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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 13th, 2026 has been entered.
Response to Amendment
The amendment filed January 13th, 2026 has been entered. Applicant’s amendments to the claims have not overcome the 112(a) rejection previously set forth in the Final Action mailed November 18th, 2025.
Response to Arguments
Applicant’s arguments, see pages 11-12, filed January 13th, 2026, with respect to claim 40 have been fully considered and are persuasive. The rejection of 40 under 35 U.S.C. 112(a) has been withdrawn.
Applicant's arguments filed January 13th, 2026 directed towards the prior art rejections have been fully considered but they are not persuasive.
Regarding Applicant’s arguments on pages 12-14 that Norton does not disclose, teach, or suggest that the thermocouple is configured to directly contact tissue and measure a temperature of tissue, the Examiner respectfully disagrees on the grounds that Norton does teach this, as detailed in [0095] cited in the new grounds of rejection: “the insulation 244 may surround the elongated shaft 206 such that the insulation 244 remains flush with the active electrode 142, with the proximal thermocouple 228B embedded in a portion of the insulation 244” and as shown in Figs. 12B-C, wherein the description of the thermocouple 228B being embedded and the thermocouple 228B being shown as exposed on a surface of the shaft in Figs. 2B-C is seen as the thermocouple being on a surface of the device such that in use, it is in direct contact with a tissue. Additionally, as cited in the original rejection, [0087] describes: “a proximal thermocouple can obtain a more accurate temperature measurement of the return electrode 146 and/or the proximal lesion being formed during the RF ablation”.
Additionally, in response to Applicant’s arguments on page 14 that Norton teaches away from the proximal thermocouple contacting tissue, the Examiner respectfully disagrees on the same grounds as recited in the previous office action, that Norton directly discloses the proximal thermocouple sensing a temperature of a tissue in paragraph [0087]: “a proximal thermocouple can obtain a more accurate temperature measurement of the return electrode 146 and/or the proximal lesion being formed during the RF ablation”. While the Examiner agrees that the Norton disclosure describes the possibility of wrapping insulation 244 around the thermocouple in [0095], however, this describing a possible embodiment and it is not shown in the Figs. 2B-C, particularly in Fig. 2C where the thermocouple is shown on the surface of the shaft 206.
Applicant argues that the additional references relied upon fail to remedy the deficiencies of those used for independent claim 1, the Examiner respectfully disagrees on the grounds laid out above for independent claim 1, in which the rejection for claim 1 is also maintained and therefore the rejection for all dependent claims are also maintained.
Therefore, these arguments are not persuasive and the Examiner maintains that Norton discloses both the original and amended claims’ limitations and the following new grounds of rejection are set forth:
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7 & 29-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the limitation “the temperature of specific regions of the elongate tubular body exterior region” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation “the temperature of the elongate tubular body exterior region” in lines 14-15. There is insufficient antecedent basis for this limitation in the claim.
Claim 30 recites the limitation “the temperature of the elongate tubular body exterior region” in lines 14-15. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitation “the temperature of the elongate tubular body exterior region” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites the limitation “the temperature of the elongate tubular body exterior region” in lines 14-15. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites the limitation “the temperature of the elongate tubular body exterior region” in lines 20-21. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites the limitation “the temperature of the elongate tubular body exterior region” in lines 33-34. There is insufficient antecedent basis for this limitation in the claim.
Claim 33 recites the limitation “the temperature of the tissue region” in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claim 33 recites the limitation “the temperature of the elongate tubular body exterior region” in lines 12-13. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 7, 27-33 & 39 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Norton (U.S. Pub. No. 20230255677, earliest effective filing date & previously cited), herein referred to as “Norton”.
