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 .
Response to Restriction/Election
Applicant’s election of isododecane (as the hydrocarbon-based oil) and Caramide NP (as the poorly soluble component) for examination is acknowledged. No claims are withdrawn from consideration. Pursuant to MPEP § 818.01(a), the Election made in the reply filed on 2026, Jun. 01 is being treated as an election without traverse. Claims 1-14 are the subject matter of this Office Action.
Status of Claims
The status of Claims are as follows:
Claims 1-14 are pending.
Claims 1-14 are rejected.
Priority
Acknowledgement is made that instant Application 18/582,083, filed on 2024, Feb. 20, claims foreign priority to KR 10-2023-0025831, filed on 2023, Feb. 27.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 2024, Feb. 20, 2024, Jun. 28, and 2024, Aug. 12 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
Claim Objections
Claim 5 is objected to for the following reasons:
The limitation “asiaticoside*madecassic acid*asiatic acid” is in error and should be corrected to “asiaticoside, madecassic acid, asiatic acid”.
“hydroxypropyl bislauramid MEA” should be correctly spelled as “hydroxypropyl bislauramide MEA”.
Claim 12 is objected to for the following reasons:
“carnuba” should be correctly spelled as “carnauba”.
“ceracin” should be correctly spelled as “ceresin”.
Appropriate action is required.
Claim Interpretation
Claim 1 is directed to a water-in-silicone cosmetic composition comprising a silicone part containing a silicone and a hydrocarbon-based oil with a weight average molecular weight of 1,000 of less. For the purposes of this examination, this is taken to mean that the hydrocarbon-based oil has a weight average molecular weight of 1,000 or less.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7 and 9-10 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Tabuchi (US 2021/0259929 A1; published 2021, Aug. 26) as evidenced by Bouwstra (Phase behavior of lipid mixtures based on human ceramides: coexistence of crystalline and liquid phases. J Lipid Res, 2001, 42(11), 1759-1770. doi.org/10.1016/S0022-2275(20)31502-9), and evidenced by van Smeden (LC/MS analysis of stratum corneum lipids: ceramide profiling and discovery. J Lipid Res. 2011, 52(6), 1211-1221. doi.org/10.1194/jlr.M014456),.
Claim 1 is directed to a water-in-silicone cosmetic composition comprising a silicone part containing a silicone and a hydrocarbon-based oil with a weight average molecular weight of 1,000 or less and an aqueous phase part containing water, wherein the water-in-silicone composition comprises a poorly soluble component having a solubility in the aqueous phase part of 1 mg/mL or less throughout the composition.
Tabuchi teaches a water-in-oil (W/O) emulsion composition comprising components (A) – (E), in which (A) is a glycerol monofatty acid ester having 12 to 26 carbon atoms; (B) is a higher alcohol having 10 to 22 carbon atoms; (C) is a ceramide; (D) is selected from a sphingosine or salt thereof and an ionic surfactant; and (E) is a nonionic surfactant including (e1) as one or more of a crosslinked polyether-modified silicone and a crosslinked polyglycerol-modified silicone, and (e2) as one or more of polyether-modified silicone, a polyglycerol-modified silicone, and a polyglycerol fatty acid ester (abstract). Importantly, the W/O composition suppresses precipitation of ceramide without necessarily using ionic surfactants. Although water-in-oil composition is not explicitly stated to be a water-in-silicone composition, the silicone component of the instant application is not considered novel over Tabuchi because component (e1) is selected as a silicone part of either or both of a crosslinked polyether-modified silicone or a crosslinked polyglycerol-modified silicone. Furthermore, Tabuchi teaches that the crosslinked polyether-modified silicone as (e1) is preferably diluted or dispersed in a volatile hydrocarbon oil that is more preferably isododecane (page 9, right column, paragraph 0103). Isododecane has a molecular weight of 170.33 g/mol and therefore this combination of components arrives at the water-in-silicone cosmetic composition recited in instant claim 1.
Claims 2-3 are directed to the water-in-silicone cosmetic composition wherein the hydrocarbon-based oil has carbon atoms of 40 or less and, per Applicant’s response to the election requirement filed on 2026, Jun. 01, is selected as isododecane.
Tabuchi teaches a water-in-silicone cosmetic composition wherein the silicone component is stabilized with a volatile hydrocarbon oil selected from a group comprising isododecane (C12H26) (page 9, right column, paragraph 0103).
Claim 4 is directed to the water-in-silicone cosmetic composition wherein the poorly soluble component is dispersed in a crystalline phase throughout the composition.
