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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on October 31, 2025 has been entered.
Response to Amendment
This Action is in response to the Amendment filed October 31, 2025.
Claims 2, 9, 17, 19, and 24 are amended.
Claims 29-31 are added.
Claims 2-31 are pending.
Response to Arguments
Applicant's arguments filed October 31, 2025 have been fully considered but they are not persuasive.
In response to Applicant’s argument that “source of energy to provide electrotherapy and/or RF therapy” refers to an electrode, Applicant has misconstrued the Office Action rejection. While Schwarz ‘705 does equate electrodes with “treatment energy sources”, cited paragraph [0012] does not mention “treatment energy sources”. As paragraph [0009 ] of Schwarz states a number of aesthetic soft tissue treatments are improved using application of RF energy and electrical stimulation to the soft tissue (last sentence of [0009] cited on pages 5, 9, and 19 of the final Office Action dated 08/01/2025). While an electrode of Schwarz ‘705 may apply/provide delivered RF energy and electrotherapy, it is not the source of power as Schwarz ‘705 illustrates power supply 101 (Fig. 1) and discloses electrodes provide electrotherapy and may have its own power supply 101 (paragraph [0121] of Schwarz ‘705) or a wireless electrode may include its own power source and hardware and/or software to communicate with control unit 102 to provide RF therapy and electrotherapy (e.g., paragraph [0122] of Schwarz ‘705) and discloses electrodes that may provide RF therapy and also electrotherapy may be switching between these two types of therapies during one treatment session ( paragraph [0126] of Schwarz ‘705). Paragraphs [0121], [0125]-[0126] of Schwarz ‘705 also were cited throughout the Final Office Action. It is the Action’s position the source of energy refers to the power supply where energy is generated. Since two types of energy are generated: RF energy and electrotherapy, Schwarz ‘705 discloses two generators of energy.
The claims do not define a generator for only producing one type of energy. Nor do the claims preclude one supply source from generating two types of energy. Moreover, since a wireless electrode (singular) can have its own power supply and electrodes can have their own power supply (e.g. paragraph [0121]), Schwarz ‘705 discloses more than one power supply.
In response to Applicant’s argument that Schwarz’s alleged generators are placed inside an applicator, electrodes apply/provide delivered energy. The source is the power supply, which Schwarz ‘705 clearly discloses and illustrates as outside of applicator 104 in Fig. 1.
In response to Applicant’s argument that Schwarz 705 does not suggest a conductive lead that couples the electrode with a first generator, the RF energy of Schwarz ‘705 that is applied to non-wireless electrodes needs to have a conductive lead from the source of the energy. Paragraph [0121] of Schwarz ‘705 discloses electrodes providing electrotherapy can be connected to the rest of the device by wire and may have its own power supply; and paragraph [0026] discloses treatment energy sources are electrodes that provide RF therapy and electrotherapy. One of ordinary skill in the art would have understood that a conductive lead would couple the electrode to the energy for both types of therapy. An electrode applies energy, it does not generate the required types of energy. As Schwarz ‘705 discloses: Power supply 101 may be managed by control unit 102. Regulation of delivered energy may be controlled by control unit 102 to influence therapy time, amount of delivered energy, controlling switching on/off different groups of electrode/s (e.g., paragraph [0127] of Schwarz ‘705) and the user interface that allows the operator to change the treatment parameters for each therapy (e.g., paragraph [0128] of Schwarz ‘705). Thus, Schwarz discloses the generation of two types of therapy using the control unit and the user interface, which are outside the applicator. In order to transfer the energy to the applicator, one of ordinary skill in the art would have understood that a conductive lead/wire would connect the electrode with the first generator of the first energy (RF therapy) and the second generator of the second energy (electrotherapy).
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.
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 2, 24, and 26-29 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2017/0333705 to Schwarz (hereinafter referred to as “Schwarz ‘705”) in view of US Patent Application Publication No. 2019/0336196 to Wolf et al. (hereinafter referred to as “Wolf”) and US Patent Application Publication No. 2019/0314638 to Kreindel.
