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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/13/2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. See attached copy of PTO-1449.
Status of Application
Applicants' arguments/remarks filed 02/27/2026 are acknowledged. Claims 16, 18 and 23 are currently amended. Claims 3-11 and 14-23 are examined on the merits within and are currently pending.
Withdrawn Rejections
With applicant's amendment and with respect to the applicant’s arguments/remarks, filed 07/07/2025:
the 35 U.S.C. 103 rejection of Claims 16, 3-5, 14-15, 17 and 21-23 by Fournial, Boland, Matts, Wakui and Ranade has been withdrawn in view of the amendment of claims 16, 18 and 23;
the 35 U.S.C. 103 rejection of Claims 16 and 6, 11 by Fournial, Boland, Matts, Wakui, Ranade and Richard has been withdrawn in view of the amendment of claims 16, 18 and 23.
Modified Rejections
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 non-obviousness.
Claims 16 and 3-5 and 14-15, 17-23, are rejected under 35 U.S.C. 103 as being unpatentable by Fournial (WO 2010044076 A2) and Boland et al. US 20190240141Al in view of Matts et al. (Matts et al., A Review of the Range of Effects of Niacinamide in Human Skin. IFSCC Magazine – vol. 5, no 4 / 2002), and further in view of Wakui (WO2020171217A1) and Ranade et al. (US 20110067720 A1) and Mcildowie et al., (US 20160074643Al).
Claim 16, 3-4 and 14-15, 17-23,
Fournial teaches cosmetic and dermatological compositions of xanthohumol. (pg. 1, lines 7-10). The compositions of the present invention can include a vitamin B3 compound. Vitamin B3 compounds are particularly useful for regulating skin conditions. In one embodiment, the composition comprises from about 0.001 % to about 50%, more preferably from about 0.01 % to about 20%, even more preferably from about 0.05% to about 10%, by weight of the composition, of the vitamin B3 compound. (pg. 13, lines 17-24). The preferred oil-in-water emulsions comprises from about 25% to about 98%, preferably from about 65% to about 95%, more preferably from about 70% to about 90% water by weight of the total composition. (pg. 60, lines 29-31). The composition is adjusted to pH at 4.0 with part F (pg. 79, line 5), where part F is MFA ComplexTM including water, lactic acid, citric acid, malic acid and Camelia sinensis leaf extract. (pg. 79). The physical form of the compositions may be in any galenic form such creams, lotions, cream ointments, gels, emulsions, dispersions. (pg. 70, line 25-27). The compositions of the present invention can comprise one or more particulate materials. Non limiting examples of particulate materials useful in the present invention include (pg. 21, lines 8-9), lauroyl lysine (pg. 21, line 22). Particulate materials are present in the composition in levels of from about 0.01 % to about 20%, more preferably from about 0.05% to about 10% by weight of the composition, (pg. 21, lines 15-17). Based on 0.001%-50% vitamin B3 and 0.01-20% lauroyl lysine, the broadest ratios can be 1:2000 – 5000:1. Or based on 0.01%-20% vitamin B3 and 0.05-10% lauroyl lysine, the broadest ratios can be 1:1000 – 400:1.
Fournial does not teach lauroyl lysine particle size, nor the lauroyl lysine comprises a flat polygonal shape.
Boland et al. teach the topical formulations, which may be foundation, blush, lip color, eye color, lotions, creams, serums, gels, cleansing formulations, eye creams, sunscreens, bronzers, powders, nail care, hair care, and other cosmetics and skin care products. (0145). The formulation comprises: niacinamide in a range of 0.05-5% w/w. (0034), where niacinamide is a form of vitamin B3. In some embodiments, the formulation comprises, consists of several or all of the groups of ingredients in Table 2: Group 2.1: 20-60% water; Group 2.8: 0.0005-5% w/w lauroyl lysine. (0046).
