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 Amendment
The Amendment filed 09/04/2026 has been entered. Applicant’s amendments are in response to the Non-Final Office Action mailed 03/09/2026. Applicant’s claims have been amended in the following manner: independent claims 1 and 55 have been modified by narrowing the instant salicylic acid amount range from 2 to 30 wt%, to 25 to 30 wt%. The narrowing of the amount prompts a new ground of rejection that incorporates Shin. Claims 20 and 25-26 are now cancelled.
The following objections/rejections are withdrawn: 112(b) rejection (based on amendment of claim 2).
The Examiner further acknowledges the following:
Claims 1-2, 5, 8, 11, 14-15, 17-18, 24, 27, 37, 39, 45-50, 55-56, and 58 are pending.
Claims 1-2, 5, 8, 11, 14-15, 17-18, 24, 27, 37, 39, 45-50, 55-56, and 58 are presented for examination and rejected as set forth below.
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.
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 1-2, 5, 8, 11, 14-15, 17-18, 24, 27, 37, 39, 46-50, 55-56, and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 2007/0172436A1, cited on IDS on 10/13/2022), and in further view of Santhanam (WO2016141315A1, cited on IDS on 10/13/2022), Shin (US20150152035A1), Thomas (US 20180228714 A1), and Waterman (International Journal of Pharmaceutics, 2005).
Applicants claims are directed to a composition, comprising ascorbic acid, a urea agent, salicylic acid (i.e., specifically in 25-30 wt%) as a chemical exfoliant, additional components, with further limitations.
Zhang teaches a nonaqueous composition in an alcohol solvent comprising ascorbic acid, a solubilization enhancer (such as urea), and an oleaginous skin protectant for topical use (abstract, [0002, 0007]). Zhang teaches ascorbic acid as suitable for preventing or treating photo-damage to skin [0003].
Regarding claims 1, 5, 8, 11, 14-15, 37, 39, and 58: Zhang teaches a topical composition [0002] comprising ascorbic acid in 5-40 wt%, urea (or urea derivatives such as hydroxyethyl urea [0047]) in 1-40 wt%, a skin protectant (reads on additional components) in 0.01-40 wt%, and nonaqueous alcohol solvent (i.e., 1,3-propanediol [0035, 0037]) in 40-70 wt% (Zhang – claim 14). Zhang teaches stability of sample compositions after 1 month (reads on “storage stable”) [0164].
Note that Zhang teaches an embodiment ([0125] = a composition comprising 22 wt% ascorbic acid, 20 wt% urea, 55 wt% propylene glycol), that is almost identical to Applicant’s embodiment ([0258] Formulation 1 = a composition comprising 25 wt% ascorbic acid, 20 wt% urea agent, 53 wt% 1,3-propanediol that is represented by instant claim 25), and the Examiner does not see anything within this comparison that would impart unexpected properties to the Applicant’s composition compared to Zhang’s exemplary formulation in [0125], where 1,3-propanediol is also taught by Zhang [0035]. Propylene glycol (or 1,2-propanediol) and 1,3-propanediol are very similar chemicals commonly used as solvents that are isomers of one another [0035], and are expected to behave similarly in the context of a solvent because of similar polarity, molecular weight, properties, etc., where polyols are generally preferred by Zhang [0036], as a nonaqueous organic solvent to stabilize ascorbic acid [0003]. Thus, when Zhang teaches an embodiment [0125] that is nearly identical to Applicant’s embodiment [0258], the same stability profile for the compositions is expected. Note that the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise. “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
For instant claim 1(e) and claim 58, in Example 2 [105], the ascorbic acid concentration is 28 wt%, and the maximum concentration of ascorbic acid in propylene glycol is 17 wt% [0006]. Thus (28-17)*1.25 = 13.75. In this case, the urea dissolved (22 wt%) is greater than 13.75 wt% meeting the claim limitation. The final mixture is a clear solution (reads on dissolved and liquid) [0106].
Regarding claim 24: Zhang teaches the skin protectant (0.01-40 wt%) can be tocopherols, tocopherol derivatives, tocotrienols [0054-0055].