Regarding claim 2, Schwarz ‘705 discloses a device for non-invasive improvement of a visual appearance of a patient (e.g., Abstract and paragraph [0009]: device for improving skin viability, skin and body rejuvenation, skin tightening scar removing, etc.), the device comprising: an applicator comprising an electrode, the applicator and the electrode being configured to be coupled to a treatment area of a body of the patient (e.g., Abstract: at least one applicator comes in contact with the patient’s body and the applicator has at least one electrode); and a main unit (e.g., power supply 1, control unit 102 and user interface 103) comprising: a first generator configured to generate radiofrequency energy (e.g., paragraph [0012]: a source of energy to provide RF therapy); a second generator configured to generate electric current with a frequency in a range of 0.1 Hz to 12 kHz (e.g., paragraph [0012]: a source of energy to provide electrotherapy; paragraph [0084]: depending upon what nerves/tissues are stimulated, the frequency can be from 0.1 Hz-150 Hz or 500 Hz to 12 kHz, both ranges are within the claimed range); a switching circuitry configured to switch between coupling the electrode with the first generator and coupling the electrode with the second generator (e.g., paragraph [0062]: controlling the electrode by control unit 102 includes changing parameters of produced energy … type of produced therapy; and paragraph [0126]: electrodes that may provide RF therapy and also electrotherapy may be switching between two types of therapies during one treatment session); and a control unit configured to control the first generator, the second generator, and the switching circuitry (e.g., paragraph [0062]: controlling the electrode by control unit 102 includes changing parameters of produced energy …, type of produced energy), wherein the applicator is configured to be connected to the main unit (e.g., Fig. 1, applicator 104 is connected to the main unit when it is connected to control unit 102; and paragraphs [0063]: control unit 102 is located out of applicator; and applicator 104 provides 5F therapy and electrotherapy) wherein the electrode is configured to deliver the radiofrequency energy from the first generator to the treatment area, thereby causing heating of skin of the treatment area (e.g., paragraph [0056]: the electrode may be used as a source of energy for electrotherapy and RF therapy; and paragraph [0021]: RF therapy provides thermal effects in the patient’s soft tissue including a patient’s skin), and to deliver the electric current from the second generator to the treatment area (e.g., paragraph [0056]: the electrode may be used as a source of energy for electrotherapy and RF therapy; paragraph [0026]: Preferred treatment energy sources are electrodes providing RF therapy and/or electrotherapy. Treatment energy is included in RF waves and/or electric current; and paragraph [0020]: electrotherapy or electrostimulation is the application of electrical energy (current) into the soft tissue for medical and aesthetic treatment with minimal and/or no thermal effect in soft tissue/skin), thereby causing a muscle contraction within the treatment area (e.g., paragraphs [0026]: treatment energy is an energy with a treatment effect (e.g., muscle contraction …; [0044]: the effect of electrotherapy may be muscle contraction; [0099]: muscle stimulation may be at least partial muscle contraction; and [0112]-[0113]), in order to improve the visual appearance of the patient (e.g., paragraph [0009] above).
Referring to claim 24, Schwarz ‘705 discloses a device providing radiofrequency and an electric current (e.g., Abstract: electrotherapy and radiofrequency therapy are provided to soft tissue; paragraph [0002]: devices for providing aesthetic soft tissue treatment via application of RF and electric currents into the human and/or animal soft tissue), the device comprising: an applicator comprising a radiofrequency electrode and an electrotherapy electrode (e.g., paragraph [0056]: the first type of electrode for the applicator may be used as a source of energy for electrotherapy and also RF therapy), wherein the radiofrequency electrode and the electrotherapy electrode are both configured to be in contact with a treatment area of the patient (e.g., Abstract: the applicator is in contact with the patient’s skin); and a main unit (e.g., Fig. 1, 101, 102, 103) a first generator coupled to the radiofrequency electrode and configured to generate radiofrequency energy (e.g., paragraph [0012]: a source of energy to provide RF therapy); a second generator coupled to the electrotherapy electrode (e.g., paragraph [0012]: a source of energy to provide electrotherapy) and configured to generate pulsed electric current (e.g., paragraph [0048]: electrotherapy may be provided by different types of pulses; paragraphs [0079] and [0081]: electrotherapy using pulse direct current and alternating current) with a frequency in a range of 0.1 Hz to 12 kHz (e.g., paragraph [0012]: a source of energy to provide electrotherapy; paragraph [0084]: depending upon what nerves/tissues are stimulated, the frequency can be from 0.1 Hz-150 Hz or 500 Hz to 12 kHz, both ranges are within the claimed range); and a control unit configured to control the first generator and the second generator (e.g., paragraph [0062]: controlling the electrode by control unit 102 includes changing parameters of produced energy …, type of produced energy; and paragraph [0126]: electrodes that may provide RF therapy and also electrotherapy may be switching between two types of therapies during one treatment session), wherein the radiofrequency electrode is configured to deliver the radiofrequency energy from the first generator to the treatment area, thereby causing heating of skin of the treatment area (e.g., paragraph [0056]: the electrode may be used as a source of energy for electrotherapy and RF therapy; and paragraph [0021]: RF therapy provides thermal effects in the patient’s soft tissue including a patient’s skin), wherein the electrotherapy electrode is configured to deliver the pulsed electric current from the second generator to the treatment area (e.g., paragraphs [0112]-[0116]: pulses are delivered to the treatment area), thereby causing a muscle contraction within the treatment area (e.g., paragraphs [0112]-[0116]: pulses are evaluated and optimal treatment parameters are set up in order to cause muscle contraction), and wherein the radiofrequency energy and the pulsed electric current are delivered during a same treatment (e.g., paragraph [0126]: electrodes that may provide RF therapy and also electrotherapy may be switching between two types of therapies during one treatment session).
