DETAILED ACTION
The receipt is acknowledged of applicant’s amendment and IDS, both filed 12/04/2025.
Claims 1-11 and 13-21 previously presented. Claim 13 is currently canceled.
Claims 1-11 and 14-21 are pending and subject of this office action.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 recites “ratio of moringa extract to the hydroxy fatty acid is present in a weight ratio ranging from 15:1 to 60:1”, and claim 2 recites broader ratio of “2:1 to 6:1”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-7, 9-11, 14-21 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Brown et al. (US 6,667,047), Danoux et al. (US 2020/0330366), and Deshayes et al. (WO 2017/178236), all references are of record.
Applicant Claims
Claim 1 is directed to a personal care composition comprising:
(a) 0.00001 to 1% of moringa extract by weight of the composition: and
(b) 0.000001 to 5% of hydroxy fatty acid having 8 to 24 carbon atoms by weight of the composition;
in cometically acceptable carrier
wherein the moringa extract to the hydroxy fatty acid is present in a weight ratio ranging from 15:1 to 60:1,
and further wherein the moringa extract is extracted from moringa selected from Moringa Oleifera Lam., Moringa pterygosperma, Moringa peregrina, Moringa concanensis and Moringa drouhardii.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Brown teaches cosmetic composition with enhanced properties and increase in oxidation stability. The cosmetic composition comprises moringa seed extract from moringa oleifera and stearic acid (abstract; col.6, lines 30-36; col. 7, lies 8-9; claim 1-2; Tables 1 and 2). Formula 6 of the reference shows composition comprising 1.0% moringa seed extract (col.13). Formula 7 of the reference teaches composition comprising moringa seed extract, ethylhexyl methoxy cinnamate and stearic acid (col.15). The composition further comprises additional active agent, e.g. anti-acne, flavonoids, ceramides, etc., and comprises water (col.17, lines 22-30). Moringa extract is present in the composition combined with tocopherol both in amount of 0-1% (col.18, lines 32-36) and this teaching implies amount of the extract of less than 1%.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Brown teaches composition comprising combination of stearic acid and moringa seed extract, and teaches 1% or less moringa seed extract, and teaches 4% stearic acid, the references does not teach single embodiment comprising moringa extract and hydroxy fatty acid in the claimed amount.
Danoux teaches nontoxic non-irritant cosmetic composition comprising Moringa oleifera seed extract that is useful for treating skin inflammation. The extract is an aqueous extract. The extract is present in the composition in amount of 0.001-5%. The composition can be aqueous or oily, or emulsion: oil-in-water (o/w) or water-in-oil (w/o) (abstract; ¶¶ 0019, 0037, 0057, 0062, 0083-0089).
Deshayes teaches cosmetic composition comprising hydroxy stearic acid. The composition comprises 0.001-5% 12-hydroxystearic acid to stabilize the composition and other acids in the composition. The composition can be o/w or w/o emulsion. The aqueous phase consists essentially of water and forms 70-90% of the composition. The composition comprises skin beneficial agents to treat skin condition, e.g. inflammation, acne. The composition comprises 0.5-8% UVA (ultraviolet absorber) or UVB (ultraviolet blocker), e.g. ethylhexyl methoxycinnamate and butyl methoxy dibenzoyl-methane. The viscosity of the composition is between 2000-15000 mPas (abstract; page 1, lines 7-10, 21-25; page 2, lines 1-5; page 4, lines 8-20, page 8, lines 1-2; page 9, lines 15-22; page 10, lines 25-31; page 11, line 10; page 12, lines 1-2; page 14, lines 8-11; table 1).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide a cosmetic composition comprising moringa seed extract and stearic acid as taught by Brown, and use 0.001-5%moringa seed extract as taught by Danoux, and replace stearic acid with 0.001-5% 12-hydroxystearic acid as taught by Deshayes. One would have been motivated to do so because Danoux teaches such amount of moringa seed extract provides non-toxic and non-irritant cosmetic composition and treats skin inflammation, and because Deshayes teaches such amount of 12-hydroxy stearic acid stabilize the cosmetic composition and other acids in the composition. One would reasonably expect formulating cosmetic composition comprising 0.001-5% moringa seed extract and 0.001-5% 12-hydroxystearic acid wherein the composition is stable, non-toxic, non-irritant, and effectively treats skin inflammation.
Regarding the claimed amounts of moringa seed extract of 0.00001 to 1% as claimed by claim 1, and 0.0001 to 0.5% as claimed by claim 6, Danoux teaches 0.001-5% moringa seed extract that overlaps with the claimed amounts. 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 [R-5].
Regarding the claimed amounts of hydroxy fatty acid of 0.000001 to 5% as claimed by claim 1, 0.005-0.2% as claimed by claim 5, and 0.0001 to 0.01% as claimed by claim 19, Deshayes teaches 0.001-5% fatty acid that either falls within or overlaps with the claimed amount. 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 [R-5].
Regarding the ratio of moringa extract to hydroxy fatty acid as claimed by claim 1 of 15:1 to 60:1, and as claimed by claim 2 of 2:1 to 60:1, and as claimed by claim 13, the amounts taught by the cited references suggest the instantly claimed ratio. For example the amount of the extract can be 2% and the amount of the acid can be 1% forming the claimed ratios by claims 1 and 2, or can be 0.015 to 0.0001 forming the ratio of claim 13.
