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
Examiner acknowledges the foreign priority date given of 02/28/2022 for the present application.
Response to Amendment
Examiner acknowledges the amendments made to claims 1 and 7 with claim 4 and 9 canceled in prosecution. Claims 1-3 and 5-8 are currently pending in the present application.
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) 1-3 and 5-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim (US Patent No 20230210581) in view of Collins (US Patent No 20200069955) further in view of Flyash (US Patent No 20150328474) further in view of Bourquin (US Patent No 20210322098). Examiner realizes that the Kim reference was published on 07/06/2023 which is after the priority date of the present application, however the Kim reference claims priority to a Korean application 10-2020-0093474 which was published 07/28/2020 and therefore qualifies the Kim reference as relevant prior art of record.
Regarding claim 1, Kim teaches a skin treatment device capable of automatically outputting high-frequency energy (high frequency energy transfer device, [0035]), the skin treatment device comprising: a tip configured to be in contact with skin and transmit high-frequency energy (signal transfer unit 100 for transferring high frequency energy, which equates to the tip, is placed in contact with the skin, [0037]); a handpiece to which the tip is mounted (the device may include a handpiece, [0035]), and configured to be gripped by a user and to allow the tip to be located on the skin (signal transfer unit 100 for transferring high frequency energy, which equates to the tip, is placed in contact with the skin, [0037]); and a controller configured to control output of the high- frequency energy so that the high-frequency energy passes through the handpiece and is transmitted through the tip (control unit 300 which controls via a signal generator unit 200 the high frequency energy that is delivered to the skin via transfer unit 100, [0068]) wherein the tip is removably coupled to the handpiece (wherein the electrode assembly can be detachably connected to the handpiece housing, [0006]), and the handpiece comprises a pressure detecting sensor configured to detect pressure applied to the tip (signal transfer unit 100 further includes a sensing unit 130 for sensing changes in pressure on the skin portion, [0083]) and an acceleration detecting sensor configured to detect acceleration input in response to movement of the handpiece (signal transfer unit 100 contains the sensor unit 130 which may also be implemented as an acceleration sensor for detecting movement, [0084]).
Kim does not teach wherein an electrode is formed at a center portion of a front surface of the tip configured to contact the skin, an insulation portion formed at the front surface of the tip configured to contact the skin in a second rectangular shape surrounding and sharing a common center with the first rectangular shape, which is insulated and forms a circumferential surface portion of the electrode the tip feature comprises a rectangular shaped electrode and at least four temperature detecting sensors at a front surface of the tip and each temperature detecting sensor being disposed within the insulation portion and outside the first rectangular shape of the electrode, disposed adjacent to the corresponding corner of the first rectangular electrode within a corner of the second rectangular shape of insulation portion, and the sensors are configured to detect temperature of the contacted skin and wherein the controller is configured to detect the temperature of the contacted skin via the temperature detecting sensor.
However, the analogous high frequency skin treatment device taught by Collins does teach an electrode of rectangular shape is formed at a center portion of a front surface of the tip (see treatment electrode 24 found on the front surface, [0023], wherein the electrode is rectangular, as seen in fig 5) configured to contact the skin (see in which the tip, which holds the treatment electrode feature is configured to be pressed against the patients skin on an electrode contact side 32, [0023]), an insulation portion formed at the front surface of the tip configured to contact the skin (see in which the tip, which holds the treatment electrode insulation substrate feature 30 is configured to be pressed against the patients skin on an contact side 32, [0023]) in a second rectangular shape surrounding and sharing a common center with the first rectangular shape which is insulated and forms a circumferential surface portion (see in which the electrode is encapsulated by the insulating substrate 30 which creates a secondary rectangular shape surrounding the electrode, [0023], see also fig 5), the electrode the tip feature comprises at least four temperature detecting sensors at a front surface of the tip and each temperature detecting sensor being disposed within the insulation portion and outside the first rectangular shape of the electrode, disposed adjacent to the corresponding corner of the first rectangular electrode within a corner of the second rectangular shape of insulation portion (see in which there may be up to four temperature sensors 44 which are found within the insulating substrate 30, [0031], the up to four temperature sensors being disposed in corners adjacent to the treatment electrode 24 and within the insulating substrate 30, thereby definition disposed within the corners of the second rectangular shape of the insulating portion, see also fig 5), and the sensors are configured to detect temperature of the contacted skin and wherein the controller is configured to detect the temperature of the contacted skin via the temperature detecting sensor (the controller 18 utilizes a control loop system to read the sensed temperature of the treated tissue via the temperature sensors 44, [0031]).