Regarding claim 1, Norton teaches a device (Abstract: A surgical tool) comprising
an elongate tubular body (elongated shaft 206) having an elongate tubular body interior region (interior of elongated shaft 206; see [0084] where tool 138 is described to house many components within 206), elongate tubular body exterior region (exterior surface of elongated shaft 206), an elongate tubular body proximal end (proximal end 204), and elongate tubular body distal end (distal end 208);
wherein the elongate tubular body defines an elongate tubular body linear axis of the device extending from the elongate tubular body proximal end to the elongate tubular body distal end (see Fig. 2A where elongated shaft 206 is a straight probe such that the straight section defines a longitudinal axis spanning the proximal end 204 to the distal end 208);
wherein the elongate tubular body exterior region has thereon one or more temperature sensors (thermocouples 228; [0088]: distal end 208 comprises the active electrode 142, the return electrode 146, a thermal bridge 224, and one or more thermocouples 228; [0094]: proximal thermocouple 228B may be disposed near the surface of the surgical tool 138; [0095]: the insulation 244 may surround the elongated shaft 206 such that the insulation 244 remains flush with the active electrode 142, with the proximal thermocouple 228B embedded in a portion of the insulation 244; wherein this describes a structure that is seen as having a temperature sensor on the surface of the device since the sensor is embedded/integral to the surface but still able to measure a surface temperature), wherein each of the one or more temperature sensors is configured to directly contact and measure a temperature of tissue ([0087]: a proximal thermocouple can obtain a more accurate temperature measurement of the return electrode 146 and/or the proximal lesion being formed during the RF ablation; [0095]: the insulation 244 may surround the elongated shaft 206 such that the insulation 244 remains flush with the active electrode 142, with the proximal thermocouple 228B embedded in a portion of the insulation 244; wherein the description of the thermocouple 228B being embedded and the thermocouple 228B being shown as exposed on a surface of the shaft in Figs. 2B-C is seen as the thermocouple being in direct contact with a tissue to measure a lesion temperature); and
wherein the elongate tubular body interior region has therein one or more coolant channels for circulating and recirculating coolant ([0084]: the elongated shaft 206 may be hollow to permit an inflow tube 212, an outflow tube 216; [0090]: The heat in the thermal bridge 224 may be removed using the fluid conduits 154 (e.g., the coolant from the inflow tube 212 absorbs the heat from the thermal bridge 224 and is pumped out by the outflow tube 216)).
Regarding claim 7, Norton teaches wherein the one or more coolant channels (inflow tube 212) are configured to reduce the temperature of specific regions of the elongate tubular body exterior region ([0090]: The heat in the thermal bridge 224 may be removed using the fluid conduits 154 (e.g., the coolant from the inflow tube 212 absorbs the heat from the thermal bridge 224 and is pumped out by the outflow tube 216); wherein the thermal bridge 224 is a specific region) or an entire length of the elongate tubular body exterior region, or
wherein each of the one or more coolant channels is separately paired with a temperature sensor of the one or more temperature sensors ([0087]: a proximal thermocouple can obtain a more accurate temperature measurement of the return electrode 146 and/or the proximal lesion being formed during the RF ablation; [0094]: the proximal thermocouple 228B may directly abut the return electrode 146; [0090]: the thermal bridge 224 may operate a heat sink that transfers heat generated in the active electrode 142 and/or the return electrode 146 into a coolant to dissipate heat from the surgical tool 138. The heat in the thermal bridge 224 may be removed using the fluid conduits 154 (e.g., the coolant from the inflow tube 212 absorbs the heat from the thermal bridge 224 and is pumped out by the outflow tube 216)).
Regarding claim 27, Norton teaches wherein the one or more temperature sensors are configured to send measured temperature information to a processor ([0094]: thermocouples 228 may generate separate temperature measurements that may be provided (wired and/or wirelessly) to the computing device 102).
Regarding claim 28, Norton teaches wherein the one or more temperature sensors are configured to wirelessly send the measured temperature information to the processor ([0094]: thermocouples 228 may generate separate temperature measurements that may be provided (wired and/or wirelessly) to the computing device 102).
