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 Amendments filed April 08, 2026 have been entered. Currently, claims 1, 11, 14, and 16 have been amended, and claims 1-20 are pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding independent claims 1, 11, and 14, the claim presently recites, “wherein each of the first probe arm and the second probe arm is configured for independent control and independent movement by the circuit controller”.
The Examiner has reviewed the instant disclosure and has identified a recitation of the movement of the first probe arm and the second probe arm, as well as a recitation of the functionality of the circuit controller. Specifically, paragraph [0026] of the filed Specification provides that, “Each probe arm 116 is respectively configured to extend from or retract into each opening 114 of the intermediate surface 104 individually and/or independently”, and paragraph [0043] which describes, “The distal end 106, 206, 306, 406 may include, or proximally include, at least one ETM 118A on a first probe arm 116A and at least one ETM 118B on a second probe arm 116B (FIG. 1), and each of the first probe arm 116A and the second probe arm 116B may be configured for independent control by the circuit controller. In embodiments, the ETMs 118 on a same probe arm 116 may be independently controlled and/or ETMs 118 on different probe arms 116, such as the first and second probe arms 116A, 116B, may be independently controlled”.
The circuit controller, as described in the Specification, is interested in controlling each ETM on each arm, but is, at most, silent as to whether this control encompasses the movement/individual deployment of each arm. The disclosure provides much of discussion about the individual control of the probes, however, this is all in context of the ETM’s on each probe arm.
Thus, it is the Examiner’s position that the requirement of claims 1, 11, and 14 of the first probe arm and the second probe arm being configured for both independent control and independent movement by the circuit controller has no support since this
was not described in the Specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject
to pre-AIA U.S.C. 112, the inventor(s), at the time the application was filed, had passion
of the claimed invention given that the disclosure specifically provides that the circuit controller only independently controls the ETMs on the different probe arms. Claims 2-10, 12-13, 15-20 are also rejected because they are dependent on claims 1, 11, and 14.
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 1-5, 7, 9-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Megerman (U.S. Patent No. 7238184 B2), in view of Moss (U.S. Application No. 20110202053 A1), in view of Larry (U.S. Application No. 20170258517 A1), and further in view of Hastings (U.S. Patent No. 8473067 B2).
Regarding independent claim 1, Megerman discloses a system for tumor ablation (100) with controlled precision of a temperature profile utilizing a tumor ablation probe device (202) (Col. 12, lines 4-8 & Figs. 1, 7-11B), the system comprising:
the tumor ablation probe device including a distal end (210), the distal end comprising a distal tip (214) (Col. 12, lines 8-11) and a plurality of electrothermal modules (ETMs) (130) proximally disposed on a device surface (in the embodiment where needle electrodes 224 are themselves the ETMs, as described in Col. 13, lines 27-28, the plurality of ETMs are proximally disposed on a device surface, at least in a retracted configuration as shown in Figures 7 and 9, wherein the ETMs are proximal to a device surface surrounding the distal tip), each ETM including a first surface component (138) and a second surface component (136) opposite and electrically connected to the first surface component (Col. 7, lines 18-26 & Fig. 3), wherein the distal end includes the at least one ETM of the plurality of ETMs on a first probe arm (224) and at least other one ETM of the plurality of ETMs on a second probe arm (224), wherein each probe arm is configured to extend from or retract (due to movement of plunger 226 relative to the handle 216) into a respective opening (i.e., out of the distal end 210) of the tumor ablation probe device. Examiner notes that Megerman is not explicitly clear on whether each of the probe arms are deployable from the distal end 210 as described in Col. 12, lines 36-41, or if they are deployable from the distal tip 214 as illustrated in Fig. 11A; however, in either scenario the probe arms are still extendable/retractable from at least one opening of the tumor ablation probe device.
Megerman further discloses a circuit controller (not shown) communicatively coupled to the tumor ablation probe device (Col. 9, lines 11-15), wherein the circuit controller causes the system to:
supply, via the circuit controller, one of a first voltage of a first polarity (i.e., positive) and a second voltage of a second polarity (i.e., negative) opposite the first polarity to at least one ETM of the plurality of ETMs (Col. 2, lines 45-48; Col. 7, lines 21-30), wherein when the first polarity is supplied, the at least one ETM heats the first surface component and cools the second surface component, and when the second polarity is supplied, the at least one ETM cools the first surface component and heats the second surface component (Col. 7, lines 21-30; Col. 11, lines 30-36); and
repeatedly alternate, via the circuit controller, between the first polarity and the second polarity based on a time sequence cycle (i.e., a period of time comprising the application of energy before and/or during a treatment, as described in Col. 2, lines 44-58), wherein each ETM is configured for independent control (e.g., independent control of on/off operations or individual adjustment the DC power supplied to each ETM) by the circuit controller (Col. 10, lines 29-41; Col. 11, lines 63-67 – Col. 12, lines 1-3).
