DETAILED ACTION
The amendment filed August 15, 2024, has been entered and fully considered. Claims 1-14, 16-21, 23-41, and 84-104 are currently pending. Claims 1, 16, 17 and 37 have been amended. Claims 15, 22, and 42-83 are cancelled.
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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 19, 2025, has been entered.
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.
Claims 1-4, 7-9, 16-17, 19-20, 23-28, 31-35, 37, 38, 84, 86-89, 91-93, 98-99, and 104 are rejected under 35 U.S.C. 103 as being unpatentable over Nebrigic et al., (hereinafter 'Nebrigic', U.S. PGPub. No. 2011/0015687) in view of Condie et al., (hereinafter ‘Condie,’ U.S. PGPub. No. 2013/0296679).
Regarding independent claim 1, Nebrigic discloses a system for treating a patient's tissue, comprising: a source of RF energy (generator 16); a first non-invasive treatment applicator (10) comprising a first plurality of non-invasive treatment electrodes (20) configured to be disposed in contact with a surface of a patient's tissue and to deliver RF energy thereto ([0030], “the conductor region of treatment electrode 20 may be segmented into plural individual electrodes that can be individually powered to deliver electromagnetic energy to the tissue 30”), wherein the first plurality of non-invasive treatment electrodes comprise at least two individually-addressable treatment electrodes to which different RF signals can be applied ([0030]; as broadly claimed, the electrodes 20 are individually powered and are capable of receiving different RF signals); at least one return electrode ([0044]); a cooling mechanism for cooling the tissue surface in contact with the plurality of electrodes ([0047]-[0049], nozzle 62 including a spray plate 76 and orifices 64 to deliver coolant); and a controller (system controller 18) configured to provide one or more RF signals to the first plurality of non-invasive treatment electrodes ([0053]; generator control program 46), the one or more RF signals having a pulse duration, energy density, a duty cycle, phase and power ([0052]-[0053]; [0057]; [0060]-[0061]; as broadly claimed, the RF signals would necessarily have a pulse duration, energy density, a duty cycle, phase and power), the one or more RF signals configured to propagate through a relatively-low impedance path through a plurality of septae that interpenetrate fat layers, the one or more RF signals selectively heat septae within cellulite while substantially avoiding conduction of heat into adjacent tissue (Fig. 3A; [0034], “The electromagnetic energy imparts a therapeutic effect to heat tissue 30 in a targeted region 32 beneath the patient's skin surface 26, as best shown in FIG. 3A, to a therapeutic temperature.… The delivered energy volumetrically heats a region 32 of the tissue 30 to a targeted temperature range. The elevation in temperature within the heated region 32 may produce for example, changes in collagen in the tissue 30 that achieve a desired treatment result, such as removing or reducing wrinkles and otherwise tightening the skin to thereby improve the appearance of a patient receiving the treatment.”; also see [0004] and [0006] for collagen fibers in the form of fibrous septae running through the fat, wherein the applied high frequency energy heats the tissue at depths beneath the cooled region 31 to a therapeutic temperature sufficient to denature the collagen, which causes the collagen fibers (i.e. fibrous septae) in the dermis to shrink and contract), the controller (system controller 18) configured to rapidly heat the plurality of septae that interpenetrate fat layers, wherein a preponderance of electrical current of the one or more RF signals is directed to flow through the plurality of septae relative to the fat layers interpenetrated by the plurality of septae to selectively increase the temperature of the plurality of septae to affect the selective treatment thereof relative to the fat layers interpenetrated by the plurality of septae ([0004]; [0006], “High frequency treatment devices, such as radio-frequency (RF)-based treatment devices, may be used to treat skin tissue non-ablatively and non-invasively with heat. Such high frequency devices operate by transmitting high frequency energy through the epidermis to the underlying tissue, while actively cooling the epidermis to prevent thermal damage to a depth of the skin tissue near the skin surface. The high frequency energy heats the tissue at depths beneath the cooled region to a therapeutic temperature sufficient to denature the collagen, which causes the collagen fibers in the dermis to shrink and contract.”).
Although Nebrigic discloses the one or more RF signals, as configured using the controller, selectively heat the plurality of septae within the fat layers ([0004]; [0006]), Nebrigic is silent regarding while substantially avoiding conduction of heat into the fat layers that the plurality of septae interpenetrate.
However, in the same field of endeavor, Levinson teaches a similar combined modality treatment system (100) configured to both cool subcutaneous tissue and also to selectively heat tissue, such as fibrous septae (202) ([0043]). Levinson teaches, “[o]ne method of selectively heating such tissue is by the delivery of radiofrequency (RF) energy, including for example capacitively coupled RF energy, such as a low-level monopolar RF energy as well as conductively coupled RF energy, to the subcutaneous tissue selectively to heat regions of tissue bound by the connective web of fibrous septae.” ([0043]). The RF current (210) “concentrates in the dermal and connective tissue such as the fibrous septum 202.” ([0044]). Fig. 3 illustrates, “[h]eating generated by application of this RF current, depicted by arrows 210, heats the fibrous septum 202 and selected of the adipose cells in the fat lobules 201 adjacent the fibrous septum 202. In the combined modality therapy associated with the embodiments described herein, the treatment parameters may be adjusted selectively to affect, in connection with cooling the subcutaneous tissue, the temperature profile of and the number of the adipose cells in the lobules 201 that are heated via the application of such RF current.” ([0044], thereby meeting the limitation of substantially avoiding conduction of heat into the fat layers that the plurality of septae interpenetrate via adjustment of the treatment parameters). It would be advantageous to control the extent to which conduction of heat into the fat layers that the plurality of septae interpenetrate occurs in order to tailor said treatment and reduce irregularities in a surface of a subject's skin resulting from an uneven distribution of adipose tissue in the subcutaneous layer, thereby increasing accuracy and overall appearance of the skin. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Nebrigic to include selectively heat the plurality of septae within the fat layers while substantially avoiding conduction of heat into the fat layers that the plurality of septae interpenetrate, as taught by Levinson, in order to tailor said treatment and reduce irregularities in a surface of a subject's skin resulting from an uneven distribution of adipose tissue in the subcutaneous layer, thereby increasing accuracy and overall appearance of the skin.
Nebrigic further discloses “[t]he duration of each of the high frequency power pulses 100, 102, 104 may be set within a range of 200 milliseconds to 300 milliseconds with an adjustment increment of 10 milliseconds,” ([0057]) and “[a]dditional embodiments of the invention may vary the number of power pulses, [and] the power and duration of each individual power pulse” ([0060]). Although Nebrigic in view of Levinson are silent regarding wherein the pulse duration ranges from about 5 ms to about 35 ms, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the pulse duration as taught by Nebrigic in view of Levinson, such that the pulse duration ranges from about 5 ms to about 35 ms 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.
Nebrigic in view of Levinson are silent regarding the controller configured to determine the impedance between each of the at least two individually-addressable treatment electrodes of the first non-invasive treatment applicator, the controller configured to separately poll each of at least two individually-addressable treatment electrodes with at least one of a low-power sub-treatment threshold RF signal or an RF treatment signal.
However, in the same field of endeavor, Condie teaches a similar system (system 10 in Fig. 1; also see Figs. 2-5 for electrode array 36) comprising a medical device (12) coupled to a control unit (14) including a radiofrequency generator (56). Condie teaches that “the medical device 12 may further include one or more electrically-conductive segments or electrodes 34 positioned on or about the elongate body for conveying an electrical signal, current, or voltage to a designated tissue region and/or for measuring, recording, or otherwise assessing one or more electrical properties or characteristics of surrounding tissue” ([0026]). The control unit (14) further includes an impedance measurement module or signal processing unit (58) to measure one or more impedance characteristics between the electrodes of the medical device ([0033]). Condie further teaches “impedance measurements may be obtained by directing sufficient current from the radiofrequency generator 56 to one or more of the electrodes 34 of the medical device 12 to obtain an impedance value between 1) two or more electrodes on the medical device…” ([0036]; as broadly claimed, this would meet the limitation of separately polling). The impedance values are utilized in order to aid in positioning the medical device as well as indicate whether electrodes used in treating tissue have maintained or lost their contact ([0039]), thereby increasing control and accuracy of treatment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified by Nebrigic in view of Levinson to include the controller configured to determine the impedance between each of the at least two individually-addressable treatment electrodes of the first non-invasive treatment applicator, the controller configured to separately poll each of at least two individually-addressable treatment electrodes with at least one of a low-power sub-treatment threshold RF signal or an RF treatment signal, as taught by Condie in order to aid in positioning the medical device as well as indicate whether electrodes used in treating tissue have maintained or lost their contact ([0039]), thereby increasing control and accuracy of treatment.
Regarding claim 2, Nebrigic further discloses wherein the tissue surface comprises a skin surface (Fig. 3A).
Regarding claim 3, Nebrigic further discloses wherein the tissue surface comprises a mucosal tissue surface (as broadly claimed, Nebrigic teaches a system for treating a patient's tissue as claimed in claim 1, including a mucosal tissue surface). A recitation of intended use of the claimed invention must result in a structural different between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 4, Nebrigic further discloses wherein the wherein the at least one return electrode is disposed on a skin surface (Fig. 3A).
Regarding claim 7, Nebrigic further discloses wherein the one or more RF signals comprise different pulse widths ([0061], “Specifically, the system controller 18 may include a pulse-width modulation (PWM) module that is capable of causing the generator 16 to deliver the output high frequency power in pulses of predetermined duration and predetermined amplitude at a desired frequency. The PWM of the high frequency signal from generator 16 involves the modulation of the duty cycle to control the amount of power sent to the treatment electrode 20.”; as broadly claimed, the generator 16 is capable of delivering RF signals comprising different pulse widths).
Regarding claim 8, Nebrigic further discloses wherein the one or more RF signals comprise different duty cycles ([0032], “The drive signals have an energy content and a duty cycle appropriate for the amount of power and the mode of operation that have been selected by the clinician, as understood by a person having ordinary skill in the art.”; [0049]; [0055]; [0061]; as broadly claimed, the generator 16 is capable of delivering RF signals comprising different duty cycles).
Regarding claim 9, Nebrigic further discloses wherein the one or more RF signals comprise different RF frequencies ([0032]-[0033]; [0055], “Various duty cycles of cooling and heating by cryogen delivery in cryogen pulses 106, 108, 110, 112 and high frequency energy transfer in power pulses 100, 102, 104 are utilized depending on the type of treatment and the desired type of therapeutic effect.”; as broadly claimed, the generator 16 is capable of delivering RF signals comprising different RF frequencies).
Regarding claim 16, Nebrigic in view of Levinson and Condie teach all of the limitations of the system according to claim 1. In view of the prior modification of Nebrigic in view of Levinson and Condie, Condie further teaches that “the medical device 12 may further include one or more electrically-conductive segments or electrodes 34 positioned on or about the elongate body for conveying an electrical signal, current, or voltage to a designated tissue region and/or for measuring, recording, or otherwise assessing one or more electrical properties or characteristics of surrounding tissue” ([0026]). The control unit (14) further includes an impedance measurement module or signal processing unit (58) to measure one or more impedance characteristics between the electrodes of the medical device ([0033]). Condie further teaches “impedance measurements may be obtained by directing sufficient current from the radiofrequency generator 56 to one or more of the electrodes 34 of the medical device 12 to obtain an impedance value between 1) two or more electrodes on the medical device…” ([0036]). The impedance values are utilized in order to aid in positioning the medical device as well as indicate whether electrodes used in treating tissue have maintained or lost their contact ([0039]), thereby increasing control and accuracy of treatment. Further, once it has been determined that the electrodes are positioned as desired, treatment may proceed “which may include delivering or conducting ablative energy through the electrode(s) in a desired position or location” ([0038]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified by Nebrigic in view of Levinson and Condie to include wherein the controller is configured to determine the impedance between each of the at least two individually-addressable treatment electrodes of the first non-invasive treatment applicator and each of the at least two individually-addressable treatment electrodes of the second non-invasive treatment applicator by generating a sub-treatment threshold RF current there between prior to applying treatment RF signals to the first plurality of electrodes as taught by Condie in order to aid in positioning the medical device as well as indicate whether electrodes used in treating tissue have maintained or lost their contact ([0039]), thereby increasing control and accuracy of treatment.
