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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/06/2026, 07/23/2026, and 09/04/2026 are being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9 and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 9 and 16, it is unclear how “the voltage” as mentioned in claims 1 and 10 goes from a single voltage to comprising more than one voltage in claims 9 and 16. How does one voltage turn into multiple? Further clarification is needed to understand whether “the voltage” as mentioned in the independent claims is a singular voltage or comprises a first and second voltage.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-8, 10-15, and 17-20 and is/are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Aronow et al. (US 20090112204 A1) herein referred to as “Aronow”.
Regarding claim 1, Aronow discloses a surgical system (system and method for detecting faults within an electrosurgical instrument, Abstract), comprising: a surgical instrument (electrosurgical apparatus 316, Figure 3), comprising: a shaft (shaft 316, Figure 3); a conductor extending within the shaft (conductive leads 318, 322 and 324 connect the shield and the electrosurgical apparatus 316 to the monitoring circuitry 320, Paragraph [0040], Figure 3); and a shield capacitively coupled to the conductor (The electrosurgical apparatus 316 includes a shield that is monitored by the system 306. Conductive leads 318, 322 and 324 connect the shield and the electrosurgical apparatus 316 to the monitoring circuitry 320, Paragraph [0040]); and a controller in operable communication with the surgical instrument (Conductive leads 318, 322 and 324 connect the shield and the electrosurgical apparatus 316 to the monitoring circuitry 320, Paragraph [0040]) and an energy generator (ESU, Figure 3), wherein the controller is operable to: provide a voltage to the conductor from the energy generator (an electrosurgical generator coupled to the electrosurgical instrument and adapted to deliver power to the active electrode of the electrosurgical instrument, claim 1); receive a shield current from the shield based on providing the voltage to the conductor (different sensing apparatus are used to individually sense the active voltage, the active current and the shield current from the electrosurgical apparatus 316, Paragraph [0041], claim 1); and determine a status of the surgical instrument based on the received shield current (The sensors 328, 330 and 332 pass the monitored shield current, active current, and the active electrode voltage to a processor 350. In one embodiment, the processor 350 comprises a field programmable gate array (FPGA) and acts in concert with a memory element 352 (such as an EEPROM), and an oscillator 356. An output 354 of the processor 350 passes visible and/or audible indications of the monitor status to a surgeon, operator or other user, Paragraph [0042], [0062], and [0065]-[0098], claim 1).
Regarding claim 2, Aronow discloses the surgical system of Claim 1, wherein the controller is further operable to determine an expected shield current based on the provided voltage (With monitoring circuitry constructed in accordance with aspects of the present invention, a wide range of potential fault conditions are capable of being programmed into the circuitry. Different fault conditions may be set in the monitor to correspond to the use of various electrosurgical instruments, various surgical procedures, or other specific surgical conditions that would warrant more precise control over when, and to what extent, the monitor will shut off the flow of power to the electrosurgical instrument. In FIG. 2, the examples shown represent one embodiment where the resistance trip is set at 2 kΩ, a power trip is set at 10 W and a current trip is set at 650 mA. In these examples, the minimum voltage for resistance trips is set at 30V and the minimum current for current trips was set at 50 mA. As mentioned above, different surgical scenarios may warrant the use of different trips conditions and ranges. Devices constructed in accordance with aspects of the present invention are capable of accommodating these specific surgical requirements, Paragraph [0035], Other aspects include the ability to customize threshold levels or scaling constants used in determining various types of faults based on differences in the components used to sense voltage and current from circuit board to circuit board. In the embodiment shown in FIGS. 3 and 4, these thresholds may be stored in a separate memory element 352 or 547 respectively. Electrically Erasable Programmable Read-Only Memory (EEPROM) is a type of non-volatile memory used in computers and other electronic devices to store data that must be saved when power is removed, e.g., calibration tables or device configuration. EEPROMs are useful for the type of calibration data stored in connection with various fault detection schemes that may be used in connection with aspects of the present invention. Memory element 547 may be an EEPROM or other memory device. Use of such non-volatile memory avoids the difficulty of having to adjust actual circuit components such as resistors or capacitors during factory calibration. The circuitry may alternatively be designed to recognize electrosurgical instruments that require different fault threshold levels or frame lengths because of the conditions under which they must operate. Multiple sets of fault threshold levels can be stored digitally for use with a multiplicity of instruments, Paragraph [0101]).
