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 .
DETAILED ACTION
The Applicant’s reply filed on 11/6/25 is acknowledged. Claims 1 and 5-12 are pending. Claims 7-9 have been withdrawn. Claims 11 and 12 have been amended. Claims 1, 5, 6 and 10-12 are under consideration.
Election/Restrictions
Applicant’s election without traverse of the species of vitamin A derivative - retinyl linoleate, vitamin C derivative - tetrahexyldecyl ascorbate/ascorbyl tetraisopalmitate, and composition form – lotion, in the reply filed on 10/16/23 is maintained.
Rejections Withdrawn
The rejection of Claims 11 and 12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in view of the amended claims.
Rejections Maintained and New Grounds of Rejections
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 5, 6, and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Mayne (US 2003/0095959) in view of Sethi et al. (Indian Journal of Dermatology. 2016).
Mayne teaches compositions and method for the prevention of the adverse or detrimental effects of reactive oxygen species (e.g. abstract). Mayne exemplifies a composition that contains one Vitamin A derivative (i.e. 0.16 wt% retinyl acetate) and one Vitamin C derivative (i.e. 0.1 wt% tetrahexyldecyl ascorbate) (e.g. Examples 2 and 3). More broadly, Mayne teaches that the composition comprises 0.001-10 wt% of a cellular activity component which may be a retinoid, including retinyl acetate or retinyl linoleate (e.g. paragraph 0055 and 0057). It would have been obvious to one of ordinary skill in the art at the time of filing to replace the 0.16 wt% retinyl acetate with 0.16 wt% of retinyl linoleate for the composition because while it is not exemplified, it is included among a short list of preferred ingredients. It would have been obvious to one of ordinary skill in the art at the time of the instant invention to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results.
Mayne further teaches the inclusion of an emollient oil (i.e. carrier oil) including olive oil or palm oil (e.g. paragraph 0062, 0070; Examples 2 and 3), but does not teach that the oil is squalane. This is made up for by the teachings of Sethi et al.
Sethi et al. teach that squalane is produced naturally by the body, the production of this chemical slows drastically after age thirty, thus contributing to dry skin. It acts as a quencher of singlet oxygen, protecting human skin surface from lipid peroxidation due to exposure to ultraviolet (UV), and other sources of ionizing radiation. Squalane is less susceptible to oxidation than squalene and is thus more commonly used as a moisturizer. An added boon of squalane is that even though it is technically oil, it does not have an oily feel, is odorless, noncomedonal, antibacterial, and is safe for sensitive skin. Besides its emollient action, it is also used in treating skin disorders such as seborrheic dermatitis, acne, psoriasis, or atopic dermatitis (e.g. page 280, column 1-2).
Regarding Claims 1, 5 and 6, it would have been obvious to one of ordinary skill in the art at the time of filing to include the squalane of Sethi et al. as the emollient of Mayne. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as both of Mayne and Sethi are directed to topical skin formulations involving skin repair and hydration. In addition to the emollient properties, one of ordinary skill in the art would have been motivated to select an emollient which also acts as a quencher of singlet oxygen, protecting human skin surface from lipid peroxidation due to exposure to ultraviolet (UV), and other sources of ionizing radiation, as taught by Sethi, which is a goal of Mayne (e.g. paragraphs 0002-0005).
Regarding Claim 10, Mayne further teaches the composition is in the form of a lotion (e.g. paragraph 0058, Claim 19).
Regarding Claim 11, Mayne teaches that the composition comprises 0.001-10 wt% of a cellular activity component which may be a retinoid, including retinyl acetate or retinyl linoleate (e.g. paragraph 0055 and 0057) and exemplify 1 and 26.5% emollients (e.g. Examples 2 and 3). This results in about 0.004-91% of retinyl linoleate in squalane, which overlaps with the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I).
Regarding Claim 12, the Specification on page 8 recites, “The enhanced stability is achieved by combining the esterified Vitamins and utilizing the synergistic anti-oxidative activities of these ingredients”. Therefore, as Mayne teaches the claimed esterified vitamins in the claimed amounts, the outcome of enhanced stability would necessarily be present. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Response to Arguments
Applicant's arguments filed 11/6/25 have been fully considered but they are not persuasive.
Applicant argues on page 5 that Mayne teaches the inclusion of an “emollient” and not a “carrier oil”.
This is not found persuasive. Applicant is arguing the function of the ingredients of the composition rather than the composition itself. Claim 1 requires a combination of retinyl linoleate and one Vitamin C derivative selected from the group consisting of tetrahexyldecyl ascorbate or ascorbyl tetraisopalmitate, ascorbyl glucoside, 3-0-ethyl ascorbic acid and magnesium ascorbyl phosphate, and a carrier oil squalane. Whether Mayne or Sethi describe the squalane as a “carrier” or an “emollient” it would nevertheless have been obvious to one of ordinary skill in the art at the time of filing to include the squalane of Sethi in the compositions of Mayne, as described supra. One of ordinary skill in the art would have predicted success as both of Mayne and Sethi are directed to topical skin formulations involving skin repair and hydration. In addition to the emollient properties, one of ordinary skill in the art would have been motivated to select an emollient which also acts as a quencher of singlet oxygen, protecting human skin surface from lipid peroxidation due to exposure to ultraviolet (UV), and other sources of ionizing radiation, as taught by Sethi, which is a goal of Mayne (e.g. paragraphs 0002-0005).
Applicant further argues that the use of squalane as a stabilizing medium for retinoids or other oxidation-sensitive additives is not disclosed in either Maybe or Sethi.
This is not found persuasive. The claims are directed to a composition and not to a method of stabilizing retinoids or other oxidation-sensitive additives. In addition, the instant Specification does not appear to attribute the stability of the composition to the presence of squalane. The Specification on page 8 recites, “The enhanced stability is achieved by combining the esterified Vitamins and utilizing the synergistic anti-oxidative activities of these ingredients”. Therefore, as Mayne teaches the claimed esterified vitamins in the claimed amounts, the outcome of enhanced stability would necessarily be present. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Conclusion
No claim is allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
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