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 with traverse of Group I, Species 1 in the reply filed on 07/28/2026 is acknowledged. The traversal is on the ground(s) that examining the species together would not impose a serious search and/or examination burden. This is not found persuasive because the species requires different fields of search, such as employing different search strategies or search queries. Applicant argues that there is no separate classification of the identified species, and that the Examiner identifies no ”different classes, resources, strategies, or queries” and does not explain why a search pertinent to one species would be unlikely to identify art pertinent to another. However, as noted in the restriction requirement of 05/28/2026, the species are distinct because the claims to the different species recite mutually exclusive characteristic of such species, which would therefore require different search strategies and queries. These characteristics include the different number of emitter bands and the number of electrodes spaced apart from each other across the embodiments.
The requirement is still deemed proper and is therefore made FINAL.
Claims 3, 6-7, 11-14, 18-26, 31-34, and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species/method, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/28/2026.
Claim Objections
Claims 2, 8 and 27 are objected to because of the following informalities:
Claim 2 line 1 “a first shock wave emitter” is suggested to read “a first shock wave emitter of the at least three shock wave emitters” for better claim language consistency.
Claim 2 lines 2-3 “a third shock wave emitter” is suggested to read “a third shock wave emitter of the at least three shock wave emitters” for better claim language consistency.
Claim 8 line 1 “a first electrode” is suggested to read “a first electrode of the at least three electrodes” for better claim language consistency.
Claim 8 lines 2-3 “a second electrode” is suggested to read “a second electrode of the at least three electrodes” for better claim language consistency.
Claim 27 line 4 “the pulse generator” is suggested to read “the shock wave energy generator” for better antecedent basis.
Claim 27 line 5 “the shock wave emitters” is suggested to read “the at least three shock wave emitters” for better claim language consistency.
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.
Claims 1, 8-10, 16, and 27-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen (US PGPub 2023/0107690).
With regards to claim 1, Nguyen discloses (Figures 1-3) a catheter 100 for generating shock waves (paragraph 43) comprising:
a catheter body 154;
an enclosure 120 mounted to the catheter body 154 (paragraph 143);
an emitter band 162 positioned at least partially around the catheter body 154 and within the enclosure 120 (figure 2; paragraph 143); and
at least three electrodes positioned adjacent to the emitter band 162 and spaced apart from the emitter band 162 by respective spark gaps, the at least three electrodes together with the emitter band 162 forming electrode pairs of at least three shock wave emitters of the emitter band 162, wherein at least one of the at least three shock wave emitters can be driven separately from at least one other of the at least three shock wave emitters (paragraphs 77-81 disclose a first insulted wire 164 and a second insulated wire 166, the shock wave source 160 includes two electrode pairs, the electrodes of each respective pair being formed from the conductive portions of the insulated wires 164, 166 and the conductive emitter band 162 mounted within the catheter body 120; paragraph 82 discloses “a catheter 100 could have more than two wires, and could be configured to generate shock waves at more than two pairs of electrodes. In a particular example, the catheter may include a second pair of insulated wires (not shown) offset from the first and second insulated wires 164, 166 by 90 degrees. For example, if the first and second insulated wires 164, 166 are positioned at 0 and 180 degrees, a third and fourth insulated wire may be positioned at 90 and 270 degrees. The third and fourth insulated wires also end near the distal end of the catheter body and include conductive exposed distal tips that function as electrodes. A conductive emitter band (e.g., the conductive emitter band 162 or a further emitter band) circumscribes the exposed distal tips of the third and fourth insulated wires, and a separate high voltage pulse may be applied across the third and fourth insulated wires to generate a second pair of shock waves between the insulated wires and the emitter band. As a result, a second set of shock waves may be initiated from a third and fourth electrode pair of the catheter formed from a conductive emitter band and conductive portions of third and fourth insulated wires. The first pair of insulated wires (i.e., the first insulated wire 164 and the second insulated wire 166) and the second pair of insulated wires (i.e., the third insulated wire and the fourth insulated wire) may be activated alternately, which may improve the effectiveness of the device by further spreading the shock waves around the circumference of the catheter” therefore meeting the claim requirement of at least three electrodes, wherein at least one of the at least three shock wave emitters can be driven separately from at least one other of the at least three shock wave emitters by being activated alternately).
With regards to claim 8, Nguyen discloses wherein a first electrode (uninsulated portion of 164) is connected to a first channel of a switching circuit by a first supply wire 164 extending along the catheter body 154, and a second electrode (uninsulated portion of 166) is connected to a second channel of a switching circuit by a second supply wire 166 extending along the catheter body 154 (paragraph 41 – “one or more insulated wires extend along the length of the catheter body 12 to provide a connection between the high voltage source 28 and the one or more electrode pairs of the shock wave source(s) 16. In some examples, at least a portion of the catheter body 12 includes internal conduits connecting elements of the distal end 14 with the proximal end handle 22 of the catheter. For instance, one or more wire lumens may be provided for carrying the insulated wires that electrically connect the pulsed high voltage source 28 with electrodes of the distal shock wave source 16”; paragraph 80 discloses the catheter 100 includes a voltage source (e.g., the generator 28 depicted in Fig. 1); and paragraph 82 discloses the alternate activation (switching circuit) of the insulated wires).
