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 12 are cancelled. A complete action on the merits of pending claims 1, 2, 4-10, and 13-23 appears herein.
Response to Arguments
Applicant’s arguments, see Remarks, filed 11/26/2025, with respect to the rejection(s) of claim(s) 1-12 under U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of van der Weide (hereinafter “van der Weide015”) (US 7,467,015 B2) in view of van der Weide (hereinafter “van der Weide257”) (US 2012/0209257 A1) in view of Brucker (US 6,458,123 B1), in view of Cosman (US 9,956,032 B1).
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, 5, 7-10, 13-20, 22, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over van der Weide (hereinafter “van der Weide015”) (US 7,467,015 B2) in view of van der Weide (hereinafter “van der Weide257”) (US 2012/0209257 A1) in view of Brucker (US 6,458,123 B1), in view of Cosman (US 9,956,032 B1).
Regarding claims 1, 16, and 18, van der Weide015 teaches
An energy delivery device, (Fig. 3) including:
a inner conductor (Fig. 3, Char. 16: inner conductor) energizable to emit ablative energy; (Fig. 1 and Col. 2, Lines 35-55)
wherein the energy delivery device is configured to generate ablative energy; (Fig. 1 and Col. 2, Lines 35-55)
van der Weide015, as applied to claims 1, 16, and 18 above, is silent regarding the inner conductor being hollow; a wire extending through the hollow inner conductor and terminating at a sensor arranged distally beyond a distal end of the hollow conductor; and a processor in operable communication with the sensor via the wire.
van der Weide257, in a similar field of endeavor, teaches an ablation device comprising a hollow inner conductor (Par. [0011]: inner conductor) and one or more sensors positioned within the ablation device; (Par. [0110]: the energy delivery devices have therein protection sensors) wherein the hollow inner conductor comprises a coolant channel therethrough; (Par. [0011]: the inner conductor may be provided as a hollow tube of conductive material, with a coolant channel provided in the center) wherein the one or more sensors are selected from the group consisting of a temperature sensor, a positioning sensor, and an imaging sensor; (Par. [0110]: The sensors can comprise a temperature sensor, skin contact sensor, and air contact sensor; The skin contact sensor and air contact sensor could be considered a “positioning” sensor at least in that they would detect if the energy delivery device positioned in contact with tissue.) and wherein the ablation device further comprises a processor in operable communication with the sensor; (Par. [0110])
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 Weide015, as applied to claim 1 above, to incorporate the teachings of van der Weide257, and include the protection sensors and processor of van der Weide257, and to configure the inner conductor (16) of van der Weide015 to include the coolant channel of van der Weide257. Including the protection sensors and processor of van der Weide257 would allow for minimize the risk of energy delivery outside of target/desired parameters and provide a means of clearly communicating various errors and statuses to a user, as suggested in van der Weide257. (Par. [0110]) Configuring the inner conductor (16) of van der Weide015 to include the coolant channel of van der Weide257 would allow for greater control over a temperature of the device, at least in that the temperature of the device can be easily lowered via circulation of coolant in the event that a temperature of the device rises above a threshold.
The combination of van der Weide015/van der Weide257, as applied to claims 1, 16, and 18 above, is silent regarding a wire extending through the hollow inner conductor and terminating at the sensor; wherein the sensor is arranged distally beyond a distal end of the hollow conductor; and wherein the processor is in operable communication with the sensor via the wire.
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 der Weide015/van der Weide257, as applied to claim 1 above, to incorporate the teachings of Brucker, and configure the protection sensors of van der Weide257 to be operably connected to the processor of van der Weide257 via respective wires extending from said protection sensors to said processor through the coolant channel in the inner electrode (16) of van der Weide015. Doing so would be a simple substitution of one wire/communication arrangement for another for the predictable result of facilitating communication between the protection sensors and the processor.
The combination of van der Weide015/van der Weide257, as applied to claims 1, 16, and 18 above, is silent regarding the sensor being arranged distally beyond a distal end of the hollow conductor.
Cosman, in a similar field of endeavor, comprises an electrosurgical system comprising a temperature sensor configured to translate distally relative to an electrode. (Fig. 6 and Col. 8, Lines 40-45)
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 Weide015/van der Weide257/Brucker, as applied to claim 1 above, to incorporate the teachings of Cosman, and configure the protection sensorsof van der Weide257 to be slidable relative to the hollow inner conductor of van der Weide015. Doing so would allow for the protection sensors to be placed in more positions and better reach a target treatment zone.
Regarding claim 2, the combination of van der Weide015/van der Weide257/Brucker/Cosman, as applied to claim 1 above, teaches the ablative energy is microwave energy. (van der Weide015: abstract)
Regarding claim 4, the combination of van der Weide015/van der Weide257/Brucker/Cosman, as applied to claim 1 above, teaches the sensor 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 Weide257: Par. [0110]: the temperature sensor is designed to measure the temperature of the energy delivery device or tissue contacting the energy delivery device – it is implicit that this feature be present in the Weide015/van der Weide257/Brucker/Cosman combination based on the rejection to claim 1 above.)
Regarding claims 5 and 22, the combination of van der Weide015/van der Weide257/Brucker/Cosman, as applied to claims 1 and 18 above respectively teaches, the sensor comprises a positioning sensor to sense a position of the energy delivery device. (van der Weide257: Par. [0110]: The sensors can comprise a temperature sensor, skin contact sensor, and air contact sensor; The skin contact sensor and air contact sensor could be considered a “positioning” sensor at least in that they would detect if the energy delivery device positioned in contact with tissue – it is implicit that this feature be present in the Weide015/van der Weide257/Brucker/Cosman combination based on the rejection to claims 1 and 18 above.)
