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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/21/2026 has been entered.
Response to Amendment
The Amendment filed 01/21/2026 has been entered. Applicant’s amendments are in response to in the Final Office Action mailed 07/28/2025. Applicant’s claims have been amended in the following manner: independent claim 1 has been narrowed by specifying “wherein the composition demonstrates less than 2 mol% degradation of ascorbic acid after 6 months of storage at 40°C ±2°C in a multi-use container” (a limitation this is moved from claim 2 to claim 1, that finds support in Applicant’s Specification at [0081]). . First Action Final is appropriate when it’s a continuing application claiming the same or a patentably indistinct invention, where the rejections made are maintained from the previous office action. See MPEP 706.07(b). The following objections/rejections are withdrawn: none.
The Examiner further acknowledges the following:
Claims 1-2, 5, 8, 11, 14-15, 17-18, 20, 24-27, 37, 39, 45-50, 55-56, and 58 are pending.
Claims 1-2, 5, 8, 11, 14-15, 17-18, 20, 24-27, 37, 39, 45-50, 55-56, and 58 are presented for examination and rejected as set forth below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites stability conditions/limitations 2(a) and 2(b), where claim 1 (from which it depends) already recites the stability condition found in 1(e). Thus, when two stability conditions/limitations are simultaneously recited as required, it is unclear which stability condition/limitation sets the boundary for the instant claim set, which is indefinite.
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, 20, 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), Thomas (US 20180228714 A1), and Waterman (International Journal of Pharmaceutics, 2005).
Applicants claims are directed to a composition, comprising ascorbic acid, a urea agent, 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, 25-26, 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. However, Zhang does not teach a chemical exfoliant such as salicylic acid and an amount (instant claims 1, 17-18, 20, 25-26, 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].
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 described by Santhanam such as salicylic acid with Zhang’s composition and to use a container taught by Santhanam that dispenses appropriate doses because the anti-aging exfoliating agent and dispensing container are useful in methods to diminish dermatological signs of aging in human skin as taught by Santhanam, and Zhang teaches ascorbic acid compositions suitable for preventing or treating photo-damage to the skin [0003].
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, 20, 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), Thomas (US 20180228714 A1), and Waterman (International Journal of Pharmaceutics, 2005), as applied to claims 1-2, 5, 8, 11, 14-15, 17-18, 20, 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 teaches madecassoside is a primary active constituent of centella asiatica which has been found to maintaining or improving 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, 20, 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):
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, less than 10 wt% additional components, and a non-aqueous skin-compatible solvent. Application No. ‘422 differs only significantly by not including 2-30 wt% of a chemical exfoliant.
This is remedied by Santhanam, who teaches exfoliating agents, including salicylic acid, mandelic acid, glycolic acid, lactic acid, etc., which may comprise 0.0001-20 wt% of the composition [000121] in methods to diminish dermatological signs of aging in human skin (Santhanam – claim 1).
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
Applicants arguments, see pg 7-12, filed 01/21/2026, 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 have been fully considered but they are not persuasive. The 103 rejection has been modified with respect to amendments made to the claim set by way of rearrangement of the references; however, the thrust of the rejection remains the same as before, relying on the same references. Note the amendment caused some rearrangement of references of the 103 rejection; however, the same grounds are applied, and the remarks will be responded to according to the new arrangement of references in the current 103 rejection.
Furthermore, a general recognized theme of the arguments is that the references are treated piecewise, which is per se unpersuasive. It is the combined teachings that define the art. However, the Examiner will respond to arguments of substance when presented.
On page 7, Applicant summarizes amendments made to instant claims 1-2 with regard to the 103 and provisional nonstatutory double patenting rejections, in general. This is noted and considered for the later more detailed arguments.
On page 8-9, Applicant argues that the previous Office Action did not establish a prima facie case to support an obviousness rejection.
