DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
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 reli1ed upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-15, and 17-20 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C 102(a)(2) as being anticipated by Shuros et al. (hereinafter ‘Shuros’, U.S. PGPub No. 2020/0376280).
In regards to claim 1, Shuros discloses a medical-device system for managing a heart condition, comprising: a data receiver circuit configured to receive heart sound information sensed from a patient, the heart sound information including an S1 sound signal, and a controller circuit configured to: generate a heart sound metric using the received heart sound information ([0026]: "In Example 19, the subject matter of any one or more of Examples 16-18 optionally includes detecting an indication of either a presence or an absence of an intermittent or rate-related AV conduction disturbance that can include steps of: determining an S1 heart sound intensity metric"), detect bundle branch block (BBB), including to discriminate a left bundle branch block (LBBB) from a right bundle branch block (RBBB), based at least in part on the generated heart sound metric ([0068]: "The AV conduction monitor 230 can be configured to detect an indication of presence or absence of intermittent or rate-related conduction disturbance using the physiologic information of the patient, such as one or more physiologic signals received by the sensing circuit 220. An intermittent AV conduction disturbance is characterized by blockage status that changes over time, such as due to patient condition or medication. A rate-related AV conduction disturbance, such a rate-related LBBB, is characterized by delayed or blocked AV conduction only at times of when the heart rate is above a heart rate cutoff Intermittent or rate-related AV conduction abnormality can often be found in patients with intra-Hisian blocks."), and provide information about the detected BBB to a user or a process executable by the medical-device system ([0069]: " In some examples, the AV conduction monitor 230 may determine a heart rate cutoff (HR.sub.block) that triggers development of intermittent or rate-related conduction disturbance. The heart rate cutoff HR.sub.block can vary from patient to patient. In some patients, conduction disturbance (e.g., LBBB)...", [0085]: "The HR.sub.block may be reported to a user (e.g., a clinician) such as via the user interface 250.").
In regards to claim 2, Shuros discloses that the heart sound metric is indicative of a presence or absence of split S1 sound, wherein to detect the BBB, the controller circuit is configured to: detect the LBBB in response to an absence of the split S1 sound or an occurrence rate of the split S1 sound falling below a threshold and detect the RBBB in response to a presence of the split S1 sound or the occurrence rate of the split S1 exceeding the threshold ([0017]: "In Example 10, the subject matter of Example 9 optionally includes the cardiac acceleration information that can include an S1 heart sound intensity metric, and the AV conduction monitor can be configured to detect an indication of a presence of intermittent AV conduction disturbance in response to the S1 heart sound intensity metric falling below an S1 intensity threshold, or an indication of an absence of intermittent AV conduction disturbance in response to the S1 heart sound intensity metric exceeding the S1 intensity threshold.").
In regards to claim 3, Shuros discloses that the heart sound metric indicative of the presence or absence of split S1 sound includes a signal width of the S1 sound signal, wherein the controller circuit is configured to detect the presence or absence of split S1 sound based on a comparison of the signal width of the S1 sound signal to a width threshold ([0081]: "The AV conduction monitor 230 may detect an indication of a presence of intermittent AV conduction disturbance in response to the QRS width metric exceeding a QRS width threshold (QRS.sub.block), and detect an indication of an absence of intermittent AV conduction disturbance in response to the QRS width metric falling below the QRS.sub.block.").
In regards to claim 5, Shuros discloses an electrostimulator configured to provide cardiac stimulation to the patient, wherein the controller circuit is configured to generate a control signal to the electrostimulator to: in response to the detected LBBB, deliver cardiac conduction system pacing (CSP) at a His bundle or septal region of the heart via first one or more electrodes ([0041]: "The ability of HBP to restore cardiac synchrony may also be dependent on the pacing site relative to the blockage site along the His-Purkinje system, such as at the His bundle or a bundle branch. Ventricular dyssynchrony in many heart failure (HF) patients may be attributed to various degrees of left bundle branch block (LBBB), which causes delayed LV depolarization lagging behind RV depolarization", [0051]: "The leadless stimulators/sensors may deliver electrostimulation, sense a physiological signal, such as cardiac electrical signals in response to cardiac stimulation, and transmit the sensed data to the IMD 104.", [0061]: "The electrostimulation circuit 210 can be configured to generate His-bundle pacing (HBP) pulses for delivery to a target pacing site at or near the His bundle or a bundle branch along the conduction pathway, such as via the lead 106 and one or more of the electrodes 112A-112B.") and in response to the detected RBBB, withhold the cardiac stimulation, or deliver right-ventricular (RV) pacing at an RV apical site of the heart via second one or more electrodes ([0045]: "HBP as discussed in the present document can leverage the electrophysiology of the His bundle region, and improve pacing efficiency utilizing the natural conduction mechanisms of the heart, while reducing long-term harmful hemodynamic effects associated with conventional RV apical pacing used for HF management.").
