DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Status of the Claims
The response and amendment filed 07/28/2026 is acknowledged.
Claims 1-11 and 16-17 are pending.
Claims 1-9 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/21/2026.
Claims 10-11 and 16-17 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Withdrawn
The previous rejections of claims 10-17 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subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention have been withdrawn because of Applicant’s amendment.
The rejection of claims 12 and 13 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subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention has been withdrawn because of Applicant’s amendment.
The rejection of claims 12-15 and 17 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subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention has been withdrawn because of Applicant’s amendment.
Response to Arguments
Applicant's arguments filed 07/28/2026 have been fully considered but they are not persuasive.
Applicant argues that Dawkins is directed to different chemical formulas of numbing compounds and briefly mentions that the compounds can be provided on a patch or mask (para. 0002). Applicant argues Dawkins para 0327 and other paragraphs regarding the shapes of patches were relied upon in the rejection. Applicant argues Dawkins only describes various shapes for the adhesive in ¶ 0327 and not the shape of the numbing compound.
This argument is unpersuasive. The claims are directed to a method which includes selecting a numbing patch from an assortment of patches having different sizes and shapes, the numbing patch comprising a flexible support layer having a shape that corresponds to a specific area of a patient’s body on which a cosmetic procedure is to be performed. The shapes in the assortment in the assortment of patches being at least those selected from the group consisting of a paisley shape corresponding to an under-eye area, an arc shape corresponding to a neck area, a face-mask shape corresponding to a face, and a lip shape corresponding to lips, and a numbing substance deposited on the support layer, wherein the numbing substance comprises an adhesive that provides a weak adhesion of the patch to the patient’s skin. The claim does not refer to the shape of the numbing compound. The claim refers to the shapes of the numbing patch. The cited sections of Dawkins refer to the shapes of the numbing patches including a pressure sensitive adhesive. Dawkins teaches the patch comprising a pressure sensitive adhesive, i.e., flexible support layer, a local anesthetic, i.e., a numbing substance, and a backing layer, i.e., flexible support layer, wherein the patch has a shape selected from a circle, square, rectangle, polygon or any other shape appropriate to cover the area affected (Dawkins, e.g., 0327, 0386, 0387, and 0395 and 0451).
In response to Applicant’s argument that claim 10 recites specific shapes for the patches and that the numbing substance adheres the patch itself (rather than just the numbing substance) to the skin: The combined teachings of Dawkins and Wilder teach the recited shapes. Dawkins teaches the appropriate shape selected for the area to be treated (area to be affected, Dawkins, e.g., 0327, 0395). In Dawkins the numbing substance may be used with a pressure sensitive adhesive and may be used to adhere the patch to the patient’s skin, e.g., this is a property of a numbing composition comprising a pressure sensitive adhesive, e.g., silicone (Dawkins, e.g., 0395-0396), and in the form of patch (Dawkins, e.g., claim 83). Dawkins’s teachings regarding patches are not limited to the exemplified rings, e.g., Fig. 15A-E, (Dawkins, e.g., Fig. 15A-D and 0161) illustrating kit and methods of Dawkins’s broader teachings. Dawkins teaches patches functionalized with a pressure sensitive adhesive and Dawkins teach numbing compositions functionalized with a pressure sensitive adhesive. The skilled artisan would have understood these teachings refer to the same thing, i.e., a patch comprising flexible backing, a pressure sensitive adhesive, and a numbing substance, wherein the patch has a defined shape selected to cover the area to be affected. Claim 10 does not exclude the presence of an adhesive in the numbing substance, e.g., see claim 16 reciting silicone which expressly provides a weak adhesion to the skin.
In response to Applicant’s argument that Wilder teaches patches that are not for numbing for a cosmetic procedure: Wilder was not cited specifically for teaching patches for numbing procedures since this teaching is found in Dawkins. However, Wilder notes their patches may be used with a variety of active agents including numbing substances, e.g., lidocaine (Wilder, e.g., 0090). Wilder was cited for teaching specific shape alternatives to rings, rectangles, and circles named in Dawkins including teardrops (paisley shape corresponding to an under eye area), ovals (lip shape corresponding to lips), or crescent shapes (an arc shape corresponding to a neck area) which conform to the shape of the area to be affected (Wilder, e.g., 0055). Thus, the recited shapes were known and suggested for patches intended to conform to areas of the face and neck in the context of skin treatment methods.
