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 .
Examiner’s Note
The claims, abstract, drawings, and specification filed on May 4th, 2026 related to a sparker array are noted to have been submitted but are not considered as they appear to be related to a different application.
Response to Amendment
The claims filed on May 4th, 2026 regarding an IVL system have been entered. Claims 1- 27 are pending in the application. The amendments to claims 1, 19, 22, 24, and 25 overcome the previous claim objections.
Priority
As discussed in the Non-Final Rejection of February 3rd, 2026, the effective filing date for claims 1-11, 15- 22, and 25 is 11/11/2022 and the effective filing date for claims 12- 13 and 23- 24 is 09/05/2023.
Claim Objections
Claims 1- 21 are objected to because of the following informalities:
Claim 1, Line 10 states “space-apart electrodes”, it is suggested to change this to “spaced-apart electrodes”.
Claims 2- 21 are objected to for being dependent on or from objected claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 1-11, 14- 15, and 22 under 35 U.S.C. 102(a)(1) over Grace et al. (US 10,850,078) has been withdrawn in light of applicant’s amendments; specifically Grace does not teach wherein the one or more subsequent series of voltage pulses are generated responsive to a determination that one or more pressure waves generated by the one or more initial series of voltage pulses have a pressure magnitude below a predetermined threshold.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 12, 13, and 23 under 35 U.S.C. 103 over Grace et al. (US 10,850,078) in view of Manucherhabadi et al. (US 2021/0315639) has been withdrawn in light of applicant’s amendments; specifically Grace does not teach wherein the one or more subsequent series of voltage pulses are generated responsive to a determination that one or more pressure waves generated by the one or more initial series of voltage pulses have a pressure magnitude below a predetermined threshold.
The rejection of claims 16- 18 under 35 U.S.C. 103 over Grace et al. (US 10,850,078) has been withdrawn in light of applicant’s amendments; specifically Grace does not teach wherein the one or more subsequent series of voltage pulses are generated responsive to a determination that one or more pressure waves generated by the one or more initial series of voltage pulses have a pressure magnitude below a predetermined threshold.
The rejection of claims 19- 21 under 35 U.S.C. 103 over Grace et al. (US 10,850,078) has been withdrawn in light of applicant’s amendments; specifically Grace does not teach wherein the one or more subsequent series of voltage pulses are generated responsive to a determination that one or more pressure waves generated by the one or more initial series of voltage pulses have a pressure magnitude below a predetermined threshold.
The rejection of claim 24 under 35 U.S.C. 103 over Grace et al. (US 10,850,078) in view of Manucherhabadi et al. (US 2021/0315639) in further view of Liu et al. (CN 107633840 English Machine Translation) has been withdrawn in light of applicant’s amendments; specifically Grace does not teach wherein the one or more subsequent series of voltage pulses are generated responsive to a determination that one or more pressure waves generated by the one or more initial series of voltage pulses have a pressure magnitude below a predetermined threshold.
The rejection of claim 25 under 35 U.S.C. 103 over Grace et al. (US 10,850,078) in view of Manucherhabadi et al. (US 2021/0315639) in further view of Liu et al. (CN 107633840 English Machine Translation) has been withdrawn in light of applicant’s amendments; specifically Grace does not teach wherein the one or more subsequent series of voltage pulses are generated responsive to a determination that one or more pressure waves generated by the one or more initial series of voltage pulses have a pressure magnitude below a predetermined threshold.
Claim(s) 1- 11, 14- 18, 22, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US 10,850,078) in view of Miao et al. (CN 215458401U English Machine Translation).
Regarding claim 1, Grace (Grace et al.) teaches an intravascular lithotripsy (IVL) system (electrically-induced angioplasty balloon catheter system 100)(Figs. 1A- 1C, Figs. 4- 4A, Fig. 7)(Column 7, Lines 47- 55) with controllable pressure output (Column 17, Lines 12- 29 and Column 23, Lines 25- 36), comprising:
At least one set of spaced- apart electrodes (electrode assemblies 140 and 142)(Column 15, Lines 17- 30) for arrangement within a body lumen (Column 13, Lines 38- 43) while disposed within a fluid-fillable member (balloon 116) configured to contain conductive fluid therein (Column 15, Lines 28- 30)(As Grace teaches in Column 15, Lines 54- 58 that the liquid medium transforms the electrical energy to a pressure wave which is then passed through the liquid of the balloon assembly to the vasculature thereby moving the energy from the electrodes to the vasculature, the liquid is a conductive fluid.);
A voltage pulse generation system (high voltage pulse generator 90, coupler 128) configured to apply generated voltage pulses to the at least one set of spaced- apart electrodes and produce a plurality of pressure waves for IVL therapy (Column 17, Lines 12-14 and 30- 55), the voltage pulse generation system including a voltage pulse generator (90) in operative communication with the at least one set of spaced- apart electrodes (Column 17, Lines 12-14 and 30- 55) and in operative communication with an IVL control system (controller 750)(Column 23, Lines 30- 34) comprising a processor (Column 23, Line 44) configured to execute instruction stored on a memory (Column 23, Lines 40- 47), and circuitry configured to communicate signals based on operation of the processor (Column 23, Liens 51- 54) wherein the voltage pulse generation system is configured to generate a plurality of voltage pulses comprising an initial series of voltage pulses configured to be applied to the at least one set of spaced-apart electrodes and wherein more than one of the initial series of voltage pulses produce a pressure wave (Column 17, Lines 30- 55), and wherein each one of the produced pressure waves comprises a pressure magnitude output (Column 15, Lines 53- 64 and Column 17, Lines 25- 29).
Regarding wherein the magnitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage magnitude that is initially set at a predetermined lower voltage magnitude threshold, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Grace teaches that the voltage pulse generation system is capable of emitting a voltage between 100V to 10,000 V (Column 17, Lines 12- 14 and Lines 30- 34) and that the magnitude of the voltage can be controlled (Column 17, Lines 25- 29 and Column, 23, Lines 30- 32), the voltage pulse generation system is capable of controlling the magnitude of each voltage pulse in the initial series of voltage pulses to comprise a target voltage magnitude that is initially set at a predetermined lower voltage magnitude threshold, such as 100V.
