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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/20/2025 has been entered. Claims 1-4, 6-10 and 12-19, 21 and 24-26 are currently pending and under examination.
Claim Rejections - 35 USC § 101
In view of the amendment filed on 6/20/2025 amending the claims to recite a therapy delivery system configured to delivery therapy to spatial locations on a heart that is controlled based on the fast firing data the 101 rejections made against the claims in the office action of 3/25/2025 have been withdrawn.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 1-4,6,12-15 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-21 of U.S. Patent No. 11,229,392 in view of US Patent No. 5,046,504 to Albert et al. (Albert) (previously cited), see analysis within claim chart below.
Instant Application
US Patent No. 11,229,392
Analysis
1. A system comprising: a processor; non-transitory memory configured to store machine-readable instructions and data, the data including electrophysiological data representing electrocardiogram (ECG) signals for a plurality of locations across a cardiac surface; wherein the machine-readable instructions include code that, when executed by the processor, cause the processor to at least: convert the plurality of ECG signals into frequency-domain ECG signals; perform cardiac fast firing detection on the frequency-domain ECG signals to identify a subset of the ECG signals exhibiting outlier frequency activity having a dominant frequency that is higher than a dominant frequency determined for baseline fibrillation activity; and generate cardiac fast firing data characterizing the detected fast firing based on the identified subset of the ECG signals; and store in the memory the cardiac fast firing data and store in the memory cardiac fast firing data, a therapy delivery system configured to deliver a therapy to one or more spatial locations of a heart of a patient exhibiting fast firing, wherein the therapy is controlled based on the fast firing data.
18. A system comprising: a measurement system configured to acquire cardiac waveform data based on body surface electrical measurements corresponding to a plurality of channels from body surface electrodes adapted to be placed on a patient's body surface; a processor configured to: perform frequency analysis of the acquired cardiac waveform data for each of the plurality of channels over a moving window; identify a proper subset of the channels exhibiting a fast-firing frequency peak within an outlier frequency cluster having a dominant frequency that is higher that a dominant frequency of a baseline frequency cluster corresponding to fibrillatory cardiac activity during a given time window within which the frequency analysis was performed; and map the proper subset of the channels identified as fast-firing in the given time window to one or more spatial regions of a heart; further comprising a therapy system configured to control delivery of a therapy based on an anatomical location of fast-firing activity that corresponds to one of the one or more spatial regions of the heart.
Claim 18 within US Patent No. 11,229,392 discloses most elements of claim 1 of the instant application. Claim 18 within US Patent No. 11,229,392 differs from claim 1 in the instant application since the patent claim does not recite non-transitory memory configured to store instructions and data representing ECG signals, however the use of memory to store instructions and data was known in the art as evidence by Albert (e.g. memory stores data, Col. 5, ll. 16-26, 45-49, Col. 13, ll. 44-47; electrocardiogram signals, Col. 5, ll. 27-48), therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system within claim 18 of US Patent No. 11,229,392 to include a non-transitory memory configured to store instructions and data to be accessed by the processor in order to provide a component to store the data and instruction to aid in automated implementation for determining fast firing and to offload collected data.
2. The system of claim 1, wherein the cardiac fast firing data is provided to specify times, channels, and/or epicardial surface regions exhibiting cardiac fast firing.
15. A system comprising: a measurement system configured to acquire cardiac waveform data based on body surface electrical measurements corresponding to a plurality of channels from body surface electrodes adapted to be placed on a patient's body surface; a processor configured to: perform frequency analysis of the acquired cardiac waveform data for each of the plurality of channels over a moving window; identify a proper subset of the channels exhibiting a fast-firing frequency peak within an outlier frequency cluster having a dominant frequency that is higher that a dominant frequency of a baseline frequency cluster corresponding to fibrillatory cardiac activity during a given time window within which the frequency analysis was performed; and map the proper subset of the channels identified as fast-firing in the given time window to one or more spatial regions of a heart.
See language above regarding claim 1 of the instant application being obvious over claim 18 within US Patent No. 11,229,392. The further limitations within claim 2 of the instant application are fully disclosed within claim 15 of US Patent No. 11,229,392.
Claim 3. The system of claim 1, wherein the instructions further comprise: code that when executed by the processor, cause the processor to remove ventricular content from the frequency-domain ECG signals, the cardiac fast firing detection code operating on the plurality of ECG signals following removal of the ventricular content.
