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 .
Claims 5 and 12-14 are cancelled. A complete action on the merits of pending claims 1-4, 6-11, and 15-24 appears herein.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/04/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 06/04/2026 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.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 7-9, 11, 15, 20, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Tu (US 6,036,689) in view of Edwards (US 2002/0072738 A1) in view of Olson (US 2019/0021620 A1).
Regarding claim 1, Tu teaches a medical treatment apparatus, (Fig. 5) comprising:
an elongate body including one or more lumens for mechanical, electrical, and fluid communication (Fig. 5 and 4C, Char. 21: inner catheter) between a proximal portion (Fig. 2) and a distal portion, (Fig. 5: The portion of the device distal to inner catheter (21)) the distal portion including a plurality of flexible shafts (Fig. 5, Char. 4: electrode means) arranged around an actuation element and coupled between the elongate body and a distal tip section (Fig. 5: Electrode means (4) are disposed between inner catheter (21) and distal joint (22));
a balloon attached to the distal tip section and positioned within a space delimited by the flexible shafts, (Fig. 5, Char. 53: balloon) the balloon being connected via the one or more lumens to receive a fluid; (Fig. 5 and Col. 6, Lines 49-52)
The Fig 5 embodiment of Tu, as applied to claim 1 above, is silent regarding the flexible shafts being arranged around an actuation element; the distal tip section being the distal tip section of the actuation element; longitudinal movement of the actuation element with respect to the elongate body flexes the flexible shafts; the expandable element being attached to the distal tip section and a plurality of electrodes arranged along the flexible shafts and electrically connected via the one or more lumens to receive electrical energy for delivery to a target tissue; wherein, when the balloon is in an inflated state, the plurality of electrodes includes a first electrode having a portion thereof covered with a layer of an electrically insulating material, the layer being in direct contact with a skin of the inflated balloon.
Tu, in another embodiment, teaches an elongate body including one or more lumens for mechanical, electrical, and fluid communication (Fig. 4, Char. 21: inner catheter) between a proximal portion (Fig. 2) and a distal portion, (Fig. 4: The portion of the device distal to inner catheter (21)) the distal portion including a plurality of flexible shafts (Fig. 4, Char. 4: electrode means) arranged around an actuation element (Col. 5, Lines 48-54, and Fig. 4, Char. 23: connecting shaft) and coupled between the elongate body and a distal tip section (Fig. 4: Electrode means (4) are disposed between inner catheter (21) and distal joint (22)) of the actuation element such that longitudinal movement of the actuation element with respect to the elongate body flexes the flexible shafts. (Fig. 4 and Col. 5, Lines 48-57; Pulling connecting shaft (23) in the proximal direction with respect to catheter (21) would result in flexing of electrode means (4))
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the Fig. 5 embodiment of Tu to incorporate the teachings of the Fig. 4 embodiment of Tu, and include the connecting shaft (23) of Tu as an additional actuation means configured to expand/retract electrode means (4). Doing so would provide a backup actuation means, ensuring the electrode means (4) could still be deployed/retracted even if balloon (53) malfunctions or breaks.
Modified Tu, as applied to claim 1 above, is silent regarding the expandable element being attached to the distal tip section and a plurality of electrodes arranged along the flexible shafts and electrically connected via the one or more lumens to receive electrical energy for delivery to a target tissue; wherein, when the balloon is in an inflated state, the plurality of electrodes includes a first electrode having a portion thereof covered with a layer of an electrically insulating material, the layer being in direct contact with a skin of the inflated balloon.
Edwards, in a similar field of endeavor, teaches a device comprising a balloon disposed within a basket structure, wherein the balloon is attached to the basket structure at the proximal and distal ends of said basket structure. (Fig. 6-7)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Tu, as applied to claim 1 above, to incorporate the teachings of Edwards, and configure the balloon (53) of Tu to be attached to the distal joint (22). Doing so would provide a second point of attachment within the basket structure of Tu, minimizing the risk of balloon (53) becoming dislodged or mispositioned outside of said basket structure during inflation.
The combination of Tu/Edwards, as applied to claim 1 above, is silent regarding a plurality of electrodes arranged along the flexible shafts and electrically connected via the one or more lumens to receive electrical energy for delivery to a target tissue; wherein, when the balloon is in an inflated state, the plurality of electrodes includes a first electrode having a portion thereof covered with a layer of an electrically insulating material, the layer being in direct contact with a skin of the inflated balloon.
