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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 18 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
This rejection has been withdrawn in view of the Amendment filed 05/06/2026.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-14, 17 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoon et al. WO 2020/080806 A1.
This rejection has been withdrawn in view of the Amendment filed 05/06/2026.
Claims 1, 8-14, 17 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al. WO 2017/186077 A1.
Liu teaches a method for preparing sustained release microparticles, comprising the following steps of: 1) preparing a solid dispersion of a water-soluble drug and a biodegradable and biocompatible water-insoluble polymer; 2) dissolving the prepared solid dispersion into an organic solvent to form an emulsion of the solid dispersion; 3) injecting the obtained emulsion of the solid dispersion into an aqueous solution containing a surfactant to form a uniform emulsion; 4) curing microparticles in the emulsion by means of solvent volatilization or solvent extraction, collecting the microparticles, washing and drying same to obtain the sustained release microparticles. The whole method for preparing the sustained release microparticles is carried out at a normal temperature or a low temperature, the prepared sustained release microparticles have a near-zero order sustained release effect, and the concentration of the drug remains stable during the sustained release period. See Abstract and page 8. Organic solvent having boiling point of less than 100°C is found in page 4. While the reference discloses water-soluble drugs, it is noted that poorly soluble drugs that recited in the present claim 8 can be found in page 5 of the Liu reference, including peptide drugs such as goserelin, triptorelin, octreotide, lanreotide, and liraglutide. Organic solvent includes at least two solvents having boiling point below 20°C is found in page 8. One of the organic solvents includes dichloromethane is found in page 8. Aqueous phase containing surfactant is found in page 9. Ratio between drug and polymer in the range 1:1 to 1:99 is found in claim 11.
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 3, 4, 6, 7, 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. WO 2017/186077 A1, in view of Kim KR 20190004189 A and Kim KR 20180018985 A.
Liu does not teach the claimed stirring steps as recited in claims 15 and 16.
Kim teaches a solvent removal method including steps: stirred at 500 rpm at room temperature, followed by stirring at 300 rpm at 35°C for 16 hours, then the solvent is removed by filtration under reduced pressure, and the microcapsules are washed. The washed microcapsules are dried in an oven at 40°C to completely remove water. See Examples.
Kim teaches a solvent removal method including steps such as solution and network silica to the reaction tank and stirring at 5 to 200 rpm for 12 to 36 hours at room temperature to prepare a rubber-silica suspension, the solvent is removed with stirring at ~ 200 rpm. At this time. The absolute pressure is preferably adjusted to 0.005 to 0.2 bar. When this operation is operated for about 3 to 8 hours, WMB is obtained. When the solvent is removed, the surface becomes soft like popcorn. When it is pressurized at a high temperature, it becomes a plate which is easy to carry and handle. See Examples.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to, by routine experimentation select the stirring parameters that fall within the claimed range in view of the teaching of the Kim references. This is because the Kim references teach a solvent removing can include steps that fall within the claimed range is known in the art. This is because Liu teaches the desirability to remove solvent and washing the microparticle to remove all residual organic solvent with the expectation to obtain a microparticle useful for the delivery of a wide variety of water-insoluble active agents.
While Liu is silent with respect to the properties of the solvent recited in claims 3, 4, and 6, Liu teaches the use of the same solvent, namely, solvent having boiling point of less than 50°C, and dichloromethane. Therefore, the burden is shifted to Applicant to show that the solvents disclosed in the Liu reference do not have the claimed density, polarity and solubility. This is because “products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.").
Response to Arguments
Applicant’s arguments filed 05/06/2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ROBERT A. WAX can be reached at 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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/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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