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 04/21/2026 is acknowledged.
Claims 1-17 are pending.
Applicant’s election of Group II in the reply filed on 04/21/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Applicant’s response did not address the species election. However, after a search of the prior art, the species election has been withdrawn.
Claims 10-17 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 Rejections not reiterated herein have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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 10-17 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 pre-AIA the applicant regards as the invention.
Claim 10 includes the limitation of 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 with a particular type of cosmetic procedure to be performed, the shape being other than rectangular or circular.
Claim 10 defines the selected shape as corresponding with a particular type of cosmetic procedure to be performed. However, the specification indicates the patch has a shape that depends on the specific body area on which the procedure is performed. See specification, e.g., pg. 2, Summary.
The specification does not appear to relate the shape selection criteria to the procedure which is being performed. That is, there is no explanation in the specification how the skilled artisan would select a particular shape for a particular procedure.
Therefore, the skilled artisan cannot determine whether the shape is selected based on the cosmetic procedure, or whether the shape is selected based on the specific body area affected by the procedure.
Notably, dependent claims 11-15 relate specific shapes to the specific body area to which they are to be applied.
This is also problematic for claim 17 because claim 17 states the patch is configured for particular cosmetic treatments. The skilled artisan cannot understand if the configuration required by claim 17 is a particular shape – as suggested by claim 10 - or some other configuration, e.g., size or numbing substance strength. The specification does not appear to explain a particular configuration for each of the recited treatments. At least to the extent that the configuration of claim 17 refers to the shape, the skilled artisan cannot understand which shape, or configuration, is required for each particular procedure named.
If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate. See MPEP 2173.02, II.
Clarification is required.
Claims 10-17 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 pre-AIA the applicant regards as the invention.
The term “rectangular” in claim 10 is a relative term which renders the claim indefinite. The term “rectangular” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Here, the term rectangular is used to define excluded shapes. However, rectangular means approximately a rectangle, and it is not clear how rectangular a shape must be to be included or excluded by the scope of the claim. For example, the skilled artisan cannot determine if the term excludes a square. The skilled artisan cannot determine if the term excludes all parallelograms. The skilled artisan cannot determine if the term excludes any rhombus, or only certain ones.
The term “circular” in claim 10 is a relative term which renders the claim indefinite. The term “circular” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Here, the term circular is used to define excluded shapes. However, circular means approximately a circle, and it is not clear how circular a shape must be to be included or excluded by the scope of the claim. For example, the skilled artisan cannot determine if the term excludes an arc. The skilled artisan cannot determine if the term excludes all ellipses. The skilled artisan cannot determine if the term excludes star or spiral shapes, etc.
An example as to why these terms are confusing is Fig. 4 of the specification. In Fig. 4, the shape ‘14’ is labeled as an arc. See Specification, e.g., pg. 4. However, the skilled artisan may reasonably consider the shape in Fig. 4 to be “rectangular,” and believe it to be excluded from the scope of the invention as presently claimed. Therefore, the skilled artisan cannot understand how to avoid infringement.
If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate. See MPEP 2173.02, II.
Clarification is required.
Claims 12 and 13 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 pre-AIA the applicant regards as the invention.
Claim 12 includes the limitation of a paisley shape.
Claim 13 includes the limitation of an arc shape.
However, claim 10 includes the limitation that the shape being other than rectangular or circular.
An arc is a segment of a circle and therefore, the skilled artisan may reasonably consider an arc “circular.”
Similarly, the skilled artisan may reasonably consider a paisley shape to be “circular.”
Since the skilled artisan may reasonably consider the particular shapes recited in claims 12 and 13 to be circular, the metes and bounds for which applicant is claiming protection are unclear.
Clarification is required.
Claims 12-15 and 17 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 pre-AIA the applicant regards as the invention.
Claims 12-15 refer to “the shape” of claim 10. However, claim 10 recites an assortment of shapes and a selected shape. It is not clear which shape of claim 10 “the shape” in claims 12-15 was intended to refer to.
Clarification is required.
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 10-17 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 other than a rectangle or a circle, 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.
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.
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. 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.
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 10-17 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.
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
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