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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 830 para. [0127]. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: #810 (Figs. 11-12). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6 and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 6 and 16 recites the limitation "the first time interval" in lines 2-3 (claim 6) and line 4 (claim 16). There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9, 11-19 and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1-9, 11-19 and 21 is/are drawn to a method and an apparatus which is/are a statutory category of invention (Step 1: YES).
The claim limitations within independent claims 1, 11 and 21 that set forth or describe the abstract idea is/are: “over a time interval comprising a plurality of ventricular cycles: applying/apply a first atrial systolic event threshold to the cardiac mechanical signal during first windows of the plurality of ventricular cycles; applying/apply a second atrial systolic event threshold to the cardiac mechanical signal during second windows of the plurality of ventricular cycles, each of the second windows starting from an ending time of one of the first windows, the second atrial systolic event threshold being less than the first atrial systolic event threshold; and accumulating/accumulate atrial event evidence from the cardiac mechanical signal sensed during the second windows; based on at least the accumulated atrial event evidence, determining/determine that atrial arrhythmia criteria are met for the time interval; and generating/generate an output in response to the atrial arrhythmia criteria being met for the time interval.”. The reasons that the limitations is/are considered an abstract idea is/are the following: The limitations of “over a time interval comprising a plurality of ventricular cycles: applying/apply a first atrial systolic event threshold to the cardiac mechanical signal during first windows of the plurality of ventricular cycles; applying/apply a second atrial systolic event threshold to the cardiac mechanical signal during second windows of the plurality of ventricular cycles, each of the second windows starting from an ending time of one of the first windows, the second atrial systolic event threshold being less than the first atrial systolic event threshold; and accumulating/accumulate atrial event evidence from the cardiac mechanical signal sensed during the second windows; based on at least the accumulated atrial event evidence, determining/determine that atrial arrhythmia criteria are met for the time interval; and generating/generate an output in response to the atrial arrhythmia criteria being met for the time interval.” is a process directed to a concept relating to organizing or analyzing information in a way that can be performed in human mental work, i.e. under its broadest reasonable interpretation covers performance of the limitation in the mind with the aid of pen and paper but for the recitation of generic computer components. That is, other than reciting “control circuit configured to” (claim 1) and “executed by a control circuit of a medical device” (claim 21) nothing in the claim element precludes the steps from practically being performed in the mind with the aid of pen and paper. For example but for the “control circuit configured to” (claim 1) and “executed by a control circuit of a medical device” (claim 21) language “over a time interval comprising a plurality of ventricular cycles: applying/apply a first atrial systolic event threshold to the cardiac mechanical signal during first windows of the plurality of ventricular cycles; applying/apply a second atrial systolic event threshold to the cardiac mechanical signal during second windows of the plurality of ventricular cycles, each of the second windows starting from an ending time of one of the first windows, the second atrial systolic event threshold being less than the first atrial systolic event threshold; and accumulating/accumulate atrial event evidence from the cardiac mechanical signal sensed during the second windows; based on at least the accumulated atrial event evidence, determining/determine that atrial arrhythmia criteria are met for the time interval; and generating/generate an output in response to the atrial arrhythmia criteria being met for the time interval.” in the context of this claim encompasses the user, with the aid of pen and paper, over a plurality of ventricular cycles applying or comparing a first systolic event threshold to a cardiac mechanical signal during first windows, applying or comparing a second atrial systolic event threshold to the cardiac mechanical signal over second windows, adding up atrial event evidence such as certain atrial features within the cardiac mechanical signal during the second windows and based on the added up atrial event evidence determining whether an atrial arrhythmia criteria is met and providing an indication if an atrial arrhythmia is determined. There is nothing to suggest an undue level of complexity in the receiving, processing and generating steps. If a claim limitation, under its broadest reasonable interpretation covers a metal process, i.e. performance of the limitation in the mind, but for the recitation of generic computer components, then it falls with the “Mental Processes” grouping of abstract ideas. Accordingly the claims recite an abstract idea. Although not drawn to the same subject matter, the claimed limitation(s) is/are similar to concepts that have been identified as abstract by the courts, such as: collecting information, analyzing it, and reporting certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom, 830 F.3d 1350, 119 U.S.P.Q.2d 1739 (Fed. Cir. 2016), selecting certain information, analyzing it using mathematical techniques, and reporting or displaying the results of the analysis in SAP America Inc. v. Investpic, LLC, 890 F.3d 1016, 126 USPQ2d 1638 (Fed Cir. 2018). Thus, the claim(s) are directed to a judicial exception and fall squarely within the realm of "abstract ideas," which is a patent-ineligible concept. (Step 2A: Prong One YES).
