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 08/26/2025 is sufficient to overcome the rejection of claims 1 based upon being rejected under 35 U.S.C. § 101 as "directed to or encompassing a human organism" and the rejection has been withdrawn.
The Amendments under 37 CFR 1.132 filed 08/26/2025 are sufficient to overcome the rejection of independent claims 1, 11, and 18 based upon rejected under 35 U.S.C. 103 as being unpatentable over Silwa (US 20160228175 A1) in view of Abi-Jaoudeh (US 20150150466 A1) based upon failing to teach all aspects of the amended claims.
Response to Arguments
Applicant’s arguments, see Remarks, filed 08/26/2025, with respect to the rejection(s) of independent claim(s) 1, 11, and 18 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made further in view of Shadduck (US 6740082 B2).
Silwa teaches the surgical device to maintain the first parameter below a threshold value ([0080] The processor 142 is configured, at least in part, to compare the determined highest temperature or a too-rapid time rate of change measured surface temperature with a predetermined threshold temperature or rate of change, and to provide the practitioner performing the ablation procedure an audible and or visual warning if the measured highest temperature approaches or reaches the predetermined threshold (e.g., a temperature at or near the highest temperature at which burning or damage to the esophageal tissue is not expected to occur, or a predetermined rate of change threshold). Silwa teaches the predetermined temperature/rate of change threshold may be adjustable so as to allow for the adjustment of the sensitivity of the system [0081] and further teaches the ablating device to be turned “down” in order to prevent or mitigate burning in the esophageal tissue. Therefore, teaching adjusting a variable parameter (temperature) when the threshold is too high that it would burn the tissue [0080]. Further, Shadduck teaches maintaining the second parameter within a parameter range ([17] The controller 60 thus can be programmed to control temperature and Rf power such that a certain particular temperature is never exceeded at a targeted treatment site. The operator further can set the desired temperature which can be maintained. The controller 60 has a timing feature further providing the operator with the capability of maintaining a particular temperature at an electrode site for a particular length of time. A power delivery profile may be incorporated into controller 60 as well as a pre-set for delivering a particular amount of energy. A feedback system or feedback circuitry can be operatively connected to the impedance measuring system, and/or the temperature sensing system or other indicators and to the controller 60 to modulate energy delivery at Rf source 40) ([26] the controller 60 will sense temperatures along the tissue-electrode interface by means of the sensor array and/or impedance monitoring system and maintain temperature at the tissue surface 104 at a level below that which ablate the surface, generally by lowering the current intensity or making the energy delivery intermittent).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
4. Claim(s) 1, 2, 5-7, 11-12, 15-17, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abi-Jaoudeh (US 20150150466 A1) in view of Silwa (US 20160228175 A1), further in view of Shadduck (US 6740082 B2).
Regarding claim 1, Abi-Jaoudeh teaches a surgical system, comprising: a surgical device configured to engage a targeted tissue within an inner wall of a body lumen ([0018] An interventional device 124 such as an ablation device is shown supported by the device support 118); an imaging device configured to have a view of an outer wall of the body lumen ([0016] The radiation source 108/detector array 110 can be used to acquire cone beam CT, fluoroscopy, and/or other image data) while having an obstructed view of the surgical device by the outer wall of the body lumen (Fig 1; [0016] The radiation source 108/detector array 110 can be used to acquire cone beam CT, fluoroscopy, and/or other image data) (imaging system is outside the target body lumen) ([0015] FIG. 1 schematically illustrates an imaging system 100. For sake of brevity and clarity, the following discusses the approach in connection with a C-arm CT scanner. However, the imaging system 100 can alternatively be a convention CT scanner or x-ray imager. The scanner includes stationary portion 102, which can be mounted to a ceiling, wall, floor, generally stationary device in an examination room, a portable device with wheels or the like which can be readily transported into and out of the examination room), and a controller operatively coupled to the surgical device and the imaging device ([0017] A console 119 controls the imaging system 100, including pivoting the C-arm 104 to a particular angular orientation with respect to the examination region 112, activating the source 108 to emit radiation, activating the detector array 110 to detect radiation, and receiving and/or conveying information with another device) ([0018] An interventional device 124 such as an ablation device is shown supported by the device support 118. An interventional device controller 126 controls the interventional device 124, for example, turning the device on and off. In the illustrated embodiment, the interventional device controller 126 includes hand activated controls, such as a joy stick or the like, that