16. A system comprising: a measurement system configured to acquire cardiac waveform data based on body surface electrical measurements corresponding to a plurality of channels from body surface electrodes adapted to be placed on a patient's body surface; a processor configured to: perform frequency analysis of the acquired cardiac waveform data for each of the plurality of channels over a moving window; identify a proper subset of the channels exhibiting a fast-firing frequency peak within an outlier frequency cluster having a dominant frequency that is higher that a dominant frequency of a baseline frequency, cluster corresponding to fibrillatory cardiac activity during a given time window within which the frequency analysis was performed; and map the proper subset of the channels identified as fast-firing in the given time window to one or more spatial regions of a heart.
wherein the frequency analysis further comprises removing QRST content from each channel of the collected cardiac waveform data.
See language above regarding claim 1 of the instant application being obvious over claim 18 within US Patent No. 11,229,392. The further limitations within claim 3 of the instant application are fully disclosed within claim 16 of US Patent No. 11,229,392.
4. The system of claim 1, wherein the instructions further comprise code that when executed by the processor, cause the processor to map the subset of the ECG signals identified as fast-firing to one or more spatial locations of a heart and store map data representative thereof.
15. A system comprising: a measurement system configured to acquire cardiac waveform data based on body surface electrical measurements corresponding to a plurality of channels from body surface electrodes adapted to be placed on a patient's body surface; a processor configured to: perform frequency analysis of the acquired cardiac waveform data for each of the plurality of channels over a moving window; identify a proper subset of the channels exhibiting a fast-firing frequency peak within an outlier frequency cluster having a dominant frequency that is higher that a dominant frequency of a baseline frequency cluster corresponding to fibrillatory cardiac activity during a given time window within which the frequency analysis was performed; and map the proper subset of the channels identified as fast-firing in the given time window to one or more spatial regions of a heart.
See language above regarding claim 1 of the instant application being obvious over claim 18 within US Patent No. 11,229,392. The further limitations within claim 4 of the instant application are fully disclosed within claim 15 of US Patent No. 11,229,392.
6. The system of claim 1, wherein the cardiac fast firing detection code comprises further instructions that when executed by the processor cause the processor to:
compare dominant frequencies of respective ECG signals from the among the plurality of ECG signals relative to a frequency threshold, the frequency threshold being between the dominant frequency of the outlier frequency activity and the dominant frequency of the baseline fibrillation activity; and identify the subset of ECG signals from among the plurality of ECG signals to be representative of a fast-firing event based on the comparison.
20. The system of claim 15, wherein the processor is further configured to identify the proper subset of the channels exhibiting a fast-firing frequency peak based on: providing a frequency value as a frequency threshold either manually as a user input or via an automatic threshold value generator, the frequency threshold being between the dominant frequency of the outlier frequency cluster and the dominant frequency of the baseline frequency cluster; comparing dominant frequencies of individual channels from among the plurality of channels against the frequency threshold during the given time window; and determining channels from among the plurality of channels exhibiting a dominant frequency greater than the frequency threshold to be fast-firing channels within the proper subset of the channels.
See language above regarding claim 1 of the instant application being obvious over claim 18 within US Patent No. 11,229,392. The further limitations within claim 6 of the instant application are fully disclosed within claim 20 of US Patent No. 11,229,392.
12. The system of claim 1, wherein the ECG signals are acquired based on electrical measurements performed invasively and/or non-invasively.
15. A system comprising: a measurement system configured to acquire cardiac waveform data based on body surface electrical measurements corresponding to a plurality of channels from body surface electrodes adapted to be placed on a patient's body surface; a processor configured to: perform frequency analysis of the acquired cardiac waveform data for each of the plurality of channels over a moving window; identify a proper subset of the channels exhibiting a fast-firing frequency peak within an outlier frequency cluster having a dominant frequency that is higher that a dominant frequency of a baseline frequency cluster corresponding to fibrillatory cardiac activity during a given time window within which the frequency analysis was performed; and map the proper subset of the channels identified as fast-firing in the given time window to one or more spatial regions of a heart.
See language above regarding claim 1 of the instant application being obvious over claim 18 within US Patent No. 11,229,392. The further limitations within claim 12 of the instant application are fully disclosed within claim 15 of US Patent No. 11,229,392.
13. The system of claim 1, wherein the instructions further comprise code programmed to localize the detected fast firing to one or more spatial regions of a heart based on the cardiac fast firing data.
21. The system of claim 20, wherein the processor is further configured to anatomically localize the fast-firing activity based on the determined fast-firing channels.
