Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Per Applicant’s amendment to the claims, submitted on 12/22/2025, claims 1, 33-35, 38, 45-46, 48, 54, 56, 60, 62, 66, 68 are amended, claims 43-44 and 52-53 are canceled, and claims 76-79 are newly added. Currently, claims 1, 33-38, 45-51, and 54-79 are pending in the instant application.
Priority
In the previous Office Action, the claims of the instant application were indicated to be ineligible to claim priority to provisional applications 60/956,448 and 61/080,444. Applicant has amended claims 1, 46, 54, 60, and 66 to recite dosing ranges of 0.1 mg/kg to 50 mg/kg, in order to align with the originally submitted disclosure in the ‘448 application (specification [191]) and the ‘444 application (specification page 6, lines 17-23). However, this amendment is not sufficient to overcome the rejections (see Interference section below).
Affidavit
Applicant has submitted an Affidavit penned by Dr. Heike Williams. Dr. Williams has provided in the Affidavit that the instant invention was reduced to practice prior to June 27, 2007, thereby predating the previously cited Lahm (US Patent No. 11278533) prior art. The Affidavit provides that the instant invention was conceived at a date no later than 08 May 2007, as disclosed in the submitted Exhibit J. However, the submitted declaration is not sufficient to overcome the rejections (see Interference section below).
Interfering Subject Matter
The Lahm reference is a U.S. patent or U.S. patent application publication of a pending or patented application that claims the rejected invention. An affidavit or declaration is inappropriate under 37 CFR 1.131(a) when the reference is claiming interfering subject matter as defined in 37 CFR 41.203(a), see MPEP Chapter 2300. If the reference and this application are not commonly owned, the reference can only be overcome by establishing priority of invention through interference proceedings. See MPEP Chapter 2300 for information on initiating interference proceedings. If the reference and this application are commonly owned, the reference may be disqualified as prior art by an affidavit or declaration under 37 CFR 1.131(c). See MPEP § 718.
Applicant is further directed to MPEP 2301.03 Interfering Subject Matter:
“A claim of one inventor can be said to interfere with the claim of another inventor if they each have a patentable claim to the same invention. The Office practice and the case law define "same invention" to mean patentably indistinct inventions. See Case v. CPC Int’l, Inc., 730 F.2d 745, 750, 221 USPQ 196, 200 (Fed. Cir. 1984); Aelony v. Arni, 547 F.2d 566, 570, 192 USPQ 486, 489-90 (CCPA 1977); Nitz v. Ehrenreich, 537 F.2d 539, 543, 190 USPQ 413, 416 (CCPA 1976); and Ex parte Card, 1904 C.D. 383, 384-85 (Comm’r Pats. 1904). If the claimed invention of one party is patentably distinct from the claimed invention of the other party, then there is no interference-in-fact. See Nitz v. Ehrenreich, 537 F.2d 539, 543, 190 USPQ 413, 416 (CCPA 1976). 37 CFR 41.203(a) states the test in terms of the familiar concepts of obviousness and anticipation. See Tas v. Beachy, 626 Fed. App'x. 999, 1001 (Fed. Cir. 2015)(nonprecedential) (an interference exists if the subject matter of a claim of one party would, if prior art, have anticipated or rendered obvious the subject matter of a claim of the opposing party and vice versa); Eli Lilly & Co. v. Bd. of Regents of the Univ. of Wa., 334 F.3d 1264, 1269-70, 67 USPQ2d 1161, 1164-65 (Fed. Cir. 2003) (affirming the Office’s interpretive rule).”
The Lahm prior art contains interfering subject matter (i.e., obvious over the instant claims) and is an issued patent not commonly owned by Applicant. Accordingly, priority may only be established by interference proceedings, rather than by declaration.
Rejections of claims 1, 46, 54, 60, and 66 under pre-AIA 35 USC 135(b)(1) are hereby maintained. Firstly, Applicant has attempted to traverse the rejections over Lahm (previously referenced) by establishing: 1) priority date of the instant claims aligning with the disclosed provisional applications (i.e., the ‘444 and ‘448 applications), and 2) that the Applicant was first to invent the relevant subject matter (i.e., declaration by Dr. Williams). However, neither is sufficient to overcome the Lahm prior art because the reference at issue is an issued US patent claiming the same invention, or patentably indistinct inventions. See MPEP715(II):
An affidavit or declaration under 37 CFR 1.131(a) is not appropriate in the following situations:
…
(C) Where the reference U.S. patent or U.S. patent application publication claims interfering subject matter as defined in 37 CFR 41.203(a). See MPEP § 715.05 for a discussion of "interfering subject matter" and MPEP Chapter 2300.
And MPEP715.05:
A 37 CFR 1.131(a) affidavit is ineffective to overcome a United States patent or patent application publication, not only where there is a verbatim correspondence between claims of the application and of the patent, but also where there is no patentable distinction between the respective claims. In re Clark, 457 F.2d 1004, 173 USPQ 359 (CCPA 1972); In re Hidy, 303 F.2d 954, 133 USPQ 650 (CCPA 1962); In re Teague, 254 F.2d 145, 117 USPQ 284 (CCPA 1958); In re Ward, 236 F.2d 428, 111 USPQ 101 (CCPA 1956); In re Wagenhorst, 62 F.2d 831, 16 USPQ 126 (CCPA 1933).