Dawkins teaches the method comprising selecting a patch having a shape other than a circle or a rectangle, where the patch may be selected from a kit, and wherein the shape is selected for appropriate dose and shape to cover the area to be affected. However, Dawkins does not expressly teach the method comprising selecting the patch from an assortment of patches having different sizes and shapes.
Wilder teaches kits comprising multiple patches having different sizes and shapes to treat different areas of the face (Wilder, e.g., 0124). Wilder teaches kits comprising multiple patches having different dosage amounts (Wilder, e.g., 0123).
Thus, Wilder cures any defect in the teachings of Dawkins with respect to the content of the kit and variety of patches from which the patch is selected from.
Rejections Addressing Applicant’s Amendment
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 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.
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 10-11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Dawkins, 20230172880 and Wilder, US 20160107004 A1.
Dawkins teaches a method comprising applying a patch to an area of a patient’s body to be numbed, removing the patch after a period of time, and performing a cosmetic procedure after the patch has been removed. See Dawkins, entire document, e.g., Figs. 15A-15D and 0161.
Dawkins teaches the patch comprising a pressure sensitive adhesive, i.e., flexible support layer, a local anesthetic, i.e., a numbing substance, and a backing layer, i.e., flexible support layer, wherein the patch has a shape selected from a circle, square, rectangle, polygon or any other shape appropriate to cover the area affected (Dawkins, e.g., 0327, 0386, 0387, and 0395 and 0451).
Dawkins teaches patches in a kit and patches comprising different strengths (Dawkins, e.g., 0449).
Thus, Dawkins teaches the method comprising selecting a patch comprising a flexible support layer and a numbing substance, wherein the shape is selected to cover the area to be affected, e.g., a square, polygon, or any other shape appropriate to cover the area affected, and wherein the patch is selected to have a numbing substance strength (dose) suitable for the particular patient being treated, e.g., adult or pediatric, to maximize efficiency and minimize risk, and wherein the patch is selected from a kit.
Dawkins teaches the patch comprising a pressure sensitive adhesive is applied and subsequently removed to allow for subsequent treatment, e.g., with a needle (Dawkins, e.g., 0395).
Since Dawkins teaches a patch comprising an anesthetic, Dawkins teaches patches configured for use with the treatments named in claim 17.
Dawkins teaches the method comprising selecting a patch having a shape other than a circle or a rectangle, where the patch may be selected from a kit, and wherein the shape is selected for appropriate dose and shape to cover the area to be affected. However, Dawkins does not expressly teach the method comprising selecting the patch from an assortment of patches having different sizes and shapes.
Dawkins teaches a mask, (Dawkins, e.g., 0002 and 0384) and a circle, i.e., arc shape (Dawkins, e.g., 0327).
Dawkins does not expressly teach a paisley shape, an arc shape, or a lip shape.
