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 .
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 7, 8, 12, 13 and 18 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Lei (US 2015/0366747, hereinafter “Lei”).
In regards to claim 1, Lei discloses an electrical applicator apparatus (abstract), the apparatus comprising:
a treatment tip portion (e.g., Fig. 7, par. 0143, “treatment plug”);
a first surface electrode comprising a first one or more elongate traces extending over a surface of the treatment tip portion (e.g., Figs. 7 and 15); and
a second surface electrode comprising a second one or more elongate traces extending over the surface of the treatment tip portion, wherein the first one or more elongate traces extend adjacent to the second one or more traces along a length of the second one or more elongate traces so that there is a uniform gap separating the first one or more traces from the second one or more traces along the length of the second one or more traces (e.g., Figs. 7 and 15),
further wherein the first surface electrode and the second surface electrode form an alternating and/or interdigitating pattern comprising an active region that spans the majority of the treatment tip portion to provide an evenly distributed electric field density over the active region (e.g., Fig. 7, par. 0055, abstract “to ensure uniform distribution between each group of RF electrode currents”).
In regards to claim 3, the active region is 25 mm2 or greater (par. 0054 --2.5 cm * 7 cm * π ≈ 55 cm2.
In regards to claim 7, the first one or more elongate traces are in electrical communication with a first electrical connector configured to be coupled to a pulse generator and the second one more elongate traces are in electrical communication with a second electrical connector configured to be coupled to the pulse generator (Fig. 15, positive and negative electrodes, respectively).
In regards to claim 8, the first surface electrode and the second surface electrode are configured to deliver fast, high-voltage electrical pulses between the first surface electrode and the second surface electrode (pars. 0004, 0112-0115; radio frequency stimulation of a high enough voltage to heat target tissue and stimulate collagen regeneration).
In regards to claim 12, Lei discloses an electrical applicator apparatus (abstract), the apparatus comprising:
a treatment tip portion (e.g., Fig. 7, par. 0143, “treatment plug”);
a first surface electrode and a second surface electrode configured to deliver high-voltage electrical pulses (e.g., Figs. 7 and 15; pars. 0004, 0112-0115; radio frequency stimulation of a high enough voltage to heat target tissue and stimulate collagen regeneration);
wherein the first and the second surface electrodes comprising a first and a second respective patterns of one or more elongate traces extending adjacent to each other over a surface of the treatment tip portion, the first and the second patterns of the one or more elongate traces are longer than they are wide and separated by a uniform gap along a length of the respective patterns (e.g., Figs. 7 and 15), and
wherein the first and the second patterns are configured to form a substantially uniform electrical field over the treatment tip portion when high-voltage electrical pulses are delivered between the first and the second electrodes (e.g., Fig. 7, par. 0055, abstract “to ensure uniform distribution between each group of RF electrode currents”).
In regards to claim 13, the treatment tip portion is disposable (par. 0116, “disposable plug”).
In regards to claim 18, Lei discloses a system comprising:
an applicator comprising (Fig. 1, par. 0042, “applicator 3”)):
a treatment tip portion (Fig. 7, par. 0042, “treatment plug”);
a first surface electrode comprising a first one or more elongate traces extending over a surface of the treatment tip portion (e.g., Figs. 7 and 15); and
a second surface electrode comprising a second one or more elongate traces extending over the surface of the treatment tip portion, wherein the first one or more elongate traces extend adjacent to the second one or more elongate traces along a length of the second one or more elongate traces so that there is a uniform gap separating the first one or more elongate traces from the second one or more elongate traces (e.g., Figs. 7 and 15),
further wherein the first surface electrode and the second surface electrode form an alternating and/or interdigitating pattern comprising an active region that spans the majority of the treatment tip portion to provide an evenly distributed electric field density over the active region (e.g., Fig. 7, par. 0055, abstract “to ensure uniform distribution between each group of RF electrode currents”); and
a pulse generator configured to generate high-voltage electric pulses,
wherein the first surface electrode and the second surface electrode are configured to electrically couple to the pulse generator such that the evenly distributed electric field density is formed across the active region when the high-voltage electrical pulses are delivered between the first surface electrode and the second surface electrode (Fig. 1, “main engine 1”; abstract, “to ensure uniform distribution between each group of RF electrode currents”).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 4-6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Lei. Lei discloses the essential features of the claimed invention, including an element separating the first one or more traces from the second one or more traces (Figs. 7 and 8) and electrode dimensions and coverage that appear to overlap with the claimed ranges of gap, aspect ratio, and coverage (Fig. 7 and pars. 0055, 0129), but does not expressly disclose the gap is between 0.5 mm and 10 mm; the first one or more elongate traces have a length that is at least five times longer than a width; the active region spans at least 70% of the treatment tip portion; or that the separator comprises an insulator within the uniform gap separating the first one or more traces from the second one or more traces. However, it is well known in the art to provide the separation between therapy electrodes with an insulator to provide the predictable results of allowing a voltage to be generated between two electrodes (i.e., prevent a short circuit) to provide the predictable results of allowing energy to be delivered to tissue more efficiently, and it has been held that “"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, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Lei by provide the separation between therapy electrodes with an insulator to provide the predictable results of allowing a voltage to be generated between two electrodes (i.e., prevent a short circuit) to provide the predictable results of allowing energy to be delivered to tissue more efficiently, and a gap that is between 0.5 mm and 10 mm; the first one or more elongate traces having a length that is at least five times longer than a width; and the active region spanning at least 70% of the treatment tip portion to provide no more than predictable results.
