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 .
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 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.
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.
Claim(s) 1-4, 9-16, and 18-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Altmann et al., (US 20170296125; hereinafter Altmann) in view of McLeod et al., (US 20200196893; hereinafter McLeod) and Hovda et al., (US 20060253117; hereinafter Hovda).
Regarding claim 1, Altmann (Figures 1, 4A, and 6) discloses an apparatus (10) comprising: an elongated shaft (12, 34) comprising a proximal portion and a distal portion, the elongated shaft (12) configured to be manipulated at the proximal portion (16) to position the distal portion into a heart of a patient ([0002], [0032]); an end effector (18) disposed proximate the distal portion of the elongated shaft (12) and comprising spines (27) each carrying at least one multi-function spine electrode (240) configured to contact cardiovascular tissue and receive electrical potentials from the tissue that are indicative of electrophysiological signals, the at least one spine electrode (240) being connected to at least one first wire (212) that is configured to transmit the electrophysiological signals to a guidance and drive system ([0050]-[0051], [0058]), as well as perform ablation as needed ([0002], [0050], [0058]), the end effector (18) comprising an unconstrained configuration aligning with a longitudinal axis extending along the elongated shaft (12), ([0032], [0037]: the spines 27 of end effector 18 are attached to the expander 17, which follows/aligns with the longitudinal axis, at the distal and proximal ends of the spines 27; therefore, the end effector 18 would follow/align with the longitudinal axis extending along the elongated shaft no matter which configuration is selected); and an irrigation tube (39), the irrigation tube (39) being configured in one mode to move irrigation fluid out of the irrigation tube (39), ([0046]).
Altmann fails to disclose the irrigation tube being configured in another mode to move body fluids from an organ into the irrigation tube. However, McLeod teaches an apparatus which may be configured as a basket catheter ([0050]), wherein an internal lumen can provide both suction and irrigation ([0028]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Altmann to include the irrigation tube/internal lumen being configured to provide both irrigation in one mode and suction in another mode to move body fluids from an organ into the irrigation tube, as taught by McLeod, because the modification would provide both irrigation and suction within one lumen (McLeod; [0028]), eliminating the need to use multiple lumens for irrigation and suction as separate processes, reducing the complexity/bulk of the apparatus, and simplifying use of the apparatus.
Altmann/McLeod fails to teach a reference electrode comprising a distal end, an inner surface, and an outer surface disposed about the longitudinal axis extending along the elongated shaft such that the inner surface faces toward the longitudinal axis and the outer surface faces away from the longitudinal axis, the reference electrode being disposed inside the elongated shaft such that (i) the reference electrode does not protrude beyond the elongated shaft, (ii) a proximal end of each spine electrode is distal to the distal end of the reference electrode along the longitudinal axis, and (iii) the inner surface of the reference electrode is more proximal the longitudinal axis than a distalmost edge of the end effector relative to a width direction of the end effector, the inner surface of the reference electrode being configured to be exposed to body fluids to receive electrical potentials from body fluids that act as a referential signal for the electrical potentials of the at least one spine electrode, and the outer surface of the reference electrode being electrically isolated from the electrical potentials of the body fluids, and the reference electrode being connected to a second wire that is configured to transmit the referential signal to the guidance and drive system; wherein the irrigation tube is in fluidic communication with the inner surface of the reference electrode such that the reference electrode is an extension of the irrigation tube, further wherein the irrigation tube is configured to move body fluids from the organ into the irrigation tube to allow for contact of the body fluids with the inner surface of the reference electrode such that the inner surface of the reference electrode receives the electric potentials from the body fluids that act as the referential signal for the electrical potentials from the at least one spine electrode. However, Hovda (Figures 1 and 7B) teaches an apparatus including a reference electrode (112) comprising an inner surface and an outer surface disposed about a longitudinal axis, corresponding to an irrigation tube (57), extending along an elongated shaft (78) such that the inner surface faces toward the longitudinal axis and the outer surface faces away from the longitudinal axis, the reference electrode (112) being disposed inside the elongated shaft (78) such that the reference electrode (112) does not protrude beyond the elongated shaft (78), the inner surface of the reference electrode (112) being exposed to body fluids ([0063]: body fluids such as blood), and the outer surface of the reference electrode (112) being electrically isolated from the body fluids by the distal end of the elongated shaft (78); wherein an irrigation tube (57) is in fluidic communication with the inner surface of the reference electrode (112) such that the reference electrode (112) is an extension of the irrigation tube (57), ([0103]-[0108], [0055]: the electrode system also measures the electrical properties of the tissue at the tip/end effector).