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 Amendment
The amendment filed 07/08/2026 has been entered. Claims 1, 2, 16, 24, 26, 48 and 59 were amended, claims 3-15, 17-23, 25, 27-47, 51-53, 55-58 and 60-83 were canceled, and claims 84-93 were newly added. No new matter was added. Claims 1-2, 16, 24, 26, 48-50, 54, 59 and 84-93 are currently pending for the examination.
The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicant’s amendment changing the scope of invention necessitates a new ground of rejection as followings:
Claim Rejections - 35 USC § 102
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 16, 24, 26, 48-50, 54, 59 and 84-93 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Bowman et al. (US 2013/0231380 A1, hereinafter “Bowman”).
Claim interpretation: Statements of intended us or purpose in a product claim do not limit the scope of the claim under 35 U.S.C. 102(a)(1) or (a)(2). Accordingly, independent claims 1, 86, and 90 are construed to encompass an oral or consumable composition comprising an amount of fipronil of not greater than about 0.0025% by weight of the composition or not greater than about 0.005% by weight of the composition.
Bowman teaches a meal bait composition comprising a combination of an insecticide such as at least 0.001% fipronil and a rodenticide (entire documents; abstract; para. [0009], [0013] and claims 77-90) that is useful for killing fleas and ticks (para. [0012] and claims 92-113). Particularly claims 79 discloses that the amount of fipronil is at least 0.0025% whereas claim 90 discloses at least 0.004% of fipronil in said composition. The reference further teaches that the bait composition includes at least one feeding stimulant and optionally at least one attractant (para. [0026]); and that the suitable stimulants (which are also attractants) include “cereal grains, sugar and sugar products, honey, meat and meat products including blood and fat, dairy products, eggs and egg product including shell and yolk, starch, whole and processed nuts, and vegetable oils…” (para. [0028]).
Regarding claims 1, 24, 26, 48–50, 54, 59, 85-86, 88–90 and 92-93:
The transitional term “comprising” is an open-ended term that does not exclude additional ingredients or elements not recited in the claim. Accordingly, the prior art composition comprising at least 0.0001% fipronil, a rodenticide, and at least one feeding stimulant falls within the scope of the claimed composition.
Additionally, the recitation in the preamble of “a vector control” is not limiting. A statement of intended use or purpose in a preamble is not given patentable weight unless it positively recites a structural limitation. In the present case, the body of the claim recites a complete invention, and the preamble term “vector” does not impart any structural limitation or otherwise define the claimed invention. Therefore, the preamble is not limiting and is of no significance to claim construction. See *Pitney Bowes, Inc. v. Hewlett-Packard Co.*, 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999); MPEP § 2111.02.
Regarding the asserted functional limitations of fipronil in decreasing “the fitness of a vector capable of transmitting a pathogen,” decreasing “said fitness of said vector upon ingestion,” decreasing “the fitness of said vector relative to said untreated vector,” or “controls ticks parasitizing said deer” in claims 1, 24, 85-86, 90 and 93, such recitations are considered non-limiting because they merely recite an intended result or function of the claimed composition. The prior art composition comprising 0.001% or 0.0025% fipronil is identical or substantially identical to the claimed composition; therefore, any alleged properties or functions of the claimed composition are presumed to be inherent in the prior art composition. See also the instant specification, page 12, line 26 through page 14, line 12.
“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” *Atlas Powder Co. v. IRECO Inc.*, 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the recitation of a new use, new function, or unknown property inherently present in the prior art does not necessarily render the claim patentable. *In re Best*, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In *In re Crish*, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that a claimed promoter sequence obtained by sequencing a prior art plasmid that had not previously been sequenced was anticipated by the prior art plasmid, which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that “just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.” Id. See also MPEP § 2112.01 regarding inherency and product-by-process claims, and MPEP § 2141.02 regarding inherency and rejections under 35 U.S.C. 103.
