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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 26 May 2026. As directed by the amendment: claims 1, 4-7, 10-11, 15, and 18-19 have been amended, no claims have been canceled, and no claims have been added. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Double Patenting
Applicant’s arguments, see Remarks, filed 26 May 2026, with respect to the double patenting rejections regarding U.S. Patent Nos. 10,583,287, 11,458,307, and 11,623,083 have been fully considered and are persuasive. The double patenting rejections regarding U.S. Patent Nos. 10,583,287, 11,458,307, and 11,623,083 have been withdrawn.
The claims of U.S. Patent Nos. 10,583,287, 11,458,307, and 11,623,083 do not require a control unit configured to control the first treatment energy and the second treatment energy, as required by claims 1, 8, and 15 of the instant application.
The double patenting rejection regarding claim 1 of the instant application and claims 1, 4, and 8 of U.S. Patent No. 11896821 is maintained for reasons explained in detail below.
Claim Rejections - 35 USC §102
Applicant’s arguments, see Remarks, filed 26 May 2026, with respect to the rejections of claims 1-3, 15 and 16 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Shalev et al. (US 20120271206 A1, cited in IDS filed 12 Feb 2024), hereinafter Shalev, and Muccio (US 20110071595 A1).
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: All reference characters in Fig. 3. The specification does not include any mention or description of Fig. 3.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Shalev et al. (US 20120271206 A1, cited in IDS filed 12 Feb 2024), hereinafter Shalev, in view of Muccio (US 20110071595 A1).
Regarding claim 1, Shalev discloses a device for a treatment of a patient (Fig. 5, paragraph [0033], device 110), comprising:
a first applicator (Fig. 1, paragraph [0023], head 115),
wherein the first applicator is configured to provide a first treatment energy to heat tissue of the body part of the patient (paragraph [0025], "Heating the adipose layer 140 using RF energy 130");
a second applicator (Fig. 1, paragraph [0023], head 115),
wherein the second applicator is configured to provide a second treatment energy to stimulate a muscle of the body part of the patient (paragraph [0026], "Stimulating the muscles 150 below the adipose layer 140 with an electrical muscle stimulation (EMS) signal"), and
wherein the second treatment energy is a pulsed biphasic electric current causing a contraction of the muscle (paragraph [0033], "fat reduction device 110 also includes an electric pulse (EP) generator 520 that provides low current DC pulse signals, for example between +500 ma to −500 ma to cause the muscles 150 to expand and contract"); and
a control unit configured to control the first treatment energy and the second treatment energy (paragraph [0033], "fat reduction device 110 includes a control board 530 that determines the actions of the device. Optionally, control board 530 may be a general purpose computer or a dedicated circuit. Control board 530 controls the duration, intensity, frequency and any other parameters of the electric pulses of the electrical current 310 for stimulating the muscles 150, and the RF energy 130 for heating the adipose layer 140. Additionally, the control board 530 determines the timing for applying the EP signal and the RF signal").
Shalev does not explicitly disclose that the first and second applicators are configured to be in a stationary position during the treatment and to be attached to the body part of the patient by a flexible belt or by an adhesive material, nor that the second treatment energy has a current density in a range of 0.1 mA/cm2 to 30 mA/cm2.
However, Muccio teaches a system for stimulating muscles using at least one electrode to deliver electrical impulses sufficient to induce muscle contractions (Abstract), wherein the applicator is configured to be in a stationary position during the treatment and to be attached to the body part of the patient by a flexible belt (paragraph [0021], " Each assembly 20 typically includes a fabric sleeve 30, which acts as a substrate or support for the components thereof"), and
wherein the second treatment energy is a pulsed biphasic electric current having a current density in a range of 0.1 mA/cm2 to 30 mA/cm2 (paragraph [0025], "with a circumferential electrode, a current density of 100 mA equals 100 mA per 25 square inches or 4 mA per square inch"; 4 mA/in2 = 0.62 mA/cm2) causing a contraction of the muscle (paragraph [0020], "The electrode is supplied with electrical impulses to induce muscle contractions').
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalev with the teachings of Muccio so that the first and second applicators are configured to be in a stationary position during the treatment and to be attached to the body part of the patient, and so that the second treatment energy has a current density in a range of 0.1 mA/cm2 to 30 mA/cm2, because doing so provides a device that is easy to implement and does not cause pain or discomfort to the patient (Muccio, paragraphs [0007], [0027]).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a range of 0.1 mA/cm2 to 30 mA/cm2, for the purpose of providing a safe but effective treatment, 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.
