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 .
Acknowledgement of Receipt
Applicant's response filed on 09/19/2025 to the Office Action mailed on 03/19/2025 is acknowledged.
Claim Status
Claims 1-4, 8-9, 11-27, 30, 32, 34, 37, 39, 41, 43, 45, 47-48, 50, 52-53, 55, and 80-81 are pending.
Claims 1, 3-4, 13, 17-23, 25, 27, 30, 32, 34, 37, 39, 41, 43, 45, 47, 50, and 52 are currently amended.
Claims 56, 63, and 78 are previously withdrawn and newly canceled.
Claims 80-81 are newly added.
Claims 5-7, 10, 28, 29, 31, 33, 35, 36, 38, 40, 42, 44, 46, 49, 51, 54, and 56-79 are canceled.
Claims 1-4, 8-9, 11-27, 30, 32, 34, 37, 39, 41, 43, 45, 47-48, 50, 52-53, 55, and 80-81 have been examined.
Claims 1-4, 8-9, 11-27, 30, 32, 34, 37, 39, 41, 43, 45, 47-48, 50, 52-53, 55, and 80-81 are rejected.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 09/19/2025 and 04/14/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
New Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 81 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 81 recites the limitation “madecassoside/asiaticoside.” The use of the “/” character makes it unclear if the claim requires a combination of madecassoside and asiaticoside or if asiaticoside is an alternative ingredient to madecassoside.
New (Modified) 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.
This rejection is modified from the previous Office Action in view of the amendments to the claims.
Claims 1-2, 4, 8-9, 11, 13-24, 27, 32, 34, 50, 52, 53, 55, and 80 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al., (US 2010/0189761 A1, July 29, 2010) (hereinafter Friedman).
Friedman discloses a topical composition (abstract). The composition may be in the form of an emulsion comprising a discontinuous phase and a continuous phase. An emulsion is a preparation of one liquid distributed in small globules throughout the body of a second liquid. The discontinuous phase or the continuous phase may be an oil phase. Either or both of the continuous phase and the discontinuous phase may contain one or more excipients such as surfactants, emulsifiers, emulsion stabilizers, anti-oxidants, emollients, humectants, chelating agents, suspending agents, thickening agents, occlusive agents, preservatives, stabilizing agents, pH modifying agents, solubilizing agents, penetration enhancers, and other excipients ([0072]). Antioxidants include all forms of Vitamin E including a-tocopherol. Antioxidants may be present in amounts from about 1% to about 90% ([0064]). The emulsion can be anhydrous ([0090]). Humectants include glycerin (i.e. glycerol), polyols, and urea and mixtures thereof ([0049]). The humectants may be present in amounts from about 5% to about 50% ([0061]). The composition may comprise from about 5% to about 20% urea ([0032]). The urea is introduced into a mixture comprising the humectant, wherein such mixture is then heated and mixed until the urea is dissolved ([0091]). Emollients include cholesterol ([0081]) soybean oil, silicone oils, polyethylene glycol, dimethicones, oleic acid, and mixtures thereof in amounts from about 10% to about 90% ([0059]). Hydroxyethyl Urea is highly hygroscopic and offers excellent moisturizing benefit, and may also be beneficially included in the composition ([0048]). Ascorbic acid may be included in amounts ranging from about 5 to about 50% by weight of the formulation ([0042]). Retinol may be included from about 1% to about 60% ([0044]). Azelaic acid may be included in amounts ranging from about 1% to about 60% by weight ([0044]). The composition is physically and chemically stable at room temperature, meaning the physical state of the composition upon packaging remains substantially constant over the shelf life of the product at room temperature and the components of the compositions do not chemically degrade to an unacceptable extent during the shelf life of the product at room temperature ([0053]). Shelf life may range from 6 months to 5 years ([0066]). The compositions comprise one or more components that aid in hydration (e.g., urea) and/or one or more active agents that have keratolytic activity (e.g., salicylic acid), in a suitable pharmaceutically acceptable topical carrier ([0031]).
