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 .
Response to Amendments
Applicant’s amendments to the claims of July 29, 2026, in response to the Office Action of March 9, 2026, are acknowledged.
Response to Arguments
The TD filed on July 29, 2026, was approved by the Office on August 11, 2026. As such, the Double Patenting Rejections are withdrawn. Applicant’s arguments and allegations of unexpected results have been considered by the Office. Rejections not reiterated below have been withdrawn in view of the Amendments to the claims.
Applicant argues that the prior art does not teach a formulation of retinol, solvent, or mixed tocopherol wherein the solvent is a mixture of undecane and tridecane, and wherein the retinol is retained in an amount of 91% for 6 weeks at 40°C.
The examiner notes that there is no showing of unexpected results as compared to the closest prior art wherein the showing is commensurate in scope with the breadth of the claims. In this case, Applicant claims stability of retinol.
The examiner notes that the prior art teaches stable compositions. For example:
Hwang teaches a stable cosmetic composition that includes C18-C21 alkanes. See par. 5. The composition includes a fat-soluble antioxidant, which includes one more of tocopherol, retinol, and lycopene. Froix also teaches compositions including emulsions that are stable and comprise retinol in a form that in can be up to 90% and preferably up to 60% retinol. Clavel teaches cosmetic compositions comprising volatile linear alkanes, wherein the stability of an emulsion is enhanced by the addition of n-undecane and n-tridecane, e.g.
Thus, unexpected results do not provide a comparison to the closest prior art. Further, Applicant alleges that Table 2 shows unexpected results. It is not clear that even if unexpected results as compared to the closest prior art were shown, that the claims are commensurate in scope with the showing. Retinol is used in Table 1 in a concentration of 47.5-48% in all examples. The claims provide for up to 75% retinol. Mixed tocopherols are used in a concentration of 1% in each example. The claims allow for 0.1% tocopherol. Further, a mixture of undecane and tridecane is taught for use in a concentration of 51.5%. The claims provide for only 20% of at least one solvent. Moreover, it is not clear that any claim is limited to a solvent comprising or consisting of undecane and tridecane.
As such, the examiner notes that without a showing of unexpected results as compared to the closest prior art, the examiner is determining if a prima facie showing is established. This is particularly the case when the prior art teach stability of the claimed components and stability is the alleged unexpected result.
Here, the claimed components are taught for use in stable cosmetic compositions. Tridecane and undecane are taught as preferred solvents and the mixed tocopherol percentages are taught. Even further, a similar method of producing the claimed product is taught. As such, a prima facie showing is established.
Without any indication that the breadth of the claims provide unexpectedly advantageous stability as compared to the closest prior art, a prima facie showing is maintained.
Status of the Claims
Claims 1-3, 5-10, 12, and 13 are pending and examined.
Claim Rejections - 35 USC § 103
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.
Claims 1-3, 5, 6, 8, 9, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hwang et al., (US2020/0383895), in view of Froix et al., (U.S. Pat. No. 5,851,538), in view of Clavel et al., (U.S. Pat. No. 8,992,953).
Hwang teaches a stable cosmetic composition that includes C18-C21 alkanes. See par. 5. The composition includes a fat-soluble antioxidant, which includes one more of tocopherol, retinol, and lycopene. See par. 28 and prior art claims 1, 7, and 11. The amount of antioxidant can be up to 35% weight of the composition. Tocopherol is used in Examples 6-19, e.g., in a concentration of 0.5%. Ascorbic acid can be used. See Tables 1-3.
Froix teaches compositions including emulsions that are stable and comprise retinol in a form that in can be up to 90% and preferably up to 60% retinol. One type of additional antioxidant ingredient can include tocopherol as it is an oil-soluble antioxidant. Ascorbic acid is contemplated as an active agent.
Clavel teaches cosmetic compositions comprising volatile linear alkanes. See Title. In particular Clavel teaches cosmetic emulsions having at least one C9 to C15 volatile linear solvent. The stability of an emulsion is enhanced by the addition of n-undecane and n-tridecane, e.g. Other examples of alkane solvents include dodecane, tetradecane, pentadecane, and mixtures. A compositions con contain up to 90% and in particular up to 40 or 50% volatile linear alkanes. An example of a composition includes a low concentration of a mixture of tocopherols. See Examples 1-7 and prior art claim 15. Examples 4-7 use 0.5% by mass tocopherol.