Therefore, it would have been obvious to one skilled in the art prior to the effective filing date to combine the high frequency delivery device of Kim to contain the specific temperature sensing structure and controlling capabilities of Collins as it is important to monitor the temperature of the patient effectively when delivering treatment energy as disclosed by Collins, [0031].
Kim nor Collins teach that the temperature detecting sensors are visibly disposed on the front surface, and the temperature detecting sensors are configured to contact the skin and detect the temperature of the contacted skin.
However, the analogous handheld RF skin treatment apparatus disclosed by Flyash does teach that the temperature detecting sensors are visibly disposed on the front surface (see in which there are multiple probes 704 found visibly disposed on the front working end of the handheld device, in which the probes 704 contain the exposed temperature sensors 644, [0051], see also fig 7A), and the temperature detecting sensors are configured to contact the skin and detect the temperature of the contacted skin (see in which the probes members 704 are distinctively configured as to be spring like members as to continually press the temperature sensors 644 in direct contact with the subject skin 212, as to detect and measure the temperature change of the skin, [0051]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the previous skin treatment device disclosed by the combination of Kim and Collins to contain the specific temperature sensors that are visible and found in direct skin contact as disclosed by Flyash as it is another known method in the art to allow for temperature sensors to be found in constant pressure and contact during movement of the treatment head to allow for continual temperature detection and measurement, as disclosed by Flyash, [0051].
Furthermore, the previous combination does not explicitly teach that the controller determines that the electrode is in contact with the skin when the electrode is brought into contact with the skin and the detected temperature of the contacted skin is equal to or higher than a preset reference temperature, and to control output of the high-frequency energy based on determination that the electrode is in contact with the skin, wherein, when the electrode is determined to be in contact with the skin based on the temperature of the contacted skin, the controller is configured to determine whether the handpiece moves by a predetermined distance on the skin based on the detected acceleration input while the detected temperature by the four temperature detecting sensors is determined to remain equal to or higher than the preset reference temperature, in response to the controller determining that the handpiece moves by the predetermined distance on the skin while the detected temperature by the four temperature detecting sensors is determined to remain equal to or higher than the preset reference temperature, the controller is configured to control the high-frequency generator to output the high-frequency energy, and in response to the controller determining that the handpiece has not moved by the predetermined distance on the skin while the detected temperature by the four temperature detecting sensors is determined to remain equal to or higher than the preset reference temperature, the controller is configured to control the high-frequency generator to stop the high-frequency energy.
