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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/6/2026 has been entered.
Information Disclosure Statement
The IDS filed on 7/6/2026 has been considered. See the attached PTO 1449 form.
Status of Action/Claims
Receipt of Remarks/Amendments filed on 7/6/2026 is acknowledged. Claims 1-2, 4, 6-7, 9-22, 24-28 are currently pending. Claims 15-20, 22, 24 and 26-28 have been withdrawn. Accordingly, claims 1-2, 4, 6-7, 9-14, 21 and 25 are presented for examination on the merits for patentability.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Modified Claim Rejection(s) Necessitated by Amendments
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4, 6, 9, 21 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Lehay et al. (WO 2015/091898 A1; Jun. 25, 2015) in view of Faassen et al. (US 8,658,687; Feb. 25, 2014).
Lehay throughout the reference teaches a composition comprising isoxazoline compound and the use of the composition to treat or prevent parasite infestation of animals (Abstract). Particularly, Lehay teaches a pharmaceutical composition comprising an isoxazoline compound of formula I and a pharmaceutically acceptable carrier (Claim 1). It teaches the isoxazoline compound is fluralaner in the amount of between 1.5mg/ml and 100 mg/ml (Claims 2 and 3). The amount of fluralener taught by Lehay equates to 0.15% to 10% w/v, which overlaps the amount recited in instant claims 1 and 6. The reference discloses that the composition according to the invention can be in the form of an aqueous suspension (Page 19, lines 27-29). Lehay also teaches that the composition can be a parenteral composition which is administered parenterally, such as via intramuscular injection (Page 19, lines 6-11). Further, the reference teaches that the composition can be diluted with water (Page 19, lines 18-21), which reads on the claimed recitation wherein the composition is to be reconstituted with a vehicle.
The teachings of Lehay have been set forth above.
Lehay does not expressly teach the particle size distribution of isoxazoline as recited in the instant claims. Also, while Lehay teaches the composition in a suspension, Lehay does not expressly disclose the suspension comprising a suspending agent such as sodium carboxymethyl cellulose and the amount thereof. However, these deficiencies are cured by Faassen.
Faassen teaches injectable formulations comprising asenapine hemipamoate suspended particles (Title, Abstract). Faassen discloses that in injectable formulations medicament comprising a particle suspension, particle size distribution of suspended active affects the release of drug. It teaches it is known in the art that an active drug in suspensions made with particles having a smaller mean particle size provide higher Cmax in a shorter time than those suspension prepared from particle fractions having a larger mean particle size. (see: col. 2, lines 70 to col. 3, lines 1-7). The reference discloses particle fractions yielding, small d50 values (e.g. 0.25 microns) or which have a large "fines" content (10 vol % or greater of particles with less than 1 micron particle size (e.g., 1.5 micron) tend to exhibit a "bursting effect" (also termed a "Burst Release"). (see: col. 16, lines 51-57). The reference in table II discloses the d10, d50 and d90 particle size distribution in microns. It states it is preferred to remove both particles smaller than 0.3 microns and particles larger than 200 microns (col. 4, lines 42-46). Additionally, Faassen teaches using caboxymethyl cellulose as dispersing agent in the suspension formulations (col. 12, line 66 to col. 13, line 2).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified Lehay to incorporate the teachings of Faassen to manipulate the particle size distribution to determine the optimal particle size based on the release of active desired. One would have been motivated to do so because based on the teachings of Faassen, it was known in the art that particle size distribution affects the release of the drug and that smaller particle size leads to burst release whereas larger particle size needs to be chosen if a long lasting effect is desired. Thus, it would have been obvious to one skilled in the art to manipulate the particle size distribution of the isoxazoline compound taught by Lehay to determine the optimal particle size for the desired release. One skilled in the art would have had a reasonable expectation of success because both Lehay and Faassen disclose injectable suspension formulations. 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).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified Lehay to incorporate the teachings of Faassen to include a dispersing agent (e.g., carboxymethyl cellulose) in the suspension of Lehay. As discussed supra, Lehay teaches the composition can be a suspension and Faassen also teaches suspension compositions comprise dispersing agents such as carboxymethyl cellulose. Thus, it would have been obvious to one skilled in the art to include the known dispersing agent in a suspension because dispersing agent or suspending agents are commonly used in the suspension formulations. Further, it would have been obvious to one skilled in the art to manipulate the amount of the carboxymethyl cellulose and determine an amount that would provide an optimal dispersion of the suspension because carboxymethyl cellulose is taught by the prior art to be used as a dispersing agent. 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).