If the application (or patent under reexamination) and the U.S. patent or patent application publication contain claims which are identical, or which are not patentably distinct, then the application and patent are claiming "interfering subject matter" as defined in 37 CFR 41.203(a).
As provided in 37 CFR 41.203(a), an interference exists if the subject matter of a claim of one party would, if prior art, have anticipated or rendered obvious the subject matter of a claim of the opposing party and vice versa. An applicant who is claiming an invention which is identical to, or obvious in view of, the invention as claimed in a domestic patent or patent application publication cannot employ an affidavit under 37 CFR 1.131(a) as a means for avoiding an interference with the reference. To allow an applicant to do so would result in the issuance of two patents to the same invention.
Applicant sets forth the intent to traverse the 135(b)(1) rejections on the basis that the claims of the instant application and the claims of the Lahm prior art are not “the same as, or for the same or substantially the same subject matter” as the claims of Lahm. Applicant contends that differences exist wherein the claims of Lahm directed to a method of protecting a mammal from fleas by oral administration, whereas the claims of the instant application are directed towards a method of reducing, eradicating, or controlling a tick infestation. Applicant further contends that the claims differ wherein (Remarks pages 11-12):
The compound of claim 1 is administered as a chewable dosage form
Claims 46, 54, and 60 recite the addition of at least one excipient or carrier
Claims 54 and 66, recite topical administration
Claim 66 recites the inclusion of at least one anthelmintic and at least one excipient or carrier
While Examiner respectfully acknowledges that the claims are not verbatim identical, it remains that the claims of Lahm are obviating of the claims of the instant application. MPEP715.05 states the following:
A 37 CFR 1.131(a) affidavit is ineffective to overcome a United States patent or patent application publication, not only where there is a verbatim correspondence between claims of the application and of the patent, but also where there is no patentable distinction between the respective claims. In re Clark, 457 F.2d 1004, 173 USPQ 359 (CCPA 1972); In re Hidy, 303 F.2d 954, 133 USPQ 650 (CCPA 1962); In re Teague, 254 F.2d 145, 117 USPQ 284 (CCPA 1958); In re Ward, 236 F.2d 428, 111 USPQ 101 (CCPA 1956); In re Wagenhorst, 62 F.2d 831, 16 USPQ 126 (CCPA 1933).
If the application (or patent under reexamination) and the U.S. patent or patent application publication contain claims which are identical, or which are not patentably distinct, then the application and patent are claiming "interfering subject matter" as defined in 37 CFR 41.203(a).
As provided in 37 CFR 41.203(a), an interference exists if the subject matter of a claim of one party would, if prior art, have anticipated or rendered obvious the subject matter of a claim of the opposing party and vice versa. An applicant who is claiming an invention which is identical to, or obvious in view of, the invention as claimed in a domestic patent or patent application publication cannot employ an affidavit under 37 CFR 1.131(a) as a means for avoiding an interference with the reference. To allow an applicant to do so would result in the issuance of two patents to the same invention.”
In the case of the instant application, the claims are held as being patentably indistinct (i.e., obvious) in view of the claims of Lahm per the outstanding rejections under 35 USC 103, and are qualifying for interfering subject matter. For this reason, Applicant’s arguments with regards to differences between the recitations of the claims cannot be considered as sufficient to overcome the rejections under 35 USC 135(b)(1).
Claim Rejections - 35 USC § 112 Second Paragraph – Withdrawn
Rejection of claim 45:
In light of Applicant’s amendment to the claims, the rejection is hereby withdrawn. Claim 45 has been amended to now recite once quarterly administration.
Claim Rejections - 35 USC § 112 Second Paragraph – Necessitated by Amendment
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.
Claim 79 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 79 is indefinite for reciting “the chewable dosage form” because a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claim. The instant claim provides improper antecedence because parent claim 46 does not recite a chewable dosage form.
Claim Rejections - 35 USC § 103 - Maintained
Claim(s) 1, 33-38, 45-51, and 54-75 is/are rejected under pre-AIA 35 U.S.C. 102 (e) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Lahm (US Patent 11278533).
Response to Applicant Remarks:
Applicant’s arguments are not persuasive, the rejections are hereby maintained. In Remarks pages 12-13 Applicant contends that Lahm is not qualified as prior art, and presents a supplemental declaration under 37 CFR 1.131 as support of establishing an earlier date of invention as applied to Lahm. However, the Affidavit submitted under 37 CFR 1.131 cannot be used to overcome the Lahm prior art because Lahm is an issued and published US patent. See the Interfering Subject Matter section above for further elaboration and relevant MPEP citations.
Applicant further provides alleged evidence of non-obviousness in the form of quotes of industry praise from various sources, including Agra-net (2015), The Times (2022), and GlobeNewswire (2015). Accompanying said quotes is a citation from Parasites & Vectors (2018) indicating the superior effects of fluralaner in dogs as compared to afoxolaner and Spinosad. While, these provided references are acknowledged by Examiner, they are not sufficient to overcome the outstanding rejections because: 1) these have no bearing on the rejections under pre-AIA 35 USC 135(b)(1) with regards to interfering subject matter and priority, and 2) each of the provided references and citations are dated to publications well beyond the claimed priority dates and date of invention.
Accordingly, the rejections in view of Lahm are hereby maintained.
For the purpose of clarity and record, a reiteration of the outstanding rejections will be provided below.