Analyzing the claim as whole for a practical application, the claim does not include additional elements/steps that are sufficient to amount to significantly more than the judicial exception. The additionally recited element(s) appended to the abstract include “a memory configured to store a first atrial systolic event threshold and a second atrial systolic event threshold…and store the output” (claim 1), “a sensor configured to sense a cardiac mechanical signal” (claim 1), “sensing/sense a cardiac mechanical signal” (claims 11 and 21), “a pulse generator” (claim 1), “a control circuit” (claims 1 and 21), “a non-transitory computer readable medium storing a set of instructions” (claim 21). The additional elements of “a sensor configured to sense a cardiac mechanical signal” (claim 1), “sensing/sense a cardiac mechanical signal” (claims 11 and 21), merely: add insignificant extra-solution activity and are recited at a high level of generality (i.e. as a general means of gathering a cardiac mechanical signal) and is merely nominally, insignificantly or tangentially related to the performance of the steps, i.e. amounts to mere data gathering, which is a form of insignificant extra-solution activity (pre-solution activity), all uses of the recited judicial exception require the pre-solution activity of data gathering. The additional elements of “a pulse generator..” (claim 1) merely: add insignificant extra-solution activity and are recited at a high level of generality and are merely nominally, insignificantly or tangentially related to the performance of the steps. The additional elements reciting "the memory being configured to store the output” (claim 1) merely: add insignificant extra-solution activity and are recited at a high level of generality (i.e. as a general means of storing data) and is merely nominally, insignificantly or tangentially related to the performance of the steps, i.e. amounts to storing and receiving information in memory, which is a form of insignificant extra-solution activity, see MPEP 2106.05(d) and MPEP 2106.05 (g). As discussed above with respect to integration of abstract idea into a practical, the additional element of “a memory configured to…” (claim 1), “a control circuit” (claims 1 and 21), “a non-transitory computer readable medium storing a set of instructions” (claim 21) amount to no more than mere instruction to apply the exception using generic computer components. The “memory”, “control unit” and “non-transitory computer readable medium” are purely general-purpose computer components recited as carrying out the general-purpose computer functions of storing data, processing data and displaying to enable the abstract process. The specification discloses that the functions are carried out using any combination of hardware, software or firmware (e.g. “The functions attributed to pacemaker 14 herein may be embodied as one or more processors, controllers, hardware, firmware, software, or any combination thereof.”, para. [0068], “In one or more examples, the functions described may be implemented in hardware, software, firmware, or any combination thereof.”, para. [0130]). As such, this/these recitation(s) is/are nothing more than nominal recitation(s) of a computer covering an abstract concept. See Bancorp Servs. v. Sun Life Assurance Co., 687 F.3d 1266, 103 USPQ2d 1425 (Fed. Circ. 2012). See also Mayo Collaborative Services v. Prometheus Laboratories Inc., 101 USPQ2d 1961 (U.S. 2012), which establishes that a claim cannot simply state the abstract idea and add the words "apply it”. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea (Step 2A, Prong Two, NO).
Claims 1, 11 and 21 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. e.g., all elements are directed to insignificant extra-solution activity which merely facilitate the abstract idea and/or purely general-purpose computer components recited as carrying out the general-purpose computer function of processing data and displaying to enable the abstract process, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Further, the use of "a sensor configured to sense a cardiac mechanical signal", a “pulse generator configured to deliver ventricular pacing pulses”, “a control circuit” and “a memory” are well-understood, routine, conventional activity, see US 2018/0085588 to Splett et al. (Fig. 3) or US 2016/0023000 to Cho et al. (Fig. 4). Furthermore, the specification discloses that the functions are carried out using any combination of hardware, software or firmware (e.g. “The functions attributed to pacemaker 14 herein may be embodied as one or more processors, controllers, hardware, firmware, software, or any combination thereof.”, para. [0068], “In one or more examples, the functions described may be implemented in hardware, software, firmware, or any combination thereof.”, para. [0130]), therefore the recited “memory”, “control unit” and “non-transitory computer readable medium” are nothing more than purely general-purpose computer components recited as carrying out the general-purpose computer functions of processing data and storing to enable the abstract process, Similarly, when considered as an ordered combination, the additional components/steps of the claim(s) add nothing that is not already present when the steps are considered separately (Step 2B: NO). The claims are not patent eligible.
