DETAILED ACTION
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 . 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.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-4, 6-11, and 16-24) in the reply filed on 12 June 2026 is acknowledged. Claims 12-15 and 25-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
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 1-4, 6-11, and 16-24 are rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (US Patent Application Publication 2020/0297651).
Ma et al. discloses pharmaceutical particles comprising a biodegradable polymer and a fibrate (abstract). The particles may be micro-sized or nano-sized (paragraph [33]). One example disclosed has microparticles of fenofibrate with a blend of two PLGA polymers (example 2). These microparticles have a size outside the range instantly recited. However, broader ranges for the microparticle size are disclosed (1 to 100 microns) (paragraph [47]). This range overlaps the instantly recited range. And in cases involving overlapping ranges, where the instantly claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. See MPEP 2144.05. Thus, the microparticles recited by independent instant claim 1 and instant claim 9 are rendered prima facie obvious.
Instant claims 2-3 and 16-17 further limit the molecular weight and/or viscosity of the PLGA polymers. Ma et al. does not state the viscosity of the polymers, but does suggest molecular weights (2.5 to 500 kDa) (paragraph [83]). The molecular weight range overlaps the ranges instantly recited. Further, with respect to the viscosity, PLGA polymers with a molecular weight of 13.5 kDa and 68 kDa have viscosities within the range instantly recited (0.21 dl/g and 0.60 dl/g, respectively). This is demonstrated by the instant specification (table 2). Thus, the molecular weight range disclosed by Ma et al. also overlaps the viscosity ranges instantly recited.
Instant claims 4 and 18-19 recite limitations to the ratio of the lactic acid and the glycolic acid in the PLGA polymer. The PLGA in the examples has a 50:50 ratio (paragraph [96]). Other ratios are not explicitly disclosed. However, relative ratios are suggested as being a variable which can be modified in order to be adjusted in order to prolong the release of the agent from the particles (paragraphs [83] & [135]). And it is noted that with respect to amounts, obvious to try is an appropriate motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. See MPEP 2144.05(II)(B). And the requirements for an obvious to try rationale are present in the instant situation, as there is a recognized problem in the art (as discussed by Ma et al.), a finite number of identified, predictable potential solutions, and a finding that one of ordinary skill in the art could have persuade potential solutions with a reasonable expectation of success. There are no functional limitations in the claims, and there is no evidence on the record that the instantly claimed amounts and ranges are critical to achieving any particular outcome. See MPEP 2143(I)(E).
Instant claim 6 recites a limitation to the size of the microparticles, and the size range cited above overlaps the instantly recited size range.
Instant claims 7 and 20-21 recite limitations to the amount of the fenofibrate in the microparticle. And Ma et al. discusses amounts for the loading of the fenofibrate (paragraph [84]) in amounts which overlap the instantly recited amount.
Instant claims 8 and 22 recite a combination of the above discussed limitations, and is rendered prima facie obvious for the reasons put forth above.
Instant claim 10 recites that the formulation is injectable, and Ma et al. discloses such an administration (paragraph [89]).
Instant claims 11 and 23-24 recite limitations to the time for the release, and Ma et al. discloses that the particles have a delayed release of the fibrate in a range of from 1 to 12 months (abstract).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian Gulledge whose telephone number is (571) 270-5756. The examiner can normally be reached Monday - Friday 7am - 4pm.
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/Brian Gulledge/Primary Examiner, Art Unit 1699
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