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 .
Terminal Disclaimer
The terminal disclaimer filed on 9/3/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Patent No 10,966,737, 11,602,363 and 11,950,793 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Amendment
This office action is in response to the amendments filed on 9/3/2026. Claim 1 is amended. Claims 1-16 are pending and addressed below.
Response to Arguments
Applicant’s arguments regarding claim 1, filed on 9/3/2026, have been fully considered but are not persuasive.
Regarding arguments on pages 5-6, the applicant states that “FIG. 4 of Hawkins depicts electrodes 22 and 24 positioned together within balloon 26 near a proximal portion of balloon 26, not "at a location ... that is proximate to a distal end" of the balloon, as required by amended claim 1. FIG. 5 of Hawkins likewise does not disclose the claimed arrangement”. The examiner disagrees with the applicant because the term “proximate” is defined as being “close to something” (dictionary.com) and since the distal ends electrodes 22, 24 are positioned within the flexible member or balloon, then they are proximate or close to a distal end of the flexible member. The electrodes are not required to be “at” the distal end of the flexible member but just “proximate” or close to the distal end of the flexible member. The term “proximate” is a relative term and one can interpret that the distal end of each of the electrodes are more proximate to the distal end of the flexible member compared to the proximal end of each of the electrodes that are connected to the HV Pulse generator 30 as shown in Figure 4. Therefore, the rejection is proper.
Regarding arguments on page 6, the applicant states that “FIG. 5 illustrates a different embodiment having electrodes 42 and 44 that Hawkins expressly describes as being "displaced along the length of the balloon 46. Consistent with this description, FIG. 5 depicts electrode 42 at a relatively proximal location within balloon 46 and electrode 44 at a more distal location. Thus, even if electrode 44 were considered to be positioned proximate to the distal end of balloon 46, electrode 42 is not. Hawkins therefore does not disclose "a pair of electrodes, each electrode of which is positioned within the enclosure at a location proximate to the distal end of the flexible member," as required by amended claim 1”. The examiner disagrees with the applicant because the term “proximate” is defined as being “close to something” (dictionary.com) and since the distal ends electrodes 42, 44 are positioned within the flexible member or balloon, then they are proximate or close to a distal end of the flexible member. The electrodes are not required to be “at” the distal end of the flexible member but just “proximate” or close to the distal end of the flexible member. The term “proximate” is a relative term and one can interpret that the distal end of the electrode 44 is more proximate to the distal end of the flexible member compared to the distal end of the electrode 42 but both the electrodes 42, 44 are still proximate to the distal end of the flexible member with a different degree of nearness. Therefore, the rejection is proper.
Applicant’s arguments are only directed to the amended claims, therefore the arguments are addressed in the body of the rejection below.
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 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.
Claims 1 and 12-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hawkins (US Pub No. 2010/0114065).
Regarding claim 1, Hawkins discloses (Figures 2-4) a catheter (20) for treating occlusions in blood vessels (Paragraphs 0037-0038), comprising: a tubular member (see annotated figure below); a flexible member (26) positioned at a distal end of the catheter (Figure 4), the flexible member forming an enclosure that is fillable with conductive fluid (Paragraphs 0037-0038); and a shock wave emitter assembly (22, 24) supported by the tubular member (Figures 2 and 4), the shock wave emitter assembly comprising a pair of electrodes (Figure 4), each electrode of which is positioned within the enclosure at a location within the enclosure that is proximate to a distal end of the flexible member (Figures 2 and 4) [The term “proximate” is defined as being “close to something” (dictionary.com) and since the distal ends electrodes 22, 24 are positioned within the flexible member or balloon, then they are proximate or close to a distal end of the flexible member. The term “proximate” is a relative term and one can interpret that the distal end of each of the electrodes are more proximate to the distal end of the flexible member compared to the proximal ends of the electrodes that are connected to the HV Pulse generator 30 as shown in Figure 4], wherein when the flexible member is filled with the conductive fluid and an electrical pulse is applied across the pair of electrodes, shock waves are generated at the location within the enclosure that is proximate to the distal end of the flexible member and propagate in a distal direction out of the distal end of the catheter (clearly shown in Figure 4) (Paragraphs 0037-0038).
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Regarding claim 1 under an alternative rejection, Hawkins discloses (Figure 5) a catheter (40) for treating occlusions in blood vessels (Paragraphs 0037-0038), comprising: a tubular member (similar to the annotated figure above); a flexible member (46) positioned at a distal end of the catheter (Figure 5), the flexible member forming an enclosure that is fillable with conductive fluid (Paragraphs 0037-0038); and a shock wave emitter assembly (42, 44) supported by the tubular member (Figure 5), the shock wave emitter assembly comprising a pair of electrodes (Figure 5), each electrode of which is positioned within the enclosure proximate to a distal end of the flexible member (Figure 5) [The term “proximate” is defined as being “close to something” (dictionary.com) and since the distal ends electrodes 42, 44 are positioned within the flexible member or balloon, then they are proximate or close to a distal end of the flexible member. The term “proximate” is a relative term and one can interpret that the distal end of electrode 44 is more proximate to the distal end of the flexible member compared to the distal end of the electrode 42 but both the electrodes 42, 44 are still proximate to the distal end of the flexible member with a different degree of nearness], wherein when the flexible member is filled with the conductive fluid and an electrical pulse is applied across the pair of electrodes, shock waves are generated at the location within the enclosure that is proximate to the distal end of the flexible member and propagate in a distal direction out of the distal end of the catheter (will be similar to what is shown in Figure 4) (Paragraphs 0037-0038 and 0041).