Schwarz ‘705 differs from claims 2 and 24 in that 1) it does not expressly disclose that output power of the first generator (RF therapy) is in a range of 1 W to 200 W, and that 2) a surface area of the electrode is configured over the treatment area and is in the range of 1 cm2 to 25 cm2, and the treatment area a forehead, a submentum, a left cheek, a right cheek, a periorbital area, a jaw line, or a perioral area.
With respect to 1), Wolf teaches, in a related art: treating of tissue using an RF generator/energy source to communicate RF energy to the treatment area using electrodes(e.g., Abstract of Wolf), Wolf teaches that the generator is configured to run between about 1 and 100 Watts (e.g., paragraph [0196] of Wolf). Accordingly, one of ordinary skill in the art would have recognized the benefits of RF electrode generator having an output of power in the claim range in view of the teachings of Wolf. Consequently, one of ordinary skill in the art would have modified the first generator of Schwarz ‘705 to output power within 1 W and 200 W in view of the teachings of Wolf that such was an effective power to deliver RF therapy to tissue, and because the combination would have yielded the predictable result of RF therapy to tissue.
As to 2), Kreindel, in a related art: RF device for skin and fat treatment, teaches that its system can be used for treatment of the face, neck and other body areas, such as the left cheek as shown in Fig. 1 using 4 identical elements having RF electrodes 25, 26, 27 as shown in Fig. 2 (e.g., paragraphs [0016] and [0023] of Kreindel, and that applicators intended for body treatment may have larger elements to cover larger area and for deeper RF energy penetration, while facial or neck applicators may have smaller elements (e.g., paragraph [0016] of Kreindel). Consequently, one of ordinary skill in the art would have recognized the benefits of using facial areas, including the cheek area and neck areas as the soft tissue treatment area in view of the teachings of Kreindel. Consequently, one of ordinary skill in the art would have modified the device of Schwarz ‘705 and Wolf so that the applicator treats a facial, such as the cheek area or neck area of the body with an electrode area configured to fit over the treatment area in view of the teachings of Kreindel, and because the combination would have yielded a predictable result.
With respect to the surface area of the electrode(s) of the applicator, Kreindel teaches that the cheek area of a user would benefit from RF treatment, and it has been held by the courts 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. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). It is the Examiner’s position, that Kreindel teaches or at least reasonably suggests a surface area of electrode(s) that would fall within the claimed numerical range (i.e., 1 cm2 to 25 cm2) in order to cover the left cheek of an infant to an adult.
With respect to claim 26, Schwarz ‘705 in view of Wolf and Kreindel teaches the device of claim 24, wherein the radiofrequency energy has an energy flux density on a surface of the radiofrequency electrode in a range of 0.01 W/cm2 to 1000 W/cm2 (e.g., paragraphs [0072] of Schwarz ‘705: electromagnetic field used for heating the soft tissue may be a radiofrequency; and [0075]: energy flux density in contact mode may be in a range between 0.01 mW x mm-2). While the Examiner believes that Schwarz’s value in paragraph [0075] is equivalent to the claimed value, it also would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device as taught by Schwarz ‘705 in view of Wolf with the claimed flux density, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233].
As to claim 27, Schwarz ‘705 in view of Wolf and Kreindel teaches the device of claim 24, further comprising a sensor configured to obtain information indicative of contact between the radiofrequency electrode and the treatment area and contact between the electrotherapy electrode and the treatment area (e.g., paragraph [0132] of Schwarz ‘705: the device may have one or more sensors 105 providing feedback information to improve efficiency of the treatment, including at least one contact sensor for monitoring the applicator and/or electrode(s) contact with the patient’s body surface).
With respect to claim 28, Schwarz ‘705 in view of Wolf and Kreindel teaches the device of claim 27, wherein the sensor is configured to obtain information about the impedance of one of the radiofrequency electrode, the electrotherapy electrode, or the body part (e.g., paragraph [0113] of Schwarz ‘705: Feedback information from testing pulses may be monitored to determine changed impedance).
As to claim 29, Schwarz’ 705 in view of Wolf and Kreindel teaches the device of claim 2, but does not expressly teach that the surface area of the electrode is in a range of 2 cm2 to 9.5 cm2. However, Kreindel teaches that the cheek area of a user would benefit from RF treatment, and it has been held by the courts 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. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). It is the Examiner’s position, that, in the absence of criticality, Kreindel teaches or at least reasonably suggests a surface area of electrode(s) that would fall within the claimed numerical range.
Claims 3-4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz ‘705 in view of Wolf and Kreindel as applied to claim 2 above, and further in view of US Patent Application Publication No. 2017/0348539 to Schwarz et al. (hereinafter referred to as “Schwarz ‘539”).
