DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed August 12, 2026 has been entered. Applicant’s amendments have overcome the 112(b) rejection and the Double Patent rejection of U.S. Application No. 20230105973 A1 previously set-forth in the Non-Final Office Action mailed on 05/12/2026. Currently, claims 1, 5, 14, and 16 have been amended, and claims 1-19 are pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites the limitation "the geometric model" in line 8 of page 6. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner if this geometric model refers to the first and the second geometric model previously cited in the claim, or if it is third geometric model. For examination purposes, Examiner will treat the geometric model as being the plural representation of the first and the second geometric models. Claims 17-19 are also rejected because they are dependent on claim 16.
Claim 16 recites the limitation "a plurality of deployment states" in line 10 of page 6. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this plurality of deployment states is different from the plurality of deployment states previously cited in the claim, or if they are the same plurality of deployment states. For examination purposes, Examiner will treat both of the plurality of deployment states as the same. Claims 17-19 are also rejected because they are dependent on claim 16.
Claim 18 recites the limitation "the geometric model" in line 1. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner if this geometric model refers to the first and the second geometric model previously cited in independent claim 16, or if it is third geometric model. For examination purposes, Examiner will treat the geometric model as being the plural representation of the first and the second geometric models. Claim 19 is also rejected because it is dependent on claim 18.
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.
Claims 1-12, 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan (U.S. Application No. 10842572 B1), in view of Raju (U.S. Application No. 20200046423A1), and further in view of Chou (U.S. Application No. 20210169394 A1).
Regarding independent claim 1, Viswanathan discloses a system (100) for electroporation ablation (Col. 5, lines 26-29 & Figs. 1B-2B), comprising:
at least one tracking electrode (set of surface electrode patches) (Col. 3, lines 47-58) configured to deliver a tracking current (Col. 3, lines 47-50; Col. 5, lines 6-12);
an ablation catheter (110, 200) including an electrode assembly, the electrode assembly including a plurality of splines (230) each including a plurality of ablation electrodes (116, 118, 232, 234, 236, 238) disposed thereon (Col. 5, lines 29-32; Col. 8, lines 50-57), the ablation catheter being configured such that the electrode assembly can be positioned proximate to target tissue (Col. 5, lines 26-29; Col. 8, lines 50-57), wherein the plurality of ablation electrodes are configured to measure electrical signals (voltages, currents or both) associated with the tracking current (Col. 3, lines 52-58). Specifically, in the embodiment where receiver(s) (118) are integrated into the ablation catheter so that the electrodes on the catheter are also able to sense voltage potentials generated by the field generator(s)(146) (Col. 6, lines 25-28); wherein each spline of the plurality of splines is configured to deform between a first shape (a substantially linear shape) in which the spline is arranged substantially parallel to a longitudinal axis of the ablation catheter and a second shape (a bulb-like shape) (Col. 8, line 65 – Col. 9, line 10); and
one or more processors (42, 142) configured to:
receive the measured electrical signals (Col. 5, lines 6-21);
estimate a position of each ablation electrode with respect to the at least one tracking electrode based on the measured electrical signals (Col. 5, lines 6-21); and
determine a deployment state (i.e., undeployed, partial deployed, or fully deployed) (Col. 9, lines 6-10) of the electrode assembly, based on a geometric model (a visual representation) of the ablation catheter and the estimated positions of the ablation electrodes (Col. 7, lines 6-11; Col. 8, lines 66-67 – Col. 9, lines 1-17); and
update the estimated positions of the ablation electrode (in real-time, e.g., within fractions of a second) based on the geometric model (Col. 6, lines 62-67 – Col. 7, lines 1-10; Col. 18, lines 17-28).
However, Viswanathan does not disclose the second shape being a configuration where the spline forms a petal-like curve having a turning point.
Raju, in the same field of endeavor, teaches a catheter comprising a plurality of electrodes (2634) disposed on a set of splines (2620), wherein the splines are flexible and may transition between a first configuration where the set of splines are arranged generally parallel to a longitudinal axis of the ablation device to a second configuration where the set of splines rotate around, or twist and bend, and generally bias away from the longitudinal axis of the ablation device to form a petal-like curve arranged generally perpendicular to the longitudinal axis (pa. 0116 & Figs. 26A-26C). In this manner, the set of splines more easily conform to the geometry of an endocardial space (pa. 0116).