Regarding wherein the voltage pulse generation system is configured to generate one or more subsequent series of voltage pulses, each subsequent series comprises a plurality of voltage pulses, wherein the target voltage magnitude is increased by a predetermined amount for each subsequent series of voltage pulses, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Grace teaches that the magnitude of the voltage of each pulse can be controlled by the high voltage pulse generator (Column 17, Lines 25- 29), and that the controller controls the high voltage pulse generator (Column 23, Lines 30- 32), the voltage pulse generation system would be capable of increasing the target voltage magnitude by a predetermined amount for each subsequent series of voltage pulses. Furthermore, since Grace incorporates the disclosure of Adams et al. (US 9,072,534), as stated in Column 17, Lines 14- 17, and Column 4, Lines 14-21 of Adams et al. teaches that a physician can increase the voltage magnitude as needed during a procedure, then Grace discloses and encompasses this teaching as well.
Regarding wherein the IVL control system is configured to control the pressure magnitude output of all of the produced pressure waves with the target voltage magnitude, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Grace teaches that the controller controls the high voltage pulse generator (Column 23, Lines 30- 32) and that adjusting the magnitude of the pulsed voltage controls the magnitude of the pressure wave (Column 17, Lines 25- 29), the IVL control system is capable of controlling the pressure magnitude output of all of the produced pressure waves with the target voltage magnitude.
Grace does not teach wherein the one or more subsequent series of voltage pulses are generated responsive to a determination that one or more pressure waves generated by the one or more initial series of voltage pulses have a pressure magnitude below a predetermined threshold.
Miao (Miao et al.) teaches a similar IVL system (Figs. 1- 7)(Paragraphs 0001 and 0042) with controllable pressure output (Paragraph 0030), comprising: at least one set of spaced- apart electrodes (4), a voltage pulse generation system (energy generation and controller 31) configured to apply generated voltage pulses to the at least one set of spaced- apart electrodes (Paragraphs 0043 and 0044) and produce a plurality of pressure waves for IVL therapy (Paragraph 0043), the voltage pulse generation system including a voltage pulse generator in operative communication with the at least one set of spaced- apart electrodes (Paragraph 0044), the voltage pulse generation system configured to: generate a plurality of voltage pulses comprising an initial series of voltage pulses configured to be applied to the at least one set of spaced- apart electrodes (Paragraphs 0044 and 0045), wherein the magnitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage magnitude (Paragraph 0044), wherein more than one of the initial series of voltage pulses produce a pressure wave (Paragraph 0044), and generate one or more subsequent series of voltage pulses (Paragraphs 0044 and 0045), each subsequent series comprising a plurality of voltage pulses (Paragraph 0044), wherein the one or more subsequent series of voltage pulses are generated responsive to a determination that one or more pressure waves generated by the one or more initial series of voltage pulses have a pressure magnitude below a predetermined threshold (Paragraph 0047), wherein each one of the produced pressure waves comprises a pressure magnitude output, and wherein the IVL control system is configured to control the pressure magnitude output of all of the produced pressure waves with the target voltage magnitude (Paragraphs 0044 and 0047).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the voltage pulse generation system as taught by Grace to have the pressure sensor and the programming of determining the pressure magnitude is below a predetermined threshold and to control the pressure magnitude as taught by Miao, since Miao teaches that doing so allows for the optimal treatment effect during an IVL procedure (Paragraph 0047).
Regarding claims 2 and 4, Grace and Miao make obvious the IVL system as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the voltage pulse generation system as taught by Grace to have the pressure sensor and the programming of determining the pressure magnitude is below a predetermined threshold and to control the pressure magnitude as taught by Miao, since Miao teaches that doing so allows for the optimal treatment effect during an IVL procedure (Paragraph 0047).
Regarding wherein the IVL control system is configured to control the pressure magnitude output such that the pressure magnitude output does not decay or decrease more than a predetermined amount across all of the produced pressure waves and wherein the IVL control system is configured to control the pressure magnitude output to remain above a predetermined lower threshold across all of the produced pressure waves, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Grace teaches that the controller controls the high voltage pulse generator (Column 23, Lines 30- 32 and 40- 46), that the high voltage pulse generator has a range of high and low voltage magnitudes (Column 17, Lines 12- 14 and Lines 30- 34), and that adjusting the magnitude of the pulsed voltage controls the magnitude of the pressure wave (Column 17, Lines 25- 29), and since Miao teaches that the system determines if the pressure is above or below a pressure threshold and adjusting the pulse voltage and/or the pulse width accordingly (Paragraph 0047), the IVL control system would be capable of controlling the pressure magnitude output such that the pressure magnitude output does not decay or decrease more than a predetermined amount and control the pressure magnitude output to remain about a predetermined lower threshold across all of the produced pressure waves.
Regarding claims 3 and 5, Grace and Miao make obvious the IVL system as discussed above.
Regarding wherein the IVL control system is configured to control the target voltage within predetermined upper and lower thresholds across all of the generated series of voltage pulses, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Grace teaches that the controller controls the high voltage pulse generator (Column 23, Lines 30- 32 and 40- 46), that the high voltage pulse generator has a range of high and low voltage magnitudes (Column 17, Lines 12- 14 and Lines 30- 34), that a user can adjust the voltage magnitude (Column 17, Lines 25- 29), and that the system has a predetermined upper and lower threshold from 100V to 10,000V as that is the capability of the generator (Column 17, Lines 12- 14), the IVL control system is capable of controlling the target voltage within predetermined upper and lower thresholds across all of the generated series of voltage pulses.
Regarding claims 6 and 7, Grace and Miao make obvious the IVL system as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the voltage pulse generation system as taught by Grace to have the pressure sensor and the programming of determining the pressure magnitude is below a predetermined threshold and to control the pressure magnitude as taught by Miao, since Miao teaches that doing so allows for the optimal treatment effect during an IVL procedure (Paragraph 0047).
Regarding wherein the IVL control system is configured to control the pressure magnitude output within predetermined upper and lower thresholds across all of the produced pressure waves and is configured to control the target voltage within predetermined upper and lower thresholds, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Grace teaches that the controller controls the high voltage pulse generator (Column 23, Lines 30- 32 and 40- 46), that the high voltage pulse generator has a range of high and low voltage magnitudes (Column 17, Lines 12- 14 and Lines 30- 34), that a user can adjust the voltage magnitude and that the voltage magnitude controls the magnitude of the pressure wave (Column 17, Lines 25- 29), and that the system has a predetermined upper and lower threshold from 100V to 10,000V as that is the capability of the generator (Column 17, Lines 12- 14) and since Miao teaches that the system determines if the pressure is above or below a pressure threshold and adjusting the pulse voltage and/or the pulse width accordingly (Paragraph 0047), the IVL control system is capable of controlling the pressure magnitude output within the predetermined upper and lower thresholds across all of the produced pressure waves and is capable of controlling the target voltage within predetermined upper and lower thresholds.
