DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/23/2026 was filed after the mailing date of the Non-Final Office Action on 12/23/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
Claims 1, 3, 11, and 13 are amended in the response filed 02/26/2026. Claims 1-20 are under examination herein.
Response to Arguments
Applicant’s arguments, see Remarks pages 6-9, filed 02/26/2026, with respect to the rejection of claims 1, 3, 4, 5, 6, 10, 11, 13, 14, 15, 16, and 20 as rejected under Govari (US 2020/0367829) have been fully considered and are not found to be persuasive.
Govari does not teach a recorded metric over a “period of time”, explicitly in the previous rejection, but does so implicitly. Although Govari does not explicitly state that the electrodes’ values are gathered over a period of time, they collection of electrode values does occur over a period of time. When the quality of contact value is taken, it is done so through the impedance values gathered by the electrodes on the device. The electrodes maintain contact with the tissue for a period of time; they do not exist on the tissue for a brief moment, and then are removed before the quality of contact is determined. Indeed, p.[0045] states that the physicians can be presented with a voltage versus time graph, suggesting that the signals are taken over a period of time, teaching the claimed limitation. Moreover, the quality of contact signal can change (hence, dim on the display, p.[0046-0048]), which would suggest that the electrodes are in fact detecting electrode quality of contact signals “over a period of time”.
The Applicant cites Govari p.[0045, 0046, 0055, 0096] as evidence that Govari determines quality of contact in a moment to moment or instantaneous value, and argues that Govari does not teach the claimed invention because “the metric that drives output is this moment-to-moment quality of contact value itself, not a metric that is calculated using a plurality of signals aggregated from each electrode over a period of time”. The current claim language does not necessitate this interpretation, either. The claimed language of the instant application only requires that the processor acquire a plurality of signals over a period of time, compute a plurality of signals from the electrodes over a period of time, and display a quality of contact between the respective electrodes over a period of time, which is contemplated and done by Govari under broadest reasonable interpretation for the reasons stated above. Although claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). If Applicant wishes to claim a metric that is calculated using a plurality of signals aggregated from each electrode over a period of time, wherein the degree of contact is reflecting of the summative signals of contact determined by the electrodes, the claim language must explicitly state so.
However, an additional new grounds of rejection is made in view of Bar-Tal (US 2015/0208942).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, 4, 5, 6, 10, 11, 13, 14, 15, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Govari (US Patent Publication 2020/0367829).
Regarding claims 1 and 11, Govari teaches “A system for electrophysiological measurement (Figures 1-3, p.[0061-0063])”, “a probe having a distal end configured for insertion into a body cavity of a living subject (Fig. 1, the heart) and comprising an array of electrodes (Fig. 2, 55) that are disposed along the distal end and are configured to contact tissue at multiple locations within the body cavity (Fig. 1, 2, 55, i.e., electrodes on the cardiac catheter, see also p.[0063])”, “a processor (Fig. 1, 24, console comprising processing circuitry 41, typically a general purpose computer, p.[0067]) configured to acquire a plurality of signals from the electrodes over a period of time during which the probe moves within the body cavity (p.[0079], the processing circuitry receives signals from the electrodes)”, “compute, in response to the plurality of signals, a plurality of metrics, each metric being (i) associated with a respective electrode of the array of electrodes and (ii) indicative of a quality of contact between the respective electrode and the tissue (p.[0079], signals from the catheter electrodes 55 for use in assessing quality of contact of the catheter electrodes 55 with the tissue)”, “output an indication of each metric (see Fig. 1, 27, i.e. a display driven by the console, see also p.[0070, 0096], i.e., modify the visual feature of the traces sensed by the electrodes having a quality of contact with the tissue greater than a threshold quality of contact)”. However, Govari does not explicitly teach “… acquire a plurality of signals from each electrode of the array of electrodes over a period of time, compute, in response to the plurality of signals acquired from each electrode over the period of time, … indicative of a quality of contact between the respective electrode and the tissue over the period of time…”, but Govari does teach these amended limitations implicitly.