Regarding the species of moringa claimed by claim 3, both Brown and Danoux teach moringa oleifera.
Regarding extract from the seed as claimed by claim 4 and 14, both Brown and Danoux teach extract from the seed.
Regarding hydroxystearic acid claimed by claim 7, and 12-hydroxystearic acid as claimed by claim 16, this is taught by Deshayes.
Regarding water claimed by claim 9, it is taught by all the cited references.
Regarding the viscosity of the composition of 1,000 to 20,000 mPas as claimed by claim 10, Deshayes teaches viscosity of cosmetic composition of 2000-15000 mPas that falls within the claimed viscosity. 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 [R-5].
Regarding anti-acne agent as claimed by claim 11, Brown teaches anti-acne agent in the composition.
Regarding aqueous extraction as claimed by claim 15, Danoux teaches aqueous extraction.
Regarding amount of water of 10-90% and 35-85% as claimed by claims 17 and 18 respectively, Deshayes teaches 70-90% that either overlaps or falls within the claimed amount. 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 [R-5].
Regarding the amount of sunscreen claimed by claim 20 of 0.1-10%, Deshayes teaches 0.5-8% that overlaps with the claimed amount. 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 [R-5].
Regarding the organic sunscreen claimed by claim 21, they are taught by Brown and Deshayes.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Brown, Danoux and Deshayes as applied to claims 1-7, 9-11, 14-21 above, and further in view of the article by MITEL (Pollution D-Toxx Facial Foam), of record.
Applicant Claims
Claim 8 further recites that the composition of claim 1 further comprises additional skin benefit agent, e.g. niacinamide.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The combined teachings of Brown, Danoux and Deshayes are previously discussed in this office action.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While the combination of Brown, Danoux and Deshayes suggests additional active agent in the composition, the references do not explicitly teach the compounds claimed by claim 8.
The article by MITEL teaches cosmetic composition comprising moringa seed extract, stearic acid and niacinamide that deep cleans the skin and leaves the skin pure and glowing (see the provided article).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide composition comprising moringa seed extract, stearic acid and additional skin benefit agent as taught by the combination of Brown, Danoux and Deshayes, and add nicotinamide taught by MITEL to the composition. One would have been motivated to do so because MINTEL teaches composition comprising these ingredients deep cleans the skin and leaves the skin pure and glowing. One would reasonably expect formulating composition comprising moringa seed extract, stearic acid and niacinamide that provides clean, pure and glowing skin.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Response to Arguments
Applicant's arguments filed 12/04/2025 have been fully considered but they are not persuasive.
Applicants argue that the Examples of the present invention illustrate the unexpected benefit provided by the composition of the present application. Table 1 on page 8 of the specification as originally filed shows that comparative example B of Table 1, which contains 3 ppm of 12-HSA alone, results in an expression of IL-6 in THP-1 cells of 91.9%. Comparative example C, which contains 100 ppm of Moringa extract alone, results in an expression of IL-6 of 15.2%. However, when 3 ppm of 12-HSA is combined with 100 ppm of Moringa extract, the resulting expression of IL-6 as seen in positive example 1 is 8.6%, which demonstrates an unexpected synergistic, not additive, effect in combining a representative hydroxy fatty acid and a Moringa extract. None of the cited references disclose or suggest such teachings in a sufficient nature to allow a skilled artisan to arrive at the present invention. As such, a prima facie case of obviousness has not been established, and the present claims are non-obvious over Brown, Danoux, or Deshayes, alone or in combination with one another.
In response to this argument, it is argued that combination of the cited references teaches the claimed composition comprising the moringa extract and hydroxy stearic acid in the claimed amounts. Further, the amounts taught by the cited references suggest the instantly claimed ratio. For example the amount of the extract can be 0.015 to 0.0001 forming the ratio of claim 1; or can be 2% and the amount of the acid can be 1% forming the claimed ratio by claim 2. Further, the claimed are directed to composition and all the elements of the claimed composition are taught by the combination of the cited references, and the effect shown by applicants is not claimed. Further applicants did not show the superior results obtained from the wide range of claimed hydroxy acids and specific extract of specific species. Applicants did not compare the prior art ratio with the claimed ratio and compare. Further applicants did not show the effect of the upper limit of the claimed ratio and the lower limit of the claimed ratio in order to establish criticality of the claimed ratio.
Regarding synergy, “There is no single, appropriate test for determining whether synergism has been demonstrated for chemical combination; rather, facts shown in each case must be analyzed to determine whether chosen method has clearly and convincingly demonstrated existence of synergism or unobvious result”. “Assuming arguendo that the differences in values presented are statistically significant, there is no evidence that they represent a true, practical advantage. In re Freeman, 474 F.2d 1318, 177 USPQ 139 (CCPA 1973); In re Klosak , 455 F.2d 1077, 173 USPQ 14 (CCPA 1972); In re D'Ancicco, 439 F.2d 1244, 169 USPQ 303 (CCPA 1971). Also, prescinding from the Colby formula test, which as we have already indicated is at best controversial and in our view probably invalid, there is no evidence that the differences are unexpected. In re Merck, 800 F.2d 1091, 231 USPQ 375 (Fed.Cir. 1986); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed.Cir. 1985); In re Freeman, supra” .
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 that is to be used for the very same purpose; the idea of combining them flows logically from their having been individually taught in the prior art. In re Kerkhoven, 205 USPQ 1069.
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 Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./