In regards to claim 6, Shuros discloses a lead having a distal portion configured to be inserted into the His bundle or septal region at adjustable depth to deliver the CSP therein via the first one or more electrodes associated with the lead, wherein, in response to the detection of LBBB, the controller circuit is configured to: receive paced heart sound information in response to the delivery of the CSP ([0050]: "In the illustrated example, the lead system may include a lead 106 having a proximal end 108 configured to be connected to the IMD 104, and a distal end 110 that includes one or more electrodes configured to deliver stimulation energy, such as in a form of pacing pulses, to the His bundle 121.", [0053]: "The His-bundle pacing system 118 may sense a physiological signal using one or more electrodes associated with the lead system or a physiological sensor. Examples of the physiological signal may include...a heart sound signal..."), generate a heart sound metric indicative of a presence or absence of split S1 sound using the paced heart sound information ([0026]: "In Example 19, the subject matter of any one or more of Examples 16-18 optionally includes detecting an indication of either a presence or an absence of an intermittent or rate-related AV conduction disturbance that can include steps of: determining an S1 heart sound intensity metric"), and determine whether or not to adjust a depth of insertion of the distal portion of the lead into the His bundle or septal region, including not to adjust the depth of insertion if the heart sound metric indicates a presence of split S1 sound, or if an occurrence rate of the split S1 sound exceeds a rate threshold, and to adjust the depth of insertion if the heart sound metric indicates an absence of split S1 sound, or if the occurrence rate of the split S1 sound falls below the rate threshold (see [0049]).
In regards to claim 7, Shuros discloses that the controller circuit is configured to generate a control signal to a user interface to display in real time the heart sound metric indicative of the presence or absence of split S1 sound while the CSP is being delivered with the distal portion of the lead being positioned at varying depths of insertion ([0055]: "Additionally, the external system 140 may receive device data from the IMB 104 via the communication link 130. Examples of the device data may include real-time or stored physiological signals collected from the patient 102, physiological response to therapies delivered to the patient 102, or device operational status of the IMD 104 (e.g., battery status and lead impedance).", [0056]: "In various embodiments, the external system 140 may include a user interface to display received information to the user, and receive user input for operation control of the IMD 104. In an example, the external system 140 can be configured to verify pacing capture status, perform pacing threshold test to determine an HBP threshold.").
In regards to claim 8, Shuros discloses that the controller circuit is configured to, in response to the detection of LBBB: generate a control signal to the electrostimulator to deliver cardiac resynchronization pacing (CRT) to left and right ventricles of the heart in accordance with a CRT pacing parameter ([0066]: "In addition to HBP, the electrostimulation circuit 210 can be configured to generate one or more of other pacing modalities, such as bradycardia ventricular demand pacing (VDP), cardiac resynchronization therapy (CRT), BiV pacing, or synchronized left ventricle (LV)-only pacing, single site pacing of only one site of a heart chamber (e.g., the left ventricle), or multisite pacing (MSP) of two or more sites of a heart chamber within the same cardiac cycle, among others."), receive paced heart sound information in response to the delivery of the CRT ([0067]: "The sensing circuit 220 may be coupled to one or more electrodes or physiologic sensors to sense a physiologic signal. The physiologic signal may be sensed in the absence of pacing therapy, or during a pacing therapy, such as HBP. Examples of the sensed signals may include an electrocardiogram (ECG), an electrogram (EGM) of a portion of the heart such as atrial EGM, ventricular EGM, or evoked His potential, a heart rate or a pulse rate signal, an impedance signal, a cardiac acceleration signal, a heart sound signal, or a pressure signal, a cardiac timing signal, among other physiological or hemodynamic signals. In some examples, the sensing circuit 220 may sense a far-field ventricular activation (FFVA) signal."), generate a heart sound metric indicative of a presence or absence of split S1 sound using the paced heart sound information ([0026]: "In Example 19, the subject matter of any one or more of Examples 16-18 optionally includes detecting an indication of either a presence or an absence of an intermittent or rate-related AV conduction disturbance that can include steps of: determining an S1 heart sound intensity metric"), and determine whether or not to adjust the CRT pacing parameter, including not to adjust the CRT pacing parameter if the heart sound metric indicates a presence of split S1 sound, or if an occurrence rate of the split S1 sound exceeds a rate threshold, and to adjust the CRT pacing parameter if the heart sound metric indicates an absence of split S1 sound, or if the occurrence rate of the split S1 sound falls below the rate threshold (see [0066]).
