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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 4th, 2025 has been entered.
Response to Arguments
Applicant’s arguments, see pages 8-10, filed December 4th, 2025, with respect to the rejection(s) of claim(s) 1, 8 & 16 under 35 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 Therefore, the rejection has been withdrawn.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 the newly found prior art of record that teaches the newly disclosed claim limitations.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Esch et al. (U.S. Pub. No. 20150272654, previously cited), herein referred to as “Esch”) in view of Nasab et al. (U.S. Pub. No. 20050010206, previously cited), herein referred to as “Nasab”, Thompson et al. (U.S. Pub. No. 20070100405), herein referred to as “Thompson” and Hossack et al. (U.S. Pat. No. 9101298, previously cited), herein referred to as “Hossack”.
Regarding claim 1, Esch discloses a method of treating a vessel at a treatment site (Title: Venous disease treatment; [0188]: The techniques described in the preceding text and figures can be mixed and matched as circumstances demand to produce alternative implementations), the method comprising:
employing an energy-emitting probe (treatment probe 102), the energy-emitting probe comprising:
a handle ([0046]: the catheter handle) having a push button ([0062]: The handle can also include a button);
circuitry to power the handle (diagram 102 in Fig. 6; [0063]: heating catheter 102 includes central processing unit (CPU) 600, which is in communication with temperature reference engine 602, debouncing circuitry 604 for pushbutton 606, thermocouple amplifier 608 for thermocouple 610, power router 616, heater resistance measurement engine 618, and communication engine 620);
an elongate shaft having a proximal end and a distal end ([0042]: heating catheter 102, which is a long, thin, flexible, or rigid device that can be inserted into a narrow anatomical lumen such as a vein);
an energy element (heating element 106) adjacent the distal end ([0042]: Heating catheter 102 is connected to energy delivery console 104 to provide energy causing heating at the distal end of heating catheter 102), the energy element comprising a generally helically shaped resistive heater coil disposed near the distal end of the elongate shaft ([0043]: heating element 106 that is heated by electrical current; [0049]: heating element 106 can be created from a coiled configuration of wire (single or double-lead); see Figs. 4A & 4B);
a thermocouple (thermocouple 124; Fig. 4A) positioned within the generally helically shaped resistive heater coil used to measure a temperature of the energy element ([0050]: temperature sensor 124 (e.g., thermocouple or thermistor) … temperature sensor 124 can be placed between coil winds);
a thermocouple amplifier (thermocouple amplifier 608, Fig. 6);
accessing the vessel through skin with a needle and cannula assembly ([0106]: For example, a needle (or short sheath) can be punctured through the skin directly into a perforator vein … the needle can be pushed into the patient towards a view until an ultrasound image shows the needle tip within the lumen of the vein and blood flashback drips from the end of the needle indicating that the needle lumen is in fluid communication with the blood lumen);
removing the needle from the cannula ([0106]: An energy delivery catheter, either flexible or rigid in design, can then be placed through the needle into the vein lumen. Once the energy delivery catheter is located within the vein lumen, the needle can be retracted if desired);
advancing the energy-emitting probe through the cannula to the treatment site ([0106]: The energy delivery catheter can be advanced further along the vein lumen if desired, guided by angulation of the catheter shaft, by rotation of a curved tip of the energy delivery catheter, and/or by advancing the energy delivery catheter over a guide wire inserted through the catheter lumen);
applying energy to the treatment site with the energy element, thereby constricting the vessel, wherein the energy is applied to the vessel endovascularly ([0107]: Energy can be delivered to the proximal superficial vein segment via segmental ablations, continuous pullback while heating, or by a combination thereof, to the junction of the vessels. Next, the catheter can be advanced down into the perforator vein (ideally past the deep fascia layer and near to the deep vein) and energy can be delivered to the perforator vein, via segmental ablations, continuous pullback while heating, or by a combination thereof; [0099]: a common method of local anesthesia used with endovenous thermal ablation is via infiltration of the nearby tissue surrounding the vein along the full length of the treated vein segment; [0006]: Endovenous thermal ablation is a recent technique where heat is applied within the vein to cause the vein wall to permanently shrink to the point the vein lumen is occluded (usually by a residual core of blood thrombus)); and
removing the energy-emitting probe and the cannula ([0102]: Successive treatment of vein segments can be repeated until the entire desired length of vein has been treated, and then the catheter (and sheath, if used) is removed from the vein);
wherein the energy-emitting probe has information in a flash memory to identify a type of the energy-emitting probe ([0064]: Heating catheter 102 may also have a memory module to store information such as device identification and operating parameters for energy delivery console 104, device-specific calibration information and past record of testing and/or product use).
