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 .
Claim Objections
Claims 1- 23 are objected to because of the following informalities:
Claim 1, Line 1 states “(“IVL”) system”, it is suggested to change this to “(IVL) system”.
Claim 1, Line 9 states “stored on memory”, it is suggested to change this to “stored on a memory”.
Claims 2- 11, and 21-23 are objected to for being dependent on or from objected claim 1.
Claims 9- 11 and 22- 23, Line 1 state “The system of claim”, it is suggested to change this to “The IVL system of claim”.
Claims 12 and 13, Line 1 state “(“IVL”) system”, it is suggested to change this to “(IVL) system”.
Claim 12, Line 10 states “stored on memory”, it is suggested to change this to “stored on a memory”.
Claim 13, Line 3 states “of an IVL system”, it is suggested to change this to “the IVL system”.
Claim 14, Line 1 states “(“IVL”) system”, it is suggested to change this to “(IVL) system”.
Claim 14, Line 9 states “stored on memory”, it is suggested to change this to “stored on a memory”.
Claims 15- 20 are objected to for being dependent on or from objected claim 14.
Appropriate correction is required.
Applicant is advised that should claims 9- 10 be found allowable, claims 21- 23 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 23 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 23 recites the limitation “The system of claim 24”, it is unclear what is intended with this limitation, as claim 24 is not presented within the claim set. For purpose of examination, and to expedite prosecution, claim 23 is herein interpreted as being dependent on claim 21, which establishes “a voltage magnitude” as mentioned within claim 23.
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) 1- 11, 13-15, and 18- 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hou (CN 114098897) in view of Chernenko et al. (US 2003/0176873).
Regarding claims 1 and 2, Hou teaches an intravascular lithotripsy (IVL) system (100)(Paragraphs 0003 and 0057)(Figs. 1- 7) comprising:
a catheter assembly (catheter 1, balloon 2) comprising an elongate member (catheter 1) defining a lumen (Paragraph 0065) and a fluid-fillable member (balloon 2) configured to contain fluid (Paragraph 0057), the fluid- fillable member associated with a longitudinal end region of the elongate member (see annotated Fig. 1 below), the catheter assembly configured to at least partially fill the fluid- fillable member with an IVL fluid medium to facilitate IVL therapy (Paragraphs 0057 and 0065);
a pulse generation system (shockwave generator, pulse wave generator) comprising a voltage pulse generator (shockwave generator) in operative communication with an IVL control system (charger, energy storage unit, booster, processor) comprising a processor for executing instructions stored on a memory and circuitry configured to communicate signals based on operation of the processor for providing IVL therapy to a patient (Paragraphs 0040- 0041 and 0057),
at least one set of spaced- apart electrodes (3, 4) arranged within the fluid- filled member for submerging within the IVL fluid medium and in operative communication with the pulse generation system (Paragraphs 0059- 0060 and 0067);
wherein the pulse generation system is configured to generate one or more voltage pulses and apply the generated one or more voltage pulses to the at least one spaced- apart electrodes under initial control settings (Paragraphs 0057- 0060).
Regarding wherein the pulse generation system is configure to determine second control settings comprising an increase of at least one of a voltage pulse duration and a voltage pulse magnitude, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Hou teaches that the voltage pulse amplitude, which correlates to the voltage pulse magnitude, and the voltage pulse width, which correlates to the voltage pulse duration, can be controlled by the processor (Paragraphs 0015, 0018, 0041, 0044, and 0061), that the processor contains an artificial intelligence that can adjust the applied energy and optimize it (Paragraphs 0040- 0041), and that the processor sends out a signal to the pulse generation system, controlling the settings of the voltage pulse sent out (Paragraph 0058), the pulse generation system would be capable of determining second control settings to increase the voltage pulse duration and the voltage pulse magnitude.
Regarding wherein the pulse generation system is configured to generate one or more voltage pulses under the second control settings and apply electrical energy generated by the one or voltage pulses under the second control settings to the at least one set of spaced- apart electrodes, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Hou teaches that the amplitude and the pulse width can be controlled by the processor (Paragraphs 0015, 0018, 0041, 0044, and 0061), and that this can occur during the operation when electrical energy is conveyed to the spaced- apart electrodes (Paragraphs 0040- 0041, 0058, and 0061), the pulse generation system would be capable of generating the voltage pulses under the second control settings and apply electrical energy to the spaced- apart electrodes.
