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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1- 30, drawn to an intravascular lithotripsy system, classified in A61B17/22022.
II. Claim 31, drawn to a method for providing controlled, adjustable energy to at least one set of spaced- apart electrodes in an IVL system, classified in A61B2017/00778.
The inventions are independent or distinct, each from the other because:
Inventions Group I and Group II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the apparatus as claimed can be used to practice another and materially different process such as clearing a sewage pipe or for removing an obstruction within the bowel.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Lloyd Pollard on June 5th, 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1- 30. Affirmation of this election must be made by applicant in replying to this Office action. Claim 31 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Specification
The abstract of the disclosure is objected to because of a minor informality. Line 5 states “member are disclosed”, it is suggested to change this to “member”, as the phrase “are disclosed” is a duplicate phrase. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1- 30 are objected to because of the following informalities:
Claim 1, Line 1 states “(“IVL”) system”, it is suggested to change this to “(IVL) system”.
Claims 2- 16 are objected to for being dependent on or from objected claim 1.
Claim 15, Line 1 states “high frequency switches control”, it is suggested to change this to “high frequency switched control”.
Claim 16 is objected to for being dependent on or from objected claim 15.
Claim 17, Line 1 states “(“IVL”) system”, it is suggested to change this to “(IVL) system”.
Claim 17, Line 15 states “with charge control system”, it is suggested to change this to “with the charge control system”.
Claims 18- 30 are objected to for being dependent on or from objected claim 17.
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 2- 16 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 2, Line 1 states the limitation “further comprising two or more energy storage elements”. It is unclear if these two or more energy storage elements are a part of the one or more energy storage elements established within claim 1, or if the two or more energy storage elements are in addition to the one or more energy storage elements as established in claim 1. For purposes of examination this limitation is herein interpreted as “wherein the one or more energy storage elements further comprises two or more energy storage elements”.
Claims 3- 16 are rejected for being dependent on or from rejected claim 2.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu (CN 113648048 English Machine Translation).
Regarding claim 1, 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 while disposed within a fluid-fillable member (balloon 2) configured to contain a fluid therein (Paragraph 0038); and
An electric pulse generation system (shock wave therapy host 1) comprising a voltage pulse generator (multi-channel high- voltage pulse power supply)(Paragraph 0040) and an IVL control system (control module, pulse switch module, power supply module)(Paragraphs 0045 and 0049), the voltage pulse generator in operative communication with the at least one set of spaced- apart electrodes and in operative communication with the IVL control system (Paragraphs 0040 and 0049), the IVL control system comprising a processor configured to execute programmed instructions and a memory in operative communication with the processor (Paragraph 0049, as the control module is capable of controlling each module in the system, it contains a memory.),
Wherein the IVL control system further comprises a charge control system (power supply module) in operative communication with an energy storage system (pulse switch module)(Paragraph 0045), the charge control system and the energy storage system being in operative communication with the processor (Paragraph 0049), the charge control system configured to control electrical charging of the energy storage system (Paragraph 0045, 0047, 0053, and 0054),
Wherein the energy storage system comprises one or more energy storage elements (plurality of energy storage capacitors of the pulse switch module) that are configured to be charged by the charge control system, and wherein the charge control system is configured to provide controlled levels of electrical power to each of the one or more energy storage elements (Paragraph 0009, 0045 and 0047).
Regarding claim 2, Liu teaches the IVL control system as discussed above.
Regarding wherein the one or more energy storage elements further comprises two or more energy storage elements, as Liu teaches in Paragraphs 0045 and 0047 that each pulse switch module contains a plurality of energy storage capacitors, and that there are four pulse switch modules that can have a voltage that is set separately, then the system comprises two or more energy storage elements,
Regarding wherein individual ones of the two or more energy storage elements are configured to be individually and controllably charged by the control system, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore as Liu teaches in Paragraphs 0045, 0047, and 0049, that each pulse switch module can have a voltage set separately, when comparing the capacitors of two different pulse switch modules, they can be individually and controllably charged by the power supply module, which is controlled by the control module.
Regarding claim 3, Liu teaches the IVL control system as discussed above.