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Altmann/McLeod to include a reference electrode arranged within the irrigation lumen, as taught by Hovda, because the modification would prevent direct electrical contact between the reference electrode of the apparatus and any adjacent body structure. Since the electrodes disclosed by Altmann are configured for ablation in addition to mapping, such direct electrical contact between a body structure and an exposed reference electrode could result in unwanted heating and necrosis of the structure at the point of contact of the reference electrode (Hovda; [0106]). Furthermore, the modified device would include the reference electrode within the irrigation lumen taught by Hovda at the distal end of the elongated shaft (12, 34) disclosed by Altmann for mapping and ablating, within the irrigation tube taught by Altmann/McLeod. The reference electrode may be configured for ablation, mapping, or both, dependent on the configuration of the control system, as evidenced by Koblish et al., (US 20200107877, hereinafter Koblish; [0133], [0392]). Therefore, the modified device would include a reference electrode comprising an inner surface and an outer surface disposed about a longitudinal axis extending along the elongated shaft such that the inner surface faces toward the longitudinal axis and the outer surface faces away from the longitudinal axis, the inner surface of the reference electrode being exposed to body fluids to receive electrical potentials from body fluids that act as a referential signal for the electrical potentials of the at least one spine electrode, and the outer surface of the reference electrode being electrically isolated from the electrical potentials of the body fluids, and the reference electrode being connected to a second wire that is configured to transmit the referential signal to the guidance and drive system. Finally, the reference electrode of the modified device would be disposed inside the elongated shaft such that (i) the reference electrode does not protrude beyond the elongated shaft (since the reference electrode would be attached to the inner surface of the distal end of the elongated shaft), (ii) a proximal end of each spine electrode would be distal to the distal end of the reference electrode along the longitudinal axis (since each spine electrode would be distal to the distal end of the elongated shaft, the reference electrode being attached to the inner surface of the distal end of the elongated shaft), and (iii) the inner surface of the reference electrode would be more proximal the longitudinal axis than a distalmost edge of the end effector relative to a width direction of the end effector (the distalmost edge of the end effector 18 of Altmann relative to the width direction would be the distal edge width of the body 25, which has the same width as the elongated body 12; therefore, the reference electrode, which would be attached to the inner surface of the distal end of the elongated shaft, would have an inner surface which is closer/more proximal to the longitudinal axis than the distal edge width of the body 25); wherein the irrigation tube is in fluidic communication with the inner surface of the reference electrode such that the reference electrode is an extension of the irrigation tube (the reference electrode of the modified device would be within the irrigation tube taught by Altmann/McLeod), further wherein the irrigation tube is configured to move body fluids from the organ into the irrigation tube to allow for contact of the body fluids with the inner surface of the reference electrode such that the inner surface of the reference electrode receives the electric potentials from the body fluids that act as the referential signal for the electrical potentials from the at least one spine electrode (the irrigation tube taught by Altmann/McLeod would provide irrigation and suction, so the irrigation tube of the Altmann/McLeod/Hovda combination would be configured to move body fluids from the organ into the irrigation tube to allow for contact of the body fluids with the inner surface of the reference electrode taught by Hovda such that the inner surface of the reference electrode receives the electric potentials from the body fluids that act as the referential signal for the electrical potentials from the at least one spine electrode).
Regarding claim 2, Altmann/McLeod/Hovda further teaches a connector (Altmann; 34) joining the elongated shaft (Altmann; 12) to the end effector (Altmann; 18), the connector (Altmann; 34) comprising the electrically insulating cover (the distal end of the elongated shaft provides the electrically insulating cover in Hovda; in the modified device, the distal end of the elongated shaft is connector 34; therefore, the connector in the modified device comprises the electrically insulating cover).
