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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Examiner acknowledges foreign priority date claimed of 12/31/2018.
Response to Amendment
The amendments made to claims 1, 10, 11 and 18 as well as the new claims 21 and 22 have been entered, with claim 8 and 17 canceled in prosecution.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-7,9-16 and 18-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chon (Korean Patent No 20180111202A) herein referred to as Chon R1 in view of Eder (US Patent No 20070129726) further in view of Mulholland (US Patent No 20090024192).
Regarding claim 1, Chon R1 (Korean Patent No 20180111202A) teaches a radio frequency (RF) treatment device comprising: an RF generator configured to generate RF energy (RF generating unit 3, para [0035]); a plurality of RF electrodes connected to the RF generator through an RF circuit(electrode 2 may be constituted in plural, para [0036]), selectively inserted in body tissue (can be configured to be inserted into the skin, para [0036]), and configured to transfer RF energy to the body tissue (configured to deliver RF energy within the tissue, para [0035]); a sensor configured to detect a loss of RF energy transferred to the body tissue due to impedance characteristics of the body tissue (sensor unit 7 configured to measure output value of RF energy… from this, it is possible to calculate the impedance value of the tissue, para [0038])
Chon R1 does not teach an impedance adjuster provided on the RF circuit and configured to have variable impedance; and a controller configured to control the impedance adjuster to reduce a loss of RF energy transferred to the body tissue, based on information detected by the sensor.
However, the analogous radiofrequency electrocautery delivery and control method of Eder does teach an impedance adjuster provided on the RF circuit and configured to have variable impedance (see the system 100 may further sense and automatically adjust the matching impedance of the circuit, done via the module 108, [0081]).
Chon R1 also does not teach a controller configured to control the impedance adjuster to reduce a loss of RF energy transferred to the body tissue, based on information detected by the sensor, wherein the loss of RF energy is a difference between the RF energy generated from the RF generator and the RF energy transferred to the body tissue.
However, impedance matching and controlling the adjusted impedance to minimize the loss of RF energy is disclosed and well known in the art. See for example the analogous RF electrocautery method and device taught by Eder does disclose a controller (controller capabilities found within the system 100, [0081]) configured to control the impedance adjuster (module 108, controls the impedance, [0081]) to reduce a loss of RF energy transferred to the body tissue, based on information detected by the sensor, wherein the loss of RF energy is a difference between the RF energy generated from the RF generator and the RF energy transferred to the body tissue (the module 108 adjusts the impedance applied to the conductive path containing the electrode surfaces 103-104 which would equate to the RF energy delivered to the body and power supply 106 equating to the RF energy produced by the generator. The impedance may be adjusted responsive to the changing of the RF energy delivered to the tissue and how it varies from the RF energy produced by the power supply 106. Alternatively, the sensors may provide raw data to the module 108, which analyzes whether and how to adjust impedance, [0081]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the RF generating and sensing unit of Chon R1 to also contain the impedance matching controller system as taught be Eder in order to minimize energy loss and have a more effective energy control system as disclosed by Eder, [0081].
The combination does not teach wherein the controller, in a first treatment mode, controls the RF electrode to be inserted into a first depth corresponding to a dermal layer and transfers RF energy, and wherein the controller, in a second treatment mode, controls the RF electrode to be inserted into a second depth corresponding to a fat layer and transfers RF energy.
However, the analogous skin and fat RF treatment device of Mulholland does disclose the controller, in a first treatment mode, controls the RF electrode to be inserted into a first depth corresponding to a dermal layer and transfers RF energy, and wherein the controller, in a second treatment mode, controls the RF electrode to be inserted into a second depth corresponding to a fat layer and transfers RF energy.
Although Mulholland does not explicitly state that there are two distinct modes, it does disclose controlling the depth of the RF electrode device between a skin or dermis layer of treatment and a fat region for treatment, [0091]. Furthermore, Mulholland discloses that there is a controller that measures the impedance of the RF circuit against the tissue which is being treated, and using the measured impedance can control the depth of the RF electrode insertion into the patient tissue and may control the RF voltage and current applied to the tissue as to control the depth and the treatment mode for the specific tissue, [0093].
Therefore, for one skilled in the art prior to the effective filing date to have the controller system disclosed by Mulholland to inherently teach the two modes of treatment corresponding to the dermal layer and the fat layer for treatment as the controller taught by Mulholland is capable of performing both modes of treatment. Furthermore, it would be obvious for one skilled in the art to combine the teachings of the prior combination with that of Mulholland in order to effectively control the RF energy delivered to the corresponding ideal treatment site as taught by Mulholland, [0093].