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Hou does not teach (claim 1) wherein the pulse generation system is configured to determine whether a threshold parameter comprising the maximum number of voltage pulses resulting in an electrical arc between the at least one set of spaced- apart electrodes is achieved under the initial control settings, and to determine second control settings comprising an increase of at least one of a voltage pulse duration and a voltage pulse magnitude in response to a determination that the threshold parameter is not achieved and (claim 2) wherein the IVL control system is configured to terminate application of the electrical energy to the at least one set of spaced- apart electrodes, responsive to the determination that the threshold parameter is achieved.
Chernenko (Chernenko et al.) teaches a pulse generation system (500)(Figs. 4b and 5) for performing lithotripsy (Paragraphs 0004) connected with a set of electrodes (abstract), the pulse generation system comprising a control system (control circuit 510) wherein the pulse generation system is configured to generate one or more voltage pulses and apply the generated one or more voltage pulses to the at least one spaced- apart electrodes (Paragraphs 0083, 0084, and 0087), to determine whether a threshold parameter comprising the maximum number of voltage pulses which is detected through a voltage pulse counter (Paragraph 0081) resulting in an electrical arc between the at least one set of spaced- apart electrodes is achieved, continue pulsing in response to a determination that the threshold parameter is not achieved (Paragraphs 0081 and 0082), and wherein the control system is configured to terminate application of the electrical energy to the at least one set of spaced- apart electrodes, responsive to the determination that the threshold parameter is achieved (Paragraphs 0081- 0083).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system as taught by Hou to have the voltage pulse counter and the programming regarding the voltage pulse counter as taught by Chernenko, since Chernenko teaches that monitoring the voltage pulse and limiting the amount of pulses makes it “possible to carry out the treatment more safely and at the same time more reliably” (Paragraph 0085).
Regarding claim 3, Hou and Chernenko 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 system as taught by Hou to have the voltage pulse counter and the programming regarding the voltage pulse counter as taught by Chernenko, since Chernenko teaches that monitoring the voltage pulse and limiting the amount of pulses makes it “possible to carry out the treatment more safely and at the same time more reliably” (Paragraph 0085).
Regarding wherein the IVL control system is configured to repeat the determination that the threshold parameter is achieved after the application of the generated electrical energy to the at least one set of spaced- apart electrodes under the second control settings, as the combination teaches that the comparison occurs every time a pulse is generated (Chernenko, Paragraphs 0081 and 0082), then the determination is repeated after the application of the generated electrical energy to the at least one set of spaced- apart electrodes. In regards to this occurring under the second control settings, as discussed above, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Hou teaches that the amplitude and the pulse width can be controlled by the processor (Hou, Paragraphs 0015, 0018, 0041, 0044, and 0061), and that this can occur during the operation when electrical energy is conveyed to the spaced- apart electrodes (Hou, Paragraphs 0040- 0041, 0058, and 0061), the pulse generation system would be capable of generating the voltage pulses under the second control settings and applying electrical energy to the spaced- apart electrodes.
Regarding wherein responsive to the determination that the threshold parameter is not achieved, generate one or more voltage pulses under the second control settings and apply the generated electrical energy under the second control settings to the at least one set of spaced- apart electrodes, as the combination teaches that the system is designed to switch off the pulses only once a predetermined amount is reached and that every pulse is sent to the pulse counter, then when it determines that the predetermined amount is not reached, the pulses continue (Chernenko, Paragraphs 0081- 0083). Furthermore as discussed above, the system would generate and apply the one or more pulses under the second control settings to the at least one set of spaced- apart electrodes.
Regarding claim 4, Hou and Chernenko make obvious the IVL system as discussed above.
Regarding wherein the IVL control system is configured to determine whether a predetermined duration of the application of the generated electrical energy to the at least one set of spaced- apart electrodes is achieved, as this language is functional, the structure of the system only needs to be able to accomplish the function, since Hou teaches that the system calculates the voltage, pulse width and frequency of the next shock wave pulse, and calculates the energy emitted by the current pulse, thereby monitoring the pulse and its characteristics (Paragraph 0061), then the system is able to determine whether a predetermined duration of the application of energy is achieved.
Regarding claim 5, Hou and Chernenko make obvious the IVL system as discussed above.