When the quality of contact value is taken, it is done so through the impedance values gathered by the electrodes on the device. The electrodes maintain contact with the tissue for a period of time; they do not exist on the tissue for a brief moment, and then are removed before the quality of contact is determined. Indeed, p.[0045] states that the physicians can be presented with a voltage versus time graph, suggesting that the signals are taken over a period of time, teaching the claimed limitation. Moreover, the quality of contact signal can change (hence, dim on the display, p.[0046-0048]), which would suggest that the electrodes are in fact detecting electrode quality of contact signals “over a period of time”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a period of time for data collection as stated in Govari. As noted in Govari, it is known in the art for clinicians to review voltage versus time graphs for determining quality of contact for catheter electrodes, and such a system produces predictable results.
Regarding claim 11 specifically, the limitations of claim 11 are taught by the rejection of claim 1 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 11 is nearly identical to the apparatus of claim 11 and therefore, claim 11 would perform the method of claim 1 and is considered to be anticipated by the rejection of claim 1, as outlined above.
Regarding claims 3 and 13, the limitations of claims 1 and 11 are taught as described above. Govari teaches “wherein the distal end of the probe comprises a plurality of flexible spines on which the electrodes are disposed along, the flexible spines being arranged in a multi-arm assembly” in p.[0062-63], i.e., deflectable arms 54 including electrodes 55, and further teaches that the metrics are indicative of contact between the sections of the expandable device and the tissues in p.[0079-0084] and illustrated in Figures 2 and 4.
Regarding claim 13 specifically, the limitations of claim 13 are taught by the rejection of claim 3 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 13 is nearly identical to the apparatus of claim 3 and therefore, claim 3 would perform the method of claim 13 and is considered to be anticipated by the rejection of claim 3, as outlined above.
Regarding claims 4 and 14, the limitations of claims 1 and 11 are taught as described above. Govari teaches the limitations “wherein each electrode is disposed at a respective location on the distal end”, “the processor is configured to render a display a graphical icon representing the distal end and to incorporate, in the graphical icon, the indication of each metric at the respective location “, and “and each indication comprises a color-coded marking, the color-coded marking comprising a color that is based on the computed metric“ in p.[0096], which states "The processing circuitry 41 is configured, in response to the signals received from the catheter 40, to render (block 68) to the display 27 respective intracardiac electrograms (IEGM) traces 88 representing electrical activity in the tissue that is sensed by the catheter electrodes 55 at respective locations, while modifying a visual feature of at least some of the traces (e.g., traces 88-4 of FIG. 6) responsively to the respective quality of contact of the catheter electrodes 55 with the tissue of the heart 26 at the respective locations". Govari explicitly teaches the use of color-coded marking in p.[0013-0014, 0024-0025,0047-0048,0051, 0093] at the least to describe how the colors may change based on the assessed quality of contact across each electrode and the tissue, therefore teaching the limitation as described.
Regarding claim 14 specifically, the limitations of claim 14 are taught by the rejection of claim 4 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 14 is nearly identical to the apparatus of claim 4 and therefore, claim 4 would perform the method of claim 14 and is considered to be anticipated by the rejection of claim 4, as outlined above.
Regarding claim 5 and 15, the limitations of claim 1 and 11 are taught as described above. Govari teaches “wherein each metric is indicative of a number of valid signals acquired by the associated respective electrode from the tissue over the period of time” in p.[0093-0094], which describes that the process of collecting metric signals via the electrodes over a period of time (at least one to three seconds), and that the valid signals from the electrodes are considered to be effective or sufficient contact with tissue overtime. The number of valid signals or sufficient contact with tissue signals is shown though the intensity, or brightness, of the color.
Regarding claim 15 specifically, the limitations of claim 15 are taught by the rejection of claim 5 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 15 is nearly identical to the apparatus of claim 5 and therefore, claim 5 would perform the method of claim 15 and is considered to be anticipated by the rejection of claim 5, as outlined above.
Regarding claim 6 and 16, the limitations of claim 5 and 15 are taught as described above. Govari teaches “wherein the processor is configured to apply one or more filtering criteria to the signals in order to classify as valid a respective first set of the signals acquired from each of the electrodes while classifying as invalid a respective second set of the signals acquired by each of the electrodes” in p.[0085], which describes that the processor is able to determine valid signals (in contact state) versus invalid signals (out-of-contact state) and therefore teaches the limitation as described.
