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) 1-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bsoul et al. (Journal of Contemporary Dental Practice, 2004), Marionnet et al. (Experimental Dermatology, 2006), and Kuellmer (entry for Ascorbic Acid, Kirk-Othmer Encyclopedia of Chemical Technology, 2000).
The claims are drawn to a method for improving the status of a health condition, comprising identifying a health condition, and administering a vitamin C preparation comprising a vitamin C component comprising at least 90% by weight of the total weight of the preparation.
Bsoul et al. teach the importance of vitamin C in health and disease. According to Bsoul et al. the recommended daily dietary allowance of vitamin C is 75 mg or women and 90 mg for men (abstract). Population including the elderly, smokers, and patients with periodontal disease may be recommended for higher doses, e.g., up to 200 mg daily (page 8).
According to the reference, vitamin C intake is beneficial for bone healing. Vitamin C has an anticarcinogenic effect related to its ability to detoxify carcinogens or block carcinogenic processes though its action as an antioxidant or as a free-radical scavenger. Other proposed mechanisms of action for vitamin C in the prevention and treatment of cancer include enhancement of the immune system, stimulation of collagen formation, necessary for “walling off” tumors, preventing metastasis, etc. Studies have shown an inverse relationship between vitamin C intake and cancers of the mouth, pharynx, esophagus, stomach, lung, and cancer (page 4).
Bsoul et al. also teach that vitamin C has an improving effect on heart disease, e.g., atherosclerosis, hypertension, age-related eye disease, such as cataracts, Alzheimer’s Disease, pneumonia and bronchitis, and viral infections (pages 4-7). Diseases such as cataracts and cancer have causes including oxidative pathogenesis, inflammatory mechanisms, cytotoxic mechanisms and/or genotoxic mechanisms.
Marionnet al. teach the beneficial effects of vitamins C in reconstructing skin, e.g., in would healing, by optimizing the formation of the dermal-epidermal junction. Vitamin C treatment led to better organization of basal keratinocytes, an increase in fibroblast number, and faster formation of the dermal-epidermal junction (abstract). The vitamin C used by Marionnet al. as in the form of magnesium l-ascorbyl-2-phosphate (100 mg/l).
Kuellmer teaches vitamin C (ascorbic acid) being useful in the inhibition of nitrosamine formation, which contributes to the etiology of cancer of the stomach, esophagus, and nasopharynx. The concentration of nitrosamine in the stomach depends on nitrate and nitrite intake. Nitrite is part of the preserving process for cured meats; cigarette smoke also contains high levels of nitrite (page 24). Such compounds are xenobiotics (claim7).
The instant claims are rendered obvious by the combined reference teachings, which show that vitamin C is known to have beneficial effects on various health and disease issues. The references do not expressly teach a vitamin C preparation containing at least 90% by weight of vitamin C; however, based on the reference teachings, a person having ordinary skill in the art would have been able to produce a formulation containing an amount of vitamin C that is within the bounds of current recommended daily doses for men and women, and upper level doses that have been found to have efficacy in mitigating a particular health condition, but do not exceed tolerable upper levels that may cause gastrointestinal upset.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bsoul et al., Marionnet et al., and Keullmer, as applied to claims 1-18 above, and further in view of Kleiman et al. (WO 01/03664).
The instant claims recite a vitamin C formulation further including a lipophilic molecule component comprising at least one C16-C34 fatty alcohol, and at least one omega-9 C18 to C24 fatty acid.
Kleiman et al. teach stabilized ascorbic acid compositions for the delivery of vitamin C disposed in wax that is inert to the vitamin C. The ingredient is used in an amount of at least 5% by weight (abstract). The ingredients that may be used in the vitamin C compositions include fatty acids like stearic acid, oleic acid, and linoleic acid (18C), and fatty alcohols like cetyl alcohol (16C), stearyl alcohol, and oleyl alcohol (18C) (page 4).
The instant claims are rendered obvious by the combined reference teachings since Kleiman et al. teach that the addition of fatty acids and fatty alcohols to vitamin C formulations help to stabilize such formulations, and increase the bioavailability of the vitamin C component. A person having ordinary skill in the art would see the benefit of adding such compounds to the vitamin C formulations taught by Bsoul et al., Marionnet et al., and Kuellmer, in order to stabilize, and increase bioavailability of the vitamin C component of those formulations.
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