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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 7th, 2026 has been entered.
Response to Amendment
The amendment filed December 5th, 2025 has been entered. Claims 9-21 remain pending in the application. Applicant’s amendments to the claims have overcome the objections and rejections previously set forth in the Final Office Action mailed October 8th, 2025.
Response to Arguments
Applicant’s arguments with respect to claims 9-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The claim amendments changed the scope of the claimed invention. See new grounds for rejection below.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 9, 16-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Jung et al. (US 20190365451 A1) herein referred to as “Jung” in view of Ghaffari et al. (US 20150320472 A1) herein referred to as “Ghaffari” further in view of Hanson et al. (US 20150025532 A1) herein referred to as “Hanson”.
Regarding claim 9, Jung discloses a balloon-type electrode catheter (cryoablation catheter, Abstract) comprising:
an outer tube (catheter shaft 240, Paragraph [0043]);
a balloon including an expansion portion expanding (cryoballoon 242, Paragraph [0043] and [0045], Figure 2) and continuous neck portions on both ends of the expansion portion (proximal balloon region 244P and distal balloon region 244D, Figure 2, Paragraph [0047]),
a proximal end side neck portion fixed to a distal end portion of the outer tube (proximal balloon region 244P includes the region where at least a portion of the cryoballoon 244P is secured or attached to a portion of the catheter shaft 240, Paragraph [0047], Figure 2);
a surface electrode formed of a metal formed on an outer surface of the balloon at the expansion portion and the distal end side neck portion (electrode array 228 on the outer surface of balloon 242 and distal end side neck portion 244D, Figures 2, and 2A, Paragraph [0049] and [0050]),
wherein a distal end of the conducting wire is connected to the electrode (conductors 234 are included in flex circuits connected to electrodes 232, Paragraphs [0049], the conductors 334 can interrogate tissue electrical activity and/or transmit electrical signals generated by the electrodes 332 to controller 14, [0077], Figures 2 and 2A),
wherein the lead wire extends in the inner portion of the balloon (at least a portion of each flex circuit 229 can be coupled and/or connected to the handle assembly 20 and/or the controller 14 and extend and/or be routed to the inner or outer surface of the cryoballoon 242, Paragraphs [0050], [0052], [0092]),
and the lead wire being capable of being energized form the proximal end region (the electrodes are in electrical communication with the controller 14 via one or more conductors, Paragraphs [0065] and [0077]).
However Jung does not explicitly disclose a metal ring attached to the distal end side neck portion of the balloon, the metal ring being electrically connected to a distal end portion of the surface electrode; and a lead wire with a distal end of the lead wire fixed to the metal ring, wherein an outer diameter of the metal ring is smaller than an outer diameter of the outer tube and the proximal end side neck portion.
Ghaffari discloses a balloon catheter comprising a balloon (inflatable body 720 is a balloon catheter, Paragraph [0335], Figures 7 and 8)
comprising a distal end side neck portion (distal portion of balloon 720, Paragraph [0035], Figure 8),
a surface electrode extending on the distal end side neck portion (sensing element 304 includes bipole electrodes 306, Paragraph [0324], sensing element 704 includes bipole electrodes 706, Paragraph [0335], sensing elements are disposed near the equator of the balloon extending from coupling bus 702 at the distal end side neck portion of the balloon, [0349], Figure 3A and 8),
and a conducting wire (coupling interconnect 308, [0049] and [0324], intermediate bus 710, [0335], Figure 8),
wherein a metal ring is provided (the coupling bus may comprise an annular ring structure, Paragraph [0023], the coupling bus is formed from a conductive material, Paragraph [0026], coupling bus 302, Paragraph [0324], coupling bus 702, [0335], Figures 3A and 8),
the metal ring being electrically connected to a distal end portion of the surface electrode (coupling bus 702 is coupled to electrodes 704 and 706 via coupling interconnect 708, Paragraphs [0335] and [0349], Figure 8),
a lead wire with a distal end of the lead wire fixed to the metal ring (intermediate bus 710, Paragraph [0335], Figure 8).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Jung to incorporate
the teachings of Ghaffari by including a metal ring attached to the distal end side neck portion of the balloon, the metal ring being electrically connected to a distal end portion of the surface electrode; and a lead wire with a distal end of the lead wire fixed to the metal ring. The motivation to do so being to facilitate electrical communication between the electrodes and an external circuit (Ghaffari, Paragraph [0266]).