Reiterated Rejections:
Claim 1 recites a method for controlling a tick infestation of an animal, wherein the method comprises systemically administering an effective amount of about 1 mg/kg to about 50 mg/kg of a isoxazoline, a salt of the isoxazoline, or a solvate of the isoxazoline to the animal; wherein the isoxazoline corresponds to the following formula:
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Lahm teaches antiparasitic compounds and methods of use in protecting animals from parasitic pests by administering said compounds orally or by injection (Abstract)1. One such compound taught by Lahm is the following compound 3 (Table A, column 56):
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As can be seen from the above structure and table, compound 3 of Lahm is identical to the formula of the instant claim. Lahm further indicates exemplary tests carried out with said compounds in order to evaluate effectiveness in protection against cat fleas. Of particular interest is Test C which indicates the subcutaneous dosing of mice with compound 3 at 10 mg/kg (column 57 lines 62-67, column 58 lines 21-26)2.
While Lahm does not explicitly teach the use of said compounds on a tick infestation, it would have been obvious for a person of ordinary skill in the art to apply the aforementioned dosing to a tick infestation because Lahm indicates use of the compound for treating infestations by a number of different invertebrates, including ticks.
Lahm expressly indicates that the disclosed compounds are effective against ectoparasites, which include stable flies, ticks, and fleas of both dogs and cats (column 49, lines 35-41)3. Without evidence of the contrary, a person of ordinary skill in the art would have found it obvious to apply Lahm’s 10 mg/kg dosing regimen for cat flea infestations to a mammal with a tick infestation because there would be a reasonable expectation that such a treatment would be effective in treating a tick infestation as both parasites are considered as ectoparasites targeted by compound 3.
Claim 33 further limits the method of claim 1 wherein the animal is a canine or feline and the isoxazoline is administered at a frequency of at least about every 2 months.
As discussed previously, Lahm obviates the method of claim 1 wherein a compound identical to the recited isoxazoline is applied to control a tick infestation. Lahm further makes mention of preferential dosing interval of once per month (page column 56 lines 19-26)4, as well as express desire for dosing to both canines and felines (column 59, claim 5)5.
Claim 34 further limits the method of claim 1 wherein the animal is a canine and the isoxazoline is administered at a dose of from about 10 to about 50 mg/kg.
As discussed previously, Lahm teaches a dosing amount of 10 mg/kg, as well as treatment of canines.
Claim 35 further limits the method of claim 1 wherein the mammal is a canine and the isoxazoline of Formula 11-1 is administered at a dose of from 10-30 mg/kg.
As discussed previously, Lahm teaches a dosing amount of 10 mg/kg of a compound identical to Formula 11-1, as well as treatment of canines.
Claim 36 further limits the method of claim 1 wherein the tick infestation comprises at least one of a brown dog tick (Rhipicephalus sanguineus) infestation, a castor bean tick (Ixodes ricinus) infestation, an ornate cow tick (Dermacentor reticulates) infestation, an American dog tick (Dermacentor variabilis) infestation, a lone star tick (Amblyomma americanum) infestation, and a chicken tick (Ornithodoros moubata) infestation.
Lahm indicates that their disclosed compounds are effective for tick infestations, including at least Rhipicephalus sanguineus (brown dog tick) (column 50, lines 4-10)6.
Claim 37 further limits the method of claim 1 wherein the tick infestation comprises at least one of a brown dog tick (Rhipicephalus sanguineus) infestation, a castor bean tick (Ixodes ricinus) infestation, an ornate cow tick (Dermacentor reticulates) infestation, a lone star tick (Amblyomma americanum) infestation, and a chicken tick (Ornithodoros moubata) infestation.
Lahm indicates that their disclosed compounds are effective for tick infestations, including at least Rhipicephalus sanguineus (brown dog tick) (column 50, lines 4-10).
Claim 38 further limits the method of claim 1 wherein the dose is administered at a frequency of from about once every month to about once every 3 months.
As discussed in the rejection of claim 33, Lahm indicates a preferred dosing interval of once per month, which meets the limitation of the instant claim.
Claim 46 recites a method for reducing, eradicating, or inhibiting a tick infestation in a canine, comprising: orally administering to the canine in need thereof a composition comprising a compound of Formula 11-1, a salt thereof, or a solvate of any of the foregoing and at least one excipient or carrier wherein the administering comprises orally administering the composition to provide the canine with a dose of 10 mg/kg to 50 mg/kg body weight of the compound, the salt thereof, or the solvate of any of the foregoing.
Lahm teaches antiparasitic compounds and methods of use in protecting animals from parasitic pests by administering said compounds orally or by injection (Abstract)7. One such compound taught by Lahm is the following compound 3 (Table A, column 56):
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As can be seen from the above structure and table, compound 3 of Lahm is identical to the formula of the instant claim. Lahm further indicates exemplary tests carried out with said compounds in order to evaluate effectiveness in protection against cat fleas. Of particular interest is Test A which indicates the oral dosing of mice with compound 3 at 10 mg/kg (column 57 lines 33-43)8 by administering a composition comprising compound 3 solubilized in propylene glycol/glycerol (60:40)..
While Lahm does not explicitly teach the use of said compounds on a tick infestation in a canine, it would have been obvious for a person of ordinary skill in the art to apply the aforementioned dosing to a tick infestation because Lahm indicates use of the compound for treating infestations by a number of different invertebrates, including ticks, and it would be further obvious to apply such a treatment to dogs, because Lahm further indicates dogs as target animals for their application of the compound.
