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 .
Response to Amendment
The Amendments under 37 CFR 1.132 filed 06/04/2025 is insufficient to overcome the rejection of independent claims 1 and 11 based upon being rejected under 35 U.S.C. 103 as being unpatentable over Harlev (US 20200229866 A1) in view of Yamamura (US 20160331473 A1), further in view of Panescu (US 20190343581 A1) and Scheib (US 20200015925 A1) as set forth in the last Office action because: Panescu teaches the newly added amendments.
Response to Arguments
Applicant's arguments filed 06/04/2025 have been fully considered but they are not persuasive.
Panescu teaches and a controller configured to be operatively coupled to the surgical instrument and to the second visualization system ([0116] FIG. 11 further comprising an computerized ablation energy (e.g., RF) console 291 comprising a programmable controller with software 292), monitor a temperature of the tissue during the energy delivery by the electrode to the tissue ([0049] For example, in a collapsed or shrunk airway, temperature sensor(s) positioned in or on the electrode(s) may provide more accurate temperature feedback to the computer-controlled ablation console used to control the energy delivery parameters such as RF power, RF power ramp up slope, or duration, while increased contact stability and pressure may allow increased stability of thermal and electrical conduction allowing the temperature sensor(s) to have a more accurate representation of temperature of the tissue around the electrode. Consequently, the ablative energy delivered to the targeted lung tissue and tumor may be optimized and the temperature of the targeted tissue may be heated to an intended temperature set point in an effective and safe manner), and control energizing of the electrode based on the temperature of the tissue monitored ([0049] For example, in a collapsed or shrunk airway, temperature sensor(s) positioned in or on the electrode(s) may provide more accurate temperature feedback to the computer-controlled ablation console used to control the energy delivery parameters such as RF power, RF power ramp up slope, or duration, while increased contact stability and pressure may allow increased stability of thermal and electrical conduction allowing the temperature sensor(s) to have a more accurate representation of temperature of the tissue around the electrode. Consequently, the ablative energy delivered to the targeted lung tissue and tumor may be optimized and the temperature of the targeted tissue may be heated to an intended temperature set point in an effective and safe manner) ([0075] The temperature sensor 242 may be used to monitor electrode 234 temperature during energy delivery in which it is used as a parameter to control energy delivery).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 6, 11-13, 16, 25, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harlev (US 20200229866 A1) in view of Yamamura (US 20160331473 A1), further in view of Panescu (US 20190343581 A1) and Scheib (US 20200015925 A1).
Regarding claim 1, Harlev teaches a controller system configured to monitor the electrode's energy delivery to the tissue during the delivery and during the second visualization system's visualization of the surgical site ([0084] Each of the conductive components 150, 152 is connected to a wire that extends through the catheter shaft 128 to the catheter interface unit 108 for transferring data signals from the conductive components 150, 152 to the control unit (e.g., processor) in the catheter interface unit 108), and control energizing of the electrode such that a parameter associated with the tissue does not exceed a predefined maximum threshold ([0096] The catheter interface unit 108 is operably connected to the ablation generator 116 such that the catheter interface unit 108 can receive data from the various sensors and/or control the output of or communicate with the ablation generator 116 according to a predetermined scheme and/or user input). Harlev fails to teach a surgical system, comprising: a first visualization system configured to visualize the surgical instrument during the energy delivery by the electrode; a surgical instrument configured to be advanced to the surgical site through a lumen of the first visualization, and the surgical including an electrode configured to deliver energy to tissue at a surgical site; a second visualization system configured to visualize the surgical site; and a controller configured to be operatively coupled to the electrosurgical instrument and to the second visualization system.
Yamamura teaches a surgical system, comprising: a surgical instrument configured to be advanced to a surgical site through a lumen of the first visualization system ([0032] The endoscope 2 is provided with an elongated flexible insertion section 21 that can be inserted into the body cavity A and an imaging element (observation unit) 22 that is built into the distal end of the insertion section 21, and a video of the inside of the body cavity A acquired by the imaging element 22 is sent to a monitor 7), and the surgical instrument including an electrode configured to deliver energy to a first side of tissue at-the surgical site ([0062] the treatment tool 4 and a treatment tool that is inserted into the channel 24 of the endoscope 2 may form electrodes for the bipolar-type electrocautery knife, and supply of a high-frequency current to the electrodes); a first visualization system configured to visualize the surgical instrument during the delivery ([0052] the doctor inserts the endoscope 2 into the body cavity A, determines an incision line surrounding the lesion C while observing the lesion C with an endoscope video, and positions the marker 23 on the incision line); a second visualization system configured to, during the delivery, visualize a second side of the tissue that is opposite to the first side of the tissue (laparoscope 3) ([0052] the doctor percutaneously inserts the laparoscope 3 and the treatment tool 4 into the body, disposes the electrocautery knife 42 outside the body cavity A, and disposes the laparoscope 3 at a position where the electrocautery knife 42 can be observed).
