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 .
Status of Claims
Receipt of Remarks/Amendments filed on 12/09/2025 is acknowledged. Claim 1 is amended and claim 5 is canceled. Claims 19-34 remain canceled and claims 35-36 remain withdrawn as being directed to a non-elected invention. In addition, the nonelected species are withdrawn from each corresponding claim. Claims 1-4 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.
Claim Interpretation
Claims 1, 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.
Withdrawn Rejections
Claims 1-4, 6, 11-14, and 17 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shang. Applicant’s amendments to claim 1 have overcome the rejection and the rejection is withdrawn.
Claims 1-3, 6, 11-14, and 17 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen. Applicant’s amendments to claim 1 have overcome the rejection and the rejection is withdrawn.
Claim 5 was rejected under 35 U.S.C. 103 over Shang, Li, and Choi. Applicant’s cancelation of claim 5 has rendered the rejection moot and the rejection is withdrawn.
The following rejections are maintained:
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 1-4, 6-14 and 17-18 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]). At present, the topical drugs for treating chloasma include hydroquinone cream, vitamin A acid ointment, kojic acid cream and glucocorticosteroid ointment, but most of the effects are unsatisfactory (¶[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]). Specifically, 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, which fall within the ranges of claims 1 and 18. The ratios of Examples 2 and 3 further fall within the range of claim 2. Regarding the wt. % of mandelic acid and tranexamic acid, 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 of tranexamic acid in Examples 1-3 therefore read on claims 3 and 18 while the concentration of mandelic acid in Example 3 reads on claims 4 and 18. 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 of claim 6. The compositions of Shang do not comprise resorcinol, thereby reading on claims 11-12. 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 and therefore reads on claims 13-14. Lastly, the composition of Shang does not comprise any kojic acid, thereby reading on claim 17.
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.
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 ascorbic acid, kojic acid, hydroquinone, sodium pyruvate, and plant extracts such as sagebrush extract and licorice extract. Hydroquinone is limited in use in cosmetics due to skin irritation and safety problems (p. 2-3, last and first para.). The composition comprising sodium pyruvate as an active ingredient according to Choi 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.).
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 at about 4:2:1 ratio; and a surfactant. In other embodiments, the invention provides a complex comprising a salt of lactic acid; a salt of acetic acid; and a salt of pyruvic acid (e.g. sodium pyruvate) (¶ [0032]). Specifically, Li claims a biomimetic blend comprising from about 2 to about 16 parts, by weight, lactic acid; from about 1 to about 8 parts, by weight, acetic acid; and from about 0.5 to about 4 parts, by weight, pyruvic acid or a salt thereof (e.g. sodium pyruvate) (claim 29). 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).
It would have been obvious to combine the teachings of Shang, Choi, and Li before the effective filing date of the claimed invention by adding 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 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 may be used as the 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. It would have been further obvious to incorporate the lactic, acetic, and pyruvic acid (i.e., sodium pyruvate) into the composition of Shang at the amounts taught by Li since these amounts result in a synergistic effect between the three.
Thus, the combined composition of Shang, Choi, and Li comprises a blend of about 2-16 parts, by weight of lactic acid; about 1-8 parts by weight of acetic acid; and about 0.5-4 parts by weight of sodium pyruvate. The lactic acid and sodium pyruvate read on the one or more acids and derivatives thereof, as defined in claims 6-10. Additionally, sodium pyruvate at 0.5-4 parts by weight reads on claims 1 and 18.
2. Claims 1-4, 6-15 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Shang, Choi, and Li as applied to claims 1-4, 6-14 and 17-18 above, and further in view of Newton, A. A. (2019, October 10). 5 surprising truths about the alcohol in your skin-care products. SELF (on record), hereinafter Newton.
The combined teachings of Shang, Choi, and Li are discussed above.
It is further noted that the biomimetic blend of Li may further comprise a short chained alcohol or a polyol ([0046]). Under one embodiment, the biomimetic blend comprises a short chain alcohol. Examples of a short chain alcohol include iso-propanol (i.e., isopropyl alcohol) ([0054]).
The combined teachings of Shang, Choi, and Li differ from that of the instantly claimed invention in that none explicitly teach a specific embodiment comprising a monoalcohol as recited in instant claim 15.
Newton teaches it is common for cosmetics to use alcohols as either solvents or emulsifiers. Alcohols with low molecular weights, like isopropyl alcohol and ethanol, function as solvents, encouraging ingredients that don’t want to dissolve in water to do just that. These lower-molecular-weight alcohols are useful in achieving a specific product texture and they help increase the skin penetration of active ingredients (p. 3, para. 2-4).
Thus, it would have been obvious to modify the combined composition of Shang, Choi, and Li before the effective filing date of the claimed invention by incorporating isopropyl alcohol into the combined composition to yield the instantly claimed invention. One of ordinary skill in the art would have been motivated to incorporate isopropyl alcohol into the combined composition of Shang, Choi, and Li since it aids in water solubility, product texture, and active ingredient penetration as taught by Newton. Additionally, it is considered prima facie obvious to combine prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have had a reasonable expectation of success in incorporating isopropyl alcohol into the combined composition of Shang, Choi, and Li since isopropyl alcohol is known and routine in cosmetics as taught by Newton, and the combined composition is a cosmetic compositions.
Regarding the amount of isopropyl alcohol to incorporate into the composition, it is well within the abilities of an ordinary artisan to optimize the amount of solvent in the composition depending on the desired consistency of the final product especially given that Newton teaches isopropyl alcohol as useful in achieving a specific product texture. 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).
3. Claims 1-4, 6-14 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Shang, Choi, and Li as applied to claims 1-4, 6-14 and 17-18 above, and further in view of Sharkey, L. (2021, September 29). What’s caprylyl glycol? uses, safety, and more. Healthline (on record), hereinafter Sharkey.
