Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
The Examiner acknowledges receipt of Applicants’ Response filed 30 September 2025. claims 1 - 3 and 5 - 7 with the instant application according to 37 CFR § 1.114, on 2 June 2025. Applicants amended claim 1 therein. Claim 7 remains withdrawn as being directed to a non-elected invention. Consequently, claims 1, 3, and 5 remain available for active consideration.
REJECTIONS WITHDRAWN
Rejections Pursuant to 35 U.S.C. § 103
The obviousness rejection set forth in the Action of 30 June 2025 is hereby withdrawn in light of Applicants’ amendment to claim 1, and in favor of the new grounds of rejection set forth below.
NEW GROUNDS OF REJECTION
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 that 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 3, and 5 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 2014/0120144 A1 to Abe, K., et al., published 1 May 2014 (“Abe ‘144”), in view of FR 3052069 B1 to Deyzac, D., et al., filed 1 June 2016 (“Deyzac FR ‘069”), and US 2009/0022700 A1 to Cassin, G. and J.T. Simmonet, published 22 January 2009 (“Cassin ‘700”), as evidenced by Selvol PVOH, obtained from the Internet at https://www.sekisui-sc.com/wp-content/uploads/-SelvolPVOH_Brochure_EN.pdf?_gl=1*lbzjv7*_up*MQ..*_ga*OTE5MzM5NzYxLjE3NTA3ODc5NjE.*_ga_SQWL1CCZGB*czE3NTA3ODc5NTgkbzEkZzAkdDE3NTA3ODc5ODkkajI5JGwwJGgw, on 24 June 2025 (“Selvol PVA”).
The Invention As Claimed
Applicant claims a moisturizing film comprising a polyvinyl alcohol film and a waterproof and water-vapor-permeable layer that is arranged closer to a body surface side than the polyvinyl alcohol film, wherein the waterproof and water-vapor-permeable layer is either an oil layer or an artificial skin, and wherein the thickness of the polyvinyl alcohol film is 0.01 µm, or more, and 7 µm, or less, and the basis weight of the waterproof and water-vapor-permeable layer is 1.0 mg/cm2, or more, and 2.0 mg cm2, or less, and wherein, when evaluated by a water evaporation test, an amount of water evaporation as measured in a 40% RH environment at 23° C is less than an amount of water evaporation as measured in a 70% RH environment at 28° C, wherein the polyvinyl alcohol film contains an unmodified polyvinyl alcohol, and wherein the oil layer contains petroleum jelly and/or liquid paraffin.
The Teachings of the Cited Art
Abe ‘144 discloses thin films having excellent manageability, moisture-retaining effect, and unevenness correction effect and a thin film cosmetic, the thin film being a laminate of a base film and carrier (see Abstract), wherein the base film supports hyaluronic acid (see ¶[0015]), and comprises polylactic acid, polyglycolic acid, polycaprolactone, or a copolymer thereof (see ¶[0018]), wherein the thin film is prepared by spin-coating (see ¶[0019]), wherein the carrier comprises a water-soluble polymer, such as polyvinyl alcohol (see ¶[0020]), wherein the laminate cosmetic film is used by applying to the skin so that the base film is in contact with the skin (see ¶[0025]), wherein the thickness of the base layer is from 10 to 500 nm (see ¶[0031]), wherein the thickness of the carrier is preferably from 1 to 500 nm (see ¶[0064]), and wherein the polyvinyl alcohol has a preferred molecular weight of 2000 to 5000 Da (see ¶[0066]). The reference does not disclose a film further comprising a waterproof and water-vapor-permeable layer arranged closer to a body surface side than the polyvinyl alcohol film, wherein the waterproof and water-vapor-permeable layer is an oil layer containing petroleum jelly, or a film comprising an unmodified polyvinyl alcohol. The teachings of Deyzac FR ‘069 and Cassin ‘700 remedy those deficiencies.