Yamamura fails to teach and a controller configured to be operatively coupled to the surgical instrument and to the second visualization system, monitor the electrode's energy delivery to the tissue during the delivery and during the second visualization system's visualization of the second side of the tissue, and control energizing of the electrode using the visualization of the second side of the tissue by the second visualization system such that a parameter associated with the tissue does not exceed a predefined maximum threshold, wherein the predefined maximum threshold includes a temperature of the tissue.
However, Panescu teaches and a controller configured to be operatively coupled to the surgical instrument and to the second visualization system ([0116] FIG. 11 further comprising an computerized ablation energy (e.g., RF) console 291 comprising a programmable controller with software 292), monitor a temperature of the tissue during the energy delivery by the electrode to the tissue ([0049] For example, in a collapsed or shrunk airway, temperature sensor(s) positioned in or on the electrode(s) may provide more accurate temperature feedback to the computer-controlled ablation console used to control the energy delivery parameters such as RF power, RF power ramp up slope, or duration, while increased contact stability and pressure may allow increased stability of thermal and electrical conduction allowing the temperature sensor(s) to have a more accurate representation of temperature of the tissue around the electrode. Consequently, the ablative energy delivered to the targeted lung tissue and tumor may be optimized and the temperature of the targeted tissue may be heated to an intended temperature set point in an effective and safe manner), and control energizing of the electrode based on the temperature of the tissue monitored ([0049] For example, in a collapsed or shrunk airway, temperature sensor(s) positioned in or on the electrode(s) may provide more accurate temperature feedback to the computer-controlled ablation console used to control the energy delivery parameters such as RF power, RF power ramp up slope, or duration, while increased contact stability and pressure may allow increased stability of thermal and electrical conduction allowing the temperature sensor(s) to have a more accurate representation of temperature of the tissue around the electrode. Consequently, the ablative energy delivered to the targeted lung tissue and tumor may be optimized and the temperature of the targeted tissue may be heated to an intended temperature set point in an effective and safe manner) ([0075] The temperature sensor 242 may be used to monitor electrode 234 temperature during energy delivery in which it is used as a parameter to control energy delivery). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Yamamura to include a first and second visualization system, monitor a temperature of the tissue during the energy delivery by the electrode to the tissue, and control energizing of the electrode based on the temperature of the tissue monitored. Doing so allows for the ablative energy delivered to the targeted lung tissue and tumor may be optimized and the temperature of the targeted tissue may be heated to an intended temperature set point in an effective and safe manner [0049].
Furthermore, Scheib teaches monitor the electrode's energy delivery to the tissue during the delivery and during the second visualization system's visualization of the second side of the tissue, and control energizing of the electrode using the visualization of the second side of the tissue by the second visualization system such that a parameter associated with the tissue does not exceed a predefined maximum threshold ([0158] a thermal imaging camera can be utilized to read the heat at the surgical site and provide a warning to the clinician that is based on the detected heat and the distance from a tool to the structure. For example, if the temperature of the tool is over a predefined threshold (such as 120 degrees F., for example), an alert can be provided to the clinician at a first distance (such as 10 mm, for example), and if the temperature of the tool is less than or equal to the predefined threshold, the alert can be provided to the clinician at a second distance (such as 5 mm, for example)). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Yamamura to include a first and second visualization system, an electrode coupled to the instrument, and a controller configured to each. Doing so allows for the perspective views of the catheter and surgical sight during operation and the connection to a controller to externally operate the device.
Regarding claim 2, Harlev teaches the system of claim 1, further comprises comprising a sensor operatively coupled to the controller and configured to measure the temperature of the tissue ([0088] Temperature data from the thermistors can be used as a safety control to stop ablation delivery if overheating (e.g. >90° C.) occurs.).
