistency on the animal and help maintain the cosmetic appearance of the animal after application of the pesticide [0043].
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over CN105010383A (hereinafter CN’383, published 11/4/2015, cited on the 7/1/2024 IDS), as evidenced Petry et al. (2017), and Cabot (2021, cited in the previous Office Action), as applied to claim 1 above, and further in view of Renkert (2021) and further evidenced by UDSA’s Technical Evaluation Report of Mineral Oil (hereinafter USDA, published 2021, cited in the previous Office Action).
Regarding claim 5-7, these claims recite limitations drawn to the paraffin content of the paraffinic oil of the claimed formulation. CN’383 teaches the use of a mineral/paraffinic oil, but does not explicitly disclose the paraffin content of the oil used in the insecticidal composition. Renkert, a manufacturer of specialty oils, teaches that its product, Renoil PSO-70, is a paraffinic, white mineral oil with an unsulfonated residue content (i.e. purity) of 99% [pg. 5]. This value overlaps with and makes obvious the paraffin content claimed in instant claims 5-7. MPEP 2144.05. Renkert does not explicitly state the ratio of paraffins to naphthenic hydrocarbons in Renoil PSO-70. However, USDA teaches that during the refining process of mineral oils, aromatic compounds (i.e. naphthenic hydrocarbons) are reduced to trace levels [pg. 8]. Thus, after the completion of the refining process, the primary component of mineral oils are paraffins [pg. 8]. Under BRI, trace levels can be interpreted to mean nearly undetectable levels. Thus, one can reasonably conclude that Renoil PSO-70 has a paraffin content of about 99%. Renkert further teaches that Renoil PSO-70 is an ideal adjuvant for use with pesticidal substances [pg. 6]. The selection of a known material based on its suitability for its intended use is prima facie obvious. MPEP 2144.07. Thus, it would be obvious to one of ordinary skill to select Renoil PSO-70 for use in the claimed composition, as it is a commercially available option taught to be suitable for pesticides.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over CN105010383A (hereinafter CN’383, published 11/4/2015, cited on the 7/1/2024 IDS), as evidenced by Petry et al. (2017), and further in view of Cabot (2021, cited in the previous Office Action), as applied to claims 1 and 13-14 above.
Regarding claim 15, CN’383 does not explicitly teach that the fumed silica of the indoxacarb composition is hydrophilic. Cabot teaches that fumed silica may be hydrophobic or hydrophilic [pg. 3, Figure 2], and that both hydrophobic and hydrophilic fumed silicas are suitable for use in oil dispersions [pg. 7, Product Selection Guide]. Cabot further teaches that fumed silicas function as rheology modifiers/thickeners of liquids [pg. 5, Anti-settling (Suspension)], and also help promote a consistent concentration of active ingredients during pesticide application by inhibiting the agglomeration and settling of active ingredients [pg. 5, Fumed Silica for Water- and Oil-based Dispersion]. It would be obvious to a skilled artisan to select hydrophilic fumed silica, as one of two available choices, for its art-recognized suitability for its intended purpose. MPEP 2144.07.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over CN105010383A (hereinafter CN’383, published 11/4/2015, cited on the 7/1/2024 IDS), as evidenced Petry et al. (2017), and Cabot (2021, cited in the previous Office Action), as applied to claim 1 above, and further in view of Fuchs et al. (US 10,864,195, patented 12/15/2020, cited in the previous Office Action).
Regarding claim 24, this claim recites a kit comprising the composition of claim 1 and instructions for pouring the formulation onto the external skin of cattle. The composition of claim 1 has been previously made obvious, said discussion/analysis will not be repeated herein. The instant claim requires no additional structure beyond the written instructions.
Fuchs teaches a localized topical pesticide formulation (i.e. pour-on) comprising an isoxazoline and pharmaceutically acceptable carrier [Abstract]. The formulation of Fuchs is for controlling and preventing parasite infestation in domestic animals, including cattle [col. 1 lines 26-38]. Fuchs further teaches a kit comprising the formulation and additional components such as instructions for administering the composition and an apparatus for administration [col. 23, lines 26-39]. It would have been obvious to one of ordinary skill in the art to combine the teachings of CN’383 and Fuchs to include instructions in a kit comprising the composition of instant invention. One of ordinary skill in the art would have been motivated to utilize a kit in order to package the formulation, provide instructions for a consumer on how to use the product, and facilitate ease of application [col. 23, lines 26-39].
Furthermore, regarding claim limitations drawn to printed matter, “[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” In re Ngai, 367 F.3d 1336, 70 USPQ2d 1862 (Fed. Cir. 2004). See MPEP 2112.01(III) and MPEP 2111.05. If the printed matter and product do not depend upon each other, no functional relationship exists. For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. Id. In the instant case, Applicant has not indicated that some unobvious functional relationship exists between the product and the instructions, thus, the printed matter is owed no patentable weight.
Conclusion
No claims are allowed.
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.
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/AMANDA LYNN CHI/ Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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