However, Megerman does not explicitly disclose the distal tip having a closed end, a non-transitory computer storage medium, nor wherein each probe arm is configured to independently extend from or retract from the probe device.
Moss, in the same field of endeavor, teaches an energy delivery device (1) comprising an elongated probe body (5) with a plurality of deployable guide sleeves (22) adapted to receive a plurality of electrodes (7,9,11,13,15,17), and a sharp, closed end, probe tip (30) at a distal end of the probe body for piercing tissue (pa. 0023-0024 & Fig. 1). The energy delivery device is coupled to a computer (40) and a generator (25) comprising a controller (56) (pa. 0030-0031 & Fig. 2), wherein the computer comprises a memory storage (44) and a data storage (50) such as a hard disk (a.k.a., a non-transitory computer storage medium) (pa. 0033).
Furthermore, Moss teaches the energy delivery device comprising a deployment mechanism (inside of handle 23) configured to independently and manually control the extent (length) of the deployment of each electrode from the probe body using electrode slide tabs (26) located on the handle (pa. 0026).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the structural configuration of the tumor ablation probe of Megerman with the structural configuration of the energy delivery device taught by Moss, including the mechanical arrangement of the plurality of guide sleeves with the plurality of electrodes being deployable from the probe body proximal from the distal closed end probe tip as well as the deployment mechanism located inside the handle, for the purpose of allowing the user to have independent control of the radial actuation and angle/length of deployment of each probe arm relative to the longitudinal axis of the ablation probe device to ensure optimal procedural results.
Furthermore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the computer of Moss to the system for tumor ablation of Megerman for the purpose of storing treatment instructions that include software which signals to the controller when/how to perform various operations, as well as allowing the user to plan, execute, and review the results of a treatment (Moss, pa. 0033).
However, Megerman/Moss combination do not teach wherein each of the first probe arm and the second probe arm is configured for independent control and independent movement by the circuit controller.
Larry, in the same field of endeavor, teaches a system comprising a plurality of electrodes (22) that are individually positionable and deployable from a lumen of a delivery member (12) in a target tissue (pa. 0047, 0050 & Fig. 1). The system further includes a hub or handle (180) coupled to a controller or control unit, wherein the deployment of the electrodes is controlled by the hub (pa. 0062, 0067).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the functionality of the circuit controller of Megerman to include the functionalities described in Larry for the purpose of allowing the circuit controller to independently control the advancement/retraction of the first and second probe arm in order to provide precise treatment to the targeted tissue.
However, Megerman/Moss/Larry combination do not teach a pre-determined cycling of heating and cooling cycles of the ETMs during the time sequence cycle such that more than one polarity switch between the first polarity and the second polarity occurs in the time sequence cycle, nor a first ETM that is configured to be supplied with the first polarity while a second ETM is configured to be supplied with the second polarity during the time sequence cycle.
Hastings, in the same field of endeavor, teaches an ablation apparatus (80) comprising a plurality of thermoelectric elements (84) configured to operate in a hyperthermic mode, for thermally denervating the targeted tissue, and a hypothermic mode, for cooling the tissue (Col. 20, lines 39-46 & Fig. 7), wherein each mode is controlled (via a control circuit; Col. 6, lines 19-20; Col. 20, lines 50-59) to be applied in a sequential and repetitive manner during an operation or time sequence cycle (Col. 9, lines 34-44; Col. 20, lines 46-49; Col. 21, lines 18-22). Furthermore, Hastings teaches a configuration in which a first set of the thermoelectric elements are configured or controlled to operate in a hyperthermic mode, while another set of thermoelectric elements are configured or controlled to operate in a hypothermic mode (Col. 21, lines 14-18) during a time sequence cycle.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the operations of the circuit controller of Megerman in order to incorporate the repetitive cycles of heat/cooling, as well as the individual but synchronous operation of each ETM to either heat or cool during a time sequence cycle as taught by Hastings for the purpose of efficiently and precisely providing treatment to the targeted tissue.
