DETAILED ACTION
The receipt is acknowledged of applicant’s amendment filed 03/31/2026.
Claims 1-8 previously presented. claims 4 and 6 are currently canceled. Claims 1-3, 5, 7-8 are pending and subject of this office action.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
The factual inquiries 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.
Claims 1-3, 5, 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Gianeti et al. (Benefits of combination of vitamin A, C, and E derivatives in the stability of cosmetic formulations), JP 2012240911 (hereinafter JP ‘911), Ladislas et al. (US 2004/0136938), and further optionally combined with Yoshimura et al. (US 2011/0236447), all references previously cited on PTO 892.
Applicant Claims
Claim 1 is directed to a cosmetic comprising:
(A) retinol;
(B) an organic acid represented by general formula (I) below or a salt thereof:
[Chemical 1]
PNG
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149
293
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and
(C) vitamin C or a derivative thereof;
wherein the formula (I)(in the formula (I), n represents an integer of 2 to 5, and
a mass ratio of a formulation amount of the retinol to a formulation amount of the organic acid or the salt thereof is 0.005 to 1.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Gianeti teaches topical composition comprising combination of vitamin C and vitamin A (retinol) that is able to reverse skin changes induced by chronologic and photoaging. Table 1 of the reference teaches both vitamin A and vitamin C are present in the composition in the same concentration. The combination of vitamins provides improved and acceptable stability (see the entire document and in particular: page 2220, third paragraph; conclusion).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012) &
While Gianeti teaches combination of vitamin A (retinol) and vitamin C in a topical composition, the reference does not teach the organic acid and its ratio to retinol as claimed by claim 1.
JP ‘911 teaches antiwrinkle, antiaging composition comprising 0.001-5% piperidine propionic acid. The composition further comprises antioxidant and whitening agents including vitamin C (abstract; ¶¶ 0006, 0016, 0025-0032).
Ladislas teaches cometic composition comprising combination of vitamin A and vitamin C in synergistic amount that significantly reduce toxic effects of the vitamins. Each vitamins are present in the composition in amount preferably 0.01-10% (abstract; ¶¶ 0010, 0070, 0211, 0212).
Yoshimura teaches antiaging stable cosmetic composition comprising 0.1% vitamin A palmitate (retinol ester) and 0.1% piperidine propionic organic acid (abstract; ¶ 0008; example 6, paragraph [0149]; and example 9, paragraph [0159]). The composition may further comprise vitamin C (ascorbic acid) as antioxidant agent and as whitening agent (¶¶ 0078, 0083).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide a topical composition that reverses skin changes induced by chronologic and photoaging as taught by Gianeti, and add piperidine propionic acid taught by JP ‘911. One would have been motivated to do so because JP ‘911 teaches combination of piperidine propionic acid with vitamin C in a single topical composition provides antiwrinkle antiaging composition wherein vitamin C adds whitening antioxidant effect to the composition. One would reasonable expect formulating topical composition comprising vitamin A, vitamin C and of piperidine propionic acid wherein the composition reverses skin changes induced by chronologic and photoaging, and further has antiwrinkle, antiaging and antioxidant effects.
Further, one having ordinary skill in the art before the effective filing date of the present invention would have add vitamin A and C to the composition taught by the combination of Gianeti and JP ‘911 in the same amount of 0.01-10% of each vitamins as taught by Ladislas, because Ladislas teaches cometic composition comprising combination of vitamin A and vitamin C in the same amounts acts synergistically to significantly reduce toxic effects of the vitamins.
Furthermore, optionally, one having ordinary skill in the art before the effective filing date of the present invention would have add piperidine propionic acid taught by Yoshimura in amount of 1% to the composition comprising vitamin A and C taught by the combination of Gianeti, JP ‘911 and Ladislas because Yoshimura teaches such amount can be used in antiaging stable compositions that may further comprising vitamin A derivatives and vitamin C.