Deyzac FR ‘069 discloses a composition comprising one or more film-forming agents, at least one hydrating agent, and a Ruscus extract, for use in the treatment of open foot cracks in diabetic patients with sensitive neuropathy (see Abstract), wherein the composition can also comprise an anti-fungal agent (see p. 1, 2nd para.)1, wherein diabetic patients having at least one fissure open on a foot respond particularly favorably to the disclosed composition (see p. 2, 8th para.), wherein a film-forming agent is a compound that acts on a skin surface by reinforcing or replacing a hydrolipidic film and effectively slowing the evaporation of water (see p. 3, 1st para.), wherein the composition comprises a hydrophobic film-former, such as petroleum jelly, and a hydrophilic film-former, such as polyvinyl alcohols (see p. 3, 2nd para.), wherein topical administration of the composition may be accomplished by application of a solution, a suspension, a gel, a lotion, a milk, an ointment, an ointment, a cream, eye drops, or other vehicle used for topical application, particularly in hydroalcoholic form, an oil-in-water, or water-in-oil, or multiple emulsion, an oily gel, or a liquid anhydrous product, a paste, or a solid (see p. 4, 1st para.), wherein the compositions are applied to the surface to be treated of the skin of a patient (see p. 4, 2nd para.), wherein the percentage of patients having a complete disappearance of the main fissure at day 28 reaches 46.3% in the group treated with the disclosed composition, and only 33.3% in the placebo group, and on day 14, 6 patients in the treated group demonstrated a complete cure of the fissure, while no patients in the placebo group displayed a complete cure (p = 0.012) (see p. 5, 2nd para.).
Cassin ‘700 discloses a composition that is in the form of a water-soluble anhydrous film comprising at least one water-soluble or water-dispersible film-forming polymer, at least one live, probiotic microorganism, and at least one oxyalkylenated polydimethylsiloxane derivative, wherein the film of which has a thickness of from 10 μm to 1000 μm, or 50 µm (see Ex. 1; see also, claim 2), wherein the film-forming polymers may be vinyl polymers, such as polyvinyl acetate, polyvinylpyrrolidones, methyl vinyl ether/maleic anhydride copolymers, vinyl acetate/crotonic acid copolymer, vinylpyrrolidone/vinyl acetate copolymers, vinylpyrrolidone/caprolactam copolymers, polyvinyl alcohols (see ¶¶[0046] – [0047]; see also, Example 1).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare thin films having excellent manageability, moisture-retaining effect, and unevenness correction effect, and a thin film cosmetic, the thin film being a laminate of a base film and carrier, wherein the base film comprises polylactic acid, polyglycolic acid, polycaprolactone, or a copolymer thereof, wherein the thin film is prepared by spin-coating, wherein the carrier comprises a water-soluble polymer, such as polyvinyl alcohol, wherein the laminate cosmetic film is used by applying to the skin so that the base film is in contact with the skin, wherein the thickness of the base layer is from 10 to 500 nm, wherein the thickness of the carrier is preferably from 1 to 500 nm, as taught by Abe ‘144, wherein the film composition comprises one or more film-forming agents, at least one hydrating agent, and a Ruscus extract, for use in the treatment of open foot cracks in diabetic patients with sensitive neuropathy, wherein the film-forming agent is a compound that acts on a skin surface by reinforcing or replacing a hydrolipidic film and effectively slowing the evaporation of water, wherein the composition comprises a hydrophobic film-former, such as petroleum jelly, in addition to, or in place of the base layer of Abe ‘144, and wherein the compositions are applied to the surface to be treated of the skin of a patient, as taught by Deyzac FR ‘069, and wherein the water-soluble film-forming polymer is a unmodified polyvinyl alcohol, as taught by Cassin ‘700. One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the express disclosures of Deyzac FR ‘069 to the effect that diabetic patients having at least one fissure open on a foot respond particularly favorably to the disclosed compositions comprising a hydrophilic PVA layer and a hydrophobic layer comprising petroleum jelly that prevents loss of moisture from the compositions (see p. 2, 8th para.), and that the percentage of patients having a complete disappearance of the main fissure at day 28 reaches 46.3% in the group treated with the disclosed composition, and only 33.3% in the placebo group, and on day 14, six patients in a treated group demonstrated a complete cure of the fissure, while no patients in the placebo group displayed a complete cure (p = 0.012).
