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 .
Claims 3, 11, and 13 are cancelled. A complete action on the merits of pending claims 1, 2, 4-10, 12, and 14-23 appears herein.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/20/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 05/20/2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4, 14, and 15-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims can be seen as “signals per se” as the processor can be interpreted as not just a hardware component.
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, 2, 4, 7-10, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Van der Weide (US 2012/0209257 A1) in view of Panescu (US 6,053,912).
Regarding claims 1, Van der Weide teaches an energy delivery device, (Par. [0011]: energy delivery device) comprising:
a hollow inner conductor; (Par. [0011]: inner conductor; claim 23)
one or more sensors; (Par. [0110]: the energy delivery devices have therein protection sensors)
wherein the energy delivery device is configured to generate ablative energy in a defined ablative emission region radiating outward from a distal end portion of the hollow inner conductor, (Fig. 9 and 29)
Van der Weide, as applied to claim 1 above, further teaches a temperature sensor configured to measure a temperature of the target tissue. (Par. [0178])
Van der Weide, as applied to claim 1 above, is silent regarding the one or more sensors being positioned distally beyond a distal end of the hollow inner conductor; wherein an ablative emission protected region is defined beyond the distal end of the hollow inner conductor and interior to the defined ablative emission region, and wherein the one or more sensors are positioned within the ablative emission protected region such that an emission of ablative energy does not compromise sensor function.
Panescu, in a similar field of endeavor, teaches a sensor positioned distally beyond a distal end of an ablation catheter; (Fig. 14, Char. 112: temperature sensing element) wherein an ablative emission protected region is defined beyond the distal end of the ablation catheter and interior to an ablative emission region, (Fig. 13 and 14, and Col. 16, Lines 5-15: The region within cap (120) can be translated distally past the distal end of the catheter and into the portion of tissue being treated with ablative energy) and wherein the one or more sensors are positioned within the ablative emission protected region such that an emission of ablative energy does not compromise sensor function. (Fig. 14; Col. 15, Lines 14-17; and Col. 16, Lines 5-15: Temperature sensing element (112) is electrically insulated from the ablative energy being delivered to the target tissue.)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Van der Weide, as applied to claim 1 above, to incorporate the teachings of Panescu, and include the temperature sensing structure of at least the cap (120) and temperature sensing element (112) of Panescu in place of the temperature sensor of Van der Weide, such that cap (120) and element (112) of Panescu are configured to translate distally past a distal end of the device of Van der Weide, be placed into contact with the tissue being treated in the ablative emission region of Van der Weide, and measure the temperature of said tissue. Doing so would be a simple substitution of one temperature sensing component for another for the predictable result of determining a target tissue temperature, and would minimize any interference between the temperature sensor and the applied ablative energy, as suggested in Panescu. (Col. 16, Lines 5-15)
Regarding claim 2, the combination of Van der Weide/Panescu, as applied to claim 1 above, teaches the ablative energy is microwave energy. (Van der Weide: Par. [0026])
Regarding claim 4, the combination of Van der Weide/Panescu, as applied to claim 1 above, teaches the one or more sensors comprises a temperature sensor to sense a temperature of the energy delivery device or a tissue contacting the energy delivery device or a combination thereof. (Van der Weide: Par. [0178])
Regarding claim 7, the combination of Van der Weide/Panescu, as applied to claim 1 above, teaches the energy delivery device has a linear shape. (Van der Weide: Fig. 9)
Regarding claims 8 and 9, the combination of Van der Weide/Panescu, as applied to claim 1 above, teaches an outer conductor arranged around the hollow inner conductor; (Van der Weide: Par. [0011]: outer conductor) and a dielectric portion positioned between the outer conductor and the hollow inner conductor. (Van der Weide: Par. [0011]: a dielectric component located between the inner and outer conductors.)
