DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
Status of Claims
The amendment, filed on 15 June 2026, is acknowledged.
Claims 1 and 4-5 been amended.
New claim 9 has been added.
Claims 1-9 are pending and under consideration in the instant Office Action, to the extent of the following previously elected species:
the specific polyglycerol ester-based emulsifier is polyglyceryl-10 laurate;
the specific polyglycerol ester-based coemulsifier is polyglyceryl-2 triisostearate;
the specific sunscreen agent is titanium dioxide; and
the specific fat is isononyl isononanoate
New Grounds of Objection
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The amendments to instant claims 1 and 4-5 changed the format of the recited ratios from, e.g., “0.75 to 8” to “0.75:1 to 8:1” in instant claim 1. The instant spec. does not disclose ratios in this format. However, the instant spec. appears to have implicit support for these amendments and this matter does not require a rejection under 35 U.S.C. § 112(a) for introducing new matter that lacks support in the original disclosure. “While an applicant is not limited to the nomenclature used in the application as filed, he or she should make appropriate amendment of the specification whenever this nomenclature is departed from by amendment of the claims so as to have clear support or antecedent basis in the specification for the new terms appearing in the claims”. MPEP § 608.01(o). As such, Applicant should amend the specification to display the ratios in the same format as in the amended claims (see, e.g., instant spec. para. [0006] and [0013-0014]).
New Grounds of Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Newly submitted claim 9 recites a range of water resistance retention (WRR) values from 64.4-75.8%. The remarks filed on 15 June 2026, state that support for this limitation can be found in instant spec. para. [0050-0053] and Table 3 (pg. 4 of the remarks, penultimate para.). However, para. [0050-0053] of the instant spec. merely discloses how the WRR value was calculated and Table 3 discloses 4 discreet values of WRR that resulted from the specific compositions tested. The instant spec. does not have support for the broad range of values recited in newly submitted claim 9. Further, the WRR values in Table 3 only result from compositions comprising the emulsifiers polyglyceryl-10 laurate and polyglyceryl-2 triisostearate while instant claim 9 recites the range of WRR values as limiting the broad genera of emulsifiers and coemulsifiers recited in instant claim 1, which does not have support.
Newly added claim 9 recites limitations, which were not clearly disclosed in the specification as filed, and now change the scope of the instant disclosure as filed. Such limitations recited in newly added claim 9, which did not appear in the specification, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C 112. Applicant is required to provide sufficient written support for the limitations recited in new claim 9 in the specification or claims, as-filed, or remove these limitations from the claims in response to this Office Action.
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.
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Pambou (U.S. Patent Application Publication No. US 2019/0314255 A1, published on 17 October 2019).
Pambou teaches a cleansing concentrate composition for use in cosmetic compositions that comprises two or more emulsifiers, an emollient, a preservative system, and an aqueous solvent (Abstract). A first emulsifier in the composition is taught to have a hydrophilic-lipophilic balance (HLB) between 1-9 and in one embodiment may be polyglyceryl-10 laurate (claims 1 and 7-8). A second emulsifier in the composition is taught to have an HLB between 9-16 and in one embodiment may be the polyglyceryl fatty ester polyglyceryl-2 triisostearate (claims 1 and 6, para. [0061]). The two emulsifiers are taught to be present in a ratio from 1:10 to 10:1, which encompasses the ratios recited in instant claims 1 and 4-5 (claim 5). In Examples 1-5, Pambou teaches the ratio of second emulsifier to first emulsifier to be ~1.7:1 (polyglyceryl 10-caprate/caprylate 12% w/w relative to polyglyceryl-10 decaoleate 7% w/w) and in Example 9b also teaches the ratio to be ~1.7:1 (polyglyceryl 10-laurate 12% w/w relative to polyglyceryl-10 decaoleate 7% w/w). Finally, Pambou teaches their cleansing concentrate to be useful as a base for other cosmetic compositions, such as skincare lotions, creams, and gels (para. [0098-0100]), and may comprise sun-protectants and/or UV-protectants (claims 9 and 19). This is interpreted as being equivalent to a suncare product and sunscreen cosmetic.
