DETAILED ACTION
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/20/2026 has been entered.
Status of Claims
Claims 1, 3-16, 18-27, 29-30, 33-39 and 32-43 are currently pending. Claims 1, 16, 20, 23-24, 27, 29-30, 33-34 and 43 have been amended. Claims 2, 17, 28, 31-32, and 40-41 are cancelled. No new subject matter is added.
Response to Arguments
Applicant’s arguments, see pg. 1, filed 02/20/2026, with respect to Claims 20-24 have been fully considered and are persuasive. The 112(b) rejection of Claims 20-24 has been withdrawn.
Applicant’s arguments, see pg. 1, filed 02/20/2026, with respect to Claim 34 have been fully considered and are persuasive. The claim objection of Claim 34 has been withdrawn.
Applicant's arguments filed 02/20/2026 have been fully considered but they are not persuasive.
Specifically, applicant argues in claim 27 that Turer alone fails to teach the newly amended limitations. Applicant further argues that Adanny fails to teach determining tissue type based on attenuation of an acoustic signal between an acoustic emitter and receiver disposed on a fat grafting probe shaft.
The examiner respectfully disagrees that Turer in view of Adanny would fail to teach determining tissue type based on attenuation of an acoustic signal between an acoustic emitter and receiver disposed on a fat grafting probe shaft. As discussed below, Turer teaches a fat grafting probe having two electrodes (a metal luer-lock cannula with two electrodes at the tip in order to measure tissue impedance, see pg. 5 Paragraph 4). Adanny teaches determining tissue type based on attenuation of an acoustic signal between an acoustic emitter and receiver (ultrasonic converter 126 and an acoustic receiver ultrasonic converter 128 used to obtain the change in sound velocity, amplitude, frequency and attenuation in related information, and analyzing the information to determine tissue of each tissue layer is formed (e.g., skin and fat, fat and muscle, etc.), type (e.g., skin, fat, muscle, etc.) and temperature, see Paragraph [0041]). Therefore, Turer in view of Adanny would read on the limitations of Claim 27.
Specifically, applicant argues in claim 1 that Turer, Keppel, or Xiao do not explicitly disclose lookup tables containing probe-specific calibration values for determining tissue type in a fat grafting probe or selecting an impedance measurement frequency to avoid interference from electrosurgical energy.
The examiner respectfully disagrees that Xiao does not teach lookup tables containing probe-specific calibration values for determining tissue type in a fat grafting probe. Paragraph [0077] of Xiao specifically discloses the impedance may be calculated based on iteratively applying voltage to the shaft (110) via electrodes (1 and 6) and calculating impedance to provide a voltage that will give the desired power output. Therefore, Xiao would read on “wherein the lookup table includes probe-specific calibration values corresponding to the at least two electrodes and the shaft”. Also Keppel teaches a filter (16), electrically connected to current monitor (14), blocks energy from RF output stage (30) from entering the impedance detection circuit (18) to effectively eliminate any effect the output current might otherwise have on the impedance calculation (see Col. 4 lines 52-56). Thus, teaches having a first signal frequency of the impedance detection circuit that avoids interference with an RF signal.
Specifically, applicant argues in claim 16 and 34 that Turer, Keppel, or Andres do not explicitly disclose the newly amended limitations disclosing the impedance measurement is performed using a signal having a frequency different from the frequency of the electrosurgical radio frequency signal.
The examiner respectfully disagrees that the prior art mentioned fails to read on the newly amended limitations. Keppel teaches operating an electrosurgical generator in an automatic bipolar mode to determine desired impedance within the tissue wherein, in the first mode, the electrosurgical generator applies an alternating current signal having a first frequency to determine impedance between the at least two electrodes (the amplifier 42 drives the transformer 46 at a constant voltage, thus by processing the voltage at the primary side 48, which will change proportionally to the impedance change, impedance can be determined, see Col. 5 ln 35-37), and a second mode where impedance falls within the activation range, as shown in step 68, then the generator 12 is automatically activated as represented by step 70 to deliver current to the forceps 10 to treat e.g. cut and/or coagulate, tissue (see Figure 3; see Col. 6 ln 19-32), and wherein, in the second mode, the electrosurgical generator outputs an electrosurgical radio frequency signal having a second frequency different from the first frequency (filter 16, electrically connected to current monitor 14, blocks energy from RF output stage 30 from entering the impedance detection circuit 18 to effectively eliminate any effect the output current might otherwise have on the impedance calculation, see Col. 4 lines 52-56). Therefore, Keppel would read on the newly amended limitations of claims 16 and 34.
Applicant’s arguments, see pg. 9-11, filed 02/20/2026, with respect to the rejection(s) of Claim 43 under 103 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 Borgmeier et al. (US 6090107 A) and in further view of Koenig et al. (US 6139546 A).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 27, 29-30, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Turer (WO 2019217883 A1) in view of view of Adanny et al. (CN 102573648 A), hereinafter referred to as “Adanny”.
Regarding Claim 27, Turer further teaches a fat grafting probe (cannula system detecting the tissue type within which the cannula tip is located in real time using electrodes adjacent the cannula tip, see Abstract; Figures 1-14C) comprising:
a base (see below) having a proximal end and a distal end (see below), the base including a first fluid channel extending between the proximal and distal ends (fluid channel extending through the base, see below), the proximal end including an opening configured to receive an output of a pressure control device (the proximal end of the base connected to a syringe pump, see Figure 11);
a shaft (cannula, see Figure 9-10) including a proximal end coupled to the distal end of the base (see below) and a distal end including at least one aperture (see below), the shaft includes a hollow interior operating as a second fluid channel which is in fluid communication with the first fluid channel (the cannula is hollow tube that is configured for suction of fat, see Figure 10; see Abstract);
at least two sensors disposed on the distal end of the shaft (a metal luer-lock cannula with two electrodes at the tip in order to measure tissue impedance, see pg. 5 Paragraph 4; the cannula acts as the first electrode, while a steel tube fitted over the cannula act as the second electrode, see Figures 9 and 10) at a predetermined distance from each other (sensing cannula system can comprise an array of electrodes on the distal portion of sheath and/or the cannula. Such an array of electrodes can be circumferentially arranged around the perimeter of the sheath or cannula, and/or can be arranged linearly along the sheath or cannula (e.g., multiple locations down length of cannula), see pg. 16 paragraph 5) and coupled to a detection circuit (an impedance sensing system or the detector unit, see Figure 8 and 11), the at least two sensors configured to come into contact with tissue when the shaft is disposed in a subcutaneous tissue plane (cannula with both electrodes are inserted into fat tissue, see Col. 2 lines 3-6); and
the detection circuit that determines whether the distal end of the shaft is in fat tissue or muscle tissue based on sensed parameters of the at least two sensors (an exemplary embodiment of the detection circuit can include an oscillator whose frequency of oscillation depends on the quantities of connected resistor and capacitor components. In the present embodiment, the tissue or fluid resistance between the two electrodes on the cannula make up a key resistor component in the circuit. Different resistances (e.g. fatty tissue under the skin vs. blood or muscle tissue) cause the frequency of oscillation to change. By measuring this frequency, the type of tissue in contact with the cannula, and thus the location of the cannula can be determined, see pg. 6 Paragraph 2).
