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 .
Specification
The disclosure is objected to because of the following informalities:
Paragraph 0023, Line 2 states “PCT/2022/074607”, it is suggested to change this to “PCT/US2022/074607”.
Paragraph 0037, Line 6 states “include updates settings”, it is suggested to change this to “include updates to the settings”.
Paragraph 0059, Line 10 states “and/or or portions”, it is suggested to change this to “and/or portions”.
Paragraph 0081, Line 4 states “can monitoring”, it is suggested to change this to “can monitor”.
Paragraph 0084, Lines 2- 3 state “box 218 is embodied as occurring immediately after attempted IVL therapy in box 216”, it is suggested to change this to “box 318 is embodied as occurring immediately after attempted IVL therapy in box 316”.
Paragraph 0085, Lines 4- 6 state “box 214, yet after attempted delivery of IVL therapy. In some embodiments, determining energy of the energy storage system 112 in box 320 may differ in methodology and/or practice from that in box 214”, it is suggested to change this to “box 314, yet after attempted delivery of IVL therapy. In some embodiments, determining energy of the energy storage system 112 in box 320 may differ in methodology and/or practice from that in box 314”.
Paragraph 0088, Line 9 states “above the knee or above the knee”, it is suggested to change this to “above the knee or below the knee”.
Paragraph 0093, Line 7 states “(“HV_WDO#)”, it is suggested to change this to “(“HV_WDO#”)”.
Paragraph 0096, Line 3 states “(“HV_WDO#)”, it is suggested to change this to “(“HV_WDO#”)”.
Paragraph 0098, Line 8 states “Communication circuitry 58”, it is suggested to change this to “Communication circuitry 28”.
Paragraph 00105, Line 11 states “box 109”, it is suggested to change this to “box 209”.
Paragraph 00107, Lines 3- 4 state “box 118”, it is suggested to change this to “box 218”.
Paragraph 00112, Lines 7-8 state “boxes 104- 110 (2.5 mm) and boxes 118- 124 (4.0 mm).”, it is suggested to change this to “boxes 204- 210 (2.5 mm) and boxes 218- 224 (4.0 mm).”
Paragraph 00117, Line 4 states “the physical”, it is suggested to change this to “the physician”.
Paragraph 00121, Line 8 states “Communication circuitry 58”, it is suggested to change this to “Communication circuitry 28”.
Appropriate correction is required.
Claim Objections
Claims 1-20 are objected to because of the following informalities:
Claim 1, Line 1 states “(“IVL”)”, it is suggested to change this to “(IVL)”.
Claim 1, Line 5 states “intravascular lithotripsy (IVL)”, it is suggested to change this to “IVL”.
Claim 1, Lines 9-10 state “wherein the electric pulse generation system comprises an electrical power system includes an AC power source and a DC power storage system and an energy charge system”, it is suggested to change this to “wherein the electric pulse generation system comprises an electrical power system including an AC power source and a DC power storage system and an energy storage system”.
Claims 2- 9 are objected to for being dependent on or from objected claim 1.
Claim 10, Line 1 states “(“IVL”)”, it is suggested to change this to “(IVL)”.
Claim 10, Lines 5-6 state “intravascular lithotripsy (IVL)”, it is suggested to change this to “IVL”.
Claim 10, Line 11 states “energy charge system”, it is suggested to change this to “energy storage system”.
Claims 11- 15 are objected to for being dependent on or from objected claim 10.
Claim 11, Line 3 states “an energy storage system”, it is suggested to change this to “the energy storage system”.
Claim 12, Lines 1- 2 states “further comprising the IVL control system being configured to”, it is suggested to change this to “wherein the IVL control system is further configured to”.
Claim 16, Line 1 states “(“IVL”)”, it is suggested to change this to “(IVL)”.
Claims 17 and 18 are objected to for being dependent on or from objected claim 16.
Claim 19, Line 1 states “(“IVL”)”, it is suggested to change this to “(IVL)”.
Claim 20 is objected to for being dependent on or from objected claim 19.
Appropriate correction is required.
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.