affix to the subject support 114 and control the interventional device 124); wherein the controller is configured to: obtain, from the imaging device, image data captured from the outer wall of the body lumen ([0019] A computing apparatus or device 128 processes imaging data, such as imaging data generated by the imaging system 100 and/or one or more other imaging systems) ([0014] The following describes an approach for generating and presenting a thermal map for a volume or region of interest in an object or subject for a needle based interventional procedure, such as RF, laser, microwave, HIFU, etc. ablation and/or pharmaceutical delivery, based on baseline and intermittent CT data, such as cone beam CT and/or conventional CT data, and/or x-ray or fluoroscopy data); generate, based on the image data, an image of the inner wall of the body lumen and the targeted tissue within the inner wall of the body lumen ([0019] the thermal map allows for real-time temperature monitoring while compensating for motion and indicates heat distribution of tissue being treated) ([0022] the computing apparatus 128 includes an interventional device identifier 130, a volume or region of interest identifier 132, an image registration component 134 and registration algorithm(s) 136, a thermometry image generator 138 and difference algorithm(s) 140, and a thermal map generator 142); determine based on the image of the inner wall of the body lumen and the targeted tissue ([0019] the thermal map allows for real-time temperature monitoring while compensating for motion and indicates heat distribution of tissue being treated) ([0022] the computing apparatus 128 includes an interventional device identifier 130, a volume or region of interest identifier 132, an image registration component 134 and registration algorithm(s) 136, a thermometry image generator 138 and difference algorithm(s) 140, and a thermal map generator 142) ([0043] second region 312), a first parameter associated with the inner wall of the body lumen ([0019] the thermal map allows for real-time temperature monitoring while compensating for motion and indicates heat distribution of tissue being treated) ([0022] the computing apparatus 128 includes an interventional device identifier 130, a volume or region of interest identifier 132, an image registration component 134 and registration algorithm(s) 136, a thermometry image generator 138 and difference algorithm(s) 140, and a thermal map generator 142) ([0043] second region 312) and a second parameter associated with the targeted tissue ([0038] The thermal map generator 142 generates a pixel-wise or voxel-wise thermal or temperature map (e.g., a stack of 2D images centered on the volume of interest) for a region or volume of interest based on the thermometry image) ([0043] first region 310 around the needle tip).
Abi-Jaoudeh fails to teach adjust a variable parameter of a control algorithm of the surgical device based on the first parameter and the second parameter, wherein the control algorithm, when executed, is configured to cause the surgical device to maintain the first parameter below a threshold value, and maintain the second parameter within a parameter range.
However, Silwa teaches adjusting a variable parameter of a control algorithm of the surgical device ([0081] the predetermined temperature/rate of change threshold may be adjustable so as to allow for the adjustment of the sensitivity of the system. In such an embodiment, the subsystem 14 may include a conventional user input device electrically coupled to, and configured for communication with, the processor 142 to allow for the adjustment of the threshold. Accordingly, in such an embodiment, the processor 142 may be preprogrammed with an initial threshold, and then reprogrammed to adjust the threshold, or may be programmable) ([0080] This information may be further communicated to the system controller 16, for example, or to ablation subsystem 12, which may then cause the ablating device 18 to be turned “off” or turned “down” in order to prevent or mitigate burning in the esophageal tissue, for example, or to take other corrective or mitigating actions) based on the first parameter and the second parameter, wherein the control algorithm, when executed, is configured to cause the surgical device to maintain the first parameter below a threshold value ([0080] The processor 142 is configured, at least in part, to compare the determined highest temperature or a too-rapid time rate of change measured surface temperature with a predetermined threshold temperature or rate of change, and to provide the practitioner performing the ablation procedure an audible and or visual warning if the measured highest temperature approaches or reaches the predetermined threshold (e.g., a temperature at or near the highest temperature at which burning or damage to the esophageal tissue is not expected to occur, or a predetermined rate of change threshold). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Abi-Jaoudeh to include adjust a variable parameter of a control algorithm of the surgical device based on the first parameter and the second parameter, wherein the control algorithm, when executed, is configured to cause the surgical device to maintain the first parameter below a threshold value. Doing so allows for the use of a surgical device on the inside of the cavity while ensuring temperature levels remain within a safe threshold value.