However, Turer does not explicitly disclose wherein the at least two sensors include an acoustic emitter and an acoustic receiver, the acoustic emitter disposed a predetermined distance from the acoustic receiver, the detection circuit including at least one processor configured to determine attenuation of a signal emitted by the acoustic emitter and determines whether the distal end of the shaft is in fat tissue or muscle tissue based on the determined attenuation.
Adanny teaches a method and apparatus for real-time monitoring of tissue layers (see Paragraph [0028]-[0099]) comprising at least two sensors including an acoustic emitter (ultrasonic converter 126) and an acoustic receiver (ultrasonic converter 128), the acoustic emitter disposed a predetermined distance from the acoustic receiver (both converters position parallel to each other sandwich tissue layer 108, see Figure 1a),
the detection circuit including at least one processor configured to determine attenuation of a signal emitted by the acoustic emitter (it will be understood that converter 126 and 128 each of which can be used as the transceiver, the voltage generator by receiving white emitting an ultrasound beam, or the received ultrasonic beam into electrical signal communicated to the controller, see Paragraph [0040]) based on the predetermined distance (see Paragraph [0045]) and determines whether the distal end of the shaft is in fat tissue or muscle tissue based on the attenuated signal (a controller also operable prior to the treatment period and, from the converters to obtain the change in sound velocity, amplitude, frequency and attenuation in related information, and analyzing the information to determine tissue of each tissue layer is formed (e.g., skin and fat, fat and muscle, etc.), type (e.g., skin, fat, muscle, etc.) and temperature, see Paragraph [0041]).
Turer and Adanny are analogous art because both teach a device for monitoring of tissue layers.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the electrode sensors of Turer and replace them with the acoustic receiver and emitter, as taught by Adanny. Adanny teaches it is beneficial in the method and device by using ultrasonic beams to the body tissue to be processed of the tissue type and temperature at each body tissue types or layers in real time. Additionally, the disclosed method and apparatus also provides ultrasound-based thermo-control of an aesthetic body treatment session (see Paragraph [0009]).
Regarding Claim 29, Modified Turer teach all of the limitation as discussed above in claim 27 and Adanny further teaches wherein the signal emitted by the acoustic emitter has at least one of a predetermined frequency and/or a predetermined amplitude (pulse repetition frequency is less than 10 kHz, see Paragraph [0088]).
Regarding Claim 30, Modified Turer teaches all of the limitations as discussed above in claim 27 and Adanny further teaches at least one processor configured to determine a time of flight of a signal emitted by the acoustic emitter to the acoustic receiver and determines whether the distal end of the shaft is in fat tissue or muscle tissue based on the speed of the signal (it will be understood that converter 126 and 128 each of which can be used as the transceiver, the voltage generator by receiving white emitting an ultrasound beam, or the received ultrasonic beam into electrical signal communicated to the controller, see Paragraph [0040]; a controller also operable prior to the treatment period and, from the converters to obtain the change in sound velocity, amplitude, frequency and attenuation in related information, and analyzing the information to determine tissue of each tissue layer is formed (e.g., skin and fat, fat and muscle, etc.), type (e.g., skin, fat, muscle, etc.) and temperature, see Paragraph [0041]).
Regarding Claim 33, Modified Turer teaches all of the limitation as discussed above in claim 27 and Turer further teaches wherein the at least two sensors are disposed on a connector (a sensing cannula system can comprise an array of electrodes on the distal portion of sheath, see pg. 16 paragraph 5; and the two electrodes can be connected to the impedance circuit through extension wires, see Figure 2) that is removably coupled to the shaft (the sheath can be removable, see pg. 2 Paragraph 3).
Claims 1, 3, 5-12, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Turer (WO 2019217883 A1) in view of Keppel (US 6203541 B1), and in further view of Xiao et al. (US 20150305805 A1), hereinafter referred to as “Xiao”.
Regarding Claim 1, Turer teaches a fat grafting probe (cannula system detecting the tissue type within which the cannula tip is located in real time using electrodes adjacent the cannula tip, see Abstract; Figures 1-14C) comprising:
a base (see below) having a proximal end and a distal end (see below), the base including a first fluid channel extending between the proximal and distal ends (fluid channel extending through the base, see below), the proximal end including an opening configured to receive an output of a pressure control device (the proximal end of the base connected to a syringe pump, see Figure 11);
a shaft (cannula, see Figure 9-10) including a proximal end coupled to the distal end of the base (see below) and a distal end including at least one aperture (see below; Figure 9), the shaft includes a hollow interior operating as a second fluid channel which is in fluid communication with the first fluid channel (the cannula is hollow tube that is configured for suction of fat, see Figure 10; see Abstract);
at least two electrodes associated with the shaft (a metal luer-lock cannula with two electrodes at the tip in order to measure tissue impedance, see pg. 5 Paragraph 4) and coupled to an impedance detection circuit (an impedance sensing system or the detector unit, see Figure 8 and 11); and
the impedance detection circuit that determines the impedance between the at least two electrodes (an exemplary embodiment of the detection circuit can include an oscillator whose frequency of oscillation depends on the quantities of connected resistor and capacitor components. In the present embodiment, the tissue or fluid resistance between the two electrodes on the cannula make up a key resistor component in the circuit. Different resistances (e.g. fatty tissue under the skin vs. blood or muscle tissue) cause the frequency of oscillation to change. By measuring this frequency, the type of tissue in contact with the cannula, and thus the location of the cannula can be determined, see pg. 6 Paragraph 2) and generates an indication whether the distal end of the shaft is in fat tissue or muscle tissue (a microcontroller that measures the frequency of the signal and then activates lights, sounds, or other indicator to indicate the kind of tissue sensed by the device. This can be done with wired or wireless transmission. In one example at uses LED indicators, three colors (green, red and blue) correspond to the frequency ranges appropriate for fat, muscle and air (open circuit)
PNG
media_image1.png
714
1152
media_image1.png
Greyscale
respectively, see pg. 2 paragraph 4; Figure 8 and 11).
However, Turer does not explicitly disclose wherein the impedance detection circuit includes: a transformer having primary windings and secondary windings, the at least two electrodes being coupled to the secondary windings; a voltage controlled alternating current source coupled to one leg of the primary windings; at least one processor coupled to the one leg of the primary windings to sense voltage on the one leg and determine the impedance between the at least two electrodes based on the sensed voltage; and wherein the impedance detection circuit is configured to apply a first alternating current signal having a first frequency selected to measure impedance without interference from an electrosurgical radio frequency signal.
.