The prior art discloses a storage stable ([0053]) topical (abstract) emulsion ([0072]) containing urea ([0049]), glycerin (i.e. glycerol) (i.e., non-aqueous skin-compatible solvent) ([0049]) and dimethicone ([0059]), wherein the components may be included in either or both of the continuous phase and the discontinuous phase ([0072]). Together these would provide a composition as claimed instantly. The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143(I)(A).
Regarding claim 1 reciting wherein the internal phase is homogenous, as discussed above, Friedman discloses in paragraph [0091] mixing the humectant (e.g., glycerol) and urea. Thus, it would have been obvious to one of ordinary skill in the art that if the humectant and urea were to be incorporated into the discontinuous phase (i.e., internal phase) that the phase would be homogenous since the components are mixed.
Regarding the limitation of claim 1 reciting, as discussed above, Friedman discloses a storage stable topical (abstract) emulsion containing urea glycerin (i.e. glycerol) (i.e., non-aqueous skin-compatible solvent) and dimethicone, wherein the components may be included in either or both of the continuous phase and the discontinuous phase, which provide a composition as claimed in instant claim 1. Accordingly, because the composition of claim 1 is storage stable for 12 months at 25̊ C ± 2̊ C in a sealed container, the composition of Friedman would necessarily be storage stable for 12 months at 25̊ C ± 2̊ C in a sealed container.
Regarding claim 9 reciting wherein the 1% to 30% urea agent of claim 1 is hydroxyethyl urea, Friedman does not disclose the amount of hydroxyethyl urea. However, as discussed above, Friedman discloses wherein the hydroxyethyl urea is a moisturizing agent. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount of hydroxyethyl urea through experimentation based on the level of moisturization desired. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
Regarding claim 13, since the emulsion of Friedman comprises a discontinuous phase (i.e., internal phase) and a continuous phase (i.e., external phase), the composition of Friedman necessarily exhibits a urea agent degradation rate that is less than the urea agent degradation rate of a homogenous internal phase solution in the absence of the external phase emulsion.
Regarding claim 16, as discussed above, either or both the discontinuous phase and the continuous phase may comprise the humectants (e.g., glycerol and urea) and the emollients (i.e., dimethicone). Thus, one may have the discontinuous phase comprise the humectants and the continuous phase comprise the emollients. Friedman discloses wherein the composition comprises from about 5% to about 20% urea, about 10% to about 90% dimethicone, and about 5% to about 50% glycerin. The claimed percent by weight ratio of the internal phase to the external phase would have been obvious from these ranges. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
Regarding claim 80, as discussed above, Friedman teaches that the compositions comprise one or more components that aid in hydration (e.g., urea) and/or one or more active agents that have keratolytic activity (e.g., salicylic acid), in a suitable pharmaceutically acceptable topical carrier. Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the composition of Friedman wherein the composition does not comprise salicylic acid or ammonium lactate since although salicylic acid may be included as an alternative to urea, the composition only requires the presence of one component that aids in hydration (e.g., urea) in a suitable pharmaceutically acceptable topical carrier.
Response to Applicant’s Arguments
The rejection of claims 7 and 17-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in view of amendments to the claims.