Regarding claim 27: Zhang teaches ascorbic acid in 5-40 wt% and urea in 1-40 wt% (Zhang – claim 14), which corresponds to an ascorbic acid to urea ratio range of 1:8 to 40:1.
Regarding claims 46-49: Zhang teaches silicone oils such as polysilicone-11, dimethicone, and cyclomethicone [0066] and silicone emulsifiers such as cetyl dimethicone copolyol and dimethicone copolyol [0069]. Zhang teaches an ascorbic acid emulsion using a nonaqueous silicone vehicle as a continuous phase [0006].
Regarding claims 55 and 56: Zhang teaches a process of mixing the components to afford a topical product [0002, 0087-0100] that is stable [0164] that contain limitations addressed in instant claim 1 above.
In summary, the art teaches each element of the claims as presented (except the salicylic acid) is obvious to combine in the manner encompassed by the claims because Zhang establishes that each element claimed is taught as a component to be selected and combined to provide the non-aqueous ascorbic acid compositions. Furthermore, Zhang teaches ascorbic acid as suitable for preventing or treating photo-damage to skin [0003]. However, Zhang does not teach a chemical exfoliant such as salicylic acid and a 25 to 30 wt% amount (instant claims 1, 17-18, and 55), stability of the ascorbic acid composition at 40 °C up to 12 months in a multi-use container (instant claims 1-2), and a multi-use container for single dosing of the topical composition (instant claim 50).
Santhanam teaches a method for diminishing dermatological signs of aging in the human skin (Santhanam – claim 1). Santhanam teaches exfoliating agents (reads on chemical exfoliant) which are also anti-aging components, including salicylic acid, mandelic acid, glycolic acid, lactic acid, etc., which may comprise 0.0001-20 wt% of the composition [000103, 000121]. Furthermore, Santhanam teaches a container that comprises reservoirs containing a skin treatment composition to be dispensed, according to the effective amount of skin active (reads on dose of instant claim 50 and multi-use container of claims 1 and 2) [00030].
Shin further teaches topical compositions intended for exfoliation skin [0003-0004], that is based on salicylic acid and/or derivatives of salicylic acid [0003-0004], whereby Shin teaches the obviousness of using these active ingredients in 0.00001 to 90 wt% (reads on the newly-amended 25 to 30 wt% salicylic acid range of instant claim 1, by encompassing the instant range) [00029] in order to provide exfoliation [0004], within a variety of formulation types, including gels, sprays, serums (i.e., liquid), lotions, ointments, creams, concentrates, emulsions etc. [0030-0031] including non-aqueous vehicles such as alcohols and polyols [0032] (i.e., similar to the nonaqueous solvents used by Zhang) and other additives (e.g., ascorbic acid [0034, 0040-0041]). Shin similarly teaches that the photoaging of skin, skin hyperpigmentation, and skin disorders such as acne and blemishes are treated by the disclosed salicylic acid derivatives and are also conventionally treated with salicylic acid [0006, 0045-0046].
Thomas teaches an ascorbic acid composition where 97.6% vitamin C remains after 10 years at room temperature [0010, 0077], and also teaches non-aqueous nonpolar organic solvents and solutions [0011]. Thomas teaches compositions and methods that are used to stabilize vitamin C [0002]. Thomas also teaches kits and containers [0071-0072] (reads on multi-use containers).
Waterman demonstrates a correlation between accelerated aging conditions and actual long-term storage conditions (abstract). The instant claim tests accelerated aging conditions of 40 °C up to 12 months. As such, it would have been routine to optimize the stability of the total composition as suggested by Zhang. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where 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). Zhang teaches the benefits of maintaining stable ascorbic acid in order to deliver the antioxidant effects to the skin.
Thus, the combined teachings above show it would be prima facie obvious to optimize the ascorbic acid stability in the composition for periods up to 10 years at room temperature or with higher temperatures and a timeframe representing accelerated aging conditions.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine an exfoliating agent salicylic acid in 0.00001 to 90 wt%, as described by Santhanam and Shin, with Zhang’s composition and to use a container taught by Santhanam that dispenses appropriate doses, because the anti-aging exfoliating agent salicylic acid in 0.00001 to 90 wt%, and dispensing container are useful in methods to diminish dermatological signs of aging in human skin as taught by Santhanam and Shin, and Zhang teaches ascorbic acid compositions suitable for preventing or treating photo-damage to the skin [0003], whereby the there is overlap of ingredients and topical formulation types between all references.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the vitamin C and salicylic acid composition of Zhang and Santhanam for prolonged stability because Zhang teaches topical products [0002, 0087-0100] that are stable [0164], where Zhang teaches ascorbic acid (vitamin C) to be unstable in water [0003], and it is advantageous to maintain ascorbic acid stability to deliver its antioxidant effect [0030].
