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 .
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.
Claim(s) 1, 3-5, 7, 10-11, 13-15, 17, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lupotti (US 2014/0275957) in view of Hauck (US 2014/0364715) (“Hauck 715”) and further in view of Hauck et al (US 2015/0005624) (“Hauck 624”) and further in view of Fay et al (US 2016/0242667) (“Fay”) and further in view of Olson (US 2020/0297239).
Regarding Claim 1, while Lupotti teaches a system for locating a medical device using an electrical field creation (Abstract, [0028]), the system comprising:
a plurality of excitation patches configured to generate an electrical field, wherein the plurality of excitation patches references a common ground patch ([0034]-[0035] three pairs of patch electrodes 54 / excitation patches and unshown reference electrode / common ground patch create the electrical field), wherein each excitation patch in the plurality of excitation patches comprises an individual frequency (each patch electrode must function at frequency, therefore exhibiting an individual frequency);
at least a catheter assembly comprising
at least a tip, wherein the at least a tip is comprised of
one or more electrodes (Fig. 2A, [0033]-[0034] catheter 14 with a tip and tip electrodes 44), including at least a biomedical sensor embedded within the tip and configured to detect and measure physiological parameters ([0031] temperature sensor, [0032] “electrophysiological studies, catheter identification and location, pacing, and cardiac mapping and ablation” electrodes 42 can be applied for diagnostic purposes with a variety of electrodes potentially envisioned);
at least a processor communicatively connected to the plurality of excitation patches and the at least a catheter assembly ([0028] electronic control unit 24 connected to the system, [0033] connected to catheter assembly, [0035] connected to excitation patches); and
the at least a processor configured to:
transmit electrical signals between each excitation patch of the plurality of excitation patches and the common ground patch ([0034]-[0035]);
measure at least a voltage at the one or more electrodes ([0033]-[0034];
determine a location of the medical device as a function of the at least a voltage at the one or more electrodes ([0034]-[0035]),
where the assessment of the impedance location and determining the location of the medical device is a step in performing at least a cardiac ablation ([0028]-[0029]).
Lupotti fails to teach the plurality of excitation patches configured to generate a hemispherical electrical field,
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the patch electrodes 54Y1 and 54Y2 of Lupotti could be moved closer in proximity to patch electrodes 54Z1, 54Z2, 54X1, and 54X2 while remaining in opposition to each other as the importance of their placement is in creating a vertical, orthogonal Y-axes. The placement of the vertically-aligned patch electrodes in [0034] is exemplary. As such, the placement may be considered an obvious rearrangement of parts [In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).]. And in slightly altering the placement of the vertically-aligned patch electrodes, one would create a larger density of patch electrodes at the chest of the patient, all using a common ground patch at the abdomen. This configuration of the patch electrodes and reference electrode would create a hemispherical electrical field as noted in Applicant’s Specification [0030] field 7/05/2024.
Yet Lupotti fails to teach wherein the at least a tip is comprised of:
one or more electrodes, including at least a biomedical sensor embedded within an electrode of the one or more electrodes and configured to detect and measure physiological parameters including an impedance measurement; and
a plurality of constraint pairs to configured to maintain a predefined relationships between pairs of electrodes for structural integrity and functional capability of the catheter assembly.