Claim(s) 2-9 and 12-19 depend directly or indirectly from claim(s) 1 and 11. Therefore, the dependent claims rely upon the same abstract idea as the independent claim(s), as set forth above. Additionally, the dependent claims do nothing more than further limiting the abstract idea while failing to qualify as "significantly more", and the specificity of an abstract idea does not make it any "less abstract” as it is still directed to concepts relating to organizing or analyzing information in a way that can be performed mentally or is analogous to human mental work subject matter. Therefore, the dependent claim(s) are also not patent eligible for the reasons discussed above. Claim(s) 2-7, 9, 12-17 and 19 fail(s) to provide significantly more, when considered as an ordered combination, as it/they merely provide further limitation regarding the abstract idea, which can still nonetheless be considered mental processes, i.e. performed in the mind with the aid of pen and paper. Claim 8 and 18 further add insignificant extra-solution activity that is merely nominally, insignificantly or tangentially related to the performance of the steps, i.e. amounts to insignificant application, which is a form of insignificant extra-solution activity (post-solution activity), see MPEP 2106.05(g).
The instantly rejected claim(s) are therefore not drawn to eligible subject matter as they are directed to an abstract idea without significantly more. In the interest of advancing prosecution, the examiner suggests: providing evidence, for example, delineating how the abstract idea and/or additional elements appended to the abstract idea results in an improvement to the technology/technical field, which can show eligibility and/or adding a practical application of the claimed method outside of the computer (e.g. treating a patient). See MPEP § 716.01(c) for examples of providing evidence supported by an appropriate affidavit or declaration. For additional guidance, applicant is directed generally to MPEP §2106.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2, 7-12 and 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0154154 to Sheldon et al. (Sheldon).
In reference to at least claim 1
Sheldon discloses a medical device (e.g. pacemaker 14) comprising: a memory (e.g. 210) configured to store a first atrial systolic event threshold and a second atrial systolic event threshold (e.g. “Memory 210 may store timing intervals and other data used by control circuit 206 to control the ventricular pacing mode and delivery of pacing pulses by pulse generator 202”, para. [0067]; “The X of Y criterion used under particular activity and/or posture conditions may be retrieved from memory 210, e.g., from a look-up table stored in memory 210.”, para. [0165]); a sensor (e.g. motion sensor 212) configured to sense a cardiac mechanical signal (e.g. “Atrial event detector circuit 240 is configured to detect atrial mechanical events from a signal received from motion sensor 212. “, para. [0056]); a pulse generator (e.g. pulse generator 202) configured to deliver ventricular pacing pulses (e.g. “a ventricular pacing pulse may be delivered by pulse generator 202 upon expiration of the LR pacing interval to prevent ventricular asystole and maintain a minimum ventricular rate.”, para. [0061]); and a control circuit (e.g. control circuit 206) configured to: over a time interval comprising a plurality of ventricular cycles: apply the first atrial systolic event threshold to the cardiac mechanical signal during first windows of the plurality of ventricular cycles (e.g. “atrial systolic detection threshold amplitude”, para. [0059], “R-wave sensing threshold, sensitivity, various blanking and refractory intervals applied to the cardiac electrical signal, and atrial event detection control signals to atrial event detector circuit 240 for use in detecting and confirming atrial systolic events, e.g., ventricular event detection windows, atrial refractory period, detection threshold amplitudes applied to the motion sensor signal,”, para. [0063]; “atrial event detector 240 may compare the motion sensor signal to one or more pre-determined detection threshold amplitudes during one or more time windows set in response to identifying the ventricular event at bock 302 for detecting the A1 through A3 events”, the first time window(s) starts after the A2 time window and includes A3 events, Figs. 4,6 para. [0075]); apply the second atrial systolic event threshold to the cardiac mechanical signal during second windows of the plurality of ventricular cycles, each of the second windows starting from an ending time of one of the first windows (e.g. “R-wave sensing threshold, sensitivity, various blanking and refractory intervals applied to the cardiac electrical signal, and atrial event detection control signals to atrial event detector circuit 240 for use in detecting and confirming atrial systolic events, e.g., ventricular event detection windows, atrial refractory period, detection threshold amplitudes applied to the motion sensor signal,”, para. [0063]; “atrial event detector 240 may compare the motion sensor signal to one or more pre-determined detection threshold amplitudes during one or more time windows set in response to identifying the ventricular event at bock 302 for detecting the A1 through A3 events”, the second time windows starts after the A3 time windows and includes A4 events, Figs. 4,6 para. [0075]) , the second atrial systolic event threshold being less than the first atrial systolic event threshold (e.g. “The sensing threshold amplitudes 440, 442 and 444 may be set uniquely during each of the respective sensing windows 420, 422 and 