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
This application contains claims directed to the following patentably distinct species:
IVL system A (Claims 1- 12)
IVL system B (Claims 13- 48)
The species are independent or distinct because IVL system A recites an IVL system with an EPROM storing at least one of parameters or instructions for how to adjust voltage, which are mutually exclusive characteristics only to IVL system A and IVL system B recites an IVL system with two pairs of electrodes, each pair of electrodes having a gap and a total set of voltage pulses being more than 120 voltage pulses, which are mutually exclusive characteristics only to IVL system B. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, no claims are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
the species or groupings of patentably indistinct species 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 a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve 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 election of species 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 on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them 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 species 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 species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Oleg Kaplun on April 14th, 2026 a provisional election was made without traverse to prosecute the invention of Species B, claims 13- 48. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1- 12 are 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 13- 48 are objected to because of the following informalities:
Claim 13, Line 1 states “intravascular coronary lithotripsy (“IVL”)”, it is suggested to change this to “intravascular coronary lithotripsy (IVL)”.
Claim 13, Line 6 states “more than120”, it is suggested to change this to “more than 120”.
Claims 14- 31 are objected to for being dependent on or from objected claim 13.
Claims 25- 28, Line 1 states “13 wherein,”, it is suggested to change this to “13, wherein”.
Claims 29 and 30, Line 1 states “24 wherein,”, it is suggested to change this to “24, wherein”.
Claim 31, Line 1 states “13 wherein”, it is suggested to change this to “13, wherein”.
Claim 32, Line 1 states “intravascular coronary lithotripsy (“IVL”)”, it is suggested to change this to “intravascular coronary lithotripsy (IVL)”.
Claim 32, Line 6 states “generate spark”, it is suggested to change this to “generate a spark”.
Claim 32, Line 9 states “within an inflatable balloon”, it is suggested to change this to “within the inflatable balloon”.
Claims 33- 48 are objected to for being dependent on or from objected claim 32.
Claims 42-45, Line 1 states “13 wherein,”, it is suggested to change this to “13, wherein”.
Claims 44 and 45, Line 1 states “41 wherein,”, it is suggested to change this to “41, wherein”.
Claim 48, Line 1 states “13 wherein”, it is suggested to change this to “13, wherein”.
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 31 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 31 recites the limitation "the at least one set of electrodes" in Line 1. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this limitation is herein interpreted as “at least one set of electrodes”.
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) 13- 22, 25- 28, 31- 40, 42- 45, and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US 10,850,078) in view of Manucherhabadi et al. (US 2021/0315639).
Regarding claims 13 and 16, Grace (Grace et al.) teaches a method of performing intravascular coronary lithotripsy (IVL) using a catheter assembly (electrically- induced angioplasty balloon catheter system 100) having an axis (see annotated Fig. 1B below)(Figs. 1A- 1C, Figs. 4- 4A, Fig. 7)(abstract and Column 7, Lines 47- 55), the method comprising:
Delivering a set of voltage pulses in a balloon (116)(Column 17, Lines 12- 29), inflated by fluid (Column 15, Lines 28- 30), the balloon being sized and shaped for use in a coronary vessel (abstract and Column 13, Lines 38- 42).
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Grace does not teach (claim 13) wherein the total of the set of voltage pulses capable of being provided by the catheter is more than 120 voltage pulses using the same balloon or (claim 16) wherein the set of voltage pulses is at least 160 pulses.
