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 .
Response to Amendment
The preliminary amendment filed on January 22nd, 2026 has been entered.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1- 27, 40, and 41, drawn to an intravascular lithotripsy catheter assembly and a method for conducting IVL comprising a generation of voltage pulses and a pause, classified in A61B17/22022.
II. Claims 28- 32 and 42, drawn to an intravascular lithotripsy catheter assembly and a method for conducting IVL comprising a determination of current flow and sufficiency in producing an electrical arc, classified in A61B2017/00017.
III. Claims 33- 39 and 43, drawn to an intravascular lithotripsy catheter assembly and a method for conducting IVL comprising an averaging of current flow over voltage pulses, classified in A61B2017/22025.
The inventions are independent or distinct, each from the other because:
Inventions Group I and Group II are related as subcombinations disclosed as usable together in a single combination. The subcombinations are distinct if they do not overlap in scope and are not obvious variants, and if it is shown that at least one subcombination is separately usable. In the instant case, subcombination Group I has separate utility such as the system of Group I being used to produce a predetermined number of voltage pulses and a pause of a predetermined duration after the generation and then produce another predetermined number of voltage pulses while Group II does not include a pause of a predetermined duration after the generation of voltage pulses and Group I does not include the monitoring of current throughout the system. See MPEP § 806.05(d).
Inventions Group I and Group III are related as subcombinations disclosed as usable together in a single combination. The subcombinations are distinct if they do not overlap in scope and are not obvious variants, and if it is shown that at least one subcombination is separately usable. In the instant case, subcombination Group I has separate utility such as the system of Group I being used to produce a predetermined number of voltage pulses and a pause of a predetermined duration after the generation and then produce another predetermined number of voltage pulses while Group III does not include a pause of a predetermined duration after the generation of voltage pulses and Group I does not include the determination of an average current flow throughout the system. See MPEP § 806.05(d).
Inventions Group II and Group III are related as subcombinations disclosed as usable together in a single combination. The subcombinations are distinct if they do not overlap in scope and are not obvious variants, and if it is shown that at least one subcombination is separately usable. In the instant case, subcombination Group III has separate utility such as the system of Group III being used to calculate an average current flow from the determined current flows generated and compare the calculated average current flow with a predetermined current threshold while Group II does not include determining an average of current flow of the voltage pulses and Group III does not include the determination of initial voltage magnitude and duration for one voltage pulse. See MPEP § 806.05(d).
The examiner has required restriction between subcombinations usable together. Where applicant elects a subcombination and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
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 prior art applicable to one invention would not likely be applicable to another invention.
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 September 15th, 2026, a provisional election was made without traverse to prosecute the invention of Group I, claims 1- 27, 40 and 41. Affirmation of this election must be made by applicant in replying to this Office action. Claims 28- 39 and 42- 43 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).
Claim Objections
Claims 1-27, 40 and 41 are objected to because of the following informalities:
Claim 1, Line 1 states “intravascular lithotripsy (“IVL”)”, it is suggested to change this to “intravascular lithotripsy (IVL)”.
Claim 1, Line 24 states “space- apart electrodes”, it is suggested to change this to “spaced- apart electrodes”.
Claims 2- 27 are objected to for being dependent on or from objected claim 1.
Claim 4, Line 1 states “wherein when the IVL”, it is suggested to change this to “wherein the IVL”. Claim 8, Line 2 states “of the voltage”, it is suggested to change this to “of the predetermined number of voltage pulses”.
Claims 9 and 10 are objected to for being dependent on or from objected claim 8.
Claim 9, Line 2 states “of the voltage”, it is suggested to change this to “of the predetermined number of voltage pulses”.
Claim 10 is objected to for being dependent on or from objected claim 9.
Claim 10, Line 2 states “of the voltage”, it is suggested to change this to “of the predetermined number of voltage pulses”.
Claim 12, Line 1 states “wherein if”, it is suggested to change this to “wherein”.
Claims 13- 18 are objected to for being dependent on or from objected claim 12.
Claim 18, Line 1 states “The intravascular lithotripsy system”, it is suggested to change this to “The IVL catheter assembly”.
Claim 19, Line 1 states “The intravascular lithotripsy system”, it is suggested to change this to “The IVL catheter assembly”.
Claims 20- 22 are objected to for being dependent on or from objected claim 19.
Claim 23, Line 3 states “the generated voltage pulse”, it is suggested to change this to “a generated voltage pulse”.
Claim 40, Line 1 states “intravascular lithotripsy (“IVL”)”, it is suggested to change this to “intravascular lithotripsy (IVL)”.
Claim 40, Line 13 states “space- apart electrodes”, it is suggested to change this to “spaced- apart electrodes”.
Claim 41, Line 1 states “intravascular lithotripsy (“IVL”)”, it is suggested to change this to “intravascular lithotripsy (IVL)”.
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.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 recites the limitation “comprises more than 10 voltage pulses”, it is unclear how there can be more than 10 voltage pulses when the previous claim, of which claim 21 depends, recites the limitation “comprises 10 voltage pulses”. Therefore, the claim limitation of claim 21 directly conflicts with the previous claim limitation and renders the claim indefinite. For purposes of examination, claim 21 is herein interpreted as being dependent on 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) 1-2, 6- 11, 19- 24, 26, and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miao et al. (CN 215458401U English Machine Translation) in view of Lu et al. (CN 113349881A English Machine Translation).
