DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. This office action is issued after the end of the suspension requested in the RCE filing.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/02/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/02/2025 have been considered by the examiner.
Status of the Claims
The response filed 09/02/2025 is acknowledged.
Claims 1-2, 5, 7-10 and 12-23 are pending.
Claim 23 is new.
Applicant’s election of Group I, claims 1-8 in the reply filed on 11/01/2024 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 9-10 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/01/2024.
Consequently, claims 20-22 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/01/2024
Claims 1-2, 5, 7-8, 12-19, and 23 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Withdrawn
Rejections under 35 U.S.C. 103 based on Takino, US 20140271510 A1 and Torihara, US 4959393 have been withdrawn. In the case of Takino, the reference does not expressly the specific resorcinol derivatives of claim 1 or 17. Resorcinol containing compositions are not the focus of Takino. Takino does not provide any detailed explanation as to why acetylmethionine is included in the compositions. There was little reason for one skilled in the art to have selected the few compositions containing resorcinol and acetylmethionine from Takino and modify those specifically with 4-ethyl, 4-isopropyl, or 4-cyclohexyl resorcinol derivatives absent improper hindsight.
Response to Arguments
Applicant's arguments filed 09/02/2025 have been fully considered but they are not persuasive with respect to the rejections based on Damodaran, WO 2018113634 in view of Millikin, US 20080206169.
Applicant respectfully asserts that the presently claimed invention is simply not taught or even suggested by the cited prior art. Applicant argues it is well established that "a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art." KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007). Applicant argues that indeed, "inventions in most, if not all, instances rely upon building blocks long since uncovered, and claimed discoveries almost of necessity will be combinations of what, in some sense, is already known". Id. at 418-419. Applicant argues it is respectfully submitted that the cited references lack any indication that if the presently claimed components were chosen, the resulting composition would be able to achieve the technical advantages described in the present application. Applicant argues it is respectfully submitted that the cited prior art simply does not provide the motivation to select the required components within the presently claimed ranges and does not provide any indication that, if the instantly claimed components in the claimed ranges were chosen, the resulting composition would provide the advantages of the present invention. Applicant submits that a skilled artisan would not have arrived at the presently claimed topical composition.
These arguments are unpersuasive.
The cited prior art, e.g., Millikin teaches n-acetyl methionine was known and used in skin care compositions for increasing the intracellular content of glutathione and activating glutathione reductase (Millikin, e.g., 0031). Millikin teaches personal care compositions comprising at least one skin care active, e.g., acetyl methionine (Millikin, e.g., abstract and 0030). Millikin suggests acetyl methionine will be effective when present in the composition in an amount ranging from about 0.01 to 10%, e.g., from about 0.5 to about 3% (Millikin, e.g., 0031).
Therefore, the skilled artisan would have clearly had motivation to modify Damodaran’s cosmetic compositions by adding n-acetyl methionine for an expected increase in intracellular content of glutathione and for activating glutathione reductase to address Damodaran’s expressly stated objective that the compositions are effective to increase intracellular glutathione in the skin (Damodaran, e.g., pg. 2:14-19, pg. 6:1-18, Example 1, and Example 2).
The stability data presented in the Specification under considerations is found in Table 1, reproduced below:
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384
700
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The data presented in the specification is not commensurate in scope with the claimed invention.
The results are shown for only a single concentration of 4-alkylresorcinol, e.g., 1% HR (example 4-5) and 1% ER (examples 8-9) and a single concentration of acetylmethionine (AceMet 1%), and a single concentration of niacinamide (B3 1%). See Table 1.
The 1% HR and 1% AceMet stability result differs from the 1% ER and 1% AceMet stability result when compared to each resorcinol alone. Thus, the data suggests that even at the same concentration, the result for one resorcinol derivative cannot be extrapolated to other resorcinol derivatives such as 4-isopropyl resorcinol.
Moreover, the testing is done in a simple, clear, aqueous solution of the components which is not representative of a complex cosmetic formulation.
It is not clear that the results for ER or HR are statistically significant. The data needs further explanation. For example, if the control has no 4-alkyl resorcinol, why is the % of control set to 100%. And further, if the colorless control is 100%, how can the “nearly colorless” of example 4 be 107% which is greater than 100% (reported as colorless for the control), and greater than the amount started with? If solution color represents degradation, then the “nearly colorless” result suggests there was some degradation and does not agree with the reported 107%. Similar results are reported for ER comparing 6 (96%) with 8 (102%) and 9 (102%).
It is unclear if the results are concentration dependent, e.g., the skilled artisan cannot extrapolate any result over the full scope of concentrations recited in claims 1 and 17.
The data is not commensurate in scope with the breadth of cosmetic compositions encompassed by the claimed invention. There is no resorcinol stability data for the more complex cosmetic formulations 2-12 spanning pp. 29-33. There is no evidence that the reported stability could be extrapolated over the full scope of possible cosmetic compositions encompassed by the claims. For example, there is no data showing stability for more complicated cosmetic formulation as that shown in table 2 which contains 20+ ingredients.
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 5, 7-8, 12-19, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Damodaran, WO 2018113634 in view of Millikin, US 20080206169.