Keppel teaches an impedance detection circuit (automatic circuit 18 that controls a surgical instrument having a pair of bipolar electrodes, see Col. 4 ln 10-Col. 7 ln 15; Figure 1-3) includes:
a transformer (transformer 46 driven at 80KHz) having primary windings (primary winding 48) and secondary windings (secondary winding 50), the at least two electrodes being coupled to the secondary windings (connecting to electrodes 10a and 10b);
a voltage controlled alternating current source coupled to one leg of the primary windings (the amplifier 42 drives the transformer 46 at a constant voltage, thus by processing the voltage at the primary side 48, which will change proportionally to the impedance change, impedance can be determined, see Col. 5 ln 35-37);
at least one processor coupled to the one leg of the primary windings to sense voltage on the one leg and determine the impedance between the at least two electrodes based on the sensed voltage (impedance detection circuit 18 processes the voltage appearing across the forceps 10a, 10b and generates an analog signal representative of the impedance measurement, this analog signal is converted to a digital signal for processing by microprocessor 22, see Col. 5 ln 37-42); and
wherein the impedance detection circuit (18) is configured to apply a first alternating current signal having a first frequency selected to measure impedance (the amplifier 42 drives the transformer 46 at a constant voltage, thus by processing the voltage at the primary side 48, which will change proportionally to the impedance change, impedance can be determined, see Col. 5 ln 35-37) without interference from an electrosurgical radio frequency signal (filter 16, electrically connected to current monitor 14, blocks energy from RF output stage 30 from entering the impedance detection circuit 18 to effectively eliminate any effect the output current might otherwise have on the impedance calculation, see Col. 4 lines 52-56).
Turer and Keppel are analogous art because both deal with an electrosurgical tool having a impedance detection circuit.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the impedance detection circuit of Turer and replace it with the impedance detection circuit, as taught by Keppel. Keppel teaches it would be beneficial to provide a system that automatically activates and deactivates an electrosurgical generator in a bipolar system. The present disclosure provides such a system that utilizes tissue impedance measurements in a bipolar system to not only turn the generator off if the impedance value is exceeded, but to key the generator as well. This automatic activation and deactivation of the generator overcomes the disadvantages associated with manual switches. The circuitry of the present disclosure also simplifies, in part by speeding up the calculations, the activation and deactivation functions (see Col. 2 ln 31-41).
Turer and Keppel teaches all of the limitations above as described above. However, Turer and Keppel do not explicitly disclose the at least one processor to determine the impedance between the at least two electrodes based on the sensed voltage using a lookup table stored in memory coupled to the at least one processor, the lookup table including values relating the voltage sense on the primary windings to impedance.
Xiao teaches a grafting probe (ablation apparatus 100, see Abstract; Figure 1) comprising an impedance detection device (controller 200, see Figure 2) having at least one processor (processor 208) to determine the impedance between at least two electrodes based on the sensed voltage (the impedance may be calculated based on iteratively applying voltage and calculating impedance to provide a voltage that will give the desired power output, see Paragraph [0077]) using a lookup table stored in memory coupled to the at least one processor (using memory 206 that store lookup tables 216), the lookup table including values relating the voltage sense on the primary windings to impedance (lookup table 216 may include information about the pattern and/or modes in which the voltages are applied, see Paragraph [0088]), wherein the lookup table includes probe-specific calibration values corresponding to the at least two electrodes and the shaft (the impedance may be calculated based on iteratively applying voltage to the shaft (110) via electrodes (1 and 6) and calculating impedance to provide a voltage that will give the desired power output, see Paragraph [0077]).
Turer, Keppel, and Xiao are analogous art because all teach a handheld probe having an impedance detection device.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the impedance detection device on Modified Turer and replace it with the at least one processor can determine the impedance between the at least two electrodes based on the sensed voltage using a lookup table stored in memory coupled to the at least one processor, the lookup table including values relating the voltage sense on the primary windings to impedance, the look up table being calibrated for the probe, as taught by Xiao. Xiao teaches that having the lookup table on the catheter or on handheld implement 101 allows more flexible energy delivery schemes since it's generally easier to update a disposable portion of hand unit 101 rather than updating controller 104 (see Paragraph [0088]).
Regarding Claim 3, Modified Turer teaches all of the limitations as discussed above in claim 1 and Turer further teaches wherein the impedance detection circuit further includes an interface module that provides the indication whether the distal end of the shaft is in fat tissue or muscle tissue (impedance detection surface provides an output interface, see Figure 8 and 11; Col. 7 paragraph 4).
Regarding Claim 5, Modified Turer teaches all of limitations as discussed above in claim 1 and Keppel further teaches wherein the impedance detection circuit further includes a low pass filter (filter 52) disposed between the second windings (see Figure 2) and the at least two electrodes to suppress radio frequency noise (the band pass filter 52 in effect blocks from the transformer 46 any output current from the bipolar RF stage 30 output which would otherwise distort the current measurement and consequently, the impedance calculation, see Col. 5 ln 48-52).
Regarding Claim 6, Modified Turer teaches all of the limitations as discussed above in claim 1 and Turer further teaches wherein if the impedance detection circuit determines the impedance is below a first predetermined setpoint, the distal end of the shaft is disposed in muscle tissue (a threshold can be set (e.g. frequency < 100 Hz for fatty tissue) the end user can be alerted to contact with muscle or blood through output interfaces if the measured frequency value is greater than the specified cutoff, see pg. 7 paragraph 4).
Regarding Claim 7, Modified Turer teaches all of the limitations as discussed above in claim 1 and Turer further teaches wherein if the impedance detection circuit determines the impedance is above a second predetermined setpoint, the distal end of the shaft is disposed in fat tissue (a threshold can be set (e.g. frequency < 100 Hz for fatty tissue) the end user can be alerted to determine if it’s in fat tissue, see pg. 7 paragraph 4, pg. 8 paragraph 1).
Regarding Claim 8, Modified Turer teaches all of limitations as discussed above in claim a and Keppel further teaches a communication module coupled to the at least one processor, the communication module communicates the indication to at least one other device (it is possible to add a radio component to the detection unit (for example a Bluetooth or WiFi or other radio) that enables the system to communicate wirelessly to a mobile device (e.g. a cell phone) or a network or a computer such that the information (measured frequencies and/or resistance values) can be transferred to such devices, computers, and/or networks, see pg. 9 paragraph 2).
Regarding Claim 9, Modified Turer teaches all of the limitations as discussed above in claim 1 and Turer further teaches a first electrode of the at least two electrodes is disposed on the distal end of the shaft (a cannula acts as the first electrode. See Figure 9; pg. 12 paragraph 3) and a second electrode is a return pad electrode (the second electrode can be a steel tube fitted over the cannula or separate from the cannula connected to the impedance sensing system, see pg. 12 paragraph 3 and 4).
Regarding Claim 10, Modified Turer teaches all of the limitations as discussed above in claim 1 and Turer further teaches wherein the shaft is configured from a conductive material (a cannula acts as the first electrode, see Figure 9; pg. 12 paragraph 3) with an insulative sheath covering at least a portion of the shaft, an exposed portion of the shaft forming the first electrode (the outer body of the cannula is covered with an insulating material (i.e. heat shrink, or polyurethane) while the tip is left exposed, see Figure 9 g. 12 paragraph 3).