With the percentages of niacinamide of 0.05-5% w/w and of lauroyl lysine of 0.0005-5% w/w, the weight ratio between the vitamin B3 and the lauroyl lysine can be 100:1 to 1:100.
Boland et al. do not teach lauroyl lysine particle size nor the lauroyl lysine comprises a flat polygonal shape.
Matts et al. teach Niacinamide (also known as nicotinamide, 3-pyridinecarboxamide) is the physiologically active form of niacin or vitamin B3. (Abs).
Wakui teaches a powder for cosmetic preparation (Title). The powder comprises one or more components. One of the components is lauroyl lysine. (Abs). The powder has the average particle size is 5 to 25 µm, and the particle size with a cumulative frequency of 90% of all particles is 35 µm or less. (Claim 6).
Matts et al. and Wakui do not teach lauroyl lysine has a flat polygonal shape.
Ranade et al. teach lauroyl lysine, which may suitably be in the form of plate-shaped hexagonal crystals of N-lauroyl-L-lysine (0019).
Fournial, Boland et al., Matts et al., Wakui and Ranade et al. do not teach coefficient of friction.
Mcildowie et al. teach a cosmetic skin care product that includes an applicator and
a skin care composition. The skin care composition includes an effective amount
of a vitamin B3 active and a dermatologically acceptable carrier. (Abs). Active agents with skin care benefits are introduced to skin via topical application of, for example, creams, lotions and essences. (0003). The vitamin B3 compound in the compositions hereof having a pH of from about 4 to about 7 typically contain less than about 50% of the salt form. (0093). In some examples, the cosmetic compositions may have a concentration of a vitamin B3 compound, by weight of the cosmetic composition, of greater than 0.0005%-11 %. (0094). The carriers may contain one or more dermatologically acceptable, hydrophilic diluents. Hydrophilic diluents include water. (0097). Carriers may also be in the form of an emulsion, such as oil-in-water emulsions, water-in-oil emulsions. (0098). However, the vitamin B3 compound is substantially uncomplexed in the composition prior to delivery to the keratinous tissue. Exemplary approaches to minimizing or preventing the formation of undesirable complexes include omission of materials which form substantially irreversible or other complexes with the vitamin B3 compound, pH adjustment, ionic strength adjustment, the use of surfactants. (0092). There is not lauroyl lysine in the formulation. Coefficient of friction is the ratio of the force of friction between two bodies and the force pressing them together. In the present method, the instrument used to determine the coefficient of friction is a Bruker® UMT-2 tribometer. However, an equivalent tribometer may be used, as desired. (0170). This method provides a means to determine the coefficient of friction of material surfaces herein. Wet coefficient of friction refers to the coefficient of friction measured on a surface on which a skin care composition is present. Dry coefficient of friction refers to the coefficient of friction measured on a surface on which a skin care composition is not
present. (0169).
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The average coefficient of friction of the samples is 0.50.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the formulation taught by Boland et al., to utilize lauroyl lysine physical properties, taught by Ranade et al. and WO2020171217A1, to utilize niacinamide as the active form of vitamin B3, taught by Matts et al. and to have carboxyvinyl polymer or alkylacrylate copolymer as thickeners, and fatty alcohol cetyl alcohol taught by Richard et al., and to have friction coefficient below 0.50 even without lauroyl lysine, taught by Mcildowie et al. since they have provided suitable information to prepare suitable cosmetic composition of vitamin B3 with low friction coefficient.
With regard to claim 5, Boland et al. teach Group 1K, a humectant with 2-20% (e.g., 5, 6, 7, 8, 9, 10, 11, 12, 15%) w/w can be included. (Table 1, pg. 6).
With regard to claim 7-10, Boland et al. teach in some embodiments, the formulation comprises, consists, essentially of or consists of several groups of ingredients is provided with glycerin about 0.2-5% (e.g., about 0.5, 0.8, 1, 1.5, 2, 4%) (Table 3, Group 3.7, pg. 8). With these possible percentage of glycerin over niacinamide in a range of 0.05-5% w/w, then the weight ratio between the glycerin and the vitamin B3 compound can be 1.5:1, 1.2: 1, 1: 1 or 0.8:1.