Regarding claim 1, Miao (Miao et al.) teaches an intravascular lithotripsy (IVL) catheter assembly (Figs. 1-3)(Paragraphs 0008 and 0042) comprising:
At least one set of electrodes (electrode pair 4) for arrangement within a body lumen while disposed within an inflatable balloon or enclosure (balloon 2)(Paragraph 0043);
An electric pulse generation system (energy supply unit) for providing electrical energy to the at least one set of spaced- apart electrodes to generate spark for IVL therapy (Paragraphs 0042 and 0043), the electric pulse generation system including an IVL control system (energy generation and controller 31, pressure sensor 72) comprising a processor (energy generation and controller 31) for executing instructions based at least in part on a set of stored control data (Paragraphs 0044 and 0045) and circuitry (pressure sensor 72) adapted for communication of signals based on operation of the processor (Paragraph 0047), the IVL control system configured to:
Generate an initial series of a predetermined number of voltage pulses to apply to the at least one set of spaced- apart electrodes (Paragraph 0044),
Generate a subsequent series of a predetermined number of voltage pulses to apply to the at least one set of spaced- apart electrodes (Paragraph 0047);
Wherein at least some of the generated voltage pulses generate an electrical arc between the spaced- apart electrodes of the at least one set of spaced- apart electrodes and wherein each electrical arc produces a pressure output (Paragraphs 0044 and 0047).
Regarding wherein the magnitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage that is set at a predetermined lower voltage magnitude threshold, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Miao teaches that the IVL control system (energy generation and controller 31, pressure sensor 72) generates a voltage between 300V to 20,000V (Paragraph 0044) and that the magnitude of each voltage pulse can be set by the operator (Paragraphs 0044 and 0045), the IVL control system is capable of setting the magnitude of each voltage pulse in the initial series of voltage pulses to be at a predetermined lower voltage magnitude threshold.
Regarding determine when the number of generated voltage pulses is sufficient to warrant an increase in the magnitude of subsequent voltage pulses and, upon such determination, increase the magnitude of the subsequent voltage pulses to apply to the at least one set of spaced- apart electrodes, as Miao teaches that the pressure sensor determines if the pressure threshold is at an appropriate pressure threshold and then increases the pulse voltage if the pressure is less than the threshold before and after the pulse is released (Paragraph 0047), then the IVL control system is capable of determining when the number of generated voltage pulses is sufficient to warrant an increase in the magnitude of the subsequent voltage pulses and increase it.
Miao does not teach after the generation of the initial series of voltage pulses, require a pause of a predetermined duration.
Lu (Lu et al.) teaches an apparatus (Fig. 1) for generating electrical pulses for affecting tissue within the body (Paragraphs 0002, 0009, and 0052)), wherein the method comprises generating an initial series of electrical pulses (second stage set mentioned in Paragraphs 0018 and 0052), then pausing for a predetermined duration and generating a subsequent series of electrical pulses (Paragraphs 0018 and 0052).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the IVL catheter assembly as taught by Miao to have the pause of a predetermined duration as taught by Lu, since Lu teaches that this pause is more efficient for treating tissue (Paragraph 0009, 0015, and 0047).
Regarding claim 2, Miao and Lu make obvious the IVL catheter assembly as discussed above.
Regarding wherein the predetermined lower voltage magnitude threshold is about 2850 volts, as Miao teaches that the voltage magnitude can be preset by the user before the initial voltage pulse and that the voltage can range from between 300V to 20,000V (Paragraph 0044), it would have been obvious to one of ordinary skill in the art to choose about 2850 volts as the predetermined lower voltage magnitude threshold. Furthermore, this value is within the range of the capabilities of the generator, between 300V and 20,000V, and the user can modify the starting voltage through the IVL control system (Paragraph 0044 and 0047), so the user is capable of choosing 2850 volts to be the predetermined lower voltage magnitude threshold.
Regarding claims 6 and 7, Miao and Lu make obvious the IVL catheter assembly 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 IVL catheter assembly as taught by Miao to have the pause of a predetermined duration as taught by Lu, since Lu teaches that this pause is more efficient for treating tissue (Paragraph 0009, 0015, and 0047).
Lu further teaches wherein the duration of the pause is between 0.4 seconds and 0.9 seconds (Paragraph 0052)
The combination does not teach wherein the duration of the pause is between about 5 seconds and about 20 seconds or wherein the duration of the pause is about 10 seconds.
However, as Miao teaches that the frequency of the pulses can be adjusted and that it is possible to deliver multiple pulses in succession individually according to the user and depending on different lesion (Paragraph 0045), then the duration of a pause is a result effective variable, dependent on the type of tissue and treatment required. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify the range of the duration of the pause to be between about 5 seconds to about 20 seconds and to be about 10 seconds, for the purpose of providing a pause between series of voltage pulses, 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)
Regarding claims 8- 10, Miao and Lu make obvious the IVL catheter assembly as discussed above.
Miao teaches a predetermined duration of application of the predetermined voltage pulses to the at least one set of electrodes, and wherein the duration or width of the application of the predetermined voltage pulses is between 10ns and 100ms (Paragraph 0044).
