DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/13/2026 has been entered.
Status of Claims
Receipt of Remarks/Amendments filed on 04/13/2026 is acknowledged. Claim 1 is amended and claims 2, 5, and 19-34 are canceled. Claims 35-36 remain withdrawn as being directed to a non-elected invention. Claims 1, 3-4, and 6-18 are examined on the merits herein.
Priority
The instant application filed 04/24/2023, claims priority to Provisional Application No. 63/336,703, filed 04/29/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/13/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
Claims 6, 10, and 18 recite the word “optionally”. Any limitation following the phrase “optionally” is being interpreted as optional and therefore not required. Claims 13-14 recite wherein the personal care composition comprises less than about 1 wt. % of hydroquinone, more specifically wherein the personal care composition is free of hydroquinone. The claims do not explicitly exclude derivatives of hydroquinone. Thus, the broadest reasonable interpretation of claims 13-14 is that the personal care composition does not comprise hydroquinone, but may comprise derivatives of hydroquinone.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claims 1, 3-4, and 6-18 are rejected under 35 U.S.C. 103 as being unpatentable over Shang, Z., et al. (CN 109453275 A, 03/12/2029, translation of 09/05/2023 used, IDS dated 09/05/2023), hereinafter Shang in view of Choi, S., et al. (WO 2022025656 A1, 02/03/2022, PE2E translation used, on record), hereinafter Choi and Li, M., et al. (WO 2020185654 A1, 09/17/2020, on record), hereinafter Li
as evidenced by National Center for Biotechnology Information (2025). PubChem Compound Summary for CID 54670067, L-Ascorbic Acid. Retrieved September 9, 2025 (on record), hereinafter NCBI and National Center for Biotechnology Information (2025). PubChem Compound Summary for CID 440936, Arbutin. Retrieved September 9, 2025 (on record), hereinafter NCBI2.
Shang discloses a compound external medicine for treating chloasma (¶ [0002]). Chloasma is also called liver spot causes yellow-brown pigmentation on the phase (¶ [0004]). Notably, the composition of Shang comprises 3~5g of tranexamic acid and 20~40g of mandelic acid among other ingredients (¶ [0008]). The tranexamic acid functions to inhibit plasma zymogen activator (sc-uPA), making tyrosinase inactivate in order to achieve the effect of eliminating melanin, while mandelic acid has the effect of eliminating ageing keratin and diluting pigmentation (¶ [0025]).
Regarding claim 1: Example 1 of Shang comprises 3 g of tranexamic acid and 20 g of mandelic acid (¶ [0052]), Example 2 comprises 4 g of tranexamic acid and 30 g of mandelic acid (¶ [0063]), and Example 3 comprises 5 g of tranexamic acid and 40 g of mandelic acid (¶ [0074]). The respective ratios of tranexamic acid to mandelic acid are 1:6.7, 1:7.5, and 1:8 in Examples 1-3, fall within the instantly claimed range (i.e., about 1:7 to 1:12).
Regarding claims 3 and 4: Examiner calculates the total weight of the compositions of Examples 1-3 to be 1032.2 g, 1505.3 g, and 1978.4 g, respectively. As such, Example 1 comprises 0.29 wt. % of tranexamic acid and 1.94 wt. % of mandelic acid. Example 2 comprises 0.27 wt. % of tranexamic acid and 1.99 wt. % of mandelic acid. Example 3 comprises 0.25 wt. % of tranexamic acid and 2.02 wt. % of mandelic acid. The concentrations in Examples 1-3 therefore read on the claimed amounts of tranexamic acid (i.e., 0.1-10 wt. %) and mandelic acid (i.e., about 2% to 20 wt. %).
Regarding claim 6: The compositions of Examples 1-3 further comprise L-vitamin C at 30 g, 35 g, and 40 g, respectively. L-vitamin C, also known as ascorbic acid, comprises 6 carbons as evidenced by NCBI, thereby reading on the one or more acid comprising 1 to 6 carbons.
Regarding claims 11-12: The compositions of Shang do not comprise resorcinol.