Claims 19- 20 are 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 19 recites the limitation "the DC power storage device" in Line 4. There is insufficient antecedent basis for this limitation in the claim. This limitation is not disclosed within claim 10, on which claim 19 depends. However, the limitation is found in claim 15. Therefore, this limitation will herein be interpreted as “a DC power storage device of the DC power storage system”, or alternatively that claim 19 depends upon claim 15.
Claim 20 is herein rejected for being dependent on rejected claim 19.
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- 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu (CN 113648048 English Machine Translation) in view of Millis (US 2017/0020598) and in view of Tsukamoto (US 9192772).
Regarding claims 1 and 10, Liu teaches an intravascular lithotripsy (IVL) system (Figs. 1- 6)(Paragraph 0006), comprising:
At least one set of spaced- apart electrodes (6) for arrangement within a body lumen and in association with a fluid-fillable member (balloon 2) configured to contain fluid therein (Paragraph 0038); and
An electric pulse generation system (shock wave therapy host 1) configured to provide electrical energy to the at least one set of spaced- apart electrodes to generate spark for IVL therapy (Paragraphs 0038- 0040, 0045, and 0048), the electric pulse generation system including an IVL control system (control module, pulse switch module, power supply module)(Paragraphs 0045 and 0049), the IVL control system comprising a processor configured to execute programmed instructions stored on memory (Paragraph 0049, as the control module is capable of controlling each module in the system, it contains a memory.) and communications circuitry configured to communicate signals based on commands from the processor (Paragraphs 0049 and 0050),
Wherein the electric pulse generation system comprises an electrical power system (multi- channel high- voltage pulse power supply, pulse switch module) including a high voltage source (multi-channel high- voltage pulse power supply)(Paragraph 0040) and an energy charge system (power supply module, pulse switch module)(Paragraph 0045) and wherein the electric pulse generation system is configured to provide power for IVL operations (Paragraphs 0040, 0045, 0047, 0049, 0053, and 0054).
Liu does not teach that the electrical power system includes an AC power source and a DC power storage system, wherein the AC power source is configured for connection with an AC power receptacle to receive AC power, wherein the electric pulse generation system is configured to selectively provide power from the AC power source or the DC power storage system for IVL operations or (claim 10) wherein the AC power source is electrically operatively connectable with the electric pulse generation system and with the DC power storage system.
Millis teaches an electrosurgical system (100) for tissue treatment (Paragraphs 0028- 0030) comprising an electrical power system (wave generator 102, battery, connector 132) that includes an AC power source (connector 132)(Paragraph 0044) and an electric pulse generation system (wave generator 102), wherein the electric pulse generation system is configured to selectively provide power from the AC power source or a DC power storage system (battery, Paragraphs 0042- 0045) for electrosurgical operations (In Paragraphs 0042- 0045, Millis teaches that a battery powers the generator when no external AC power source is available and is capable of recharging via the AC power source. Millis also teaches that the system selects the battery for portability or the AC power source when plugged in). Millis further teaches wherein the system is battery powered for portability without continuous AC connection (Paragraphs 0043) and wherein the battery recharges from the AC power source (Paragraph 0044) and wherein the AC power source is electrically operatively connectable with the electric pulse generation system and with the DC power storage system (Paragraph 0044).
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 Liu to incorporate an electrical power system including an AC power source and a DC power storage system as taught by Millis, since Millis teaches that with these power sources provide the device with portability, such that the device can be used in areas outside of the hospital or during times when power is not available within the hospital (Paragraph 0043).
The combination of Liu and Millis does not teach wherein the AC power source is configured for connection with an AC power receptacle to receive AC power, wherein the electric pulse generation system is configured to selectively provide power from the AC power source or the DC power storage system for IVL operations, or (claim 10) wherein the AC power source is electrically operatively connectable with the electric pulse generation system and with the DC power storage system.
