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 .
The examiner has considered the amendment filed by applicants on May 26, 2026. In light of the amendment, the examiner has withdrawn the rejections made in the previous Office Action. However, the amendment has necessitated the following new rejection.
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, and 16-20 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 Kleiman et al. (WO 01/03664).
The instant claims are drawn to a vitamin C preparation comprising a homogeneous mixture of a vitamin C component comprising at least about 90% by wt. of the preparation, 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, wherein the lipophilic molecule component is dispersed within said homogenous mixture together with the vitamin C component. 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, Kleiman et al. teach stabilized ascorbic acid (vitamin C) compositions dispersed in wax, e.g., jojoba esters, in an amount of at least 5% by weight (abstract). Compounds present in the jojoba wax include fatty acids such as stearic acid, oleic acid, and linoleic acid, and fatty alcohols such as cetyl alcohol, stearyl alcohol, and oleyl alcohol (page 4).
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.
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 formulation and increase the bioavailability of the vitamin C therein. A person having ordinary skill in the art would have seen the benefit of adding such compounds to the vitamin C composition taught by Rath, in order to stabilize and increase the bioavailability of such a vitamin C composition, as suggested by Kleiman et al.
A person having ordinary skill in the art would also be able to adjust the concentration of the components of the ascorbic acid composition taught by Rath in order to afford a composition that provides 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 6-14, and 16-20 have been considered but are moot because the new ground of rejection relies on a combination of references not previously considered by applicant, and therefore the matters specifically challenged in applicant’s arguments are not germane to the current rejection.
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 SIKARL A WITHERSPOON whose telephone number is (571)272-0649. The examiner can normally be reached M-F 9am-9pm IFP.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SIKARL A WITHERSPOON/Primary Examiner, Art Unit 1692
Prosecution Insights