Regarding claim 2, Megerman discloses the circuit controller causes the system to supply one of the first voltage of the first polarity and the second voltage of the second polarity to the at least one ETM of the plurality of ETMs and not to at least one other ETM of the plurality of ETMs (Col. 4, lines 13-19; Col. 10, lines 61-65 & Fig. 6C).
However, Megerman does not explicitly disclose a non-transitory computer storage medium.
Moss, in the same field of endeavor, teaches systems, an energy delivery device (1) coupled to a computer (40) and a generator (25) comprising a controller (56) (pa. 0030-0031 & Figs. 1-2), wherein the computer comprises a memory storage (44) and a data storage (50) such as a hard disk (i.e., a non-transitory computer storage medium) (pa. 0033). Furthermore, Moss teaches the energy delivery device comprising a deployment mechanism (inside of handle 23) configured to independently and manually control the extent (length) of the deployment of each electrode from probe (5) using electrode slide tabs (26) located on the handle (pa. 0026).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the computer of Moss to the system for tumor ablation of Megerman for the purpose of storing treatment instructions that include software which signals to the controller when/how to perform various operations, as well as allowing the user to plan, execute, and review the results of a treatment (Moss, pa. 0033).
Regarding claims 3, 13, and 16, Megerman discloses the distal tip facing in a longitudinal orientation aligned with a longitudinal axis of the tumor ablation probe device (see Figs. 7-9).
However, Megerman does not explicitly disclose each opening of the tumor ablation probe device from which or into which each probe arm extends or retracts is disposed on an intermediate surface of the tumor ablation probe device, the intermediate surface disposed proximal of the distal tip, and each opening facing in a lateral orientation laterally disposed with respect to the longitudinal axis.
Moss, in the same field of endeavor, teaches the probe body (5) of the delivery device (1) includes a plurality of openings (Examiner interprets the presence of a plurality of openings on the probe body since the guide sleeves 22 are described to be radially deployable and retractable from the probe body, pa. 0027) from which or into which each probe arm (7,9,11,13,15,17) extends or retracts is disposed on an intermediate surface of the probe body (see Fig. 1), the intermediate surface disposed proximal of a distal tip (30) (pa. 0025, see Fig. 1), and each opening facing in a lateral orientation laterally disposed with respect to a longitudinal axis (see Fig. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the location of the openings of Megerman to be on an intermediate surface and facing in a lateral orientation, as taught by Moss, since they are both known equivalents in the art and they would both yield the same predictable results of providing treatment in an annular fashion.
Regarding claims 4 and 17, Megerman/Moss/Larry/Hastings combination discloses wherein the first polarity is positive and the second polarity is negative (Megerman, Col. 7, lines 21-30).
Regarding claims 5 and 18, Megerman/Moss/Larry/Hastings combination discloses wherein the first polarity is negative and the second polarity is positive (Megerman, Col. 11, lines 30-36).
Regarding claims 7 and 20, Megerman/Moss/Larry/Hastings combination discloses wherein the first voltage is different from the second voltage (i.e., by dynamically controlling the amount of voltage delivered depending on the stage of the ablation progress) (Megerman, Col. 10, lines 29-41).
Regarding claim 9, Megerman/Moss/Larry/Hastings combination discloses wherein when the first polarity is supplied, the at least one ETM heats the first surface component to a range from about 45 degrees Celsius to about 50 degrees Celsius, and when the second polarity is supplied, the at least one ETM cools the first surface component to about −10 degrees Celsius (Megerman, Col. 11, lines 12-18; Col. 11, lines 40-43).
Examiner is highlighting the fact that the hot sides of the thermoelectric devices of the prior art can be effectively maintained at body temperature (approximately, 37.degree. C.) and could potentially be heated to a temperature of 96 degrees C. Therefore, the device is capable of reaching the temperatures of 45 degrees Celsius to about 50 degrees Celsius. Moreover, since the cold sides of the thermoelectric devices can reach a temperature of -22.degree. C, then effectively, it is able to pass/reach -10 degrees Celsius. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 10, Megerman/Moss/Larry/Hastings combination discloses wherein the first surface component of each ETM is electrically connected to the second surface component of each respective ETM through a p-n couple (Megerman, Col. 7, lines 38-43 & Figs. 4-5).