It would have been prima facie obvious prior to the filing of the instant application to arrive at the claimed products and process for producing the same. Hwang teaches a cosmetic topical composition having retinol, tocopherol, and an alkane. Tocopherol and retinol are each taught as oil/fat soluble. Hwang also teaches the claimed concentration of tocopherol and a similar concentration of retinol (i.e., up to 35%). Similarly, Froix teaches also teaches an emulsion that is stable and comprises a claimed concentration of retinol (up to 90% and preferred up to 60%) and can include tocopherol. Finally, Clavel teaches an emulsion that uses the claimed alkanes, including undecane and tridecane at a claimed concentration of 40 and 50%, and the mixture can also include tocopherol. Moreover, the compositions taught by Hwang and Froix can also incorporate ascorbic acid. There are stability and other that are known for using the claimed alkanes as a solvent and using tocopherol, including a mixture of tocopherols and retinol in pharmaceutical compositions. Overall, the claimed components at the claimed concentration are each known and used in stable formulations that deliver known antioxidants to the skin of a subject in a cosmetic formulation. Further, Hwang teaches retinol, tocopherol, and alkanes for use in a single composition while the secondary references provide the claimed concentrations.
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); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 1-3, 5, 6, 8-10, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hwang et al., (US2020/0383895), in view of Froix et al., (U.S. Pat. No. 5,851,538), in view of Clavel et al., (U.S. Pat. No. 8,992,953), and in view of CN101156648A (published April 9, 2008).
Hwang teaches a stable cosmetic composition that includes C18-C21 alkanes. See par. 5. The composition includes a fat-soluble antioxidant, which includes one more of tocopherol, retinol, and lycopene. See par. 28 and prior art claims 1, 7, and 11. The amount of antioxidant can be up to 35% weight of the composition. Tocopherol is used in Examples 6-19, e.g., in a concentration of 0.5%. Ascorbic acid can be used. See Tables 1-3.
Froix teaches compositions including emulsions that are stable and comprise retinol in a form that in can be up to 90% and preferably up to 60% retinol. One type of additional antioxidant ingredient can include tocopherol as it is an oil-soluble antioxidant. Ascorbic acid is contemplated as an active agent.
Clavel teaches cosmetic compositions comprising volatile linear alkanes. See Title. In particular Clavel teaches cosmetic emulsions having at least one C9 to C15 volatile linear solvent. The stability of an emulsion is enhanced by the addition of n-undecane and n-tridecane, e.g. Other examples of alkane solvents include dodecane, tetradecane, pentadecane, and mixtures. A compositions con contain up to 90% and in particular up to 40 or 50% volatile linear alkanes. An example of a composition includes a low concentration of a mixture of tocopherols. See Examples 1-7 and prior art claim 15. Examples 4-7 use 0.5% by mass tocopherol.
CN101156648A teaches compositions wherein vitamins A and E are mixed with oil in 50-60 degree heat and dissolving the vitamin E in vitamin A oil with heat of 45-60°C, and dissolving the solvent and components at that temperature prior to cooling. See prior art claims 1-4.
It would have been prima facie obvious prior to the filing of the instant application to arrive at the claimed products and process for producing the same. Hwang teaches a cosmetic topical composition having retinol, tocopherol, and an alkane. Tocopherol and retinol are taught as oil/fat soluble. Hwang also teaches the claimed concentration of tocopherol and a similar concentration of retinol (i.e., up to 35%). Similarly, Froix teaches also teaches an emulsion that is stable and comprises a claimed concentration of retinol (up to 90% and preferred up to 60%) and can include tocopherol. Finally, Clavel teaches an emulsion that uses the claimed alkanes, including undecane and tridecane at a claimed concentration of 40 and 50%, and the mixture can also include tocopherol. Moreover, the compositions taught by Hwang and Froix can also incorporate ascorbic acid. There are stability and other that are known for using the claimed alkanes as a solvent and using tocopherol, including a mixture of tocopherols and retinol in pharmaceutical compositions. Overall, the claimed components at the claimed concentration are each known and used in stable formulations that deliver known antioxidants to the skin of a subject in a cosmetic formulation. Further, Hwang teaches retinol, tocopherol, and alkanes for use in a single composition while the secondary references provide the claimed concentrations.