Regarding claim 2, the combination teaches The RF treatment device of claim 1, wherein the RF electrode is inserted up to a fat layer in a body and configured to transfer RF energy (from Eder, structure is configured to apply RF energy to the target tissue within the body, [0030]), and the sensor is configured to detect a loss of RF energy due to impedance characteristics of the fat layer (and from R1, sensor unit 7 configured to measure output value of RF energy… from this, it is possible to calculate the impedance value of the tissue, para [0038]).
Regarding claim 3, the combination teaches The RF treatment device of claim 1, wherein the sensor is configured to measure power supplied from the RF generator, and voltage and current applied through an RF electrode, and detect a loss of RF energy due to the impedance characteristics of the tissue (from R1, sensor unit 7 is configured to measure an output value of RF energy. The sensor unit 7 may be provided on the electrical path between the RF generator 3 and the electrode 2 and may be configured to measure the current, voltage, and power applied to the electrode 2. From this, it is possible to calculate the impedance value of the tissue, para [0039]).
Regarding claim 4, the combination teaches The RF treatment device of claim 3, wherein the sensor is configured to detect a loss of the RF energy based on power of the RF energy generated by the RF generator and power of RF energy calculated with the measured voltage and current (from R1, The control unit 5 is configured to receive the sensing value from the sensor unit 7 and to control the RF generation unit 3…The control unit 5 can determine the state in the tissue during RF energy application and adjust the applied RF energy or block the RF energy accordingly, para [0039], and therefore is able to detect a loss of the RF energy through the measured sensor components mentioned previously).
Regarding claim 5, the combination teaches The RF treatment device of claim 3, wherein the controller controls the impedance adjuster to increase RF energy to be transferred to the tissue or decrease a phase difference between the measured current and voltage (from R1, The control unit 5 is configured to receive the sensing value from the sensor unit 7 and to control the RF generation unit 3…The control unit 5 can determine the state in the tissue during RF energy application and adjust the applied RF energy or block the RF energy accordingly, para [0039]).
Regarding claim 6, the combination teaches The RF treatment device of claim 5, wherein the impedance adjuster comprises a variable capacitor connected in series to the RF circuit (Eder, the module 108 contains capacitors which can be adjusted or selectively introduced to control the amount of impedance in the circuit, [0057]).
Regarding claim 7, the combination teaches The RF treatment device of claim 6, wherein the variable capacitor is adjusted to reduce a loss of RF energy, after identifying change in the loss of the RF energy through the sensor while controlling capacitance of the variable capacitor to be increased or decreased (Eder, the module 108 contains capacitors which can be adjusted or selectively introduced to control the amount of impedance in the circuit, and are in further communication with the power supply which will adjust the delivery of energy to the treatment electrodes 103, 104, [0057], see also [0059] explaining how impedance matching and measurement occurs to sense the RF energy).
Regarding claim 9, the combination teaches The RF treatment device of claim 1, wherein the controller performs control to carry out an adjustment mode where RF energy is transferred to the body tissue to adjust the impedance adjuster, and a treatment mode where the RF energy is transferred to the body tissue using the adjusted impedance adjuster, and RF energy provided through the RF generator in the adjustment mode is controlled to be smaller than RF energy provided in the treatment mode (from Eder, the module 108 adjusts the impedance applied to the conductive path containing the electrode surfaces 103-104 which would equate to the RF energy delivered to the body and power supply 106 equating to the RF energy produced by the generator. The impedance may be adjusted responsive to the changing of the RF energy delivered to the tissue and how it varies from the RF energy produced by the power supply 106. Alternatively, the sensors may provide raw data to the module 108, which analyzes whether and how to adjust impedance, [0081]).