Regarding independent claim 11, Megerman discloses a method for tumor ablation with controlled precision of a temperature profile (Col. 9, lines 64-67) utilizing a tumor ablation probe device (202) (Col. 12, lines 4-8 & Figs. 1, 7-11B), the method comprising:
disposing a distal end (210) of the tumor ablation probe device in a tissue, the distal end comprising a distal tip (214) (Col. 12, lines 8-11) and a plurality of electrothermal modules (ETMs) (130) proximally disposed on a device surface (in the embodiment where needle electrodes 224 are themselves the ETMs, as described in Col. 13, lines 27-28, the plurality of ETMs are proximally disposed on a device surface, at least in a retracted configuration as shown in Figures 7 and 9, wherein the ETMs are proximal to a device surface surrounding the distal tip), each ETM including a first surface component (138) and a second surface component (136) opposite and electrically connected to the first surface component (Col. 7, lines 18-26 & Fig. 3), wherein the distal end includes the at least one ETM of the plurality of ETMs on a first probe arm (224) and at least other one ETM of the plurality of ETMs on a second probe arm (224), wherein each probe arm is configured to extend from or retract (due to movement of plunger 226 relative to the handle 216) into a respective opening (i.e., out of the distal end 210) of the tumor ablation probe device. Examiner notes that Megerman is not explicitly clear on whether each of the probe arms are deployable from the distal end 210 as described in Col. 12, lines 36-41, or if they are deployable from the distal tip 214 as illustrated in Fig. 11A; however, in either scenario the probe arms are still extendable/retractable from at least one opening of the tumor ablation probe device.
Megerman further discloses supplying, via a circuit controller (not shown) communicatively coupled to the tumor ablation probe device, one of a first voltage of a first polarity (i.e., positive) and a second voltage of a second polarity (i.e., negative) opposite the first polarity to at least one ETM of the plurality of ETMs (Col. 2, lines 45-48; Col. 7, lines 21-30), wherein when the first polarity is supplied, the at least one ETM heats the first surface component and cools the second surface component, and wherein when the second polarity is supplied, the at least one ETM cools the first surface component and heats the second surface component (Col. 7, lines 21-30; Col. 11, lines 30-36); and
repeatedly alternate, via the circuit controller, between the first polarity and the second polarity based on a time sequence cycle (i.e., a period of time comprising the application of energy before or during a treatment, as described in Col. 2, lines 44-58), wherein each ETM is configured for independent control (e.g., independent control of on/off operations or individual adjustment the DC power supplied to each ETM) by the circuit controller (Col. 10, lines 29-41; Col. 11, lines 63-67 – Col. 12, lines 1-3).
However, Megerman does not explicitly disclose the distal tip having a closed end, wherein each probe arm is configured to independently extend from or retract from the probe device.
Moss, in the same field of endeavor, teaches an energy delivery device (1) comprising an elongated probe body (5) with a plurality of deployable guide sleeves (22) adapted to receive a plurality of electrodes (7,9,11,13,15,17), and a sharp, closed end, probe tip (30) at a distal end of the probe body for piercing tissue (pa. 0023-0024 & Fig. 1).
Furthermore, Moss teaches the energy delivery device comprising a deployment mechanism (inside of handle 23) configured to independently and manually control the extent (length) of the deployment of each electrode from the probe body using electrode slide tabs (26) located on the handle (pa. 0026).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the structural configuration of the tumor ablation probe of Megerman with the structural configuration of the energy delivery device taught by Moss, including the mechanical arrangement of the plurality of guide sleeves with the plurality of electrodes being deployable from the probe body proximal from the distal closed end probe tip as well as the deployment mechanism located inside the handle, for the purpose of allowing the user to have independent control of the radial actuation and angle/length of deployment of each probe arm relative to the longitudinal axis of the ablation probe device to ensure optimal procedural results.
However, Megerman/Moss combination do not teach wherein each of the first probe arm and the second probe arm is configured for independent control and independent movement by the circuit controller.
Larry, in the same field of endeavor, teaches a system comprising a plurality of electrodes (22) that are individually positionable and deployable from a lumen of a delivery member (12) in a target tissue (pa. 0047, 0050 & Fig. 1). The system further includes a hub or handle (180) coupled to a controller or control unit, wherein the deployment of the electrodes is controlled by the hub (pa. 0062, 0067).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the functionality of the circuit controller of Megerman to include the functionalities described in Larry for the purpose of allowing the circuit controller to independently control the advancement/retraction of the first and second probe arm in order to provide precise treatment to the targeted tissue.