Regarding claims 13-14: The composition of Shang comprises arbutin which is a derivative of hydroquinone as evidenced by NCBI2. According to the broadest reasonable interpretation of the instant claims, as explained above, the composition of Shang does not comprise hydroquinone.
Regarding claim 16: The compositions of Shang further comprise 3~5g of butanediol and 10~15g of glycerol (¶ [0008]).). Specifically, Example 1 comprises 3 g of butanediol and 10 g of glycerol, which results in a total wt. % of polyols of 1.26 wt. %, as calculated by the Examiner. Example 2 comprises 4 g of butanediol and 12.5 g of glycerol, which results in a total wt. % of polyols of 1.10 wt. %. Example 3 comprises 5 g of butanediol and 15 g of glycerol, which results in a total wt. % of polyols of 1.01 wt. %. The weight percentages of the polyols present in the compositions of Examples 1-3 therefore fall within the instantly claimed range (i.e., 0.1 to 20 wt. %).
Regarding claim 17: The composition of Shang does not comprise any kojic acid.
Regarding claim 18: Example 1 of Shang comprises 3 g of tranexamic acid and 20 g of mandelic acid (¶ [0052]), Example 2 comprises 4 g of tranexamic acid and 30 g of mandelic acid (¶ [0063]), and Example 3 comprises 5 g of tranexamic acid and 40 g of mandelic acid (¶ [0074]). The respective ratios of tranexamic acid to mandelic acid are 1:6.7, 1:7.5, and 1:8 in Examples 1-3, fall within the instantly claimed range (i.e., 1:6 to 1:17). Examiner calculates the total weight of the compositions of Examples 1-3 to be 1032.2 g, 1505.3 g, and 1978.4 g, respectively. As such, Example 1 comprises 0.29 wt. % of tranexamic acid and 1.94 wt. % of mandelic acid. Example 2 comprises 0.27 wt. % of tranexamic acid and 1.99 wt. % of mandelic acid. Example 3 comprises 0.25 wt. % of tranexamic acid and 2.02 wt. % of mandelic acid. The concentrations in Examples 1-3 therefore read on the claimed amounts of tranexamic acid (i.e., 0.1-10 wt. %) and mandelic acid (i.e., about 2% to 20 wt. %).
The teachings of Shang differ from the instantly claimed invention in that Shang does not teach wherein the composition further comprises sodium pyruvate as recited in claims 1 and 18, nor does Shang teach the acids of claims 7-10 or the monoalcohol of claim 15.
Choi discloses a cosmetic composition for whitening comprising sodium pyruvate (p. 2, para. 2). Choi teaches that when melanin is excessively produced by external environmental changes such as excessive exposure to ultraviolet rays, air pollution, stress, etc., it causes pigmentation in the skin, which causes skin blackening (melanism) or blemishes and freckles (p. 2, para. 3). Specifically, when the skin is exposed to ultraviolet light, tyrosinase is activated, and the tyrosinase acts on tyrosine present in the skin tissue to produce dopa (DOPA) and dopaquinone (dopaquinone) by an oxidation process. Melanin is then synthesized in melanosomes in melanocytes, which are skin pigment cells, and this melanin is transferred to keratinocytes of the skin, and reaches the skin surface through the keratinization process. As a result, melanin is deposited on the skin surface, causing melasma, freckles and various pigmentation (p. 2, para. 3). Given this mechanism, in the preparation of a whitening cosmetic or a pigmentation improvement medical composition, substances having an inhibitory effect on the activity of tyrosinase, an enzyme involved in the skin blackening process, are desired. Representative materials used for this purpose include chemical substances such as sodium pyruvate (p. 2-3, last and first para.). The composition comprising sodium pyruvate as an active ingredient which has the effect of inhibiting melanin synthesis of melanocytes, and thus can exhibit a whitening effect (p. 4, para. 8). The composition may include sodium pyruvate in an amount of 0.001 to 2% (w/w) based on the total weight of the composition (p. 5, last para.; claim 2), which reads on the sodium pyruvate of claims 1 and 18.