Regarding claim 17, Nebrigic in view of Levinson and Condie teach all of the limitations of the system according to claim 1. In view of the prior modification of Nebrigic in view of Levinson and Condie, Condie further teaches that “the medical device 12 may further include one or more electrically-conductive segments or electrodes 34 positioned on or about the elongate body for conveying an electrical signal, current, or voltage to a designated tissue region and/or for measuring, recording, or otherwise assessing one or more electrical properties or characteristics of surrounding tissue” ([0026]). The control unit (14) further includes an impedance measurement module or signal processing unit (58) to measure one or more impedance characteristics between the electrodes of the medical device ([0033]). Condie further teaches “impedance measurements may be obtained by directing sufficient current from the radiofrequency generator 56 to one or more of the electrodes 34 of the medical device 12 to obtain an impedance value between 1) two or more electrodes on the medical device…” ([0036]) and furthermore, “impedance measurements may be obtained, processed, and compared…during the conduction of the ablative radiofrequency signal to prevent or signal an unwanted change in electrode position during a procedure, e.g., if any of the active electrodes migrate into the pulmonary vein while ablating” ([0038]), thereby increasing control, accuracy and safety during treatment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified by Nebrigic in view of Levinson and Condie to include wherein the controller is configured to determine the impedance between each of the at least two individually-addressable treatment electrodes of the first non-invasive treatment applicator and each of the at least two individually-addressable treatment electrodes of the second non-invasive treatment applicator while applying treatment RF signals to the first plurality of electrodes so as to determine when to terminate treatment by terminating the treatment RF signals as taught by Condie. Doing so prevents or signals an unwanted change in electrode position during a procedure, e.g., if any of the active electrodes migrate while ablating ([0038]), thereby increasing control, accuracy and safety during treatment.
Regarding claim 19, Nebrigic further discloses wherein the return electrode is a passive electrode configured to be disposed in contact with a tissue surface spaced apart from the tissue surface to which the first non-invasive treatment applicator is disposed ([0043]-[0044], passive return electrode 56). It is noted that the return electrode is capable of being disposed anywhere in contact with a tissue surface, including spaced apart from the tissue surface to which the first non-invasive treatment applicator is disposed.
Regarding claim 20, Nebrigic further discloses wherein the passive electrode comprises a drain pad ([0043]-[0044], passive return electrode 56).
Regarding claim 23, Nebrigic further discloses wherein the one or more RF signals are configured to reduce skin laxity by stimulating the production of collagen ([0034], “The electromagnetic energy imparts a therapeutic effect to heat tissue 30 in a targeted region 32 beneath the patient's skin surface 26, as best shown in FIG. 3A, to a therapeutic temperature.… The delivered energy volumetrically heats a region 32 of the tissue 30 to a targeted temperature range. The elevation in temperature within the heated region 32 may produce for example, changes in collagen in the tissue 30 that achieve a desired treatment result, such as removing or reducing wrinkles and otherwise tightening the skin to thereby improve the appearance of a patient receiving the treatment.” Also see [0005]-[0006]; [0034];[0042]).
Regarding claim 24, Nebrigic further discloses wherein the one or more RF signals are configured to reduce the appearance of cellulite ([0034], “The electromagnetic energy imparts a therapeutic effect to heat tissue 30 in a targeted region 32 beneath the patient's skin surface 26, as best shown in FIG. 3A, to a therapeutic temperature.… The delivered energy volumetrically heats a region 32 of the tissue 30 to a targeted temperature range. The elevation in temperature within the heated region 32 may produce for example, changes in collagen in the tissue 30 that achieve a desired treatment result, such as removing or reducing wrinkles and otherwise tightening the skin to thereby improve the appearance of a patient receiving the treatment.”; also see [0004] and [0006] for collagen fibers in the form of fibrous septae running through the fat, wherein the applied high frequency energy heats the tissue at depths beneath the cooled region 31 to a therapeutic temperature sufficient to denature the collagen, which causes the collagen fibers (i.e. fibrous septae) in the dermis to shrink and contract).
Regarding claim 25, Nebrigic in view of Levinson and Condie teach all of the limitations of the system according to claim 24. Nebrigic further discloses wherein each electrode is configured to deliver RF pulses exhibiting an energy per pulse in a range from about 10 J/cm2 to about 1000 J/cm2 ([0056], “The maximum energy permitted to be delivered by a set of power pulses 100, 102, 104 during a repetition may range from 10 Joules to 300 Joules with a precision of 1 Joule using electrodes having a size ranging from 1 cm2 to 20 cm2.”). Nebrigic also discloses “the system controller 18 may include a pulse-width modulation (PWM) module that is capable of causing the generator 16 to deliver the output high frequency power in pulses of predetermined duration and predetermined amplitude at a desired frequency. The PWM of the high frequency signal from generator 16 involves the modulation of the duty cycle to control the amount of power sent to the treatment electrode 20.” ([0061]).
Nebrigic in view of Levinson and Condie are silent regarding wherein the one or more RF signals has a pulse width less than about 500 ms, however, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the pulse width as taught by Nebrigic in view of Levinson and Condie to have a pulse width less than about 500 ms 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 26, Nebrigic further discloses wherein the one or more RF signals are configured to cause lipolysis in fat tissue below the tissue surface ([0034], “The electromagnetic energy imparts a therapeutic effect to heat tissue 30 in a targeted region 32 beneath the patient's skin surface 26, as best shown in FIG. 3A, to a therapeutic temperature.… The delivered energy volumetrically heats a region 32 of the tissue 30 to a targeted temperature range. The elevation in temperature within the heated region 32 may produce for example, changes in collagen in the tissue 30 that achieve a desired treatment result, such as removing or reducing wrinkles and otherwise tightening the skin to thereby improve the appearance of a patient receiving the treatment.”; also see [0004] and [0006] for collagen fibers in the form of fibrous septae running through the fat, wherein the applied high frequency energy heats the tissue at depths beneath the cooled region 31 to a therapeutic temperature sufficient to denature the collagen, which causes the collagen fibers (i.e. fibrous septae) in the dermis to shrink and contract).
Regarding claim 27, Nebrigic in view of Levinson and Condie teach all of the limitations of the system according to claim 26. In view of the prior modification of Nebrigic in view of Levinson and further in view of Condie and Anderson, Levinson teaches wherein each electrode is configured to deliver RF power in a range from about 1 W/cm2 to about 5 W/cm2 ([0044]; also see claims 14 and 15).
The combination is silent, however, regarding wherein the one or more RF signals has a pulse width greater than about 1 second.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the RF signal pulse width as taught by Nebrigic in view of Levinson and Condie to provide the RF signal has a pulse width greater than about 1 second 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 28, Nebrigic further discloses wherein the cooling mechanism comprises a circulating fluid ([0047]-[0049], see nozzle 62 including a spray plate 76 and orifices 64 to deliver coolant).
Regarding claim 31, Nebrigic further discloses wherein at least a portion of a fluid pathway of the circulating fluid is in thermal contact with a side of the electrodes (20) that is not configured for contact with the tissue surface ([0048]; see nozzle 62 including a spray plate 76 and orifices 64 to deliver coolant in Figs. 2 and 3).
Regarding claim 32, Nebrigic further discloses wherein at least a portion of a fluid pathway of the circulating fluid is in thermal contact with the tissue surface at a location between adjacent electrodes of the plurality of non-invasive treatment electrodes (as best illustrated in Figs. 2-3, [0048], “cryogen is ejected in a pulse as an atomized or non-atomized stream of coolant from each of the orifices 64 toward the backside 51 of the treatment electrode 20 and, in particular, toward the conductor region 24.”).
Regarding claim 33, Nebrigic further discloses wherein the cooling mechanism comprises one of thermoelectric elements and a phase change material disposed in the first non-invasive treatment applicator in thermal contact with the electrode (as best illustrated in Figs. 2-3, [0048], “cryogen is ejected in a pulse as an atomized or non-atomized stream of coolant from each of the orifices 64 toward the backside 51 of the treatment electrode 20 and, in particular, toward the conductor region 24.” Also see [0047]-[0049]). It is noted that the claim is written in the alternative.
Regarding claim 34, Nebrigic further discloses further comprising one or more temperature detectors (sensors 52) for detecting a temperature of the tissue surface around the perimeter of the electrode array (20), wherein the controller (controller 18; [0036]; [0040]) is further configured to reduce the power of the one or more RF signals applied to electrodes on a side of the first non-invasive treatment applicator exhibiting the highest temperature ([0040], “the temperature sensors 52 are disposed on the surface 51. The measured temperature reflects the temperature of the treated tissue 30 and may be used as feedback in a control loop by the system controller 18 for controlling energy delivery and/or cooling of the skin surface 26.”; [0059], “If the selected maximum temperature is exceeded and sustained over a given time period, corrective measures may be taken. For example, power delivery may be discontinued, the pulses 112 may be triggered for delivery, and an audible warning tone may be sounded.”)
Regarding claim 35, Nebrigic further discloses comprising one or more temperature detectors (sensors 52) for detecting a temperature of the tissue surface around the perimeter of the electrode array (20). Nebrigic discloses the controller (18) includes circuitry that interfaces the generator (20) for supplying control signals to the generator (20) and receiving feedback information from sensors that is used in generating the control signals ([0036). Further, “the temperature sensors 52 are disposed on the surface 51. The measured temperature reflects the temperature of the treated tissue 30 and may be used as feedback in a control loop by the system controller 18 for controlling energy delivery and/or cooling of the skin surface 26.” ([0040]).
Nebrigic in view of Levinson and Condie are silent regarding wherein the controller is further configured to increase the power of the one or more RF signals applied to electrodes on a side of the first non-invasive treatment applicator opposed to the side of the first non-invasive treatment applicator exhibiting the lowest temperature.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Nebrigic in view of Levinson and Condie to include wherein the controller is further configured to increase the power of the treatment RF signals applied to electrodes on a side of the first non-invasive treatment applicator opposed to the side of the first non-invasive treatment applicator exhibiting the lowest temperature, as Nebrigic teaches “the temperature of the treated tissue 30 and may be used as feedback in a control loop by the system controller 18 for controlling energy delivery and/or cooling of the skin surface 26.” ([0040]). The energy delivery can be controlled and varied in accordance with tissue temperature such that the temperature is maintained within a desired range. Therefore, it is contemplated that the controller is further configured to increase the power of the treatment RF signals applied to electrodes on a side of the first non-invasive treatment applicator opposed to the side of the first non-invasive treatment applicator exhibiting the lowest temperature as taught by Nebrigic in order to maintain the temperature within a desired range, thereby increasing safety and control. Further, this modification would have merely comprised combining prior art elements according to known methods to yield predictable results, MPEP 2143(I)(A).