Tsukamoto teaches portable medical power systems for medical devices requiring reliable, redundant power (abstract)(Figs. 1 and 3) comprising an electrical power system (wearable power source 20, cart 30, nonportable power source 40) that includes an AC power source (nonportable power source 40)(Column 7, Lines 5-9) and a DC power storage system (wearable power source 20 and cart 30 with batteries)(Column 5, Lines 5-17, Column 6, Lines 16- 17, and Column 6, Line 46- Column 7, Line 4), wherein the AC power source is configured for connection with an AC power receptacle (wall socket 44) to receive AC power (Column 7, Lines 5- 9) and wherein the system is configured to selectively provide power from the AC power source or the DC power storage system for medical operations (Fig.3)(Column 3, Line 66- Column 4, Line 2; Column 7, Line 21- Column 9, line 22; Column 10, Lines 16- 54). Tsukamoto further teaches selective switching between AC and DC power sources for reliability and mobility in medical contexts (Column 10, Lines 24- 38 and 41- 47) and wherein the AC power source is electrically operatively connectable with the electric pulse generation system and with the DC power storage system (Column 7, Lines 6-9).
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 incorporate the AC power source’s configuration to be connected with an AC power receptacle and the selective switching between the AC power source and the DC power storage system as taught by Tsukamoto, since Tsukamoto teaches that selective switching between AC and DC power sources for reliability and mobility in medical contexts (Column 10, Lines 24- 38 and 41- 47).
Regarding claim 2, Liu, Millis, and Tsukamoto 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 Liu to incorporate an electrical power system including an AC power source and a DC power storage system as taught by Millis, since Millis teaches that with these power sources provide the device with portability, such that the device can be used in areas outside of the hospital or during times when power is not available within the hospital (Paragraph 0043) and to modify the system as taught by the combination to incorporate the AC power source’s configuration to be connected with an AC power receptacle and the selective switching between the AC power source and the DC power storage system as taught by Tsukamoto, since Tsukamoto teaches that selective switching between AC and DC power sources for reliability and mobility in medical contexts (Column 10, Lines 24- 38 and 41- 47).
The combination further teaches wherein the AC power source is electrically operatively connectable with the electric pulse generation system and with the DC power storage system (Paragraphs 0043- 0045 of Millis; Column 3, Lines 48- 53, Column 3, Line 66- Column 4, Line 2 and Column 7, Lines 5-9 of Tsukamoto.).
Regarding claim 3 and 14, Liu, Millis, and Tsukamoto 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 Liu to incorporate an electrical power system including an AC power source and a DC power storage system as taught by Millis, since Millis teaches that with these power sources provide the device with portability, such that the device can be used in areas outside of the hospital or during times when power is not available within the hospital (Paragraph 0043) and to modify the system as taught by the combination to incorporate the AC power source’s configuration to be connected with an AC power receptacle and the selective switching between the AC power source and the DC power storage system as taught by Tsukamoto, since Tsukamoto teaches that selective switching between AC and DC power sources for reliability and mobility in medical contexts (Column 10, Lines 24- 38 and 41- 47).
The combination further teaches wherein the DC power storage system is configured to receive AC power from the AC power source (In Paragraph 0044, Millis teaches that the battery (DC power storage system) receives AC via connector (132) for recharging; Column 7, Lines 5-9 of Tsukamoto).
Regarding claims 4 and 15, Liu, Millis, and Tsukamoto 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 Liu to incorporate an electrical power system including an AC power source and a DC power storage system as taught by Millis, since Millis teaches that with these power sources provide the device with portability, such that the device can be used in areas outside of the hospital or during times when power is not available within the hospital (Paragraph 0043) and to modify the system as taught by the combination to incorporate the AC power source’s configuration to be connected with an AC power receptacle and the selective switching between the AC power source and the DC power storage system as taught by Tsukamoto, since Tsukamoto teaches that selective switching between AC and DC power sources for reliability and mobility in medical contexts (Column 10, Lines 24- 38 and 41- 47).
The combination further teaches wherein the DC power storage system is configured to convert AC power to DC power for charging a DC power storage device (battery in Millis and Tsukamoto) of the DC power storage system (Paragraph 0044 of Millis; Column 7, Lines 5- 10 of Tsukamoto).