Regarding claim 3, Harlev teaches the system of claim 1, wherein the electrode includes an electrode array configured to measure the temperature of the tissue, and the controller is configured to use the temperature measured by the electrode array as a baseline temperature in controlling the energizing of the electrode ([0088] The thermistors are attached to the inner surfaces of the flexible printed circuit 154, opposite the central conductive components 150 of the outer electrodes 146. Each of the thermistors can be used to detect the temperature of its associated outer electrode 146. Temperature data from the thermistors can be used as a safety control to stop ablation delivery if overheating (e.g. >90° C.) occurs.). Harlev and Yamamura fail to teach and the controller uses the temperature measured by the electrode array as a baseline temperature in the controlling of the energizing of the electrode.
However, Panescu teaches and the controller uses the temperature measured by the electrode array as a baseline temperature in the controlling of the energizing of the electrode. ([0116] FIG. 11 further comprising an computerized ablation energy (e.g., RF) console 291 comprising a programmable controller with software 292) ([0075] The temperature sensor 242 may be used to monitor electrode 234 temperature during energy delivery in which it is used as a parameter to control energy delivery). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Yamamura to include a first and second visualization system, an electrode coupled to the instrument, and a controller configured to each. Doing so allows for the perspective views of the catheter and surgical sight during operation and the connection to a controller to externally operate the device.
Regarding claim 6, Harlev teaches the system of claim 1, but fails to teach wherein the first visualization system is configured to visualize within a hollow organ at the surgical site; the tissue is tissue within the hollow organ; and the second visualization system is configured to visualize outside the hollow organ. However, Yamamura teaches wherein the first visualization system is configured to visualize within a hollow organ at the surgical site (Fig 1; endoscope 2); the tissue is tissue within the hollow organ (Fig 1; laparoscope 3); and the second visualization system is configured to visualize outside the hollow organ (Fig 1; laparoscope 3 configured outside the hollow organ). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harlev to include a first visualization system to observe the tissue within a hollow organ and a second system to view the outside of the hollow organ. Doing so allows for two perspectives to monitor the surgical sight during operation.
Regarding claim 11, Harlev teaches a surgical method configured for monitoring, with a controller and during the second visualization system's visualization of the surgical site, energy delivery to tissue at the surgical site ([0084] Each of the conductive components 150, 152 is connected to a wire that extends through the catheter shaft 128 to the catheter interface unit 108 for transferring data signals from the conductive components 150, 152 to the control unit (e.g., processor) in the catheter interface unit 108), and controlling, with the controller, energizing of the electrode such that a parameter associated with the tissue does not exceed a predefined maximum threshold ([0096] The catheter interface unit 108 is operably connected to the ablation generator 116 such that the catheter interface unit 108 can receive data from the various sensors and/or control the output of or communicate with the ablation generator 116 according to a predetermined scheme and/or user input). Harlev fails to teach visualizing a surgical site with a first visualization system; visualizing the surgical site with a second visualization system configured to visualize the surgical site; monitoring the energy being delivered to the tissue by an electrode of a surgical instrument positioned in a lumen of the first visualization system.
However, Yamamura teaches a surgical system, comprising: visualizing a surgical site with a first visualization system (Fig 1; endoscope 2); visualizing the surgical site with a second visualization system configured to visualize the surgical site (Fig 1; laparoscope 3); monitoring, with a controller and during the second visualization system's visualization of the surgical site (Fig 2; [0031] a controller 6 that controls the treatment tool 4 on the basis of an input to the manipulation input device 5), energy delivery to tissue at the surgical site, the energy being delivered to the tissue by an electrode of a surgical instrument ([0062] the treatment tool 4 and a treatment tool that is inserted into the channel 24 of the endoscope 2 may form electrodes for the bipolar-type electrocautery knife) positioned in a lumen of the first visualization system ([0033] Instead of the wire 25, a desired treatment tool that can be inserted into the channel 24 may be used). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harlev to include a first and second visualization system, an electrode coupled to the instrument, and a controller configured to each. Doing so allows for the perspective views of the catheter and surgical sight during operation and the connection to a controller to externally operate the device.
Yamamura fails to teach monitoring a temperature of the tissue, with the controller configured to be operatively coupled to the surgical instrument and to the second visualization system, monitor the electrode's energy delivery to the tissue during the delivery and during the second visualization system's visualization of the second side of the tissue, and control energizing of the electrode based on the temperature of the tissue monitored using the visualization of the second side of the tissue by the second visualization system such that the temperature of the tissue does not exceed a predefined maximum threshold.