Regarding independent claim 37, Nebrigic discloses a system for treating a patient's skin, comprising: a source of RF energy (generator 16); a non-invasive treatment applicator (10) comprising a non-invasive treatment electrode (20) configured to be disposed in contact with a tissue surface of a patient's and to deliver RF energy thereto ([0030], “the conductor region of treatment electrode 20 may be segmented into plural individual electrodes that can be individually powered to deliver electromagnetic energy to the tissue 30”); at least one return electrode ([0044]); a cooling mechanism for cooling the tissue surface in contact with the electrodes ([0047]-[0049], nozzle 62 including a spray plate 76 and orifices 64 to deliver coolant); and a controller (system controller 18) configured to provide an RF signal to the treatment electrode ([0053]; generator control program 46), the controller (18) configured to rapidly heat septae that interpenetrates fat layers ([0004]; [0006]); the RF signal, as configured using the controller (18), having a pulse duration, energy density, and power that selectively heats septae that interpenetrate fat layers in the region of cellulite ([0003]; [0052]-[0053]; [0057]; [0060]-[0061]; as broadly claimed, the RF signals would necessarily have a pulse duration, energy density, a duty cycle, phase and power), the RF signal configured to propagate through a relatively-low impedance path through septae that interpenetrate the fat layers (Fig. 3A; [0034], “The electromagnetic energy imparts a therapeutic effect to heat tissue 30 in a targeted region 32 beneath the patient's skin surface 26, as best shown in FIG. 3A, to a therapeutic temperature.… The delivered energy volumetrically heats a region 32 of the tissue 30 to a targeted temperature range. The elevation in temperature within the heated region 32 may produce for example, changes in collagen in the tissue 30 that achieve a desired treatment result, such as removing or reducing wrinkles and otherwise tightening the skin to thereby improve the appearance of a patient receiving the treatment.”; also see [0004] and [0006] for collagen fibers in the form of fibrous septae running through the fat, wherein the applied high frequency energy heats the tissue at depths beneath the cooled region 31 to a therapeutic temperature sufficient to denature the collagen, which causes the collagen fibers (i.e. fibrous septae) in the dermis to shrink and contract), wherein a preponderance of electrical current of the one or more RF signals is directed to flow through the plurality of septae relative to the fat layers interpenetrated by the plurality of septae to selectively increase the temperature of the plurality of septae to affect the selective treatment thereof relative to the fat layers interpenetrated by the plurality of septae ([0004]; [0006], “High frequency treatment devices, such as radio-frequency (RF)-based treatment devices, may be used to treat skin tissue non-ablatively and non-invasively with heat. Such high frequency devices operate by transmitting high frequency energy through the epidermis to the underlying tissue, while actively cooling the epidermis to prevent thermal damage to a depth of the skin tissue near the skin surface. The high frequency energy heats the tissue at depths beneath the cooled region to a therapeutic temperature sufficient to denature the collagen, which causes the collagen fibers in the dermis to shrink and contract.”), and an impedance tracker configured to monitor a patient's tissue impedance during the pulse duration and to detect one or more impedance value changes indicative of septae in a tissue region ([0014], “the method may further include measuring an attribute of the tissue, such as tissue temperature or tissue impedance and the adjusting a power of the electromagnetic energy delivered in each of the power pulses based upon the measured attribute.” Also see [0037]; [0040], sensors 52 may be impedance sensors; [0061], impedance is used by the system controller 18 to determine the high frequency power to be applied in each of the power pulses and is adjusted based upon output from the sensors), the controller (18) further configured to deliver RF energy, using the RF signal, to treat the tissue region by rapidly heating the septae that interpenetrate fat layer, wherein the tissue region comprises at least a portion of the cellulite region, wherein treatment of the tissue region reduces appearance of cellulite in the cellulite region ([0034], “The electromagnetic energy imparts a therapeutic effect to heat tissue 30 in a targeted region 32 beneath the patient's skin surface 26, as best shown in FIG. 3A, to a therapeutic temperature.… The delivered energy volumetrically heats a region 32 of the tissue 30 to a targeted temperature range. The elevation in temperature within the heated region 32 may produce for example, changes in collagen in the tissue 30 that achieve a desired treatment result, such as removing or reducing wrinkles and otherwise tightening the skin to thereby improve the appearance of a patient receiving the treatment.”; also see [0004] and [0006] for collagen fibers in the form of fibrous septae running through the fat, wherein the applied high frequency energy heats the tissue at depths beneath the cooled region 31 to a therapeutic temperature sufficient to denature the collagen, which causes the collagen fibers (i.e. fibrous septae) in the dermis to shrink and contract; also see [0003]), the impedance tracker configured to monitor impedance of the tissue region to track changes in tissue composition in the tissue region ([0014], “the method may further include measuring an attribute of the tissue, such as tissue temperature or tissue impedance and the adjusting a power of the electromagnetic energy delivered in each of the power pulses based upon the measured attribute.” See [0037]; [0040]; [0061]).
Although Nebrigic discloses the RF signal, as configured using the controller (18), selectively heats septae that interpenetrate fat layers in the region of cellulite ([0034]; [0004]; [0006]; [0003]), Nebrigic is silent regarding while substantially avoiding conduction of heat into the fat layers that the septae interpenetrate.
However, in the same field of endeavor, Levinson teaches a similar combined modality treatment system (100) configured to both cool subcutaneous tissue and also to selectively heat tissue, such as fibrous septae (202) ([0043]). Levinson teaches, “[o]ne method of selectively heating such tissue is by the delivery of radiofrequency (RF) energy, including for example capacitively coupled RF energy, such as a low-level monopolar RF energy as well as conductively coupled RF energy, to the subcutaneous tissue selectively to heat regions of tissue bound by the connective web of fibrous septae.” ([0043]). The RF current (210) “concentrates in the dermal and connective tissue such as the fibrous septum 202.” ([0044]). Fig. 3 illustrates, “[h]eating generated by application of this RF current, depicted by arrows 210, heats the fibrous septum 202 and selected of the adipose cells in the fat lobules 201 adjacent the fibrous septum 202. In the combined modality therapy associated with the embodiments described herein, the treatment parameters may be adjusted selectively to affect, in connection with cooling the subcutaneous tissue, the temperature profile of and the number of the adipose cells in the lobules 201 that are heated via the application of such RF current.” ([0044], thereby meeting the limitation of substantially avoiding conduction of heat into the fat layers that the plurality of septae interpenetrate via adjustment of the treatment parameters). It would be advantageous to control the extent to which conduction of heat into the fat layers that the plurality of septae interpenetrate occurs in order to tailor said treatment and reduce irregularities in a surface of a subject's skin resulting from an uneven distribution of adipose tissue in the subcutaneous layer, thereby increasing accuracy and overall appearance of the skin. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Nebrigic to include selectively heats septae that interpenetrate fat layers in the region of cellulite while substantially avoiding conduction of heat into the fat layers that the septae interpenetrate, as taught by Levinson, in order to tailor said treatment and reduce irregularities in a surface of a subject's skin resulting from an uneven distribution of adipose tissue in the subcutaneous layer, thereby increasing accuracy and overall appearance of the skin.
Nebrigic further discloses “[t]he duration of each of the high frequency power pulses 100, 102, 104 may be set within a range of 200 milliseconds to 300 milliseconds with an adjustment increment of 10 milliseconds,” ([0057]) and “[a]dditional embodiments of the invention may vary the number of power pulses, [and] the power and duration of each individual power pulse” ([0060]). Although Nebrigic is silent regarding wherein the pulse duration ranges from about 5 ms to about 35 ms, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the pulse duration as taught by Nebrigic such that the pulse duration ranges from about 5 ms to about 35 ms 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.
Nebrigic in view of Levinson are silent regarding the controller configured to determine the impedance between each of the at least two individually-addressable treatment electrodes of the first non-invasive treatment applicator, the controller configured to separately poll each of at least two individually-addressable treatment electrodes with at least one of a low-power sub-treatment threshold RF signal or an RF treatment signal.
However, in the same field of endeavor, Condie teaches a similar system (system 10 in Fig. 1; also see Figs. 2-5 for electrode array 36) comprising a medical device (12) coupled to a control unit (14) including a radiofrequency generator (56). Condie teaches that “the medical device 12 may further include one or more electrically-conductive segments or electrodes 34 positioned on or about the elongate body for conveying an electrical signal, current, or voltage to a designated tissue region and/or for measuring, recording, or otherwise assessing one or more electrical properties or characteristics of surrounding tissue” ([0026]). The control unit (14) further includes an impedance measurement module or signal processing unit (58) to measure one or more impedance characteristics between the electrodes of the medical device ([0033]). Condie further teaches “impedance measurements may be obtained by directing sufficient current from the radiofrequency generator 56 to one or more of the electrodes 34 of the medical device 12 to obtain an impedance value between 1) two or more electrodes on the medical device…” ([0036]; as broadly claimed, this would meet the limitation of separately polling). The impedance values are utilized in order to aid in positioning the medical device as well as indicate whether electrodes used in treating tissue have maintained or lost their contact ([0039]), thereby increasing control and accuracy of treatment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified by Nebrigic in view of Levinson to include the controller configured to determine the impedance between each of the at least two individually-addressable treatment electrodes of the first non-invasive treatment applicator, the controller configured to separately poll each of at least two individually-addressable treatment electrodes with at least one of a low-power sub-treatment threshold RF signal or an RF treatment signal, as taught by Condie in order to aid in positioning the medical device as well as indicate whether electrodes used in treating tissue have maintained or lost their contact ([0039]), thereby increasing control and accuracy of treatment.
Regarding claim 38, Nebrigic in view of Levinson and Condie teach all of the limitations of the system according to claim 37. Nebrigic further discloses wherein the treatment electrode is configured to deliver RF pulses exhibiting an energy per pulse in a range from about 10 J/cm2 to about 1000 J/cm2 ([0056], “The maximum energy permitted to be delivered by a set of power pulses 100, 102, 104 during a repetition may range from 10 Joules to 300 Joules with a precision of 1 Joule using electrodes having a size ranging from 1 cm2 to 20 cm2.”). Nebrigic also discloses “the system controller 18 may include a pulse-width modulation (PWM) module that is capable of causing the generator 16 to deliver the output high frequency power in pulses of predetermined duration and predetermined amplitude at a desired frequency. The PWM of the high frequency signal from generator 16 involves the modulation of the duty cycle to control the amount of power sent to the treatment electrode 20.” ([0061]).
Nebrigic in view of Levinson and Condie are silent regarding wherein the RF signal has a pulse width less than about 500 ms, however, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the pulse width as taught by Nebrigic in view of Levinson and Condie to have a pulse width less than about 500 ms 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 84, Nebrigic further discloses wherein the lower impedance value and the higher impedance value are relative impedance measurements measured using different treatment electrodes (see Fig. 2A with sensors 52 relative to treatment electrode 20, wherein “the conductor region of treatment electrode 20 may be segmented into plural individual electrodes that can be individually powered to deliver electromagnetic energy to the tissue 30,” [0030]; also see [0040], for impedance sensors 52; as broadly claimed, the impedance measurements would necessarily be relative in value). Further, it is noted that claim 93 is written in the alternative, and therefore only requires one or more of a lower impedance value or a higher impedance value at one or more treatment electrodes.
Regarding claim 86, Nebrigic further discloses wherein controller (18) is configured such that an increase or a reduction in RF power delivered to a treatment zone is adjusted proportionally to a variation in electrode impedance ([0014], “the method may further include measuring an attribute of the tissue, such as tissue temperature or tissue impedance and the adjusting a power of the electromagnetic energy delivered in each of the power pulses based upon the measured attribute.”; [0061]).
Regarding claim 87, Nebrigic further discloses further comprising distribution electronics in electrical communication with controller, wherein the distribution electronics are configured to adjust an RF signal sent to one or more of the electrodes in response to differences in impedance measured using the impedance tracker ([0014], “the method may further include measuring an attribute of the tissue, such as tissue temperature or tissue impedance and the adjusting a power of the electromagnetic energy delivered in each of the power pulses based upon the measured attribute.” Also see [0037]; [0040], sensors 52 may be impedance sensors; [0061], impedance is used by the system controller 18 to determine the high frequency power to be applied in each of the power pulses and is adjusted based upon output from the sensors).
