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 claims 1-16 in the reply filed on February 3, 2026 is acknowledged.
Claims 17-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 February 3, 2026.
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 1-6 and 8-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kat-Kuoy (US 20180153568).
Regarding claim 1, Kat-Kuoy discloses an apparatus comprising an elongated body (104, 106) comprising a guidewire lumen (104), a first electrode (110) at least partially surrounding the guidewire lumen and comprising a first face (see image below); and a second electrode at least partially surrounding the guidewire lumen and comprising a second face (see image below), wherein the second face is longitudinally spaced from the first face such that the longitudinal spacing forms a spark gap between the first face and the second face (paragraph 0048), and wherein the first face is parallel to the second face (figure 3B, edges of 110 facing each other are parallel to one another).
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Regarding claim 2, Kat-Kuoy discloses all of the limitations set forth in claim 1, wherein each of the first face and the second face are circumferential about the guidewire lumen (figure 3B).
Regarding claim 3, Kat-Kuoy discloses all of the limitations set forth in claim 1, wherein the first face is defined on a first plane, and wherein the second face is defined on a second plane (see image above).
Regarding claim 4, Kat-Kuoy discloses all of the limitations set forth in claim 3, wherein the first plane and the second plane are parallel (see image above).
Regarding claim 5, Kat-Kuoy discloses all of the limitations set forth in claim 1, wherein the first electrode and the second electrode each comprise an elliptical cross-section (110, circular around the shaft, and a circle is an ellipse where the major and minor axis are equal, as defined in the instant specification paragraph 0609).
Regarding claim 6, Kat-Kuoy discloses all of the limitations set forth in claim 1, further comprising: an inflation lumen (120) extending through the elongated body, and a balloon (105) positioned at a distal portion of the elongated body, the balloon configured to receive a fluid via the inflation lumen (figure 10).
Regarding claim 8, Kat-Kuoy discloses an apparatus, comprising: an elongated body comprising a guidewire lumen (104); a first electrode (110) at least partially surrounding the guidewire lumen and comprising a first face (see image below); a second electrode (110) at least partially surrounding the guidewire tumen and comprising a proximal second face and a distal second face; and a third electrode (110, figures 9 and 10 shows more than two electrodes) at least partially surrounding the guidewire lumen and comprising a third face (between second and third electrodes as shown above), wherein the proximal second face is longitudinally spaced from the first face so as to form a first spark gap between the first face and the proximal second face (paragraph 0048), wherein the third face is longitudinally spaced from the distal second face so as to form a second spark gap between the distal second face and the third face (paragraph 0048), wherein the first face is parallel to the proximal second face (see image above), and wherein the distal second face is parallel to the third face (respective second and third faces are also parallel when the multiple electrodes are in the straight orientation such as those figures 3A-3B).
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Regarding claim 9, Kat-Kuoy discloses all of the limitations set forth in claim 8, wherein the proximal second face is parallel to the distal second face (See image above).
Regarding claim 10, Kat-Kuoy discloses all of the limitations set forth in claim 8, wherein each of the first face, the proximal second face, the distal second face, and the third face are circumferential about the guidewire lumen (figure 3B, shows first and second faces circumferential and thus third electrode would also be circumferential).
Regarding claim 11, Kat-Kuoy discloses all of the limitations set forth in claim 8, wherein the first face is defined on a first plane, wherein the proximal second face is defined on a second plane, wherein the distal second face is defined on a third plane, and wherein the third face is defined on a fourth plane (see images above, each of the faces define planes perpendicular to longitudinal axis).
Regarding claim 12, Kat-Kuoy discloses all of the limitations set forth in claim 11, wherein the first plane and the second plane are parallel, and wherein the third plane and the fourth plane are parallel (see images above, each of the faces define planes perpendicular to longitudinal axis and parallel to one another).
Regarding claim 13, Kat-Kuoy discloses all of the limitations set forth in claim 12, wherein the second plane and the third plane are parallel (see images above, each of the faces define planes perpendicular to longitudinal axis and parallel to one another).