Lahm expressly indicates that the disclosed compounds are effective against ectoparasites, which include stable flies, ticks, and fleas of both dogs and cats (column 49, lines 35-41)9. Furthermore, Lahm expressly indicates the intent to treat canines as a target animal using the disclosed compounds (column 58, lines 66-67)10.
Without evidence of the contrary, a person of ordinary skill in the art would have found it obvious to apply Lahm’s 10 mg/kg oral dosing regimen for cat flea infestations to a canine with a tick infestation because there would be a reasonable expectation that such a treatment would be effective in treating said tick infestation, as both parasites are considered as ectoparasites targeted by compound 3.
Claim 48 further limits the method of claim 46 wherein the method comprises administering the composition at a frequency in the range of once every month to once every 3 months.
Lahm teaches a preferential dosing interval of once per month (page column 56 lines 19-26).
Claim 49 further limits the method of claim 46 wherein the composition does not comprise and is not administered in the form of microspheres, granules, or implants.
Lahm’s Test A comprises the administration of an oral formulation which does not comprise or is not administered in the form of microspheres, granules, or implants.
Claim 50 further limits the method of claim 46 wherein the tick infestation comprises at least one of a brown dog tick (Rhipicephalus sanguineus) infestation, a castor bean tick (Ixodes ricinus) infestation, an ornate cow tick (Dermacentor reticulates) infestation, an American dog tick (Dermacentor variabilis) infestation, a lone star tick (Amblyomma americanum) infestation, and a chicken tick (Ornithodoros moubata) infestation.
Lahm indicates that their disclosed compounds are effective for tick infestations, including at least Rhipicephalus sanguineus (brown dog tick) (column 50, lines 4-10).
Claim 51 further limits the method of claim 46 wherein the tick infestation comprises at least one of a brown dog tick (Rhipicephalus sanguineus) infestation, a castor bean tick (Ixodes ricinus) infestation, an ornate cow tick (Dermacentor reticulates) infestation, a lone star tick (Amblyomma americanum) infestation, and a chicken tick (Ornithodoros moubata) infestation.
Lahm indicates that their disclosed compounds are effective for tick infestations, including at least Rhipicephalus sanguineus (brown dog tick) (column 50, lines 4-10).
Claim 54 recites a method for reducing, eradicating, or inhibiting a tick infestation in a canine, comprising: administering to the canine in need thereof a composition comprising a compound of Formula 11-1, a salt thereof, or a solvate of any of the foregoing and least one excipient or carrier wherein the administering comprises administering the composition to provide the canine with a dose of 1 mg/kg to 50 mg/kg body weight of the compound, the salt thereof, or the solvate of any of the foregoing.
Lahm teaches antiparasitic compounds and methods of use in protecting animals from parasitic pests by administering said compounds orally or by injection (Abstract)11. One such compound taught by Lahm is the following compound 3 (Table A, column 56):
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As can be seen from the above structure and table, compound 3 of Lahm is identical to the formula of the instant claim. Lahm further indicates exemplary tests carried out with said compounds in order to evaluate effectiveness in protection against cat fleas. Of particular interest is Test A which indicates the oral dosing of mice with compound 3 at 10 mg/kg (column 57 lines 33-43)12 by administering a composition comprising compound 3 solubilized in propylene glycol/glycerol (60:40)..
While Lahm does not explicitly teach the use of said compounds on a tick infestation in a canine, it would have been obvious for a person of ordinary skill in the art to apply the aforementioned dosing to a tick infestation because Lahm indicates use of the compound for treating infestations by a number of different invertebrates, including ticks, and it would be further obvious to apply such a treatment to dogs, because Lahm further indicates dogs as target animals for their application of the compound.
Lahm expressly indicates that the disclosed compounds are effective against ectoparasites, which include stable flies, ticks, and fleas of both dogs and cats (column 49, lines 35-41)13. Furthermore, Lahm expressly indicates the intent to treat canines as a target animal using the disclosed compounds (column 58, lines 66-67)14.
Without evidence of the contrary, a person of ordinary skill in the art would have found it obvious to apply Lahm’s 10 mg/kg oral dosing regimen for cat flea infestations to a canine with a tick infestation because there would be a reasonable expectation that such a treatment would be effective in treating said tick infestation, as both parasites are considered as ectoparasites targeted by compound 3.
Claim 56 further limits the method of claim 54 wherein the composition is administered in the range of once every 2 months to once every 3 months.
While Lahm does not explicitly teach a dosing regimen in the range of once every 2 months to once every 3 months, Lahm does make the suggestion of dosing in a range of about weekly to about once every 6 months (column 56, lines 19-26), indicating acceptable variation in dosing intervals. While the such a range does not outright obviate the limitation of the instant claim, the use of such a dosing regimen would still remain obvious to a person of ordinary skill in the art per the principle of routine optimization. Lahm obviates a method of treating tick infestations by administration of a composition comprising a compound of Formula 11-1, and at the same time makes the suggestion of multiple administration intervals of preferably one month, or weekly to every six months. A skilled artisan would have motivation to find the optimal dosing interval through experimentation and routine optimization. Such experimentation is supported by Lahm, wherein Lahm indicates that a desired pesticidal effect and duration, the target parasitic invertebrate pest species, the animal to be protected, the mode of application and the amount needed to achieve a particular result can be determined through experimentation (column 56, lines 4-13)15. See MPEP 2144.05(II):
“Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").”