Regarding claim 88, Nebrigic in view of Levinson and Condie teach all of the limitations of the system according to claim 93. In view of the prior modification of Nebrigic in view of Levinson and Condie, Condie further teaches that “the medical device 12 may further include one or more electrically-conductive segments or electrodes 34 positioned on or about the elongate body for conveying an electrical signal, current, or voltage to a designated tissue region and/or for measuring, recording, or otherwise assessing one or more electrical properties or characteristics of surrounding tissue” ([0026]). The control unit (14) further includes an impedance measurement module or signal processing unit (58) to measure one or more impedance characteristics between the electrodes of the medical device ([0033]). Condie further teaches “impedance may be measured and/or monitored and used as a basis for determining tissue type, electrode location, and/or contact between an electrode and a tissue region” ([0035]). For example, “[u]pon obtaining one or more of the impedance measurements, the obtained measurements from each electrode may then be compared to a pre-defined impedance value (which may include an expected impedance value for atrial tissue and/or an expected value for pulmonary vein tissue)” ([0037]). It is well known in the art (as can be seen in Condie) that various tissue types (i.e. atrial tissue or pulmonary vein tissue) exhibit different impedance values ([0037]), and detecting one or more impedance value changes would be indicative of the various tissue types in a desired region ([0037]). By providing impedance, and accordingly valuable information regarding tissue type, it can be determined if the device should be repositioned or if treatment should be adjusted ([0035]-[0036]; [0037]), thereby increasing control and safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system and impedance tracker as taught by Nebrigic in view of Levinson and Condie to include wherein the impedance tracker is configured to measure differences in impedance values between fat tissue and muscle tissue, wherein relative thickness of a subcutaneous fat layer is calculated using the measured difference in impedance values, as taught by Condie. Doing so provides valuable information regarding tissue type, such that it can be determined if the device should be repositioned or if treatment should be adjusted ([0035]-[0036]; [0037]), thereby increasing control and safety. Further, it is noted that by identifying tissue type, it is contemplated that relative thickness of a subcutaneous fat layer can be calculated by identifying the various tissue types in a targeted region.
Regarding claim 89, Nebrigic discloses wherein changes in tissue composition in the tissue region correspond to treatment of septae (Fig. 3A; [0034], “The electromagnetic energy imparts a therapeutic effect to heat tissue 30 in a targeted region 32 beneath the patient's skin surface 26, as best shown in FIG. 3A, to a therapeutic temperature.… The delivered energy volumetrically heats a region 32 of the tissue 30 to a targeted temperature range. The elevation in temperature within the heated region 32 may produce for example, changes in collagen in the tissue 30 that achieve a desired treatment result, such as removing or reducing wrinkles and otherwise tightening the skin to thereby improve the appearance of a patient receiving the treatment.”; also see [0004] and [0006] for collagen fibers in the form of fibrous septae running through the fat, wherein the applied high frequency energy heats the tissue at depths beneath the cooled region 31 to a therapeutic temperature sufficient to denature the collagen, which causes the collagen fibers (i.e. fibrous septae) in the dermis to shrink and contract).
Regarding claim 91, Nebrigic further discloses wherein the controller (18) is further configured to preferentially heat septae by delivering substantially all of the RF energy available to the non-invasive treatment electrode (20) (Fig. 3A; [0034], “The electromagnetic energy imparts a therapeutic effect to heat tissue 30 in a targeted region 32 beneath the patient's skin surface 26, as best shown in FIG. 3A, to a therapeutic temperature.… The delivered energy volumetrically heats a region 32 of the tissue 30 to a targeted temperature range. The elevation in temperature within the heated region 32 may produce for example, changes in collagen in the tissue 30 that achieve a desired treatment result, such as removing or reducing wrinkles and otherwise tightening the skin to thereby improve the appearance of a patient receiving the treatment.”; also see [0004] and [0006] for collagen fibers in the form of fibrous septae running through the fat, wherein the applied high frequency energy heats the tissue at depths beneath the cooled region 31 to a therapeutic temperature sufficient to denature the collagen, which causes the collagen fibers (i.e. fibrous septae).
Regarding claim 92, Nebrigic further discloses “[t]he maximum energy permitted to be delivered by a set of power pulses 100, 102, 104 during a repetition may range from 10 Joules to 300 Joules with a precision of 1 Joule using electrodes having a size ranging from 1 cm2 to 20 cm2.”), but is silent regarding wherein an energy density per pulse ranges from about 500 J/cm2 to about 1000 J/cm2 per pulse. It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the energy density per pulse as taught by Nebrigic in view of Levinson and Condie, such that it ranges from about 500 J/cm2 to about 1000 J/cm2 per pulse 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 93, Nebrigic further discloses an impedance tracker configured to monitor the patient's tissue impedance during the pulse duration and to detect one or more of a lower impedance value or a higher impedance value at one or more treatment electrodes ([0014], “the method may further include measuring an attribute of the tissue, such as tissue temperature or tissue impedance and the adjusting a power of the electromagnetic energy delivered in each of the power pulses based upon the measured attribute.” Also see [0037]; [0040], sensors 52 may be impedance sensors; [0061], impedance is used by the system controller 18 to determine the high frequency power to be applied in each of the power pulses and is adjusted based upon output from the sensors), the controller (18) further configured to adjust or modulate RF energy delivered by a treatment electrode in response to impedance value detected relative to tissue beneath the treatment electrode ([0014], “the method may further include measuring an attribute of the tissue, such as tissue temperature or tissue impedance and the adjusting a power of the electromagnetic energy delivered in each of the power pulses based upon the measured attribute.” See [0037]; [0040]; [0061]).
Regarding claim 98, Nebrigic further discloses wherein the applicator is a handpiece (12 in Fig. 1) and the handpiece (12) comprises the first plurality of non-invasive treatment electrodes (20), wherein the first plurality of non-invasive treatment electrodes (20) are configured to operate in stamping mode (Fig. 3A; [0041]; as broadly claimed, the electrodes are ‘stamped’ on the skin to treat the targeted tissue and are moved for the cycle of treatment to repeat).
Regarding claim 99, Nebrigic further discloses “[t]he maximum energy permitted to be delivered by a set of power pulses 100, 102, 104 during a repetition may range from 10 Joules to 300 Joules with a precision of 1 Joule using electrodes having a size ranging from 1 cm2 to 20 cm2.”), but Nebrigic in view of Levinson and Condie are silent regarding wherein an energy density per pulse ranges from about 500 J/cm2 to about 1000 J/cm2 per pulse. However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the energy density per pulse as taught by Nebrigic in view of Levinson and Condie such that it ranges from about 500 J/cm2 to about 1000 J/cm2 per pulse 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 104, Nebrigic further discloses wherein the applicator is a handpiece (12 in Fig. 1) and the handpiece (12) comprises the first plurality of non-invasive treatment electrodes (20), wherein the first plurality of non-invasive treatment electrodes (20) are configured to operate in stamping mode (Fig. 3A; [0041]; as broadly claimed, the electrodes are ‘stamped’ on the skin to treat the targeted tissue and are moved for the cycle of treatment to repeat).
Claims 5-6, 10-11, 39-41, 85, 90, 97, and 103 are rejected under 35 U.S.C. 103 as being unpatentable over Nebrigic in view of Levinson and Condie as applied to claims 1 and 37 above, and further in view of Anderson et al., (hereinafter ‘Anderson’, U.S. PGPub. No. 2009/0093864).
Regarding claim 5, Nebrigic in view of Levinson and Condie teach all of the limitations of the system according to claim 1, but is silent regarding wherein the one or more RF signals applied simultaneously to the at least two individually-addressable treatment electrodes comprise different powers.
However, in the same field of endeavor, Anderson teaches a similar system (Figs. 1-3C) comprising a device (300) including a plurality of electrodes (306) configured as blunt probes such as not to pierce the skin. Each electrode may be coupled to a controller, such as controller (102), in order to regulate how and when energy is applied to the one or more electrodes ([0032]). Energy may be applied independently or incrementally “in order to provide a uniform treatment to the skin, which thereby provides a uniform treatment and avoids localized burns and untreated portions of tissue” ([0034]). During independent activation, each electrode is supplied with RF energy independently from the other electrodes, and thus each electrode would have a power source which applies load dependent RF energy ([0034]). Anderson teaches “[l]oad will vary per electrode depending on impedance factors which include electrode contact, tissue type, and blood vessel interaction. For example an electrode in close vicinity to a blood vessel will have a lower load than an electrode which is not in the same vicinity, and thus if the electrodes shared the same power source more RF energy will flow to the electrode near the blood vessel and the electrode with the higher load may provide in sufficient treatment.” ([0034]). It would be advantageous to provide different powers to the individually-addressable treatment electrodes in order to accommodate differences in and meet the requirements of the targeted tissue and ensure a uniform treatment, thereby increasing control, uniformity and safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Nebrigic in view of Levinson and Condie to include wherein the one or more RF signals applied simultaneously to the at least two individually-addressable treatment electrodes comprise different powers as taught by Anderson. Doing so would accommodate differences in and meet the requirements of the targeted tissue and ensure a uniform treatment, thereby increasing control, uniformity and safety.
Regarding claim 6, Nebrigic in view of Levinson and further in view of Condie and Anderson teach all of the limitations of the system according to claim 5. Nebrigic further discloses, “the method may further include measuring an attribute of the tissue, such as tissue temperature or tissue impedance and the adjusting a power of the electromagnetic energy delivered in each of the power pulses based upon the measured attribute.” ([0014]). Further, “[t]he output of the sensors 52, such as a property or attribute like skin temperature or impedance, at each of the sensor readings 120, 122, 124 is used by the system controller 18 to determine the high frequency power to be applied in each of the power pulses 100, 102, 104. The power level, P1, P2, P3, for each of the respective pulses 100, 102, 104 may be specified by adjusting a duty cycle for the delivered power based upon the output from the sensors 52.” ([0061]).
Further, in view of the prior modification of Nebrigic in view of Levinson and further in view of Condie and Anderson, Anderson further teaches wherein the controller is configured to reduce the power of the one or more RF signals exhibiting a lower impedance ([0034], “Load will vary per electrode depending on impedance factors which include electrode contact, tissue type, and blood vessel interaction. For example an electrode in close vicinity to a blood vessel will have a lower load than an electrode which is not in the same vicinity, and thus if the electrodes shared the same power source more RF energy will flow to the electrode near the blood vessel and the electrode with the higher load may provide in sufficient treatment.”; as broadly claimed, the electrode in close vicinity to a blood vessel will have a lower load, and therefore a lower power). See rejection of claim 5 above obviousness rationale.
Regarding claim 10, Nebrigic in view of Levinson and Condie teach all of the limitations of the system according to claim 1, but are silent regarding wherein the one or more RF signals comprise RF signals of different phases.
However, in the same field of endeavor, Anderson teaches a similar system (Figs. 1-3C) comprising a device (300) including a plurality of electrodes (306) configured as blunt probes such as not to pierce the skin. Each electrode may be coupled to a controller, such as controller (102), in order to regulate how and when energy is applied to the one or more electrodes ([0032]). Energy may be applied independently or incrementally “in order to provide a uniform treatment to the skin, which thereby provides a uniform treatment and avoids localized burns and untreated portions of tissue” ([0034]). During independent activation, each electrode is supplied with RF energy independently from the other electrodes, and thus each electrode would have a power source which applies load dependent RF energy ([0034]). Anderson teaches “[l]oad will vary per electrode depending on impedance factors which include electrode contact, tissue type, and blood vessel interaction. For example an electrode in close vicinity to a blood vessel will have a lower load than an electrode which is not in the same vicinity, and thus if the electrodes shared the same power source more RF energy will flow to the electrode near the blood vessel and the electrode with the higher load may provide in sufficient treatment.” ([0034]). Further, “the electrodes may be separated into groups or sets which are activated separately and incrementally over time” ([0035]). It would be advantageous to provide different RF signals in order to accommodate differences in and meet the requirements of the targeted tissue and ensure a uniform treatment, thereby increasing control, uniformity and safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Nebrigic in view of Levinson and Condie to include wherein the one or more RF signals comprise RF signals of different phases as taught by Anderson. Doing so would accommodate differences in and meet the requirements of the targeted tissue and ensure a uniform treatment, thereby increasing control, uniformity and safety.