Manucherhabadi (Manucherhabadi et al.) teaches a similar system (abstract) comprising at least one set of spaced-apart electrodes (probes 210) and a method for using the electrodes that delivers a set of voltage pulses to tissue within a vessel, wherein the total of the set of voltage pulses capable of being provided by the catheter is more than 120 voltage pulses, at around 600 total voltage pulses delivered to the tissue, using the same pairs of electrodes (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 method of using the IVL control system as taught by Grace to have the total of the set of voltage pulses capable of being provided by the catheter to be more than 120 voltage pulses and at least 160 pulses using the same balloon as taught by Manucherhabadi, since Grace teaches a method for delivering a set of voltage pulses and that the IVL control system can contain programming that control the high voltage generator, which controls the repetition of voltage pulses (Grace, Column 23, Lines 30- 36 and Column 17, Lines 12- 29), and Manucherhabadi teaches a protocol for delivering a set of voltage pulses for treating tissue (abstract, Paragraphs 0095 and 0096).
Regarding claim 14, Grace and Manucherhabadi make obvious the method and the system as discussed above.
The combination is silent to causing 10 to 40 sequential voltage pulses of a substantially same voltage magnitude, after which the voltage magnitude is changed for subsequent voltage pulses.
Manucherhabadi (Manucherhabadi et al.) teaches a similar system (abstract) comprising at least one set of spaced-apart electrodes (probes 210) and a method for using the electrodes that delivers a set of voltage pulses to tissue within a vessel, wherein the total of the set of voltage pulses capable of being provided by the catheter is more than 120 voltage pulses, at around 600 total voltage pulses delivered to the tissue, using the same pairs of electrodes (Paragraph 0095), and causing 10- 100 sequential voltage pulses of a substantially same voltage magnitude, after which the voltage magnitude is changed for subsequent voltage pulses (In Paragraph 0096, Manucherhabadi teaches a method of delivering 10 to 100 voltage pulses for a first pair of probes and then applying 10 to 100 voltage pulses for a second pair of probes with a specific magnitude. Therefore, the voltage magnitude can be changed for a subsequent voltage pulse. Furthermore as the range set forth through the claim limitation falls within the range of the voltage pulses as taught by Manucherhabadi, Manucherhabadi teaches this claim limitation.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of using the IVL control system as taught by Grace to cause 10 to 100 sequential voltage pulses of the same voltage magnitude, after which the voltage magnitude is changed for subsequent voltage pulses as taught by Manucherhabadi, since Grace teaches a method for delivering a set of voltage pulses and that the IVL control system can contain programming that control the high voltage generator, which controls the repetition of voltage pulses (Grace, Column 23, Lines 30- 36 and Column 17, Lines 12- 29), and Manucherhabadi teaches a protocol for delivering a set of voltage pulses for treating tissue (abstract, Paragraphs 0095 and 0096).
Regarding causing 10 to 40 sequential voltage pulses, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the range of 10 to 100 voltage as taught by the combination to be 10 to 40 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 15, Grace and Manucherhabadi make obvious the method and the system as discussed above.
The combination is silent to causing 25 sequential voltage pulses of a substantially same voltage magnitude, after which the voltage magnitude is changed for subsequent voltage pulses.
Manucherhabadi (Manucherhabadi et al.) teaches a similar system (abstract) comprising at least one set of spaced-apart electrodes (probes 210) and a method for using the electrodes that delivers a set of voltage pulses to tissue within a vessel, wherein the total of the set of voltage pulses capable of being provided by the catheter is more than 120 voltage pulses, at around 600 total voltage pulses delivered to the tissue, using the same pairs of electrodes (Paragraph 0095), and causing 10- 100 sequential voltage pulses of a substantially same voltage magnitude, after which the voltage magnitude is changed for subsequent voltage pulses (In Paragraph 0096, Manucherhabadi teaches a method of delivering 10 to 100 voltage pulses for a first pair of probes and then applying 10 to 100 voltage pulses for a second pair of probes with a specific magnitude. Therefore, the voltage magnitude can be changed for a subsequent voltage pulse.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of using the IVL control system as taught by Grace to cause 10 to 100 sequential voltage pulses of the same voltage magnitude, after which the voltage magnitude is changed for subsequent voltage pulses as taught by Manucherhabadi, since Grace teaches a method for delivering a set of voltage pulses and that the IVL control system can contain programming that control the high voltage generator, which controls the repetition of voltage pulses (Grace, Column 23, Lines 30- 36 and Column 17, Lines 12- 29), and Manucherhabadi teaches a protocol for delivering a set of voltage pulses for treating tissue (abstract, Paragraphs 0095 and 0096).
