DETAILED ACTION
This action is a response to the filing on 3/11/2026. Examiner acknowledges the amendments made to claims 1, 9-20, 23-25, 27, 28, 30-31, 35, 37, 39, 41-47, and 50.
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 .
Drawings
The drawings were received on 3/11/2026. These drawings are accepted.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-50 have been considered but are moot because the new ground of rejection relies on a different combination of references that teaches the amended claims.
Applicant has not addressed a 112 rejection of claim 15. Thus, claim 15 is still rejected.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites the limitation "said dynamic magnetic field" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
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.
Claim(s) 1, 3-19, 23, 25, 29, 35-38, 45, and 49-50 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0028831 (Ron Edoute et al., hereinafter Edoute) in view of US 2006/0173518 (Kreindel) in view of US 2010/0049177 (Boone, III et al., hereinafter Boone).
As per claim 1, Edoute discloses an integrated system for increasing skin rejuvenation of a region of a patient's skin and treating a subcutaneous fat region of said patient (an integrated system for increasing skin rejuvenation of a patient's skin and treating a subcutaneous tissue; abstract; paragraph [0269]), said system comprising:
at least one applicator comprising:
at least one RF electrode adapted to be placed on said region of said patient's skin (an integrated system comprising at least two electrodes placed on a skin region of the patient's skin for emitting RF energy; paragraphs [0103], [0104]);
wherein none of said at least one RF electrodes is configured to penetrate said skin (the electrodes are rounded and do not penetrate the skin; figure 1B; paragraph [0103]);
each of said at least one RF electrodes is configured to apply RF energy to said region of a patient's skin to heat up to a temperature T in a range of 25 degrees Celsius to 80 degrees Celsius (the electrodes apply RF energy to the skin to heat up to a temperature T of said region of the skin in the range of 30 to 80 degrees C; paragraphs [0103], [0104], [0116]);
an optical system (an optical device adapted to emit light in wavelengths absorbed by subcutaneous tissue, and thus is in communication with an optical system; paragraphs [0270], [0271]).
Edoute does not disclose at least one second applicator, in communication with an optical system, said optical system comprising: at least one laser source having a wavelength of about 800 nm - 1200 nm; said optical system is adapted to provide a homogeneous illumination to the skin surface to effect at least one target tissue at a depth of from about 1 mm to about 3 cm from said patient's skin's surface, at a power density in the range of 0.2 to 3 w/cm2, nor does Edoute disclose that the laser source is made of a plurality of diodes where each diode is individually activated.
Kreindel discloses an integrated system for increasing skin rejuvenation of a region of a patient's skin and treating a subcutaneous fat region of said patient (a system for skin rejuvenation and for subcutaneous treatment and cellulite treatment; paragraph [0004]), said system comprising:
a. an applicator comprising: at least one RF electrode adapted to be placed on said region of said patient's skin (a pair of electrodes 12 and 14 connected to an RF generator; wherein the electrodes 12 and 14 are placed on the region of the patient's skin; figures 2, 3; paragraphs [0019], [0020]); wherein none of said at least one RF electrodes is configured to penetrate said skin (the electrodes 12 and 14 are rounded to allow for smooth moving of the applicator over the skin surface; paragraph [0020]); each of said at least one RF electrodes is configured to apply RF energy to said region of a patient's skin to heat up to a temperature T in a range of 25 degrees Celsius to 80 degrees Celsius (the RF electrodes 12 and 14 apply RF energy to heat the skin in a range of 42 degrees C to 60 degrees C; paragraphs [0004], [0005], [0025]);
b. an optical system comprising: at least one laser source having a wavelength of about 800 nm - 1200 nm (a laser light source, comprising an optical energy spectrum in the range of 400-1800 nm; paragraph [0021]); said optical system is adapted to provide a homogeneous illumination to the skin surface to effect at least one target tissue at a depth of from about 1 mm to about 3 cm from said patient's skin's surface (a laser light source comprising a single wavelength or several wavelengths, wherein the wavelengths are in the range of 400 to 1800 nm, and so is capable of providing a homogeneous illumination to the skin surface to effect at least one target tissue at a depth of from about 1 mm to about 3 cm from said patient's skin's surface; paragraph [0021]), at a power density in the range of 0.2 to 3 w/cm2 (optical energy power in the range of 1 to 20 W/cm2; paragraph [0031]).