However, Panescu teaches monitor a temperature of the tissue during the energy delivery by the electrode to the tissue ([0049] For example, in a collapsed or shrunk airway, temperature sensor(s) positioned in or on the electrode(s) may provide more accurate temperature feedback to the computer-controlled ablation console used to control the energy delivery parameters such as RF power, RF power ramp up slope, or duration, while increased contact stability and pressure may allow increased stability of thermal and electrical conduction allowing the temperature sensor(s) to have a more accurate representation of temperature of the tissue around the electrode. Consequently, the ablative energy delivered to the targeted lung tissue and tumor may be optimized and the temperature of the targeted tissue may be heated to an intended temperature set point in an effective and safe manner), with the controller configured to be operatively coupled to the surgical instrument and to the second visualization system ([0116] FIG. 11 further comprising an computerized ablation energy (e.g., RF) console 291 comprising a programmable controller with software 292), and control energizing of the electrode based on the temperature of the tissue monitored ([0049] For example, in a collapsed or shrunk airway, temperature sensor(s) positioned in or on the electrode(s) may provide more accurate temperature feedback to the computer-controlled ablation console used to control the energy delivery parameters such as RF power, RF power ramp up slope, or duration, while increased contact stability and pressure may allow increased stability of thermal and electrical conduction allowing the temperature sensor(s) to have a more accurate representation of temperature of the tissue around the electrode. Consequently, the ablative energy delivered to the targeted lung tissue and tumor may be optimized and the temperature of the targeted tissue may be heated to an intended temperature set point in an effective and safe manner) ([0075] The temperature sensor 242 may be used to monitor electrode 234 temperature during energy delivery in which it is used as a parameter to control energy delivery). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Yamamura to include a first and second visualization system, monitor a temperature of the tissue during the energy delivery by the electrode to the tissue, and control energizing of the electrode based on the temperature of the tissue monitored. Doing so allows for the ablative energy delivered to the targeted lung tissue and tumor may be optimized and the temperature of the targeted tissue may be heated to an intended temperature set point in an effective and safe manner [0049] and for the connection to a controller to externally operate the device.
Furthermore, Scheib teaches monitor the electrode's energy delivery to the tissue during the delivery and during the second visualization system's visualization of the second side of the tissue, and control energizing of the electrode using the visualization of the second side of the tissue by the second visualization system such that a parameter associated with the tissue does not exceed a predefined maximum threshold, wherein the predefined maximum threshold includes a temperature of the tissue ([0158] a thermal imaging camera can be utilized to read the heat at the surgical site and provide a warning to the clinician that is based on the detected heat and the distance from a tool to the structure. For example, if the temperature of the tool is over a predefined threshold (such as 120 degrees F., for example), an alert can be provided to the clinician at a first distance (such as 10 mm, for example), and if the temperature of the tool is less than or equal to the predefined threshold, the alert can be provided to the clinician at a second distance (such as 5 mm, for example)). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Yamamura to include a first and second visualization system, an electrode coupled to the instrument, and a controller configured to each. Doing so allows for the perspective views of the catheter and surgical sight during operation and the connection to a controller to externally operate the device.
Regarding claim 12, Harlev teaches the method of claim 11, wherein the predefined maximum threshold includes a temperature of the tissue; and the method further comprises measuring the temperature of the tissue with a sensor operatively coupled to the controller ([0088] Temperature data from the thermistors can be used as a safety control to stop ablation delivery if overheating (e.g. >90° C.) occurs.).
Regarding claim 13, Harlev teaches the method of claim 11, wherein the predefined maximum threshold includes a temperature of the tissue; the electrode includes an electrode array; and the method further comprises measuring the temperature of the tissue with the electrode array ([0088] The thermistors are attached to the inner surfaces of the flexible printed circuit 154, opposite the central conductive components 150 of the outer electrodes 146. Each of the thermistors can be used to detect the temperature of its associated outer electrode 146. Temperature data from the thermistors can be used as a safety control to stop ablation delivery if overheating (e.g. >90° C.) occurs.). Harlev and Yamamura fail to teach and the controller uses the temperature measured by the electrode array as a baseline temperature in the controlling of the energizing of the electrode.
However, Panescu teaches and the controller uses the temperature measured by the electrode array as a baseline temperature in the controlling of the energizing of the electrode. ([0116] FIG. 11 further comprising an computerized ablation energy (e.g., RF) console 291 comprising a programmable controller with software 292) ([0075] The temperature sensor 242 may be used to monitor electrode 234 temperature during energy delivery in which it is used as a parameter to control energy delivery). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Yamamura to include a first and second visualization system, an electrode coupled to the instrument, and a controller configured to each. Doing so allows for the perspective views of the catheter and surgical sight during operation and the connection to a controller to externally operate the device.