Regarding claim 5, Liu, Millis, and Tsukamoto 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 Liu to incorporate an electrical power system including an AC power source and a DC power storage system as taught by Millis, since Millis teaches that with these power sources provide the device with portability, such that the device can be used in areas outside of the hospital or during times when power is not available within the hospital (Paragraph 0043) and to modify the system as taught by the combination to incorporate the AC power source’s configuration to be connected with an AC power receptacle and the selective switching between the AC power source and the DC power storage system as taught by Tsukamoto, since Tsukamoto teaches that selective switching between AC and DC power sources for reliability and mobility in medical contexts (Column 10, Lines 24- 38 and 41- 47).
The combination further teaches wherein the IVL control system is configured to selectively charge the energy storage system from the DC power storage system only (Paragraphs 0042 – 0043 of Millis, battery powers the system and would selectively charge the energy storage system of the combination (power supply module, pulse switch module of Liu)(Paragraph 0045 of Liu) when the AC power source is unavailable; Tsukamoto, Column 7, Line 21- Column 8, Line 56).
Regarding claim 6, Liu, Millis, and Tsukamoto 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 Liu to incorporate an electrical power system including an AC power source and a DC power storage system as taught by Millis, since Millis teaches that with these power sources provide the device with portability, such that the device can be used in areas outside of the hospital or during times when power is not available within the hospital (Paragraph 0043) and to modify the system as taught by the combination to incorporate the AC power source’s configuration to be connected with an AC power receptacle and the selective switching between the AC power source and the DC power storage system as taught by Tsukamoto, since Tsukamoto teaches that selective switching between AC and DC power sources for reliability and mobility in medical contexts (Column 10, Lines 24- 38 and 41- 47).
The combination further teaches wherein the IVL control system is further configured to selectively charge the energy storage system from the AC power source (Paragraph 0044 of Millis, Column 7, Line 21- Column 8, Line 56 of Tsukamoto; the AC power source would selectively charge the energy storage system of the combination (power supply module, pulse switch module of Liu)(Paragraph 0045 of Liu) as it acts as the voltage source of the combination.).
Regarding claim 7, Liu, Millis, and Tsukamoto 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 Liu to incorporate an electrical power system including an AC power source and a DC power storage system as taught by Millis, since Millis teaches that with these power sources provide the device with portability, such that the device can be used in areas outside of the hospital or during times when power is not available within the hospital (Paragraph 0043) and to modify the system as taught by the combination to incorporate the AC power source’s configuration to be connected with an AC power receptacle and the selective switching between the AC power source and the DC power storage system as taught by Tsukamoto, since Tsukamoto teaches that selective switching between AC and DC power sources for reliability and mobility in medical contexts (Column 10, Lines 24- 38 and 41- 47).
The combination further teaches wherein the IVL control system is further configured to selectively charge the energy storage system directly from DC power that is converted from the AC power source (Paragraph 0044 of Millis, the AC from the power source is converted to DC for recharging, thus selectively charging the energy storage system from DC power; Column 7, Lines 5-9 of Tsukamoto, AC from the power source is converted or recharges the DC systems.).
Regarding claims 8 and 11, Liu, Millis, and Tsukamoto 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 Liu to incorporate an electrical power system including an AC power source and a DC power storage system as taught by Millis, since Millis teaches that with these power sources provide the device with portability, such that the device can be used in areas outside of the hospital or during times when power is not available within the hospital (Paragraph 0043) and to modify the system as taught by the combination to incorporate the AC power source’s configuration to be connected with an AC power receptacle and the selective switching between the AC power source and the DC power storage system as taught by Tsukamoto, since Tsukamoto teaches that selective switching between AC and DC power sources for reliability and mobility in medical contexts (Column 10, Lines 24- 38 and 41- 47).
The combination further teaches wherein, when the AC power source is not connected with the electric pulse generation system and the DC power storage system, DC power from the DC power storage system is delivered directly to the energy storage system (Paragraph 0043 of Millis, the battery delivers power when AC power is not available; Column 8, Line 57- Column 9, Line 22 of Tsukamoto).