Regarding Claim 11, Modified Turer teaches all of the limitations as discussed above in claim 1 and Turer further teaches wherein the shaft is configured from a conductive material with an insulative sheath covering at least a portion of the shaft, an exposed portion of the shaft forming a first electrode (a cannula acts as the first electrode, the outer body of the cannula is covered with an insulating material (i.e. heat shrink, or polyurethane) while the tip is left exposed See Figure 9; pg. 12 paragraph 3) and a second electrode disposed on the sheath (a steel tube fitted over the cannula act as the second electrode, see Figure 10).
Regarding Claim 12, Modified Turer teaches all of the limitations as discussed above in claim 1 and Turer further teaches wherein the at least two electrodes are disposed at selected positions on the shaft, a first electrode being disposed a predetermined distance from a second electrode (sensing cannula system can comprise an array of electrodes on the distal portion of sheath and/or the cannula. Such an array of electrodes can be circumferentially arranged around the perimeter of the sheath or cannula, and/or can be arranged linearly along the sheath or cannula (e.g., multiple locations down length of cannula), see pg. 16 paragraph 5).
Regarding Claim 14, Modified Turer teaches all of limitations as discussed above in claim 1 and Keppel further teaches an impedance detection circuit (automatic circuit that controls a surgical instrument having a pair of bipolar electrodes, see Col. 4 ln 10-Col. 7 ln 15; Figure 1-3) including: a connector for coupling conductive wire of the at least two electrodes to a power source (the electrodes electrically connected to a power source 28, see Figure 2), wherein at least a portion of the impedance detection circuit is disposed in the connector (controller 26 will generate and transmit control signals to the power supply 28 which in turn will control the energy output of the RF output stage 30 which delivers current to the bipolar forceps 10, see Col. 4 ln 49-52; to facilitate the use of the probe, at least a part of the impedance detection circuit is provided in the connector).
Regarding Claim 15, Modified Turer teaches all of the limitations as discussed above in claim 1 and Turer further teaches wherein the at least two electrodes are disposed on a connector (a sensing cannula system can comprise an array of electrodes on the distal portion of sheath, see pg. 16 paragraph 5; and the two electrodes can be connected to the impedance circuit through extension wires, see Figure 2) that is removably coupled to the shaft (the sheath can be removable, see pg. 2 Paragraph 3).
Claims 16, 18-21, 23-25, 34-39, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Turer (WO 2019217883 A1) in view of Keppel (US 6203541 B1), and in further view of Andres et al. (US 20190380766 A1), hereinafter referred to as “Andres”.
Regarding Claim 16, Turer teaches a fat grafting system (cannula system detecting the tissue type within which the cannula tip is located in real time using electrodes adjacent the cannula tip, see Abstract; Figures 1-14C) comprising:
the fat grafting probe (a cannula is hollow tube that is configured for suction of fat, see Figure 10; see Abstract)
a base (see above) having a proximal end (see above) and a distal end (see above), the base including a first fluid channel extending between the proximal and distal ends (fluid channel extending through the base, see above), the proximal end including an opening (see above)configured to receive an output of a pressure control device (the proximal end of the base connected to a syringe pump, see Figure 11);
a shaft (cannula, see Figure 9-10) including a proximal end coupled to the distal end of the base (see below) and a distal end including at least one aperture (distal end of cannula having an aperture, see Figure 9), the shaft includes a hollow interior operating as a second fluid channel which is in fluid communication with the first fluid channel (the cannula is hollow tube that is configured for suction of fat through the syringe, see Figure 10; see Abstract); and
at least two electrodes associated with the shaft (a metal luer-lock cannula with two electrodes at the tip in order to measure tissue impedance, see pg. 5 Paragraph 4) and coupled to an impedance detection circuit (an impedance sensing system or the detector unit, see Figure 8 and 11; pg. 5 Paragraph 4); and
the impedance detection circuit that determines the impedance between the at least two electrodes (an exemplary embodiment of the detection circuit can include an oscillator whose frequency of oscillation depends on the quantities of connected resistor and capacitor components. In the present embodiment, the tissue or fluid resistance between the two electrodes on the cannula make up a key resistor component in the circuit. Different resistances (e.g. fatty tissue under the skin vs. blood or muscle tissue) cause the frequency of oscillation to change. By measuring this frequency, the type of tissue in contact with the cannula, and thus the location of the cannula can be determined, see pg. 6 Paragraph 2) and generates an indication whether the distal end of the shaft is in fat tissue or muscle tissue (a microcontroller that measures the frequency of the signal and then activates lights, sounds, or other indicator to indicate the kind of tissue sensed by the device. This can be done with wired or wireless transmission. In one example at uses LED indicators, three colors (green, red and blue) correspond to the frequency ranges appropriate for fat, muscle and air (open circuit) respectively, see pg. 2 paragraph 4; Figure 8 and 11).
However, Turer does not explicitly disclose an electrosurgical generator configured to function as an impedance device in a first mode when a probe is coupled thereto and to provide electrosurgical energy to the probe in a second mode; the at least two electrodes disposed in the electrosurgical generator; and the probe coupled to the electrosurgical generator; wherein, in the first mode, the electrosurgical generator is configured to apply an alternating current signal having a first frequency to determine impedance between the at least two electrodes, and wherein, in the second mode, the electrosurgical generator is configured to output an electrosurgical radio frequency signal having a second frequency different from the first frequency.
Keppel teaches an impedance detection circuit (automatic circuit that controls a surgical instrument having a pair of bipolar electrodes, see Col. 4 ln 10-Col. 7 ln 15; Figure 1-3) including: an electrosurgical generator (all the components shown in Figure 1) configured to function as an impedance device in a first mode when a probe (forceps 10) is coupled thereto (automatic bipolar mode to determine desired impedance within the tissue, see Figure 3; see Col. 6 ln 64-67; Col. 7 ln 1-18) and to provide electrosurgical energy to the probe in a second mode (a second mode where impedance does fall within the activation range, as shown in step 68, then the generator 12 is automatically activated as represented by step 70 to deliver current to the forceps 10 to treat e.g. cut and/or coagulate, tissue, see Figure 3; see Col. 6 ln 19-32) wherein the at least two electrodes are disposed in the electrosurgical generator (bipolar forceps 10a and 10b being a part of the electrosurgical generator device, see Figure 1) wherein the probe is coupled to the electrosurgical generator (see Figures 1-2)
wherein, in the first mode, the electrosurgical generator applies an alternating current signal having a first frequency to determine impedance between the at least two electrodes (the amplifier 42 drives the transformer 46 at a constant voltage, thus by processing the voltage at the primary side 48, which will change proportionally to the impedance change, impedance can be determined, see Col. 5 ln 35-37), and
wherein, in the second mode, the electrosurgical generator outputs an electrosurgical radio frequency signal having a second frequency different from the first frequency (filter 16, electrically connected to current monitor 14, blocks energy from RF output stage 30 from entering the impedance detection circuit 18 to effectively eliminate any effect the output current might otherwise have on the impedance calculation, see Col. 4 lines 52-56).