Regarding claims 8 and 10, Grace and Miao make obvious the IVL system as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the voltage pulse generation system as taught by Grace to have the pressure sensor and the programming of determining the pressure magnitude is below a predetermined threshold and to control the pressure magnitude as taught by Miao, since Miao teaches that doing so allows for the optimal treatment effect during an IVL procedure (Paragraph 0047).
Regarding wherein the IVL control system is configured to control the pressure magnitude output to remain at a substantially constant magnitude across all of the produced pressure waves and is configured to control the pressure magnitude output such that the pressure magnitude output does not increase more than a predetermined amount across all of the produced pressure waves, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Grace teaches that the controller controls the high voltage pulse generator (Column 23, Lines 30- 32 and 40- 46) and that a user can adjust the voltage magnitude to control the magnitude of the pressure wave (Column 17, Lines 25- 29) and since Miao teaches that the system determines if the pressure is above or below a pressure threshold and adjusting the pulse voltage and/or the pulse width accordingly (Paragraph 0047), the IVL control system is capable of controlling the pressure magnitude to remain at a substantially constant magnitude across all of the produced pressure waves and control the pressure magnitude output such that the pressure magnitude output does not increase more than a predetermined amount across all of the produced pressure waves.
Regarding claims 9 and 11, Grace and Miao make obvious the IVL system as discussed above.
Regarding wherein the IVL control system is configured to control the target voltage within predetermined upper and lower thresholds across all of the generated series of voltage pulses, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Grace teaches that the controller controls the high voltage pulse generator (Column 23, Lines 30- 32 and 40- 46), that the high voltage pulse generator has a range of high and low voltage magnitudes (Column 17, Lines 12- 14 and Lines 30- 34), that a user can adjust the voltage magnitude (Column 17, Lines 25- 29), and that the system has a predetermined upper and lower threshold from 100V to 10,000V as that is the capability of the generator (Column 17, Lines 12- 14), the IVL control system is capable of controlling the target voltage within predetermined upper and lower thresholds across all of the generated series of voltage pulses.
Regarding claim 14, Grace and Miao make obvious the IVL system as discussed above.
Regarding wherein the IVL control system is configured to define an acceptable voltage magnitude window comprising a predetermined lower voltage magnitude threshold and a predetermined upper voltage magnitude threshold, and to control the magnitude of the voltage pulses to remain within the acceptable voltage magnitude window, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Grace teaches that the controller controls the high voltage pulse generator (Column 23, Lines 30- 32 and 40- 46), that the controller can receive input from an operator (Column 23, Lines 47- 48), that the high voltage pulse generator has a range of high and low voltage magnitudes (Column 17, Lines 12- 14 and Lines 30- 34), that a user can adjust the voltage magnitude (Column 17, Lines 25- 29), and that the system has a predetermined upper and lower threshold from 100V to 10,000V as that is the capability of the generator (Column 17, Lines 12- 14), the IVL control system is capable of defining an acceptable voltage magnitude window through an operator and through the capability of the high voltage pulse generator, and to control the magnitude of the voltage pulses to remain within the acceptable voltage magnitude window.
Regarding claim 15, Grace and Miao make obvious the IVL system as discussed above.
Regarding wherein the predetermined lower voltage magnitude threshold is within a range of about 2500V to about 3250V, as Grace teaches that the range of capability for the high voltage pulse generator is between 100V to 10,000V (Column 17, Lines 12- 14), that a user can adjust the voltage magnitude (Column 17, Lines 25- 29), that the controller can receive input from an operator and controls the high voltage pulse generator (Column 23, Lines 30- 32 and 40- 48), and as the lower threshold is defined in Applicant’s disclosure as the starting voltage (Paragraph 0099), then the predetermined lower voltage magnitude threshold can be within a range of about 2500V to about 3250V as those values are within the range of the high voltage pulse generator as taught by Grace.
Regarding claim 16, Grace and Miao make obvious the IVL system as discussed above.
Grace teaches wherein the fluid- filled member comprises an inflatable balloon (balloon 116)(Column 13, Lines 45- 48).
Regarding wherein the acceptable voltage magnitude window is different for inflatable balloons of different outer diameters, Grace incorporates the disclosure of Adams et al. (US 9,072,534 B2), as stated in Column 17, Lines 14- 17, and Column 6, Lines 4- 20 of Adams et al. teaches that the pressure wave is affected by the voltage and the spacing of the electrodes, then Grace discloses and encompasses this teaching, furthermore it would have been obvious to one of ordinary skill in the art that the spacing of the electrodes is affected by the outer diameter of the inflatable balloon as the electrodes as disposed within the balloon (see Fig. 1A of Grace). So, in order to maintain a determined pressure magnitude, one of ordinary skill in the art would recognize that the acceptable voltage magnitude window would be different for inflatable balloons of different outer diameters.
Regarding claim 17, Grace and Miao make obvious the IVL system as discussed above.
Grace teaches wherein the fluid- filled member comprises an inflatable balloon (balloon 116)(Column 13, Lines 45- 48).
The combination does not teach wherein the predetermined lower voltage magnitude threshold is about 3000V for inflatable balloons having a nominal inflated outer diameter of 2.5 mm or 3.0 mm.
Regarding the inflatable balloon having a nominal inflated outer diameter of 2.5 mm or 3.0 mm, since Grace teaches that the system is used within the vasculature and perform intravascular lithotripsy (Column 7, Lines 47- 55 and Column 13, Lines 38- 43), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the outer diameter of the balloon to be between 2.5 mm to 3.0 mm, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
Regarding wherein the predetermined lower voltage magnitude threshold is about 3000V, as discussed above, Grace incorporates the disclosure of Adams et al. (US 9,072,534 B2), as stated in Column 17, Lines 14- 17 of Grace, and Adams et al. teaches in Column 6, Lines 4- 20 that the pressure wave is affected by the voltage and the spacing of the electrodes, then Grace discloses and encompasses this teaching, therefore it would have been obvious to one of ordinary skill in the art that the spacing of the electrodes is affected by the outer diameter of the inflatable balloon as the electrodes as disposed within the balloon (see Fig. 1A of Grace). So, in order to maintain a determined pressure magnitude for breaking up a calcification, one of ordinary skill in the art would recognize that the acceptable voltage magnitude window would be different for inflatable balloons of different outer diameters. Therefore, for a balloon of 2.5 mm to 3.0 mm, it would have been obvious to one of ordinary skill in the art to choose 3000V as the predetermined lower voltage magnitude threshold. Furthermore this value is within the range of the capabilities of the generator, between 100V to 10,000V (Column 17, Lines 12- 14), and the operator can modify the starting voltage through the controller (Column 23, Lines 25- 36), so the operator is capable of choosing 3000 V to be the predetermined lower voltage.