Regarding claim 16 specifically, the limitations of claim 16 are taught by the rejection of claim 6 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 16 is nearly identical to the apparatus of claim 6 and therefore, claim 6 would perform the method of claim 16 and is considered to be anticipated by the rejection of claim 6, as outlined above.
Regarding claim 10 and 20, the limitations of claim 1 and 11 are taught as described above. Govari teaches “wherein each metric is indicative of a respective duration during which the respective electrode was in contact with the tissue in the body cavity over the period of time” in p.[0099], which describes how the processor is able to use a fading effect on the displayed electrode to demonstrate the duration of time the electrode was in sufficient contact with the desired tissue, therefore teaching the limitation as described.
Regarding claim 20 specifically, the limitations of claim 20 are taught by the rejection of claim 10 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 20 is nearly identical to the apparatus of claim 10 and therefore, claim 10 would perform the method of claim 20 and is considered to be anticipated by the rejection of claim 10, as outlined above.
Claims 2, 7, 8, 9, 12, 17, 18, 19, are rejected under 35 U.S.C. 103 as being obvious over Govari (US Patent Publication 2020/0367829) in view of Mosesov (US Patent Publication 2019/0183378).
Regarding claims 2 and 12, the limitations of claim 1 and 11 are taught as described above. Govari teaches that a series of metrics indicative of contact between an expandable electrode assembly and tissue (abstract, p.[0078-0079,0081]), but Govari does not teach the use of a basket assembly, and instead teaches the use of a system of splines. However, Mosesov teaches the use of a basket catheter in an analogous ablative catheter device. Mosesov teaches the use of a basket catheter to determine the contact between electrodes and tissue in Fig. 4, basket 18a-h, and p.[0058,0094]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the basket catheter of Mosesov in Govari's system. The use of a basket catheter allows for the selective expansion and retraction of the electrodes (p.[0111]) as needed for navigating the circulatory system before arriving at the desired hollow organ, and is known in the art as a predictable design choice for ablative catheters (as suggested in Govari, p.[0075], which states "Any suitable catheter may be used instead of catheter 40... or a different probe shape, such as a balloon catheter or a lasso catheter...").
Regarding claim 12 specifically, the limitations of claim 12 are taught by the rejection of claim 2 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 12 is nearly identical to the apparatus of claim 2 and therefore, claim 2 would perform the method of claim 12 and is considered to be anticipated by the rejection of claim 2, as outlined above.
Regarding claims 7 and 17, the limitations of claim 6 and 16 are taught as described above. Govari does not teach that the processor is configured to determine a proximity of each electrode to the tissue, nor classify the set of signals as valid based on the proximity of the tissue to the electrode based on a threshold distance, but Mosesov does in an analogous electrosurgical catheter device. Mosesov teaches the establishment of baseline impedance values (threshold) to determine the tissue proximity or contact (p.[0110, 0113, 0117]), via a processor, and further identify valid or "desired" signals based on the proximity or contact conditions stored in the memory 94 of the processor. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the processor of Mosesov in view of Govari. As stated in Mosesov, p.[0004] "In many procedures, it may be beneficial to know the contact status of an electrode (e.g., in contact with tissue, in a blood pool) on a catheter. For example, in an electrophysiology mapping procedure, the electrical signal present on an electrode may vary depending on whether the electrode is in contact with tissue, or adjacent to the tissue in a blood pool, and that difference may be accounted for in software."
Regarding claim 17 specifically, the limitations of claim 17 are taught by the rejection of claim 7 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 17 is nearly identical to the apparatus of claim 7 and therefore, claim 7 would perform the method of claim 17 and is considered to be anticipated by the rejection of claim 7, as outlined above.