Regarding claim 3, Aronow discloses the surgical system of Claim 2, wherein the controller is further operable to receive an input indicative of a selected operating mode of the surgical instrument, and wherein the expected shield current is further based on the selected operating mode (An identification element 326 is coupled to its own sensing element 338 and the processor 350, and provides a variety of customizable features to the monitoring system 320. In one embodiment, the identification element 326 is a resistor identification device that tells the processor 350 what type of conditions should be employed in the sensing process. In general terms, the monitor 320 can measure the resistor 326 and accordingly define the instrument class within the processor. For example, a low resistance may indicate a standard electrosurgical instrument classification, while a high resistance may indicate devices used in hysteroscopy. Different instruments (and/or instrument cords) are recognized through different identification (ID) resistors 326. As new instruments are developed, additional fault thresholds can be programmed into the monitor without significant hardware modification as the processor and monitor itself will obtain this information from the identification resistor 326. Other types of instrument identification may also be used, such as bar codes/scanners and other identification techniques known in the art. The identification element may be incorporated into the instrument 316 itself or may reside as a separate input to the monitor 320. The representation in FIG. 3 is meant to include each of these embodiments, Paragraph [0043], claim 13).
Regarding claim 4, Aronow discloses the surgical system of Claim 2, wherein the controller is further operable to compare the shield current to the expected shield current and determine the status of the surgical instrument based on the comparison (FIG. 5 depicts an exemplary method 600 implemented within a monitoring system constructed in accordance with aspects of the present invention. In one aspect, at step 610 fault tolerances and trip point thresholds are set based on specified surgical conditions. A surgeon keys or otherwise activates the power delivery at 612 and allows a voltage at electrosurgical frequencies to appear on the shielded electrosurgical instrument. The monitoring system determines the average real power in the instrument shield at step 615, determines the RMS of the real part of the shield current at step 620, determines the RMS current in the shield at step 625, determines the magnitude of the impedance between the active ESU electrode and the shield at step 630, and determines the resistance between the active ESU electrode and the shield at step 635. At step 640, based on one or more pieces of the information collected during the prior steps, the monitoring system determines whether a resistance, capacitance, power, low current, or high current fault exists by comparing the sensed values to the defined threshold values and then based on that condition determines whether to restrict or cut off power from the ESU at step 645. An alarm is then sent to the user at 650 and the system initiates a program delay prior to re-enabling power flow to the active electrode at 655, Paragraph [0062]).
Regarding claim 5, Aronow discloses the surgical system of Claim 4, wherein the status of the surgical instrument comprises a low impedance condition based on the received shield current being a threshold amount greater than the expected shield current (The monitoring system determines the average real power in the instrument shield at step 615, determines the RMS of the real part of the shield current at step 620, determines the RMS current in the shield at step 625, determines the magnitude of the impedance between the active ESU electrode and the shield at step 630, and determines the resistance between the active ESU electrode and the shield at step 635. At step 640, based on one or more pieces of the information collected during the prior steps, the monitoring system determines whether a resistance, capacitance, power, low current, or high current fault exists by comparing the sensed values to the defined threshold values and then based on that condition determines whether to restrict or cut off power from the ESU at step 645. An alarm is then sent to the user at 650 and the system initiates a program delay prior to re-enabling power flow to the active electrode at 655, Paragraphs [0062]-[0098], claims 19-22).
Regarding claim 6, Aronow discloses the surgical system of Claim 4, wherein the status of the surgical instrument comprises a high impedance condition based on the received shield current being a threshold amount less than the expected shield current (The monitoring system determines the average real power in the instrument shield at step 615, determines the RMS of the real part of the shield current at step 620, determines the RMS current in the shield at step 625, determines the magnitude of the impedance between the active ESU electrode and the shield at step 630, and determines the resistance between the active ESU electrode and the shield at step 635. At step 640, based on one or more pieces of the information collected during the prior steps, the monitoring system determines whether a resistance, capacitance, power, low current, or high current fault exists by comparing the sensed values to the defined threshold values and then based on that condition determines whether to restrict or cut off power from the ESU at step 645. An alarm is then sent to the user at 650 and the system initiates a program delay prior to re-enabling power flow to the active electrode at 655., Paragraphs [0062]-[0098], claims 19-22).
