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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 5-6, 8-9, 12, 13, 15, 18, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US 2022/0287732 A1) in view of Yates et al. (US 2019/0201047 A1)
Regarding claim 1, Anderson discloses a method of operating an intravascular lithotripsy (IVL) system 100 having a catheter assembly 104 comprising an elongate member 106 defining a lumen 320 and an inflatable balloon 110 disposed on a longitudinal end of the elongate member (Fig. 1, Fig. 3), the catheter assembly being adapted to inflate the inflatable balloon with an IVL fluid medium to facilitate IVL therapy (para. [0259], [0270]), at least one set of electrodes (i.e., 114A-114E has a pair of electrodes as disclosed in para. [0262]) for arrangement within the inflatable balloon (Fig. 1) for submerging within the IVL fluid medium (para. [0270]), and an IVL therapy control system 226 adapted for communication of signals for providing IVL therapy to a patient (Fig. 2), the method comprising: applying electrical energy to the at least one set of electrodes (para. [0270]), wherein applying electrical energy comprises: inputting an intermittent pulse width (i.e., para. [0276]; see also para. [0321] and [0349])) modulation control signal into a pulse generation system 102 (para. [0270]-[0276]).
Anderson doesn’t directly disclose: as a result of inputting the intermittent pulse width modulation control signal into the pulse generation system, the pulse generation system generating a high-voltage output signal having a voltage greater than a voltage of the intermittent pulse width modulation control signal, the high-voltage output signal being provided to the at least one set of electrodes for pulse delivery.
In the same field of endeavor, namely method for smart energy device infrastructure, Yates discloses a similar pulse width modulation device including a surgical system 102 and a pulse width modulation circuit 2992 coupled to an oscillator 2994. Yates also discloses as a result of inputting the intermittent pulse width modulation control signal into the pulse generation system (i.e., see para. [0579 in which a first signal is provided and then converted into an analog waveform (para. [0579])), the pulse generation system generating a high-voltage output signal having a voltage greater than a voltage of the intermittent pulse width modulation control signal, the high-voltage output signal being provided to the at least one set of electrodes for pulse delivery (para. [0579] i.e., at least by going through the transistor output stages such that it is amplified).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anderson to have the above limitations for the purpose of amplifying the input signal (para. [0579]).
Regarding claim 2, Anderson and Yates disclose the method of claim 1. Anderson also discloses wherein inputting the intermittent pulse width modulation control signal comprises using a high-frequency switched signal (para. [0039], i.e., see also para. [0256] which discloses a high-energy pressure waves (i.e., note that frequency and energy are directly related)) from a processor 218 provided to the pulse generation system (Fig 2; see also paras. [0348]-[0349]).
Regarding claim 3, Anderson and Yates disclose the method of claim 1. Anderson doesn’t directly disclose wherein the pulse width modulation control signal comprises a duty cycle between 0 percent and 100 percent.
Yates discloses wherein the pulse width modulation control signal comprises a duty cycle between 0 percent and 100 percent (para. [0588]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anderson to include a duty cycle between 0 and 100 percent for the purposes of achieving a desired and actual output from the switch (para. [0588]).
Regarding claim 4, Anderson discloses the method of claim 1. Anderson doesn’t directly disclose further comprising low-pass filtering the intermittent pulse width modulation control signal.
Yates discloses comprising low-pass filtering the intermittent pulse width modulation control signal (para. [0588]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anderson such that the intermittent pulse width modulation control signal would experience low-pass filtering for purposes of including the output values in a feedback architecture to adjust the pulse width modulation (para. [0588]).
Regarding claim 5, Anderson and Yates disclose the method of claim 1. Anderson also discloses further comprising conditioning the intermittent pulse width modulation control signal (para. [0349]-[0350] discloses conditioning the intermittent pulse width modulation signal based on real-time monitoring and adjusting energy levels based on those conditions).
Regarding claim 6, Anderson and Yates disclose the method of claim 1. Anderson also discloses wherein the intermittent pulse width modulation control signal is used by the pulse generation system to generate a high-voltage output signal in the range of 0V to 4000 V (i.e., paras. [0352]-[0353] at least discloses applying voltage and also as an all or nothing (i.e., 0V)).