Claim 57 further limits the method of claim 54 wherein the composition does not comprise and is not administered in the form of microspheres, granules, or implants.
Lahm does not teach the administration of a composition comprising a compound of Formula 11-1 and microspheres, granules, or implants.
Claim 58 further limits the method of claim 54 wherein the tick infestation comprises at least one of a brown dog tick (Rhipicephalus sanguineus) infestation, a castor bean tick (Ixodes ricinus) infestation, an ornate cow tick (Dermacentor reticulates) infestation, an American dog tick (Dermacentor variabilis) infestation, a lone star tick (Amblyomma americanum) infestation, and a chicken tick (Ornithodoros moubata) infestation.
Lahm indicates that their disclosed compounds are effective for tick infestations, including at least Rhipicephalus sanguineus (brown dog tick) (column 50, lines 4-10).
Claim 59 further limits the method of claim 54 wherein the tick infestation comprises at least one of a brown dog tick (Rhipicephalus sanguineus) infestation, a castor bean tick (Ixodes ricinus) infestation, an ornate cow tick (Dermacentor reticulates) infestation, a lone star tick (Amblyomma americanum) infestation, and a chicken tick (Ornithodoros moubata) infestation.
Lahm indicates that their disclosed compounds are effective for tick infestations, including at least Rhipicephalus sanguineus (brown dog tick) (column 50, lines 4-10).
Claim 60 recites a method for reducing, eradicating, or inhibiting a tick infestation in a feline, comprising: administering to the feline in need thereof a composition comprising a compound of Formula 11-1, a salt thereof, or a solvate of any of the foregoing and least one excipient or carrier wherein the administering comprises administering the composition to provide the feline with a dose of 10 mg/kg to 50 mg/kg of the compound, the salt thereof, or the solvate of any of the foregoing.
Lahm teaches antiparasitic compounds and methods of use in protecting animals from parasitic pests by administering said compounds orally or by injection (Abstract)16. One such compound taught by Lahm is the following compound 3 (Table A, column 56):
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As can be seen from the above structure and table, compound 3 of Lahm is identical to the formula of the instant claim. Lahm further indicates exemplary tests carried out with said compounds in order to evaluate effectiveness in protection against cat fleas. Of particular interest is Test A which indicates the oral dosing of mice with compound 3 at 10 mg/kg (column 57 lines 33-43)17 by administering a composition comprising compound 3 solubilized in propylene glycol/glycerol (60:40).
While Lahm does not explicitly teach the use of said compounds on a tick infestation in a feline, it would have been obvious for a person of ordinary skill in the art to apply the aforementioned dosing to a tick infestation because Lahm indicates use of the compound for treating infestations by a number of different invertebrates, including ticks, and it would be further obvious to apply such a treatment to a feline, because Lahm further indicates felines as target animals for their application of the compound.
Lahm expressly indicates that the disclosed compounds are effective against ectoparasites, which include stable flies, ticks, and fleas of both dogs and cats (column 49, lines 35-41)18. Furthermore, Lahm expressly indicates the intent to treat felines as a target animal using the disclosed compounds (column 59, lines 1-2)19.
Without evidence of the contrary, a person of ordinary skill in the art would have found it obvious to apply Lahm’s 10 mg/kg oral dosing regimen for cat flea infestations to a canine with a tick infestation because there would be a reasonable expectation that such a treatment would be effective in treating said tick infestation, as both parasites are considered as ectoparasites targeted by compound 3.
Claim 62 further limits the method of claim 60 wherein the method comprises administering the composition at a frequency in the range of once every 2 months to once every 3 months.
While Lahm does not explicitly teach a dosing regimen in the range of once every 2 months to once every 3 months, Lahm does make the suggestion of dosing in a range of about weekly to about once every 6 months (column 56, lines 19-26), indicating acceptable variation in dosing intervals. While the such a range does not outright obviate the limitation of the instant claim, the use of such a dosing regimen would still remain obvious to a person of ordinary skill in the art per the principle of routine optimization. Lahm obviates a method of treating tick infestations by administration of a composition comprising a compound of Formula 11-1, and at the same time makes the suggestion of multiple administration intervals of preferably one month, or weekly to every six months. A skilled artisan would have motivation to find the optimal dosing interval through experimentation and routine optimization. Such experimentation is supported by Lahm, wherein Lahm indicates that a desired pesticidal effect and duration, the target parasitic invertebrate pest species, the animal to be protected, the mode of application and the amount needed to achieve a particular result can be determined through experimentation (column 56, lines 4-13)20. See MPEP 2144.05(II).
Claim 63 further limits the method of claim 60 wherein the tick infestation comprises at least one of a brown dog tick (Rhipicephalus sanguineus) infestation, a castor bean tick (Ixodes ricinus) infestation, an ornate cow tick (Dermacentor reticulates) infestation, an American dog tick (Dermacentor variabilis) infestation, a lone star tick (Amblyomma americanum) infestation, and a chicken tick (Ornithodoros moubata) infestation.
Lahm indicates that their disclosed compounds are effective for tick infestations, including at least Rhipicephalus sanguineus (brown dog tick) (column 50, lines 4-10).