Regarding claim 10, the combination teaches A control method based on a radio frequency (RF) treatment device, comprising: inserting an RF electrode into body tissue; generating RF energy from an RF generator (from R1, RF generating unit 3, para [0035]) to provide the generated RF energy to the RF electrode along an RF circuit (from R1, electrode 2 may be constituted in plural, para [0036]), and transfer RF energy to the body tissue (from R1, can be configured to be inserted into the skin, para [0036]); detecting a loss of RF energy due to impedance characteristics of the body tissue while the RF energy is being transferred to the body tissue (from R1, sensor unit 7 configured to measure output value of RF energy… from this, it is possible to calculate the impedance value of the tissue, para [0038]); wherein the loss of RF energy is a difference between the RF energy generated from the RF generator and the RF energy transferred to the body tissue (from Eder, the module 108 adjusts the impedance applied to the conductive path containing the electrode surfaces 103-104 which would equate to the RF energy delivered to the body and power supply 106 equating to the RF energy produced by the generator. The impedance may be adjusted responsive to the changing of the RF energy delivered to the tissue and how it varies from the RF energy produced by the power supply 106, [0081]); adjusting impedance of an impedance adjuster provided on the RF circuit to reduce the loss of the RF energy; and transferring the RF energy to the body tissue by providing the RF energy to the RF electrode through the RF circuit of which the impedance is adjusted (from Eder, the module 108 adjusts the impedance applied to the conductive path containing the electrode surfaces 103-104 which would equate to the RF energy delivered to the body and power supply 106 equating to the RF energy produced by the generator. The impedance may be adjusted responsive to the changing of the RF energy delivered to the tissue and how it varies from the RF energy produced by the power supply 106. Alternatively, the sensors may provide raw data to the module 108, which analyzes whether and how to adjust impedance, [0081]).
The combination does not teach wherein the controller, in a first treatment mode, controls the RF electrode to be inserted into a first depth corresponding to a dermal layer and transfers RF energy, and wherein the controller, in a second treatment mode, controls the RF electrode to be inserted into a second depth corresponding to a fat layer and transfers RF energy.
However, the analogous skin and fat RF treatment device of Mulholland does disclose the controller, in a first treatment mode, controls the RF electrode to be inserted into a first depth corresponding to a dermal layer and transfers RF energy, and wherein the controller, in a second treatment mode, controls the RF electrode to be inserted into a second depth corresponding to a fat layer and transfers RF energy.
Although Mulholland does not explicitly state that there are two distinct modes, it does disclose controlling the depth of the RF electrode device between a skin or dermis layer of treatment and a fat region for treatment, [0091]. Furthermore, Mulholland discloses that there is a controller that measures the impedance of the RF circuit against the tissue which is being treated, and using the measured impedance can control the depth of the RF electrode insertion into the patient tissue and may control the RF voltage and current applied to the tissue as to control the depth and the treatment mode for the specific tissue, [0093].
Therefore, for one skilled in the art prior to the effective filing date to have the controller system disclosed by Mulholland to inherently teach the two modes of treatment corresponding to the dermal layer and the fat layer for treatment as the controller taught by Mulholland is capable of performing both modes of treatment. Furthermore, it would be obvious for one skilled in the art to combine the teachings of the prior combination with that of Mulholland in order to effectively control the RF energy delivered to the corresponding ideal treatment site as taught by Mulholland, [0093].
Regarding claim 11, the combination teaches the control method of claim 10, wherein the insertion of the RF electrode comprises inserting an end portion of the RF electrode into the dermal layer in the first treatment mode and into the fat layer in a body in the second treatment mode (Mulholland discloses controlling the depth of the RF electrode device between a skin or dermis layer of treatment and a fat region for treatment, [0091]), and the detection of the loss of the RF energy comprises detecting a loss of RF energy due to impedance characteristics of the fat in the body tissue (from R1, sensor unit 7 configured to measure output value of RF energy… from this, it is possible to calculate the impedance value of the tissue, para [0038]).
Regarding claim 12, the combination teaches the control method of claim 10, wherein the detection of the loss of the RF energy comprises detecting a loss of the RF energy by measuring power supplied from the RF generator and voltage and current applied through the RF electrode (from R1, the sensor unit 7 may be provided on the electrical path between the RF generator 3 and the electrode 2 and may be configured to measure the current, voltage, and power applied to the electrode 2, para [0039]).
Regarding claim 13, the combination teaches The control method of claim 12, wherein the detection of the loss of the RF energy comprises detecting a loss of the RF energy based on comparison between power supplied from the RF generator and power obtained by calculating the measured voltage and current (from R1, The control unit 5 is configured to receive the sensing value from the sensor unit 7 and to control the RF generation unit 3…The control unit 5 can determine the state in the tissue during RF energy application and adjust the applied RF energy or block the RF energy accordingly, para [0039], and therefore is able to detect a loss of the RF energy through the measured sensor components mentioned previously).
Regarding claim 14, the combination teaches The control method of claim 12, wherein the adjustment of the impedance of the RF circuit comprises controlling the impedance adjuster to increase the RF energy transferred to the tissue, or decrease a phase difference between the measured current and voltage (from R1, The control unit 5 is configured to receive the sensing value from the sensor unit 7 and to control the RF generation unit 3…The control unit 5 can determine the state in the tissue during RF energy application and adjust the applied RF energy or block the RF energy accordingly, para [0039]).