Regarding claim 29, Norton teaches wherein the processor (computing device 102) comprises software that, when executed, causes the processor to manually or automatically ([0047]: the described methods, processes, and techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit):
process the measured temperature information received from the one or more temperature sensors ([0109]: The method 400 also comprises monitoring one or more thermocouple measurements (step 420)),
identify a specific temperature sensor of the one or more temperature sensors measuring a temperature of the tissue in a vicinity of the specific temperature sensor determined to be above a first pre-determined level ([0110]: The method 400 also comprises adjusting, when the thermocouple measurements fall outside a first range, the current flow or a fluid flow rate (step 424). The step 424 may implement a comparison (e.g., comparison 122) to compare the thermocouple measurements to baseline, anticipated, or otherwise predetermined measurements. When the thermocouple measurements fall outside the first range, this may indicate that the surgical tool is not functioning optimally (e.g., the temperature values are too high which may indicate that the anatomical tissue is being charred, the temperature values are too low which may indicate that the surgical tool is not ablating the anatomical tissue, etc.)),
identify a specific temperature sensor of the one or more temperature sensors measuring a temperature of the tissue in a vicinity of the specific temperature sensor determined to be at or below a second pre- determined level ([0110]: The method 400 also comprises adjusting, when the thermocouple measurements fall outside a first range, the current flow or a fluid flow rate (step 424). The step 424 may implement a comparison (e.g., comparison 122) to compare the thermocouple measurements to baseline, anticipated, or otherwise predetermined measurements. When the thermocouple measurements fall outside the first range, this may indicate that the surgical tool is not functioning optimally (e.g., the temperature values are too high which may indicate that the anatomical tissue is being charred, the temperature values are too low which may indicate that the surgical tool is not ablating the anatomical tissue, etc.)), and
direct the device to reduce the temperature of the elongate tubular body exterior region in the vicinity of a specific temperature sensor identified as measuring a temperature of the tissue in the vicinity of the specific temperature sensor determined to be above the first pre- determined level ([0110]: the computing device may generate an alert (e.g., a visual alert rendered to a display, an alarm, etc.) and/or adjust the operating parameters of the surgical tool. For example, the computing device may increase or decrease the current flow (e.g., to generate more or less RF energy to adjust the ablation of the anatomical tissue), and/or increase or decrease the coolant flow rate (e.g., increasing coolant flow rate to remove excess heat)).
Regarding claim 30, wherein the processor comprises software that, when executed, causes the processor to manually or automatically ([0047]: the described methods, processes, and techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit):
process the measured temperature information received from the one or more temperature sensors ([0109]: The method 400 also comprises monitoring one or more thermocouple measurements (step 420)),
identify a specific temperature sensor of the one or more temperature sensors measuring a temperature of the tissue in a vicinity of the specific temperature sensor determined to be above a first pre-determined level ([0110]: The method 400 also comprises adjusting, when the thermocouple measurements fall outside a first range, the current flow or a fluid flow rate (step 424). The step 424 may implement a comparison (e.g., comparison 122) to compare the thermocouple measurements to baseline, anticipated, or otherwise predetermined measurements. When the thermocouple measurements fall outside the first range, this may indicate that the surgical tool is not functioning optimally (e.g., the temperature values are too high which may indicate that the anatomical tissue is being charred, the temperature values are too low which may indicate that the surgical tool is not ablating the anatomical tissue, etc.)),
identify a specific temperature sensor of the one or more temperature sensors measuring a temperature of the tissue in a vicinity of the specific temperature sensor determined to be at or below a second pre- determined level ([0110]: The method 400 also comprises adjusting, when the thermocouple measurements fall outside a first range, the current flow or a fluid flow rate (step 424). The step 424 may implement a comparison (e.g., comparison 122) to compare the thermocouple measurements to baseline, anticipated, or otherwise predetermined measurements. When the thermocouple measurements fall outside the first range, this may indicate that the surgical tool is not functioning optimally (e.g., the temperature values are too high which may indicate that the anatomical tissue is being charred, the temperature values are too low which may indicate that the surgical tool is not ablating the anatomical tissue, etc.)); and
direct the device to reduce the temperature of the elongate tubular body exterior region ([0110]: the computing device may generate an alert (e.g., a visual alert rendered to a display, an alarm, etc.) and/or adjust the operating parameters of the surgical tool. For example, the computing device may increase or decrease the current flow (e.g., to generate more or less RF energy to adjust the ablation of the anatomical tissue), and/or increase or decrease the coolant flow rate (e.g., increasing coolant flow rate to remove excess heat)).