Claims 1-2, 5, 8, 11, 14-15, 17-18, 24, 27, 37, 39, 45-50, 55-56, and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 2007/0172436A1, cited on IDS on 10/13/2022), Santhanam (WO2016141315A1, cited on IDS on 10/13/2022), Shin (US20150152035A1), Thomas (US 20180228714 A1), and Waterman (International Journal of Pharmaceutics, 2005), as applied to claims 1-2, 5, 8, 11, 14-15, 17-18, 24, 27, 37, 39, 46-50, 55-56, and 58 and in further view of Zimmerman (US20070003536A1).
As discussed above, the Prior Art teaches a storage stable topical ascorbic acid composition containing urea, salicylic acid, solvent, and emulsifiers in the amounts claimed stored in a multi-use container demonstrating stability over time. This encompasses nearly the entirety of the instant invention, including the composition components and amounts. However, they do not teach madecassoside (instant claim 45).
Zimmerman is directed to topical skin compositions that prevent the adverse or detrimental effects of free radicals (abstract), including downstream photodamage to the skin, etc. [0003]. Zimmerman teaches madecassoside is a primary active constituent of centella asiatica which has been found to maintain or improve the firmness, elasticity, and general strength of the skin [0032].
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to add madecassoside to the teachings of the combined Prior Art because madecassoside would maintain or improve the firmness, elasticity, and general strength of the skin. This merges with purpose of the compositions of Zhang and Santhanam which are useful for treatment of skin, where Zhang also teaches oleaginous dermatologically active/aesthetic agents [0065-0066].
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 5, 8, 11, 14-15, 17-18, 24, 27, 37, 39, and 45-49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over, and in further view of Santhanam (WO2016141315A1, cited on IDS on 10/13/2022) and Shin (US20150152035A1):
claims 1, 4-6, 8, 11, 13, 15, 17-18, 20, 24, 26, 29, 33, 36, 39, 42, 46, 52, 54-56, 61, 69 of copending Application No. 17286434 (reference application)
claims 1, 5-6, 8, 11, 13, 17-18, 20, 24, 29, 33, 39, 42, 52-54, 70-72 copending Application No. 18/501,422 (reference application),
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications teach 5-28 wt% ascorbic acid, 5-20 wt% urea agent, and a non-aqueous skin-compatible solvent. Application No. ‘422 differs only significantly by not including 25-30 wt% of a chemical exfoliant.
This is remedied by Santhanam and Shin, who teach exfoliating agents, including salicylic acid, which may comprise 0.00001 to 90 wt%, of the composition in methods to diminish dermatological signs of aging in human skin (see 103 rejection above).
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending ‘422 subject matter. One of ordinary skill in the art would have been motivated to modify the teachings of ‘422 because the inclusion of a chemical exfoliant would complement the purpose of the instant composition in the treatment of skin.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s arguments, see pg 7-13, filed 09/04/2026, with respect to the 103 rejection of claims 1-2, 5, 8, 11, 14-15, 17-18, 20, 24-27, 37, 39, 45-50, 55-56, and 58 are persuasive. Therefore, the 103 rejection has been withdrawn. However, upon further consideration and in view of applicant’s amendments to the claims, a new ground of rejection is made in view of the new Shin reference (i.e., Shin introduction is prompted by Applicant’s amendment).
With regard to the arguments as a whole, the arguments are based on the amended claim set, which is addressed by modifying the 103 rejection. Thus, many of the arguments are moot, based on the modified rejection presented above. Elements of the remaining arguments will be addressed as best as can.
On page 7-8, Applicant discusses amendments made to resolve the 112(b) issue of the last Office Action, which is found acceptable.
