DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/22/2025 has been entered.
Response to Amendment
The Amendment filed August 11/24/2025 has been entered. Applicant’s amendments have overcome the Double Patent rejection of U.S. Application No. 20240238041 A1n previously set-forth in the Final Office Action mailed on 09/22/2025. Currently, claims 1 and 16 has been amended, claim 20 has been cancelled, 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.
Claim 5 is 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 5 recites the limitation "includes one or more constraints" in lines 1-2. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether these one or more constraints are different from the constraints already cited in claim 1, or if they are the same type of constraints. For examination purposes, Examiner will treat both constraints as being the same.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 14-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Viswanathan (U.S. Application No. 10842572 B1).
Regarding independent claim 14, Viswanathan discloses a method of electroporation ablations (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);
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).
Regarding claims 15 and 17, Viswanathan discloses further comprising:
accessing a field map (i.e., generated by the mapping system 140) (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 (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 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).
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 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan as applied to claim 16 above, and further in view of Gliner (U.S. Application No. 20200397338 A1).
Regarding claim 18, Viswanathan discloses the invention substantially as claimed in claim 1 discussed above.
However, Viswanathan does not disclose wherein the geometric model includes one or more constraints on one or more relative positions of the plurality of ablation electrodes.
Gliner, in the same field of endeavor, teaches a medical procedure system (20) configured to determine the position and orientation of a shaft (22) of a probe (40) based on signals provided by a magnetic sensor (50) and/or the shaft electrodes (52) (pa. 0053 & Fig. 1). The method of determining the position and orientation including using a processing circuitry (41) that is configured to measure (block 62) electrical readings of the position sensor (53), or electrical impedances between the body surface electrodes (49) and the shaft electrode (pa. 0080-0081), and to compute (block 64) position coordinates of the proximal ends (57) of the deflectable arms (54) responsively to the measured electrical readings and the predefined spatial relation between the position sensor and the proximal ends of the deflectable arms (pa. 0078 & Figs. 5-8). The processing circuitry is then configured to fit (block 70) a respective curve (59) corresponding to each deflectable arm responsively to the respective position coordinates of the position sensor and the position coordinates of each of the respective at least two electrodes, wherein the fitting of the curve is based on a Bezier curve (i.e., a constraint applied to refine the estimated positions after an initial estimation) (pa. 0082). The computation step of block 72 uses the respective fitted curve and the known locations of the electrodes along the respective deflectable arm as input to compute the positions of the electrodes (pa. 0083). Lastly, the processing circuitry is configured to render (block 74) a display (27) of a graphical representation of the probe including the shaft, and the deflectable arms including the electrodes (pa. 0084).
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 processing circuitry of Gliner, which includes the implementation of a Bezier curve used to refine the estimated positions of the electrode after an initial estimation, to the processor of Viswanathan for the purpose of providing a more accurate geometric model of the electrode assembly.
Regarding claim 19, Viswanathan/Gliner 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).
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan (U.S. Application No. 10842572 B1), and further in view of Gliner (U.S. Application No. 20200397338 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); 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 update the estimated positions of the ablation electrodes by applying constraints from the geometric model to refine the estimated positions after the initial estimation.
Gliner, in the same field of endeavor, teaches a medical procedure system (20) configured to determine the position and orientation of a shaft (22) of a probe (40) based on signals provided by a magnetic sensor (50) and/or the shaft electrodes (52) (pa. 0053 & Fig. 1). The method of determining the position and orientation including using a processing circuitry (41) that is configured to measure (block 62) electrical readings of the position sensor (53), or electrical impedances between the body surface electrodes (49) and the shaft electrode (pa. 0080-0081), and to compute (block 64) position coordinates of the proximal ends (57) of the deflectable arms (54) responsively to the measured electrical readings and the predefined spatial relation between the position sensor and the proximal ends of the deflectable arms (pa. 0078 & Figs. 5-8). The processing circuitry is then configured to fit (block 70) a respective curve (59) corresponding to each deflectable arm responsively to the respective position coordinates of the position sensor and the position coordinates of each of the respective at least two electrodes, wherein the fitting of the curve is based on a Bezier curve (i.e., a constraint applied to refine the estimated positions after an initial estimation) (pa. 0082). The computation step of block 72 uses the respective fitted curve and the known locations of the electrodes along the respective deflectable arm as input to compute the positions of the electrodes (pa. 0083). Lastly, the processing circuitry is configured to render (block 74) a display (27) of a graphical representation of the probe including the shaft, and the deflectable arms including the electrodes (pa. 0084).