See language above regarding claim 1 of the instant application being obvious over claim 18 within US Patent No. 11,229,392. The further limitations within claim 13 of the instant application are fully disclosed within claim 21 of US Patent No. 11,229,392.
14. The system of claim 1, wherein the cardiac fast firing detection code is programmed to determine respective outlier dominant frequencies for a set of channels exhibiting a frequency that is at least one standard deviation greater than a mean of the baseline fibrillation activity.
19. The system of claim 15, wherein the proper subset of the channels exhibiting a fast-firing frequency peak is identified based on determining respective channels from among the plurality of channels that have a mean dominant frequency that is at least one standard deviation greater than a mean dominant frequency of the baseline frequency cluster during cardiac fibrillation.
See language above regarding claim 1 of the instant application being obvious over claim 18 within US Patent No. 11,229,392. The further limitations within claim 14 of the instant application are fully disclosed within claim 19 of US Patent No. 11,229,392.
15. The system of claim 1, wherein the plurality of ECG signals are provided via a respective plurality of channels, and the instructions further comprise code that when executed by the processor cause the processor to
removing QRST content from the ECG signals provided by each of the plurality of channels.
16. The system of claim 15, wherein the frequency analysis further comprises removing QRST content from each channel of the collected cardiac waveform data.
See language above regarding claim 1 of the instant application being obvious over claim 18 within US Patent No. 11,229,392. The further limitations within claim 15 of the instant application are fully disclosed within claim 16 of US Patent No. 11,229,392.
24. The system of claim 4, further comprising a display, the instructions providing output data that includes a graphical representation to visualize on the display the one or more spatial locations of the heart exhibiting fast firing.
17. The system of claim 15, wherein the processor is further configured to generate a graphical output indicative of at least one of the time and/or anatomical location of fast-firing activity.
See language above regarding claim 1 of the instant application being obvious over claim 18 within US Patent No. 11,229,392. The further limitations within claim 24 of the instant application are fully disclosed within claim 17 of US Patent No. 11,229,392.
Allowable Subject Matter
Claims 17-19 and 21 are allowed. Claims 7-10, 16 and 25-26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: In view of the art that is relevant to the claimed invention the prior art does not teach or reasonably suggests, within the context of the other claimed elements, system that includes a processor that performs a frequency analysis on a respective frequency-domain electrophysiological to generate signal frequency plot data for the one or more time intervals; performing a frequency analysis on an identified QRST frequency template to generate template frequency plot data; subtracting the template frequency plot data from the signal frequency plot data to generate frequency data of a QRST-removed electrophysiological signal corresponding to the respective frequency-domain electrophysiological signal for the one or more time intervals, repeating the signal frequency plot data generation and the subtraction for additional channels, perform cardiac fast firing detection to identify a subset of QRST-removed electrophysiological signals of the respective QRST-removed electrophysiological signals exhibiting outlier frequency activity having a dominant frequency that is higher than a dominant frequency determined for baseline fibrillation activity and a therapy system configured to deliver to one or more spatial locations of a heart of a patient exhibiting fast firing, wherein the therapy is controlled based on the fast firing data, respectively in combination with the other claim limitations. Several prior art references teach mapping fibrillatory activity including WO 2008/035070 to Jarman et al. (previously cited) which discloses a method for determining dominant frequency at at least a portion of a cardiac area and comparing the dominant frequency with a reference value to determine where ablation will be provided and US 2014/0088395 to Dubois et al. (previously cited) which discloses physiological mapping for arrhythmia but the prior art does not teach or reasonably suggest the specifics of performing frequency analysis as claimed and performing fast firing detection to identify channels exhibiting a fast-firing frequency peak within an outlier frequency cluster having a dominant frequency that is higher than a dominant frequency of a baseline fibrillation activity and a therapy system to provide therapy to one or more spatial locations of a heart of a patient exhibiting fast firing, wherein the therapy is controlled based on the fast firing data.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1,17 and 21 with respect to the 101 rejections have been considered and in view of the amendments adding language that includes a therapy system configured to deliver a therapy to one or more spatial locations of a heart based on the fast firing data the 101 rejections made against the claims in the office action of 3/25/2025 have been withdrawn. Regarding the double patenting rejection, it is noted that the rejection has been updated in view of the claim amendments. Applicant has not provided any arguments regarding the double patenting rejection, therefore the double patenting rejection has been maintained.
Conclusion
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/JENNIFER L GHAND/Examiner, Art Unit 3796