Turer and Keppel are analogous art because both deal with an electrosurgical tool having a impedance detection circuit.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the impedance detection circuit of Turer and replace it with the impedance detection circuit including a electrosurgical generator configured to function as an impedance device in a first mode when a probe is coupled thereto to detect impedance and a second mode which outputs an electrosurgical radio frequency signal, as taught by Keppel. Keppel teaches it would be beneficial to provide a system that automatically activates and deactivates an electrosurgical generator in a bipolar system. The present disclosure provides such a system that utilizes tissue impedance measurements in a bipolar system to not only turn the generator off if the impedance value is exceeded, but to key the generator as well. This automatic activation and deactivation of the generator overcomes the disadvantages associated with manual switches. The circuitry of the present disclosure also simplifies, in part by speeding up the calculations, the activation and deactivation functions (see Col. 2 ln 31-41).
Turer and Keppel teaches all of the limitations as discussed above. However, Turer and Keppel do not explicitly teaches provide electrosurgical energy to a plasma applicator.
Andres teaches an electrosurgical system (an electrosurgical handpiece or plasma generator 102, see Figure 3A; Paragraph [0053]) comprising a probe (tube 104) and wherein the probe is coupled to an electrosurgical generator (not shown) that provides energy to a plasma applicator (the apparatus 102 is suitable for generating plasma; RF energy is conducted to a tip 146 of the blade 118 from an electrosurgical generator (not shown) via the flow tube 122; an inert gas, such as helium, is then supplied through the flow tube 122 from either the electrosurgical generator or an external gas source; as the inert gas flows over the sharp point 146 of the blade 118 held at high voltage and high frequency, a cold plasma beam is generated, see Paragraph [0060]).
Turer, Keppel and Andres are analogous art because all teach a surgical probe that is used for removing tissue.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the fat grafting probe of Modified Turer and further include a plasma applicator within the probe operated by an electrosurgical generator, as taught by Andres. Andres teaches a plasma applicator having cold plasma generated with helium is ideal for the applications of subdermal skin tightening, coagulation, sculpting and contouring as contemplated herein (see last line of Paragraph [0060]).
Regarding Claim 18, Modified Turer teaches all of the limitations as discussed above in claim 16 and Turer further teaches a pressure control device coupled to the electrosurgical generator (electrosurgical device of Keppel being integral to the impedance detection device of Turer, as discussed in claim 16), the pressure control device provides processed fat to a layer of fat tissue of a patient via the first fluid channel, the second fluid channel and the at least one aperture (a cannula that is coupled with a syringe for injection or suction of fat, see Figure 10; pg. 5 paragraph 5).
Regarding Claim 19, Modified Turer teaches all of the limitations as discussed above in claim 18 and Turer further teaches wherein the pressure control device is at least one of a syringe and/or a pump (see Figure 10).
Regarding Claim 20, Modified Turer teaches all of the limitations as discussed above in claim 16 and Keppel further teaches wherein the impedance detection circuit (Figure 2) includes:
a transformer (transformer 46 driven at 80KHz) having primary windings (primary winding 48) and secondary windings (secondary winding 50), the at least two electrodes being coupled to the secondary windings (windings 50 connecting to electrodes 10a and 10b);
a voltage controlled alternating current source coupled to one leg of the primary windings (the amplifier 42 drives the transformer 46 at a constant voltage, thus by processing the voltage at the primary side 48, which will change proportionally to the impedance change, impedance can be determined, see Col. 5 ln 35-37); and
at least one processor coupled to the one leg of the primary windings to sense voltage on the one leg and determine the impedance between the at least two electrodes based on the sensed voltage (impedance detection circuit 18 processes the voltage appearing across the forceps 10a, 10b and generates an analog signal representative of the impedance measurement, this analog signal is converted to a digital signal for processing by microprocessor 22, see Col. 5 ln 37-42).
Regarding Claim 21, Modified Turer teaches all of the limitations as discussed above in claim 20 and Turer further teaches wherein the impedance detection circuit further includes an interface module that provides the indication whether the distal end of the shaft is in fat tissue or muscle tissue (impedance detection surface provides an output interface, see Figure 8 and 11; Col. 7 paragraph 4).
Regarding Claim 23, Modified Turer teaches all of the limitations as discussed above in claim 20 and Andres further teaches wherein the electrosurgical generator is further configured to be coupled to a plasma generator (102) and provide the electrosurgical radio frequency signal to the plasma generator (the apparatus 102 is suitable for generating plasma; RF energy is conducted to a tip 146 of the blade 118 from an electrosurgical generator (not shown) via the flow tube 122; an inert gas, such as helium, is then supplied through the flow tube 122 from either the electrosurgical generator or an external gas source; as the inert gas flows over the sharp point 146 of the blade 118 held at high voltage and high frequency, a cold plasma beam is generated, see Paragraph [0060]).
Regarding Claim 24, Modified Turer teaches all of the limitations as discussed above in claim 23 and Keppel further teaches providing a first frequency (the oscillator and transformer are driven at a frequency of about 60 kHz to about 90 kHz, see Col. 3 lines 10-11) without interference from the electrosurgical radio frequency signal (filter 16, electrically connected to current monitor 14, blocks energy from RF output stage 30 from entering the impedance detection circuit 18 to effectively eliminate any effect the output current might otherwise have on the impedance calculation, see Col. 4 lines 52-56). Andres further teaches wherein the first frequency is lower than the second frequency (high frequency electrical energy is fed from the secondary of the transformer 24 through an active conductor 30 to the electrode 28 (collectively active electrode) in the handpiece 26 to create the plasma stream 16 for application to the surgical site 18 on the patient 20, see Paragraph [0049]).
Regarding Claim 25, Modified Turer teaches all of the limitations as discussed above in claim 18 and Turer further teaches wherein the impedance detection circuit further comprising a communication module coupled to the at least one processor (it is possible to add a radio component to the detection unit (for example a Bluetooth or Wi-Fi or other radio) that enables the system to communicate wirelessly to a mobile device (e.g. a cell phone) or a network or a computer such that the information (measured frequencies and/or resistance values) can be transferred to such devices, computers, and/or networks, see pg. 9 paragraph 2), the communication module communicates a control signal to the pressure control device when the at least one processor determines that the distal end of the shaft is in muscle tissue( a software application on a mobile device or computer can be configured to enable the hardware (electrode system, detection unit, or a combination) to operate the same or differently for medical procedures other than liposuction or fat injection., see pg. 9 paragraph 2).
