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 .
Amended claims 1, 4, 15, 16, 18, 20, 21, 25-27 are pending.
Upon further consideration, previously made suggestion with regards to allowable subject atter is withdrawn.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Previously presented rejection of claims 1, 4, 15, 16, 18, 20, 21, 25-27 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12616677 (US Application No. 17606262) further in view of Cady US 20170020848, Rohdich, Parasites & Vectors (2018) 11:598, 1-11, Wendt, US 20160296499, Kim, KR 20190027349 and Lengyel, Sci. Pharm. 2019, 87, 20, 1-31. Although the claims at issue are not identical, they are not patentably distinct from each other as explained below:
The difference here is the presence of microspheres of polycaprolactones (PCL).
All other active and inactive agents are present in both claims.
(For more on this see Rohdich, Wendt, Kim and Lengyel see below)
Cady teaches injectable formulations for combating parasites in animals, comprising at least one isoxazoline active agent, a pharmaceutically acceptable polymer. Cady teaches, instant polycaprolactones (PCL) at page 19 [0346]-[0347] as inactive ingredient pharmaceutically acceptable polymer. Also see Cady claims in particular claims 32 and 38.
The difference here is the presence of microspheres of polycaprolactones (PCL).
All other active and inactive agents are present in both claims.
(For more on this see Rohdich, Wendt, Kim and Lengyel see below)
Cady teaches injectable formulations for combating parasites in animals, comprising at least one isoxazoline active agent, a pharmaceutically acceptable polymer. Cady teaches, instant polycaprolactones (PCL) at page 19 [0346]-[0347] as inactive ingredient pharmaceutically acceptable polymer. Also see Cady claims in particular claims 32 and 38.
Rohdich , titled “ Field effectiveness and safety of fluralaner plus moxidectin (Bravecto Plus) against ticks and fleas: a European randomized, blinded, multicenter field study in naturally-infested client-owned cats” teach a
spot-on formulation containing fluralaner (280 mg/ml) plus moxidectin (14 mg/ml) (Bravecto® Plus) has been developed to provide broad spectrum parasite protection for cats. The effectiveness and safety of this product against ticks and fleas was assessed in a randomized, controlled, 12-week study in client-owned cats in Germany and Spain.
Rohdich at page 2 column B and at page 3, column B dose combinations of fluralaner and moxidectin.
The active ingredients fluralaner and moxidectin fall under the scope of the instant base claim, see dependent claim 5 and dependent claim 2.
While Rohdich teach oral and topical formulation, Rohdich is silent with respect to injectable formulations,
Wendt teach antiparasitic injectable formulations of moxidectin and fluralaner at page 22 [0299] and page 23 [0300] and at page 106 claim 13.
Kim teaches
microparticles containing moxidectin and a biodegradable polymer, wherein the microparticles containing moxidectin have a form allowing a moxidectin drug to be uniformly distributed in spherical biodegradable polymer particles, and the average particle diameter of the microparticles is 80 to 130 μm. invention relates to: sustained release microparticles capable of continuously maintaining a heartworm disease prevention. Se section under Brief Description for method making such formulation.
Lengyel teaches microspheres for advanced drug delivery. Microparticles, microspheres, and microcapsules are widely used constituents of multiparticulate drug delivery systems, offering both therapeutic and technological advantages.
Microparticles are generally in the 1–1000 µm size range, serve as multiunit drug delivery systems with well-defined physiological and pharmacokinetic benefits. Lengyel teaches in this Review article, many examples for the use of plant, animal, or microbial-origin biopolymers are propitious; semi-synthetic cellulose derivatives and biodegradable or non-biodegradable synthetic polymers are used as well.
At bottom of page 1 onto page 2, Lengyel teaches that such drug delivery methods offers outstanding advantages:
PNG
media_image1.png
36
570
media_image1.png
Greyscale
PNG
media_image2.png
170
540
media_image2.png
Greyscale
Lengyel concludes at page 24 of 31, that in the past few decades, numerous microparticulate formulations gained therapeutical and diagnostical significance. A great number of polymers have been tested, of which several have been proved effective. To accomplish the traditional coacervation, new methods have been developed (freeze drying, spray drying, microfluidic flow-focusing, lithography, etc.). The various created structures offer a large potential for the fine-tuning of drug release mechanisms and the optimization of the pharmacokinetic profile.