Regarding claim 16, Harlev teaches the method of claim 11, but fails to teach wherein the first visualization system is configured to visualize within a hollow organ at the surgical site; the tissue is tissue within the hollow organ; and the second visualization system is configured to visualize outside the hollow organ. However, Yamamura teaches wherein the first visualization system is configured to visualize within a hollow organ at the surgical site (Fig 1; endoscope 2); the tissue is tissue within the hollow organ (Fig 1; laparoscope 3); and the second visualization system is configured to visualize outside the hollow organ (Fig 1; laparoscope 3 configured outside the hollow organ). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harlev to include a first visualization system to observe the tissue within a hollow organ and a second system to view the outside of the hollow organ. Doing so allows for two perspectives to monitor the surgical sight during operation.
Regarding claim 25, Harlev teaches the system of claim 1, but fails to teach wherein the processor further comprises: monitoring the temperature of the second side of the tissue. However, Yamamura teaches wherein the processor further comprises: monitoring the temperature of the second side of the tissue ([0037] a heating element and a thermal detector; and an AC-voltage generator and an impedance detector. In this way, the distance measuring unit 8 detects magnetism, the intensity of light, temperature, or the magnitude of impedance and measures the distance between the marker 23 and the electrocautery knife 42, which are disposed with the body-cavity wall B located therebetween, on the basis of the obtained detected value). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harlev to include wherein the processor further comprises: monitoring the temperature of the second side of the tissue. Doing so monitors the tissue outside of the lumen to ensure that it does not overheat from the ablation device inside the lumen.
Regarding claim 26, Harlev teaches the method of claim 11, but fails to teach wherein the method further comprises: monitoring the temperature of the second side of the tissue. However, Yamaura teaches wherein the method further comprises: monitoring the temperature of the second side of the tissue ([0037] a heating element and a thermal detector; and an AC-voltage generator and an impedance detector. In this way, the distance measuring unit 8 detects magnetism, the intensity of light, temperature, or the magnitude of impedance and measures the distance between the marker 23 and the electrocautery knife 42, which are disposed with the body-cavity wall B located therebetween, on the basis of the obtained detected value). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harlev to include wherein the method further comprises: monitoring the temperature of the second side of the tissue. Doing so monitors the tissue outside of the lumen to ensure that it does not overheat from the ablation device inside the lumen.
Claim(s) 7 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harlev (US 20200229866 A1) in view of Yamamura (US 20160331473 A1), Panescu (US 20190343581 A1), Scheib (US 20200015925 A1), and further in view of Amirana (US 10722301 B2).
Regarding claim 7, the combination of Harlev and Yamamura teach the system of claim 1, wherein Yamamura teaches the energy includes one of radiofrequency (RF) energy ([0102] During treatment, RF power that is supplied by the ablation generator 116 is transmitted through tissue of the patient, between the ablation electrode 120). The combination fails to teach microwave energy. However, Amirana teaches microwave energy ([32] ablation energy selected from the group consisting of radiofrequency (RF) energy, microwave energy, electrical energy, electromagnetic energy, cryoenergy, laser energy, ultrasound energy, acoustic energy, chemical energy, thermal energy and combinations thereof). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harlev and Yamamura to include wherein the energy includes microwave energy. Doing so allows for an alternate energy application similar to RF.
Regarding claim 17, the combination of Harlev and Yamamura teach the method of claim 11, wherein Yamamura teaches the energy includes one of radiofrequency (RF) energy ([0102] During treatment, RF power that is supplied by the ablation generator 116 is transmitted through tissue of the patient, between the ablation electrode 120). The combination fails to teach microwave energy. However, Amirana teaches microwave energy ([32] ablation energy selected from the group consisting of radiofrequency (RF) energy, microwave energy, electrical energy, electromagnetic energy, cryoenergy, laser energy, ultrasound energy, acoustic energy, chemical energy, thermal energy and combinations thereof). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harlev and Yamamura to include wherein the energy includes microwave energy. Doing so allows for an alternate energy application similar to RF.
Claim(s) 8 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harlev (US 20200229866 A1) in view of Yamamura (US 20160331473 A1), Panescu (US 20190343581 A1), Scheib (US 20200015925 A1), and further in view of Kochavi (US 20200297403 A1).