Regarding claim 18, Grace and Miao make obvious the IVL system as discussed above.
Grace teaches wherein the fluid- filled member comprises an inflatable balloon (balloon 116)(Column 13, Lines 45- 48).
The combination does not teach wherein the predetermined lower voltage magnitude threshold is about 3250V for inflatable balloons having a nominal inflated outer diameter of 3.5 mm or 4.0 mm.
Regarding the inflatable balloon having a nominal inflated outer diameter of 3.5 mm or 4.0 mm, since Grace teaches that the system is used within the vasculature and perform intravascular lithotripsy (Column 7, Lines 47- 55 and Column 13, Lines 38- 43), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the outer diameter of the balloon to be 3.5 mm or 4.0mm, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
Regarding wherein the predetermined lower voltage magnitude threshold is about 3250V, as discussed above, Grace incorporates the disclosure of Adams et al. (US 9,072,534 B2), as stated in Column 17, Lines 14- 17 of Grace, and Adams et al. teaches in Column 6, Lines 4- 20 that the pressure wave is affected by the voltage and the spacing of the electrodes, then Grace discloses and encompasses this teaching, therefore it would have been obvious to one of ordinary skill in the art that the spacing of the electrodes is affected by the outer diameter of the inflatable balloon as the electrodes as disposed within the balloon (see Fig. 1A of Grace). So, in order to maintain a determined pressure magnitude for breaking up a calcification, one of ordinary skill in the art would recognize that the acceptable voltage magnitude window would be different for inflatable balloons of different outer diameters. Therefore, for a balloon of 3.5 mm to 4.0 mm, it would have been obvious to one of ordinary skill in the art to choose 3250V as the predetermined lower voltage magnitude threshold. Furthermore this value is within the range of the capabilities of the generator, between 100V to 10,000V (Column 17, Lines 12- 14), and the operator can modify the starting voltage through the controller (Column 23, Lines 25- 36), so the operator is capable of choosing 3250 V to be the predetermined lower voltage.
Regarding claim 22, Grace (Grace et al.) teaches an intravascular lithotripsy (IVL) system (electrically-induced angioplasty balloon catheter system 100)(Figs. 1A- 1C, Figs. 4- 4A, Fig. 7)(Column 7, Lines 47- 55) with controllable pressure output (Column 17, Lines 12- 29 and Column 23, Lines 25- 36), comprising:
At least one set of spaced- apart electrodes (electrode assemblies 140 and 142)(Column 15, Lines 17- 30) for arrangement within a body lumen (Column 13, Lines 38- 43) while disposed within a fluid-fillable member (balloon 116) configured to contain conductive fluid therein (Column 15, Lines 28- 30)(As Grace teaches in Column 15, Lines 54- 58 that the liquid medium transforms the electrical energy to a pressure wave which is then passed through the liquid of the balloon assembly to the vasculature thereby moving the energy from the electrodes to the vasculature, the liquid is a conductive fluid.);
A voltage pulse generation system (high voltage pulse generator 90, coupler 128) configured to apply generated voltage pulses to the at least one set of spaced- apart electrodes and produce a plurality of pressure waves for IVL (Column 17, Lines 12-14 and 30- 55), the voltage pulse generation system including a voltage pulse generator (90) in operative communication with the at least one set of spaced- apart electrodes (Column 17, Lines 12-14 and 30- 55) and in operative communication with an IVL control system (controller 750)(Column 23, Lines 30- 34) comprising a processor (Column 23, Line 44) configured to execute instruction stored on a memory (Column 23, Lines 40- 47), and circuitry configured to communicate signals based on operation of the processor (Column 23, Liens 51- 54) wherein the voltage pulse generation system is configured to generate a plurality of voltage pulses comprising an initial series of voltage pulses configured to be applied to the at least one set of spaced-apart electrodes, wherein more than one of the initial series of voltage pulses produce a pressure wave (Column 17, Lines 30- 55), and wherein each one of the produced pressure waves comprises a pressure magnitude output (Column 15, Lines 53- 64 and Column 17, Lines 25- 29).
Regarding wherein the magnitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage that is initially set at a predetermined lower voltage magnitude threshold, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Grace teaches that the voltage pulse generation system is capable of emitting a voltage between 100V to 10,000 V (Column 17, Lines 12- 14 and Lines 30- 34) and that the magnitude of the voltage can be controlled (Column 17, Lines 25- 29 and Column, 23, Lines 30- 32), the voltage pulse generation system is capable of controlling the magnitude of each voltage pulse in the initial series of voltage pulses to comprise a target voltage that is initially set at a predetermined lower voltage magnitude threshold, such as 100V.
Regarding wherein the voltage pulse generation system is configured to generate one or more subsequent series of voltage pulses, each subsequent series comprises a plurality of voltage pulses, wherein the target voltage is increased by a predetermined amount for each subsequent series of voltage pulses, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Grace teaches that the magnitude of the voltage of each pulse can be controlled by the high voltage pulse generator (Column 17, Lines 25- 29), and that the controller controls the high voltage pulse generator (Column 23, Lines 30- 32), the voltage pulse generation system would be capable of increasing the target voltage by a predetermined amount for each subsequent series of voltage pulses. Furthermore, since Grace incorporates the disclosure of Adams et al. (US 9,072,534), as stated in Column 17, Lines 14- 17, and Column 4, Lines 14-21 of Adams et al. teaches that a physician can increase the voltage magnitude as needed during a procedure, then Grace discloses and encompasses this teaching as well.