Regarding wherein the duration or width of the application of the predetermined voltage pulses is about 20 microseconds to about 30 microseconds, 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 Miao to be about 20 microseconds to about 30 microseconds, since it has been held that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a primae facie case of obviousness exists”. (MPEP 2144.05)(In re Wertheim, 541 F.2d 257, 191 USPQ90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Regarding wherein the duration or width of the application of the predetermined voltage pulses is about 25 microseconds, Miao teaches this limitation as Miao teaches that the duration can be between 10ns and 100ms, which encompasses 25 microseconds. Furthermore, Miao teaches that the user is capable of choosing the duration of the voltage pulse (Paragraphs 0044 and 0045), so the user is capable of choosing 25 microseconds.
Regarding claim 11, Miao and Lu make obvious the IVL catheter assembly as discussed above.
Regarding wherein the IVL control system is further configured to increase the magnitude of the subsequent voltage pulses by a predetermined amount of about 25 volts when the number of generated voltage pulses is determined by the IVL control system to be sufficient to warrant an increase in the magnitude of subsequent voltage pulses, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Miao teaches that the IVL control system (energy generation and controller 31, pressure sensor 72) is capable of emitting a voltage between 300V to 20,000V (Paragraph 0044), that the magnitude of each voltage pulse can be set by the operator and adjusted (Paragraphs 0044 and 0045), and that the magnitude of the voltage can be increased when it is determined that the pressure is not enough within the balloon (Paragraph 0047), then the IVL control system of the combination would be capable of increasing the target voltage magnitude by 25 volts when the number of generated voltage pulses is determined to be sufficient to warrant an increase in magnitude.
Regarding claim 19, Miao and Lu make obvious the IVL catheter assembly as discussed above.
Miao further teaches the IVL catheter assembly further comprising a plurality of the generated series of the predetermined number of voltage pulses (Paragraphs 0044, 0045, and 0047).
Regarding claim 20, Miao and Lu make obvious the IVL catheter assembly as discussed above.
The combination does not teach wherein one or more of the series of the generated voltage pulses in the plurality of generated series of voltage pulses comprises 10 voltage pulses.
Lu teaches an apparatus (Fig. 2) for generating electrical pulses for affecting tissue within the body (Paragraphs 0002, 0009, and 0053), wherein the method comprises generating an initial series of electrical pulses (second stage set mentioned in Paragraphs 0020 and 0053), then pausing for a predetermined duration and generating a subsequent series of electrical pulses (Paragraphs 0020 and 0052), wherein the series of pulses comprises 10 voltage pulses (Paragraphs 0020 and 0053, Lu encompasses the value of 10 voltage pulses as the range taught by Lu is 4 to 10 pulse repetitions.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the IVL catheter assembly as taught by Miao to have the series of the generated voltage pulses comprise 10 voltage pulses, since Lu teaches that this is a way to treat tissue more efficiently (Paragraph 0009, 0015, and 0047) and Miao teaches that the number of pulses can be adjusted by a user (Paragraphs 0044, 0045 and 0047).
Regarding claim 21, Miao and Lu make obvious the IVL catheter assembly as discussed above.
The combination does not teach wherein one or more of the series of the generated voltage pulses in the plurality of generated series of voltage pulses comprises more than 10 voltage pulses.
Lu (Lu et al.) teaches an apparatus (Fig. 1) for generating electrical pulses for affecting tissue within the body (Paragraphs 0002, 0009, and 0052)), wherein the method comprises generating an initial series of electrical pulses (second stage set mentioned in Paragraphs 0018 and 0052), then pausing for a predetermined duration and generating a subsequent series of electrical pulses (Paragraphs 0018 and 0052), wherein the series of pulses comprises more than 10 voltage pulses (15 to 35 pulses, which is more than 10 pulses, as taught in Paragraph 0052).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the IVL catheter assembly as taught by Miao to have the series of the generated voltage pulses comprise more than 10 voltage pulses, since Lu teaches that this is a way to treat tissue more efficiently (Paragraph 0009, 0015, and 0047) and Miao teaches that the number of pulses can be adjusted by a user (Paragraphs 0044, 0045 and 0047).
Regarding claim 22, Miao and Lu make obvious the IVL catheter assembly as discussed above.
The combination does not teach wherein one or more of the series of the generated voltage pulses in the plurality of generated series of voltage pulses comprises less than 10 voltage pulses.
Lu teaches an apparatus (Fig. 2) for generating electrical pulses for affecting tissue within the body (Paragraphs 0002, 0009, and 0053), wherein the method comprises generating an initial series of electrical pulses (second stage set mentioned in Paragraphs 0020 and 0053), then pausing for a predetermined duration and generating a subsequent series of electrical pulses (Paragraphs 0020 and 0052), wherein the series of pulses comprises 10 or less voltage pulses (Paragraphs 0020 and 0053, Lu encompasses the value of 10 voltage pulses as the range taught by Lu is 4 to 10 pulse repetitions.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the IVL catheter assembly as taught by Miao to have the series of the generated voltage pulses comprise 10 or less voltage pulses, since Lu teaches that this is a way to treat tissue more efficiently (Paragraph 0009, 0015, and 0047) and Miao teaches that the number of pulses can be adjusted by a user (Paragraphs 0044, 0045 and 0047).
It would have been obvious to one of ordinary skill in the art to modify the range of the combination to be less than 10 voltage pulses, as Lu teaches that the repetition number can be less than 10 (Paragraph 0053) and Miao teaches that the number of pulses can be adjusted by a user (Paragraphs 0044, 0045 and 0047).