424, respectively, or set to a fixed common value for all sensing windows. The sensing threshold amplitudes 440, 442, and 444 may be fixed or decaying thresholds and may be automatically adjusted thresholds set to starting threshold values based on the peak motion sensor signal amplitude detected during each respective window 420, 422 and 424.”, para. [0093]); and accumulate atrial event evidence from the cardiac mechanical signal sensed during the second windows (e.g. (e.g.” The one or more motion signal metrics are compared to first pacing mode switching criteria at block 656. If the first pacing mode switching criteria are met, the control circuit switches from the current, first pacing mode, either an atrial tracking pacing mode or a non-atrial tracking pacing mode, to a second pacing mode. The second pacing mode is the other one of the atrial tracking pacing mode or the non-atrial tracking pacing mode depending on which pacing mode the control circuit 206 is switching from”, para. [0115], “The X of Y criterion may be programmable and may be based in part on the patient's history of atrial fibrillation…. In a patient with no history of atrial fibrillation, it may be desirable to remain in the VDD pacing mode for a relatively longer period of time to enable detection of the A4 events and promote atrial-synchronized ventricular pacing. In the case of little or no history of atrial fibrillation, a relatively high number of ventricular cycles without A4 event detections may be required before switching the pacing mode….In a patient with a strong history of atrial fibrillation, however, it may be desirable to switch to a non-atrial tracking pacing mode relatively quickly since the loss of A4 event detection may be due to atrial fibrillation.”, para. [0132]-[0133]).
Regarding the limitations based on at least the accumulated atrial event evidence, determine that atrial arrhythmia criteria are met for the time interval, generate an output in response to the atrial arrhythmia criteria being met for the time interval; and the memory being further configured to store the output, Sheldon discloses that during fibrillation the A4 may become too small to detect (e.g. “During atrial fibrillation, the A4 signal may become too small to be detected. In this case non-atrial tracking ventricular pacing is appropriate to avoid pacemaker-mediated tachycardia.”, para. [0123], [0132]), therefore in a patient with atrial fibrillation it may be desirable to switch to a non-atrial tracking pacing mode relatively quick since the loss of A4 event detection, i.e. atrial event evidence, may be due to atrial fibrillation (e.g. “In a patient with a strong history of atrial fibrillation, however, it may be desirable to switch to a non-atrial tracking pacing mode relatively quickly since the loss of A4 event detection may be due to atrial fibrillation. The X of Y criteria may be set relatively less stringent compared to in a patient with no or minimal atrial fibrillation history to more rapidly switch to the non-atrial tracking pacing mode to provide ventricular rate support pacing.”, para. [0133]). Therefore, it would have been obvious to one having ordinary skill in the art to use X of Y criteria which utilizes the A4 event detection criteria during ventricular cycles, i.e. accumulate atrial event evidence from the mechanical signal sensed during the second windows, to determine the presence of an atrial arrhythmia such as atrial fibrillation since Sheldon discloses that the loss of A4 is associated with atrial fibrillation in order to provide ventricular rate support pacing avoiding pacemaker-mediated tachycardia (‘154, para. [0123]). Further, Sheldon discloses generate an output in response to the atrial arrhythmia criteria being met for the time interval (e.g. “External device 20 may display data and information relating to pacemaker functions to a user for reviewing pacemaker operation and programmed parameters as well as EGM signals transmitted from pacemaker 14 or pacemaker 12,”, para. [0038]; and the memory being further configured to store the output (e.g. “The A3-A4 time interval may be used to update a running average A3-A4 time interval stored in memory 210 and/or stored individually in a buffer in memory 210 storing a sequence of consecutive or non-consecutive A3-A4 time intervals.”, para. [0194]).
In reference to at least claim 2
Sheldon modified as disclosed above, see rejection of claim 1 above, would include using X of Y criteria which utilizes the A4 event detection criteria during ventricular cycles, i.e. accumulate atrial event evidence from the mechanical signal sensed during the second windows, to determine the presence of an atrial arrhythmia such as atrial fibrillation which would provide for the time interval a heart rhythm classification by classifying the time interval as one of at least atrial arrhythmia or not atrial arrhythmia based on at least the accumulated atrial event evidence.
In reference to at least claim 7
Sheldon modified as disclosed above, see rejection of claim 1, renders obvious a device according to claim 1. Sheldon further discloses wherein the control circuit is further configured to accumulate the atrial event evidence by determining one or more signal features from the motion signal sensed during the second windows (e.g. “The count of A4 events detected out of a predetermined number of ventricular cycles is updated at block 711. At block 712, the control circuit 206 determines if the A4 detection count obtained over a predetermined number of ventricular cycles is less than a mode-switching threshold”, the A4 signal feature of the motion signal is used, para. [0131]-[0133]).