Claim 65 further limits the method of claim 60 wherein the tick infestation comprises at least one of a brown dog tick (Rhipicephalus sanguineus) infestation, a castor bean tick (Ixodes ricinus) infestation, an ornate cow tick (Dermacentor reticulates) infestation, a lone star tick (Amblyomma americanum) infestation, and a chicken tick (Ornithodoros moubata) infestation.
Lahm indicates that their disclosed compounds are effective for tick infestations, including at least Rhipicephalus sanguineus (brown dog tick) (column 50, lines 4-10).
Claim 66 recites a method for reducing, eradicating, or inhibiting a tick infestation in a feline, comprising: administering to the feline in need thereof a composition comprising a compound of Formula 11-1, a salt thereof, or a solvate of any of the foregoing, at least one anthelmintic, and at least one excipient or carrier wherein the administering comprises administering the composition to provide the feline with a dose of 10 mg/kg to 50 mg/kg body weight of the compound, the salt thereof, or the solvate of any of the foregoing.
Lahm teaches antiparasitic compounds and methods of use in protecting animals from parasitic pests by administering said compounds orally or by injection (Abstract)21. One such compound taught by Lahm is the following compound 3 (Table A, column 56):
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As can be seen from the above structure and table, compound 3 of Lahm is identical to the formula of the instant claim. Lahm further indicates exemplary tests carried out with said compounds in order to evaluate effectiveness in protection against cat fleas. Of particular interest is Test A which indicates the oral dosing of mice with compound 3 at 10 mg/kg (column 57 lines 33-43)22 by administering a composition comprising compound 3 solubilized in propylene glycol/glycerol (60:40).
Lahm does not explicitly teach the following:
Administration to a feline having a tick infestation
A composition comprising both a compound of Formula 11-1 together with an anthelmintic
However, it would be obvious for a person or ordinary skill in the art to apply Lahm’s method to a feline having a tick infestation because Lahm teaches that the compound of Formula 11-1 is effective for treating ticks infestation, and Lahm further indicates that felines are a target animal for the dosing of the disclosed compound. It would further be obvious to combine a compound of Formula 11-1 with an anthelmintic, because Lahm suggests the inclusion of an additional biologically active compound in the form of an anthelminthic.
Lahm expressly indicates that the disclosed compounds are effective against ectoparasites, which include stable flies, ticks, and fleas of both dogs and cats (column 49, lines 35-41)23. Furthermore, Lahm expressly indicates the intent to treat felines as a target animal using the disclosed compounds (column 59, lines 1-2)24.
Lahm further indicates the inclusion of anthelminthics as additionally active biologic compounds in formulations comprising a compound of Formula 11-1. More specifically, Lahm indicates the inclusion of avermectins such as ivermectin, moxidectin, and milbemycin, as well as praziquantel (column 51, lines 23-29)25. The inclusion of such compounds would be obvious to a person of ordinary skill in the art as there would be a reasonable expectation that they would provide a clear improvement by providing the antiparasitic formulation a broader spectrum effect in treating different types of parasites.
Claim 68 further limits the method of claim 66 wherein the method comprises administering the composition at a frequency in the range of once every 2 months to every 3 months.
While Lahm does not explicitly teach a dosing regimen in the range of once every 2 months to once every 3 months, Lahm does make the suggestion of dosing in a range of about weekly to about once every 6 months (column 56, lines 19-26), indicating acceptable variation in dosing intervals. While the such a range does not outright obviate the limitation of the instant claim, the use of such a dosing regimen would still remain obvious to a person of ordinary skill in the art per the principle of routine optimization. Lahm obviates a method of treating tick infestations by administration of a composition comprising a compound of Formula 11-1, and at the same time makes the suggestion of multiple administration intervals of preferably one month, or weekly to every six months. A skilled artisan would have motivation to find the optimal dosing interval through experimentation and routine optimization. Such experimentation is supported by Lahm, wherein Lahm indicates that a desired pesticidal effect and duration, the target parasitic invertebrate pest species, the animal to be protected, the mode of application and the amount needed to achieve a particular result can be determined through experimentation (column 56, lines 4-13)26. See MPEP 2144.05(II).
Claim 69 further limits the method of claim 66 wherein the composition does not comprise and is not administered in the form of microspheres, granules, or implants.
Lahm does not teach a method of the claim 66 wherein the composition comprises or is administered in the form of microspheres, granules, or implants.
Claim 70 further limits the method of claim 66 wherein the tick infestation comprises at least one of a brown dog tick (Rhipicephalus sanguineus) infestation, a castor bean tick (Ixodes ricinus) infestation, an ornate cow tick (Dermacentor reticulates) infestation, an American dog tick (Dermacentor variabilis) infestation, a lone star tick (Amblyomma americanum) infestation, and a chicken tick (Ornithodoros moubata) infestation.
Lahm indicates that their disclosed compounds are effective for tick infestations, including at least Rhipicephalus sanguineus (brown dog tick) (column 50, lines 4-10).
Claim 71 further limits the method of claim 60 wherein the tick infestation comprises at least one of a brown dog tick (Rhipicephalus sanguineus) infestation, a castor bean tick (Ixodes ricinus) infestation, an ornate cow tick (Dermacentor reticulates) infestation, a lone star tick (Amblyomma americanum) infestation, and a chicken tick (Ornithodoros moubata) infestation.
