DETAILED ACTION
Status of Application
Claims 1-9, filed 10/10/2024, are pending in this action. Claims 1-9 are currently under consideration.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Priority
This application is a 371 of PCT/KR2022/005968, filed April 27, 2022, which claims benefit of foreign priority to KR10-2022-0045772, filed April 13, 2022. No English translations of the certified copies of priority application(s) have been received. Failure to provide a certified translation may result in no benefit being accorded for the non-English application. 37 CFR 41.154(b) and 41.202(e).
Inventorship
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.
Specification
The lengthy specification (51 pages, exclusive of claims), filed 10/10/2024, is objected to because of the following informalities: List of prior art documents (Page 2) should be removed from the specification. MPEP 608.01. If applicant wants these references be printed in the patent, he/she should submit them in the form of information disclosure statement to be considered by examiner. Appropriate correction is required.
Drawings
The drawings, filed 10/10/2024, are objected to because in Figs. 1-3 x-axis and/or y-axis are not identified. Further, in Figs. 4-18 the scale of the particle size is not clearly delineated/shown. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Information Disclosure Statement
The information disclosure statements, filed 10/10/2024, 05/01/2026, 11/12/2025, 09/30/2025, are acknowledged and have been considered. Please see the attached initialed PTO-1449.
Foreign language references listed in the information disclosure statement(s), for which no English translation has been provided, have not been considered. If an English abstract has been provided or available for a foreign language document then only the English abstract has been considered.
Claim Objections
Claims 1, 3-4, 6-8 are objected to because of the following informalities:
Claim 1 comprises the typographic error “viscosity of 0.1 dl/g to 1 dl/g” that needs to be corrected to “viscosity of from 0.1 dl/g to 1 dl/g”. Similar is applied to the limitation “diameter of 60 to 110 µm” recited in claim 1 as well as to claims 3, 4, 7, 8.
The acronyms “CV” recited in claim 3, “PLA”, “PLGA” recited in claim 6 should be removed, because said acronyms are not used in subsequent claims.
Claim 4 comprises the typographic error “biodegradable and moxidectin” that needs to be corrected to “biodegradable polymer and moxidectin” or clarified.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-9 are 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 pre-AIA the applicant regards as the invention.
Claim 1 recites the limitation “Microparticles containing” that is not reasonably clear. In the present case, it is unclear what the term “containing” does imply – consisting of, OR comprising. See MPEP 2111.03. Therefore, the metes and bounds of the claimed subject matter are not reasonably clear. Similar is applied to claims 4, 9. Clarification is required.
Claim 1 recites the limitation “microparticles have an average diameter of 60 to 110 µm” that is unclear and indefinite. First, given that the ranges are shown with and without units of measurements, the metes and bounds of the claim are not reasonably clear. Second, where a claimed value (i.e., particle size/diameter) varies with its method of measurement and several alternative methods of measurement are available, the value is indefinite when the claim fails to concurrently recite the method of measurement used to obtain it. Honeywell Intl. v. Intl. Trade Commn., 341 F.3d 1332, 1340 (Fed. Cir. 2003). It is well known in the field that there is no a comprehensive standard for particle size measurements, and different methods of particle size analysis yield different estimates of particle size for the same sample (see Wikipedia and references cited wherein), i.e., experimental estimates of particle sizes/diameters depend on methods of measurements used to obtain it. Similar is applied to claim 3 regarding the limitation “coefficient of variation”. Clarification is required.
Claim 2 recites the term “uniformly”, which renders the claim indefinite. This term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Similar is applied to term “sustainably” recited in claim 4. Clarification is required.
Claim 5 recites the limitation “microparticles release moxidectin sustainably over 3 months or more” that is not reasonably clear, because claimed boundaries are not clearly delineated. Can it be 1 year? Clarification is required.
Claims 7, 8 are unclear and indefinite, because said claims define “macroparticles” by a process of use including such steps as (i) "mixing with a suspending solution”, (ii) “administering the injectable formulation to a plurality of beagle dogs”, and one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Furthermore, claim 7 is unclear and indefinite, because parameter “n”, to be used in disclosed calculations, is not defined. Clarification is required.