Regarding claim 8, the combination of Harlev and Yamamura teach the system of claim 1, but fails to teach wherein the tissue includes a tumor; and the energy includes cold so as to treat the tumor with cyroablation. However, Kochavi teaches wherein the tissue includes a tumor ([0216] intended to include any type of condition that may be treated cryogenically, such as lesions (including cancerous and benign tumors, cysts, polyps and the like)); and the energy includes cold so as to treat the tumor with cyroablation ([0002] The present invention, in some embodiments thereof, relates to ablation, including cryoablation, cryosurgery or cryotherapy devices and, more particularly, but not exclusively, to cryotherapy of body lumen diseases). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harlev and Yamamura to include treatment of a tumor with cryoablation. Doing so creates an effective treatment of a tumor with cryoablation.
Regarding claim 18, the combination of Harlev and Yamamura teach the method of claim 11, but fails to teach wherein the tissue includes a tumor; and the energy includes cold so as to treat the tumor with cyroablation. However, Kochavi teaches wherein the tissue includes a tumor ([0216] intended to include any type of condition that may be treated cryogenically, such as lesions (including cancerous and benign tumors, cysts, polyps and the like)); and the energy includes cold so as to treat the tumor with cyroablation ([0002] The present invention, in some embodiments thereof, relates to ablation, including cryoablation, cryosurgery or cryotherapy devices and, more particularly, but not exclusively, to cryotherapy of body lumen diseases). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harlev and Yamamura to include treatment of a tumor with cryoablation. Doing so creates an effective treatment of a tumor with cryoablation.
Claim(s) 9, 10, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harlev (US 20200229866 A1) in view of Yamamura (US 20160331473 A1), Panescu (US 20190343581 A1), Scheib (US 20200015925 A1), and further in view of Shirazian (WO 2020243432 A1) and Shelton (US 20190207857 A1).
Regarding claim 9, the combination of Harlev and Yamamura teach the system of claim 1, but fails to teach wherein a surgical hub includes the controller. However, Shirazian teaches wherein a surgical hub includes the controller ([0052] augmentation region 302 may be movable relative to the surgical space by way of user input to a computer-assisted surgical system. The computer-assisted surgical system may be configured to receive any suitable user input that may be used to move augmentation region 302 relative to the surgical space. Such input may include actuation of buttons, movement of a controller (e.g., a joystick controller, a master control, etc.)). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harlev and Yamamura to include a surgical hub with a controller. Doing so allows the system to be connected via a surgical hub and controlled with a controller.
The combination above fails to teach the surgical instrument is configured to at least one of communicate first data to the surgical hub and to receive second data from the surgical hub; the surgical hub is configured to be operatively coupled to a robotic surgical system; and the surgical instrument is configured to be releasably coupled to and be controlled by the robotic surgical system. However, Shelton teaches the surgical instrument is configured to at least one of communicate first data to the surgical hub and to receive second data from the surgical hub; the surgical hub is configured to be operatively coupled to a robotic surgical system; and the surgical instrument is configured to be releasably coupled to and be controlled by the robotic surgical system ([0022] the one or more capabilities of the first hub may include one or more of a computing capacity of the first hub, a type of the first hub, a type of data associated with the first hub, an interaction of the data needed to perform a specified surgical procedure by the first hub, or a computing requirement of the first hub) ([0025] the first controller may be further configured to allow the second controller to control the one or more interactions between the first surgical hub and the second surgical hub based on an anticipated surgical task). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of the combination above to include the teachings by Shelton. Doing so allows for communication between the controller and the device by taking in data from the site.
Regarding claim 10, the combination of Harlev and Yamamura teach the system of claim 1, but fails to teach wherein a robotic surgical system includes the controller; and the surgical instrument is configured to be releasably coupled to and controlled by the robotic surgical system. However, Shirazian teaches wherein a robotic surgical system includes the controller; and the surgical instrument is configured to be releasably coupled to and controlled by the robotic surgical system ([0052] augmentation region 302 may be movable relative to the surgical space by way of user input to a computer-assisted surgical system. The computer-assisted surgical system may be configured to receive any suitable user input that may be used to move augmentation region 302 relative to the surgical space. Such input may include actuation of buttons, movement of a controller (e.g., a joystick controller, a master control, etc.)). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harlev and Yamamura to include a surgical hub with a releasably connected controller. Doing so allows the system to be connected via a surgical hub and controlled with a controller that may be detached.
Regarding claim 19, the combination of Harlev and Yamamura teach the method of claim 11, but fails to teach wherein a surgical hub includes the controller. However, Shirazian teaches wherein a surgical hub includes the controller ([0052] augmentation region 302 may be movable relative to the surgical space by way of user input to a computer-assisted surgical system. The computer-assisted surgical system may be configured to receive any suitable user input that may be used to move augmentation region 302 relative to the surgical space. Such input may include actuation of buttons, movement of a controller (e.g., a joystick controller, a master control, etc.)). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harlev and Yamamura to include a surgical hub with a controller. Doing so allows the system to be connected via a surgical hub and controlled with a controller.