Regarding causing 25 sequential voltage pulses, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the range of 10 to 100 voltage as taught by the combination to be 25 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 claims 17- 22, Grace and Manucherhabadi make obvious the method as discussed above.
Regarding wherein the set of voltage pulses cause a mean pressure within the balloon over the course of the IVL that approximates a substantially flat pressure profile, an increasing mean pressure profile, a declining- flat pressure profile, a sawtooth declining pressure profile, a sawtooth increasing pressure profile, or a decreasing-flat-decreasing-flat pressure profile, it would have been obvious to a person of ordinary skill in the art at the time of the invention to vary the voltage magnitude of successive pulses in the system of the combination in order to achieve a desired pressure response within the balloon, since Grace teaches that pressure wave generation is dependent on voltage pulse magnitude, voltage pulse duration and voltage pulse repetition rate (Column 17, Lines 25- 29), and therefore pressure is a result-effective variable. Once a parameter is known to affect the result, 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).
Accordingly, varying pulse magnitude across a series of pulses to produce a substantially flat, increasing, declining-flat, sawtooth declining, sawtooth increasing, or decreasing-flat-decreasing-flat pressure profile would have been a predictable use of a known variable according to its established function. The specific pressure profiles recited in claims 17–22 are merely different desired patterns of pressure over time achieved by routine optimization of the known voltage parameter.
Regarding claims 25- 28, Grace and Manucherhabadi make obvious the method as discussed above.
Grace further teaches that the balloon has a length of 20 mm (Column 15, Lines 40- 44).
The combination is silent to (claim 25) wherein, when inflated, the balloon has a radius from an axis of the balloon of approximately 2.5 mm, (claim 26) wherein, when inflated, the balloon has a radius from an axis of the balloon of approximately 3.0 mm, (claim 27) wherein, when inflated, the balloon has a radius from an axis of the balloon of approximately 3.5 mm, or (claim 28) wherein, when inflated, the balloon has a radius from an axis of the balloon of approximately 4.0 mm.
However, since Grace teaches that the IVL method is used within the coronary vessel and performs an IVL procedure on the vessel (abstract and Column 13, Lines 38- 42), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the radius of the balloon to be 2.5 mm, 3 mm, 3.5 mm, or 4.0 mm, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
Regarding claim 31, Grace and Manucherhabadi make obvious the method as discussed above.
Grace further teaches at least one set of electrodes (electrode assemblies 140 and 142) and the at least one set of electrodes comprises two pairs of electrodes (Column 15, Lines 17- 19), each pair of electrodes having a gap (Column 15, Lines 47- 52), and each pulse provides a spark in the gap between both of the pairs of electrodes (Column 15, Lines 53- 61).
Regarding claim 32, Grace (Grace et al.) teaches an intravascular lithotripsy (IVL) system (angioplasty balloon catheter system 100)(Figs. 1A- 1C, Figs. 4- 4A, Fig. 7)(abstract and Column 7, Lines 47- 55) including a catheter assembly (balloon catheter 104, electrode catheter 124), the system comprising:
At least one set of electrodes (electrode assemblies 140 and 142) for arrangement within a coronary vessel lumen while disposed within an inflatable balloon (116)(Column 7, Lines 47- 55 and Column 13, Lines 38- 43);
An electric pulse generation system (high voltage pulse generator 90, coupler 128, controller 750) for providing electrical energy to the at least one set of electrodes to generate spark for IVL therapy (Column 17, Lines 12- 14 and 30- 55), the electric pulse generation system including an IVL control system (controller 750)(Column 23, Lines 30- 34); and
Wherein the combination of the at least one set of electrodes for arrangement within a body lumen while disposed within an inflatable balloon and the electric pulse generation system are configured to provide a set of voltage pulses (Column 15, Lines 53- 64, Column 17, Lines 25- 55).