Regarding claim 14, Kat-Kuoy discloses all of the limitations set forth in claim 8, wherein the first electrode, the second electrode, and the third electrode each comprise an elliptical cross-section (110, circular around the shaft, and a circle is an ellipse where the major and minor axis are equal, as defined in the instant specification paragraph 0609).
Regarding claim 15, Kat-Kuoy discloses all of the limitations set forth in claim 8, further comprising: an inflation lumen (120) extending through the elongated body, and a balloon (105) positioned at a distal portion of the elongated body, the balloon configured to receive a fluid via the inflation lumen.
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.
Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kat-Kuoy (US 20180153568) as applied to claims 1 and 8 above, and further in view of Wasdyke et al (US 10786267).
Regarding claims 7 and 16, Kat-Kuoy discloses all of the limitations set forth in claims 1 and 8, wherein Kat-Kuoy discloses the high voltage pulsed signals arc between the emitters (paragraph 0048) based on their relative polarity and spacing and that it was known to have a pulsing gap between negative and positive poles between electrodes (paragraph 0048). Kat-Kuoy also discloses power conductors (132) electrically coupled to the electrodes (110), but does not specifically disclose a grounded conductor electrically coupled to the second electrode; a first power conductor electrically coupled to the first electrode; and a second power conductor electrically coupled to the third electrode. However, Wasdyke et al (hereafter Wasdyke) also teaches it was known in the art at the time of the invention to include power conductors to multiple electrodes and to generate a potential difference between the electrodes sufficient for shockwave creation, wherein negative poles and ground poles are obvious variants at the time of the invention. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to substitute the negative pole between electrode pairs in the device of Kat-Kuoy comprise a grounded conductor, as taught as an art-recognized equivalent to negative poles for creating shockwaves by Wasdyke, in order to generate a potential difference between the electrodes sufficient for shockwave creation, wherein all of the conductors and electrodes are coupled to one another to form the device as a whole.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 7, 8, 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 6, 7, 18 of U.S. Patent No. 11911056. Although the claims at issue are not identical, they are not patentably distinct from each other because Patent 11911056 claim 1, 3, 4, 6, 7, 18 recites all of the limitations set forth in application claims 1, 7, 8, 16. Therefore, patent claim 1 is in essence a “species” of the generic invention of application claims 1, 7, 8, 16. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claims 1, 7, 8, 16 is anticipated by patent claim 1, 3, 4, 6, 7, 18, it is not patentably distinct from patent claims 1, 3, 4, 6, 7, 18.
Application
1
7
8
16
Patent 11911056
1, 18
3
4, 6
7
Claims 1, 5-8, 15, 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 8, 13, 16 of U.S. Patent No. 12156668. Although the claims at issue are not identical, they are not patentably distinct from each other because Patent 11911056 claims 1-3, 5, 8, 13, 16 recites all of the limitations set forth in application claims 1, 5-8, 15, 16. Therefore, patent claims 1-3, 5, 8, 13, 16 is in essence a “species” of the generic invention of application claims 1, 5-8, 15, 16. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29. USPQ2d 2010 (Fed. Cir. 1993). Since application claim 1, 5-8, 15, 16 is anticipated by patent claims 1-3, 5, 8, 13, 16, it is not patentably distinct from patent claims 1-3, 5, 8, 13, 16.
Application
1
5
7
6, 15
8
16
Patent 12156668
1
2
3
5
8
13, 16
Claims 1, 5-7, 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7, 15 of U.S. Patent No. 12376869. Although the claims at issue are not identical, they are not patentably distinct from each other because Patent 11911056 claims 1-4, 7, 15 recites all of the limitations set forth in application claims 1, 5-7, 16. Therefore, patent claims 1-4, 7, 15 is in essence a “species” of the generic invention of application claims 1, 5-7, 16. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29. Since application claims 1, 5-7, 16 are anticipated by patent claims 1-4, 7, 15, it is not patentably distinct from patent claims 1-4, 7, 15.
Application
1
5
6
7
16
Patent 12156668
1, 7, 15
2
3
4
7, 15
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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/ANH T DANG/ Primary Examiner, Art Unit 3771