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 Application
Claims 1-18 are pending.
No claims have been newly added, amended, or cancelled.
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-12) in the reply filed on February 23, 2026 is acknowledged.
Claims 13-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim.
After further consideration, the election of species election has been withdrawn.
Therefore, claims 1-12 are under examination in this application.
Information Disclosure Statement
The IDS filed on January 10, 2025 has been considered. A signed copy is enclosed herewith.
Claim Objections
Claim 4 is objected to because of the following informalities: the claim recites the acronyms EGCG for Epigallocatechin gallate and CoQ10 for Coenzyme Q10. The acronyms are defined in the specification in paragraph [0042], however, when an acronym appears in the claims, it is appropriate to recite the full name, followed by the acronym in parenthesis, such as “epigallocatechin gallate (EGCG)” and “Coenzyme Q10 (CoQ10)” and then recite only the acronyms in subsequent reiterations. 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.
Claim 5 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.
Regarding claim 5, the claim recites “the elastomeric film barrier layer is not directly or indirectly coupled to a substrate…”. “Not directly” and “indirectly” are considered synonyms, therefore, the recitation of both in the claim is considered redundant and unnecessary. Alternatively, it is unclear if the recitation is intended to be the substrate is “not directly” and “not indirectly” coupled to elastomeric film barrier layer. If the latter is the intended limitation, it is unclear how the substrate can be coupled to the elastomeric film barrier layer since it can’t be directly or indirectly coupled. The specification provides contradictory guidance on the coupling. For example, paragraph [0019] utilizes the same wording as recited in the instant claim, however, paragraph [0050] which defines coupled to be coupled directly or indirectly. Clarification is requested.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 8, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kawahara et al. (US 2015/0320606 A1, Nov. 12, 2015, hereafter as “Kawahara”).
The instant claims are drawn to a therapeutic skin mask comprising: an elastomeric film barrier layer; and a pressure sensitive adhesive (PSA) disposed on a first side of the elastomeric film barrier layer, the PSA comprising a therapeutic ingredient configured to treat an area of skin upon which the PSA is applied; wherein the elastomeric film barrier layer comprises a shape configured to cover the area of skin.
Regarding instant claim 1, Kawahara discloses a facial patch including a support, a pressure sensitive layer, and a release layer (abstract). Examples of supports include plastic films of polyesters and polyurethanes, for example (paragraph [0009]). It is noted polyurethane adds an elastomeric property to the support. The pressure sensitive adhesive layer can contain a drug, examples include tocopherol acetate (vitamin E) (paragraph [0075]). Since Kawahara discloses the patch to be facial patch, it is the position of the Examiner that said patch would comprise a shape configured to cover the area of the skin (i.e., face). The release layer is preferably polyethylene terephthalate (PET) film having a silicone treated surface (paragraph [0090]). The facial patch can additionally include a carrier film, adjacent to the support that is on the opposite side of the pressure sensitive adhesive layer (paragraph [0094]).
Regarding claim 2, as noted above, the support is plastic film which include synthetic resins such as polyurethanes and polyesters (paragraph [0041]).
Regarding claim 8, as noted above, the facial patch comprises a release layer (paragraph [0030]).
Regarding claim 10, as noted above, the patch is discloses a facial patch.
Thus, the teachings of Kawahara render the instant claims anticipated.
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.
Claim 1, 2, 4, 8, 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kawahara et al. (US 2015/0320606 A1, Nov. 12, 2015, hereafter as “Kawahara”).
The claimed invention is described above.
The teachings of Kawahara are discussed above.
Kawahara does not exemplify the therapeutic agent included in the pressure sensitive adhesive (instant claim 4). Additionally, Kawahara does not disclose the shape or size of the facial mask recited in claims 11-12.
Regarding claim 4, as noted above, the pressure sensitive adhesive layer can contain a drug, examples include tocopherol acetate (vitamin E) (paragraph [0075]).
While Kawahara does not exemplify the use of vitamin E in the pressure sensitive adhesive, it is disclosed within a finite grouping of disclosed therapeutic agents. It is additionally a well-known and utilized active agent to be included in topical facial cosmetic formulations. Applicant’s attention is directed to MPEP 2143(I) which discusses its inclusion would have been “obvious to try” within the mask of Kawahara since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, per KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), is identified within a number of rationales to support a conclusion of obviousness which is consistent with the proper "functional approach" to the determination of obviousness.
Regarding claims 11-12, Applicant’s attention is directed to MPEP 2144.04(IV)(A)-(B) which discloses In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device and In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.). Therefore, based on the intended use of the skin mask, it would have been obvious to one of ordinary skill in the art prior before the effective filing date of the claimed invention to have optimized and adjusted the size and shape of the mask of Kawahara to treat specific areas of the face or the face as a whole. The skilled artisan would have a reasonable expectation of success since the mask is already disclosed for application to the face, therefore, it would readily be adapted for any suitable like intended use.