The combination above fails to teach the surgical instrument is configured to at least one of communicate first data to the surgical hub and to receive second data from the surgical hub; the surgical hub is configured to be operatively coupled to a robotic surgical system; and the surgical instrument is configured to be releasably coupled to and be controlled by the robotic surgical system. However, Shelton teaches the surgical instrument is configured to at least one of communicate first data to the surgical hub and to receive second data from the surgical hub; the surgical hub is configured to be operatively coupled to a robotic surgical system; and the surgical instrument is configured to be releasably coupled to and be controlled by the robotic surgical system ([0022] the one or more capabilities of the first hub may include one or more of a computing capacity of the first hub, a type of the first hub, a type of data associated with the first hub, an interaction of the data needed to perform a specified surgical procedure by the first hub, or a computing requirement of the first hub) ([0025] the first controller may be further configured to allow the second controller to control the one or more interactions between the first surgical hub and the second surgical hub based on an anticipated surgical task). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of the combination above to include the teachings by Shelton. Doing so allows for communication between the controller and the device by taking in data from the site.
Regarding claim 20, the combination of Harlev and Yamamura teach the method of claim 11, but fails to teach wherein a robotic surgical system includes the controller; and the surgical instrument is configured to be releasably coupled to and controlled by the robotic surgical system. However, Shirazian teaches wherein a robotic surgical system includes the controller; and the surgical instrument is configured to be releasably coupled to and controlled by the robotic surgical system ([0052] augmentation region 302 may be movable relative to the surgical space by way of user input to a computer-assisted surgical system. The computer-assisted surgical system may be configured to receive any suitable user input that may be used to move augmentation region 302 relative to the surgical space. Such input may include actuation of buttons, movement of a controller (e.g., a joystick controller, a master control, etc.)). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harlev and Yamamura to include a surgical hub with a releasably connected controller. Doing so allows the system to be connected via a surgical hub and controlled with a controller that may be detached.
Claim(s) 21 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harlev (US 20200229866 A1) in view of Yamamura (US 20160331473 A1), Panescu (US 20190343581 A1), Scheib (US 20200015925 A1), and further in view of Kumar (US 20140253684 A1).
Regarding claim 21, Harlev teaches the system of claim 1, but fails to teach wherein the second visualization system is configured to gather infrared images of the second side of the tissue using infrared thermal imaging; and the controller is configured to use the infrared images in the control of the energizing of the electrode.
However, Kumar teaches wherein the second visualization system is configured to gather infrared images of the second side of the tissue using infrared thermal imaging ([0025] the second camera or the second channel of the first camera is a near infrared imager (NIR)).
Furthermore, Scheib teaches and the controller is configured to use the infrared images in the control of the energizing of the electrode. ([0158] a thermal imaging camera can be utilized to read the heat at the surgical site and provide a warning to the clinician that is based on the detected heat and the distance from a tool to the structure. For example, if the temperature of the tool is over a predefined threshold (such as 120 degrees F., for example), an alert can be provided to the clinician at a first distance (such as 10 mm, for example), and if the temperature of the tool is less than or equal to the predefined threshold, the alert can be provided to the clinician at a second distance (such as 5 mm, for example)).
It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harlev and Yamamura to include teachings of Kumar and Scheib. Doing so allows for non-invasive infrared images to be captured and relayed to the controller to determine the energy that should be applied.
Regarding claim 23, Harlev teaches the system of claim 11, but fails to teach wherein the second visualization system is configured to gather infrared images of the second side of the tissue using infrared thermal imaging; and the controller is configured to use the infrared images in the control of the energizing of the electrode.
However, Kumar teaches wherein the second visualization system is configured to gather infrared images of the second side of the tissue using infrared thermal imaging ([0025] the second camera or the second channel of the first camera is a near infrared imager (NIR)).
Furthermore, Scheib teaches and the controller is configured to use the infrared images in the control of the energizing of the electrode. ([0158] a thermal imaging camera can be utilized to read the heat at the surgical site and provide a warning to the clinician that is based on the detected heat and the distance from a tool to the structure. For example, if the temperature of the tool is over a predefined threshold (such as 120 degrees F., for example), an alert can be provided to the clinician at a first distance (such as 10 mm, for example), and if the temperature of the tool is less than or equal to the predefined threshold, the alert can be provided to the clinician at a second distance (such as 5 mm, for example)).