In reference to at least claim 8
Sheldon modified as disclosed above, see rejection of claim 1, renders obvious a device according to claim 1. Sheldon further discloses wherein the control circuit is further configured to generate the output by at least storing a segment of the cardiac mechanical signal sensed by the sensor in the memory (e.g. “One set of A4 detection control parameters and characteristics of the A1, A2 and A3 events may be determined and stored for use during episodes of ventricular sensing (ventricular intrinsic rhythm), and another set of A4 detection control parameters and characteristics of the A1, A2 and A3 events may be determined and stored for use during episodes of ventricular pacing”, para. [0073]); the medical device further comprising a telemetry circuit configured to transmit the output (e.g. “Telemetry circuit 208 includes a transceiver 209 and antenna 211 for transferring and receiving data via a radio frequency (RF) communication link… Motion sensor signals and cardiac electrical signals, and/or data derived therefrom may be transmitted by telemetry circuit 208 to external device 20.”, para. [0069]).
In reference to at least claim 9
Sheldon modified as disclosed above, see rejection of claim 1, renders obvious a device according to claim 1. Sheldon further discloses wherein the control circuit is further configured to: detect an atrial arrhythmia episode in response to at least the atrial arrhythmia criteria being met for the time interval; and generate the output by at least one of: determining an atrial arrhythmia burden using the time interval; and adjusting a pacing therapy delivered by the pulse generator (e.g. “The count of A4 events detected out of a predetermined number of ventricular cycles is updated at block 711. At block 712, the control circuit 206 determines if the A4 detection count obtained over a predetermined number of ventricular cycles is less than a mode-switching threshold…. Less than a threshold number of A4 events out of Y ventricular cycles may be set as one motion signal metric criterion for switching from the VDD atrial tracking pacing mode to a non-atrial tracking pacing mode.”, para. [0131]-[0133]).
In reference to at least claim 10
Sheldon modified as disclosed above, see rejection of claim 1, renders obvious a device according to claim 1. Sheldon further discloses wherein the pulse generator is further configured to: generate ventricular pacing pulses in an atrial tracking ventricular pacing mode; and switch to generating the ventricular pacing pulses in a non-atrial tracking ventricular pacing mode in response to the control circuit determining that the atrial arrhythmia detection criteria are met (e.g. “The count of A4 events detected out of a predetermined number of ventricular cycles is updated at block 711. At block 712, the control circuit 206 determines if the A4 detection count obtained over a predetermined number of ventricular cycles is less than a mode-switching threshold…. Less than a threshold number of A4 events out of Y ventricular cycles may be set as one motion signal metric criterion for switching from the VDD atrial tracking pacing mode to a non-atrial tracking pacing mode.”, para. [0131]-[0133]).
In reference to at least claim 11
Sheldon discloses a method comprising: sensing a cardiac mechanical signal (e.g. “Atrial event detector circuit 240 is configured to detect atrial mechanical events from a signal received from motion sensor 212. “, para. [0056]); over a time interval comprising a plurality of ventricular cycles: applying the first atrial systolic event threshold to the cardiac mechanical signal during first windows of the plurality of ventricular cycles (e.g. “atrial systolic detection threshold amplitude”, para. [0059], “R-wave sensing threshold, sensitivity, various blanking and refractory intervals applied to the cardiac electrical signal, and atrial event detection control signals to atrial event detector circuit 240 for use in detecting and confirming atrial systolic events, e.g., ventricular event detection windows, atrial refractory period, detection threshold amplitudes applied to the motion sensor signal,”, para. [0063]; “atrial event detector 240 may compare the motion sensor signal to one or more pre-determined detection threshold amplitudes during one or more time windows set in response to identifying the ventricular event at bock 302 for detecting the A1 through A3 events”, the first time window(s) starts after the A2 time window and includes A3 events, Figs. 4,6 para. [0075]); applying the second atrial systolic event threshold to the cardiac mechanical signal during second windows of the plurality of ventricular cycles, each of the second windows starting from an ending time of one of the first windows (e.g. “R-wave sensing threshold, sensitivity, various blanking and refractory intervals applied to the cardiac electrical signal, and atrial event detection control signals to atrial event detector circuit 240 for use in detecting and confirming atrial systolic events, e.g., ventricular event detection windows, atrial refractory period, detection threshold amplitudes applied to the motion sensor signal,”, para. [0063]; “atrial