But Esch fails to disclose an isolation amplifier to galvanically isolate the thermocouple amplifier from a reference ground; and a voltage source to power the isolation amplifier, the voltage source being galvanically isolated from the circuitry to power the handle; wherein the thermocouple is galvanically isolated from circuitry powering the single heating element.
However, Nasab discloses a method of treating a vessel at a treatment site (Abstract: A system and method for efficient delivery of radio frequency (RF) energy), comprising a flexible heating catheter (ablation catheter 160) comprising
an energy element (electrode 164) adjacent the distal end (see Fig. 1a), the energy element comprising a generally helically shaped resistive heater coil disposed near the distal end of the elongate shaft ([0044]: coil electrodes);
a thermocouple (thermocouple sensors 162) positioned within the heater coil used to measure a temperature of the energy element ([0057]: each electrode 164 has a corresponding thermocouple sensor 162 that provides temperature feedback information at the tissue site immediately proximal to the electrode delivering the RF energy);
a thermocouple amplifier (“Instrumentation AMP” in patient isolation 12 in Fig. 3; [0048]: thermocouple amplifiers);
an isolation amplifier (“Isolation Amp” in patient isolation 12 in Fig. 3) to galvanically isolate the thermocouple amplifier from a reference ground ([0054]: The isolation circuits, both the power supply and the thermocouple amplifiers, are designed to isolate the patient from the main power source circuitry by 2500 volts); and
a voltage source to power the isolation amplifier (“Isolation Power Supply” in patient isolation 12 in Fig. 3), the voltage source being galvanically isolated from the circuitry to power the handle ([0054]: The isolation circuits, both the power supply and the thermocouple amplifiers, are designed to isolate the patient from the main power source circuitry by 2500 volts);
wherein the thermocouple is galvanically isolated from circuitry powering the single heating element ([0042]: As described above, the information processor and RF output controller 100 are connected to and regulate RF energy delivered to multiple electrodes arranged in various configurations at the distal end of a catheter; [0053]: The channel card functional block diagram (FIGS. 3 and 4) of the system 10 provide thermocouple inputs and patient isolation 12; [0054]: The common mode input filter is designed to handle high common mode of RF energy level on the thermocouples. The isolation circuits, both the power supply and the thermocouple amplifiers, are designed to isolate the patient from the main power source circuitry by 2500 volts; see Figs. 3 & 4).
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Fig. 3 of Nasab showing the thermocouple amplifiers & isolation
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the energy-emitting probe of Esch to include the isolation of Nasab for the purpose that using isolated circuits for all patient connections ensures patient safety even with failed components and to isolate the patient from the main power source circuitry by 2500 volts (Nasab: [0048], [0054]).
While Esch discloses a shell (non-stick outer layer 116) extending along an exterior of the energy element (see Fig. 3) but Esch in view of Nasab fail to disclose a bulging rounded distal tip; and
a shell extending along an exterior of the energy element and abutting and terminating at a proximal curve of the bulging rounded distal tip, a distal end of the energy element set back from a distalmost end of the energy-emitting probe by only the bulging rounded distal tip.
However, Thompson discloses a bulging rounded distal tip (thermally-conductive tip 30; [0254]: a thermally-conductive tip 30 or extension near the tip); and
a shell (sleeve 47) extending along an exterior of the energy element and abutting and terminating at a proximal curve of the bulging rounded distal tip, a distal end of the energy element set back from a distalmost end of the energy-emitting probe by only the bulging rounded distal tip ([0255]: The distal section of the catheter in FIG. 4 shows the resistive element 14 covered by a sleeve 47 … The sleeve material may also be preferably chosen to provide uniformity of heating along the full length of the heating coil; see Figs. 3-4 where the sleeve 47 covers the length of the resistive element 14 such that the sleeve abuts and terminates at a proximal curve of the thermally conductive tip 30 & a distal end of resistive element 14 is set back from a distalmost end of the energy-emitting probe by only the thermally conductive tip 30).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the energy emitting probe of Esch in view of Nasab to include a bulging rounded distal tip and a shell, as taught by Thompson for the purpose of the tip extending heating toward the distal tip of the catheter and the shell providing uniformity of heating along the full length of the heating coil (Thompson: [0254]-[0255]).
But Esch in view of Nasab and Thompson fails to disclose wherein the energy-emitting probe has information in a flash memory to identify a type of the energy-emitting probe, including regional codes that limit the use of particular catheter types to particular geographic regions, and including one or more treatment cycle use limits.
