DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Response to Arguments
3. Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference or combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
4. Claims 6, 8, and 12 were previously rejected under 35 U.S.C. 112(b) for indefiniteness. However, these claims have been amended to overcome the rejections. Therefore, the rejections have been withdrawn.
Claim Rejections - 35 USC § 103
5. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
6. Claims 1, 2, 7, 8, 10-13, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Mangual-Soto U.S. 2021/0145344 (herein referred to as “Mangual-Soto”) and in view of Olson U.S. 2017/0042481 (herein referred to as “Olson”).
7. Regarding Claim 1, Mangual-Soto teaches a system to generate an electroanatomical map of a patient’s heart (Fig. 1), the system comprising:
a. a catheter (Figs. 1 and 2, ref num 13) including an electrode configured to detect a plurality of physiological signals from within the patient’s heart (Fig. 2, ref num 17; para 0033, “each of electrodes 17, 52, 54, and 56 can be used to gather electrophysiological data from the cardiac surface”) and a location sensor configured to generate a plurality of location signals representative of a location of the catheter within the patient’s heart (para 0032, “ Since each of these electrodes 17, 52, 54, 56 lies within the patient, location data may be collected simultaneously for each of the electrodes by system 8”);
b. a display device (Fig. 1, ref num 23); and
c. a controller (Fig. 1, ref num 28) configured to:
c.1 determine a catheter context characteristic based on the plurality of location signals (Fig. 3, ref num 304; para 0047, “block 304, the signal processor receives information regarding the proximal stability of an electrophysiology catheter (e.g., catheter 13) used to measure the electrogram signal received in block 302 at the time that signal was acquired. The proximal stability information is determined relative to an anatomical region, such as the cardiac surface being studied”), wherein the catheter context characteristic comprises a velocity of the catheter or a location of the catheter within the patient’s heart (Abstract, “The proximal stability information can include a distance between the electrophysiology catheter and an anatomical surface, a velocity of the electrophysiology catheter”; para 0048, “the proximal stability information can include a distance between catheter 13 and the cardiac surface at the signal acquisition time”; para 0050, “The proximal stability information can also include information regarding the velocity of catheter 13 at the signal acquisition time”).;
c.2 collect the plurality of physiological signals according to a collection parameter, the collection parameter based on the determined catheter context characteristic (Fig. 3, ref num 308; Fig. 4, ref num 400; para 0053-0054);
c.3 collect a plurality of anatomical location signals corresponding to a measurement location associated with each of the plurality of physiological signals (Fig. 3, ref num 310); and
c.4 generate, on the display device, a three-dimensional representation of the patient’s heart based on the plurality of physiological signals and the plurality of anatomical location signals (Fig. 3, ref num 314).
Mangual-Soto fails to teach the collection parameter comprises a sampling rate selected based on the catheter context characteristic.
Olson teaches a system of analogous art (Fig. 1), wherein the system comprises a controller (Fig. 1, ref num 20) that is configured to collect a plurality of physiological signals according to a collection parameter (para 0033), such that the collection parameter comprises a sampling rate (para 0035) based on the catheter context characteristic, such as a location of the catheter (para 0035). By selecting the sampling rate based on the catheter context characteristic, this aligns each data point with the cardiac phase at which the data point is taken, improving the accuracy of the physiological signals (para 0034-0036). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mangual-Soto to have the collection parameter comprising a sampling rate, in order to improve the accuracy of the collection of physiological signals.
8. Regarding Claim 2, Mangual-Soto teaches the catheter context characteristic is associated with a velocity of the catheter determined using the plurality of location signals (para 0050).
9. Regarding Claim 7, Mangual-Soto teaches the controller is configured to generate a three-dimensional representation using a plurality of mapping processes, each mapping process of the plurality of mapping processes including an associated set of parameters (para 0004, “To increase the quality and density of electrophysiology maps, medical devices and systems (e.g., electrophysiology catheters, electroanatomical mapping systems) that simultaneously collect many (e.g., more than ten) intracardiac electrogram signals can be used”; para 0025, “three-dimensionally mapping the electrical activity and/or information related to or representative of the electrical activity so measured”).