Regarding claim 10, the combination of Van der Weide/Panescu, as applied to claim 1 above, teaches at least a portion of the energy delivery device is flexible. (Van der Weide: Par. [0012]: The tube comprising the fluid channel is flexible)
Regarding claim 13, the combination of Van der Weide/Panescu, as applied to claim 1 above, teaches the ablative energy is radiofrequency energy. (Van der Weide: Par. [0021]: the energy is microwave and/or RF energy)
Regarding claim 14, the combination of Van der Weide/Panescu, as applied to claim 4 above, teaches the processor is associated with the energy delivery device and is operable to adjust the ablative energy based on the sensed temperature. (Van der Weide: Par. [0159]: The processors of the energy delivery systems monitor, control, and provide feedback including regulating energy provided to the target tissue via monitoring the tissue temperature.)
Regarding claim 15, the combination of Van der Weide/Panescu, as applied to claim 4 above, teaches the processor is associated with the energy delivery device and is provide coolant to the energy delivery device based on the sensed temperature. (Van der Weide: Par. [0159]: The processors of the energy delivery systems monitor, control, and provide feedback including regulating energy provided to the target tissue via monitoring the tissue temperature and a device temperature; Par. [0127]: Coolant delivery is controlled at least partially in response to a measured device temperature; The temperature of the device and the tissue would be the same at the point of contact between said deice and tissue.)
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van der Weide (US 2012/0209257 A1) in view of Panescu (US 6,053,912) as applied to claim 1 above, and further in view of Schiff (US 2005/0065584 A1).
Regarding claim 5, the combination of Van der Weide/Panescu, as applied to claim 1 above, is silent regarding the one or more sensors comprising a positioning sensor to sense a position of the energy delivery device.
Schiff, in a similar field of endeavor, teaches using a plurality of temperature sensors to determine a degree of contact between a device and a target tissue. (Par. [0040])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Van der Weise/Panescu, as applied to claim 1 above, to incorporate the teachings of Schiff, and configure the device of Van der Weise to comprise a plurality of the cap (120) and temperature sensing element (112) structures of Panescu, such that contact with a target tissue is determined based on the measurements from said sensing elements (112). Doing so would allow a user to determine if the device is contacting tissue or not, thereby minimizing the risk of delivering ablative energy without proper tissue contact levels.
In this combination, the temperature sensors would be considered a “positioning” sensor at least in that they would detect if the energy delivery device is positioned in contact with tissue.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van der Weide (US 2012/0209257 A1) in view of Panescu (US 6,053,912) as applied to claim 1 above, and further in view of Sliwa (US 2012/0265192 A1).
Regarding claim 6, the combination of Van der Weide/Panescu, as applied to claims 1 above, is silent regarding the sensor comprises an imaging sensor to image the energy delivery device and/or tissue contacting the energy delivery device or a combination thereof; a display operably connected to the processor; and wherein the processor is operable to display the image on the display.
Sliwa, in a similar field of endeavor, teaches an electrosurgical device comprising an image sensor configured to image the energy delivery device and/or tissue contacting the energy delivery device or a combination thereof; (Par. [0070]) a display configured to display images captured by the image sensor (Par. [0087]) operably connected to a control subsystem such that the control subsystem is operable to display the image on the display. (Par. [0087])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Van der Weide/Panescu, as applied to claim 1, to incorporate the teachings of Sliwa, and include the display of Sliwa and configure the protection sensors of van der Weide to comprise the imaging sensor of Sliwa, such that the processor of van der Weide receives the imaging data from said imaging sensors and displays the imaging data on the display of Sliwa. Doing so would allow a user to easily view the device’s surroundings and would increase the types of measurements that can be taken, thereby increasing the amount of information that would be available to the user and providing said user with a better situational awareness within the target treatment zone.
Claim(s) 16-20 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van der Weide (US 2012/0209257 A1) in view of Panescu (US 6,053,912) in view of Brucker (US 6,458,123 B1).