Regarding claim 7, Anderson and Yates disclose the method of claim 1. Anderson doesn’t directly disclose amplifying the intermittent pulse width modulation control signal.
Yates discloses amplifying the intermittent pulse width modulation control signal (para. [0579]).
Regarding claim 8, Anderson discloses an intravascular lithotripsy (IVL) system (Figs. 1-3) comprising: a catheter assembly 104 including an elongate member 106 defining a lumen 320 and an inflatable balloon 110 disposed on a longitudinal end of the elongate member (Fig. 1, Fig. 3); at least one set of electrodes (i.e., 114A-114E has a pair of electrodes as disclosed in para. [0262]) arranged within the inflatable balloon (Fig. 1) for submersion within an IVL fluid medium (para. [0270]); a pulse generation system 102 configured to apply high-voltage output signals to the at least one set of electrodes (paras. [0270]-[0276]); and an IVL therapy control system 100 in communication with the pulse generation system and configured to provide intermittent pulse width modulation control signals to the pulse generation system (para. [0270]).
Anderson doesn’t directly disclose the high-voltage output signals having voltages greater than voltages of the intermittent pulse width modulation control signals; the pulse generation system is configured to apply the high-voltage output signals to the at least one set of electrodes based on the intermittent pulse width modulation control signals being input into the pulse generation system.
Yates also discloses the high-voltage output signals having voltages greater than voltages of the intermittent pulse width modulation control signals (i.e., see para. [0579] in which a first signal is amplified (para. [0579])), the pulse generation system is configured to apply the high-voltage output signals to the at least one set of electrodes based on the intermittent pulse width modulation control signals being input into the pulse generation system (para. [0579] i.e., at least by going through the transistor output stages such that it is amplified).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anderson to have the above limitations for the purpose of amplifying the input signal (para. [0579]).
Regarding claim 9, Anderson and Yates disclose the IVL system of claim 8. Anderson also discloses wherein the IVL therapy control system comprises a processor configured to generate a high-frequency switched control signals as the intermittent pulse width modulation control signals for the pulse generation system (para. [0039], i.e., see also para. [0256] which discloses a high-energy pressure waves (i.e., note that frequency and energy are directly related)) from a processor 218 provided to the pulse generation system (Fig 2; see also paras. [0348]-[0349]).
Regarding claim 10, Anderson and Yates disclose the IVL system of claim 8. Anderson doesn’t directly disclose wherein the pulse generation system is configured to receive the intermittent pulse width modulation control signals having a duty cycle that increases within a range of 0 percent to 100 percent.
Yates discloses herein the pulse generation system is configured to receive the intermittent pulse width modulation control signals having a duty cycle that increases within a range of 0 percent to 100 percent (para. [0588]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anderson to include herein the pulse generation system is configured to receive the intermittent pulse width modulation control signals having a duty cycle that increases within a range of 0 percent to 100 percent (para. [0588]).
Regarding claim 11, Anderson discloses the IVL system of claim 8. Anderson doesn’t directly disclose further comprising a low-pass filter, the low-pass filter configured to condition the intermittent pulse width modulation control signals prior to use in generating the high-voltage output signals.
Yates discloses comprising a low-pass filter, the low-pass filter configured to condition the intermittent pulse width modulation control signals prior to use in generating the high-voltage output signals (para. [0588]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anderson such that a low-pass filter, the low-pass filter configured to condition the intermittent pulse width modulation control signals prior to use in generating the high-voltage output signals for purposes of including the output values in a feedback architecture to adjust the pulse width modulation (para. [0588]).
Regarding claim 12, Anderson and Yates disclose the IVL system of claim 8. Anderson also discloses further comprising signal conditioning circuitry configured to condition the intermittent pulse width modulation control sign from the IVL therapy control system (para. [0349]-[0350] discloses conditioning the intermittent pulse width modulation signal based on real-time monitoring and adjusting energy levels based on those conditions).