With regard to the rejection of claims 1-9, 11, 13-24, 27, 32, 34, 50, 52, 53, 55, and 80 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al., (US 2010/0189761 A1, July 29, 2010) (hereinafter Friedman):
Applicant argues that Friedman fails to provide any reasoning, suggestion, or motivation for utilizing dimethicone, or dimethicone in combination with dimethiconepolyethylene glycol (PEG)-10 15 crosspolvmer or lauryl PEG-9 polvdimethylsiloxyethyl dimethicone, in its composition because all of Friedman's disclosed exemplary compositions comprise other suitable emollients, and none comprise a silicone agent, let alone dimethicone, or dimethicone in combination with dimethicone/polyethylene glycol (PEG)-10/15 crosspolymer or lauryl PEG-9 polydimethylsiloxyethyl dimethicone. Applicant’s argument has been fully considered but found not to be persuasive. A rejection made under 103 and does not need to exemplify all embodiments, only suggest. “Disclosed examples and preferred embodiments do not constitute a teaching away from the broader disclosure or non-preferred embodiment.” In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). MPEP 2123. As discussed above, Friedman teaches that suitable emollients include silicone oils, dimethicones, and mixtures thereof. Thus, one of ordinary skill in the art would have been motivated to utilize dimethicone as an emollient in the composition of Friedman. Further, claim 1 does not require dimethicone/polyethylene glycol (PEG)-10/15 crosspolymer or lauryl PEG-9 polydimethylsiloxyethyl dimethicone as recited in amended claim 3, which is rejected in a following rejection.
Applicant argues that Friedman fails to teach storage stability of the claimed topical emulsion composition because Friedman broadly disclose the alleged storage stability of its disclosed compositions but compositions that exemplify stability do not comprise dimethicone. Applicant’s argument has been fully considered but found not to be persuasive. As discussed above, Friedman discloses a storage stable topical (abstract) emulsion containing urea glycerin (i.e. glycerol) (i.e., non-aqueous skin-compatible solvent) and dimethicone, wherein the components may be included in either or both of the continuous phase and the discontinuous phase, which provide a composition as claimed in instant claim 1. Accordingly, because the composition of claim 1 is storage stable for 12 months at 25̊ C ± 2̊ C in a sealed container, the composition of Friedman would necessarily be storage stable for 12 months at 25̊ C ± 2̊ C in a sealed container.
Applicant argues that in addition to not teaching, suggesting, or providing motivation for the specific combination of the components urea, glycerin, and dimethicone, let alone in an emulsion form, nowhere does Friedman teach or suggest that such a specific combination yields a storage stable topical emulsion composition. Applicant’s argument has been fully considered but found not to be persuasive for reasons discussed above.
Applicant argues that because all of Friedman’s exemplary compositions comprise urea in combination with the active agent salicylic acid or ammonium lactate, when considered as a whole, the collective teachings of Friedman discourage one of ordinary skill in the art from preparing or utilizing compositions comprising urea but not salicylic acid or ammonium lactate. Applicant’s argument has been fully considered but found not to be persuasive. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). As discussed above, Friedman teaches that the compositions comprise one or more components that aid in hydration (e.g., urea) and/or one or more active agents that have keratolytic activity (e.g., salicylic acid), in a suitable pharmaceutically acceptable topical carrier. Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the composition of Friedman wherein the composition does not comprise salicylic acid or ammonium lactate since although salicylic acid may be included as an alternative to urea, the composition only requires the presence of one component that aids in hydration (e.g., urea) in a suitable pharmaceutically acceptable topical carrier.
For the foregoing reasons the rejection is modified and maintained.
This rejection is modified from the previous Office Action in view of the amendments to the claims.
Claims 12 and 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al., (US 2010/0189761 A1, July 29, 2010) (hereinafter Friedman) in view of Zhang (US 2007/0172436 A1, July 26, 2007) (cited by applicant on IDS 03/21/2023) (hereinafter Zhang).
As discussed above, Friedman makes obvious the limitations of claims 11-9, 11, 13-24, 27, 32, 34, 50, 52, 53, 55, and 80 but does not disclose wherein the composition comprises 1,3 propanediol or a ceramide.
However, Zhang teaches a nonaqueous ascorbic acid composition in an alcohol solvent comprising a solubilization enhancer and an oleaginous skin protectant ([0002]). Polyols suitable for preparing the nonaqueous compositions include 1,3-propanediol, diglycerin, and combinations thereof and they may serve as a nonaqueous alcohol solvent or a thickener to adjust the viscosity of the nonaqueous compositions ([0035]). The nonaqueous alcohol solvents may be present in an amount of 20 to 90% by weight ([0037]). The composition may comprise ceramide VI (i.e. ceramide AP) ([0077]). Ceramides help with restoration of damaged skin barrier ([0082]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As discussed above, Friedman discloses wherein the composition may comprise polyols and thickening agents. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated 1,3 propanediol into the emulsion of Friedman since this is a known and effective polyol and thickening agent for topical compositions as taught by Zhang.