Regarding the limitations followed by the contingent clause “wherein,” specifically the (highlighted) phrases “formulated for oral delivery to a host of said vector,” “delivering said oral composition to a host of said vector,” “formulated for ingestion by said vector during blood-feeding on said host,” “formulated as a comestible composition for ingestion by said host,” “is formulated as feed for said host,” “a carrier palatable to a target said host and edible by said target host,” “consumption of not greater than 1 mg/kg of said fipronil by a host of a vector is effective to decrease the fitness of said vector relative to an untreated vector,” “said consumption occurs within 48 hours,” and/or “consumption of greater than 1 mg/kg of said fipronil by said host is effective to decrease the fitness of said vector relative to said untreated vector” in claims 1, 26, 48, 49, 86, 90, 92, and 93, such language does not particularly limit the claim to a specific structure. Accordingly, each of these clauses is determined to be non-limiting.
Therefore, the prior art composition comprising 0.001% fipronil, a rodenticide, and at least one feeding stimulant (e.g., cereal grains, sugar and sugar products, starch, whole and processed nuts, and vegetable oils), prepared in bait/feed form, anticipates the claimed composition because the prior art composition and the claimed invention are identical or substantially identical.
For example, the specification discloses that the term “feed” refers to “the combination of at least a purposely selected amount of an active agent and a purposely selected carrier for use as targeted vector control composition . . . . The feed should be both palatable to a target host and edible by the target host” (page 14, lines 18–21). The specification further discloses that, in one non-limiting example, “the carrier can comprise cornmeal or cornmeal formulation” (page 14, lines 6–11), and that “the feed can also include one or more attractants . . . [including] a plant-derived component, such as corn, corn products, corn meal, wheat, wheat products, oats, oat products, cereals, sugars, syrups, fruits, vegetables, seeds, nuts or the like” (page 14, lines 13–18). The feed may also “include more than one carrier and attractant, and can further include additional components, such as additives, preservatives, plasticizers, humectants, buffering agents or the like” (page 16, lines 5–7).
Similarly, Bowman teaches a meal bait composition comprising fipronil at 0.001%, 0.0025% or 0.004% and feeding stimulants such as cornmeal or corn starch. See paragraph [0039] and the Examples.
To satisfy an intended use limitation, where limiting, a prior art structure that is capable of performing the intended use as recited in the claim meets the claim. See, e.g., *In re Schreiber*, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997); see also MPEP §§ 2112–2112.02. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention rather than any distinct definition of a claim limitation, then the preamble is not considered a limitation and is of no significance to claim construction. See *Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC*, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020); *Pitney Bowes, Inc. v. Hewlett-Packard Co.*, 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999); *Rowe v. Dror*, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997).
Regarding claims 2, 16, 84, 86, 87, and 91:
Regarding the limitations “a vector comprises a tick,” “said host comprises an ungulate,” and “said ungulate comprises a deer,” recited in claims 2, 16, 84, 86, 87, and 91, such language similarly does not particularly limit the claim to a specific structure. Accordingly, each of these clauses is determined to be non-limiting. As discussed above, statements of purpose or intended use in a product/composition claim are non-limiting. Therefore, the prior art composition comprising identical or substantially identical ingredients in same concentration inherently possesses the claimed feature, thus clearly anticipates the claimed invention.
Regarding claim 54:
The reference teaches meal baits in the form of pellets, molded wax blocks, or compressed blocks. See paragraphs [0044]–[0051]. Therefore, the reference anticipates the claimed invention.
Claims 1-2, 16, 24, 26, 48-50, 54, 59 and 84-93 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Piorkowski et al. (US 2024/0206467)-effective filing date 12/22/2022, hereinafter “Piorkowski”.
Claim interpretation: Statements of intended us or purpose in a product claim do not limit the scope of the claim under 35 U.S.C. 102(a)(1) or (a)(2). Accordingly, independent claims 1, 86, and 90 are construed to encompass an oral or consumable composition comprising an amount of fipronil of not greater than about 0.0025% by weight of the composition or not greater than about 0.005% by weight of the composition.
