DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Remarks filed 12/5/2025.
Change of Examiner
The examiner assigned to the instant application has changed to Examiner Hagopian. Contact information is provided at the end of this Office 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 .
Status of the Claims
Claims 1 and 5 have been amended. Claims 3 and 11-20 are cancelled. No claims are newly added. Accordingly, claims 1, 2 and 4-10 remain pending in the application and are currently under examination.
Withdrawn Rejections
Applicant’s amendment renders the rejection of claims 1-20 under 35 USC 112(a) (enablement) moot. Specifically, the claims have been amended from the unenabled “method of treating...” to the enabled “method of exfoliating and moisturizing...”. Thus, said rejection has been withdrawn.
Applicant’s amendment renders the rejection of claims 3, 5, 16 and 18 under 35 USC 112(b) moot. Specifically, the claims have either been amended to remove the indefinite language or cancelled. Thus, said rejection has been withdrawn.
Applicant’s amendment renders the rejection of claims 12 and 13 under 35 USC 112(d) moot. Specifically, said claims have been cancelled. Thus, said rejection has been withdrawn.
Applicant’s amendment renders the rejection of claims 1, 2, 7, 8, 14, 15 and 20 under 35 USC 102 over Florence moot. Specifically, Florence does not teach the limitations from unrejected claims 3, 11 and 13 that have been incorporated into claim 1. Thus, said rejection has been withdrawn.
Applicant’s amendment renders the rejection of claims 1, 2, 7, 8, 12, 14, 15 and 20 under 35 USC 103 over Florence moot. Specifically, Florence does not teach the limitations from unrejected claims 3, 11 and 13 that have been incorporated into claim 1. Thus, said rejection has been withdrawn.
Applicant’s amendment renders the rejection of claims 1, 2, 5-11, 13-15 and 18-20 under 35 USC 103 over Mendoza in view of Florence moot. Specifically, Mendoza and Florence do not teach the limitations from unrejected claim 3 which have been incorporated into claim 1. Thus, said rejection has been withdrawn.
Applicant’s amendment renders the double patenting rejection of claims 1-8 and 14-20 over USPN 9,801,900 in view of Florence, Mendoza, Regimen Lab and Carle. Specifically, the limitations of unrejected claims 11 and 13 have been incorporated into independent claim 1. However, after further consideration, a new grounds of rejection is made over USPN 9,801,900 in view of Florence, Mendoza, Regimen Lab and Carle (see New Rejections below).
Applicant’s amendment renders the double patenting rejection of claims 1-2, 7-8, 11, 14-15 and 20 over USPN 8,858,455 in view of Florence. Specifically, the limitations of unrejected claims 3 and 13 have been incorporated into independent claim 1. Thus, said rejection has been withdrawn.
Applicant’s amendment renders the double patenting rejection of claims 1-3, 7-10, 13-16 and 20 over USPA 18/500,625 in view of Florence. Specifically, the limitations of unrejected claim 11 have been incorporated into independent claim 1. However, after further consideration, a new grounds of rejection is made over USPA 18/500,625 in view of Florence, Mendoza and Carle (see New Rejections below).
Maintained Rejections
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.
Claims 1, 2 and 4-10 stand rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0118176 A1 (Mendoza, R. et al) published 04/30/2015 in view of US 2012/0237540 A1 (Florence, T. et al) published 11/20/2012 and further in view of “Hydroxyacetophenone.” Regimen Lab, Available online 05/24/2022, regimenlab.com/blogs/skincare-encyclopedia/hydroxyacetophenone (hereinafter “Regimen Lab”) and US 2020/0297600 A1 (Carle, T. et al) published 09/24/2020.
The instant claims are drawn to a method of exfoliating and moisturizing skin, comprising: topically applying to the skin of a subject a composition comprising: glycerin; butylene glycol; PEG-32; caprylyl glycol; and hydroxyacetophenone; and applying an additional moisturization agent to the skin, wherein the skin is exfoliated and moisturized.
