DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after May 26, 2026, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt is acknowledged of Applicants’ claimed invention filed on 05/26/2026 in the matter of Application N° 18/250,350. Said documents are entered on the record. The Examiner further acknowledges the following:
Thus, claims 1-9 and 12-16 represent all claims currently under consideration.
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 1-9 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Niimi et al. (WO 2020/110716) in view of Sang-Hyun et al. (KR 2018/0087034A).
As previously set forth, Niimi et al. disclose a composition comprising at least one first polyglyceryl fatty acid ester having an HLB value of 13 or more, which satisfies the claimed HLB value of 12.o or more; at least one second polyglyceryl fatty acid ester having ab HLB value of 10.0 or less; and water. Niimi et al. further disclose the first polyglyceryl fatty acid ester in an amount of 0.01% to 15% by weight and the second polyglyceryl fatty acid ester in an amount of 0.01% to 10% by weight, thereby teaching the respective concentration ranges recited in claim 1.
Niimi et al. however, do not expressly disclose a skin care active ingredient selected from the group presently recited in amended claim 1.
Sang-Hyun et al. teaches a cosmetic composition comprising an aqueous phase, a polyglyceryl-based surfactant, and salicylic acid. Sang-Hyun et al. expressly identifies salicylic acid as an active ingredient and teaches stabilization of salicylic acid using polyglyceryl based surfactants. Sang-Hyun further teaches that the resulting cosmetic composition is useful for improving acne (See Abstract and claim 1). Salicylic acid is expressly one of the skin care active ingredients recited in amended claim 1.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to incorporate salicylic acid, as taught by Sang-Hyun et al., into the skin-care composition of Niimi et al. the skilled artisan would have been motivated to make such a modification in order to provide the composition with the known skin-care benefit associated with salicylic acid, including treatment or improvement of acne, while utilizing the polyglyceryl-based surfactant system to facilitate incorporation and stabilization of the active ingredient. Sang-Hyun et al. demonstrates the compatibility and use of salicylic acid with polyglyceryl-based surfactants, thereby providing a reasonable expectation that salicylic acid could successfully be incorporated into the polyglyceryl fatty acid ester-containing cosmetic composition of Niimi et al.
Accordingly, the combination of Niimi et al. and Sang-Hyun teaches or suggests each limitation of amended claim 1.
Niimi et al. teach a composition comprising at least one oil, at least one first polyglyceryl fatty acid ester having an HLB of 13 or more and at least one second polyglyceryl fatty acid ester having an HLB value of 10 or less and water. These teachings meet the limitations of claim 2 and most of the limitations of claim 1.
Regarding claim 3, Niimi et al. teach 2 to 4 glycerol units can make up the first polyglyceryl fatty acid ester (See pg. 2, lines 5 and 6, and claim 5).
Regarding claim 4, Niimi et al. teach the first polyglyceryl fatty acid ester’s fatty acid moiety can have 12 or less carbon atoms (See pg. 2, lines 8-9 and claim 6).
Regarding claim 5, Niimi et al. teach the amounts of the first polyglycerol fatty acid ester to be 0.01% to 15% (See page 10, lines 20-23).
Regarding claim 6, Niimi et al. teach the second polyglyceryl fatty acid ester can contain 2 to 4 glycerol units (See pg. 2, lines 15-16, and claim 8).
Regarding claim 7, Niimi et al. teach the second polyglyceryl fatty acid ester’s fatty acid moiety can have 14 or more carbon atoms (See pg. 2, lines 18-19, and claim 9).
Regarding claim 8, Niimi et al. teach wherein the amounts of the second polyglycerol fatty acid ester to be 0.01% to 10% (See page 11, lines 41-44).
Regarding claim 9, Niimi et al. teach the weight ratio of (the total amounts of the first polyglyceryl fatty acid ester(s) and the second polyglyceryl fatty acid ester(s))/the amount of the oil(s) in the composition according to the present invention may be 1. (See pg. 2, lines 25-29).
Regarding claim 12, Niimi et al. teach the presence of oil, see the abstract.
Regarding claim 13, Niimi et al. teach the amount of the oil(s) in the composition may range from 0.01 % to 20% by weight. (See pg. 2, lines 1-3).
Regarding claim 14, Niimi et al. teach that their composition is in the form of a nano-or micro-emulsion, (see page 15, line 1).