Piorkowski teaches a composition comprising fipronil in an amount of from 0.0001 wt% to about 0.1 wt % wherein said composition is prepared in gel form with additional ingredients such as surfactant(s), stabilizer(s) and arthropod attractant(s) (see entire documents; abstract; para. [0010], claim 1), that is useful in killing arthropod including ticks (para. [0029]-[0030]). The reference teaches that at least one arthropod attract is selected from a sugar, a combination of sugars, corn syrup, and a combination (claim 2); at least one surfactant is selected from polyoxythylene (20 sorbitan monoplamitate, ethoxylated hydrogenated castor oil, glycereth-17 cocoate and a combination (claim 3), Table 1 shows 0.001% fipronil in said composition (Examples 1-3).
Regarding claims 1, 24, 26, 48–50, 54, 59, 85-86, 88–90 and 92-93:
It is determined that the recitation of “a vector control” in the preamble is not limiting. A statement of intended use or purpose in a preamble is not given patentable weight unless it positively recites a structural limitation. In the present case, the body of the claim recites a complete invention, and the preamble term “vector” does not impart any structural limitation or otherwise define the claimed invention. Therefore, the preamble is not limiting and is of no significance to claim construction. See *Pitney Bowes, Inc. v. Hewlett-Packard Co.*, 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999); MPEP § 2111.02.
Regarding the asserted functional limitations of fipronil in decreasing “the fitness of a vector capable of transmitting a pathogen,” decreasing “said fitness of said vector upon ingestion,” decreasing “the fitness of said vector relative to said untreated vector,” or “controls ticks parasitizing said deer” in claims 1, 24, 85-86, 90 and 93, such recitations are considered non-limiting because they merely recite an intended result or function of the claimed composition. The prior art composition comprising 0.001% fipronil is identical or substantially identical to the claimed composition; therefore, any alleged properties or functions of the claimed composition are presumed to be inherent in the prior art composition. See also the instant specification, page 12, line 26 through page 14, line 12.
“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” *Atlas Powder Co. v. IRECO Inc.*, 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the recitation of a new use, new function, or unknown property inherently present in the prior art does not necessarily render the claim patentable. *In re Best*, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In *In re Crish*, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that a claimed promoter sequence obtained by sequencing a prior art plasmid that had not previously been sequenced was anticipated by the prior art plasmid, which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that “just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.” Id. See also MPEP § 2112.01 regarding inherency and product-by-process claims, and MPEP § 2141.02 regarding inherency and rejections under 35 U.S.C. 103.
Regarding the limitations followed by the contingent clause “wherein,” specifically the (highlighted) phrases “formulated for oral delivery to a host of said vector,” “delivering said oral composition to a host of said vector,” “formulated for ingestion by said vector during blood-feeding on said host,” “formulated as a comestible composition for ingestion by said host,” “is formulated as feed for said host,” “a carrier palatable to a target said host and edible by said target host,” “consumption of not greater than 1 mg/kg of said fipronil by a host of a vector is effective to decrease the fitness of said vector relative to an untreated vector,” “said consumption occurs within 48 hours,” and/or “consumption of greater than 1 mg/kg of said fipronil by said host is effective to decrease the fitness of said vector relative to said untreated vector” in claims 1, 26, 48, 49, 86, 90, 92, and 93, such language does not particularly limit the claim to a specific structure. Accordingly, each of these clauses is determined to be non-limiting.
Therefore, the prior art gel composition comprising 0.001% fipronil, surfactant(s), stabilizer(s) and arthropod attractant (e.g., sugars and corn syrup) anticipates the claimed composition because the prior art composition and the claimed invention are identical or substantially identical.