With respect to claims 3-4, Schwarz ‘705 in view of Wolf and Kreindel teaches the device of claim 2, but does not expressly teach a pump (a vacuum pump), wherein the applicator further comprises a suction opening coupled to the pump (and providing a vacuum to the suction opening thereby causing a coupling of the applicator to the treatment area). However, Schwarz ‘539, in a related art: device including RF energy for soft tissue treatment, teaches a vacuum pump for controlling the pressure in the cavity under the applicator (e.g., paragraph [0124] of Schwarz ‘539), and at least one vacuum aperture (suction opening) through which a vacuum may be delivered under the applicator (e.g., paragraphs [0092]-[0093] of Schwarz ‘539). Accordingly, one of ordinary skill in the art would have recognized the benefits of a pump and an applicator with a suction opening in view of the teachings of Schwarz ‘539. Consequently, one of ordinary skill in the art would have modified the applicator of Schwarz ‘705 to have a vacuum pump and a suction opening coupled to the vacuum pump in order to attach the applicator to the patient’s surface as taught by Schwarz ‘539, and because the combination would have yielded the predictable result of an applicator of RF therapy and electrotherapy being attached to the patient’s treatment area.
As to claim 8, Schwarz ‘705 in view of Wolf, Kreindel, and Schwarz ‘539 teaches the device of claim 3, wherein the applicator comprises between 1 to 40 suction openings (e.g., paragraph [0093] of Schwarz ‘539: at least one inlet/outlet vacuum aperture providing a vacuum to the cavity under the applicator). One of ordinary skill in the art would have modified the applicator of Schwarz ‘705 in view of Wolf further to have 1 to 40 suction openings coupled to the vacuum pump in order to attach the applicator to the patient’s surface as taught by Schwarz ‘539, and because the combination would have yielded the predictable result of an applicator of RF therapy and electrotherapy being attached to the patient’s treatment area.
Claims 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz ‘705 in view of Wolf, Kreindel, and Schwarz ‘539 as applied to claim 3 above, and further in view of US Patent Application Publication No. 2018/0236254 to Schwarz et al. (hereinafter referred to as “Schwarz ‘254”).
With respect to claim 5, Schwarz ‘705 in view of Wolf, Kreindel, and Schwarz ‘539 teaches the device of claim 3, but does not expressly teach that the pump is configured to provide a positive pressure to the suction opening. However, Schwarz ‘254, in a related art: aesthetic treatment method for enhancing a visual appearance of the patient, teaches that it was known in the art to treat a patient with an electromagnetic field and a device providing mechanical waves and/or pressure (e.g., paragraph [0523] of Schwarz ‘254) where the mechanical treatment applies a pressure such as positive or negative (e.g., paragraphs [0030], [0518]-[0519] of Schwarz ‘254) in order to quicken the results achieved by the magnetic field. Accordingly, one of ordinary skill in the art before the effective filing date of the claimed invention would have recognized the benefits of providing a positive pressure to the suction opening of an applicator treating the visual appearance of a patient in view of the teachings of Schwarz ‘254. Consequently, one of ordinary skill in the art would have modified the pump of Schwarz ‘705 in view of Wolf and Schwarz ‘539 so that it is configured to provide a positive pressure to the suction opening in order to quicken the results achieved by the RF and electrotherapy treatments as taught by Schwarz ‘254, and because the combination would have yielded predictable results.
As to claim 6, Schwarz ‘705 in view of Wolf, Kreindel, Schwarz ‘539, and Schwarz ‘254 teaches the device of claim 5, wherein the positive pressure is provided in pulses to cause a massage of the treatment area (e.g., paragraphs [0134] and [0136] of Schwarz ‘539: changing pressure value under the applicator may be cyclically repeated during the therapy and the effect may be used as massage of the adjacent soft tissue). Consequently, one of ordinary skill in the art would have modified the pump of Schwarz ‘705 in view of Wolf, Schwarz ‘539 and Schwarz ‘254 so that the positive pressure is provided in pulses (changed cyclically) to cause a massage of the treatment area as taught by Schwarz ‘539, and because the combination would have yielded predictable results.
With respect to claim 7, Schwarz ‘705 in view of Wolf, Kreindel, Schwarz ‘539, and Schwarz ‘254 teaches the device of claim 6, wherein the positive pressure is higher than an atmospheric pressure in a range of 10 Pa to 30,000 Pa (e.g., paragraph [0138] of Schwarz ‘539: the pressure value under the applicator may be changed compared to pressure in the room (atmospheric pressure) during treatment in the range from 0.1 to 100k Pa or 0.5kPa to 20 kPa -within the claimed range). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device as taught by Schwarz ‘705 in view of Wolf, Schwarz ‘539 and Schwarz ‘254 with the claimed positive pressure greater than an atmospheric pressure in the range of 10 Pa to 30, 000Pa, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233].
Claim 9-12 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz ‘705 in view of Kreindel.