Additionally, it would have been obvious to one of ordinary skill in the art to have incorporated ceramide AP into the composition of Friedman motivated by the desire to formulate the composition to help with restoration of damaged skin barrier as taught by Zhang.
In regards to the amount of ceramide recited in claim 17, since Zhang discloses wherein ceramide help with restoration of damaged skin barrier, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount through routine experimentation based on the level of restoration of damaged skin barrier desired. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
Response to Applicant’s Arguments
With regard to the rejection of Claims 12 and 47-48 under 35 U.S.C. 103 as being unpatentable over Friedman et al., (US 2010/0189761 A1, July 29, 2010) (hereinafter Friedman) in view of Zhang (US 2007/0172436 A1, July 26, 2007) (cited by applicant on IDS 03/21/2023) (hereinafter Zhang):
Applicant argues that Zhang fails to remedy the deficiencies of Friedman. Applicant’s argument has been fully considered but found not to be persuasive because Applicant’s arguments against Friedman were unpersuasive.
For the foregoing reasons the rejection is modified and maintained.
This rejection is modified from the previous Office Action in view of the amendments to the claims.
Claims 30, 37 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al., (US 2010/0189761 A1, July 29, 2010) (hereinafter Friedman) in view of Albrecht (US 2018/0071190 A1, March 15, 2018) (hereinafter Albrecht).
As discussed above, Friedman makes obvious the limitations of claims 1-9, 11, 13-24, 27, 32, 34, 50, 52, 53, 55, and 80 but does not disclose wherein the composition comprises bis-ethylhexyl hydroxydimethoxy benzylmalonate, bakuchiol, or glycyrrhetinic acid.
However, Albrecht teaches a cosmetic product which has a particularly high activity with respect to the prevention or elimination of barrier disorders of the skin ([0003]). The composition comprises at least one antioxidant such as bakuchiol and bis-ethylhexyl hydroxydimethoxy benzylmalonate in an amount between 0.01% by weight and 10% by weight ([0016]). The composition may comprise glycyrrhetinic acid as an anti-inflammatory active substance ([0036]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Friedman discloses wherein the composition may comprise antioxidants. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated bakuchiol and bis-ethylhexyl hydroxydimethoxy benzylmalonate into the composition of Friedman since they are known and effective antioxidants as taught by Albrecht.
It would have been prima facie obvious to one of ordinary skill in the art to have incorporated glycyrrhetinic acid into the composition of Friedman motivated by the desire to formulate the composition to have anti-inflammatory effects as taught by Albrecht.
In regards to the amount of glycyrrhetinic acid recited in claim 17, since Albrecht discloses wherein glycyrrhetinic acid is an anti-inflammatory agent, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount through routine experimentation based on the level of anti-inflammation desired. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
Response to Applicant’s Arguments
With regard to the rejection of claims 30, 37 and 43 under 35 U.S.C. 103 as being unpatentable over Friedman et al., (US 2010/0189761 A1, July 29, 2010) (hereinafter Friedman) in view of Albrecht (US 2018/0071190 A1, March 15, 2018) (hereinafter Albrecht):
Applicant argues that Albrecht fails to remedy the deficiencies of Friedman. Applicant’s argument has been fully considered but found not to be persuasive because Applicant’s arguments against Friedman were unpersuasive.
For the foregoing reasons the rejection is modified and maintained.
This rejection is modified from the previous Office Action in view of the amendments to the claims.
Claims 25-26 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al., (US 2010/0189761 A1, July 29, 2010) (hereinafter Friedman) in view of Maruyama (US 2019/0336421 A1, Nov 7, 2019) (hereinafter Maruyama).