Regarding wherein the controlled levels of electrical power provided to the two or more storage elements are configured to be substantially the same voltage level, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore as Liu teaches in Paragraphs 0045 and 0047 that the voltage of each power module can be set separately and that each pulse switch module is connected to a power module which contains a capacitor, the voltage for each power module can be set to be substantially the same voltage level.
Regarding claim 4, Liu teaches the IVL control system as discussed above.
Regarding wherein the controlled levels of electrical power of at least two of the individual ones of the two or more storage elements are configured to be of different voltage levels, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore as Liu teaches in Paragraphs 0045 and 0047 that the voltage of each power module can be set separately and that each pulse switch module is connected to a power module which contains a capacitor, the voltage for each power module can be set to be different and so the controlled levels of electrical power can have different voltage levels.
Regarding claim 5, Liu teaches the IVL control system as discussed above.
Regarding wherein the two or more energy storage elements are configured to be charged by the charge control system at the same voltage level, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore as Liu teaches in Paragraphs 0045 and 0047 that the voltage of each power module can be set separately and that each pulse switch module is connected to a power module which contains a capacitor, the capacitors of each power module can be charged at the same voltage level.
Regarding claims 6 and 7, Liu teaches the IVL control system as discussed above.
Liu further teaches wherein the IVL control system is configured to adjust a voltage provided to the energy storage system and wherein the energy storage system is configured to accumulate electrical energy that is provided at an adjusted voltage (Paragraphs 0045 and 0047).
Regarding claims 8, 9, and 10, Liu teaches the IVL control system as discussed above.
Regarding wherein the energy storage system is configured to be controlled by the IVL control system during a discharge of the energy storage system, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore as Liu teaches that the control system controls the pulse switch module in Paragraph 0049, which is the energy storage system and that the discharge energy can be adjusted in Paragraph 0045, then the energy storage system is controlled by the IVL control system during a discharge of the energy storage system.
Liu teaches wherein the discharge of the energy storage system comprises a controlled discharge of stored electrical energy to generate a voltage pulse and wherein the generated voltage pulse is communicated to the at least one set of spaced- apart electrodes (Paragraphs 0009, 0039, and 0044- 0045).
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) 11-12, 15- 26, and 29- 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu (CN 113648048 English Machine Translation) in view of Anderson et al. (WO 2022/183075) and in view of Li et al. (EP 3021473).
Regarding claim 11, Liu teaches the IVL control system as discussed above.
Liu teaches a high- voltage direct current power supply circuit which outputs a high- voltage direct current signal to the pulse switch module (Paragraph 0019).
Liu does not teach a high voltage DC/DC converter system in operative communication with the IVL control system that is configured to issue high frequency switched control signals to the high voltage DC/DC converter system.
Anderson (Anderson et al.) teaches a similar IVL control system (100)(Page 17, Lines 27- 29)(Figs. 1-2) comprising a balloon (110), a plurality of electrodes (emitter array 112) within the balloon (Page 18, Lines 4- 12), a processor (Page 19, Lines 10- 14), a power module (224) with a high voltage DC/DC converter system (210) and a capacitor (212)(Page 19, Lines 1- 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the high voltage direct current power supply circuit as taught by Liu to have a high voltage DC/DC converter system as taught by Anderson, as Liu teaches a device for providing a high voltage to electrodes (Liu, Paragraph 0019) and Anderson teaches that a DC/DC converter is known in the art as a way to provide power to electrodes (Anderson, Page 19, Lines 1- 9).
Regarding the high voltage DC/DC converter system in operative communication with the IVL control system, as Liu teaches that the IVL control system is in communication with the power module that comprises the high voltage direct current power supply circuit (Paragraphs 0019 and 0049), then as the combination has the high voltage DC/DC converter system as a part of the power module, then the converter system is in operative communication with the IVL control system.
The combination does not teach the IVL control system is configured to issue high frequency switched control signals to the high voltage DC/DC converter system.
Li (Li et al.) teaches a controller (DC/DC controller 202)(Fig. 2) for a high voltage DC/DC converter system (200)(abstract, Paragraph 0018), wherein the controller issues high frequency switched control signals to the high voltage DC/DC converter system (Paragraphs 0018- 0022).
