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 .
All previous claim rejections made under 35 U.S.C 102 as indicated in the Office action dated April 24, 2026 have been withdrawn in view of applicant’s amendment made a) to claim 1 which requires “a lethal concentration of one or more second generation anticoagulant rodenticides” and b) to claim 2 which requires a third generation anticoagulant rodenticide.
New rejections have been made to address the amended claims.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-15) in the reply filed on July 24, 2026 is acknowledged. The traversal is on the ground(s) that the method of Group II “cannot be practiced with any known bait avail known in the art”. This is not found persuasive because, as indicated in the restriction requirement, the process of using the rodenticide product of claim 1, i.e., killing rodents, can be practiced with any other known baits.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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 and 3-15 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Endepols (US 20180027813 A1, published on February 1, 2018, cited in IDS) as evidenced by applicant’s own disclosure.
The present claim 1 is directed to a rodenticide bait composition, the composition comprising; a lethal concentration of one or more second generation anticoagulant rodenticides or third generation anticoagulant rodenticides; and a sublethal concentration of one or more calciferols, wherein the sublethal concentration achieves no more than 10% mortality in ad libitum feeding.
Applicant defines the term “a sublethal concentration” of the one or more calciferols as less than 750 mg/kg of calciferol, or 0.075 wt % of the total weight of the bait. See specification as filed, p. 7, line 31 – p. 8, line 13.
Endepols discloses a rodenticide bait comprising a first-generation anticoagulant rodenticides and sublethal concentration of ergocalciferol or cholecalciferol; the reference teaches that the composition provides a controlling effect against resistance to a second-generation anticoagulant. See [0001, 0008]. Endepols teaches it is well known in the art that calciferols in low doses cause bait shyness after one feeding and do not represent a risk for predators feeding off the rats or mice. See [0008].
Example 1 contains coumatetrayl (375 mg/kg) and cholecalciferol (100 mg/kg), which the reference teaches is an ineffective amount per se. See [0039]. The reference teaches that the addition of the small amount of cholecalciferol which is not effective per se to an anticoagulant rodenticide of the first generation produces a control agent which acts against resistant rat strains, a delayed-release of the active agent and also reduces environmental risks associated with the use of the active ingredients. See [0039].
Regarding claims 1, 3, 4 and 10-12, Endepols discloses an embodiment comprising between 20- 750 mg/kg warfarin (first-generation hydroxycoumarin) or 10-50 mg/kg second generation hydroxycoumarin such as bromadiolone, difenacoum, brodifacoum, etc. See [0035]. The reference teaches the limitations claims 5-9 in Example 1.
Regarding claims 13, applicant defines an LC50 mice and/or rats of 2.0 mg/kg bw or less includes “most preferably of (in mg/kg bw) 1.0 or less” and also teaches that the second generation anticoagulants, specifically including brodifacoum, “shows the lowest LD50 and have the highest tissue persistence in rodents and non-target animals”. See the present specification, p. 9, the first full paragraph and p. 10, the first full paragraph. Based on applicant’s own disclosure, brodifacoum must be among the anticoagulants having an LC50 of 2.0 mg/kg bw or less.
Regarding claim 14, applicant discloses that the half-life of brodifacoum is 307.4 days in liver. See p. 2, second full paragraph.
Regarding claim 15, Endepols discloses feed baits in paste or wax blocks. See [0043].
Claims 1, 3, 5, 6, 13 and 14 are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by Mainx et al. (US 20100292191 A1, published on November 18, 2010, cited in IDS) (“Mainx” hereunder) as evidenced by Difenacoum (AgriFutures Chicken Meat, 30 October 2023).
Mainx discloses a rodenticide composition comprising difenacoum, a second generation anticoagulant rodenticide, at 0.005 % in lethal dose and cholecalciferol 0.01 %. See [047]; the present claims 1, 3, 5.
Regarding claims 13 and 14, LD50 of difenacoum in mouse is 0.8 mg/kg, and the half-life of difenacoum is 120 days in rat liver. See Acute Toxicity; Mode of Action, second paragraph.
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Endepols as applied to claims 1 and 3-15 as above, and further in view of Swaine (US 4783481 A, published on November 8, 1998).
Endepols fails to teach using third generation anticoagulant rodenticides.
Swaine teaches the trans stereoisomer of brodifacoum is metabolized more rapidly than the "cis" stereoisomer in tissues of non-target and non-rodent species and that this trans stereoisomer reduces the risk of poisoning of these non-target species.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the teachings of Endepols to incorporate the trans isomer of brodifacoum into the rodenticide composition as motivated by Swaine; the skilled artisan would have been motivated to do so, as the latter teaches the trans stereoisomer of bodifacoum is useful in reducing the risk of poisoning of non-target species. Since both references are directed to rodenticides comprising anticoagulants, the skilled artisan would have had a reasonable expectation of successfully combining the teachings of the references and producing a rodenticide composition that is safer for non-target animals.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Mainx and Difenacoum as applied to Claims 1, 3, 5, 6, 13 and 14 as above, and further in view of Swaine.
Mainx fails to teach using third generation anticoagulant rodenticides.
Swaine teaches the trans stereoisomer of brodifacoum is metabolized more rapidly than the "cis" stereoisomer in tissues of non-target and non-rodent species and that this trans stereoisomer reduces the risk of poisoning of these non-target species.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the teachings of Mainx and incorporate the trans isomer of brodifacoum as motivated by Swaine; the skilled artisan would have been motivated to do so, as the latter teaches the trans stereoisomer of bodifacoum is useful in reducing the risk of poisoning of non-target species. Since both references are directed to rodenticides comprising anticoagulants, the skilled artisan would have had a reasonable expectation of successfully combining the teachings of the references and producing a rodenticide composition that is safer for non-target animals.
Response to Arguments
Applicant’s arguments with respect to claims 1-15 have been considered but are moot in view of the new grounds of rejection as indicated above.
Applicant characterizes the teaching of Endepols on using the second generation anticoagulants as “the general listing of anticoagulant alternatives”. However, it is well settled in patent law, "[t]he use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." See In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)) A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component). Furthermore, “[a] known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." See In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994).
In this case, rodenticide compositions comprising a lethal-dose of second generation anticoagulant are plainly disclosed in the Endepol reference. It is implied that the compositions mentioned in the paragraph [0035] also contain a sublethal amount of a calciferol. This disclosure is not a mere generic list but constitutes an explicit teaching of known rodenticidal compositions.
Regarding Mainx, applicant points out that the reference teaches synergism through the association of the anticoagulant with calciferol and lacks teachings on the mortality rate of the cholecalciferol used in the prior art invention. However, an old product does not become patentable upon the discovery of a new proper. See MPEP 2112, I. It is well known, "the 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 claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In this case, the low mortality rate of the sublethal amount of the calciferol as recited in the present claim 1 is merely a feature of the invention which naturally flows from the prior art composition which comprises the same sublethal amount (less than 750 mg/kg) of the same calciferol. The limitation does not render the same composition novel or unobvious.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GINA JUSTICE whose telephone number is (571)272-8605. The examiner can normally be reached M-F 9:00 AM - 5 PM.
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/GINA C JUSTICE/Primary Examiner, Art Unit 1617