Further, Shadduck teaches maintaining the second parameter within a parameter range ([17] The controller 60 thus can be programmed to control temperature and Rf power such that a certain particular temperature is never exceeded at a targeted treatment site. The operator further can set the desired temperature which can be maintained. The controller 60 has a timing feature further providing the operator with the capability of maintaining a particular temperature at an electrode site for a particular length of time. A power delivery profile may be incorporated into controller 60 as well as a pre-set for delivering a particular amount of energy. A feedback system or feedback circuitry can be operatively connected to the impedance measuring system, and/or the temperature sensing system or other indicators and to the controller 60 to modulate energy delivery at Rf source 40) ([26] the controller 60 will sense temperatures along the tissue-electrode interface by means of the sensor array and/or impedance monitoring system and maintain temperature at the tissue surface 104 at a level below that which ablate the surface, generally by lowering the current intensity or making the energy delivery intermittent). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Abi-Jaoudeh to include maintaining the second parameter within a parameter range. Doing so allows for the use of a surgical device on the inside of the cavity while ensuring temperature levels remain within a safe range.
Regarding claim 2, Abi-Jaoudeh teaches the system of claim 1, but fails to fully teach wherein the variable parameter affects a movement of the surgical device, a power level of the surgical device, or voltage control of the surgical device. However, Silwa teaches wherein the variable parameter affects a movement of the surgical device, a power level of the surgical device, or voltage control of the surgical device ([0080] This information may be further communicated to the system controller 16, for example, or to ablation subsystem 12, which may then cause the ablating device 18 to be turned “off” or turned “down” in order to prevent or mitigate burning in the esophageal tissue, for example, or to take other corrective or mitigating actions). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Abi-Jaoudeh to include wherein the variable parameter affects a movement of the surgical device, a power level of the surgical device, or voltage control of the surgical device. Doing so decreases the risk of overheating of the tissue during ablation.
Regarding claim 5, Abi-Jaoudeh teaches the system of claim 1, but fails to fully teach wherein the controller is further configured to determine whether the first parameter satisfies the threshold value; and adjust the variable parameter further based on the determination of whether the first parameter satisfies the threshold value and based on the determination of whether the second parameter is within the parameter range.
However, Silwa teaches wherein the controller is further configured to determine whether the first parameter satisfies the threshold value ([0080] The processor 142 is configured, at least in part, to compare the determined highest temperature or a too-rapid time rate of change measured surface temperature with a predetermined threshold temperature or rate of change, and to provide the practitioner performing the ablation procedure an audible and or visual warning if the measured highest temperature approaches or reaches the predetermined threshold (e.g., a temperature at or near the highest temperature at which burning or damage to the esophageal tissue is not expected to occur, or a predetermined rate of change threshold)), and adjust the variable parameter further based on the determination of whether the first parameter satisfies the threshold value and based on the determination of whether the second parameter is within the parameter range ([0081] the predetermined temperature/rate of change threshold may be adjustable so as to allow for the adjustment of the sensitivity of the system. In such an embodiment, the subsystem 14 may include a conventional user input device electrically coupled to, and configured for communication with, the processor 142 to allow for the adjustment of the threshold. Accordingly, in such an embodiment, the processor 142 may be preprogrammed with an initial threshold, and then reprogrammed to adjust the threshold, or may be programmable) ([0080] This information may be further communicated to the system controller 16, for example, or to ablation subsystem 12, which may then cause the ablating device 18 to be turned “off” or turned “down” in order to prevent or mitigate burning in the esophageal tissue, for example, or to take other corrective or mitigating actions). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Abi-Jaoudeh to include wherein the controller is further configured to determine whether the first parameter satisfies the threshold value; and adjust the variable parameter further based on the determination of whether the first parameter satisfies the threshold value and based on the determination of whether the second parameter is within the parameter range. Doing so decreases the risk of overheating of the tissue during ablation by meeting thresholds and monitoring temperatures within safe ranges.
Abi-Jaoudeh and Silwa fail to teach determine whether the second parameter is within the parameter range. However, Shadduck teaches determine whether the second parameter is within the parameter range ([17] The controller 60 thus can be programmed to control temperature and Rf power such that a certain particular temperature is never exceeded at a targeted treatment site. The operator further can set the desired temperature which can be maintained. The controller 60 has a timing feature further providing the operator with the capability of maintaining a particular temperature at an electrode site for a particular length of time. A power delivery profile may be incorporated into controller 60 as well as a pre-set for delivering a particular amount of energy. A feedback system or feedback circuitry can be operatively connected to the impedance measuring system, and/or the temperature sensing system or other indicators and to the controller 60 to modulate energy delivery at Rf source 40) ([26] the controller 60 will sense temperatures along the tissue-electrode interface by means of the sensor array and/or impedance monitoring system and maintain temperature at the tissue surface 104 at a level below that which ablate the surface, generally by lowering the current intensity or making the energy delivery intermittent). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Abi-Jaoudeh to include maintaining the second parameter within a parameter range. Doing so allows for the use of a surgical device on the inside of the cavity while ensuring temperature levels remain within a safe range.