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 issue high frequency switched control signals to the converter system as taught by Li, since Li teaches that through the signals the controller can adjust the output voltage of the DC/DC converter system (Paragraphs 0018- 0021).
Regarding claim 12, Liu, Anderson, and Li make obvious the IVL control 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 high voltage direct current power supply circuit as taught by Liu to have a high voltage DC/DC converter system as taught by Anderson, as Liu teaches a device for providing a high voltage to electrodes (Liu, Paragraph 0019) and Anderson teaches that a DC/DC converter is known in the art as a way to provide power to electrodes (Anderson, Page 19, Lines 1- 9). It also would have been obvious to one of ordinary skill in the art to modify the IVL control system as taught by the combination to issue high frequency switched control signals to the converter system as taught by Li, since Li teaches that through the signals the controller can adjust the output voltage of the DC/DC converter system (Paragraphs 0018- 0021).
Regarding wherein the high voltage DC/DC converter system is in operative communication with the charge control system, the power supply module as taught by Liu is considered the charge control system and the high- voltage direct current power supply circuit is taught to be a part of the power supply module (Liu, Paragraph 0048), therefore the high voltage direct current power supply circuit is in operative communication with the charge control system. Within the combination, the high voltage DC/DC converter system is a part of the power module, so the high voltage DC/DC converter system is in operative communication with the charge control system.
Regarding wherein the high voltage DC/DC converter system is configured to receive indication of one or more of the issued high frequency switched control signals and further configured to provide a corresponding charge voltage to the charge control system, Li teaches that the output voltage of the DC/DC converter system is adjusted to a target value after the duty cycle of the pulse width modulated signal is adjusted (Li, Paragraph 0021) therefore, once the control signal is sent to the DC/DC system, the system receives indication of the signal and provides an output voltage. Within the combination, the signal is received, then the DC/DC system sends an output voltage, or charge voltage, to the charge control system.
Regarding claims 15 and 16, Liu, Anderson, and Li make obvious the IVL control 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 high voltage direct current power supply circuit as taught by Liu to have a high voltage DC/DC converter system as taught by Anderson, as Liu teaches a device for providing a high voltage to electrodes (Liu, Paragraph 0019) and Anderson teaches that a DC/DC converter is known in the art as a way to provide power to electrodes (Anderson, Page 19, Lines 1- 9). It also would have been obvious to one of ordinary skill in the art to modify the IVL control system as taught by the combination to issue high frequency switched control signals to the converter system as taught by Li, since Li teaches that through the signals the controller can adjust the output voltage of the DC/DC converter system (Paragraphs 0018- 0021).
Regarding wherein, in response to the high frequency switched control signals, the high voltage DC/DC converter system is configured to provide a corresponding high voltage charge voltage to the charge control system, as Anderson teaches that the high voltage DC/DC converter system provides a charge to the emitters (Page 18, Lines 13- 19 and Page 19, Lines 1- 9) and Liu teaches that the high- voltage direct current power supply outputs a high-voltage direct current signal (Liu, Paragraph 0048), then within the combination the high voltage DC/DC converter system would provide a corresponding charge voltage to the charge control system. Furthermore, as Li teaches that the high frequency switch control signals activates the high voltage DC/DC converter system to emit an output voltage (Li, Paragraphs 0018- 0021).