As discussed above, Friedman makes obvious the limitations of claims 1-9, 11, 13-24, 27, 32, 34, 50, 52, 53, 55, and 80 but does not disclose wherein the composition comprises 0.1% to 2% by weight of ferulic acid or a pinus pinaster bark extract.
However, Maruyama discloses a cosmetic composition (abstract) for facial skin ([0453]) comprising an antioxidant agent such as polyphenols ([0345]) derived from pinus pinaster (bark extract) ([0347]) or a lipophilic antioxidant (c) such as ferulic acid ([0359]). The amount of ingredient(s) (c) in the composition according to the present invention may range from 0.01 to 20% by weight ([0362])
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Friedman discloses wherein the composition comprises antioxidants. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated ferulic acid or pinus pinaster bark extract into the composition of Friedman since they are known and effective antioxidants as taught by Maruyama.
Response to Applicant’s Arguments
With regard to the rejection of claims 25-26 and 45 under 35 U.S.C. 103 as being unpatentable over Friedman et al., (US 2010/0189761 A1, July 29, 2010) (hereinafter Friedman) in view of Maruyama (US 2019/0336421 A1, Nov 7, 2019) (hereinafter Maruyama):
Applicant argues that Maruyama fails to remedy the deficiencies of Friedman. Applicant’s argument has been fully considered but found not to be persuasive because Applicant’s arguments against Friedman were unpersuasive.
For the foregoing reasons the rejection is modified and maintained.
This rejection is maintained from the previous Office Action.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al., (US 2010/0189761 A1, July 29, 2010) (hereinafter Friedman) in view of Revolution (Good Vibes Lip Balm, Dec. 29, 2019) (hereinafter Revolution).
As discussed above, Friedman makes obvious the limitations of claims 1-9, 11, 13-24, 27, 32, 34, 50, 52, 53, 55, and 80 but does not disclose wherein the composition comprises C10-C30 cholesterol/lanosterol esters.
However, Revolution discloses a tinted lip balm comprising C10-C30 cholesterol/lanosterol esters and teaches that C10-30 Cholesterol/Lanosterol Esters, aka Super Sterol Liquid is an extremely efficient emollient that can repair dry hands or cracked lips and is great at maintaining a healthy skin barrier (Ingredients Explained, C10-30 Cholesterol/Lanosterol Esters).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Friedman discloses wherein the composition comprises emollients in amounts from about 10% to about 90%. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated C10-C30 cholesterol/lanosterol esters into the composition of Friedman since they are known and effective emollients as taught by Revolution.
Response to Applicant’s Arguments
With regard to the rejection of claim 39 under 35 U.S.C. 103 as being unpatentable over Friedman et al., (US 2010/0189761 A1, July 29, 2010) (hereinafter Friedman) in view of Revolution (Good Vibes Lip Balm, Dec. 29, 2019) (hereinafter Revolution):
Applicant argues that Revolution fails to remedy the deficiencies of Friedman. Applicant’s argument has been fully considered but found not to be persuasive because Applicant’s arguments against Friedman were unpersuasive.
For the foregoing reasons the rejection is maintained.
This rejection is modified from the previous Office Action in view of the amendments to the claims.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al., (US 2010/0189761 A1, July 29, 2010) (hereinafter Friedman) in view of Nurlaily et al., (Comparative Antioxidant and Anti-inflammatory Activity of Different Extracts of Centella asiatica (L.) Urban and Its Active Compounds, Asiaticoside and Madecassoside, January 2012) (hereinafter Nurlaily).
As discussed above, Friedman makes obvious the limitations of claims 1-9, 11, 13-24, 27, 32, 34, 50, 52, 53, 55, and 80 but does not disclose wherein the composition comprises madecassoside.