Regarding wherein, responsive to a determination that the predetermined maximum duration of application of the generated electrical energy to the at least one set of spaced- apart electrodes is achieved, the IVL control system is configured to increase the voltage pulse magnitude by a predetermined magnitude, as this language is functional, the structure of the system only needs to be able to accomplish the function, since Hou teaches that the system calculates the voltage, pulse width (the duration of the pulse) and frequency of the next shock wave pulse, and calculates the energy emitted by the current pulse, thereby monitoring the pulse and its characteristics and that the system can change the pulse amplitude and therefore the pulse magnitude (Paragraphs 0061 and 0070), then the IVL control system is able to increase the voltage pulse magnitude by a predetermined magnitude after a determination that the predetermined maximum duration of the application of energy to the electrodes is achieved.
Regarding claim 6, Hou and Chernenko make obvious the IVL system as discussed above.
Regarding wherein the IVL control system is configured to determine if the generated voltage pulse magnitude has achieved a maximum threshold, as this language is functional, the structure of the system only needs to be able to accomplish the function, since Hou teaches that the system has a maximum threshold of voltage through the limit of what the generator can produce (Paragraph 0067), and that the system calculates the voltage, pulse width and frequency of the next shock wave pulse, and calculates the energy emitted by the current pulse, thereby monitoring the pulse and its characteristics (Paragraph 0061), then the system is able to determine the voltage and able determine if it is at a maximum threshold, such as at the limit of the electric pulse.
Regarding claim 7, Hou and Chernenko make obvious the IVL system as discussed above.
Regarding wherein, responsive to the determination that the generated voltage magnitude has achieved the maximum threshold, the IVL control system is configured to adjust the duration of application of the generated electrical energy to the at least one set of spaced- apart electrodes, as this language is functional, the structure of the system only needs to be able to accomplish the function, since Hou teaches that the system has a maximum threshold of voltage through the limit of what the generator can produce (Paragraph 0067), and that the system calculates the voltage, pulse width and frequency of the next shock wave pulse, and calculates the energy emitted by the current pulse, thereby monitoring the pulse and its characteristics (Paragraph 0061 and 0070), then the system is able to determine that the voltage magnitude has achieved the maximum threshold, and then adjust the duration, which is a part of the pulse width, of the application of the generated electrical energy.
Regarding claim 8, Hou and Chernenko make obvious the IVL system as discussed above.
Regarding wherein the IVL control system is configured to adjust the duration of application of the generated electrical energy to the at least one set of spaced- apart electrodes to the duration of the initial control settings, as this language is functional, the structure of the system only needs to be able to accomplish the function, as Hou teaches that the system calculates the pulse width (Paragraph 0061 and 0070), which correlates to the duration of the voltage pulse, then the system is capable of adjusting the duration of the generated electrical energy to the duration of the initial control settings.
Regarding claims 9 and 21, Hou and Chernenko make obvious the IVL system as discussed above.
Hou further teaches wherein the application of electrical energy to the at least one set of spaced- apart electrodes is generated by a voltage pulse having a voltage magnitude and duration (As amplitude is known to be a synonym for magnitude, and as the pulse width is the duration of the pulse since it is the length of the pulse, and as Hou teaches that the pulse has a voltage amplitude and voltage width (Paragraph 0055), then Hou teaches this limitation.).
Regarding claims 10 and 22, Hou and Chernenko make obvious the IVL system as discussed above.
The combination does not teach wherein the electrical energy applied to the at least one set of spaced- apart electrodes is generated by a voltage pulse having a duration that is controlled by the IVL control system to be within the range of about 0.1 microseconds to about 2 microseconds.
Chernenko teaches Chernenko (Chernenko et al.) teaches a pulse generation system (500)(Figs. 4b and 5) for performing lithotripsy (Paragraphs 0004) connected with a set of electrodes (abstract), the pulse generation system comprising a control system (control circuit 510) wherein the pulse generation system is configured to generate one or more voltage pulses and apply the generated one or more voltage pulses to the at least one spaced- apart electrodes (Paragraphs 0083, 0084, and 0087), to determine whether a threshold parameter comprising the maximum number of voltage pulses which is detected through a voltage pulse counter (Paragraph 0081) resulting in an electrical arc between the at least one set of spaced- apart electrodes is achieved, continue pulsing in response to a determination that the threshold parameter is not achieved (Paragraphs 0081 and 0082), and wherein the duration of the voltage pulse is within the range of 500 to 3000 nanoseconds, or 0.5 microseconds to 3 microseconds (Paragraph 0059).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system as taught by the combination to have a duration of the voltage pulse be within the range of 0.5 microseconds to 3 microseconds as taught by Chernenko, since Chernenko teaches that it is “advantageous to apply high voltage impulses defined by very short rise time and duration” (Paragraph 0059).