Ghaffari discloses the claimed invention except for wherein an outer diameter of the metal ring is smaller than an outer diameter of the outer tube and the proximal end side neck portion. It would have been an obvious matter of design choice to include wherein an outer diameter of the metal ring is smaller than an outer diameter of the outer tube and the proximal end side neck portion, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
However Jung in view of Ghaffari does not explicitly disclose wherein current is applied to the surface electrode for ablation treatment nor wherein the expansion portion of the balloon includes a cylindrical portion, a distal end side cone portion from the distal end of the cylindrical portion to the proximal end of the distal end side neck portion, and a proximal end side cone portion from the proximal end of the cylindrical portion to the distal end of the proximal end side neck portion, and wherein the surface electrode is formed on at least a portion of the outer surface of the cylindrical portion.
Hanson discloses a medical device for tissue ablation comprising a ballon with electrodes on the outer surface (Abstract), wherein current is applied to the surface electrode for ablation treatment (active electrode 30 may be coupled to expandable member 28, active electrode may be an ablation electrode that is capable of delivering ablation energy to a suitable target, for example, active electrode 30 may be capable of delivering ablation energy to tissue positioned adjacent to a blood vessel, Paragraph [0051], Figures 2, 4, 4A, Ablation energy may be transmitted from active electrode 30/130, through the target tissue, Paragraph [0056], Figure 15, one or more or a plurality of electrodes may be applied to expandable member 1128, to emit ablation energy to ablate tissue during a medical procedure, the electrodes may be monopolar or bipolar electrode, Figures 16-21, Paragraph [0077]), and wherein the expansion portion of the balloon includes a cylindrical portion (expansion portion of the balloon includes a cylindrical portion, Figures 2, 4, 4A, 15, expandable member 1128, Figures 22-23), a distal end side cone portion from the distal end of the cylindrical portion to the proximal end of the distal end side neck portion (distal side cone portion, Figures 2, 4, 4A, 15, distal side cone portion 1162, Figure 23, Paragraph [0074]-[0076]), and a proximal end side cone portion from the proximal end of the cylindrical portion to the distal end of the proximal end side neck portion (proximal end side cone portion, Figures 2, 4, 4A, 15, proximal side cone portion 1164, Figure 23), and wherein the surface electrode is formed on at least a portion of the outer surface of the cylindrical portion (surface electrode 1130, 1180a, 1180b, is on outer portion of the cylindrical portion 1160,1128, Figures, 20 and 22-23).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Jung to incorporate
the teachings of Hanson by including wherein current is applied to the surface electrode for ablation treatment wherein the surface electrode is formed on at least a portion of the outer surface of the cylindrical portion. The motivation to do so being use the electrodes on the balloon for ablation of tissue adjacent to a blood vessel (Hanson, Paragraph [0056]).
It would have been an obvious matter of design choice to make the different portions of the balloon to include wherein the expansion portion of the balloon includes a cylindrical portion, a distal end side cone portion from the distal end of the cylindrical portion to the proximal end of the distal end side neck portion, and a proximal end side cone portion from the proximal end of the cylindrical portion to the distal end of the proximal end side neck portion. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 16, Jung in view of Ghaffari and Hanson discloses the balloon-type electrode catheter according to claim 9.
Jung discloses wherein the surface electrode is a plurality of strip electrodes formed to extend along an axial direction of the balloon and disposed at intervals along a circumferential direction of the balloon (electrode array 228 including flex circuits 229, Paragraphs [0049] and [0053], Figures 2 and 2A).