Regarding wherein the high voltage charge is within the range of about 0 volts to about 4,000 volts, as Liu teaches that the high voltage direct current power supply circuit has a voltage range between 500V to 5000V (Paragraph 0048), it would have been obvious to one of ordinary skill in the art to have the DC/DC converter system have a high voltage charge within that range. Furthermore, 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 Liu to be 0V to 4,000 V, since it has been held that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a primae facie case of obviousness exists”. (MPEP 2144.05)(In re Wertheim, 541 F.2d 257, 191 USPQ90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Regarding claim 17, 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 while disposed within a fluid-fillable member (balloon 2) configured to contain a fluid therein (Paragraph 0038); and
An electric pulse generation system (shock wave therapy host 1) comprising a voltage pulse generator (multi-channel high- voltage pulse power supply)(Paragraph 0040) and an IVL control system (control module, pulse switch module, power supply module)(Paragraphs 0045 and 0049), the voltage pulse generator in operative communication with the at least one set of spaced- apart electrodes and in operative communication with the IVL control system (Paragraphs 0040 and 0049), the IVL control system comprising a processor configured to execute programmed instructions and a memory in operative communication with the processor (Paragraph 0049, as the control module is capable of controlling each module in the system, it contains a memory.), a high- voltage direct current power supply circuit which outputs a high- voltage direct current signal to the pulse switch module (Paragraph 0019),
Wherein the IVL control system further comprises a charge control system (power supply module), an energy storage system (pulse switch module) in operative communication with the charge control system (Paragraph 0045), the charge control system and the energy storage system being in operative communication with the processor (Paragraph 0049), the charge control system configured to control electrical charging of the energy storage system (Paragraph 0045, 0047, 0053, and 0054),
Wherein the energy storage system comprises two or more energy storage elements (plurality of energy storage capacitors of each of the four pulse switch modules)(Paragraph 0047) that are configured to be charged by the charge control system, and wherein the charge control system is configured to provide controlled levels of electrical power to each of the one or more energy storage elements (Paragraph 0009, 0045 and 0047).
Regarding wherein individual ones of the two or more energy storage elements are configured to be individually and controllably charged by the charge control system, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore as Liu teaches in Paragraphs 0045, 0047, and 0049, that each pulse switch module can have a voltage set separately, when comparing the capacitors of two different pulse switch modules, they can be individually and controllably charged by the power supply module, which is controlled by the control module.
Liu does not teach a high voltage DC/DC converter system in operative communication with the charge control system, wherein the charge control system is configured to issue high frequency switched control signals to the high voltage DC/DC converter system and wherein the high voltage DC/DC converter system is configured to provide a corresponding charge voltage to the charge control system.
Anderson (Anderson et al.) teaches a similar IVL control system (100)(Page 17, Lines 27- 29)(Figs. 1-2) comprising a balloon (110), a plurality of electrodes (emitter array 112) within the balloon (Page 18, Lines 4- 12), a processor (Page 19, Lines 10- 14), a power module (224) with a high voltage DC/DC converter system (210) and a capacitor (212)(Page 19, Lines 1- 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the high voltage direct current power supply circuit as taught by Liu to have a high voltage DC/DC converter system as taught by Anderson, as Liu teaches a device for providing a high voltage to electrodes (Liu, Paragraph 0019) and Anderson teaches that a DC/DC converter is known in the art as a way to provide power to electrodes (Anderson, Page 19, Lines 1- 9).
Regarding the high voltage DC/DC converter system in operative communication with the IVL control system, as Liu teaches that the IVL control system is in communication with the power module that comprises the high voltage direct current power supply circuit (Paragraphs 0019 and 0049), then as the combination has the high voltage DC/DC converter system as a part of the power module, then the converter system is in operative communication with the IVL control system.
The combination does not teach the IVL control system is configured to issue high frequency switched control signals to the high voltage DC/DC converter system.
Li (Li et al.) teaches a controller (DC/DC controller 202)(Fig. 2) for a high voltage DC/DC converter system (200)(abstract, Paragraph 0018), wherein the controller issues high frequency switched control signals to the high voltage DC/DC converter system (Paragraphs 0018- 0022).
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 issue high frequency switched control signals to the converter system as taught by Li, since Li teaches that through the signals the controller can adjust the output voltage of the DC/DC converter system (Paragraphs 0018- 0021).
Regarding wherein the high voltage DC/DC converter system is configured to provide a corresponding charge voltage to the charge control system, as Anderson teaches that the high voltage DC/DC converter system provides a charge to the emitters (Page 18, Lines 13- 19 and Page 19, Lines 1- 9) and Liu teaches that the high- voltage direct current power supply outputs a high-voltage direct current signal (Liu, Paragraph 0048), then within the combination the high voltage DC/DC converter system would provide a corresponding charge voltage to the charge control system.
Regarding claim 18, Liu, Anderson, and Li make obvious the IVL control system as discussed above.
Regarding wherein the controlled levels of electrical power provided to the two or more storage elements are configured to be substantially the same voltage level, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore as Liu teaches in Paragraphs 0045 and 0047 that the voltage of each power module can be set separately and that each pulse switch module is connected to a power module which contains a capacitor, the voltage for each power module can be set to be substantially the same voltage level.