event detector 240 may compare the motion sensor signal to one or more pre-determined detection threshold amplitudes during one or more time windows set in response to identifying the ventricular event at bock 302 for detecting the A1 through A3 events”, the second time windows starts after the A3 time windows and includes A4 events, Figs. 4,6 para. [0075]) , the second atrial systolic event threshold being less than the first atrial systolic event threshold (e.g. “The sensing threshold amplitudes 440, 442 and 444 may be set uniquely during each of the respective sensing windows 420, 422 and 424, respectively, or set to a fixed common value for all sensing windows. The sensing threshold amplitudes 440, 442, and 444 may be fixed or decaying thresholds and may be automatically adjusted thresholds set to starting threshold values based on the peak motion sensor signal amplitude detected during each respective window 420, 422 and 424.”, para. [0093]); and accumulating atrial event evidence from the cardiac mechanical signal sensed during the second windows (e.g. (e.g.” The one or more motion signal metrics are compared to first pacing mode switching criteria at block 656. If the first pacing mode switching criteria are met, the control circuit switches from the current, first pacing mode, either an atrial tracking pacing mode or a non-atrial tracking pacing mode, to a second pacing mode. The second pacing mode is the other one of the atrial tracking pacing mode or the non-atrial tracking pacing mode depending on which pacing mode the control circuit 206 is switching from”, para. [0115], “The X of Y criterion may be programmable and may be based in part on the patient's history of atrial fibrillation…. In a patient with no history of atrial fibrillation, it may be desirable to remain in the VDD pacing mode for a relatively longer period of time to enable detection of the A4 events and promote atrial-synchronized ventricular pacing. In the case of little or no history of atrial fibrillation, a relatively high number of ventricular cycles without A4 event detections may be required before switching the pacing mode….In a patient with a strong history of atrial fibrillation, however, it may be desirable to switch to a non-atrial tracking pacing mode relatively quickly since the loss of A4 event detection may be due to atrial fibrillation.”, para. [0132]-[0133]).
Regarding the limitations based on at least the accumulated atrial event evidence, determining that atrial arrhythmia criteria are met for the time interval, and generating an output in response to the atrial arrhythmia criteria being met for the time interval, Sheldon discloses that during fibrillation the A4 may become too small to detect (e.g. “During atrial fibrillation, the A4 signal may become too small to be detected. In this case non-atrial tracking ventricular pacing is appropriate to avoid pacemaker-mediated tachycardia.”, para. [0123], [0132]), therefore in a patient with atrial fibrillation it may be desirable to switch to a non-atrial tracking pacing mode relatively quick since the loss of A4 event detection, i.e. atrial event evidence, may be due to atrial fibrillation (e.g. “In a patient with a strong history of atrial fibrillation, however, it may be desirable to switch to a non-atrial tracking pacing mode relatively quickly since the loss of A4 event detection may be due to atrial fibrillation. The X of Y criteria may be set relatively less stringent compared to in a patient with no or minimal atrial fibrillation history to more rapidly switch to the non-atrial tracking pacing mode to provide ventricular rate support pacing.”, para. [0133]). Therefore, it would have been obvious to one having ordinary skill in the art to use X of Y criteria which utilizes the A4 event detection criteria during ventricular cycles, i.e. accumulate atrial event evidence from the mechanical signal sensed during the second windows, to determine the presence of an atrial arrhythmia such as atrial fibrillation since Sheldon discloses that the loss of A4 is associated with atrial fibrillation in order to provide ventricular rate support pacing avoiding pacemaker-mediated tachycardia (‘154, para. [0123]). Further, Sheldon discloses generating an output in response to the atrial arrhythmia criteria being met for the time interval (e.g. “External device 20 may display data and information relating to pacemaker functions to a user for reviewing pacemaker operation and programmed parameters as well as EGM signals transmitted from pacemaker 14 or pacemaker 12,”, para. [0038]).
In reference to at least claim 12
Sheldon modified as disclosed above, see rejection of claim 11 above, would include using X of Y criteria which utilizes the A4 event detection criteria during ventricular cycles, i.e. accumulate atrial event evidence from the mechanical signal sensed during the second windows, to determine the presence of an atrial arrhythmia such as atrial fibrillation which would provide for the time interval a heart rhythm classification by classifying the time interval as one of at least atrial arrhythmia or not atrial arrhythmia based on at least the accumulated atrial event evidence.