Regarding the mass ratio of the amount of retinol to the organic acid 0.005 to 1 as claimed by claim 1, the combination of cited references teaches 0.01-10% retinol as taught by Ladislas, and teaches 0.001-5% piperidine propionic acid as taught by JP ‘911 and further 0.1% piperidine propionic as taught by Yoshimura. Therefore, the combination of the cited references can provide composition comprising 0.01% retinol and 10% of the acid forming the ratio of 0.001 to 1 that overlaps with the claimed ratio. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to find the desired effective ratio of retinol to organic acid based on the specific intended use. It would have been customary for an artisan of ordinary skill to determine the optimal ratio of vitamin A to organic acid in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed ratio, this optimization of the ratio would have been obvious at the time of applicant's invention. “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05. There is no evidence of record as to the criticality of the claimed ratio. The amount of a specific ratio of ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ.
Regarding claim 2, the Ladislas teaches the composition comprises 0.01-10% vitamin A that overlaps with the claimed range of 0.01-0.5%.
Regarding claim 3 that the amount of the organic acid is 0.005-5%, JP ‘911 teaches the composition comprises 0.001-5% piperidine propionic acid, and Yoshimura teaches 0.1% organic acid. The amounts taught by the references either overlaps or falls within 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. See MPEP 2144.05 [R-5].
Regarding piperidine propionic acid claimed by claim 5, JP ‘911 teaches the claimed organic acid, and Yoshimura exemplified the claimed organic acid.
Regarding the claimed amounts of vitamin C of 0.005 to 1% as claimed by claim 7, Gianeti teaches equal amounts of both vitamin A and vitamin C in cosmetic that would suggest the amount of 0.1% vitamin A that falls within the claimed amount. Further, Ladislas teaches 0.01-10% that overlaps with the claimed amount. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding claim 8 that the ratio of vitamin C to the organic acid is 1/300 to 1, combination of the cited references teaches 0.01-10% vitamin C and 0.001-5% organic acid that embrace the claimed ratio. It would have been customary for an artisan of ordinary skill to determine the optimal ratio of vitamin C to the organic acid in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed ratio, this optimization of ingredient amount would have been obvious at the time of applicant's invention. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to find the desired effective ratio of vitamin C to organic acid based on the specific intended use. “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05. There is no evidence of record as to the criticality of the claimed ratio.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Response to Arguments
Applicant's arguments filed 03/31/2026 have been fully considered but they are not persuasive.
Applicants argue that present claim 1 requires combination of retinol, organic acid and vitamin C. Yoshimura discloses and uses a derivative (ester) of retinol (vitamin A palmitate), while the claimed retinol is not the same thing as retinol palmitate taught by Yoshimura, and derivative of retinol cannot be considered to have the same reactivity as retinol. In the claimed subject matter, retinol (alcohol) can react with organic acids within the composition. In contrast, in Yoshimura's cosmetic, vitamin A palmitate does not readily react with piperidine propionic acid.
In response to this argument, it is argued that the combination of the cited references as set forth in this office action and as necessitated by the amendment, teaches the claimed subject matter as a whole as recited by the claims. Gianeti teaches combination of vitamin A and C, and Ladislas teaches combination of vitamin C and organic acid. Applicant’s attention is directed to the scope of the present claims, and all the elements of the claimed product are taught by combination of the cited references. Applicant is also reminded, that it has been decided by the Courts that even in a case where the reference does not teach the same use of the composition, the two different intended uses are not distinguishable in terms of the composition, see In re Thuau, 57 USPQ 324; Ex parte Douros, 163 USPQ 667; and In re Craige, 89 USPQ 393. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR, 127 S. Ct. at 1739.3 "Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious." In re Fout, 675 F.2d at 301; see also In re Mayne, 104 F.3d at 1340; according KSR, 127 S. Ct. at 1740. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR, 127 S. Ct. at 1739.3. In re Best, 562 F.2d at 1255; In re Rijckaert, 9 F.3d at 1532.
The current rejection, as necessitated by applicant’s amendment, teaches cosmetic composition comprising the three claimed elements. Yoshimura teaches organic acid in the claimed amount. Further, retinol and its derivatives are all known as equivalent antiaging agents as evidenced by the article by Zasada et al. (“Retinoids: active molecules influencing skin structure formation in cosmetic and dermatological treatments”, currently provided), and applicants failed to show the difference between retinol and any of its derivatives as antiaging.