However, the prior art of record Kim does teach an acceleration detecting sensor configured to detect acceleration input in response to movement of the handpiece (signal transfer unit 100 further includes a sensing unit 130 for sensing changes in acceleration on the skin portion, [0083]), the controller is configured to determine whether the handpiece moves by a predetermined distance on the skin based on the detected acceleration input (from Kim, the acceleration of the transfer unit is measured by the sensing unit 130 and is measured with the control unit 300 to see if the acceleration surpasses or is equal to a preset acceleration value, [0092]), in response to the controller determining that the handpiece moves by the predetermined distance on the skin, the controller is configured to control the high-frequency generator to output the high-frequency energy, and in response to the controller determining that the handpiece has not moved by the predetermined distance on the skin, the controller is configured to control the high-frequency generator to stop the high-frequency energy (see from Kim, [0092] –[0093] in which the sensor unit 130 is continuously sensing the acceleration when moving the handpiece along the skin, and the sensor unit 130 can control the signal transfer unit 100 and generator unit 200 to either continue delivering high frequency energy or cease the delivery of high frequency energy in response to the acceleration input in comparison to the preset threshold). Furthermore, the prior art of Collins does disclose that the temperature sensors can be used to measure the temperature of the skin when in contact [0031] and the analogous handheld RF delivery treatment device taught by Bourquin does disclose that the temperature sensor and controller can be used with the functionality to determine that the electrode is in contact with the skin when the electrode is brought into contact with the skin and the detected temperature of the contacted skin is equal to or higher than a preset reference temperature (see Bourquin, [0050], in which it is taught that the skin property sensors 14 and 16 which are found next to the treatment aperture 6 can detect if skin is in contact with the treatment device if the temperature sensor detects that the skin has a higher threshold temperature than the ambient air), and to control output of the high-frequency energy based on determination that the electrode is in contact with the skin (see Bourquin, [0050] in which the skin property sensors 14 and 16 detect skin contact and are then in communication with the control unit 10 so that the treatment end 7 can deliver the energy pulse to the skin, wherein the treatment energy may be high frequency treatment, [0008]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the skin treatment device with an active accelerometer for measuring the distance or movement of the device taught by Kim to also contain the specific skin contact temperature sensing capabilities taught by Collins and Bourquin to result in a combination containing a temperature-distance operation as both temperature sensing control and acceleration movement control are known methods in the art for determining skin contact and it also allows for more precise and specific energy treatment capabilities to limit excessive or damaging energy delivery towards the treatment location as taught by Bourquin, [0050].
Regarding claim 2, the combination teaches the skin treatment device of claim 1, the electrode is provided to transmit the high-frequency energy via the front surface when the electrode is in contact with the skin (from Kim, the electrode assembly is configured to be detachably connected to the handpiece housing and configured to transfer high frequency energy to the skin, [0006]).
Regarding claim 3, the combination teaches the skin treatment device of claim 2, further comprising: a high-frequency generator configured to generate the high-frequency energy having specific frequency, waveform, and power and to transmit the high-frequency energy to the tip (see Kim, [0067], which discloses the signal generator unit 200 capable of generating a high frequency signal with predetermined power and frequency to be delivered via the electrode assembly 110), wherein the controller is configured to generate a pulse signal to control at least one of frequency, power, and pulse interval of the high-frequency energy generated from the high- frequency generator and to transmit the pulse signal to the high-frequency generator, so that the high-frequency generator generates the high-frequency energy corresponding to the pulse signal (Kim, the signal generator unit 200 may receive a pulse signal from the control unit 300 for a specific frequency or pattern to generate a high frequency pulse signal to be delivered, [0068]).
Regarding claim 5, the combination teaches the skin treatment device of claim 1, wherein the controller is configured to detect pressure applied to the tip via the pressure detecting sensor as the tip is brought into contact with the skin (Kim, signal transfer unit 100 further includes a sensing unit 130 for sensing changes in pressure on the skin portion, [0083]), and to determine whether the detected pressure is less than a preset pressure value or equal to or higher than the preset pressure to determine whether or not the tip is in contact with the skin (Kim, the sensor may measure if the contact pressure is higher or lower than a preset reference pressure value measured by the controller, [0018]).
Regarding claim 6, the combination teaches the skin treatment device of claim 1, wherein the controller is configured to detect acceleration input as the handpiece moves, via the acceleration detecting sensor (Kim, signal transfer unit 100 contains the sensor unit 130 which may also be implemented as an acceleration sensor for detecting movement, [0084]), and to determine whether the detected acceleration is less than a preset acceleration value or equal to or higher than the preset acceleration value to determine whether or not the handpiece moves (from Kim, the acceleration of the transfer unit is measured by the sensing unit 130 and is measured with the control unit 300 to see if the acceleration surpasses or is equal to a preset acceleration value, [0092]).