In reference to at least claim 17
Sheldon modified as disclosed above, see rejection of claim 11, renders obvious a device according to claim 11. Sheldon further discloses accumulating the atrial event evidence by determining one or more signal features from the motion signal sensed during the second windows (e.g. “The count of A4 events detected out of a predetermined number of ventricular cycles is updated at block 711. At block 712, the control circuit 206 determines if the A4 detection count obtained over a predetermined number of ventricular cycles is less than a mode-switching threshold”, the A4 signal feature of the motion signal is used, para. [0131]-[0133]). .
In reference to at least claim 18
Sheldon modified as disclosed above, see rejection of claim 11, renders obvious a device according to claim 11. Sheldon further discloses generating the output by at least storing a segment of the cardiac mechanical signal sensed by the sensor in the memory (e.g. “One set of A4 detection control parameters and characteristics of the A1, A2 and A3 events may be determined and stored for use during episodes of ventricular sensing (ventricular intrinsic rhythm), and another set of A4 detection control parameters and characteristics of the A1, A2 and A3 events may be determined and stored for use during episodes of ventricular pacing”, para. [0073]); the medical device further comprising a telemetry circuit configured to transmitting the output (e.g. “Telemetry circuit 208 includes a transceiver 209 and antenna 211 for transferring and receiving data via a radio frequency (RF) communication link… Motion sensor signals and cardiac electrical signals, and/or data derived therefrom may be transmitted by telemetry circuit 208 to external device 20.”, para. [0069]).
In reference to at least claim 19
Sheldon modified as disclosed above, see rejection of claim 11, renders obvious a device according to claim 11. Sheldon further discloses detecting an atrial arrhythmia episode in response to at least the atrial arrhythmia criteria being met for the time interval; and generating the output by at least one of: determining an atrial arrhythmia burden using the time interval; and adjusting a pacing therapy delivered by the pulse generator (e.g. “The count of A4 events detected out of a predetermined number of ventricular cycles is updated at block 711. At block 712, the control circuit 206 determines if the A4 detection count obtained over a predetermined number of ventricular cycles is less than a mode-switching threshold…. Less than a threshold number of A4 events out of Y ventricular cycles may be set as one motion signal metric criterion for switching from the VDD atrial tracking pacing mode to a non-atrial tracking pacing mode.”, para. [0131]-[0133]).
In reference to at least claim 20
Sheldon modified as disclosed above, see rejection of claim 11, renders obvious a device according to claim 11. Sheldon further discloses generating ventricular pacing pulses in an atrial tracking ventricular pacing mode; and switching to generating the ventricular pacing pulses in a non-atrial tracking ventricular pacing mode in response to the control circuit determining that the atrial arrhythmia detection criteria are met (e.g. “The count of A4 events detected out of a predetermined number of ventricular cycles is updated at block 711. At block 712, the control circuit 206 determines if the A4 detection count obtained over a predetermined number of ventricular cycles is less than a mode-switching threshold…. Less than a threshold number of A4 events out of Y ventricular cycles may be set as one motion signal metric criterion for switching from the VDD atrial tracking pacing mode to a non-atrial tracking pacing mode.”, para. [0131]-[0133]).
In reference to at least claim 21
Sheldon discloses a non-transitory computer readable medium storing a set of instructions that, when executed by a control circuit of a medical device (e.g. “Memory 210 may include computer-readable instructions that, when executed by control circuit 206, cause control circuit 206 to perform various functions attributed throughout this disclosure to pacemaker 14.”, para. [0067]), cause the medical device to: sense a cardiac mechanical signal (e.g. “Atrial event detector circuit 240 is configured to detect atrial mechanical events from a signal received from motion sensor 212. “, para. [0056]); over a time interval comprising a plurality of ventricular cycles: apply the first atrial systolic event threshold to the cardiac mechanical signal during first windows of the plurality of ventricular cycles (e.g. “atrial systolic detection threshold amplitude”, para. [0059], “R-wave sensing threshold, sensitivity, various blanking and refractory intervals applied to the cardiac electrical signal, and atrial event detection control signals to atrial event detector circuit 240 for use in detecting and confirming atrial systolic events, e.g., ventricular event detection windows, atrial refractory period, detection threshold amplitudes applied to the motion sensor signal,”, para. [0063]; “atrial event detector 240 may compare the motion sensor signal to one or more pre-determined detection threshold amplitudes during one or more time windows set in response to identifying the ventricular event at bock 302 for detecting the A1 through A3 events”, the first time window(s) starts after the A2 time window and includes A3 events, Figs. 4,6 para. [0075]); apply the second atrial systolic event threshold to