Regarding claim 7, Aronow discloses the surgical system of Claim 1, wherein the status of the surgical instrument comprises a status of the shield (further comprising structure for contemporaneously recording and/or displaying at least one of: the power delivered to patient and active electrode, the active electrode current, the return electrode current, the active electrode voltage, the shield power, the shield current, the shield resistance, and shield fault status, claim 6).
Regarding claim 8, Aronow discloses the surgical system of Claim 1, wherein the shaft is comprised of a conductive material (A tubular safety shield assembly 25 includes a tubular shield 20 having a layer of insulation 22 provided on the outer surface thereof and an optional layer of insulation 24 provided on the inner surface thereof. The tubular shield assembly is inserted through trocar sheath 10 to thereby provide a passageway through which the active electrode probe 12 may be inserted. An elongated port 31 may extend through the active electrode through which irrigation fluids, suction, a pressurized gas stream, etc. may pass. When active probe 12 and tubular shield assembly 25 are in their respective inserted positions as shown in FIG. 1, the shield 20 surrounds the active probe from at least (a) a proximal point 26 prior to the entry point 28 of the active probe into the trocar sheath 10 to (b) a distal point 30 in proximity to the tip 18 of the active probe, Paragraph [0004]).
Regarding claim 10, Aronow discloses a surgical system (system and method for detecting faults within an electrosurgical instrument, Abstract), comprising: a surgical instrument (electrosurgical apparatus 316, Figure 3), comprising: a shaft (shaft 316, Figure 3); an electrode arranged at an end of the shaft and energizable to provide energy to tissue ( Electrosurgical apparatus 316 includes an active electrode tip 317 that includes one or more types of end effectors such as graspers, ablation devices, scissors, and various other tools known in the art, and delivers electrosurgical power through the active electrode tip 317, Paragraph [0040]); a conductor extending within the shaft and electrically coupled to the electrode (conductive leads 318, 322 and 324 connect the shield and the electrosurgical apparatus 316 to the monitoring circuitry 320, Paragraph [0040], Figure 3); and a shield capacitively coupled to the conductor (The electrosurgical apparatus 316 includes a shield that is monitored by the system 306. Conductive leads 318, 322 and 324 connect the shield and the electrosurgical apparatus 316 to the monitoring circuitry 320, Paragraph [0040]); and a controller in operable communication with the surgical instrument (Conductive leads 318, 322 and 324 connect the shield and the electrosurgical apparatus 316 to the monitoring circuitry 320, Paragraph [0040]) and an energy generator (ESU, Figure 3), wherein the controller is operable to: receive an input indicative of an operating mode of the surgical instrument (FIG. 5 depicts an exemplary method 600 implemented within a monitoring system constructed in accordance with aspects of the present invention. In one aspect, at step 610 fault tolerances and trip point thresholds are set based on specified surgical conditions. A surgeon keys or otherwise activates the power delivery at 612 and allows a voltage at electrosurgical frequencies to appear on the shielded electrosurgical instrument. The monitoring system determines the average real power in the instrument shield at step 615, determines the RMS of the real part of the shield current at step 620, determines the RMS current in the shield at step 625, determines the magnitude of the impedance between the active ESU electrode and the shield at step 630, and determines the resistance between the active ESU electrode and the shield at step 635. At step 640, based on one or more pieces of the information collected during the prior steps, the monitoring system determines whether a resistance, capacitance, power, low current, or high current fault exists by comparing the sensed values to the defined threshold values and then based on that condition determines whether to restrict or cut off power from the ESU at step 645. An alarm is then sent to the user at 650 and the system initiates a program delay prior to re-enabling power flow to the active electrode at 655, Paragraph [0062]); provide a voltage to the conductor and the electrode from the energy generator in the operating mode (an electrosurgical generator coupled to the electrosurgical instrument and adapted to deliver power to the active electrode of the electrosurgical instrument, claim 1); determine an expected shield current based on the operating mode of the surgical instrument and the voltage (FIG. 5 depicts an exemplary method 600 implemented within a monitoring system constructed in accordance with aspects of the present invention. In one aspect, at step 610 fault tolerances and trip point thresholds are set based on specified surgical conditions. A surgeon keys or otherwise activates the power delivery at 612 and allows a voltage at electrosurgical frequencies to appear on the shielded electrosurgical instrument. The monitoring system determines the average real power in the instrument shield at step 615, determines the RMS of the real part of the shield current at step 620, determines the RMS current in the shield at step 625, determines the magnitude of the impedance between the active ESU electrode and the shield at step 630, and determines the resistance between the active