Regarding claims 9 and 13, Liu, Millis, and Tsukamoto 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 Liu to incorporate an electrical power system including an AC power source and a DC power storage system as taught by Millis, since Millis teaches that with these power sources provide the device with portability, such that the device can be used in areas outside of the hospital or during times when power is not available within the hospital (Paragraph 0043) and to modify the system as taught by the combination to incorporate the AC power source’s configuration to be connected with an AC power receptacle and the selective switching between the AC power source and the DC power storage system as taught by Tsukamoto, since Tsukamoto teaches that selective switching between AC and DC power sources for reliability and mobility in medical contexts (Column 10, Lines 24- 38 and 41- 47).
The combination further teaches wherein the DC power storage system comprises one or more batteries (Paragraphs 0042- 0044 of Millis; Column 5, Lines 31- 34, Column 7, Lines 21- 36, and Column 7, Line 53- Column 8, Line 31 of Tsukamoto).
Regarding claim 12, Liu, Millis, and Tsukamoto 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 Liu to incorporate an electrical power system including an AC power source and a DC power storage system as taught by Millis, since Millis teaches that with these power sources provide the device with portability, such that the device can be used in areas outside of the hospital or during times when power is not available within the hospital (Paragraph 0043) and to modify the system as taught by the combination to incorporate the AC power source’s configuration to be connected with an AC power receptacle and the selective switching between the AC power source and the DC power storage system as taught by Tsukamoto, since Tsukamoto teaches that selective switching between AC and DC power sources for reliability and mobility in medical contexts (Column 10, Lines 24- 38 and 41- 47).
The combination further teaches the system further comprising the IVL control system being configured to selectively charge the energy storage system from at least one of the group consisting of: the DC power storage system only, the AC power source, and directly from DC power that is converted from the AC power source (Paragraphs 0042- 0045 of Millis, Column 10, Lines 30- 38 of Tsukamoto).
Regarding claim 16, Liu, Millis, and Tsukamoto make obvious the IVL system as discussed above, including the system as in claim 10 (see above rejection of claims 1 and 10).
Liu teaches a method of providing an IVL system (Paragraph 0038), selectively charging the energy storage system with energy from a voltage source (Paragraphs 0040, 0044- 0045, and 0052), discharging energy from the charged energy storage system (Paragraph 0045) and initiating voltage pulses with the IVL system with the discharged energy (Paragraphs 0039, 0045, and 0052).
Liu does not teach a method comprising connecting the AC power source to the electric pulse generation system, connecting the AC power source to the DC power storage system, or selectively charging the energy storage system with energy from the AC power source to the IVL system.
Millis teaches a method (abstract) for an electrosurgical system (100) for tissue treatment (Paragraphs 0028- 0030) comprising an electrical power system (wave generator 102, battery, connector 132) that includes an AC power source (connector 132)(Paragraph 0044) and an electric pulse generation system (wave generator 102), including the step of connecting the AC power source to the electric pulse generation system and the step of connecting the AC power source to the DC power storage system (Paragraphs 0042- 0045).
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 Liu to incorporate the steps of connecting the AC power source to the electric pulse generation system and to the DC power storage system as taught by Millis, since Millis teaches that with these power sources provide the device with portability, such that the device can be used in areas outside of the hospital or during times when power is not available within the hospital (Paragraph 0043).
The combination of Liu and Millis does not teach the step of selectively charging the energy storage system with energy from the AC power source to the IVL system.
Tsukamoto teaches a method for using portable medical power systems for medical devices requiring reliable, redundant power (abstract)(Figs. 1 and 3) comprising an electrical power system (wearable power source 20, cart 30, nonportable power source 40) that includes an AC power source (nonportable power source 40)(Column 7, Lines 5-9) and a DC power storage system (wearable power source 20 and cart 30 with batteries)(Column 5, Lines 5-17, Column 6, Lines 16- 17, and Column 6, Line 46- Column 7, Line 4), the method comprising the step of selectively provide power from the AC power source to the system (Column 3, Line 66- Column 4, Line 2; Column 7, Line 21- Column 9, line 22; Column 10, Lines 16- 54). Tsukamoto further teaches selective switching between AC and DC power sources for reliability and mobility in medical contexts (Column 10, Lines 24- 38 and 41- 47) and wherein the AC power source is electrically operatively connectable with the electric pulse generation system and with the DC power storage system (Column 7, Lines 6-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method as taught by the combination to incorporate the step of selectively providing power from the AC power source to the system and the selective switching between the AC power source and the DC power storage system as taught by Tsukamoto, since Tsukamoto teaches that selective switching between AC and DC power sources for reliability and mobility in medical contexts (Column 10, Lines 24- 38 and 41- 47).