For example, the specification discloses that the term “feed” refers to “the combination of at least a purposely selected amount of an active agent and a purposely selected carrier for use as targeted vector control composition . . . . The feed should be both palatable to a target host and edible by the target host” (page 14, lines 18–21). The specification further discloses that, in one non-limiting example, “the carrier can comprise cornmeal or cornmeal formulation” (page 14, lines 6–11), and that “the feed can also include one or more attractants . . . [including] a plant-derived component, such as corn, corn products, corn meal, wheat, wheat products, oats, oat products, cereals, sugars, syrups, fruits, vegetables, seeds, nuts or the like” (page 14, lines 13–18). The feed may also “include more than one carrier and attractant, and can further include additional components, such as additives, preservatives, plasticizers, humectants, buffering agents or the like” (page 16, lines 5–7).
Similarly, Piorkowski teaches a composition comprising fipronil at 0.001%, surfactant(s), stabilizer(s) and food-based attractant (e.g., sugars).
To satisfy an intended use limitation, where limiting, a prior art structure that is capable of performing the intended use as recited in the claim meets the claim. See, e.g., *In re Schreiber*, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997); see also MPEP §§ 2112–2112.02. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention rather than any distinct definition of a claim limitation, then the preamble is not considered a limitation and is of no significance to claim construction. See *Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC*, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020); *Pitney Bowes, Inc. v. Hewlett-Packard Co.*, 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999); *Rowe v. Dror*, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997).
Regarding claims 2, 16, 84, 86, 87, and 91:
Regarding the limitations “a vector comprises a tick,” “said host comprises an ungulate,” and “said ungulate comprises a deer,” recited in claims 2, 16, 84, 86, 87, and 91, such language similarly does not particularly limit the claim to a specific structure. Accordingly, each of these clauses is determined to be non-limiting. As discussed above, statements of purpose or intended use in a product/composition claim are non-limiting. Therefore, the prior art composition comprising identical or substantially identical ingredients in same concentration inherently possesses the claimed feature, thus clearly anticipates the claimed invention.
Regarding claim 54:
The instant specification discloses a particular embodiment where the composition is prepared in capsule form (Figures 4-6, 9).
Similarly, the reference teaches said composition can be delivered in the form of a capsule (para. [0083], [0107]; claim 18). Therefore, the reference anticipates the claimed invention.
Claims 86-88 and 90-93 is/are rejected under 35 U.S.C. 102 (a)(1) or (a)(2) as being anticipated by Poche et al. (“Efficacy of a low dose fipronil bait against blacklegged tick (Ixodes scapularis) larvae feeding on white-footed mice (Peromyscus leucopus) under laboratory conditions”, Parasites & Vectors, 2020, 13:391, pp. 1-15, cited in IDS filed 02/19/2026, hereinafter Poche’20) or Poche et al. (“Efficacy of a low dose fipronil bait against blacklegged tick (Ixodes scapularis) larvae blood-feeding on white-footed mice (Peromyscus leucopus) under laboratory conditions”, Parasites & Vectors, 2021, 14(459), pp. 1-18, cited in IDS filed 02/19/2026, hereinafter Poche’21).
Claim interpretation: Statements of intended us or purpose in a product claim do not limit the scope of the claim under 35 U.S.C. 102(a)(1) or (a)(2). Accordingly, independent claims 86 and 90 are construed to encompass an oral or consumable composition comprising an amount of fipronil of not greater than about 0.005% by weight of the composition.
Poche ’20 discloses a bait composition comprised of a low dose (0.005% w/w) of fipronil (see entire documents, particularly abstract, pages 4-11, Figure 1, Results and Conclusion). In a laboratory study, white-footed mice (the primary pathogen reservoir/host) were orally given this bait and then exposed to blacklegged ticks (vector). The results demonstrate that the low-dose fipronil bait effectively controls blacklegged tick larvae blood-feeding on the treated mice and/or is effective in preventing larvae from successfully detaching from mice.