Olson, in a similar field of endeavor, teaches a basket catheter (Fig. 3) comprising a plurality of electrodes (Fig. 7, Char. 54: conductive band) arranged along the flexible shafts of the basket (Fig. 3 and 5, Char. 38: body) and electrically connected via one or more lumens in the shafts to receive electrical energy for delivery to a target tissue; (Par. [0063]: Conductors (44) may comprise wires or cables disposed within the lumen (46) of a body (38) of a given spline (36) and be coupled at a distal end to a corresponding electrode) wherein, the plurality of electrodes includes a first electrode having a portion thereof covered with a layer of an electrically insulating material, (Fig. 6 and 7; Par. [0064]) the layer wrapping circumferentially around each shaft. (Fig. 7)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Tu/Edwards, as applied to claim 1 above, to incorporate the teachings of Olson, and include at least the splines (36), conductors (44), and partially masked electrodes (42) of Olson comprising the conductive band (54) and insulative coating (56) of Olson in place of electrode means (4) of Tu. Doing so would be a simple substitution of one basket electrode/tine structure for another for the predictable result of delivering electrosurgical energy to a target tissue.
In this combination, the insulative coating (56) of Olson would be in direct contact with the skin of the balloon (53) of Tu when the balloon is in the inflated state due to the insulative coating (56) wrapping circumferentially around each spline (36). (Olson: Fig. 7)
Regarding claims 7 and 8, the combination of Tu/Edwards/Olson, as applied to claim 1 above, is silent regarding in the inflated state, the balloon takes up less than 70% by volume of the space delimited by the flexible shafts; and in the inflated state, the balloon takes up less than 50% by volume of the space delimited by the flexible shafts.
Absent a statement of criticality AND unexpected results, it would have been an obvious matter of design choice to make the different portions of the balloon (53) of Tu of whatever form or shape was desired or expedient, including of a size and shape such that balloon (53) takes up less than 50% by volume of the space delimited by the spines (36) of Olson. 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 9, the combination of Tu/Edwards/Olson, as applied to claim 1 above, teaches a fluid delivery conduit connected via the one or more lumens to receive the fluid and configured to release the fluid from one or more openings, apertures, or ports thereof within the balloon. (Tu: Fig. 5 and Col. 6, Lines 44-56)
Regarding claim 15, the combination of Tu/Edwards/Olson, as applied to claim 1 above, teaches when the balloon is in the inflated state, the layer of the electrically insulating material is configured to cause the first electrode to project electrical currents away from the balloon. (Olson: Fig. 5 and Par. [0065]: Openings (58) are oriented such that when splines (36) of basket electrode assembly (30) are expanded, openings (58) face the tissue of interest such that they can contact the tissue of interest – it is implicit that this feature be present in the Tu/Edwards/Olson combination based on the rejection to claim 1 above. Openings (58) facing away from the balloon (53) of Tu would direct electrical currents produced by the conductive bands (54) away from said balloon (53))
Regarding claim 20, the combination of Tu/Edwards/Olson, as applied to claim 1 above, teaches retraction of the actuation element causes the plurality of flexible shafts to flex away from the actuation element thereby increasing in volume the space delimited by the flexible shafts. (Tu: Fig. 4 and Col. 5, Lines 48-57; Pulling connecting shaft (23) in the proximal direction with respect to catheter (21) would result in flexing of electrode means (4))
Regarding claim 21, the combination of Tu/Edwards/Olson, as applied to claim 1 above, teaches when the balloon is in the inflated state, the plurality of electrodes includes a second electrode having a respective portion thereof covered with a respective layer of the electrically insulating material, the respective portion oriented towards the actuating element; (Olson: Fig. 3: There is a plurality of ablative elements on each spline; Fig. 5-7: Each ablative element comprises an electrode (conductive band (54)) covered with an insulative coating that wraps circumferentially around each spline (36) – it is implicit that this feature be present in the Tu/Edwards/Olson combination based on the rejection to claim 1 above.) and wherein the layer of the electrically insulating material on the first electrode and the respective layer of the electrically insulating material on the second electrode are configured to cause the first and second electrodes to project electrical currents away from the space delimited by the flexible shafts. (Olson: Fig. 5 and Par. [0065]: Openings (58) are oriented such that when splines (36) of basket electrode assembly (30) are expanded, openings (58) face the tissue of interest such that they can contact the tissue of interest – it is implicit that this feature be present in the Tu/Edwards/Olson combination based on the rejection to claim 1 above. Openings (58) facing away from the balloon (53) of Tu would direct electrical currents produced by the conductive bands (54) away from said balloon (53))
Regarding claim 22, the combination of Tu/Edwards/Olson, as applied to claim 1 above, teaches when the balloon is in the inflated state, the layer of electrically insulating material is positioned on an inward facing surface of the first electrode (Olson: Fig. 6 and 7: Insulated coating (56) wraps circumferentially around the spline (36) – it is implicit that this feature be present in the Tu/Edwards/Olson combination based on the rejection to claim 1 above.) and is mechanically pressed into surface contact with the skin of the inflated balloon (Tu: Fig. 5: The balloon contacts the inner surface of the basket splines when in the inflated configuration.) such that the balloon, the insulating layer, and the first electrode together form a stacked dielectric interface extending along a longitudinal length of the first electrode. (Tu: Fig. 5 and Olson: Fig. 7: When the balloon (53) of Tu contacts the insulated coating (56) of Olson, balloon (53), coating (56) and conductive band (54) form a stacked configuration – it is implicit that this feature be present in the Tu/Edwards/Olson combination based on the rejection to claim 1 above.)