Argument (a): Applicant suggests that Zhang does not teach or suggest the claimed long-term accelerated stability requirement in a multi-use container. Note that even though Zhang does not explicitly state a less than 2 mol% degradation of ascorbic acid after 6 months of storage at 40 °C, by way of example, Zhang teaches stability of sample compositions after 1 month (reads on storage stable) [0164]. Furthermore, 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]. Thus, Zhang directly teaches the advantage of limiting ascorbic acid degradation (as sought by instant claim 1(e)). By this logic, a PHOSITA would desire no degradation of ascorbic acid over any time period, and would optimize for this result. Furthermore, Thomas and Waterman are incorporated to teach the obviousness of extending the stability of cosmetic compositions containing ascorbic acid to up to 10 years and at accelerated conditions (40 °C), where are parameters incorporated in instant claim 1(e).
The so-called compounding factor of a multi-use storage container (as discussed in the arguments on pg 9 bullet “a”), does not add a significant limitation to the claim scope because the stability of the instant composition is at question here. Applicant has not provided any evidence that multi-use storage (i.e., headspace exchange, etc.) is any more detrimental to compositions than the containers used by Zhang for experimentation. Furthermore, the interpretation of “multi-use container” is very broad. Even containers intended for stability sampling would be considered to undergo “multi-use” by repeated sampling. Additionally, 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 claim 1) [00030], and it would be obvious to perform stability studies in such containers because they represent the real-use test case of product stability.
Finally, the purported challenges of the “multi-use container” (i.e., specifically the headspace exchange, transient oxygen/moisture ingress, etc.) are not limited by the claim scope. Thus, limitations are being argued that are not claimed: Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1571-72, 7 USPQ2d 1057, 1064-1065 (Fed. Cir.), cert. denied, 488 U.S. 892 (1988) (Various limitations on which appellant relied were not stated in the claims; the specification did not provide evidence indicating these limitations must be read into the claims to give meaning to the disputed terms.); In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993) (although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims).
Argument (b): Applicant suggests that Santhanam does not cure Zhang's deficiency regarding the amended stability limitation. Santhanam is mainly applied to introduce the obviousness of incorporating the chemical exfoliant and the multi-use containers, as shown in the 103 rejection.
Argument (c): Applicant suggests that the rejection lacks a sufficient rationale to conclude that the amended stability requirement would have been achieved with a reasonable expectation of success. With regard to reasonable expectation of success: “Applicants are reminded that obviousness does not require absolute predictability. See In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (indicating that evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness).” The combined teachings and rationale of Zhang, Santhanam, Thomas, and Waterman provide the necessary elements for a PHOSITA to arrive at the solution found in instant claim 1, and its dependent claims. Thus, the instant claim set is obvious. Also, there is no evidence provided by the applicants to call into question the predictability of the art.
On page 9-10, Applicant argues against Thomas and Waterman, and the Office Action’s reliance on them for teachings related to stability. Note that it is the combined teachings that are relevant to an obviousness analysis, where consideration to the primary reference Zhang is given to teach the obviousness of the claim set.
Argument (a): Applicant argues Thomas does not teach or suggest the claimed accelerated stability outcome in a multi-use container for the claimed composition system. In this case, the argument is piecewise, and rationale for incorporating Thomas as an analogous reference has been provided in the 103 rejection above.
Further note that Thomas is not required to teach all elements of the instant claim 1. Rather it’s the combined teachings of the Prior Art that render instant claim 1 obvious. When Applicant asks that the Prior Art teaches the specific “outcome,” this has been made obvious where Zhang, Santhanam, Thomas, and Waterman teach the essential limitations of claim 1 and a rationale for combination.
Argument (b): Applicant argues that Waterman does not teach stabilizing ascorbic acid compositions to meet the amended claim 1 stability limitation. Along the same lines, the argument is piecewise, and rationale for incorporating Waterman as an analogous reference has been provided in the 103 rejection above.
Argument (c): Applicant argues that "routine optimization" is not established for the amended stability limitation. Note that stability is found critical for the performance of cosmetic compositions: 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]. One can optimize the stability of a composition by adjust the amounts of various ingredients, and this is routinely performed in laboratories by PHOSITA. 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). Furthermore, Zhang teaches methods for increasing ascorbic acid stability (i.e., “ascorbic acid is much more stable in nonaqueous organic solvents” [0003]), providing potential pathways for ingredient optimization for a PHOSITA. Furthermore, Thomas and Waterman are incorporated to teach the obviousness of extending the stability of cosmetic compositions containing ascorbic acid to up to 10 years and at accelerated conditions (40 °C), where are parameters incorporated in instant claim 1(e).