Damodaran teaches compositions comprising 4-subsutitued resorcinols and amino acids (Damodaran, e.g., Title, Abstract, claims), wherein the 4-subsutitued resorcinol is, e.g., 4-ethyl resorcinol (Damodaran, e.g., pg. 2, 0.001 to about 3% of a resorcinol of formula 1, wherein R is an ethyl group). See also, Damodaran, e.g., pp. 40-41, Table 1, column 2, 4-ethylresorcinol in an amount ranging from 0.001-3%. See also Damodaran, e.g., pp. 41-42, Table 2, column 2 (WO-2) comprising 4-ethylresorcinol in an amount ranging from 0.001-3% and glycolic acid (alpha hydroxy acid). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05. Additional 4-substituted resorcinol derivatives within the scope of claim 1 are also found in Damodaran, e.g., claim 1, formula I. 4-ethyl resorcinol and isopropyl resorcinol are found in claims 6 and 8 respectively.
Damodaran teaches the composition is effective for potentiating glutathione synthesis within skin cells (Damodaran, e.g., Abstract and claims). Compositions increase glutathione production in skin cells (Damodaran, e.g., pg. 1, Field of the Invention). It is highly desirable to enhance the effects of glutathione in the skin because glutathione protects cells from oxidation caused by radiation, heat, chemicals, sun exposure, and environmental pollutants. See Damodaran, e.g., pg. 1, 9-21.
It is an expressly stated objective in Damodaran that the compositions are effective to increase intracellular glutathione in the skin (Damodaran, e.g., pg. 2:14-19, pg. 6:1-18, Example 1, and Example 2).
Applicable to claims 16 and 17-19: Damodaran teaches compositions further comprising niacinamide in an amount ranging from 0.5 to 2wt% (Damodaran, e.g., pg. 14:14-32). Compositions comprising niacinamide (0.1-5wt%) and resorcinol derivatives, e.g., ethylresorcinol are exemplified (Damodaran, e.g., Example 5, pp. 39-43, Tables).
Applicable to claim 23: Damodaran teaches wherein the composition is an oil in water emulsion. See Damodaran, e.g., Table 1, spanning pp. 40-41 is an oil in water emulsion.
Applicable to claims 8 and 19: Damodaran teaches compositions further comprising skin benefit agents, e.g., alpha-hydroxy acids and esters, beta- hydroxy acids and esters, polyhydroxy acids and esters, and ferulic acid (Damodaran, e.g., pg. 17:30-pg. 18:3). Compositions comprising stearic acid and resorcinol derivatives, e.g., ethylresorcinol are exemplified (Damodaran, e.g., Example 5, pp. 39-43, Tables).
Applicable to claims 12 and 18: Damodaran teaches compositions further comprising fatty acids, e.g., stearic acid (Damodaran, e.g., ¶ spanning pp. 19-20). Compositions comprising stearic acid and resorcinol derivatives, e.g., ethylresorcinol are exemplified (Damodaran, e.g., Example 5, pp. 39-43, Tables).
Applicable to claims 13-14: Damodaran teaches compositions further comprising humectants, e.g., glycerol/glycerine (Damodaran, e.g., pg. 11:7-14). Compositions comprising glycerine are exemplified (Damodaran, e.g., Example 5, pp39-43, Tables).
Applicable to claim 15: Damodaran teaches compositions further comprising a sunscreen (Damodaran, e.g., ppg. 12-14). Compositions comprising sunscreens are exemplified (Damodaran, e.g., Example 5, pp. 39-43, Tables).
Damodaran teaches methionine is utilized for intracellular glutathione synthesis (Damodaran, e.g., pg. 13:3-13). However, Damodaran does not expressly teach compositions comprising n-acetyl methionine.
Millikin teaches n-acetyl methionine was known and used in skin care compositions for increasing the intracellular content of glutathione and for activating glutathione reductase (Millikin, e.g., 0031). Millikin teaches personal care compositions comprising at least one skin care active, e.g., acetyl methionine (Millikin, e.g., abstract and 0030). Millikin suggests acetyl methionine will be effective when present in the composition in an amount ranging from about 0.01 to 10%, e.g., from about 0.5 to about 3% (Millikin, e.g., 0031). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05
It would have been obvious before the effective filing date of the presently claimed invention to combine the teachings of Damodaran and Millikin to arrive at compositions within the scope of the claimed invention with a reasonable expectation of success. The skilled artisan would have been motivated to modify compositions exemplified in Damodaran comprising a resorcinol derivative, such as 4-ethyl resorcinol in an amount ranging from 0.001-3% by including acetyl methionine in an amount suggested by Millikin for improved content of glutathione in the skin in the same way with a reasonable expectation of success. The teachings of Millikin provide an express teaching which would have prompted the skilled artisan to modify Damodaran’s compositions with acetyl methionine. The skilled artisan would have seen this modification as including a known skin active agent effective for improving the effect of glutathione in the skin thereby improving on Damodaran’s stated objectives. The skilled artisan would have had a reasonable expectation of success because Damodaran notes methionine can be used for glutathione synthesis.
Applicable to claim 2: The combined teachings of Damodaran and Millikin teach acetyl methionine and 4-substituted resorcinol derivative within the scope of claim 1 together in a composition. Therefore, the prior art teaches wherein said 4-substituted resorcinol derivative is stabilized in said composition with said n-acetyl methionine.
Accordingly, the subject matter of claims 1-2, 5, 7-8, 12-19, and 23 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615