Regarding wherein the IVL control system is configured to define an acceptable voltage magnitude window comprising a predetermined lower voltage magnitude threshold and a predetermined upper voltage magnitude threshold, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Grace teaches that the controller controls the high voltage pulse generator (Column 23, Lines 30- 32 and 40- 46), that the controller can receive input from an operator (Column 23, Lines 47- 48), that the high voltage pulse generator has a range of high and low voltage magnitudes (Column 17, Lines 12- 14 and Lines 30- 34), that a user can adjust the voltage magnitude (Column 17, Lines 25- 29), and that the system has a predetermined upper and lower threshold from 100V to 10,000V as that is the capability of the generator (Column 17, Lines 12- 14), the IVL control system is capable of defining an acceptable voltage magnitude window through an operator, and the acceptable voltage magnitude window comprising a predetermined lower voltage magnitude threshold and a predetermined upper voltage magnitude threshold through the capability of the high voltage pulse generator, and to control the magnitude of the voltage pulses to remain within the acceptable voltage magnitude window.
Regarding wherein the IVL control system is configured to control the magnitude of the voltage pulses to remain within the acceptable voltage magnitude window to control the pressure magnitude output within an upper threshold and a lower threshold, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Grace teaches that the controller controls the high voltage pulse generator (Column 23, Lines 30- 32) and that adjusting the magnitude of the pulsed voltage controls the magnitude of the pressure wave (Column 17, Lines 25- 29), the IVL control system is capable of controlling the magnitude of the voltage pulses to remain within the acceptable voltage magnitude window to control the pressure magnitude output within an upper threshold and a lower threshold.
Grace does not teach wherein a number of the one or more subsequent series of voltage pulses is responsive to a number of voltage pulses generated in the initial series of voltage pulses to counteract a decrease in a pressure magnitude across the plurality of voltage pulses.
Miao (Miao et al.) teaches a similar IVL system (Figs. 1- 7)(Paragraphs 0001 and 0042) with controllable pressure output (Paragraph 0030), comprising: at least one set of spaced- apart electrodes (4), a voltage pulse generation system (energy generation and controller 31) configured to apply generated voltage pulses to the at least one set of spaced- apart electrodes (Paragraphs 0043 and 0044) and produce a plurality of pressure waves for IVL therapy (Paragraph 0043), the voltage pulse generation system including a voltage pulse generator in operative communication with the at least one set of spaced- apart electrodes (Paragraph 0044), the voltage pulse generation system configured to: generate a plurality of voltage pulses comprising an initial series of voltage pulses configured to be applied to the at least one set of spaced- apart electrodes (Paragraphs 0044 and 0045), wherein the magnitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage magnitude (Paragraph 0044), wherein more than one of the initial series of voltage pulses produce a pressure wave (Paragraph 0044), and generate one or more subsequent series of voltage pulses (Paragraphs 0044 and 0045), each subsequent series comprising a plurality of voltage pulses (Paragraph 0044), wherein a number of the one or more subsequent series of voltage pulses is responsive to a number of voltage pulses generated in the initial series of voltage pulses to counteract a decrease in a pressure magnitude across the plurality of voltage pulses (Paragraph 0047), wherein each one of the produced pressure waves comprises a pressure magnitude output, and wherein the IVL control system is configured to control the pressure magnitude output of all of the produced pressure waves with the target voltage magnitude (Paragraphs 0044 and 0047).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the voltage pulse generation system as taught by Grace to have the pressure sensor and the programming of having a number of one or more subsequent series of voltage pulses be responsive to a number of voltage pulses generated to counteract a decrease in a pressure magnitude as taught by Miao, since Miao teaches that doing so allows for the optimal treatment effect during an IVL procedure (Paragraph 0047).
Regarding claim 27, Grace (Grace et al.) teaches an intravascular lithotripsy (IVL) system (electrically-induced angioplasty balloon catheter system 100)(Figs. 1A- 1C, Figs. 4- 4A, Fig. 7)(Column 7, Lines 47- 55) with controllable pressure output (Column 17, Lines 12- 29 and Column 23, Lines 25- 36), comprising:
At least one set of spaced- apart electrodes (electrode assemblies 140 and 142)(Column 15, Lines 17- 30) for arrangement within a body lumen (Column 13, Lines 38- 43) while disposed within a fluid-fillable member (balloon 116) configured to contain conductive fluid therein (Column 15, Lines 28- 30)(As Grace teaches in Column 15, Lines 54- 58 that the liquid medium transforms the electrical energy to a pressure wave which is then passed through the liquid of the balloon assembly to the vasculature thereby moving the energy from the electrodes to the vasculature, the liquid is a conductive fluid.);
A voltage pulse generation system (high voltage pulse generator 90, coupler 128) configured to apply generated voltage pulses to the at least one set of spaced- apart electrodes to produce a plurality of pressure waves (Column 17, Lines 12-14 and 30- 55); and
an IVL control system (controller 750) in operative communication with the voltage pulse generation system (Column 23, Lines 30- 34),
wherein the voltage pulse generation system:
generates an initial series of voltage pulses (Column 17, Lines 30- 55); and
generate a subsequent series of voltage pulses following the initial series (Column 17, Lines 30- 55), wherein each voltage pulse produces a pressure wave (Column 17, Lines 30- 55), having a pressure magnitude output (Column 15, Lines 53- 64 and Column 17, Lines 25- 29).
Regarding wherein the initial series of voltage pulses produces a decrease in the pressure magnitude output across the initial series of voltage pulses, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Grace teaches that the voltage pulse generation system is capable of emitting a voltage between 100V to 10,000 V (Column 17, Lines 12- 14 and Lines 30- 34) and that the magnitude of the voltage can be controlled (Column 17, Lines 25- 29 and Column, 23, Lines 30- 32), the initial series of voltage pulses are capable of producing a decrease in the pressure magnitude output.
Regarding wherein a number of voltage pulses in the subsequent series of voltage pulses are generated to counteract the decrease in the pressure magnitude output across the initial series of voltage pulses, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Grace teaches that the magnitude of the voltage of each pulse can be controlled by the high voltage pulse generator (Column 17, Lines 25- 29), and that the controller controls the high voltage pulse generator (Column 23, Lines 30- 32), the voltage pulse generation system would be capable of increasing the target voltage magnitude by a predetermined amount for each subsequent series of voltage pulses to counteract the decrease in the pressure magnitude. Furthermore, since Grace incorporates the disclosure of Adams et al. (US 9,072,534), as stated in Column 17, Lines 14- 17, and Column 4, Lines 14-21 of Adams et al. teaches that a physician can increase the voltage magnitude as needed during a procedure, then Grace discloses and encompasses this teaching as well.