Lahm indicates that their disclosed compounds are effective for tick infestations, including at least Rhipicephalus sanguineus (brown dog tick) (column 50, lines 4-10).
Claim 72 further limits the method of claim 66 wherein the at least one anthelmintic comprises a macrocyclic lactone parasiticide.
Lahm teaches the inclusion of macrocyclic lactones as additional actives.
Claim 73 further limits the method of claim 72 wherein the macrocyclic lactone parasiticide is selected from ivermectin, moxidectin, and milbemycin.
Lahm teaches moxidectin as an additional active.
Claim 74 further limits the method of claim 72 wherein the macrocyclic lactone parasiticide is moxidectin.
Lahm teaches moxidectin as an additional active.
Claim 75 further limits the method of claim 66 wherein the at least one anthelmintic comprises praziquantel.
Lahm teaches praziquantel as an additional active.
Claim Rejections - 35 USC § 103 – Necessitated by Amendment
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Newly added claim(s) 76-79 is/are rejected under pre-AIA 35 U.S.C. 102(e) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Lahm (previously referenced).
Claim 76 further limits the method of claim 46 wherein the composition is a unit dosage form.
Lahm teaches an embodiment wherein their disclosed compositions may be in the form of a chewable treat or edible tablet (specification col. 55, lines 4-9)27. An edible tablet would be considered a unit dosage form.
Claim 77 further limits the method of claim 46 wherein the composition is solid.
Lahm teaches an embodiment wherein their disclosed compositions may be in the form of a chewable treat or edible tablet (specification col. 55, lines 4-9). Such dosage forms would be considered to be solids.
Claim 78 further limits the method of claim 46 wherein the composition is in a chewable dosage form.
Lahm teaches an embodiment wherein their disclosed compositions may be in the form of a chewable treat (specification col. 55, lines 4-9).
Claim 79 further limits the method of claim 46 wherein the method further comprises administering the chewable dosage form with food.
As iterated in the rejection of claim 78, Lahm teaches their compositions as chewable dosage forms. Lahm further indicates that their compounds and composition may be administered with food depending on the contemplated end use (specification Col. 46, lines 4-9)28.
Double Patenting – Withdrawn
Double Patenting Rejections Over Copending Application 16/709,370:
Copending application 16/709,370, has been indicated as abandoned, the rejections of the claims are hereby withdrawn.
Conclusion
Claims 1, 33-38, 45-51, and 54-79 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/ERIC TRAN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 “Disclosed is a method for protecting an animal from a parasitic invertebrate pest comprising treating an animal orally or by injection with a pesticidally effective amount of a compound of Formula: (I)…”
2 “For evaluating control of the cat flea (Ctenocephalides felis), a CD-I® mouse (about 30 g, male, obtained from Charles River Laboratories, Wilmington, MA) was subcutaneously dosed with a test compound in an amount of 1 0 mg/kg solubilized in propylene glycol/glycerol formal (60:40). Two hours after oral administration of the test compound, approximately 8 to 16 adult fleas were applied to each mouse. The fleas were then evaluated for mortality 48 hours after flea application to the mouse. Of the compounds tested, the following compounds resulted in at least 20% mortality: I, 2 and 3. The following compounds resulted in at least 50% mortality: I and 3.”
3 “In particular, the compounds of Formula I are especially effective against ectoparasites including Stomoxys calcitrans (stable fly); ticks such as Ixodes spp., Boophilus spp., Rhipicephalus spp., Amblyomma spp., Dermacentor spp., Hyalomma spp. and Haemaphysalis spp.; and fleas such as Ctenocephalides felis (cat flea) and Ctenocephalides canis (dog flea).”
4 “Suitable intervals for the administration of compounds of the present invention to animals range from about daily to about yearly. Of note are administration intervals ranging 20 from about weekly to about once every 6 months. Of particular note are monthly administration intervals (i.e. administering the compound to the animal once every month).”
5 “5. The method according to claim 1, wherein the mammal
is a cat or dog.”
6 “Ticks include, e.g., soft-bodied ticks including Argasidae spp. for example Argas spp. and Ornithodoros spp.; hardbodied ticks including Ixodidae spp., for example Rhipicephalus sanguineus, Dermacentor variabilis, Dermacentor andersoni, Amblyomma americanum, Ixodes scapularis and other Rhipicephalus spp. (including the former Boophilus genera).”
7 “Disclosed is a method for protecting an animal from a parasitic invertebrate pest comprising treating an animal orally or by injection with a pesticidally effective amount of a compound of Formula: (I)…”
8 “For evaluating control of the cat flea (Ctenocephalides felis), a CD-1® mouse (about 30 g, male, obtained from Charles River Laboratories, Wilmington, Mass.) was orally dosed with a test compound in an amount of 10 mg/kg solubilized in propylene glycol/glycerol formal (60:40). Two hours after oral administration of the test compound, approximately 8 to 16 adult fleas were applied to each mouse. The fleas were then evaluated for mortality 48 hours after flea application to the mouse.”
9 “In particular, the compounds of Formula I are especially effective against ectoparasites including Stomoxys calcitrans (stable fly); ticks such as Ixodes spp., Boophilus spp., Rhipicephalus spp., Amblyomma spp., Dermacentor spp., Hyalomma spp. and Haemaphysalis spp.; and fleas such as Ctenocephalides felis (cat flea) and Ctenocephalides canis (dog flea).”
