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 .
Response to Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9, 13 and 14 in the reply filed on 11/24/2025 is acknowledged.
Claims 10-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/24/2025.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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) 1-9, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Grune et al. (US Patent 2016/0338923) in view of Matsuda et al. (US Patent 5,650,172).
Grune et al. disclose liposome composition comprising natural phospholipids or lecithin (([0045]). Grune et al. disclose the composition comprises black pepper and clove is present in an amount of between about 0.1% and about 10% ([0047]). Grune et al. disclose the composition is a carrier for food and /or pharmaceutical grade products (reference claim 2). Grune et al. disclose the composition comprises tocopherol acetate ([0068]).
Grune et al. differs from the instant claims insofar as they do not disclose a ratio of bioactive to vesicle.
Matsuda et al. disclose a fat emulsion of fat microparticles, which can be lyophilized and easily and rapidly reconstituted (ABSTRACT). Matsuda et al. disclose a fat emulsion comprising 48 g lecithin, 5g of oleic acid, and 5 g of tocopherol acetate, which is a ratio of 9.6:1:1 and meets the limitation of instant claim 4 (EXAMPLE 10). Matsuda et al. disclose the fat emulsion has a mean particle diameter of about 80 nm.
It would have been obvious to one or ordinary skill in the art to have used the pharmaceutical composition of Matsuda with the carrier of Grune since Grune teaches the liposomal carrier for food and pharmaceutical products. One of ordinary skill in the art would have by routine experimentation found the claimed ratio of bioactive to vesicle and to have formulated the vesicles in the claimed size range. The composition suggested by the references would be capable to be used for the intended use of claim 13 and 14.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANNETTE HOLLOMAN whose telephone number is (571)270-5231. The examiner can normally be reached Monday-Friday 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NANNETTE HOLLOMAN/Primary Examiner, Art Unit 1612