Regarding instant claim 1, Mendoza teaches formulations which may be capable of moisturizing skin, treating the skin around the eyes, or cleansing the skin ([0006]). Mendoza teaches a moisturizer formulation comprising, in % concentration by weight, 2.5-5% glycerin, 1-3% butylene glycol, 0.08% allantoin, and 0.1% panthenol, among other ingredients; additionally, the composition comprises PEG-100 stearate in a concentration of 0.7-0.8%, and it is noted that, to modify the rheological properties of the composition, the amount of water can be varied so long as the amount of water is preferably 35-85% w/w (p. 10 [0071]; Table 1). Mendoza teaches its cream can include one, a combination, or all of ingredients from a list that includes caprylyl glycol ([0031]). Mendoza exemplifies the use of caprylyl glycol in another moisturizer formulation ([0071]; p. 10 Table 2). The amounts for glycerin and butylene glycol in the moisturizer fall within or overlap the amounts for these ingredients recited in instant claim 2. Additionally, the presence of allantoin and panthenol in the moisturizer read on the limitations of instant claim 5, and their % concentrations in the moisturizer fall within the claimed amount ranges for these ingredients recited in instant claim 6. The preferred amount for water overlaps, and thus renders obvious, the recited amount range for water in instant claim 7.
Mendoza contemplates that the moisturizer composition can be used as a leave-on product, which is topically applied to skin and remains for a period of time ([0016]). This reads on the method of exfoliating and moisturizing skin, comprising topically applying a composition to the skin of a subject, as is the method step of instant claim 1; the leave-on nature of the moisturizer reads on instant claim 9. Mendoza teaches the moisturizer can be used to moisturize, maintain, and improve the health of skin; typically, this moisturizer is formulated as an oil-in-water emulsion ([0030]). An oil-in-water emulsion reads on the limitation of the composition in instant claim 8. Additionally, the fact that the composition moisturizes the skin reads on the method of moisturizing the skin as recited in instant claim 1, and more specifically reads on the intended result of the method recited in instant claim 10 (“the method is to increase moisturization of the skin and wherein an effective amount of the composition promotes moisturization by increasing hydration of the skin”).
Mendoza teaches that both PEG-100 stearate and PEG-32 stearate are moisturizing agents ([0043] and [0044] at right col. 10-11 lines from the bottom).
Mendoza teaches additional moisturizing compositions besides the moisturizer described above, including a topical skin composition capable of moisturizing skin and treating skin around the eyes, a topical skin composition formulated as a cream with sun protection factor of around 30, and a topical skin composition formulated as a cream capable of reducing the appearance of dark circles or puffy eyes ([0007]-[0009]). Mendoza teaches the formulations can be used individually, or in combination ([0003]). Mendoza teaches that when the formulations are used in combination, additional benefits can be obtained ([0006]).
Mendoza differs from the instantly claimed invention in that it fails to teach the composition includes PEG-32, as is recited in the method of instant claim 1. Therefore, Mendoza fails to teach a % concentration by weight for PEG-32 in the composition, as is recited in instant claim 2. Additionally, Mendoza fails to teach the method of applying an additional moisturizing agent, as is recited in instant claim 1. Finally, Mendoza fails to teach the method is to exfoliate the skin, as is recited in instant claim 1.
Florence teaches a particular combination of ingredients that synergistically work on all skin-types ranging from normal skin, dry skin, oily skin and combination skin ([0006]). Florence teaches effective formulations which can be used as vehicles for these combinations ([0009]). Florence exemplifies a formulation comprising, in % concentration by weight, q.s. water, 3-5% butylene glycol, 3-5% glycerin, and 3-5% PEG-32, along with 0.001-5% extracts (p. 18 Table 15).
Regarding the inclusion of PEG-32 in claim 1, it would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the PEG-100 stearate in the moisturizer of Mendoza with PEG-32, and arrive at the instantly-claimed invention. Per MPEP 2143 I(B), simple substitution of one known element for another to obtain predictable results is prima facie obvious. The moisturizer of Mendoza differed from the instantly claimed composition by substitution of the PEG-100 stearate with PEG-32 stearate. PEG-32 stearate was also known in the art at the time of the invention to be a moisturizing agent, akin to PEG-100 stearate, within topical skin compositions. One of ordinary skill in the art would have predicted that substitution of the PEG-100 stearate with PEG-32 stearate in the invention of Mendoza would result in a composition with an equivalent skincare formulation capable of moisturizing the skin based on Florence’s demonstration that PEG-32 is effectively used in combination with similar ingredients to those in the moisturizer of Mendoza (glycerin and butylene glycol) in a topical skincare formulation.
