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
Applicant’s election without traverse of Group I in the reply filed on 07/10/2026 is acknowledged.
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/10/2026.
Claim Objections
Claims 1-19 are objected to because of the following informalities:
Claim 1, line 9, “an” before “external pulse generator” should read “the”.
Claim 1, line 11, “an” before “in a fluid” should be deleted.
Claim 1, line 15, “that” should read “than”.
Claim 16, line 13, “an” before “external pulse generator” should read “the”.
Claim 16, line 21, “that” should read “than”.
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 12, 15, 16, and 18-20 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by US 2023/0414234 (Anderson).
1. A lithotripsy device (system 100) for tunneling through vascular occlusions of calcified tissue in a liquid environment of a blood vessel (FIG. 1; P0001 and P0112), the device comprising:
a tunneling catheter (catheter 104) including
a tunneling catheter shaft (elongated catheter body 106) having a distal end (distal catheter portion 304) and a proximal end (proximal catheter portion 302)(FIG. 1 and 3; P0112);
a tunneling probe (outer elongated structure 316) disposed on the distal end of the tunneling catheter shaft (FIG. 3; P0112), the tunneling probe having a pair of electrodes (electrodes 402A, 402B)(FIG. 4; P0498);
each electrode being operatively connected to an electrical lead (conductive wire 406A, 406B) within the tunneling catheter shaft (FIG. 3-4; P0495);
wherein the leads are configured for operative connection to an external pulse generator (generator 102)(FIG.1; P0488);
wherein activation of an external pulse generator operatively connected to the leads causes repeated electrical discharges between the electrodes (P0490);
wherein, when the electrodes are in a fluid, the repeated electrical discharges produce repeated hydraulic shock waves in the fluid directed away from the electrical discharges (P0490);
wherein, when the repeated hydraulic shock waves strike calcified tissue, the calcified tissue is broken into a modified plaque (P0486); and
wherein the modified plaque has a lower resistance to mechanical dislocation than the original calcified tissue (P0021, P0033).
2. The tunneling probe is configured with a raised rim on the distal end; and wherein the electrodes are inset within the raised rim (FIG. 3, the outer elongated structure 316 expands to a wider diameter at the distal portion 304 of catheter 104, and it is within this raised rim of the outer elongated structure 316 that the electrodes reside).
3. The electrodes are configured in a concentric arrangement within the raised rim (Fig. 4, the electrodes 402A and 402B are configured in a concentric arrangement within the raised rim of the outer elongated structure 316).
4. The electrodes are configured in an opposing arcuate arrangement within the raised rim (Fig. 4B, the first electrode 402A is positioned opposite at least a portion of the second electrode 402B, where both electrodes 402A and 402B are arcuate in shape).
12. The lithotripsy device comprising a positioning balloon (balloon 110) operatively attached to the tunneling catheter shaft near the distal end (FIG. 1 and 3; P0489); and wherein the positioning balloon can be selectively inflated to position the catheter tunneling probe at a desired location within a cross section of the vessel (P0494).
15. The lithotripsy device comprising a pulse generator (generator 102) operatively connected to the electrical leads (FIG.1; P0488 and P0504);
16. A lithotripsy device (system 100) for tunneling through vascular occlusions of calcified tissue in a liquid environment of a blood vessel (FIG. 1; P0001 and P0112), the device comprising:
a tunneling catheter (catheter 104) including
a tunneling catheter shaft (elongated catheter body 106) having a distal end (distal catheter portion 304) and a proximal end (proximal catheter portion 302)(FIG. 1 and 3; P0112);
a tunneling probe (outer elongated structure 316) disposed on the distal end of the tunneling catheter shaft (FIG. 3; P0112), the tunneling probe having a pair of electrodes (electrodes 402A, 402B)(FIG. 4; P0498); each electrode being operatively connected to an electrical lead (conductive wire 406A, 406B) within the tunneling catheter shaft (FIG. 3-4; P0495);
a raised rim on the distal end; and wherein the electrodes are inset within the raised rim (FIG. 3, the outer elongated structure 316 expands to a wider diameter at the distal portion 304 of catheter 104, and it is within this raised rim of the outer elongated structure 316 that the electrodes reside); and
a flexible diaphragm (balloon 110) affixed across the raised rim (FIG. 1 and 3; P0489);
wherein the raised rim and the flexible diaphragm define a probe cavity containing the electrodes, the probe cavity being fluidly isolated from a fluid environment external to the probe cavity (FIG. 1 and 3; P0488 and P0495);
wherein the leads are configured for operative connection to an external pulse generator (generator 102)(FIG.1; P0488);
wherein activation of an external pulse generator operatively connected to the leads causes repeated electrical discharges between the electrodes (P0490);
wherein, when the probe cavity contains a working fluid, the repeated electrical discharges produce repeated primary shock waves in the working fluid that repeatedly vibrate the flexible diaphragm (P0490);
wherein the repeated vibration of the flexible diaphragm produces repeated secondary shock waves propagated into the fluid environment external to the probe cavity (P0490); and
wherein, when the repeated secondary shock waves strike calcified tissue in the fluid environment, the calcified tissue breaks into a modified plaque (P0486 and P0490); and
wherein the modified plaque has a lower resistance to mechanical dislocation that the original calcified tissue (P0021, P0033).
18. The flexible diaphragm is formed of a plastic, polymer, elastomer or other non-metallic material (P0497).
19. The lithotripsy device comprising a fluid lumen (port 310) formed within the tunneling catheter shaft and fluidly connecting the probe cavity to a source of fresh working fluid for circulating the fresh working fluid through the probe cavity during the repeated electrical discharges (FIG. 3; P0494-P0495).
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) 17 is rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0414234 (Anderson), as applied above, and further in view of US 2023/0277810 (Massimini).
Anderson discloses the invention substantially as claimed as discussed above but does not disclose the diaphragm being of a metal or metal alloy. Massimini teaches a catheter device having a diaphragm (balloon 122) in the same field of endeavor of a metal or metal alloy (P0161) for the purpose of fortifying the flexile diaphragm to enhance durability, improve resistance to war or deformation under stress, and ensure it can withstand high operating pressures. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the diaphragm of Anderson to be a metal or metal alloy as taught by Massimini in order to fortify the flexile diaphragm to enhance durability, improve resistance to war or deformation under stress, and ensure it can withstand high operating pressures.
Allowable Subject Matter
Claims 5-11 and 13-14 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 TODD J SCHERBEL whose telephone number is (571)270-7085. The examiner can normally be reached Mon - Fri 9:00-6:00.
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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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TJ SCHERBEL
Primary Examiner
Art Unit 3771
/TODD J SCHERBEL/Primary Examiner, Art Unit 3771
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