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 .
Status of the Claims
Claims 21-23 have been cancelled in a previous communication. Claims 1-20 and 24-25 are pending. Claims 1-11 are withdrawn without traverse.
Claims 12-20 and 24-25 are currently under examination.
All rejections not reiterated have been withdrawn.
Claim Objections
Claim 12 is objected to because of the following informalities: The claim recites “the skin” in line 1. The examiner suggest amending the claim to recite “skin” rather than “the skin” in line 1. Appropriate correction is required.
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.
Claims 15-16 are 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 15 recites the limitation "the water-soluble polysaccharide-based material" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites “polysaccharide-based material”. The word “based” renders the claim indefinite because it is unclear the extent to which the film material must resemble a polysaccharide in order to fall within the scope of the claims.
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, 15-20 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (KR20060124927A, Published 12/06/2006) 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; retinol or a retinol derivative and ascorbic acid or an ascorbic acid derivative dispersed throughout the film; and at least 10% water; 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, 15-18, 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 disclose a single embodiment or example where every limitation recited in the instant claims is taught.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The claims are considered prima facie obvious to one of ordinary skill in the art at the time of filing because Kim teaches all of the claimed elements. It would have been prima facie obvious to one of ordinary skill 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; retinol or a retinol derivative and ascorbic acid or an ascorbic acid derivative dispersed throughout the film; and at least 10% water; 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).
With regards to claims 17-19, wherein the retinol is present in an amount ranging from 5 to 30 wt %, the ascorbic acid is present in an amount ranging from 1 to 7 wt%, and wherein the retinol and ascorbic acid are present in a weight to weight ratio ranging from 2 to 40, it would have been obvious to one of ordinary skill in the art to optimize the amounts of the retinol and the ascorbic acid depending on the desired results. One would have understood in view of Kim 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). Therefore, 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 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) as evidenced by Grice et al (Journal of Investigative Dermatology, Volume 57, Issue 2, Published 1971, Pages 108-110) in view of Yang et al. (KR20180069488A, Published 06/25/2018).
Applicant’s Invention
Kim 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 does 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) as evidenced by Grice et al (Journal of Investigative Dermatology, Volume 57, Issue 2, Published 1971, Pages 108-110) in view of Batchvarova et al. (US20170087109A1, Published 03/30/2017).
Applicant’s Invention
Kim 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)
Km does 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 07/25/2025, 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.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AFUA BAMFOAA BOATENG whose telephone number is (703)756-1358. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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AFUA BAMFOAA BOATENGExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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