Regarding claims 8 and 18, the limitations of claims 6 and 16 are taught as described above. Govari does not teach that the processor is configured to determine a second set of signals as invalid based on the probe moving more than a maximal distance during acquisition of the plurality of signals, but Mosesov does in an analogous electrosurgical device. Mosesov teaches the establishment of baseline impedance values (threshold) to determine the tissue proximity or contact (p.[0110, 0113, 0117]), via a processor, and further identify invalid or "undesired" signals based on the proximity or contact conditions stored in the memory 94 of the processor. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the processor of Mosesov in view of Govari. As stated in Mosesov, p.[0004] "In many procedures, it may be beneficial to know the contact status of an electrode (e.g., in contact with tissue, in a blood pool) on a catheter. For example, in an electrophysiology mapping procedure, the electrical signal present on an electrode may vary depending on whether the electrode is in contact with tissue, or adjacent to the tissue in a blood pool, and that difference may be accounted for in software."
Regarding claim 18 specifically, the limitations of claim 18 are taught by the rejection of claim 8 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 18 is nearly identical to the apparatus of claim 8 and therefore, claim 8 would perform the method of claim 18 and is considered to be anticipated by the rejection of claim 8, as outlined above.
Regarding claim 9 and 19, the limitations of claim 6 and 16 are taught as described above. Govari does not teach "wherein the processor is configured to filter the plurality of signals by voltage level and classify the respective first set of the signals as valid based on the voltage levels being above a predetermined minimum voltage levels", but Mosesov teaches this limitation in an analogous electrosurgical device. Mosesov teaches the establishment of baseline impedance values (threshold) to determine the tissue proximity or contact (p.[0110, 0113, 0117]), via a processor, and further identify valid or "desired" signals based on the proximity or contact conditions stored in the memory 94 of the processor. The Examiner notes for the sake of the record and clarity that impedance (Z) is calculated as a function of resistance voltage (V) and current (I), as given in the equation Z = V/I. Therefore, the processor is determining the voltage level and classifying the signals as valid or invalid based on voltage levels being above a certain predetermined voltage (impedance) level. Impedance will vary as voltage will vary, therefore, while Mosesov does not explicitly teach measuring voltage levels for classifying signals, Mosesov is capable of doing so, and does so indirectly by calculating impedance values as a threshold. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the processor of Mosesov in view of Govari. As stated in Mosesov, p.[0004] "In many procedures, it may be beneficial to know the contact status of an electrode (e.g., in contact with tissue, in a blood pool) on a catheter. For example, in an electrophysiology mapping procedure, the electrical signal present on an electrode may vary depending on whether the electrode is in contact with tissue, or adjacent to the tissue in a blood pool, and that difference may be accounted for in software."
Regarding claim 19 specifically, the limitations of claim 19 are taught by the rejection of claim 9 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 19 is nearly identical to the apparatus of claim 9 and therefore, claim 9 would perform the method of claim 19 and is considered to be anticipated by the rejection of claim 9, as outlined above.
Claims 1, 3, 4, 5, 6, 10, 11, 13, 14, 15, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Govari (US Patent Publication 2020/0367829) in view of Bar-Tal (US 2015/0208942).
Regarding claims 1 and 11, Govari teaches “A system for electrophysiological measurement (Figures 1-3, p.[0061-0063])”, “a probe having a distal end configured for insertion into a body cavity of a living subject (Fig. 1, the heart) and comprising an array of electrodes (Fig. 2, 55) that are disposed along the distal end and are configured to contact tissue at multiple locations within the body cavity (Fig. 1, 2, 55, i.e., electrodes on the cardiac catheter, see also p.[0063])”, “a processor (Fig. 1, 24, console comprising processing circuitry 41, typically a general purpose computer, p.[0067]) configured to acquire a plurality of signals from the electrodes over a period of time during which the probe moves within the body cavity (p.[0079], the processing circuitry receives signals from the electrodes)”, “compute, in response to the plurality of signals, a plurality of metrics, each metric being (i) associated with a respective electrode of the array of electrodes and (ii) indicative of a quality of contact between the respective electrode and the tissue (p.[0079], signals from the catheter electrodes 55 for use in assessing quality of contact of the catheter electrodes 55 with the tissue)”, “output an indication of each metric (see Fig. 1, 27, i.e. a display driven by the console, see also p.[0070, 0096], i.e., modify the visual feature of the traces sensed by the electrodes having a quality of contact with the tissue greater than a threshold quality of contact)”. However, Govari does not explicitly teach “… acquire a plurality of signals from each electrode of the array of electrodes over a period of time, compute, in response to the plurality of signals acquired from each electrode over the period of time, … indicative of a quality of contact between the respective electrode and the tissue over the period of time…”, as the amended claims now state, but Bar-Tal does in an analogous catheter device.