Regarding claim 23, Miao and Lu make obvious the IVL catheter assembly as discussed above.
Miao further teaches wherein the stored control data comprises the predetermined lower voltage magnitude threshold and a predetermined duration of the application of a generated voltage pulse to the at least one set of electrodes (Paragraph 0045 and 0047)
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the IVL catheter assembly as taught by Miao to have the pause of a predetermined duration as taught by Lu, since Lu teaches that this pause is more efficient for treating tissue (Paragraph 0009, 0015, and 0047).
Regarding wherein the stored control data comprises the predetermined duration of the pause, as the combination includes this data, and Miao teaches that the data memory stores various parameters (Paragraph 0045), then the combination would have the stored control data comprise the predetermined duration of the pause.
Regarding claim 24, Miao and Lu make obvious the IVL catheter assembly as discussed above.
Miao further teaches wherein the stored control data further comprises a predetermined duration between adjacent voltage pulses within a series of voltage pulses (Paragraph 0045).
Regarding claim 26, Miao and Lu make obvious the IVL catheter assembly as discussed above.
Miao further teaches wherein the stored control data further comprises a current threshold value (Paragraphs 0044 and 0045).
Regarding claim 41, Miao teaches a method for conducting intravascular lithotripsy (IVL) (Figs. 1-3)(Paragraphs 0008 and 0042) comprising:
Providing a catheter assembly (catheter body 1, balloon 2, electrode pair 4, energy generation and controller 31, pressure sensor 72)(Paragraph 0042) comprising:
At least one of set of electrodes (electrode pair 4) for arrangement within a body lumen while disposed within an inflatable balloon or enclosure (balloon 2)(Paragraph 0043);
An electric pulse generation system (energy supply unit) for providing electrical energy to the at least one set of electrodes to generate spark for IVL therapy (Paragraphs 0042 and 0043), the electrical pulse generation system including an IVL control system (energy generation and controller 31, pressure sensor 72) comprising a processor (energy generation and controller 31) for executing instruction based at least in part on a set of stored control data (Paragraphs 0044 and 0045), and circuitry (pressure sensor 72) adapted for communication of signals based on operation of the processor (Paragraph 0047);
Generating an initial series of a predetermined number of voltage pulses to apply to the at least one set of electrodes, wherein the magnitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage that is set at a predetermined lower voltage magnitude threshold (Paragraphs 0044 and 0045),
Generating a subsequent series of a predetermined number of voltage pulses to apply to the at least one set of electrodes (Paragraph 0047);
Determining when the number of generated voltage pulses is sufficient to warrant an increase in the magnitude of subsequent voltage pulses and, upon such determination, increase the magnitude of the subsequent voltage pulses by a predetermined amount (Paragraph 0047); and
Generating another series of a predetermined number of voltage pulses to the at least one set of electrodes (Paragraph 0044 and 0047).
Miao does not teach the step of after the generation of the initial series of voltage pulses, require a pause of a predetermined duration.
Lu (Lu et al.) teaches a method for operating an apparatus (Fig. 1) for generating electrical pulses for affecting tissue within the body (Paragraphs 0002, 0009, and 0052)), wherein the method comprises generating an initial series of electrical pulses (second stage set mentioned in Paragraphs 0018 and 0052), then pausing for a predetermined duration and generating a subsequent series of electrical pulses (Paragraphs 0018 and 0052).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of operating the IVL catheter assembly as taught by Miao to have the step of having a pause of a predetermined duration as taught by Lu, since Lu teaches that this pause is more efficient for treating tissue (Paragraph 0009, 0015, and 0047).
Claim(s) 3- 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miao et al. (CN 215458401U English Machine Translation) in view of Lu et al. (CN 113349881A English Machine Translation), as applied to claim 1 above, in view of Liu et al. (CN 107633840 English Machine Translation).
Regarding claims 3 and 5, Miao and Lu make obvious the IVL catheter assembly as discussed above.
The combination does teach wherein the IVL control system is further configured to determine when a predetermined upper threshold voltage magnitude has been reached or wherein the predetermined upper threshold voltage magnitude is about 3250 volts.
Liu (Liu et al.) teaches a lithotripsy system (Paragraph 0003), wherein the lithotripsy system comprises a predetermined upper voltage magnitude threshold (Umax)(Paragraphs 0010 and 0041) and the steps of determining whether the target voltage is not at the predetermined upper voltage magnitude target for a prior executed series of voltage pulses, and increasing the target voltage magnitude by a predetermined amount when the target voltage is determined to be less than the predetermined upper voltage magnitude target (Paragraphs 0010- 0011, and 0028).
It would have been obvious to one of ordinary skill in the art to modify the IVL control system as taught by the combination to have an upper voltage magnitude threshold as taught by Liu, since Miao teaches that the IVL control system is capable of controlling the voltage (Paragraph 0044 and 00047) and since Liu teaches that this method “significantly reduces the pre-breakdown delay of the liquid gap and improves the conversion efficiency of the liquid electric pulse shock wave transmission system to the mechanical energy” (Liu, Paragraph 0021).