The Examiner notes that claim 1 recites a preamble directed to a “film cosmetic.” It is the Examiner’s position that such recitation in the claim is no more than a statement of intended purpose and, as such, is not accorded patentable weight. See, In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976), and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). Such is the case with claim 1, wherein the features of the composition are fully recited in claim 1, and the use does not further define any structure.
With respect claim 1, which claim Applicant amended to recite that the thickness of the PVA film is from 0.01 to 7 µm, the Examiner notes that the primary reference, Abe ‘144, teaches that the PVA films have thicknesses in the range of from 1 to 500 nm (see ¶[0064]), which range, although not congruent with the claimed range, overlaps with the claimed thickness range. As such, the disclosed range would render the claimed invention obvious. See MPEP § 2144.05. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).”
Further with respect claim 1, which claim Applicant amended to recite a limitation directed to evaluation of the PVA film by way of a water evaporation test, it is the Examiner’s position that such limitation is directed to a functional characteristic of the claimed PVA film, and not to compositional or structural characteristics of the film. However, the invention as claimed is not structurally distinguishable from films consistent with the teachings of the references cited in the instant rejection. It is, therefore, the Examiner's position that the ability of the formulations of the prior art to perform functions consistent with the claim limitations at question is an inherent property of the invention taught by those references. Because the Patent and Trademark Office does not have the facilities for examining and comparing the claimed formulation with the formulation of that art, the burden of proof is upon Applicants to show an unobvious distinction between the structural and functional characteristics of the claimed formulation and the formulations of the prior art. See In re Best, 562 F.2d 1252, 195 U.S.P.O. 430 (CCPA 197), and Ex parte Gray, 10 USPO 2d 1922 1923 (PTO Bd. Pat. App. & Int.).
With respect to claim 3, which claim recites a limitation directed to the PVA film layer comprising “an unmodified polyvinyl alcohol,” the Examiner notes that the references do not expressly characterize the disclosed PVA films as “unmodified.” However, the Examiner further notes that Cassin ‘700 discloses that the PVA of the disclosed film compositions comprises Celvol 540 PVA (see ¶[0057]; see also, Ex. 1), which PVA, as evidenced by Selvol PVA,2 is not modified and differs from other available grades only in degree of hydrolysis.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 1, 3, and 5 would have been obvious within the meaning of 35 USC § 103.
Response to Applicant’s Arguments
The Examiner has considered the arguments that Applicant has offered in the Response filed 30 September 2025 but does not find them persuasive, to the extent still relevant in light of the new grounds of rejection set forth above. Applicant points to the recent amendments to claim 1, which amended language is acknowledged, and fully addressed in the new grounds of rejection set forth above. Applicant argues that “the references [do not] teach or suggest arranging a PVA film of a specific thickness and a waterproof and water-vapor-permeable layer of a specific thickness at specific positions.” The Examiner respectfully disagrees, primarily on the basis that the new grounds of rejection set forth above now cite to Abe ‘144, which reference discloses PVA films with a thickness of 1 to 500 nm, which thickness range overlaps with the amended thickness range cited in claim 1, rendering it obvious. In addition, the multilayer film of Deyzac FR ‘069 discloses a petroleum, jelly layer arranged to be in contact with the wearer’s skin, thus further reading on claim 1.
Consequently, based on the above discussion, Applicant’s arguments are unpersuasive and claims 1, 3, and 5 stand rejected pursuant to 35 U.S.C. § 103.
NO CLAIM IS 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.
CONCLUSION
Any inquiry concerning this communication or any other communications from the Examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The Examiner can normally be reached on M - F 8:30 a.m. - 5:00 p.m.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, David Blanchard, can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619
1 Page cites are to the English language machine translation of the original French document.
2 Sekisui Chemical acquired the PVA line of Celanese Chemical, as first reported in Chemical & Engineering News, 87(18): p. 11 (2009), thus leading to the name change from Celvol 540, as disclosed in Cassin ‘700, to Selvol 540.