Since Edoute discloses an integrated system that can include an optical device (Edoute; paragraphs [0270], [0271]), it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to have modified the device of Edoute, to include the applicator of Kreindel as a second applicator that would communicates with the optical system, for the advantage of treating skin targets such as vascular lesions, varicose veins, acne, and mole marks (Kreindel; paragraph [0021]).
Edoute and Kreindel do not disclose that the laser source is made of a plurality of diodes where each diode is individually activated. In a related area, Boone discloses a system used for combination skin therapies (title and abstract). Boone has an optical therapy system that can be configured to use a plurality of diodes that allows control of individual LED sources due to each wavelength being used to treat specific skin conditions (Boone; paragraphs [0057])-[0063], [0091]-[009], and [0139]). Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the device of Edoute and Kreindel to use multiple individually controlled diodes in order to be able to configure specific skin therapies as taught by Boone.
In regards to claim 3, Edoute, Kreindel, and Boone disclose the system according to claim 1. Kreindel further discloses wherein said at least one laser source is configured to emit laser energy in the form of radiation having a wavelength of about 1060 nm - 1064 nm (a laser light source, comprising an optical energy spectrum in the range of 400-1800 nm; paragraphs [0021]).
In regards to claim 4, Edoute, Kreindel, and Boone discloses the system according to claim 1. Kreindel further discloses wherein said power density in the range of 0.8 to 1.4 w/cm2 (optical energy power in the range of 1 to 20 W/cm2; paragraph [0031]).
In regards to claim 5, Edoute, Kreindel, and Boone discloses the system according to claim 1. Kreindel further discloses wherein said power density in the range of 0.8 to 2.25 w/cm2 (optical energy power in the range of 1 to 20 W/cm2; paragraph [0031]).
In regards to claim 6, the combination of Edoute, Kreindel, and Boone discloses the system according to claim 1. Edoute further discloses wherein said at least one first applicator additionally comprises an electromagnetic field generator adapted to generate magnetic pulses (an electromagnetic field generated adapted to generate magnetic pulses; paragraph [0243], [0296]).
In regards to claim 7, the combination of Edoute, Kreindel, and Boone discloses the system according to claim 6. Edoute further discloses wherein said at least one first applicator additionally comprises at least one coil (each of said electrodes is at least partially coiled via a coil 42; paragraph [0103]).
In regards to claim 8, the combination of Edoute, Kreindel, and Boone discloses the system according to claim 7. Edoute further discloses wherein at least one of said RF electrodes is encircled by said at least one coil (each of said electrodes is at least partially coiled via a coil 42; paragraph [0103]).
In regards to claim 9, the combination of Edoute, Kreindel and Boone discloses the system according to claim 8. Edoute further discloses wherein each of said at least one RF electrodes is encircled by at least one of said coils to provide RF energy and varied magnetic pulses to said region of a patient's skin (each of said electrodes is at least partially coiled via a coil 42 to provide RF energy and varied magnetic pulses to the region of the patient's skin; paragraph [0103], [0243], [0296]).
In regards to claims 10-11, the combination of Edoute, Kreindel and Boone discloses the system according to claim 6. Edoute further discloses the presence of a control system (6) as part of the system (paragraph [0030], [0041], [0042], [0118], [0252]-[0253], [0301]-[0302] ) where the control system controls parameters including temperature applied to skin, frequency of pulses, and magnetic field strength.