Although “picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference...has no place in...a 102, anticipation rejection,” picking and choosing may be entirely proper in an obviousness rejection. In re Arkley, 455 F.2d 586, 587 (CCPA 1972). Addressing the issue of obviousness, the Supreme Court noted that analysis under 35 U.S.C. 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ” (KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007)). The Court further emphasized that “[a] person of ordinary skill is…a person of ordinary creativity, not an automaton” (Id. at 1742).
The only difference between Pambou and the instant claims is that Pambou does not teach the specific combination of components as claimed in a single embodiment (e.g., a cosmetic composition with sun-protection that comprises polyglyceryl-10 laurate and polyglyceryl-2 triisostearate in the recited ratios), or with sufficient specificity to be anticipatory. The specific combination of features claimed is disclosed within the teaching of Pambou, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Where, as here, the reference does not provide any explicit motivation to select this specific combination of variables, anticipation cannot be found. However, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” See MPEP § 2141.I. Consistent with this reasoning, it would have been prima facie obvious to a person having ordinary skill in the art, prior to the effective filing date of the instant application, to have selected various combinations of the various disclosed ingredients from within the teachings of Pambou, to arrive at an invention such as the one being sought.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Pambou (U.S. Patent Application Publication No. US 2019/0314255 A1, published on 17 October 2019) as applied to claims 1-7 above, and further in view of Naden et al. (U.S. Patent Application Publication No. US 2008/0057008 A1, published on 6 march 2008, hereafter referred to as Naden).
Pambou has been described above, and particularly relevant to instant claim 8, also teaches that their cleansing concentrate is typically used in an amount of 0.5-30% w/w of the total composition, which encompasses the range recited in instant claim 8 (para. [0098-0100]), and that the composition may comprise an ester oil as an emollient (claim 9).
Pambou does not teach titanium dioxide as a sun-protectant nor isononyl isononanoate as a fatty component. These deficiencies are offset by the teachings of Naden.
Naden teaches a dispersion comprising metal oxide particles for use in a sunscreen product that “exhibits effective UV protection, transparency, and improved skin feel” (Abstract). Metal oxides are taught to be useful in protecting users’ skin for the sun and a preferred metal oxide used in cosmetic compositions is taught to be titanium dioxide (para. [0002-0010]). Naden further teaches that their invention exhibits improved skin feel compared to conventional sunscreens when the metal oxide is used in conjunction with a polar material and a non-polar material (para. [0008-0009]) and [0038] and claim 19). Preferred polar materials are taught to include, among other species, isononyl isononanoate (para. [0033] and claims 17, 19, and 21).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, in view of the teachings of Naden to use titanium dioxide as the sun-protectant and isononyl isononanoate as an oily emollient in the invention of Pambou because combining prior art elements according to known methods yields predictable results. Pambou rendered obvious a cosmetic composition comprising a cleansing concentrate that contains two emulsifiers, one with an HLB of 1-9 that may be polyglyceryl-10 laurate and the other 9-16 that may be polyglyceryl-2 triisostearate, in a ratio from 1:10 to 10:1, alongside water, a sun-protectant, and an oily emollient. Further, Pambou taught that their cleansing concentrate is typically used in an amount of 0.5-30% w/w of the total composition.