Bar-Tal teaches the use of a processor that can acquire a plurality of signals from each electrode of the array of electrodes over a period of time, compute a plurality of metrics from the electrodes over a period of time, and indicate the quality of contact between the electrode and tissue over a period of time, in p.[0024] which states “a processor, which is configured to receive an electrical signal from the electrodes and to perform the steps of recording a bipolar electrogram and a unipolar electrogram from one of the electrodes at a location in the heart, defining a time interval including a window of interest…” Note, the time interval including a window of interest falls under the broadest reasonable interpretation of a period of time, as required by the instant application, and therefore teaches the instant application as described. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Bar-Tal in Govari. Govari’s system is already capable of determining a quality of contact, albeit instantaneously (as the applicant argues, which the Examiner does not agree with as described above), but Applicant argues Govari does not teach that Govari can use a series of signals over a period of time. Bar-Tal does show that the processor can use a series of values from an electrode over a period of time to determine a desired quality, (p.[0014, p.[0024], p.[0060] p.[0081]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Bar-Tal in Govari. It is known in the art to gather data over a period of time, and such modifications produce predictable results.
Regarding claim 11 specifically, the limitations of claim 11 are taught by the rejection of claim 1 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 11 is nearly identical to the apparatus of claim 11 and therefore, claim 11 would perform the method of claim 1 and is considered to be anticipated by the rejection of claim 1, as outlined above.
Regarding claims 3 and 13, the limitations of claims 1 and 11 are taught as described above. Govari teaches “wherein the distal end of the probe comprises a plurality of flexible spines on which the electrodes are disposed along, the flexible spines being arranged in a multi-arm assembly” in p.[0062-63], i.e., deflectable arms 54 including electrodes 55, and further teaches that the metrics are indicative of contact between the sections of the expandable device and the tissues in p.[0079-0084] and illustrated in Figures 2 and 4.
Regarding claim 13 specifically, the limitations of claim 13 are taught by the rejection of claim 3 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 13 is nearly identical to the apparatus of claim 3 and therefore, claim 3 would perform the method of claim 13 and is considered to be anticipated by the rejection of claim 3, as outlined above.
Regarding claims 4 and 14, the limitations of claims 1 and 11 are taught as described above. Govari teaches the limitations “wherein each electrode is disposed at a respective location on the distal end”, “the processor is configured to render a display a graphical icon representing the distal end and to incorporate, in the graphical icon, the indication of each metric at the respective location “, and “and each indication comprises a color-coded marking, the color-coded marking comprising a color that is based on the computed metric“ in p.[0096], which states "The processing circuitry 41 is configured, in response to the signals received from the catheter 40, to render (block 68) to the display 27 respective intracardiac electrograms (IEGM) traces 88 representing electrical activity in the tissue that is sensed by the catheter electrodes 55 at respective locations, while modifying a visual feature of at least some of the traces (e.g., traces 88-4 of FIG. 6) responsively to the respective quality of contact of the catheter electrodes 55 with the tissue of the heart 26 at the respective locations". Govari explicitly teaches the use of color-coded marking in p.[0013-0014, 0024-0025,0047-0048,0051, 0093] at the least to describe how the colors may change based on the assessed quality of contact across each electrode and the tissue, therefore teaching the limitation as described.
Regarding claim 14 specifically, the limitations of claim 14 are taught by the rejection of claim 4 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 14 is nearly identical to the apparatus of claim 4 and therefore, claim 4 would perform the method of claim 14 and is considered to be anticipated by the rejection of claim 4, as outlined above.