However Jung does not explicitly disclose wherein a distal end portion of each of the strip electrodes is electrically connected to the metal ring.
Ghaffari discloses wherein a distal end portion of each of the strip electrodes is electrically connected to the metal ring (coupling bus 702 is coupled to electrodes 704 and 706 via coupling interconnect 708, Paragraphs [0335] and [0349], Figure 8).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Jung in view of Ghaffari and Hanson to incorporate the teachings of Ghaffari by including wherein a distal end portion of each of the strip electrodes is electrically connected to the metal ring. The motivation to do so being to facilitate electrical communication between the electrodes and an external circuit (Ghaffari, Paragraph [0266]).
Regarding claim 17, Jung in view of Ghaffari and Hanson discloses the balloon-type electrode catheter according to claim 9.
However Jung does not explicitly disclose wherein the metal ring is coated for insulation.
Ghaffari further discloses wherein the metal ring is coated for insulation (apparatus includes an encapsulation material disposed over substantially a portion of the coupling bus, Paragraph [0008]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Jung in view of Ghaffari and Hanson to incorporate the teachings of Ghaffari by including wherein the metal ring is coated for insulation. The motivation to do so being to minimize delamination (Ghaffari, Paragraph [0426]).
Regarding claim 18, Jung in view of Ghaffari and Hanson discloses the balloon-type electrode catheter according to claim 17.
However Jung does not explicitly disclose wherein the distal end side neck portion, the metal ring, and the surface electrode at the distal end side neck portion are coated for insulation.
Ghaffari discloses wherein the distal end side neck portion, the metal ring, and the surface electrode at the distal end side neck portion are coated for insulation. (the encapsulation layer can be applied to cover the serpentine structures as well (including the coupling bus and the flexible interconnects) (seen as covering the distal end side neck portion of the balloon which is covered by the coupling bus and flexible interconnects), Paragraph [0459]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Jung in view of Ghaffari and Hanson to incorporate the teachings of Ghaffari by including wherein the distal end side neck portion, the metal ring, and the surface electrode at the distal end side neck portion are coated for insulation. The motivation to do so being to minimize delamination (Ghaffari, Paragraph [0426]).
Regarding claim 19, Jung in view of Ghaffari and Hanson discloses the balloon-type electrode catheter according to claim 17.
However Jung does not explicitly disclose wherein the expansion portion includes a cylindrical portion and a cone portion connecting the cylindrical portion and the neck portion.
Hanson wherein wherein the expansion portion includes a cylindrical portion and a cone portion connecting the cylindrical portion and the neck portion (cylindrical portion 1128 and cone portion 1164 connecting the proximal waist 1168 (neck portion) to the cylindrical portion 1128, Figure 23).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jung in view of Ghaffari and Hanson to incorporate the teachings of Hanson by including wherein the expansion portion includes a cylindrical portion and a cone portion connecting the cylindrical portion and the neck portion. The motivation to do so being to secure the expandable member to a component of the catheter shaft (Hanson, Paragraph [0075]).
However Jung does not explicitly disclose wherein the cone portion, the metal ring, and the surface electrode on the cone portion are coated for insulation.
Ghaffari discloses wherein the cone portion, the metal ring, and the surface electrode on the cone portion are coated for insulation (the encapsulation layer can be applied to cover the serpentine structures as well (including the coupling bus and the flexible interconnects) (seen as covering the distal end side neck portion of the balloon which is covered by the coupling bus and flexible interconnects), Paragraph [0459]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Jung in view of Ghaffari and Hanson to incorporate the teachings of Ghaffari by including wherein the cone portion, the metal ring, and the surface electrode on the cone portion are coated for insulation. The motivation to do so being to minimize delamination (Ghaffari, Paragraph [0426]).
Regarding claim 21, Jung in view of Ghaffari and Hanson discloses the balloon-type electrode catheter according to claim 9.
