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 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.
Claim(s) 1-3, 6-14, 16, and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rath (US 6,693,129) in view of Vinson et al (Am. J. Clin. Nutr., 1988), and Endicott et al. (US 2,881,085).
The instant claims are drawn to a vitamin C preparation comprising a homogeneous mixture of a vitamin C component and a lipophilic component comprising at least one saturated straight-chain C16 to C34 fatty alcohol, and at least one unsaturated omega-9 C18 to C24 fatty acid. Further limitations include the presence of a bioflavonoid component.
Rath teaches a composition for lowering plasma lipoproteins and risk factors of cardiovascular diseases in humans (abstract). The composition comprises ascorbic acid (vitamin C) and its salts, and citrus bioflavonoids (col. 3, lines 20-34; table 1). The composition may be administered by pharmaceutically acceptable means of delivery, including oral, nasal, parenteral, topical, or transdermal administration, or delivered in the form of solid, semi-solid, liquid, or powder dosage forms. This includes tablets, pills, etc. (col. 5, lines 44-56).
Rath does not expressly teach the presence of fatty acids and/or fatty alcohols; however, Endicott et al. teach thin film coatings for tablets and the like that may contain, inter alia, castor oil, which comprises fatty acids ricinoleic acid, oleic acid, linoleic acid, and stearic acid; cocoa butter, which contains stearic acid, palmitic acid, arachidic acid, and oleic acid; corn oil, which comprises palmitic acid, stearic acid, arachidic acid, and oleic acid; beeswax, which comprises esters of fatty acid palmitic acid and cerotic acid, and fatty alcohol like triacontanol, octacosanol, hexacosanol, and tetracosanol (see examples).
Vinson et al. teach a study on the bioavailability of ascorbic acid alone or in a citrus extract, The citric extract contains ascorbic acid along with bioflavonoids naringin, naringenin, and hesperidin.
It would have been obvious to a person having ordinary skill in the art, at the time the present invention was made, to add a thin film coating comprising one or more of the solutions taught by Endicott et al. to the ascorbic acid-containing compositions taught by Rath, that may be in tablet form, in order to preserve the active composition, and also mask any unpleasant taste that may be perceived by a subject in need thereof.
A person having ordinary skill in the art would be able to adjust the concentration of the components of the ascorbic acid composition taught by Rath and/or the thin film coating taught by Endicott et al. in order to afford a composition that provide optimal results in lowering plasma lipoproteins according to Rath, and allows for minimal unpleasantness for the subject requiring such as composition.
Vinson et al. was cited to teach the specific bioflavonoids that would be present in citrus bioflavonoid composition taught by Rath. The fact that Rath teaches compounds in its composition that are not recited in the instant claims is immaterial, since the instant claims do not preclude such compounds from the vitamin C preparation, due to the open-ended, i.e., “comprising” language used in the claims. Therefore, the instant claims are found to be obvious in view of the combined reference teachings.
Claims 4, 5, and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIKARL A WITHERSPOON whose telephone number is (571)272-0649. The examiner can normally be reached M-F 9am-9pm IFP.
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/SIKARL A WITHERSPOON/Primary Examiner, Art Unit 1692