Regarding the concentration of PEG-32 in instant claim 2, it would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to perform routine optimization on the amount of PEG-32 stearate in the moisturizer of Mendoza, with the goal of optimizing the moisturizing effects of the formulation when applied to skin, and arrive at a concentration of PEG-32 within the instantly claimed range. Per MPEP 2143 I(E), it is “obvious to try” choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. Mendoza teaches that PEG-32 stearate is a known moisturizing agent appropriate for use in topical skin formulations, and it is understood that the amount of moisturizing agent within a topical skin formulation is a routinely optimizable variable if there is a finite range of workable solutions. Florence teaches a finite concentration range for PEG-32 within a topical skin formulation (3-5% by weight) which is appropriate in combination with other ingredients glycerin and butylene glycol in the formulation. The ordinarily skilled artisan could have performed routine optimization on the amount of PEG-32 stearate in the moisturizer of Mendoza using the finite concentration range established by Florence and expect that any concentration of PEG-32 within 3-5% by weight of the composition will be appropriate in combination with at least the glycerin and butylene glycol present in Mendoza’s moisturizer.
Regarding the application of an additional moisturizing agent to the skin of the subject recited in instant claim 1, it would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to use more than one moisturizing formulation taught by Mendoza in combination with the moisturizer described above, and arrive at the instantly claimed invention. The ordinarily skilled artisan would have been motivated to do so because Mendoza teaches that when these formulations are used in combination, additional benefits can be obtained. The ordinarily skilled artisan would have a reasonable expectation of success using the moisturizer in combination with other moisturizing formulations taught by Mendoza because Mendoza teaches the formulations can be used in combination.
Regarding the intended result of exfoliation of the skin, it would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to not only perform Mendoza’s established method of applying its moisturizer (as modified by the teachings of Florence) to skin in order to moisturize the skin, but also to exfoliate the skin. The instant specification discloses that a combination of one or more of the key ingredients – glycerin, butylene glycol, and PEG-32 – can be used to hydrate and exfoliate the skin (emphasis added, instant specification [0037]). When the ordinarily skilled artisan would have been performing the obvious method step of applying the moisturizer of Mendoza (as modified by the teachings of Florence) to skin to moisturize the skin, it would have also become apparent that exfoliation is a necessary result of the method. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
The teachings of Mendoza and Florence differ from the instantly claimed invention in that they fail to include caprylyl glycol and hydroxyacetophenone in the composition, as recited in instant claim 1; therefore, these teachings fail to address the concentrations for these ingredients, as is recited in instant claim 4.
Regimen Lab teaches that hydroxyacetophenone is a multi-functional ingredient which acts as a preservative, anti-oxidant and soothing agent (“Regimen’s Take” p. 1). Regimen Lab teaches it is a common ingredient in cosmetics for these reasons, and is used at a maximum concentration of 5% in leave-on products with dermal exposure, more specifically at 0.23% in eye creams (“What is it used for?” p. 2).
Carle teaches a night cream formulation which comprises common ingredients with those of the moisturizer of Mendoza, including water, glycerin, butylene glycol, and PEG-100 stearate; additionally, the night cream comprises, in % concentration by weight, 0.2% caprylyl glycol and 0.5% hydroxyacetophenone ([0124]; p. 20 Table 17). Carle teaches the topical composition can contain 0.01 to 3% by weight of hydroxyacetophenone ([0018] R. Col. lines 13-18).
It would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to add caprylyl glycol to the moisturizer of Mendoza, at the specific concentration in the night cream taught by Carle (0.2 % concentration by weight), and arrive at the instant invention. The ordinarily skilled artisan would have been motivated to do so based on the explicit suggestion of Mendoza that caprylyl glycol be incorporated into its moisturizer cream. The ordinarily skilled artisan would have also noted the successful incorporation of caprylyl glycol into the night cream of Carle, at the concentration of 0.2%, and would have sought to incorporate caprylyl glycol into the moisturizer of Mendoza at this concentration in order to formulate a moisturizer similar to the night cream of Carle. The ordinarily skilled artisan would have a reasonable expectation of success incorporating caprylyl glycol into the moisturizer of Mendoza because Mendoza demonstrates that caprylyl glycol is appropriate for use in a moisturizing cream.
Additionally, it would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to add hydroxyacetophenone to the moisturizer of Mendoza and arrive at the instant invention. The ordinarily skilled artisan would have been motivated to do so based on Regimen Lab’s teaching that hydroxyacetophenone is a multi-functional ingredient which acts as a preservative, anti-oxidant and soothing agent in cosmetic formulations for application on skin. The ordinarily skilled artisan would find a reasonable expectation of success incorporating hydroxyacetophenone into the moisturizer of Mendoza because Regimen Lab teaches that hydroxyacetophenone is commonly incorporated into topical skincare compositions, and Carle demonstrates the incorporation of hydroxyacetophenone into a night cream which shares similar ingredients and a similar purpose with the moisturizer of Mendoza.