Regarding wherein the predetermined upper threshold voltage is about 3250 volts, as Miao teaches that the voltage magnitude can be altered by the user and that the voltage can range from between 300V to 20,000V (Paragraph 0044), it would have been obvious to one of ordinary skill in the art to choose about 3250 volts as the predetermined upper voltage magnitude threshold. Furthermore, this value is within the range of the capabilities of the generator, between 300V and 20,000V, and the user can modify the voltage through the IVL control system (Paragraph 0044 and 0047), so the user is capable of choosing 3250 volts to be the predetermined upper voltage magnitude threshold.
Regarding claim 4, Miao, Lu, and Liu make obvious the IVL catheter assembly as discussed above.
The combination does not teach wherein the IVL control system is further configured to stop subsequent voltage magnitude increases when the predetermined upper threshold voltage magnitude is determined to have been reached.
Liu (Liu et al.) teaches a lithotripsy system (Paragraph 0003), wherein the lithotripsy system comprises a predetermined upper voltage magnitude threshold (Umax)(Paragraphs 0010 and 0041) and the steps of determining whether the target voltage is not at the predetermined upper voltage magnitude target for a prior executed series of voltage pulses, and increasing the target voltage magnitude by a predetermined amount when the target voltage is determined to be less than the predetermined upper voltage magnitude target (Paragraphs 0010- 0011, and 0028) and to terminate the IVL therapy if the predetermined upper voltage magnitude threshold is determined to have been reached (Paragraph 0041).
It would have been obvious to one of ordinary skill in the art to modify the IVL control system as taught by the combination to perform the method according to the predetermined upper voltage magnitude threshold as taught by Liu, since Miao teaches that the IVL control system is capable of controlling the voltage (Paragraph 0044 and 00047) and since Liu teaches that this method “significantly reduces the pre-breakdown delay of the liquid gap and improves the conversion efficiency of the liquid electric pulse shock wave transmission system to the mechanical energy” (Liu, Paragraph 0021).
Claim(s) 12-18, 25 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miao et al. (CN 215458401U English Machine Translation) in view of Lu et al. (CN 113349881A English Machine Translation), as applied to claim 1 above, in view of Manucherhabadi et al. (US 2021/0315639).
Regarding claim 12, Miao and Lu make obvious the IVL catheter assembly as discussed above.
The combination does not teach wherein if the IVL control system further comprises a predetermined maximum number of voltage pulses for IVL catheter assembly that is within the range of 10 to 300 voltage pulses, and wherein the IVL control system is configured to prevent any further voltage pulses to be executed upon a determination that the maximum predetermined number of voltage pulses have been generated.
Manucherhabadi (Manucherhabadi et al.) teaches a similar system (abstract) comprising at least one set of spaced-apart electrodes (probes 210) and a protocol for uses with the probes that determines the total number of generated voltage pulses and to terminate the execution of voltage pulses when a predetermined maximum number of voltage pulses is determined to be generated, wherein the predetermined maximum number of voltage pulses is within a range of 10 to 100 voltage pulses (Paragraphs 0095 and 0096).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the IVL control system as taught by the combination to determine the total number of generated voltage pulses and to terminate the execution of voltage pulses when a predetermined maximum number of voltage pulses is determined to be generated, wherein the predetermined maximum number of voltage pulses is within a range of 10 to 100 voltage pulses as taught by Manucherhabadi, since Miao teaches that the IVL control system has programming for controlling the amount of voltage pulses (Paragraph 0044, 0045 and 00047), and Manucherhabadi teaches a protocol for controlling the repetition of voltage pulses (Manucherhabadi, Paragraph 0096).
The combination does not teach wherein the predetermined maximum number of voltage pulses is within a range of 10 to 300 voltage pulses.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the range as taught by the combination to be between 10 to 300 voltage pulses, since it has been held that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a primae facie case of obviousness exists”. (MPEP 2144.05)(In re Wertheim, 541 F.2d 257, 191 USPQ90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Regarding claim 13, Miao, Lu, and Manucherhabadi make obvious the IVL catheter assembly as discussed above.
Regarding wherein the electrical arcs produce pressure outputs that do not decay or decrease on average more than 0.25 MPa across the predetermined maximum number of voltage pulses, as this language is functional, the structure of system only needs to be able to accomplish the function, therefore as Miao teaches that the pressure sensor determines if the pressure threshold is at an appropriate pressure threshold and then increases the pulse voltage if the pressure is less than the threshold before and after the pulse is released (Paragraph 0047), then the IVL control system is capable of having each electrical arc produce a pressure output that does not decrease and it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the IVL control system to prevent the pressure output from decreasing more than 0.25 MPa across the generated voltage pulses.
Regarding claim 14, Miao, Lu, and Manucherhabadi make obvious the IVL catheter assembly as discussed above.
Regarding wherein the electrical arcs produce pressure outputs that do not decrease more than 10% across the predetermined maximum number of voltage pulses, as this language is functional, the structure of system only needs to be able to accomplish the function, therefore as Miao teaches that the pressure sensor determines if the pressure threshold is at an appropriate pressure threshold and then increases the pulse voltage if the pressure is less than the threshold before and after the pulse is released (Paragraph 0047), then the IVL control system is capable of having each electrical arc produce a pressure output that does not decrease and it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the IVL control system to prevent the pressure output from decreasing more than 10% across the generated voltage pulses.
Regarding claim 15, Miao, Lu, and Manucherhabadi make obvious the IVL catheter assembly as discussed above.