Regarding claim 15, Niimi et al. teach the present invention relates to a cosmetic process for treating a keratin substance (See page 16, lines 15-29).
Regarding claim 16, applicant argues that paragraph 0047 of Niimi discloses oil as an optional component and therefore inherently discloses a composition that may or may not contain oil. Niimi et al. affirmatively teaches compositions comprising at least one oil as a structural component of the emulsion system. Where a reference consistently describes oil as part of the essential composition, the mere characterization of oil as “optional” in a general disclosure does not constitute a teaching or suggestion of a specifically oil-free embodiment unless such embodiment is expressly described or exemplified. Furthermore, Niimi’s et al. emulsion system relies on the presence of oil as part of the dispersed phase. Removal of oil would materially alter the structural nature of the composition. No explicit oil-free embodiment is described or enabled in Niimi et al. An optional disclosure does not automatically render every conceivable absence of that component expressly taught or inherently disclosed. See MPEP 2112 (Inherency requires inevitability, not possibility). Accordingly. Niimi et al. does not teach or suggest an oil-free composition. However, the elimination of oil from an emulsion type cosmetic composition represents a routine formulation modification that would have been within the ordinary skill of a cosmetic formulator, particularly in view of the well-known development of oil-free cosmetic compositions for consumers seeking lighter skin feel or reduced comedogenicity.
Response to Arguments
Applicant’s arguments filed May 26, 2026 have been fully considered but they are not persuasive.
Applicant’s argument has been fully considered. In view of the amendment deleting phenylethyl resorcinol from claim 1. Instead, the rejection has been modified to rely upon Sang-Hyun et al., which expressly teaches salicylic acid as an active ingredient in a cosmetic composition containing polyglyceryl-based surfactants.
Sang-Hyun et al. specifically teaches a cosmetic composition comprising an aqueous phase, a polyglyceryl-based surfactant, and salicylic acid and identifies salicylic acid as an active ingredient useful in an acne-improving cosmetic composition. because salicylic acid remains expressly recited as one of the alternatives in the closed Markush group of amended claims 1, the disclosure of salicylic acid satisfies the claimed requirement for “at least one skin care active ingredient” selected from the recited group.
It is not necessary for the cited prior art to disclose each individual alternative listed in the Markush group. The claim requires at least one skin care active ingredient selected from the recited group, and salicylic acid is one expressly claimed alternative. Thus, Sang Hyun et al. supplies a skin care active ingredient falling squarely within the scope of amended claim 1.
Applicant’s arguments regarding unexpected results have been fully considered but are not persuasive.
Applicant argues that the claimed combination of a first polyglyceryl fatty acid ester having an HLB value of 12.0 or more and a second polyglyceryl fatty acid ester having an HLB value of 10.0 or less unexpectedly enhances penetration of the recited skin-care active ingredients relative to compositions employing a single polyglyceryl fatty acid ester or no polyglyceryl fatty acid ester. Applicant relies upon the experimental results reported in Tables 1–6 as evidence of this asserted improvement.
The office acknowledges that the experimental results provide evidence that the exemplified combination of polyglyceryl-4 caprate and polyglyceryl-2 oleate is associated with good stability in the particular formulations tested, whereas certain otherwise similar formulations containing only one of these esters exhibit poor stability. For example, in Table 1, Example 1, containing both polyglyceryl-4 caprate and polyglyceryl-2 oleate, is reported as having good stability, while Comparative Examples 1 and 2, respectively containing only polyglyceryl-4 caprate or polyglyceryl-2 oleate, are reported as having poor stability. Similar results are reported for the other exemplified active ingredients in Tables 2–6.
However, the unexpected result relied upon by Applicant is enhanced skin penetration, rather than merely improved emulsion stability, and the evidence does not establish that the claimed combination itself produces an unexpected enhancement in penetration relative to use of a single ester or no ester.
First, the otherwise similar comparative formulations containing only one of the two exemplified polyglyceryl fatty acid esters generally provide no penetration data. For example, Table 1 reports penetration of 102 ± 5% for Example 1 containing both esters, but reports penetration as “NA” for Comparative Examples 1 and 2 containing only one of the respective esters. Thus, while these comparisons support a difference in stability, they do not provide penetration values for the single-ester formulations from which an enhancement in penetration attributable to combining the two esters can be determined. An “NA” penetration result does not establish a lower penetration value and therefore does not constitute a quantitative comparison demonstrating enhanced penetration.