With respect to the instantly claimed limitation wherein the isoxazoline compound is in suspension in the composition and particularly an aqueous suspension, as discussed supra, Lehay teaches that the composition according to the invention can be in the form of an aqueous suspension (Page 19, lines 27-29). While Lehay does not exemplify an aqueous suspension, Lehay clearly teaches an aqueous suspension being within the scope of the invention and therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007). Thus, it would have been obvious to one skilled in the art to form a suspension of the isoxazoline compound because Lehay teaches that an aqueous suspension is a suitable form of the invention and within the scope of the invention taught by Lehay.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 1-2, 4, 6, 7, 9, 10-13, 21 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Lehay et al. (WO 2015/091898 A1; Jun. 25, 2015) in view of Faassen et al. (US 8,658,687; Feb. 25, 2014) as applied to claims 1-2, 4, 6, 9, 21 and 25 above and further in view of Cady et al. (US 2016/0256442A1; Sep. 8, 2016) (Cited in IDS filed 8/13/2020).
The teachings of Lehay and Faassen have been set forth above.
Lehay and Faassen do not expressly teach wherein the isoxazoline compound is present in an amount of about 15% w/v. Lehay and Faassen also do not expressly teach the composition further comprises another parasiticide compound which is moxidectin. However, these deficiencies are cured by Cady.
Cady throughout the reference teaches long acting injectable formulations for combating parasites in animals, comprising at least one isoxazoline active agent (Abstract). Particularly, Cady discloses fluralaner as the isoxazoline compound (claim 10). It also teaches the composition comprising about 15% to about 40% of an isoxazoline compound (Para 0240) which overlaps the amount recited in instant claim 7. Cady teaches the composition further comprises moxidectin as an additional active ingredient (claim 24-26).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified Lehay to incorporate the teachings of Cady and include an amount of fluralaner taught by Cady in the composition of Lehay. One would have been motivated to do so because both Lehay and Cady teach formulations for combating parasites in animals, comprising isoxazoline active agent and Cady teaches that the instantly claimed amount of about 15% of fluralaner was known for combating parasites in animals. Further, it would have been obvious to one skilled in the art to manipulate the amount to determine the optimal amount needed for combating parasites during routine optimization. “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). See MPEP 2144.05.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified Lehay to incorporate the teachings of Cady and further include moxidectin as an additional active ingredient as taught by Cady into the composition of Lehay. One would have been motivated to do so because both Lehay and Cady teach formulations for combating parasites in animals, comprising isoxazoline active agent and Cady teaches further adding moxidectin for combating parasites in animals. As a general principle it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose, the idea of combining them flows logically from their having been individually taught in the prior art. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) MPEP 2144.06.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 1-2, 4, 6, 7, 9, 10-13, 14, 21 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Lehay et al. (WO 2015/091898 A1; Jun. 25, 2015) in view of Faassen et al. (US 8,658,687; Feb. 25, 2014) and Cady et al. (US 2016/0256442A1; Sep. 8, 2016) (Cited in IDS filed 8/13/2020) as applied to claims 1-2, 4, 6, 7, 9, 10-13, 21 and 25 above and further in view of Wang et al. (WO 2008/030385 A2; Mar. 13, 2008).
The teachings of Lehay, Faassen and Cady have been set forth above.
The above cited references do not teach wherein moxidectin is present in an amount between about 0.1% to about 1% as recited in instant claim 14. However, this deficiency is cured by Wang.