Regarding wherein the pressure output of a last voltage pulse of the predetermined maximum number of voltage pulses is greater than the pressure output of a first voltage pulse, as Miao teaches increasing the pulse voltage when the pressure threshold is not enough, and that the pressure output is dependent on the parameters of the voltage magnitude and width (Paragraph 0047), then when the last voltage pulse is reached the pressure output would be greater than the pressure output of the first voltage pulse.
Regarding claim 16, Miao, Lu, and Manucherhabadi make obvious the IVL catheter assembly as discussed above.
Regarding wherein the electrical arcs produce pressure outputs that comprises a slope of the pressure outputs of the generated voltage pulses over time wherein the slope of the pressure outputs increases over time, since Miao teaches that pressure output is dependent on voltage magnitude, voltage pulse duration, and voltage pulse repetition rate (Paragraphs 0044, 0045, and 0047) and that the pressure sensor makes sure that the voltage increases to lead to an increasing pressure rate (Paragraph 0047), then the slope of pressure outputs increases over time.
Regarding claim 17, Miao, Lu, and Manucherhabadi make obvious the IVL catheter assembly as discussed above.
Regarding wherein the electrical arcs produce pressure outputs that comprise a slop of the pressure outputs of the generated voltage pulses over time, wherein a slope of the pressure output of the voltage pulses decreases over time, since Miao teaches that pressure output is dependent on voltage magnitude, voltage pulse duration, and voltage pulse repetition rate (Paragraphs 0044, 0045, and 0047) and that the pressure sensor monitors the pressure and that the pressure can decrease (Paragraph 0047), then the slope of the pressure output over time is a result- effective variable and it would have been obvious to one of ordinary skill in the art to modify the pressure outputs to have a slope that decreases over time, as it is ordinarily obvious to optimize that parameter to achieve a desired result. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Regarding claim 18, Miao, Lu, and Manucherhabadi make obvious the IVL catheter assembly as discussed above.
Regarding wherein the electrical arcs produce pressure outputs that comprise a slope of the pressure output of the voltage pulses over time, wherein the slope of the pressure output of the voltage pulses indicates a substantially constant pressure magnitude output across the voltage pulses, since Miao teaches that pressure output is dependent on voltage magnitude, voltage pulse duration, and voltage pulse repetition rate (Paragraphs 0044, 0045, and 0047) and that the pressure sensor monitors the pressure and that the pressure can stay the same once it reaches a predetermined pressure threshold (Paragraph 0047), then the slope of the pressure output over time is a result- effective variable and it would have been obvious to one of ordinary skill in the art to modify the pressure outputs to have a slope that indicates a substantially constant pressure magnitude output across the voltage pulses, as it is ordinarily obvious to optimize that parameter to achieve a desired result. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Regarding claim 25, Miao and Lu make obvious the IVL catheter assembly as discussed above.
The combination does not teach wherein the stored control data further comprises a maximum number of voltage pulses allowed for the IVL catheter assembly.
Manucherhabadi (Manucherhabadi et al.) teaches a similar system (abstract) comprising at least one set of spaced-apart electrodes (probes 210) and a protocol for uses with the probes that determines the total number of generated voltage pulses and to terminate the execution of voltage pulses when a predetermined maximum number of voltage pulses is determined to be generated, wherein the predetermined maximum number of voltage pulses is within a range of 10 to 100 voltage pulses (Paragraphs 0095 and 0096).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the IVL control system as taught by the combination to determine the total number of generated voltage pulses and to terminate the execution of voltage pulses when a predetermined maximum number of voltage pulses is determined to be generated, wherein the predetermined maximum number of voltage pulses is within a range of 10 to 100 voltage pulses as taught by Manucherhabadi, since Miao teaches that the IVL control system has programming for controlling the amount of voltage pulses (Paragraph 0044, 0045 and 00047), and Manucherhabadi teaches a protocol for controlling the repetition of voltage pulses (Manucherhabadi, Paragraph 0096).
Regarding wherein the stored control data further comprises a maximum number of voltage pulses allowed for the IVL catheter assembly, as the combination includes this data, and Miao teaches that the data memory stores various parameters (Paragraph 0045), then the combination would have the stored control data comprise a maximum number of voltage pulses allowed for the IVL catheter assembly.
Regarding claim 27, Miao, Lu, and Manucherhabadi make obvious the IVL catheter assembly as discussed above.
The combination is silent to the assembly further comprising an EPROM configured to store the stored control data.
Manucherhabadi (Manucherhabadi et al.) teaches a similar system (abstract) comprising at least one set of spaced-apart electrodes (probes 210) with an EPROM configured to store control data (Paragraph 0192) and a protocol for uses with the probes that determines the total number of generated voltage pulses and to terminate the execution of voltage pulses when a predetermined maximum number of voltage pulses is determined to be generated, wherein the predetermined maximum number of voltage pulses is within a range of 10 to 100 voltage pulses (Paragraphs 0095 and 0096).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the assembly as taught by the combination to have an EPROM configured to store the stored control data as Manucherhabadi teaches this is a known example of memory used within treatment systems (Paragraph 0192) and Miao teaches that the system comprises a memory (Paragraph 0045).
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miao et al. (CN 215458401 U English Machine Translation).