the cardiac mechanical signal during second windows of the plurality of ventricular cycles, each of the second windows starting from an ending time of one of the first windows (e.g. “R-wave sensing threshold, sensitivity, various blanking and refractory intervals applied to the cardiac electrical signal, and atrial event detection control signals to atrial event detector circuit 240 for use in detecting and confirming atrial systolic events, e.g., ventricular event detection windows, atrial refractory period, detection threshold amplitudes applied to the motion sensor signal,”, para. [0063]; “atrial event detector 240 may compare the motion sensor signal to one or more pre-determined detection threshold amplitudes during one or more time windows set in response to identifying the ventricular event at bock 302 for detecting the A1 through A3 events”, the second time windows starts after the A3 time windows and includes A4 events, Figs. 4,6 para. [0075]) , the second atrial systolic event threshold being less than the first atrial systolic event threshold (e.g. “The sensing threshold amplitudes 440, 442 and 444 may be set uniquely during each of the respective sensing windows 420, 422 and 424, respectively, or set to a fixed common value for all sensing windows. The sensing threshold amplitudes 440, 442, and 444 may be fixed or decaying thresholds and may be automatically adjusted thresholds set to starting threshold values based on the peak motion sensor signal amplitude detected during each respective window 420, 422 and 424.”, para. [0093]); and accumulate atrial event evidence from the cardiac mechanical signal sensed during the second windows (e.g. (e.g.” The one or more motion signal metrics are compared to first pacing mode switching criteria at block 656. If the first pacing mode switching criteria are met, the control circuit switches from the current, first pacing mode, either an atrial tracking pacing mode or a non-atrial tracking pacing mode, to a second pacing mode. The second pacing mode is the other one of the atrial tracking pacing mode or the non-atrial tracking pacing mode depending on which pacing mode the control circuit 206 is switching from”, para. [0115], “The X of Y criterion may be programmable and may be based in part on the patient's history of atrial fibrillation…. In a patient with no history of atrial fibrillation, it may be desirable to remain in the VDD pacing mode for a relatively longer period of time to enable detection of the A4 events and promote atrial-synchronized ventricular pacing. In the case of little or no history of atrial fibrillation, a relatively high number of ventricular cycles without A4 event detections may be required before switching the pacing mode….In a patient with a strong history of atrial fibrillation, however, it may be desirable to switch to a non-atrial tracking pacing mode relatively quickly since the loss of A4 event detection may be due to atrial fibrillation.”, para. [0132]-[0133]).
Regarding the limitations based on at least the accumulated atrial event evidence, determine that atrial arrhythmia criteria are met for the time interval, generate an output in response to the atrial arrhythmia criteria being met for the time interval, Sheldon discloses that during fibrillation the A4 may become too small to detect (e.g. “During atrial fibrillation, the A4 signal may become too small to be detected. In this case non-atrial tracking ventricular pacing is appropriate to avoid pacemaker-mediated tachycardia.”, para. [0123], [0132]), therefore in a patient with atrial fibrillation it may be desirable to switch to a non-atrial tracking pacing mode relatively quick since the loss of A4 event detection, i.e. atrial event evidence, may be due to atrial fibrillation (e.g. “In a patient with a strong history of atrial fibrillation, however, it may be desirable to switch to a non-atrial tracking pacing mode relatively quickly since the loss of A4 event detection may be due to atrial fibrillation. The X of Y criteria may be set relatively less stringent compared to in a patient with no or minimal atrial fibrillation history to more rapidly switch to the non-atrial tracking pacing mode to provide ventricular rate support pacing.”, para. [0133]). Therefore, it would have been obvious to one having ordinary skill in the art to use X of Y criteria which utilizes the A4 event detection criteria during ventricular cycles, i.e. accumulate atrial event evidence from the mechanical signal sensed during the second windows, to determine the presence of an atrial arrhythmia such as atrial fibrillation since Sheldon discloses that the loss of A4 is associated with atrial fibrillation in order to provide ventricular rate support pacing avoiding pacemaker-mediated tachycardia (‘154, para. [0123]). Further, Sheldon discloses generate an output in response to the atrial arrhythmia criteria being met for the time interval (e.g. “External device 20 may display data and information relating to pacemaker functions to a user for reviewing pacemaker operation and programmed parameters as well as EGM signals transmitted from pacemaker 14 or pacemaker 12,”, para. [0038]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2018/0028814 to Ghosh which discloses controlling pace mode switching using atrial mechanical events. US Patent No. 6,128,533 to Florio et al which teaches pacemaker mode switching based on variance in atrial and ventricular events.
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