In view of the teachings of Naden, an ordinary artisan would be motivated to use titanium oxide as the sun-protectant because Naden teaches it to be a preferred metal oxide for use in a cosmetic that provides users protection from the sun. In addition, Pambou did not teach a specific sun-protectant and the teachings of Naden provide missing information that an ordinary artisan would require. Further in view of the teachings of Naden, the person of ordinary skill would be motivated to use isononyl isononanoate as an oily emollient in the composition of Pambou because the species is an ester oil, which Pambou teaches to be an appropriate sub-genus of emollient for their invention. In addition, Naden teaches isononyl isononanoate to be an emollient that is compatible with titanium dioxide and that provides users with an improved skin feel, which the ordinary artisan would recognize as desirable in a cosmetic composition that provides sun protection. As a result, there is a reasonable expectation of success in arriving at the invention of claim 8 in view of the teachings of Pambou and further in view of the teachings of Naden.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Pambou (U.S. Patent Application Publication No. US 2019/0314255 A1, published on 17 October 2019) in view of Naden et al. (U.S. Patent Application Publication No. US 2008/0057008 A1, published on 6 march 2008, hereafter referred to as Naden) as applied to claims 1-8 above, and further and Sanogueira et al. (WIPO Patent Application Publication No. WO 2017/048706 A1, published on 23 March 2017, hereafter referred to as Sanogueira).
Pambou has been described above.
Pambou does not teach the water resistance retention (WRR) of sunscreen lotion compositions. These deficiencies are offset by the teachings of Naden and Sanogueira.
Naden has been described above.
Sanogueira teaches sunscreen compositions with improved water resistance (Title and Abstract). Water resistance is taught to be important so that sunscreen compositions retain protective agents against UVA and UVB radiation after exposure to water and/or sweat (pg. 7, lines 2-9). Sanogueira teaches that water retention percentages that are desirable for sunscreen compositions are “greater than at least 60%” (pg. 14, lines 17-25) and in Table II teaches specific values of 73%, 86%, 87%, and others.
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, in view of the teachings of Naden to use titanium dioxide as the sun-protectant and isononyl isononanoate as an oily emollient in the invention of Pambou because combining prior art elements according to known methods yields predictable results. Pambou rendered obvious a cosmetic composition comprising a cleansing concentrate that contains two emulsifiers, one with an HLB of 1-9 that may be polyglyceryl-10 laurate and the other 9-16 that may be polyglyceryl-2 triisostearate, in a ratio from 1:10 to 10:1, alongside water, a sun-protectant, and an oily emollient. Further, Pambou taught that their cleansing concentrate is typically used in an amount of 0.5-30% w/w of the total composition.
In view of the teachings of Naden, an ordinary artisan would be motivated to use titanium oxide as the sun-protectant because Naden teaches it to be a preferred metal oxide for use in a cosmetic that provides users protection from the sun. In addition, Pambou did not teach a specific sun-protectant and the teachings of Naden provide missing information that an ordinary artisan would require to complete their invention. Further in view of the teachings of Naden, the person of ordinary skill would be motivated to use isononyl isononanoate as an oily emollient in the composition of Pambou because the species is an ester oil, which Pambou teaches to be an appropriate sub-genus of emollient for their invention. In addition, Naden teaches isononyl isononanoate to be an emollient that is compatible with titanium dioxide and that provides users with an improved skin feel, which the ordinary artisan would recognize as desirable in a cosmetic composition that provides sun protection.
Finally, in view of the teachings of Sanogueira a person of ordinary skill in the art would be motivated to formulate their composition to have a water resistance retention percentage of greater than 60%, which encompasses the range recited in instant claim 9, because Sanogueira teaches this range to ensure that sunscreen compositions retain protective agents against UVA and UVB radiation after exposure to water and/or sweat, which the ordinary artisan would recognize as desirable. As a result, there is a reasonable expectation of success in arriving at the invention of instant claim 9 in view of the teachings of Pambou and further in view of the teachings of Naden and Sanogueira.
Response to Arguments
The Applicant’s arguments, filed on 15 June 2026, have been fully considered but are not persuasive.