Regarding claim 13, Anderson and Yates disclose the IVL system of claim 8. Anderson also discloses wherein the pulse generation system includes a high-voltage converter 210 configured to generate high-voltage output signals in a range of about 0 V to about 4000 V in response to the intermittent pulse width modulation control signals (paras. [0352]-[0353]).
Regarding claim 14, Anderson and Yates disclose the IVL system of claim 8. Anderson doesnt directly discloses further comprising an amplifier configured to amplify the intermittent pulse width modulation control signals prior to input into the pulse generation system.
Yates discloses an amplifier configured to amplify the intermittent pulse width modulation control signals prior to input into the pulse generation system (para. [0579]).
Regarding claim 15, Anderson discloses an intravascular lithotripsy (IVL) system (Figs. 1-3) comprising: a catheter assembly 104 including an elongate member 106 defining a lumen 320 and an inflatable balloon 110 disposed on a longitudinal end of the elongate member (Fig. 1, Fig. 3); at least one set of electrodes (i.e., 114A-114E has a pair of electrodes as disclosed in para. [0262]) arranged within the inflatable balloon (Fig. 1) for submersion within an IVL fluid medium (paras. [0259], [0270]); a pulse generation system 102 configured to apply high-voltage output signals to the at least one set of electrodes (paras. [0270]-[0276]); and an IVL therapy control system 100 comprising a processor 218 and a memory storing instructions that, when executed by the processor, cause the processor to: generate intermittent pulse width modulation control signal (i.e., see Fig. 2; paras. [0270]-[0276]); and input the intermittent pulse width modulation control signals into the pulse generation system to cause pulse delivery at the electrodes (Fig. 2; paras. [0270]-[0276]).
Anderson doesn’t directly disclose wherein the pulse generation system is configured to apply the high-voltage output signals to the at least one set of electrodes based on the intermittent pulse width modulation control signals being input into the pulse generation system.
Yates discloses the pulse generation system is configured to apply the high-voltage output signals to the at least one set of electrodes based on the intermittent pulse width modulation control signals being input into the pulse generation system (para. [0579] i.e., at least by going through the transistor output stages such that it is amplified).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anderson to have the above limitations for the purpose of amplifying the input signal (para. [0579]).
Regarding claim 16, Anderson and Yates disclose the IVL system of claim 15. Anderson doesn’t directly disclose wherein the processor is configured to generate the intermittent pulse width modulation control signals having a duty cycle that increases within a range of 0 percent to 100 percent.
Yates discloses wherein the processor is configured to generate the intermittent pulse width modulation control signals having a duty cycle that increases within a range of 0 percent to 100 percent (para. [0588]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anderson to include the processor is configured to generate the intermittent pulse width modulation control signals having a duty cycle that increases within a range of 0 percent to 100 percent (para. [0588]).
Regarding claim 17, Anderson discloses the IVL system of claim 15. Anderson doesn’t directly disclose a low-pass filter, the low-pass filter configured to condition the intermittent pulse width modulation control signal.
Yates discloses a low-pass filter, the low-pass filter configured to condition the intermittent pulse width modulation control signal (para. [0588]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anderson such that a low-pass filter, the low-pass filter configured to condition the intermittent pulse width modulation control signal (para. [0588]).
Regarding claim 18, Anderson and Yates disclose the IVL system of claim 15. Anderson also discloses further comprising signal conditioning circuitry configured to condition the intermittent pulse width modulation control signals (para. [0349]-[0350] discloses conditioning the intermittent pulse width modulation signal based on real-time monitoring and adjusting energy levels based on those conditions).
Regarding claim 19, Anderson and Yates disclose the IVL system of claim 15. Anderson also discloses wherein the pulse generation system includes a high-voltage converter 210 configured to generate output signals in a range of about 0 V to about 4000 V in response to the intermittent pulse width modulation control signals (paras. [0352]-[0353]).
Regarding claim 20, Anderson and Yates disclose the IVL system of claim 15. Anderson doesn’t directly disclose further comprising an amplifier configured to amplify the intermittent pulse width modulation control signals.
Yates discloses an amplifier configured to amplify the intermittent pulse width modulation control signals (para. [0579]).
Response to Arguments
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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