Regarding claim 5 and 15, the limitations of claim 1 and 11 are taught as described above. Govari teaches “wherein each metric is indicative of a number of valid signals acquired by the associated respective electrode from the tissue over the period of time” in p.[0093-0094], which describes that the process of collecting metric signals via the electrodes over a period of time (at least one to three seconds), and that the valid signals from the electrodes are considered to be effective or sufficient contact with tissue overtime. The number of valid signals or sufficient contact with tissue signals is shown though the intensity, or brightness, of the color.
Regarding claim 15 specifically, the limitations of claim 15 are taught by the rejection of claim 5 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 15 is nearly identical to the apparatus of claim 5 and therefore, claim 5 would perform the method of claim 15 and is considered to be anticipated by the rejection of claim 5, as outlined above.
Regarding claim 6 and 16, the limitations of claim 5 and 15 are taught as described above. Govari teaches “wherein the processor is configured to apply one or more filtering criteria to the signals in order to classify as valid a respective first set of the signals acquired from each of the electrodes while classifying as invalid a respective second set of the signals acquired by each of the electrodes” in p.[0085], which describes that the processor is able to determine valid signals (in contact state) versus invalid signals (out-of-contact state) and therefore teaches the limitation as described.
Regarding claim 16 specifically, the limitations of claim 16 are taught by the rejection of claim 6 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 16 is nearly identical to the apparatus of claim 6 and therefore, claim 6 would perform the method of claim 16 and is considered to be anticipated by the rejection of claim 6, as outlined above.
Regarding claim 10 and 20, the limitations of claim 1 and 11 are taught as described above. Govari teaches “wherein each metric is indicative of a respective duration during which the respective electrode was in contact with the tissue in the body cavity over the period of time” in p.[0099], which describes how the processor is able to use a fading effect on the displayed electrode to demonstrate the duration of time the electrode was in sufficient contact with the desired tissue, therefore teaching the limitation as described.
Regarding claim 20 specifically, the limitations of claim 20 are taught by the rejection of claim 10 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 20 is nearly identical to the apparatus of claim 10 and therefore, claim 10 would perform the method of claim 20 and is considered to be anticipated by the rejection of claim 10, as outlined above.
Claims 2, 7, 8, 9, 12, 17, 18 and 19 are rejected under 35 U.S.C. 103 as being obvious over Govari (US Patent Publication 2020/0367829) in view of Bar-Tal (US 2015/0208942) and Mosesov (US Patent Publication 2019/0183378).
Regarding claims 2 and 12, the limitations of claim 1 and 11 are taught as described above. Govari teaches that a series of metrics indicative of contact between an expandable electrode assembly and tissue (abstract, p.[0078-0079,0081]), but Govari does not teach the use of a basket assembly, and instead teaches the use of a system of splines. However, Bar-Tal and Mosesov teaches the use of a basket catheter in an analogous ablative catheter device. Bar-Tal teaches the use of a basket catheter in Figure 3, and Mosesov teaches the use of a basket catheter to determine the contact between electrodes and tissue in Fig. 4, basket 18a-h, and p.[0058,0094]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the basket catheter of Mosesov in Govari's system. The use of a basket catheter allows for the selective expansion and retraction of the electrodes (p.[0111]) as needed for navigating the circulatory system before arriving at the desired hollow organ, and is known in the art as a predictable design choice for ablative catheters (as suggested in Govari, p.[0075], which states "Any suitable catheter may be used instead of catheter 40... or a different probe shape, such as a balloon catheter or a lasso catheter...").
Regarding claim 12 specifically, the limitations of claim 12 are taught by the rejection of claim 2 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 12 is nearly identical to the apparatus of claim 2 and therefore, claim 2 would perform the method of claim 12 and is considered to be anticipated by the rejection of claim 2, as outlined above.