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 processing circuitry of Gliner, which includes the implementation of a Bezier curve used to refine the estimated positions of the electrode after an initial estimation, to the processor of Viswanathan for the purpose of providing a more accurate geometric model of the electrode assembly.
Regarding claim 2, Viswanathan/Gliner 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/Gliner 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/Gliner 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, as best understood, Viswanathan discloses the invention substantially as claimed in claim 1 discussed above.
However, Viswanathan does not disclose wherein the geometric model includes one or more constraints on one or more relative positions of the plurality of ablation electrodes.
Gliner, in the same field of endeavor, teaches a medical procedure system (20) configured to determine the position and orientation of a shaft (22) of a probe (40) based on signals provided by a magnetic sensor (50) and/or the shaft electrodes (52) (pa. 0053 & Fig. 1). The method of determining the position and orientation including using a processing circuitry (41) that is configured to measure (block 62) electrical readings of the position sensor (53), or electrical impedances between the body surface electrodes (49) and the shaft electrode (pa. 0080-0081), and to compute (block 64) position coordinates of the proximal ends (57) of the deflectable arms (54) responsively to the measured electrical readings and the predefined spatial relation between the position sensor and the proximal ends of the deflectable arms (pa. 0078 & Figs. 5-8). The processing circuitry is then configured to fit (block 70) a respective curve (59) corresponding to each deflectable arm responsively to the respective position coordinates of the position sensor and the position coordinates of each of the respective at least two electrodes, wherein the fitting of the curve is based on a Bezier curve (i.e., a constraint applied to refine the estimated positions after an initial estimation) (pa. 0082). The computation step of block 72 uses the respective fitted curve and the known locations of the electrodes along the respective deflectable arm as input to compute the positions of the electrodes (pa. 0083). Lastly, the processing circuitry is configured to render (block 74) a display (27) of a graphical representation of the probe including the shaft, and the deflectable arms including the electrodes (pa. 0084).
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 processing circuitry of Gliner, which includes the implementation of a Bezier curve used to refine the estimated positions of the electrode after an initial estimation, to the processor of Viswanathan for the purpose of providing a more accurate geometric model of the electrode assembly.
Regarding claim 6, Viswanathan/Gliner 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/Gliner 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/Gliner 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/Gliner 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/Gliner 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/Gliner 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/Gliner 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).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan and Gliner as applied to claim 1 above, and further in view of Ludvin (J.P. Application No. 2019202139 A).
Regarding claim 13, Viswanathan/Gliner 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 (page 3, lines 29-30).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Application No. 20230105973 A1 in view of Viswanathan (U.S. Application No. 10842572 B1).
Regarding instant claim 14, it is the Examiner’s position that copending independent claims 16 is narrower in some aspects given that the copending claim recites a plurality of the limitations that overlap, or otherwise narrower in scope than, those in instant claim 14. These narrower aspects include the claimed ablation catheter, electrode assembly, splines, ablation electrodes, and tracking electrode. With respect to the narrower aspects, the Examiner notes that it has been held that the generic aspects of the instant invention would be anticipated by the narrower species aspects of the copending claim. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
With respect to the broader aspects of the copending claim, the Examiner notes that the difference between the instant claim 14 and the copending claim 16 exists in that the copending claim 16 fails to provide the method steps of “injecting a current via the one or more tracking electrodes, measuring electrical signals via at least one of the plurality of electrodes associated with each of the plurality of splines, and updating the electrode position based on a geometric model of the ablation catheter.” Viswanathan, however, provides for a similar method as that of the copending claim and specifically contemplates injecting a current via the one or more tracking electrodes (Col. 3, lines 47-50; Col. 5, lines 6-12), measuring electrical signals via at least one of the plurality of electrodes associated with each of the plurality of splines (Col. 3, lines 52-58), and updating the electrode position based on a geometric model of the ablation catheter (Col. 6, lines 62-67 – Col. 7, lines 1-10; Col. 18, lines 17-28). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have incorporated the method steps of Viswanathan in combination with the method steps of the copending claim 1 to provide for an accurate process of estimating the location of the ablation electrodes.