Regarding claim 23, the combination of Tu/Edwards/Olson, as applied to claim 22 above, teaches the stacked dielectric interface constrains the electrical energy delivery to project radially outward from the flexible shafts and away from the space delimited by the flexible shafts. (The insulated coating (56) of Olson would naturally direct electrical energy out through openings (58) of Olson and away from the space delimited by the basket splines – it is implicit that this feature be present in the Tu/Edwards/Olson combination based on the rejection to claim 1 above.)
Regarding claim 24, the combination of Tu/Edwards/Olson, as applied to claim 1 above, teaches when the balloon is in the inflated state, the portion of the first electrode covered with the electrically insulating material is in direct contact with the skin of the inflated balloon (Tu: Fig. 5: The balloon contacts the inner surface of the basket splines when in the inflated configuration; Olson: Fig. 6 and 7: Insulated coating (56) wraps circumferentially around the spline (36) – it is implicit that this feature be present in the Tu/Edwards/Olson combination based on the rejection to claim 1 above.) such that the electrically insulating material is configured to electrically isolate the first electrode from the skin of the inflated balloon while directing electrical currents caused by the electrical energy delivery away from the space delimited by the flexible shafts. (The insulated coating (56) of Olson would naturally direct electrical energy out through openings (58) of Olson and away from the space delimited by the basket splines due to said coatings being insulative and wrapping circumferentially around the basket spline – it is implicit that this feature be present in the Tu/Edwards/Olson combination based on the rejection to claim 1 above.)
Claim(s) 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Tu (US 6,036,689) in view of Edwards (US 2002/0072738 A1) in view of Olson (US 2019/0021620 A1), as applied to claim 1 above, and further in view of Bencini (US 2009/0299355 A1).
Regarding claim 2, the combination of Tu/Edwards/Olson, as applied to claim 1 above, is silent regarding a plurality of retention elements, each of the retention elements being coupled between a respective one of the flexible shafts and the balloon to anchor a corresponding portion of the balloon to the respective one of the flexible shafts.
Bencini, in a similar field of endeavor, teaches attaching the splines of a basket structure to a balloon disposed within said basket structure along multiple points of the splines/balloon. (Par. [0064]: Splines (701A-D may be attached to the surface of the balloon (103) at one or more points on the surface of the balloon (103))
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Tu/Edwards/Olson, as applied to claim 1 above, to incorporate the teachings of Bencini, and attach the splines (36) of Olson to the balloon (53) of Tu along various points of the splines/balloon via retention elements. Doing so would minimize the risk of the balloon (53) of Tu becoming dislodged while in the deflated configuration.
Regarding claims 3 and 4, the combination of Tu/Edwards/Olson/Bencini, as applied to claim 2 above, is silent regarding the plurality of retention elements includes a first retention element located between the distal tip section and the first electrode of the plurality of electrodes on the respective one of the flexible shafts; wherein the plurality of retention elements includes a second retention element located between the first electrode and a second electrode of the plurality of electrodes on the respective one of the flexible shafts.