However Hauck 715 teaches a multi-electrode impedance sensing device (Abstract) utilizing catheter mapping and navigation with body surface patch electrodes ([0056]-[0057]) that further teaches including at least a biomedical sensor as an electrode and configured to detect and measure physiological parameters including an impedance measurement (Figs. 3-4, [0025] multiple pairs of ring electrodes which can serve multiple purposes such as “applying ablation energy to tissue, acquiring electrophysiology data from tissue, determining the position and orientation (P&O) of the shaft, and/or other purposes.” [0027]-[0030] using a measured impedance of the ring electrodes to determine contact state of the tip with tissue); and
a plurality of constraint pairs to configured to maintain a predefined relationships between pairs of electrodes ([0025] “The ring electrodes 20 may be placed in pairs, in an embodiment, with the two electrodes 20 in a pair disposed a first distance away from each other along the length of the shaft 28, and non-pair electrodes 20 separated by a second distance along the length of the shaft 28. For example, electrodes 20B and 20C may be considered a first pair, electrodes 20D and 20E may be considered a second pair, and so on. The first distance may be less than the second distance, in an embodiment. For example, the first distance may be about one (1) mm, and the second distance may be about 4.5 mm.” the disposition of electrodes maintains a predefined distance relationship between pairs of electrodes along the tip of the catheter) for structural integrity and functional capability of the catheter assembly ([0042], [0045] predefined distance relationship used for impedance measurement, therefore providing functional capability. Examiner notes that this language is not further limiting and thus seems to indicate that maintaining a predefined relationship between pairs of electrodes will lead to “structural integrity and functional capability.”); and
further teaches that the same electrodes may be used for position tracking and for physiological parameter purposes ([0056], [0058]-[0059], [0061] the physiological parameter being the impedance from tissue contact).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that Lupotti’s navigating catheter further include the impedance-based contact monitoring details of Hauck 715 as the contact monitoring enables ablation and electrophysiology mapping procedures (Hauck 715: [0006]) a functionality envisioned in Lupotti ([0032]). Furthermore, it would be obvious to one of ordinary skill in the art that if the same electrodes are used for both position tracking and physiological parameter measuring as taught by Hauck, then one could consider the electrode as embedding a “biological sensor” within itself by the electrode providing this functionality.
Yet their combined efforts fail to teach the processor steps being from memory instructions
generating an assessment of an impedance location at an electrode of the one or more electrodes as a function of a plurality of voltages; and
aggregate the assessment of the impedance location across the plurality of excitation patches as a function of known positions of each excitation patch of the plurality of excitation patches, and
determining a location of the medical device as a function of the at least a voltage at the one or more electrodes, the aggregated assessment of the impedance location, and the known positions of each excitation patch of the plurality of excitation patches.
However Hauck 642 teaches a system for locating a medical device using impedance measurements to guide ablation (Abstract, [0017], [0022], [0029]-[0032]) comprises:
generating an assessment of an impedance location at an electrode of one or more electrodes as a function of a plurality of voltages ([0023] mapping done with paired external electrodes, [0029] “The method may continue with the process 54 of receiving impedance signals from a plurality of passive electrodes 46. The impedance signals are indicative of a measured impedance at the passive electrodes 46 resulting from the transmission of current across the active electrodes 46.”, [0031] where the assessments of impedance are also assessments of location with respect to a known position of a known reference coordinate and thus impedance data is also impedance location data, where Hauck 715 [0037]-[0039] confirms that impedance values are functions of voltages); and
aggregate the assessment of the impedance location across the plurality of excitation patches as a function of known positions of each excitation patch of the plurality of excitation patches ([0031] “Process 56 may include the subprocess 58 of determining a position for the virtual reference electrode along an axis extending through body 14. This subprocess may be repeated for additional axes. Referring to FIG. 1, for example, the position for the virtual reference electrode along the x-axis within coordinate system 44 may be determined, along with the position along the y-axis perpendicular to the x-axis and the z-axis which is perpendicular to both the x-axis and y-axis in order to arrive at a three dimensional coordinate for the virtual reference electrode… Where IMP[i][U] represents the impedance measured on an electrode i during transmission of current across an electrode pair j from the first listed electrode to the second listed electrode and Xscale, Yscale, and Zscale are scaling factors used to convert the unit of measurement to a measure of distance (e.g., millimeters). Thus, the subprocess 58 of determining the position along a given axis may include subprocesses of summing impedances at a subset of passive electrodes 46 to obtain a cumulative impedance value, dividing the cumulative impedance value by the number of passive electrodes in the subset and scaling the resulting value.” As a way to provide a virtual reference electrode), and
determining a location of the medical device as a function of the at least a voltage at the one or more electrodes, the aggregated assessment of the impedance location, and the known positions of each excitation patch of the plurality of excitation patches ([0032] Equation 7-9. The voltages are used to identify uncorrected positions along the x-axis, y-axis, and x-axis. The aggregated assessment is used to identify the position of a virtual reference electrode to compensate for drift due to changes in body impedance. The reference initial position values may preserve the range of the navigation domain),
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that Lupotti’s and Hauck 715’s navigating catheter further include an aggregated impedance assessment and a determination of medical device position with the known position of excitation patches and aggregated impedance assessment as taught by Hauck 642 as Hauck 642 teaches that these parameters account for known sources of error in the position tracking.
