DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claim 38 is objected to because of the following informalities:
Claim 38 line 3: “energy to heat to the skin tissue” should read “energy to heat the skin tissue”.
Appropriate correction is required.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 25, 27-37, and 48-57 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bernabei et al. 2004/0220622 in view of Rosen et al. 2008/0287839
Regarding claim 25, Bernabei a method of treating a person's skin tissue (abstract), comprising: providing a radio frequency (RF) generator configured to provide RF energy to heat the skin tissue of the person (Figure 31, 3110 radiofrequency generator, 0138 describes the RF generator as being used to heat the skin); providing an electrical pulse generator (Pulse generator 400, figure 4) configured to provide electrical muscle stimulation (EMS) to muscles in a muscle layer located below the skin tissue (paragraph 0072); providing an applicator (Figure 5, probe 500), the applicator configured to be placed in contact with the surface of the skin tissue (abstract) and including one or more electrodes (Figure 2b) configured to deliver the RF energy from the RF generator (0094 states “The rollers 830 are conductive rollers, whereby the rollers 830 are electrically coupled to electrodes (see FIGS. 2A through 2C, for example) provided on the vibrating plate 810.” 0138 states “whereby the rf is provided to the skin by way of the rollers positioned on the head of the probe.”) and the EMS from the electrical pulse generator to the skin tissue and the muscles respectively (Figure 4 depicts electrodes connected with pulse generator, claim 3 states “wherein the treatment method is for reducing cellulite or fatty tissue disposed beneath the surface of the patient's skin.”); wherein the method comprises: contacting the applicator to the surface of the skin tissue (abstract), then turning on and off the RF energy and the EMS (0092), whereby application of the RF energy heats the skin tissue (0138) and application of the EMS provides the muscle stimulation (0072 mechanical stimulation); Operating the RF generator and the electrical pulse generator to deliver the RF energy and the EMS to the skin tissue and to the muscles (0137 states “controlled heating of the skin surface and the area beneath the skin surface having the cellulite and the fatty tissue, causes an increase in the absorption rate of a substance to be introduced into the skin (and thereby to the region beneath the skin having the cellulite and the fatty tissue). This results in a faster and more efficient reduction of cellulite and fatty tissue in the patient.”) and wherein delivery of the RF energy and the EMS produces a physiological effect in a dermal layer and a muscle layer beneath the dermal layer (0125 states “a skin treatment device is configured to deliver a defined amount of lidocaine, ascorbic acid, or other type of skin treatment drug into the dermis”. The device has the ability to make contact with the dermal layer and the fatty layer below the skin layer as prefaced by paragraph 0136).
Bernabei fails to teach wherein the RF energy and the EMS are delivered in a synchronized coordinated sequence comprising repetitive alternating time intervals of RF energy delivery and EMS delivery. Rosen discloses an analogous skin treatment device that does teach a sequence of skin treatment that alternates between temperature application and the application of a vibratory treatment (0073 states “varying combinations of actuation to impart mechanical energy as described herein with applying treatment devices to affect the lipid-rich cells in any number of ways (e.g., varying frequency, intensity (amplitude), duration, start and stop times, temperature, etc.), applying mechanical energy alone without cooling, applying cooling alone without mechanical energy”, teaches the concept of skin treatment alternating between temperature application and vibrational stimulation). One of ordinary skill in the art would be able to take this concept and apply it to Bernabei to make the device of alternate treatment between rf energy and EMS delivery as this effect is able to enhance the desired effect of skin treatment to achieve the necessary goal (0045 and 0073). Once this modification is made, modified Bernabei would now teach wherein the RF energy and the EMS are delivered in a synchronized coordinated sequence comprising repetitive alternating time intervals of RF energy delivery and EMS delivery.
Regarding claim 27, Bernabei teaches the method of claim 25, wherein at least one electrode of the one or more electrodes is in electrical contact with the RF generator and is configured to deliver the RF energy to the skin tissue (0094 states “The rollers 830 are conductive rollers, whereby the rollers 830 are electrically coupled to electrodes (see FIGS. 2A through 2C, for example) provided on the vibrating plate 810.” 0138 states “whereby the rf is provided to the skin by way of the rollers positioned on the head of the probe.”).
Regarding claim 28, Bernabei teaches the method of claim 25, wherein at least one electrode of the one or more electrodes is in electrical contact with the electrical pulse generator and is configured to deliver the EMS to the muscle layer (Figure 4 depicts electrodes connected with pulse generator, The device has the ability to make contact with the dermal layer and the fatty layer below the skin layer as prefaced by paragraph 0136).