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 the second shape of the ablation catheter of Viswanathan to be the petal-like curve having a turning point, as taught by Raju, for the purpose of allowing the splines to more easily conform to the geometry of an endocardial space (Raju, pa. 0116).
However, Viswanathan/Raju combination do not disclose updating the estimated positions of the ablation electrodes by applying constraints from the geometric model to refine the estimated positions after the initial estimation, wherein the constraints encode physical behavior of the plurality of splines across a plurality of deployment states of the electrode assembly.
Chou, in the same field of endeavor, teaches a mapping catheter (10) comprising an electrode array (12) electrically connected to a mapping console (20) of a mapping subsystem (100), wherein the mapping subsystem includes a localization (LOC) module (150) configured to localize (e.g. determine the position and/or orientation of) the mapping catheter within a patient (pa. 0068 & Fig. 1). The mapping console includes a localization (LOC) processor (46) configured to perform various calculation such as, performing a “fitting” to align measured electrode positions with known possible configurations, which is further optimized with one or more constraints (e.g. a physical constraints, such as distance between two electrodes on a single spline, distance between two electrodes on two different splines, maximum distance between two electrodes, minimum distance between two electrodes, and/or minimum and/or maximum curvature of a spine, and the like) (pa. 0140).
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 incorporated the functionality of the localization processor taught by Chou, including the implementation of the fitting to align measured electrode positions with known possible configurations and to further refine the estimated electrode position with the one or more physical constraints, to the processor of Viswanathan for the purpose of providing a more accurate geometric model of the ablation catheter based on a specific spine configuration/deployment state.
Regarding claim 2, Viswanathan/Raju/Chou combination discloses wherein the one or more processors are further configured to:
access a field map (i.e., generated by the mapping system 140) (Viswanathan, Col. 5, lines 60-61, lines 64-66; Col. 6, lines 16-18); and
estimate the electrode positions based on the measured electrical signals and the field map (Viswanathan, Col. 8, lines 25-36).
Regarding claim 3, Viswanathan/Raju/Chou combination discloses wherein the field map is generated by a mapping catheter (Viswanathan, Col. 10, lines 65-67 – Col. 11, lines 1-2).
Regarding claim 4, Viswanathan/Raju/Chou combination discloses wherein the ablation catheter further comprises a navigation sensor (i.e., a receiver sensor) (Viswanathan, Col. 9, lines 27-34), wherein the one or more processors are configured to generate the field map based on sensing signals collected by the ablation electrode, wherein the ablation electrode has a known position relative to the navigation sensor (Viswanathan, Col. 11, lines 27-37).
Regarding claim 5, Viswanathan/Raju combination discloses the invention substantially as claimed in claim 1 discussed above.
However, they do not disclose wherein the one or more constraints applied to update the estimated positions include one or more constraints on one or more relative positions of the plurality of ablation electrodes, wherein the one or more relative position constraints govern spatial relationships between ablation electrodes in the petal-like curve configuration of the plurality of splines.
Chou, in the same field of endeavor, teaches a mapping catheter (10) comprising an electrode array (12) electrically connected to a mapping console (20) of a mapping subsystem (100), wherein the mapping subsystem includes a localization (LOC) module (150) configured to localize (e.g. determine the position and/or orientation of) the mapping catheter within a patient (pa. 0068 & Fig. 1). The mapping console includes a localization (LOC) processor (46) configured to perform various calculation such as, performing a “fitting” to align measured electrode positions with known possible configurations, which is further optimized with one or more constraints (e.g. a physical constraints, such as distance between two electrodes on a single spline, distance between two electrodes on two different splines, maximum distance between two electrodes, minimum distance between two electrodes, and/or minimum and/or maximum curvature of a spine, and the like) (pa. 0140).