ESU electrode and the shield at step 635. At step 640, based on one or more pieces of the information collected during the prior steps, the monitoring system determines whether a resistance, capacitance, power, low current, or high current fault exists by comparing the sensed values to the defined threshold values and then based on that condition determines whether to restrict or cut off power from the ESU at step 645. An alarm is then sent to the user at 650 and the system initiates a program delay prior to re-enabling power flow to the active electrode at 655, Paragraph [0062]); receive an actual shield current from the shield based on providing the voltage (As an alternative to using average real power in the shield for the primary fault detection, the real portion of the shield current may also be used. Since the shield current is normally capacitive, as the shield current develops a significant real part, it likely contains at least a partial short circuit to the active electrode. In calculating the RMS of the real part of the shield current, the phase difference between either the active electrode voltage or current and the shield current is taken into account, Paragraphs[0027]-[0028]); and determine a condition of the surgical instrument based on the expected shield current and the actual shield current (At step 640, based on one or more pieces of the information collected during the prior steps, the monitoring system determines whether a resistance, capacitance, power, low current, or high current fault exists by comparing the sensed values to the defined threshold values and then based on that condition determines whether to restrict or cut off power from the ESU at step 645, Paragraph [0062], The sensors 328, 330 and 332 pass the monitored shield current, active current, and the active electrode voltage to a processor 350. In one embodiment, the processor 350 comprises a field programmable gate array (FPGA) and acts in concert with a memory element 352 (such as an EEPROM), and an oscillator 356. An output 354 of the processor 350 passes visible and/or audible indications of the monitor status to a surgeon, operator or other user, Paragraph [0042], [0062], and [0065]-[0098], claim 1).
Regarding claim 11, Aronow discloses the surgical system of Claim 10, wherein determining the condition of the surgical instrument comprises comparing the actual shield current to the expected shield current (At step 640, based on one or more pieces of the information collected during the prior steps, the monitoring system determines whether a resistance, capacitance, power, low current, or high current fault exists by comparing the sensed values to the defined threshold values and then based on that condition determines whether to restrict or cut off power from the ESU at step 645. An alarm is then sent to the user at 650 and the system initiates a program delay prior to re-enabling power flow to the active electrode at 655. It is noted that one or more of the data gathering steps may be obtained in real time and either simultaneously or in serial fashion, Paragraph [0062]).
Regarding claim 12, Aronow discloses the surgical system of Claim 11, wherein the condition of the surgical instrument comprises a low impedance condition based on the actual shield current being a threshold amount greater than the expected shield current (The monitoring system determines the average real power in the instrument shield at step 615, determines the RMS of the real part of the shield current at step 620, determines the RMS current in the shield at step 625, determines the magnitude of the impedance between the active ESU electrode and the shield at step 630, and determines the resistance between the active ESU electrode and the shield at step 635. At step 640, based on one or more pieces of the information collected during the prior steps, the monitoring system determines whether a resistance, capacitance, power, low current, or high current fault exists by comparing the sensed values to the defined threshold values and then based on that condition determines whether to restrict or cut off power from the ESU at step 645. An alarm is then sent to the user at 650 and the system initiates a program delay prior to re-enabling power flow to the active electrode at 655., Paragraphs[0062]-[0098], claims 19-22).
Regarding claim 13, Aronow discloses a surgical system of Claim 11, wherein the condition of the surgical instrument comprises a high impedance condition based on the actual shield current being a threshold amount less than the expected shield current (The monitoring system determines the average real power in the instrument shield at step 615, determines the RMS of the real part of the shield current at step 620, determines the RMS current in the shield at step 625, determines the magnitude of the impedance between the active ESU electrode and the shield at step 630, and determines the resistance between the active ESU electrode and the shield at step 635. At step 640, based on one or more pieces of the information collected during the prior steps, the monitoring system determines whether a resistance, capacitance, power, low current, or high current fault exists by comparing the sensed values to the defined threshold values and then based on that condition determines whether to restrict or cut off power from the ESU at step 645. An alarm is then sent to the user at 650 and the system initiates a program delay prior to re-enabling power flow to the active electrode at 655., Paragraphs[0062]-[0098], claims 19-22).