Regarding claim 9, Schwarz ‘705 discloses a device for non-invasive improvement of a visual appearance of a patient(e.g., Abstract and paragraph [0009]: device for improving skin viability, skin and body rejuvenation, skin tightening scar removing, etc.), the device comprising :an electrode configured to be in contact with a treatment area of a body of the patient (e.g., Abstract: the device in contact with the patient’s body has at least one electrode); a main unit (e.g., Fig. 1, 101, 102, 103), comprising: a first generator configured to generate radiofrequency energy (e.g., paragraph [0012]: a source of energy to provide RF therapy); a second generator configured to generate electric current with a frequency in a range of 0.1 Hz to 12 kHz (e.g., paragraph [0012]: a source of energy to provide electrotherapy; paragraphs [0079]-[0084]: effects of electrotherapy can be achieved at frequencies between 0.1 to 150 Hz depending on the nerve/muscle targeted; or between 5-12 kHz if galvanic intermittent current is applied); and a control unit configured to control the first generator and the second generator (e.g., paragraph [0127] of Schwarz ‘705: power supply 101 is managed by control unit 102 by controlling regulation of delivered energy where control unit 102 has influence on treatment parameters of the therapy including therapy time, amount of delivered energy, frequency of provided energy, intensity of energy, controlling switching on/off different groups of electrode/s, shape of pulses, etc.); and a conductive lead configured to couple the electrode with the second generator (e.g., paragraph [0121]: electrodes providing electrotherapy may connect to the rest of the device by wire and its power supply 101; paragraph [0125]: system may comprise power supply 101, control unit 102, and applicator/device 104 providing RF therapy and electrotherapy), wherein the electrode is configured to deliver the radiofrequency energy from the first generator to the treatment area, thereby causing heating of skin of the treatment area (e.g., paragraph [0056]: the electrode may be used as a source of energy for electrotherapy and RF therapy; and paragraph [0021]: RF therapy provides thermal effects in the patient’s soft tissue including a patient’s skin), and to deliver the electric current from the second generator to the treatment area (e.g., paragraph [0056]: the electrode may be used as a source of energy for electrotherapy and RF therapy; paragraph [0026]: Preferred treatment energy sources are electrodes providing RF therapy and/or electrotherapy. Treatment energy is included in RF waves and/or electric current; and paragraph [0020]: electrotherapy or electrostimulation is the application of electrical energy (current) into the soft tissue for medical and aesthetic treatment with minimal and/or no thermal effect in soft tissue/skin), thereby causing a muscle contraction within the treatment area (e.g., paragraphs [0026]: treatment energy is an energy with a treatment effect (e.g., muscle contraction …; [0044]: the effect of electrotherapy may be muscle contraction; [0099: muscle stimulation may be at least partial muscle contraction; and [0112]-[0113]), in order to improve the visual appearance of the patient (e.g., paragraph [0009]: above).
Schwarz ‘705 differs from the claimed invention in that it does not expressly disclose 1) that a conductive lead couples the electrode with the first generator (RF therapy), 2) the treatment area comprises a forehead, a submentum, a left cheek, a right cheek, a periorbital area, a jaw area, or a perioral area, and 3) that a surface area of the electrode is configured to fit over the treatment area and is in a range of 1 cm2 to 25 cm2.
With respect to 1), Schwarz ‘705 discloses that preferred treatment energy sources are electrodes for RF therapy, but does not expressly state that a conductive wire couples the RF electrode with the RF generator/power source. In order for RF therapy to work the power source/generator would necessarily be coupled to the electrode. It is submitted that one of ordinary skill in the art would have understood that a wireless connection (e.g., paragraph [0122]: wireless electrode includes its own power supply and may include hardware to communicate with the control unit to provide RF therapy and/or electrotherapy) or a wire connection would achieve that goal. Since electrotherapy is expressly disclosed as being coupled to its power source via a wire (conductive lead) in paragraph [0121], one of ordinary skill in the art would have recognized that the electrode for RF therapy could be connected to the power source/generator via a wire, as well. Consequently, one of ordinary skill in the art would have modified the wire (conductive lead) of Schwarz ‘705 to be coupled to both the RF therapy generator and the electrotherapy generator as such was a well-known engineering expedient to provide power to electrodes as taught by Schwarz ‘705, and because the combination would have yielded predictable results.