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 incorporated the functionality of the localization processor taught by Chou, including the implementation of the fitting to align measured electrode positions with known possible configurations and to further refine the estimated electrode position with the one or more physical constraints, to the processor of Viswanathan for the purpose of providing a more accurate geometric model of the ablation catheter based on the spatial relationships between ablation electrodes in the petal-like curve configuration of the plurality of splines.
Regarding claim 6, Viswanathan/Raju/Chou combination discloses wherein the geometric model includes a relative position for two ablation electrodes disposed on one spline of the plurality of splines (Viswanathan, Col. 11, lines 62-65).
Regarding claim 7, Viswanathan/Raju/Chou combination discloses wherein the geometric model includes a relative electrode position for two or more ablation electrodes, each being disposed on a respective spline of the plurality of splines (Viswanathan, Col. 11, lines 44-49; Col. 12, lines 12-15).
Regarding claim 8, Viswanathan/Raju/Chou combination discloses wherein the ablation catheter includes a longitudinal axis (e.g., an imaginary line that is parallel to the shaft) defined by a catheter shaft (210), wherein the electrode assembly extends from the catheter shaft, wherein the two or more ablation electrodes form a plane generally perpendicular to the longitudinal axis (Viswanathan, Col. 8, lines 54-61 & Figs. 2A-2B).
Regarding claim 9, Viswanathan/Raju/Chou combination discloses wherein the geometric model includes a first predetermined radius range (i.e., the diameter 310) of a first portion of a spline of the plurality of splines (Viswanathan, Col. 11, lines 44-54 & Fig. 3).
Regarding claim 10, Viswanathan/Raju/Chou combination discloses wherein the geometric model includes a second predetermined radius range (i.e., the diameter 330) of a second portion of the spline of the plurality of splines (Viswanathan, Col. 11, lines 44-54 & Fig. 3), wherein the second portion of the spline of the plurality of splines is different from the first portion of the spline of the plurality of splines, wherein the second predetermined radius range is different from the first predetermined radius range (Viswanathan, see Fig. 3).
Regarding claims 11, Viswanathan/Raju/Chou combination discloses further comprising:
a deployment sensor (an electromagnetic tracking sensor) (Viswanathan, Col. 3, lines 35-38) configured to collect data (magnetic field) associated with a deployment state (Viswanathan, Col. 3, lines 66-67 – Col. 4, lines 1-4; Col. 4, lines 62-67 – Col. 5, lines 1-21);
wherein the one or more processors are configured to:
receive the collected data associated with the deployment state (Viswanathan, Col. 5, lines 6-21); and
select the geometric model based on the collected data (Viswanathan, Col. 11, lines 27-44).
Regarding claim 12, Viswanathan/Raju/Chou combination discloses wherein the at least one tracking electrodes includes a first tracking electrode configured to be disposed on a body surface of a patient (Viswanathan, Col. 3, lines 47-52).
Regarding independent claim 14, Viswanathan discloses a method of electroporation ablation (Col. 5, lines 26-29 & Figs. 1A-2B), comprising:
deploying an ablation catheter (110, 200) proximate to target tissue (Col. 5, lines 26-29; Col. 8, lines 50-57), the ablation catheter including an electrode assembly, the electrode assembly including a plurality of splines (230) each including a plurality of electrodes (116, 118, 232, 234, 236, 238) disposed thereon (Col. 5, lines 29-32; Col. 8, lines 50-57). Specifically, in the embodiment where receiver(s) (118) are integrated into the ablation catheter so that the electrodes on the catheter are also able to sense voltage potentials generated by the field generator(s)(146) (Col. 6, lines 25-28); wherein each spline of the plurality of splines is configured to deform between a first shape (a substantially linear shape) in which the spline is arranged substantially parallel to a longitudinal axis of the ablation catheter and a second shape (a bulb-like shape) (Col. 8, line 65 – Col. 9, line 10);
deploying one or more tracking electrodes (set of surface electrode patches) to one or more target locations (surface of a patient) (Col. 3, lines 47-58);
injecting a current via the one or more tracking electrodes (Col. 3, lines 47-50; Col. 5, lines 6-12);
measuring electrical signals (voltages, currents or both) via at least one of the plurality of electrodes associated with each of the plurality of splines (Col. 3, lines 52-58);
estimating an electrode position (using processor 42, 142) corresponding the plurality of electrodes based on the measured electrical signals (Col. 6, lines 32-41; Col. 11, lines 27-37); and
updating the electrode position (in real-time, e.g., within fractions of a second) based on a geometric model (a visual representation) of the ablation catheter (Col. 6, lines 62-67 – Col. 7, lines 1-10; Col. 18, lines 17-28).