Regarding claim 14, Aronow discloses the surgical system of Claim 10, wherein the condition of the surgical instrument comprises a condition of the shield (further comprising structure for contemporaneously recording and/or displaying at least one of: the power delivered to patient and active electrode, the active electrode current, the return electrode current, the active electrode voltage, the shield power, the shield current, the shield resistance, and shield fault status, claim 6).
Regarding claim 15, Aronow discloses the surgical system of Claim 10, wherein the shaft is comprised of a conductive material (A tubular safety shield assembly 25 includes a tubular shield 20 having a layer of insulation 22 provided on the outer surface thereof and an optional layer of insulation 24 provided on the inner surface thereof. The tubular shield assembly is inserted through trocar sheath 10 to thereby provide a passageway through which the active electrode probe 12 may be inserted. An elongated port 31 may extend through the active electrode through which irrigation fluids, suction, a pressurized gas stream, etc. may pass. When active probe 12 and tubular shield assembly 25 are in their respective inserted positions as shown in FIG. 1, the shield 20 surrounds the active probe from at least (a) a proximal point 26 prior to the entry point 28 of the active probe into the trocar sheath 10 to (b) a distal point 30 in proximity to the tip 18 of the active probe, Paragraph [0004]).
Regarding claim 17, Aronow discloses a non-transitory computer readable medium storing instructions that (monitoring circuitry 320, Paragraph [0040], Figure 3), when executed by a processor (processor 350, Paragraph [0042], Figure 3), cause the processor to: receive an input indicative of an operating mode of a surgical instrument (FIG. 5 depicts an exemplary method 600 implemented within a monitoring system constructed in accordance with aspects of the present invention. In one aspect, at step 610 fault tolerances and trip point thresholds are set based on specified surgical conditions. A surgeon keys or otherwise activates the power delivery at 612 and allows a voltage at electrosurgical frequencies to appear on the shielded electrosurgical instrument. The monitoring system determines the average real power in the instrument shield at step 615, determines the RMS of the real part of the shield current at step 620, determines the RMS current in the shield at step 625, determines the magnitude of the impedance between the active ESU electrode and the shield at step 630, and determines the resistance between the active ESU electrode and the shield at step 635. At step 640, based on one or more pieces of the information collected during the prior steps, the monitoring system determines whether a resistance, capacitance, power, low current, or high current fault exists by comparing the sensed values to the defined threshold values and then based on that condition determines whether to restrict or cut off power from the ESU at step 645. An alarm is then sent to the user at 650 and the system initiates a program delay prior to re-enabling power flow to the active electrode at 655, Paragraph [0062]); control an energy generator to provide a voltage to a conductor of the surgical instrument (an electrosurgical generator coupled to the electrosurgical instrument and adapted to deliver power to the active electrode of the electrosurgical instrument, claim 1), the conductor being capacitively coupled to a shield of the surgical instrument (The electrosurgical apparatus 316 includes a shield that is monitored by the system 306. Conductive leads 318, 322 and 324 connect the shield and the electrosurgical apparatus 316 to the monitoring circuitry 320, Paragraph [0040]); determine an expected shield current based on the operating mode of the surgical instrument and the voltage (FIG. 5 depicts an exemplary method 600 implemented within a monitoring system constructed in accordance with aspects of the present invention. In one aspect, at step 610 fault tolerances and trip point thresholds are set based on specified surgical conditions. A surgeon keys or otherwise activates the power delivery at 612 and allows a voltage at electrosurgical frequencies to appear on the shielded electrosurgical instrument. The monitoring system determines the average real power in the instrument shield at step 615, determines the RMS of the real part of the shield current at step 620, determines the RMS current in the shield at step 625, determines the magnitude of the impedance between the active ESU electrode and the shield at step 630, and determines the resistance between the active ESU electrode and the shield at step 635. At step 640, based on one or more pieces of the information collected during the prior steps, the monitoring system determines whether a resistance, capacitance, power, low current, or high current fault exists by comparing the sensed values to the defined threshold values and then based on that condition determines whether to restrict or cut off power from the ESU at step 645. An alarm is then sent to the user at 650 and the system initiates a program delay prior to re-enabling power flow to the active electrode at 655, Paragraph [0062]); receive an actual shield current from the shield based on providing the voltage (As an alternative to using average real power in the shield for the primary fault detection, the real portion of the shield current may also be used. Since the shield current is normally capacitive, as the shield current develops a significant real part, it likely contains at least a partial short circuit to the active electrode. In