Regarding claim 19, Liu, Anderson, and Li make obvious the IVL control system as discussed above.
Regarding wherein the provided controlled levels of electrical power of at least two of the individual ones of the two or more storage elements are configured to be of different voltage levels, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore as Liu teaches in Paragraphs 0045 and 0047 that the voltage of each power module can be set separately and that each pulse switch module is connected to a power module which contains a capacitor, the voltage for each power module can be set to be different and so the controlled levels of electrical power can have different voltage levels.
Regarding claim 20, Liu, Anderson, and Li make obvious the IVL control system as discussed above.
Regarding wherein the two or more energy storage elements are configured to be charged by the charge control system at the same voltage level, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore as Liu teaches in Paragraphs 0045 and 0047 that the voltage of each power module can be set separately and that each pulse switch module is connected to a power module which contains a capacitor, the capacitors of each power module can be charged at the same voltage level.
Regarding claims 21 and 22, Liu, Anderson, and Li make obvious the IVL control system as discussed above.
Liu further teaches wherein the IVL control system is configured to adjust a voltage provided to the energy storage system and wherein the energy storage system is configured to accumulate electrical energy that is provided at an adjusted voltage (Paragraphs 0045 and 0047).
Regarding claims 23, 24 and 25, Liu, Anderson, and Li make obvious the IVL control system as discussed above.
Regarding wherein the energy storage system is configured to be controlled by the IVL control system during a discharge of the energy storage system, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore as Liu teaches that the control system controls the pulse switch module in Paragraph 0049, which is the energy storage system and that the discharge energy can be adjusted in Paragraph 0045, then the energy storage system is controlled by the IVL control system during a discharge of the energy storage system.
Liu teaches wherein the discharge of the energy storage system comprises a controlled discharge of stored electrical energy to generate a voltage pulse and wherein the generated voltage pulse is communicated to the at least one set of spaced- apart electrodes (Paragraphs 0009, 0039, and 0044- 0045).
Regarding claim 26, Liu, Anderson, and Li make obvious the IVL control 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 high voltage direct current power supply circuit as taught by Liu to have a high voltage DC/DC converter system as taught by Anderson, as Liu teaches a device for providing a high voltage to electrodes (Liu, Paragraph 0019) and Anderson teaches that a DC/DC converter is known in the art as a way to provide power to electrodes (Anderson, Page 19, Lines 1- 9). It also would have been obvious to one of ordinary skill in the art to modify the IVL control system as taught by the combination to issue high frequency switched control signals to the converter system as taught by Li, since Li teaches that through the signals the controller can adjust the output voltage of the DC/DC converter system (Paragraphs 0018- 0021).
Regarding wherein the high voltage DC/DC converter system is configured to receive indication of one or more of the issued high frequency switched control signals and further configured to provide a corresponding charge voltage to the charge control system, Li teaches that the output voltage of the DC/DC converter system is adjusted to a target value after the duty cycle of the pulse width modulated signal is adjusted (Li, Paragraph 0021) therefore, once the control signal is sent to the DC/DC system, the system receives indication of the signal and provides an output voltage. Within the combination, the signal is received, then the DC/DC system sends an output voltage, or charge voltage, to the charge control system.
Regarding claims 29 and 30, Liu, Anderson, and Li make obvious the IVL control 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 high voltage direct current power supply circuit as taught by Liu to have a high voltage DC/DC converter system as taught by Anderson, as Liu teaches a device for providing a high voltage to electrodes (Liu, Paragraph 0019) and Anderson teaches that a DC/DC converter is known in the art as a way to provide power to electrodes (Anderson, Page 19, Lines 1- 9). It also would have been obvious to one of ordinary skill in the art to modify the IVL control system as taught by the combination to issue high frequency switched control signals to the converter system as taught by Li, since Li teaches that through the signals the controller can adjust the output voltage of the DC/DC converter system (Paragraphs 0018- 0021).