Regarding claim 3, Altmann/McLeod/Hovda further teaches the distal end of the reference electrode (Hovda; 112) being approximately coplanar to a distal end of the connector (Altmann; 34).The distal end of the reference electrode 112 is coplanar to the distal end of the elongated shaft in Hovda. In the modified device, the distal end of the elongated shaft is connector 34. Therefore, the distal end of the reference electrode is coplanar to the distal end of the connector in the modified device.
Regarding claim 4, Altmann/McLeod/Hovda further teaches the connector (Altmann; 34) being capable of contacting the cardiovascular tissue while the spine electrodes (Altmann; 27) are in contact with the cardiovascular tissue and the outer surface of the reference electrode (Hovda; 112) is electrically insulated, by the connector (Altmann; 34), from the cardiovascular tissue, as explained in the rejections of claims 1-3 above.
Regarding claim 9, Altmann (Figures 1, 4A, and 6) further discloses the elongated shaft (12, 34) defining a longitudinal axis of the apparatus (10), the end effector (18) comprising three loop members (groups of splines 27) each comprising at least one of the spines (27) and joined at a common distal vertex along the longitudinal axis, each of the three loop members comprising a respective pair of ends affixed to the distal portion of the elongated shaft (12, 34), and the end effector (18) configured to deflect at an angle relative to the longitudinal axis to position the spine electrodes (240) against a planar surface ([0032], [0037], [0050], [0058], [0067]).
Regarding claim 10, Altmann (Figures 1, 4A, and 6) further discloses the spine electrodes (240) being configured to receive electrical potentials from the cardiovascular tissue when in contact with the cardiovascular tissue ([0032], [0058]).
Regarding claim 11, Altmann (Figures 1, 4A, and 6) further discloses the spine electrodes (240) being configured to ablate when in contact with the cardiovascular tissue ([0002], [0032], [0058], [0067]).
Regarding claim 12, Altmann/McLeod/Hovda further teaches the reference electrode (Hovda; 112) comprising a cylindrical member (as seen in Figure 7B of Hovda) disposed about the longitudinal axis with the inner surface of the cylindrical member configured to contact with body fluids when placed into an organ (Hovda; [0103]-[0109]).
Regarding claim 13, Altmann (Figures 1, 4A, and 6) discloses a method comprising: assembling an end effector (18) such that the end effector (18) comprises at least one multi-function spine electrode (240) thereon configured to contact cardiovascular tissue and receive electrical potentials from the tissue that are indicative of electrophysiological signals, the at least one spine electrode (240) being connected to at least one first wire (212) that is configured to transmit the electrophysiological signals to a guidance and drive system ([0050]-[0051], [0058]), as well as perform ablation as needed ([0002], [0050], [0058]), the end effector (18) comprising an unconstrained configuration aligning with a longitudinal axis of an elongated shaft (12), ([0032], [0037]: the spines 27 of end effector 18 are attached to the expander 17, which follows/aligns with the longitudinal axis, at the distal and proximal ends of the spines 27; therefore, the end effector 18 would follow/align with the longitudinal axis no matter which configuration is selected); and affixing the end effector (240) to a distal portion of an elongated shaft (12, 34), the elongated shaft (12, 34) configured to be manipulated at a proximal portion (16) of the elongated shaft (12, 34) to position the distal portion into a heart of a patient ([0002], [0032], [0050], [0058], [0067]); and positioning an irrigation tube (39) within the elongated shaft (12), the irrigation tube (39) being configured in one mode to move irrigation fluid out of the irrigation tube (39), ([0046]).
Altmann fails to disclose the irrigation tube being configured in another mode to move body fluids from an organ into the irrigation tube. However, McLeod teaches an method using an end effector which may be configured as a basket catheter ([0050]), wherein an internal lumen can provide both suction and irrigation ([0028]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Altmann to include the irrigation tube/internal lumen being configured to provide both irrigation in one mode and suction in another mode to move body fluids from an organ into the irrigation tube, as taught by McLeod, because the modification would provide both irrigation and suction within one lumen (McLeod; [0028]), eliminating the need to use multiple lumens for irrigation and suction as separate processes, reducing the complexity/bulk of the method/apparatus, and simplifying use of the method/apparatus.