Claims 16 and 6 and 11, are rejected under 35 U.S.C. 103 as being unpatentable by Fournial (WO 2010044076 A2) and Boland et al. US 20190240141Al in view of Matts et al. (Matts et al., A Review of the Range of Effects of Niacinamide in Human Skin. IFSCC Magazine – vol. 5, no 4 / 2002), and further in view of Wakui (WO2020171217A1), Ranade et al. (US 20110067720 A1), Mcildowie et al., (US 20160074643Al) and Richard et al. (WO 2013011094 A2).
The teachings of Fournial, Boland et al., Matts et al., Wakui, Ranade et al. and Mcildowie et al. are described in claim 16.
Fournial, Boland et al., Matts et al., Wakui, Ranade et al. and Mcildowie et al. do not teach the composition of Claim 16, further comprising up to about 0.5% of a total level of cetyl, stearyl, and behenyl alcohols and the composition further comprises from about 0.2% to about 2% of one or more hydrophilic thickeners; wherein the one or more hydrophilic thickener comprises carboxyvinyl polymers, acrylic acid/alkyl (meth)acrylate copolymers, or a combination thereof.
Boland et al. teach thickeners (0071) and in one embodiment, a thickener or viscosity
increasing agent is provided in a range of about 0.1-15% of the total formulation (e.g., 0.1%, 0.5%, 1%, 2%, 3%, 4%, 5%, 10%, 12%, 15%, and ranges in between). In one embodiment, the percentages provided are % m/m or % w/w. (0073).
Boland et al. do not teach hydrophilic thickener comprises carboxyvinyl polymers, acrylic acid/alkyl (meth)acrylate copolymers, or a combination thereof.
Richard et al. teach 0-5% cetyl alcohol as one of fatty alcohols, which can be used in the cosmetic composition. (pg. 105, or pg. 106 of 124, Table of Ingredients) and acrylate/C10-C30- alkylacrylate crosspolymer 0-2% w/w. (pg. 106, or pg. 107 of 124, Table of Ingredients)
Richard et al. teach the compounds of formula (I) are preferably present, alone or as a mixture, in the cosmetic compositions according to the invention in an amount of from 0.5% to 40% by weight hydrophilic thickeners that may be mentioned include carboxyvinyl polymers such as the Carbopol products (carbomers) and the Pemulen products (acrylate/C10-C30- alkylacrylate copolymer); and Sodium Acrylates Copolymer. (pg. 57, lines 10-19, or pg. 58 or 124).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the formulation taught by Boland et al., to utilize lauroyl lysine physical properties, taught by Ranade et al. and WO2020171217A1, to utilize niacinamide as the active form of vitamin B3, taught by Matts et al. and to have carboxyvinyl polymer or alkylacrylate copolymer as thickeners, and fatty alcohol cetyl alcohol taught by Richard et al. since they have provided suitable information to prepare suitable cosmetic composition of vitamin B3 with lauroyl lysine.
Response to Arguments
Claim Rejections - 35 USC § 103
Applicant argues that independent claims 16 and 23 are amended. The cited documents fail to
address the problem that cosmetic compositions containing vitamin B3 compounds have a draggy feeling and/or reduced smooth feeling during and after application to the skin. Instead, it
selectively picks-and-chooses various components from the encyclopedic disclosures found in the multiple cited documents and reassembles them unerringly to arrive at the present invention, including vitamin B3 and lauroyl lysine. Mcildowie fails to remedy these deficiencies and does not teach or suggest the "the composition comprises a coefficient of friction of less than 0.8 at 30 counts according to the method described herein using an i-tester (TL201 Tt) from Trinity Lab Inc.," as recited in claims 16 and 23. Instead, the test in Mcildowie measures the friction between a probe covered with nitrile glove material (902) and the "skin-contacting surface [920] of an applicator [910]," which was "tested with [i.e., wet] and without [i.e., dry] a skin care composition .... "The Office Action alleges that Table 13 of Mcildowie discloses "the average coefficient of friction of the samples is 0.50," which indicates that the skin care composition is reducing the friction between two solid surfaces (i.e., the nitrile glove and the applicator), which does not teach or suggest that the skin care composition comprises a coefficient of friction of 0.50, as the Office Action alleges.