The combination does not teach wherein the range of the duration is about 0.1 microseconds to about 2 microseconds.
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 about 0.1 microseconds to about 2 microseconds, 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 claims 11 and 23, Hou and Chernenko make obvious the IVL system as discussed above.
Hou further teaches wherein the voltage magnitude that is controlled by the IVL control system to be within the range of about 100 volts to about 10,000 volts (Paragraph 0067)(As 500 volts to about 4000 volts is within the range taught by Hou, Hou encompasses this claim limitation.).
Regarding claim 13, Hou teaches a method of operating an intravascular lithotripsy (IVL) system (100)(Paragraphs 0003, 0015), the method comprising: applying initial electrical energy to at least one set of electrodes (3, 4) of the IVL system (Paragraphs 0057- 0059).
Regarding the step of increasing a duration of electrical energy for application to the at least one set of electrodes, it would have been obvious to try to one of ordinary skill in the art before the effective filing date to modify the method as taught by Hou to have the step of increasing a duration of electrical energy. As Hou disclosed that the processor can adjust and control the pulse width (Paragraphs 0061 and 0070), which is the duration of the voltage pulse as both are the length of the pulse occurring, then one of ordinary skill in the art would recognize that after each pulse the processor can increase, decrease or keep the duration the same. Thus, increasing a duration of electrical energy would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp”. If this leads to the anticipated success, it is likely that product was not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Hou does not teach the steps of determining whether a threshold parameter is achieved; or responsive to determination that the threshold parameter is not achieved, increasing a duration of a pulse of electrical energy for application to the at least one set of electrodes.
Chernenko (Chernenko et al.) teaches a pulse generation system (500)(Figs. 4b and 5) for performing lithotripsy (Paragraphs 0004) connected with a set of electrodes (abstract), the pulse generation system comprising a control system (control circuit 510) wherein the pulse generation system is configured to generate one or more voltage pulses and apply the generated one or more voltage pulses to the at least one spaced- apart electrodes (Paragraphs 0083, 0084, and 0087), to determine whether a threshold parameter comprising the maximum number of voltage pulses which is detected through a voltage pulse counter (Paragraph 0081) resulting in an electrical arc between the at least one set of spaced- apart electrodes is achieved, continue pulsing in response to a determination that the threshold parameter is not achieved (Paragraphs 0081 and 0082), and wherein the control system is configured to terminate application of the electrical energy to the at least one set of spaced- apart electrodes, responsive to the determination that the threshold parameter is achieved (Paragraphs 0081- 0083).
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 Hou to have the steps of determining whether a threshold parameter is achieved and having a pulse occur after a determination that the threshold has not been reached as taught by Chernenko, since Chernenko teaches that monitoring the voltage pulse and limiting the amount of pulses makes it “possible to carry out the treatment more safely and at the same time more reliably” (Paragraph 0085).
Regarding the step of responsive to determination that the threshold parameter is not achieved, increasing a duration of a pulse of electrical energy for application to the at least one set of electrodes, as Chernenko teaches the step of a pulse occurring after a determination of the threshold having not been reached (Paragraphs 0081- 0083) and the combination has the increase of duration for the next pulse, then the combination teaches this step.
Regarding claim 14, Hou teaches an intravascular lithotripsy (IVL) system (100)(Paragraphs 0003 and 0057)(Figs. 1- 7) comprising:
At least one set of spaced- apart electrodes (3, 4) for arrangement within a body lumen while disposed within a fluid- fillable member (balloon 2) configured to contain fluid therein (Paragraphs 0057, 0059- 0060, 0065, and 0067);
An electric pulse generation system (shockwave generator, pulse wave generator) for providing electrical energy to the at least one set of spaced- apart electrodes configured to generate electrical arcs for IVL therapy (Paragraphs 0058- 0060), the electric pulse generation system including a voltage pulse generator (shockwave generator) in operative communication with the at least one set of spaced- apart electrodes and in operative communication with an IVL control system (charger, energy storage unit, booster, processor) comprising a processor for executing instructions stored on a memory and circuitry configured for communication of signals based on operation of the processor (Paragraphs 0040- 0041 and 0057), the IVL control system configured to:
Initiate one or more voltage pulses having electrical energy (Paragraphs 0057 and 0058), and
Apply the electrical energy generated by the initiated one or more voltage pulses to the at least one set of electrodes (Paragraphs 0057- 0060).