Altmann/McLeod fails to teach affixing a reference electrode in relation to the end effector such that a tubular inner surface of the reference electrode faces a longitudinal axis of the elongated shaft, does not contact cardiovascular tissue and is exposed to fluids to receive electrical potentials from fluids that act as a referential signal for the electrical potentials received by the at least one spine electrode, the reference electrode being connected to a second wire that is configured to transmit the referential signal to the guidance and drive system; electrically insulating an outer surface of the reference electrode such that the outer surface faces away from the longitudinal axis and is electrically isolated from the electrical potentials from fluids approximate the cardiovascular tissue while the inner surface is configured to receive the electrical potentials of the fluids; and affixing the reference electrode to a distal portion of an elongated shaft such that (i) the reference electrode is disposed inside the elongated shaft, (ii) a proximal end of the at least one spine electrode is distal to a distal end of the reference electrode along the longitudinal axis, and (iii) the inner surface of the reference electrode is more proximal the longitudinal axis than a distalmost edge of the end effector relative to a width direction of the end effector; wherein the irrigation tube is positioned in fluidic communication with the inner surface of the reference electrode such that the reference electrode is an extension of the irrigation tube, the irrigation tube being configured to allow for contact of the body fluids with the inner surface of the reference electrode such that the inner surface of the reference electrode receives the electric potentials from the body fluids that act as the referential signal for the electrical potentials from the at least one spine electrode. However, Hovda (Figures 1 and 7B) teaches a method comprising affixing a reference electrode (112) in relation to an end effector (104) such that a tubular inner surface of the reference electrode (112) faces a longitudinal axis, corresponding to an irrigation tube (57), of an elongated shaft (78), does not contact cardiovascular tissue and is configured to be exposed to fluids ([0063]: body fluids such as blood); electrically insulating an outer surface of the reference electrode (112) such that the outer surface faces away from the longitudinal axis and is electrically isolated; wherein an irrigation tube (57) is positioned in fluidic communication with the inner surface of the reference electrode (112) such that the reference electrode (112) is an extension of the irrigation tube (57), ([0103]-[0109], [0055]: the electrode system also measures the electrical properties of the tissue at the tip/end effector).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Altmann/McLeod to include the reference electrode within the irrigation tube, as taught by Hovda, because the modification would prevent direct electrical contact between the reference electrode of the apparatus and any adjacent body structure. Since the electrodes disclosed by Altmann are configured for ablation in addition to mapping, such direct electrical contact between a body structure and an exposed reference electrode could result in unwanted heating and necrosis of the structure at the point of contact of the reference electrode (Hovda; [0106]). Furthermore, the modified method would include the reference electrode within the irrigation tube, as taught by Hovda, at the distal end of the elongated shaft (12, 34) disclosed by Altmann for mapping and ablating, within the irrigation tube taught by Altmann/McLeod. The reference electrode may be configured for ablation, mapping, or both, dependent on the configuration of the control system, as evidenced by Koblish et al., (US 20200107877, hereinafter Koblish; [0133], [0392]). Therefore, the modified method would include affixing a reference electrode in relation to the end effector such that a tubular inner surface of the reference electrode faces a longitudinal axis of the elongated shaft, does not contact cardiovascular tissue and is configured to be exposed to fluids to receive electrical potentials from fluids that act as a referential signal for the electrical potentials received by the at least one spine electrode, the reference electrode being connected to a second wire that is configured to transmit the referential signal to the guidance and drive system; electrically insulating an outer surface of the reference electrode such that the outer surface faces away from the longitudinal axis and is electrically isolated from the electrical potentials from fluids approximate the cardiovascular tissue while the inner surface is capable of receiving the electrical potentials of the fluids. Finally, the reference electrode of the modified method would be affixed to the distal portion of the elongated shaft such that (i) the reference electrode does not protrude beyond the elongated shaft (since the reference electrode would be attached to the inner surface of the distal end of the elongated shaft), (ii) a proximal end of each spine electrode would be distal to the distal end of the reference electrode along the longitudinal axis (since each spine electrode would be distal to the distal end of the elongated shaft, the reference electrode being attached to the inner surface of the distal end of the elongated shaft) , and (iii) the inner surface of the reference electrode would be more proximal the longitudinal axis than a distalmost edge of the end effector relative to a width direction of the end effector (the distalmost edge of the end effector 18 of Altmann relative to the width direction would be the distal edge width of the body 25, which has the same width as the elongated body 12; therefore, the reference electrode, which would be attached to the inner surface of the distal end of the elongated shaft, would have an inner surface which is closer/more proximal to the longitudinal axis than the distal edge width of the body 25); and positioning the irrigation tube in fluidic communication with the inner surface of the reference electrode such that the reference electrode is an extension of the irrigation tube (the reference electrode of the modified device would be within the irrigation tube taught by Altmann/McLeod), the irrigation tube being configured to allow for contact of the body fluids with the inner surface of the reference electrode such that the inner surface of the reference electrode receives the electric potentials from the body fluids that act as the referential signal for the electrical potentials from the at least one spine electrode (the irrigation tube taught by Altmann/McLeod would provide irrigation and suction, so the irrigation tube of the Altmann/McLeod/Hovda combination would be configured to move body fluids from the organ into the irrigation tube to allow for contact of the body fluids with the inner surface of the reference electrode taught by Hovda such that the inner surface of the reference electrode receives the electric potentials from the body fluids that act as the referential signal for the electrical potentials from the at least one spine electrode).