Yet their combined efforts fail to teach wherein the determined location of the medical is used control at least one operation parameter of an ablation procedure performed by the at least a catheter, wherein controlling the at least one operational parameter of the ablation procedure comprises:
dynamically adjusting the at least one operational parameter as a function of a change in location of the medical device.
However Fay teaches a combined mapping and ablation probe (Abstract, [0074]) where the ablation portion consists of an electrode for delivering ablation energy at an appropriate anatomical feature and the ablation electrode being movable with respect to target anatomical features ([0078]), using mapping data and impedance data to identify a target location for ablation and navigate the ablation electrode to the target location ([0080]), and dynamically controlling the operation of ablative therapy based on the position of the ablation probe relative toa given cardiac location ([0122] an operational parameter recognized is the initiation or cessation of ablative energy delivery).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that Lupotti’s, Hauck 715, and Hauck 642 mapping and ablation probe includes controlling at least one operation parameter of an ablation procedure through dynamically adjusting the at least one operational parameter as a function of a change in location of the medical device as taught by Fay as this change in location can identify whether the ablation probe has reached the intended and therefore whether ablative energy should be delivered.
Yet their combined efforts fail to teach continually updating the determined location of the medical device during an ablation procedure.
However Olson teaches an electrophysiological mapping catheter (Abstract, [0028]) where the system may be used in in for real-time control of treatment control ([0028]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the ablation catheter of Lupotti, Hauck 715, and Hauck 642 be utilized for continually updating the determined location of the medical device during a treatment procedure as taught by Olson to maximize the utility of the mapping catheter’s location when used for ablating.
Regarding Claim 3, Lupotti, Hauck 715, Hauck 642, Fay, and Olson teach the system of claim 1, and Lupotti further teaches wherein transmitting the electrical signals between each excitation patch of the plurality of excitation patches comprises sequentially transmitting the electrical signals from each excitation patch of the plurality of excitation patches ([0035]).
Regarding Claim 4, Lupotti, Hauck 715, Hauck 642, Fay, and Olson teach the system of claim 1, and Lupotti teaches wherein generating the assessment of the impedance location comprises a prediction model ([0034] the interaction steps between the excitation patches / patches electrodes and catheter electrodes reflect a prediction model of catheter electrode location, See Claim 1 Rejection).
Regarding Claim 5, Lupotti, Hauck 715, Hauck 642, Fay, and Olson teach the system of claim 4, and Lupotti teaches wherein the prediction model is configured to:
determine a relative distance to each excitation patch of the plurality of excitation patches as a function of the measured at least a voltage at the one or more electrodes ([0034]); and
convert the relative distance to absolute coordinates using a known position of each excitation patch of the plurality of excitation patches ([0033]-[0034] coordinates created by reference electrode acting as an origin, and the known positions of the patch electrodes creating the x-, y-, and z-axes).
Regarding Claim 7, Lupotti, Hauck 715, Hauck 642, Fay, and Olson teach the system of claim 1, wherein the configuration of the plurality of excitation patches eliminates dead zones in an electric field created by the electrical signals (See Claim 1 Rejection, Examiner notes that this claim isn’t further limiting and is understood as describing that a hemispherical electrical field will have this characteristic).
Regarding Claim 10, Lupotti, Hauck 715, Hauck 642, Fay, and Olson teach the system of claim 1, wherein the hemispherical electrical field is configured to transform into a cylindrical field as a function of excitation patch configuration wherein a positioning of at least an additional excitation patch transforms the hemispherical field to a cylindrical field (See Claim 1 Rejection, Examiner notes that this claim does not further limit the system and is merely stating that a different electrical field shape is possible with more excitation patches).