Regarding Claim 34, Turer further teaches a method for performing a medical procedure (cannula system detecting the tissue type within which the cannula tip is located in real time using electrodes adjacent the cannula tip, see Abstract; Figures 1-14C) comprising:
a fat graphing cannula (cannula system detecting the tissue type within which the cannula tip is located in real time using electrodes adjacent the cannula tip, see Abstract; Figures 1-14C).
inserting a distal end of the fat grafting cannula into a subcutaneous tissue plane (inserting cannula into subcutaneous tissue, see Figure 1-2);
monitoring at least one property of tissue disposed proximately to the distal end of the fat grafting cannula (the cannula can be a metal luer-lock cannula with two electrodes at the tip in order to measure tissue impedance via a impedance sensing unit, see pg. 5 Paragraph 4; Figure 8 and 11), the distal end of the fat grafting cannula inducing at least two sensors disposed thereon (a metal luer-lock cannula with two electrodes at the tip in order to measure tissue impedance, see pg. 5 Paragraph 4; Figure 9 and 10);
determining if the distal end of the fat grafting cannula is disposed (an exemplary embodiment of the detection circuit can include an oscillator whose frequency of oscillation depends on the quantities of connected resistor and capacitor components. In the present embodiment, the tissue or fluid resistance between the two electrodes on the cannula make up a key resistor component in the circuit. Different resistances (e.g. fatty tissue under the skin vs. blood or muscle tissue) cause the frequency of oscillation to change. By measuring this frequency, the type of tissue in contact with the cannula, and thus the location of the cannula can be determined, see pg. 6 Paragraph 2); and
generating an indication of whether the distal end is in fat tissue or muscle tissue (a microcontroller that measures the frequency of the signal and then activates lights, sounds, or other indicator to indicate the kind of tissue sensed by the device. This can be done with wired or wireless transmission. In one example at uses LED indicators, three colors (green, red and blue) correspond to the frequency ranges appropriate for fat, muscle and air (open circuit) respectively, see pg. 2 paragraph 4; Figure 8 and 11);
injecting processed fat into fat tissue via the fat grafting cannula when the electrosurgical generator determines that the distal end of the fat grafting cannula is disposed in fat tissue (cannula system may incorporate a fully controlled injection or suction system, whereby the material flow is controlled by a microcontroller or other control system instead of manual control. For example, an actuator (such as a rotary or linear motor), controlled by a microcontroller, may be used to move the plunger in the syringe as shown in the figures. Such a system can have a preset rate of flow and can be automatically stopped upon detection that the cannula is encountering problematic tissue, see pg. 13 paragraph 3),
Turer teaches all of the limitations as discussed above and further teaches an impedance detection device to monitor, determine, and indicate if the distal end of the fat grafting cannula is disposed in fat tissue or muscle tissue (an impedance sensing system or the detector unit, see Figure 8 and 11; pg. 5 Paragraph 4).
However, Turer does not explicitly disclose an electrosurgical generator causing the electrosurgical generator to enter a first mode as a property measuring device when coupled to the fat grafting probe; and monitoring, determining, and generating an indication, by the electrosurgical generator if the distal end of the fat grafting cannula is disposed in fat tissue or muscle tissue,
wherein, in the first mode, the electrosurgical generator applies a first alternating current signal having a first frequency to monitor the at least one property of tissue, and
wherein, in the second mode, the electrosurgical generator outputs an electrosurgical radio frequency signal having a second frequency different from the first frequency.
Keppel teaches an impedance detection circuit (automatic circuit that controls a surgical instrument having a pair of bipolar electrodes, see Col. 4 ln 10-Col. 7 ln 15; Figure 1-3) including: an electrosurgical generator (all the components shown in Figure 1) configured to function as an impedance device in a first mode when a probe (forceps 10) is coupled thereto (automatic bipolar mode to determine desired impedance within the tissue, see Figure 3; see Col. 6 ln 64-67; Col. 7 ln 1-18),
to provide electrosurgical energy to the probe in a second mode (a second mode where impedance does fall within the activation range, as shown in step 68, then the generator 12 is automatically activated as represented by step 70 to deliver current to the forceps 10 to treat e.g. cut and/or coagulate, tissue, see Figure 3; see Col. 6 ln 19-32),
wherein, in the first mode, the electrosurgical generator applies a first alternating current signal having a first frequency to monitor the at least one property of tissue (the amplifier 42 drives the transformer 46 at a constant voltage, thus by processing the voltage at the primary side 48, which will change proportionally to the impedance change, impedance can be determined, see Col. 5 ln 35-37), and
wherein, in the second mode, the electrosurgical generator outputs an electrosurgical radio frequency signal having a second frequency different from the first frequency (filter 16, electrically connected to current monitor 14, blocks energy from RF output stage 30 from entering the impedance detection circuit 18 to effectively eliminate any effect the output current might otherwise have on the impedance calculation, see Col. 4 lines 52-56).
Turer and Keppel are analogous art because both deal with an electrosurgical tool having a impedance detection circuit.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the impedance detection circuit of Turer and further include a electrosurgical generator configured to function as an impedance device in a first mode when a probe is coupled thereto to detect impedance and a second mode which outputs an electrosurgical radio frequency signal, as taught by Keppel. Keppel teaches it would be beneficial to provide a system that automatically activates and deactivates an electrosurgical generator in a bipolar system. The present disclosure provides such a system that utilizes tissue impedance measurements in a bipolar system to not only turn the generator off if the impedance value is exceeded, but to key the generator as well. This automatic activation and deactivation of the generator overcomes the disadvantages associated with manual switches. The circuitry of the present disclosure also simplifies, in part by speeding up the calculations, the activation and deactivation functions (see Col. 2 ln 31-41).
Turer and Keppel teaches all of the limitations as discussed above. However, Turer and Keppel do not explicitly teaches coupling a plasma device to the electrosurgical generator causing the electrosurgical generator to provide electrosurgical energy to the plasma device; and performing a tissue tightening procedure with the plasma device after injecting the processed fat into the fat tissue.
Andres teaches an electrosurgical system (an electrosurgical handpiece or plasma generator 102, see Figure 3A; Paragraph [0053]) comprising a probe (tube 104) and wherein the probe is coupled to an electrosurgical generator (not shown) that provides energy to a plasma applicator (the apparatus 102 is suitable for generating plasma; RF energy is conducted to a tip 146 of the blade 118 from an electrosurgical generator (not shown) via the flow tube 122; an inert gas, such as helium, is then supplied through the flow tube 122 from either the electrosurgical generator or an external gas source; as the inert gas flows over the sharp point 146 of the blade 118 held at high voltage and high frequency, a cold plasma beam is generated, see Paragraph [0060]); and
performing a tissue tightening procedure with the plasma device after injecting the processed fat into the fat tissue (the cold plasma generated with helium is ideal for the applications of subdermal skin tightening, coagulation, sculpting and contouring as contemplated herein, see Paragraph [0060]).
Turer, Keppel and Andres are analogous art because all teach a surgical probe that is used for removing tissue.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the fat grafting probe of Modified Turer and further include a plasma applicator within the probe operated by an electrosurgical generator, as taught by Andres. Andres teaches a plasma applicator having cold plasma generated with helium is ideal for the applications of subdermal skin tightening and allow for precise, immediate heating and contraction of the target tissue followed by immediate cooling with minimal depth of thermal effect (see Paragraph [0060]).
Regarding Claim 35, Modified Turer teaches all of the limitations as discussed above in claim 34 and Turer further teaches if the distal end of the fat grafting cannula is disposed in fat tissue, generating an alert to proceed to inject processed fat into the fat tissue (a microcontroller that measures the frequency of the signal and then activates lights, sounds, or other indicator to indicate the kind of tissue sensed by the device, see pg. 2 paragraph 4; Figure 8 and 11; thus indicating to the user to either proceed with fat grafting or stopping).