Regarding claim 14, Altmann/McLeod/Hovda further teaches joining the elongated shaft (Altmann; 12) to the end effector (Altmann; 18) with a connector (Altmann; 34); and electrically insulating a portion of the outer surface of the reference electrode (Hovda; 112) with the connector (Altmann; 34) so that an electrically exposed portion of the outer surface is positioned to preclude the exposed portion from coming into contact with tissue during treatment. The distal end of the elongated shaft provides the electrically insulating cover in Hovda. In the modified method, the distal end of the elongated shaft is connector 34. Therefore, the connector in the modified method comprises the electrically insulating cover such that an electrically exposed portion of the outer surface is positioned to preclude the exposed portion from coming into contact with tissue during treatment.
Regarding claim 15, Altmann/McLeod/Hovda further teaches affixing the reference electrode (Hovda; 112) and the connector (Altmann; 34) such that the distal end of the reference electrode (Hovda; 112) and a distal end of the connector (Altmann; 34) are approximately coplanar and coaxial to each other. The distal end of the reference electrode 112 is coplanar and coaxial to the distal end of the elongated shaft in Hovda. In the modified method, the distal end of the elongated shaft is connector 34. Therefore, the distal end of the reference electrode is coplanar and coaxial to the distal end of the connector in the modified device.
Regarding claim 16, Altmann/McLeod/Hovda further teaches joining the elongated shaft (Altmann; 12, 34) to the end effector (Altmann; 18) such that the connector (Altmann; 34) is capable of contacting the cardiovascular tissue while the spine electrode (Altmann; 240) is in contact with the cardiovascular tissue and while the reference electrode (Hovda; 112) is electrically insulated, by the connector (Altmann; 34), from the cardiovascular tissue, as explained in the rejections of claims 13-15 above.
Regarding claim 18, Altmann (Figures 1, 4A, and 6) discloses a method comprising: moving a distal portion of an elongated shaft (12, 34) and an end effector (18) extending distally from the distal portion through a catheter (guiding sheath) to a heart, the end effector (18) comprising an unconstrained configuration aligning with a longitudinal axis extending along the elongated shaft (12), ([0032], [0037]: the spines 27 of end effector 18 are attached to the expander 17, which follows/aligns with the longitudinal axis, at the distal and proximal ends of the spines 27; therefore, the end effector 18 would follow/align with the longitudinal axis extending along the elongated shaft no matter which configuration is selected); moving the end effector (18) from a distal end of the catheter (guiding sheath) via manipulation of a proximal portion of the elongated shaft (12, 34); opposing spine electrodes (240), carried by the end effector (18), to cardiovascular tissue via manipulation of the proximal portion (16) of the elongated shaft (12, 34); and receiving, while the spine electrodes (240) are opposed to the cardiovascular tissue, electrical potentials from the cardiovascular tissue via the spine electrodes (240) that are indicative of electrophysiological signals; transmitting the electrophysiological signals to a guidance and drive system ([0032], [0037], [0050], [0058], [0067]), and moving irrigation fluid out of an irrigation tube (39) to a target area ([0046]).