Grace does not teach wherein the set of voltage pulses is more than 120 voltage pulses.
Manucherhabadi (Manucherhabadi et al.) teaches a similar system (abstract) comprising at least one set of spaced-apart electrodes (probes 210) and a method for using the electrodes that delivers a set of voltage pulses to tissue within a vessel, wherein the total of the set of voltage pulses capable of being provided by the catheter is more than 120 voltage pulses, at around 600 total voltage pulses delivered to the tissue, using the same pairs of electrodes (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 Grace to have the total of the set of voltage pulses capable of being provided by the catheter to be more than 120 voltage pulses and at least 160 pulses using the same balloon as taught by Manucherhabadi, since Grace teaches a method for delivering a set of voltage pulses and that the IVL control system can contain programming that control the high voltage generator, which controls the repetition of voltage pulses (Grace, Column 23, Lines 30- 36 and Column 17, Lines 12- 29), and Manucherhabadi teaches a protocol for delivering a set of voltage pulses for treating tissue (abstract, Paragraphs 0095 and 0096).
Regarding claim 33, Grace and Manucherhabadi make obvious the method and the system as discussed above.
The combination is silent to causing 10 to 40 sequential voltage pulses of a substantially same voltage magnitude, after which the voltage magnitude is changed for subsequent voltage pulses.
Manucherhabadi (Manucherhabadi et al.) teaches a similar system (abstract) comprising at least one set of spaced-apart electrodes (probes 210) and a method for using the electrodes that delivers a set of voltage pulses to tissue within a vessel, wherein the total of the set of voltage pulses capable of being provided by the catheter is more than 120 voltage pulses, at around 600 total voltage pulses delivered to the tissue, using the same pairs of electrodes (Paragraph 0095), and causing 10- 100 sequential voltage pulses of a substantially same voltage magnitude, after which the voltage magnitude is changed for subsequent voltage pulses (In Paragraph 0096, Manucherhabadi teaches a method of delivering 10 to 100 voltage pulses for a first pair of probes and then applying 10 to 100 voltage pulses for a second pair of probes with a specific magnitude. Therefore, the voltage magnitude can be changed for a subsequent voltage pulse. Furthermore as the range set forth through the claim limitation falls within the range of the voltage pulses as taught by Manucherhabadi, Manucherhabadi teaches this claim limitation.).
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 Grace to cause 10 to 40 sequential voltage pulses of the same voltage magnitude, after which the voltage magnitude is changed for subsequent voltage pulses as taught by Manucherhabadi, since Grace teaches a method for delivering a set of voltage pulses and that the IVL control system can contain programming that control the high voltage generator, which controls the repetition of voltage pulses (Grace, Column 23, Lines 30- 36 and Column 17, Lines 12- 29), and Manucherhabadi teaches a protocol for delivering a set of voltage pulses for treating tissue (abstract, Paragraphs 0095 and 0096).
Regarding causing 10 to 40 sequential voltage pulses, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the range of 10 to 100 voltage as taught by the combination to be 10 to 40 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 34, Grace and Manucherhabadi make obvious the method and the system as discussed above.
The combination is silent to causing 25 sequential voltage pulses of a substantially same voltage magnitude, after which the voltage magnitude is changed for subsequent voltage pulses.