Regarding Claim 36, Modified Turer teaches all of the limitations as discussed above in claim 34 and Turer further if the distal end of the fat grafting cannula is disposed in fat tissue, transmitting a signal to a processed fat pressure controlling device to proceed to inject processed fat into the fat tissue via the fat grafting cannula (cannula system may incorporate a fully controlled injection or suction system, whereby the material flow is controlled by a microcontroller or other control system instead of manual control. For example, an actuator (such as a rotary or linear motor), controlled by a microcontroller, may be used to move the plunger in the syringe as shown in the figures. Such a system can have a preset rate of flow and can be automatically stopped upon detection that the cannula is encountering problematic tissue, see pg. 13 paragraph 3).
Regarding Claim 37, Modified Turer teaches all of the limitations as discussed above in claim 34 and Turer further if the distal end of the fat grafting cannula is disposed in muscle tissue, transmitting a signal to the processed fat pressure controlling device to stop providing processed fat to the fat grafting cannula (system can have a preset rate of flow and can be automatically stopped upon detection that the cannula is encountering problematic tissue, see pg. 13 paragraph 3)
Regarding Claim 38, Modified Turer teaches all of the limitations as discussed above in claim 34 and Turer further if the distal end of the fat grafting cannula is disposed in muscle tissue, generating an alert that the distal end of the fat grafting cannula is disposed in muscle tissue (a microcontroller that measures the frequency of the signal and then activates lights, sounds, or other indicator to indicate the kind of tissue sensed by the device, see pg. 2 paragraph 4; Figure 8 and 11).
Regarding Claim 39, Turer and Keppel teaches all of the limitations as discussed above in claim 34 and Turer further wherein the at least one property includes at least one of electrical impedance, acoustic impedance and/or heat capacity (measurement of impedance, see pg. 6 Paragraph 2).
Regarding Claim 42, Modified Turer teaches all of the limitations as discussed above in claim 16 and Turer further teaches wherein a first electrode of the at least two electrodes is disposed on the distal end of the shaft (the cannula is first electrode, see Figures 9 and 10) and a second electrode is a return pad electrode (a steel tube fitted over the cannula act as the second electrode, see Figures 9 and 10) coupled to the electrosurgical generator (coupled to the impedance detection device; the electrosurgical generator is integral to impedance detection circuit as described in claim 16).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Turer, Keppel, and Xiao, as applied in claim 3, and in further view of Kenan et al. (WO 2009019707 A1), hereinafter referred to as “Kenan”.
Regarding Claim 4, Modified Turer teaches all of limitations as discussed above in claim 3. However, Modified Turer does not explicitly disclose wherein the interface module is disposed on the base.
Kenan teaches a medical device (100) of the present invention for tissue identification/characterization, suitable for guiding/monitoring the position of a medical tool (e.g. a needle tip) within a body (see pg. 10 ln 24-28; Figure 1) wherein the interface module (a display 110, the anatomy of the targeted tissue may be displayed on the display, see pg.11 ln 18-20 ) is disposed on the base (housing 102).
Turer, Keppel, Xiao, and Kenan are analogous art because both teach medical device for determining tissue composition.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the base of Modified Turer and further include wherein the base has a housing with a interface module attached, as taught by Kenan. Kenan teaches its beneficial for the housing to be configured as a hand held housing. Moreover, the housing may be configured as an independent unit connectable to a control unit, or as a stand-alone device (see pg. 6 ln 13-16).
Claims 22 are rejected under 35 U.S.C. 103 as being unpatentable over Turer, Keppel, and Andres, as applied to claim 21 above, and further in view of Woloszko et al. (US 20170143401 A1), hereinafter referred to as “Woloszko”.
Regarding Claim 22, Modified Turer teaches all of the limitations as discussed above in claim 21. However, Modified Turer do not explicitly disclose a display module coupled to the interface module configured to display the indication, the display module disposed on a surface of a housing of the electrosurgical generator.
Woloszko teaches an electrosurgical device (see Abstract; Figure 1) comprising an electrosurgical generator (controller 104), a display module (130) coupled to the interface module configured to display the indication (a display device or interface device 130 is visible through the enclosure 122 of the controller 104, see Figure 6), and the display module disposed on a surface of a housing of the electrosurgical generator (visible through the enclosure 122 of the controller 104).
Turer, Keppel, Andres, and Woloszko are analogous art because all teach a medical device for determining tissue composition.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the electrosurgical generator of modified Turer and further include a display module coupled to the interface module, as taught by Woloszko. Woloszko teaches the interface device may be used select operational modes of the controller (either directly on the interface device or by way of related buttons), and the interface device may also be the location where information is provided to the surgeon (see Paragraph [0050]).
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Turer, Keppel, Xiao, as applied to claim 1 above, and further in view of Rencher et al. (US 20160022347 A1), hereinafter referred to as “Rencher”.
Regarding Claim 13, Modified Turer teaches all of limitations as discussed above in claim 1. However, Turer does not explicitly disclose a connector for coupling conductive wire of the at least two electrodes to a power source.
Keppel teaches an impedance detection circuit (automatic circuit that controls a surgical instrument having a pair of bipolar electrodes, see Col. 4 ln 10-Col. 7 ln 15; Figure 1-3) including: an impedance detection circuit (the impedance detection circuit 18, see Col. 4 ln 10-Col. 7 ln 15; Figure 1-3) comprising electrodes (10a and 10b) and a connector for coupling conductive wire of the at least two electrodes to a power source (the electrodes electrically connected to a power source 28, see Figure 2).
Turer and Keppel are analogous art because both deal with an electrosurgical tool having a impedance detection circuit.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the impedance detection circuit of Turer and replace it with the impedance detection circuit having electrodes connected electrical to a power source, as taught by Keppel. Keppel teaches it would be beneficial to provide a system that automatically activates and deactivates an electrosurgical generator in a bipolar system. The present disclosure provides such a system that utilizes tissue impedance measurements in a bipolar system to not only turn the generator off if the impedance value is exceeded, but to key the generator as well. This automatic activation and deactivation of the generator overcomes the disadvantages associated with manual switches. The circuitry of the present disclosure also simplifies, in part by speeding up the calculations, the activation and deactivation functions (see Col. 2 ln 31-41).
Turer and Keppel teaches all of the limitations as discussed above. However, Turer and Keppel do not explicitly disclose the connector including at least one memory configured to store parameters associated with the probe and transmit the parameters to at least one processor of the electrosurgical generator.
Rencher teaches a handpiece (600) comprising a impedance circuit (see Figure 11) comprising a connector (662) including at least one memory (670) configured to store parameters associated with the probe (memory, including information associated with the handpiece so the generator may recognize the handpiece, see Paragraph [073]).