Regarding claim 6, Abi-Jaoudeh teaches the system of claim 1, is further configured to generate the image data while having the obstructed view of the surgical device by the outer wall of the tissue ([0019] A computing apparatus or device 128 processes imaging data, such as imaging data generated by the imaging system 100 and/or one or more other imaging systems) ([0014] The following describes an approach for generating and presenting a thermal map for a volume or region of interest in an object or subject for a needle based interventional procedure, such as RF, laser, microwave, HIFU, etc. ablation and/or pharmaceutical delivery, based on baseline and intermittent CT data, such as cone beam CT and/or conventional CT data, and/or x-ray or fluoroscopy data), and wherein the image data is associated with a visual representation of the inner wall of the tissue ([0019] the thermal map allows for real-time temperature monitoring while compensating for motion and indicates heat distribution of tissue being treated) ([0022] the computing apparatus 128 includes an interventional device identifier 130, a volume or region of interest identifier 132, an image registration component 134 and registration algorithm(s) 136, a thermometry image generator 138 and difference algorithm(s) 140, and a thermal map generator 142).
Regarding claim 7, Abi-Jaoudeh teaches the system of claim 1, wherein the first parameter indicates a temperature of the inner wall of the body lumen ([0019] the thermal map allows for real-time temperature monitoring while compensating for motion and indicates heat distribution of tissue being treated) ([0022] the computing apparatus 128 includes an interventional device identifier 130, a volume or region of interest identifier 132, an image registration component 134 and registration algorithm(s) 136, a thermometry image generator 138 and difference algorithm(s) 140, and a thermal map generator 142); wherein the second monitored parameter indicates includes a temperature of the targeted tissue within the inner wall of the body lumen tissue ([0038] The thermal map generator 142 generates a pixel-wise or voxel-wise thermal or temperature map (e.g., a stack of 2D images centered on the volume of interest) for a region or volume of interest based on the thermometry image) ([0043] first region 310 around the needle tip), but fails to fully teach and wherein the variable parameter affects calibration of an electrode of the surgical device that is configured to deliver energy to the inner wall of the tissue.
However, Silwa teaches wherein the variable parameter affects calibration of an electrode of the surgical device that is configured to deliver energy to the inner wall of the tissue ([0080] This information may be further communicated to the system controller 16, for example, or to ablation subsystem 12, which may then cause the ablating device 18 to be turned “off” or turned “down” in order to prevent or mitigate burning in the esophageal tissue, for example, or to take other corrective or mitigating actions) ([0081] the predetermined temperature/rate of change threshold may be adjustable so as to allow for the adjustment of the sensitivity of the system. In such an embodiment, the subsystem 14 may include a conventional user input device electrically coupled to, and configured for communication with, the processor 142 to allow for the adjustment of the threshold. Accordingly, in such an embodiment, the processor 142 may be preprogrammed with an initial threshold, and then reprogrammed to adjust the threshold, or may be programmable). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Abi-Jaoudeh to include the variable parameter affects calibration of an electrode of the surgical device that is configured to deliver energy to the inner wall of the tissue. Doing so decreases the risk of overheating of the tissue during ablation.