Jung further discloses wherein a temperature sensor is disposed on a tube wall of the balloon (the array can sense various physiological parameters such as temperature, Paragraphs [0065]-[0066] and [0071]).
Claims 10, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Jung in view of Ghaffari and Hanson further in view of Vrba et al. (US 20170348049 A1) herein referred to as “Vrba”.
Regarding claim 10, Jung in view of Ghaffari and Hanson discloses the balloon-type electrode catheter according to claim 9.
Jung discloses wherein the outer tube includes a central lumen (catheter 12 includes a central lumen in shaft 240 and guidewire lumen 238, Paragraphs [0043], [0044] and [0047], Figure 2),
the balloon-type electrode catheter comprises an inner tube including a lumen (guidewire lumen 238, Paragraph [0043]),
the inner tube being inserted into the central lumen of the outer tube and extending inside the balloon (guidewire lumen 238 extends within the balloon, Figure 1, Paragraph [0043]),
wherein the conducting wire extends in the inner lumen (seen as a sub-lumen) of the balloon (at least a portion of each flex circuit 229 can be coupled and/or connected to the handle assembly 20 and/or the controller 14 and extend and/or be routed to the inner or outer surface of the cryoballoon 242, Paragraphs [0050], [0052], [0092]).
However Jung in view of Ghaffari and Hanson does not explicitly disclose a plurality of sub-lumens disposed to surround the central lumen.
Vrba discloses a balloon catheter (balloon catheter 400, [0219], Figure 4) comprising an outer tube (an elongate shaft 405, Paragraph [0219], Figure 4),
and a balloon (balloon 401, Paragraph [0219], Figure 4)
the outer tube comprising a central lumen (the guidewire lumen 404a is centrally located within the shaft, Paragraph [0220], Figure 4)
and a plurality of sub-lumens disposed to surround the central lumen (one or more lumens, Paragraph [0220], Figure 4A).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Jung in view of Ghaffari and Hanson to incorporate the teachings of Vrba by including a plurality of sub-lumens disposed to surround the central lumen. The motivation to do so being to provide passages for electrode wires, fluid delivery, fluid discharge, and guidewires (Vrba, Paragraph [0209]).
Regarding claim 13, Jung in view of Ghaffari, Hanson, and Vrba discloses the balloon-type electrode catheter according to claim 10.
However Jung in view of Ghaffari and Hanson does not explicitly disclose wherein at least one of the sub-lumens included in the outer tube is a fluid supply sub-lumen configured to supply a fluid to the inside of the balloon, and at least one of the sub-lumens included in the outer tube is a fluid discharge sub-lumen configured to discharge the fluid supplied to the inside of the balloon from the inside of the balloon.
Vrba further discloses wherein at least one of the sub-lumens included in the outer tube is a fluid supply sub-lumen configured to supply a fluid to the inside of the balloon (inflation lumen 404B, Paragraph [0220], Figure 4), and at least one of the sub-lumens included in the outer tube is a fluid discharge sub-lumen configured to discharge the fluid supplied to the inside of the balloon from the inside of the balloon (the shaft includes an outflow lumen to remove fluid from the balloon, Paragraph [0220]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Jung in view of Ghaffari, Hanson, and Vrba to incorporate the teachings of Vrba by including wherein at least one of the sub-lumens included in the outer tube is a fluid supply sub-lumen configured to supply a fluid to the inside of the balloon, and at least one of the sub-lumens included in the outer tube is a fluid discharge sub-lumen configured to discharge the fluid supplied to the inside of the balloon from the inside of the balloon. The motivation to do so being to provide passages for the fluid delivery and fluid discharge to properly maintain proper inflation pressure (Vrba, Paragraphs [0209] and [0260]).
Regarding claim 14, Jung in view of Ghaffari, Hanson, and Vrba discloses the balloon-type electrode catheter according to claim 13.