Regarding claim 11, Nebrigic in view of Levinson and Condie teach all of the limitations of the system according to claim 1. Nebrigic further discloses wherein the at least two individually-addressable treatment electrodes comprises at least two groups of individually-addressable treatment electrodes ([0030], “the conductor region of treatment electrode 20 may be segmented into plural individual electrodes that can be individually powered to deliver electromagnetic energy to the tissue 30”; as broadly claimed, the electrodes 20 are individually powered and are capable of receiving different RF signals and can be divided into at least two groups).
Nebrigic in view of Levinson and Condie are silent regarding wherein each treatment electrode in each of group of individually-addressable treatment electrodes have the same RF signal simultaneously applied thereto as the other treatment electrodes in the group and wherein each group of individually-addressable treatment electrodes are configured to have different RF signals applied simultaneously thereto.
However, in the same field of endeavor, Anderson teaches a similar system (Figs. 1-3C) comprising a device (300) including a plurality of electrodes (306) configured as blunt probes such as not to pierce the skin. Each electrode may be coupled to a controller, such as controller (102), in order to regulate how and when energy is applied to the one or more electrodes ([0032]). Energy may be applied independently or incrementally “in order to provide a uniform treatment to the skin, which thereby provides a uniform treatment and avoids localized burns and untreated portions of tissue” ([0034]). During independent activation, each electrode is supplied with RF energy independently from the other electrodes, and thus each electrode would have a power source which applies load dependent RF energy ([0034]). Anderson teaches “[l]oad will vary per electrode depending on impedance factors which include electrode contact, tissue type, and blood vessel interaction. For example an electrode in close vicinity to a blood vessel will have a lower load than an electrode which is not in the same vicinity, and thus if the electrodes shared the same power source more RF energy will flow to the electrode near the blood vessel and the electrode with the higher load may provide in sufficient treatment.” ([0034]). Further, “the electrodes may be separated into groups or sets which are activated separately and incrementally over time” ([0035]). It would be advantageous to provide different RF signals in order to accommodate differences in and meet the requirements of the targeted tissue and ensure a uniform treatment, thereby increasing control, uniformity and safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Nebrigic in view of Levinson and Condie to include wherein each treatment electrode in each of group of individually-addressable treatment electrodes have the same RF signal simultaneously applied thereto as the other treatment electrodes in the group and wherein each group of individually-addressable treatment electrodes are configured to have different RF signals applied simultaneously thereto as taught by Anderson. Doing so would accommodate differences in and meet the requirements of the targeted tissue and ensure a uniform treatment, thereby increasing control, uniformity and safety.
Regarding claim 39, Nebrigic in view of Levinson and Condie teach all of the limitations of the system according to claim 37. Nebrigic further discloses further comprising a plurality of electrodes ([0030], “the conductor region of treatment electrode 20 may be segmented into plural individual electrodes that can be individually powered to deliver electromagnetic energy to the tissue 30”), wherein the non-invasive treatment electrode is one of the plurality of electrodes (treatment electrode 20).
Nebrigic in view of Levinson and Condie are silent regarding wherein the controller is further configured to adjust the RF signals provided to the plurality of electrodes such that second treatment RF signals are simultaneously provided to each of the plurality of electrodes, wherein the second RF signals comprise a lower RF power and longer pulse width relative to the RF treatment signals for selectively heating the septae.
However, in the same field of endeavor, Anderson teaches a similar system (Figs. 1-3C) comprising a device (300) including a plurality of electrodes (306) configured as blunt probes such as not to pierce the skin. Each electrode may be coupled to a controller, such as controller (102), in order to regulate how and when energy is applied to the one or more electrodes ([0032]). Energy may be applied independently or incrementally “in order to provide a uniform treatment to the skin, which thereby provides a uniform treatment and avoids localized burns and untreated portions of tissue” ([0034]). During independent activation, each electrode is supplied with RF energy independently from the other electrodes, and thus each electrode would have a power source which applies load dependent RF energy ([0034]). Anderson teaches “[l]oad will vary per electrode depending on impedance factors which include electrode contact, tissue type, and blood vessel interaction. For example an electrode in close vicinity to a blood vessel will have a lower load than an electrode which is not in the same vicinity, and thus if the electrodes shared the same power source more RF energy will flow to the electrode near the blood vessel and the electrode with the higher load may provide in sufficient treatment.” ([0034]). Further, “the electrodes may be separated into groups or sets which are activated separately and incrementally over time” ([0035]). It would be advantageous to provide different RF signals in order to accommodate differences in and meet the requirements of the targeted tissue and ensure a uniform treatment, thereby increasing control, uniformity and safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Nebrigic in view of Levinson and Condie to include wherein the controller is further configured to adjust the RF signals provided to the plurality of electrodes such that second treatment RF signals are simultaneously provided to each of the plurality of electrodes, wherein the second RF signals comprise a lower RF power and longer pulse width relative to the RF treatment signals for selectively heating the septae, as taught by Anderson. Doing so would accommodate differences in and meet the requirements of the targeted tissue and ensure a uniform treatment, thereby increasing control, uniformity and safety.
Regarding claim 40 , Nebrigic in view of Levinson and Condie and further in view of Anderson teach all of the limitations of the system according to claim 39. In view of the prior modification Nebrigic in view of Levinson and further in view of Condie and Anderson, Nebrigic discloses wherein the RF treatment signals are configured to at least one of reduce skin laxity and cause lipolysis ([0034], “The electromagnetic energy imparts a therapeutic effect to heat tissue 30 in a targeted region 32 beneath the patient's skin surface 26, as best shown in FIG. 3A, to a therapeutic temperature.… The delivered energy volumetrically heats a region 32 of the tissue 30 to a targeted temperature range. The elevation in temperature within the heated region 32 may produce for example, changes in collagen in the tissue 30 that achieve a desired treatment result, such as removing or reducing wrinkles and otherwise tightening the skin to thereby improve the appearance of a patient receiving the treatment.”; also see [0004]- [0006] for collagen fibers in the form of fibrous septae running through the fat, wherein the applied high frequency energy heats the tissue at depths beneath the cooled region 31 to a therapeutic temperature sufficient to denature the collagen, which causes the collagen fibers (i.e. fibrous septae) in the dermis to shrink and contract). Therefore, in view of the combination, it would necessarily follow that the second RF treatment signals are configured for the same purpose.
Regarding claim 41 , Nebrigic in view of Levinson and further in view of Condie and Anderson teach all of the limitations of the system according to claim 40. In view of the prior modification of Nebrigic in view of Levinson and further in view of Condie and Anderson, Levinson teaches wherein each electrode is configured to deliver RF power in a range from about 1 W/cm2 to about 5 W/cm2 ([0044]; also see claims 14 and 15).
The combination is silent, however, regarding wherein the one or more RF signals has a pulse width greater than about 1 second.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the RF signal pulse width as taught by Nebrigic in view of Levinson and further in view of Condie and Anderson to provide the RF signal has a pulse width greater than about 1 second 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 85, Nebrigic in view of Levinson and Condie teach all of the limitations of the system according to claim 93, but are silent regarding wherein the controller is configured to homogenize an RF treatment relative to a target treatment zone using an impedance map generated using measurements from the impedance tracker.
However, in the same field of endeavor, Anderson teaches a similar system (Fig. 1-3C) comprising a device (300) including a plurality of electrodes (306) wherein each electrode may be coupled to a controller, such as controller (102), which regulates how and when energy is applied to the one or more electrodes based off the measured impedance of the tissue ([0033]). The electrodes (306) are configured to sense tissue contact before activation by supplying very low RF power to each electrode in order to determine the proper impedance value upon tissue contact ([0036]), (thereby meeting in part the limitations regarding an impedance map). Energy may be applied independently or incrementally “in order to provide a uniform treatment to the skin, which thereby provides a uniform treatment and avoids localized burns and untreated portions of tissue” ([0034]). In independent activation, “each electrode would be supplied RF energy independently from other electrodes, and thus each electrode would have a power source which applies load dependent RF energy” ([0034]). Alternatively, incremental activation, “can use the same power source for all electrodes, however each set of electrodes is switched such that only one electrode (or set of electrodes) is activated (e.g. RF energy is applied) at a given time” ([0035]). Anderson teaches that “the electrodes may be separated into groups or sets which are activated separately and incrementally over time” ([0035]). It is well known in the art (as can be seen in Anderson) to provide the same RF signal simultaneously to all of the treatment electrodes in the group or to provide different RF signals applied simultaneously depending on the requirements of the tissue and treatment, thereby providing a uniform distribution of treatment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Nebrigic in view of Levinson and Condie to include wherein the controller is configured to homogenize an RF treatment relative to a target treatment zone using an impedance map generated using measurements from the impedance tracker as taught by Anderson. Doing so would accommodate differences in and meet the requirements of the targeted tissue, ensure uniform treatment, and would avoid localized burns and untreated portions of tissue ([0034]), thereby increasing control, uniformity and safety.
Regarding claim 90, Nebrigic in view of Levinson and Condie teach all of the limitations of the system according to claim 37, but are silent regarding wherein the impedance tracker is further configured to detect impedance values in a target treatment zone such that impedance value differences can be compensated for by controlling RF power delivered through each individual electrode based upon an impedance map of the target treatment zone.
However, in the same field of endeavor, Anderson teaches a similar system (Fig. 1-3C) comprising a device (300) including a plurality of electrodes (306) wherein each electrode may be coupled to a controller, such as controller (102), which regulates how and when energy is applied to the one or more electrodes based off the measured impedance of the tissue ([0033]). The electrodes (306) are configured to sense tissue contact before activation by supplying very low RF power to each electrode in order to determine the proper impedance value upon tissue contact ([0036]), (thereby meeting in part the limitations regarding to detect impedance values in a target treatment zone). In independent activation, “each electrode would be supplied RF energy independently from other electrodes, and thus each electrode would have a power source which applies load dependent RF energy” ([0034]). Alternatively, incremental activation, “can use the same power source for all electrodes, however each set of electrodes is switched such that only one electrode (or set of electrodes) is activated (e.g. RF energy is applied) at a given time” ([0035]). Anderson teaches “[l]oad will vary per electrode depending on impedance factors which include electrode contact, tissue type, and blood vessel interaction. For example an electrode in close vicinity to a blood vessel will have a lower load than an electrode which is not in the same vicinity, and thus if the electrodes shared the same power source more RF energy will flow to the electrode near the blood vessel and the electrode with the higher load may provide in sufficient treatment.” ([0034]). Further, “the electrodes may be separated into groups or sets which are activated separately and incrementally over time” ([0035]). It would be advantageous to provide different RF signals in order to accommodate differences in and meet the requirements of the targeted tissue and ensure a uniform treatment, thereby increasing control, uniformity and safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Nebrigic in view of Levinson and Condie to include wherein the impedance tracker is further configured to detect impedance values in a target treatment zone such that impedance value differences can be compensated for by controlling RF power delivered through each individual electrode based upon an impedance map of the target treatment zone, as taught by Anderson. Doing so would accommodate differences in and meet the requirements of the targeted tissue and ensure a uniform treatment, thereby increasing control, uniformity and safety.
Regarding claim 97, Nebrigic in view of Levinson and Condie teach all of the limitations of the system according to claim 1, but is silent regarding wherein the applicator is configured to attach directly to tissue surface through suction.
However, in the same field of endeavor, Anderson teaches a similar system (Figs. 1-3C) comprising a device (100, 300) including a plurality of electrodes (306) configured as blunt probes such as not to pierce the skin. The device (100) “can apply positive pressure (e.g. pressures slightly above normal atmospheric or higher pressures) and negative pressure (e.g. pressures below atmospheric pressure such as a partial vacuum) to a portion of skin on a patient” ([0026]) in order to maintain secure attachment to the skin at a target location, thereby minimizing unwanted movement and increasing accuracy. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the applicator as taught by Nebrigic in view of Levinson and Condie such that it is configured to attach directly to tissue surface through suction as taught by Anderson. Doing so maintains secure attachment to the skin at the target location, thereby minimizing unwanted movement and increasing accuracy.