Regarding claim 2, the device of claim 1 is obvious over Shalev and Muccio, as explained above. Shalev further discloses that the first applicator and the second applicator are configured to treat different treatment areas of the body part simultaneously (paragraph [0007], "electrical muscle stimulation (EMS) to contract the muscles below the heated area thus providing pressure on the adipose layer from below. The apparatus is designed to apply the above three methods either separately or any combination of them simultaneously: namely, massaging the skin from above, causing electrical muscle stimulation from below, and heating the fatty tissue with RF radiation").
Regarding claim 3, the device of claim 2 is obvious over Shalev and Muccio, as explained above. Shalev further discloses a user interface configured to allow an operator of the device to change or set up parameters of the first treatment energy and the second treatment energy during the treatment (paragraph [0033], "fat reduction device 110 includes a control board 530 that determines the actions of the device. Optionally, control board 530 may be a general purpose computer or a dedicated circuit. Control board 530 controls the duration, intensity, frequency and any other parameters of the electric pulses of the electrical current 310 for stimulating the muscles 150, and the RF energy 130 for heating the adipose layer 140. Additionally, the control board 530 determines the timing for applying the EP signal and the RF signal. In some embodiments of the invention, control board 530 includes a CPU, a memory, and input/output devices, for example a keypad and a screen").
Regarding claim 4, the device of claim 3 is obvious over Shalev and Muccio, as explained above. Shalev further discloses that the first applicator is rigid or semi rigid (paragraph [0039], "massage contacts 560 may be made from a soft material or hard material") and
wherein the first applicator comprises a radiofrequency electrode configured to provide the first treatment energy comprising a radiofrequency field (Fig. 5, paragraph [0033], "fat reduction device 110 includes an RF generator 510 to provide an AC current in the form of a radio frequency (RF) electrical pulse for heating the user's skin 120"; paragraph [0036], electrodes 570),
wherein the second applicator is rigid or semi rigid (paragraph [0039], "massage contacts 560 may be made from a soft material or hard material") and comprises an electrotherapy electrode configured to provide the second treatment energy comprising an electric current (Fig. 5, paragraphs [0036]-[0037], electrodes 570), and
wherein the control unit is configured to provide muscle stimulation followed by relaxation, during continual or pulsed heating (paragraph [0031], "electrical current 310 from the electrical muscle stimulation (EMS) pulse causes the muscles 150 to contract"; paragraph [0033], "fat reduction device 110 also includes an electric pulse (EP) generator 520 that provides low current DC pulse signals, for example between +500 ma to −500 ma to cause the muscles 150 to expand and contract").
Regarding claim 5, the device of claim 3 is obvious over Shalev and Muccio, as explained above. Shalev further discloses that the second applicator comprises an electrotherapy electrode configured to be in contact with the body part and configured to provide the second treatment energy (Fig. 5, paragraphs [0036]-[0037], electrodes 570).
Regarding claim 6, the device of claim 5 is obvious over Shalev and Muccio, as explained above. Shalev further discloses that the first applicator comprises a monopolar radiofrequency electrode configured to be in contact with the body part and configured to provide the first treatment energy (paragraph [0037], "fat reduction device 110 may use a mono-polar configuration wherein one pole of the circuit is represented by one or more electrodes on heads 115 and placed in contact with the user's skin"),
wherein the first treatment energy is a monopolar radiofrequency field having a frequency in a range of 100 kHz to 3.5 MHz (paragraph [0033], "a frequency between 0.5 MHz-2 MHz").
Regarding claim 7, the device of claim 5 is obvious over Shalev and Muccio, as explained above. Shalev further discloses that the first applicator comprises a first treatment energy source configured to provide the first treatment energy (Fig. 5, paragraph [0033], RF generator 510),
wherein the first treatment energy source comprises a thermoelectric element (paragraph [0033], "fat reduction device 110 includes an RF generator 510 to provide an AC current in the form of a radio frequency (RF) electrical pulse for heating the user's skin 120"), and
wherein the first energy is a heating energy configured to provide heating of a skin of the body part in a range of 30 to 50 degrees C (paragraph [0030], "the RF energy is set to heat the fat cells 210 to a level wherein the temperature on the surface of the skin does not exceed 40° C.-45° C").