Applicants argue that the claimed cosmetic is characterized by a limited mass ratio of a formulation amount of the retinol to a formulation amount of the organic acid or a salt thereof, and the Office states that this is not disclosed in Yoshimura. Furthermore, no description of such a range of ratio is found in any other citations. In the present application, as described in paragraph [0015] of the Specification as filed, the ratio being within a specific range optimizes the balance between the wrinkle-improving effect of retinol and the irritation-suppressing effect of the organic acid or its salt. However, no such range of ratio is suggested in any of the cited references.
In response to this argument, it is argue that the combination of cited references teaches 0.01-10% retinol as taught by Ladislas, and teaches 0.001-5% piperidine propionic acid as taught by JP ‘911. Therefore, the combination of the cited references can provide composition comprising 0.01% retinol and 10% of the acid forming the ratio of 0.001 to 1 that overlaps with the claimed ratio. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to find the desired effective ratio of retinol to organic acid based on the specific intended use. It would have been customary for an artisan of ordinary skill to determine the optimal ratio of vitamin A to organic acid in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed ratio, this optimization of the ratio would have been obvious at the time of applicant's invention. “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05. There is no evidence of record as to the criticality of the claimed ratio. The amount of a specific ratio of ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ.
Applicants argue that, while the incorporation of vitamin C is disclosed in Gianeti, JP ‘911, and Ladislas, combining vitamin C with the combination of retinol and a specific organic acid or salt thereof is not suggested. In the present application, as described in paragraph [0017] of the Specification as filed, it exhibits an effect of compensating for the irritation suppression effect of the above-described organic acid or a salt thereof. This effect has been confirmed by Examples 7 and 8 described in the Specification as filed, see Table 1. Such an effect is not suggested in any of the cited references. Applicants argue that any prima facie case of obviousness is more than overcome by surprising and unexpected results in Table 1 of the Specification as filed. Specifically, Table 1 provides evidence of superior results in irritation evaluation and moisturizing feeling evaluation for Examples 7-11, which are within the scope of amended claim 1, compared to Comparative Examples 1 and 3.
In response to this argument, it is argued that the cited references teaches the combination of both vitamins A and C. For example, Gianeti teaches combination of vitamins A and C provides improved and acceptable stability of the composition including both. Ladislas teaches cometic composition comprising combination of vitamin A and vitamin C in synergistic amount significantly reduces toxic effects of the vitamins, and the amount taught by the reference is the same used by applicants. Further, JP ‘911 teaches combination of antioxidants: vitamin C and organic acid, in cosmetic composition, provides more stability to the composition, because both are antioxidants. Stability of the composition implies its safety and absence of skin irritability. Therefore, stability of composition taught by the cited references is suggested by combination of the cited references. The data in the specification regarding stability of composition comprising the claimed ingredients are not unexpected results and therefore cannot rebut prima facie obviousness. The examiner directs applicant's attention to MPEP 716.02 (a). "A greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness of the claims at issue." In re Corkhill, 711 F.2d 1496, 266 USPQ 1006 (Fed.Cir. 1985). In Corkhill, the claimed combination showed an additive result when a diminished result would have been expected. Furthermore, the MPEP states, "Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967). Any property applicants achieved is expected from combination of the prior art, absence comparative with the cited references. The burden is shifted to applicants to show the prior art composition is skin irritating and non- moisturizing.
Further, it has been decided by the Courts that even in a case where the reference does not teach the same use of the composition, the two different intended uses are not distinguishable in terms of the composition, see In re Thuau, 57 USPQ 324; Ex parte Douros, 163 USPQ 667; and In re Craige, 89 USPQ 393.
Finally, obviousness does not require absolute predictability of success all that is required is a reasonable expectation of success. See In re Kubin, 561 F.3d at 1360. The Court has held that "the test of obviousness is not express suggestion of the claimed invention in any or all of the references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to be familiar with them." See In re Rosselet, 146 USPQ 183, 186 (CCPA 1965). "There is no requirement (under 35 USC 103(a)) that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art." Motorola, Inc. V. Interdigital Tech. Corp., 43 USPQ2d 1481, 1489 (Fed. Cir. 1997). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR Int'l Co. V. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) ("The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.").
Conclusion
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 Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./
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