Regarding claim 31, Norton teaches wherein the processor comprises software that, when executed, causes the processor to manually or automatically ([0047]: the described methods, processes, and techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit):
direct the device to reduce the temperature of the elongate tubular body exterior region ([0110]: the computing device may generate an alert (e.g., a visual alert rendered to a display, an alarm, etc.) and/or adjust the operating parameters of the surgical tool. For example, the computing device may increase or decrease the current flow (e.g., to generate more or less RF energy to adjust the ablation of the anatomical tissue), and/or increase or decrease the coolant flow rate (e.g., increasing coolant flow rate to remove excess heat)).
Regarding claim 32, Norton teaches a system (system 100, see Fig. 1A) comprising the device (surgical tool 138, see Fig. 1B) of Claim 1 and a processor ([0048]: Instructions may be executed by one or more processors) comprising software that, when executed, causes the processor to manually or automatically:
process temperature information received from the one or more temperature sensors,
identify a specific temperature sensor of the one or more temperature sensors measuring a temperature of the tissue in a vicinity of the specific temperature sensor determined to be above a first pre-determined level,
identify a specific temperature sensor of the one or more temperature sensors measuring a temperature of the tissue in a vicinity of the specific temperature sensor determined to be at or below a second pre- determined level, and
direct the device to reduce the temperature of the elongate tubular body exterior region in the vicinity of a specific temperature sensor identified as measuring a temperature of the tissue in the vicinity of the specific temperature sensor to be above a pre- determined level;
or
direct the device to reduce the temperature of the elongate tubular body exterior region ([0110]: computing device may generate an alert (e.g., a visual alert rendered to a display, an alarm, etc.) and/or adjust the operating parameters of the surgical tool. For example, the computing device may increase or decrease the current flow (e.g., to generate more or less RF energy to adjust the ablation of the anatomical tissue), and/or increase or decrease the coolant flow rate (e.g., increasing coolant flow rate to remove excess heat));
or
process temperature information received from the one or more temperature sensors,
identify a specific temperature sensors sensor of the one or more temperature sensors measuring a temperature of the tissue in a vicinity of the specific temperature sensor determined to be above the first pre-determined level,
identify a specific temperature sensors sensor of the one or more temperature sensors measuring a temperature of the tissue in a vicinity of the specific temperature sensor determined to be at or below the second pre-determined level, direct the device to reduce the temperature of the elongate tubular body exterior region;
or combinations thereof.
Regarding claim 33, Norton teaches a method (method 400), comprising:
providing the device of Claim 1 ([0102]: FIG. 4 depicts a method 400 that may be used, for example, to ablate anatomical tissue using a surgical tool);
positioning the device in a tissue region such that at least one of the one or more temperature sensors are positioned to directly contact and measure the temperature of the tissue region in a vicinity of each specific temperature sensor ([0104]: positioning a surgical tool at a surgical site (step 404); [0109]: monitoring one or more thermocouple measurements (step 420). The one or more thermocouples may be positioned proximate to the active electrode and/or the return electrode and may be configured to generate a temperature measure of the active electrode, the return electrode, and/or of the surrounding anatomical tissue (e.g., the lesion being formed); [0095]: the insulation 244 may surround the elongated shaft 206 such that the insulation 244 remains flush with the active electrode 142, with the proximal thermocouple 228B embedded in a portion of the insulation 244; wherein the description of the thermocouple 228B being embedded and the thermocouple 228B being shown as exposed on a surface of the shaft in Figs. 2B-C is seen as the thermocouple being in direct contact with a tissue);
measuring the temperature of the tissue region with the positioned device ([0109]: monitoring one or more thermocouple measurements (step 420) … generate a temperature measure of the active electrode, the return electrode, and/or of the surrounding anatomical tissue (e.g., the lesion being formed));
identifying a specific temperature sensor of the one or more temperature sensors measuring a temperature of the tissue region in the vicinity of the specific temperature sensor determined to be above a pre-determined level ([0110]: step 424 may implement a comparison (e.g., comparison 122) to compare the thermocouple measurements to baseline, anticipated, or otherwise predetermined measurements. When the thermocouple measurements fall outside the first range, this may indicate that the surgical tool is not functioning optimally (e.g., the temperature values are too high which may indicate that the anatomical tissue is being charred, the temperature values are too low which may indicate that the surgical tool is not ablating the anatomical tissue, etc.)), and
directing the device to reduce the temperature of the elongate tubular body exterior region ([0110]: computing device may generate an alert (e.g., a visual alert rendered to a display, an alarm, etc.) and/or adjust the operating parameters of the surgical tool. For example, the computing device may increase or decrease the current flow (e.g., to generate more or less RF energy to adjust the ablation of the anatomical tissue), and/or increase or decrease the coolant flow rate (e.g., increasing coolant flow rate to remove excess heat)).
