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 1-20 are pending and under examination in this office action.
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed September 18, 2024. 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) 1-12, 14, 16,18-19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR 19980042501 in view of Fein et al. (WO 2015/013454).
KR 19980042501 et al. teaches promoting skin penetration drugs; comprising beta-3-adrenergic receptor (see sec under Examples of suitable pharmaceutical actives) combined with penetration enhancers such as dimethyl sulfoxide (see translation that can be combined with a monoalcohol such as ethanol (as required by instant claims 1, 4-7 and 18, see translation and claim 40) and excipients (as required by instant claim 2, see translation) prepared as with a gel base containing compound (see translation, see also Example 4, Fig. 13, as required by instant claims 3 and 16))as a topical form (i.e., transdermal, as required by instant claims 1 an12, see translated text) in the form of an ointment, lotion, cream(as required by instant claim 20). With regards to the concentration, the reference teaches have the drug beta-3-adrenergic receptor/drug to 1% or from 0.01-20% the penetration enhancer from 0.1-0.3%. Additionally, the reference teaches the topical formulation comprises hydroxypropyl cellulose (as required by instant claim 4), and teaches that the penetration enhancer or solvent at 30% isopropanol.
However, the reference fails to teach that the beta-3-adrenergic receptor is mirabegron. Also fails to teach the required percentages recited by the claims.
Fein et al. teach that mirabegron is an exemplary beta-3-adrenergic receptor (see 0005; 0074) and that beta-3-adrenergic receptor can be transdermally formulated (see 0008) as cream, ointment (see 0073), comprising a penetration enhancer dimethyl sulfoxide (see 0036) with pharmaceutical excipients (see 0075) and that the glycol ether is diethylene glycol monoethyl ether (see 0036 as required by instant claim 19..
Therefore it would have been obvious to one of ordinary skill in the art to have substituted the beta-3-adrenergic receptor with Fein’s teaching of mirabegron as the beta-3-adrenergic receptor to result in the instant claimed invention with a reasonable expectation of success.
With regards to the concentration, of the mirabegron, dimethyl sulfoxide etc. it is the position of the Examiner that once the concept is known or available, one of ordinary skill in the art would be motivated to find the optimum working range. Also it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine. See In re Aller, 220 F.2d 454 105 USPQ 233,235 (CCPA 1955). Based on that the determination of a dosage having the optimum therapeutic index is well within the level of the ordinary skill in the art, and the artisan would be motivated to determine the optimum amounts to get the maximum effect of the drug hence the reference makes obvious the instant invention.
With regards to instant claims 13-15, once the topical or transdermal formulation is administered it will decrease the quantity of subcutaneous fat, treat obesity, cosmetic method and treating.. tissue as stated in the MPEP 2112.01 "products of identical chemical composition cannot have mutually exclusive properties." 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. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
“Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical
processes, a prima facie case of either anticipation or obviousness has been established.
In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." It is noted that claims 13-15 recites a cosmetic method, all it requires is the administration and therefore a cosmetic method as the cosmetic method does not depend on the preamble for completeness but that the process steps or structural limitations are able to stand alone”. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
Therefore One of ordinary skill in the art would have been motivated to combine and make the necessary adjustment to result in the instant claimed invention and the claims would have been prima-facie obvious at the time the claimed invention was filed.
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 6/1/26
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