With regards to claim 9, Nguyen discloses wherein at least two of the at least three shock wave emitters are spaced apart from one another in a circumferential direction about the emitter band 162 by any of 90 degrees (paragraph 82).
With regards to claim 10, Nguyen discloses wherein at least two of the at least three shock wave emitters are spaced apart from one another in a circumferential direction about the emitter band 162 by a range of 60 degrees to less than 180 degrees (paragraph 82 – 90 degrees).
With regards to claim 16, Nguyen discloses wherein the at least three electrodes respectively comprise a conductive portion of at least three insulated wires (paragraphs 39 and 73).
With regards to claim 27, Nguyen discloses (Figures 1-3) a system for generating shock waves (Abstract; paragraph 43) comprising:
the catheter 100 of claim 1 (see rejection to claim 1 above); and
a shock wave energy generator 28 for generating energy pulses for driving the at least three shock wave emitters, the pulse generator 28 comprising a switching circuit for driving at least one of the shock wave emitters independently of at least one other shock wave emitter of the at least three shock wave emitters (paragraph 82 – “The first pair of insulated wires (i.e., the first insulated wire 164 and the second insulated wire 166) and the second pair of insulated wires (i.e., the third insulated wire and the fourth insulated wire) may be activated alternately, which may improve the effectiveness of the device by further spreading the shock waves around the circumference of the catheter”).
With regards to claim 28, Nguyen discloses wherein the at least one shock wave emitter and the at least one other shock wave emitter are respectively connected to a first channel and a second channel of the switching circuit by a first supply wire 164 and a second supply wire (paragraph 41 – “one or more insulated wires extend along the length of the catheter body 12 to provide a connection between the high voltage source 28 and the one or more electrode pairs of the shock wave source(s) 16. In some examples, at least a portion of the catheter body 12 includes internal conduits connecting elements of the distal end 14 with the proximal end handle 22 of the catheter. For instance, one or more wire lumens may be provided for carrying the insulated wires that electrically connect the pulsed high voltage source 28 with electrodes of the distal shock wave source 16”; paragraph 80 discloses the catheter 100 includes a voltage source (e.g., the generator 28 depicted in Fig. 1); and paragraph 82 discloses the alternate activation (switching circuit) of the insulated wires).
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.
Claims 1-2, 4-5, 15, 27, 29-30, and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Adams et al. (US PGPub 2014/0005576), hereinafter known as “Adams.”
With regards to claim 1, Adams discloses (Figures 1 and 3-4) a catheter 20 for generating shock waves (Abstract) comprising:
a catheter body 21 (paragraph 50);
an enclosure 26 mounted to the catheter body 21 (paragraph 50);
an emitter band 242 positioned at least partially around the catheter body 21 and within the enclosure 26 (paragraph 59; figure 3); and
at least three electrodes plurality of 248/250 positioned adjacent to the emitter band 242 and spaced apart from the emitter band 242 by respective spark gaps, the at least three electrodes 248/250 together with the emitter band 242 forming electrode pairs of at least three shock wave emitters of the emitter band 242.
Adams is silent to the figures 3-4 embodiment wherein at least one of the at least three shock wave emitters can be driven separately from at least one other of the at least three shock wave emitters.
However, in the figure 14 embodiment of Adams, Adams teaches wherein at least one of the at least three shock wave emitters 802 can be driven separately from at least one other 804 of the at least three shock wave emitters 802/804/806 (paragraph 79 – “The multiplexer is arranged to connect a high voltage source 730 across each series circuit 802, 804, and 806 individually, one at a time, or in any combination”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the figures 3-4 embodiment of Adams to include a multiplexer wherein at least one of the at least three shock wave emitters can be driven separately from at least one other of the at least three shock wave emitters as taught by the figure 14 embodiment of Adams for the purpose of selectively activating the shock wave emitter for a targeted application during use.
With regards to claim 2, Adams discloses wherein a first shock wave emitter 248/250/242 is electrically connected in series to a second shock wave emitter 248/250/242 of the at least three shock wave emitters, a third shock wave emitter 248/250/242 is electrically connected in series to the second shock wave emitter 248/250/242, and the first shock wave emitter 248/250/242 and the third shock wave emitter 248/250/242 are not electrically connected in series (paragraph 79 - “The multiplexer is arranged to connect a high voltage source 730 across each series circuit 802, 804, and 806 individually, one at a time, or in any combination” therefore since any combination of the series circuit can be electrically activated, a combination of a first shock wave emitter is electrically connected in series to a second shock wave emitter, a third shock wave emitter is electrically connected in series to the second shock wave emitter, and the first shock wave emitter and the third shock wave emitter are not electrically connected in series).