calculating the RMS of the real part of the shield current, the phase difference between either the active electrode voltage or current and the shield current is taken into account, Paragraphs[0027]-[0028]); compare the expected shield current and the actual shield current (The sensors 328, 330 and 332 pass the monitored shield current, active current, and the active electrode voltage to a processor 350. In one embodiment, the processor 350 comprises a field programmable gate array (FPGA) and acts in concert with a memory element 352 (such as an EEPROM), and an oscillator 356. An output 354 of the processor 350 passes visible and/or audible indications of the monitor status to a surgeon, operator or other user, Paragraph [0042], [0062], and [0065]-[0098], claim 1); and detect an abnormality in the surgical instrument based on the comparison (FIG. 5 depicts an exemplary method 600 implemented within a monitoring system constructed in accordance with aspects of the present invention. In one aspect, at step 610 fault tolerances and trip point thresholds are set based on specified surgical conditions. A surgeon keys or otherwise activates the power delivery at 612 and allows a voltage at electrosurgical frequencies to appear on the shielded electrosurgical instrument. The monitoring system determines the average real power in the instrument shield at step 615, determines the RMS of the real part of the shield current at step 620, determines the RMS current in the shield at step 625, determines the magnitude of the impedance between the active ESU electrode and the shield at step 630, and determines the resistance between the active ESU electrode and the shield at step 635. At step 640, based on one or more pieces of the information collected during the prior steps, the monitoring system determines whether a resistance, capacitance, power, low current, or high current fault exists by comparing the sensed values to the defined threshold values and then based on that condition determines whether to restrict or cut off power from the ESU at step 645. An alarm is then sent to the user at 650 and the system initiates a program delay prior to re-enabling power flow to the active electrode at 655. It is noted that one or more of the data gathering steps may be obtained in real time and either simultaneously or in serial fashion. Because of the FPGA's parallel processing ability, many different parameters may be monitored at the same time, providing a wide range of information for determining whether a fault condition exists. Further embodiments of fault detection processes used in the above process are described below, Paragraphs [0062]-[0098]).
Regarding claim 18, Aronow discloses the non-transitory computer readable medium of Claim 17, wherein the abnormality comprises a high impedance condition of the surgical instrument based on the actual shield current being a threshold amount below the expected shield current (The monitoring system determines the average real power in the instrument shield at step 615, determines the RMS of the real part of the shield current at step 620, determines the RMS current in the shield at step 625, determines the magnitude of the impedance between the active ESU electrode and the shield at step 630, and determines the resistance between the active ESU electrode and the shield at step 635. At step 640, based on one or more pieces of the information collected during the prior steps, the monitoring system determines whether a resistance, capacitance, power, low current, or high current fault exists by comparing the sensed values to the defined threshold values and then based on that condition determines whether to restrict or cut off power from the ESU at step 645. An alarm is then sent to the user at 650 and the system initiates a program delay prior to re-enabling power flow to the active electrode at 655., Paragraphs[0062]-[0098], claims 19-22).
Regarding claim 19, Aronow discloses the non-transitory computer readable medium of Claim 17, wherein the abnormality comprises a low impedance condition of the surgical instrument based on the actual shield current being a threshold amount above the expected shield current (The monitoring system determines the average real power in the instrument shield at step 615, determines the RMS of the real part of the shield current at step 620, determines the RMS current in the shield at step 625, determines the magnitude of the impedance between the active ESU electrode and the shield at step 630, and determines the resistance between the active ESU electrode and the shield at step 635. At step 640, based on one or more pieces of the information collected during the prior steps, the monitoring system determines whether a resistance, capacitance, power, low current, or high current fault exists by comparing the sensed values to the defined threshold values and then based on that condition determines whether to restrict or cut off power from the ESU at step 645. An alarm is then sent to the user at 650 and the system initiates a program delay prior to re-enabling power flow to the active electrode at 655., Paragraphs[0062]-[0098], claims 19-22).
Regarding claim 20, Aronow discloses the non-transitory computer readable medium of Claim 17, wherein the abnormality of the surgical instrument comprises an abnormality in the shield (further comprising structure for contemporaneously recording and/or displaying at least one of: the power delivered to patient and active electrode, the active electrode current, the return electrode current, the active electrode voltage, the shield power, the shield current, the shield resistance, and shield fault status, claim 6).