Regarding claim 11, Abi-Jaoudeh teaches a surgical method, comprising: obtaining, from an imaging device, image data captured from an outer wall of a body lumen ([0015] FIG. 1 schematically illustrates an imaging system 100. For sake of brevity and clarity, the following discusses the approach in connection with a C-arm CT scanner. However, the imaging system 100 can alternatively be a convention CT scanner or x-ray imager. The scanner includes stationary portion 102, which can be mounted to a ceiling, wall, floor, generally stationary device in an examination room, a portable device with wheels or the like which can be readily transported into and out of the examination room) while the imaging device has an obstructed view of a surgical device by the outer wall of the body lumen ([0015] FIG. 1 schematically illustrates an imaging system 100. For sake of brevity and clarity, the following discusses the approach in connection with a C-arm CT scanner. However, the imaging system 100 can alternatively be a convention CT scanner or x-ray imager. The scanner includes stationary portion 102, which can be mounted to a ceiling, wall, floor, generally stationary device in an examination room, a portable device with wheels or the like which can be readily transported into and out of the examination room); generating an image of an inner wall of the body lumen and a targeted tissue within the inner wall of the body lumen tissue based on the image data ([0019] A computing apparatus or device 128 processes imaging data, such as imaging data generated by the imaging system 100 and/or one or more other imaging systems) ([0014] The following describes an approach for generating and presenting a thermal map for a volume or region of interest in an object or subject for a needle based interventional procedure, such as RF, laser, microwave, HIFU, etc. ablation and/or pharmaceutical delivery, based on baseline and intermittent CT data, such as cone beam CT and/or conventional CT data, and/or x-ray or fluoroscopy data); determining, based on the image of the inner wall of the body lumen and the targeted tissue within the inner wall of the body lumen ([0019] the thermal map allows for real-time temperature monitoring while compensating for motion and indicates heat distribution of tissue being treated) ([0022] the computing apparatus 128 includes an interventional device identifier 130, a volume or region of interest identifier 132, an image registration component 134 and registration algorithm(s) 136, a thermometry image generator 138 and difference algorithm(s) 140, and a thermal map generator 142) ([0043] second region 312); a first parameter associated with the inner wall of the body lumen ([0019] the thermal map allows for real-time temperature monitoring while compensating for motion and indicates heat distribution of tissue being treated) ([0022] the computing apparatus 128 includes an interventional device identifier 130, a volume or region of interest identifier 132, an image registration component 134 and registration algorithm(s) 136, a thermometry image generator 138 and difference algorithm(s) 140, and a thermal map generator 142) ([0043] second region 312) and a second parameter associated with the targeted tissue ([0038] The thermal map generator 142 generates a pixel-wise or voxel-wise thermal or temperature map (e.g., a stack of 2D images centered on the volume of interest) for a region or volume of interest based on the thermometry image) ([0043] first region 310 around the needle tip); thereby causing the surgical device to engage the inner wall of the body lumen ([0018] An interventional device 124 such as an ablation device is shown supported by the device support 118).
Abi-Jaoudeh fails to teach adjusting a variable parameter of a control algorithm of the surgical device based on the first parameter and the second parameter, executing the control algorithm based on the adjusted variable parameter; and causing the surgical device to maintain the first parameter below a threshold, and maintain the second parameter within a parameter range.
However, Silwa teaches adjusting a variable parameter of a control algorithm of the surgical device ([0081] the predetermined temperature/rate of change threshold may be adjustable so as to allow for the adjustment of the sensitivity of the system. In such an embodiment, the subsystem 14 may include a conventional user input device electrically coupled to, and configured for communication with, the processor 142 to allow for the adjustment of the threshold. Accordingly, in such an embodiment, the processor 142 may be preprogrammed with an initial threshold, and then reprogrammed to adjust the threshold, or may be programmable) ([0080] This information may be further communicated to the system controller 16, for example, or to ablation subsystem 12, which may then cause the ablating device 18 to be turned “off” or turned “down” in order to prevent or mitigate burning in the esophageal tissue, for example, or to take other corrective or mitigating actions) based on the first parameter and the second parameter, executing the control algorithm based on the adjusted variable parameter; and causing the surgical device to maintain the first parameter below a threshold ([0080] The processor 142 is configured, at least in part, to compare the determined highest temperature or a too-rapid time rate of change measured surface temperature with a predetermined threshold temperature or rate of change, and to provide the practitioner performing the ablation procedure an audible and or visual warning if the measured highest temperature approaches or reaches the predetermined threshold (e.g., a temperature at or near the highest temperature at which burning or damage to the esophageal tissue is not expected to occur, or a predetermined rate of change threshold). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Abi-Jaoudeh to include adjust a variable parameter of a control algorithm of the surgical device based on the first parameter and the second parameter, wherein the control algorithm, when executed, is configured to cause the surgical device to maintain the first parameter below a threshold value. Doing so allows for the use of a surgical device on the inside of the cavity while ensuring temperature levels remain within a safe threshold value.
Further, Shadduck teaches maintaining the second parameter within a parameter range based on the executed control algorithm ([17] The controller 60 thus can be programmed to control temperature and Rf power such that a certain particular temperature is never exceeded at a targeted treatment site. The operator further can set the desired temperature which can be maintained. The controller 60 has a timing feature further providing the operator with the capability of maintaining a particular temperature at an electrode site for a particular length of time. A power delivery profile may be incorporated into controller 60 as well as a pre-set for delivering a particular amount of energy. A feedback system or feedback circuitry can be operatively connected to the impedance measuring system, and/or the temperature sensing system or other indicators and to the controller 60 to modulate energy delivery at Rf source 40) ([26] the controller 60 will sense temperatures along the tissue-electrode interface by means of the sensor array and/or impedance monitoring system and maintain temperature at the tissue surface 104 at a level below that which ablate the surface, generally by lowering the current intensity or making the energy delivery intermittent). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Abi-Jaoudeh to include maintaining the second parameter within a parameter range. Doing so allows for the use of a surgical device on the inside of the cavity while ensuring temperature levels remain within a safe range.