As to 2)-3), while Schwarz ‘705 expressly discloses that the treatment area is on the patient’s body (e.g., abstract of Schwarz ‘705), Kreindel, in a related art: RF device for skin and fat treatment, teaches that its system can be used for treatment of the face, neck and other body areas, such as the left cheek as shown in Fig. 1 using 4 identical elements having RF electrodes 25, 26, 27 as shown in Fig. 2 (e.g., paragraphs [0016] and [0023] of Kreindel, and that applicators intended for body treatment may have larger elements to cover larger area and for deeper RF energy penetration, while facial or neck applicators may have smaller elements (e.g., paragraph [0016] of Kreindel). Consequently, one of ordinary skill in the art would have recognized the benefits of using facial areas, including the cheek area and neck areas as the soft tissue treatment area in view of the teachings of Kreindel. Consequently, one of ordinary skill in the art would have modified the device of Schwarz so that the applicator treats a facial, such as the cheek area or neck area of the body with an electrode area configured to fit over the treatment area in view of the teachings of Kreindel, and because the combination would have yielded a predictable result.
With respect to the surface area of the electrode(s) of the applicator, Kreindel teaches that the cheek area of a user would benefit from RF treatment, and it has been held by the courts 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. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). It is the Examiner’s position, that Kreindel teaches or at least reasonably suggests a surface area of electrode(s) that would fall within the claimed numerical range (i.e., 1 cm2 to 25 cm2) in order to cover the left cheek of an infant to an adult.
With respect to claim 10, Schwarz ‘705 in view of Kreindel teaches the device of claim 9, further comprising a pad configured to be attached to the treatment area, wherein the pad comprises the electrode. Kreindel, in a related art: RF device for skin and fat treatment, teaches an applicator 11 connected to an RF generator 13 where the applicator is treating a cheek of a patient (e.g., Fig. 1 of Kreindel) and each applicator comprises multiple RF elements (electrode) coupled to the skin where the applicator connects the multiple elements (electrodes) with a pad (e.g., paragraphs [0005]-[0007] of Kreindel). Accordingly, one of ordinary skill in the art would have recognized that a pad attached to the treatment area where the pad comprises the electrode was a known device for applying RF treatment to the face of the patient in view of the teachings of Kreindel. Consequently, one of ordinary skill in the art would have modified the device of Schwarz ‘705 in view of Kreindel further to have a pad comprising the electrode in view of the teachings of Kreindel that such was a known engineering expedient to treat the right cheek of a patient, and because the combination would have yielded predictable results.
As to claims 11-12, Schwarz ‘705 in view of Kreindel teaches the device of claim 10, further comprising a band or a felt configured to fix the pad to the treatment area where the band or felt is made from an elastic material (e.g., paragraph [0022] of Kreindel: Fig. 1, belt 12 is made from an elastic material and can be adjusted for an individual patient). One of ordinary skill in the art would have modified the device of Schwarz ‘705 in view of Kreindel further to have a band (belt) made from elastic in view of the teachings of Kreindel that such was a known engineering expedient to hold the device to the face of a patient, and because the combination would have yielded predictable results.
As to claim 30, Schwarz’ 705 in view of Wolf and Kreindel teaches the device of claim 9, but does not expressly teach that the surface area of the electrode is in a range of 2 cm2 to 9.5 cm2. However, Kreindel teaches that the cheek area of a user would benefit from RF treatment, and it has been held by the courts 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. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). It is the Examiner’s position, that, in the absence of criticality, Kreindel teaches or at least reasonably suggests a surface area of electrode(s) that would fall within the claimed numerical range.
Claims 10 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz ‘705 in view of Kreindel as applied to claim 9 above, and further in view of US Patent Application Publication No. 2022/0001175 to Ko et al. (hereinafter referred to as “Ko”).
With respect to claim 10, Schwarz ‘705 in view of Kreindel teaches the device of claim 9, but does not expressly teach a pad configured to be attached to the treatment area. Ko, in a related art: facial muscle treatment comprising stimulation electrode, teaches a device comprising a pad configures to be attached to the treatment area where the pad comprises the electrode (e.g., paragraphs [0037], [0076], [0135], and [0139]-[0140]; Figs. 1, 14-15, electrode pad 10, base/pad 100 electrodes 200). One of ordinary skill in the art would have modified the device of Schwarz ‘705 in view of Schwarz ‘254 further to have a pad configured to be attached to the treatment area where the pad comprises the electrode in view of the teachings of Ko that such was a known engineering expedient to apply electrotherapy, and because the combination would have yielded predictable results.
As to claim 13, Ko further teaches that the device comprises a mask, wherein the pad is coupled to the mask, and wherein the mask is configured to provide attachment of the pad to the treatment area (e.g., paragraphs [0135]-[0140] of Ko, and Figs. 14-15 of Ko: mask 20, electrode pad 10). One of ordinary skill in the art would have modified the device of Schwarz ‘705 in view of Kreindel and Ko further to have a mask coupled to the pad comprising the electrode in view of the teachings of Ko that such was a known engineering expedient to treat the face of a patient, and because the combination would have yielded predictable results.
With respect to claim 14, Ko further teaches that the mask covers from 5 % to 100 % of the face of the patient (see Figs. 14-15 of Ko, mask covers forehead, chin area, left and right cheeks of a patient’s face). One of ordinary skill in the art would have modified the device of Schwarz ‘705 in view of Kreindel and Ko further to have a mask that covers 5% to 100% of a patient’s face in view of the teachings of Ko that such was a known engineering expedient to treat the face of a patient, and because the combination would have yielded predictable results.