Second, the comparative examples that contain neither of the exemplified polyglyceryl fatty acid esters and for which penetration was actually measured are materially different formulations in numerous respects. For example, in Table 1, Comparative Example 3 lacks both polyglyceryl-4 caprate and polyglyceryl-2 oleate but also differs from Example 1 in the oil phase, surfactant/emulsifier system, polyol system, preservatives, and other excipients. Nevertheless, Comparative Example 3 is reported as having good stability and 85 ± 5% penetration, compared with 102 ± 5% for Example 1. Because numerous formulation variables were changed simultaneously, the difference in penetration between these formulations cannot reasonably be attributed specifically to the presence or absence of the claimed combination of polyglyceryl fatty acid esters.
The same issue is reflected throughout the submitted data. For example, the alternative formulation of Comparative Example 9 in Table 3, which lacks the claimed ester combination but changes numerous other formulation components, is nevertheless reported as stable and provides 59 ± 5% penetration, compared with 109 ± 10% for Example 5. Likewise, Comparative Example 12 of Table 4 provides good stability and 25 ± 5% penetration in the absence of the exemplified ester combination, and Comparative Example 15 of Table 5 provides good stability and 72 ± 5% penetration compared with 94 ± 9% for Example 9. These results may demonstrate that the particular formulations differ in their penetration characteristics, but because the formulations differ in multiple components, they do not isolate the claimed two-ester combination as the cause of the observed differences.
Table 5 further illustrates the difficulty in attributing penetration specifically to the asserted combination. Example 9, containing 1.05% polyglyceryl-4 caprate and 0.45% polyglyceryl-2 oleate, is reported as having good stability and penetration of 94 ± 9%. Comparative Example 14 likewise contains 1.05% polyglyceryl-4 caprate and 0.45% polyglyceryl-2 oleate, but omits isopropyl myristate, and is reported as having good stability and penetration of 99 ± 12%. Thus, the data demonstrate that the exemplified ester combination can function in more than one formulation environment, but do not establish that penetration is enhanced specifically as a consequence of combining the two esters.
Accordingly, the experimental evidence presents two different types of comparisons. The relatively controlled comparisons between the two-ester and single-ester formulations provide evidence regarding stability, but generally provide no comparative penetration measurement. Conversely, the formulations for which penetration can be compared in the presence versus absence of the two-ester combination differ in numerous additional formulation variables and therefore do not establish that the difference in penetration is attributable to the claimed ester combination. Thus, the evidence does not support Applicant’s asserted conclusion that the claimed combination unexpectedly enhances skin penetration relative to the use of a single polyglyceryl fatty acid ester or no polyglyceryl fatty acid ester.
Moreover, the evidence is not commensurate with the full scope of the claimed ester combination. Although Applicant has provided examples encompassing the skin-care active ingredients now recited in amended claim 1, the evidence appears to employ the same specific ester pair—polyglyceryl-4 caprate and polyglyceryl-2 oleate—at substantially the same relative amounts. Claim 1, however, is not limited to these particular ester species, but broadly encompasses a first polyglyceryl fatty acid ester defined by an HLB value of 12.0 or more in combination with a second polyglyceryl fatty acid ester defined by an HLB value of 10.0 or less. The fact that the examples span the recited active ingredients therefore addresses the breadth of the active-ingredient limitation, but does not establish that the asserted penetration effect would reasonably extend across the substantially broader genus of ester combinations encompassed by the claim.
Finally, Applicant’s contention that Niimi and Bo-Sik do not teach or suggest that the claimed ester combination would enhance skin penetration does not, by itself, overcome the prima facie case of obviousness. The rejection does not require the prior art to have predicted every property or advantage subsequently discovered for an otherwise obvious composition. Rather, the asserted unexpected property is considered as objective evidence together with the evidence supporting the prima facie case. For the reasons discussed above, the experimental evidence has been considered and afforded appropriate weight, but does not establish that enhanced skin penetration is an unexpected result attributable to the claimed combination and commensurate in scope with the claims.
Accordingly, Applicant’s evidence of unexpected results is insufficient to outweigh the evidence supporting the prima facie case of obviousness, and the rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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 Kimberly Barber whose telephone number is (703) 756-5302. The examiner can normally be reached on Monday through Friday from 6:30 AM to 3:30 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax, can be reached at telephone number (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIMBERLY BARBER/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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