It would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to perform routine optimization on the amount of hydroxyacetophenone incorporated into the moisturizer of Mendoza, with the goal of optimizing the antioxidant, preservative, and soothing effects of the ingredient within the moisturizer formulation when applied to skin, and arrive at a concentration of hydroxyacetophenone within the instantly claimed range. Per MPEP 2143 I(E), it is “obvious to try” choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. Regimen Lab teaches that hydroxyacetophenone is a known antioxidant, preservative, and soothing agent appropriate for use in topical skin formulations, and it is understood that the amount of antioxidant, preservative, and soothing agent within a topical skin formulation is a routinely optimizable variable if there is a finite range of workable solutions. Carle teaches a finite concentration range for hydroxyacetophenone within a topical skin formulation (0.01 to 3% by weight) which is appropriate in combination with other ingredients glycerin and butylene glycol in a similar topical skincare formulation. The ordinarily skilled artisan could have performed routine optimization on the amount of hydroxyacetophenone in the moisturizer of Mendoza using the finite concentration range established by Carle and expect that any concentration of hydroxyacetophenone within 0.01 to 3% by weight of the composition will be appropriate in Mendoza’s moisturizer. This expectation of success is further confirmed by the teachings of Regimen Lab that hydroxyacetophenone can be used at a maximum concentration of 5% in leave-on products with dermal exposure.
Thus, the combined teachings of Mendoza, Florence, Regimen Lab and Carle render the instant claims prima facie obvious.
Response to Arguments
Applicant's arguments, filed 12/5/2025, regarding the 103 rejection over Mendoza, Florence, Regimen Lab and Carle have been fully considered but they are not persuasive.
Applicant argues that claim 1 has been amended to incorporate the subject matter of non-rejected claim 11, and claims 14-20 have been cancelled. Remarks, page 6.
In response, it is respectfully submitted that the rejection heading in the Office action dated 8/6/2025 recited, “Claims 3-4 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0118176 A1 (Mendoza, R. et al) published 04/30/2015 in view of US 2012/0237540 A1 (Florence, T. et al) published 11/20/2012, as applied to claims 1-2, 5-11, 13-15 and 18-20 above, and further in view of “Hydroxyacetophenone.” Regimen Lab, Available online 05/24/2022, regimenlab.com/blogs/skincare-encyclopedia/hydroxyacetophenone (hereinafter “Regimen Lab”) and US 2020/0297600 A1 (Carle, T. et al) published 09/24/2020”. Claim 11 was addressed in the rejection over Mendoza and Florence and, thus, was also applicable to the rejection over Mendoza, Florence, Regimen Lab and Carle. Furthermore, the rejection, at pages 13-14, stated,
Regarding the application of an additional moisturizing agent to the skin of the subject recited in instant claim 11, it would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to use more than one moisturizing formulation taught by Mendoza in combination with the moisturizer described above, and arrive at the instantly claimed invention. The ordinarily skilled artisan would have been motivated to do so because Mendoza teaches that when these formulations are used in combination, additional benefits can be obtained. The ordinarily skilled artisan would have a reasonable expectation of success using the moisturizer in combination with other moisturizing formulations taught by Mendoza because Mendoza teaches the formulations can be used in combination.
Due to the claim amendments, the rejection heading has been modified; however, the substance of the rejection remains the same.
Thus, for these reasons, Applicant’s arguments are found unpersuasive. The rejection is maintained.
New Rejections
Due to applicant’s claim amendment and after further consideration, the following rejections have been newly added:
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 4 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 4 recites the limitation "The method of claim 3" in the 1st line of the claim. There is insufficient antecedent basis for this limitation in the claim because claim 3 is a cancelled claim. For purposes of art and compact prosecution, the claim is being interpreted to depend from claim 1.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2 and 4-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-14 and 19 of U.S. Patent No. US 9,801,900 B2 (cited in PTO-892) in view of US 2012/0237540 A1 (Florence, T. et al) published 11/20/2012, US 2015/0118176 A1 (Mendoza, R. et al) published 04/30/2015, “Hydroxyacetophenone.” Regimen Lab, Available online 05/24/2022, regimenlab.com/blogs/skincare-encyclopedia/hydroxyacetophenone (hereinafter “Regimen Lab”) and US 2020/0297600 A1 (Carle, T. et al) published 09/24/2020.
The instant claims are described above.