Regarding claim 103, Nebrigic in view of Levinson and Condie teach all of the limitations of the system according to claim 37, but are silent regarding wherein the applicator is configured to attach directly to tissue surface through suction.
However, in the same field of endeavor, Anderson teaches a similar system (Figs. 1-3C) comprising a device (100, 300) including a plurality of electrodes (306) configured as blunt probes such as not to pierce the skin. The device (100) “can apply positive pressure (e.g. pressures slightly above normal atmospheric or higher pressures) and negative pressure (e.g. pressures below atmospheric pressure such as a partial vacuum) to a portion of skin on a patient” ([0026]) in order to maintain secure attachment to the skin at a target location, thereby minimizing unwanted movement and increasing accuracy. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the applicator as taught by Nebrigic in view of Levinson and Condie, such that it is configured to attach directly to tissue surface through suction as taught by Anderson. Doing so maintains secure attachment to the skin at the target location, thereby minimizing unwanted movement and increasing accuracy.
Claims 10 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Nebrigic in view of Levinson and Condie, as applied to claim 1 above, and further in view of Kothare (hereinafter ‘Kothare’, U.S. PGPub. No. 2013/0245727).
Regarding claim 10, Nebrigic in view of Levinson and Condie teach all of the limitations of the system according to claim 1, but are silent regarding wherein the one or more RF signals comprise RF signals of different phases.
However, in the same field of endeavor, Kothare teaches a similar system (RF system 1 in Fig. 1) comprising a handpiece (2) including at least one electrode and a control console (4). The system may optionally include a second handpiece and an RF generator configured to drive the two handpiece simultaneously (e.g., at the same or different frequency and/or power and/or current), and/or may be configured to drive the two handpieces alternately (e.g., with a non-zero phase shift) ([0024]). Kothare teaches that electrodes may be operated “in phase (e.g., phase shift of about 0°) in conjunction with a ground pad located remotely from the target tissue, which may act to heat tissue deep beneath the surface of the skin (e.g., current may flow from each of the two handpieces to the remotely located ground pad) [or] [t]he two handpieces may be operated out of phase (e.g., phase shift of about 180°) which may act to heat shallow tissues near the surface of the skin (e.g., current may flow along more superficial tissue between the two handpieces)” ([0024]), thereby improving control over the depth of the tissue that is to be heated. It is well known in the art (as can be seen in Kothare) to provide RF signals applied simultaneously to the at least two individually-addressable treatment electrodes at different energies and properties (as claimed) in order to more specifically tailor the energy application to a tissue and achieve a desired result. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Nebrigic in view of Levinson and Condie to include wherein the one or more RF signals comprise RF signals of different phases as taught by Kothare. Doing so allows for more specifically tailored energy application to achieve a desired result, thereby increasing accuracy and improving control over the depth of the tissue that is to be heated ([0024]).
Regarding claim 36, Nebrigic in view of Levinson and Condie teach all of the limitations of the system according to claim 1, but are silent regarding wherein the source of RF energy comprises two or more individually-controllable RF energy sources, each of the individually controllable RF energy sources configured to operate at the same fundamental frequency, but the RF signals generated thereby can have different phases and amplitudes, and wherein the system comprises two or more treatment applicators each associated with one of the RF energy sources, wherein current amongst each of the two or more treatment applicators can be shared such that the two or more applicators can be disposed on two or more distinct treatment regions of the body of the subject and each of the two or more applicators is configured to deliver a suitable amount of RF energy to each of the distinct treatment regions.
However, in the same field of endeavor, Kothare teaches a similar system (RF system 1 in Fig. 1) comprising a handpiece (2) including at least one electrode and a control console (4). The system may optionally include a second handpiece wherein in the dual-handpiece system, two electrosurgical generators may be used to separately drive each handpiece ([0024]). The controller for a dual-handpiece RF system is configured to drive the two handpiece simultaneously (e.g., at the same or different frequency and/or power and/or current), and/or may be configured to drive the two handpieces alternately (e.g., with a non-zero phase shift) ([0024]). Kothare teaches that electrodes may be operated “in phase (e.g., phase shift of about 0°) in conjunction with a ground pad located remotely from the target tissue, which may act to heat tissue deep beneath the surface of the skin (e.g., current may flow from each of the two handpieces to the remotely located ground pad) [or] [t]he two handpieces may be operated out of phase (e.g., phase shift of about 180°) which may act to heat shallow tissues near the surface of the skin (e.g., current may flow along more superficial tissue between the two handpieces)” ([0024]), thereby improving control over the depth of the tissue that is to be heated. It is well known in the art (as can be seen in Kothare) to provide RF signals applied simultaneously to electrodes at the same or different energies and properties (as claimed) in order to more specifically tailor the energy application to a tissue and achieve a desired result. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Nebrigic in view of Levinson and Condie to include wherein the source of RF energy comprises two or more individually-controllable RF energy sources, each of the individually controllable RF energy sources configured to operate at the same fundamental frequency, but the RF signals generated thereby can have different phases and amplitudes, and wherein the system comprises two or more treatment applicators each associated with one of the RF energy sources, wherein current amongst each of the two or more treatment applicators can be shared such that the two or more applicators can be disposed on two or more distinct treatment regions of the body of the subject and each of the two or more applicators is configured to deliver a suitable amount of RF energy to each of the distinct treatment regions as taught by Kothare. Doing so allows for more specifically tailored energy application to achieve a desired result, thereby increasing accuracy and improving control over the depth of the tissue that is to be heated ([0024]).
Further, it is noted in view of the combination of Nebrigic in view of Levinson and further in view of Condie and Kothare, the two or more applicators can be disposed anywhere on the body, including on two or more distinct treatment regions of the body of the subject, and each of the two or more applicators would necessarily be capable of delivering a suitable amount of RF energy to any region, including to each of the distinct treatment regions.
Claims 12-14, 18, 21 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Nebrigic in view of Levinson and Condie as applied to claim 1 above, and further in view of Ingle et al., (hereinafter ‘Ingle’, U.S. Pat. 6,546,934).
Regarding claims 12 and 13, Nebrigic in view of Levinson and Condie teach all of the limitation of the system according to claim 1, but fails to explicitly disclose wherein a second non-invasive treatment applicator configured to be disposed in contact with a tissue surface spaced apart from the tissue surface to which the first non-invasive treatment applicator is disposed comprises the at least one return electrode (claim 12) and wherein the non-invasive second treatment applicator comprises a second plurality of non-invasive treatment electrodes configured to be disposed in contact with the patient's tissue surface and to deliver RF energy thereto, wherein the second plurality of non-invasive treatment electrodes comprise at least two individually-addressable treatment electrodes to which different RF signals can be applied (claim 13).
However, in the same field of endeavor, Ingle teaches a similar system (Figs. 1-2F and 5-7) comprising a first and second non-invasive treatment applicators (vaginal probe 42 and a bladder probe 44 in Fig. 5, electrode segment(s) 12 and 14), wherein the second non-invasive treatment applicator configured to be disposed in contact with a tissue surface spaced apart from the tissue surface to which the first treatment applicator is disposed (see probes 42, 44 spaced apart in Fig. 6) comprises the at least one return electrode (col. 12, ll.66-67, “ RF power is applied uniformly across parallel plate electrodes 12, 14 to produce a current through tissue T”; col. 14, ll. 12-38, “electrode segments 12 a, 12 b, 12 c . . . , and 14 a, 14 b, 14 c . . . , can be energized, thereby heating an entire target zone 32 extending throughout tissue T between the electrodes”; it is noted that the second treatment applicator would necessarily provide at least one return electrode as the system is a bipolar configuration). The second treatment applicator further comprises a second plurality of treatment electrodes (plurality of electrodes 12 and 14; col. 14, ll. 12-38) configured to be disposed in contact with the patient's tissue surface (Fig. 6) and to deliver RF energy thereto, wherein the second plurality of treatment electrodes comprise at least two individually-addressable treatment electrodes to which different RF signals can be applied (col. 12, ll. 44-62, electrodes are individually energized and can be provided with varying RF power). This configuration is utilized in order to provide uniform heating and increased flexibility regarding the selective targeting of tissues between the electrodes (col. 14, ll. 1-38), thereby increasing control and accuracy of treatment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Nebrigic in view of Levinson and Condie to include a second non-invasive treatment applicator comprising the at least one return electrode and wherein the second non-invasive treatment applicator comprises a second plurality of treatment electrodes configured to deliver RF energy thereto, wherein the second plurality of treatment electrodes comprise at least two individually-addressable treatment electrodes to which different RF signals can be applied as taught by Ingle in order to provide uniform heating and increased flexibility regarding the selective targeting of tissues between the electrodes (col. 14, ll. 1-38), thereby increasing control and accuracy of treatment.
Regarding claim 14, Nebrigic in view of Levinson and Condie and Ingle teach each and every limitation of the system according to claim 13. In view of the prior modification of Nebrigic in view of Levinson and further in view of Condie and Ingle, Ingle teaches wherein the controller (controller 22 in Fig. 1) is configured to activate only one of the individually-addressable treatment electrodes on each of the first and second treatment non-invasive applicator at a given time (electrodes 12 and 14; col. 12, ll. 44-62, electrode segments are individually energized and can be provided with varying RF power). See rejection of claims 12 and 13 for obviousness rationale.
Regarding claim 18, Nebrigic in view of Levinson and further in view of Condie and Ingle teach each and every limitation of the system according to claim 12. Ingle further teaches wherein the second non-invasive treatment applicator (see Figs. 1, 2E and 2F) comprises a cooling mechanism for cooling the tissue surface in contact with the plurality of electrodes of the second non-invasive treatment applicator (col. 12, ll. 29-43, “electrodes 12, 14 which engage the tissue are cooled by a cooling system 16”). In one embodiment, Ingle teaches “a plastic housing 23 defines a flow path between a cooling inflow port 25 and a cooling outflow port 27, while heat transfer between the cooling fluid and the electrode surface is enhanced by a thermally conductive front plate 29” (col. 14, ll. 42-46). The cooling system is used to cool “an area which extends beyond the energized electrode surfaces to prevent any hot spots adjacent the tissue surface, and to maximize the heat removal from the tissue without chilling it to or below temperatures that irreversibly damage the tissue, such as might occur when freezing the tissue” (col. 12, ll.38-43). Further, cooling may be provided in order to “minimize collateral damage to the adjacent tissues 36 and stunned tissue 38, the cooling system continues to circulate cold fluid through the electrode, and to remove heat from the tissue, after the heating radiofrequency energy is halted” (col. 16, ll. 21-25). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Nebrigic in view of Levinson and further in view of Condie and Ingle to further include wherein the second non-invasive treatment applicator comprises a cooling mechanism as taught by Ingle in order to “prevent any hot spots adjacent the tissue surface, and to maximize the heat removal from the tissue without chilling it to or below temperatures that irreversibly damage the tissue, such as might occur when freezing the tissue” (col. 12, ll.38-43) and further “minimize collateral damage to the adjacent tissues 36 and stunned tissue 38” (col. 16, ll. 21-25), thereby increasing safety.
Regarding claim 21, Nebrigic in view of Levinson and Condie teach all of the limitation of the system according to claim 19, including the first non-invasive treatment applicator and the passive electrode (see rejection above). Nebrigic in view of Levinson and Condie are silent regarding a second non-invasive treatment applicator configured to be disposed in contact with a tissue surface spaced apart from the tissue surfaces to which the first treatment applicator and the passive electrode are disposed, wherein the second non-invasive treatment applicator comprises a second plurality of treatment electrodes configured to be disposed in contact with the patient’s tissue surface and to deliver RF energy thereto.