Grace does not teach wherein voltage within the subsequent series of voltage pulses is increased relative to the initial series of voltage pulses to counteract the decrease in the pressure magnitude output.
Miao (Miao et al.) teaches a similar IVL system (Figs. 1- 7)(Paragraphs 0001 and 0042) with controllable pressure output (Paragraph 0030), comprising: at least one set of spaced- apart electrodes (4), a voltage pulse generation system (energy generation and controller 31) configured to apply generated voltage pulses to the at least one set of spaced- apart electrodes (Paragraphs 0043 and 0044) and produce a plurality of pressure waves for IVL therapy (Paragraph 0043), the voltage pulse generation system including a voltage pulse generator in operative communication with the at least one set of spaced- apart electrodes (Paragraph 0044), the voltage pulse generation system configured to: generate a plurality of voltage pulses comprising an initial series of voltage pulses configured to be applied to the at least one set of spaced- apart electrodes (Paragraphs 0044 and 0045), wherein the magnitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage magnitude (Paragraph 0044), wherein more than one of the initial series of voltage pulses produce a pressure wave (Paragraph 0044), and generate one or more subsequent series of voltage pulses (Paragraphs 0044 and 0045), each subsequent series comprising a plurality of voltage pulses (Paragraph 0044), wherein voltage within the subsequent series of voltage pulses is increased relative to the initial series of voltage pulses to counteract the decrease in the pressure magnitude output (Paragraph 0047), wherein each one of the produced pressure waves comprises a pressure magnitude output, and wherein the IVL control system is configured to control the pressure magnitude output of all of the produced pressure waves with the target voltage magnitude (Paragraphs 0044 and 0047).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the voltage pulse generation system as taught by Grace to have the pressure sensor and the programming of increasing the voltage to counteract a decrease in the pressure magnitude output as taught by Miao, since Miao teaches that doing so allows for the optimal treatment effect during an IVL procedure (Paragraph 0047).
Claim(s) 12, 13, 23, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US 10,850,078) in view of Miao et al. (CN 215458401U English Machine Translation), as applied to claims 1 and 22 above, in further view of Manucherhabadi et al. (US 2021/0315639).
Regarding claims 12, 13, and 23, Grace and Miao make obvious the IVL system as discussed above.
Grace teaches wherein the high voltage pulse generator allows an operator to adjust the repetition rate of the voltage pulses (Column 17, Lines 25- 29) and where a controller controls the high voltage pulse generator (Column 23, Lines 32- 36).
The combination does not teach wherein the IVL control system is further configured to determine the total number of generated voltage pulses and to terminate the execution of voltage pulses when a predetermined maximum number of voltage pulses is determined to be generated in claim 12 and claim 23 or wherein the predetermined maximum number of voltage pulses is within a range of 10 to 300 voltage pulses in claim 13.
Manucherhabadi (Manucherhabadi et al.) teaches a similar system (abstract) comprising at least one set of spaced-apart electrodes (probes 210) and a protocol for uses with the probes that determines the total number of generated voltage pulses and to terminate the execution of voltage pulses when a predetermined maximum number of voltage pulses is determined to be generated, wherein the predetermined maximum number of voltage pulses is within a range of 10 to 100 voltage pulses (Paragraphs 0095 and 0096).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the IVL control system as taught by the combination to determine the total number of generated voltage pulses and to terminate the execution of voltage pulses when a predetermined maximum number of voltage pulses is determined to be generated, wherein the predetermined maximum number of voltage pulses is within a range of 10 to 100 voltage pulses as taught by Manucherhabadi, since Grace teaches that the IVL control system can contain programming that control the high voltage generator, which controls the repetition of voltage pulses (Grace, Column 23, Lines 30- 36 and Column 17, Lines 25- 29), and Manucherhabadi teaches a protocol for controlling the repetition of voltage pulses (Manucherhabadi, Paragraph 0096).
The combination does not teach wherein the predetermined maximum number of voltage pulses is within a range of 10 to 300 voltage pulses.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the range as taught by the combination to be between 10 to 300 voltage pulses, since it has been held that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a primae facie case of obviousness exists”. (MPEP 2144.05)(In re Wertheim, 541 F.2d 257, 191 USPQ90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Regarding claim 26, Grace and Miao make obvious the IVL system as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the voltage pulse generation system as taught by Grace to have the pressure sensor and the programming of determining the pressure magnitude is below a predetermined threshold and to control the pressure magnitude as taught by Miao, since Miao teaches that doing so allows for the optimal treatment effect during an IVL procedure (Paragraph 0047).
The combination does not teach wherein the determination that one or more pressure waves generated by the one or more subsequent series of voltage pulses have a pressure magnitude below the predetermined threshold includes determining a predetermined number of voltage pulses have been generated in the one or more subsequent series of voltage pulses.
Manucherhabadi (Manucherhabadi et al.) teaches a similar system (abstract) comprising at least one set of spaced-apart electrodes (probes 210) and a protocol for uses with the probes that determines the total number of generated voltage pulses and to terminate the execution of voltage pulses when a predetermined maximum number of voltage pulses is determined to be generated, wherein the predetermined maximum number of voltage pulses is within a range of 10 to 100 voltage pulses (Paragraphs 0095 and 0096).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the IVL control system as taught by the combination to determine the total number of generated voltage pulses and to terminate the execution of voltage pulses when a predetermined maximum number of voltage pulses is determined to be generated, as taught by Manucherhabadi, since Grace teaches that the IVL control system can contain programming that control the high voltage generator, which controls the repetition of voltage pulses (Grace, Column 23, Lines 30- 36 and Column 17, Lines 25- 29), and Manucherhabadi teaches a protocol for controlling the repetition of voltage pulses (Manucherhabadi, Paragraph 0096).
Regarding wherein the determination that one or more pressure waves generated by the one or more subsequent series of voltage pulses have a pressure magnitude below the predetermined threshold includes determining a predetermined number of voltage pulses have been generated in the one or more subsequent series of voltage pulses, as Miao teaches that the controller keeps track of a predetermined pressure magnitude and other parameters within the system (Paragraphs 0044- 0047), then within the combination, it would have been obvious to one of ordinary skill in the art to have part of the determination be when the predetermined number of voltage pulses have been reached.
Claim(s) 19- 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US 10,850,078) in view of Miao et al. (CN 215458401U English Machine Translation), as applied to claim 14 above, in further view of Liu et al. (CN 107633840 English Machine Translation).