Wang teaches formulations for the control of parasites in animals (Abstract). It teaches the formulation comprises moxidectin in an amount of about 0.05% to about 10% which overlaps the amount recited in the instant claims.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified the above cited references to incorporate the teachings of Wang and include an amount of moxidectin taught by Wang in the composition of Lehay. One would have been motivated to do so because Lehay, Cady and Wang teach formulations for combating and controlling parasites in animals and Wang teaches that the instantly claimed amount of moxidectin was known to be used in formulations for combating parasites in animals. Further, it would have been obvious to one skilled in the art to manipulate the amount to determine the optimal amount needed for combating parasites during routine optimization. “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). See MPEP 2144.05.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Arguments
Applicant's arguments filed 7/6/2026 with respect to the 103 rejections have been fully considered but they are not persuasive.
Applicant appear to argue the claimed amount of about 7.5% to 15% of isoxazoline provides unexpected results and that the results are commensurate in scope with the claims.
In response, the examiner respectfully draws applicant’s attention to MPEP 716.02(d): “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range.” In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). In the instant case, the results provided by applicant do not show that an amount of isoxazoline in the claimed range of 7.5% to 15% provides an unexpected effect wherein the difference in the effect between the claimed amount and an amount outside of the claimed range is of statistical and practical significance. Particularly, the only data provided by applicant which - shows results of isoxazoline outside the claimed amounts is in declaration filed in 10/25/2023. In table 7-5, results are provided for isoxazoline amount which is 6.7% and this amount appears to show no selling present. Thus, applicant have not shown evidence of criticality of the claimed amounts of isoxazoline. Therfore, applicant’s arguments of the claimed amounts of isoxazoline being critical and providing unexpected effect is not persuasive at this time.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2, 4, 6-7, 9-14, 21 and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 15-21 and 25-27 of copending Application No. 17/999,024 in view of Lehay et al. (WO 2015/091898 A1; Jun. 25, 2015), Cady et al. (US 2016/0256442A1; Sep. 8, 2016) (Cited in IDS filed 8/13/2020) and Faassen et al. (US 8,658,687; Feb. 25, 2014).
The ‘024 application claims an injectable pharmaceutical composition comprising microspheres which include about 1% to about 40% of macrocyclic lactones and the composition comprises isoxazoline compound and an aqueous carrier, wherein the microspheres and the particles of the compound are suspended in the aqueous carrier. The composition comprises a suspending agent which is carboxymethyl cellulose. The macrocyclic lactone is moxidectin. ‘024 also claims the particle size distribution is from about 8 micron to about 250 micron. The isoxazoline compound comprises fluralaner.
The ‘024 application does not claim the amount of the isoxazoline compound. However, this deficiency is cured by Lehay and Cady.
As discussed supra, Lehay teaches the isoxazoline compound is fluralaner in the amount of between 1.5mg/ml and 100 mg/ml (Claims 2 and 3). The amount of fluralener taught by Lehay equates to 0.15% to 10% w/v, which overlaps the amounts recited in instant claims 1 and 6.
As discussed supra, Cady discloses fluralaner as the isoxazoline compound (claim 10). It also teaches the composition comprising about 15% to about 40% of an isoxazoline compound (Para 0240) which overlaps the amount recited in instant claim 7.
The ‘024 application does not claim the thickness recited in the instant claims. However, Faassen cures this deficiency.
Faassen teaches it is known in the art that an active drug in suspensions made with particles having a smaller mean particle size provide higher Cmax in a shorter time than those suspension prepared from particle fractions having a larger mean particle size. (see: col. 2, lines 70 to col. 3, lines 1-7). The reference discloses particle fractions yielding, small d50 values (e.g. 0.25 microns) or which have a large "fines" content (10 vol % or greater of particles with less than 1 micron particle size (e.g., 1.5 micron) tend to exhibit a "bursting effect" (also termed a "Burst Release"). (see: col. 16, lines 51-57).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified ‘024 to incorporate the teachings of Lehay and Cady and include an amount of fluralaner taught by Lehay and Cady in the ‘024 composition. One would have been motivated to do so because ‘024 is silent on the amount of isoxazoline compound and Lehay and Cady teach that the claimed amounts of the isoxazoline compounds were known in the art and it would have been obvious to one skilled in the art to look towards the teachings of Lehay and Cady for the amounts of the isoxazoline compound. “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). See MPEP 2144.05.