Regarding claim 29, modified Bernabei teaches the method of claim 25, but fails to explicitly teach wherein the electrical pulse generator is configured to generate pulses in a range of 100 to 500 milliamperes, however it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the Bernabei such that the electrical pulse generator is configured to generate pulses in a range of 100 to 500 milliamperes, for the purpose of effectively stimulating muscle surrounding the area of treatment in order to contract to aid in squeezing out fat in the cellulite and fat (adipose) layers, 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 30, modified Bernabei teaches the method of claim 25, but fails to explicitly teach wherein stimulating the muscle layer occurs with electrical current in a range of 100 to 500 milliamperes, however it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the Bernabei such that wherein stimulating the muscle layer occurs with electrical current in a range of 100 to 500 milliamperes, for the purpose of effectively stimulating muscle surrounding the area of treatment in order to contract to aid in squeezing out fat in the cellulite and fat (adipose) layers, 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 31, Bernabei teaches the method of claim 25, further comprising providing a control board for controlling the RF generator and the electrical pulse generator to coordinate delivery of the RF energy and the EMS (0054 discusses the use of current control and 0140 discusses the use of controlled heating in response to sensor data. Both are only possible through some method of control.).
Regarding claim 32, Bernabei teaches the method of claim 31, further comprising providing a sensor in the applicator to provide skin tissue measurements from the surface of the skin tissue to the control board (0140 states “a temperature sensor is provided on the head of the probe, to determine when the skin reaches the desired temperature.”).
Regarding claim 33, Bernabei teaches the method of claim 32, wherein the sensor is a temperature sensor (0140 states “a temperature sensor is provided on the head of the probe, to determine when the skin reaches the desired temperature.”).
Regarding claim 34, Bernabei teaches the method of claim 25, wherein the electrical pulse generator provides DC pulse signals between +500 ma to -500 ma (0061 discusses pulses being delivered at a peak current of 10 ma).
Regarding claim 35, Bernabei teaches the method of claim 25, wherein the RF energy is delivered with a frequency between 0.5 MHz to 2 MHz (0142 states “a radio frequency of between 0.5 MHz and 27 MHz may be used instead”).
Regarding claim 36, Bernabei teaches the method of claim 25, wherein the EMS is delivered with pulses of DC current between +1 to 500 ma (0061 discusses pulses being delivered at a peak current of 10 ma and states “The voltage of the second and following pulses applied to the skin decreases with the decreasing of the impedance of the skin, while maintaining the peak current at the same or almost the same value.”).
Regarding claim 37, modified Bernabei teaches the method of claim 25, wherein the RF energy and the EMS are delivered according to a repeating temporal sequence comprising a first time interval during which the EMS is delivered and a second time interval during which the RF energy is delivered (Paragraph 0045 of Rosen discusses the vacuum vibratory energy having the ability to be applied before, during, or after cooling. Meaning that the modified Bernabei which has the ability to deliver an alternating RF and EMS due to the teachings of Rosen, would also contain a time interval in which the EMS is delivered and the RF energy is delivered, as that is exactly what is happening with the temperature delivery and vibratory delivery in Rosen.).
Regarding claim 48, modified Bernabei teaches the method of claim 28, wherein at least one electrode of the one or more electrodes is configured to alternately deliver the RF energy and the EMS (based on the inclusion of the teaching of Rosen wherein the temperature delivery and stimulation delivery are both applied at alternating times, this would occur once modification of this teaching to the electrode of Bernabei occurs.). Regrading claim 49, modified Bernabei teaches the method of claim 37, wherein the second time interval is longer than the first time interval (0043, 0045 and 0071-0073 of Rosen discuss the use of providing varied times of vibratory and temperature delivery).
Regarding claim 50, modified Bernabei teaches the method of claim 37, wherein the repeating temporal sequence is applied continuously during a treatment session (0073 of Rosen states that this treatment can be applied throughout a treatment session with varying profiles.).
Regarding claim 51, modified Bernabei teaches the method of claim 37, wherein the repeating temporal sequence enhances the physiological effect in the skin tissue (0073 states “applying mechanical energy alone without cooling, applying cooling alone without mechanical energy, utilizing reheating to accelerate damage to lipid-rich cells, to achieve the desired effect.”).
Regrading claim 52, modified Bernabei teaches the method of claim 25, wherein the EMS is delivered as a plurality of pulses during delivery of the RF energy (0045 of Rosen states that the vibratory energy can be applied at a same time as the temperature application).
Regarding claim 53, Modified Bernabei teaches the method of claim 25, wherein the RF energy and the EMS are selectively delivered either independently or in a synchronized manner (0045 of Rosen states that the delivery can be in multiple different ways, either independently or in a synchronized manner.).