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.
Claim(s) 9 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aronow in view of Tasto et al. (US 20020068930 A1) herein referred to as “Tasto”.
Regarding claim 9, Aronow discloses the surgical system of Claim 1.
Aronow discloses wherein the surgical instrument further comprises an electrode electrically coupled to the conductor and operable to provide energy to tissue (Paragraph [0040]). However Aronow does not explicitly disclose wherein the voltage is a second voltage , wherein the controller is further operable to: provide a first voltage to the tissue from the energy generator via the conductor and the electrode; determine an impedance of the tissue based on providing the first voltage; and determine the second voltage to provide to the conductor based on the determined impedance.
Tasto discloses a probe device with an active electrode (Abstract) wherein the surgical instrument further comprises an electrode electrically coupled to the conductor and operable to provide energy to tissue, wherein the controller is further operable to: provide a first voltage to the tissue from the energy generator via the conductor and the electrode; determine an impedance of the tissue based on providing the first voltage; and determine the second voltage to provide to the conductor based on the determined impedance (impedance measurement circuitry integrated with active electrodes 110 to detect when probe 100 is adjacent blood vessels and/or the outer or inner boundaries of the heart wall. Specifically, the current limiting circuitry includes a number of impedance monitors coupled to each active electrode 110 to determine the impedance between the individual active electrode 110 and the return electrode 102. Thus, for example, if the measured impedance suddenly decreases at active electrodes 110 at the tip of the probe 100, the applied voltage will be interrupted to avoid power delivery to blood filled ventricular cavity 258 of the heart, thereby avoiding formation of a thrombus or damage to other tissue structures within the ventricular cavity 258, Paragraph [0122]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Aronow to incorporate the teachings of Tasto by including wherein the controller is further operable to: provide a first voltage to the tissue from the energy generator via the conductor and the electrode; determine an impedance of the tissue based on providing the first voltage; and determine the second voltage to provide to the conductor based on the determined impedance. The motivation to do so being to facilitate adjusting the voltage to avoid power delivery to an unwanted area (Tasto, Paragraph [0122]).
Regarding claim 16, Aronow discloses the surgical system of Claim 10.
Aronow discloses wherein the surgical instrument further comprises an electrode electrically coupled to the conductor and operable to provide energy to tissue (Paragraph [0040]). However Aronow does not explicitly disclose wherein the voltage is a second voltage and the controller is further operable to: provide a first voltage to the conductor and the electrode; determine an impedance of the tissue based on providing the first voltage; and determine the second voltage to provide to the conductor and the electrode based on the determined impedance.
Tasto discloses a probe device with an active electrode (Abstract) the controller is further operable to: provide a first voltage to the conductor and the electrode; determine an impedance of the tissue based on providing the first voltage; and determine the second voltage to provide to the conductor and the electrode based on the determined impedance (impedance measurement circuitry integrated with active electrodes 110 to detect when probe 100 is adjacent blood vessels and/or the outer or inner boundaries of the heart wall. Specifically, the current limiting circuitry includes a number of impedance monitors coupled to each active electrode 110 to determine the impedance between the individual active electrode 110 and the return electrode 102. Thus, for example, if the measured impedance suddenly decreases at active electrodes 110 at the tip of the probe 100, the applied voltage will be interrupted to avoid power delivery to blood filled ventricular cavity 258 of the heart, thereby avoiding formation of a thrombus or damage to other tissue structures within the ventricular cavity 258, Paragraph [0122]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Aronow to incorporate
the teachings of Tasto by including wherein the controller is further operable to: provide a first voltage to the conductor and the electrode; determine an impedance of the tissue based on providing the first voltage; and determine the second voltage to provide to the conductor and the electrode based on the determined impedance. The motivation to do so being to facilitate adjusting the voltage to avoid power delivery to an unwanted area (Tasto, Paragraph [0122]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Odell et al. (US 5769841 A) discloses an electrosurgical instrument with a safety shield.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dana Stumpfoll whose telephone number is (703)756-4669. The examiner can normally be reached 9-5 pm (CT), M-F.
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, Joanne Rodden can be reached at (303) 297-4276. 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.
/D.S./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights