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
Claims 5-6, 10, 14, 19 and 24-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/28/2026.
Applicant’s election without traverse of Invention I, Group I - Species B, and Group II - Species L in the reply filed on 5/28/2026 is acknowledged.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “the electrode assembly” in line 4 which should read “the shock wave electrode assembly”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Claim 1 recites “the at least one emitter band” in line 5 which should read “the at least one discontinuous emitter band”. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: Claim 2 recites “the at least one emitter band” in line 2 which should read “the at least one discontinuous emitter band”. Appropriate correction is required.
Claim 27 is objected to because of the following informalities: Claim 27 recites “the electrode assembly” in line 4 which should read “the shock wave electrode assembly”. Appropriate correction is required.
Claim 28 is objected to because of the following informalities: Claim 28 recites “the electrode assembly” in line 4 which should read “the shock wave electrode assembly”. 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)(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, 7-9, 11-12, 15-18, 20-23 and 27-28 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Batchelder et al. (US 12,622,718 B2).
Regarding claim 1, Batchelder discloses a catheter (Figs. 15A, 15B, 17) for treating an occlusion in a body lumen (for breaking up calcified lesions in an anatomical conduit; abstract), the catheter comprising: an elongated tube (elongate catheter or member 302 and sleeve 300; Fig. 17); a shock wave electrode assembly (pressure wave generator 600; Figs. 15A, 15B, 17) at least partially embedded within the elongated tube (as 600 is positioned between 302 and 300; Fig. 17), the electrode assembly (600) comprising: at least one discontinuous emitter band (600 is discontinuous due to channels 406; Figs. 15A, 15B), the at least one emitter band (600) forming a first electrode (either electrode 411 or 412; Fig. 15A) of an electrode pair (as 411 or 412 pair with electrode 410; column 17, lines 25-39), and at least one wire (wire conductor W), a distal end of the at least one wire (W) forming a second electrode (electrode 410) of the electrode pair (Fig. 15A), wherein the shock wave electrode assembly (600) is configured to emit a shock wave when a voltage pulse is applied across the electrode pair (generated via arcs 414, 415; Fig. 15A); and an enclosure (balloon 304) surrounding the shock wave electrode assembly (see for example, Fig. 9 in which pressure wave generators 600 are an alternative to pressure wave generators 352, 353; column 17, lines 24-25).
Regarding claim 2, Batchelder discloses wherein discontinuity of the at least one discontinuous emitter band (600) enables the at least one emitter band to have circumferential flexibility (channels 406 inherently add at least some circumferential flexibility to an otherwise solid annular band; Fig. 15A).
Regarding claim 3, Batchelder discloses wherein the at least one discontinuous emitter band (600) comprises a first end (distal end of 600) and a second end (proximal end of 600) separated by a gap (cutout 404 where arcs 414, 415 are shown in Fig. 15A), and wherein a connecting region (region below 412 of Fig. 15A) between the first end and the second end at least partially encircles an inner layer (302) of the elongated tube (Fig. 17).
Regarding claim 4, Batchelder discloses wherein the at least one discontinuous emitter band (600) encircles at least 180 degrees of the inner layer (Figs. 15B, 17).
Regarding claim 7, Batchelder discloses wherein the at least one discontinuous emitter band (600) comprises a first enlarged region, a second enlarged region, and at least one connecting region extending therebetween (see annotated Fig. 15A below).
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Regarding claim 8, Batchelder discloses wherein a width of at least one of the first enlarged region and the second enlarged region is greater than a width of the at least one connecting region (see annotated Fig. 15A above).
Regarding claim 9, Batchelder discloses wherein the at least one discontinuous emitter band (600) comprises an aperture (channel 406 and cutout 404) extending through the first enlarged region (Fig. 15A).
Regarding claim 11, Batchelder discloses wherein an edge (edge of 411 or 412) of the aperture (406, 404) forms the first electrode (411 or 412) of the electrode pair (Fig. 15A).
Regarding claim 12, Batchelder discloses wherein the distal end of the at least one wire (W) is positioned proximate to the edge of the aperture (Fig. 15A).
Regarding claim 15, Batchelder discloses wherein the elongated tube (302, 300) comprises an inner layer (302) and an outer layer (300 and/or insulative layer F; Figs. 16-17, 21), the outer layer at least partially surrounding the at least one discontinuous emitter band (600; Figs. 16-17, 21; column 20, lines 1-3, 14-15).
Regarding claim 16, Batchelder discloses wherein a hole (hole in insulative layer F) in the outer layer provides a spark gap between the first electrode (411 or 412) and the second electrode (410) of the electrode pair (Figs. 15A-15B, 16-17, 21).
Regarding claim 17, Batchelder discloses wherein the outer layer (300 and/or insulative layer F) overlays at least a portion of an outer surface of the at least one discontinuous emitter band (Figs. 16-17, 21).
Regarding claim 18, Batchelder discloses wherein the outer layer (300) encapsulates at least a portion of the at least one wire (W; Fig. 17).
Regarding claim 20, Batchelder discloses wherein the inner layer (302) is formed of a first polymer (as 302 consists of I, J and K i.e., polyimide, which can resist high temperatures; column 20, lines 18-28), the outer layer (300) is formed of a second polymer (silicone; column 11, lines 36-44), and the first polymer (polyimide) has a higher melting temperature than the second polymer (silicone; as polyimide has a melting point of 365 degrees C and silicone begins to melt a 300 degrees C as evidenced by the attached NPL).
