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 .
Status of Claims
Claims 1-14 are pending and under examination in this office action.
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed 4/4/25; 1/8/25 and 4/9/25. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
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.
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.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yano et al. (US 2003/019443).
Yano teaches preparation of polyhydroxyalkanoate (i.e. PHA, see 0067) microspheres (see same) comprising dissolving the PHA in an organic solvent (see 0065, 0087) wherein the organic solvent is chloroform (see 0087, as required by instant claim 3) to obtain an oil phase (see abstract, claim 30) wherein the PHA is from 0.01-60% depending on the PHA (see 0393)with a molecular weight of the PHA is from 1-10 (see 0124), dissolving hyaluronic acid in water (see 0398) with a concentration of 0.01% (see 0398), stirred and evaporated (as required by instant claim 1, see 0088), with a mixing ratio of 1:1-100 (see 0348 as required by instant claim 2), with a magnetic stirrer (see 0358) at a stirring rate from 50-3,000 rpm (see 0409, as required by instant claim 8) at a temperature from 15-40 degrees (see 0296, as required by instant claim 11). With regards to the molecular weight (as required by instant claims 1, 4-5), Yano teaches that the molecular weight of PHA can range from 1000-10million, preferable 1 to 5 (see 0124), therefore it is within the purview of the skilled artisan to use the appropriate PHA for the intended invention. Yano also teaches stirring from 1 minute to 24 hours, therefore one of ordinary skill in the art would have a good reason to pursue the known options for the preparation and determine the particular conventional working condition through experimentation (as required by instant claims 9-10). Jano also teaches the particle size is from 2-200 µM, therefore it is within reason that the particle size is less than 60 since the molecular weight of PHA is within the cited range.
However Yano did not per se teach the freeze drying at temperatures from -80- -20. Nonetheless teaches the preparation using lyophilization (see 0381). Accordingly, the person of ordinary skill in the art, having the laboratory walls would have been motivated to attain the known advantages of freeze drying and lyophilization to and choose between the methods to get a better overall indication of efficacy. Accordingly, the invention as claimed is prima facie obvious. As optimization of parameters is routine practice that would be obvious to a person of ordinary skill. It would havebeen customary for an artisan of ordinary skill to determine the particle size of the active ingredient in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of dosage amount would have been obvious at the time of applicant's invention.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 2/11/26