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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/07/2026 has been entered.
Status of the Claims
Claims 21-23 have been cancelled in a previous communication. Claims 3-4 and 17-18 have been cancelled. Claims 1-2, 5-16, 19-20 and 24-25 are pending. Claims 1-2, and 5-11 are withdrawn without traverse.
Claims 12-16, 20 and 24-25 are currently under examination.
All rejections not reiterated have been withdrawn.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 12, 15-16, 19-20 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (KR20060124927A, Published 12/06/2006) in view of Shefer et al. (US20030232091A1, Published 12/18/2003) as evidenced by Grice et al (Journal of Investigative Dermatology, Volume 57, Issue 2, Published 1971, Pages 108-110).
Applicant’s Invention
The claims are drawn to a method of delivering cosmetically active agents to the skin comprising: providing a dissolvable film comprising a water-soluble film material comprising a polysaccharide; 15-30% by weight of retinol or a retinol derivative relative to the total weight of the film and 1-7% by weight of ascorbic acid or an ascorbic acid derivative relative to the total weight of the film and dispersed throughout the film; and at least 10% by weight water relative to the total weight of the film; wetting the film; and applying the wetted dissolvable film on the skin for a sufficient time to release at least a portion of the active agents.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 12, 15-16, and 25 Kim teaches accordingly, the present invention provides a water-soluble film (i.e., dissolvable film) for skin care and wound treatment, which can be slowly dissolved by moisture of the skin when being adhered to the skin, so that a skin care agent (i.e., cosmetically active agents) or a therapeutic drug can be quickly delivered into the skin (paragraph 8). Kim also teaches 0.01-20 wt % of at least one natural polymeric material selected from the group consisting of agar, carrageenan, alginate, chitosan, chitosan derivatives, starch, pullulan (i.e., polysaccharide film material) and 0.1 to 10% by weight of at least one skin affinity enhancer selected from the group consisting of retinol, vitamin C (i.e., ascorbic acid), and vitamin C derivative (paragraphs 12-13). Kim further teaches the method of manufacturing the water-soluble film mixing at least one synthetic polymer material, 8-98.76 wt% water, and at least one natural polymer material (i.e., polysaccharide film material) then adding at least one skin affinity enhancer (i.e., retinol and vitamin C), then molding the solution to a predetermined size having a thickness of 2-3,000 μm (paragraphs 20-22).
Regarding claim 20, Kim teaches functional additives may include tween 80 (i.e., surfactant) (paragraph 36). Kim further teaches vitamin A and vitamin E (i.e., vitamins)(paragraph 13).
Regarding claim 24, Kim teaches a water-soluble film (i.e., dissolvable film) for skin care and wound treatment, which can be slowly dissolved by moisture of the skin when being adhered to the skin (paragraph 8). As evidenced by Grice, skin temperature changes ranging from 25°-39°C were obtained in 17 subjects (abstract). Therefore, the limitation of claim 24, wherein the dissolvable film dissolves in water, the water having a temperature less than or equal to 30°C, is inherently met because Kim teaches that the film is dissolved by the moisture of the skin (i.e., water) and it would be expected that the temperature of the moisture of the skin would be no more than the temperature of the skin.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Kim does not teach 15-30% by weight of retinol or a retinol derivative relative to the total weight of the film. However this deficiency is cured by Shefer et al.