10. Regarding Claim 8, Mangual-Soto teaches the parameter is associated with a parameter value, and the parameter value for the parameter is adjusted based on the catheter context characteristic (Fig. 3, ref num 308; Fig. 4, ref num 400; para 0053-0054).
11. Regarding Claim 10, Mangual-Soto teaches the controller is configured to adjust the parameter value via a calculation (para 0056).
12. Regarding Claim 11, Mangual-Soto teaches the catheter includes mapping and ablation electrodes (para 0032).
13. Regarding Claim 12, Mangual-Soto teaches a method for generating an electroanatomical map of a patient’s heart (Figs. 1-4; para 0002-0004), the method comprising:
a. receiving a plurality of physiological signals from a catheter within the patient’s heart (Fig. 2, ref num 17 part of catheter, ref num 35; para 0033, “each of electrodes 17, 52, 54, and 56 can be used to gather electrophysiological data from the cardiac surface”) and a plurality of location signals representative of a location of the catheter within the patient’s heart (para 0032, “ Since each of these electrodes 17, 52, 54, 56 lies within the patient, location data may be collected simultaneously for each of the electrodes by system 8”);
b. determining a catheter context characteristic based on the plurality of location signals (Fig. 3, ref num 304; para 0047, “block 304, the signal processor receives information regarding the proximal stability of an electrophysiology catheter (e.g., catheter 13) used to measure the electrogram signal received in block 302 at the time that signal was acquired. The proximal stability information is determined relative to an anatomical region, such as the cardiac surface being studied”), wherein the catheter context characteristic comprises a velocity of the catheter or a location of the catheter within the patient’s heart (Abstract, “The proximal stability information can include a distance between the electrophysiology catheter and an anatomical surface, a velocity of the electrophysiology catheter”; para 0048, “the proximal stability information can include a distance between catheter 13 and the cardiac surface at the signal acquisition time”; para 0050, “The proximal stability information can also include information regarding the velocity of catheter 13 at the signal acquisition time”);
c. collecting the plurality of physiological signals according to a collection parameter, the collection parameter based on the determined catheter context characteristic (Fig. 3, ref num 308; Fig. 4, ref num 400; para 0053-0054);
d. collecting a plurality of anatomical location signals corresponding to a measurement location associated with each of the plurality of physiological signals (Fig. 3, ref num 310); and
e. generating, on a display device, a three-dimensional representation of the patient’s heart based on the plurality of physiological signals and the plurality of anatomical location signals (Fig. 3, ref num 314).
Mangual-Soto fails to teach the collection parameter comprises a sampling rate selected based on the catheter context characteristic.
Olson teaches a system/method of analogous art (Fig. 1), wherein the system comprises a controller (Fig. 1, ref num 20) that is configured to collect a plurality of physiological signals according to a collection parameter (para 0033), such that the collection parameter comprises a sampling rate (para 0035) based on the catheter context characteristic, such as a location of the catheter (para 0035). By selecting the sampling rate based on the catheter context characteristic, this aligns each data point with the cardiac phase at which the data point is taken, improving the accuracy of the physiological signals (para 0034-0036). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mangual-Soto to have the collection parameter comprising a sampling rate, in order to improve the accuracy of the collection of physiological signals.
14. Regarding Claim 13, Mangual-Soto teaches the catheter context characteristic is associated with a velocity of the catheter determined using the plurality of location signals (para 0050).
15. Regarding Claim 17, Mangual-Soto teaches the parameter is associated with a parameter value, and the parameter value for the parameter is adjusted based on the catheter context characteristic (Fig. 3, ref num 308; Fig. 4, ref num 400; para 0053-0054).