US’900 claims a method of reducing CGRP production in skin cells and protecting skin from oxidative damage from free radicals comprising topically applying to skin in need thereof a composition comprising, among other ingredients: glycerin; butylene glycol; caprylyl glycol; and panthenol; and an effective amount of extract, wherein the composition is capable of reducing cytokine production, reducing CGRP production, and protecting skin from oxidative damage from free radicals, and wherein the skin is erythemic, sensitive, inflamed, dry, flaky, and/or itchy skin (claim 13). US’900 claims the composition further comprises between 80 to 90% by weight of water (claim 19). US’900 claims the amounts for the ingredients include 0.01-1% by weight of butylene glycol, 3-7% by weight of glycerin, 0.01 to 0.1% caprylyl glycol, and 0.005-0.1% by weight of panthenol (claim 14). These amounts for water, butylene glycol, glycerin, caprylyl glycol, and panthenol, either overlap or are so close to the instantly claimed concentrations for these ingredients recited in instant claims 2, 4 and 6, that they render these amounts prima facie obvious. See MPEP 2144.05 (I). Additionally, the method step of claim 1 is read upon.
The claims of US’900 differ from the instantly claimed invention in that they fail to claim inclusion of PEG-32, as recited in instant claim 1; additionally, they fail to claim the amount of PEG-32 recited in instant claim 2. Furthermore, they fail to claim the inclusion of hydroxyacetophenone, as recited in instant claim 1, and amounts thereof recited in instant claim 4. US’900 is silent to applying an additional moisturization agent to the skin recited in claim 1. They also fail to claim inclusion of allantoin, as recited in instant claim 5 and amounts thereof recited in instant claim 6. US’900 also fails to claim the composition form, as recited in instant claim 8.
Florence teaches a particular combination of ingredients that synergistically work on all skin-types ranging from normal skin, dry skin, oily skin and combination skin ([0006]). Florence teaches effective formulations which can be used as vehicles for these combinations ([0009]). Florence teaches these compositions can be a cream, lotion, gel, serum, oil-in-water emulsion, or a water-in-oil emulsion ([0018]). Florence exemplifies a formulation comprising, in % concentration by weight, q.s. water, 3-5% butylene glycol, 3-5% glycerin, and 3-5% PEG-32, along with 0.001-5% extracts (p. 18 Table 15). Florence teaches PEG-32 stearate to be a moisturizing agent (p. 12 R. Col. final line).
Mendoza teaches formulations which may be capable of moisturizing skin, treating the skin around the eyes, or cleansing the skin ([0006]). Mendoza teaches additional compositions besides the moisturizer described above, including a topical skin composition capable of moisturizing skin and treating skin around the eyes, a topical skin composition formulated as a cream with sun protection factor of around 30, and a topical skin composition formulated as a cream capable of reducing the appearance of dark circles or puffy eyes ([0007]-[0009]). Mendoza teaches the inclusion of antioxidants ([0045]). Mendoza teaches the formulations can be used individually, or in combination ([0003]). Mendoza teaches that when the formulations are used in combination, additional benefits can be obtained ([0006]). Mendoza teaches a moisturizer formulation comprising, in % concentration by weight, 2.5-5% glycerin, 1-3% butylene glycol, 0.08% allantoin, and 0.1% panthenol, among other ingredients, and the amount of water can be varied so long as the amount of water is preferably 35-85% w/w (p. 10 [0071]; Table 1).
Regimen Lab teaches that hydroxyacetophenone is a multi-functional ingredient which acts as a preservative, anti-oxidant and soothing agent (“Regimen’s Take” p. 1). Regimen Lab teaches it is a common ingredient in cosmetics for these reasons, and is used at a maximum concentration of 5% in leave-on products with dermal exposure, more specifically at 0.23% in eye creams (“What is it used for?” p. 2).
Carle teaches a night cream formulation which comprises common ingredients with those of the moisturizer of Mendoza, including water, glycerin, butylene glycol, and PEG-100 stearate; additionally, the night cream comprises, in % concentration by weight, 0.2% caprylyl glycol and 0.5% hydroxyacetophenone ([0124]; p. 20 Table 17). Carle teaches the topical composition can contain 0.01 to 3% by weight of hydroxyacetophenone ([0018] R. Col. lines 13-18).