Regarding claim 12, Abi-Jaoudeh teaches the method of claim 11, but fails to fully teach wherein the variable parameter affects a movement of the surgical device, a power level of the surgical device, or voltage control of the surgical device. However, Silwa teaches wherein the variable parameter affects a movement of the surgical device, a power level of the surgical device, or voltage control of the surgical device ([0080] This information may be further communicated to the system controller 16, for example, or to ablation subsystem 12, which may then cause the ablating device 18 to be turned “off” or turned “down” in order to prevent or mitigate burning in the esophageal tissue, for example, or to take other corrective or mitigating actions). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Abi-Jaoudeh to include wherein the variable parameter affects a movement of the surgical device, a power level of the surgical device, or voltage control of the surgical device. Doing so decreases the risk of overheating of the tissue during ablation.
Regarding claim 15, Abi-Jaoudeh teaches the method of claim 11, but fails to fully teach wherein the controller is further configured to determine whether the first parameter satisfies the threshold value; and adjust the variable parameter further based on the determination of whether the first parameter satisfies the threshold value and based on the determination of whether the second parameter is within the parameter range.
However, Silwa teaches wherein the controller is further configured to determine whether the first parameter satisfies the threshold value ([0080] The processor 142 is configured, at least in part, to compare the determined highest temperature or a too-rapid time rate of change measured surface temperature with a predetermined threshold temperature or rate of change, and to provide the practitioner performing the ablation procedure an audible and or visual warning if the measured highest temperature approaches or reaches the predetermined threshold (e.g., a temperature at or near the highest temperature at which burning or damage to the esophageal tissue is not expected to occur, or a predetermined rate of change threshold)), and adjust the variable parameter further based on the determination of whether the first parameter satisfies the threshold value and based on the determination of whether the second parameter is within the parameter range ([0081] the predetermined temperature/rate of change threshold may be adjustable so as to allow for the adjustment of the sensitivity of the system. In such an embodiment, the subsystem 14 may include a conventional user input device electrically coupled to, and configured for communication with, the processor 142 to allow for the adjustment of the threshold. Accordingly, in such an embodiment, the processor 142 may be preprogrammed with an initial threshold, and then reprogrammed to adjust the threshold, or may be programmable) ([0080] This information may be further communicated to the system controller 16, for example, or to ablation subsystem 12, which may then cause the ablating device 18 to be turned “off” or turned “down” in order to prevent or mitigate burning in the esophageal tissue, for example, or to take other corrective or mitigating actions). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Abi-Jaoudeh to include wherein the controller is further configured to determine whether the first parameter satisfies the threshold value; and adjust the variable parameter further based on the determination of whether the first parameter satisfies the threshold value and based on the determination of whether the second parameter is within the parameter range. Doing so decreases the risk of overheating of the tissue during ablation.
Abi-Jaoudeh and Silwa fail to teach determine whether the second parameter is within the parameter range. However, Shadduck teaches determine whether the second parameter is within the parameter range ([17] The controller 60 thus can be programmed to control temperature and Rf power such that a certain particular temperature is never exceeded at a targeted treatment site. The operator further can set the desired temperature which can be maintained. The controller 60 has a timing feature further providing the operator with the capability of maintaining a particular temperature at an electrode site for a particular length of time. A power delivery profile may be incorporated into controller 60 as well as a pre-set for delivering a particular amount of energy. A feedback system or feedback circuitry can be operatively connected to the impedance measuring system, and/or the temperature sensing system or other indicators and to the controller 60 to modulate energy delivery at Rf source 40) ([26] the controller 60 will sense temperatures along the tissue-electrode interface by means of the sensor array and/or impedance monitoring system and maintain temperature at the tissue surface 104 at a level below that which ablate the surface, generally by lowering the current intensity or making the energy delivery intermittent). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Abi-Jaoudeh to include maintaining the second parameter within a parameter range. Doing so allows for the use of a surgical device on the inside of the cavity while ensuring temperature levels remain within a safe range.