In regards to claim 12, the combination of Edoute, Kreindel, and Boone discloses the system according to claim 1. Edoute further discloses wherein said second at least one applicator additionally comprising cooling means adapted to cool said skin region (the device includes a mechanism for skin cooling; paragraph [0274]).
In regards to claim 13, the combination of Edoute, Kreindel, and Boone discloses the system according to claim 6. Edoute further discloses wherein a shape of said at least one coil is selected from a group consisting of a helical coil (as shown; figure 5), a spiral coil, a flat coil, a planar coil, a circular coil, a helical coil with a pitch and any combination thereof.
In regards to claim 14, the combination of Edoute, Kreindel, and Boone discloses the system according to claim 11. Edoute further discloses wherein a magnetic field is a time varying magnetic field (dynamic magnetic field which varies with time; paragraph [0243]).
In regards to claim 15, the combination of Edoute, Kreindel, and Boone discloses the system according to claim 14. Edoute further discloses wherein a shape of at least one pulse applied by said time varying magnetic field is selected from the group consisting of a square wave, a sine wave, a triangular wave, a sawtooth wave, a ramp wave, a spiked wave and any combination thereof (paragraph [02581).
In regards to claim 16, the combination of Edoute, Kreindel, and Boone discloses the system according to claim 14. Edoute further discloses wherein a magnetic flux ranges between about 15 gauss and about 3 Tesla (electing the magnetic field intensity B of each pulse applied by said step of applying pulsed electromagnetic therapy to said region to be higher than about and lower than about 3 Tesla; paragraph [0296]).
In regards to claim 17, the combination of Edoute, Kreindel, and Boone discloses the system according to claim 14. Edoute further discloses wherein a duration of each pulse of said magnetic pulses ranges between about 0.2 and about 1000 milliseconds (magnetic pulses generated comprising a duration of about 5 milliseconds; paragraph [0243]).
In regards to claim 18, the combination of Edoute, Kreindel, and Boone discloses the system according to claim 14. Edoute further discloses wherein a frequency of said magnetic pulses ranges between about 1 Hz and about 1 MHz (pulses at a frequency of 16 Hz; paragraph [0243]).
In regards to claim 19, Kreindel discloses the system according to claim 1. Kreindel further discloses wherein power of said at least one RF electrode ranges between about 1 and about 250 watts (an RF power in the range of 2-10 Watts; paragraph [0027]) and frequency of said pulses ranges between about 1 MHz - 40 MHz (an RF frequency in the range of 0.2-10 MHz; paragraph [0029]).
In regards to claim 23, the combination of Edoute, Kreindel, and Boone discloses the system according to claim 1. Edoute further discloses additionally comprising at least one third applicator adapted to provide an electrical signal so as to provide electrical stimulation (an electrical output device to provide an electrical current to the skin; paragraphs [0235]-[0238]).
In regards to claim 25, the combination of Edoute, Kreindel, and Boone discloses the system according to claim 23. Edoute further discloses wherein said electric signal is adapted to provide electrical stimulation to stimulate at least one selected from a group consisting of muscles, tissue (the electrical current is applied to the skin; paragraphs [0235]-[0238]), nerve and any combination thereof.
In regards to 29, the combination of Edoute, Kreindel, and Boone discloses the system according to claim 23. Edoute does not disclose wherein at least one of the following is being held true: a. said at least one first and at least one second applicators are integrated into a single applicator; b. said at least one first and at least one third applicators are integrated into a single applicator; c. said at least one third and at least one second applicators are integrated into a single applicator; d. said at least one first, at least one second and at least one third applicators are integrated into a single applicator. Kreindel discloses an applicator that integrates the application of two different therapy types into a single applicator (RF electrodes 12 and 14 and light source 21 are integrated into a single applicator 2; figure 3; paragraphs [0020], [0021]). It would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to have modified the system of Edoute and Kreindel, said at least one first and at least one second applicators are integrated into a single applicator, as taught by Kreindel, for the advantage of being able to use a single hand-held device to deliver multiple forms a skin treatment.