Regarding the inclusion of PEG-32 at the claimed concentration, it would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to add PEG-32 at the amount exhibited by Florence to the topical skincare composition for reducing CGRP production of US’900, and arrive at the instantly-claimed invention. Per MPEP 2143 I(A), combination of prior art elements by known methods to yield predictable results is prima facie obvious. The composition for reducing CGRP production of US’900 differed from the instantly claimed composition by a lack of PEG-32. PEG-32 was known in the art at the time of the invention to be a moisturizing agent within topical skin compositions. One of ordinary skill in the art would have predicted that addition of PEG-32 stearate in the topical skin composition for reducing CGRP production of US’900 would result in a composition with an equivalent skincare formulation capable of moisturizing the skin in addition to providing reduction of CGRP production because Florence demonstrates this concentration of PEG-32 is effectively used in combination with similar ingredients to those in the composition of US’900 (at least glycerin and butylene glycol) in a topical skincare formulation.
Regarding the inclusion of hydroxyacetophenone, it would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to add hydroxyacetophenone to the topical skincare composition for reducing CGRP production of US’900 and arrive at the instant invention. The ordinarily skilled artisan would have been motivated to do so based on Regimen Lab’s teaching that hydroxyacetophenone is a multi-functional ingredient which acts as a preservative, anti-oxidant and soothing agent in cosmetic formulations for application on skin. The ordinarily skilled artisan would find a reasonable expectation of success incorporating hydroxyacetophenone into the topical skincare composition for reducing CGRP production of US’900 because Regimen Lab teaches that hydroxyacetophenone is commonly incorporated into topical skincare compositions.
It would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to perform routine optimization on the amount of hydroxyacetophenone incorporated into the topical skincare composition for reducing CGRP production of US’900, with the goal of optimizing the antioxidant, preservative, and soothing effects of the ingredient within the topical skincare composition for reducing CGRP production when applied to skin, and arrive at a concentration of hydroxyacetophenone within the instantly claimed range. Per MPEP 2143 I(E), it is “obvious to try” choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. Regimen Lab teaches that hydroxyacetophenone is a known antioxidant, preservative, and soothing agent appropriate for use in topical skin formulations, and it is understood that the amount of antioxidant, preservative, and soothing agent within a topical skin formulation is a routinely optimizable variable if there is a finite range of workable solutions. Carle teaches a finite concentration range for hydroxyacetophenone within a topical skin formulation (0.01 to 3% by weight) which is appropriate in combination with other ingredients glycerin and butylene glycol in a similar topical skincare formulation. The ordinarily skilled artisan could have performed routine optimization on the amount of hydroxyacetophenone in the topical skincare composition for reducing CGRP production of US’900 using the finite concentration range established by Carle and expect that any concentration of hydroxyacetophenone within 0.01 to 3% by weight of the composition will be appropriate in the composition. This expectation of success is further confirmed by the teachings of Regimen Lab that hydroxyacetophenone can be used at a maximum concentration of 5% in leave-on products with dermal exposure.
Regarding the application of an additional moisturizing agent to the skin of the subject, it would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to use a moisturizing formulation taught by Mendoza in combination with the composition described above, and arrive at the instantly claimed invention. The ordinarily skilled artisan would have been motivated to do so because Mendoza teaches that when multiple formulations are used in combination, additional benefits can be obtained. The ordinarily skilled artisan would have a reasonable expectation of success of using multiple topical formulations because Mendoza teaches the formulations can be used in combination and additional benefits can be obtained.
With regards to the limitation, “exfoliating and moisturizing the skin”, said limitation is interpreted as an intended result of the method of topically applying the composition to skin. When the ordinarily skilled artisan would have been performing the obvious method step of applying the moisturizer of Mendoza to skin to moisturize the skin, it would have also become apparent that exfoliation is another necessary result of the method. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Regarding the inclusion of allantoin at the claimed concentration, it would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to add allantoin to the topical skincare composition for reducing CGRP production of US’900 at the amount exhibited in the moisturizer of Mendoza, and arrive at the instantly-claimed invention. Per MPEP 2143 I(A), combination of prior art elements by known methods to yield predictable results is prima facie obvious. The composition for reducing CGRP production of US’900 differed from the instantly claimed composition by a lack of allantoin. Allantoin was known in the art at the time of the invention to be an ingredient beneficial in topical skin compositions, particularly the moisturizer of Mendoza. One of ordinary skill in the art would have predicted that addition of allantoin in the topical skin composition for reducing CGRP production of US’900 would result in a composition with an equivalent skincare formulation capable of moisturizing the skin in addition to providing reduction of CGRP production because Mendoza demonstrates its concentration of allantoin is effectively used in combination with similar ingredients to those in the composition of US’900 (at least glycerin and butylene glycol) in a topical skincare formulation.