Regarding claim 15, the combination teaches the control method of claim 14, wherein the impedance adjuster comprises a variable capacitor connected in series to the RF circuit (Eder, the module 108 contains capacitors which can be adjusted or selectively introduced to control the amount of impedance in the circuit, [0057]).
Regarding claim 16, the combination teaches The control method of claim 15, wherein the adjustment of the impedance of the RF circuit comprises a first stage where the loss of the RF energy is detected by adjusting impedance to increase capacitance of the variable capacitor; a second stage where the loss of the RF energy is detected by adjusting the impedance to decrease the capacitance of the variable capacitor, and a third stage where the capacitance of the variable capacitor is adjusted to reduce the loss of the RF energy based on detection results of the first stage and the second stage (Eder, the module 108 contains capacitors which can be adjusted or selectively introduced to control the amount of impedance in the circuit, and are in further communication with the power supply which will adjust the delivery of energy to the treatment electrodes 103, 104, [0057], see also [0059] explaining how impedance matching and measurement occurs to sense the RF energy).
Regarding claim 18, the combination teaches A treatment method based on a radio frequency (RF) treatment device, comprising: inserting an RF electrode; generating RF energy from an RF generator (from R1, RF generating unit 3, para [0035]) to provide the generated RF energy to the RF electrode along an RF circuit (from R1, electrode 2 may be constituted in plural, para [0036]), and transfer energy to the fat layer; detecting a loss of RF energy due to capacitance characteristics of the fat layer while the RF energy is being transferred to the fat layer (from R1, sensor unit 7 configured to measure output value of RF energy… from this, it is possible to calculate the impedance value of the tissue, para [0038]); wherein the loss of RF energy is a difference between the RF energy generated from the RF generator and the RF energy transferred to the fat layer (from Eder, the module 108 adjusts the impedance applied to the conductive path containing the electrode surfaces 103-104 which would equate to the RF energy delivered to the body and power supply 106 equating to the RF energy produced by the generator. The impedance may be adjusted responsive to the changing of the RF energy delivered to the tissue and how it varies from the RF energy produced by the power supply 106, [0081]); adjusting an impedance adjuster provided on the RF circuit to reduce the loss of the RF energy transferred to the fat layer; and treating the body tissue by providing the RF energy to the RF electrode through the RF circuit of which the impedance is adjusted (from Eder, the module 108 adjusts the impedance applied to the conductive path containing the electrode surfaces 103-104 which would equate to the RF energy delivered to the body and power supply 106 equating to the RF energy produced by the generator. The impedance may be adjusted responsive to the changing of the RF energy delivered to the tissue and how it varies from the RF energy produced by the power supply 106. Alternatively, the sensors may provide raw data to the module 108, which analyzes whether and how to adjust impedance, [0081]).
The combination does not teach wherein the controller, in a first treatment mode, controls the RF electrode to be inserted into a first depth corresponding to a dermal layer and transfers RF energy, and wherein the controller, in a second treatment mode, controls the RF electrode to be inserted into a second depth corresponding to a fat layer and transfers RF energy.
However, the analogous skin and fat RF treatment device of Mulholland does disclose the controller, in a first treatment mode, controls the RF electrode to be inserted into a first depth corresponding to a dermal layer and transfers RF energy, and wherein the controller, in a second treatment mode, controls the RF electrode to be inserted into a second depth corresponding to a fat layer and transfers RF energy.
Although Mulholland does not explicitly state that there are two distinct modes, it does disclose controlling the depth of the RF electrode device between a skin or dermis layer of treatment and a fat region for treatment, [0091]. Furthermore, Mulholland discloses that there is a controller that measures the impedance of the RF circuit against the tissue which is being treated, and using the measured impedance can control the depth of the RF electrode insertion into the patient tissue and may control the RF voltage and current applied to the tissue as to control the depth and the treatment mode for the specific tissue, [0093].
Therefore, for one skilled in the art prior to the effective filing date to have the controller system disclosed by Mulholland to inherently teach the two modes of treatment corresponding to the dermal layer and the fat layer for treatment as the controller taught by Mulholland is capable of performing both modes of treatment. Furthermore, it would be obvious for one skilled in the art to combine the teachings of the prior combination with that of Mulholland in order to effectively control the RF energy delivered to the corresponding ideal treatment site as taught by Mulholland, [0093].