However, absent a statement of criticality AND unexpected results, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Tu/Edwards/Olson/Bencini, as applied to claim 2 above, such that the retention elements are disposed anywhere along the splines (36) of Olson, including the claimed locations of claims 3 and 4, as it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. Furthermore, one of ordinary skill in the art would expect the combination of Tu/Edwards/Olson/Bencini to function just as well with the claimed retention element locations of claims 3 and 4 as it would with retention elements disposed along any other location along splines (36) of Olson.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tu (US 6,036,689) in view of Edwards (US 2002/0072738 A1) in view of Olson (US 2019/0021620 A1), as applied to claim 1 above, and further in view of Nagale (US 2017/0035496 A1).
Regarding claim 6, the combination of Tu/Edwards/Olson, as applied to claim 1 above, is silent regarding a skin of the balloon is made of an electrically insulating material.
Nagale, in a similar field of endeavor, teaches an ablation device comprising a balloon made of an electrically insulating material. (Par. [0009]: The balloon may be formed of rubbers or other non-electrically conductive material.)
It has been held that “the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination”- MPEP 2144.07 It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Tu/Edwards/Olson, as applied to claim 1 above, to incorporate the teachings of Nagale and have the balloon (53) of Tu be/include one of the electrically insulating materials taught by Nagale since these materials are recognized by Nagale as being suitable for their intended use in forming a balloon.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tu (US 6,036,689) in view of Edwards (US 2002/0072738 A1) in view of Olson (US 2019/0021620 A1), as applied to claim 9 above, and further in view of Harlev (US 10,219,860 B2).
Regarding claim 10, the combination of Tu/Edwards/Olson, as applied to claim 9 above, is silent regarding the fluid delivery conduit has a segment thereof disposed circumferentially, spirally, or helically within the balloon around the actuation element.
Harlev, in a similar field of endeavor, teaches a fluid delivery conduit having a segment thereof disposed spirally around a central shaft within a balloon. (Fig. 16 and Col. 37, Lines 4-9)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Tu/Edwards/Olson, as applied to claim 9 above, to incorporate the teachings of Harlev, and configure the inflation tubing to comprise a segment thereof disposed circumferentially, spirally, or helically within the balloon around the actuation element. Doing so would be a simple substitution of one fluid delivery structure for another for the predictable result of delivering an inflation fluid to a balloon element.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tu (US 6,036,689) in view of Edwards (US 2002/0072738 A1) in view of Olson (US 2019/0021620 A1), as applied to claim 9 above, and further in view of Loeb (US 2014/0088575 A1).
Regarding claim 11, the combination of Tu/Edwards/Olson, as applied to claim 9 above, teaches the fluid delivery conduit is in fluid communication with a fluid supply source connected to the proximal portion; (Tu: Fig. 5 and Col. 6, Lines 44-56)
The combination of Tu/Edwards/Olson, as applied to claim 9 above, is silent regarding wherein the fluid supply source comprises a pressurized bottle or a syringe filled with a solution or a gas.
Loeb, in a similar field of endeavor, teaches a fluid source (Par. [0229]: the system comprising at least the container of uninfused fluid, the pump used to inflate said balloon, and the collection bottle used to receive returned fluid) configured to inflate a balloon with a gas; (Par. [0229]) wherein the fluid source comprises a pressurized bottle filled with the gas. (Par. [0229]: The collection bottle would be filled with a pressurized gas)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Tu/Edwards/Olson, as applied to claim 11 above, to incorporate the teachings of Loeb, and configure the fluid delivery system of Tu to comprise a fluid return such that fluid returns to a pressurized bottle for reuse/disposal, and to use a gas to inflate the balloon (53) of Tu. Including the fluid return comprising a pressurized bottle would allow for a user to easily reuse or dispose of returned fluid as said fluid would be automatically collected in a single container. Using a gas to inflate the balloon (53) of Tu would be a simple substitution of one inflation medium for another for the predictable result of inflating said balloon.
Claim(s) 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Tu (US 6,036,689) in view of Edwards (US 2002/0072738 A1) in view of Olson (US 2019/0021620 A1), as applied to claim 1 above, and further in view of Cheng (US 2007/0225729 A1).
Regarding claim 16, the combination of Tu/Edwards/Olson, as applied to claim 1 above, is silent regarding the plurality of flexible shafts includes a braided shaft.
Cheng, in a similar field of endeavor, teaches a basket structure in which the splines (legs) of the basket comprise at least two materials braided together. (Fig. 6-9 and Par. [0029])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Tu/Edwards/Wu/Viswanathan, as applied to claim 1 above, to incorporate the teachings of Cheng, and include the braided legs (22) of Cheng in place of splines (36) of Olson. Doing so would be a simple substitution of one basket tine structure for another for the predictable result of creating a basket structure around balloon (53) of Tu on which to support electrodes (42) of Olson.
