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 .
Claim Objections
Claim 3 is objected to because of the following informalities: the term “claim” is missing preceding the “2”. Appropriate correction is required.
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 and 11-23 are rejected under 35 U.S.C. 103 as being unpatentable over Kaufman (U.S. 2016/0263047, disclosed by applicant).
Kaufman teaches placing nutraceuticals into nanodelivery vehicles for administration to humans [0001]. The nanodelivery vehicles are preferably formed from phosphatidylcholine (i.e. lecithin) [0036]. The assembly of the nanostructures may include emulsifiers, such a polysorbate 80 [0039, 0285]. Assembly methods include forming emulsions and micelles [0048]. The lipid nanoparticles may also be formed as liposomes [0101][0276]. Suitable nutraceuticals include resveratrol, PQQ (pyrroloquinoline quinone), genistein, tocotrienols, ginseng root extract and CoQ10 [0157, 0237] (see also examples and whole document). Medium chain triglycerides may be included in the lipid carrier [0174-0175, 0214, 0231, 0270-0271]. A particle size of less 25-50m can be administered to and absorbed through the oral mucosa [0074]. Carriers for the emulsion include water, ethanol and glycerin (Examples, e.g.[0175, 0231, 0269, 0270]). The dose of
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention forming the nutraceutical delivering nanostructures of Kaufman to use a combination emulsified nanostructures in order to deliver different nutraceuticals such as resveratrol, CoQ10 and PQQ in order to optimize the delivery of each nutraceutical. The blend may be spit out rather than swallowed, in which case 100% of the bloodstream delivered concentration would be transmucosal.
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 experimentation. See MPEP 2144.05. Therefore, it would be obvious to have varied the amount of components in the composition motivated by the desire to achieve the desired effect.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kaufman (U.S. 2016/0263047) in view of Bromley (U.S. 8,741,373, disclosed by applicant).
Kaufman is discussed above, but does not explicitly teach the inclusion of Vitamin E TGPS.
Bromley teaches a compositions comprising nutraceuticals as micelles, liposomes, and other forms of nanoemulsions wherein the surface active agent includes polysorbates and PEG derivatives of Vitamin E such as TGPS 1000 (col. 20 – see entire document).
It would have been prima facie obvious to one of ordinary skill in the art making the composition of Kaufman to include Vitamin E TGPS as a surface active agent given it is taught by Bromley as equivalent to polysorbate. See MPEP 2144.06.
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
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