Regarding claim 8, Shalev discloses a device for a treatment of a patient (Fig. 5, paragraph [0033], device 110), comprising:
an applicator (Fig. 1, paragraph [0023], head 115), the applicator comprising:
a first treatment energy source (Fig. 5, paragraph [0033], RF generator 510) configured to provide a first treatment energy to heat tissue within the body part of the patient to a temperature in a range of 30 to 50 degrees C (paragraph [0030], "the RF energy is set to heat the fat cells 210 to a level wherein the temperature on the surface of the skin does not exceed 40° C.-45° C"); and
a second treatment energy source (Fig. 5, paragraph [0033], electric pulse (EP) generator 520) configured to provide a second treatment energy to stimulate a muscle of the body part of the patient (paragraph [0033], "fat reduction device 110 also includes an electric pulse (EP) generator 520 that provides low current DC pulse signals, for example between +500 ma to −500 ma to cause the muscles 150 to expand and contract"); and
a control unit configured to control the first treatment energy and the second treatment energy (paragraph [0033], "fat reduction device 110 includes a control board 530 that determines the actions of the device. Optionally, control board 530 may be a general purpose computer or a dedicated circuit. Control board 530 controls the duration, intensity, frequency and any other parameters of the electric pulses of the electrical current 310 for stimulating the muscles 150, and the RF energy 130 for heating the adipose layer 140. Additionally, the control board 530 determines the timing for applying the EP signal and the RF signal").
Shalev does not explicitly disclose that the applicator is configured to be in a stationary position during the treatment and to be attached to the body part of the patient by a flexible belt or by an adhesive material.
However, Muccio teaches a system for stimulating muscles using at least one electrode to deliver electrical impulses sufficient to induce muscle contractions (Abstract), wherein the applicator is configured to be in a stationary position during the treatment and to be attached to the body part of the patient by a flexible belt (paragraph [0021], "Each assembly 20 typically includes a fabric sleeve 30, which acts as a substrate or support for the components thereof").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalev with the teachings of Muccio so that the applicator is configured to be in a stationary position during the treatment and to be attached to the body part of the patient by a flexible belt or by an adhesive material, because doing so provides a device that is easy to implement and does not cause pain or discomfort to the patient (Muccio, paragraphs [0007], [0027]).
Regarding claim 9, the device of claim 8 is obvious over Shalev and Muccio, as explained above. Shalev further discloses a user interface configured to allow an operator of the device to change or set up parameters of the first treatment energy and the second treatment energy during the treatment (paragraph [0033], "fat reduction device 110 includes a control board 530 that determines the actions of the device. Optionally, control board 530 may be a general purpose computer or a dedicated circuit. Control board 530 controls the duration, intensity, frequency and any other parameters of the electric pulses of the electrical current 310 for stimulating the muscles 150, and the RF energy 130 for heating the adipose layer 140. Additionally, the control board 530 determines the timing for applying the EP signal and the RF signal. In some embodiments of the invention, control board 530 includes a CPU, a memory, and input/output devices, for example a keypad and a screen"),
wherein the control unit is configured to provide the first treatment energy and the second treatment energy with some overlay during the treatment (paragraph [0007], "The apparatus is designed to apply the above three methods either separately or any combination of them simultaneously: namely, massaging the skin from above, causing electrical muscle stimulation from below, and heating the fatty tissue with RF radiation").
Regarding claim 10, the device of claim 8 is obvious over Shalev and Muccio, as explained above. Muccio further teaches that the second treatment energy is a galvanic current with a current density in a range of 0.05 mA/cm2 to 3 mA/cm2 (paragraph [0025], "with a circumferential electrode, a current density of 100 mA equals 100 mA per 25 square inches or 4 mA per square inch"; 4 mA/in2 = 0.62 mA/cm2) causing a contraction of the muscle (paragraph [0020], "The electrode is supplied with electrical impulses to induce muscle contractions').
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Shalev et al. (US 20120271206 A1, cited in IDS filed 12 Feb 2024), hereinafter Shalev, in view of Muccio (US 20110071595 A1), and further in view of Nachum et al. (US 20180185639 A1), hereinafter Nachum.