In regards to claim 35, Kreindel discloses the system according to claim 1. Kreindel further discloses wherein said at least one first applicator and said at least one second applicators are integrated into a single applicator (RF electrodes 12 and 14 and light source 21 are integrated into a single applicator 2; figure 3; paragraphs [0020], [0021]).
As per claim 36, the combination of Edoute, Kreindel, and Boone discloses the limitations of claim 29. Edoute further discloses wherein said at least one first applicator additionally comprises an electromagnetic field generator adapted to generate magnetic pulses (an electromagnetic field generated adapted to generate magnetic pulses; paragraph [0243], [0296]).
As per claim 37, Edoute, Kreindel, and Boone discloses the limitations of claim 23. In addition, as noted in the rejection of claim 1, Edoute has an integrated system comprising at least two electrodes (a plurality of first applicators) placed on a skin region of the patient's skin for emitting RF energy (paragraphs [0103], [0104]). Thus, meeting the limitations of the claim.
As per claim 38, Edoute and Kreindal discloses the limitations of claim 37. In addition, Edoute states in paragraphs [0095], [0148], and [0328], that the therapies can be applied simultaneously, sequentially, or individually, which suggests individual activation of applicators as one of the therapy paradigms.
As per claims 45 and 49, Edoute, Kreindel, and Boone discloses the limitations of claims 1 and 23. In addition, Edoute discloses the presence of several sensor types including ones that sense temperature of the tissue (paragraphs [0042]-[0045], [0118]-[0121], and [0253]-[0256]), which makes the sensor adapted to provide real-time thermal feedback from the tissue.
As per claim 50, Edoute, Kreindel, and Boone disclose the limitations of claim 1. Edoute describes in paragraphs [0127] the step of obtaining the system and applying heat to the subcutaneous tissue up to a temperature T energy to said region of a patient's skin to heat up to the temperature T. Edoute states in paragraphs [0095], [0148], and [0328], that the therapies can be applied simultaneously, sequentially, or individually. Kreindal shows that application of radiation in the form of a laser with a wavelength from 400-1800 nm (paragraph [0021]). Since Edoute discloses an integrated system that can include an optical device (Edoute; paragraphs [0270], [0271]), it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to have modified the method of Edoute, to include the radiation using the second applicator of Kreindel that comprises the optical system, for the advantage of treating skin targets such as vascular lesions, varicose veins, acne, and mole marks (Kreindel; paragraph [0021]).
While the wavelength disclosed by Kreindel is larger than the claimed range, one of ordinary skill in the art would have been motivated to arrive at the claimed range to optimize therapeutic outcomes for the patient.
Claim(s) 2 and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over (Ron Edoute et al., hereinafter Edoute) in view of US 2006/0173518 (Kreindel) in view of US 2010/0049177 (Boone, III et al., hereinafter Boone) as applied to claim 1 above, and further in view of US 2006/0224148 (Cho et al., hereinafter Cho).
In regards to claim 2, Edoute, Kreindel, and Boone disclose the system according to claim 1. Edoute, Kreindel, and Boone does not disclose wherein said at least one laser source is configured to emit laser energy either in a continuous wave or a pulsed like manner. Cho discloses wherein said at least one laser source is configured to emit laser energy either in a continuous wave or a pulsed like manner (the treatment laser 20 emits a beam which is preferably pulsed to liquify fat for fat removal while cauterizing small veins; paragraphs [0025]-[0027]). It would have been obvious to one of ordinary skill in the art, at the time of the invention, to have modified the second applicator of Edoute, Kreindel, and Boone wherein said at least one laser source is configured to emit laser energy in a pulsed like manner, as taught by Cho, to liquify fat for fat removal while cauterizing small veins when treating adipose tissue.