Regarding claim 19, Grace and Miao make obvious the IVL system as discussed above.
The combination does not teach wherein the IVL control system is configured to determine whether the target voltage is not at the predetermined upper voltage magnitude target for a prior executed series of voltage pulses, and to increase the target voltage magnitude by a predetermined amount when the target voltage is determined to be less than the predetermined upper voltage magnitude target.
Liu (Liu et al.) teaches a method for a lithotripsy system (Paragraph 0003), wherein the method comprises determining whether the target voltage is not at the predetermined upper voltage magnitude target for a prior executed series of voltage pulses, and increasing the target voltage magnitude by a predetermined amount when the target voltage is determined to be less than the predetermined upper voltage magnitude target (Paragraphs 0010- 0011, and 0028).
It would have been obvious to one of ordinary skill in the art to modify the IVL control system as taught by the combination to perform the method as taught by Liu, since Grace teaches that the controller is capable of controlling the voltage (Grace, Column 23, Lines 32- 54) and since Liu teaches that this method “significantly reduces the pre-breakdown delay of the liquid gap and improves the conversion efficiency of the liquid electric pulse shock wave transmission system to the mechanical energy” (Liu, Paragraph 0021).
Regarding claim 20, Grace, Miao, and Liu make obvious the IVL system as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the IVL control system as taught by Grace to perform the method as taught by Liu, since Grace teaches that the controller is capable of controlling the voltage (Grace, Column 23, Lines 32- 54) and since Liu teaches that this method “significantly reduces the pre-breakdown delay of the liquid gap and improves the conversion efficiency of the liquid electric pulse shock wave transmission system to the mechanical energy” (Liu, Paragraph 0021).
Regarding wherein the predetermined amount of voltage magnitude increase is within the range of 1 to 250 V, since Grace teaches that the system is capable of generating voltages between 100V and 10,000V, that an operator can adjust the voltage magnitude (Column 17, Lines 25- 29), that the controller controls the high pulse voltage generator (Column 23, Lines 32- 34), and since Grace incorporates the disclosure of Adams et al. (US 9,072,534), as stated in Column 17, Lines 14- 17, and Column 4, Lines 14-21 of Adams et al. teaches that a physician can increase the voltage magnitude as needed during a procedure, it would have been obvious to one of ordinary skill in the art that the predetermined amount of voltage magnitude increase can be within the range of 1 to 250 V.
Regarding claim 21, Grace, Miao, and Liu make obvious the IVL system as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the IVL control system as taught by Grace to perform the method as taught by Liu, since Grace teaches that the controller is capable of controlling the voltage (Grace, Column 23, Lines 32- 54) and since Liu teaches that this method “significantly reduces the pre-breakdown delay of the liquid gap and improves the conversion efficiency of the liquid electric pulse shock wave transmission system to the mechanical energy” (Liu, Paragraph 0021).
Regarding wherein the IVL control system is configured to increase the target voltage magnitude by 25V when the target voltage is not at the predetermined upper voltage magnitude target for a prior executed series of voltage pulses, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Grace teaches that the voltage pulse generation system is capable of emitting a voltage between 100V to 10,000 V (Column 17, Lines 12- 14 and Lines 30- 34) and that the magnitude of the voltage can be controlled (Column 17, Lines 25- 29 and Column, 23, Lines 30- 32), then the IVL control system of the combination would be capable of increasing the target voltage magnitude by 25V when the target voltage is not at the predetermined upper voltage magnitude target for a prior executed series of voltage pulses.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US 10,850,078) in view of Miao et al. (CN 215458401U English Machine Translation ) and in view of Manucherhabadi et al. (US 2021/0315639), as applied to claim 23 above, in further view of Liu et al. (CN 107633840 English Machine Translation).
Regarding claim 24, Grace, Miao, and Manucherhabadi make obvious the IVL system as discussed above.
The combination does not teach wherein the IVL control system is configured to determine whether the target voltage is not at the predetermined upper voltage magnitude target for a prior executed series of voltage pulses, and to increase the target voltage magnitude by a predetermined amount when the target voltage is determined to not be at the predetermined upper voltage magnitude target.
Liu (Liu et al.) teaches a method for a lithotripsy system (Paragraph 0003), wherein the method comprises determining whether the target voltage is not at the predetermined upper voltage magnitude target for a prior executed series of voltage pulses, and increasing the target voltage magnitude by a predetermined amount when the target voltage is determined to not be at the predetermined upper voltage magnitude target (Paragraphs 0010- 0011, and 0028).
It would have been obvious to one of ordinary skill in the art to modify the IVL control system as taught by the combination to perform the method as taught by Liu, since Grace teaches that the controller is capable of controlling the voltage (Grace, Column 23, Lines 32- 54) and since Liu teaches that this method “significantly reduces the pre-breakdown delay of the liquid gap and improves the conversion efficiency of the liquid electric pulse shock wave transmission system to the mechanical energy” (Liu, Paragraph 0021).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US 10,850,078) in view of Miao et al. (CN 215458401U English Machine Translation), as applied to claim 22 above, in view of Manucherhabadi et al. (US 2021/0315639) and in view of Liu et al. (CN 107633840 English Machine Translation).
Regarding claim 25, Grace (Grace et al.) teaches a method for conducting intravascular lithotripsy (IVL) therapy, comprising:
Providing the IVL system of claim 22 (As discussed above for claim 22, Grace and Miao make obvious this system; system 100)(Figs. 1A- 1C, Figs. 4- 4A, Fig. 7)(Column 7, Lines 47- 55), generating the initial series of voltage pulses at a predetermined voltage magnitude (Column 17, Lines 25- 29, Column 23, Lines 32- 36), applying the generated initial series of voltage pulses to the at least one set of spaced- apart electrodes, producing a first series of pressure waves (Column 17, Lines 30- 55), increasing the predetermined voltage magnitude by a predetermined amount (Grace incorporates the disclosure of Adams et al. (US 9,072,534), as stated in Column 17, Lines 14- 17, and Column 4, Lines 14-21 of Adams et al. teaches that a physician can increase the voltage magnitude as needed during a procedure, then Grace discloses and encompasses this teaching as well.), generating a second series of voltage pulses at the increased predetermined voltage magnitude (Column 17, Lines 25- 29, Column 23, Lines 32- 36), producing a second series of pressure waves (Column 17, Lines 30- 55), and eventually terminating the procedure (Column 28, Lines 1-5).