In the analogous art of delivering a cosmetic, dermatological, and pharmaceutical active ingredient, Shefer teaches a method to stabilize retinol in cosmetic, dermatological, and pharmaceutical compositions. The present invention provides a controlled release system comprising stable retinol which targets biological surfaces of various tissues. The present invention also provides a controlled release system comprising stable retinol which sustains the release of retinol, and enables a gradual and prolonged release of effective levels of retinol and other cosmetic, dermatological, and pharmaceutical active ingredients (paragraph [0066]). Shefer continues to teach retinol can be present in an amount in the range of about 0.01% to about 50% by weight of the composition and can be stabilized indefinitely (paragraph [0086]). Shefer also teaches various vitamins can be included in the controlled release system for stabilizing retinol of the present invention. For example, vitamin A and derivatives thereof, vitamin B 2, biotin, pantothenic acid, vitamin K, vitamin D, vitamin E and mixtures thereof can be used (paragraph [0095]). Shefer further teaches many studies have been conducted to stabilize retinol in a cosmetic composition. In particular, there has been proposed an oil-in-water type (O/W type) emulsion wherein retinol is stabilized by an antioxidant such as BHT (butylated hydroxytoluene), BHA (butylated hydroxyanisole), tocopherol and its derivatives, ascorbic acid (vitamin C) and citric acid (paragraph [0018]). Shefer also teaches Skin barrier repair actives are those skin care actives which can help repair and replenish the natural moisture barrier function of the epidermis and can be included in the controlled release system for stabilizing retinol of the present invention sch as ascorbic acid (paragraph [0105]).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use the method of delivering cosmetically active agents to the skin comprising: providing a dissolvable film comprising a water-soluble film material comprising a polysaccharide; 15-30% by weight of retinol or a retinol derivative relative to the total weight of the film and 1-7% by weight of ascorbic acid or an ascorbic acid derivative relative to the total weight of the film and dispersed throughout the film; and at least 10% by weight water relative to the total weight of the film; wetting the film; and applying the wetted dissolvable film on the skin for a sufficient time to release at least a portion of the active agents because Kim teaches and contemplates all the elements required to deliver cosmetically active agents to the skin. The examiner points out that the end results of Kim’s method of delivering cosmetically active agents and Applicants methods of delivering cosmetically active agents would be the same, wherein the dissolvable film is placed on the skin for a sufficient time to release at least a portion of the active agents. This would have been obvious and would have been expected to exhibit the same properties, absent unexpected results. The order of steps, namely applying the dissolvable film onto the skin before wetting the film to release at least a portion of the active agents versus wetting the film and then applying the film onto the skin would be prima facie obvious to one of ordinary skill in the art in the absence of unexpected results. Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.). See MPEP 2144.04 (IV)(C).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have 15-30% by weight of retinol or a retinol derivative relative to the total weight of the film in Kim’s water-soluble film (i.e., dissolvable film) for skin care and wound treatment. Kim teaches that 0.1 to 10% by weight of at least one skin affinity enhancer selected from the group consisting of retinol, vitamin C (i.e., ascorbic acid), and vitamin C derivative (paragraphs 12-13). One would have understood in view of Shefer that a stabilized retinol composition can comprise retinol in an amount in the range of about 0.01% to about 50% by weight of the composition and can be stabilized indefinitely (paragraph [0086]) wherein various vitamins can be included in the controlled release system for stabilizing retinol, such as vitamin A and derivatives thereof, vitamin E and mixtures thereof can be used (paragraph [0095]). Shefer further teaches many studies have been conducted to stabilize retinol in a cosmetic composition, wherein retinol is stabilized by an antioxidant such as tocopherol and its derivatives, ascorbic acid (vitamin C) and citric acid (paragraph [0018]). Shefer also teaches skin barrier repair actives are those skin care actives which can help repair and replenish the natural moisture barrier function of the epidermis and can be included in the controlled release system for stabilizing retinol of the present invention sch as ascorbic acid (paragraph [0105]). It would have been obvious to one of ordinary skill in the art to have 15-30% by weight of retinol or a retinol derivative relative to the total weight of the film in Kim’s water-soluble film (i.e., dissolvable film) for skin care and wound treatment because Kim teaches 0.1 to 10% by weight of at least one skin affinity enhancer selected from the group consisting of retinol, vitamin C (i.e., ascorbic acid), and vitamin C derivative, vitamin E (i.e., tocopherol) (paragraphs 12-13) and Shefer teaches that a stabilized retinol composition can comprise retinol in the amount of 0.01% to about 50% by weight of the composition and can be stabilized indefinitely (paragraph [0086]), wherein retinol can be stabilized by components such as ascorbic acid, vitamin E. Therefore, it would be suitable for Kim’s water-soluble film (i.e., dissolvable film) for skin care and wound treatment to have higher amounts of retinol present and still be stabilized because Shefer teaches the presence of stabilizing components for retinol and Kim teaches the presence of these same stabilizing components in Kim’s water-soluble film (i.e., dissolvable film) for skin care and wound treatment. The Examiner also points out that it would have been obvious to one of ordinary skill in the art to optimize the amounts of the retinol and ascorbic acid because Kim teaches 0.1 to 10% by weight of at least one skin affinity enhancer and Shefer teaches a stabilized retinol composition can comprise retinol in the amount of 0.01% to about 50% by weight of the composition and can be stabilized indefinitely (paragraph [0086]), which can be used as a starting point for optimization. Determining optimal concentrations is routine experimentation and is practiced by one of ordinary skill. 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. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). See MPEP 2144.05(II). In addition, according to the MPEP, “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker.” (MPEP 716.07).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (KR20060124927A, Published 12/06/2006) in view of Shefer et al. (US20030232091A1, Published 12/18/2003) as evidenced by Grice et al (Journal of Investigative Dermatology, Volume 57, Issue 2, Published 1971, Pages 108-110) further in view of Yang et al. (KR20180069488A, Published 06/25/2018).