Altmann fails to disclose also moving fluids approximate the cardiovascular tissue into the irrigation tube. However, McLeod teaches an method using an end effector which may be configured as a basket catheter ([0050]), wherein an internal lumen can provide both suction and irrigation ([0028]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Altmann to include the irrigation tube/internal lumen being configured to provide both irrigation in one mode and suction in another mode to move body fluids approximate the cardiovascular tissue into the irrigation tube, as taught by McLeod, because the modification would provide both irrigation and suction within one lumen (McLeod; [0028]), eliminating the need to use multiple lumens for irrigation and suction as separate processes, reducing the complexity/bulk of the method/apparatus, and simplifying use of the method/apparatus.
Altmann/McLeod fails to teach receiving, while the spine electrodes are opposed to the cardiovascular tissue, electrical potentials from fluids approximate the cardiovascular tissue via an inner surface of a reference electrode, the electrical potentials of the fluids acting as a referential signal for the electrical potentials received by the spine electrodes, the reference electrode being disposed inside the elongated shaft such that a proximal end of each spine electrode distal to a distal end of the reference electrode along a longitudinal axis of the elongated shaft and the inner surface of the reference electrode is more proximal the longitudinal axis than a distalmost edge of the end effector relative to a width direction of the end effector, the inner surface facing toward the longitudinal axis, an outer surface of the reference electrode facing away from the longitudinal axis and being electrically insulated from the electrical potentials; the irrigation tube being in fluidic communication with the inner surface of the reference electrode such that the reference electrode is an extension of the irrigation tube; and transmitting the referential signal to the guidance and drive system. However, Hovda (Figures 1 and 7B) teaches a method comprising receiving electrical potentials via an inner surface of a reference electrode (112), the reference electrode (112) being disposed inside an elongated shaft (78), the inner surface facing toward a longitudinal axis, corresponding to an irrigation tube (57), of the elongated shaft (78), an outer surface of the reference electrode (112) facing away from the longitudinal axis and being electrically insulated; the irrigation tube (57) being in fluidic communication with the inner surface of the reference electrode (112) such that the reference electrode (112) is an extension of the irrigation tube (57), ([0103]-[0109], [0055]: the electrode system also measures the electrical properties of the tissue at the tip/end effector).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Altmann to include the reference electrode within the irrigation tube, as taught by Hovda, because the modification would prevent direct electrical contact between the reference electrode of the apparatus and any adjacent body structure. Since the electrodes disclosed by Altmann are configured for ablation in addition to mapping, such direct electrical contact between a body structure and an exposed reference electrode could result in unwanted heating and necrosis of the structure at the point of contact of the reference electrode (Hovda; [0106]). Furthermore, the modified method would include the reference electrode within the irrigation tube, as taught by Hovda, at the distal end of the elongated shaft (12, 34) disclosed by Altmann for mapping and ablating, within the irrigation tube taught by Altmann/McLeod. The reference electrode may be configured for ablation, mapping, or both, dependent on the configuration of the control system, as evidenced by Koblish et al., (US 20200107877, hereinafter Koblish; [0133], [0392]). Therefore, the modified method would include receiving, while the spine electrodes are opposed to the cardiovascular tissue, electrical potentials from fluids approximate the cardiovascular tissue via an inner surface of a reference electrode, the reference electrode being disposed inside the elongated shaft, the inner surface facing toward the longitudinal axis, an outer surface of the reference electrode facing away from the longitudinal axis and being electrically insulated from the electrical potentials; and transmitting the referential signal to the guidance and drive system. Finally, the reference electrode of the modified method would be disposed inside the elongated shaft such that a proximal end of each spine electrode is distal to a distal end of the reference electrode along a longitudinal axis of the elongated shaft (since each spine electrode would be distal to the distal end of the elongated shaft, the reference electrode being attached to the inner surface of the distal end of the elongated shaft) and the inner surface of the reference electrode is more proximal the longitudinal axis than a distalmost edge of the end effector relative to a width direction of the end effector (the distalmost edge of the end effector 18 of Altmann relative to the width direction would be the distal edge width of the body 25, which has the same width as the elongated body 12; therefore, the reference electrode, which would be attached to the inner surface of the distal end of the elongated shaft, would have an inner surface which is closer/more proximal to the longitudinal axis than the distal edge width of the body 25).; the irrigation tube being in fluidic communication with the inner surface of the reference electrode such that the reference electrode is an extension of the irrigation tube (the irrigation tube taught by Altmann/McLeod would provide irrigation and suction, so the irrigation tube of the Altmann/McLeod/Hovda combination would be configured to move body fluids from the organ into the irrigation tube to allow for contact of the body fluids with the inner surface of the reference electrode taught by Hovda such that the inner surface of the reference electrode receives the electric potentials from the body fluids).
