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 amendment filed June 18th, 2026 has been entered. Applicant’s amendments to the claims have overcome most of the 112(b) rejections previously set forth in the Non-Final Action mailed May 19th, 2026 with the exception of the 112(b) rejection of claim 33.
Response to Arguments
Applicant’s arguments, see pages 8-9, filed June 18th, 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102 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 Therefore, the rejection has been withdrawn.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 other current prior art of record.
Applicant argues claim 9 on page 10 that claim 9 has been cancelled, however, claim 9 still remains amended in the submitted claims. Therefore, the rejection of claim 9 is still maintained. Applicant argues on page 10 that Prakash does not disclose or suggest pairing the temperature sensors with respective cooling tubes, the Examiner respectfully disagrees on the grounds that as claimed, this relationship will be interpreted broadly until further limited to describe the nature of the relationship. While claim 1 recites that they are paired, this could be interpreted as them being positioned nearby to one another, as the nearest temperature sensor would correspond to a different cooling tube for each region (Prakash) or it could describe how a processor/method of use pairs them but this feature that has not yet been explicitly described in the claims. Therefore, these arguments are not persuasive and the Examiner maintains that the current prior art of record discloses the claimed invention, as detailed below.
Claim Objections
Claim 1-2, 23, 26 & 31 objected to because of the following informalities:
Claim 1, line 10: “tubular body” should read --elongated tubular body--,
Claim 1, line 12: “tubular body” should read --elongated tubular body--,
Claim 1, line 14: “the corresponding temperature sensor of the plurality of temperature sensors--,
Claim 2, line 2: “tubular body” should read --elongated tubular body--,
Claim 23, lines 1-2: “tubular body” should read --elongated tubular body--,
Claim 26, lines 1-2: “tubular body” should read --elongated tubular body--,
Claim 31, line 3: “temperature of the” should read --temperature--.
Appropriate correction is required.
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 1-2, 9, 14, 16, 23, 26-31, 33, 38 & 40-43 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.
Regarding claim 1, the claim recites “the tubular body” in line 9 and it is unclear if this is the same tubular body as the elongated tubular body recited in line 2 or is a different tubular body. For examination purposes, these are the same tubular bodies and the limitation will be interpreted as “the elongated tubular body”. For other recitations, see Claim Objections section.
Regarding claim 1, the claim recites “each cooling channel” in line 13 and it is unclear if this is the same cooling channel as the plurality of cooling channels recited in lines 11-12 or is a different cooling channel. For examination purposes, these are the same cooling channels and the limitation will be interpreted as “each cooling channel of the plurality of cooling channels”.
Regarding claim 1, the claim recites “a corresponding temperature sensor” in line 13 and it is unclear if this is the same temperature sensor as the plurality of temperature sensors recited in lines 7-8 or is a different temperature sensor. For examination purposes, these are the same temperature sensors and the limitation will be interpreted as “a corresponding temperature sensor of the plurality of temperature sensors”. For other recitations, see Claim Objections section.
Claims 2, 9, 14, 16, 23, 26-31, 33, 38 & 40-43 are also rejected by virtue of their dependency on claim 1.
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.
Regarding claim 43, the claim recites “coolant” in line 3 and it is unclear if this is the same coolant or is a different coolant from that recited in claim 1, from which claim 43 depends. For examination purposes, these are the same coolants and the limitation will be interpreted as “the coolant”.
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 1-2, 9, 14, 16, 27, 38 & 43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prakash et a. (U.S. Pub. No. 20130110102, previously cited), herein referred to as “Prakash”.
Regarding claim 1, Prakash teaches a device (Abstract: The devices and methods disclosed herein utilize an antenna assembly which includes an elongate member, an outer conductor, an inner conductor, at least a portion of which is deployable, and a cooling system; [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) comprising
an elongate tubular body (elongate member 114) defining a longitudinal axis ([0043]: Elongate member 114 has proximal and distal ends 118, 120 and defines longitudinal axis "A") and having an interior region (inside of elongate member 114), exterior region (outside of elongate member 114), a proximal end (proximal end 118), and a distal end (distal end 120);
a plurality of axially spaced apart temperature sensors (temperature sensor or sensors 994) on the exterior region of the tubular body ([0072]: sensors 994 may be located on the sleeve 916, e.g., on an external surface thereof; see Fig. 11 where there are three sensors 994 spaced apart axially, each corresponding to a different region of the device) for measuring temperature of tissue at locations along a length of the tubular body ([0010]: The cavity defined by the sleeve may include at least two regions, such as, for example, a proximal region, an intermediate region, and a distal region; [0012]: The microwave tissue treatment device may include at least one temperature sensor operatively connected to the cavity, or a region thereof; [0072]: one or more temperature sensors 994 coupled to a distal portion 902a of an inner conductor for monitoring a temperature fluctuation at or about the distal portion 902a; see Fig. 11 where there are three regions with a temperature sensor disposed at each region); and
a plurality of cooling channels in the interior region of the tubular body for circulating coolant, wherein each cooling channel is paired with a corresponding temperature sensor to regulate temperature at or near a location of the corresponding temperature sensor ([0011]: In yet another embodiment, the microwave tissue treatment device cooling system includes first, second, and third inflow and outflow members, the first inflow and outflow members, the second inflow and outflow members, and the third inflow and outflow members being in fluid communication with a respective proximal, intermediate, and distal regions of the cavity defined by the sleeve; [0012]: The microwave tissue treatment device may include at least one temperature sensor operatively connected to the cavity, or a region thereof; [0056]: it may also be desirable, however, to prevent the temperature in intermediate section 548 from rising beyond a particular threshold to protect surrounding sensitive tissue structures from undesired effects; see Fig. 11 where there are three regions with a cooling channel and a temperature sensor disposed at each region and also entirety of [0056] such that each pairing of temperature sensor and cooling channel is capable of regulating a temperature at or near a location of the corresponding temperature sensor).