Manucherhabadi (Manucherhabadi et al.) teaches a similar system (abstract) comprising at least one set of spaced-apart electrodes (probes 210) and a method for using the electrodes that delivers a set of voltage pulses to tissue within a vessel, wherein the total of the set of voltage pulses capable of being provided by the catheter is more than 120 voltage pulses, at around 600 total voltage pulses delivered to the tissue, using the same pairs of electrodes (Paragraph 0095), and causing 10- 100 sequential voltage pulses of a substantially same voltage magnitude, after which the voltage magnitude is changed for subsequent voltage pulses (In Paragraph 0096, Manucherhabadi teaches a method of delivering 10 to 100 voltage pulses for a first pair of probes and then applying 10 to 100 voltage pulses for a second pair of probes with a specific magnitude. Therefore, the voltage magnitude can be changed for a subsequent voltage pulse.).
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 Grace to cause 10 to 100 sequential voltage pulses of the same voltage magnitude, after which the voltage magnitude is changed for subsequent voltage pulses as taught by Manucherhabadi, since Grace teaches a method for delivering a set of voltage pulses and that the IVL control system can contain programming that control the high voltage generator, which controls the repetition of voltage pulses (Grace, Column 23, Lines 30- 36 and Column 17, Lines 12- 29), and Manucherhabadi teaches a protocol for delivering a set of voltage pulses for treating tissue (abstract, Paragraphs 0095 and 0096).
Regarding causing 25 sequential voltage pulses, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the range of 10 to 100 voltage as taught by the combination to be 25 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 claims 35- 40, Grace and Manucherhabadi make obvious the system as discussed above.
Regarding wherein the set of voltage pulses cause a mean pressure within the balloon over the course of the IVL that approximates a substantially flat pressure profile, an increasing mean pressure profile, a declining- flat pressure profile, a sawtooth declining pressure profile, a sawtooth increasing pressure profile, or a decreasing-flat-decreasing-flat pressure profile, it would have been obvious to a person of ordinary skill in the art at the time of the invention to vary the voltage magnitude of successive pulses in the system of the combination in order to achieve a desired pressure response within the balloon, since Grace teaches that pressure wave generation is dependent on voltage pulse magnitude, voltage pulse duration and voltage pulse repetition rate (Column 17, Lines 25- 29), and therefore pressure is a result-effective variable. Once a parameter is known to affect the result, 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).
Accordingly, varying pulse magnitude across a series of pulses to produce a substantially flat, increasing, declining-flat, sawtooth declining, sawtooth increasing, or decreasing-flat-decreasing-flat pressure profile would have been a predictable use of a known variable according to its established function. The specific pressure profiles recited in claims 35-40 are merely different desired patterns of pressure over time achieved by routine optimization of the known voltage parameter.
Regarding claims 42- 45, Grace and Manucherhabadi make obvious the system as discussed above.
Grace further teaches that the balloon has a length of 20 mm (Column 15, Lines 40- 44).
The combination is silent to (claim 25) wherein, when inflated, the balloon has a radius from an axis of the balloon of approximately 2.5 mm, (claim 26) wherein, when inflated, the balloon has a radius from an axis of the balloon of approximately 3.0 mm, (claim 27) wherein, when inflated, the balloon has a radius from an axis of the balloon of approximately 3.5 mm, or (claim 28) wherein, when inflated, the balloon has a radius from an axis of the balloon of approximately 4.0 mm.
However, since Grace teaches that the IVL method is used within the coronary vessel and performs an IVL procedure on the vessel (abstract and Column 13, Lines 38- 42), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the radius of the balloon to be 2.5 mm, 3 mm, 3.5 mm, or 4.0 mm, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
Regarding claim 48, Grace and Manucherhabadi make obvious the system as discussed above.
Grace further teaches at least one set of electrodes (electrode assemblies 140 and 142) and the at least one set of electrodes comprises two pairs of electrodes (Column 15, Lines 17- 19), each pair of electrodes having a gap (Column 15, Lines 47- 52), and each pulse provides a spark in the gap between both of the pairs of electrodes (Column 15, Lines 53- 61).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US 10,850,078) in view of Manucherhabadi et al. (US 2021/0315639), as applied to claim 13 above, in further view of Hawkins et al. (US 2014/0046229).