Regarding wherein the IVL control system is configured to increase a duration of application of the generated electrical energy and apply the generated electrical energy to the at least one set of spaced- apart electrodes for the increased duration, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Hou teaches that the voltage pulse width, which correlates to the voltage pulse duration, can be controlled by the processor (Paragraphs 0015, 0018, 0041, 0044, and 0061), that the processor contains an artificial intelligence that can adjust the applied energy and optimize it (Paragraphs 0040- 0041), and that the processor sends out a signal to the pulse generation system, controlling the settings of the voltage pulse sent out (Paragraph 0058), the pulse generation system would be capable of increasing a duration of application of the generated electrical energy and apply the generated electrical energy to the at least one set of spaced- apart electrodes for the increased duration.
Hou does not teach wherein the IVL control system is configured to determine whether a threshold parameter is achieved or wherein responsive to determination that the threshold parameter is not achieved, increase a duration of application of the generated electrical energy and apply the generated electrical energy to the at least one set of spaced- apart electrodes for the increased duration.
Chernenko (Chernenko et al.) teaches a pulse generation system (500)(Figs. 4b and 5) for performing lithotripsy (Paragraphs 0004) connected with a set of electrodes (abstract), the pulse generation system comprising a control system (control circuit 510) wherein the pulse generation system is configured to generate one or more voltage pulses and apply the generated one or more voltage pulses to the at least one spaced- apart electrodes (Paragraphs 0083, 0084, and 0087), to determine whether a threshold parameter comprising the maximum number of voltage pulses which is detected through a voltage pulse counter (Paragraph 0081) resulting in an electrical arc between the at least one set of spaced- apart electrodes is achieved, continue pulsing in response to a determination that the threshold parameter is not achieved (Paragraphs 0081 and 0082), and wherein the control system is configured to terminate application of the electrical energy to the at least one set of spaced- apart electrodes, responsive to the determination that the threshold parameter is achieved (Paragraphs 0081- 0083).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system as taught by Hou to have the voltage pulse counter and the programming regarding the voltage pulse counter as taught by Chernenko, since Chernenko teaches that monitoring the voltage pulse and limiting the amount of pulses makes it “possible to carry out the treatment more safely and at the same time more reliably” (Paragraph 0085).
Regarding the step of responsive to determination that the threshold parameter is not achieved, increasing a duration of a pulse of electrical energy for application to the at least one set of electrodes, as Chernenko teaches the step of a pulse occurring after a determination of the threshold having not been reached (Paragraphs 0081- 0083) and Hou teaches that the pulse width can be controlled by the processor (Paragraphs 0015, 0018, 0041, 0044, and 0061), then the combination teaches a system capable of increasing a duration of a pulse of electrical energy.
Regarding claim 15, Hou and Chernenko make obvious the IVL system as discussed above.
The combination does not teach wherein the IVL control system is configured to re-apply initial electrical energy to the at least one set of electrodes, responsive to determination that the threshold parameter is achieved.
Chernenko (Chernenko et al.) teaches a pulse generation system (500)(Figs. 4b and 5) for performing lithotripsy (Paragraphs 0004) connected with a set of electrodes (abstract), the pulse generation system comprising a control system (control circuit 510) wherein the pulse generation system is configured to generate one or more voltage pulses and apply the generated one or more voltage pulses to the at least one spaced- apart electrodes (Paragraphs 0083, 0084, and 0087), to determine whether a threshold parameter comprising the maximum number of voltage pulses which is detected through a voltage pulse counter (Paragraph 0081) resulting in an electrical arc between the at least one set of spaced- apart electrodes is achieved, continue pulsing in response to a determination that the threshold parameter is not achieved (Paragraphs 0081 and 0082), wherein the control system is configured to terminate application of the electrical energy to the at least one set of spaced- apart electrodes, responsive to the determination that the threshold parameter is achieved and then wherein the IVL control system is configured to re-apply initial electrical energy to the at least one set of electrodes responsive to the determination that the threshold parameter is achieved (Paragraphs 0081- 0083).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system as taught by Hou to have the voltage pulse counter and the programming regarding the voltage pulse counter as taught by Chernenko, since Chernenko teaches that monitoring the voltage pulse and limiting the amount of pulses makes it “possible to carry out the treatment more safely and at the same time more reliably” (Paragraph 0085).
