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 .
Response to Argument
The response filed on 5/18/26 has been entered.
Applicant’s arguments filed 5/18/26 have been fully considered but they are not deemed to be persuasive.
Claims 1-14 are pending under examination in this office action.
Maintained 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.
Applicant argues that Yano’s teaching involves using PHA as an encapsulation material to achieve sustained release of drugs or other substances, which belongs to the field of drug sustained release; while the present application belongs to the field of dermal fillers. Although both involve microspheres or microparticles, they actually belong to different application technical fields and address different technical problems.
Yano aims to prepare PHA drug-loaded microcapsules/microparticles, focusing on sustained release and imaging but it does not address the injectability and aggregation issues of the particles. In contrast, the present application aims to prepare injectable, non- agglomerated PHA microspheres to solve the technical problem of needle clogging. As a result, the technical problems to be solved are completely different. Applicant’s strongest argument is that Yano here involves the preparation of a w/o/w emulsion, where an external aqueous phase containing an emulsifier is added to an already prepared w/o emulsion to form another w/o/w emulsion. In contrast, the method of claim 1 involves adding an organic phase dropwise into an aqueous phase to form an o/w emulsion. As a result of their being directed to completely different final products, the disclosure in paragraph [0398] of Yano cannot provide effective technical guidance to result in the solution of the present application..
In response, after careful consideration, Applicant’s argument is found unpersuasive for the following reason; one of ordinary skill in the art would have been motivated to use hyaluronic acid as Yano clearly teaches the use of hyaluronic acid (see 0398). Specifically Yano teaches 1) dissolving PHA in an organic solvent such as chloroform, and emulsifying it by adding an aqueous solution to obtain an w/o emulsion, 2) if necessary charging the emulsion in a large amount of water and emulsifying it to obtain a w/o/w emulsion, and 3) removing the organic solvent by, for example, evaporation under a reduced pressure to precipitate small spherical particles, which are subjected to recovery and drying, if necessary (see 0087). Additionally the reference teaches the injection preparation can be produced by dispersing the aforementioned particulate construct in aqueous or oily dispersion medium thus depends on the skilled artisan end use.
Thus the unexpected result claimed is truly not unexpected because when hyaluronic acid is used in the molecular weight required the result is expected to be the same.
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 extension fee 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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 5/26/26
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