Similar to Poche’20 study discussed above, Poche ’21 also discloses a bait composition comprised of a low dose (0.005% w/w) of fipronil (see entire documents, particularly abstract, pages 2-14, Figure 1, Results and conclusion). In a laboratory study, white-footed mice (the primary pathogen reservoir/host) were orally given this bait and then exposed to blacklegged ticks (vector). The results demonstrate that the low-dose fipronil bait effectively controls blacklegged tick larvae blood-feeding on the treated mice and/or is effective in preventing larvae from successfully detaching from mice.
Regarding the asserted functional limitations of fipronil in decreasing “the fitness of a vector capable of transmitting a pathogen,” or decreasing “the fitness of said vector relative to said untreated vector,” in claims 86, 90 and 93, such recitations are considered non-limiting because they merely recite an intended result or function of the claimed composition. The prior art composition comprising 0.005% fipronil is identical or substantially identical to the claimed composition; therefore, any alleged properties or functions of the claimed composition are presumed to be inherent in the prior art composition. See also the instant specification, page 12, line 26 through page 14, line 12.
“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” *Atlas Powder Co. v. IRECO Inc.*, 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the recitation of a new use, new function, or unknown property inherently present in the prior art does not necessarily render the claim patentable. *In re Best*, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In *In re Crish*, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that a claimed promoter sequence obtained by sequencing a prior art plasmid that had not previously been sequenced was anticipated by the prior art plasmid, which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that “just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.” Id. See also MPEP § 2112.01 regarding inherency and product-by-process claims, and MPEP § 2141.02 regarding inherency and rejections under 35 U.S.C. 103.
Regarding the limitations “a host of said vector”, “said host comprises an ungulate,” and “said ungulate comprises a deer” recited in claims 86, 87, and 91, such language similarly does not particularly limit the claim to a specific structure. Accordingly, each of these clauses is determined to be non-limiting. As discussed above, statements of purpose or intended use in a product/composition claim are non-limiting. Therefore, the prior art composition comprising identical or substantially identical ingredients in same concentration inherently possesses the claimed feature, thus clearly anticipates the claimed invention.
Regarding the limitations followed by the contingent clause “wherein,” specifically the (highlighted) phrases “consumption of not greater than 1 mg/kg of said fipronil by a host of a vector is effective to decrease the fitness of said vector relative to an untreated vector,” “said consumption occurs within 48 hours,” or “consumption of greater than 1 mg/kg of said fipronil by said host is effective to decrease the fitness of said vector relative to said untreated vector” in claims 90, 92, and 93, such language does not particularly limit the claim to a specific structure. Accordingly, each of these clauses is determined to be non-limiting. Therefore, the prior art bait composition comprising 0.005% fipronil and paraffin wax in Poche’20 or Poche’21 anticipates the claimed composition because the prior art composition and the claimed invention are identical or substantially identical.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Even if assuming arguendo that the bait (oral) composition comprising 0.005% fipronil and paraffin wax disclosed in Poche’20 or Poche’21-which is intended to control ticks population-is not identical or substantially identical to the instant claimed invention described in claims 86-88 and 90-93, making of such formulation of composition containing 0.005% fipronil and other excipients that is inherently consumable or palatable to the ungulate would nevertheless have been obvious under the meaning of 103, for the following reasons:
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.
Claims 86–88 and 90–93 are rejected under 35 U.S.C. § 103 as being unpatentable over Poche’20 (“Efficacy of a low dose fipronil bait against blacklegged tick (Ixodes scapularis) larvae feeding on white-footed mice (Peromyscus leucopus) under laboratory conditions,” Parasites & Vectors, 2020, 13:391, pp. 1–15, cited in IDS filed 02/19/2026, hereinafter Poche’20) or Poche’21 (“Efficacy of a low dose fipronil bait against blacklegged tick (Ixodes scapularis) larvae blood-feeding on white-footed mice (Peromyscus leucopus) under laboratory conditions,” Parasites & Vectors, 2021, 14(459), pp. 1–18, cited in IDS filed 02/19/2026, hereinafter Poche’21), in view of Borchert et al. (U.S. Patent No. 7,943,160 B2, hereinafter Borchert).