Regarding Claim 11, while Lupotti teaches a method of locating a medical device using an electrical field creation (Abstract, [0028]), the method comprising:
Generating, by a plurality of excitation patches, an electrical field, wherein the plurality of excitation patches references a common ground patch ([0034]-[0035] three pairs of patch electrodes 54 / excitation patches and unshown reference electrode / common ground patch create the electrical field), wherein each excitation patch in the plurality of excitation patches comprises an individual frequency (each patch electrode must function at frequency, therefore exhibiting an individual frequency);
Transmitting, by at least a processor, electrical signals between each excitation patch of the plurality of excitation patches and the common ground patch ([0028] electronic control unit 24 connected to the system, [0033] connected to catheter assembly, [0035] connected to excitation patches, [0034]-[0035]);
Measuring, by the at least a processor, at least a voltage at one or more electrodes of a catheter assembly comprising at least a tip, wherein the at least a tip is comprised of one or more electrodes (Fig. 2A, [0033]-[0034] catheter 14 with a tip and tip electrodes 44), including at least a biomedical sensor embedded within the tip and configured to detect and measure physiological parameters ([0031] temperature sensor, [0032] “electrophysiological studies, catheter identification and location, pacing, and cardiac mapping and ablation” electrodes 42 can be applied for diagnostic purposes with a variety of electrodes potentially envisioned); and
Determining, by the at least a processor, a location of the medical device as a function of the at least a voltage at the one or more electrodes ([0034]-[0035]).
Lupotti fails to teach the plurality of excitation patches configured to generate a hemispherical electrical field,
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the patch electrodes 54Y1 and 54Y2 of Lupotti could be moved closer in proximity to patch electrodes 54Z1, 54Z2, 54X1, and 54X2 while remaining in opposition to each other as the importance of their placement is in creating a vertical, orthogonal Y-axes. The placement of the vertically-aligned patch electrodes in [0034] is exemplary. As such, the placement may be considered an obvious rearrangement of parts [In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).]. And in slightly altering the placement of the vertically-aligned patch electrodes, one would create a larger density of patch electrodes at the chest of the patient, all using a common ground patch at the abdomen. This configuration of the patch electrodes and reference electrode would create a hemispherical electrical field as noted in Applicant’s Specification [0030] field 7/05/2024.
Yet Lupotti fails to teach wherein the at least a tip is comprised of:
at least a biomedical sensor embedded within each electrode of the one or more electrodes and configured to detect and measure physiological parameters including an impedance measurement; and
a plurality of constraint pairs to configured to maintain a predefined relationships between pairs of electrodes for structural integrity and functional capability of the catheter assembly.
However Hauck 715 teaches a multi-electrode impedance sensing device (Abstract) utilizing catheter mapping and navigation with body surface patch electrodes ([0056]-[0057]) that further teaches including at least a biomedical sensor as an electrode and configured to detect and measure physiological parameters including an impedance measurement (Figs. 3-4, [0025] multiple pairs of ring electrodes which can serve multiple purposes such as “applying ablation energy to tissue, acquiring electrophysiology data from tissue, determining the position and orientation (P&O) of the shaft, and/or other purposes.” [0027]-[0030] using a measured impedance of the ring electrodes to determine contact state of the tip with tissue); and
a plurality of constraint pairs to configured to maintain a predefined relationships between pairs of electrodes ([0025] “The ring electrodes 20 may be placed in pairs, in an embodiment, with the two electrodes 20 in a pair disposed a first distance away from each other along the length of the shaft 28, and non-pair electrodes 20 separated by a second distance along the length of the shaft 28. For example, electrodes 20B and 20C may be considered a first pair, electrodes 20D and 20E may be considered a second pair, and so on. The first distance may be less than the second distance, in an embodiment. For example, the first distance may be about one (1) mm, and the second distance may be about 4.5 mm.” the disposition of electrodes maintains a predefined distance relationship between pairs of electrodes along the tip of the catheter) for structural integrity and functional capability of the catheter assembly ([0042], [0045] predefined distance relationship used for impedance measurement, therefore providing functional capability. Examiner notes that this language is not further limiting and thus seems to indicate that maintaining a predefined relationship between pairs of electrodes will lead to “structural integrity and functional capability.”); and
further teaches that the same electrodes may be used for position tracking and for physiological parameter purposes ([0056], [0058]-[0059], [0061] the physiological parameter being the impedance from tissue contact).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that Lupotti’s navigating catheter further include the impedance-based contact monitoring details of Hauck 715 as contact monitoring enables ablation and electrophysiology mapping procedures (Hauck 715: [0006]) a functionality envisioned in Lupotti ([0032]). Furthermore, it would be obvious to one of ordinary skill in the art that if the same electrodes are used for both position tracking and physiological parameter measuring as taught by Hauck, then one could consider the electrode as embedding a “biological sensor” within itself by the electrode providing this functionality.