Regarding claim 39, Norton teaches wherein the one or more temperature sensors are linearly positioned along a length of the elongate tubular body exterior region and spaced apart from each other ([0088]: one or more thermocouples 228; [0092]: The thermocouples 228 may include a distal thermocouple 228A and a proximal thermocouple 228B; [0093]: The distal thermocouple 228A may be disposed within and contact a tip 230 or other portion of the return electrode 146, such that the distal thermocouple 228A can measure the temperature of the active electrode 142).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 23, 26 & 38 are rejected under 35 U.S.C. 103 as being unpatentable over Norton as applied to claim 1 above, and further in view of Curley (U.S. Pub. No. 20200138502, previously cited), herein referred to as “Curley”.
Regarding claim 2, Norton fails to disclose a stylet tip attached at the elongate tubular body distal end.
However, Curley discloses a stylet tip (pointed distal tip 104) attached at the elongate tubular body distal end ([0039]: elongate body 102 can include a pointed distal tip 104). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the elongate body distal end of Norton to comprise a stylet tip, as taught by Curley, for the purpose of facilitating introduction of the device into a target volume of tissue (Curley: [0039]).
Regarding claim 23, Norton fails to disclose wherein a diameter of the device is approximately 3 mm or less.
However, Curley discloses wherein a diameter of the device is approximately 3 mm or less ([0030]: the elongate body can be a thin-walled stainless steel needle between about 16- and about 18-gauge (i.e., an outer diameter of about 1.27 millimeters to about 1.65 millimeters)). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the diameter of the device of Norton to be 3 mm or less, as taught by Curley, for the purpose of the particular size of the elongate body can depend on a variety of factors including the type and location of tissue to be treated, the size of the tissue volume to be treated, etc. (Curley: [0039]).
Regarding claim 26, Norton fails to disclose wherein a size of the device is 15 gauge or smaller ([0030]: the elongate body can be a thin-walled stainless steel needle between about 16- and about 18-gauge (i.e., an outer diameter of about 1.27 millimeters to about 1.65 millimeters); wherein in needle gauge sizing, 16 & 18 gauge is smaller than 15 gauge).
However, Curley discloses wherein a size of the device is 15 gauge or smaller ([0030]: the elongate body can be a thin-walled stainless steel needle between about 16- and about 18-gauge (i.e., an outer diameter of about 1.27 millimeters to about 1.65 millimeters)). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the size of the device of Norton to be 15 gauge or smaller, as taught by Curley, for the purpose of the particular size of the elongate body can depend on a variety of factors including the type and location of tissue to be treated, the size of the tissue volume to be treated, etc. (Curley: [0039]).
Regarding claim 38, Norton fails to disclose wherein the one or more temperature sensors comprise three or more temperature sensors.