Regarding claim 7, the combination of van der Weide015/van der Weide257/Brucker/Cosman, as applied to claim 1 above, teaches the energy delivery device has a linear shape. (van der Weide015: Fig. 3)
Regarding claims 8, 9, and 23 the van der Weide015/van der Weide257/Brucker/Cosman combination, as applied to claims 1 and 18 above, teaches an outer conductor arranged around the hollow inner conductor; (van der Weide015: Fig. 3, Char. 14: inner conductor) and a dielectric portion positioned between the outer conductor and the hollow inner conductor. (van der Weide015: Fig. 3, Char. 12: dielectric bridges; Col. 3, Lines 58-60)
Regarding claim 10, the van der Weide015/van der Weide257/Brucker/Cosman combination, as applied to claim 1 above, teaches at least a portion of the energy delivery device is flexible. (van der Weide257: Par. [0012]: The tube comprising the fluid channel is flexible – it is implicit that this feature be present in the van der Weide015/van der Weide257/Brucker/Cosman combination based on the rejection to claim 1 above.)
Regarding claim 13, the van der Weide015/van der Weide257/Brucker/Cosman combination, as applied to claim 1 above, teaches the ablative energy is radiofrequency energy. (van der Weide015: abstract)
Regarding claims 14 and 19, the van der Weide015/van der Weide257/Brucker/Cosman combination, as applied to claims 4 and 18 above respectively, teaches the sensor comprises a temperature sensor to sense a temperature. (van der Weide257: Par. [0110]: the temperature sensor is designed to measure the temperature of the energy delivery device or tissue contacting the energy delivery device – it is implicit that this feature be present in the Weide015/van der Weide257/Brucker/Cosman combination based on the rejection to claims 1, 16, and 18 above.)
The van der Weide015/van der Weide257/Brucker/Cosman combination, as applied to claims 4 and 18 above respectively, is silent regarding the processor being operable to adjust the ablative energy based on the sensed temperature.
van der Weide257 further teaches an embodiment in which a processor configured to receive information from a plurality of sensors, including temperature sensors, (Par. [0033]) and adjust energy delivery accordingly. (Par. [0159])
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 Weide015/van der Weide257/Brucker/Cosman, as applied to claim 4 above, to further incorporate the teachings of van der Weide257, and configure the processor of van der Weide257 to be operable to adjust the ablative energy based on the sensed temperature. Doing so would be a simple substitution of one data processing/power control component for another for the predictable result of controlling energy delivery based on sensed temperature data.
Regarding claims 15 and 17, the van der Weide015/van der Weide257/Brucker/Cosman combinations, as applied to claims 4 and 16 above respectively, teaches the sensor comprises a temperature sensor to sense a temperature; (van der Weide257: Par. [0110]: the temperature sensor is designed to measure the temperature of the energy delivery device or tissue contacting the energy delivery device – it is implicit that this feature be present in the van der Weide015/van der Weide257/Brucker/Cosman combination based on the rejection to claims 1, 16, and 18 above.) and a cooling system to provide coolant to the energy delivery device. (There would have to be some form of fluid source and/or a pump in order to deliver fluid through the coolant channel of van der Weide257 – it is implicit that this feature be present in the van der Weide015/van der Weide257/Brucker/Cosman combination based on the rejection to claims 1, 16, and 18 above.)
The van der Weide015/van der Weide257/Brucker/Cosman combinations, as applied to claims 4 and 16 above respectively, is silent regarding the processor being operable to provide coolant to the energy delivery device based on the sensed temperature.
van der Weide257 further teaches an embodiment in which a processor is configured to receive information from a plurality of sensors, including temperature sensors, (Par. [0033] and [0159]) and provide coolant to the energy delivery device based on the sensed temperature. (Par. [0127] and [0159])
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 Weide015/van der Weide257/Brucker/Cosman, as applied to claims 4 and 16 above respectively, to further incorporate the teachings of van der Weide257, and configure the processor of van der Weide257 to be operable to provide coolant to the energy delivery device based on the sensed temperature. Doing so would allow for automatic fluid delivery, providing better/more precise temperature control.
Claim(s) 6 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over van der Weide (hereinafter “van der Weide015”) (US 7,467,015 B2) in view of van der Weide (hereinafter “van der Weide257”) (US 2012/0209257 A1) in view of Brucker (US 6,458,123 B1), in view of Cosman (US 9,956,032 B1), as applied to claims 1 and 18 above, and further in view of Sliwa (US 2012/0265192 A1).
Regarding claims 6 and 21, the van der Weide015/van der Weide257/Brucker/Cosman, combination, as applied to claims 1 and 18 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 van der Weide015/van der Weide257/Brucker/Cosman, combination, as applied to claims 1 and 18 above, to incorporate the teachings of Sliwa, and include the display of Sliwa and configure the protection sensors of van der Weide257 to comprise the imaging sensor of Sliwa, such that the processor of van der Weide257 receives the imaging data from said imaging sensors and displays the imaging data on the display of Sliwa. Doing so 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS SHEA BORSCH whose telephone number is (571)272-5681. The examiner can normally be reached Monday-Thursday 7:30AM-5:30PM EST.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/N.S.B./Examiner, Art Unit 3794