Regarding claims 7 and 17, the limitations of claim 6 and 16 are taught as described above. Govari/Bar-Tal does not teach that the processor is configured to determine a proximity of each electrode to the tissue, nor classify the set of signals as valid based on the proximity of the tissue to the electrode based on a threshold distance, but Mosesov does in an analogous electrosurgical catheter device. Mosesov teaches the establishment of baseline impedance values (threshold) to determine the tissue proximity or contact (p.[0110, 0113, 0117]), via a processor, and further identify valid or "desired" signals based on the proximity or contact conditions stored in the memory 94 of the processor. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the processor of Mosesov in view of Govari/Bar-Tal. As stated in Mosesov, p.[0004] "In many procedures, it may be beneficial to know the contact status of an electrode (e.g., in contact with tissue, in a blood pool) on a catheter. For example, in an electrophysiology mapping procedure, the electrical signal present on an electrode may vary depending on whether the electrode is in contact with tissue, or adjacent to the tissue in a blood pool, and that difference may be accounted for in software."
Regarding claim 17 specifically, the limitations of claim 17 are taught by the rejection of claim 7 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 17 is nearly identical to the apparatus of claim 7 and therefore, claim 7 would perform the method of claim 17 and is considered to be anticipated by the rejection of claim 7, as outlined above.
Regarding claims 8 and 18, the limitations of claims 6 and 16 are taught as described above. Govari/Bar-Tal does not teach that the processor is configured to determine a second set of signals as invalid based on the probe moving more than a maximal distance during acquisition of the plurality of signals, but Mosesov does in an analogous electrosurgical device. Mosesov teaches the establishment of baseline impedance values (threshold) to determine the tissue proximity or contact (p.[0110, 0113, 0117]), via a processor, and further identify invalid or "undesired" signals based on the proximity or contact conditions stored in the memory 94 of the processor. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the processor of Mosesov in view of Govari/Bar-Tal. As stated in Mosesov, p.[0004] "In many procedures, it may be beneficial to know the contact status of an electrode (e.g., in contact with tissue, in a blood pool) on a catheter. For example, in an electrophysiology mapping procedure, the electrical signal present on an electrode may vary depending on whether the electrode is in contact with tissue, or adjacent to the tissue in a blood pool, and that difference may be accounted for in software."
Regarding claim 18 specifically, the limitations of claim 18 are taught by the rejection of claim 8 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 18 is nearly identical to the apparatus of claim 8 and therefore, claim 8 would perform the method of claim 18 and is considered to be anticipated by the rejection of claim 8, as outlined above.
Regarding claim 9 and 19, the limitations of claim 6 and 16 are taught as described above. Govari/Bar-Tal does not teach "wherein the processor is configured to filter the plurality of signals by voltage level and classify the respective first set of the signals as valid based on the voltage levels being above a predetermined minimum voltage levels", but Mosesov teaches this limitation in an analogous electrosurgical device. Mosesov teaches the establishment of baseline impedance values (threshold) to determine the tissue proximity or contact (p.[0110, 0113, 0117]), via a processor, and further identify valid or "desired" signals based on the proximity or contact conditions stored in the memory 94 of the processor. The Examiner notes for the sake of the record and clarity that impedance (Z) is calculated as a function of resistance voltage (V) and current (I), as given in the equation Z = V/I. Therefore, the processor is determining the voltage level and classifying the signals as valid or invalid based on voltage levels being above a certain predetermined voltage (impedance) level. Impedance will vary as voltage will vary, therefore, while Mosesov does not explicitly teach measuring voltage levels for classifying signals, Mosesov is capable of doing so, and does so indirectly by calculating impedance values as a threshold. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the processor of Mosesov in view of Govari. As stated in Mosesov, p.[0004] "In many procedures, it may be beneficial to know the contact status of an electrode (e.g., in contact with tissue, in a blood pool) on a catheter. For example, in an electrophysiology mapping procedure, the electrical signal present on an electrode may vary depending on whether the electrode is in contact with tissue, or adjacent to the tissue in a blood pool, and that difference may be accounted for in software."
Regarding claim 19 specifically, the limitations of claim 19 are taught by the rejection of claim 9 above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The method of claim 19 is nearly identical to the apparatus of claim 9 and therefore, claim 9 would perform the method of claim 19 and is considered to be anticipated by the rejection of claim 9, as outlined 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Bock whose telephone number is (571)272-8856. The examiner can normally be reached M-F 7:30am - 5:00pm.
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, Linda Dvorak can be reached at 5712724764. 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.
/ABIGAIL BOCK/Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
Prosecution Insights