Regarding claim 19, the combination teaches the treatment method of claim 18, wherein the fat layer is treated for at least one of removal of the fat layer, microcontouring-plasty, and skin elasticity improvement (From R1, the treatment can be purposed for removing tissues or for retightening of the skin, [0044]).
Regarding claim 20, the combination teaches the RF treatment device of claim 1, wherein the sensor measures power from the RF generator and calculates the RF energy generated from the RF generator by integrating the measured power from the RF generator, and calculates power transferred to the body tissue and obtains the RF energy transferred to the body tissue by integrating the calculated power transferred to the body tissue (Eder, the module 108 adjusts the impedance applied to the conductive path containing the electrode surfaces 103-104 which would equate to the RF energy delivered to the body and power supply 106 equating to the RF energy produced by the generator. The impedance may be adjusted responsive to the changing of the RF energy delivered to the tissue and how it varies from the RF energy produced by the power supply 106. Alternatively, the sensors may provide raw data to the module 108, which analyzes whether and how to adjust impedance, [0081]).
Regarding claim 21, the combination teaches the RF treatment device of claim 1, wherein the loss of RF energy is due to impedance characteristics of a fat in the body tissue, wherein the controller, in the first treatment mode, controls the RF electrode to be inserted into the first depth corresponding to the dermal layer and transfers RF energy without performing impedance adjustment to reduce the loss of RF energy, and wherein the controller, in the second treatment mode, controls the RF electrode to be inserted into the second depth corresponding to the fat layer and transfers RF energy by performing impedance adjustment to reduce the loss of RF energy (Mulholland discloses controlling the depth of the RF electrode device between a skin or dermis layer of treatment and a fat region for treatment, [0091]. Furthermore, Mulholland discloses that there is a controller that measures the impedance of the RF circuit against the tissue which is being treated, and using the measured impedance can control the depth of the RF electrode insertion into the patient tissue and may control the RF voltage and current applied to the tissue as to control the depth and the treatment mode for the specific tissue, [0093] and therefore Mulholland inherently teaches the two modes of treatment corresponding to the dermal layer and the fat layer).
Regarding claim 22, the combination teaches the control method of claim 11, wherein, in the first treatment mode, the RF electrode is inserted into the first depth corresponding to the dermal layer and the RF energy is transferred without performing impedance adjustment to reduce the loss of RF energy, and wherein, in the second treatment mode, the RF electrode is inserted into the second depth corresponding to the fat layer and the RF energy is transferred by performing impedance adjustment to reduce the loss of RF energy (Mulholland discloses controlling the depth of the RF electrode device between a skin or dermis layer of treatment and a fat region for treatment, [0091]. Furthermore, Mulholland discloses that there is a controller that measures the impedance of the RF circuit against the tissue which is being treated, and using the measured impedance can control the depth of the RF electrode insertion into the patient tissue and may control the RF voltage and current applied to the tissue as to control the depth and the treatment mode for the specific tissue, [0093] and therefore Mulholland inherently teaches the two modes of treatment corresponding to the dermal layer and the fat layer).
Response to Arguments
Applicant’s arguments, see remarks, filed 01/15/2025, with respect to the rejection(s) of claim(s) 1-20 under Chon R1 in view of Chon R2 further in view of Eder have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Mulholland.
As discussed in the prior interview with applicant dated 01/07/2025, the examiner has given further consideration to the arguments regarding the Chon R2 reference and the eligibility of Chon R2 as obvious prior art of record. This consideration has resulted in the examiners agreement with the arguments set forth by the applicant and therefore the rejection using the Chon R2 reference has been withdrawn. However, upon further search and consideration it has been found that the prior art of record of Eder set forth in the previous office action contains the disclosure to teach the impedance adjuster and control method as seen in the present office action set forth.
Furthermore, in regards to the amended claims 1, 10, 11 and 18, it has been found that the new prior art of record reference of Mulholland teaches the specific amended limitation of the separate control modes corresponding to the dermal layer and fat layer for RF treatment as seen in the present office action set forth. Therefore, the amended claims 1, 10, 11 and 18 remain rejected under the new prior art of record rejection of Chon in view of Eder further in view of Mulholland. As the new claims 21 and 22 do not contain any further limitations that are not disclosed by the presented prior art of record, new claims 21 and 22 also remain rejected in prosecution.
As no further disclosure or arguments have been made in regards to the dependent claims within this application, all dependents remain rejected under the new grounds of rejection presented within this office action.
Conclusion
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/LINDA C DVORAK/Supervisory Patent Examiner, Art Unit 3794
/KYLE M. BROWN/Examiner, Art Unit 3794