Turer, Keppel, and Rencher are analogous art because all disclose a electrosurgical tool with an impedance detection circuit.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the impedance circuit of modified Turer and further include at least one memory in the connector, as taught by Rencher. Rencher teaches the memory allows the generator to recognize the handpiece. When coupled to a generator via pins 681 and 682, the controller 677 of generator 623 reads the information contained on the chip 670 and may perform or execute instructions based on the handpiece type (see Paragraph [0073]).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Turer, Keppel, Andres, as applied to claim 16 above, and further in view of Rencher et al. (US 20160022347 A1), hereinafter referred to as “Rencher”.
Regarding Claim 26, Modified Turer teach all of the limitations as discussed above in claim 16 and Keppel further teaches wherein the probe (10) further comprising a connector for coupling conductive wire of the at least two electrodes to the electrosurgical generator (electrodes electrically connected to the generator 12, see Figure 1-2). However, Modified Turer do not explicitly disclose the connector including at least one memory configured to store parameters associated with the probe and transmit the parameters to at least one processor of the electrosurgical generator.
Rencher teaches a handpiece (600) comprising a impedance circuit (see Figure 11) comprising a connector (662) including at least one memory (670) configured to store parameters associated with the probe (memory, including information associated with the handpiece so the generator may recognize the handpiece, see Paragraph [073]).
are analogous art because all teach a medical device for determining tissue composition.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the impedance circuit of modified Turer and further include at least one memory in the connector, as taught by Rencher. Rencher teaches the memory allows the generator to recognize the handpiece. When coupled to a generator via pins 681 and 682, the controller 677 of generator 623 reads the information contained on the chip 670 and may perform or execute instructions based on the handpiece type (see Paragraph [0073]).
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Turer (WO 2019217883 A1) in view of Borgmeier et al. (US 6090107 A), hereinafter referred to as “Borgmeier” and in further view of Koenig et al. (US 6139546 A), hereinafter referred to as “Koenig”.
Regarding Claim 43, Turer teaches a fat grafting probe (cannula system detecting the tissue type within which the cannula tip is located in real time using electrodes adjacent the cannula tip, see Abstract; Figures 1-14C) comprising:
a base (see above) having a proximal end and a distal end (see above), the base including a first fluid channel extending between the proximal and distal ends (fluid channel extending through the base, see above), the proximal end including an opening configured to receive an output of a pressure control device (the proximal end of the base connected to a syringe pump, see Figure 11);
a shaft (cannula, see Figure 9-10) including a proximal end coupled to the distal end of the base (see above) and a distal end including at least one aperture (see above; Figure 9), the shaft includes a hollow interior operating as a second fluid channel which is in fluid communication with the first fluid channel (the cannula is hollow tube that is configured for suction of fat, see Figure 10; see Abstract);
a connector configured to be removably coupled to a portion of the shaft (a steel tube fitted over the cannula act as an electrode, see Figures 9 and 10; the steel tubing that can be removed, see Figure 10), the connector including a single electrode disposed thereon and configured to contact tissue when the shaft is inserted into a patient (a steel tube fitted over the cannula act as the second electrode, see Figure 18B; pg. 12 paragraph 3; it is understood the steel tube is in contact with tissue when inserted into the patient);
at least one conductive wire coupled to the single electrode and configured to electrically couple the single electrode to an impedance detection circuit (the electrodes are connected to wires at the base of the cannula and then to an impedance sensing system, the detector unit in FIG. 11, see Col. 12 paragraph 4); and
the impedance detection circuit being configured to receive signals from the signal electrode and grounding electrode, determines the impedance between the single electrode and grounding electrode (an exemplary embodiment of the detection circuit can include an oscillator whose frequency of oscillation depends on the quantities of connected resistor and capacitor components. In the present embodiment, the tissue or fluid resistance between the two electrodes on the cannula make up a key resistor component in the circuit. Different resistances (e.g. fatty tissue under the skin vs. blood or muscle tissue) cause the frequency of oscillation to change. By measuring this frequency, the type of tissue in contact with the cannula, and thus the location of the cannula can be determined, see pg. 6 Paragraph 2) and generates an indication whether the distal end of the shaft is in fat tissue or muscle tissue (a microcontroller that measures the frequency of the signal and then activates lights, sounds, or other indicator to indicate the kind of tissue sensed by the device. This can be done with wired or wireless transmission. In one example at uses LED indicators, three colors (green, red and blue) correspond to the frequency ranges appropriate for fat, muscle and air (open circuit) respectively, see pg. 2 paragraph 4; Figure 8 and 11), wherein the connector is configured to be removably attached to and detached from the shaft (a steel tube fitted over the cannula act as the second electrode, see Figure 18B; pg. 12 paragraph 3;)
However, Turer does not explicitly disclose a grounding pad electrode configured to be coupled to a patient and electrically coupled to the impedance detection circuit, the grounding pad electrode cooperating with the single electrode to permit impedance measurement through tissue disposed between the single electrode and the grounding pad electrode.
Koenig teaches an electrosurgical instrument (see Abstract; Figure 1 and 9) comprising: a surgical probe (108) having one or more electrodes (126) and a grounding pad electrode (110) configured to be coupled to a patient (the tissue is in contact with the electrical grounding pad, see Figure 9) and electrically coupled to the impedance detection circuit (the equivalent electrical circuit representing the tissue impedance from the electrodes to the grounding pad 910 A-B and the inter-electrode coupling (cross-talk) impedance 912, see Col. 12 lines 63-67), the grounding pad electrode cooperating with the single electrode to permit impedance measurement (see Col. 12 lines 63-67).
Turer and Koenig are analogous art because both discloses an electro-surgical instrument comprising an impedance detection circuit.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the impedance detection circuit and further including a grounding pad electrode configured to be coupled to a patient and electrically coupled to the impedance detection circuit, the grounding pad electrode cooperating with the single electrode to permit impedance measurement through tissue disposed between the single electrode and the grounding pad electrode, as taught by Koenig. Koenig teaches the return pad is beneficial for an accurate tissue impedance determination (see Col. 13 lines 27-30).
Turer and Koenig teaches all of the limitations as discussed above. However, Turer and Koenig do not explicitly disclose wherein the connector is configured to be removably attached to and detached from the shaft to enable reuse of the shaft with a different connector including a single electrode.
Borgmeier teaches an electrosurgical assembly (10, see Abstract; Figure 1) comprising: a connector (an elongated extension shaft or electrode 14), wherein the connector is configured to be removably attached to and detached from the shaft to enable reuse of the shaft with a different connector including a single electrode (whereas extension shaft or electrode 14 may be resterilized and reused for multiple procedures, see Col. 5 lines 45-46).
Turer, Koenig, and Borgmeier are analogous art because both teach an electrosurgical device comprising a connector sheath.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the connector of Modified Turer and further include wherein the connector is configured to be removably attached to and detached from the shaft to enable reuse of the shaft with a different connector including a single electrode, as taught by Borgmeier. Borgmeier teaches it is beneficial to reuse the connector to reducing the equipment cost and, thus, the overall cost of performing laparoscopic procedures (see Col. 5 lines 46-47).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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, Sarah Al-Hashimi can be reached at (571) 272-7159. 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.
/ERIC RASSAVONG/ (6/23/2026)Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
Prosecution Insights