Thus, the teachings of Kawahara render the instant claims prima facie obvious.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kawahara et al. (US 2015/0320606 A1, Nov. 12, 2015, hereafter as “Kawahara”), as applied to claim 1 above, in view of Stempel et al. (US 2005/0282977 A1, Dec. 22, 2005, hereafter as “Stempel”).
The claimed invention is described above.
The teachings of Kawahara are discussed above.
Kawahara does not disclose the pressure sensitive adhesive comprises a solid, solvent free silicone gel.
Stempel discloses pressure sensitive adhesive compositions comprising a silicone gel. Silicone gels, which are lightly cross-linked silicone polymer networks that are swollen with a fluid, are also well known and may be sufficiently tacky to adhere to the skin for at least limited periods. In recent years, such adhesive silicone gels have been found particularly beneficial as skin-contacting dressings for scar therapy (paragraph [0003]). Aggressive silicone PSA are high in solids and have increased viscosities. The gels are disclosed to be formed with or without solvents (100% solids).
It would have been prima facie obvious to one of ordinary skill in the art prior before the effective filing date of the claimed invention to have utilized the silicone gels disclosed by Stempel in order to obtain a PSA which is sufficiently tacky with the added benefit of scar treatment when applied to the skin.
Thus, the combined teachings of Kawahara and Stempel render the instant claims prima facie obvious.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kawahara et al. (US 2015/0320606 A1, Nov. 12, 2015, hereafter as “Kawahara”), as applied to claims 1 and 8 above, in view of Sasaki et al. (JP H0577364 A, Mar. 30, 1993, machine translation, hereafter as “Sasaki”).
The teachings of Kawahara are discussed above.
Kawahara does not disclose the release layer comprises a PET film coated on one side with a fluorosilicone release coating.
Sasaki discloses a release sheet enhanced for the adhesion of a base material and a fluorosilicone release agent, generating no detachment of the release agent from the base material and excellent release capacity (abstract). Example 1 discloses a fluorosilicone coated on a PET film to form a release layer.
It would have been obvious to one of ordinary skill in the art prior before the effective filing date of the invention to have modified silicone treated surface of the PET release layer of Kawahara to be a fluorosilicone modification in order to obtain enhanced adhesion and excellent release capacity. The skilled artisan would have a reasonable expectation of success since both references are drawn to PET release layers utilized with pressure sensitive adhesives.
Thus, the combined teachings of Kawahara and Sasaki render the instant claims prima facie obvious.
Claims 1 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (USPN 5,223,261, Jun. 29, 1993, hereafter as “Nelson”) in view of Wittmayer (US 2025/0352493 A1, eff. filing date May 19, 2022, hereafter as “Wittmayer”).
The claimed invention is described above.
Regarding instant claim 1, Nelson discloses a transdermal estradiol delivery system comprising a pressure-sensitive adhesive sheet material comprising a backing with a layer of pressure-sensitive adhesive adjacent thereto. The pressure sensitive adhesive comprising estradiol (a therapeutic ingredient) (abstract). The backing layer is disclosed to be flexible (column 2, lines 35-60). The flexible backing layer may be occlusive, non-occlusive, or a breathable film made of polyurethane (column 5, lines 44), for example. It is noted polyurethane is a known elastomer. The properties of the disclosed backing materials are well known to the skilled artisan with well-known and established properties. Applicant’s attention is directed to MPEP 2143(I) which discloses it would be “obvious to try” preparing a composition/formulation when one can chose from a finite number of identified, predictable alternatives, with a reasonable expectation of success per KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) which identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness. The patch is disclosed to be transdermal, therefore, it would necessarily be shaped to cover an area of skin.
Nelson does not disclose how the elastomeric film barrier layer is coupled to the substrate (instant claim 5), a fabric substrate disposed on a second side on the elastomeric film barrier layer opposite the first side (instant claim 6), or that fabric is stretchable (instant claim 7).
Wittmayer discloses highly elastic patches and masks for delivery of therapeutic agents. The patch comprises a fabric layer made of synthetic fibers stretchable in both directions along a substantially orthogonal transverse axis of the patch (abstract).
Regarding claim 5, due to the 112(b) rejection above, the Examiner has interpreted the substrate layer can “not indirectly” be coupled to the elastomeric film barrier. Therefore, an intermediate layer is not required.
Regarding claims 6 and 7, as noted above, the substrate of Wittmayer is a stretchable fabric layer.
It would have been obvious to one of ordinary skill in the art prior before the effective filing date of the claimed invention to have included a fabric support layer to the patch of Nelson since Wittmayer discloses the stretch characteristics are extremely important for a topical/transdermal patch applied to moving joints and muscles. Human skin, muscles, and joints can stretch or flex up to 180 degrees and if a patch doesn't stretch greater than or equal to the application area it will restrict movement or detach. Equally important to a fabric's stretch characteristics is its ability to recoil back into shape repeatedly without deformation.
Thus, the combined teachings of Nelson and Wittmayer render the instant claims prima facie obvious.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M, T, Th and F 9:00 am - 3:30 pm.
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617
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