However, Megerman/Moss/Larry combination do not teach a pre-determined cycling of heating and cooling cycles of the ETMs during the time sequence cycle such that more than one polarity switch between the first polarity and the second polarity occurs in the time sequence cycle, nor a first ETM that is configured to be supplied with the first polarity while a second ETM is configured to be supplied with the second polarity during the time sequence cycle.
Hastings, in the same field of endeavor, teaches an ablation apparatus (80) comprising a plurality of thermoelectric elements (84) configured to operate in a hyperthermic mode, for thermally denervating the targeted tissue, and a hypothermic mode, for cooling the tissue (Col. 20, lines 39-46 & Fig. 7), wherein each mode is controlled (via a control circuit; Col. 6, lines 19-20; Col. 20, lines 50-59) to be applied in a sequential and repetitive manner during an operation or time sequence cycle (Col. 9, lines 34-44; Col. 20, lines 46-49; Col. 21, lines 18-22). Furthermore, Hastings teaches a configuration in which a first set of the thermoelectric elements are configured or controlled to operate in a hyperthermic mode, while another set of thermoelectric elements are configured or controlled to operate in a hypothermic mode (Col. 21, lines 14-18) during a time sequence cycle.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the operations of the circuit controller of Megerman in order to incorporate the repetitive cycles of heat/cooling, as well as the individual but synchronous operation of each ETM to either heat or cool during a time sequence cycle as taught by Hastings for the purpose of efficiently and precisely providing treatment to the targeted tissue.
Regarding claim 12, Megerman/Moss/Larry/Hastings combination discloses wherein the one of the first voltage of the first polarity and the second voltage of the second polarity is supplied to the at least one ETM of the plurality of ETMs and not to at least one other ETM of the plurality of ETMs (Megerman, Col. 4, lines 13-19; Col. 10, lines 61-65 & Fig. 6C).
Regarding independent claim 14, Megerman discloses a method for tumor ablation with controlled precision of a temperature profile (Col. 9, lines 64-67) utilizing a tumor ablation probe device (202) (Col. 12, lines 4-11 & Figs. 7-8), the method comprising:
disposing a distal end (210) (Col. 12, lines 3-540) of the tumor ablation probe device in a tissue, the distal end comprising a distal tip (214) (Col. 12, lines 8-11) and at least one electrothermal module (ETM) (130) (Col. 6, lines 56-60) on a first probe arm (224) and at least one ETM on a second probe arm (224) (Col. 13, lines 24-28 & Fig. 8), wherein each probe arm is configured to extend from or retract (due to movement of plunger 226 relative to the handle 216) into a respective opening (i.e., out of the distal end 210) of the tumor ablation probe device. Examiner notes that Megerman is not explicitly clear on whether each of the probe arms are deployable from the distal end 210 as described in Col. 12, lines 36-41, or if they are deployable from the distal tip 214 as illustrated in Fig. 11A; however, in either scenario the probe arms are still extendable/retractable from at least one opening of the tumor ablation probe device.
Megerman further discloses each ETM including a first surface component (138) and a second surface component (136) opposite and electrically connected to the first surface component (Col. 7, lines 18-26 & Fig. 3);
supplying, via a circuit controller (not shown) communicatively coupled to the tumor ablation probe device, one of a first voltage of a first polarity (i.e., positive) and a second voltage of a second polarity (i.e., negative) opposite the first polarity to the at least one ETM on the first probe arm, the at least one ETM on the second probe arm, or both as one or more voltage-supplied ETMs (Col. 2, lines 45-48; Col. 7, lines 21-30), wherein when the first polarity is supplied, the one or more voltage-supplied ETMs respectively heats the first surface component and cools the second surface component, and when the second polarity is supplied, the one or more voltage-supplied ETMs cools the first surface component and heats the second surface component (Col. 7, lines 21-30; Col. 11, lines 30-36); and
repeatedly alternating, via the circuit controller, between the first polarity and the second polarity using a time sequence cycle (i.e., a period of time comprising the application of energy before or during a treatment, as described in Col. 2, lines 44-58), wherein each of the first probe arm and the second probe arm is configured for independent control by the circuit controller (Col. 4, lines 22-34; Col. 10, lines 29-34).
However, Megerman does not explicitly disclose the distal tip having a closed end, wherein each probe arm is configured to independently extend from or retract from the probe device.