Rohdich , titled “ Field effectiveness and safety of fluralaner plus moxidectin (Bravecto Plus) against ticks and fleas: a European randomized, blinded, multicenter field study in naturally-infested client-owned cats” teach a
spot-on formulation containing fluralaner (280 mg/ml) plus moxidectin (14 mg/ml) (Bravecto® Plus) has been developed to provide broad spectrum parasite protection for cats. The effectiveness and safety of this product against ticks and fleas was assessed in a randomized, controlled, 12-week study in client-owned cats in Germany and Spain.
Rohdich at page 2 column B and at page 3, column B dose combinations of fluralaner and moxidectin.
The active ingredients fluralaner and moxidectin fall under the scope of the instant base claim, see dependent claim 5 and dependent claim 2.
While Rohdich teach oral and topical formulation, Rohdich is silent with respect to injectable formulations,
Wendt teach antiparasitic injectable formulations of moxidectin and fluralaner at page 22 [0299] and page 23 [0300] and at page 106 claim 13.
Kim teaches
microparticles containing moxidectin and a biodegradable polymer, wherein the microparticles containing moxidectin have a form allowing a moxidectin drug to be uniformly distributed in spherical biodegradable polymer particles, and the average particle diameter of the microparticles is 80 to 130 μm. invention relates to: sustained release microparticles capable of continuously maintaining a heartworm disease prevention. Se section under Brief Description for method making such formulation.
Lengyel teaches microspheres for advanced drug delivery. Microparticles, microspheres, and microcapsules are widely used constituents of multiparticulate drug delivery systems, offering both therapeutic and technological advantages.
Microparticles are generally in the 1–1000 µm size range, serve as multiunit drug delivery systems with well-defined physiological and pharmacokinetic benefits. Lengyel teaches in this Review article, many examples for the use of plant, animal, or microbial-origin biopolymers are propitious; semi-synthetic cellulose derivatives and biodegradable or non-biodegradable synthetic polymers are used as well.
At bottom of page 1 onto page 2, Lengyel teaches that such drug delivery methods offers outstanding advantages:
PNG
media_image1.png
36
570
media_image1.png
Greyscale
PNG
media_image2.png
170
540
media_image2.png
Greyscale
Lengyel concludes at page 24 of 31, that in the past few decades, numerous microparticulate formulations gained therapeutical and diagnostical significance. A great number of polymers have been tested, of which several have been proved effective. To accomplish the traditional coacervation, new methods have been developed (freeze drying, spray drying, microfluidic flow-focusing, lithography, etc.). The various created structures offer a large potential for the fine-tuning of drug release mechanisms and the optimization of the pharmacokinetic profile.
As such there is extensive overlap between the conflicting claims.
Claims 1, 2, 4, 5, 15, 16, 18, 20-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 6-14
of copending Application No. 16761670 (reference application) further in view of Rohdich, Parasites & Vectors (2018) 11:598, 1-11, Wendt, US 20160296499, Cady US 20170020848, Kim, KR 20190027349, Lengyel, Sci. Pharm. 2019, 87, 20, 1-31, Corace US 20180177730 and Freehauf WO 2019091936. Although the claims at issue are not identical, they are not patentably distinct from each other as explained below:
The difference here is the presence of microspheres of polycaprolactones (PCL).
All other active and inactive agents are present in both claims.
(For more on this see Rohdich, Wendt, Kim and Lengyel see below)
Cady teaches injectable formulations for combating parasites in animals, comprising at least one isoxazoline active agent, a pharmaceutically acceptable polymer. Cady teaches, instant polycaprolactones (PCL) at page 19 [0346]-[0347] as inactive ingredient pharmaceutically acceptable polymer. Also see Cady claims in particular claims 32 and 38.
Rohdich , titled “ Field effectiveness and safety of fluralaner plus moxidectin (Bravecto Plus) against ticks and fleas: a European randomized, blinded, multicenter field study in naturally-infested client-owned cats” teach a
spot-on formulation containing fluralaner (280 mg/ml) plus moxidectin (14 mg/ml) (Bravecto® Plus) has been developed to provide broad spectrum parasite protection for cats. The effectiveness and safety of this product against ticks and fleas was assessed in a randomized, controlled, 12-week study in client-owned cats in Germany and Spain.
Rohdich at page 2 column B and at page 3, column B dose combinations of fluralaner and moxidectin.
The active ingredients fluralaner and moxidectin fall under the scope of the instant base claim, see dependent claim 5 and dependent claim 2.
While Rohdich teach oral and topical formulation, Rohdich is silent with respect to injectable formulations,
Wendt teach antiparasitic injectable formulations of moxidectin and fluralaner at page 22 [0299] and page 23 [0300] and at page 106 claim 13.