Regarding wherein, in response to the high frequency switched control signals, the high voltage DC/DC converter system is configured to provide a corresponding high voltage charge voltage to the charge control system, as Anderson teaches that the high voltage DC/DC converter system provides a charge to the emitters (Page 18, Lines 13- 19 and Page 19, Lines 1- 9) and Liu teaches that the high- voltage direct current power supply outputs a high-voltage direct current signal (Liu, Paragraph 0048), then within the combination the high voltage DC/DC converter system would provide a corresponding charge voltage to the charge control system. Furthermore, as Li teaches that the high frequency switch control signals activates the high voltage DC/DC converter system to emit an output voltage (Li, Paragraphs 0018- 0021).
Regarding wherein the high voltage charge is within the range of about 0 volts to about 4,000 volts, as Liu teaches that the high voltage direct current power supply circuit has a voltage range between 500V to 5000V (Paragraph 0048), it would have been obvious to one of ordinary skill in the art to have the DC/DC converter system have a high voltage charge within that range. Furthermore, 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 Liu to be 0V to 4,000 V, since it has been held that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a primae facie case of obviousness exists”. (MPEP 2144.05)(In re Wertheim, 541 F.2d 257, 191 USPQ90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Claim(s) 13- 14 and 27- 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu (CN 113648048 English Machine Translation) in view of Anderson et al. (WO 2022/183075) and in view of Li et al. (EP 3021473), as applied to claim 12 and claim 17 above, in further view of Millis et al (US 2017/0020598).
Regarding claim 13, 14, 27 and 28, Liu, Anderson, and Li make obvious the IVL control system as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the IVL control system as taught by the combination to issue high frequency switched control signals to the converter system as taught by Li, since Li teaches that through the signals the controller can adjust the output voltage of the DC/DC converter system (Paragraphs 0018- 0021).
The combination does not teach wherein the high frequency switched control signals comprise a low voltage range in claims 13 and 27, or wherein the low voltage range is within about 0 volts to about 12 volts in claims 14 and 28.
Millis (Millis et al.) teaches a controller (wave generator 102) for use in a medical procedure involving the charging of electrodes (Paragraphs 0030 and 0065) that issues high frequency switched control signals (PWM)(Paragraphs 0065 and 0066), wherein the high frequency switch control signals comprise a low voltage range and varying duty cycles (Paragraphs 0066- 0073, Millis teaches that the power level can be low, which is associated with a particular voltage and a low power level can be a low voltage.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the high frequency switched control signals to comprise a low voltage range, since Millis teaches that the signals allow for the altering of the voltage of the electrodes to address specific conditions that occur during surgery (Paragraphs 0071 and 0073).
The combination of Liu, Anderson, Li, and Millis discloses the claimed invention except for wherein the low voltage range is within about 0 volts to about 12 volts in claims 14 and 28. Millis sets forth that the low voltage range is a result effective variable, wherein the low voltage range is a result of the power levels of the wave generator and the settings of the PWM pulses (Paragraph 0071). It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the low voltage range to be within about 0 volts to about 12 volts, for the purpose of providing a low voltage range of PWM signals with a low power level to a system of electrodes and to prevent the overheating of the electrodes (Paragraphs 0071- 0073), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (MPEP 2144.05)(In re Aller, 105 USPQ 233). Furthermore, applicant has placed no criticality upon this range.
Double Patenting
Claims 1- 30 of this application is patentably indistinct from claims 1- 30 of Application No. 18/506,339. 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- 30 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1- 30 of copending Application No. 18/506,339 (reference application). 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, ‘339 claims an intravascular lithotripsy ("IVL") system (claim 1 of ’339), comprising: at least one set of spaced-apart electrodes for arrangement within a body lumen while disposed within a fluid-fillable member configured to contain a fluid therein (claim 1 of ’339); and an electric pulse generation system comprising a voltage pulse generator and an IVL control system (claim 1 of ’339), the voltage pulse generator in operative communication with the at least one set of space-apart electrodes and in operative communication with the IVL control system (claim 1 of ’339), the IVL control system comprising a processor configured to execute programmed instructions (claim 1 of ’339) and a memory in operative communication with the processor (claim 1 of ’339), wherein the IVL control system further comprises a charge control system in operative communication with an energy storage system (claim 1 of ’339), the charge control system and the energy storage system being in operative communication with the processor, the charge control system configured to control electrical charging of the energy storage system (claim 1 of ’339), wherein the energy storage system comprises one or more energy storage elements that are configured to be charged by the charge control system (claim 1 of ’339), and wherein the charge control system is configured to provide controlled levels of electrical power to each of the one or more energy storage elements (claim 1 of ‘339).