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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kim, US 2020/0375902 (cited in IDS), in view of Hudson et al., US 2011/0142906 A1 (hereinafter referred to as Hudson), Guimberteau et al., US 2020/0222440 A1 (cited in IDS; hereinafter referred to as Guimberteau), and Winchester et al., US 2011/0204533 A1 (hereinafter referred to as Winchester).
Kim teaches microparticles having an average particle diameter of 80-130 μm and comprising moxidectin and a biodegradable polymer, e.g., polylactide, poly(lactide-co-glycolide), polyphosphazine, polyiminocarbonate, polyphosphoester, polyanhydride, polyorthoester, polycaprolactone, polyhydroxyvalerate, polyhydroxybutyrate, polyamine acid, and a combination thereof (Claims 1, 4; Abstract; Para. 0015, 0022, 0047 as applied to claims 1, 6).
Kim teaches that moxidectin is uniformly distributed in spherical biodegradable polymer microparticles (Para. 0012, 0041 as applied to claim 2).
Kim teaches that the microparticles include the biodegradable polymer and moxidectin at a weight ratio of 4:1 to 9:1 (Claim 2; Para. 0013 as applied to claim 4).
Kim teaches that said microparticles may release moxidectin continuously for 3 months to 6 months (Claim 3; Para. 0014, 0031 as applied to claim 5).
Kim teaches that that said microparticles can be administrated to an animal through injection (Abstract; Para. 0032 as applied to claim 9).
Kim does not teach specifically teaches to use biodegradable polymers having intrinsic viscosities of 0.1-1 dl/g (claim 1).
Hudson teaches formulations comprising a biodegradable polymer, e.g., polylactide, poly(lactide-co-glycolide), polyphosphazine, polyphosphoester, polyanhydride, polyorthoester, polycaprolactone, polyhydroxyvalerate, polyhydroxybutyrate, polyamine acid, and a bioactive agent, e.g., moxidectin, wherein said formulations release the bioactive agent into a fluid or tissue of a subject effectively providing a desired release profile of bioactive agents as the polymer biodegrades (Para. 0035-0038, 0051). Hudson teaches that the molecular weight of said polymer(s) can be important given that molecular weight influences the biodegradation rate of a biodegradable polymer (Para. 0032), and provide examples of using poly(DL-lactide) and/or poly(DL-lactide-co-glycolide) having an inherent viscosity of 0.26 -0.37 dL/g (Para. 0076-0086).
Guimberteau teaches injectable compositions comprising an effective amount of a macrocyclic lactone, e.g., moxidectin, and a bioresorbable polymer, e.g., polylactides, polycaprolactones, polyorthoesters, polyiminocarbonates, polyphosphoesters, polyorthoesters, polyanhydrides, polyorthoesters, polyhydroxyvalerates, polyhydroxybutyrates, polyamino acids, and the use of said composition in preventing and/or treating parasites infestations in non-human mammals, especially pets and providing extended drug release profile (Abstract; Para. 0045, 0046, 0065, 0075). Guimberteau specifically teaches the use of polylactide having viscosity of 0.25-0.35 dL/g (Para. 0067-0068).
Winchester teaches microparticles that can be injected into a living subject (Para. 0035), wherein said microparticles include an active agent, e.g., moxidectin (Para. 0076) and such degradable polymers as polylactides, poly(lactide-co-glycolide), polycaprolactone, polyorthoester, polyphosphazine, polyhydroxybutyrate, polyhydroxyvalerate, polyphosphoester, polyanhydride (Para. 0065). Winchester provide examples of using polylactide having intrinsic viscosity of 0.36 dL/g (Para. 0092); and/or poly(lactide-co-glycolide intrinsic viscosity of 0.4 dL/g (Para. 0099).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to control intrinsic viscosity of biodegradable polymers as taught by Hudson, Guimberteau and Winchester preparing microparticles as taught by Kim. One would do so with expectation of beneficial results, because the cited prior art teaches that controlling molecular weight of biodegradable polymers in used (e.g., characterized by the intrinsic viscosity) allow controlling polymer degradation rate and provide a desired drug release rate. Claims 3, 7-8 are rejected as being dependent on rejected base claim. Applicant is advised to clarify the claim language/scope, the structure of the claimed compositions and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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