However, Wilder teaches kits for applying compositions to skin, wherein the composition is part of a patch having a backing layer and a pressure sensitive adhesive (Wilder, entire document, e.g., Abstract). Wilder teaches the kits configured with a variety of patches (Wilder, entire document, e.g., 0103-0125). Wilder teaches kits comprising multiple patches having different sizes and shapes to treat different areas of the face (Wilder, e.g., 0124). Wilder teaches kits comprising multiple patches having different dosage amounts (Wilder, e.g., 0123). Wilder teaches the size and shape of the patch will depend on the intended use, e.g., the shape may be oval (lip shape), crescent (arc), teardrop (paisley), or conform to the face target area (face mask shape). See Wilder, e.g., 0054-0055). Wilder teaches the kit as part of a solution to improve user satisfaction and optimize effective delivery of the active to target area of the skin (Wilder, e.g., 0005).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to combine the teachings of Dawkins and Wilder to practice a method as claimed with a reasonable expectation of success. Since Dawkins teaches the patch may be selected from a kit, the patch may be selected based on desired strength, and the shape of the patch may be selected based on the location to which it is applied, the skilled artisan would have been motivated to modify the kit with a selection of patches which differ in strength, size, and shape as suggested by Wilder with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification to facilitate the practice of Dawkins’ method, e.g., to enable selection from a variety of preformulated patches of different shapes, sizes, and strengths as suggested by Wilder. Further from Wilder the skilled artisan would have been motivated to include a selection of patches having an oval (lip shape), crescent (arc), teardrop (paisley), or conform to the face target area (face mask shape) so that the kit addresses the variety of specific facial areas which may be affected. The skilled artisan would have had a reasonable expectation of success since the reference are directed to methods of applying cosmetic compositions to the skin using topical delivery patches optimized for local delivery.
Claim 10 recites specific shapes for the patches and that the numbing substance adheres the patch itself (rather than just the numbing substance) to the skin: The combined teachings of Dawkins and Wilder teach the recited shapes. Dawkins teaches the appropriate shape selected for the area to be treated (area to be affected, Dawkins, e.g., 0327, 0395). In Dawkins the numbing substance may be used with a pressure sensitive adhesive and may be used to adhere the patch to the patient’s skin, e.g., this is a property of a numbing composition comprising a pressure sensitive adhesive, e.g., silicone (Dawkins, e.g., 0395-0396), and in the form of patch (Dawkins, e.g., claim 83). Dawkins’s teachings regarding patches are not limited to the exemplified rings, e.g., Fig. 15A-D, (Dawkins, e.g., Fig. 15A-D and 0161) illustrating kits and methods of Dawkins’s broader teachings.
Applicable to claim 16: The combined teachings of Dawkins and Wilder teach wherein the adhesive comprises silicone (Wilder, e.g., 0063, 0074, claim 8; Dawkins, e.g., 0396, 0451, 0453, claim 55). Wilder additionally teaches wherein the adhesion is optimized to balance keeping the patch in place, comfort on the skin and ease of removal (Wilder, e.g., 0148).
Accordingly, the subject matter of claims 10-11 and 16 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Dawkins, 20230172880 and Wilder, US 20160107004 A1 as applied to claims 10-11 and 16 above, and further in view of Schneider, US 20180133403.
The combined teachings of Dawkins and Wilder teach wherein the method comprises performing a procedure, e.g., an injection (Dawkins, e.g., 0161 and 0449-0454). However, the combined teachings of Dawkins and Wilder do not expressly teach wherein the procedure comprises at least one of injecting neurotoxins, injecting fillers, injecting PRP/PRF, injecting peptides, injecting exosomes, laser treatments, microneedling, PDO thread lifts, and nitrogen plasma treatments.
Schneider teaches needle skin procedures involving injection which include the injection of neurotoxins, e.g., botulinum toxin for cosmetic effect, e.g., relax muscles to reduce lines, wrinkles, or otherwise smooth appearance of the skin around an individual’s eyes, forehead, mouth, neck, scalp, or other areas of the face or body (Schneider, e.g., 0004).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to practice a method suggested by the combined teachings of Dawkins and Wilder, wherein the needle procedure is injecting a neurotoxin as known from Schneider with a reasonable expectation of success. Since Dawkins teaches removing the patch so that the practitioner may perform a needling procedure at an injection site, the skilled artisan would have been motivated to look to prior art teachings for injection procedures practiced on the face, such as injecting a neurotoxin to relax muscles to reduce lines, wrinkles, or otherwise smooth appearance of the skin around an individual’s eyes, forehead, mouth, neck, scalp, or other areas of the face as known from Schneider. The skilled artisan would have had a reasonable expectation of successfully making this modification since Dawkins teaches the method is effective for reducing pain associated with injection procedures practiced on the face and since Schneider expressly teaches procedures practiced on the face include injecting neurotoxins.
Accordingly, the subject matter of claim 17 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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