Regarding claim 54, modified Bernabei teaches the method of claim 25, wherein the RF energy and the EMS are delivered to concurrently affect a dermal layer and a muscle layer (0137 states “in order to increase the speed and efficiency of the cellulite reduction, it has been determined by the inventor that a controlled heating of the skin surface and the area beneath the skin surface having the cellulite and the fatty tissue, causes an increase in the absorption rate of a substance to be introduced into the skin”).
Regrading claim 55, modified Bernabei teaches the method of claim 25, wherein the RF energy and the EMS are delivered simultaneously or in a coordinated temporal relationship (0045 of Rosen).
Regrading claim 56, modified Bernabei teaches the method of claim 25, wherein the physiological effect comprises at least one of: skin tightening, collagen production, fibroblast stimulation, or reduction of a distance between an epidermal layer and a muscle layer (Claim 3 states “wherein the treatment method is for reducing cellulite or fatty tissue disposed beneath the surface of the patient's skin.”).
Regarding claim 57, modified Bernabei teaches the method of claim 25, wherein the physiological effect comprises at least one of: release of fat from adipose tissue or increased fat metabolism and increased blood flow or enhanced lymphatic drainage (Claim 3 states “wherein the treatment method is for reducing cellulite or fatty tissue disposed beneath the surface of the patient's skin.”).
Claim 26 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over modified Bernabei in view of Manstein et al. 2005/0222565
Regarding claim 26, modified Bernabei teaches the method of claim 25, wherein the electrical pulse generator delivers direct current pulses (paragraph 0076 of Bernabei), but fails to teach wherein the RF generator delivers AC current. Manstein discloses an analogous skin tissue treatment device that does teach wherein the RF generator delivers AC current (0032 states “the energy source 320 is a radio frequency (RF) device capable of outputting signals having frequencies in a desired range. In another exemplary embodiment, the energy source is capable of outputting an AC or DC electric current.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Bernabei with the teachings of Manstein an include wherein the RF generator delivers AC current in order to enhance a delivery of heat through efficient conversion of electrical current.
Claims 38-47 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bernabei, in view of Rosen and Azar et al. 2008/0183251
Regarding claim 38, Bernabei teaches a device for treating a person's skin tissue (abstract), comprising: a radio frequency (RF) generator configured to provide RF energy to heat the skin tissue (Figure 31, 3110 radiofrequency generator, 0138 describes the RF generator as being used to heat the skin); an electrical pulse generator (Pulse generator 400, figure 4) configured to provide electrical muscle stimulation (EMS) to muscles in a muscle layer located below the skin tissue (paragraph 0072); an applicator (Figure 5, probe 500) configured to be placed in contact with a surface of the skin tissue (abstract) and including one or more electrodes (Figure 2b) configured to deliver the RF energy from the RF generator (0094 states “The rollers 830 are conductive rollers, whereby the rollers 830 are electrically coupled to electrodes (see FIGS. 2A through 2C, for example) provided on the vibrating plate 810.” 0138 states “whereby the rf is provided to the skin by way of the rollers positioned on the head of the probe.”) and the EMS from the electrical pulse generator to the skin tissue and the muscles respectively (Figure 4 depicts electrodes connected with pulse generator, claim 3 states “wherein the treatment method is for reducing cellulite or fatty tissue disposed beneath the surface of the patient's skin.”); and a control board (inherent within the device as 0054 discusses the use of current control and 0140 discusses the use of controlled heating in response to sensor data. Both are only possible through some method of control.) control controls the RF generator (0140) and the electrical pulse generator (Figure 4, transistor 430 provides a method of controlling the pulse delivery as discussed in 0058), wherein the control board is configured to control the electrical pulse generator such that the EMS are turned on and off to deliver the RF Energy and the EMS to the skin tissue and muscles. (0070 states “In the preferred embodiments described herein, an optical sensor (not shown) detects the movement of the eccentric of a motor that is used to provide the mechanical vibrations (see FIGS. 1A and 1B, for example), and gates the burst of electrical pulses based on the detected movement.” Figure 4 depicts electrodes connected with pulse generator, claim 3 states “wherein the treatment method is for reducing cellulite or fatty tissue disposed beneath the surface of the patient's skin.”), wherein delivery of the RF energy and the EMS produces a physiological effect in a dermal layer and a muscle layer beneath the dermal layer (0125 states “a skin treatment device is configured to deliver a defined amount of lidocaine, ascorbic acid, or other type of skin treatment drug into the dermis”. The device has the ability to make contact with the dermal layer and the fatty layer below the skin layer as prefaced by paragraph 0136).