In regards to claim 9, Shuros discloses that to adjust the CRT pacing parameter includes to adjust a pacing dosage parameter or a pacing timing parameter, or to switch from a single-site ventricular pacing to multi-site ventricular pacing ([0053]: "The His-bundle pacing system 118 may sense a physiological signal using one or more electrodes associated with the lead system or a physiological sensor. Examples of the physiological signal may include an electrocardiogram (ECG), an intracardiac electrogram (EGM) such as an atrial EGM, a ventricular EGM, or a His bundle EGM, a heart rate or a pulse rate signal, a thoracic impedance signal, a cardiac impedance signal, an arterial pressure signal, a pulmonary artery pressure signal, a left atrial pressure signal, an RV pressure signal, an LV coronary pressure signal, a coronary blood temperature signal, a blood oxygen saturation signal, a cardiac acceleration signal, a heart sound signal, an intracardiac acceleration signal, a respiration signal, or a physical activity or exertion level signal, a cardiac timing signal, among others.", [0073]: "In some examples, the control circuit 240 controls the electrostimulation circuit 210 to deliver one or more modalities of cardiac stimulation other than HBP, such as bradycardia pacing, CRT, BiV pacing, LV-only pacing, multisite pacing (MSP) of two or more sites of a heart chamber (e.g., LV) within the same cardiac cycle, etc.").
In regards to claim 10, Shuros discloses that the data receiver circuit is configured to receive respiration information sensed from the patient, the respiration information including an inspiration phase and an expiration phase in a respiration cycle, wherein the controller circuit is configured to generate the heart sound metric using a portion of the received heart sound information corresponding to the inspiration phase of the respiration cycle, and to detect the BBB based on the heart sound metric during the inspiration phase ([0053]: "The His-bundle pacing system 118 may sense a physiological signal using one or more electrodes associated with the lead system or a physiological sensor. Examples of the physiological signal may include an electrocardiogram (ECG), an intracardiac electrogram (EGM) such as an atrial EGM, a ventricular EGM, or a His bundle EGM, a heart rate or a pulse rate signal, a thoracic impedance signal, a cardiac impedance signal, an arterial pressure signal, a pulmonary artery pressure signal, a left atrial pressure signal, an RV pressure signal, an LV coronary pressure signal, a coronary blood temperature signal, a blood oxygen saturation signal, a cardiac acceleration signal, a heart sound signal, an intracardiac acceleration signal, a respiration signal, or a physical activity or exertion level signal, a cardiac timing signal, among others.", [0079]: "Examples of the sensors may include an activity sensor (e.g., an accelerometer) to sense physical activity, a respiration sensor (e.g., a thoracic impedance sensor) to sense respiration rate, tidal volume, respiration pattern, among other respiratory parameters. A sensor-driven atrial pacing rate may be determined according to the patient physiologic responses.").
In regards to claim 11, Shuros discloses that the heart sound metric further includes one or more of an intensity of the S1 sound signal, or a pre-ejection period ([0026]: "In Example 19, the subject matter of any one or more of Examples 16-18 optionally includes detecting an indication of either a presence or an absence of an intermittent or rate-related AV conduction disturbance that can include steps of: determining an S1 heart sound intensity metric...").
