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 .
Response to Arguments
Applicant’s arguments filed June 2, 2026 have been considered but are unpersuasive in view of the rejection set forth below.
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Eggert et al (US 20180304053) in view of Kat-Kuoy (US 20180153568).
Regarding claim 1, Eggert et al (hereafter Eggert) discloses an apparatus, comprising: an elongated body (16); a first electrode(26) at least partially surrounding elongated body and comprising a first face; and a second electrode (26) at least partially surrounding the guidewire lumen and comprising a second face, 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, and wherein the first face is parallel to the second face (figure 4, paragraph 0048). Eggert further teaches using another suitable energy between the pairs of bipolar electrodes, but does not specifically disclose that the device comprises a guidewire lumen. However, Kat-Kuoy discloses an apparatus comprising an elongated body (104, 106) comprising pairs of electrodes forming a spark gap between the first face and the second face of electrode pairs (paragraph 0048) in order to initiate a shock wave that propagates out from each electrode pair through the conducting fluid to break apart calcifications with a guidewire lumen (104) disposed within the elongated body to position the angioplasty balloon adjacent to a lesion. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to both include a guidewire lumen in the elongate body of Eggert in order to position the angioplasty balloon adjacent to a lesion as well as to modify the electrode pairs to specifically initiate a shock wave that propagates out from each electrode pair through the conducting fluid to break apart calcifications as a suitable alternative energy for bipolar electrode pairs at the time of the invention, since it has been held that mere substitution of art-recognized equivalents involves routine skill in the art.
Regarding claim 2, Eggert in view of Kat-Kuoy teaches all of the limitations set forth in claim 1, wherein each of the first face and the second face would be circumferential about the guidewire lumen (figure 1, Eggert since guide wire would extend within elongate body 16).
Regarding claim 3, Eggert in view of Kat-Kuoy teaches 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 (Eggert, figure 4).
Regarding claim 4, Eggert in view of Kat-Kuoy teaches all of the limitations set forth in claim 3, wherein the first plane and the second plane are parallel (Eggert, Figure 4).
Regarding claim 5, Eggert in view of Kat-Kuoy teaches all of the limitations set forth in claim 1, wherein Kat-Kuoy further teaches it was known in the art at the time of the invention to make electrode pairs 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, Eggert in view of Kat-Kuoy teaches all of the limitations set forth in claim 1, further comprising: an inflation lumen (paragraph 0047) extending through the elongated body, and a balloon (22) positioned at a distal portion of the elongated body, the balloon configured to receive a fluid via the inflation lumen (paragraph 0047).
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Eggert et al (US 20180304053) in view of Kat-Kuoy (US 20180153568) as applied to claim 1 above, and further in view of Wasdyke et al (US 10786267).
Regarding claims 7, Eggert in view of Kat-Kuoy teaches 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 Eggert in view 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.
Allowable Subject Matter
Claims 8-16 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art teaches an apparatus, comprising: an elongated body comprising a guidewire lumen; a first electrode at least partially surrounding the guidewire lumen and comprising a first face; a second electrode at least partially surrounding the guidewire tumen and comprising a proximal second face and a distal second face; and a third electrode at least partially surrounding the guidewire lumen and comprising a third face, 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, wherein the third face is longitudinally spaced from the distal second face, wherein the first face is parallel to the proximal second face, and wherein the distal second face is parallel to the third face. However, the claims have not been rejected over the body of prior art because the prior art does not teach forming a second spark gap between the distal second face and the third face, in combination with the limitations above, specifically the distal second face being parallel to the third face, since there is no teaching, suggestion, or motivation to produce the claimed invention.
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
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