Faassen teaches it was known in the art that particle size distribution affects the release of the drug and that smaller particle size leads to burst release whereas larger particle size needs to be chosen if a long lasting effect is desired. Thus, it would have been obvious to one skilled in the art to manipulate the particle size distribution or the thickness of the isoxazoline compound taught by Lehay to determine the optimal particle size for the desired release rate.
With respect to the claimed mechanical resiliency, the copending application expressly teaches the claimed fluralaner compound and its particle size and thus the same fluralaner compound as claimed would necessarily have the same properties with regards to particle size relationship with mechanical resiliency.
Further, it would have been obvious to one skilled in the art to manipulate the amount of the carboxymethyl cellulose and determine an amount that would provide an optimal dispersion of the suspension because carboxymethyl cellulose is taught by the prior art to be used as a dispersing agent. 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).
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
This is a provisional nonstatutory double patenting rejection.
Claims 1-2, 4, 6-7, 9-14, 21 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of US12616677B2 in view of Lehay et al. (WO 2015/091898 A1; Jun. 25, 2015), Cady et al. (US 2016/0256442A1; Sep. 8, 2016) (Cited in IDS filed 8/13/2020) and Wang et al. (WO 2008/030385 A2; Mar. 13, 2008).
The ‘677 claims an injectable composition comprising moxidectin and particles of an isoxazoline compound, wherein the moxidectin and isoxazoline compound particles are suspended in an aqueous carrier. The composition comprises a suspending agent such as sodium carboxymethyl cellulose. The isoxazoline compound particles have a particles size distribution of from 75 micron to 150 micron. Isoxazoline compound comprises fluralaner. Isoxazoline particles have a thickness greater than 10 micrometer.
The ‘677 does not claim the amount of the isoxazoline compound. However, this deficiency is cured by Lehay and Cady.
As discussed supra, Lehay teaches the isoxazoline compound is fluralaner in the amount of between 1.5mg/ml and 100 mg/ml (Claims 2 and 3). The amount of fluralener taught by Lehay equates to 0.15% to 10% w/v, which overlaps the amounts recited in instant claims 1 and 6.
As discussed supra, Cady discloses fluralaner as the isoxazoline compound (claim 10). It also teaches the composition comprising about 15% to about 40% of an isoxazoline compound (Para 0240) which overlaps the amount recited in instant claim 7.
The ‘677 also does not claim the amount of moxidectin. However, this deficiency is cured by Wang.
As discussed supra, Wang teaches formulations for the control of parasites in animals (Abstract). It teaches the formulation comprises moxidectin in an amount of about 0.05% to about 10% which overlaps the amount recited in the instant claims.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified ‘677 to incorporate the teachings of Lehay and Cady and include an amount of fluralaner taught by Lehay and Cady in the ‘677 composition. One would have been motivated to do so because ‘677 is silent on the amount of isoxazoline compound and Lehay and Cady teach that the claimed amounts of the isoxazoline compounds were known in the art and it would have been obvious to one skilled in the art to look towards the teachings of Lehay and Cady for the amounts of the isoxazoline compound. “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). See MPEP 2144.05.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified ‘677 to incorporate the teachings of Wang and include an amount of moxidectin taught by Wang in the ‘677 composition. One would have been motivated to do so because ‘677 is silent on the amount of moxidectin compound and Wang teaches that the claimed amounts of the moxidectin to control parasites were known in the art and it would have been obvious to one skilled in the art to look towards the teachings of Wang for the amounts of moxidectin. “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). See MPEP 2144.05.
With respect to the claimed mechanical resiliency, the copending application expressly teaches the claimed fluralaner compound and its particle size and thus the same fluralaner compound as claimed would necessarily have the same properties with regards to particle size relationship with mechanical resiliency.
Further, it would have been obvious to one skilled in the art to manipulate the amount of the carboxymethyl cellulose and determine an amount that would provide an optimal dispersion of the suspension because carboxymethyl cellulose is taught by the prior art to be used as a dispersing agent. 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).