As per claim 20, Edoute, Kreindel, and Boone disclose the system according to claim 1. Edoute, Kreindel, and Boone do not disclose wherein said at least one second applicator is in communication with said optical system by means of at least one optical fiber. Cho discloses wherein said at least one applicator is in communication with said optical system by means of at least one optical fiber (a laser for dermatological treatment comprises an applicator in communication with a laser source via an optical fiber; paragraph [0022]; the treatment laser 20 emits a beam which is preferably pulsed to liquify fat for fat removal while cauterizing small veins; paragraphs [0024]-[0027]). It would have been obvious to one of ordinary skill in the art, at the time of the invention, to have modified the second applicator of Edoute, Kreindel, and Boone, wherein said applicator is in communication with said optical system by means of at least one optical fiber, as taught by Cho, for the advantage of using a well-known system to liquify fat for fat removal while cauterizing small veins when treating adipose tissue.
As per claim 21, the combination of Edoute, Kreindel, Boone, and Cho discloses the system according to claim 20. Edoute, Kreindel, and Boone do not disclose wherein said at least one optical fiber is characterized by having a fiber core having a cross sectional area selected from a group consisting of a square cross section area, a rectangular cross section area, an elliptical cross section area, a circular cross section area, a triangular cross section area, a pentagonal cross section area, a hexagonal cross section area, a heptagonal cross section area, an octagonal cross section area, a nonagonal cross section area, a decagonal cross section area and any combination thereof. Cho does not disclose wherein said at least one optical fiber is characterized by having a fiber core having a cross sectional area selected from a group consisting of a square cross section area, a rectangular cross section area, an elliptical cross section area, a circular cross section area, a triangular cross section area, a pentagonal cross section area, a hexagonal cross section area, a heptagonal cross section area, an octagonal cross section area, a nonagonal cross section area, a decagonal cross section area and any combination thereof. However, since Cho discloses wherein the optical fiber comprises a diameter (Cho; paragraph [0024]), it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to have modified the optical fiber of Cho, to comprises a circular cross section area, since diameters are often associated with circular objects. Furthermore, optical fibers with circular cross sectional areas are welk-known within the art and since such a modification involves a mere change in shape of the optical fiber, such a modification would have required only routine skill in the art. Additionally, it would have been obvious to one of ordinary skill in the art, at the lime of the invention, to have modified the second applicator of Edoute, Kreindel, and Boone, with the optical fiber of Cho, for the advantage of using a well-known system to liquify fat for fat removal while cauterizing small veins when treating adipose tissue.
As per claim 22, the combination of Edoute, Kreindel, Boone, and Cho discloses the system according to claim 21. Edoute, Kreindel, and Boone do not disclose wherein said fiber core is characterized by dimensions of 100-1000 micron. Cho discloses wherein said fiber core is characterized by dimensions of 100-1000 micron (the optical fiber of the present invention has a core diameter of about 300 m; paragraph [0024]). It would have been obvious to one of ordinary skill in the art, at the time of the invention, to have modified the second applicator of Kreindel, with the optical fiber of Cho, for the advantage of using a well-known system to liquify fat for fat removal while cauterizing small veins when treating adipose tissue (paragraphs [0024]-[0027]).
Claim(s) 24, 27, and 30-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0028831 (Ron Edoute et al., hereinafter Edoute) in view of US 2006/0173518 (Kreindel) in view of US 2010/0049177 (Boone, III et al., hereinafter Boone) as applied to claim 23 above, and further in view of US 6,684,107 (Binder).