The teachings of Poche’20 or Poche’21 have been discussed above in the rejection under 35 U.S.C. § 102.
The instant specification discloses that the term “feed” refers to “the combination of at least a purposely selected amount of an active agent and a purposely selected carrier for use as targeted vector control composition . . . . The feed should be both palatable to a target host and edible by the target host” (page 14, lines 18–21). The specification further discloses that, in one non-limiting example, “the carrier can comprise cornmeal or cornmeal formulation” (page 14, lines 6–11), and that “the feed can also include one or more attractants . . . [including] a plant-derived component, such as corn, corn products, corn meal, wheat, wheat products, oats, oat products, cereals, sugars, syrups, fruits, vegetables, seeds, nuts or the like” (page 14, lines 13–18). The feed may also “include more than one carrier and attractant, and can further include additional components, such as additives, preservatives, plasticizers, humectants, buffering agents or the like” (page 16, lines 5–7).
Borchert teaches a bait composition comprising fipronil that is useful in preventing ticks from feeding to repletion on fed mice (col. 1, lines 27–31; col. 3, line 45 through col. 5, line 40; Tables 1–3). Borchert further teaches that fipronil diets may be formulated at 0.001% to 1.5% by weight (col. 4, lines 24–28). Borchert also teaches that the bait composition is used to simultaneously control rodents and at least one insect pest, including ticks, by orally administering to the rodent a bait composition comprising fipronil (abstract).
As a specific embodiment, Borchert discloses a bait composition comprising 485 ppm fipronil using inert ingredients such as rolled oats, corn meal, powdered sugar, and corn oil (Table 3). Borchert further teaches that various inert ingredients may be used to formulate the bait composition, including grains such as corn, corn meal, oats, barley, peanuts, wheat, and grain flours, which may be mixed with powdered sugar and vegetable or mineral oil (col. 1, line 51 through col. 2, line 5). Borchert additionally teaches that certain embodiments relate to the control of larvae, subadult, and adult ticks on rodents with insecticides for simultaneous control of ectoparasites and their mammalian hosts (col. 1, lines 15–26), and to simultaneous control of rodents and at least one insect pest using the same bait composition (col. 2, line 64 through col. 3, line 10; col. 5, lines 42–45).
Borchert further describes mammalian hosts as including research laboratory animals, companion animals, and farm animals (col. 5, lines 46–61). Borchert therefore teaches or suggests a fipronil bait composition formulated with non-toxic carriers and attractants suitable for oral consumption by a mammal.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the bait composition of Poche’20 or Poche’21 in view of Borchert to provide a feed or bait formulation that is (inherently) palatable and consumable, because Borchert teaches that fipronil may be incorporated into orally consumable bait compositions using various carriers, grains, sugars, and oils, and because selecting an appropriate carrier and attractant to improve palatability and facilitate consumption would have been a predictable and routine design choice. Accordingly, claims 86–88 and 90–93 would have been obvious over Poche’20 or Poche’21 in view of Borchert.
Claim(s) 89 is/are rejected under 35 U.S.C. 103 as being unpatentable over Poche’20 (“Efficacy of a low dose fipronil bait against blacklegged tick (Ixodes scapularis) larvae feeding on white-footed mice (Peromyscus leucopus) under laboratory conditions”, Parasites & Vectors, 2020, 13:391, pp. 1-15, cited in IDS filed 02/19/2026, hereinafter Poche’20) or Poche’21 (“Efficacy of a low dose fipronil bait against blacklegged tick (Ixodes scapularis) larvae blood-feeding on white-footed mice (Peromyscus leucopus) under laboratory conditions”, Parasites & Vectors, 2021, 14(459), pp. 1-18, cited in IDS filed 02/19/2026, hereinafter Poche’21) as applied to claims 86-88 and 90-93 above, in view of in view of Borchert et al. (U.S. Patent No. 7,943,160 B2, hereinafter Borchert), and further in view of Bowman et al. (US 2013/0231380 A1, hereinafter “Bowman”).
