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 .
Claims 1-10 are pending.
Claims 9-10 are withdrawn.
Claims 1, 6, and 7 are amended.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over OH (KR102027311B1) in view of SAXENA (Poloxamer 407/TPGS mixed micelles for delivery of gambogic acid to breast and multidrug-resistant cancer. International Journal of Nanomedicine. 2012.).
With respect to claim 1 and 3, OH teaches a method of forming a nano-diagnostic agent for tumors (abstract) in the form of a micelle (Page 2, paragraph 15) that comprises: mixing polysorbate 80, soybean oil, and a water-insoluble dyeing material to forma a uniform and transparent first mixture(claim 1), which reads on mixing a polysorbate, soybean oil, and a staining substance to form a first mixture. Then mixing the first mixture with poloxamer 188 and heating the mixture to 55-65 Celsius to form a second mixture (claim 1), which reads on mixing the first mixture with a poloxamer and heating the resulting mixture at 40 to 70 0C to form a second mixture. The second mixture is then cooled to 0-10 Celsius to form nano platform solids (claim 1), which reads on cooling the second mixture to form a nanoplatform solid. The staining substance used methylene blue, which reads on a staining substance that emits light at a wavelength of 650 to 800 nm.
With respect to claim 4, the soybean oil is mixed in an amount of 1 to 67 parts per polysorbate (claim 1).
With respect to claim 5, the staining substance is mixed in a ratio of 0.01 to 0.1 parts by weight of polysorbate (claim 1).
With respect to claim 8, after the mixture is cooled, it is mixed with a solvent (claim 1), the impurities are removed (claim 1) and the mixture is lyophilized (claim 1), which reads on freeze-drying.
Additional disclosures: The polysorbate and soybean oil are used as an inner core to dissolve the water-insoluble stain material. The poloxamer is used as an outer layer which allows formation of uniform particles without aggregation due to the precipitation of the components contained in the inner core (Page 2, paragraph 15). OH further teaches that multiple Poloxamers are commercially available including poloxamer 188 and 407 (Page 4, paragraph 17).
Note for claim 2, is an intended use for the composition created using the method described above. Therefor it would be able to perform the same function.
OH does not teach adding vitamin E TPGS to the mixture.
SAXENA teaches a micelle for use as a therapeutic for tumors made of a poloxamer, specifically poloxamer 407, and D-α-Tocopheryl polyethylene glycol 1000 succinate (Vitamin E TPGS) (abstract). The poloxamer and vitamin E TPGS are used to make the outer layer of the micelles and increases the stability of the micelle (conclusion). The vitamin E TPGS is in an amount of 34 parts by weight (23 mg) relative to 100 parts by weight (68 mg) of the poloxamer (Page 714, preparation of micelles).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate adding vitamin E TPGS. The person of ordinary skill in the art would have been motivated to make those modifications, because when vitamin E TPGS is mixed with a poloxamer to form the outer layer of a micelle it increases the stability, and reasonably would have expected success because both references are in the same field of endeavor, such as micelles with an outer layer of poloxamer that are used for tumors.
The reference does not specifically teach the vitamin E TPGS, poloxamer and soybean oil weight ratios as claimed by the Applicant. The weight ratios are clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal weight ratios in order to best achieve desired results, such as an optimal amount to achieve an inner core to hold the water-insoluble dye material and a stable outer core to form uniform particles. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the weight ratios would have been obvious at the time of Applicant’s invention.
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618