Claims 2, 11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Lei in view of Wijay et al. (US 2022/0071803, hereinafter “Wijay”). Lei discloses the essential features of the claimed invention, including providing the RF electrodes on a “flexible circuit plate” (par. 0118), but does not expressly disclose that the treatment tip portion comprises a flexible insulating substrate on which the first surface electrode and the second surface electrode extend. However, Wijay in the same field of endeavor of electrical surface applicators teaches providing a treatment tip portion that comprises a flexible insulating substrate (par. 0044, Nylon) on which the first surface electrode and the second surface electrode extend (Fig. 2, elements 250, par. 0051) to provide the predictable results of improving patient comfort (par. 0048). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Lei by providing a treatment tip portion that comprises a flexible insulating substrate on which the first surface electrode and the second surface electrode extend to provide the predictable results of improving patient comfort.
Claims 10, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Lei in view of Casalino et al. (US 2021/0268299, hereinafter “Casalino”). Lei discloses the essential features of the claimed invention, but does not expressly disclose wherein the first surface electrode comprises a first electrically conductive hydrogel extending to an outer, tissue-contacting surface, and wherein the second surface electrode comprises a second electrically conductive hydrogel extending to the outer, tissue-contacting surface; or wherein the pulse generator is configured to generate microsecond, nanosecond or picosecond pulses. However, Casalino in the same field of endeavor of surface electrical application teaches providing RF stimulation electrodes with hydrogel extending to an outer, tissue-contacting surface (par. 0023) to provide the predictable results of improved biocompatibility and RF energy conduction (par. 0023); and a pulse generator is configured to generate microsecond, nanosecond or picosecond pulses (par. 0018 -- the example frequencies provide pulse periods in the microsecond to nanosecond range) to provide the predictable results of more effectively cosmetically treating a patient’s skin (par. 0016). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Lei by providing RF stimulation electrodes with hydrogel extending to an outer, tissue-contacting surface to provide the predictable results of improved biocompatibility and RF energy conduction; and a pulse generator is configured to generate microsecond, nanosecond or picosecond pulses to provide the predictable results of more effectively cosmetically treating a patient’s skin.
Claims 14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lei in view of Schwartz et al. (US 2022/0305275, hereinafter “Schwartz”). Lei discloses the essential features of the claimed invention except for one or more vacuum ports or a vacuum pump configured to provide suction to the applicator to secure the applicator to a treatment surface. However, Schwartz in the same field of endeavor of surface electrical stimulation teaches providing one or more vacuum ports and a vacuum pump configured to provide suction to the applicator to secure the applicator to a treatment surface (par. 0073) to provide the predictable results of stronger coupling of the applicator with the patient (par. 0073). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Lei by providing one or more vacuum ports and a vacuum pump configured to provide suction to the applicator to secure the applicator to a treatment surface to provide the predictable results of stronger coupling of the applicator with the patient.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Lei in view of Karni (US 2012/0071794, hereinafter “Karni”). Lei discloses the essential features of the claimed invention, but does not expressly disclose the apparatus is coupled to a movable arm of a robotic system. However, Karni in the same field of endeavor of RF surface application (par. 0016) teaches providing an RF apparatus coupled to a movable arm of a robotic system (abstract, Figs. 1 and 2, par. 0016) to provide the predictable results of a robotic system for delivering energy for medical or cosmetic treatment of a region of skin of a subject which would provide a simple and low cost solution to ensure correct positioning of an applicator relative to the skin surface (par. 0006). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Lei by providing the RF apparatus coupled to a movable arm of a robotic system to provide the predictable results of a robotic system for delivering energy for medical or cosmetic treatment of a region of skin of a subject which would provide a simple and low cost solution to ensure correct positioning of an applicator relative to the skin surface.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Prouza et al. (US 2019/0134414) is another example of an RF treatment device with a vacuum source.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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