Regarding claim 21, Batchelder discloses wherein the at least one discontinuous emitter band (600) forms electrodes of a plurality of electrode pairs (as 411 and 410 are a pair, and 412 and 410 are a pair which form arcs 414, 415, 414’, 415’; Fig. 15A).
Regarding claim 22, Batchelder discloses wherein the elongated tube comprises a central lumen for accommodating a guide wire (as 302 is hollow; Fig. 18).
Regarding claim 23, Batchelder discloses a system for treating an occlusion in a body lumen, the system comprising: the catheter of claim 1 (see claim 1 above); and a voltage pulse generator (voltage pulse generator; Fig. 15A) electrically connected to the shock wave electrode assembly (600) and configured for applying voltage pulses to the electrode pair to generate shock waves (Fig. 15A).
Regarding claim 27, Batchelder discloses a catheter (Figs. 15A, 15B, 17) for treating an occlusion in a body lumen (for breaking up calcified lesions in an anatomical conduit; abstract), the catheter comprising: an elongated tube (elongate catheter or member 302 and sleeve 300; Fig. 17) comprising an inner layer (member 302) and an outer layer (sleeve 300); a shock wave electrode assembly (pressure wave generator 600) at least partially embedded within the elongated tube (as 600 is positioned between 302 and 300; Fig. 17), the electrode assembly comprising: at least one emitter band (600) comprising an enlarged region (at least one enlarged region of 402 surrounding channels 406 and cutout 404; Fig. 15A) and an aperture (cutout 404, channels 406) extending through the enlarged region (Fig. 15A), an edge (edge of 411 or 412) of the aperture of the at least one emitter band (600) forming a first electrode (electrode 411 or 412) of an electrode pair (as 411 or 412 pair with electrode 410; column 17, lines 25-39), and at least one wire (wire conductor W), a distal end of the at least one wire (W) forming a second electrode (electrode 410) of the electrode pair such that the electrode pair emits a shock wave (via arcs 414 or 415) when a voltage pulse is applied across the electrode pair (via voltage generator; Fig. 15A), wherein the at least one emitter band (600) encircles the inner layer (302) and the outer layer (300) at least partially surrounds the at least one emitter band (600; Fig. 17); and an enclosure (balloon 304) surrounding the shock wave electrode assembly (see for example, Fig. 9 in which pressure wave generators 600 are an alternative to pressure wave generators 352, 353; column 17, lines 24-25).
Regarding claim 28, Batchelder discloses a catheter (Figs. 15A, 15B, 17) for treating an occlusion in a body lumen (for breaking up calcified lesions in an anatomical conduit; abstract), the catheter comprising: an elongated tube (elongate catheter or member 302 and sleeve 300; Fig. 17) comprising an inner layer (member 302) and an outer layer (sleeve 300); a shock wave electrode assembly (pressure wave generator 600) at least partially embedded within the elongated tube (as 600 is positioned between 302 and 300; Fig. 17), the electrode assembly comprising: an emitter band (600) that forms a first electrode (electrode 411 or 412) of an electrode pair (as 411 or 412 pair with electrode 410; column 17, lines 25-39), and a wire (conductor wire W) including a distal end that forms a second electrode (electrode 410) of the electrode pair (Fig. 15A), wherein the emitter band (600) at least partially encircles the inner layer (302) and the outer layer (300) at least partially surrounds the emitter band (600; Fig. 17), wherein the shock wave electrode assembly (600) is configured to emit a shock wave (arcs 411, 414) when a voltage pulse is applied across the electrode pair (via voltage pulse generator; Fig. 15A); and an enclosure (balloon 304) surrounding the shock wave electrode assembly (see for example, Fig. 9 in which pressure wave generators 600 are an alternative to pressure wave generators 352, 353; column 17, lines 24-25).
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) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Batchelder et al. (US 12,622,718 B2) in view of Nunes et al. (US 12,035,932 B1).
Regarding claim 13, Batchelder fails to disclose wherein the at least one discontinuous emitter band forms a spiral coil shape.
However, Nunes teaches a catheter for treating an occlusion in a body lumen (abstract) and various embodiments of discontinuous emitters (300, 310, 320, 330, 340, 400; Figs. 3A-3E, 4A), some of which are slotted (see for example, Fig. 4A), similar to that of Nunes, or alternatively one which forms a spiral coil shape (330; Fig. 3D). The helical shape of the slots can ensure that even as a wire retreats in a proximal direction due to erosion from shock wave generation, the wire is following the path of the helical slot, and the origin point of the shock waves (jumping from the distal end of the wire to the slotted emitter sheath 330) remains adjacent to the distal end of the slotted emitter sheath for a longer period. Accordingly, incorporating a helical slotted sheath can promote forward biased shock waves for a longer period than an emitter sheath having one or more slots that do not have a helical path (column 11, lines 24-47).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one discontinuous emitter band of Batchelder to be formed as a spiral coil shape as taught by Nunes in order to promote forward biased shock waves for a longer period.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cook et al. (US 12,102,384 B2) teaches discontinuous emitters. Hawkins (US 11,020,135 B1) teaches emitters with openings/holes (Figs. 3A-3B). Hakala et al. (US 9,433,428 B2) teaches various shaped emitters.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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