Regarding claim 11, the device of claim 8 is obvious over Shalev and Muccio, as explained above. Shalev further discloses that the second treatment energy source is an electrotherapy electrode configured to provide the second treatment energy comprising a pulsed electric current (Fig. 5, paragraph [0036], electrodes 570) having a repetition frequency up to 12 kHz (Fig. 6, paragraph [0040], 10 ms P-pulse period = 0.1 kHz), and configured to increase a flow of blood within the body part (paragraph [0029], "The heating and massaging also increase blood flow").
Shalev does not explicitly disclose that the second treatment energy comprises a pulsed electric current having a voltage on the electrotherapy electrode in a range of 1 V to 100 V.
However, Nachum teaches a non-invasive method and device for promoting a localized change in a flow of blood through a blood vessel in a limb segment of a body by a series of electrically stimulated contractions of muscle tissue in the limb segment (Abstract) wherein the pulse electric current has a voltage on the electrotherapy electrode in a range of 1 V to 100 V (paragraph [0093], "The impulses provided are square waves having an intensity of 60 Volts"; paragraph [0097], "More generally, the voltage differential is up to 80V, and more typically, 30-60V, depending, inter alia, on the impedance of the patient's skin").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalev and Muccio with the teachings of Nachum so that the second treatment energy comprises a pulsed electric current having a voltage on the electrotherapy electrode in a range of 1 V to 100 V, because doing so provides localized increase in the flow of blood (Nachum, paragraph [0107]).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a range of 1 V to 100 V, for the purpose of providing a safe but effective treatment, 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.
Regarding claim 12, the device of claim 11 is obvious over Shalev, Muccio, and Nachum, as explained above. Shalev further discloses that the applicator further comprises a sensor configured to measure a feedback information comprising at least one of a contact of the applicator with the body part (paragraph [0036], "the applicator may include an activation switch 580 to turn on and off fat reduction device 110, Optionally, activation switch 580 may be independently controlled by the user or may be automatically controlled, for example by placing fat reduction device 110 in contact with the user1s body so that an electric circuit is formed or by pressing the fat reduction device 110 against the user's body causing the activation switch 580 to be depressed"), or a temperature of the body part (paragraph [0034], "the control board accepts measurements from various sensors and controls fat reduction device 110 responsive to the measurements, for example temperature readings from a temperature sensor 550, which may include a thermistor or thermocouple monitoring the skin temperature"),
wherein the sensor is configured to provide the feedback information to the control unit (paragraph [0034], "the control board accepts measurements from various sensors"), and
wherein the control unit is configured to automatically stop the treatment based on the feedback information (paragraph [0036], "the applicator may include an activation switch 580 to turn on and off fat reduction device 110").
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Shalev et al. (US 20120271206 A1, cited in IDS filed 12 Feb 2024), hereinafter Shalev, in view of Muccio (US 20110071595 A1), and Nachum et al. (US 20180185639 A1), hereinafter Nachum, and further in view of Duncan et al. (Basic Radiofrequency: Physics and Safety and Application to Aesthetic Medicine, 2014), hereinafter Duncan.
Regarding claim 13, the device of claim 12 is obvious over Shalev, Muccio, and Nachum, as explained above. Although Shalev further discloses that the first treatment energy is a radiofrequency field causing a fat reduction of the body part (paragraph [0028], "The RF energy 130 accelerates natural fat cell metabolism causing the release of liquefied fat from the cells into the extra cellular matrix"), Shalev does not explicitly disclose that the first treatment energy source comprises a resistive radiofrequency electrode, nor that a distance between the resistive radiofrequency electrode and the electrotherapy electrode is in a range of 0.1 cm to 40 cm.