As to claim 15, Ko further teaches that the mask is elastic (e.g., paragraphs [0108]-[0112] of Ko: a graphene layer 800 is made from high elasticity material, and thus is elastic). One of ordinary skill in the art would have modified the device of Schwarz ‘705 in view of Kreindel and Ko further to have a mask that is made from elastic in view of the teachings of Ko that such was a known engineering expedient to treat the face of a patient, and because the combination would have yielded predictable results.
With respect 16, Ko further teaches that the mask is rigid or semi rigid (e.g., paragraph [0093] of Ko: electrode pad 10 is formed of rigid material). One of ordinary skill in the art would have modified the device of Schwarz ‘705 in view of Kreindel and Ko further to have a mask with an elastic part (semi-rigid) or a rigid part in view of the teachings of Ko that such were known engineering expedients to treat the face of a patient, and because the combination would have yielded predictable results.
Claims 17 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz ‘705 in view of Wolf and Kreindel.
Referring to claim 17, Schwarz ‘705 discloses a device for providing radiofrequency and an electric current (e.g., Abstract: electrotherapy and radiofrequency therapy are provided to soft tissue; paragraph [0002]: devices for providing aesthetic soft tissue treatment via application of RF and electric currents into the human and/or animal soft tissue), the device comprising: an electrode configured to be coupled to a treatment area of a body of the patient (e.g., Abstract: the device in contact with the patient’s body has at least one electrode); a main unit (e.g., Fig. 1, 101, 102, 103), comprising a first generator configured to generate radiofrequency energy (e.g., paragraph [0012]: a source of energy to provide RF therapy); and a second generator configured to generate electric current (e.g., paragraph [0012]: a source of energy to provide electrotherapy); a conductive lead configured to couple the electrode with the first generator and the second generator (e.g., paragraph [0121]: electrodes providing electrotherapy may connect to the rest of the device by wire and its power supply 101; paragraph [0125]: system may comprise power supply 101, control unit 102, and applicator/device 104 providing RF therapy and electrotherapy); and a control unit configured to control the first generator and the second generator (e.g., paragraph [0062]: controlling the electrode by control unit 102 includes changing parameters of produced energy … type of produced therapy); and a conductive lead configured to couple the electrode with the second generator (e.g., paragraph [0121]: electrodes providing electrotherapy may connect to the rest of the device by wire and its power supply 101; paragraph [0125]: system may comprise power supply 101, control unit 102, and applicator/device 104 providing RF therapy and electrotherapy) wherein the electrode is configured to deliver the radiofrequency energy from the first generator to the treatment area, thereby causing heating of a skin of the treatment area (e.g., paragraph [0056]: the electrode may be used as a source of energy for electrotherapy and RF therapy; and paragraph [0021]: RF therapy provides thermal effects in the patient’s soft tissue including a patient’s skin), and wherein the electrode is configured to deliver the electric current from the second generator to the treatment area (e.g., paragraph [0056]: the electrode may be used as a source of energy for electrotherapy and RF therapy; paragraph [0026]: Preferred treatment energy sources are electrodes providing RF therapy and/or electrotherapy. Treatment energy is included in RF waves and/or electric current; and paragraph [0020]: electrotherapy or electrostimulation is the application of electrical energy (current) into the soft tissue for medical and aesthetic treatment with minimal and/or no thermal effect in soft tissue/skin) with a current density in a range of 0.1 mA/cm2 to 30 mA/cm2 (e.g., paragraph [0106]: current density of electrotherapy may be between 0.1 mA x cm-2 and 30 mA x cm-2), thereby causing a muscle contraction within the treatment area (e.g., paragraphs [0026]: treatment energy is an energy with a treatment effect (e.g., muscle contraction …; [0044]: the effect of electrotherapy may be muscle contraction; [0099: muscle stimulation may be at least partial muscle contraction; and [0112]-[0113]), in order to improve the visual appearance of the patient (e.g., paragraph [0009]: above).
Schwarz ‘705 differs from the claimed invention in that it does not expressly disclose that 1) a conductive lead couples the electrode with the first generator (RF therapy), 2) that its electrode comprises a copper, aluminum, lead, silver, gold, or graphite; 3) a surface area of the electrode is configured over the treatment area, which is in the range of 1 cm2 to 25 cm2, and the treatment area comprises a forehead, a submentum, a left cheek, a right cheek, a periorbital area, a jaw line, or a perioral area, and 4) the first generator (providing RF energy) has output power in a range of 1W to 200 W.