Moss, in the same field of endeavor, teaches an energy delivery device (1) comprising an elongated probe body (5) with a plurality of deployable guide sleeves (22) adapted to receive a plurality of electrodes (7,9,11,13,15,17), and a sharp, closed end, probe tip (30) at a distal end of the probe body for piercing tissue (pa. 0023-0024 & Fig. 1).
Furthermore, Moss teaches the energy delivery device comprising a deployment mechanism (inside of handle 23) configured to independently and manually control the extent (length) of the deployment of each electrode from the probe body using electrode slide tabs (26) located on the handle (pa. 0026).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the structural configuration of the tumor ablation probe of Megerman with the structural configuration of the energy delivery device taught by Moss, including the mechanical arrangement of the plurality of guide sleeves with the plurality of electrodes being deployable from the probe body proximal from the distal closed end probe tip as well as the deployment mechanism located inside the handle, for the purpose of allowing the user to have independent control of the radial actuation and angle/length of deployment of each probe arm relative to the longitudinal axis of the ablation probe device to ensure optimal procedural results.
However, Megerman/Moss combination do not teach wherein each of the first probe arm and the second probe arm is configured for independent control and independent movement by the circuit controller.
Larry, in the same field of endeavor, teaches a system comprising a plurality of electrodes (22) that are individually positionable and deployable from a lumen of a delivery member (12) in a target tissue (pa. 0047, 0050 & Fig. 1). The system further includes a hub or handle (180) coupled to a controller or control unit, wherein the deployment of the electrodes is controlled by the hub (pa. 0062, 0067).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the functionality of the circuit controller of Megerman to include the functionalities described in Larry for the purpose of allowing the circuit controller to independently control the advancement/retraction of the first and second probe arm in order to provide precise treatment to the targeted tissue.
However, Megerman/Moss/Larry combination do not teach a pre-determined cycling of heating and cooling cycles of the ETMs during the time sequence cycle such that more than one polarity switch between the first polarity and the second polarity occurs in the time sequence cycle, nor a first ETM of the first probe arm is configured to be supplied with the first polarity while a second ETM of the second probe arm is configured to be supplied with the second polarity during the time sequence cycle.
Hastings, in the same field of endeavor, teaches an ablation apparatus (80) comprising a plurality of thermoelectric elements (84) configured to operate in a hyperthermic mode, for thermally denervating the targeted tissue, and a hypothermic mode, for cooling the tissue (Col. 20, lines 39-46 & Fig. 7), wherein each mode is controlled (via a control circuit; Col. 6, lines 19-20; Col. 20, lines 50-59) to be applied in a sequential and repetitive manner during an operation or time sequence cycle (Col. 9, lines 34-44; Col. 20, lines 46-49; Col. 21, lines 18-22). Furthermore, Hastings teaches a configuration in which a first set of the thermoelectric elements are configured or controlled to operate in a hyperthermic mode, while another separate set of thermoelectric elements are configured or controlled to operate in a hypothermic mode (Col. 21, lines 14-18) during a time sequence cycle.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the operations of the circuit controller of Megerman in order to incorporate the repetitive cycles of heat/cooling, as well as the individual but synchronous operation of each ETM to either heat or cool during a time sequence cycle as taught by Hastings for the purpose of efficiently and precisely providing treatment to the targeted tissue.
Regarding claim 15, Megerman/Moss/Larry/Hastings combination discloses wherein the one of the first voltage of the first polarity and the second voltage of the second polarity is supplied to one of the at least one ETM on the first probe arm and the at least one ETM on the second probe arm and not to the other of the at least one ETM on the first probe arm and the at least one ETM on the second probe arm (Megerman, Col. 4, lines 13-19; Col. 10, lines 61-65 & Fig. 6C).
Claims 6, 8, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Megerman, Moss, Larry, and Hastings as applied to claims 1 and 14 above, and further in view of Mickelson (W.O. Application No. 2015192018 A1).
Regarding claims 6 and 19, Megerman/Moss/Larry/Hastings combination discloses the invention substantially as claimed in claims 1 and 14 discussed above.
However, they do not disclose wherein the first voltage is equal to the second voltage.
Mickelson, in the same field of endeavor, teaches generating a plurality of voltages which can be generated with constant, or equal, positive and negative amplitudes (pa. 1049 & Fig. 3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the voltages of Megerman in order to produce equal amplitudes to allow the user to control the ablation process during a procedure.