However, Curley discloses wherein the one or more temperature sensors comprise three or more temperature sensors ([0076]: In addition, the elongate body can include a plurality of temperature sensors including first, second, and third proximal temperature sensors 710, 711, 712; [0077]: In a symmetrical arrangement, the elongate body can also include first, second, and third distal temperature sensors 713, 714, 715).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the device of Norton to comprise three or more temperature sensors, as taught by Curley, for the purpose of enabling the device to be capable of measuring temperature along a longitudinal axis of the elongate body at a variety of locations on either side of an ablation element to accurately map the temperature of tissue surrounding the elongate body (Curley: [0077]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Norton as applied to claim 1 above, and further in view of Prakash et al. (U.S. Pub. No. 20130110102), herein referred to as “Prakash”.
Regarding claim 9, Norton discloses wherein the one or more temperature sensors (one or more thermocouples 228) comprises a first temperature sensor (proximal thermocouple 228B) and a second temperature sensor (distal thermocouple 228A);
But Norton fails to disclose wherein the one or more coolant channels comprises a first coolant channel and a second coolant channel;
wherein the first coolant channel is positioned such that circulation of the coolant through the first coolant channel results in a reduction of temperature of the elongate tubular body exterior region at and/or in the vicinity of the first temperature sensor; and
wherein the second coolant channel is positioned such that circulation of the coolant through the second coolant channel results in a reduction of temperature of the elongate tubular body exterior region at and/or in a vicinity of the second temperature sensor.
However, Prakash discloses wherein the one or more temperature sensors ([0072]: one or more temperature sensors 994; see Fig. 11) comprises a first temperature sensor (proximal temperature sensor 994) and a second temperature sensor (distal temperature sensor 994) wherein the one or more coolant channels comprises a first coolant channel and a second coolant channel (coolant tubes in Fig. 11 not given numerical call outs, see Fig. 8: inflow tubes 554, 556, 558; [0039]: Referring now in detail to the figures, in which like references numerals identify similar or identical elements; [0075]: Although the illustrative embodiments of the present disclosure have been described herein with reference to the accompanying drawings, the above description, disclosure, and figures should not be construed as limiting, but merely as exemplifications of particular embodiments. It is to be understood, therefore, that the disclosure is not limited to those precise embodiments, and that various other changes and modifications may be effected therein by one skilled in the art without departing from the scope or spirit of the disclosure);
wherein the first coolant channel is positioned such that circulation of the coolant through the first coolant channel results in a reduction of temperature of the elongate tubular body exterior region at and/or in the vicinity of the first temperature sensor ([0057]: With continued reference to FIG. 8, antenna assembly 500 further includes a cooling system 552 for regulating the temperature of distal portion 502a of the inner conductor; [0060]: As seen in FIG. 8, each of the proximal, intermediate, and distal regions 536, 538, 540, respectively, has a corresponding inflow tube 554, 556, and 558 in fluid communication therewith; see Fig. 11 where the proximal temperature sensor 994 corresponds to the proximal cooled region 536 & cooling the interior of the device is known to also cool the exterior of the device); and
wherein the second coolant channel is positioned such that circulation of the coolant through the second coolant channel results in a reduction of temperature of the elongate tubular body exterior region at and/or in a vicinity of the second temperature sensor ([0057]: With continued reference to FIG. 8, antenna assembly 500 further includes a cooling system 552 for regulating the temperature of distal portion 502a of the inner conductor; [0060]: As seen in FIG. 8, each of the proximal, intermediate, and distal regions 536, 538, 540, respectively, has a corresponding inflow tube 554, 556, and 558 in fluid communication therewith; see Fig. 11 where the distal temperature sensor 994 corresponds to the distal cooled region 540 & the proximal temperature sensor corresponds to the proximal cooled region 536, and cooling the interior of the device is known to also cool the exterior of the device). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the device of Norton to comprise two coolant channels, as taught by Prakash, for the purpose of minimizes unnecessarily high temperatures during tissue treatment and for circulating a dissipative fluid throughout the cavity and/or any individual regions thereof (Prakash: [0008], [0059]).
Claims 14 & 16 are rejected under 35 U.S.C. 103 as being unpatentable over Norton as applied to claim 1 above, and further in view of Jaikamal et al. (U.S. Pub. No. 20230063557, earliest effective filing date & previously cited), herein referred to as “Jaikamal”.