However, Hossack discloses wherein the energy-emitting probe has information in a flash memory to identify a type of the energy-emitting probe, including regional codes that limit the use of particular catheter types to particular geographic regions, and including one or more treatment cycle use limits (Col. 6, lines 46-53: The RFID chip 203 may have a memory of 128 bytes, alternatively 1K byte, alternatively 2K bytes alternatively 4K bytes to store catheter specific information, including for example catheter serial number, name, make or model, calibration coefficients, imaging element sensitivity, time gain control, post amp gain, number of permissible uses, geographic location of permissible use, boot mode, pulse width, or expiration date of the catheter).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the energy emitting probe of Esch in view of Nasab and Thompson to include a flash memory as taught by Hossack, since it is advantageous to know information regarding the function and performance of the catheter (Hossack: Abstract).
Regarding claim 2, Esch discloses advancing the needle and cannula assembly into the vessel above the fascia layer and advancing the energy-emitting probe through the cannula to the treatment site at or below the fascia layer ([0107]: Energy can be delivered to the proximal superficial vein segment via segmental ablations, continuous pullback while heating, or by a combination thereof, to the junction of the vessels. Next, the catheter can be advanced down into the perforator vein (ideally past the deep fascia layer and near to the deep vein) and energy can be delivered to the perforator vein, via segmental ablations, continuous pullback while heating, or by a combination thereof; where the positioning to the deep vein includes going through (above) a fascia layer).
Regarding claim 3, Esch discloses monitoring the temperature at the treatment site and modulating power delivery to the energy element in response to the temperature ([0115]: In a specific implementation, control of the actual delivery of energy to the heating element can be via temperature feedback (e.g., proportional-integral-derivative (PID) control) to achieve and maintain a desired treatment temperature, by delivery of a set power level, or by delivery of a variable power level according to a power-time relationship. A power-time relationship can be configured to approximate the level of power per time that would normally be delivered to an intended vessel if that system were temperature-controlled to attain and maintain a desired set temperature).
Regarding claim 4, Esch discloses wherein the vessel comprises a perforator vein ([0106]: For example, a needle (or short sheath) can be punctured through the skin directly into a perforator vein).
Regarding claim 5, Esch discloses wherein the elongate shaft is flexible ([0042]: heating catheter 102, which is a long, thin, flexible).
Regarding claim 6, Esch discloses a TRS connector on the proximal end of the elongate shaft ([0068]: In a specific implementation, a push-to-engage type connector (such as a IA″ mono or tip, ring, and sleeve (TRS) stereo plug, card-edge connector or a LEMO®-style connector) can be used to connect the heating catheter and the energy delivery system).
Regarding claim 7, Esch discloses advancing the needle and cannula assembly into the vessel at or below a fascia layer and advancing the energy-emitting probe through the cannula to the treatment site at or below the fascia layer ([0107]: Energy can be delivered to the proximal superficial vein segment via segmental ablations, continuous pullback while heating, or by a combination thereof, to the junction of the vessels. Next, the catheter can be advanced down into the perforator vein (ideally past the deep fascia layer and near to the deep vein) and energy can be delivered to the perforator vein, via segmental ablations, continuous pullback while heating, or by a combination thereof); where the junction of the vessels around a fascia layer is seen as a junction at a fascia layer).
Regarding claim 8, Esch discloses a method of treating a perforator vein of a patient (Title: Venous disease treatment; [0106]: For example, a needle (or short sheath) can be punctured through the skin directly into a perforator vein; [0188]: The techniques described in the preceding text and figures can be mixed and matched as circumstances demand to produce alternative implementations), comprising the steps of:
accessing the perforator vein of the patient at an access location located at or above a fascia layer of the patient with a cannula assembly ([0106]: For example, a needle (or short sheath) can be punctured through the skin directly into a perforator vein; where perforator veins are located above, at, and below a fascia layer),
introducing a flexible heating catheter through the cannula assembly into the perforator vein at the access location at or above the fascia layer ([0107]: introducing the energy delivery catheter into the superficial vein at a site that is distal or proximal to the perforator vein, and then advancing it past the perforator vein junction to a site more proximal or distal. Energy can be delivered to the proximal superficial vein segment via segmental ablations, continuous pullback while heating, or by a combination thereof, to the junction of the vessels; where the junction of the vessels (superficial vein & perforator vein) is seen as an access location above the fascia layer), the flexible heating catheter (treatment probe 102) comprising:
a handle ([0046]: the catheter handle) having a push button ([0062]: The handle can also include a button);