Li discloses personal care compositions comprising a complex comprising a plurality of short chain fatty acids; along with methods of making and using the same (abstract). Personal care compositions include hair care, skin care, sun care, nail care, and oral care compositions. In some embodiments, the personal care composition is applied to the person’s skin or scalp (¶ [0040]). The invention of Li is directed to a personal care composition comprising a biomimetic blend comprising lactic acid, acetic acid and pyruvic acid or a salt thereof (e.g. sodium pyruvate) (¶ [0032]; claim 29), wherein sodium pyruvate reads on that of instant claims 1 and 18 and lactic acid reads on the acid of claims 6-10. One advantage of the invention is that the personal care composition comprising such a blend provides for an improved skin microflora balance and inhibits the growth of harmful bacteria (¶ [0033]-[0034]). Other advantages include the promotion of beneficial bacteria growth and the regulation of specific gene expressions (¶ [0035]-[0037]). Additionally, Figure 2 depicts the tyrosinase inhibition provided by the biomimetic blend, which is much higher when lactic, acetic, and pyruvic acid are combined versus when they are alone in the same concentrations (Fig. 2). Table 3 further reports the strong synergy exhibited between lactic, acetic, and pyruvic acid in a dose-dependent study of 50% tyrosinase inhibition (Ex. 5). Li also teaches that the biomimetic blend may comprise a short chained alcohol ([0046]). Under one embodiment, the biomimetic blend comprises a short chain alcohol such as methanol, ethanol, propanol, etc. ([0054]), all of which read on the monoalcohol of claim 15.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to add the biomimetic blend of Li into the composition of Shang, wherein sodium pyruvate is the source of pyruvic acid as reasonable suggested by Choi and Li, to yield the instantly claimed invention. First, Shang teaches a composition for treating chloasma, which is a pigmentation disorder of the skin. Tranexamic acid is specifically used as an active ingredient due to its ability to inactivate tyrosinase. Choi elucidates the role of tyrosinase in melanin production and therefore skin pigmentation. Choi explicitly discloses the benefit of substances, such as sodium pyruvate, having an inhibitory effect on tyrosinase activity in whitening compositions. Lastly, Li teaches a biomimetic blend which not only provides improved skin microflora balance and inhibits the growth of harmful bacteria, but also exhibits strong tyrosinase inhibition. Thus, one of ordinary skill in the art would have been motivated to add the biomimetic blend of Li (i.e., lactic acid + acetic acid + pyruvic acid) into the de-pigmentation composition of Shang since the blend of Li results in desirable skin effects and tyrosinase inhibition. One would have been further motivated to use sodium pyruvate as the source of pyruvic acid since sodium pyruvate inhibits melanin synthesis and exhibits a whitening effect as taught by Choi. Additionally, Li teaches that sodium pyruvate is a known and routine pyruvic acid source in the biomimetic blend. One of ordinary skill in the art would have had a reasonable expectation of success in combining the compositions of Shang, Choi, and Li since all teach personal care compositions for external use. The sodium pyruvate reads on that of claims 1 and 18 while the lactic acid reads on the one or more acids of claims 6-10.
Regarding the amount of sodium pyruvate, it would have been further prima facie obvious to one of ordinary skill in the art to incorporate it at the amounts disclosed by Choi since these amounts are known and routine in the art as taught by Choi. One of ordinary skill in the art could have incorporated sodium pyruvate at 0.001 to 2% by weight, as taught by Choi, according to known methods to predictably yield the instant invention. The range of 0.001 to 2% sodium pyruvate overlaps with the instantly claimed range of claims 1 and 18 (i.e., 0.5 to 5/10 wt. %). 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. One of ordinary skill in the art could have further incorporated the urea disclosed by Choi which maintains the efficacy of sodium pyruvate at these low amounts, or relied on the synergistic effect achieved by the biomimetic blend of Li, which would reasonably allow sodium pyruvate to be incorporated at these low amounts. As such, one of ordinary skill in the art would have had a reasonable expectation of success in incorporating sodium pyruvate at this amount.