Regarding claim 2, Prakash teaches a stylet tip attached at the distal end of the tubular body ([0050]: the present disclosure contemplates that distal-most tip 134 may be substantially arcuate, duckbilled, or any other such configuration suitable for facilitating the entry of the microwave tissue treatment device into the tissue of a patient).
Regarding claim 9, Prakash teaches wherein the plurality of temperature sensors ([0072]: one or more temperature sensors 994; see Fig. 11) includes a first temperature sensor (proximal temperature sensor 994) and a second temperature sensor (distal temperature sensor 994) wherein the plurality of coolant channels includes 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);
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).
Regarding claim 14, Prakash teaches wherein the plurality of coolant channels are configured to circulate a pressurized gas, wherein the pressurized gas is CO2 ([0057]: In various embodiments, gases, such as air, nitrous oxide, nitrogen, carbon dioxide, etc., may also be utilized as the dissipative fluid. In yet another variation, a combination of liquids and/or gases may be utilized; wherein ambient room pressure is approximately 14.7 psi (101.3 kPa) such that this is seen as pressurized gas).
Regarding claim 16, Prakash teaches wherein the plurality of coolant channels are configured to circulate a pressurized gas at zero to 1000 psi ([0057]: In various embodiments, gases, such as air, nitrous oxide, nitrogen, carbon dioxide, etc., may also be utilized as the dissipative fluid. In yet another variation, a combination of liquids and/or gases may be utilized; wherein ambient room pressure is approximately 14.7 psi (101.3 kPa)).
Regarding claim 27, Prakash teaches wherein the plurality of temperature sensors are configured to send measured temperature information to a processor ([0074]: A closed loop control mechanism, such as a feedback controller with a microprocessor, may be implemented for controlling the delivery of energy, e.g., microwave energy, to the target tissue based on temperature measured by the temperature sensor or sensors 994).
Regarding claim 38, Prakash teaches wherein the plurality of temperature sensors comprise three or more temperature sensors (see Fig. 11 where three temperature sensors 994 are shown).
Regarding claim 43, Prakash teaches wherein each of the plurality of cooling channels has a respective coolant intake portion and a coolant outtake portion, and wherein the coolant intake portion receives coolant through the proximal end of the tubular body and the coolant outtake portion circulates coolant out to the proximal end of the tubular body ([0060]: 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, and a corresponding outflow tube 560, 562, and 564 in fluid communication therewith … a proximal end (not shown) of first inflow tube 554 may be connected to pump 40 (FIG. 1), while a distal end 566 of first inflow tube 554 is in fluid communication with proximal region 536 … In conjunction with first inflow tube 554, a proximal end (not shown) of first outflow tube 560 may be connected to pump 40 (FIG. 1), while a distal end 572 of first outflow tube is in fluid communication with proximal region 536, thereby allowing the dissipative fluid "F" to flow, either constantly or intermittently, out of the proximal region 536, and return to the pump 40 (FIG. 1); [0061]: As with the proximal region 536, a dissipative fluid may be pumped into and out of intermediate region 538 through respective distal ends 568, 574 of the second inflow and outflow tubes 556, 562 thereby dissipating the heat generated by the intermediate section 548 of distal portion 502a of the inner conductor through the fluid circulated therein).
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 28-31 & 33 are rejected under 35 U.S.C. 103 as being unpatentable over Prakash as applied to claim 1 above, and further in view of Norton (U.S. Pub. No. 20230255677, earliest effective filing date & previously cited), herein referred to as “Norton”.
Regarding claim 28, Prakash fails to disclose wherein the plurality of temperature sensors are configured to wirelessly send the measured temperature information to the processor.
However, Norton discloses wherein the plurality of 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). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the plurality of temperature sensors of Prakash to be configured to wirelessly send measured temperature information to a processor, as taught by Norton, for the purpose of enabling the device to communicate with one or more other processors or computing devices, whether to reduce the time needed to accomplish a computing-intensive task (Norton: [0066]).
Regarding claim 29, Prakash fails to disclose wherein the processor comprises software that, when executed, causes the processor to manually or automatically: process the measured temperature information received from the plurality of temperature sensors, identify a specific temperature sensor of the plurality of temperature sensors measuring a temperature of the tissue in a vicinity of the specific temperature sensor determined to be above a first predetermined level, identify a specific temperature sensor of plurality of 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 measured temperature of the elongate tubular body exterior region in the vicinity of the 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.