Applicant’s Invention
Kim and Shefer render obvious all of the limitations of instant claim 12. Applicant’s claim 13 further adds the limitation wherein the ascorbic acid derivative is selected from the group consisting of ascorbyl glucoside, alkylated ascorbic acid and an ascorbyl phosphate salt.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 13, Kim teaches the present invention provides a water-soluble film (i.e., dissolvable film) for skin care and wound treatment, which can be slowly dissolved by moisture of the skin when being adhered to the skin, so that a skin care agent (i.e., cosmetically active agents) or a therapeutic drug can be quickly delivered into the skin (paragraph 8). Kim also teaches 0.01-20 wt % of at least one natural polymeric material selected from the group consisting of agar, carrageenan, alginate, chitosan, chitosan derivatives, starch, pullulan (i.e., polysaccharide film material) and 0.1 to 10% by weight of at least one skin affinity enhancer selected from the group consisting of retinol, vitamin C (i.e., ascorbic acid), and vitamin C derivative (paragraphs 12-13). Kim further teaches the water-soluble film for skin care and wound treatment according to the present invention is a water-soluble film containing skin treatment and a skin care agent, and when attached to the skin, the water-soluble film can be dissolved even with a small amount of moisture (e.g. 1% moisture on the weight of the film), so that an active ingredient such as a skin affinity enhancer can be rapidly delivered to the skin in a large amount (paragraph 24).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Kim and Shefer do not teach the ascorbic acid derivative is selected from the group consisting of ascorbyl glucoside, alkylated ascorbic acid and an ascorbyl phosphate salt. However, this deficiency is cured by Yang et al.
In the analogous art of cosmetics, Yang teaches the cosmetic composition capable of promoting skin absorption by a soluble film (i.e., dissolvable film) containing speckles may be at least one selected from the group consisting of retinol, ascorbic acid, ascorbyl glucoside, and may include one or more active ingredients (paragraph 32).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have ascorbic acid derivative selected from the group consisting of ascorbyl glucoside, alkylated ascorbic acid and an ascorbyl phosphate salt in Kim’s water-soluble film. Kim teaches 0.1 to 10% by weight of at least one skin affinity enhancer selected from the group consisting of retinol, vitamin C (i.e., ascorbic acid), and vitamin C derivative (paragraphs 12-13), wherein the skin affinity enhancer is an active ingredient (paragraph 24). One would have understood in view of Yang that the cosmetic composition capable of promoting skin absorption by a soluble film (i.e., dissolvable film) containing speckles may be at least one selected from the group consisting of retinol, ascorbic acid, ascorbyl glucoside, and may include one or more active ingredients (paragraph 32). It would have been obvious to one of ordinary skill to have ascorbic acid derivative selected from the group consisting of ascorbyl glucoside, alkylated ascorbic acid and an ascorbyl phosphate salt in Kim’s water-soluble film because Yang teaches a cosmetic composition capable of promoting skin absorption by a soluble film can be ascorbic acid and ascorbyl glucoside, therefore ascorbic acid and ascorbyl glucoside (i.e., vitamin C derivative) are suitable for the purpose of promoting skin absorption such as Kim’s vitamin C (i.e., ascorbic acid) and vitamin C derivatives which are skin affinity enhancers. See MPEP 2144.07.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (KR20060124927A, Published 12/06/2006) in view of Shefer et al. (US20030232091A1, Published 12/18/2003) as evidenced by Grice et al (Journal of Investigative Dermatology, Volume 57, Issue 2, Published 1971, Pages 108-110) further in view of Batchvarova et al. (US20170087109A1, Published 03/30/2017).