However, Nurlaily teaches madecassoside and asiaticoside are bioactive compounds of Centella asiatica (CA) and showed considerable antioxidant activity (Abstract). Centella asiatica is a medicinal herb used in Ayurvedic and Chinese traditional medicines to treat various ailments such as wounds, ulcer and leprosy (page 64, first and second column).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Friedman discloses wherein the composition comprises antioxidants. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated madecassoside into the composition of Friedman since it is a known and effective antioxidant as taught by Nurlaily.
Response to Applicant’s Arguments
With regard to the rejection of claim 41 under 35 U.S.C. 103 as being unpatentable over Friedman et al., (US 2010/0189761 A1, July 29, 2010) (hereinafter Friedman) in view of Nurlaily et al., (Comparative Antioxidant and Anti-inflammatory Activity of Different Extracts of Centella asiatica (L.) Urban and Its Active Compounds, Asiaticoside and Madecassoside, January 2012) (hereinafter Nurlaily):
Applicant argues that Nurlaily fails to remedy the deficiencies of Friedman. Applicant’s argument has been fully considered but found not to be persuasive because Applicant’s arguments against Friedman were unpersuasive.
For the foregoing reasons the rejection is modified and maintained.
New Claim Rejections - 35 USC § 103
This is a new claim rejection in view of the amendments to the claims.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al., (US 2010/0189761 A1, July 29, 2010) (hereinafter Friedman) in view of Becker et al., (Safety Assessment of Dimethicone Crosspolymers as Used in Cosmetics, May 26, 2014) (hereinafter Becker).
As discussed above, Friedman makes obvious the limitations of claims 11-9, 11, 13-24, 27, 32, 34, 50, 52, 53, 55, and 80 but does not disclose wherein the silicone agent further comprises dimethicone/polyethylene glycol (PEG)-10/15 crosspolymer or lauryl PEG-9 polydimethylsiloxyethyl dimethicone.
However, Becker teaches 62 dimethicone crosspolymers that function as emollient skin-conditioning agents, including dimethicone/PEG-10/15 crosspolymer (Introduction, page 1). Dimethicone/PEG-10/15 crosspolymer is a copolymer of dimethicone cross-linked with a mixture of PEG-10 and PEG-15 diallyl ethers. Dimethicone/PEG-10/15 crosspolymer also function as an emulsion stabilizer and viscosity-increasing agent (Table 1, page 68). Dimethicone/PEG-10/15 crosspolymer is suitable for use as a leave-on product (First column, page 102). Dimethicone crosspolymers are typically supplied as swollen gels that contain various oils (e.g., silicone oils such as dimethicone) (i.e., silicone agent further comprises dimethicone/PEG-10/15 crosspolymer) (Summary, page 110).
As discussed above, Friedman discloses emulsions comprising dimethicone as an emollient, and further comprising emulsion stabilizers, and thickening agents. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the dimethicone (i.e., silicone agent) further comprising dimethicone/PEG-10/15 crosspolymer since Dimethicone/PEG-10/15 crosspolymer containing dimethicone oils function as emollient skin-conditioning agents with emulsion stabilizing and thickening properties as taught by Becker. One would have a reasonable expectation of success since Friedman teaches that emollients may also be mixtures of PEG and dimethicone.
Claim 81 is rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al., (US 2010/0189761 A1, July 29, 2010) (hereinafter Friedman) in view of Zhang (US 2007/0172436 A1, July 26, 2007) (cited by applicant on IDS 03/21/2023) (hereinafter Zhang) in view of Albrecht (US 2018/0071190 A1, March 15, 2018) (hereinafter Albrecht) in view of Maruyama (US 2019/0336421 A1, Nov 7, 2019) (hereinafter Maruyama) in view of Revolution (Good Vibes Lip Balm, Dec. 29, 2019) (hereinafter Revolution) in view of Nurlaily et al., (Comparative Antioxidant and Anti-inflammatory Activity of Different Extracts of Centella asiatica (L.) Urban and Its Active Compounds, Asiaticoside and Madecassoside, January 2012) (hereinafter Nurlaily) in view of Becker et al., (Safety Assessment of Dimethicone Crosspolymers as Used in Cosmetics, May 26, 2014) (hereinafter Becker) and further in view of Polla et al., (US20100015072A1, Jan. 21, 2010) (hereinafter Polla) and further in view of Shah et al., (US20150352016A1, Dec. 10, 2015) (hereinafter Shah).