In regards to claim 13, Shuros discloses a method of managing a heart condition using a medical-device system, the method comprising: receiving heart sound information sensed from a patient, the heart sound information including an S1 sound signal, generating a heart sound metric using the received heart sound information ([0026]: "In Example 19, the subject matter of any one or more of Examples 16-18 optionally includes detecting an indication of either a presence or an absence of an intermittent or rate-related AV conduction disturbance that can include steps of: determining an S1 heart sound intensity metric"), detecting bundle branch block (BBB), including discriminating a left bundle branch block (LBBB) from a right bundle branch block (RBBB) based at least in part on the generated heart sound metric ([0068]: "The AV conduction monitor 230 can be configured to detect an indication of presence or absence of intermittent or rate-related conduction disturbance using the physiologic information of the patient, such as one or more physiologic signals received by the sensing circuit 220. An intermittent AV conduction disturbance is characterized by blockage status that changes over time, such as due to patient condition or medication. A rate-related AV conduction disturbance, such a rate-related LBBB, is characterized by delayed or blocked AV conduction only at times of when the heart rate is above a heart rate cutoff Intermittent or rate-related AV conduction abnormality can often be found in patients with intra-Hisian blocks."), and providing information about the detected BBB to a user or a process ([0069]: " In some examples, the AV conduction monitor 230 may determine a heart rate cutoff (HR.sub.block) that triggers development of intermittent or rate-related conduction disturbance. The heart rate cutoff HR.sub.block can vary from patient to patient. In some patients, conduction disturbance (e.g., LBBB)...", [0085]: "The HR.sub.block may be reported to a user (e.g., a clinician) such as via the user interface 250.").
In regards to claim 14, Shuros discloses that the heart sound metric is indicative of a presence or absence of split S1 sound, wherein detecting the BBB includes detecting the LBBB in response to an absence of the split S1 sound or an occurrence rate of the split S1 sound falling below a threshold, and detecting the RBBB in response to a presence of the split S1 sound or the occurrence rate of the split S1 exceeding the threshold ([0017]: "In Example 10, the subject matter of Example 9 optionally includes the cardiac acceleration information that can include an S1 heart sound intensity metric, and the AV conduction monitor can be configured to detect an indication of a presence of intermittent AV conduction disturbance in response to the S1 heart sound intensity metric falling below an S1 intensity threshold, or an indication of an absence of intermittent AV conduction disturbance in response to the S1 heart sound intensity metric exceeding the S1 intensity threshold.").
In regards to claim 15, Shuros discloses that the heart sound metric indicative of the presence or absence of split S1 sound includes a signal width of the S1 sound signal, the method comprising detecting the presence or absence of split S1 sound based on a comparison of the signal width of the S1 sound signal to a width threshold ([0081]: "The AV conduction monitor 230 may detect an indication of a presence of intermittent AV conduction disturbance in response to the QRS width metric exceeding a QRS width threshold (QRS.sub.block), and detect an indication of an absence of intermittent AV conduction disturbance in response to the QRS width metric falling below the QRS.sub.block.").
In regards to claim 17, Shuros discloses that in response to the detected LBBB, delivering cardiac conduction system pacing (CSP) at a His bundle or septal region of the heart via first one or more electrodes ([0055]: "Additionally, the external system 140 may receive device data from the IMB 104 via the communication link 130. Examples of the device data may include real-time or stored physiological signals collected from the patient 102, physiological response to therapies delivered to the patient 102, or device operational status of the IMD 104 (e.g., battery status and lead impedance).", [0056]: "In various embodiments, the external system 140 may include a user interface to display received information to the user, and receive user input for operation control of the IMD 104. In an example, the external system 140 can be configured to verify pacing capture status, perform pacing threshold test to determine an HBP threshold.") and in response to the detected RBBB, withholding cardiac stimulation, or delivering right-ventricular (RV) pacing at an RV apical site of the heart via second one or more electrodes ([0045]: "HBP as discussed in the present document can leverage the electrophysiology of the His bundle region, and improve pacing efficiency utilizing the natural conduction mechanisms of the heart, while reducing long-term harmful hemodynamic effects associated with conventional RV apical pacing used for HF management.").