Regarding claim 18, Hou and Chernenko make obvious the IVL system as discussed above.
Regarding wherein the IVL control system is configured to determine if the generated voltage pulse magnitude has achieved a maximum threshold, as this language is functional, the structure of the system only needs to be able to accomplish the function, since Hou teaches that the system has a maximum threshold of voltage through the limit of what the generator can produce (Paragraph 0067), and that the system calculates the voltage, pulse width and frequency of the next shock wave pulse, and calculates the energy emitted by the current pulse, thereby monitoring the pulse and its characteristics (Paragraph 0061), then the system is able to determine the voltage and able determine if it is at a maximum threshold, such as at the limit of the electric pulse.
Regarding claim 19, Hou and Chernenko make obvious the IVL system as discussed above.
Regarding wherein, responsive to the determination that the generated voltage magnitude has achieved the maximum threshold, the IVL control system is configured to adjust the duration of application of the generated electrical energy to the at least one set of spaced- apart electrodes, as this language is functional, the structure of the system only needs to be able to accomplish the function, since Hou teaches that the system has a maximum threshold of voltage through the limit of what the generator can produce (Paragraph 0067), and that the system calculates the voltage, pulse width and frequency of the next shock wave pulse, and calculates the energy emitted by the current pulse, thereby monitoring the pulse and its characteristics (Paragraph 0061 and 0070), then the system is able to determine that the voltage magnitude has achieved the maximum threshold, and then adjust the duration, which is a part of the pulse width, of the application of the generated electrical energy.
Regarding claim 20, Hou and Chernenko make obvious the IVL system as discussed above.
Regarding wherein the IVL control system is configured to adjust the duration of application of the generated electrical energy to the at least one set of spaced- apart electrodes to the duration of the initial control settings, as this language is functional, the structure of the system only needs to be able to accomplish the function, as Hou teaches that the system calculates the pulse width (Paragraph 0061 and 0070), which correlates to the duration of the voltage pulse, then the system is capable of adjusting the duration of the generated electrical energy to the duration of the initial control settings.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hou (CN 114098897) in view of Chernenko et al. (US 2003/0176873), as applied to claim 15 above, in further view of Liu et al. (CN 107633840 English Machine Translation).
Regarding claim 12, Hou teaches a method of operating an intravascular lithotripsy (IVL) system (100)(Paragraphs 0003 and 0057)(Figs. 1- 7) having a catheter assembly (catheter 1, balloon 2) comprising an elongate member (catheter 1) defining a lumen (Paragraph 0065) and a fluid- fillable member (balloon 2) configured to contain fluid therein (Paragraph 0057) and that is associated with a longitudinal end region of the elongate member (see annotated Fig. 1 below), the catheter assembly configured to at least partially fill the fluid- fillable member with an IVL fluid medium to facilitate IVL therapy (Paragraphs 0057 and 0065), at least one set of spaced- apart electrodes (3, 4) for arrangement within the fluid- fillable member for submerging within the IVL fluid medium (Paragraphs 0057, 0059- 0060, 0065, and 0067), and a voltage pulse generator (shockwave generator) in operative communication with the at least one set of spaced- apart electrodes and in operative communication with an IVL control system (charger, energy storage unit, booster, processor) comprising a processor (processor) configured to execute instructions stored on a memory and communications circuitry configured to communicate signals based on operation of the processor for providing IVL therapy to a patient (Paragraphs 0040- 0041 and 0057), the method comprising:
Generating voltage pulses and applying electrical energy generated by the voltage pulses under initial electrical settings comprising voltage pulse magnitude and voltage pulse duration of application of the generated electrical energy to the at least one set of spaced- apart electrodes (Paragraphs 0057- 0060); and
Terminating the generating of the voltage pulses (Paragraph 0073).