Regarding wherein each produced pressure wave comprising a pressure magnitude output that is controlled within an upper threshold and a lower threshold, since Grace teaches that the controller controls the high voltage pulse generator (Column 23, Lines 30- 32 and 40- 46) and that a user can adjust the voltage magnitude to control the magnitude of the pressure wave (Column 17, Lines 25- 29), that the high voltage pulse generator has a lower threshold of 100V and an upper threshold of 10,000V (Column 17, Lines 12- 14), then each produced pressure wave comprises a pressure magnitude output that is controlled within an upper threshold and a lower threshold.
Grace does not teach the method step of determining that a maximum number of voltage pulses have not been generated, generating a second series of voltage pulses at the increased predetermined voltage magnitude wherein a number of voltage pulses within the second series is responsive to a number of voltage pulses within the first series to counteract a decrease in the pressure magnitude output, determining if a predetermined upper voltage magnitude threshold has been reached by the increased predetermined voltage magnitude, or if the predetermined upper voltage magnitude threshold is determined to have been reached, terminating the IVL therapy.
Miao (Miao et al.) teaches a similar IVL system (Figs. 1- 7)(Paragraphs 0001 and 0042) with controllable pressure output (Paragraph 0030), comprising: at least one set of spaced- apart electrodes (4), a voltage pulse generation system (energy generation and controller 31) configured to apply generated voltage pulses to the at least one set of spaced- apart electrodes (Paragraphs 0043 and 0044) and produce a plurality of pressure waves for IVL therapy (Paragraph 0043), the voltage pulse generation system including a voltage pulse generator in operative communication with the at least one set of spaced- apart electrodes (Paragraph 0044), the voltage pulse generation system configured to: generate a plurality of voltage pulses comprising an initial series of voltage pulses configured to be applied to the at least one set of spaced- apart electrodes (Paragraphs 0044 and 0045), wherein the magnitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage magnitude (Paragraph 0044), wherein more than one of the initial series of voltage pulses produce a pressure wave (Paragraph 0044), and generate one or more subsequent series of voltage pulses (Paragraphs 0044 and 0045), each subsequent series comprising a plurality of voltage pulses (Paragraph 0044), wherein a number of the one or more subsequent series of voltage pulses is responsive to a number of voltage pulses generated in the initial series of voltage pulses to counteract a decrease in a pressure magnitude across the plurality of voltage pulses (Paragraph 0047), wherein each one of the produced pressure waves comprises a pressure magnitude output, and wherein the IVL control system is configured to control the pressure magnitude output of all of the produced pressure waves with the target voltage magnitude (Paragraphs 0044 and 0047).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the voltage pulse generation system as taught by Grace to have the pressure sensor and the programming of having a number of one or more subsequent series of voltage pulses be responsive to a number of voltage pulses generated to counteract a decrease in a pressure magnitude as taught by Miao, since Miao teaches that doing so allows for the optimal treatment effect during an IVL procedure (Paragraph 0047).
Manucherhabadi (Manucherhabadi et al.) teaches a similar system (abstract) comprising at least one set of spaced-apart electrodes (probes 210) and a protocol for use with the probes that determines the total number of generated voltage pulses, to determine that a maximum number of voltage pulse have not been generated, and to terminate the execution of voltage pulses when a predetermined maximum number of voltage pulses is determined to be generated (Paragraphs 0095 and 0096).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method as taught by the combination to determine the total number of generated voltage pulses, to determine that a maximum number of voltage pulses have not been generated, and to terminate the execution of voltage pulses when a predetermined maximum number of voltage pulses is determined to be generated as taught by Manucherhabadi, since Grace teaches that the IVL control system can contain programming that control the high voltage generator, which controls the repetition of voltage pulses (Grace, Column 23, Lines 30- 36 and Column 17, Lines 25- 29), and Manucherhabadi teaches a protocol for controlling the repetition of voltage pulses (Manucherhabadi, Paragraph 0096).
The combination does not teach the method step of determining if a predetermined upper voltage magnitude threshold has been reached by the increased predetermined voltage magnitude, or if the predetermined upper voltage magnitude threshold is determined to have been reached, terminating the IVL therapy.
Liu (Liu et al.) teaches a method for a lithotripsy system (Paragraph 0003), wherein the method comprises determining whether the target voltage is not at the predetermined upper voltage magnitude target for a prior executed series of voltage pulses, and increasing the target voltage magnitude by a predetermined amount when the target voltage is determined to be less than the predetermined upper voltage magnitude target (Paragraphs 0010- 0011, and 0028) and to terminate the IVL therapy if the predetermined upper voltage magnitude threshold is determined to have been reached (Paragraph 0041).
It would have been obvious to one of ordinary skill in the art to modify the IVL control system as taught by the combination to perform the method as taught by Liu, since Grace teaches that the controller is capable of controlling the voltage (Grace, Column 23, Lines 32- 54) and since Liu teaches that this method “significantly reduces the pre-breakdown delay of the liquid gap and improves the conversion efficiency of the liquid electric pulse shock wave transmission system to the mechanical energy” (Liu, Paragraph 0021).
Response to Arguments
Regarding applicant’s arguments filed on May4th, 2026 with respect to the rejection of claims 1-11, 14- 15, and 22 under 35 U.S.C. 102(a)(1) over Grace et al. (US 10,850,078), the rejection of claims 12, 13, and 23 under 35 U.S.C. 103 over Grace et al. (US 10,850,078) in view of Manucherhabadi et al. (US 2021/0315639), the rejection of claims 16- 18 under 35 U.S.C. 103 over Grace et al. (US 10,850,078), the rejection of claims 19- 21 under 35 U.S.C. 103 over Grace et al. (US 10,850,078), the rejection of claim 24 under 35 U.S.C. 103 over Grace et al. (US 10,850,078) in view of Manucherhabadi et al. (US 2021/0315639) in further view of Liu et al. (CN 107633840 English Machine Translation), and the rejection of claim 25 under 35 U.S.C. 103 over Grace et al. (US 10,850,078) in view of Manucherhabadi et al. (US 2021/0315639) in further view of Liu et al. (CN 107633840 English Machine Translation) have been fully considered but are moot since, as discussed above, the previous prior art rejection has been withdrawn in view of applicant’s amendments. However, it is noted that Grace, Manucherhabadi, and Liu are still relied upon for limitations not argued.
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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/L.R.R./Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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