circuitry to power the handle (diagram 102 in Fig. 6; [0063]: heating catheter 102 includes central processing unit (CPU) 600, which is in communication with temperature reference engine 602, debouncing circuitry 604 for pushbutton 606, thermocouple amplifier 608 for thermocouple 610, power router 616, heater resistance measurement engine 618, and communication engine 620);
an elongate shaft having a proximal end and a distal end ([0042]: heating catheter 102, which is a long, thin, flexible, or rigid device that can be inserted into a narrow anatomical lumen such as a vein);
a heating element (heating element 106) adjacent the distal end ([0042]: Heating catheter 102 is connected to energy delivery console 104 to provide energy causing heating at the distal end of heating catheter 102), the heating element comprising a generally helically shaped resistive heater coil disposed near the distal end of the elongate shaft ([0043]: heating element 106 that is heated by electrical current; [0049]: heating element 106 can be created from a coiled configuration of wire (single or double-lead); see Figs. 4A & 4B);
a thermocouple (thermocouple 124; Fig. 4A) positioned within the generally helically shaped resistive heater coil used to measure a temperature of the heating element ([0050]: temperature sensor 124 (e.g., thermocouple or thermistor) … temperature sensor 124 can be placed between coil winds);
a thermocouple amplifier (thermocouple amplifier 608, Fig. 6);
advancing the flexible heating catheter within the perforator vein, past the fascia layer, to a first treatment location within the perforator vein and at or below the fascia layer ([0107]: Next, the catheter can be advanced down into the perforator vein (ideally past the deep fascia layer and near to the deep vein)),
activating a heating element of the flexible heating catheter to provide heat therapy at the first treatment location ([0107]: energy can be delivered to the perforator vein, via segmental ablations, continuous pullback while heating, or by a combination thereof);
withdrawing the flexible heating catheter within the perforator vein to a second treatment location within the perforator vein ([0107]: energy can be delivered to the perforator vein, via segmental ablations, continuous pullback while heating, or by a combination thereof); and
activating the flexible heating element of the heating catheter to provide heat therapy at the second treatment location ([0107]: energy can be delivered to the perforator vein, via segmental ablations, continuous pullback while heating, or by a combination thereof; where each segmental ablation is seen as a discrete treatment location along the perforator vein);
wherein the flexible heating catheter has information in a flash memory to identify a type of the flexible heating element ([0064]: Heating catheter 102 may also have a memory module to store information such as device identification and operating parameters for energy delivery console 104, device-specific calibration information and past record of testing and/or product use; see 112(b) section, above, where “flexible heating element” is being interpreted as “flexible heating catheter”).
But Esch fails to disclose an isolation amplifier to galvanically isolate the thermocouple amplifier from a reference ground; and a voltage source to power the isolation amplifier, the voltage source being galvanically isolated from the circuitry to power the handle.
However, Nasab discloses a method of treating a vessel at a treatment site (Abstract: A system and method for efficient delivery of radio frequency (RF) energy), comprising a flexible heating catheter (ablation catheter 160) comprising
an energy element (electrode 164) adjacent the distal end (see Fig. 1a), the energy element comprising a generally helically shaped resistive heater coil disposed near the distal end of the elongate shaft ([0044]: coil electrodes);
a thermocouple (thermocouple sensors 162) positioned within the heater coil used to measure a temperature of the energy element ([0057]: each electrode 164 has a corresponding thermocouple sensor 162 that provides temperature feedback information at the tissue site immediately proximal to the electrode delivering the RF energy);
a thermocouple amplifier (“Instrumentation AMP” in patient isolation 12 in Fig. 3; [0048]: thermocouple amplifiers);
an isolation amplifier (“Isolation Amp” in patient isolation 12 in Fig. 3) to galvanically isolate the thermocouple amplifier from a reference ground ([0054]: The isolation circuits, both the power supply and the thermocouple amplifiers, are designed to isolate the patient from the main power source circuitry by 2500 volts); and
a voltage source to power the isolation amplifier (“Isolation Power Supply” in patient isolation 12 in Fig. 3), the voltage source being galvanically isolated from the circuitry to power the handle ([0054]: The isolation circuits, both the power supply and the thermocouple amplifiers, are designed to isolate the patient from the main power source circuitry by 2500 volts).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the energy-emitting probe of Esch to include the isolation of Nasab for the purpose that using isolated circuits for all patient connections ensures patient safety even with failed components and to isolate the patient from the main power source circuitry by 2500 volts (Nasab: [0048], [0054]).
While Esch discloses a shell (non-stick outer layer 116) extending along an exterior of the energy element (see Fig. 3) but Esch in view of Nasab fail to disclose a bulging rounded distal tip; and
a shell extending along an exterior of the energy element and abutting and terminating at a proximal curve of the bulging rounded distal tip, a distal end of the energy element set back from a distalmost end of the energy-emitting probe by only the bulging rounded distal tip.