On page 11, Applicant sums up its position by stating the combine Prior Art does not teach all elements of the very specific stability limitation of claim 1, as written. While no single reference details this specific limitation, the Examiner suggests the combined Art teaches the obviousness of the limitation. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually.
From a general view of Applicant’s arguments, it appears that Applicant is attempting to claim the Prior Art does not demonstrate a very specific stability result (i.e., “the claimed long-term accelerated stability requirement in a multi-use container”), and therefore, the limitation is not obvious. The Office has demonstrated the combined teachings show that the instant claim set as obvious. Thus, Applicant can demonstrate non-obviousness, by way of providing data in support of unexpected results. Furthermore, to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). Any range demonstrated as critical should be commensurate in scope with the claim set. The Examiner has not noticed an instance where Applicant seeks to demonstrate non-obviousness by way of unexpected results, whereby the results must be based on evidence (and not argument/speculation). It should be remembered that “a showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997) (conclusory statements regarding unusually low immune response or unexpected biological activity that were unsupported by comparative data held insufficient to overcome prima facie case of obviousness).” There is no evidence that results are surprising with respect to the prior art.
Finally, in Applicant’s Specification (Example 3: Storage Stability Studies at [00259-00262]), the Examiner notes that the storage stability of Table 3 from the Specification shows more than 2 mol% degradation over 6 weeks (i.e., 1.5 months) at 40 °C in the exemplary “mask” composition (which contrasts with the instant limitation of independent claim 1 that requires < 2 mol% degradation over 6 months at 40 °C; such that even if unexpected results were argued, the current data does not appear to be commensurate in scope with the current claim 1, that currently specifies a 6-month storage time). Furthermore, the relationship of wt% degradation of Table 3 of the Specification, and the mol% degradation of instant claim 1 is not made clear. Additionally, the “control compositions” contain only Vitamin C in water [00261] (as compared to Exemplary compositions of Table 2), where Zhang teaches the solubilization enhancing and thus, stabilizing effect of urea agents in nonaqueous compositions [0004-0008], rendering the stabilizing result on vitamin C that is demonstrated below, as expected.
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Furthermore, if Applicant seeks argument by unexpected results, Applicant should consider 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). With regard to expected stability result of the instant compositions, the Examiner does not see anything within this comparison that would impart unexpected properties to the Applicant’s composition (e.g. the additional 2 wt% salicylic acid of Formulation 1; when Zhang teaches the addition of even hydrophobic additives do not significantly impact the solubilizing enhancing effect [0052]) compared to Zhang’s exemplary formulation in [0125], where 1,3-propanediol is also taught as suitable by Zhang [0035].
Thus, from the position of PHOSITA, due to the extreme similarities in the embodiment of Zhang [0125] and the instant Formulation 1 [0258], one would expect very similar stability profiles for these compositions. In this case, the beneficial results are expected based on the teachings of the prior art: “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), see also In re Skoner, 517 F.2d 947, 950 (CCPA 1975).
On page 11, Applicant argues against Zimmerman for madecassoside, with regard to the now incorporated stability limitation of claim 1. Zimmerman is not required to teach all elements of instant claim 1. All elements of each prior art reference need not read on the claimed invention, rather, the proper test for obviousness is what the combined teachings would have suggested to a person of ordinary skill in the art. In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000). In this case, Zimmerman teaches madecassoside where 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.
On page 11-12, Applicant concludes.
The Examiner has rearranged the references to fit the amendments made by Applicant; however, the same ground of rejection has been applied, allowing for a Final Action to be proper. First Action Final is appropriate when it’s a continuing application claiming the same or a patentably indistinct invention, where the rejections made are maintained from the previous office action. In this case, the incorporation of the stability conditions of claim 1(e), does not significantly differentiate the claim set from the previously filed claim set, when this limitation was found in the previous claim 2.
Correspondence
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/R.P./Examiner, Art Unit 1614 2/23/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614