However, Viswanathan does not disclose the second shape being a configuration where the spline forms a petal-like curve having a turning point.
Raju, in the same field of endeavor, teaches a catheter comprising a plurality of electrodes (2634) disposed on a set of splines (2620), wherein the splines are flexible and may transition between a first configuration where the set of splines are arranged generally parallel to a longitudinal axis of the ablation device to a second configuration where the set of splines rotate around, or twist and bend, and generally bias away from the longitudinal axis of the ablation device to form a petal-like curve arranged generally perpendicular to the longitudinal axis (pa. 0116 & Figs. 26A-26C). In this manner, the set of splines more easily conform to the geometry of an endocardial space (pa. 0116).
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 the second shape of the ablation catheter of Viswanathan to be the petal-like curve having a turning point, as taught by Raju, for the purpose of allowing the splines to more easily conform to the geometry of an endocardial space (Raju, pa. 0116).
However, Viswanathan/Raju combination do not disclose updating the electrode positions by applying constraints from the geometric model to refine the estimated positions after the initial estimation, wherein the constraints encode physical behavior of the plurality of splines across a plurality of deployment states.
Chou, in the same field of endeavor, teaches a mapping catheter (10) comprising an electrode array (12) electrically connected to a mapping console (20) of a mapping subsystem (100), wherein the mapping subsystem includes a localization (LOC) module (150) configured to localize (e.g. determine the position and/or orientation of) the mapping catheter within a patient (pa. 0068 & Fig. 1). The mapping console includes a localization (LOC) processor (46) configured to perform various calculation such as, performing a “fitting” to align measured electrode positions with known possible configurations, which is further optimized with one or more constraints (e.g. a physical constraints, such as distance between two electrodes on a single spline, distance between two electrodes on two different splines, maximum distance between two electrodes, minimum distance between two electrodes, and/or minimum and/or maximum curvature of a spine, and the like) (pa. 0140).
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 incorporated the functionality of the localization processor taught by Chou, including the implementation of the fitting to align measured electrode positions with known possible configurations and to further refine the estimated electrode position with the one or more physical constraints, to the processor of Viswanathan for the purpose of providing a more accurate geometric model of the ablation catheter based on a specific spine configuration/deployment state.
Regarding claims 15 and 17, Viswanathan/Raju/Chou combination discloses further comprising:
accessing a field map (i.e., generated by the mapping system 140) (Viswanathan, Col. 5, lines 60-61, lines 64-66; Col. 6, lines 16-18);
wherein each electrode position is estimated based on the measured electrical signals and the field map (Viswanathan, Col. 8, lines 25-36).