Regarding claim 40, Miao teaches an intravascular lithotripsy (IVL) catheter assembly (Figs. 1-3)(Paragraphs 0008 and 0042) comprising:
At least one set of electrodes (electrode pair 4) for arrangement within a body lumen while disposed within an inflatable balloon or enclosure (balloon 2)(Paragraph 0043);
An electric pulse generation system (energy supply unit) for providing electrical energy to the at least one set of spaced- apart electrodes to generate spark for IVL therapy (Paragraphs 0042 and 0043), the electric pulse generation system including an IVL control system (energy generation and controller 31, pressure sensor 72) comprising a processor (energy generation and controller 31) for executing instructions based at least in part on a set of stored control data (Paragraphs 0044 and 0045) and circuitry (pressure sensor 72) adapted for communication of signals based on operation of the processor (Paragraph 0047), the IVL control system configured to:
Generate a predetermined number of voltage pulses to apply to the at least one set of spaced- apart electrodes (Paragraphs 0044 and 0047),
Wherein at least some of the generated voltage pulses generate an electrical arc between the spaced- apart electrodes of the at least one set spaced- apart electrodes, wherein each electrical arc produces a pressure output (Paragraphs 0044 and 0047).
Regarding wherein each electrical arc produces a pressure output that does not decrease more than 10% across the generated voltage pulses, as this language is functional, the structure of system only needs to be able to accomplish the function, therefore as Miao teaches that the pressure sensor determines if the pressure threshold is at an appropriate pressure threshold and then increases the pulse voltage if the pressure is less than the threshold before and after the pulse is released (Paragraph 0047), then the IVL control system is capable of having each electrical arc produce a pressure output that does not decrease and it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the IVL control system to prevent the pressure output from decreasing more than 10% across the generated voltage pulses.
Double Patenting
Claims 1-27, 40, and 41 of this application is patentably indistinct from claims 1- 27, 40, and 41 of Application No. 18/825,683. 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- 27, 40, and 41 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1- 27, 40, and 41 of copending Application No. 18.825,683 (‘683) (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, ‘683 claims an intravascular lithotripsy ("IVL") catheter assembly comprising: at least one set of electrodes for arrangement within a body lumen while disposed within an inflatable balloon or enclosure (claim 1 of ‘683); an electric pulse generation system for providing electrical energy to the at least one set of spaced-apart electrodes to generate spark for IVL therapy (claim 1 of ‘683), the electric pulse generation system including an IVL control system comprising a processor for executing instructions based at least in part on a set of stored control data (claim 1 of ‘683), and circuitry adapted for communication of signals based on operation of the processor (claim 1 of ‘683), the IVL control system configured to: generate an initial series of a predetermined number of voltage pulses to apply to the at least one set of spaced-apart electrodes (claim 1 of ‘683), wherein the magnitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage that is set at a predetermined lower voltage magnitude threshold, after the generation of the initial series of voltage pulses, require a pause of a predetermined duration (claim 1 of ‘683); generate a subsequent series of a predetermined number of voltage pulses to apply to the at least one set of spaced-apart electrodes (claim 1 of ‘683); determine when the number of generated voltage pulses is sufficient to warrant an increase in the magnitude of subsequent voltage pulses and, upon such determination, increase the magnitude of the subsequent voltage pulses by a predetermined amount (claim 1 of ‘683); and generate another series of a predetermined number of voltage pulses to apply to the at least one set of spaced-apart electrodes, wherein at least some of the generated voltage pulses generate an electrical are between the spaced-apart electrodes of the at least one set of space-apart electrodes and wherein each electrical are produces a pressure output (claim 1 of ‘683).
Regarding claim 2, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein the predetermined lower voltage magnitude threshold is about 2850 volts (claim 2 of ‘683).
Regarding claim 3, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein the IVL control system is further configured to determine when a predetermined upper threshold voltage magnitude has been reached (claim 3 of ‘683).
Regarding claim 4, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein when the IVL control system is further configured to stop subsequent voltage magnitude increases when the predetermined upper threshold voltage magnitude is determined to have been reached (claim 4 of ‘683).
Regarding claim 5, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein the predetermined upper threshold voltage magnitude is about 3250 volts (claim 5 of ‘683).
Regarding claim 6, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein the duration of the pause is between about 5 seconds and about 20 seconds (claim 6 of ‘683).
Regarding claim 7, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein the duration of the pause is about 10 seconds (claim 7 of ‘683).
Regarding claim 8, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims further comprising a predetermined duration of application of the voltage to the at least one set of electrodes (claim 8 of ‘683).
Regarding claim 9, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein the duration or width of the application of the voltage is about 20 microseconds to about 30 microseconds (claim 9 of ‘683).
Regarding claim 10, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein the duration or width of the application of the voltage is about 25 microseconds (claim 10 of ‘683).
Regarding claim 11, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein the IVL control system is further configured to increase the magnitude of the subsequent voltage pulses by a predetermined amount of about 25 volts when the number of generated voltage pulses is determined by the IVL control system to be sufficient to warrant an increase in the magnitude of subsequent voltage pulses (claim 11 of ‘683).
Regarding claim 12, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein if the IVL control system further comprises a predetermined maximum number of voltage pulses for the IVL catheter assembly that is within the range of 10 to 300 voltage pulses, and wherein the IVL control system is configured to prevent any further voltage pulses to be executed upon a determination that the maximum predetermined number of voltage pulses have been generated (claim 12 of ‘683).