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
This is a provisional nonstatutory double patenting rejection.
Claims 1-2, 4, 6-7 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11858904B2 in view of Lehay et al. (WO 2015/091898 A1; Jun. 25, 2015), Cady et al. (US 2016/0256442A1; Sep. 8, 2016) and Faassen et al. (US 8,658,687; Feb. 25, 2014).
‘904 patent claims an isoxazoline compound particle composition comprising particles having a volume weighted particle size distribution (d50) as measured by a static light scattering instrument of between 50 and 150 μm and with a thickness of greater than 10 μm, as measured by scanning electron microscopy (SEM) wherein, the volume weighted particle size distribution (d50) as measured by a static light scattering instrument of the particles does not decrease by more than 40% when the mechanical resiliency as measured by a pressure titration is increased from 1 to 3 bar dispersion pressure, wherein the isoxazoline compound is fluralaner. The particle size distribution (d50) of the particles does not decrease by more than 35% from 1 to 3 bar dispersion pressure. The volume weighted particle size distribution (d50) as measured by a static light scattering instrument is between 75 and 120 μm. The thickness is greater than 20 μm as measured by scanning electron microscopy (SEM).
‘904 patent does not teach the isoxazoline compound is in suspension and composition comprising a suspending agent. ‘904 also does not teach the amount of isoxazoline compound. However, Lehay, Cady and Faassen cure these deficiencies.
As disucussed supra, Lehay throughout the reference teaches a composition comprising isoxazoline compound and the use of the composition to treat or prevent parasite infestation of animals (Abstract). Particularly, Lehay teaches a pharmaceutical composition comprising an isoxazoline compound of formula I and a pharmaceutically acceptable carrier (Claim 1). It teaches the isoxazoline compound is fluralaner in the amount of between 1.5mg/ml and 100 mg/ml (Claims 2 and 3). The amount of fluralener taught by Lehay equates to 0.15% to 10% w/v, which overlaps the amounts recited in instant claims 1 and 6. The reference discloses that the composition according to the invention can be in the form of an aqueous suspension (Page 19, lines 27-29), which would include having a suspending agent.
As discussed supra, Cady discloses fluralaner as the isoxazoline compound (claim 10). It also teaches the composition comprising about 15% to about 40% of an isoxazoline compound (Para 0240) which overlaps the amount recited in instant claim 7.
As discussed supra, Faassen teaches using carboxymethyl cellulose as dispersing agent in the suspension formulations (col. 12, line 66 to col. 13, line 2).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified ‘904 to incorporate the teachings of Lehay and Cady and include an amount of fluralaner taught by Lehay and Cady in the ‘904 composition. One would have been motivated to do so because ‘904 is silent on the amount of isoxazoline compound and Lehay and Cady teach that the claimed amounts of the isoxazoline compounds were known in the art and it would have been obvious to one skilled in the art to look towards the teachings of Lehay and Cady for the amounts of the isoxazoline compound. “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). See MPEP 2144.05.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified ‘904 to incorporate the teachings of Lehay and Faassen and include isoxazoline compound in suspension comprising a suspending agent such carboxymethyl cellulose. One would have been motivated to do so because both Lehay and ‘904 teach compositions comprising the isoxazoline compound and Lehay teaches that compositions comprising such compound can be made in the form of a suspension and thus, one skilled in the art would have readily envision making a suspension based on the type of administration (e.g., a suspension if an oral or an injection formulation was desired) using carboxymethyl cellulose as dispersing agent in the suspension formulations.
Further, it would have been obvious to one skilled in the art to manipulate the amount of the carboxymethyl cellulose and determine an amount that would provide an optimal dispersion of the suspension because carboxymethyl cellulose is taught by the prior art to be used as a dispersing agent. 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).
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 1-2, 4, 6-7 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of US12630517B2 in view of Lehay et al. (WO 2015/091898 A1; Jun. 25, 2015), Cady et al. (US 2016/0256442A1; Sep. 8, 2016) and Faassen et al. (US 8,658,687; Feb. 25, 2014).