As per claim 24, the combination of Edoute, Kreindel, and Boone discloses the system according to claim 23. Edoute, Kreindle, or Boone does not disclose wherein a shape of the electric signal is selected from the group consisting of a square wave, a sine wave, asymmetrical ladder, a trapezoid, a symmetrical ladder, symmetrical bi phasic, asymmetrical bi phasic, a triangular wave, a sawtooth wave, a ramp wave, a spiked wave and any combination thereof. Binder discloses wherein a shape of the electric signal is a square wave (a skin treatment device for supplying an electrical current to the skin having a square wave; see claims 1 and 11 of Binder). It would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to have modified the device of Edoute, Kreindel and Boone wherein a shape of the electric signal is a square wave, as taught by Binder, for the advantage of applying the electrical current with a waveform shape sufficient for treating wrinkles (Binder; abstract). Furthermore, such a modification involves a mere change in shape of the waveform of the electrical current and thus would have required only routine skill in the art.
As per claim 27, the combination of Edoute, Kreindel, and Boone discloses the system according to claim 23. Edoute does not disclose wherein a frequency of the electric signal is in the range of about 1 Hz-2500 kHz. Binder discloses wherein a frequency of the electric signal is in the range of about 1 Hz-2500 kHz (a skin treatment device for supplying an electrical current to the skin having a frequency range of 5-15 Hz; abstract). It would have been obvious to one of ordinary skill in the art, at the time of the invention, to have modified the device of Edoute and Kreindel, wherein the frequency of the electric signal is in the range of about 1 Hz-2500 kHz, as taught by Binder, for the advantage of applying the electrical current at a frequency sufficient for treating wrinkles (Binder; abstract). Furthermore, such a modification involves a mere change in frequency of the electrical current and thus would have required only routine skill in the art.
As per claim 30, the combination of Edoute, Kreindel, Boone and Binder discloses the system according to claim 27. Edoute further discloses wherein said electrical stimulation comprises at least three phases including: a) a warm-up phase; b) a contraction phase; and, c) a relax phase (an electrical output device to provide an electrical current to the skin, and so is capable of delivering electrical stimulation comprising a warm-up phase, contraction phase, and a relax phase; paragraphs [0235]-[0238]).
As per claim 31, the combination of Edoute, Kreindel, Boone and Binder discloses the system according to claim 30. Edoute further discloses wherein in said warm-up phase, a frequency of the electric signal increases (an electrical output device to provide an electrical current to the skin, and so is capable of delivering electrical stimulation comprising a warm-up phase, wherein in said warm-up phase, the frequency of the applied the electric signal increases; paragraphs [0235]-[0238]).
As per claim 32, the combination of Edoute, Kreindel, Boone and Binder discloses the system according to claim 30. Edoute further discloses wherein in said relax phase, a frequency of the electric signal decreases (an electrical output device to provide an electrical current to the skin, and so is capable of delivering electrical stimulation comprising a relax phase, wherein in said relax phase, the frequency of the applied the electric signal decreases; paragraphs [0235]-[0238]).
As per claim 33, the combination of Edoute, Kreindel, Boone and Binder discloses the system according to claim 30. Edoute further discloses wherein said contraction phase comprises at least one cycle of at least 3 sub-treatments: a) a first frequency, F1, of the applied the electric signal for a first predetermined period of time, T1; b) a second frequency, F2, of the applied the electric signal for a second predetermined period of time, T2; c) a third frequency, F3, of the applied the electric signal for a third predetermined period of time, T3 (an electrical output device to provide an electrical current to the skin, and so is capable of delivering electrical stimulation comprising a contraction phase, wherein said contraction phase comprises at least one cycle of at least 3 sub-treatments: a) a first frequency, F1, of the applied the electric signal for a first predetermined period of time, T1; b) a second frequency, F2, of the applied the electric signal for a second predetermined period of time, T2; c) a third frequency, F3, of the applied the electric signal for a third predetermined period of time, T3; paragraphs [0235]-[0238]).