With regards to claim 4, Adams discloses wherein the emitter band 242 comprises at least three apertures 246 corresponding to the at least three electrodes 248 (paragraph 59; figures 3-4).
With regards to claim 5, Adams discloses the catheter as claimed in claim 4. Adams further discloses in paragraph 55 “The voltage needed to produce the arcs will depend on the gap between the electrodes.” Adams does not explicitly disclose wherein the at least three apertures are respectively spaced apart 120-degrees from one another in a circumferential direction about the emitter band.
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 catheter of Adams to have wherein the at least three apertures are respectively spaced apart 120-degrees from one another in a circumferential direction about the emitter band since 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 dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the catheter of Adams would not operate differently with the claimed angled distance and since the voltage needed to produce the arcs depends on the gap between electrodes, the catheter would function appropriately having the claimed angled distance. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the angle is “optional” in the claimed ranges (specification pp. [0012]).
With regards to claim 15, Adams discloses wherein the enclosure 26 is a balloon configured to be filled or inflated with a conductive fluid (paragraphs 54 and 59).
With regards to claim 27, Adams discloses a system (Figures 1, 3-4, and 14) for generating shock waves (Abstract; paragraph 59) comprising:
the catheter of claim 1 (see rejection above); and
a shock wave energy generator 30 for generating energy pulses for driving the at least three shock wave emitters plurality of 248/250, the pulse generator 30 comprising a switching circuit 734 for driving at least one of the shock wave emitters 248/250/242 independently of at least one other shock wave emitter 248/250/242 of the at least three shock wave emitters (paragraph 79 – “The multiplexer is arranged to connect a high voltage source 730 across each series circuit 802, 804, and 806 individually, one at a time, or in any combination”).
With regards to claim 29, Adams discloses wherein at least one 248/250/242 of the at least three shock wave emitters is connected to a ground terminal (see the negative “-“ sign on the shock wave energy generator 30 in figure 1) of the switching circuit 734 (paragraph 59 – electrode 250 is a counter/common electrode; paragraph 14 - “The electrical arc shock wave generator may further include at least one counter electrode adapted to be in contact with the liquid and to receive a voltage polarity opposite a voltage polarity applied to the plurality of electrode”).
With regards to claim 30, Adams discloses wherein the shock wave energy generator 30 is configured to deliver high voltage pulses to at least one of the at least three shock wave emitters 248/250/242 (paragraphs 52-53).
With regards to claim 35, Adams discloses (Figures 1 and 3-4) a catheter 20 comprising:
a catheter body 21, an enclosure 26 mounted to the catheter body 21 (paragraph 50);
an emitter band 242 positioned at least partially around the catheter body 21 and within the enclosure 26 (figure 3; paragraph 59);
a first shock wave emitter 248/250/242 connected to a first channel of a power supply 30, the first shock wave emitter 248/250/242 comprising at least one electrode pair 248/250, the at least one electrode pair 248/250 comprising the emitter band 242 (paragraph 59; figure 3); and
a second shock wave emitter 248/250/242 connected to a second channel of the power supply 30, the second shock wave emitter 248/250/242 comprising at least one electrode pair 248/250 that comprises the emitter band 242 (paragraph 59; figure 3).
Adams is silent wherein the second shock wave emitter can be driven independently of the first shock wave emitter.
However, in the figure 14 embodiment of Adams, Adams teaches wherein the second shock wave emitter 804 can be driven independently of the first shock wave emitter 802 (paragraph 79 – “The multiplexer is arranged to connect a high voltage source 730 across each series circuit 802, 804, and 806 individually, one at a time, or in any combination”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the figures 1 and 3-4 embodiment of Adams to include a multiplexer wherein the second shock wave emitter can be driven independently of the first shock wave emitter as taught by the figure 14 embodiment of Adams for the purpose of selectively activating the shock wave emitter for a targeted application during use.
With regards to claim 36, Adams discloses comprising a third shock wave emitter 248/250/242 connected to a ground terminal (see the negative “-“ sign on the shock wave energy generator 30 in figure 1), the third shock wave emitter 248/250/242 comprising at least one electrode pair 248/250, the at least one electrode pair 248/250 comprising the emitter band 242 (paragraph 59; figure 3).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen.
With regards to claim 17, Nguyen discloses the catheter as claimed in claim 1. Nguyen further discloses the emitter band 162 near at the distal end 124 of the catheter 100, and paragraph 46 discloses “the distal end 124 of the catheter body 120 (e.g., at least the most distal 10 mm-20 mm portion of the catheter body) is formed from a flexible material.” Nguyen does not explicitly disclose wherein the emitter band is at least 3 millimeters long.
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 catheter of Nguyen to have wherein the emitter band is at least 3 millimeters long since 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 dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the catheter of Nguyen would not operate differently with the claimed length and since the emitter band is intended to reside within the distal end of the catheter being at least 10 mm – 20 mm long, the catheter would function appropriately having the claimed length. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the length is “optional” within the claimed ranges (specification pp. [0014]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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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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/MOHAMMED S ADAM/Examiner, Art Unit 3771 08/06/2026
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