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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/10/2025 has been entered.
Response to Amendment
The Amendments filed 12/10/2025 have been entered. Currently, claims 1, 3, 11, 13-14, and 16 have been amended, and claims 1-20 are pending in the application.
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. 20110202053A1), 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 (Col. 13, lines 24-28), 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 (Col. 12, lines 34-41); and
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 a non-transitory computer storage medium, nor 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.
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 (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 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).
Moreover, 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 deployment mechanism of Moss into the handle of Megerman to allow the user to have more precise control of the deployment length of each probe arm.
Lastly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the manual method of independently controlling the deployment of each of the probe arms, as taught by Moss, to be automatically controlled by the circuit controller of Megerman, since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
However, Megerman/Moss 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 able to be deployed radially away and retracted 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/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/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/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/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/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 (Col. 6, lines 56-60), 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 (Col. 12, lines 34-41); and
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 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.
Moss, in the same field of endeavor, teaches systems, an energy delivery device (1) 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 deployment mechanism of Moss into the handle of Megerman to allow the user to have more precise control of the deployment length of each probe arm.
Moreover, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the manual method of independently controlling the deployment of each of the probe arms, as taught by Moss, to be automatically controlled by the circuit controller of Megerman, since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
However, Megerman/Moss combination do not disclose 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/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 (Col. 12, lines 34-41), 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 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.
Moss, in the same field of endeavor, teaches systems, an energy delivery device (1) 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 deployment mechanism of Moss into the handle of Megerman to allow the user to have more precise control of the deployment length of each probe arm.
Moreover, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the manual method of independently controlling the deployment of each of the probe arms, as taught by Moss, to be automatically controlled by the circuit controller of Megerman, since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
However, Megerman/Moss combination do not disclose 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/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, 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/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/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 12/10/2025, with respect to the 103 rejection of independent claim 1 under Megerman, Mickelson, and Hastings, and with respect to the 103 rejection of independent claims 11 and 20 under Megerman and Hastings the arguments have been fully considered and are found to be persuasive. Specifically, Applicant’s amendments to claims to further require the system for tumor ablation to comprise each probe arm to be configured to independently extend from or extract into a respective opening of the tumor ablation probe device and to be independently controlled by the circuit controller is defined over each of Megerman, Mickelson, and Hastings given that neither contemplates this claimed configuration. 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. 20110202053A1), 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 Megerman, Moss, and Hastings are tenable for at least the reasoning set forth in the action above.
Conclusion
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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794