Regarding claim 17, Liu, Millis, and Tsukamoto make obvious the IVL method 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 method as taught by Liu to incorporate the steps of connecting the AC power source to the electric pulse generation system and to the DC power storage system as taught by Millis, since Millis teaches that with these power sources provide the device with portability, such that the device can be used in areas outside of the hospital or during times when power is not available within the hospital (Paragraph 0043) and to modify the method as taught by the combination to incorporate the step of selectively providing power from the AC power source to the system and the selective switching between the AC power source and the DC power storage system as taught by Tsukamoto, since Tsukamoto teaches that selective switching between AC and DC power sources for reliability and mobility in medical contexts (Column 10, Lines 24- 38 and 41- 47).
The combination further teaches the method further comprising selectively charging the energy storage system directly with DC power that is converted from the AC power source (Paragraph 0044 of Millis).
Regarding claim 18, Liu, Millis, and Tsukamoto make obvious the IVL method 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 method as taught by Liu to incorporate the steps of connecting the AC power source to the electric pulse generation system and to the DC power storage system as taught by Millis, since Millis teaches that with these power sources provide the device with portability, such that the device can be used in areas outside of the hospital or during times when power is not available within the hospital (Paragraph 0043) and to modify the method as taught by the combination to incorporate the step of selectively providing power from the AC power source to the system and the selective switching between the AC power source and the DC power storage system as taught by Tsukamoto, since Tsukamoto teaches that selective switching between AC and DC power sources for reliability and mobility in medical contexts (Column 10, Lines 24- 38 and 41- 47).
The combination further teaches the method further comprising charging the DC power storage system with energy from the AC power source (Paragraph 0044 of Millis; Column 7, Lines 5- 10 of Tsukamoto).
Regarding claim 19, Liu, Millis, and Tsukamoto make obvious the IVL system of claim 10 as discussed above (see above rejection of claims 1 and 10).
Liu teaches a method of providing an IVL system (Paragraph 0038), selectively charging the energy storage system with energy from a voltage source (Paragraphs 0040, 0044- 0045, and 0052), discharging energy from the charged energy storage system (Paragraph 0045) and initiating voltage pulses with the IVL system with the discharged energy (Paragraphs 0039, 0045, and 0052).
Liu does not teach a method comprising connecting the AC power source to the electric pulse generation system, connecting the AC power source to a DC power storage device, or selectively charging the energy storage system with energy from the DC power source to the IVL system.
Millis teaches a method (abstract) for an electrosurgical system (100) for tissue treatment (Paragraphs 0028- 0030) comprising an electrical power system (wave generator 102, battery, connector 132) that includes an AC power source (connector 132)(Paragraph 0044) and an electric pulse generation system (wave generator 102), including the step of connecting the AC power source to the electric pulse generation system and the step of connecting the AC power source to the DC power storage device (Paragraphs 0042- 0045).
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 Liu to incorporate the steps of connecting the AC power source to the electric pulse generation system and to the DC power storage system as taught by Millis, since Millis teaches that with these power sources provide the device with portability, such that the device can be used in areas outside of the hospital or during times when power is not available within the hospital (Paragraph 0043).
The combination of Liu and Millis does not teach the step of selectively charging the energy storage system with energy from the AC power source to the IVL system.