Tabuchi teaches the ceramides of the emulsion composition has a lamellar α-gel structure (page 8, right column, paragraph 0093), which is not meaningfully distinct from a crystalline phase. This is evidenced by Bouwstra who explains the stratum corneum (SC) of human skin contains ceramides with two coexisting crystalline lipid lamellar phases (abstract). Ceramide-based models show highly ordered molecular packing within the lamellar structure, which is identified by X-ray diffraction (Figure 2). Furthermore, a wide-angle diffraction curve of a ceramide mixture indicates a pseudo-hexagonal phase coexists with a liquid phase (Figure 3). Accordingly, one of ordinary skill in the art would reasonably understand that a lamellar α-gel structure would inherently be crystalline in character.
Claims 5-6 are directed to the water-in-silicone cosmetic composition wherein the poorly soluble component is ceramide NP, per Applicant’s response to the election requirement filed on 2026, Jun. 01.
Tabuchi teaches the use of a ceramide as component (C), wherein the preferred ceramide is selected from a group comprising ceramides 1-5 and 6II (page 2, right column, paragraph 0044). It is known in the art that the ceramide classification system was changed circa 2010 and ceramide 3 is synonymous with ceramide NP (see van Smeden).
Claim 7 is directed to the water-in-silicone cosmetic composition wherein the content of the poorly soluble component is 1 to 10% by weight based on the total weight of the cosmetic composition.
Tabuchi teaches the use of ceramide in the emulsion composition in an amount between 0.05 to 15% by mass, or more preferably from 0.1 to 13% by mass, or more preferably from 0.5 to 10% by mass (paragraph 0051).
Claims 9-10 are directed to the water-in-silicone cosmetic composition wherein the aqueous phase part further includes a polyol that is selected from the group consisting of glycerin, 1,3-butylene glycol, propylene glycol, dipropylene glycol, polyethylene glycol, and sorbitol.
Tabuchi teaches the water-in-oil composition comprises moisturizers, including 1,3-butylene glycol, propylene glycol, dipropylene glycol, polyethylene glycol, and sorbitol (page 13, paragraph 0167).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tabuchi as evidenced by Bouwstra, and evidenced by van Smeden in view of Sasaki (US 2012/0220670 A1; published 2012, Aug. 30).
Claim 8 is directed to the water-in-silicone cosmetic composition wherein the weight ratio of the hydrocarbon-based oil to the poorly soluble component is 1:0.5 to 10.
Tabuchi teaches the use of isododecane as a volatile hydrocarbon oil to dilute the crosslinked polyether-modified silicone (paragraph 00103).
The difference between the composition of Tabuchi and the instant claim is that Tabuchi fails to teach a specific weight ratio of the hydrocarbon-based oil, specifically isododecane.
However, Sasaki teaches a water-in-oil cosmetic composition comprising a volatile hydrocarbon oil, a non-volatile silicone oil, a polyethylene glycol mono-or di-isostearate having 4 to 12 oxyethylene groups, a polyoxyethylene-polydimethylsiloxyethyl-dimethicone copolymer, and an organically modified clay material, wherein the emulsion is stabilized by the inclusion of the volatile hydrocarbon-based oil (title, abstract). Sasaki further teaches the use of 3-25% by mass of the volatile hydrocarbon oil to the emulsion (abstract, claim 1), where the volatile hydrocarbon oil used may include isododecane (pages 1-2, paragraph 0023).
A person of ordinary skill in the art would have been motivated to use the ratio set forth by Sasaki to stabilize the emulsion taught by Tabuchi because Sasaki teaches the use of a stabilizing hydrocarbon-based oil (e.g., isododecane) in a composition comprised of a dimethicone-based copolymer (page 1, right column, paragraph 0015) and Tabuchi teaches dimethicone crosspolymers as examples of the crosslinked polyether-modified silicone of component (e1) that is diluted by the hydrocarbon-based oil (e.g., isododecane) (page 9, right column, paragraph 0104). Therefore, said skilled artisan would have had a reasonable expectation of success to use isododecane in an amount between 3-25% by mass to stabilize the water-in-oil emulsion as taught by Tabuchi. An amount of isododecane between 3-25% by mass with respect to the amount of the poorly soluble component discussed above (0.05 to 15% by mass) falls within the range recited by instant claim 8.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tabuchi as evidenced by Bouwstra, and evidenced by van Smeden, in view of Lee (EP 3741353 A1; published 2020, Nov. 25).
Claims 11-12 are directed to the water-in-silicone cosmetic composition wherein the silicone part further includes wax that is selected from the group consisting of carnauba, ceresin, cetyl esters, microcrystalline wax, montan wax, earth wax, and synthetic wax.
The teachings of Tabuchi are disclosed above and incorporated herein by reference.