Regarding the composition type, it would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to formulate the topical skincare composition for reducing CGRP production of US’900 into any one of a cream, lotion, gel, serum, oil-in-water emulsion, or a water-in-oil emulsion, and arrive at the instantly claimed invention. The ordinarily skilled artisan would have been motivated to do so because Florence teaches a highly similar formulation for application on skin which can be formulated into these composition types. The ordinarily skilled artisan would want to also formulate the topical skincare composition for reducing CGRP production of US’900 into one of these types for ease of application on skin. The ordinarily skilled artisan would have a reasonable expectation of success because Florence demonstrates that a highly similar formulation for application on skin can be formulated into these composition types.
Regarding the limitation, “the composition is topically applied to the skin and allowed to remain on the skin”, the patent states that the compositions disclosed can be used as a leave-on or a rinse-off composition (col. 7, lines 18-22). Accordingly, topical application as recited in the patented claims encompass leave-on embodiments. The examiner has relied upon the specification to delineate the scope of the invention embraced by the patent, consistent with the decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. U.S. Court of Appeals Federal Circuit, 95 USPQ2d 1797.
With regards to the limitation, “wherein the method is to increase moisturization of the skin and wherein an effective amount of the composition promotes moisturization by increasing hydration of the skin”, said limitation is interpreted as an intended result of the claimed method. A “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited” (MPEP 2111.04(I)).
Thus, the instant claims are unpatentable over the patented claims in view of Florence, Mendoza, Regimen Lab and Carle.
Claims 1, 2 and 4-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8-16 and 18-22 of copending Application No. 18/500,625 in view of US 2012/0237540 A1 (Florence, T. et al) published 11/20/2012, US 2015/0118176 A1 (Mendoza, R. et al) published 04/30/2015 and US 2020/0297600 A1 (Carle, T. et al) published 09/24/2020.
The instant claims are described above.
App’625 claims a method of moisturizing skin comprising topically applying to the skin of a subject a composition comprising: glycerin; dimethicone; and hydroxyacetophenone; wherein the skin is moisturized (Claim 1). App’625 claims the composition comprises 3-7% by weight glycerin and 0.1% to 0.5% by weight of hydroxyacetophenone (Claim 2). App’625 claims the composition further comprises caprylyl glycol (Claim 3). App’625 claims the composition also further comprises butylene glycol (Claim 7). App’625 claims the method wherein the composition is an emulsion, solution, serum, gel, gel emulsion, gel serum, lotion, cream, or ointment (Claim 9). App’625 claims the method wherein the composition is topically applied and allowed to remain on skin (Claim 10). The composition further comprises 60-95% by weight of water (Claim 20). These claims read on the composition and method of instant claim 1, with the amounts for glycerin and hydroxyacetophenone recited in instant claim 2 as well as the amounts for water recited in instant claim 7. These claims also read on the incorporation of caprylyl glycol as recited in instant claim 1. Additionally, claims 8, 9 and 10 are read upon by the claims.
App’625 differs from the instantly claimed invention in that it fails to claim an amount for butylene glycol as recited in instant claim 2. App’625 fails to claim incorporation of PEG-32, as recited in instant claim 1, as well as the amounts for PEG-32 recited in instant claim 2. App’25 is silent to the step of “applying an additional moisturization agent to the skin” recited in instant claim 1. App’625 also fails to address the method is to exfoliate the skin, as recited in instant claim 1. App’625 is silent to the amounts of caprylyl glycol as recited in claim 4 as well as the inclusion of panthenol and allantoin and amounts thereof (instant claims 5-6).
Florence teaches a particular combination of ingredients that synergistically work on all skin-types ranging from normal skin, dry skin, oily skin and combination skin ([0006]). Florence teaches effective formulations which can be used as vehicles for these combinations ([0009]). Florence exemplifies a formulation comprising, in % concentration by weight, q.s. water, 3-5% butylene glycol, 3-5% glycerin, and 3-5% PEG-32, along with 0.001-5% extracts (p. 18 Table 15).
Mendoza teaches formulations which may be capable of moisturizing skin, treating the skin around the eyes, or cleansing the skin ([0006]). Mendoza teaches a moisturizer formulation comprising, in % concentration by weight, 2.5-5% glycerin, 1-3% butylene glycol, 0.08% allantoin, and 0.1% panthenol, among other ingredients, and the amount of water can be varied so long as the amount of water is preferably 35-85% w/w (p. 10 [0071]; Table 1). Mendoza teaches additional moisturizing compositions and said the compositions can be used individually, or in combination ([0003] and [0007]-[0009]). Mendoza teaches that when the formulations are used in combination, additional benefits can be obtained ([0006]).