Regarding claim 19, Altmann/McLeod/Hovda further teaches contacting, to the cardiovascular tissue, while the spine electrodes (Altmann; 240) are opposed to the cardiovascular tissue, a connector (Altmann; 34) joining the end effector (Altmann; 18) to the distal portion of the elongated shaft (Altmann; 12, 34) and electrically insulating the outer surface of the reference electrode (Hovda; 112) from the electrical potentials. The distal end of the elongated shaft provides the electrically insulating cover in Hovda. In the modified method, the distal end of the elongated shaft is connector 34. Therefore, the connector in the modified method comprises the electrically insulating cover to electrically insulate the outer surface of the reference electrode from the electrical potentials.
Regarding claim 20, Altmann (Figures 1, 4A, and 6) deflecting the end effector (18) at an angle relative to a longitudinal axis defined by the elongated shaft (12, 34) to oppose the spine electrodes (240) to the cardiovascular tissue; and ablating the cardiovascular tissue via the spine electrodes (240), while the spine electrodes (240) are opposed to the cardiovascular tissue ([0032], [0037], [0050], [0058], [0067]).
Regarding claim 21, Altmann/McLeod/Hovda further teaches the irrigation tube (Altmann; 39) being positioned within a lumen of the reference electrode or around the outer surface of the reference electrode (Hovda; 112).
Regarding claim 22, Altmann/McLeod/Hovda further teaches the irrigation tube (Altmann; 39) being positioned within a lumen of the reference electrode or around the outer surface of the reference electrode (Hovda; 112).
Regarding claim 23, Altmann/McLeod/Hovda further teaches the irrigation tube (Altmann; 39) being positioned within a lumen of the reference electrode or around the outer surface of the reference electrode (Hovda; 112).
Regarding claim 24, Altmann/McLeod/Hovda further teaches the guidance and drive system comprising a processor and a non-transitory computer readable memory storing instructions that, when executed by the processor, cause the processor to receive the electrophysiological signals and receive the referential signal. Specifically, the guidance and drive system (mapping system) disclosed by Altmann ([0058]) requires a processor and a non-transitory computer readable memory storing instructions that, when executed by the processor, cause the processor to receive the electrophysiological signals and receive the referential signal, as evidenced by Koblish ([0297], [0653]-[0654]).
Regarding claim 25, Altmann/McLeod/Hovda further teaches connecting the end effector to a guidance and drive system, the guidance and drive system comprising a processor and a non-transitory computer readable memory storing instructions that, when executed by the processor, cause the processor to receive the electrophysiological signals and receive the referential signal. Specifically, the end effector (18) is connected to the guidance and drive system (mapping system) disclosed by Altmann ([0058]), which requires a processor and a non-transitory computer readable memory storing instructions that, when executed by the processor, cause the processor to receive the electrophysiological signals and receive the referential signal, as evidenced by Koblish ([0297], [0653]-[0654]).
Regarding claim 26, Altmann/McLeod/Hovda further teaches receiving, at the guidance and drive system, the electrophysiological signals and the referential signal. Specifically, the guidance and drive system (mapping system) disclosed by Altmann ([0058]) must be configured to receive the electrophysiological signals and receive the referential signal, as evidenced by Koblish ([0297], [0653]-[0654]).
Claim(s) 5 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Altmann/McLeod/Hovda, as applied to claims 1-2 above, and further in view of Hoitink et al., (US 20160143588; hereinafter Hoitink).