Tsukamoto teaches a method for using portable medical power systems for medical devices requiring reliable, redundant power (abstract)(Figs. 1 and 3) comprising an electrical power system (wearable power source 20, cart 30, nonportable power source 40) that includes an AC power source (nonportable power source 40)(Column 7, Lines 5-9) and a DC power storage system (wearable power source 20 and cart 30 with batteries)(Column 5, Lines 5-17, Column 6, Lines 16- 17, and Column 6, Line 46- Column 7, Line 4), the method comprising the step of selectively provide power from the AC power source to the system (Column 3, Line 66- Column 4, Line 2; Column 7, Line 21- Column 9, line 22; Column 10, Lines 16- 54). Tsukamoto further teaches selective switching between AC and DC power sources for reliability and mobility in medical contexts (Column 10, Lines 24- 38 and 41- 47) and wherein the AC power source is electrically operatively connectable with the electric pulse generation system and with the DC power storage system (Column 7, Lines 6-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method as taught by the combination to incorporate the step of selectively providing power from the DC power source to the system and the selective switching between the AC power source and the DC power storage system as taught by Tsukamoto, since Tsukamoto teaches that selective switching between AC and DC power sources for reliability and mobility in medical contexts (Column 10, Lines 24- 38 and 41- 47).
Regarding claim 20, Liu, Millis, and Tsukamoto make obvious the IVL method 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 method as taught by Liu to incorporate the steps of connecting the AC power source to the electric pulse generation system and to the DC power storage system as taught by Millis, since Millis teaches that with these power sources provide the device with portability, such that the device can be used in areas outside of the hospital or during times when power is not available within the hospital (Paragraph 0043) and to modify the method as taught by the combination to incorporate the step of selectively providing power from the AC power source to the system and the selective switching between the AC power source and the DC power storage system as taught by Tsukamoto, since Tsukamoto teaches that selective switching between AC and DC power sources for reliability and mobility in medical contexts (Column 10, Lines 24- 38 and 41- 47).
The combination further teaches the method further comprising the step of charging the DC power storage system with the AC power source (Paragraph 0044 of Millis; Column 7, Lines 5- 10 of Tsukamoto).
Double Patenting
Claims 1- 20 of this application is patentably indistinct from claims 1- 20 of Application No.18/506,429. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1- 20 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1- 20 of copending Application No. 18/506,429 (‘429). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Regarding claim 1, ‘429 claims an intravascular lithotripsy ("IVL") system comprising: at least one set of spaced-apart electrodes for arrangement within a body lumen and in association with a fluid-fillable member configured to contain fluid therein (claim 1 of ‘429); an electric pulse generation system configured to provide electrical energy to the at least one set of spaced-apart electrodes to generate spark for intravascular lithotripsy (IVL) therapy (claim 1 of ‘429), the electric pulse generation system including an IVL control system comprising a processor configured to execute instructions stored on memory and communications circuitry configured to communicate signals based on commands from the processor (claim 1 of ‘429), wherein the electric pulse generation system comprises an electrical power system includes an AC power source and a DC power storage system and an energy charge system (claim 1 of ‘429), wherein the AC power source is configured for connection with an AC power receptacle to receive AC power (claim 1 of ‘429), and wherein the electric pulse generation system is configured to selectively provide power from the AC power source or the DC power storage system for IVL operations (claim 1 of ‘429).
Regarding claim 2, ‘429 claims the IVL system as discussed above.
‘429 further claims wherein the AC power source is electrically operatively connectable with the electric pulse generation system and with the DC power storage system (claim 2 of ‘429).
Regarding claim 3, ‘429 claims the IVL system as discussed above.
‘429 further claims wherein the DC power storage system is configured to receive AC power from the AC power source (claim 3 of ‘429).
Regarding claim 4, ‘429 claims the IVL system as discussed above.
‘429 further claims wherein the DC power storage system is configured to convert AC power to DC power for charging a DC power storage device of the DC power storage system (claim 4 of ‘429).
Regarding claim 5, ‘429 claims the IVL system as discussed above.
‘429 further claims wherein the IVL control system is configured to selectively charge the energy storage system from the DC power storage system only (claim 5 of ‘429).
Regarding claim 6, ‘429 claims the IVL system as discussed above.
‘429 further claims wherein the IVL control system is further configured to selectively charge the energy storage system from the AC power source (claim 6 of ‘429).
Regarding claim 7, ‘429 claims the IVL system as discussed above.
‘429 further claims wherein the IVL control system is further configured to selectively charge the energy storage system directly from DC power that is converted from the AC power source (claim 7 of ‘429)
Regarding claim 8, ‘429 claims the IVL system as discussed above.