However, Duncan teaches basic science of radiofrequency (RF) and its application in aesthetic medicine (Abstract), wherein the first treatment energy source comprises a resistive radiofrequency electrode (page 3, "RF energy propagates
in the tissue in the form of electrical current between applied electrodes"; page 12, "In the RF range of 200 kHz to 1 MHz, the tissue resistivity significantly dominates in tissue behavior"),
wherein the first treatment energy is a radiofrequency field causing a fat reduction of the body part (page 3, "The RF energy can be delivered in continuous wave (CW) mode, burst mode and pulsed mode (fig. 2). For gradual treatment of large areas, the CW mode is most useful as it allows a slow increase in temperature in bulk tissue. This approach is applied for targeting cellulite, subcutaneous fat, and skin tightening"; page 15, "In aesthetic medicine, the RF applications can be divided into three main groups: ... Minimally invasive treatment for volumetric collagen shrinkage and fat melting"), and
wherein a distance between the electrodes is in a range of 0.1 cm to 40 cm (page 11, "both electrodes have an equal size of 10 mm and the distance between them is 10 mm"; 10 mm = 1 cm).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalev, Muccio, and Nachum with the teachings of Duncan so that the first treatment energy source comprises a resistive radiofrequency electrode, and so that a distance between the resistive radiofrequency electrode and the electrotherapy electrode is in a range of 0.1 cm to 40 cm, because doing so optimizes the penetration depth of the RF heating effect (Duncan, page 5).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a range of 0.1 cm to 40 cm, for the purpose of providing a safe but effective treatment, 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.
Regarding claim 13, the device of claim 12 is obvious over Shalev, Muccio, Nachum, and Duncan, as explained above. Muccio further teaches that the applicator further comprises the adhesive material comprising an adhesive polymer configured to fixedly attach the applicator to the body part, and wherein the applicator is flexible (paragraph [0026], "circumferential electrodes 22, 24 utilize either an adhesive or non-adhesive biogel to interface with the patient's skin. ... The circumferential electrodes of the present invention...are flexible for accommodating the contours of limbs which may vary widely due to variations in underlying muscle and bone").
Claims 15-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Shalev et al. (US 20120271206 A1, cited in IDS filed 12 Feb 2024), hereinafter Shalev, in view of Muccio (US 20110071595 A1), and Moore (US 20150174399 A1).
Regarding claim 8, Shalev discloses a device for a treatment of a patient (Fig. 5, paragraph [0033], device 110), comprising:
an applicator (Fig. 1, paragraph [0023], head 115), the applicator comprising:
a treatment energy source configured to provide a first treatment energy to heat tissue within the body part of the patient (paragraph [0025], "Heating the adipose layer 140 using RF energy 130") and configured to provide a second treatment energy to stimulate a muscle of the body part of the patient (paragraph [0026], "Stimulating the muscles 150 below the adipose layer 140 with an electrical muscle stimulation (EMS) signal"),
wherein the first treatment energy is a radiofrequency field (paragraph [0033], "fat reduction device 110 includes an RF generator 510 to provide an AC current in the form of a radio frequency (RF) electrical pulse for heating the user's skin 120") having a frequency in a range of 0.1 MHz to 25 GHz (paragraph [0033], "a frequency between 0.5 MHz-2 MHz") configured to heat the tissue to a temperature in a range of 30 to 50 degrees C (paragraph [0030], "the RF energy is set to heat the fat cells 210 to a level wherein the temperature on the surface of the skin does not exceed 40° C.-45° C"); and
a control unit configured to control the first treatment energy and the second treatment energy (paragraph [0033], "fat reduction device 110 includes a control board 530 that determines the actions of the device. Optionally, control board 530 may be a general purpose computer or a dedicated circuit. Control board 530 controls the duration, intensity, frequency and any other parameters of the electric pulses of the electrical current 310 for stimulating the muscles 150, and the RF energy 130 for heating the adipose layer 140. Additionally, the control board 530 determines the timing for applying the EP signal and the RF signal").
Shalev does not explicitly disclose that the applicator is configured to be in a stationary position during the treatment and to be attached to the body part of the patient by a flexible belt or by an adhesive material.
However, Muccio teaches a system for stimulating muscles using at least one electrode to deliver electrical impulses sufficient to induce muscle contractions (Abstract), wherein the applicator is configured to be in a stationary position during the treatment and to be attached to the body part of the patient by a flexible belt (paragraph [0021], "Each assembly 20 typically includes a fabric sleeve 30, which acts as a substrate or support for the components thereof").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalev with the teachings of Muccio so that the applicator is configured to be in a stationary position during the treatment and to be attached to the body part of the patient by a flexible belt or by an adhesive material, because doing so provides a device that is easy to implement and does not cause pain or discomfort to the patient (Muccio, paragraphs [0007], [0027]).
Neither Shalev nor Muccio explicitly discloses that the treatment session lasts for a duration in a range of 5 minutes to 40 minutes.
