DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 3 is objected to because of the following informalities: “wherein the electrodes are arc segments of conductive material that as spaced similarly from the conductive tubing are coaxial with the conductive tubing, and the distal ends of the electrodes and the distal end of the conductive tubing extend to a similar axial length so as to terminated adjacent to one another.” (emphasis added). It is understood that applicant intended to recite “wherein the electrodes are arc segments of conductive material that are spaced similarly from the conductive tubing are coaxial with the conductive tubing, and the distal ends of the electrodes and the distal end of the conductive tubing extend to a similar axial length so as to be terminated adjacent to one another.” (emphasis added). Appropriate correction is required.
Claim 9 is objected to because of the following informalities: line 5 recites “located beyond the distal end of the balloon” (emphasis added). Examiner suggests applicant to amend this limitation to read “located beyond a distal end of the balloon.”
Claims 10-13 is objected to because of the following informalities: line 1 recites “The IVL system of claim” (emphasis added). Examiner notes that claim 9 recites “A method of using an intravascular lithotripsy (IVL) system against a lesion within a vasculature.” The limitation of “The IVL system of claim” must be amended to read “The method of claim” (emphasis added). Appropriate correction is required.
Claim 16 is objected to because of the following informalities: “wherein the extension portion extends from the flex pad at an angle so that the traces are arrange at that angle relative to the positioning of the electrodes to facilitate spirally winding of the extension portion within and along the catheter.” (emphasis added). For examination purpose this limitation has been interpreted as “wherein the extension portion extends from the flex pad at an angle so that the traces are arrange at an angle relative to the positioning of the electrodes to facilitate spirally winding of the extension portion within and along the catheter.”
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 8 and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 depend on itself (“The IVL system of claim 4” (line 1)), therefore, the scope of the claim is unclear. For examination purpose, examiner’s position is claim 4 dependent on claim 1.
Claim 7 recite “wherein the electrode and insulating layer comprise a flex circuit that can be rolled into a cylinder and inserted within the conductive tubing.” (emphasis added). However, claim 8, which is dependent on claim 7, recites “wherein the conductive tubing is also created as a part of the flex circuit.” Examiner notes that the conductive tubing, the electrode and the insulating layer are part of the flexible circuit then the statement of “a flexible circuit that can be rolled into a cylinder and inserted within the conductive tubing” in claim 7 is no longer valid. Thus, the scope of claim 8 is unclear.
Claim 10 recites the limitation "the insulating layer" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. For examination purpose this limitation has been interpreted as “an insulating layer.”
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 5-6 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Nguyen et al. (US 2023/0165598, hereinafter “Nguyen”).
Referring to claim 1, Nguyen discloses an intravascular lithotripsy (IVL) system for use in providing an energy wave as a force to a lesion within a vasculature (para. [0009]), the IVL system comprising,
a catheter (FIG. 3, which is reproduced below, paras. [0011]-[0013] and [0081]) that extends from a proximal end to a distal end with an electrode 121 and conductive tube 122 arrangement at a distal end of the catheter, wherein the electrode is provided within the conductive tubing and spaced from the conductive tubing by an insulating layer 141, the electrode having a forward-facing electrode distal end, the conductive tubing also including a forward-facing conductive tubing distal end that is spaced radially relative to the distal end of the electrode to create at least one spark gap between the forward facing electrode distal end (paras. [0011]-[0013], “An exemplary embodiment provides a catheter for treating an occlusion in a body lumen. The catheter includes an elongated tube and a cylindrical inner conductive sheath mounted within the elongated tube. The inner conductive sheath has a distal side edge. A cylindrical outer conductive sheath is mounted circumferentially around the inner conductive sheath within the elongated tube. The outer conductive sheath has a distal side edge proximal to the distal side edge of the inner conductive sheath. An insulation sheath is mounted within the elongated tube between the outer conductive sheath and the inner conductive sheath. When a voltage pulse is applied across the inner conductive sheath and the outer conductive sheath, current flows across an arcing region between the inner conductive sheath and the outer conductive sheath to generate cavitation bubbles and/or shock waves, which can be used to treat an occlusion in a body lumen.” (para. [0012])).
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Referring to claim 5, Nguyen discloses the IVL system of claim 1, wherein the distal end of the conductive tubing 122 extends axially more distally than the distal end of the electrode 120 so that the entire distal end of the electrode is proximally positioned within the conductive tubing and spaced from the distal end of the conductive tubing (FIG. 5A shows distal side edge 121 of electrode 120 is proximal to the distal end of conductive tubing 122. Examiner notes that claim 5 does not require the entire distal end of the conductive tubing extends axially more distally than the distal end of the electrode 120).