Response to Arguments
Applicant's arguments filed 11/24/2025 have been fully considered but they are not persuasive.
With regards to newly amended claim 1 and claim independent 14, Applicant argues that the amended claim recites an iterative updating process where geometric constraints are applied to refine previously estimated electrode positions. In contrast, Viswanathan's system operates differently by selecting from pre-existing configurations rather than iteratively refining estimated positions through geometric constraint application. Specifically, Viswanathan's system selects a closest pre-existing configuration using a cost function. However, Examiner, respectfully, disagrees.
While Examiner concedes that one embodiment of Viswanathan does disclose selecting a closest pre-existing configuration using a cost function, this is not the embodiment that is relied upon in the rejection set-forth above. In this new interpretation of the Viswanathan reference, Examiner highlights a method of using an ablation catheter (110, 200), including a plurality of ablation electrodes (116, 118, 232, 234, 236, 238) disposed thereon (Col. 5, lines 29-32; 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), 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).
In regards to the newly amended language which requires updating the estimated positions of the ablation electrodes by applying constraints from the geometric model to refine the estimated positions after the initial estimation. Examiner agrees that the Viswanathan reference does not disclose this limitation. Therefore, the Gliner reference is utilized to ameliorate these short-comings.
With regards to newly amended claim 16, Applicant argues that Viswanathan does not disclose a deployment sensor that collects data associated with deployment state for use in selecting a geometric model since Viswanathan's approach relies on calculating geometric parameters from electrode position data derived from tracking signals, not on deployment sensor data. However, Examiner, disagrees.
The claim language of independent claim 16 is broad and does not clearly define what a deployment sensor is, or how its function differs from type of tracking sensor (one that different from the one or more tracking electrodes already claimed). The claim language only requires the deployment sensor to be a separate component from the one or more tracking electrodes and to collect data associated with a deployment state. Therefore, the Viswanathan reference discloses a tracking method which combines an electromagnetic tracking sensor (i.e., a deployment sensor) that is integrated into a catheter device using electrodes configured to track the device position (e.g., in real time) within a three-dimensional volume of interest, as well as a device location tracking system that determines a location of the catheter using an electric field or voltage gradients generated by a set of surface electrode patches on a patient (i.e., the one or more tracking electrodes), e.g., with potential differences set up between the surface electrode patches (Col. 3, lines 35-38 and lines 47-52). In the impedance-based tracking system, the electric field generator (46) includes the set of electrode patches between subsets of which electric potential differences are maintained over a range of frequencies. In the electromagnetic tracking system (10), the electric field generator (46) includes a set of transmitter coils each configured to generate a time-varying magnetic field. The generated electric and magnetic fields are received as signals (voltages, currents or both) by a set of receivers (18) on the ablation catheter to be spatially tracked. The received signals may be amplified by an amplifier (43) and then digitized and processed by one or more processors (42), wherein the processor is configured to estimate and/or determine the position and/or orientation of the catheter based on the received signals. The estimated position and orientation information may be displayed on an input/output device (48) (e.g., graphic display (160)) in the form of a visual rendering of the spatially tracked device (Col. 4, lines 62-67 – Col. 5, lines 1-21). Therefore, the rejection using this new interpretation of the Viswanathan reference is set-forth.
Conclusion
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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
Prosecution Insights