Yet their combined efforts fail to teach the method comprising
Generating, by the at least a processor, an assessment of an impedance location at an electrode of the one or more electrodes as a function of a plurality of voltages; and
aggregating, using the at least a processor, the assessment of the impedance location across the plurality of excitation patches as a function of known positions of each excitation patch of the plurality of excitation patches, and
determining, by the at least a processor, a location of the medical device as a function of the at least a voltage at the one or more electrodes, the aggregated assessment of the impedance location, and the known positions of each excitation patch of the plurality of excitation patches.
However Hauck 642 teaches a system for locating a medical device using impedance measurements to guide ablation (Abstract, [0017], [0022], [0029]-[0032]) comprises:
generating an assessment of an impedance location at an electrode of one or more electrodes as a function of a plurality of voltages ([0023] mapping done with paired external electrodes, [0029] “The method may continue with the process 54 of receiving impedance signals from a plurality of passive electrodes 46. The impedance signals are indicative of a measured impedance at the passive electrodes 46 resulting from the transmission of current across the active electrodes 46.”, [0031] where the assessments of impedance are also assessments of location with respect to a known position of a known reference coordinate and thus impedance data is also impedance location data, where Hauck 715 [0037]-[0039] confirms that impedance values are functions of voltages); and
aggregate the assessment of the impedance location across the plurality of excitation patches as a function of known positions of each excitation patch of the plurality of excitation patches ([0031] “Process 56 may include the subprocess 58 of determining a position for the virtual reference electrode along an axis extending through body 14. This subprocess may be repeated for additional axes. Referring to FIG. 1, for example, the position for the virtual reference electrode along the x-axis within coordinate system 44 may be determined, along with the position along the y-axis perpendicular to the x-axis and the z-axis which is perpendicular to both the x-axis and y-axis in order to arrive at a three dimensional coordinate for the virtual reference electrode… Where IMP[i][U] represents the impedance measured on an electrode i during transmission of current across an electrode pair j from the first listed electrode to the second listed electrode and Xscale, Yscale, and Zscale are scaling factors used to convert the unit of measurement to a measure of distance (e.g., millimeters). Thus, the subprocess 58 of determining the position along a given axis may include subprocesses of summing impedances at a subset of passive electrodes 46 to obtain a cumulative impedance value, dividing the cumulative impedance value by the number of passive electrodes in the subset and scaling the resulting value.” As a way to provide a virtual reference electrode), and
determining a location of the medical device as a function of the at least a voltage at the one or more electrodes, the aggregated assessment of the impedance location, and the known positions of each excitation patch of the plurality of excitation patches ([0032] Equation 7-9. The voltages are used to identify uncorrected positions along the x-axis, y-axis, and x-axis. The aggregated assessment is used to identify the position of a virtual reference electrode to compensate for drift due to changes in body impedance. The reference initial position values may preserve the range of the navigation domain),
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that Lupotti’s and Hauck 715’s navigating catheter further include an aggregated impedance assessment and a determination of medical device position with the known position of excitation patches and aggregated impedance assessment as taught by Hauck 642 as Hauck 642 teaches that these parameters account for known sources of error in the position tracking.
Yet their combined efforts fail to teach wherein the determined location of the medical is used control at least one operation parameter of an ablation procedure performed by the at least a catheter, wherein controlling the at least one operational parameter of the ablation procedure comprises:
dynamically adjusting the at least one operational parameter as a function of a change in location of the medical device.
However Fay teaches a combined mapping and ablation probe (Abstract, [0074]) where the ablation portion consists of an electrode for delivering ablation energy at an appropriate anatomical feature and the ablation electrode being movable with respect to target anatomical features ([0078]), using mapping data and impedance data to identify a target location for ablation and navigate the ablation electrode to the target location ([0080]), and dynamically controlling the operation of ablative therapy based on the position of the ablation probe relative toa given cardiac location ([0122] an operational parameter recognized is the initiation or cessation of ablative energy delivery).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that Lupotti’s, Hauck 715, and Hauck 642 mapping and ablation probe includes controlling at least one operation parameter of an ablation procedure through dynamically adjusting the at least one operational parameter as a function of a change in location of the medical device as taught by Fay as this change in location can identify whether the ablation probe has reached the intended and therefore whether ablative energy should be delivered.