16. Regarding Claim 18, Mangual-Soto teaches a system to generate an electroanatomical map of a patient’s heart (Fig. 1), the system comprising:
a. a catheter (Figs. 1 and 2, ref num 13) including an electrode configured to detect a plurality of physiological signals from within the patient’s heart (Fig. 2, ref num 17; para 0033, “each of electrodes 17, 52, 54, and 56 can be used to gather electrophysiological data from the cardiac surface”) and a location sensor configured to generate a plurality of location signals representative of a location of the catheter within the patient’s heart (para 0032, “ Since each of these electrodes 17, 52, 54, 56 lies within the patient, location data may be collected simultaneously for each of the electrodes by system 8”);
b. a display device (Fig. 1, ref num 23); and
c. a controller (Fig. 1, ref num 28) configured to:
c.1 determine a catheter context characteristic based on the plurality of location signals (Fig. 3, ref num 304; para 0047, “block 304, the signal processor receives information regarding the proximal stability of an electrophysiology catheter (e.g., catheter 13) used to measure the electrogram signal received in block 302 at the time that signal was acquired. The proximal stability information is determined relative to an anatomical region, such as the cardiac surface being studied”), wherein the catheter context characteristic comprises a velocity of the catheter or a location of the catheter within the patient’s heart (Abstract, “The proximal stability information can include a distance between the electrophysiology catheter and an anatomical surface, a velocity of the electrophysiology catheter”; para 0048, “the proximal stability information can include a distance between catheter 13 and the cardiac surface at the signal acquisition time”; para 0050, “The proximal stability information can also include information regarding the velocity of catheter 13 at the signal acquisition time”);
c.2 collect the plurality of physiological signals according to a selected value of a collection parameter from a range of values, the selected value based on the determined catheter context characteristic (Fig. 3, ref num 308; Fig. 4, ref num 400; para 0053-0054; para 0025, “System 8 can also be used to measure electrophysiology data at a plurality of points along a cardiac surface and store the measured data in association with location information for each measurement point at which the electrophysiology data was measured, for example to create a diagnostic data map of the patient's heart 10. In some embodiments, and as discussed further herein, the system 8 can determine the signal quality of measured electrophysiological data and compute a corresponding signal quality score”);
c.3 collect a plurality of anatomical location signals corresponding to a measurement location associated with each of the plurality of physiological signals (Fig. 3, ref num 310); and
c.4 generate, on the display device, a three-dimensional representation of the patient’s heart based on the plurality of physiological signals and the plurality of anatomical location signals (Fig. 3, ref num 314).
Mangual-Soto fails to teach the collection parameter comprises a sampling rate selected based on the catheter context characteristic.
Olson teaches a system of analogous art (Fig. 1), wherein the system comprises a controller (Fig. 1, ref num 20) that is configured to collect a plurality of physiological signals according to a collection parameter (para 0033), such that the collection parameter comprises a sampling rate (para 0035) based on the catheter context characteristic, such as a location of the catheter (para 0035). By selecting the sampling rate based on the catheter context characteristic, this aligns each data point with the cardiac phase at which the data point is taken, improving the accuracy of the physiological signals (para 0034-0036). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mangual-Soto to have the collection parameter comprising a sampling rate, in order to improve the accuracy of the collection of physiological signals.
17. Claims 3, 6, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Mangual-Soto and Olson, and further in view of Koyrakh U.S. 2015/0057507 (herein referred to as “Koyrakh”).
18. Regarding Claim 3, Mangual-Soto fails to teach the collection parameter includes collecting the physiological signals at a first sampling rate associated with a first context characteristic and at a second sampling rate associated with a second context characteristic.
Koyrakh teaches a system of analogous art (Fig. 1; para 0002-0003), wherein the system is configured to collect physiological signals associated with a first and second sampling rates (para 0051, “Each of the various inclusion criteria identified above offers certain advantages. For example, a catheter velocity criterion can help ensure that only electrophysiology data points collected when the probe (e.g., catheter 13) is relatively stable are included in the electrophysiology map. Thus, the catheter velocity criterion can be defined such that it is only satisfied when the electrophysiology data point is collected with the probe velocity below a preset velocity threshold (e.g., 10 mm/sec)”; this indicates that there are different data points collected, each with an individual velocity/sampling rate). By collecting these physiological signals at certain sampling rates, this determines whether the data points are added to the electroanatomical map (Fig. 5, ref num 540, 560) and ensures that the most accurate data is used (para 0049-0055). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mangual-Soto to have collected the physiological signals at individual sampling rates in order to properly map the data set and output the desired electroanatomical map.