Regarding claim 7, Kim teaches a control method of a skin treatment device, the control method comprising: obtaining a control signal to generate high-frequency energy (signal transfer unit 100 for transferring high frequency energy, which equates to the tip, is placed in contact with the skin, [0037]), the control signal being capable of controlling output of the high-frequency energy by a controller (control unit 300 which controls via a signal generator unit 200 the high frequency energy that is delivered to the skin via transfer unit 100, [0068]); determining whether or not the obtained control signal is a first mode; determining whether or not the obtained control signal is a second mode (see [0124] and [0125] which disclose the control unit 300 deciphering if the signal is in a first or second mode); and performing an individual mode to control high-frequency energy generation of a high-frequency generator (control unit 300 may signal the signal generator unit 200 to delivery high frequency signal after acquiring the mode input, [0126]) by each of a pressure detecting sensor (signal transfer unit 100 further includes a sensing unit 130 for sensing changes in pressure on the skin portion, [0083]), and an acceleration detecting sensor (signal transfer unit 100 contains the sensor unit 130 which may also be implemented as an acceleration sensor for detecting movement, [0084]).
Kim does not teach wherein an electrode is formed at a center portion of a front surface of the tip configured to contact the skin, an insulation portion formed at the front surface of the tip configured to contact the skin in a second rectangular shape surrounding and sharing a common center with the first rectangular shape, which is insulated and forms a circumferential surface portion of the electrode the tip feature comprises a rectangular shaped electrode and at least four temperature detecting sensors at a front surface of the tip and each temperature detecting sensor being disposed within the insulation portion and outside the first rectangular shape of the electrode, disposed adjacent to the corresponding corner of the first rectangular electrode within a corner of the second rectangular shape of insulation portion, and the sensors are configured to detect temperature of the contacted skin and wherein the controller is configured to detect the temperature of the contacted skin via the temperature detecting sensor.
However, the analogous high frequency skin treatment device taught by Collins does teach an electrode of rectangular shape is formed at a center portion of a front surface of the tip (see treatment electrode 24 found on the front surface, [0023], wherein the electrode is rectangular, as seen in fig 5) configured to contact the skin (see in which the tip, which holds the treatment electrode feature is configured to be pressed against the patients skin on an electrode contact side 32, [0023]), an insulation portion formed at the front surface of the tip configured to contact the skin (see in which the tip, which holds the treatment electrode insulation substrate feature 30 is configured to be pressed against the patients skin on an contact side 32, [0023]) in a second rectangular shape surrounding and sharing a common center with the first rectangular shape which is insulated and forms a circumferential surface portion (see in which the electrode is encapsulated by the insulating substrate 30 which creates a secondary rectangular shape surrounding the electrode, [0023], see also fig 5), the electrode the tip feature comprises at least four temperature detecting sensors at a front surface of the tip and each temperature detecting sensor being disposed within the insulation portion and outside the first rectangular shape of the electrode, disposed adjacent to the corresponding corner of the first rectangular electrode within a corner of the second rectangular shape of insulation portion (see in which there may be up to four temperature sensors 44 which are found within the insulating substrate 30, [0031], the up to four temperature sensors being disposed in corners adjacent to the treatment electrode 24 and within the insulating substrate 30, thereby definition disposed within the corners of the second rectangular shape of the insulating portion, see also fig 5), and the sensors are configured to detect temperature of the contacted skin and wherein the controller is configured to detect the temperature of the contacted skin via the temperature detecting sensor (the controller 18 utilizes a control loop system to read the sensed temperature of the treated tissue via the temperature sensors 44, [0031]).
Therefore, it would have been obvious to one skilled in the art prior to the effective filing date to combine the high frequency delivery device of Kim to contain the specific temperature sensing structure and controlling capabilities of Collins as it is important to monitor the temperature of the patient effectively when delivering treatment energy as disclosed by Collins, [0031].