However, Norton discloses 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 plurality of temperature sensors ([0109]: The method 400 also comprises monitoring one or more thermocouple measurements (step 420)),
identify a specific temperature sensor of the plurality of 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 measured temperature 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)).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the processor of Prakash to include the processor of Norton for the purpose of measurements may be reflective of the overall operating health of the surgical tool, as well as the health of the anatomical tissue being ablated and enable cooling ablation while simultaneously better monitoring of lesion size and temperature, decreasing the time needed to perform the surgery or surgical procedure. The increased accuracy of the readings of the temperatures of the proximal and distal lesion may be displayed real-time (e.g., to a controller/generator screen), reducing patient risk of damage to critical structures (e.g., critical structures in a vertebra) (Norton: [0109], [0060]).
Regarding claim 30, Prakash fails to disclose wherein the processor comprises software that, when executed, causes the processor to manually or automatically: process the measured temperature information received from the plurality of temperature sensors, identify a specific temperature sensor of the plurality of 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 plurality of 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 measured temperature.
However, Norton discloses 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 plurality of temperature sensors ([0109]: The method 400 also comprises monitoring one or more thermocouple measurements (step 420)),
identify a specific temperature sensor of the plurality of 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 plurality of 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 measured temperature ([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)).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the processor of Prakash to include the processor of Norton for the purpose of measurements may be reflective of the overall operating health of the surgical tool, as well as the health of the anatomical tissue being ablated and enable cooling ablation while simultaneously better monitoring of lesion size and temperature, decreasing the time needed to perform the surgery or surgical procedure. The increased accuracy of the readings of the temperatures of the proximal and distal lesion may be displayed real-time (e.g., to a controller/generator screen), reducing patient risk of damage to critical structures (e.g., critical structures in a vertebra) (Norton: [0109], [0060]).
Regarding claim 31, Prakash discloses closed loop control, but Prakash fails to disclose wherein the processor comprises software that, when executed, causes the processor to manually or automatically: direct the device to reduce the measured temperature.
However, Norton discloses 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 measured temperature ([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)).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the processor of Prakash to include the processor of Norton for the purpose of measurements may be reflective of the overall operating health of the surgical tool, as well as the health of the anatomical tissue being ablated and enable cooling ablation while simultaneously better monitoring of lesion size and temperature, decreasing the time needed to perform the surgery or surgical procedure. The increased accuracy of the readings of the temperatures of the proximal and distal lesion may be displayed real-time (e.g., to a controller/generator screen), reducing patient risk of damage to critical structures (e.g., critical structures in a vertebra) (Norton: [0109], [0060]).
Regarding claim 33, Prakash discusses a method in [0018]-[0019] but fails to disclose a method, comprising: providing the device of claim 1; positioning the device in a tissue region such that the plurality of temperature sensors are positioned to directly contact and measure the temperature of the tissue region in a vicinity of each specific temperature sensor; measuring the temperature of the tissue region with the positioned device; identifying a specific temperature sensor of the plurality of 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, and directing the device to reduce the measured temperature.
However, Norton discloses 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 the plurality of 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 plurality of 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 measured temperature ([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)).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the method of Prakash to include the steps of Norton for the purpose of measurements may be reflective of the overall operating health of the surgical tool, as well as the health of the anatomical tissue being ablated and enable cooling ablation while simultaneously better monitoring of lesion size and temperature, decreasing the time needed to perform the surgery or surgical procedure. The increased accuracy of the readings of the temperatures of the proximal and distal lesion may be displayed real-time (e.g., to a controller/generator screen), reducing patient risk of damage to critical structures (e.g., critical structures in a vertebra) (Norton: [0109], [0060]).
Claims 23 & 26 are rejected under 35 U.S.C. 103 as being unpatentable over Prakash 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 23, Prakash fails to disclose wherein a diameter of the tubular body is approximately 3 mm or less.
However, Curley discloses wherein a diameter of the tubular body 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 Prakash 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, Prakash fails to disclose wherein a size of the tubular body is 15 gauge or smaller.
However, Curley discloses wherein a size of the tubular body 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 Prakash 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]).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Prakash.
Regarding claim 40, Prakash fails to disclose wherein the plurality of temperature sensors are axially 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 plurality of temperature sensors to be axially 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 Prakash 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, Prakash fails to disclose wherein each of the plurality of temperature sensors is wrapped around an entirety of the exterior region of elongate tubular body.
However, Varol discloses wherein each of the plurality of temperature sensors is wrapped around an entirety of the exterior region of the elongate tubular body ([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 Prakash 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 Prakash as applied to claim 1 above, and further in view of Frushour et al. (U.S. Pub. No. 20240225728, earliest effective filing date & previously cited), herein referred to as “Frushour”.
Regarding claim 42, Prakash fails to disclose wherein each of the plurality of temperature sensors comprise a Fiber Bragg Grating optical fiber.
However, Frushour discloses wherein each of the plurality of 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 Prakash 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
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 Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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