Regarding claim 14, Norton fails to disclose wherein the one or more coolant channels are configured to circulate a pressurized gas, wherein the pressurized gas is CO2
However, Jaikamal discloses wherein the one or more coolant channels are configured to circulate a pressurized gas, wherein the pressurized gas is CO2 ([0025]: Example cryogenic fluids may include one or more of nitrous oxide, argon, carbon dioxide, and/or phase change fluids (e.g., liquid nitrogen)). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the coolant channels of Norton to be configured to circulate a pressurized gas, wherein the pressurized gas is CO2, as taught by Jaikamal, for the purpose of cooling a tissue-contacting portion (Jaikamal: [0003]).
Regarding claim 16, Norton fails to disclose wherein the one or more coolant channels are configured to circulate a pressurized gas at zero to 1000 psi.
However, Jaikamal discloses wherein the one or more coolant channels are configured to circulate a pressurized gas at zero to 1000 psi ([0031]: the nitrous oxide may be supplied as a liquid at a temperature of about 27 C and a pressure of about 800 psi upstream of the nozzle 126, and may comprise a gaseous phase or a mixed phase of gas and liquid at approximately 45 psi and −68 C within the ablation tip 110 internal cavity 124). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the coolant channels of Norton to be configured to circulate a pressurized gas at zero to 1000 psi, as taught by Jaikamal, for the purpose of cooling a tissue-contacting portion (Jaikamal: [0003]).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Norton.
Regarding claim 40, Norton fails to disclose wherein the one or more temperature sensors are spaced apart from each other by at least two centimeters.
It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the claimed invention for the one or more temperature sensors to be spaced apart from each other by at least two centimeters, since applicant has not disclosed that the spacing solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with a spacing larger or smaller than at least two centimeters. Additionally, in reference to the Instant Application’s Specification, paragraph [0080] recites “Such embodiments are not limited to a particular positioning of the temperature sensor 13 along the exterior main body region 4 … In some embodiments having two or more temperature sensors 13, each temperature sensor 13 is separated along the length of exterior main body region 4 by at least two centimeters.” Suggesting that the two centimeter spacing is not critical.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Norton as applied to claim 1 above, and further in view of Varol (U.S. Pub. No. 20240008923, earliest effective filing date & previously cited), herein referred to as “Varol”.
Regarding claim 41, Norton fails to disclose wherein each of the one or more temperature sensors is wrapped around an entirety of the elongate tubular body exterior region.
However, Varol discloses wherein each of the one or more temperature sensors is wrapped around an entirety of the elongate tubular body exterior region ([0110]: one or more ring-type thermocouple can be physically positioned on the outside of outer tube 2160; see Fig. 30). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the one or more temperature sensors of Norton to be wrapped around an entirety of the elongate tubular body exterior region, as taught by Varol, for the purpose that a ring-type thermocouple positioned on the outside of, or embedded within, outer tube provides direct temperature readings of surrounding tissue (Varol: [0110]).
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Norton as applied to claim 1 above, and further in view of Frushour et al. (U.S. Pub. No. 20240225728, earliest effective filing date & earliest effective filing date), herein referred to as “Frushour”.
Regarding claim 42, Norton fails to disclose wherein the one or more temperature sensors comprise a Fiber Bragg Grating optical fiber.
However, Frushour discloses wherein the one or more temperature sensors comprise a Fiber Bragg Grating optical fiber (Abstract: The ablation device includes fiber Bragg gratings for monitoring temperature; [0058]: The ablation device 130 includes a fiber 300 which may be coupled to the outer jacket 132; [0059]: Fiber 300 includes a plurality of Bragg gratings 302a, 302b, . . . 302n (referred to collectively as Bragg gratings 302) etched into the fiber 300). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the one or more temperature sensors of Norton to be a Fiber Bragg Grating, as taught by Frushour, for the purpose of incorporating fiber Bragg gratings into a microwave ablation device enables real-time parameter sensing, for example real-time temperature sensing, which can be utilized to inform the treating physician of the dimensions of ablation volume being generated in real time as the application of ablation energy progresses (Frushour: [0034]).
Conclusion
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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