However, Moore teaches a method and device for reducing muscle tension through electrical manipulation by applying a low level current to muscles of a user (Abstract) wherein the treatment session lasts for a duration in a range of 5 minutes to 40 minutes (paragraphs [0023], [0025]-[0026]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalev and Muccio with the teachings of Moore so that the treatment session lasts for a duration in a range of 5 minutes to 40 minutes, because doing so prevents further injury while maintaining efficacy in eliminating or reducing pain caused by injury or disease (Moore, paragraph [0052]).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a range of 5 minutes to 40 minutes, for the purpose of providing a safe but effective treatment, 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.
Regarding claim 16, the device of claim 15 is obvious over Shalev, Muccio, and Moore, as explained above. Shalev further discloses a user interface configured to allow an operator of the device to change or set up parameters of the first treatment energy and the second treatment energy during the treatment (paragraph [0033], "fat reduction device 110 includes a control board 530 that determines the actions of the device. Optionally, control board 530 may be a general purpose computer or a dedicated circuit. Control board 530 controls the duration, intensity, frequency and any other parameters of the electric pulses of the electrical current 310 for stimulating the muscles 150, and the RF energy 130 for heating the adipose layer 140. Additionally, the control board 530 determines the timing for applying the EP signal and the RF signal. In some embodiments of the invention, control board 530 includes a CPU, a memory, and input/output devices, for example a keypad and a screen"),
wherein the control unit is configured to provide the first treatment energy and the second treatment energy with some overlay during the treatment (paragraph [0007], "The apparatus is designed to apply the above three methods either separately or any combination of them simultaneously: namely, massaging the skin from above, causing electrical muscle stimulation from below, and heating the fatty tissue with RF radiation").
Shalev does not explicitly disclose that the user interface allows the operator to select partially predetermined treatment protocol.
However, Moore further teaches a user interface configured to allow an operator of the device to select partially predetermined treatment protocol and to change or set up parameters of the first treatment energy and the second treatment energy during the treatment, wherein the control unit is configured to provide the treatment based on the selected partially predetermined treatment protocol (paragraph [0025], "The sequence of frequencies are predetermined and preferably pre-programmed into the device through a programmable controller").
Regarding claim 17, the device of claim 16 is obvious over Shalev, Muccio, and Moore, as explained above. Shalev further teaches that the treatment energy source comprises a flexible electrode configured to be in contact with the body part during the treatment (paragraph [0039], "massage contacts 560 may be made from a soft material or hard material selected for providing a comfortable feeling to the user while massaging the user's skin 120"). Muccio also further teaches a flexible electrode configured to be in contact with the body part during the treatment (paragraph [0026], "The circumferential electrodes of the present invention...are flexible for accommodating the contours of limbs which may vary widely due to variations in underlying muscle and bone").
Regarding claim 19, the device of claim 18 is obvious over Shalev, Muccio, Moore, and Nachum, as explained above. Shalev further discloses that the treatment energy source comprises an electrode configured to switch between providing the radiofrequency energy and the pulsed electric current (paragraph [0038], "the same electrodes may deliver RF energy 130 and electrical current 310 intermittently") in order to provide skin tightening of the body part (paragraph [0028], "RF energy 130 heats collagen fibers and stimulates fibroblast metabolism resulting in tightening of the skin 120 and an increase in new collagen production").
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Shalev et al. (US 20120271206 A1, cited in IDS filed 12 Feb 2024), hereinafter Shalev, in view of Muccio (US 20110071595 A1), and Moore (US 20150174399 A1), and further in view of Nachum et al. (US 20180185639 A1), hereinafter Nachum.
Regarding claim 18, the device of claim 17 is obvious over Shalev, Muccio, and Moore, as explained above. Shalev further discloses that the second treatment energy source is an electrotherapy electrode configured to provide the second treatment energy comprising a pulsed electric current (Fig. 5, paragraph [0036], electrodes 570) having a repetition frequency up to 12 kHz (Fig. 6, paragraph [0040], 10 ms P-pulse period = 0.1 kHz), and configured to increase a flow of blood within the body part (paragraph [0029], "The heating and massaging also increase blood flow").
Shalev does not explicitly disclose that the second treatment energy comprises a pulsed electric current having a voltage on the electrotherapy electrode in a range of 1 V to 100 V.