10 “The method according to claim 1, wherein the mammal is a canine.”
11 “Disclosed is a method for protecting an animal from a parasitic invertebrate pest comprising treating an animal orally or by injection with a pesticidally effective amount of a compound of Formula: (I)…”
12 “For evaluating control of the cat flea (Ctenocephalides felis), a CD-1® mouse (about 30 g, male, obtained from Charles River Laboratories, Wilmington, Mass.) was orally dosed with a test compound in an amount of 10 mg/kg solubilized in propylene glycol/glycerol formal (60:40). Two hours after oral administration of the test compound, approximately 8 to 16 adult fleas were applied to each mouse. The fleas were then evaluated for mortality 48 hours after flea application to the mouse.”
13 “In particular, the compounds of Formula I are especially effective against ectoparasites including Stomoxys calcitrans (stable fly); ticks such as Ixodes spp., Boophilus spp., Rhipicephalus spp., Amblyomma spp., Dermacentor spp., Hyalomma spp. and Haemaphysalis spp.; and fleas such as Ctenocephalides felis (cat flea) and Ctenocephalides canis (dog flea).”
14 “The method according to claim 1, wherein the mammal is a canine.”
15 “One skilled in the art will appreciate that the pesticidally effective dose can vary for the various compounds and compositions useful for the method of the present invention, the desired pesticidal effect and duration, the target parasitic invertebrate pest species, the animal to be protected, the mode of application and the like, and the amount needed to achieve a particular result can be determined through simple experimentation.”
16 “Disclosed is a method for protecting an animal from a parasitic invertebrate pest comprising treating an animal orally or by injection with a pesticidally effective amount of a compound of Formula: (I)…”
17 “For evaluating control of the cat flea (Ctenocephalides felis), a CD-1® mouse (about 30 g, male, obtained from Charles River Laboratories, Wilmington, Mass.) was orally dosed with a test compound in an amount of 10 mg/kg solubilized in propylene glycol/glycerol formal (60:40). Two hours after oral administration of the test compound, approximately 8 to 16 adult fleas were applied to each mouse. The fleas were then evaluated for mortality 48 hours after flea application to the mouse.”
18 “In particular, the compounds of Formula I are especially effective against ectoparasites including Stomoxys calcitrans (stable fly); ticks such as Ixodes spp., Boophilus spp., Rhipicephalus spp., Amblyomma spp., Dermacentor spp., Hyalomma spp. and Haemaphysalis spp.; and fleas such as Ctenocephalides felis (cat flea) and Ctenocephalides canis (dog flea).”
19 “The method according to claim 1, wherein the mammal is a feline.”
20 “One skilled in the art will appreciate that the pesticidally effective dose can vary for the various compounds and compositions useful for the method of the present invention, the desired pesticidal effect and duration, the target parasitic invertebrate pest species, the animal to be protected, the mode of application and the like, and the amount needed to achieve a particular result can be determined through simple experimentation.”
21 “Disclosed is a method for protecting an animal from a parasitic invertebrate pest comprising treating an animal orally or by injection with a pesticidally effective amount of a compound of Formula: (I)…”
22 “For evaluating control of the cat flea (Ctenocephalides felis), a CD-1® mouse (about 30 g, male, obtained from Charles River Laboratories, Wilmington, Mass.) was orally dosed with a test compound in an amount of 10 mg/kg solubilized in propylene glycol/glycerol formal (60:40). Two hours after oral administration of the test compound, approximately 8 to 16 adult fleas were applied to each mouse. The fleas were then evaluated for mortality 48 hours after flea application to the mouse.”
23 “In particular, the compounds of Formula I are especially effective against ectoparasites including Stomoxys calcitrans (stable fly); ticks such as Ixodes spp., Boophilus spp., Rhipicephalus spp., Amblyomma spp., Dermacentor spp., Hyalomma spp. and Haemaphysalis spp.; and fleas such as Ctenocephalides felis (cat flea) and Ctenocephalides canis (dog flea).”
24 “The method according to claim 1, wherein the mammal is a feline.”
25 “Of note are additional biologically active compounds or agents selected from art-known anthelmintics, such as, for example, avermectins (e.g., ivermectin, moxidectin, milbemycin), benzimidazoles (e.g., albendazole, triclabendazole), salicylanilides (e.g., closantel, oxyclozanide), substituted phenols (e.g., nitroxynil), pyrimidines (e.g., pyrantel), imidazothiazoles (e.g., levamisole) and praziquantel.”
26 “One skilled in the art will appreciate that the pesticidally effective dose can vary for the various compounds and compositions useful for the method of the present invention, the desired pesticidal effect and duration, the target parasitic invertebrate pest species, the animal to be protected, the mode of application and the like, and the amount needed to achieve a particular result can be determined through simple experimentation.”
27 “A preferred embodiment is a composition of the present method formulated into a chewable and/or edible product (e.g., a chewable treat or edible tablet). Such a product would ideally have a taste, texture and/or aroma favored by the animal to be protected so as to facilitate oral administration of the compound of Formula 1.”
28 “The compounds of Formula 1 can be applied without other adjuvants, but most often application will be of a formulation comprising one or more active ingredients with suitable carriers, diluents, and surfactants and possibly in combination with a food depending on the contemplated end use.”
Prosecution Insights