With respect to 1), Schwarz ‘705 discloses that preferred treatment energy sources are electrodes for RF therapy, but does not expressly state that a conductive wire couples the RF electrode with the RF generator/power source. In order for RF therapy to work the power source/generator would necessarily be coupled to the electrode. It is submitted that one of ordinary skill in the art would have understood that a wireless connection (e.g., paragraph [0122]: wireless electrode includes its own power supply and may include hardware to communicate with the control unit to provide RF therapy and/or electrotherapy) or a wire connection would achieve that goal. Since electrotherapy is expressly disclosed as being coupled to its power source via a wire (conductive lead) in paragraph [0121], one of ordinary skill in the art would have recognized that the electrode for RF therapy could be connected to the power source/generator via a wire, as well. Consequently, one of ordinary skill in the art would have modified the wire (conductive lead) of Schwarz ‘705 to be coupled to both the RF therapy generator and the electrotherapy generator as such was a well-known engineering expedient to provide power to electrodes as taught by Schwarz ‘705, and because the combination would have yielded predictable results.
As to the 2) and 4), Wolf, in a related art: RF treatment of body tissue, teaches that its treatment electrodes or energy delivery elements can comprise aluminum, silver or gold (e.g., paragraph [0194] of Wolf) and that the RF generator is configured to run between about 1 and 100 Watts (e.g., paragraph [0196] of Wolf). Accordingly, one of ordinary skill in the art would have recognized the benefits of an aluminum, silver or gold electrode and of an RF electrode generator having an output of power in the claimed range in view of the teachings of Wolf. Consequently, one of ordinary skill in the art would have modified the electrode of Schwarz ‘705 to comprise aluminum, silver, or gold and the first generator of Schwarz ‘705 to output power within 1 W and 200 W in view of the teachings of Wolf that such were known electrode materials used to apply RF energy and that the claimed output power was a known effective power to deliver RF therapy to tissue, and because the combination would have yielded the predictable result of RF therapy to tissue.
With respect to 3), Kreindel, in a related art: RF device for skin and fat treatment, teaches that its system can be used for treatment of the face, neck and other body areas, such as the left cheek as shown in Fig. 1 using 4 identical elements having RF electrodes 25, 26, 27 as shown in Fig. 2 (e.g., paragraphs [0016] and [0023] if Kreindel, and that applicators intended for body treatment may have larger elements to cover larger area and for deeper RF energy penetration, while facial or neck applicators may have smaller elements (e.g., paragraph [0016] of Kreindel). Consequently, one of ordinary skill in the art would have recognized the benefits of using facial areas, including the cheek area and neck areas as the soft tissue treatment area in view of the teachings of Kreindel. Consequently, one of ordinary skill in the art would have modified the device of Schwarz so that the applicator treats a facial, such as the cheek area or neck area of the body with an electrode area configured to fit over the treatment area in view of the teachings of Kreindel, and because the combination would have yielded a predictable result.
With respect to the surface area of the electrode(s) of the applicator, Kreindel teaches that the cheek area of a user would benefit from RF treatment, and it has been held by the courts 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. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). It is the Examiner’s position, that Kreindel teaches or at least reasonably suggests a surface area of electrode(s) that would fall within the claimed numerical range (i.e., 1 cm2 to 25 cm2) in order to cover the left cheek of an infant to an adult.
With respect to claim 31, Schwarz’ 705 in view of Wolf and Kreindel teaches the device of claim 9, but does not expressly teach that the surface area of the electrode is in a range of 2 cm2 to 9.5 cm2. However, Kreindel teaches that the cheek area of a user would benefit from RF treatment, and it has been held by the courts 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. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). It is the Examiner’s position, that, in the absence of criticality, Kreindel teaches or at least reasonably suggests a surface area of electrode(s) that would fall within the claimed numerical range.
Claims 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz ‘705 in view of Wolf and Kreindel, as applied to claim 17 above, and further in view of US Patent Application Publication No. 2018/0272118 to Goldwasser et al. (hereinafter referred to as “Goldwasser”).
With respect to claim 18, Schwarz ‘705 in view of Wolf and Kreindel teaches the device of claim 17, but does not expressly teach that the device comprises a garment configured to be mounted on the body of the patient, wherein the electrode is coupled to the garment, and wherein the garment is configured to provide the attachment of the electrode to the treatment area. However, Goldwasser, in a related art: transdermal electrical stimulation at the neck, teaches that a device comprising an electrode configured to be coupled to a treatment area of a body of the patient includes a neck-worn device comprising a garment/clothing (e.g., Figs. 36A-36D of Goldwasser) where the electrode pad 3608 is coupled to the garment 3603, and the garment is configured to provide the attachment of the electrode to the treatment area (e.g., paragraph [0178] of Goldwasser). Accordingly, one of ordinary skill in the art would have recognized the benefits of an electrode coupled to a garment worn by a patient where the garment provides attachment of the electrode to the treatment area in view of the teachings of Goldwasser. Consequently, one of ordinary skill in the art would have modified the device of Schwa