‘517 claims an isoxazoline compound particle composition comprising particles having a volume weighted particle size distribution (d50) as measured by a static light scattering instrument of between 50 and 150 μm and with a thickness of greater than 10 μm, as measured by scanning electron microscopy (SEM) wherein, the volume weighted particle size distribution (d50) as measured by a static light scattering instrument of the particles does not decrease by more than 40% when the mechanical resiliency as measured by a pressure titration is increased from 1 to 3 bar dispersion pressure, wherein the isoxazoline compound is fluralaner. The particle size distribution (d50) of the particles does not decrease by more than 35% from 1 to 3 bar dispersion pressure. The volume weighted particle size distribution (d50) as measured by a static light scattering instrument is between 75 and 120 μm.
‘517 does not teach the isoxazoline compound is in suspension and composition comprising a suspending agent. ‘517 also does not teach the amount of isoxazoline compound. However, Lehay, Faassen and Cady cure these deficiencies.
As disucussed supra, Lehay throughout the reference teaches a composition comprising isoxazoline compound and the use of the composition to treat or prevent parasite infestation of animals (Abstract). Particularly, Lehay teaches a pharmaceutical composition comprising an isoxazoline compound of formula I and a pharmaceutically acceptable carrier (Claim 1). It teaches the isoxazoline compound is fluralaner in the amount of between 1.5mg/ml and 100 mg/ml (Claims 2 and 3). The amount of fluralener taught by Lehay equates to 0.15% to 10% w/v, which overlaps the amounts recited in instant claims 1 and 6. The reference discloses that the composition according to the invention can be in the form of an aqueous suspension (Page 19, lines 27-29), which would include having a suspending agent.
As discussed supra, Cady discloses fluralaner as the isoxazoline compound (claim 10). It also teaches the composition comprising about 15% to about 40% of an isoxazoline compound (Para 0240) which overlaps the amount recited in instant claim 7.
As discussed supra, Faassen teaches using carboxymethyl cellulose as dispersing agent in the suspension formulations (col. 12, line 66 to col. 13, line 2).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified ‘517 to incorporate the teachings of Lehay and Cady and include an amount of fluralaner taught by Lehay and Cady in the ‘517 composition. One would have been motivated to do so because ‘517 is silent on the amount of isoxazoline compound and Lehay and Cady teach that the claimed amounts of the isoxazoline compounds were known in the art and it would have been obvious to one skilled in the art to look towards the teachings of Lehay and Cady for the amounts of the isoxazoline compound. “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). See MPEP 2144.05.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified ‘517 to incorporate the teachings of Lehay and Faassen and include isoxazoline compound in suspension comprising a suspending agent such as carboxymethyl cellulose. One would have been motivated to do so because both Lehay and ‘517 teach compositions comprising the isoxazoline compound and Lehay teaches that compositions comprising such compound can be made in the form of a suspension and thus, one skilled in the art would have readily envision making a suspension based on the type of administration (e.g., a suspension if an oral or an injection formulation was desired) using carboxymethyl cellulose as dispersing agent in the suspension formulations.
Further, it would have been obvious to one skilled in the art to manipulate the amount of the carboxymethyl cellulose and determine an amount that would provide an optimal dispersion of the suspension because carboxymethyl cellulose is taught by the prior art to be used as a dispersing agent. 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).
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Arguments
Applicant's arguments filed 7/6/2026 with respect to the double patenting rejections have been fully considered but they are not persuasive.
Regarding ‘904 and ‘517 patents, applicant argued the patents do not teach the formulation compris about 7.5 to about 15% w/ of fluralaner (isoxazoline compound) and NaCMC in amount of about 2 to 2.5% w/v. It was argued that for the same reasons discussed regarding 103 rejection, the pending claims are not obvious over the reference patents.
In response, as discussed supra, Lehay, Cady and Faassen cure these deficiencies in the reference patents and render obvious the amounts of the isoxazoline compound and NaCMC and amounts thereof. Further, as discussed supra, applicant’s arguments regarding unexpected effect with respect to the claimed amounts of isoxazoline are not persuasive to overcome the obviousness rejections.
Conclusion
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/ALI S SAEED/ Examiner, Art Unit 1616
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