It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harlev and Yamamura to include teachings of Kumar and Scheib. Doing so allows for non-invasive infrared images to be captured and relayed to the controller to determine the energy that should be applied.
Claim(s) 22, 24, 27, and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harlev (US 20200229866 A1) in view of Yamamura (US 20160331473 A1), Panescu (US 20190343581 A1), Scheib (US 20200015925 A1).
Regarding claim 22, Harlev teaches the surgical system of claim 21, wherein the surgical instrument includes an ablation device (Fig 1; ablation system 100); but fails to teach the first visualization system includes a first surgical scope having the lumen; and the second visualization system includes a second surgical scope. However, Yamamura teaches the first visualization system includes a first surgical scope having the lumen; and the second visualization system includes a second surgical scope (Fig 1; endoscope 2 and laparascope 3). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harlev to include the teachings of Yamamura. Doing so includes a second visualization system to monitor the outside of the surgical site.
Regarding claim 24, Harlev teaches the surgical system of claim 23, wherein the surgical instrument includes an ablation device (Fig 1; ablation system 100); but fails to teach the first visualization system includes a first surgical scope having the lumen; and the second visualization system includes a second surgical scope. However, Yamamura teaches the first visualization system includes a first surgical scope having the lumen; and the second visualization system includes a second surgical scope (Fig 1; endoscope 2 and laparascope 3). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harlev to include the teachings of Yamamura. Doing so includes a second visualization system to monitor the outside of the surgical site.
Regarding claim 27, Harlev teaches the surgical system of claim 22, wherein the processor is further configured to determine, based on the second visualization system's visualization of the second side of the tissue, a temperature of an ablation zone of the ablation device in the tissue, wherein the energizing of the electrode is controlled based on the determined temperature of the ablation zone ([0042] This can further help to improve the accuracy with which the temperature sensor can detect the temperature of the tissue being ablated. As a result of this design, many of the ablation catheters described herein can achieve more accurate tissue temperature measurements) ([0088] Since the outer electrodes 146 are exposed along the outer surface of the distal tip 122 and can be placed in direct contact with tissue of the patient during use, their temperature can provide an accurate indication of the tissue temperature during treatment. Tissue temperature has been found to be a good indicator of ablation lesion formation). Harlev fails to fully teach based on the second visualization system's visualization of the second side of the tissue, wherein the energizing of the electrode is controlled based on the determined temperature of the ablation zone.
However, Schieb teaches based on the second visualization system's visualization of the second side of the tissue ([0158] a thermal imaging camera can be utilized to read the heat at the surgical site and provide a warning to the clinician that is based on the detected heat and the distance from a tool to the structure. For example, if the temperature of the tool is over a predefined threshold (such as 120 degrees F., for example), an alert can be provided to the clinician at a first distance (such as 10 mm, for example), and if the temperature of the tool is less than or equal to the predefined threshold, the alert can be provided to the clinician at a second distance (such as 5 mm, for example)). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Yamamura to include a second visualization system's visualization of the second side of the tissue. Doing so allows for the perspective views of the catheter and surgical sight during operation and the connection to a controller to externally operate the device.
Further, Panescu teaches wherein the energizing of the electrode is controlled based on the determined temperature of the ablation zone ([0049] For example, in a collapsed or shrunk airway, temperature sensor(s) positioned in or on the electrode(s) may provide more accurate temperature feedback to the computer-controlled ablation console used to control the energy delivery parameters such as RF power, RF power ramp up slope, or duration, while increased contact stability and pressure may allow increased stability of thermal and electrical conduction allowing the temperature sensor(s) to have a more accurate representation of temperature of the tissue around the electrode. Consequently, the ablative energy delivered to the targeted lung tissue and tumor may be optimized and the temperature of the targeted tissue may be heated to an intended temperature set point in an effective and safe manner) ([0075] The temperature sensor 242 may be used to monitor electrode 234 temperature during energy delivery in which it is used as a parameter to control energy delivery). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Yamamura to include wherein the energizing of the electrode is controlled based on the determined temperature of the ablation zone. Doing so allows for the ablative energy delivered to the targeted lung tissue and tumor may be optimized and the temperature of the targeted tissue may be heated to an intended temperature set point in an effective and safe manner [0049].
Regarding claim 28, Harlev teaches the surgical system of claim 24, wherein the method further comprises a temperature of an ablation zone of the ablation device ([0042] This can further help to improve the accuracy with which the temperature se