Regarding claim 16, Abi-Jaoudeh teaches the method of claim 11, wherein the method further comprises: generating the image data while having the obstructed view of the surgical device by the outer wall of the body lumen ([0019] A computing apparatus or device 128 processes imaging data, such as imaging data generated by the imaging system 100 and/or one or more other imaging systems) ([0014] The following describes an approach for generating and presenting a thermal map for a volume or region of interest in an object or subject for a needle based interventional procedure, such as RF, laser, microwave, HIFU, etc. ablation and/or pharmaceutical delivery, based on baseline and intermittent CT data, such as cone beam CT and/or conventional CT data, and/or x-ray or fluoroscopy data), and wherein the image data is associated with a visual representation of the inner wall of the body lumen ([0019] the thermal map allows for real-time temperature monitoring while compensating for motion and indicates heat distribution of tissue being treated) ([0022] the computing apparatus 128 includes an interventional device identifier 130, a volume or region of interest identifier 132, an image registration component 134 and registration algorithm(s) 136, a thermometry image generator 138 and difference algorithm(s) 140, and a thermal map generator 142).
Regarding claim 17, Abi-Jaoudeh teaches the method of claim 11, wherein the first parameter indicates a temperature of the inner wall of the body lumen ([0019] the thermal map allows for real-time temperature monitoring while compensating for motion and indicates heat distribution of tissue being treated) ([0022] the computing apparatus 128 includes an interventional device identifier 130, a volume or region of interest identifier 132, an image registration component 134 and registration algorithm(s) 136, a thermometry image generator 138 and difference algorithm(s) 140, and a thermal map generator 142); wherein the second monitored parameter indicates includes a temperature of the targeted tissue within the inner wall of the body lumen ([0038] The thermal map generator 142 generates a pixel-wise or voxel-wise thermal or temperature map (e.g., a stack of 2D images centered on the volume of interest) for a region or volume of interest based on the thermometry image) ([0043] first region 310 around the needle tip), but fails to fully teach and wherein the variable parameter affects calibration of an electrode of the surgical device that is configured to deliver energy to the inner wall of the tissue.
However, Silwa teaches wherein the variable parameter affects calibration of an electrode of the surgical device that is configured to deliver energy to the inner wall of the tissue ([0080] This information may be further communicated to the system controller 16, for example, or to ablation subsystem 12, which may then cause the ablating device 18 to be turned “off” or turned “down” in order to prevent or mitigate burning in the esophageal tissue, for example, or to take other corrective or mitigating actions) ([0081] the predetermined temperature/rate of change threshold may be adjustable so as to allow for the adjustment of the sensitivity of the system. In such an embodiment, the subsystem 14 may include a conventional user input device electrically coupled to, and configured for communication with, the processor 142 to allow for the adjustment of the threshold. Accordingly, in such an embodiment, the processor 142 may be preprogrammed with an initial threshold, and then reprogrammed to adjust the threshold, or may be programmable). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Abi-Jaoudeh to include wherein the variable parameter affects calibration of an electrode of the surgical device that is configured to deliver energy to the inner wall of the tissue. Doing so decreases the risk of overheating of the tissue during ablation.
Regrading claim 24, Abi-Jaoudeh teaches the system of claim 9, wherein the inner wall of the body lumen includes an inner wall of a lung ([0038] The thermal map generator 142 generates a pixel-wise or voxel-wise thermal or temperature map (e.g., a stack of 2D images centered on the volume of interest) for a region or volume of interest based on the thermometry image), wherein the targeted tissue within the inner wall of the body lumen includes a tumor located within the lung ([0018] An interventional device 124 such as an ablation device is shown supported by the device support 118), wherein the surgical device includes an ablation device configured to apply energy to the tumor ([0018] An interventional device 124 such as an ablation device is shown supported by the device support 118), and wherein the obstructed view is based on the surgical device being positioned inside the lung (Fig 1; [0016] The radiation source 108/detector array 110 can be used to acquire cone beam CT, fluoroscopy, and/or other image data) (imaging system is outside the target body lumen) ([0015] FIG. 1 schematically illustrates an imaging system 100. For sake of brevity and clarity, the following discusses the approach in connection with a C-arm CT scanner. However, the imaging system 100 can alternatively be a convention CT scanner or x-ray imager. The scanner includes stationary portion 102, which can be mounted to a ceiling, wall, floor, generally stationary device in an examination room, a portable device with wheels or the like which can be readily transported into and out of the examination room) and the imaging device being positioned outside the lung ([0016] The radiation source 108/detector array 110 can be used to acquire cone beam CT, fluoroscopy, and/or other image data).
It would have been an obvious matter of design choice to one having ordinary skill in the art at the time the invention was made to use the device for ablation of a tumor in the lung, since applicant has not disclosed that ablation of a tumor in the lung solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with ablation in the region of interest, as ablation in the region of interest and ablation in the lung are equivalent in the art as taught by Abi-Jaoudeh.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abi-Jaoudeh (US 20150150466 A1) in view of Silwa (US 20160228175 A1), further in view of Shadduck (US 6740082 B2), in view of Yamamura (US 20160331473 A1), further in view of Rajagopalan (WO 2012099974 A2).