19. Regarding Claim 6, Mangual-Soto fails to teach the first sampling rate is applied when the first context characteristic is a velocity of from about 10 to about 50 mm/s and wherein the wherein the second sampling rate is applied when the second context characteristic is a velocity of from about 2 to about 10 mm/s.
Koyrakh teaches the sampling rate having a velocity threshold of 10 mm/sec (para 0051). The data points of the physiological signals are collected when the sampling rate is at or below this threshold (para 0051). Therefore, one of ordinary skill in the art would understand that any individual signal collected under this velocity threshold would read on various ranges of sampling rates described in the claim language (since one range begins at 10 mm/s and the other range ends at 10 mm/s, then the threshold of 10 mm/s would read on both of these ranges; para 0051). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the first and second sampling rates be within the desired velocity ranges, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
20. Regarding Claim 14, Mangual-Soto fails to teach the collection parameter includes collecting the physiological signals at a first sampling rate associated with a first context characteristic and at a second sampling rate associated with a second context characteristic.
Koyrakh teaches a system of analogous art (Fig. 1; para 0002-0003), wherein the system is configured to collect physiological signals associated with a first and second sampling rates (para 0051, “Each of the various inclusion criteria identified above offers certain advantages. For example, a catheter velocity criterion can help ensure that only electrophysiology data points collected when the probe (e.g., catheter 13) is relatively stable are included in the electrophysiology map. Thus, the catheter velocity criterion can be defined such that it is only satisfied when the electrophysiology data point is collected with the probe velocity below a preset velocity threshold (e.g., 10 mm/sec)”; this indicates that there are different data points collected, each with an individual velocity/sampling rate). By collecting these physiological signals at certain sampling rates, this determines whether the data points are added to the electroanatomical map (Fig. 5, ref num 540, 560) and ensures that the most accurate data is used (para 0049-0055). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mangual-Soto to have collected the physiological signals at individual sampling rates in order to properly map the data set and output the desired electroanatomical map.
21. Claims 4 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Mangual-Soto, Olson, and Koyrakh, and further in view of Leo U.S. 9,393,068 (herein referred to as “Leo”).
22. Regarding Claim 4, Mangual-Soto fails to teach wherein the controller configured to generate includes the controller configured to employ a process applying a higher degree of interpolation to the physiological signals collected at the first sampling rate and applying a lower degree of interpolation to the physiological signals collected at the second sampling rate.
Leo teaches a system of analogous art (Fig. 1; Col. 5, lines 66-67 – Col. 6, lines 1-11), wherein the system comprises a controller that applies interpolation to collected physiological signals (Fig. 10, ref num 124; Col. 15, line 11, “control system 124”; Col. 16, lines 31-37, “It is noted that while the data presented herein (i.e. lesion size vs. force-time integral and power) can form the basis of linear interpolations, the invention is not limited to linear interpolation of these parameters. For example, additional functions at other energization parameter levels (e.g., 25-, 30- and/or 35-watts) could provide the basis of a higher order interpolation between energization parameter levels”). The order of interpolation is applied based on the physiological signal collected (Col. 16, lines 31-37), indicating various degrees of interpolation that may be applied. Since it is well known in the art that interpolation provides the benefit of data estimation, then it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mangual-Soto to apply a certain degree of interpolation dependent on the sampling rate of the collected physiological signals in order to provide an accurate estimation of data when mapping the patient’s heart.
23. Regarding Claim 15, Mangual-Soto fails to teach wherein the generating includes applying a higher degree of interpolation to the physiological signals collected at the first sampling rate and applying a lower degree of interpolation to the physiological signals collected at the second sampling rate.