Regarding claims 16 and 18, Van der Weide teaches a system, (Fig. 1) comprising:
an energy delivery device, (Par. [0011]: energy delivery device) including:
a hollow inner conductor (Par. [0011]: inner conductor; claim 23) energizable to emit ablative energy in a defined ablative emission region radiating outward from a distal end portion of the hollow inner conductor, (Fig. 9 and 29)
one or more sensors (Par. [0110]: the energy delivery devices have therein protection sensors)
a processor in communication with the one or more sensors. (Par. [0110]: processor; The sensors communicate with the processor)
Van der Weide, as applied to claim 1 above, further teaches a temperature sensor configured to measure a temperature of the target tissue. (Par. [0178])
Van der Weide, as applied to claims 16 and 18 above, is silent regarding an ablative emission protected region is defined beyond the distal end of the hollow inner conductor and interior to the defined ablative emission region; the one or more sensors are positioned distally beyond a distal end of the hollow inner conductor within the ablative emission protected region such that an emission of ablative energy does not compromise sensor function; and a wire extending proximally from each of the one or more sensors through the hollow inner conductor; and wherein the communication between the one or more sensors and the processor occurs via each of the wires.
Panescu, in a similar field of endeavor, teaches a sensor positioned distally beyond a distal end of an ablation catheter; (Fig. 14, Char. 112: temperature sensing element) a processor in communication with the sensor via at least one wire extending proximally from the sensor; (Fig. 13-14; Col. 15, Lines 40-45: Lead wires (114) communicate temperature signals from temperature sensing element (112) to a generator that would have a processor or control unit configured to process/use said temperature signals.) wherein an ablative emission protected region is defined beyond the distal end of the ablation catheter and interior to an ablative emission region, (Fig. 13 and 14, and Col. 16, Lines 5-15: The region within cap (120) can be translated distally past the distal end of the catheter and into the portion of tissue being treated with ablative energy) and wherein the one or more sensors are positioned within the ablative emission protected region such that an emission of ablative energy does not compromise sensor function. (Fig. 14; Col. 15, Lines 14-17; and Col. 16, Lines 5-15: Temperature sensing element (112) is electrically insulated from the ablative energy being delivered to the target tissue.)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Van der Weide, as applied to claims 16 and 18 above, to incorporate the teachings of Panescu, and include the temperature sensing structure of at least the cap (120), temperature sensing element (112), and lead wires (114) of Panescu in place of the temperature sensor of Van der Weide, such that cap (120) and element (112) of Panescu are configured to translate distally past a distal end of the device of Van der Weide, be placed into contact with the tissue being treated in the ablative emission region of Van der Weide, and measure the temperature of said tissue; and to couple the temperature sensing elements (112) to the processor of Van der Weide via the lead wires (114) of Panescu. Doing so would be a simple substitution of one temperature sensing component for another for the predictable result of determining a target tissue temperature, and would minimize any interference between the temperature sensor and the applied ablative energy, as suggested in Panescu. (Col. 16, Lines 5-15)
The combination of Van der Weide/Panescu, as applied to claims 16 and 18 above, is silent regarding Van der Weide, as applied to claims 16 and 18 above, is silent regarding the wire(s) extending through the hollow inner conductor.
Brucker, in a similar field of endeavor, teaches an electrosurgical device comprising a fluid channel; (Fig. 5) wherein wires of a position sensor are disposed in said fluid channel. (Col. 3, Lines 58-63)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of van Van der Weide/Panescu, as applied to claims 16 and 18 above, to incorporate the teachings of Brucker, and configure the lead wires (114) of Panescu to extend through the coolant channel in the inner conductor of Van der Weide. Doing so would be a simple rearrangement of parts. It has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 17, the combination of Van der Weide/Panescu/Brucker, as applied to claim 16 above, teaches the one or more sensors comprise a temperature sensor to sense a temperature, (Van der Weide: Par. [0178]) and wherein the processor is associated with the energy delivery device and is provide coolant to the energy delivery device based on the sensed temperature. (Van der Weide: Par. [0159]: The processors of the energy delivery systems monitor, control, and provide feedback including regulating energy provided to the target tissue via monitoring the tissue temperature and a device temperature; Par. [0127]: Coolant delivery is controlled at least partially in response to a measured device temperature; The temperature of the device and the tissue would be the same at the point of contact between said deice and tissue.)