Regarding claim 2, ‘339 claims the IVL system of claim 1 as discussed above.
‘339 further claims further comprising two or more energy storage elements, wherein individual ones of the two or more energy storage elements are configured to be individually and controllably charged by the charge control system (claim 2 of ‘339).
Regarding claim 3, ‘339 claims the IVL system of claim 2 as discussed above.
‘339 further claims wherein the controlled levels of electrical power provided to the two or more storage elements are configured to be substantially the same voltage level (claim 3 of ’339).
Regarding claim 4, ‘339 claims the IVL system of claim 2 as discussed above.
‘339 further claims wherein the controlled levels of electrical power of at least two of the individual ones of the two or more storage elements are configured to be of different voltage levels (claim 4 of ’339).
Regarding claim 5, ‘339 claims the IVL system of claim 2 as discussed above.
‘339 further claims wherein the two or more energy storage elements are configured to be charged by the charge control system at the same voltage level (claim 5 of ’339).
Regarding claim 6, ‘339 claims the IVL system of claim 2 as discussed above.
‘339 further claims wherein the IVL control system is configured to adjust a voltage provided to the energy storage system (claim 6 of ’339).
Regarding claim 7, ‘339 claims the IVL system of claim 6 as discussed above.
‘339 further claims wherein the energy storage system is configured to accumulate electrical energy that is provided at an adjusted voltage (claim 7 of ’339).
Regarding claim 8, ‘339 claims the IVL system of claim 7 as discussed above.
‘339 further claims wherein the energy storage system is configured to be controlled by the IVL control system during a discharge of the energy storage system (claim 8 of ’339).
Regarding claim 9, ‘339 claims the IVL system of claim 8 as discussed above.
‘339 further claims wherein the discharge of the energy storage system comprises a controlled discharge of stored electrical energy to generate a voltage pulse (claim 9 of ’339).
Regarding claim 10, ‘339 claims the IVL system of claim 9 as discussed above.
‘339 further claims wherein the generated voltage pulse is communicated to the at least one set of spaced-apart electrodes (claim 10 of ’339).
Regarding claim 11, ‘339 claims the IVL system of claim 2 as discussed above.
‘339 further claims further comprising: a high voltage DC/DC converter system in operative communication with the IVL control system that is configured to issue high frequency switched control signals to the high voltage DC/DC converter system (claim 11 of ’339).
Regarding claim 12, ‘339 claims the IVL system of claim 11 as discussed above.
‘339 further claims wherein the high voltage DC/DC converter system is in operative communication with the charge control system and is configured to receive indication of one or more of the issued high frequency switched control signals and further configured to provide a corresponding charge voltage to the charge control system (claim 12 of ’339).
Regarding claim 13, ‘339 claims the IVL system of claim 12 as discussed above.
‘339 further claims wherein the high frequency switched control signals comprise a low voltage range (claim 13 of ’339).
Regarding claim 14, ‘339 claims the IVL system of claim 13 as discussed above.
‘339 further claims wherein the low voltage range is within about 0 volts to about 12 volts (claim 14 of ’339).
Regarding claim 15, ‘339 claims the IVL system of claim 14 as discussed above.
‘339 further claims wherein, in response to the high frequency switches control signals, the high voltage DC/DC converter system is configured to provide a corresponding high voltage charge voltage to the charge control system (claim 15 of ‘339).
Regarding claim 16, ‘339 claims the IVL system of claim 15 as discussed above.
‘339 further claims wherein the high voltage charge voltage is within the range of about 0 volts to about 4,000 volts (claim 16 of ‘339).