Applicant’s Invention
Kim and Shefer renders obvious all of the limitations of instant claim 12. Applicant’s claim 14 further adds the limitation wherein the retinol derivative is selected from the group consisting of retinal, retinoic acid, a retinyl c2-c20 ester, and 13-cis-retinoic acid.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 14, Kim teaches the present invention provides a water-soluble film (i.e., dissolvable film) for skin care and wound treatment, which can be slowly dissolved by moisture of the skin when being adhered to the skin, so that a skin care agent (i.e., cosmetically active agents) or a therapeutic drug can be quickly delivered into the skin (paragraph 8). Kim also teaches 0.01-20 wt % of at least one natural polymeric material selected from the group consisting of agar, carrageenan, alginate, chitosan, chitosan derivatives, starch, pullulan (i.e., polysaccharide film material) and 0.1 to 10% by weight of at least one skin affinity enhancer selected from the group consisting of retinol, vitamin C (i.e., ascorbic acid), and vitamin C derivative (paragraphs 12-13). Kim further teaches the water-soluble film for skin care and wound treatment according to the present invention is a water-soluble film containing skin treatment and a skin care agent, and when attached to the skin, the water-soluble film can be dissolved even with a small amount of moisture (e.g. 1% moisture on the weight of the film), so that an active ingredient such as a skin affinity enhancer can be rapidly delivered to the skin in a large amount (paragraph 24).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Kim and Shefer do not teach retinol derivative is selected from the group consisting of retinal, retinoic acid, a retinyl c2-c20 ester, and 13-cis-retinoic acid. However this deficiency is cured by Batchvarova et al.
In the analogous art of cosmetics, Batchvarova teaches a leave-on composition for treating blackheads comprising a neutralized fatty acid and a substrate, wherein the substrate may be a dissolvable substrate such as a film (paragraph [0087-0088]). The leave on composition may further comprise cosmetically active agents (paragraph [0033]) such as retinoids which include, but are not limited to, retinol (Vitamin A alcohol), retinal (Vitamin A aldehyde), and isotretinoin (i.e., 13-cis-retinoic acid) (paragraph [0045]).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have retinol derivatives selected from retinal, retinoic acid, a retinyl c2-c20 ester, and 13-cis-retinoic acid in Kim’s dissolvable film. Kim teaches 0.1 to 10% by weight of at least one skin affinity enhancer selected from the group consisting of retinol (paragraph 13). One would have understood in view of Batchvarova that cosmetically active agents (paragraph [0033]) such as retinoids include, but are not limited to, retinol (Vitamin A alcohol), retinal (Vitamin A aldehyde), and isotretinoin (i.e., 13-cis-retinoic acid) (paragraph [0045]). It would have been obvious to one of ordinary skill to have retinol derivatives selected from retinal, retinoic acid, a retinyl c2-c20 ester, and 13-cis-retinoic acid in Kim’s dissolvable film because Batchvarova teaches retinoids which include, but are not limited to, retinol (Vitamin A alcohol), retinal (Vitamin A aldehyde), and isotretinoin (i.e., 13-cis-retinoic acid) (paragraph [0045]), therefore retinal (Vitamin A aldehyde), and isotretinoin (i.e., 13-cis-retinoic acid) (paragraph [0045]) are types of retinol derivatives. See MPEP 2144.07.
Response to Arguments
Applicant’s arguments, filed 01/07/2026, with respect to the rejection(s) of claim(s) under 35 USC 103 have been fully considered and are persuasive in view of the amendment to the claims. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made as set forth above.
Conclusion
No claims are allowed.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
AFUA BAMFOAA BOATENGExaminer, Art Unit 1617
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