Regarding claim 8, Megerman/Moss/Larry/Hastings combination discloses the invention substantially as claimed in claim 1 discussed above.
However, they do not disclose wherein the time sequence cycle is from about 2 seconds to about 5 seconds.
Mickelson, in the same field of endeavor, teaches a pulse having a duration between 2 and 30 seconds (pa. 1065).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the duration of each cycle in order to ensure that the temperature of the tissue can be controlled.
Response to Arguments
Applicant’s arguments, see pages 8-12, filed 04/08/2026, with respect to the 103 rejection of independent claim 1 under Megerman, Moss, and Hastings the arguments have been fully considered.
With regards to independent claims 1, 11 and 14, Applicant argues that Megerman does not disclose “the distal end comprising a distal tip having a closed end and a plurality of electrothermal modules (ETMs) proximally disposed on a device surface" are recited in amended claims. Specifically, Applicant contends that Megerman describes a delivery cannula with a slidably disposed inner probe 206, a distal end 210 having a sharpened distal tip 214, … and an electrode array 222 (of needle electrodes 224) being deployed from the cannula 204 at the distal end 210 through sharpened distal tip 214. Examiner finds this argument to partially unpersuasive.
Regarding the claim limitation of “a plurality of electrothermal modules (ETMs) proximally disposed on a device surface”, the Megerman reference discloses this claim language in the embodiment where needle electrodes 224 are themselves the ETMs, as described in Col. 13, lines 27-28, the plurality of ETMs are proximally disposed on a device surface, at least in a retracted configuration as shown in Figures 7 and 9, wherein the ETMs are proximal to a device surface surrounding the distal tip. Therefore, the rejection is maintained.
With regards to the claim limitation of “the distal end comprising a distal tip having a closed end”, Examiner agrees that the Megerman reference is, at best, unclear on whether or not the distal tip is open or closed given that Col. 12, lines 36-41 describes how the probe arms are deployable from the distal end 210, but figure 11A illustrates the probe arms being deployable from the distal tip 214. Examiner finds that Megerman is deficient in disclosing the newly amended language requiring the distal tip to have a closed end. Therefore, the Moss reference is relied upon to teach a structural arrangement of an ablation probe more in-line with the limitations set-forth in the independent claims. Moss teaches an energy delivery device (1) comprising an elongated probe body (5) with a plurality of deployable guide sleeves (22) adapted to receive a plurality of electrodes (7,9,11,13,15,17), and a sharp, closed end, probe tip (30) at a distal end of the probe body for piercing tissue (pa. 0023-0024 & Fig. 1). Furthermore, Moss teaches a deployment mechanism (inside of handle 23) configured to independently and manually control the extent (length) of the deployment of each electrode from the probe body using electrode slide tabs (26) located on the handle (pa. 0026). Therefore, it would have been prima facie obvious to have substituted the structural configuration of the tumor ablation probe of Megerman with the structural configuration of the energy delivery device taught by Moss, including the mechanical arrangement of the plurality of guide sleeves with the plurality of electrodes being deployable from the probe body proximal from the distal closed end probe tip as well as the deployment mechanism located inside the handle, for the purpose of allowing the user to have independent control of the radial actuation and angle/length of deployment of each probe arm relative to the longitudinal axis of the ablation probe device to ensure optimal procedural results. Therefore, based on the interpretations set-forth above, the rejection is maintained.
With regards to independent claims 1, 11 and 14, Applicant argues that the combination or references do not teach “wherein each probe arm is configured to independently extend from or retract from the probe device, nor wherein each of the first probe arm and the second probe arm is configured for independent control and independent movement by the circuit controller”. Specifically, Applicant contends that the Moss reference does not have any teaching or suggestion to modify the manual process to become an automated one, and that Megerman is also silent as to any independent control of needle electrodes 224, manual or automatic, and any such modification would further require a substantial reconstruction and redesign of Megerman. Examiner finds these arguments to be persuasive, and therefore, the rejection has been withdrawn. However, upon further consideration, the following
new grounds of rejection have been set forth in the action above:
Claims 1-5, 7, 9-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Megerman (U.S. Patent No. 7238184 B2), in view of Moss (U.S. Application No. 20110202053 A1), in view of Larry (U.S. Application No. 20170258517 A1), and further in view of Hastings (U.S. Patent No. 8473067 B2).
It is the Examiner’s position that the newly filed rejections based on the combination of references are tenable for at least the reasoning set forth in the action above.
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.
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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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