Regarding claim 12 under any of the rejections for claim 1 above, wherein the conductive fluid comprises saline (Paragraph 0038).
Regarding claim 13 under the second rejection for claim 1, wherein the shock wave emitter assembly is a primary shock wave emitter assembly (44) and the catheter comprises at least one secondary shock wave emitter assembly (42) located within the enclosure proximally of the primary shock wave emitter assembly (clearly shown in Figure 5), wherein the at least one secondary shock wave emitter assembly is configured to generate shock waves that propagate radially outwardly (will be similar to what is shown in Figure 4) (Paragraphs 0037-0038 and 0041).
Regarding claim 14 under the second rejection for claim 1, wherein the at least one secondary shock wave emitter assembly is configured to generate shock waves independently of the primary shock wave emitter assembly (Paragraphs 0037-0038 and 0041).
Regarding claim 15 under the second rejection for claim 1, wherein the at least one secondary shock wave emitter assembly comprises at least one conductive sheath (tip of 42).
Regarding claim 16 under any of the rejections for claim 1 above, wherein the tubular member includes a guide wire lumen (tubular member includes a lumen as shown in Figures 2, 4 and 5 to where a guidewire is fully capable in being inserted).
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 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 of this title, 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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hawkins (US Pub No. 2010/0114065) as applied to claim 1 above, and further in view of Loeb (US Pub No. 2003/0060813).
Regarding claim 10, Hawkins discloses all of the elements of claim 1 above except for a fluid pump connected to a proximal end of the device configured to provide conductive fluid to fill the flexible member; and a fluid return line having an inlet proximate to the distal end of the catheter and configured to remove the conductive fluid from the flexible member, wherein the fluid pump and fluid return line are configured to circulate the conductive fluid under pressure inside the flexible member.
Loeb, in the analogous art of balloon catheters, teaches (Figures 1-2) a balloon catheter system (10) that includes a fluid pump (22) connected to a proximal end of the device configured to provide conductive fluid (saline, Paragraphs 0047 and 0064) to the volume inside the balloon (16) (clearly shown in Figure 2) (Paragraphs 0046 0055); and a fluid return line (28) having an inlet (26, 27) proximate to the distal end of the device (Figure 1) and configured to remove the conductive fluid from the volume of the balloon (Figures 1-2) (Paragraph 0063), wherein the fluid pump and fluid return line are configured to circulate the conductive fluid under pressure within the volume of the balloon (clearly shown in Figures 1-2) (Paragraphs 0011, 0055 and 0061-0063). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hawkins to have included a fluid pump connected to a proximal end of the device configured to provide the conductive fluid to fill the flexible member; and a fluid return line having an inlet proximate to the distal end of the catheter and configured to remove the conductive fluid from the flexible member as taught by Loeb, in order to provide a cooling system to prevent damage to the interior components of the device and also to the patient’s tissue (Loeb, Paragraphs 0011 and 0053). [Hawkins modified by Loeb as a whole would result in a fluid pump to be connected to a proximal end of the device configured to provide conductive fluid to fill the flexible member; and a fluid return line having an inlet proximate to the distal end of the catheter and configured to remove the conductive fluid from the flexible member, wherein the fluid pump and fluid return line are configured to circulate the conductive fluid under pressure inside the flexible member]
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hawkins (US Pub No. 2010/0114065) and Loeb (US Pub No. 2003/0060813) as applied to claim 10 above, and further in view of Kurth (US Pub No. 2010/0274189).
Regarding claim 11, Hawkins modified by Loeb discloses all of the elements of claim 10 above except for a pressure relief valve at an outlet of the fluid return line.
Kurth, in the analogous art of balloon catheters, teaches (Figure 1) a balloon catheter (10) that includes pressure relief valve (20) at an outlet (22) of a hub (18) (Paragraphs 0035 and 0054). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hawkins modified by Loeb to have included a pressure relief valve at an outlet of the fluid return line as taught by Kurth, in order to regulate the pressure inside the balloon and thereby rendering rupture impossible and making the use of the catheter fail-safe (Kurth, Paragraphs 0035 and 0054).
Allowable Subject Matter
Claims 2-9 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 and also, if they overcome the double patenting rejection set forth in this Office Action.
The following is an examiner’s statement of reasons for indicating allowable subject matter in the dependent claims:
The prior art of record fails to disclose or render obvious the combination of features as claimed. In particular, the prior art of record fails to disclose wherein the shock wave emitter assembly comprises: first and second wires extending along at least a portion of the tubular member; and a conductive sheath extending around the first and second wires such that a first spark gap is formed between the conductive sheath and a distal face of the first wire and a second spark gap is formed between the conductive sheath and a distal face of the second wire, wherein the shock waves are generated at the first and second spark gaps (claim 2).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAJID JAMIALAHMADI whose telephone number is (571) 270-0172. The examiner can normally be reached on Monday-Friday 7am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAJID JAMIALAHMADI/Primary Examiner, Art Unit 3771
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