The affidavit submitted on 15 June 2026, is acknowledged. Applicant argues in para. 3 of pg. 5 that Comparative Example 4 of the instant spec. demonstrates that a weight ratio of polyglyceryl-10 laurate to polyglyceryl-2 triisostearate of 9:1 demonstrates the criticality of the range of ratios recited in instant claims 1 and 4-5 because it is outside the claimed range of ratios of 0.75:1 to 8:1 and does not possess the claimed desirable properties. Applicant further argues from the final para. of pg. 5 to para. 2 of pg. 6, citing the affidavit submitted on 15 June 2026, that a composition comprising a weight ratio of polyglyceryl-10 laurate to polyglyceryl-2 triisostearate of ~0.74:1 also does not possess the claimed desirable properties and further demonstrates the criticality of the claimed range of ratios.
Guidelines on determining whether results demonstrate the criticality of a range are provided in MPEP § 716.02. To demonstrate that the range is critical and supports a claim of unexpected results, the Applicant has the responsibility of presenting evidence that establishes “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). “Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims” (bold added for emphasis). See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) and MPEP § 716.02(d) - § 716.02(e).
The Applicant has not compared their invention with the closest prior art. See MPEP § 716.02(e). The comparison provided in the instant spec. and affidavit is between two compositions with the limitations recited in the instant claims, two compositions possessing only one of the two recited emulsifiers (Comparative Examples 1 and 3), a composition comprising a lower total concentration of emulsifiers at a ratio of 1.5:1 (Comparative Example 2), and two compositions possessing a weight ratio of emulsifiers of 9:1 (Comparative Example 4) and ~0.74:1 (Comparative Example 5). The previous Office Action, mailed on 16 March 2026, cited the Pambou reference in rejections under U.S.C. § 103 and the affidavit, filed on 15 June 2026, did not compare the claimed invention to Pambou.
The Applicant also has not demonstrated unexpected results commensurate in scope with the claimed invention. “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). See MPEP § 716.02(d).
First, the ratio in Comparative Example 5 is stated to be “~0.74:1” (Table, Affidavit filed 15 June 2026) or “approximately 0.74:1” (final line of pg. 5 to line 1 of pg. 6, Remarks filed on 15 June 2026). The instant spec. does not provide guidelines on the meaning of “about” (interpreted as the meaning of the tilde preceding 0.74) or “approximately”. MPEP § 2173.05(b) provides guidelines on relative terminology and in § 2173.05(b).III.A. states that the approximation “about” must be considered in “the context of the term as it is used in the specification and claims of the application.” Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir. 2007). Using the plain meaning of the words “about” and “approximately”, ~0.74 is considered to be approximately equal to 0.75 and it is therefore not clear that a ratio of ~0.74:1 is outside the range of 0.75:1 to 8:1.
Second, even if the ratio of ~0.74:1 in Comparative Example 5 is considered to be outside the claimed range, only two examples outside the claimed range of ratios and two examples inside the claimed range of ratios (1.5:1 for Example 1 and 1:1 for Example 2) have been provided. This is not a sufficient showing of the criticality of the range commensurate in scope with the claimed range, particularly in view of the breadth of the range and the teachings of Pambou which encompass the range. Of particular note is the teachings of Pambou in Examples 1-5 and 9b which teach the ratio of ~1.7:1 which demonstrates the recite ratio is not in fact unexpected and unobvious (vide supra).
Finally, Applicant has used only the two species polyglyceryl-10 laurate and polyglyceryl-2 triisostearate in Examples 1-2 and Comparative Examples 1-5. Instant claim 1 recites the range of ratios from 0.75:1 to 8:1 for any polyglycerol ester-based emulsifier with a degree of polymerization from 4-20 and an HLB >10 and any polyglycerol ester-based emulsifier with a degree of polymerization from 2-10 and an HLB ≤10. This is also not a sufficient showing of the criticality of the range commensurate in scope with the claimed invention.
The comparisons of Examples 1-2 to Comparative Examples 1-4 in the instant spec. and Comparative Example 5 in the affidavit filed on 15 June 2026, do not demonstrate the criticality of the claimed range are therefore not a persuasive demonstration of unexpected and surprising results.
Conclusion
No claims are allowed.
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.
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/S.J.S./
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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