However, in the same field of endeavor, Ingle teaches a similar system (Figs. 1-2F and 5-7) comprising a first and second non-invasive treatment applicator (vaginal probe 42 and a bladder probe 44 in Fig. 5, electrode segment(s) 12 and 14), wherein the second treatment applicator is configured to be disposed in contact with a tissue surface spaced apart from the tissue surface to which the first treatment applicator is disposed (see probes 42, 44 spaced apart in Fig. 6; it is noted that the second treatment applicator is capable of being disposed in contact with any tissue surface). The second treatment applicator further comprises a second plurality of treatment electrodes (plurality of electrodes 12 and 14; col. 14, ll. 12-38) configured to be disposed in contact with the patient's tissue surface (Fig. 6) and to deliver RF energy thereto (col. 12, ll. 44-62). This configuration is utilized in order to provide uniform heating and increased flexibility regarding the selective targeting of tissues between the electrodes (col. 14, ll. 1-38), thereby increasing control and accuracy of treatment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Nebrigic in view of Levinson and Condie to include a second non-invasive treatment applicator comprising a second plurality of treatment electrodes configured to be disposed in contact with the patient’s tissue surface and to deliver RF energy thereto as taught by Ingle in order to provide uniform heating and increased flexibility regarding the selective targeting of tissues between the electrodes (col. 14, ll. 1-38), thereby increasing control and accuracy of treatment.
Regarding claim 29, Nebrigic in view of Levinson and Condie teach all of the limitation of the system according to claim 28, but are silent regarding wherein a temperature of the circulating fluid is controlled by a temperature regulator such that a target tissue region disposed below the tissue surface is maintain at a temperature in a range from about 42 ºC to about 47 ºC.
However, in the same field of endeavor, Ingle teaches a similar system comprising a cooling mechanism comprising a circulating fluid (col. 12, ll. 29-43, “electrodes 12, 14 which engage the tissue are cooled by a cooling system 16”). Ingle teaches “a plastic housing 23 defines a flow path between a cooling inflow port 25 and a cooling outflow port 27, while heat transfer between the cooling fluid and the electrode surface is enhanced by a thermally conductive front plate 29” (col. 14, ll. 42-46). Further, “a controller 22 will typically include a computer program which directs the application of cooling flow and RF power through electrodes 12, 14, ideally based at least in part on a temperature signal sensed by a temperature sensor 24” (col. 12, ll. 52-56). The cooling maintains a cooled tissue region (28) adjacent each electrode below a maximum safe tissue temperature, typically being below about 45° C (col. 13, ll. 28-30). The cooling system is used to cool “an area which extends beyond the energized electrode surfaces to prevent any hot spots adjacent the tissue surface, and to maximize the heat removal from the tissue without chilling it to or below temperatures that irreversibly damage the tissue, such as might occur when freezing the tissue” (col. 12, ll.38-43). Further, cooling may be provided in order to “minimize collateral damage to the adjacent tissues 36 and stunned tissue 38, the cooling system continues to circulate cold fluid through the electrode, and to remove heat from the tissue, after the heating radiofrequency energy is halted” (col. 16, ll. 21-25). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Nebrigic in view of Levinson and Condie to further include a temperature of the circulating fluid is controlled by a temperature regulator such that a target tissue region disposed below the tissue surface is maintain a ta temperature in a range from about 42 ºC to about 47 ºC as taught by Ingle in order to “prevent any hot spots adjacent the tissue surface, and to maximize the heat removal from the tissue without chilling it to or below temperatures that irreversibly damage the tissue, such as might occur when freezing the tissue” (col. 12, ll.38-43) and further “minimize collateral damage to the adjacent tissues 36 and stunned tissue 38” (col. 16, ll. 21-25), thereby increasing safety.
Nebrigic in view of Levinson and further in view of Condie and Ingle are silent regarding during a treatment time in a range from about 10 minutes to about 30 minutes, however, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the treatment time as taught by Nebrigic in view of Levinson and further in view of Condie and Ingle to range from about 10 minutes to about 30 minutes, 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, Nebrigic in view of Levinson and Condie teach all of the limitation of the system according to claim 28, but are silent regarding wherein the circulating fluid comprises water.
However, in the same field of endeavor, Ingle teaches a similar system comprising a cooling mechanism (cooling lumen 318, coolant flow 316 in Fig. 13F) wherein the cooling fluid comprises water. Ingle teaches that “[i]t should at least be possible to maintain the housing below a maximum safe tissue temperature by using an adequate flow a cooling liquid such as water, and still further cooling may be possible” (col. 26, ll. 49-52). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the fluid as taught by Nebrigic in view of Levinson and Condie to include water as taught by Ingle. This modification would have merely comprised a simple substitution of one well known fluid for another in order to produce a predictable result, MPEP 2143(I)(B).
Claims 94-96 and 100-102 are rejected under 35 U.S.C. 103 as being unpatentable over Nebrigic in view of Levinson and Condie as applied to claims 37 and 93 above, and further in view of Knowlton et al., (hereinafter ‘Knowlton, U.S. PGPub. No. 2004/0210214).
Regarding claim 94, Nebrigic in view of Levison and Condie teach all of the limitations of the system according to claim 93. Nebrigic further discloses “measuring an attribute of the tissue, such as tissue temperature or tissue impedance, and the adjusting a power of the electromagnetic energy delivered in each of the power pulses based upon the measured attribute” ([0014]; also see [0061]), therefore the RF signal is adjusted or modulated and RF energy is delivered in response thereto sufficient to coagulate the plurality of septae (Fig. 3A; [0034], “The electromagnetic energy imparts a therapeutic effect to heat tissue 30 in a targeted region 32 beneath the patient's skin surface 26, as best shown in FIG. 3A, to a therapeutic temperature.… The delivered energy volumetrically heats a region 32 of the tissue 30 to a targeted temperature range. The elevation in temperature within the heated region 32 may produce for example, changes in collagen in the tissue 30 that achieve a desired treatment result, such as removing or reducing wrinkles and otherwise tightening the skin to thereby improve the appearance of a patient receiving the treatment.”; also see [0004] and [0006] for collagen fibers in the form of fibrous septae running through the fat, wherein the applied high frequency energy heats the tissue at depths beneath the cooled region 31 to a therapeutic temperature sufficient to denature the collagen, which causes the collagen fibers (i.e. fibrous septae) in the dermis to shrink and contract).
Although Nebrigic discloses adjusting or modulating the RF signal in accordance with the tissue impedance, Nebrigic in view of Levison and Condie are silent regarding wherein the RF signal is adjusted or modulated to approach and then maintain the impedance value at a target value.
However, in the same field of endeavor, Knowlton teaches a similar impedance feedback system comprising an impedance monitoring device (420) used to control energy delivery by an energy source (392) to a desired tissue site ([0182]; Fig. 25). The monitor (420) “ascertains tissue impedance (at electrode 314, tissue site 416 or a passive electrode 314'), based on the energy delivered to tissue, and compares the measured impedance value to a set value. If measured impedance is within acceptable limits, energy continues to be applied to the tissue. However if the measured impedance exceeds the set value, a disabling signal 422 is transmitted to energy source 392, ceasing further delivery of energy to RF electrode 314.” ([0182]). It is advantageous to utilize impedance monitoring in order to provide a controlled delivery of energy to a desired tissue site and eliminate unwanted thermal damage to surrounding tissues, thereby improving control and safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Nebrigic in view of Levison and Condie to include wherein the RF signal is adjusted or modulated to approach and then maintain the impedance value at a target value, as taught by Knowlton. Doing so provides a controlled delivery of energy to a desired tissue site and eliminates unwanted thermal damage to surrounding tissues, thereby improving control and safety.
Regarding claim 95, Nebrigic in view of Levison and Condie teach all of the limitations of the system according to claim 93. Nebrigic further discloses “measuring an attribute of the tissue, such as tissue temperature or tissue impedance, and the adjusting a power of the electromagnetic energy delivered in each of the power pulses based upon the measured attribute” ([0014]; also see [0061]), therefore the RF signal is adjusted or modulated and RF energy is delivered in response thereto sufficient to heat the plurality of septae (Fig. 3A; [0034], “The electromagnetic energy imparts a therapeutic effect to heat tissue 30 in a targeted region 32 beneath the patient's skin surface 26, as best shown in FIG. 3A, to a therapeutic temperature.… The delivered energy volumetrically heats a region 32 of the tissue 30 to a targeted temperature range. The elevation in temperature within the heated region 32 may produce for example, changes in collagen in the tissue 30 that achieve a desired treatment result, such as removing or reducing wrinkles and otherwise tightening the skin to thereby improve the appearance of a patient receiving the treatment.”; also see [0004] and [0006] for collagen fibers in the form of fibrous septae running through the fat, wherein the applied high frequency energy heats the tissue at depths beneath the cooled region 31 to a therapeutic temperature sufficient to denature the collagen, which causes the collagen fibers (i.e. fibrous septae) in the dermis to shrink and contract).
Although Nebrigic discloses adjusting or modulating the RF signal in accordance with the tissue impedance, Nebrigic in view of Levison and Condie are silent regarding wherein the RF signal is adjusted or modulated to approach and then maintain the impedance value at a target value.
However, in the same field of endeavor, Knowlton teaches a similar impedance feedback system comprising an impedance monitoring device (420) used to control energy delivery by an energy source (392) to a desired tissue site ([0182]; Fig. 25). The monitor (420) “ascertains tissue impedance (at electrode 314, tissue site 416 or a passive electrode 314'), based on the energy delivered to tissue, and compares the measured impedance value to a set value. If measured impedance is within acceptable limits, energy continues to be applied to the tissue. However if the measured impedance exceeds the set value, a disabling signal 422 is transmitted to energy source 392, ceasing further delivery of energy to RF electrode 314.” ([0182]). It is advantageous to utilize impedance monitoring in order to provide a controlled delivery of energy to a desired tissue site and eliminate unwanted thermal damage to surrounding tissues, thereby improving control and safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Nebrigic in view of Levison and Condie to include wherein the RF signal is adjusted or modulated to approach and then maintain the impedance value at a target value, as taught by Knowlton. Doing so provides a controlled delivery of energy to a desired tissue site and eliminates unwanted thermal damage to surrounding tissues, thereby improving control and safety.
Regarding claim 96, Nebrigic in view of Levison and Condie teach all of the limitations of the system according to claim 93. Nebrigic further discloses “measuring an attribute of the tissue, such as tissue temperature or tissue impedance, and the adjusting a power of the electromagnetic energy delivered in each of the power pulses based upon the measured attribute” ([0014]; also see [0061]), therefore the RF signal is adjusted or modulated and RF energy is delivered in response thereto sufficient to disrupt the plurality of septae (Fig. 3A; [0034], “The electromagnetic energy imparts a therapeutic effect to heat tissue 30 in a targeted region 32 beneath the patient's skin surface 26, as best shown in FIG. 3A, to a therapeutic temperature.… The delivered energy volumetrically heats a region 32 of the tissue 30 to a targeted temperature range. The elevation in temperature within the heated region 32 may produce for example, changes in collagen in the tissue 30 that achieve a desired treatment result, such as removing or reducing wrinkles and otherwise tightening the skin to thereby improve the appearance of a patient receiving the treatment.”; also see [0004] and [0006] for collagen fibers in the form of fibrous septae running through the fat, wherein the applied high frequency energy heats the tissue at depths beneath the cooled region 31 to a therapeutic temperature sufficient to denature the collagen, which causes the collagen fibers (i.e. fibrous septae) in the dermis to shrink and contract).
Although Nebrigic discloses adjusting or modulating the RF signal in accordance with the tissue impedance, Nebrigic in view of Levison and Condie are silent regarding wherein the RF signal is adjusted or modulated to approach and then maintain the impedance value at a target value.
However, in the same field of endeavor, Knowlton teaches a similar impedance feedback system comprising an impedance monitoring device (420) used to control energy delivery by an energy source (392) to a desired tissue site ([0182]; Fig. 25). The monitor (420) “ascertains tissue impedance (at electrode 314, tissue site 416 or a passive electrode 314'), based on the energy delivered to tissue, and compares the measured impedance value to a set value. If measured impedance is within acceptable limits, energy continues to be applied to the tissue. However if the measured impedance exceeds the set value, a disabling signal 422 is transmitted to energy source 392, ceasing further delivery of energy to RF electrode 314.” ([0182]). It is advantageous to utilize impedance monitoring in order to provide a controlled delivery of energy to a desired tissue site and eliminate unwanted thermal damage to surrounding tissues, thereby improving control and safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Nebrigic in view of Levison and Condie to include wherein the RF signal is adjusted or modulated to approach and then maintain the impedance value at a target value, as taught by Knowlton. Doing so provides a controlled delivery of energy to a desired tissue site and eliminates unwanted thermal damage to surrounding tissues, thereby improving control and safety.