Jung discloses wherein the distal end portion of the outer tube fixed to the proximal end side neck portion of the balloon is incorporated in the expansion portion of the balloon (proximal balloon region 244P includes the region where at least a portion of the cryoballoon 242 is secured or attached to a portion of the catheter shaft 240, Paragraph [0047], Figure 2).
However Jung in view of Ghaffari and Hanson does not explicitly disclose wherein an opening of the fluid supply sub-lumen is positioned on a distal end side relative to an intermediate position in an axial direction of the expansion portion, and an opening of the fluid discharge sub-lumen is positioned on a proximal end side relative to the intermediate position in the axial direction of the expansion portion.
Vrba discloses wherein an opening of the fluid supply sub-lumen is positioned on a distal end side relative to an intermediate position in an axial direction of the expansion portion (the inflation lumen extends within the balloon, the inflation lumen discharges the fluid directly into the distal portion of the balloon, Paragraph [0220] and [0260]), and an opening of the fluid discharge sub-lumen is positioned on a proximal end side relative to the intermediate position in the axial direction of the expansion portion (the return lumen is located at the proximal end of the balloon, [0200] and [0260]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Jung in view of Ghaffari, Hanson, and and Vrba to incorporate the teachings of Vrba by including wherein at least one of the sub-lumens included in the outer tube is a fluid supply sub-lumen configured to supply a fluid to the inside of the balloon, and at least one of the sub-lumens included in the outer tube is a fluid discharge sub-lumen configured to discharge the fluid supplied to the inside of the balloon from the inside of the balloon. The motivation to do so being to provide passages for the fluid delivery and fluid discharge to properly maintain the correct inflation pressure (Vrba, Paragraphs [0209] and [0260]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Jung in view of Ghaffari, Hanson, and Vrba further in view of Miyagawa et al. (US 10631930) herein referred to as “Miyagawa”.
Regarding claim 11, Jung in view of Ghaffari, Hong, and Vrba discloses the balloon-type electrode catheter according to claim 10.
However Jung in view of Ghaffari, Hanson, and Vrba does not explicitly disclose wherein the balloon-type electrode catheter comprises a distal end tip including a lumen in communication with the lumen of the inner tube, the distal end tip being fixed to the distal end side neck portion of the balloon.
Miyagawa discloses a balloon catheter (ablation device 61 has a main shaft 72 provided with a balloon 71 on the distal end side thereof, Col. 11, lines 60-67, Figures 4 and 5), comprising a balloon with a distal end side neck portion (the distal end side neck portion being distal portion of balloon 71, Col. 11, lines 60-67, Figure 4) an inner shaft defining a guidewire lumen (guidewire shaft 84, Col. 12, lines 1-13 , Figure 4), and a distal end tip that has a lumen in communication with the lumen of the inner tube (distal tip 75, Col. 12, lines 43-60, guidewire shaft 84 is connected to distal tip 75, Col. 13, lines 5-15, Figure 4), the distal end tip being fixed to the distal end side neck portion of the balloon (distal tip 75 is provided on the distal end side of the balloon 71, Col. 12, lines 43-60, Figure 4).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Jung in view of Ghaffari, Hanson, and Vrba to incorporate the teachings of Miyagawa by including wherein the balloon-type electrode catheter comprises a distal end tip including a lumen in communication with the lumen of the inner tube, the distal end tip being fixed to the distal end side neck portion of the balloon. The motivation to do so being to include a distal tip that can be provided with a marker such that the insertion position of the ablation device can be confirmed under X-rays (Miagawa, Col. 10, lines 10-14, and Col. 12, lines 57-60).
Claims 12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Jung in view of Ghaffari, Hanson, and Vrba further in view of Watson et al. (US 20100241112 A1) herein referred to as “Watson”.
Regarding claim 12, Jung in view of Ghaffari, Hanson, and Vrba discloses the balloon-type electrode catheter according to claim 10.