Bernabei fails to teach wherein the RF energy and the EMS are delivered in a synchronized coordinated sequence comprising repetitive alternating time intervals of RF energy delivery and EMS delivery. Rosen discloses an analogous skin treatment device that does teach a sequence of skin treatment that alternates between temperature application and the application of a vibratory treatment (0073 states “varying combinations of actuation to impart mechanical energy as described herein with applying treatment devices to affect the lipid-rich cells in any number of ways (e.g., varying frequency, intensity (amplitude), duration, start and stop times, temperature, etc.), applying mechanical energy alone without cooling, applying cooling alone without mechanical energy”, teaches the concept of skin treatment alternating between temperature application and vibrational stimulation). One of ordinary skill in the art would be able to take this concept and apply it to Bernabei to make the device of alternate treatment between rf energy and EMS delivery as this effect is able to enhance the desired effect of skin treatment to achieve the necessary goal (0045 and 0073). Once this modification is made, modified Bernabei would now teach wherein the RF energy and the EMS are delivered in a synchronized coordinated sequence comprising repetitive alternating time intervals of RF energy delivery and EMS delivery.
Bernabei still fails to explicitly teach the use of a control board to control the RF generator such that the RF is turned on and off. Azar discloses an analogous skin treatment method that does teach the use of a control board to control the RF generator such that the RF is turned on and off (paragraph 0014 states that a controller unit is used to control the RF generating unit). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Bernabei with the teachings of Azar and include the use of a control board to control the RF generator such that the RF is turned on and off as this allows for an initiation or termination of RF energy to the skin based on processed data (0024).
Regarding claim 39, Bernabei teaches the method of claim 38, wherein at least one electrode of the one or more electrodes is in electrical contact with the RF generator (0094 states “The rollers 830 are conductive rollers, whereby the rollers 830 are electrically coupled to electrodes (see FIGS. 2A through 2C, for example) provided on the vibrating plate 810.” 0138 states “whereby the rf is provided to the skin by way of the rollers positioned on the head of the probe.”).
Regarding claim 40, Bernabei teaches the method of claim 38, wherein at least one electrode of the one or more electrodes is in electrical contact with the electrical pulse generator (Figure 4 depicts electrodes connected with pulse generator).
Regarding claim 41, modified Bernabei teaches the method of claim 38, but fails to explicitly teach wherein the electrical pulse generator is configured to generate pulses in a range of 100 to 500 milliamperes, however it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the Bernabei such that the electrical pulse generator is configured to generate pulses in a range of 100 to 500 milliamperes, for the purpose of effectively stimulating muscle surrounding the area of treatment in order to contract to aid in squeezing out fat in the cellulite and fat (adipose) layers, 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 42, modified Bernabei teaches the method of claim 38, but fails to explicitly teach wherein stimulating the muscle layer occurs with electrical current in a range of 100 to 500 milliamperes, however it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the Bernabei such that wherein stimulating the muscle layer occurs with electrical current in a range of 100 to 500 milliamperes, for the purpose of effectively stimulating muscle surrounding the area of treatment in order to contract to aid in squeezing out fat in the cellulite and fat (adipose) layers, 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 43, Bernabei teaches the method of claim 38, further comprising a temperature sensor in the applicator to provide temperature measurements from the surface of the skin tissue to (0140 states “a temperature sensor is provided on the head of the probe, to determine when the skin reaches the desired temperature.”).
Regarding claim 44, Bernabei teaches the method of claim 38, wherein the electrical pulse generator provides DC pulse signals between +500 ma to -500 ma (0061 discusses pulses being delivered at a peak current of 10 ma).
Regarding claim 45, Bernabei teaches the method of claim 38, wherein the RF energy is delivered with a frequency between 0.5 MHz to 2 MHz (0142 states “a radio frequency of between 0.5 MHz and 27 MHz may be used instead”).
Regarding claim 46, Bernabei teaches the method of claim 38, wherein the EMS is delivered with pulses of DC current between +1 to 500 ma (0061 discusses pulses being delivered at a peak current of 10 ma and states “The voltage of the second and following pulses applied to the skin decreases with the decreasing of the impedance of the skin, while maintaining the peak current at the same or almost the same value.”).
Regarding claim 47, modified Bernabei teaches the method of claim 38, wherein the control board is operated to activate the electrical pulse generator and the Rf generator (activated by control board of Bernabei in view of Azar) to deliver the RF energy and the EMS are delivered according to a repeating temporal sequence comprising a first time interval during which the EMS is delivered and a second time interval during which the RF energy is delivered (Paragraph 0045 of Rosen discusses the vacuum vibratory energy having the ability to be applied before, during, or after cooling. Meaning that the modified Bernabei which has the ability to deliver an alternating RF and EMS due to the teachings of Rosen, would also contain a time interval in which the EMS is delivered and the RF energy is delivered, as that is exactly what is happening with the temperature delivery and vibratory delivery in Rosen.).
Response to Arguments
Applicant’s arguments with respect to claims 25 and 38 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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/ROHAN PATEL/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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