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); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With regard to claim 10, CN101156648A teaches mixing vitamin A and E with an oil and/or solvent for fat-soluble vitamins and doing so in 45-60°C heat as the components are mixed and prior to cooling. Hwang teaches combinations that can include retinol, tocopherol, and a solvent. As such, in view of CN101156648A a POSA would mix those components as a vitamin A and E components in the presence of 45-60°C and a known solvent for the same. The components are stirred evenly and mixed evenly prior to cooling. Even further, the Abstract notes that vitamins A and E are fat-soluble and unstable to heat. Thus, it would be obvious to mix and heat at mild temperatures up to about 60°C.
Claims 1-3, 5-9, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hwang et al., (US2020/0383895), in view of Froix et al., (U.S. Pat. No. 5,851,538), in view of Clavel et al., (U.S. Pat. No. 8,992,953), and in further view of Benham (US2003/0105157).
Hwang teaches a stable cosmetic composition that includes C18-C21 alkanes. See par. 5. The composition includes a fat-soluble antioxidant, which includes one more of tocopherol, retinol, and lycopene. See par. 28 and prior art claims 1, 7, and 11. The amount of antioxidant can be up to 35% weight of the composition. Tocopherol is used in Examples 6-19, e.g., in a concentration of 0.5%. Ascorbic acid can be used. See Tables 1-3.
Froix teaches compositions including emulsions that are stable and comprise retinol in a form that in can be up to 90% and preferably up to 60% retinol. One type of additional antioxidant ingredient can include tocopherol as it is an oil-soluble antioxidant. Ascorbic acid is contemplated as an active agent.
Clavel teaches cosmetic compositions comprising volatile linear alkanes. See Title. In particular Clavel teaches cosmetic emulsions having at least one C9 to C15 volatile linear solvent. The stability of an emulsion is enhanced by the addition of n-undecane and n-tridecane, e.g. Other examples of alkane solvents include dodecane, tetradecane, pentadecane, and mixtures. A compositions con contain up to 90% and in particular up to 40 or 50% volatile linear alkanes. An example of a composition includes a low concentration of a mixture of tocopherols. See Examples 1-7 and prior art claim 15. Examples 4-7 use 0.5% by mass
It would have been prima facie obvious prior to the filing of the instant application to arrive at the claimed products and process for producing the same. Hwang teaches a cosmetic topical composition having retinol, tocopherol, and an alkane. Tocopherol and retinol are taught as oil/fat soluble. Hwang also teaches the claimed concentration of tocopherol and a similar concentration of retinol (i.e., up to 35%). Similarly, Froix teaches also teaches an emulsion that is stable and comprises a claimed concentration of retinol (up to 90% and preferred up to 60%) and can include tocopherol. Finally, Clavel teaches an emulsion that uses the claimed alkanes, including undecane and tridecane at a claimed concentration of 40 and 50%, and the mixture can also include tocopherol. Moreover, the compositions taught by Hwang and Froix can also incorporate ascorbic acid. There are stability and other that are known for using the claimed alkanes as a solvent and using tocopherol, including a mixture of tocopherols and retinol in pharmaceutical compositions. Overall, the claimed components at the claimed concentration are each known and used in stable formulations that deliver known antioxidants to the skin of a subject in a cosmetic formulation. Further, Hwang teaches retinol, tocopherol, and alkanes for use in a single composition while the secondary references provide the claimed concentrations.
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); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Benham teaches a composition that can be a cosmetic that can be added to skin products, e.g. See par. 6. The composition comprises tocopherol including a mixture of alpha, beta, gamma, and delta forms. See par. 9. Further, the concentrations include 8-20% alpha, 1.5-4.5% beta, 55 to 75% gamma, and 15 to 27% delta. See par. 9 Ascorbic acid is incorporated as an active agent.
As such, it would have been further prima facie obvious to use a known and used claimed mixture of tocopherols taught by Benham as they are used in a composition that comprises the claimed concentrations of tocopherols and an overall percentage of mixture tocopherols that are claimed. Further, Benham also teaches formulations that include antioxidants, such as ascorbic acid. Thus, in view of the teachings of Hwang and Froix to use tocopherols and the teaching of Clavel to use mixed tocopherols, a POSA would consider using the concentrations of mixed tocopherols taught by Benham for use in a cosmetic formulation that, similar to Hwang and Froix, can also use ascorbic acid.
As such, no claim is allowed.
Conclusion
THIS ACTION IS MADE FINAL. 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D. BARSKY whose telephone number is (571)-272-2795. The examiner can normally be reached on Monday through Friday from 8:30 to 5:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Amy L. Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628
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