The combined teachings of Shang, Choi, and Li are discussed above.
It is further noted that 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 range of claim 16.
The combined teachings of Shang, Choi, and Li differ from the instantly claimed invention in that Shang, Choi, nor Li teach the elected polyol of claim 16.
Sharkey discusses the use of caprylyl glycol in skin care products. Caprylyl glycol is a humectant found in products designed to hydrate skin (p. 1, para. 5). Aside from attracting moisture and locking it into the skin, caprylyl glycol also works as a skin softener or emollient and helps to support a healthy skin barrier (p. 2, para. 6-7). Additionally, caprylyl glycol works as a preservative, preventing bacteria from growing and spoiling the formula. This protects your skin while also extending the life of your products (p. 2, para. 10-12). Lastly, caprylyl glycol can also improve the texture of skin care products (p. 2, final paragraph).
Thus, it would have been obvious to modify the combined composition of Shang, Choi, and Li before the effective filing date of the claimed invention by substituting the polyols of Shang with caprylyl glycol to yield the instantly claimed invention. One of ordinary skill in the art would have been motivated to include caprylyl glycol in the combined composition of Shang, Choi, and Li since caprylyl glycol is a known and effective skincare ingredient with several beneficial properties as taught by Sharkey. Additionally, it is considered prima facie obvious to perform simple substitution of one known element for another (i.e., polyols) to obtain predictable results. See MPEP 2143. One of ordinary skill in the art would have had a reasonable expectation of success in incorporating caprylyl glycol into the combined composition of Shang, Choi, and Li since Sharkey teaches that caprylyl glycol is a common ingredient in skincare products and Shang, Choi, and Li disclose skincare products.
Response to Arguments
Applicant's arguments filed 12/09/2025 have been fully considered but they are not persuasive:
(1) Applicant argues that Choi teaches away from the claimed invention since Choi teaches that thickening systems can be disrupted by sodium pyruvate. Choi solves such an issue by using a low concentration of sodium pyruvate in combination with urea which is in contrast to the present invention which recites sodium pyruvate in an amount of 0.5 to 10 wt.% and does not require the presence of urea to maintain efficacy or stability (p. 8 of Remarks).
In response to Applicant’s above arguments, Choi teaches a concentration of sodium pyruvate of 0.001 to 2%, as discussed above and as acknowledged by the Applicant. Such a range has an end point of 2% which falls within Applicant’s claimed range and cannot be characterized as a “teaching away”. Furthermore, the amount of sodium pyruvate, as recited in instant claim 1, is optional. Additionally, Li provides its own teaching of about 0.5 to about 4 parts, by weight, of pyruvic acid or a salt thereof (e.g. sodium pyruvate) in a personal care composition. Such an amount falls entirely within the instantly claimed range. Even if Chen were to be overcome, Li teaches everything needed to establish a prima facie case of obviousness for adding sodium pyruvate, at the instantly claimed amount, into the composition of Shang.
Furthermore, one of ordinary skill in the art could have incorporated the urea of Li in addition to the sodium pyruvate if such a combination is required, as argued by the Applicant. Shang and Choi both teach compounds for inactivating tyrosinase and reducing pigmentation. Thus, the addition of any actives taught to achieve this affect, such as urea and sodium pyruvate in combination, would have been obvious. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). The instant claims recite the phrase “comprising” which is inclusive of other ingredients, such as urea.
(2) Applicant further argues that Li fails to establish a motivation to combine since Li describes a complex specifically designed to mimic a probiotic fermentation product for microbiome balance (p. 8 of Remarks). Li’s teaching is specific to a blend, meaning a POSITA would be motivated to incorporate all three acids (lactic, acetic, and pyruvic) in order to obtain the synergistic effect of tyrosine reduction. Accordingly, Applicant argues that there is no motivation to extract only sodium pyruvate from the blend of Li. Lastly, Applicant argues that Shang and Li disclose incompatible utilities since Shang is directed to eliminating melanin while Li is directed to skin microflora balance (p. 9 of Remarks).
In response to this argument, it is discussed in the above rejection that all three acids of Li are combined in the final composition: “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 may be used as the pyruvic acid source in the biomimetic blend.” A POSITA would expect the synergy to be retained when using sodium pyruvate as the pyruvic acid source, since such an embodiment is explicitly suggested by Li. The above rejection does not attempt to make obvious the extraction of only sodium pyruvate from the blend of Li, as argued by the Applicant. Regarding Applicant’s assertion of incompatible utilities, Examiner disagrees. Given the technical background provided by Shang on the correlation between tyrosinase inactivation and reducing melanin, a POSITA would recognize the disclosure of Li as relevant, since it teaches compositions with tyrosinase inhibition.
(3) Applicant argues that the tranexamic acid, mandelic acid, and sodium pyruvate of instant claim 1 provides unexpected synergistic benefits not predicted by the cited reference, specifically regarding superior binding affinity and total composition efficacy (p. 9-10 of Remarks).
In response to Applicant’s argument of unexpected results, 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. In the instant case, the superiority of the binding affinity between tranexamic acid and mandelic acid in Example 5 and Figure 4 is not a comparison to the closest prior art since Shang explicitly teaches tranexamic acid and mandelic acid together. Thus, Applicant is simply showing that superior binding affinity is inherent to a composition which comprises tranexamic and mandelic acid together, such as that of Shang. Example 2 and Figure 1, which are cited by Applicant as evidence for the unexpected increase in total composition efficacy, is also not a comparison to the closest prior art since the comparative example is a kojic acid and hydroquinone composition which cannot be considered equivalent to the composition of Shang.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 7:30-5 (Flex).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616