Carle teaches a night cream formulation which comprises common ingredients with those of the moisturizer of Mendoza, including water, glycerin, butylene glycol, and PEG-100 stearate; additionally, the night cream comprises, in % concentration by weight, 0.2% caprylyl glycol and 0.5% hydroxyacetophenone ([0124]; p. 20 Table 17). Carle teaches the topical composition can contain 0.01 to 3% by weight of hydroxyacetophenone ([0018] R. Col. lines 13-18).
Regarding the concentration of butylene glycol, it would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to use the concentration of butylene glycol demonstrated by Florence in the composition of App’625, and arrive at the instantly claimed concentration range for butylene glycol. Per MPEP 2143 I(A), combination of prior art elements by known methods to yield predictable results is prima facie obvious. The composition of App’625 differed from the instantly claimed composition by failing to address a concentration for butylene glycol within its composition. Butylene glycol was known in the art at the time of the invention to incorporated within topical skin compositions alongside glycerin, particularly in the composition of Florence. One of ordinary skill in the art would have predicted that use of Florence’s taught concentration of butylene glycol in the composition of App’625 would result in a composition with an equivalent skincare formulation capable of moisturizing the skin based on Florence’s demonstration that this concentration of butylene glycol is effectively used in combination with similar ingredients to those in the composition of App’625 (at least glycerin and water in similar concentrations) in a topical skincare formulation for all skin types.
Regarding the inclusion of PEG-32 at the claimed concentrations, it would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to add PEG-32 at the amount exhibited by Florence to the composition of App’625, and arrive at the instantly-claimed invention. Per MPEP 2143 I(A), combination of prior art elements by known methods to yield predictable results is prima facie obvious. The composition of App’625 differed from the instantly claimed composition by a lack of PEG-32. PEG-32 was known in the art at the time of the invention to be a moisturizing agent within topical skin compositions. One of ordinary skill in the art would have predicted that addition of PEG-32 stearate in the composition of App’625 (which is used to moisturize skin) would result in a composition with an equivalent skincare formulation capable of moisturizing the skin based on Florence’s demonstration that this concentration of PEG-32 is effectively used in combination with similar ingredients to those in the composition of App’625 (at least glycerin and butylene glycol) in a topical skincare formulation for the purpose of moisturizing the skin.
Regarding the application of an additional moisturizing agent to the skin of the subject, it would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to use a moisturizing formulation taught by Mendoza in combination with the composition described above, and arrive at the instantly claimed invention. The ordinarily skilled artisan would have been motivated to do so because Mendoza teaches that when multiple formulations are used in combination, additional benefits can be obtained. The ordinarily skilled artisan would have a reasonable expectation of success of using multiple topical formulations because Mendoza teaches the formulations can be used in combination and additional benefits can be obtained.
With regards to the limitation, “exfoliating”, said limitation is interpreted as an intended result of the method of topically applying the composition to skin. When the ordinarily skilled artisan would have been performing the method steps of applying the composition and moisturizer to skin to moisturize the skin, it would have also become apparent that exfoliation is another necessary result of the method. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Regarding the inclusion of allantoin and panthenol at the claimed concentrations, it would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to add allantoin and panthenol to the topical skincare composition of the copending application at the amounts exhibited in the moisturizer of Mendoza, and arrive at the instantly-claimed invention. Per MPEP 2143 I(A), combination of prior art elements by known methods to yield predictable results is prima facie obvious. The composition for moisturizing skin of the copending application differed from the instantly claimed composition by a lack of allantoin and panthenol. Allantoin and panthenol were known in the art at the time of the invention to be beneficial ingredients in topical skin compositions, particularly the moisturizer of Mendoza. One of ordinary skill in the art would have predicted that addition of allantoin and panthenol in the topical skin composition for moisturizing skin of the copending application would result in a composition with an equivalent skincare formulation capable of moisturizing the skin because Mendoza demonstrates its concentrations of allantoin and panthenol are effectively used in combination with similar ingredients to those in the composition of the copending application in a topical skincare formulation.
With regards to the limitation, “wherein the method is to increase moisturization of the skin and wherein an effective amount of the composition promotes moisturization by increasing hydration of the skin” (instant claim 10), said limitation is interpreted as an intended result of the claimed method. A “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited” (MPEP 2111.04(I)).
Thus, the instant claims are unpatentable over the copending claims in view of Florence, Mendoza and Carle.
This is a provisional nonstatutory double patenting rejection.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617
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