On page 8, Applicant argues that the newly amended claim language specifying 25 to 30 wt% salicylic acid is not reasonably taught by Santhanam. However, Applicant is directed to the Shin reference (prompted by amendment), who teaches salicylic acid in 0.00001 to 90 wt% for topical skin-benefitting and exfoliating compositions (see 103 above). With regard to the numerical range, note that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) (see 2144.05(I)).
On page 8-9 (sections 1 and 2), Applicant summarizes the case and relevant law which is noted.
On page 9-10 (sections 3-5), Applicant argues that the combination and rationale do not teach the subject matter of independent claims 1 and 55 which now include an instant range of 25 to 30 wt% of salicylic acid. Applicant is directed to the Shin reference (prompted by amendment), who teaches salicylic acid in 0.00001 to 90 wt% for topical skin-benefitting and exfoliating compositions (as provided in the 103 above). Thus, Shin teaches topical exfoliating compositions comprising salicylic acid and/or derivatives of salicylic acid [0003-0004], whereby Shin teaches the obviousness of using these active ingredients in 0.00001 to 90 wt% (reads on the newly-amended 25 to 30 wt% salicylic acid range of instant claim 1, by encompassing the instant range) [00029] in order to provide exfoliation [0004], within a variety of formulation types, including gels, sprays, serums (i.e., liquid), lotions, ointments, creams, concentrates, emulsions etc. [0030-0031] including non-aqueous vehicles such as alcohols and polyols [0032] (i.e., similar to the nonaqueous solvents used by Zhang) and other additives (e.g., ascorbic acid [0034, 0040-0041]).
On page 10-11 (section 6), Applicant argues the ‘nearly identical’ Zhang formulation no longer supports a burden shift. However, Applicant is directed to the Shin reference (prompted by amendment), who teaches salicylic acid in 0.00001 to 90 wt% for topical skin-benefitting and exfoliating compositions (see 103 above). Thus, obviousness is established for the instant claim range of 25 to 30 wt% salicylic acid. Therefore, the burden still remains on Applicant to demonstrate an unexpected result, when Zhang already teaches the solubilizing effect of urea on ascorbic acid in non-aqueous formulations.
Note, that any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Consequently, we must determine whether the results obtained in the closest prior art and those set forth by Applicants are sufficiently different in kind, and not merely in degree, so as to be unexpected by a person of ordinary skill in the art at the time of invention. See Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) (Unexpected results that are probative of nonobviousness are those that are "different in kind and not merely in degree from the results of the prior art") (citation omitted). In this case, Zhang already teaches the solubilizing effect of urea on ascorbic acid in non-aqueous formulations (i.e., in a highly similar embodiment), and Shin teaches salicylic acid in 0.00001 to 90 wt% suitably exfoliates for topical skin-benefitting and exfoliating compositions.
On page 11 (section 7), Applicant argues that routine optimization does not cure the missing compositional limitation. The newly amended instant range of 25-30 wt% for salicylic acid is obvious based on the literature. Applicant is directed to the Shin reference (prompted by amendment), who teaches salicylic acid in 0.00001 to 90 wt% for topical skin-benefitting and exfoliating compositions (see 103 above).
On page 12 (section 8), Applicant argues Thomas and Waterman do not cure the deficiency related to the newly amended instant range of 25-30 wt% for salicylic acid. Thomas and Waterman are used to teach the obviousness of stability and/or storage conditions. Shin is used to address the newly amended limitations concerning salicylic acid amount of 25-30 wt%.
On page 12 (section 9), Applicant states that unexpected results evidence are not relied upon to establish non-obvious. However, obviousness is established through the salicylic acid range taught by Shin.
On page 12-13 (section 8), Applicant argues Zimmerman does not cure the deficiency related to the newly amended instant range of 25-30 wt% for salicylic acid. Zimmerman is used to teach the obviousness of incorporating madecassoside. Shin is used to address the newly amended limitations concerning salicylic acid amount of 25-30 wt%.
On page 13, Applicant summarizes and concludes. The amendment prompted incorporation of a new reference Shin, which addresses the obviousness of the new amended amount range for salicylic acid.
Correspondence
Applicant's amendment necessitated the new ground 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 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.
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/R.P./Examiner, Art Unit 1614 9/21/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