Kim nor Collins teach that the temperature detecting sensors are visibly disposed on the front surface, and the temperature detecting sensors are configured to contact the skin and detect the temperature of the contacted skin.
However, the analogous handheld RF skin treatment apparatus disclosed by Flyash does teach that the temperature detecting sensors are visibly disposed on the front surface (see in which there are multiple probes 704 found visibly disposed on the front working end of the handheld device, in which the probes 704 contain the exposed temperature sensors 644, [0051], see also fig 7A), and the temperature detecting sensors are configured to contact the skin and detect the temperature of the contacted skin (see in which the probes members 704 are distinctively configured as to be spring like members as to continually press the temperature sensors 644 in direct contact with the subject skin 212, as to detect and measure the temperature change of the skin, [0051]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the previous skin treatment device disclosed by the combination of Kim and Collins to contain the specific temperature sensors that are visible and found in direct skin contact as disclosed by Flyash as it is another known method in the art to allow for temperature sensors to be found in constant pressure and contact during movement of the treatment head to allow for continual temperature detection and measurement, as disclosed by Flyash, [0051].
Furthermore, the previous combination does not explicitly teach that the controller determines that the electrode is in contact with the skin when the electrode is brought into contact with the skin and the detected temperature of the contacted skin is equal to or higher than a preset reference temperature, and to control output of the high-frequency energy based on determination that the electrode is in contact with the skin, wherein, when the electrode is determined to be in contact with the skin based on the temperature of the contacted skin, the controller is configured to determine whether the handpiece moves by a predetermined distance on the skin based on the detected acceleration input while the detected temperature by the four temperature detecting sensors is determined to remain equal to or higher than the preset reference temperature, in response to the controller determining that the handpiece moves by the predetermined distance on the skin while the detected temperature by the four temperature detecting sensors is determined to remain equal to or higher than the preset reference temperature, the controller is configured to control the high-frequency generator to output the high-frequency energy, and in response to the controller determining that the handpiece has not moved by the predetermined distance on the skin while the detected temperature by the four temperature detecting sensors is determined to remain equal to or higher than the preset reference temperature, the controller is configured to control the high-frequency generator to stop the high-frequency energy.
However, the prior art of record Kim does teach an acceleration detecting sensor configured to detect acceleration input in response to movement of the handpiece (signal transfer unit 100 further includes a sensing unit 130 for sensing changes in acceleration on the skin portion, [0083]), the controller is configured to determine whether the handpiece moves by a predetermined distance on the skin based on the detected acceleration input (from Kim, the acceleration of the transfer unit is measured by the sensing unit 130 and is measured with the control unit 300 to see if the acceleration surpasses or is equal to a preset acceleration value, [0092]), in response to the controller determining that the handpiece moves by the predetermined distance on the skin, the controller is configured to control the high-frequency generator to output the high-frequency energy, and in response to the controller determining that the handpiece has not moved by the predetermined distance on the skin, the controller is configured to control the high-frequency generator to stop the high-frequency energy (see from Kim, [0092] –[0093] in which the sensor unit 130 is continuously sensing the acceleration when moving the handpiece along the skin, and the sensor unit 130 can control the signal transfer unit 100 and generator unit 200 to either continue delivering high frequency energy or cease the delivery of high frequency energy in response to the acceleration input in comparison to the preset threshold). Furthermore, the prior art of Collins does disclose that the temperature sensors can be used to measure the temperature of the skin when in contact [0031] and the analogous handheld RF delivery treatment device taught by Bourquin does disclose that the temperature sensor and controller can be used with the functionality to determine that the electrode is in contact with the skin when the electrode is brought into contact with the skin and the detected temperature of the contacted skin is equal to or higher than a preset reference temperature (see Bourquin, [0050], in which it is taught that the skin property sensors 14 and 16 which are found next to the treatment aperture 6 can detect if skin is in contact with the treatment device if the temperature sensor detects that the skin has a higher threshold temperature than the ambient air), and to control output of the high-frequency energy based on determination that the electrode is in contact with the skin (see Bourquin, [0050] in which the skin property sensors 14 and 16 detect skin contact and are then in communication with the control unit 10 so that the treatment end 7 can deliver the energy pulse to the skin, wherein the treatment energy may be high frequency treatment, [0008]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the skin treatment device with an active accelerometer for measuring the distance or movement of the device taught by Kim to also contain the specific skin contact temperature sensing capabilities taught by Collins and Bourquin to result in a combination containing a temperature-distance operation as both temperature sensing control and acceleration movement control are known methods in the art for determining skin contact and it also allows for more precise and specific energy treatment capabilities to limit excessive or damaging energy delivery towards the treatment location as taught by Bourquin, [0050].