Regarding claim 13, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein the electrical arcs produce pressure outputs that do not decay or decrease on average more than 0.25MPa across the predetermined maximum number of voltage pulses (claim 13 of ‘683).
Regarding claim 14, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein the electrical arcs produce pressure outputs that do not decrease more than 10% across the predetermined maximum number of voltage pulses (claim 14 of ‘683).
Regarding claim 15, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein the pressure output of a last voltage pulse of the predetermined maximum number of voltage pulses is greater than the pressure output of a first voltage pulse (claim 15 of ‘683).
Regarding claim 16, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein the electrical arcs produce pressure outputs that comprise a slope of the pressure outputs of the generated voltage pulses over time, wherein the slope of the pressure outputs increases over time (claim 16 of ‘683).
Regarding claim 17, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein the electrical arcs produce pressure outputs that comprise a slope of the pressure outputs of the generated voltage pulses over time, wherein a slope of the pressure output of the voltage pulses decreases over time (claim 17 of ‘683).
Regarding claim 18, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein the electrical arcs produce pressure outputs that comprise a slope of the pressure output of the voltage pulses over time, wherein the slope of the pressure output of the voltage pulses indicates a substantially constant pressure magnitude output across the voltage pulses (claim 18 of ‘683).
Regarding claim 19, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims further comprising a plurality of the generated series of the predetermined number of voltage pulses (claim 19 of ‘683).
Regarding claim 20, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein one or more of the series of generated voltage pulses in the plurality of generated series of voltage pulses comprises 10 voltage pulses (claim 20 of ‘683).
Regarding claim 21, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein one or more of the series of generated voltage pulses in the plurality of generated series of voltage pulses comprises more than 10 voltage pulses (claim 21 of ‘683).
Regarding claim 22, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein one or more of the series of generated voltage pulses in the plurality of generated series of voltage pulses comprises less than 10 voltage pulses (claim 22 of ‘683).
Regarding claim 23, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein the stored control data comprises the predetermined lower voltage magnitude threshold, a predetermined duration of the application of the generated voltage pulse to the at least one set of electrodes, and the predetermined duration of the pause (claim 23 of ‘683).
Regarding claim 24, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein the stored control data further comprises one or more of a maximum upper voltage threshold, a predetermined duration between adjacent voltage pulses within a series of voltage pulses, a predetermined number of voltage pulses required before an increase in voltage magnitude is warranted, and at least one predetermined magnitude to increase the voltage (claim 24 of ‘683).
Regarding claim 25, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein the stored control data further comprises a maximum number of voltage pulses allowed for the IVL catheter assembly (claim 25 of ‘683).
Regarding claim 26, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims wherein the stored control data further comprises a current threshold value (claim 26 of ‘683).
Regarding claim 27, ‘683 claims the IVL catheter assembly as discussed above.
‘683 further claims further comprising an EPROM configured to store the stored control data (claim 27 of ‘683).
Regarding claim 40, ‘683 claims an intravascular lithotripsy (“IVL”) catheter assembly comprising: at least one set of electrodes for arrangement within a body lumen while disposed within an inflatable balloon or enclosure (claim 40 of ‘683); an electric pulse generation system for providing electrical energy to the at least one set of spaced-apart electrodes to generate spark for IVL therapy, the electric pulse generation system including an IVL control system comprising a processor for executing instructions based at least in part on a set of stored control data (claim 40 of ‘683), and circuitry adapted for communication of signals based on operation of the processor, the IVL control system configured to: generate a predetermined number of voltage pulses to apply to the at least one set of spaced-apart electrodes (claim 40 of ‘683), wherein at least some of the generated voltage pulses generate an electrical arc between the spaced-apart electrodes of the at least one set of space-apart electrodes, wherein each electrical arc produces a pressure output that does not decrease more than 10% across the generated voltage pulses (claim 40 of ‘683).
Regarding claim 41, ‘683 claims a method for conducting intravascular lithotripsy ("IVL") comprising: providing a catheter assembly comprising: at least one set of electrodes for arrangement within a body lumen while disposed within an inflatable balloon or enclosure (claim 41 of ‘683); an electric pulse generation system for providing electrical energy to the at least one set of electrodes to generate spark for IVL therapy, the electric pulse generation system including an IVL control system comprising a processor for executing instructions based at least in part on a set of stored control data (claim 41 of ‘683), and circuitry adapted for communication of signals based on operation of the processor (claim 41 of ‘683); generating an initial series of a predetermined number of voltage pulses to apply to the at least one set of electrodes (claim 41 of ‘683), wherein the magnitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage that is set at a predetermined lower voltage magnitude threshold (claim 41 of ‘683), after the generation of the initial series of voltage pulses, requiring a pause of a predetermined duration (claim 41 of ‘683); generating a subsequent series of a predetermined number of voltage pulses to apply to the at least one set of electrodes (claim 41 of ‘683); determining when the number of generated voltage pulses is sufficient to warrant an increase in the magnitude of subsequent voltage pulses and, upon such determination, increase the magnitude of the subsequent voltage pulses by a predetermined amount (claim 41 of ‘683); and generating another series of a predetermined number of voltage pulses to the at least one set of electrodes (claim 41 of ‘683).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272- 4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
Prosecution Insights