However, Thompson discloses a bulging rounded distal tip (thermally-conductive tip 30; [0254]: a thermally-conductive tip 30 or extension near the tip); and
a shell (sleeve 47) extending along an exterior of the energy element and abutting and terminating at a proximal curve of the bulging rounded distal tip, a distal end of the energy element set back from a distalmost end of the energy-emitting probe by only the bulging rounded distal tip ([0255]: The distal section of the catheter in FIG. 4 shows the resistive element 14 covered by a sleeve 47 … The sleeve material may also be preferably chosen to provide uniformity of heating along the full length of the heating coil; see Figs. 3-4 where the sleeve 47 covers the length of the resistive element 14 such that the sleeve abuts and terminates at a proximal curve of the thermally conductive tip 30 & a distal end of resistive element 14 is set back from a distalmost end of the energy-emitting probe by only the thermally conductive tip 30).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the energy emitting probe of Esch in view of Nasab to include a bulging rounded distal tip and a shell, as taught by Thompson for the purpose of the tip extending heating toward the distal tip of the catheter and the shell providing uniformity of heating along the full length of the heating coil (Thompson: [0254]-[0255]).
But Esch in view of Nasab and Thompson fails to disclose wherein the flexible heating catheter has information in a flash memory to identify a type of the flexible heating catheter, including regional codes that limit the use of particular catheter types to particular geographic regions, and including one or more treatment cycle use limits.
However, Hossack discloses wherein the flexible heating catheter has information in a flash memory to identify a type of the flexible heating catheter, including regional codes that limit the use of particular catheter types to particular geographic regions, and including one or more treatment cycle use limits (Col. 6, lines 46-53: The RFID chip 203 may have a memory of 128 bytes, alternatively 1K byte, alternatively 2K bytes alternatively 4K bytes to store catheter specific information, including for example catheter serial number, name, make or model, calibration coefficients, imaging element sensitivity, time gain control, post amp gain, number of permissible uses, geographic location of permissible use, boot mode, pulse width, or expiration date of the catheter).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the energy emitting probe of Esch in view of Nasab and Thompson to include a flash memory as taught by Hossack, since it is advantageous to know information regarding the function and performance of the catheter (Hossack: Abstract).
Regarding claim 9, Esch discloses wherein the second treatment location is positioned within the perforator vein and below the fascia layer ([0107]: Next, the catheter can be advanced down into the perforator vein (ideally past the deep fascia layer and near to the deep vein) and energy can be delivered to the perforator vein, via segmental ablations, continuous pullback while heating, or by a combination thereof).
Regarding claim 10, Esch discloses withdrawing the flexible heating catheter within the perforator vein to a third treatment location within the perforator vein; and activating the heating element of the flexible heating catheter to provide heat therapy at the third treatment location ([0107]: energy can be delivered to the perforator vein, via segmental ablations, continuous pullback while heating, or by a combination thereof; where each segmental ablation is seen as a discrete treatment location along the perforator vein & this includes a third treatment location).
Regarding claim 11, Esch discloses wherein the third treatment location is positioned within the perforator vein and at or above the fascia layer ([0107]: energy can be delivered to the perforator vein, via segmental ablations, continuous pullback while heating, or by a combination thereof; where each segmental ablation is seen as a discrete treatment location along the perforator vein) and pulling it back includes an area that would be at or above the fascia layer).
Regarding claim 12, Esch discloses wherein the second treatment location is positioned within the perforator vein and at or above the fascia layer ([0107]: energy can be delivered to the perforator vein, via segmental ablations, continuous pullback while heating, or by a combination thereof; where each segmental ablation is seen as a discrete treatment location along the perforator vein) and pulling it back includes an area that would be at or above the fascia layer).
Regarding claim 13, Esch discloses imaging the flexible heating catheter with real-time ultrasound imaging (0106]: A needle can be guided into a vein using ultrasound visualization. In guiding a needle into a vein using ultrasound visualization, the needle can be pushed into the patient towards a view until an ultrasound image shows the needle tip within the lumen of the vein).
Regarding claim 14, Esch discloses identifying successful occlusion of the perforator vein under the real-time ultrasound imaging ([0132]: In a specific implementation, after treatment, it is preferable if the user is able to know that the treated vessel has been substantially coagulated, with shrunken vessel diameter being a key indicator. This can be observed under ultrasound visualization).
Regarding claim 15, Esch discloses identifying a decreasing bubbling effect within the perforator vein under the real-time ultrasound imaging ([0133]: In a specific implementation, a Doppler ultrasound crystal is included in the energy delivery catheter to measure blood flow within the vessel lumen, providing a direct means of measuring or indicating blood flow or the desired lack of blood flow; [0104]: In one example the initial temperature is at or near boiling temperature for the fluid (e.g., blood) in the lumen and then after an initial period that can cause spasm of the vessel and/or drive the soluble gas from within the surrounding fluid the temperature is increased above the boiling temperature for the fluid; wherein according to paragraph [0308], an indicator of ablation progress is a decrease in bubbling in which this would be visible via ultrasound utilized for monitoring of occlusion of a blood vessel, as detailed in [0133] of Esch).