Regarding claim 17, the combination of Tu/Edwards/Olson/Cheng, as applied to claim 16 above, teaches the braided shaft comprises a plurality of braided strands including: a first type of strands comprising a first electrically conducting wire; and a second type of strands comprising an electrically insulating fiber. (Cheng: Par. [0032]: Legs can be formed from braded metal wires and ceramic fibers – it is implicit that this feature be present in the Tu/Edwards/Olson/Cheng combination based on the rejection to claim 16 above.)
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Tu (US 6,036,689) in view of Edwards (US 2002/0072738 A1) in view of Olson (US 2019/0021620 A1), in view of Cheng (US 2007/0225729 A1), as applied to claim 17 above, and further in view of McGovern (US 2001/0003798 A1)
Regarding claim 18, the combination of Tu/Edwards/Olson/Cheng, as applied to claim 17 above, teaches the plurality of braided strands further includes a third type of strands comprising a second electrically conducting wire. (Fig. 5 and Par. [0031] – it is implicit that this feature be present in the Tu/Edwards/Olson/Cheng combination based on the rejection to claim 16 above.)
Cheng further teaches the metal wires can comprise a plurality of metals (Par. [0028])
The combination of Tu/Edwards/Olson/Cheng, as applied to claim 17 above, is silent regarding the first electrically conducting wire and the second electrically conducting wire comprising different respective electrically conducting materials, wherein the first and second electrically conducting wires form a thermocouple junction for temperature measurements at the target site.
It has been held that “the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination”- MPEP 2144.07 In the instant case, one of ordinary skill in the art would recognize the benefits or suitability of the disclosed materials (e.g. cost-effectiveness, manufacturing feasibility, etc.) Absent a statement of criticality AND unexpected results, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Tu/Edwards/Olson/Cheng, as applied to claim 17 above, to have the second electrically conducting wire be/include a different metal (e.g. stainless steel, cobalt chromium, nickel, titanium, and nitinol listed by Cheng) as the first electrically conducting wire since these materials offer the benefits of cost-effectiveness, manufacturing feasibility, etc, as stated above, and are recognized in the art as each being suitable materials.
The combination of Tu/Edwards/Olson/Cheng, as applied to claim 17 above, is silent regarding wherein the first and second electrically conducting wires form a thermocouple junction for temperature measurements at the target site.
McGovern, in a similar field of endeavor, teaches a thermocouple junction disposed on an outer portion of a catheter for temperature sensing. (Fig. 2 and Par. [0078])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Tu/Edwards/Olson/Cheng, as applied to claim 17 above, to incorporate the teachings of McGovern, and configure the first and second electrically conducting wires to form a thermocouple junction for temperature measurements at the target site. Doing so would be a simple substitution of one temperature sensing mechanism for another for the predictable result of measuring a tissue temperature at the treatment site.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Tu (US 6,036,689) in view of Edwards (US 2002/0072738 A1) in view of Olson (US 2019/0021620 A1), in view of Cheng (US 2007/0225729 A1), as applied to claim 17 above, and further in view of Hettel (US 2017/0164999 A1).
Regarding claim 19, the combination of Tu/Edwards/Olson/Cheng, as applied to claim 17 above, is silent regarding the braided shaft further comprises a central elastic member; and wherein the braided strands form a braided jacket around the central elastic member.
Hettel, in a similar field of endeavor, teaches an ablation catheter comprising a basket structure formed of a plurality of splines having a central elastic member (Par. [0039]: Spines (32) are composed of a stainless-steel core with a non-conductive coating) and a braided jacket around the central elastic member. (Par. [0039]: a braided polymer tube such as PEBAX)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Tu/Edwards/Olson/Cheng, as applied to claim 17 above, to incorporate the teachings of Hettel, and configure the legs (22) of Cheng to comprise the stainless-steel core of Hettel, such that the wires (30) and fibers (32) of Cheng form a braided jacked around the stainless steel core of Hettel. Doing so would allow for the stainless-steel core to provide more elasticity to the legs of Cheng.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS SHEA BORSCH whose telephone number is (571)272-5681. The examiner can normally be reached Monday-Thursday 7:30AM-5:30PM EST.
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/N.S.B./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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