However Jung in view of Ghaffari, Hanson, and Vrba does not explicitly disclose wherein the number of the sub-lumen at the proximal end portion of the outer tube is greater than the number of the sub- lumen at the distal end portion of the outer tube.
Watson discloses a balloon catheter (cryoballoon catheter 900 that includes one or more balloons 932, Paragraph [0051]) wherein the number of sub-lumen at the proximal end portion of the outer tube is greater than the number of sub-lumen at the distal end portion of the outer tube (annular spaces 330-1, 330-2, and 330-3, Paragraph [0043], [0044], [0052], Figure 3 and 10 (Figure 10 illustrates the sub-lumen at the distal end portion being less than the sub-lumen at the proximal end portion ).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Jung in view of Ghaffari, Hanson, and Vrba to incorporate the teachings of Watson by including wherein the number of sub-lumen at the proximal end portion of the outer tube is greater than the number of sub-lumen at the distal end portion of the outer tube. The motivation to do so being to improve the effectiveness of cryoablation procedures by addressing issues of uneven or non-uniform coolant pressures or coolant flows (Watson, Paragraph [0036]).
Regarding claim 15, Jung in view of Ghaffari, Hanson, and Vrba discloses the balloon-type electrode catheter according to claim 13.
However Jung in view of Ghaffari, Hanson, and Vrba does not explicitly disclose wherein the number of the fluid supply sub-lumen is greater than the number of the fluid discharge sub-lumen.
Watson discloses a balloon catheter (cryoballoon catheter 900 that includes one or more balloons 932, Paragraph [0051]) wherein the number of the of the fluid supply sub-lumen is greater than the number of the fluid discharge sub-lumen (fluid supply lumen elements 330-1, 330-2, 330-3, are greater than the number of fluid discharge lumen 310-1, Paragraphs [0040], [0043], [0044], [0052], Figure 3 and 10).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Jung in view of Ghaffari, Hanson, and Vrba to incorporate the teachings of Watson by including wherein the number of the fluid supply sub-lumen is greater than the number of the fluid discharge sub-lumen. The motivation to do so being to improve the effectiveness of cryoablation procedures by addressing issues of uneven or non-uniform coolant pressures or coolant flows (Watson, Paragraph [0036]).
Claim 20 are rejected under 35 U.S.C. 103 as being unpatentable over Jung in view of Ghaffari and Hanson further in view of Clark et al. (US 10905490) herein referred to as “Clark”.
Regarding claim 20, Jung in view of Ghaffari and Hong discloses the balloon-type electrode catheter according to claim 9.
However Jung in view of Ghaffari and Hong does not explicitly disclose wherein an outer diameter of the distal end portion of the outer tube to which the proximal end side neck portion of the balloon is fixed is formed smaller than an outer diameter of the proximal end portion of the outer tube.
Clark discloses a balloon catheter (applicator 140 with expandable member 142, Col. 8, lines 31-46, Figure 6), the balloon comprising a proximal end side neck portion (the ballon 142 can have a proximal attachment region 144, Col. 8, lines 31-46, Figure 6), an outer tube (shaft 122, Col. 8, lines 31-46, Figure 6), wherein an outer diameter of the distal end portion of the outer tube to which the proximal end side neck portion of the balloon is fixed is formed smaller than an outer diameter of the proximal end portion of the outer tube (distal portion of shaft 122 can include a first zone 127a and a second zone 127b recessed inwardly relative to the first zone, the first zone 127a can be demarcated from the second zone 127b by a step 128, Col. 8, lines 6-46, Figure 6, element 127b and 128).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jung in view of Ghaffari and Hong to incorporate the teachings of Clark by including wherein an outer diameter of the distal end portion of the outer tube to which the proximal end side neck portion of the balloon is fixed is formed smaller than an outer diameter of the proximal end portion of the outer tube. The motivation to do so being to provide for the proximal end of the outer tube to be substantially flush with the connection portion of the balloon (Clark, Col. 16, lines 42-55).
Conclusion
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/D.S./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794