The difference between the teachings of Tabuchi and the instant application is that Tabuchi does not teach the use of waxes in the water-in-silicone composition.
However, Lee teaches the water-in-oil cosmetic composition is comprised of commonly used cosmetic waxes, including carnauba, ceresin, microcrystalline, and ozokerite (earth wax), (paragraph 0036) and may further be comprised of cetyl esters (page 4, paragraph 0032).
One would be motivated to incorporated the waxes as taught by Lee into the water-in-silicone composition as taught by Tabuchi because waxes add provide structure, texture, stability, and protective benefits to cosmetic compositions. Furthermore, ceramide is known in the art to easily precipitate in cosmetic compositions (Lee, page 2, paragraph 0004). Lee teaches a water-in-oil cosmetic composition (page 5, paragraph 0045) containing high content of ceramide between 10-50% (title, claim 2). The teachings of Lee suggest that use of the above waxes does not precipitate ceramide despite the high content. Therefore, one would reasonably expect the waxes could be added to the composition as taught by Tabuchi to provide additional beneficial features without ceramide precipitation.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tabuchi as evidenced by Bouwstra, and evidenced by van Smeden, in view of Lee, and in further view of Dederen (US 6,831,107 B2; published 2004, Dec. 14).
Claim 13 is directed to the water-in-silicone composition wherein the viscosity of the cosmetic composition is 10,000 cps or more.
The teachings of Tabuchi are disclosed above and incorporated herein by reference. Tabuchi further teaches that the emulsion composition may be formed into a cosmetic in various forms, e.g., a cream such as a hair cream and hand cream (page 14, paragraph 187)
The difference between the teachings of Tabuchi and the instant application is that Tabuchi does not teach the viscosity of the composition in the form of a cream.
However, Lee teaches the cosmetic composition may be in a formulation having a viscosity of 0.1 to 40,000 cps (page 5, paragraph 0040).
One would be motivated to combine the teachings of Lee and Tabuchi because Lee further teaches that ceramide tends to easily crystallize in low-viscosity compositions (page 5, paragraph 0040). As such, a skilled artisan would know the ceramide-containing cosmetic composition should be of high viscosity.
The difference between the combined teachings and the instant application is that the combined teachings fail to teach a cosmetic cream with a viscosity that overlaps with that of the instant application.
However, Dederen teaches that personal care emulsions can be divided by viscosity into milks and lotions, which typically have a low shear viscosity from about 100 to about 10,000 mPa.s (column 2, lines 24-25), and creams, which typically have a low shear viscosity of about 20,000 – 80,000 mPa.s (column 2, lines 23-29). This applies to the current invention because the instant specification states that the claimed cosmetic composition is a cream by noting there were “differences in the hardness of cream formation” (page 8, line 20).
Accordingly, one would find it prima facie obvious to formulate the ceramide-containing cosmetic composition of Tabuchi into a cream with an art-recognized viscosity of >10,000 cps for the prevention of ceramide crystallization and thereby arriving at the current invention.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tabuchi as evidenced by Bouwstra, and evidenced by van Smeden, in view of Tai (Texture analysis of cosmetic/pharmaceutical raw materials and formulations. Int J Cosmet Sci, 2014, 36, 291-304. Doi: 10.1111/ics.12125).
Claim 14 is directed to the water-in-silicone composition wherein the hardness of the cosmetic composition is 80 Kgf or less.
The teachings of Tabuchi are discussed above and incorporated herein by reference.
The difference between the teachings of Tabuchi and the instant application is that Tabuchi fails to teach the hardness of the cosmetic composition wherein the hardness is 80 Kfg or less. However, one of ordinary skill in the art would arrive at this value through routine optimization, as evidenced by Tai.
Tai performed a texture analysis of cosmetic/pharmaceutical raw materials and formulations (title). The texture analysis plots force as a function of time and includes one cosmetic formulation in the form of a cream. The cream required around 400 N of force to cause deformation on three separate trials (page 301, Figure 14). Given the conversion of Newtons to Kgf is 1 N = 0.102 Kgf, the tested cream has a hardness of about 40 Kgf. This applies to the instant invention because the instant specification states that the claimed cosmetic composition is a cream by noting there were “differences in the hardness of cream formation” (page 8, line 20). Therefore, one would be able to routinely optimize a cosmetic formulation into a cream that has a hardness of 80 Kgf or less.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Paul Arcoria whose telephone number is (571)272-8719. The examiner can normally be reached Mon-Fri 8:00-5:00 EST.
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, Clinton Brooks can be reached at (571)270-7682. 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.
/P.A./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
Prosecution Insights