Regarding claim 8, the combination teaches the control method of claim 7, wherein in the determining of the existing of the first mode, the first mode is a mode generating high-frequency energy corresponding to a pulse signal input only during a specific time, via the high-frequency generator (from Kim, The first mode may be a mode for generating a high-frequency signal corresponding to the pulse signal input only for a specific time period through the signal generation unit 200, [0127]), and in the determining of the existing of the second mode, the second mode is a mode automatically and repeatedly generating a high-frequency signal corresponding to a pulse signal input without a specific time limit, via the high-frequency generator (from Kim, The second mode may be a mode for repeatedly generating a high-frequency signal corresponding to the pulse signal input through the signal generation unit 200 without a specific time limit, [0128]), and the second mode is continuously maintained when pressure applied to a tip and movement of a handpiece are detected (from Kim, the second mode is continuously maintained when movement of the transfer unit 100 is sensed, [0128]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the arguments made with respect to claims 1 and 7 in view of the amended claim limitations, as discussed in the interview on 06/23/2026 the examiner agrees that neither of the previous prior art references of Kim, Collins or Bourquin appear to teach the specific structure of the temperature detecting sensors are visibly disposed on the front surface, and the temperature detecting sensors are configured to contact the skin and detect the temperature of the contacted skin. However, due to the amendments made to claims 1 and 7, this necessitated further search and consideration by the examiner in which it has been found that the new prior art of record of disclosed by Flyash does teach that the temperature detecting sensors are visibly disposed on the front surface (see in which there are multiple probes 704 found visibly disposed on the front working end of the handheld device, in which the probes 704 contain the exposed temperature sensors 644, [0051], see also fig 7A), and the temperature detecting sensors are configured to contact the skin and detect the temperature of the contacted skin (see in which the probes members 704 are distinctively configured as to be spring like members as to continually press the temperature sensors 644 in direct contact with the subject skin 212, as to detect and measure the temperature change of the skin, [0051]). Therefore, as the new prior art of record of Flyash teaches the limitations of the independent claims 1 and 7 as currently amended, the claims remain rejected under the new prior art of record rejection of Kim in view of Collins further in view of Flyash set forth in the present office action.
Furthermore, in regard to the other arguments pertaining to the other claim limitation amendments of claims 1 and 7, that the prior art of record does not teach the specific limitation that the electrode and insulation portions are configured to contact the skin during use has been found unpersuasive. After further consideration of the prior art of record it has been found that the previous prior art of Collins does teach both that the electrode surface and the insulation surface configured on the working end of the tip piece are both configured to come in contact with the skin of the patient via the contact side 32 of the tip feature as disclosed in the specification paragraph [0023]. Therefore, as the newly considered previous prior art of record of Collins does teach the limitations of the independent claims 1 and 7 as currently amended, the claims remain rejected under the new prior art of record rejection of Kim in view of Collins further in view of Flyash set forth in the present office action.
As no further remarks or arguments have been made regarding any further dependent claims, they too remain rejected under the new prior art of record rejection set forth in the present office action.
Conclusion24. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
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/KYLE M. BROWN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