Regarding independent claim 16, Viswanathan discloses a system for electroporation ablation (Col. 5, lines 26-29 & Figs. 1A-2B), comprising:
one or more tracking electrodes (set of surface electrode patches) (Col. 3, lines 47-58) configured to deliver a tracking current (Col. 3, lines 47-50; Col. 5, lines 6-12);
an ablation catheter (110, 200) including an electrode assembly, the electrode assembly including a plurality of splines (230) each including a plurality of electrodes (116, 118, 232, 234, 236, 238) (Col. 5, lines 29-32; Col. 8, lines 50-57), the ablation catheter capable of being disposed proximate to a target tissue (Col. 5, lines 26-29; Col. 8, lines 50-57), wherein the plurality of electrodes includes a plurality of sensing electrodes. Specifically, in the embodiment where receiver(s) (118) are integrated into the ablation catheter so that the electrodes on the catheter are also able to sense voltage potentials generated by the field generator(s)(146) (Col. 6, lines 25-28),
wherein the sensing electrodes are configured to measure electrical signals (voltages, currents or both) when the tracking current is delivered (Col. 3, lines 52-58); wherein each spline of the plurality of splines is configured to deform between a first shape (a substantially linear shape) in which the spline is arranged substantially parallel to a longitudinal axis of the ablation catheter and a second shape (a bulb-like shape) (Col. 8, line 65 – Col. 9, line 10);
wherein the electrode assembly has a plurality of deployment states (e.g., undeployed, partial deployed, and fully deployed) (Col. 9, lines 6-10), wherein the electrode assembly is in a first shape (e.g., when the splines have a largest diameter) when the electrode assembly is at a first state (fully deployed) of the plurality of deployment states, wherein the electrode assembly is in a second shape (e.g., when the splines have a lowest diameter/are fully compressed, or when they partially expanded) when the electrode assembly is at a second state (delivery or retrieval of the catheter device to/from the patient, or when transitioning to a second location inside the patient) of the plurality of deployment states (Col. 7, lines 6-11; Col. 8, lines 66-67 – Col. 9, lines 1-17);
wherein the first state corresponds to a first geometric model, and the second state corresponds to a second geometric model (Col. 6, lines 62-67 – Col. 7, lines 1-10; Col. 18, lines 17-28); and
a deployment sensor (an electromagnetic tracking sensor) (Col. 3, lines 35-38) configured to collect data (magnetic field) associated with a deployment state (Col. 3, lines 66-67 – Col. 4, lines 1-4; Col. 4, lines 62-67 – Col. 5, lines 1-21);
one or more processors (42, 142) configured to:
receive the measured electrical signals (Col. 5, lines 6-21);
estimate each electrode position based on the measured electrical signals (Col. 5, lines 6-21);
receive the collected data associated with the deployment state (Col. 5, lines 6-21);
select a selected geometric model from the first geometric model and the second geometric model based on deployment collected data (Col. 11, lines 27-44); and
determine a shape of the ablation catheter, based on the selected geometric model of the ablation catheter and the estimated electrode positions (Col. 11, lines 27-44).
However, Viswanathan does not disclose the second shape of the splines being a configuration where the spline forms a petal-like curve having a turning point.
Raju, in the same field of endeavor, teaches a catheter comprising a plurality of electrodes (2634) disposed on a set of splines (2620), wherein the splines are flexible and may transition between a first configuration where the set of splines are arranged generally parallel to a longitudinal axis of the ablation device to a second configuration where the set of splines rotate around, or twist and bend, and generally bias away from the longitudinal axis of the ablation device to form a petal-like curve arranged generally perpendicular to the longitudinal axis (pa. 0116 & Figs. 26A-26C). In this manner, the set of splines more easily conform to the geometry of an endocardial space (pa. 0116).
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 the second shape of the ablation catheter of Viswanathan to be the petal-like curve having a turning point, as taught by Raju, for the purpose of allowing the splines to more easily conform to the geometry of an endocardial space (Raju, pa. 0116).
However, Viswanathan/Raju combination do not disclose updating the estimated positions of the ablation electrodes by applying constraints from the geometric model to refine the estimated positions after the initial estimation, wherein the constraints encode physical behavior of the plurality of splines across a plurality of deployment states of the electrode assembly.
Chou, in the same field of endeavor, teaches a mapping catheter (10) comprising an electrode array (12) electrically connected to a mapping console (20) of a mapping subsystem (100), wherein the mapping subsystem includes a localization (LOC) module (150) configured to localize (e.g. determine the position and/or orientation of) the mapping catheter within a patient (pa. 0068 & Fig. 1). The mapping console includes a localization (LOC) processor (46) configured to perform various calculation such as, performing a “fitting” to align measured electrode positions with known possible configurations, which is further optimized with one or more constraints (e.g. a physical constraints, such as distance between two electrodes on a single spline, distance between two electrodes on two different splines, maximum distance between two electrodes, minimum distance between two electrodes, and/or minimum and/or maximum curvature of a spine, and the like) (pa. 0140).
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 incorporated the functionality of the localization processor taught by Chou, including the implementation of the fitting to align measured electrode positions with known possible configurations and to further refine the estimated electrode position with the one or more physical constraints, to the processor of Viswanathan for the purpose of providing a more accurate geometric model of the ablation catheter based on a specific spine configuration/deployment state.