Regarding claim 23, Grace and Manucherhabadi make obvious the method and the system as discussed above.
The combination is silent to the method further comprising advancing the balloon to a first therapy location to facilitate delivering a first subset of voltage pulses from among the set of voltage pulses and repositioning the balloon to a second therapy location to facilitate delivering a second subset of voltage pulses from among the set of voltage pulses.
Hawkins (Hawkins et al.) teaches a similar method (abstract) of delivering voltage pulses in a vessel (Fig. 4B) using a catheter assembly (shock wave device 100)(Figs. 1A- 1C), the method comprising: delivering a set of voltage pulses in a balloon (104)(Paragraphs 0021 and 0025), advancing the balloon to a first therapy location to facilitate delivering a first subset of voltage pulses from among the set of voltage pulses and repositioning the balloon to a second therapy location to facilitate delivering a second subset of voltage pulses from among the set of voltage pulses (Paragraph 0025).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method as taught by the combination to comprise advancing the balloon to a first therapy location to a second therapy location as taught by Hawkins, since Grace teaches a method for delivering a set of voltage pulses for treating tissue (Column 23, Lines 30- 36 and Column 17, Lines 12- 29) and Hawkins teaches a known protocol for using an IVL system to treat tissue and that doing so allows for a user to treat multiple areas of the vasculature (abstract and Paragraphs 0025 and 0026).
Claim(s) 24, 29- 30, 41, 46 and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US 10,850,078) in view of Manucherhabadi et al. (US 2021/0315639), as applied to claims 13 and 32 above, in further view of Chin et al. (CA 2402062).
Regarding claims 24 and 41, Grace and Manucherhabadi make obvious the method and the system as discussed above.
The combination is silent to wherein the balloon is constructed from a polymeric material with a double- wall thickness of 0.0023” or less.
Chin (Chin et al.) teaches a medical device (2)(Fig. 1)(abstract) for insertion into the vasculature and perform a procedure (abstract and Page 1, Lines 1- 12) comprising a balloon (6), wherein the balloon is constructed from a polymeric material (Page 8, Lines 25- 30) with a double- wall thickness of 0.0015” or less (Page 3, Lines 8- 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the balloon as taught by the combination to be constructed from a polymeric material with a double- wall thickness of 0.0015” or less as taught by Chin, since Chin teaches that this type of balloon “exhibit enhanced burst strength, burst pressure, and/or puncture resistance” (Page 4, Lines 9- 19).
Regarding wherein the double-wall thickness is 0.0023” or less, as the combination teaches that the thickness can be 0.0001” to 0.0015” (Page 3, Lines 8- 11), then the combination teaches that the double-wall thickness is 0.0023” or less, as 0.0015” is less than 0.00023”. Alternatively, 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 0.0023” or less, since it has been held that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a primae facie case of obviousness exists”. (MPEP 2144.05)(In re Wertheim, 541 F.2d 257, 191 USPQ90 (CCPA 1976); In re Woodruff¸919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Regarding claims 29 and 46, Grace, Manucherhabadi, and Chin make obvious the method and the 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 balloon as taught by the combination to be constructed from a polymeric material with a double- wall thickness of 0.0015” or less as taught by Chin, since Chin teaches that this type of balloon “exhibit enhanced burst strength, burst pressure, and/or puncture resistance” (Page 4, Lines 9- 19).
The combination further teaches wherein the polymeric material is a nylon (Page 8, Lines 25- 30).
Regarding claims 30 and 47, Grace, Manucherhabadi, and Chin make obvious the method and the 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 balloon as taught by the combination to be constructed from a polymeric material with a double- wall thickness of 0.0015” or less as taught by Chin, since Chin teaches that this type of balloon “exhibit enhanced burst strength, burst pressure, and/or puncture resistance” (Page 4, Lines 9- 19).
The combination further teaches wherein the polymeric material is a vestamid (Page 8, Lines 25- 30).
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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