Referring to claim 6, Nguyen discloses the IVL system of claim 5, wherein the insulating layer 140 extends to terminate adjacent to the distal end of the electrode 120 so that a spark can be generated between the distal end of the electrode and an inside side wall of the conductive tubing 122 (FIG. 5A shows distal side edge of insulating layer 140 is adjacent to the distal end of the electrode (the portion at lead line 125 as shown in FIG. 5A)).
Claim(s) 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adams et al. (US 2014/0005576, hereinafter “Adams”).
Referring to claim 9, Adams discloses a method of using an intravascular lithotripsy (IVL) system against a lesion within a vasculature (“FIG. 1 shows an angioplasty system 10 embodying the invention including a dilating angioplasty balloon catheter 20 including a plurality of shock wave sources according to one embodiment of the invention.” (paras. [0050] and [0080], FIG. 15 is reproduced below)) comprising: inserting an IVL catheter 920 (para. [0080]) having a balloon 926, a conductive tubing 946, and at least one electrode 940, 942, 944 within the vasculature of a patient to the point of a lesion within the vasculature being located beyond the distal end of the catheter (“The balloon 26 may be filled with water or saline in order to gently fix the balloon in the walls of the artery in the direct proximity with the calcified lesion. The fluid may also contain an x-ray contrast to permit fluoroscopic viewing of the catheter during use. As previously mentioned, the carrier 21 includes a lumen 29 through which a guidewire (not shown) may be inserted to guide the catheter into position.” ([0054])), wherein the electrode has a distal end and the conductive tube also has a distal end so that a spark gap is created between the distal ends of the electrode and the conductive tubing; electrically connecting the conductive tubing and the electrode with a high voltage pulse generator 930; delivering a fluid that is at least partially conductive to the balloon; and generating a high voltage pulse at the high voltage pulse generator and thereby creating a spark at the spark gap with a cavitation bubble (“The catheter 920 also includes electrodes 940, 942, and 944 carried on the carrier 921 in non-touching relation to the sidewalls of the balloon 926, and a counter electrode 946, also carried on the carrier 921. The electrodes 940, 942, and 944 are each connected to a multiplexer 934 of the high voltage source 930. When an electrode is activated, a high voltage from source 930 is applied across a selected one of the electrodes and the counter electrode to create an electrical arc. The electrical arc causes a plasma to be formed. The creation of the plasma causes a shock wave. Hence, each electrode 940, 942, and 944 forms a shock wave source. The shock waves are propagated through the liquid to impinge upon the balloon sidewall and the calcium deposit to break the calcium deposit up.” (para. [0080])).
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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.
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Nguyen (US 2022/0125453, hereinafter “Nguyen 5453”).
Referring to claim 2, Nguyen discloses the IVL system of claim 1 but fails to disclose wherein plural electrodes are provided within the conductive tubing, each spaced from the conductive tubing by the insulating layer and with the electrodes being electrically isolated from one another so as to create plural gaps with the conductive tubing that can be energized in series to create plural sparks.
Referring again to claim 2, however, in the same field of endeavor, which is a IVL system, Nguyen 5453 discloses (FIG. 1A, which is reproduced below) two electrodes 102a, 104a are diametrically disposed from each other and the electrodes are positioned within the conductive tube 106. Nguyen 5453 discloses current i traverses through the first electrode 102a to create a spark between gap of the distal end of electrode 102a and the conductive sheath 106 then the current i further traverses the gap between the conductive sheath 106 and the distal end of the second electrode 104a to create a second spark (paras. [0039]-[0041]). Apparently, the advantage of having two electrodes is to ensure that the device still work in the event that one of the electrodes is less effective because of the erosion in the electrode. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have modified the electrode 121 of Nguyen into two arc segments so that it too would have the same advantage.
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Referring to claim 3, Nguyen/Nguyen 5453 discloses the IVL system of claim 2, wherein the electrodes are arc segments of conductive material that as spaced similarly from the conductive tubing are coaxial with the conductive tubing, and the distal ends of the electrodes and the distal end of the conductive tubing extend to a similar axial length so as to terminated adjacent to one another (FIGS. 3A and 31A of Nguyen reference show the conductive tubing and electrode are extending to a similar axial length so as to be terminated adjacent to one another).
Referring to claim 4, Nguyen discloses the IVL system of claim [[4]]1, but fails to disclose wherein the insulating layer similarly extends to terminate adjacent to the distal ends of the electrodes and the conductive tubing, and a guide wire insulating layer is provided inside of the electrodes to define a guidewire lumen. However, in the same field of endeavor, which is an IVL system, Nguyen 5453 discloses a central tube 108 is provided between two electrodes 102a and 104a to provide a central lumen for receiving guidewire 110 (FIGS. 3A-3B, para. [0035]. FIG. 3A is reproduced above). In view of Nguyen 5453’s teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have provided a central tube to the IVL system of Nguyen to provide a central lumen for receiving a guidewire to allow the surgeon to guide the IVL system to the lesion deep inside the patient’s body.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Anderson et al. (US 2022/0287732, hereinafter “Anderson”).