Claims 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over Esch in view of Nasab, Thompson, Nguyen et al. (U.S. Pub. No. 20110166519, previously cited), herein referred to as “Nguyen” and further in view of Hossack.
Regarding claim 16, Esch discloses a method of delivering a heat based treatment to a perforator vein of a patient (Title: Venous disease treatment; [0106]: For example, a needle (or short sheath) can be punctured through the skin directly into a perforator vein; [0188]: The techniques described in the preceding text and figures can be mixed and matched as circumstances demand to produce alternative implementations), comprising:
coupling a heating catheter (catheter 102) to an energy delivery console using a TRS connector associated with the heating catheter ([0067]: an electrical connection between the heating catheter 102 and energy delivery console 104 can be made by plugging a long catheter cable (built as part of the disposable energy delivery catheter) directly into energy delivery console 104; [0118]: The cable may plug into energy delivery console 104 by a ¼″ TRS stereo plug if the cable is grounded, or by a ¼″ TS mono plug if the cable is not grounded), the heating catheter (treatment probe 102) comprising:
a handle ([0046]: the catheter handle) having a push button ([0062]: The handle can also include a button);
circuitry to power the handle (diagram 102 in Fig. 6; [0063]: heating catheter 102 includes central processing unit (CPU) 600, which is in communication with temperature reference engine 602, debouncing circuitry 604 for pushbutton 606, thermocouple amplifier 608 for thermocouple 610, power router 616, heater resistance measurement engine 618, and communication engine 620);
an elongate shaft having a proximal end and a distal end ([0042]: heating catheter 102, which is a long, thin, flexible, or rigid device that can be inserted into a narrow anatomical lumen such as a vein);
a single heating element (heating element 106) formed from a resistive coil positioned at a distal most end of the heating catheter ([0042]: Heating catheter 102 is connected to energy delivery console 104 to provide energy causing heating at the distal end of heating catheter 102; [0043]: heating element 106 that is heated by electrical current; [0049]: heating element 106 can be created from a coiled configuration of wire (single or double-lead); see Figs. 4A & 4B & Fig. 2 where heating element 106 is shown as being at the distal most end);
a thermocouple (thermocouple 124; Fig. 4A) positioned within the single heating element used to measure a temperature of the heating element ([0050]: temperature sensor 124 (e.g., thermocouple or thermistor) … temperature sensor 124 can be placed between coil winds);
a thermocouple amplifier (thermocouple amplifier 608, Fig. 6);
preparing the energy delivery console for delivery of thermal energy using the heating catheter by automatically recognizing the heating catheter as having the heating element ([0085]: In a specific implementation, a multi-use cable is configured to include a radio-frequency (RF) antenna that is capable of sensing an RFID tag embedded in the catheter near the point of connection between the catheter and the cable; [0118]: The cable plug housing may include an RFID tag that can be recognized by energy delivery console 104 to identify the catheter type);
accessing a vessel of the patient using a needle and cannula assembly ([0106]: For example, a needle (or short sheath) can be punctured through the skin directly into a perforator vein … the needle can be pushed into the patient towards a view until an ultrasound image shows the needle tip within the lumen of the vein and blood flashback drips from the end of the needle indicating that the needle lumen is in fluid communication with the blood lumen);
introducing the heating catheter into the vessel of the patient to an initial treatment site ([0106]: The energy delivery catheter can be advanced further along the vein lumen if desired, guided by angulation of the catheter shaft, by rotation of a curved tip of the energy delivery catheter, and/or by advancing the energy delivery catheter over a guide wire inserted through the catheter lumen);
initiating a single heating segment thermal delivery profile in the energy delivery console by pressing a button on the handle or a footswitch of the heating catheter ([0112]: pressing one of two or more treatment buttons on a catheter handle whereas each of the treatment buttons signifies a desired treatment time or energy delivery);
providing heat therapy at the initial treatment site according to the single heating segment thermal delivery profile while the energy delivery console monitors an output of the thermocouple associated with the heating element to a setpoint ([0107]: Energy can be delivered to the proximal superficial vein segment via segmental ablations, continuous pullback while heating, or by a combination thereof, to the junction of the vessels. Next, the catheter can be advanced down into the perforator vein (ideally past the deep fascia layer and near to the deep vein) and energy can be delivered to the perforator vein, via segmental ablations, continuous pullback while heating, or by a combination thereof; [0115]: In a specific implementation, control of the actual delivery of energy to the heating element can be via temperature feedback (e.g., proportional-integral-derivative (PID) control) to achieve and maintain a desired treatment temperature, by delivery of a set power level, or by delivery of a variable power level according to a power-time relationship. A power-time relationship can be configured to approximate the level of power per time that would normally be delivered to an intended vessel if that system were temperature-controlled to attain and maintain a desired set temperature; [0055]: One or more temperature measuring features (e.g., thermocouple, thermistor, resistance temperature detector) can be located along the length of the heating element or configured within the heating element);
wherein the heating catheter has information in a flash memory to identify a type of the heating catheter ([0064]: Heating catheter 102 may also have a memory module to store information such as device identification and operating parameters for energy delivery console 104, device-specific calibration information and past record of testing and/or product use).