Kim teaches
microparticles containing moxidectin and a biodegradable polymer, wherein the microparticles containing moxidectin have a form allowing a moxidectin drug to be uniformly distributed in spherical biodegradable polymer particles, and the average particle diameter of the microparticles is 80 to 130 μm. invention relates to: sustained release microparticles capable of continuously maintaining a heartworm disease prevention. Se section under Brief Description for method making such formulation.
Lengyel teaches microspheres for advanced drug delivery. Microparticles, microspheres, and microcapsules are widely used constituents of multiparticulate drug delivery systems, offering both therapeutic and technological advantages.
Microparticles are generally in the 1–1000 µm size range, serve as multiunit drug delivery systems with well-defined physiological and pharmacokinetic benefits. Lengyel teaches in this Review article, many examples for the use of plant, animal, or microbial-origin biopolymers are propitious; semi-synthetic cellulose derivatives and biodegradable or non-biodegradable synthetic polymers are used as well.
At bottom of page 1 onto page 2, Lengyel teaches that such drug delivery methods offers outstanding advantages:
PNG
media_image1.png
36
570
media_image1.png
Greyscale
PNG
media_image2.png
170
540
media_image2.png
Greyscale
Lengyel concludes at page 24 of 31, that in the past few decades, numerous microparticulate formulations gained therapeutical and diagnostical significance. A great number of polymers have been tested, of which several have been proved effective. To accomplish the traditional coacervation, new methods have been developed (freeze drying, spray drying, microfluidic flow-focusing, lithography, etc.). The various created structures offer a large potential for the fine-tuning of drug release mechanisms and the optimization of the pharmacokinetic profile.
Rohdich , titled “ Field effectiveness and safety of fluralaner plus moxidectin (Bravecto Plus) against ticks and fleas: a European randomized, blinded, multicenter field study in naturally-infested client-owned cats” teach a
spot-on formulation containing fluralaner (280 mg/ml) plus moxidectin (14 mg/ml) (Bravecto® Plus) has been developed to provide broad spectrum parasite protection for cats. The effectiveness and safety of this product against ticks and fleas was assessed in a randomized, controlled, 12-week study in client-owned cats in Germany and Spain.
Rohdich at page 2 column B and at page 3, column B dose combinations of fluralaner and moxidectin.
The active ingredients fluralaner and moxidectin fall under the scope of the instant base claim, see dependent claim 5 and dependent claim 2.
While Rohdich teach oral and topical formulation, Rohdich is silent with respect to injectable formulations,
Wendt teach antiparasitic injectable formulations of moxidectin and fluralaner at page 22 [0299] and page 23 [0300] and at page 106 claim 13.
Kim teaches
microparticles containing moxidectin and a biodegradable polymer, wherein the microparticles containing moxidectin have a form allowing a moxidectin drug to be uniformly distributed in spherical biodegradable polymer particles, and the average particle diameter of the microparticles is 80 to 130 μm. invention relates to: sustained release microparticles capable of continuously maintaining a heartworm disease prevention. Se section under Brief Description for method making such formulation.
Lengyel teaches microspheres for advanced drug delivery. Microparticles, microspheres, and microcapsules are widely used constituents of multiparticulate drug delivery systems, offering both therapeutic and technological advantages.
Microparticles are generally in the 1–1000 µm size range, serve as multiunit drug delivery systems with well-defined physiological and pharmacokinetic benefits. Lengyel teaches in this Review article, many examples for the use of plant, animal, or microbial-origin biopolymers are propitious; semi-synthetic cellulose derivatives and biodegradable or non-biodegradable synthetic polymers are used as well.
At bottom of page 1 onto page 2, Lengyel teaches that such drug delivery methods offers outstanding advantages:
PNG
media_image1.png
36
570
media_image1.png
Greyscale
PNG
media_image2.png
170
540
media_image2.png
Greyscale
Lengyel concludes at page 24 of 31, that in the past few decades, numerous microparticulate formulations gained therapeutical and diagnostical significance. A great number of polymers have been tested, of which several have been proved effective. To accomplish the traditional coacervation, new methods have been developed (freeze drying, spray drying, microfluidic flow-focusing, lithography, etc.). The various created structures offer a large potential for the fine-tuning of drug release mechanisms and the optimization of the pharmacokinetic profile.
As such there is extensive overlap between the conflicting claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The art made of record and not relied upon is considered pertinent to applicant's
disclosure.