Referring to claim 7, Nguyen discloses the IVL system of claim 1 but fails to disclose wherein the electrode and insulating layer comprise a flex circuit that can be rolled into a cylinder and inserted within the conductive tubing.
Referring again to claim 7, however, in the same field of endeavor, which is an IVL system, Anderson discloses “FIGS. 11A and 11B illustrate an example flex circuit 1100 for an electronic emitter assembly 400 (FIG. 4) of an IVL catheter 104 (FIG. 1). For instance, conductive electrodes (e.g., copper strips) 1102A-1102C may be printed onto a flexible, planar substrate 1106 ... The flexible substrate 1106 may then be rolled into the tubular shape shown in FIG. 11B… Such techniques may significantly reduce the manufacturing time of an IVL catheter 104 including such circuits 1100.” (para. [0303]). In view of Anderson’s teaching it would have been obvious to one of ordinary kill in the art, before the effective filing date of the application, to have made the inner electrode 120 and insulating layer 140 in a form of flexible substrate as suggested by Anderson so that it too would have the same advantage.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US 2023/0165598, hereinafter “Nguyen”).
Referring to claim 9, Nguyen discloses a method of using an intravascular lithotripsy (IVL) system against a lesion within a vasculature (paras. [0009]-[0013], FIG. 3 is reproduced above) comprising: inserting an IVL catheter, a conductive tubing 122, and at least one electrode 121 within the vasculature of a patient to the point of a lesion within the vasculature being located beyond the distal end of the catheter, wherein the electrode has a distal end and the conductive tube also has a distal end so that a spark gap is created between the distal ends of the electrode and the conductive tubing; electrically connecting the conductive tubing and the electrode with a high voltage pulse generator; and generating a high voltage pulse at the high voltage pulse generator and thereby creating a spark at the spark gap with a cavitation bubble (paras. [0011]-[0013], “An exemplary embodiment provides a catheter for treating an occlusion in a body lumen. The catheter includes an elongated tube and a cylindrical inner conductive sheath mounted within the elongated tube. The inner conductive sheath has a distal side edge. A cylindrical outer conductive sheath is mounted circumferentially around the inner conductive sheath within the elongated tube. The outer conductive sheath has a distal side edge proximal to the distal side edge of the inner conductive sheath. An insulation sheath is mounted within the elongated tube between the outer conductive sheath and the inner conductive sheath. When a voltage pulse is applied across the inner conductive sheath and the outer conductive sheath, current flows across an arcing region between the inner conductive sheath and the outer conductive sheath to generate cavitation bubbles and/or shock waves, which can be used to treat an occlusion in a body lumen.” (para. [0012])).
Referring to claim 9 again, Nguyen discloses the invention substantially as claimed except for disclosing the distal end of the conductive tube and the distal end electrode are positioned within a balloon. However, Nguyen discloses that angioplasty balloon with one or more electrode pair for generating shock waves inside the balloon is well known in the art (para. [0005]). Nguyen further disclose the combination of the balloon and electrode pair allow the shock waves to crack and disrupt lesion near the angioplasty balloon without harming the surrounding tissue (“Such shock wave devices can be particularly effective for treating calcified lesions because the acoustic pressure from the shock waves can crack and disrupt lesions near the angioplasty balloon without harming the surrounding tissue.” (para. [0050])) and the balloon is to expand the lesion after the lesion is weakening by the shock waves. In view of this disclosure it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have provided an angioplasty balloon over the distal end of the conducting tubing and the electrode to allow the surgeon to use the balloon to open the blockage after the shock wave crack and disrupt lesion.
Claim(s) 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Nguyen (US 2022/0125453, hereinafter “Nguyen 5453”).
Referring to claim 10, Nguyen/Nguyen 5453 discloses the IVL system of claim 9, wherein plural electrodes are provided within the conductive tubing, each spaced from the conductive tubing by the insulating layer and with the electrodes being electrically isolated from one another so as to create plural spark gaps with the conductive tubing, the method further comprising energizing the electrodes in series to create plural sparks at the plural spark gaps (please see rejection of claims 2-3 above)
Referring to claim 11, Nguyen/Nguyen 5453 discloses the IVL system of claim 10, wherein the distal end of the electrodes and the distal end of the conductive tubing extend axially a similar distance and terminate adjacent to one another with the insulating layer between them so that the spark can be generated from the distal end of the electrodes and the distal end of the conductive tubing (please see rejection of claim 3 above).