As per claim 34, the combination of Edoute, Kreindel, Boone and Binder discloses the system according to claim 33. Edoute further discloses wherein said F1 is in the range of to 100 Hz; F2 is in the range of 50 to 1000 Hz; F3 is in the range of to 50 Hz; T1, T2 and T3 are in the range of 0-10 minutes (an electrical output device to provide an electrical current to the skin, wherein the electrical current can be provided up to 1 MHz, and so is capable of delivering electrical stimulation comprising a contraction phase, wherein said F1 is in the range of to 100 Hz; F2 is in the range of 50 to 1000 Hz; F3 is in the range of to 50 Hz; T1, T2 and T3 are in the range of 0-10 minutes paragraphs [0235]-[0238], [0263]).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0028831 (Ron Edoute et al., hereinafter Edoute) in view of US 2006/0173518 (Kreindel) in view of US 2010/0049177 (Boone, III et al., hereinafter Boone) as applied to claim 23 above, and further in view of US 2018/0361137 (Kern et al., hereinafter Kern).
In regards to claim 26, the combination of Edoute, Kreindel, and Boone discloses the system according to claim 23. Edoute does not disclose wherein said electric signal is adapted to provide transcutaneous electrical nerve stimulation. Kern discloses wherein said electric signal is adapted to provide transcutaneous electrical nerve stimulation (a skin treatment device for providing transcutaneous electrical nerve stimulation 'TENS'; paragraphs [0009], [0033]). It would have been obvious to one of ordinary skill in the art, at the time of the invention, to have modified the device of Edoute, Kreindel and Boone, wherein said electric signal is adapted to provide transcutaneous electrical nerve stimulation, as taught by Kern, for the advantage of increasing healing of the skin (Kern; paragraph [0007]).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0028831 (Ron Edoute et al., hereinafter Edoute) in view of US 2006/0173518 (Kreindel) in view of US 2010/0049177 (Boone, III et al., hereinafter Boone) as applied to claim 23 above, and further in view of US 4,233,986 (Tannenbaum).
In regards to claim 28, the combination of Edoute, Kreindel, and Boone discloses the system according to claim 23. Edoute, Kreindel, and Boone do not disclose wherein a pulse length of the electric signal is in the range of about 100-5,000 microsecond. Tannenbaum discloses wherein a pulse length of the electric signal is in the range of about 100-5,000 microsecond (a system for applying electric current to the skin having a pulse width of 500 microseconds; column 3, lines 50-55). It would have been obvious to one of ordinary skill in the art, at the time of the invention, to have modified the device of Edoute, Kreindel, and Boone wherein a pulse length of the electric signal is in the range of about 100-5,000 microsecond, as taught by Tannenbaum, for the advantage of having a pulse width suitable for enhance muscle stimulation which increases the blood flow and decreases the local stagnant anoxia in the small blood vessels (Tannenbaum; column 1, lines 40-50). Furthermore, such a modification involves a mere change in pulse width and thus would have required only routine skill in the art.
Claim(s) 39-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0028831 (Ron Edoute et al., hereinafter Edoute) in view of US 2006/0173518 (Kreindel) in view of US 2010/0049177 (Boone, III et al., hereinafter Boone) as applied to claim 23 above, and further in view of US 2013/03317580 (Simon et al., hereinafter Simon).
As per claims 39-42, Edoute, Kreindel, and Boone disclose the limitations of claim 23 but do not state the presence of a wearable accessory. In a related area, Simon discloses a stimulation applicator device (title and abstract). The applicator device is put on the surface of a patient’s body and held in place via straps or collars, a type of sleeve (paragraphs [0223] and [0252]) where the applicator device is reversibly coupled to the collar/sleeve and strap. Furthermore, it is shown in figure 6B that the collar allows for hands-free operation of the device, thus meeting the limitation of claim 42. Thus, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the device of Edoute and Kreindel to include the strap and sleeve disclosed by Simon in order to reversibly couple the device to an accessory that holds the device against a patient’s skin.