However, Nachum teaches a non-invasive method and device for promoting a localized change in a flow of blood through a blood vessel in a limb segment of a body by a series of electrically stimulated contractions of muscle tissue in the limb segment (Abstract) wherein the pulse electric current has a voltage on the electrotherapy electrode in a range of 1 V to 100 V (paragraph [0093], "The impulses provided are square waves having an intensity of 60 Volts"; paragraph [0097], "More generally, the voltage differential is up to 80V, and more typically, 30-60V, depending, inter alia, on the impedance of the patient's skin").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalev, Muccio, and Moore with the teachings of Nachum so that the second treatment energy comprises a pulsed electric current having a voltage on the electrotherapy electrode in a range of 1 V to 100 V, because doing so provides localized increase in the flow of blood (Nachum, paragraph [0107]).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a range of 1 V to 100 V, for the purpose of providing a safe but effective treatment, 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 20 is rejected under 35 U.S.C. 103 as being unpatentable over Shalev et al. (US 20120271206 A1, cited in IDS filed 12 Feb 2024), hereinafter Shalev, in view of Muccio (US 20110071595 A1), and Moore (US 20150174399 A1), and further in view of Hurtado (US 6341237 B1).
Regarding claim 20, the device of claim 19 is obvious over Shalev, Muccio, Moore, and Nachum, as explained above. Shalev further discloses a return electrode (paragraph [0008], "a first electrode of one polarity, and a second electrode of the opposite polarity"), but does not explicitly disclose that the return electrode has a larger surface area than the electrode.
However, Hurtado teaches a device for administrating electro-muscle stimulation (EMS) (Abstract), comprising a return electrode having a larger surface area than a positive electrode (column 12, lines 4-6, "The central return electrode 226 is somewhat larger in surface area than the positive electrodes 222 and 224").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalev, Muccio, Moore, and Nachum with the teachings of Hurtado so that the return electrode has a larger surface area than the electrode, because doing so allows the concentration of stimuli to the return electrode to become dispersed in order to dilute the intensity of the stimulation feed from both positive electrodes (Hurtado, column 12, lines 6-9).
Furthermore, it would have been an obvious matter of design choice to make the return electrode with a larger surface area than the electrode, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 8 of U.S. Patent No. 11,896,821. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims recite a device for a treatment of a patient. A brief mapping of claimed elements is provided below.
Application No. 18/439561 (Instant Application)
U.S. Patent No. 11,896,821
Claim
Element
Claim
Element
1
A device for a treatment of a patient, comprising:
1
A device for providing treatment by radiofrequency field and electric current to a patient, the device comprising:
1
a first applicator configured to be in a stationary position during a treatment and to be attached to a body part of the patient by a flexible belt or by an adhesive material,
1
a first applicator configured to be in a stationary position during the treatment and to be attached to a body part of the patient by a flexible belt or by an adhesive material, the first applicator comprising:
1
wherein the first applicator is configured to provide a first treatment energy to heat tissue of the body part of the patient;
1
a radiofrequency electrode configured to provide a radiofrequency field to heat tissue within the body part of the patient;
1
a second applicator configured to be in a stationary position during the treatment and to be attached to the body part of the patient,
1
a second applicator, comprising:
4
The device of claim 1, wherein the second applicator is configured to be attached to the body part of the patient, and wherein the electrotherapy electrode is configured to be in contact with the body part, when the second applicator is attached to the body part.
1
wherein the second applicator is configured to provide a second treatment energy to stimulate a muscle of the body part of the patient, and
1
an electrotherapy electrode configured to provide electric current to stimulate a muscle of the body part of the patient; and
1
wherein the second treatment energy is a pulsed biphasic electric current having a current density in a range of 0.1 mA/cm2 to 30 mA/cm2 causing a contraction of the muscle; and
8
The device of claim 4, wherein the electric current has a current density in a range of 0.1 mA/cm.sup.2 to 30 mA/cm.sup.2, wherein the stimulation of the muscle causes a contraction of the muscle, and wherein the radiofrequency field has an energy flux density on a surface of the radiofrequency electrode in a range of 0.5 mW/mm.sup.2 to 1 W/mm.sup.2.
1
a control unit configured to control the first treatment energy and the second treatment energy.
1
a control unit configured to: control the radiofrequency field; and control the electric current.
Conclusion
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/CHRISTINE SISON/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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