Referring to claim 12, Nguyen/Nguyen 5453 discloses the IVL system of claim 9, wherein the distal end of the conductive tubing 122 extends axially more distally than the distal end of the electrode so that the entire distal end of the electrode is proximally positioned within the conductive tubing and spaced from the distal end of the conductive tubing (FIG. 3A of Nguyen 5453 is reproduced above. The figure shows two electrodes 102, 104 are position proximal of the distal end of conducting tubing 106. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have located the distal end of the electrodes of Nguyen device according to Nguyen 5453 suggestion since both designs appears to perform equally well), the method further comprising generating a spark between a distal end of the electrode and an inside side wall of the conductive tubing and thus generating a cavitation bubble at least partially within the distal end of the conductive tubing so that energy waves can be directed from an open distal end of the conductive tubing in a desired forward direction.
Referring to claim 13, Nguyen/Nguyen 5453 discloses the IVL system of claim 12, wherein the distal end of the conductive tubing extends sufficiently axially beyond the distal end of the electrode so that the entire cavitation bubble is formed within the distal end of the conductive tubing (see rejection of claim 12 above).
Claim(s) 14, 15 and 17 and is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US 2023/0165598, hereinafter “Nguyen”) in view of Nguyen (US 2022/0125453, hereinafter “Nguyen 5453”) further in view of Anderson et al. (US 2022/0287732, hereinafter “Anderson”) and Caplan et al. (US 2015/0141987, hereinafter “Caplan”).
Referring to claim 14, Nguyen discloses an intravascular lithotripsy (IVL) system for use in providing an energy wave as a force to a lesion with a vasculature (para. [0009]), the IVL system comprising,
a catheter (FIG. 3, which is reproduced above, paras. [0011]-[0013] and [0081]) that extends from a proximal end to a distal end with an electrode 121 and conductive tube 122 arrangement at a distal end of the catheter provided adjacent to the distal end of the catheter, also including wire 130 extending from the proximal end of the catheter to the electrodes for electrically connecting the electrodes to a high voltage pulse generator (“The insulated wires 130, 132 provide an electrical connection between the conductive sheaths 120, 122 and an external voltage source, e.g., a high voltage pulse generator (not pictured).” (paras. [0086] and [0121]) at the proximal end of the wire.
Nguyen discloses the invention substantially as claimed except for disclosing (1) a plurality of electrodes and (2) a flexible circuit extending from the proximal end of the catheter to the electrodes and the flex circuit is spirally wound within and along at least a portion of the catheter.
As to (1), however, in the same field of endeavor, which is a IVL system, Nguyen 5453 discloses (FIG. 1A, which is reproduced above) two electrodes 102a, 104a are diametrically disposed from each other and the electrodes are position within the conductive tube 106. Nguyen 5453 discloses current i traverses through the first electrode 102a to create a spark between gap of the distal end of electrode 102a and the conductive sheath 106 then the current i further traverses the gap between the conductive sheath 106 and the distal end of the second electrode 104a to create a second spark (paras. [0039]-[0041]). Apparently, the advantage of having two electrodes is to ensure that the device still work in the event that one of the electrode is less effective because of the erosion in the electrode. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have modified the electrode 1201 of Nguyen into two arc segments so that it too would have the same advantage.
As to (2), however, in the same field of endeavor, which is an IVL system, Anderson discloses “FIGS. 11A and 11B illustrate an example flex circuit 1100 for an electronic emitter assembly 400 (FIG. 4) of an IVL catheter 104 (FIG. 1). For instance, conductive electrodes (e.g., copper strips) 1102A-1102C may be printed onto a flexible, planar substrate 1106 ... The flexible substrate 1106 may then be rolled into the tubular shape shown in FIG. 11B… Such techniques may significantly reduce the manufacturing time of an IVL catheter 104 including such circuits 1100.” (para. [0303]). Furthermore, Caplan disclose electrical wires and electrodes can be formed on a flexible substrate (FIG. 8A, which is reproduced below, para. [0194]). In view of Anderson and Caplan teachings it would have been obvious to one of ordinary kill in the art, before the effective filing date of the application, to have made the wires, the inner electrodes (in view of Nguyen 5453 the electrode 120 of Nguyen is now two arc segments) and insulating layer 140 in a form of flexible substrate as suggested by Anderson and Caplan so that it too would have the same advantage.
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Referring to claim 15, the modified IVL system of Nguyen discloses the IVL system of claim 14, wherein the electrodes are formed on a flex pad portion of the flex circuit at the distal end thereof, and an extension portion of the flex circuit extends from the flex pad proximally within the catheter, the extension portion of the flex circuit also having plural conductive traces running along the extension portion (see rejection of claim 14 above).
Referring to claim 17, the modified IVL system of Nguyen discloses the IVL system of claim 15, wherein plural traces are provided along one side surface of the extension portion of the flex circuit (see FIG. 8A of Caplan reference, which is reproduced above).
Allowable Subject Matter
Claim 8 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 16 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
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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.
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771
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