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0028831 (Ron Edoute et al., hereinafter Edoute) in view of US 2006/0173518 (Kreindel) in view of US 2010/0049177 (Boone, III et al., hereinafter Boone) as applied to claim 23 above, and further in view of US 2013/0158634 (Edoute et al., hereinafter Edoute ‘34).
As per claim 43, Edoute, Kreindel, and Boone discloses the limitations of claim 1. However, Edoute and Kreindel do not disclose the presence of contact sensors. In a related area, Edoute ’34 discloses an esthetic device used to treat the skin of a patient with RF radiation (title and abstract). Paragraphs [0029]-[0033], [0143]-[0147], and [0229]-[0231] disclose the presence of contact sensors around or integrated with the RF electrodes of the applicator. Edoute ’34 states that the contact sensors activate or deactivate the electrodes based on proximity between the skin and the substrate. Thus, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention, to modify the device Edoute, Kreindel, and Boone to include contact sensors as taught by Edoute ’34 in order to control activation of the applicator based on proximity between the skin and the substrate.
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0028831 (Ron Edoute et al., hereinafter Edoute) in view of US 2006/0173518 (Kreindel) in view of US 2010/0049177 (Boone, III et al., hereinafter Boone) in view of US 2013/0158634 (Edoute et al., hereinafter Edoute ‘34), as applied to claim 43 above, and further in view of US 2008/0097558 (Eggers et al., hereinafter Eggers).
As per claim 44, the combination of Edoute, Kreindel, Boone, and Edoute ’34 disclose the limitations of claim 43. As noted in claim 43, Edoute ’34 discloses the presence of a light sensor as a tissue contact sensor. However, they do not state that the tissue-contact sensor is an LED light. In a related area, Eggers disclseos a method and system used for heating tissue (Title and abstract). The device uses LEDs in combination with electrodes, where photodetectors are used to insure proper alignment of electrodes with LEDs (abstract; paragraph [0139]). Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the device of Edoute, Kreindel, Boone, and Edoute ’34 to incorporate LEDs in the tissue contact sensor as taught by Eggers in order to ensure proper alignment of the applicator electrodes.
Claim(s) 46-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0028831 (Ron Edoute et al., hereinafter Edoute) in view of US 2006/0173518 (Kreindel) in view of US 2010/0049177 (Boone, III et al., hereinafter Boone) as applied to claims 1 and 23 above, and further in view of US 2016/0346561 (Ron Edoute et al., hereinafter Edoute ‘61).
As per claims 46 and 47, Edoute and Kreindel disclose the limitations of claim 23. As noted in the rejection of claim 1, there a first and second applicator but does not state the presence of a negative pressure source. In a related area, Edoute ’61 discloses a device that uses pulsed electromagnetic frequencies and RF energies to rejuvenate tissues (see title and abstract). Of note are paragraphs [0525]-[0532] figures 22a-f which discloses the presence of a suction mechanism (negative pressure source) as part of the applicator that delivers a constant or pulsed suction. Edoute ’61 states that the suction is used to draw the skin in a manner so that it makes physical contact with electrodes and transducers on the applicator. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the device of Edoute, Kreindel, and Boone to include a negative pressure source that administers pulsed suction as taught by Edoute ’61 in order to draw the skin in a manner that makes the skin make physical contact with electrodes and transducers on the applicator.
As per claim 48, Edoute, Kreindel, and Boone disclose the limitations of claim 1. However, there is no mention of an automatic temperature control that is set at least one target temperature. In a related area, Edoute ’61 discloses a device that uses pulsed electromagnetic frequencies and RF energies to rejuvenate tissues (see title and abstract). Of note are paragraphs [0026], [0060], [0178], [0202], [0227], [0245], [0288], [0516]-[0518] which mentions a feedback control mechanism that maintains a temperature profile at a specific region during therapy. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the device of Edoute, Kreindel, and Boone to include an automatic temperature control as taught by Edoute ’61 in order to maintain a temperature profile at a specific region during therapy.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791
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