‘429 further claims wherein, when the AC power source is not connected with the electric pulse generation system and the DC power storage system, DC power from the DC power storage system is delivered directly to the energy storage system (claim 8 of ‘429).
Regarding claim 9, ‘429 claims the IVL system as discussed above.
‘429 further claims wherein the DC power storage system comprises one or more batteries (claim 9 of ‘429).
Regarding claim 10, ‘429 claims an intravascular lithotripsy ("IVL") system comprising: at least one set of spaced-apart electrodes for arrangement within a body lumen and in association with a fluid-fillable member configured to contain fluid therein (claim 10 of ‘429); an electric pulse generation system configured to provide electrical energy to the at least one set of spaced-apart electrodes to generate an electrical are for intravascular lithotripsy (IVL) therapy (claim 10 of ‘429), the electric pulse generation system including an IVL control system comprising a processor configured to execute instructions stored on memory and communications circuitry configured to communicate signals based on commands from the processor (claim 10 of ‘429), wherein the electric pulse generation system comprises an electrical power system including an AC power source and a DC power storage system and an energy charge system (claim 10 of ‘429), wherein the AC power source is configured for connection with an AC power receptacle to receive AC power (claim 10 of ‘429), and wherein the AC power source is electrically operatively connectable with the electric pulse generation system and with the DC power storage system (claim 10 of ‘429).
Regarding claim 11, ‘429 claims the IVL system as discussed above.
‘429 further claims wherein, when the AC power source is not connected with the electric pulse generation system and the DC power storage system, DC power from the DC power storage system is delivered directly to an energy storage system (claim 11 of ‘429).
Regarding claim 12, ‘429 claims the IVL system as discussed above.
‘429 further claims further comprising the IVL control system being configured to selectively charge the energy storage system from at least one of the group consisting of: the DC power storage system only; the AC power source; and directly from DC power that is converted from the AC power source (claim 12 of ‘429).
Regarding claim 13, ‘429 claims the IVL system as discussed above.
‘429 further claims wherein the DC power storage system comprises one or more batteries (claim 13 of ‘429).
Regarding claim 14, ‘429 claims the IVL system as discussed above.
‘429 further claims wherein the DC power storage system is configured to receive energy from the AC power source (claim 14 of ‘429).
Regarding claim 15, ‘429 claims the IVL system as discussed above.
‘429 further claims wherein the DC power storage system is configured to convert AC power to DC power for charging a DC power storage device of the DC power storage system (claim 15 of ‘429).
Regarding claim 16, ‘429 claims a method of powering an intravascular lithotripsy ("IVL") system, comprising: providing the IVL system of claim 10 (claim 16 of ‘429); connecting the AC power source to the electric pulse generation system (claim 16 of ‘429); connecting the AC power source to the DC power storage system (claim 16 of ‘429); selectively charging the energy storage system with energy from the AC power source to the IVL system (claim 16 of ‘429); and discharging energy from the charged energy storage system (claim 16 of ‘429); and initiating voltage pulses with the IVL system with the discharged energy (claim 16 of ‘429).
Regarding claim 17, ‘429 claims the IVL method as discussed above.
‘429 further claims further comprising selectively charging the energy storage system directly with DC power that is converted from the AC power source (claim 17 of ‘429).
Regarding claim 18, ‘429 claims the IVL method as discussed above.
‘429 further claims further comprising charging the DC power storage system with energy from the AC power source (claim 18 of ‘429).
Regarding claim 19, ‘429 claims a method of powering an intravascular lithotripsy ("IVL") system, comprising: providing the IVL system of claim 10 (claim 19 of ‘429); connecting the AC power source to the electric pulse generation system (claim 19 of ‘429); connecting the AC power source to the DC power storage device (claim 19 of ‘429); selectively charging the energy storage system with energy from the DC power storage system to the IVL system (claim 19 of ‘429); and discharging energy from the charged energy storage system (claim 19 of ‘429); and initiating voltage pulses with the IVL system with the discharged energy (claim 19 of ‘429).
Regarding claim 20, ‘429 claims the IVL method as discussed above.
‘429 further claims further comprising charging the DC power storage system with the AC power source (claim 20 of ‘429).
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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