Yet their combined efforts fail to teach continuously updating the determined location of the medical device during an ablation procedure.
However Olson teaches an electrophysiological mapping catheter (Abstract, [0028]) where the system may be used in in for real-time control of treatment control ([0028]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the ablation catheter of Lupotti, Hauck 715, and Hauck 642 be utilized for continually updating the determined location of the medical device during a treatment procedure as taught by Olson to maximize the utility of the mapping catheter’s location when used for ablating.
Regarding Claim 13, Lupotti, Hauck 715, Hauck 642, Fay, and Olson teach the method of claim 11, and Lupotti teaches wherein transmitting the electricals between each excitation patch of the plurality of excitation patches comprises sequentially transmitting the electrical signals from each excitation patch of the plurality of excitation patches ([0035]).
Regarding Claim 14, Lupotti, Hauck 715, Hauck 642, Fay, and Olson teach the method of claim 11, and Lupotti teaches wherein generating the assessment of the impedance location comprises a prediction model ([0034] the interaction steps between the excitation patches / patches electrodes and catheter electrodes reflect a prediction model of catheter electrode location, See Claim 11 Rejection).
Regarding Claim 15, Lupotti, Hauck 715, Hauck 642, Fay, and Olson teach the method of claim 14, and Lupotti teaches wherein the prediction model is configured to:
determine a relative distance to each excitation patch of the plurality of excitation patches as a function of the measured at least a voltage at the one or more electrodes ([0034]); and
convert the relative distance to absolute coordinates using a known position of each excitation patch of the plurality of excitation patches ([0033]-[0034] coordinates created by reference electrode acting as an origin, and the known positions of the patch electrodes creating the x-, y-, and z-axes).
Regarding Claim 17, Lupotti, Hauck 715, Hauck 642, Fay, and Olson teach the method of claim 11, wherein the configuration of excitation patches eliminates dead zones in an electric field created by the electrical signals (See Claim 11 Rejection, Examiner notes that this claim isn’t further limiting and is understood as describing that a hemispherical electrical field will have this characteristic).
Regarding Claim 20, Lupotti, Hauck 715, Hauck 642, Fay, and Olson teach the method of claim 11, wherein the hemispherical electrical field is configured to transform into a cylindrical field as a function of excitation patch configuration wherein a positioning of at least an additional excitation patch transforms the hemispherical field to a cylindrical field (See Claim 11 Rejection, Examiner notes that this claim does not further limit the system and is merely stating that a different electrical field shape is possible with more excitation patches).
Claim(s) 2 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lupotti in view of Hauck 715 and further in view of Hauck 642 and further in view of Fay and further in view of Olson as evidenced by Gopinathan et al (US 2011/0306867) (“Gopinathan”).
Regarding Claim 2 Lupotti, Hauck 715, Hauck 642, Fay, and Olson teach the system of claim 1, and Lupotti teaches wherein the electrical signals transmitted between excitation patch of the plurality of excitation patches and the common ground patch is an alternating current ([0034] sinusoidal currents driven through the pair of patch electrodes understood to be alternating current as evidenced by Gopinathan [0154]).
Regarding Claim 12, Lupotti, Hauck 715, Hauck 642, Fay, and Olson teach the method of claim 11, and Lupotti teaches wherein the electrical signals transmitted between each excitation patch of the plurality of excitation patches and the common ground patch is an alternating current ([0034] sinusoidal currents driven through the pair of patch electrodes understood to be alternating current as evidenced by Gopinathan [0154]).
Claim(s) 6 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lupotti in view of Hauck 715 and further in view of Hauck 642 and further in view of Fay and further in view of Olson and further in view of Schwartz et al (US 2018/0125575) (“Schwartz”).
Regarding Claim 6, while Lupotti, Hauck 715, Hauck 642, Fay, and Olson teach the system of claim 4, their combined efforts fail to teach wherein the prediction model comprises an impedance location machine learning model iteratively trained using training data configured to correlate voltage deviation inputs to impedance location outputs.