Leo teaches a system of analogous art (Fig. 1; Col. 5, lines 66-67 – Col. 6, lines 1-11), wherein the system comprises a controller that applies interpolation to collected physiological signals (Fig. 10, ref num 124; Col. 15, line 11, “control system 124”; Col. 16, lines 31-37, “It is noted that while the data presented herein (i.e. lesion size vs. force-time integral and power) can form the basis of linear interpolations, the invention is not limited to linear interpolation of these parameters. For example, additional functions at other energization parameter levels (e.g., 25-, 30- and/or 35-watts) could provide the basis of a higher order interpolation between energization parameter levels”). The order of interpolation is applied based on the physiological signal collected (Col. 16, lines 31-37), indicating various degrees of interpolation that may be applied. Since it is well known in the art that interpolation provides the benefit of data estimation, then it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mangual-Soto to apply a certain degree of interpolation dependent on the sampling rate of the collected physiological signals in order to provide an accurate estimation of data when mapping the patient’s heart.
24. Claims 5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Mangual-Soto, Olson, and Koyrakh, and further in view of Harlev U.S. 10,285,611 (herein referred to as “Harlev”).
25. Regarding Claim 5, Mangual-Soto fails to teach wherein the controller configured to generate includes the controller configured to employ a process applying a higher degree of smoothing to the physiological signals collected at the first sampling rate and applying a lower degree of smoothing to the physiological signals collected at the second sampling rate.
Harlev teaches a system of analogous art (Fig. 1), wherein a controller employes a process of smoothing data points that are collected (Col. 21, lines 9-21; Col. 22, lines 17-27). The various data sets may have different degrees of smoothing applied (Col. 22, lines 28-41). Since it is well known in the art that smoothing provides the benefit of data estimation, then it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mangual-Soto to apply a certain degree of smoothing dependent to the sampling rate of the collected physiological signals in order to provide an accurate estimation of data when mapping the patient’s heart.
26. Regarding Claim 16, Mangual-Soto fails to teach wherein generating includes the employing a process applying a higher degree of smoothing to the physiological signals collected at the first sampling rate and applying a lower degree of smoothing to the physiological signals collected at the second sampling rate.
Harlev teaches a system of analogous art (Fig. 1), wherein a controller employes a process of smoothing data points that are collected (Col. 21, lines 9-21; Col. 22, lines 17-27). The various data sets may have different degrees of smoothing applied (Col. 22, lines 28-41). Since it is well known in the art that smoothing provides the benefit of data estimation, then it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mangual-Soto to apply a certain degree of smoothing dependent to the sampling rate of the collected physiological signals in order to provide an accurate estimation of data when mapping the patient’s heart.
27. Claims 9, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mangual-Soto, Olson, and in view of Fang U.S. 2017/0056103 (herein referred to as “Fang”).
28. Regarding Claim 9, Mangual-Soto fails to teach the controller is configured to adjust the parameter value via a lookup table in a memory device.
Fang teaches a system of analogous art (Fig. 1A), wherein the system comprises a controller (para 0020, “a controller including a processor and a memory”) such that the controller is configured to adjust a parameter value via a lookup table in a memory device (para 0066, “The output power control curves may be implemented in the memory of the controller in any of a number of ways, such as a lookup table mapping a contact force to an output power, a function call, and a state machine”). This allows for the parameter to be adjusted based on the needs or circumstances at that time (para 0065). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mangual-Soto to have adjusting the parameter value via a lookup table, as this is a widely known technique to adjust parameters based on the circumstances of the procedure at that time.
29. Regarding Claims 19 and 20, Mangual-Soto teaches including information about the selected value being velocity (para 0050, “proximal stability information can also include information regarding the velocity of catheter 13 at the signal acquisition time”), but fails to teach the controller is configured to select the parameter value via a lookup table in a memory device, by inputting information into the lookup table.
Fang teaches a system of analogous art (Fig. 1A), wherein the system comprises a controller (para 0020, “a controller including a processor and a memory”) such that the controller is configured to select a parameter value via a lookup table in a memory device via user input (para 0019, “receive a user parameter”; para 0066, “The output power control curves may be implemented in the memory of the controller in any of a number of ways, such as a lookup table mapping a contact force to an output power, a function call, and a state machine”). This allows for the parameter to be selected based on the needs or circumstances at that time (para 0065). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mangual-Soto to have selecting the parameter value via a lookup table, as this is a widely known technique to adjust parameters based on the circumstances of the procedure at that time.
Conclusion
29. 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.
30. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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