Regarding claim 100, Nebrigic in view of Levinson and Condie teach all of the limitations of the system according to claim 37. Nebrigic further discloses “measuring an attribute of the tissue, such as tissue temperature or tissue impedance, and the adjusting a power of the electromagnetic energy delivered in each of the power pulses based upon the measured attribute” ([0014]; also see [0061]), therefore the RF signal is adjusted or modulated and RF energy is delivered in response thereto sufficient to coagulate the plurality of septae (Fig. 3A; [0034], “The electromagnetic energy imparts a therapeutic effect to heat tissue 30 in a targeted region 32 beneath the patient's skin surface 26, as best shown in FIG. 3A, to a therapeutic temperature.… The delivered energy volumetrically heats a region 32 of the tissue 30 to a targeted temperature range. The elevation in temperature within the heated region 32 may produce for example, changes in collagen in the tissue 30 that achieve a desired treatment result, such as removing or reducing wrinkles and otherwise tightening the skin to thereby improve the appearance of a patient receiving the treatment.”; also see [0004] and [0006] for collagen fibers in the form of fibrous septae running through the fat, wherein the applied high frequency energy heats the tissue at depths beneath the cooled region 31 to a therapeutic temperature sufficient to denature the collagen, which causes the collagen fibers (i.e. fibrous septae) in the dermis to shrink and contract).
Although Nebrigic discloses adjusting or modulating the RF signal in accordance with the tissue impedance, Nebrigic in view of Levinson and Condie are silent regarding wherein the RF signal is adjusted or modulated to approach and then maintain the impedance value at a target value.
However, in the same field of endeavor, Knowlton teaches a similar impedance feedback system comprising an impedance monitoring device (420) used to control energy delivery by an energy source (392) to a desired tissue site ([0182]; Fig. 25). The monitor (420) “ascertains tissue impedance (at electrode 314, tissue site 416 or a passive electrode 314'), based on the energy delivered to tissue, and compares the measured impedance value to a set value. If measured impedance is within acceptable limits, energy continues to be applied to the tissue. However if the measured impedance exceeds the set value, a disabling signal 422 is transmitted to energy source 392, ceasing further delivery of energy to RF electrode 314.” ([0182]). It is advantageous to utilize impedance monitoring in order to provide a controlled delivery of energy to a desired tissue site and eliminate unwanted thermal damage to surrounding tissues, thereby improving control and safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Nebrigic in view of Levinson and Condie to include wherein the RF signal is adjusted or modulated to approach and then maintain the impedance value at a target value, as taught by Knowlton. Doing so provides a controlled delivery of energy to a desired tissue site and eliminates unwanted thermal damage to surrounding tissues, thereby improving control and safety.
Regarding claim 101, Nebrigic in view of Levinson and Condie teach all of the limitations of the system according to claim 37. Nebrigic further discloses “measuring an attribute of the tissue, such as tissue temperature or tissue impedance, and the adjusting a power of the electromagnetic energy delivered in each of the power pulses based upon the measured attribute” ([0014]; also see [0061]), therefore the RF signal is adjusted or modulated and RF energy is delivered in response thereto sufficient to heat the plurality of septae (Fig. 3A; [0034], “The electromagnetic energy imparts a therapeutic effect to heat tissue 30 in a targeted region 32 beneath the patient's skin surface 26, as best shown in FIG. 3A, to a therapeutic temperature.… The delivered energy volumetrically heats a region 32 of the tissue 30 to a targeted temperature range. The elevation in temperature within the heated region 32 may produce for example, changes in collagen in the tissue 30 that achieve a desired treatment result, such as removing or reducing wrinkles and otherwise tightening the skin to thereby improve the appearance of a patient receiving the treatment.”; also see [0004] and [0006] for collagen fibers in the form of fibrous septae running through the fat, wherein the applied high frequency energy heats the tissue at depths beneath the cooled region 31 to a therapeutic temperature sufficient to denature the collagen, which causes the collagen fibers (i.e. fibrous septae) in the dermis to shrink and contract).
Although Nebrigic discloses adjusting or modulating the RF signal in accordance with the tissue impedance, Nebrigic in view of Levinson and Condie are silent regarding wherein the RF signal is adjusted or modulated to approach and then maintain the impedance value at a target value.
However, in the same field of endeavor, Knowlton teaches a similar impedance feedback system comprising an impedance monitoring device (420) used to control energy delivery by an energy source (392) to a desired tissue site ([0182]; Fig. 25). The monitor (420) “ascertains tissue impedance (at electrode 314, tissue site 416 or a passive electrode 314'), based on the energy delivered to tissue, and compares the measured impedance value to a set value. If measured impedance is within acceptable limits, energy continues to be applied to the tissue. However if the measured impedance exceeds the set value, a disabling signal 422 is transmitted to energy source 392, ceasing further delivery of energy to RF electrode 314.” ([0182]). It is advantageous to utilize impedance monitoring in order to provide a controlled delivery of energy to a desired tissue site and eliminate unwanted thermal damage to surrounding tissues, thereby improving control and safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Nebrigic in view of Levinson and Condie to include wherein the RF signal is adjusted or modulated to approach and then maintain the impedance value at a target value, as taught by Knowlton. Doing so provides a controlled delivery of energy to a desired tissue site and eliminates unwanted thermal damage to surrounding tissues, thereby improving control and safety.
Regarding claim 102, Nebrigic in view of Levinson and Condie teach all of the limitations of the system according to claim 37. Nebrigic further discloses “measuring an attribute of the tissue, such as tissue temperature or tissue impedance, and the adjusting a power of the electromagnetic energy delivered in each of the power pulses based upon the measured attribute” ([0014]; also see [0061]), therefore the RF signal is adjusted or modulated and RF energy is delivered in response thereto sufficient to disrupt the plurality of septae (Fig. 3A; [0034], “The electromagnetic energy imparts a therapeutic effect to heat tissue 30 in a targeted region 32 beneath the patient's skin surface 26, as best shown in FIG. 3A, to a therapeutic temperature.… The delivered energy volumetrically heats a region 32 of the tissue 30 to a targeted temperature range. The elevation in temperature within the heated region 32 may produce for example, changes in collagen in the tissue 30 that achieve a desired treatment result, such as removing or reducing wrinkles and otherwise tightening the skin to thereby improve the appearance of a patient receiving the treatment.”; also see [0004] and [0006] for collagen fibers in the form of fibrous septae running through the fat, wherein the applied high frequency energy heats the tissue at depths beneath the cooled region 31 to a therapeutic temperature sufficient to denature the collagen, which causes the collagen fibers (i.e. fibrous septae) in the dermis to shrink and contract).
Although Nebrigic discloses adjusting or modulating the RF signal in accordance with the tissue impedance, Nebrigic in view of Levinson and Condie are silent regarding wherein the RF signal is adjusted or modulated to approach and then maintain the impedance value at a target value.
However, in the same field of endeavor, Knowlton teaches a similar impedance feedback system comprising an impedance monitoring device (420) used to control energy delivery by an energy source (392) to a desired tissue site ([0182]; Fig. 25). The monitor (420) “ascertains tissue impedance (at electrode 314, tissue site 416 or a passive electrode 314'), based on the energy delivered to tissue, and compares the measured impedance value to a set value. If measured impedance is within acceptable limits, energy continues to be applied to the tissue. However if the measured impedance exceeds the set value, a disabling signal 422 is transmitted to energy source 392, ceasing further delivery of energy to RF electrode 314.” ([0182]). It is advantageous to utilize impedance monitoring in order to provide a controlled delivery of energy to a desired tissue site and eliminate unwanted thermal damage to surrounding tissues, thereby improving control and safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Nebrigic in view of Levinson and Condie to include wherein the RF signal is adjusted or modulated to approach and then maintain the impedance value at a target value, as taught by Knowlton. Doing so provides a controlled delivery of energy to a desired tissue site and eliminates unwanted thermal damage to surrounding tissues, thereby improving control and safety.
Response to Arguments
Applicant’s arguments, Remarks filed February 19, 2025, with respect to claim(s) 1-14, 16-21, 23-41, and 84-104 have been considered but are moot because the amendment has necessitated a new grounds of rejection.
Applicant argument that the amendments to independent claims 1 and 37 are not taught by the prior art is not found persuasive. It is the Examiner’s position that Nebrigic in view of Levinson and Condie teach each and every limitation of independent claim 1 and 37. Nebrigic teaches the controller (system controller 18) configured to rapidly heat the plurality of septae that interpenetrate fat layers, wherein a preponderance of electrical current of the one or more RF signals is directed to flow through the plurality of septae relative to the fat layers interpenetrated by the plurality of septae to selectively increase the temperature of the plurality of septae to affect the selective treatment thereof relative to the fat layers interpenetrated by the plurality of septae ([0004]; [0006], “High frequency treatment devices, such as radio-frequency (RF)-based treatment devices, may be used to treat skin tissue non-ablatively and non-invasively with heat. Such high frequency devices operate by transmitting high frequency energy through the epidermis to the underlying tissue, while actively cooling the epidermis to prevent thermal damage to a depth of the skin tissue near the skin surface. The high frequency energy heats the tissue at depths beneath the cooled region to a therapeutic temperature sufficient to denature the collagen, which causes the collagen fibers in the dermis to shrink and contract.”).
Further, Levinson teaches the amended limitations related to selective treatment. Levinson teaches a similar combined modality treatment system (100) configured to both cool subcutaneous tissue and also to selectively heat tissue, such as fibrous septae (202) ([0043]). Levinson teaches, “[o]ne method of selectively heating such tissue is by the delivery of radiofrequency (RF) energy, including for example capacitively coupled RF energy, such as a low-level monopolar RF energy as well as conductively coupled RF energy, to the subcutaneous tissue selectively to heat regions of tissue bound by the connective web of fibrous septae.” ([0043]). The RF current (210) “concentrates in the dermal and connective tissue such as the fibrous septum 202.” ([0044]). Fig. 3 illustrates, “[h]eating generated by application of this RF current, depicted by arrows 210, heats the fibrous septum 202 and selected of the adipose cells in the fat lobules 201 adjacent the fibrous septum 202. In the combined modality therapy associated with the embodiments described herein, the treatment parameters may be adjusted selectively to affect, in connection with cooling the subcutaneous tissue, the temperature profile of and the number of the adipose cells in the lobules 201 that are heated via the application of such RF current.” ([0044], thereby meeting the limitation of substantially avoiding conduction of heat into the fat layers that the plurality of septae interpenetrate via adjustment of the treatment parameters). It would be advantageous to control the extent to which conduction of heat into the fat layers that the plurality of septae interpenetrate occurs in order to tailor said treatment and reduce irregularities in a surface of a subject's skin resulting from an uneven distribution of adipose tissue in the subcutaneous layer, thereby increasing accuracy and overall appearance of the skin.
It is emphasized that Levinson teaches “the treatment parameters may be adjusted selectively to affect, in connection with cooling the subcutaneous tissue, the temperature profile of and the number of the adipose cells in the lobules 201 that are heated via the application of such RF current.” ([0044]). Therefore, Levinson teaches the selective heating of fat layers, thereby providing a system and method of substantially avoiding conduction of heat into the fat layers that the plurality of septae interpenetrate via adjustment of the treatment parameters.
No further arguments are set forth regarding the dependent claims.\
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE A DEDOULIS whose telephone number is (571)272-2459. The examiner can normally be reached M-F, 8am to 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.A.D./Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794