However Schwartz teaches a tissue analysis system (Abstract) based on creating an electric field with excitation patches, measuring electrical properties of catheter electrodes within the electric field, and aggregating correlations of the interactions between the excitation patches and the catheter electrodes to make an assessment of an impedance parameter (Fig. 2, [0130]-[0140] applies these steps to find impedance characteristics of tissue) and further utilizing machine learning to perform the impedance assessments ([0139]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply machine learning to the prediction model of Lupotti, Hauck 715, and Hauck 642 as taught by Schwartz as a way to quickly create a prediction model that accounts for unconsidered variables and noise deviations.
Regarding Claim 16, while Lupotti, Hauck 715, Hauck 642, Fay, and Olson teach the method of claim 14, wherein the prediction model comprises an impedance location machine learning model iteratively trained using training data configured to correlate voltage deviation inputs to predicted impedance location outputs.
However Schwartz teaches a tissue analysis system (Abstract) based on creating an electric field with excitation patches, measuring electrical properties of catheter electrodes within the electric field, and aggregating correlations of the interactions between the excitation patches and the catheter electrodes to make an assessment of an impedance parameter (Fig. 2, [0130]-[0140] applies these steps to find impedance characteristics of tissue) and further utilizing machine learning to perform the impedance assessments ([0139]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply machine learning to the prediction model of Lupotti, Hauck 715, and Hauck 642 as taught by Schwartz as a way to quickly create a prediction model that accounts for unconsidered variables and noise deviations.
Claim(s) 9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lupotti in view of Hauck 715 and further in view of Hauck 642 and further in view of Fay and further in view of Olson and further in view of Sliwa (US 2009/0163801).
Regarding Claim 9, while Lupotti, Hauck 715, Hauck 642, Fay, and Olson teach the system of claim 1, and Lupotti teaches that the catheter further utilizes acceleration sensing, and magnetic position sensing and compares the position and orientation of the catheter by electrical field sensing by the other sensing modalities for calibration purposes ([0010]), their combined efforts fail to teach wherein the memory contains instructions further configuring the at least a processor to calibrate the assessment of the impedance location as a function of a movement of one of more of the plurality of excitation patches.
However Sliwa teaches a system for electrophysiological mapping (Abstract) and teaches performing a correction step on the location data between excitation patches and catheter electrodes by position sensors tracking movement due to respiration ([0025]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the impedance location of Lupotti, Hauck 715, and Hauck 642 in be corrected for changes in the coordinate system due to respiration movement as taught by Sliwa as respiration movements will be constantly be causing deviations in the positioning of the various and will thus require a correction step.
Regarding Claim 19, while Lupotti, Hauck 715, Hauck 642, Fay, and Olson teach the method of claim 11, and Lupotti teaches that the catheter further utilizes acceleration sensing, and magnetic position sensing and compares the position and orientation of the catheter by electrical field sensing by the other sensing modalities for calibration purposes ([0010]), their combined efforts fail to teach the method further comprising calibrating, using the at least a processor, the assessment of the impedance location as a function of a movement of one of more of the plurality of excitation patches.
However Sliwa teaches a system for electrophysiological mapping (Abstract) and teaches performing a correction step on the location data between excitation patches and catheter electrodes by position sensors tracking movement due to respiration ([0025]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the impedance location of Lupotti, Hauck 715, and Hauck 642 be corrected for changes in the coordinate system due to respiration movement as taught by Sliwa as respiration movements will be constantly be causing deviations in the positioning of the various and will thus require a correction step.
Response to Arguments
Applicant’s amendments and arguments filed 2/24/2026 with respect to the claim objections have been fully considered, and are persuasive. The objection is withdrawn.
Applicant’s amendments and arguments filed 2/24/2026 with respect to the 35 USC 101 rejections have been fully considered, and are persuasive. The claims are now integrated into a feedback loop for an operational parameter of an ablation routine – leading to a transformation step. The rejection is withdrawn.
Applicant’s amendments and arguments filed 2/24/2026 with respect to the 35 USC 103 rejections of claims 1 and 11 have been fully considered, and are persuasive. The rejection(s) is/are withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lupotti, Hauck 715, Hauck 642, Fay, and Olson.
Consequently, claims 2-10, 12-17, and 19-20 remain rejected due to their dependency on rejected independent claims 1 and 11.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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