Regarding claim 5, Altmann/McLeod/Hovda teaches the apparatus of claim 2, wherein the connector (Altmann; 34) comprises a tubular outer surface comprising a diameter measured orthogonal to the longitudinal axis (Altmann; Figure 6), but fails to teach the unconstrained configuration aligning with a longitudinal axis of the apparatus, the connector comprising a tubular outer surface comprising a diameter measured orthogonal to the longitudinal axis, the end effector comprising a height measured orthogonal to the longitudinal axis and a width measured orthogonal to the height and longitudinal axis when the end effector is in the unconstrained configuration, the height measuring approximately equal to or less than the diameter of the tubular outer surface of the connector, and the width measuring greater than the diameter of the tubular outer surface of the connector. However, Hoitink (Figures 6-8C) teaches an apparatus with an end effector (generally element 15, specific embodiment shown in Figure 8C) comprising an unconstrained configuration aligned with a longitudinal axis of the apparatus, the end effector (15) comprising a height measured orthogonal to the longitudinal axis and a width measured orthogonal to the height and longitudinal axis when the end effector (15) is in the unconstrained configuration, the height measuring approximately equal to or less than the diameter of a tubular outer surface of a connector (46), and the width measuring greater than the diameter of the tubular outer surface of the connector (46), ([0006], [0037], [0050], [0063]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Altmann/McLeod/Hovda to include the end effector comprising an unconstrained configuration aligned with a longitudinal axis of the apparatus, the connector comprising a tubular outer surface comprising a diameter measured orthogonal to the longitudinal axis, the end effector comprising a height measured orthogonal to the longitudinal axis and a width measured orthogonal to the height and longitudinal axis when the end effector is in the unconstrained configuration, the height measuring approximately equal to or less than the diameter of the tubular outer surface of the connector, and the width measuring greater than the diameter of the tubular outer surface of the connector, as taught by Hoitink, because the modification would provide uniformity and predictability in electrode placement on the tissue surface with very high density signals (Hoitink; [0006]).
Regarding claim 8, Altmann/McLeod/Hovda teaches the apparatus of claim 1, but fails to teach the spine electrodes positioned to form a grid when the spine electrodes are configured to contact with the cardiovascular tissue. However, Hoitink (Figures 6-8C) teaches an apparatus with an end effector (generally element 15, specific embodiment shown in Figure 8C) comprising spine electrodes (37) positioned to form a grid when the spine electrodes (37) are configured to contact with the cardiovascular tissue ([0006], [0037], [0050], [0063]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Altmann/McLeod/Hovda to include the spine electrodes positioned to form a grid when the spine electrodes are configured to contact with the cardiovascular tissue, as taught by Hoitink, because the modification would provide uniformity and predictability in electrode placement on the tissue surface with very high density signals (Hoitink; [0006]).
Response to Arguments
Applicant's arguments filed 01/02/2026 have been fully considered but they are not persuasive.
With regard to Applicant’s argument that the cited combination of references fails to teach the newly amended limitations directed to the spine electrode configured to “at least one spine electrode configured to…receive electrical potentials from the tissue that are indicative of electrophysiological signals, the at least one spine electrode being connected to at least one first wire that is configured to transmit the electrophysiological signals to a guidance and drive system” and “the reference electrode being connected to a second wire that is configured to transmit the referential signal to the guidance and drive system,” Examiner respectfully disagrees. The primary Altmann reference discloses the base mapping/ablation system comprising at least one spine electrode 240 configured to receive electrical potentials from the tissue that are indicative of electrophysiological signals, the at least one spine electrode being connected to at least one first wire that is configured to transmit the electrophysiological signals to a guidance and drive system ([0050]-[0051], [0058]). Hovda teaches a specific reference electrode to be used in combination with at least one active electrode. Although the reference electrode is configured as an ablation reference electrode in Hovda, it is known in the art to use an electrode as a mapping, ablation, or both electrode, depending on how the electrode is configured with the control system, as evidenced by Koblish ([0133], [0392]). Accordingly, since the primary reference discloses a control system capable of both ablation and mapping (Altmann; [0058]), the modified device/method taught by Altmann/McLeod/Hovda would include a mapping system including the active spine electrodes disclosed by Altmann with a respective reference electrode as taught by Hovda configured to receive referential signals in combination with the active electrodes. Therefore, Examiner maintains that the cited combination of references teaches the invention as recited at least in amended independent claims 1, 13, and 18.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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