The teachings of Friedman, Zhang, Albrecht, Maruyama, Revolution, Nurlaily, and Becker are discussed above but the combined teachings do not disclose wherein the composition comprises 4% by weight lauryl PEG-9 polydimethylsiloxyethyl dimethicone or 10% by weight C12-15 alkyl benzoate.
However, Polla discloses topical compositions for treating keratinous surfaces (Abstract). The composition may be an emulsion comprising silicone surfactants in an amount from about 0.001 to 30% ([0073]). Examples of silicone surfactants lauryl PEG-9 polydimethylsiloxyethyl dimethicone ([0079]). The composition may comprise urea ([0089]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As discussed above, Friedman discloses wherein the composition may comprise surfactants. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated lauryl PEG-9 polydimethylsiloxyethyl dimethicone in an amount from about 0.001 to 30% into the emulsion of Friedman since this is a known and effective surfactant and amount for topical compositions as taught by Polla.
The combined teachings do not disclose 10% by weight C12-15 alkyl benzoate.
However, Shah discloses a meta-stable emulsion used for protecting a keratinous substrate (Abstract) also suitable for treating keratinous tissue (0129]). The composition includes an active ingredient such as an emollient ([0079]). Suitable emollients include C12-15 alkyl benzoate ([0085]) present at a concentration of, by weight of the entire composition, between about 1.0% and about 30% ([0086]). The composition may comprise urea and hydroxyethyl urea ([0090]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As discussed above, Friedman discloses wherein the composition may comprise mixtures of emollients. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated C12-15 alkyl benzoate in an amount between about 1.0% and about 30% into the emulsion of Friedman since this is a known and effective emollient and amount for topical compositions as taught by Shah.
Regarding the limitation of claim 81 wherein the composition comprises diglycerin, generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As discussed above, Friedman discloses wherein the composition may comprise polyols and thickening agents. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated diglycerin into the emulsion of Friedman since this is a known and effective polyol and thickening agent for topical compositions as taught by Zhang.
In regard to the claimed amount of diglycerin and pinus pinaster bark extract, as discussed above, Maruyama teaches pinus pinaster (bark extract) for use as an antioxidant and Zhang teaches diglycerin may be used as a thickener. Accordingly, one of ordinary skill in the art would have arrived at the claimed amount of 1% by weight of diglycerin and pinus pinaster bark extract through routine experimentation depending on the desired level of antioxidant activity and desired thickness of the composition, as taught by Maruyama and Zhang. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
Regarding the claimed amount of madecassoside/asiaticoside, as discussed above, Nurlaily teaches madecassoside and asiaticoside for use as an antioxidant. Accordingly, one of ordinary skill in the art would have arrived at the claimed amount of 0.1% by weight madecassoside/asiaticoside through routine experimentation depending on the desired level of antioxidant activity. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
Regarding the claimed amount of , as discussed above, the composition of Friedman comprises emollients such as dimethicones in amounts from about 10% to about 90%. Accordingly, it would have been obvious to one of ordinary skill in the art to formulate the composition of Friedman in view of Becker comprising from about 10% to about 90% of Dimethicone/PEG-10/15 crosspolymer in dimethicone oil since this it is suitable for use as a skin conditioning emollient as taught by Becker.
Regarding the claimed weight of retinol and glycine soja (soybean) oil, as discussed above, Friedman teaches that retinol may be included from about 1% to about 60% and the use of soybean oil in a mixture of emollient agents. Accordingly, one of ordinary skill in the art would have selected an amount of retinol according to the range disclosed by Friedman and an amount of soybean oil through routine experimentation depending on the desired level of emollient activity, thus arriving at the claimed range of 3% by weight. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
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.
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/S.J.K./Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614