DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
INFORMATION DISCLOSURE STATEMENT
2. Information Disclosure Statements filed 10/10/2024, 11/12/2025, 1/23/2026, 4/20/2026 and 6/16/2026 are acknowledged.
Claim Rejections- 35 USC § 103
3. 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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (EP 3733164B1) in view of Albayrak (US 20200030245).
Kim (EP 3733164B1) (hereinafter Kim) disclose in claim 5, a method for preparing microparticles comprising moxidectin, the method comprising:
1) preparing a first mixture by dissolving a biodegradable polymer and moxidectin in an organic solvent (e.g., oil phase);
2) preparing a second mixture by dissolving a surfactant in water (e.g., water phase);
3) infusing the first mixture in Step 1) into a microchannel in a straight-line direction and allowing the first mixture to flow;
4) preparing microparticles in which the moxidectin drug is uniformly distributed in spherical biodegradable polymer particles by infusing the second mixture in Step 2) into a microchannel formed on both side surfaces or one side surface and allowing the second mixture to flow so as to form an intersection point with a microchannel through which the first mixture in Step 3) flows in a straight-line direction, and intersecting a flow of the first mixture in a straight-line direction with a flow of the second mixture;
5) collecting the microparticles produced at the intersection point in Step 4);
6) evaporating and removing an organic solvent present in the microparticles collected in Step 5) by stirring the microparticles; and
7) washing and drying the microparticles in Step 6), wherein the microparticles have an average particle diameter of 80 to 130 µm,
wherein the first mixture in Step 1) comprises the biodegradable polymer and the moxidectin at a weight ratio of 4 : 1 to 9 : 1, and the biodegradable polymer is poly(lactide-co-glycolide)(PLGA) and the microparticles are configured to continuously release moxidectin for 3 months to 6 months.
The reference teaches that the microparticles are uniformly formed and the shape is spherical (para 0078, claim 1). The weight ratio of the biodegradable polymer and the moxidectin at a weight ratio of 4 : 1 to 9 : 1. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). The instant specification teaches that the coefficient of variation is a value indicating the monodispersity of particle size distribution, and a smaller CV value indicates a more uniform particle size and Kim teaches the microparticles have a uniform size during application through injection and is uniformly distributed in spherical biodegradable polymer microparticles therefore it is uniform in size and expected to have a coefficient of variation value that overlaps the instant claims and it is uniform in particle size and thus would have a smaller CV value. While the flow rate is not expressly disclosed, Kim discloses that in order to allow the second mixture forming an intersection point with the flow of the first mixture to flow at a faster flow rate than the first mixture to be infused into the microchannel in a straight-line direction, the second mixture is allowed to flow under a higher pressure condition. As described above, the second mixture having a relatively faster flow rate compresses the first mixture at a point where the flow of the first mixture and the flow of the second mixture meet each other by varying the flow rates of the first mixture and the second mixture and making the flow rate of the second mixture faster than the flow rate of the first mixture, and in this case, due to repulsive force between the first mixture and the second mixture, the biodegradable polymer and moxidectin in the first mixture form spherical microparticles, and more specifically, microparticles in which moxidectin is uniformly distributed in the spherical biodegradable polymer are formed. Step 5)(S500) is a step of collecting microparticles, and prevents aggregation of initially produced microparticles by collecting the microparticles in a bath comprising the second mixture (para 0052-0055).
While the Kim reference does not teach a suspending solution, the reference teaches the microparticles are to be administered through injection (para 0032) and thus would need to be suspended in a solution for injection.
Kim does not teach that the biodegradable polymer has an intrinsic viscosity of 0.1 dl/g to 1 dl/g.
Albayrak (US 20200030245) (Albayrak) discloses it will be appreciated by the skilled reader that the degradation rate of the nano- and/or microparticles of the invention can be influenced by the molecular weight of the polymer. Polymers of different molecular weights (or inherent viscosities) can be mixed to yield a desired degradation profile. Generally, polymers with an intrinsic viscosity in the range of 0.1 to 3 dL/g, preferably to 2 dL/g (0.1% (w/v), chloroform, at 25° C.) are used (para 0044). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to optimize the intrinsic viscosity. One would have been motivated to do so in view of Albayrak which discloses that degradation rate of the microparticles can be influenced by the molecular weight of the polymers and polymers of different molecular weights can be mixed to yield the desired degradation profiles (para 0044).
DOUBLE PATENTING
4. 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.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11931461. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to microparticles which contain biodegradable polymer and the polymer can be those such as PLGA. The difference being that the instant application teaches a carrier however, the copending ‘461 patent discloses in the specification that the administration is to be administered through injection would have a suspending solution for the microparticles in order to administer the microparticles.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11504688. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to methods of preparing microparticles which contain biodegradable polymer and the polymer can be those such as PLGA. The difference being that the instant application teaches the drug moxidectin which is an antiparasitic however, the copending ‘688 patent discloses drugs include those such as palonosetron, minocycline, liraglutide, exenatide, olanzapine, aripiprazole, donepezil, memantine, lanreotide, octreotide, and naltrexone, however, these microparticles are produced by a similar process and it would be obvious to one of ordinary skill in the art to prepare the microparticles of the desired drug for the desired treatment (e.g., antiparasitic or antibiotic).
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-7 of U.S. Patent No. 12016897. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to methods of preparing microparticles which contain biodegradable polymer and the polymer can be those such as PLGA. The difference being that the instant application teaches the drug moxidectin which is an antiparasitic however, the copending ‘897 patent discloses drugs such as leuprlide, however, these microparticles are produced by a similar process and it would be obvious to one of ordinary skill in the art to prepare the microparticles of the desired drug for the desired treatment.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Application No. 18856000. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to moxidectin microparticles which contain biodegradable polymer and the polymer can be those such as PLGA.
CORRESPONDENCE
5. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAH AL-AWADI/ Primary Examiner, Art Unit 1615