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Hou does not teach wherein the method includes determining whether a predetermined maximum number of electrical arcs produced between the at least one set of spaced- apart electrodes is achieved under the initial electrical settings, increasing at least one of the voltage pulse duration and a voltage pulse magnitude of the electrical settings in response to a determination that a predetermined maximum number of produced electrical arcs is not achieved; and terminating the generating of the voltage pulses in response to a subsequent determination that the predetermined maximum number of produced electrical arcs is achieved.
Chernenko (Chernenko et al.) teaches a pulse generation system (500)(Figs. 4b and 5) for performing lithotripsy (Paragraphs 0004) connected with a set of electrodes (abstract), the pulse generation system comprising a control system (control circuit 510) wherein the pulse generation system is configured to generate one or more voltage pulses and apply the generated one or more voltage pulses to the at least one spaced- apart electrodes (Paragraphs 0083, 0084, and 0087), to determine whether a threshold parameter comprising the maximum number of voltage pulses which is detected through a voltage pulse counter (Paragraph 0081) resulting in an electrical arc between the at least one set of spaced- apart electrodes is achieved, continue pulsing in response to a determination that the threshold parameter is not achieved (Paragraphs 0081 and 0082), and wherein the control system is configured to terminate application of the electrical energy to the at least one set of spaced- apart electrodes, responsive to the determination that the threshold parameter is achieved (Paragraphs 0081- 0083).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system as taught by Hou to have the voltage pulse counter and the programming regarding the voltage pulse counter as taught by Chernenko, since Chernenko teaches that monitoring the voltage pulse and limiting the amount of pulses makes it “possible to carry out the treatment more safely and at the same time more reliably” (Paragraph 0085).
Regarding the step of determining the maximum number of electrical arcs, as Hou teaches that each pulse corresponds to an arc (Paragraph 0068), then the pulse counter would count the number of electrical arcs.
The combination does not teach wherein the method includes a step of increasing at least one of the voltage pulse duration and a voltage pulse magnitude of the electrical settings in response to a determination that a predetermined maximum number of produced electrical arcs is not achieved.
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 Hou teaches that the controller is capable of controlling the voltage (Hou, Paragraphs 0061 and 0070) 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) 16- 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hou (CN 114098897) in view of Chernenko et al. (US 2003/0176873), as applied to claim 15 above, in further view of Hakala et al. (US 2014/0074113).
Regarding claims 16 and 17, Hou and Chernenko make obvious the IVL system as discussed above.
The combination does not teach (claim 16) wherein the threshold parameter is a value of current for achieving an electrical arc between the at least one set of spaced- apart electrodes or (claim 17) wherein the threshold parameter value of current is about 20 amperes.
Hakala (Hakala et al.) teaches an intravascular lithotripsy (IVL) system (abstract and Paragraph 0001)(Figs. 1- 6) comprising: at least one set of electrodes (22, 24) for arrangement within a body lumen (Paragraphs 0054 and 0055), an electric pulse generation system (40) for providing electrical energy to the at least one set of electrodes (Paragraph 0057), the electric pulse generation system in operative communication with the electrodes and an IVL control system (microprocessor 90), the IVL control system configured to: initiate one or more voltage pulses having electrical energy, apply the electrical energy, determine whether a threshold parameter is achieved, and when the threshold parameter is achieved terminating the application of energy (Paragraphs 0057, 0061 and 0062). Hakala further teaches wherein the threshold parameter is a value of current for achieving an electrical arc between the at least one set of spaced- apart electrodes and wherein the threshold parameter value of current is about 50 amperes (Paragraphs 0024, 0061 and 0062).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system to have a current sensor and a threshold parameter that is a value of current as taught by Hakala, since Hakala teaches that this “conserves energy applied to the electrodes, causing the electrodes to remain useful for a greater number of pulses than otherwise would be the case” (Paragraph 0060).
The combination does not teach wherein the threshold parameter value of current is about 20 amperes.
However, as applicant has place no criticality on the threshold parameter value of current as evidenced by Paragraph 0029 of Applicant’s specification “the threshold current value is embodied as a predetermined fixed value, e.g., 20 amperes (amps), but in some embodiments, may have any suitable value, for example 50 amps, 100 amps, 150 amps, 175 amps…” since Applicant states that the threshold current value can be any suitable value and thus is not critical to the function of the device, and modifying the combination to have the specified threshold value would not adversely affect the function of the device, as the device of the combination is designed to be used in a similar IVL procedure (Hou, Paragraphs 0003 and 0013).
Conclusion
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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