Regarding claim 8, Abi-Jaoudeh teaches the system of claim 1, wherein the inner wall of the body lumen includes a first portion ([0019] the thermal map allows for real-time temperature monitoring while compensating for motion and indicates heat distribution of tissue being treated) ([0022] the computing apparatus 128 includes an interventional device identifier 130, a volume or region of interest identifier 132, an image registration component 134 and registration algorithm(s) 136, a thermometry image generator 138 and difference algorithm(s) 140, and a thermal map generator 142) ([0043] second region 312), and the targeted tissue within the inner wall of the body lumen includes a second portion ([0038] The thermal map generator 142 generates a pixel-wise or voxel-wise thermal or temperature map (e.g., a stack of 2D images centered on the volume of interest) for a region or volume of interest based on the thermometry image) ([0043] first region 310 around the needle tip), wherein surgical device includes an ablation device ([0018] An interventional device 124 such as an ablation device is shown supported by the device support 118); and wherein the surgical device is further configured to apply energy from the ablation device to the duodenum ([0018] An interventional device 124 such as an ablation device is shown supported by the device support 118), wherein the obstructed view is based on the surgical device being positioned inside the duodenum and the imaging device being positioned outside the duodenum (Fig 1; [0016] The radiation source 108/detector array 110 can be used to acquire cone beam CT, fluoroscopy, and/or other image data) (imaging system is outside the target body lumen) ([0019] A computing apparatus or device 128 processes imaging data, such as imaging data generated by the imaging system 100 and/or one or more other imaging systems) ([0014] The following describes an approach for generating and presenting a thermal map for a volume or region of interest in an object or subject for a needle based interventional procedure, such as RF, laser, microwave, HIFU, etc. ablation and/or pharmaceutical delivery, based on baseline and intermittent CT data, such as cone beam CT and/or conventional CT data, and/or x-ray or fluoroscopy data).
Abi-Jaoudeh fails to fully teach wherein the tissue includes a duodenum; configured to apply energy to the second portion of the duodenum.
However, Yamamura teaches wherein the tissue includes a duodenum ([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) ([0052] Furthermore, the doctor inserts the endoscope 2 into the body cavity A); the surgical device includes an ablation device; the obstructed view (Fig 1; cavity A blocks view of surgical device 2) is based on the surgical device being positioned inside the duodenum (Fig 1; surgical device 2 inside cavity A) and the imaging device being positioned outside the duodenum (Fig 1; laparoscope 3 located on outside of treatment cavity A). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Abi-Jaoudeh to include wherein the tissue includes a duodenum; the surgical device includes an ablation device; the imaging device has the obstructed view of the surgical device based on the surgical device being positioned inside the duodenum and the imaging device being positioned outside the duodenum. Doing so allows for the use of an ablation device on the inside of the cavity while monitoring parameters from the outside of the cavity.
Further, Rajagopalan teaches wherein the tissue includes a duodenum ([018] target tissue may include tissue of the duodenum); configured to apply energy to the duodenum ([018] target tissue may include tissue of the duodenum). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Abi-Jaoudeh to include teaches wherein the tissue includes a duodenum; configured to apply energy to the duodenum. Doing so allows for the use of an ablation device on the inside of the cavity while monitoring parameters from the outside of the cavity.
Claim(s) 18, 21, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abi-Jaoudeh (US 20150150466 A1) in view of Silwa (US 20160228175 A1), further in view of Shadduck (US 6740082 B2), further in view of Rajagopalan (WO 2012099974 A2).
Regarding claim 18, Abi-Jaoudeh teaches a surgical method obtaining image data ([0019] A computing apparatus or device 128 processes imaging data, such as imaging data generated by the imaging system 100 and/or one or more other imaging systems) associated with a visual representation of an inner wall of a body lumen of a duodenum (Fig 6; side of probe 100) ([0077] the subsystem 14 further includes a temperature monitoring apparatus at least a portion of which is coupled, mounted, otherwise disposed within or on the probe 100 at or near the distal end thereof) ([0077] the temperature monitoring apparatus (e.g., the thermal imaging chip 136, for example) has a field of view 138 and is configured to generate an image or images of the tissue, such as, for example, esophageal tissue, disposed within the field of view 138), wherein the image data is captured from an imaging device having an obstructed view of an ablation device by an outer wall of th