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 .
Priority
The instant application, filed on 11/10/2023 claims priority to Provisional Application 63/242,573, filed on 09/10/2021, Provisional Application 63/424,573, filed on 11/11/2022, Provisional Application 63/580,547, filed on 09/05/2023, and is a 371 of PCT/US2023/079209 filed on 11/09/2023. Claims 1-11, 14- 22, and 25 of the instant application are directed to subject matter that was introduced for the first time in the provisional application 63/424,573, filed on 11/11/2022. The earlier Provisional Application 63/242,573 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for an “intravascular lithotripsy system” or “a voltage pulse generation system” as recited by independent claims 1 and 22. Accordingly, claims 1-25 are not entitled to the benefit of the prior application because the terms “intravascular lithotripsy system” or “a voltage pulse generation system”, recited in claims 1 and 22 of the instant application, are unsupported within the disclosure listed above. The earliest disclosure for the subject matter of claims 1-11, 15- 22, and 25 and thus the effective filing date for the subject matter of claims 1-11, 14- 22, and 25 is 11/11/2022.
The earlier Provisional Application 63/424,573 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for the limitation of “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 recited in claim 12, “wherein the predetermined maximum number of voltage pulses is within a range of 10 to 300 voltage pulses” as recited in claim 13, or “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 recited in claim 23. Accordingly, claims 12-13 and 23- 24 are not entitled to the benefit of the prior application because the limitations “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 300 voltage pulses” or “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”, recited in claims 12- 13 and 23- 24, are unsupported within the disclosure listed above. The earliest disclosure for the subject matter of claims 12-13 and 23- 24 and thus the effective filing date for the subject matter of claims 13-13 and 23- 24 is 09/05/2023.
Claim Objections
Claims 1- 25 are objected to because of the following informalities:
Claim 1, Lines 1- 2 states “(“IVL”) system with controllable pressure output, comprising at”, it is suggested to change this to “(IVL) system with controllable pressure output, comprising: at”.
Claim 1, Line 7 states “intravascular lithotripsy therapy”, it is suggested to change this to “IVL therapy”.
Claims 2- 21 are objected to for being dependent on or from objected claim 1.
Claim 19, Lines 4-5 states “magnitude is increased by a predetermined amount when the target voltage is determined be less”, it is suggested to change this to “magnitude by a predetermined amount when the target voltage is determined to be less”.
Claims 20 and 21 are objected for being dependent on or from objected claim 19.
Claim 22, Lines 1- 2 states “(“IVL”) system with controllable pressure output, comprising at”, it is suggested to change this to “(IVL) system with controllable pressure output, comprising: at”.
Claim 22, Line 7 states “intravascular lithotripsy therapy”, it is suggested to change this to “IVL therapy”.
Claims 23- 25 are objected to for being dependent on or from objected claim 22.
Claim 24, Lines 3-4 states “magnitude is increased by a predetermined amount”, it is suggested to change this to “magnitude by a predetermined amount”.
Claim 25, Lines 1 states “(“IVL”) system”, it is suggested to change this to “(IVL) system”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1- 11, 14- 15 and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grace et al. (US 10,850,078).
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.
Regarding claims 2 and 4, Grace teaches the IVL system as discussed above.
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), 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 teaches 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 teaches the IVL system as discussed above.
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), 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 teaches the IVL system as discussed above.
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), 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 teaches 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 teaches 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 teaches 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 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.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 12, 13, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US 10,850,078) in view of Manucherhabadi et al. (US 2021/0315639).
Regarding claims 12, 13, and 23, Grace teaches 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).
Grace 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 Grace 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)).
Claim(s) 16- 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US 10,850,078).
Regarding claim 16, Grace teaches 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 teaches the IVL system as discussed above.
Grace teaches wherein the fluid- filled member comprises an inflatable balloon (balloon 116)(Column 13, Lines 45- 48).
Grace 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 teaches the IVL system as discussed above.
Grace teaches wherein the fluid- filled member comprises an inflatable balloon (balloon 116)(Column 13, Lines 45- 48).
Grace 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.
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 Liu et al. (CN 107633840 English Machine Translation).
Regarding claims 19 and 24, Grace teaches the IVL system as discussed above.
Grace 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 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 claim 20, Grace 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 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 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 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 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).
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 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 teaches 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, 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.
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 Grace 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 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).
Conclusion
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/L.R.R./Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771