It would have been further prima facie obvious to one of ordinary skill in the art to incorporate a monoalcohol in the combined composition above since monoalcohols are known and routine in the art as taught by Li. One of ordinary skill in the art could have added a monoalcohol, such those taught by Li, into the combined composition via known methods to predictably yield the instant invention. Regarding the amount at which to incorporate such a monoalcohol, it is well within the abilities of an ordinary artisan to optimize the amount of alcohol in the composition depending on the desired consistency of the final product. As such, one of ordinary skill in the art would have arrived at the instantly claimed range of claim 15 through no more than routine experimentation. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant's arguments filed 04/13/2026 have been fully considered but they are not persuasive:
In response to the 103 rejection over Shang, Choi, and Li:
(A) Applicant provides arguments against In re Kerkhoven, stating that Choi teaches that the instantly claimed amount of sodium pyruvate is unstable. In response to this argument it is noted that 1) In re Kerkhoven is not relied on in the above rejection. Rather a specific technical motivation is described regarding the known tyrosinase inhibition of sodium pyruvate, specifically in a blend with other organic acids. 2) The instant claims do not prohibit the use of urea, meaning one of ordinary skill in the art could have added urea as suggested by Choi. Even so, Choi only teaches the “collapse” of the thickening system when sodium pyruvate is at a “high concentration”. Choi explicitly teaches its invention to comprise a “low concentration of sodium pyruvate” (See abstract). The urea of Choi is not used as a stabilizer for high amounts but rather a synergistic additive that enhances the action of pyruvate at low amounts (See “Advantageous Effect”). Thus, the amount of sodium pyruvate taught by Choi (i.e., 0.001 to 2%) is considered a low concentration which would not collapse the system. There is no explicit teaching in Choi that the instantly claimed amount of sodium pyruvate (0.5 to 5 wt. %) would result in an expected collapse. Thus, one of ordinary skill in the art would have had a reasonable expectation of success in incorporating sodium pyruvate at the amounts of Choi with no stability issues. The maintained efficacy of sodium pyruvate at low amounts, attributed to urea in Choi, would be also be expected when it is incorporated in the biomimetic blend of Li due to their synergistic effect disclosed by Li.
(B) Applicant asserts unexpected results, pointing to Example 6 and Fig. 4, which show an improvement in binding affinity. Applicant describes how individual acids like mandelic and TXA only exhibit moderate binding but when combined at the claimed ratios their combination achieves a high binding affinity. Applicant states that combinations of TXA and lactic or pyruvic acid remain moderate. In response to this argument, Applicant is reminded that Shang, not Li, is the primary reference. Shang explicitly teaches the combination of mandelic acid and TXA at the instantly claimed ratios. Therefore, obviousness is not relied on for teaching mandelic acid and TXA at the claimed ratio, it is simply anticipated by Shang. The unexpected results are inherent to the compositions of Shang since Shang defines the exact same combination as claimed and discussed in the “unexpected results”.
(C) Applicant argues an unexpected improvement in collagen stimulation as shown in Example 3 and Fig. 2, a property not suggested or taught by the prior art. In response to this argument, an affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. See In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). In this case, applicant has not provided a comparison to the closest prior art to sufficiently show unexpected results. Example 3 compares example composition A and comparative composition 1. As seen in Table 1, comparative composition 1 does not comprise the TXA and mandelic acid taught by the closest prior art (Shang). As such, comparative composition 1 is not considered the closest prior art and is not an effective showing of an unexpected improvement.
(D) Applicant argues that there was no motivation to combine the acids, arguing that following the teachings of Choi would discourage one of ordinary skill from using 0.5-5% pyruvate and that Li is restricted to a ratio of 4:2:1. Applicant asserts their specific ratio of 1:7 to 1:12 is a “non-obvious” selection. In response to this argument, there is no teaching in Choi against 0.5-5% of pyruvate, as stated above in response to (A). Secondly, the 4:2:1 ratio of Li is completely different than Applicants claimed ratio of 1:7 to 1:12 since the ratio of Li is lactic acid to acetic acid to sodium pyruvate while the instantly claimed ratio is tranexamic acid to mandelic acid. The two ratios can exist simultaneously without contradicting one another. Lastly, the above rejection does not define the instantly claimed ratio of 1:7 to 1:12 as an “obvious” selection. It is a limitation explicitly taught by the primary reference Shang.
Applicant’s arguments with respect to Newton and Sharkey have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims allowed.
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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