Regarding claim 19, the combination of Van der Weide/Panescu/Brucker, as applied to claim 18 above, teaches the one or more sensors comprise a temperature sensor to sense a temperature, (Van der Weide: Par. [0178]) and wherein the processor is associated with the energy delivery device and is operable to adjust the ablative energy based on the sensed temperature. (Van der Weide: Par. [0159]: The processors of the energy delivery systems monitor, control, and provide feedback including regulating energy provided to the target tissue via monitoring the tissue temperature.)
Regarding claim 20, the combination of Van der Weide/Panescu/Brucker, as applied to claim 18 above, teaches the one or more sensors comprise a temperature sensor to sense a temperature; (Van der Weide: Par. [0178]) the system further comprising: a cooling system to provide coolant to the energy delivery device, and wherein the processor is operable to provide the coolant to the energy delivery device based on the sensed temperature. (Van der Weide: Par. [0159]: The processors of the energy delivery systems monitor, control, and provide feedback including regulating energy provided to the target tissue via monitoring the tissue temperature and a device temperature; Par. [0127]: Coolant delivery is controlled at least partially in response to a measured device temperature; The temperature of the device and the tissue would be the same at the point of contact between said deice and tissue.)
Regarding claim 23, the combination of Van der Weide/Panescu/Brucker, as applied to claim 18 above, teaches the energy delivery device further includes: an outer conductor arranged around the hollow inner conductor; (Van der Weide: Par. [0011]: outer conductor) and a dialectic interposing the outer conductor and the hollow inner conductor. (Van der Weide: Par. [0011]: a dielectric component located between the inner and outer conductors.)
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van der Weide (US 2012/0209257 A1) in view of Panescu (US 6,053,912) in view of Brucker (US 6,458,123 B1), as applied to claim 18 above, and further in view of Sliwa (US 2012/0265192 A1).
Regarding claim 21, the combination of Van der Weide/Panescu/Brucker, as applied to claims 18 above, is silent regarding the sensor comprises an imaging sensor to capture an image, and the system further comprises a display and wherein the processor is operable to display the image on the display.
Sliwa, in a similar field of endeavor, teaches an electrosurgical device comprising an image sensor configured to image the energy delivery device and/or tissue contacting the energy delivery device or a combination thereof; (Par. [0070]) a display configured to display images captured by the image sensor (Par. [0087]) operably connected to a control subsystem such that the control subsystem is operable to display the image on the display. (Par. [0087])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Van der Weide/Panescu/Brucker, as applied to claim 1, to incorporate the teachings of Sliwa, and include the display of Sliwa and include the image sensors of Sliwa in a cap (120) of Panescu, such that the processor of van der Weide receives the imaging data from said imaging sensors and displays the imaging data on the display of Sliwa. Doing so would allow a user to easily view the device’s surroundings and would increase the types of measurements that can be taken, thereby increasing the amount of information that would be available to the user and providing said user with a better situational awareness within the target treatment zone.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van der Weide (US 2012/0209257 A1) in view of Panescu (US 6,053,912) in view of Brucker (US 6,458,123 B1), as applied to claim 18 above, and further in view of Schiff (US 2005/0065584 A1).
Regarding claim 22, the combination of Van der Weide/Panescu/Brucker, as applied to claim 18 above, is silent regarding the one or more sensors comprising a positioning sensor.
Schiff, in a similar field of endeavor, teaches using a plurality of temperature sensors to determine a degree of contact between a device and a target tissue. (Par. [0040])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Van der Weise/Panescu/Brucker, as applied to claim 1 above, to incorporate the teachings of Schiff, and configure the device of Van der Weise to comprise a plurality of the cap (120) and temperature sensing element (112) structures of Panescu, such that contact with a target tissue is determined based on the measurements from said sensing elements (112). Doing so would allow a user to determine if the device is contacting tissue or not, thereby minimizing the risk of delivering ablative energy without proper tissue contact levels.
In this combination, the temperature sensors would be considered a “positioning” sensor at least in that they would detect if the energy delivery device is positioned in contact with tissue.
Conclusion
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/N.S.B./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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