Therefore, the resultant combination of references would yield a product where the system for electroporation ablation is capable of updating the estimated electrode positions by applying constraints from the first and the second geometric models to refine the estimated positions after the initial estimation, wherein the constraints encode physical behavior of the plurality of splines across the plurality of deployment states which includes when the electrode assembly is in the first state of the plurality of deployment states and when the electrode assembly is in the second state of the plurality of deployment states. Furthermore, the system for electroporation ablation would be able to determine the shape of the ablation catheter based on the selected geometric model of the ablation catheter and the updated estimated electrode positions.
Regarding claims 18-19, Viswanathan/Raju combination discloses the invention substantially as claimed in claim 16 discussed above.
However, they do not disclose wherein the geometric model includes one or more constraints on one or more relative positions of the plurality of ablation electrodes, nor wherein the geometric model includes a relative position for two ablation electrodes disposed on one spline of the plurality of splines.
Chou, in the same field of endeavor, teaches a mapping catheter (10) comprising an electrode array (12) electrically connected to a mapping console (20) of a mapping subsystem (100), wherein the mapping subsystem includes a localization (LOC) module (150) configured to localize (e.g. determine the position and/or orientation of) the mapping catheter within a patient (pa. 0068 & Fig. 1). The mapping console includes a localization (LOC) processor (46) configured to perform various calculation such as, performing a “fitting” to align measured electrode positions with known possible configurations, which is further optimized with one or more constraints (e.g. a physical constraints, such as distance between two electrodes on a single spline, distance between two electrodes on two different splines, maximum distance between two electrodes, minimum distance between two electrodes, and/or minimum and/or maximum curvature of a spine, and the like) (pa. 0140).
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 incorporated the functionality of the localization processor taught by Chou, including the implementation of the fitting to align measured electrode positions with known possible configurations and to further refine the estimated electrode position with the one or more physical constraints, to the processor of Viswanathan for the purpose of providing a more accurate geometric model of the ablation catheter based on a specific spine configuration/deployment state.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan, Raju, and Chou as applied to claim 1 above, and further in view of Ludvin (J.P. Application No. 2019202139 A).
Regarding claim 13, Viswanathan/Raju/Chou combination discloses the invention substantially as claimed in claim 1 discussed above.
However, they do not disclose a second tracking electrode configured to be disposed in a cardiac chamber of a patient.
Ludvin, in the same field of endeavor, teaches a system of tracking a probe position within a living body, comprising a catheter (40) having at least one tracking electrode configured to be disposed in a cardiac chamber of a patient (page 3, lines 4-6, lines 28-29 & Fig. 2).
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 added an additional tracking sensor at the distal end of a catheter for the purpose of providing an accurate measurement of the angular orientation of the catheter, and to further refine the estimated position and orientation of the ablation electrode (Ludvin, page 3, lines 29-30).
Response to Arguments
Applicant’s arguments, see pages 7-9, filed 08/12/2026, with respect to the 102
rejection of claims 14 and 16 under Viswanathan and the 103 rejection of claim 1 under Viswanathan in view of Gliner have been fully considered and are persuasive. Specifically, Applicant’s amendments to all of the independent claims to further require each spline to be configured to deform to a second shape in which the spline forms a petal-like curve having a turning point, as well as updating the estimated positions of the ablation electrodes based on the geometric model and applying constraints from the geometric model to refine the estimated positions after the initial estimation, wherein the constraints encode physical behavior of the plurality of splines across a plurality of deployment states of the electrode assembly is defined over both the Viswanathan and the Gliner reference given that they do not contemplate these claimed features. Therefore, the rejection has been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 1-12, 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan (U.S. Application No. 10842572 B1), in view of Raju (U.S. Application No. 20200046423A1), and further in view of Chou (U.S. Application No. 20210169394 A1).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan, Raju, and Chou as applied to claim 1 above, and further in view of Ludvin (J.P. Application No. 2019202139 A).
It is the Examiner’s position that the newly filed rejections based on the combination of references are tenable for at least the reasoning set forth in the action above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