Applicant’s arguments with new amendments are fully considered and are not persuasive because the composition is taught by Fournial, Boland, Matts, Wakui and Ranade. Mcildowie also teaches a cosmetic skin care product and a skin care composition. The skin care composition includes an effective amount of a vitamin B3 active and a dermatologically acceptable carrier, (Abs), with of range of 0.0005%-11 %. (0094) in oil-in-water or water-in-oil emulsions, (0098), with the use of surfactants. (0092). Even without lauroyl lysine in the formulation, coefficient of friction is the ratio of the force of friction, of Mcildowie’s composition is below 0.50, so it would be obvious that if the Mcildowie’s composition includes lauroyl lysine in the formulation, its coefficient of friction would be lower or unless other surfactants may help reducing coefficient of friction as much as lauroyl lysine.
Coefficient of friction by definition is the ratio of the force of friction between two bodies and the force pressing them together. In the present method, the instrument used to determine the coefficient of friction is a Bruker® UMT-2 tribometer. However, an equivalent tribometer may be used, as desired. Mcildowie measures friction coefficient by two ways: 1) A purple nitrile glove material is used as one of the two materials in the test. 2) The other material the test surface ( e.g., skin contacting surface of the applicator or cover). The purple nitrile glove material is placed over the probe of the tribometer. The test surface to be measured is placed in contact with the nitrile-covered probe of the instrument, and the force is measured according to the manufacturer's operating instructions for the instrument. (0170). This method provides a means to determine the coefficient of friction of material surfaces herein. Wet coefficient of friction refers to the coefficient of friction measured on a surface on which a skin care composition is present. Dry coefficient of friction refers to the coefficient of friction measured on a surface on which a skin care composition is present. (0169). But tacted with the skin-contacting surface 720 of an applicator 710. In this example, the cover has been removed from the applicator 710 and the magnetic array provides the skin contacting surface 720. The skin-contacting surface of the cover (not shown) was also measured. Both the applicator surface 720 and the cover were tested with and without a skin care composition (Olay® ProX Deep Wrinkle Cream® brand skin care composition available from the Proctor&Gamble Co., Ohio). For measuring wet coefficient of friction, 0.1 g of the skin care composition was spread over the test surface. The rate of the probe was set to 1 mm/sec with a force of 100 grams. Each leg of the test was repeated three times. The coefficient of friction results are shown in Table 13 below.
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Mcildowie teaches that an equivalent tribometer may be used, as desired. (0170). Test Duration: Tests can run for thousands of cycles (e.g., 554 cycles) or a set time (e.g., 1 hour) to measure continuous friction evolution. In some contexts, a "count" might refer to the number of revolutions or strokes (cycles) a sample undergoes, but the final friction measurement is a dimensionless coefficient. (Ramalho. Experimental approach in tribology: Effects of test equipment dynamic response on the reliability and reproducibility of the results. Wear 571 (2025) 205770.). It would be acceptable to have a different instrument to measure friction, with 30 counts of a itester TL201Tt or 554 cycles with a tribometer as long as the instruments provide reliability and reproducibility of the results.
Conclusion
Applicants' 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 extension fee 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 date of this final action.
Correspondence
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NGOC-ANH THI NGUYEN whose telephone number is (571)270-0867. The examiner can normally be reached Monday - Friday 8:00 am.
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/NGOC-ANH THI NGUYEN/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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