The modified teaching of Poche’20 or Poche’21 has been discussed above. However, the modified teaching of Poche’20 or Poche’21 is silent as to the limitation “not greater than about 0.0025% by weight of said composition” recited in claim 89.
Bowman has been discussed in the above 35 U.S.C. § 102 rejection. Bowman discloses an insecticidal composition comprising various amounts of fipronil, including 0.0001% fipronil, 0.001% fipronil, 0.0025% fipronil, and 0.0040% fipronil (see claims 77, 79–80).
As discussed above, Bowman teaches that the amount of fipronil may be varied within the composition, and thus teaches or suggests the claimed concentration of “not greater than about 0.0025% by weight of said composition.” One of ordinary skill in the art would have recognized the amount of fipronil as a result-effective variable, and would have been motivated to select and optimize the concentration to achieve the desired insecticidal or rodenticidal effect. The selection of an optimum or workable range of a known variable is considered routine optimization and within the ordinary skill of the art. See MPEP § 2144.05; In re Boesch, 617 F.2d 272, 276 (CCPA 1980) (“Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.”).
Accordingly, claim 89 would have been obvious over Poche’20 or Poche’21 in view of Borchert et al. (U.S. Patent No. 7,943,160 B2, hereinafter Borchert), and further in view of Bowman.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 16, 24, 26, 48-50, 54, 59 and 84-93 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9, 15-20, 23-53, 57-58, 61 and 63-86 of copending Application No. 19645936(reference application) in view of Poche et al. (“Efficacy of a low dose fipronil bait against blacklegged tick (Ixodes scapularis) larvae feeding on white-footed mice (Peromyscus leucopus) under laboratory conditions”, Parasites & Vectors, 2020, 13:391, pp. 1-15, cited in IDS filed 02/19/2026, hereinafter Poche’20) and/or Bowman et al. (US 2013/0231380 A1, hereinafter “Bowman”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the both compositions disclosed in the prior art and the instant claims are drawn to a vector control composition comprising an active agent, namely a low dose of fipronil (which reads on a “pyrazole acaricide”, “a phenylpyrazole acaricide”), wherein the active is formulated for oral delivery.
Even though claims in the copending application do not identify a targeted host as ungulate, namely deer, such recitation does not particularly limit the claim to a specific structure. Accordingly, each of these clauses recited in the instant claims is determined to be non-limiting. As discussed above, statements of purpose or intended use in a product/composition claim are non-limiting. Therefore, the copending application directed to identical or substantially identical composition anticipates the claimed invention, thus makes obvious.
Even though the referenced claims 1 and 68-86 do not recite the specific amounts of fipronil, namely “not greater than about 0.0025% by weight of said composition” or “not greater than about 0.005% by weight of said composition”, such determination would have been obvious in view Poche’20 that discloses a bait composition comprised of a low dose (0.005% w/w) of acaricide such as fipronil (see entire documents, particularly abstract, pages 2-14, Figure 1, Results and conclusion) or Bowman that discloses various insecticidal/rodenticidal compositions comprising various amounts of fipronil, particularly, 0.0001%, 0.001%, 0.0025% or 0.004%. One of ordinary skill in the art would have recognized the amount of fipronil as a result-effective variable, and would have been motivated to select and optimize the concentration to achieve the desired insecticidal or rodenticidal effect. The selection of an optimum or workable range of a known variable is considered routine optimization and within the ordinary skill of the art. See MPEP § 2144.05; In re Boesch, 617 F.2d 272, 276 (CCPA 1980) (“Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.”).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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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/BRIAN-YONG S KWON/ Supervisory Patent Examiner, Art Unit 1613
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