Regarding claim 17, ‘339 claims an intravascular lithotripsy ("IVL") system (claim 17 of ’339), comprising: at least one set of spaced-apart electrodes configured for association with a body lumen while disposed within a fluid-fillable member configured to contain a fluid therein (claim 17 of ’339); and an electric pulse generation system comprising a voltage pulse generator and an IVL control system (claim 17 of ’339), the voltage pulse generator in operative communication with the at least one set of space-apart electrodes and in operative communication with the IVL control system (claim 17 of ’339), the IVL control system comprising a processor configured to execute programmed instructions and a memory in operative communication with the processor (claim 17 of ’339), wherein the IVL control system further comprises a charge control system (claim 17 of ’339), an energy storage system in operative communication with the charge control system (claim 17 of ’339), the charge control system and the energy storage system being in operative communication with the processor (claim 17 of ’339), the charge control system configured to control electrical charging of the energy storage system (claim 17 of ’339), and a high voltage DC/DC converter system in operative communication with charge control system (claim 17 of ’339), wherein the charge control system is configured to issue high frequency switched control signals to the high voltage DC/DC converter system (claim 17 of ’339) and wherein the high voltage DC/DC converter system is configured to provide a corresponding charge voltage to the charge control system (claim 17 of ’339), wherein the energy storage system comprises two or more energy storage elements that are configured to be charged by the charge control system (claim 17 of ’339), wherein the charge control system is configured to provide controlled levels of electrical power to each of the two or more energy storage elements (claim 17 of ’339), and wherein individual ones of the two or more energy storage elements are configured to be individually and controllably charged by the charge control system (claim 17 of ‘339).
Regarding claim 18, ‘339 claims the IVL system of claim 17 as discussed above.
‘339 further claims wherein the controlled levels of electrical power provided to the two or more energy storage elements are configured to be substantially the same voltage level (claim 18 of ‘339).
Regarding claim 19, ‘339 claims the IVL system of claim 17 as discussed above.
‘339 further claims wherein the provided controlled levels of electrical power of at least two of the individual ones of the two or more energy storage elements are configured to be of different voltage levels (claim 19 of ‘339).
Regarding claim 20, ‘339 claims the IVL system of claim 17 as discussed above.
‘339 further claims wherein the two or more energy storage elements are configured to be charged by the charge control system at the same voltage level (claim 20 of ‘339).
Regarding claim 21, ‘339 claims the IVL system of claim 17 as discussed above.
‘339 further claims wherein the TVL control system is configured to adjust a voltage provided to the energy storage system (claim 21 of ‘339).
Regarding claim 22, ‘339 claims the IVL system of claim 21 as discussed above.
‘339 further claims wherein the energy storage system is configured to accumulate electrical energy that is provided at an adjusted voltage (claim 22 of ‘339).
Regarding claim 23, ‘339 claims the IVL system of claim 22 as discussed above.
‘339 further claims wherein the energy storage system is configured to be controlled by the IVL control system during a discharge of the energy storage system (claim 23 of ‘339).
Regarding claim 24, ‘339 claims the IVL system of claim 23 as discussed above.
‘339 further claims wherein the discharge of the energy storage system comprises a controlled discharge of stored electrical energy to generate a voltage pulse (claim 24 of ‘339).
Regarding claim 25, ‘339 claims the IVL system of claim 24 as discussed above.
‘339 further claims wherein the generated voltage pulse is communicated to the at least one set of spaced-apart electrodes (claim 25 of ‘339).
Regarding claim 26, ‘339 claims the IVL system of claim 17 as discussed above.
‘339 further claims wherein the high voltage DC/DC converter system is configured to receive an indication of the high frequency switched control signals and further configured to provide a corresponding charge voltage to the charge control system (claim 26 of ‘339).
Regarding claim 27, ‘339 claims the IVL system of claim 26 as discussed above.
‘339 further claims wherein the high frequency switched control signals comprise a low voltage range (claim 27 of ‘339).
Regarding claim 28, ‘339 claims the IVL system of claim 27 as discussed above.
‘339 further claims wherein the low voltage range is within about 0 volts to about 12 volts (claim 28 of ‘339).
Regarding claim 29, ‘339 claims the IVL system of claim 27 as discussed above.
‘339 further claims wherein, in response to the high frequency switched control signals, the high voltage DC/DC converter system is configured to provide a corresponding high voltage charge voltage to the charge control system (claim 29 of ‘339).
Regarding claim 30, ‘339 claims the IVL system of claim 29 as discussed above.
‘339 further claims wherein the high voltage charge voltage is within the range of about 0 volts to about 4,000 volts (claim 30 of ‘339).
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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