While Esch fails to disclose wherein the heating element having a length of 5 mm. However, it would be obvious to one of ordinary skill in the art for the heating element to have a length of 5 mm because it involves a change in size of a feature, in which it has been held that a change in size is within the level of ordinary skill in the art, see MPEP 2144.04 (IV)(A).
But Esch fails to disclose an isolation amplifier to galvanically isolate the thermocouple amplifier from a reference ground; and a voltage source to power the isolation amplifier, the voltage source being galvanically isolated from the circuitry to power the handle.
However, Nasab discloses a method of treating a vessel at a treatment site (Abstract: A system and method for efficient delivery of radio frequency (RF) energy), comprising a flexible heating catheter (ablation catheter 160) comprising
an energy element (electrode 164) adjacent the distal end (see Fig. 1a), the energy element comprising a generally helically shaped resistive heater coil disposed near the distal end of the elongate shaft ([0044]: coil electrodes);
a thermocouple (thermocouple sensors 162) positioned within the heater coil used to measure a temperature of the energy element ([0057]: each electrode 164 has a corresponding thermocouple sensor 162 that provides temperature feedback information at the tissue site immediately proximal to the electrode delivering the RF energy);
a thermocouple amplifier (“Instrumentation AMP” in patient isolation 12 in Fig. 3; [0048]: thermocouple amplifiers);
an isolation amplifier (“Isolation Amp” in patient isolation 12 in Fig. 3) to galvanically isolate the thermocouple amplifier from a reference ground ([0054]: The isolation circuits, both the power supply and the thermocouple amplifiers, are designed to isolate the patient from the main power source circuitry by 2500 volts); and
a voltage source to power the isolation amplifier (“Isolation Power Supply” in patient isolation 12 in Fig. 3), the voltage source being galvanically isolated from the circuitry to power the handle ([0054]: The isolation circuits, both the power supply and the thermocouple amplifiers, are designed to isolate the patient from the main power source circuitry by 2500 volts).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the energy-emitting probe of Esch to include the isolation of Nasab for the purpose that using isolated circuits for all patient connections ensures patient safety even with failed components and to isolate the patient from the main power source circuitry by 2500 volts (Nasab: [0048], [0054]).
While Esch discloses a shell (non-stick outer layer 116) extending along an exterior of the energy element (see Fig. 3) but Esch in view of Nasab fail to disclose a bulging rounded distal tip; and
a shell extending along an exterior of the energy element and abutting and terminating at a proximal curve of the bulging rounded distal tip, a distal end of the energy element set back from a distalmost end of the energy-emitting probe by only the bulging rounded distal tip.
However, Thompson discloses a bulging rounded distal tip (thermally-conductive tip 30; [0254]: a thermally-conductive tip 30 or extension near the tip); and
a shell (sleeve 47) extending along an exterior of the energy element and abutting and terminating at a proximal curve of the bulging rounded distal tip, a distal end of the energy element set back from a distalmost end of the energy-emitting probe by only the bulging rounded distal tip ([0255]: The distal section of the catheter in FIG. 4 shows the resistive element 14 covered by a sleeve 47 … The sleeve material may also be preferably chosen to provide uniformity of heating along the full length of the heating coil; see Figs. 3-4 where the sleeve 47 covers the length of the resistive element 14 such that the sleeve abuts and terminates at a proximal curve of the thermally conductive tip 30 & a distal end of resistive element 14 is set back from a distalmost end of the energy-emitting probe by only the thermally conductive tip 30).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the energy emitting probe of Esch in view of Nasab to include a bulging rounded distal tip and a shell, as taught by Thompson for the purpose of the tip extending heating toward the distal tip of the catheter and the shell providing uniformity of heating along the full length of the heating coil (Thompson: [0254]-[0255]).
But Esch in view of Nasab and Thompson fails to disclose a 130 degrees Celsius setpoint.