Feldman, Understanding ‘Evergreening’ : Making Minor Modifications Of Existing
Medications To Extend Protections, Health Affairs June 2022 41:6, 801-804
Dwivedi, Evergreening: A deceptive device in patent rights, Technology in Society 32
(2010) 324–330.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Previously presented rejection of 1, 4, 15, 16, 18, 20, 21, 25-27 rejected under 35 U.S.C. 103 as being unpatentable over Rohdich, Parasites & Vectors (2018) 11:598, 1-11, Wendt, US 20160296499, Cady US 20170020848, Kim, KR 20190027349 and Lengyel, Sci. Pharm. 2019, 87, 20, 1-31.
Rohdich , titled “ Field effectiveness and safety of fluralaner plus moxidectin (Bravecto Plus) against ticks and fleas: a European randomized, blinded, multicenter field study in naturally-infested client-owned cats” teach a
spot-on formulation containing fluralaner (280 mg/ml) plus moxidectin (14 mg/ml) (Bravecto® Plus) has been developed to provide broad spectrum parasite protection for cats. The effectiveness and safety of this product against ticks and fleas was assessed in a randomized, controlled, 12-week study in client-owned cats in Germany and Spain.
Rohdich at page 2 column B and at page 3, column B dose combinations of fluralaner and moxidectin.
The active ingredients fluralaner and moxidectin fall under the scope of the instant base claim, see dependent claim 5 and dependent claim 2.
While Rohdich teach oral and topical formulation, Rohdich is silent with respect to injectable formulations,
Wendt teach antiparasitic injectable formulations of moxidectin and fluralaner at page 22 [0299] and page 23 [0300] and at page 106 claim 13.
Cady teaches
injectable formulations for combating parasites in animals, comprising at least one isoxazoline active agent, a pharmaceutically acceptable polymer. Cady teaches, instant PCL polycaprolactones at page 19 [0346]-[0347] as inactive ingredient pharmaceutically acceptable polymer. Also see Cady claims in particular claims 32 and 38.
Kim teaches
microparticles containing moxidectin and a biodegradable polymer, wherein the microparticles containing moxidectin have a form allowing a moxidectin drug to be uniformly distributed in spherical biodegradable polymer particles, and the average particle diameter of the microparticles is 80 to 130 μm. invention relates to: sustained release microparticles capable of continuously maintaining a heartworm disease prevention. Se section under Brief Description for method making such formulation.
Lengyel teaches microspheres for advanced drug delivery. Microparticles, microspheres, and microcapsules are widely used constituents of multiparticulate drug delivery systems, offering both therapeutic and technological advantages.
Microparticles are generally in the 1–1000 µm size range, serve as multiunit drug delivery systems with well-defined physiological and pharmacokinetic benefits. Lengyel teaches in this Review article, many examples for the use of plant, animal, or microbial-origin biopolymers are propitious; semi-synthetic cellulose derivatives and biodegradable or non-biodegradable synthetic polymers are used as well.
At bottom of page 1 onto page 2, Lengyel teaches that such drug delivery methods offers outstanding advantages:
PNG
media_image1.png
36
570
media_image1.png
Greyscale
PNG
media_image2.png
170
540
media_image2.png
Greyscale
Lengyel concludes at page 24 of 31, that in the past few decades, numerous microparticulate formulations gained therapeutical and diagnostical significance. A great number of polymers have been tested, of which several have been proved effective. To accomplish the traditional coacervation, new methods have been developed (freeze drying, spray drying, microfluidic flow-focusing, lithography, etc.). The various created structures offer a large potential for the fine-tuning of drug release mechanisms and the optimization of the pharmacokinetic profile.
As such the combination of active ingredients macrocyclic lactone-isooxazoline (and the concentration needed), inactive ingredient polymer carrier PCL in microspheres are all known in the art. Specific limitation of amount of the active ingredient is not found in the cited references. Optimizing particle size (and particle size distribution) in injectable formulations is routinely practiced in the art, see for example US 7871642 (claims). “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. As such, one of skill in the art would have reasonable expectation of success in arriving at the injectable microspheres comprising combination of previously known components at the concentrations and particle size as instantly limited. As per Examination guidelines, differences in concentrations will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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).
Note: US Application No. 17327929 equivalent to Cody 20170020848 cited in this action has a NOA filed on 04/28/2026.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NIZAL S CHANDRAKUMAR/ Primary Examiner, Art Unit 1625
Prosecution Insights