However, Nguyen discloses a method of delivering a heat based treatment to a perforator vein of a patient (Abstract: A method of performing therapy on tissue using a medical apparatus; [0148]: heating the coil sufficiently for treating the adjacent wall of the perforator vein P), comprising a 130 degrees Celsius setpoint ([0148]: Alternatively, the treatment temperature can be between 70 and 200 degrees Celsius, or between 120 and 160 degrees Celsius, and the treatment period can be varied above or below one minute to achieve the desired therapeutic effect). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the temperature setpoint of Esch to the setpoint of Nguyen for the purpose of temperature causing the vein to heat up in response to the temperature and to shrink around the heating coil (Nguyen: [0149]).
But Esch in view of Nasab, Thompson and Nguyen fail to disclose wherein the heating catheter has information in a flash memory to identify a type of the heating catheter, including regional codes that limit the use of particular catheter types to particular geographic regions, and including one or more treatment cycle use limits.
However, Hossack discloses wherein the heating catheter has information in a flash memory to identify a type of the heating catheter, including regional codes that limit the use of particular catheter types to particular geographic regions, and including one or more treatment cycle use limits (Col. 6, lines 46-53: The RFID chip 203 may have a memory of 128 bytes, alternatively 1K byte, alternatively 2K bytes alternatively 4K bytes to store catheter specific information, including for example catheter serial number, name, make or model, calibration coefficients, imaging element sensitivity, time gain control, post amp gain, number of permissible uses, geographic location of permissible use, boot mode, pulse width, or expiration date of the catheter).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the energy emitting probe of Esch in view of Nasab, Thompson and Nguyen to include a flash memory as taught by Hossack, since it is advantageous to know information regarding the function and performance of the catheter (Hossack: Abstract).
Regarding claim 17, Esch discloses wherein the initial treatment site is a perforator vein at or below a fascia layer ([0107]: Energy can be delivered to the proximal superficial vein segment via segmental ablations, continuous pullback while heating, or by a combination thereof, to the junction of the vessels. Next, the catheter can be advanced down into the perforator vein (ideally past the deep fascia layer and near to the deep vein) and energy can be delivered to the perforator vein, via segmental ablations, continuous pullback while heating, or by a combination thereof).
Regarding claim 18, Esch discloses wherein pressing the button initiates delivery of a single 20 second heat treatment of the single heating segment thermal delivery profile ([0112]: In a specific implementation, the length of the treatment time (e.g., 20 seconds, 30 seconds, 40 seconds) or the total amount of energy delivered (e.g., 60 J/cm, 80 J/cm, 100 J/cm, 120 J/cm) may be user-selectable, such as by pressing a touchscreen to select a desired time or by pressing one of two or more treatment buttons on a catheter handle whereas each of the treatment buttons signifies a desired treatment time or energy delivery).
Regarding claim 19, Esch discloses advancing the needle and cannula assembly into the vessel above a fascia layer and advancing the heating segment through the cannula to the initial treatment site at or below the fascia layer ([0107]: Energy can be delivered to the proximal superficial vein segment via segmental ablations, continuous pullback while heating, or by a combination thereof, to the junction of the vessels. Next, the catheter can be advanced down into the perforator vein (ideally past the deep fascia layer and near to the deep vein) and energy can be delivered to the perforator vein, via segmental ablations, continuous pullback while heating, or by a combination thereof).
Regarding claim 20, Esch discloses monitoring temperature at the initial treatment site and modulating power delivery to the heating element in response to the monitored temperature ([0115]: In a specific implementation, control of the actual delivery of energy to the heating element can be via temperature feedback (e.g., proportional-integral-derivative (PID) control) to achieve and maintain a desired treatment temperature, by delivery of a set power level, or by delivery of a variable power level according to a power-time relationship. A power-time relationship can be configured to approximate the level of power per time that would normally be delivered to an intended vessel if that system were temperature-controlled to attain and maintain a desired set temperature).
Regarding claim 21, Esch discloses initiating a plurality of heat treatments within the perforator vein at multiple segments from the initial treatment site at or below the fascia layer, across the fascia layer, and above the fascia layer ([0107]: Energy can be delivered to the proximal superficial vein segment via segmental ablations, continuous pullback while heating, or by a combination thereof, to the junction of the vessels. Next, the catheter can be advanced down into the perforator vein (ideally past the deep fascia layer and near to the deep vein) and energy can be delivered to the perforator vein, via segmental ablations, continuous pullback while heating, or by a combination thereof; where starting at the deep vein and pulling back while ablating in segments includes ablating at multiple segments, at or below the fascia, across the fascia and above the fascia).
Conclusion
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794