In regards to claim 18, Shuros discloses that in response to the detection of LBBB: receiving paced heart sound information in response to the delivery of the CSP at the His bundle or septal region of the heart ([0050]: "In the illustrated example, the lead system may include a lead 106 having a proximal end 108 configured to be connected to the IMD 104, and a distal end 110 that includes one or more electrodes configured to deliver stimulation energy, such as in a form of pacing pulses, to the His bundle 121.", [0053]: "The His-bundle pacing system 118 may sense a physiological signal using one or more electrodes associated with the lead system or a physiological sensor. Examples of the physiological signal may include...a heart sound signal..."), generating a heart sound metric indicative of a presence or absence of split S1 sound using the paced heart sound information ([0026]: "In Example 19, the subject matter of any one or more of Examples 16-18 optionally includes detecting an indication of either a presence or an absence of an intermittent or rate-related AV conduction disturbance that can include steps of: determining an S1 heart sound intensity metric"), and determining whether or not to adjust a depth of insertion of a distal portion of a lead into the His bundle or septal region to deliver the CSP therein via the first one or more electrodes associated with the lead, including not adjusting the depth of insertion if the heart sound metric indicates a presence of split S1 sound, or if an occurrence rate of the split S1 sound exceeds a rate threshold, and adjusting the depth of insertion if the heart sound metric indicates an absence of split S1 sound, or if the occurrence rate of the split S1 sound falls below the rate threshold (see [0049]).
In regards to claim 19, Shuros discloses that in response to the detection of LBBB: delivering cardiac resynchronization pacing (CRT) to left and right ventricles of the heart in accordance with a CRT pacing parameter ([0066]: "In addition to HBP, the electrostimulation circuit 210 can be configured to generate one or more of other pacing modalities, such as bradycardia ventricular demand pacing (VDP), cardiac resynchronization therapy (CRT), BiV pacing, or synchronized left ventricle (LV)-only pacing, single site pacing of only one site of a heart chamber (e.g., the left ventricle), or multisite pacing (MSP) of two or more sites of a heart chamber within the same cardiac cycle, among others."), receiving paced heart sound information in response to the delivery of the CRT ([0067]: "The sensing circuit 220 may be coupled to one or more electrodes or physiologic sensors to sense a physiologic signal. The physiologic signal may be sensed in the absence of pacing therapy, or during a pacing therapy, such as HBP. Examples of the sensed signals may include an electrocardiogram (ECG), an electrogram (EGM) of a portion of the heart such as atrial EGM, ventricular EGM, or evoked His potential, a heart rate or a pulse rate signal, an impedance signal, a cardiac acceleration signal, a heart sound signal, or a pressure signal, a cardiac timing signal, among other physiological or hemodynamic signals. In some examples, the sensing circuit 220 may sense a far-field ventricular activation (FFVA) signal."), generating a heart sound metric indicative of a presence or absence of split S1 sound using the paced heart sound information ([0026]: "In Example 19, the subject matter of any one or more of Examples 16-18 optionally includes detecting an indication of either a presence or an absence of an intermittent or rate-related AV conduction disturbance that can include steps of: determining an S1 heart sound intensity metric"), and determining whether or not to adjust the CRT pacing parameter, including not adjusting the CRT pacing parameter if the heart sound metric indicates a presence of split S1 sound, or if an occurrence rate of the split S1 sound exceeds a rate threshold, and adjusting the CRT pacing parameter if the heart sound metric indicates an absence of split S1 sound, or if the occurrence rate of the split S1 sound falls below the rate threshold (see [0066]).
In regards to claim 20, Shuros discloses that receiving respiration information sensed from the patient, the respiration information including an inspiration phase and an expiration phase in a respiration cycle, wherein detecting the BBB is based at least in part on the heart sound metric that is generated using a portion of the received heart sound information corresponding to the inspiration phase of the respiration cycle ([0053]: "The His-bundle pacing system 118 may sense a physiological signal using one or more electrodes associated with the lead system or a physiological sensor. Examples of the physiological signal may include an electrocardiogram (ECG), an intracardiac electrogram (EGM) such as an atrial EGM, a ventricular EGM, or a His bundle EGM, a heart rate or a pulse rate signal, a thoracic impedance signal, a cardiac impedance signal, an arterial pressure signal, a pulmonary artery pressure signal, a left atrial pressure signal, an RV pressure signal, an LV coronary pressure signal, a coronary blood temperature signal, a blood oxygen saturation signal, a cardiac acceleration signal, a heart sound signal, an intracardiac acceleration signal, a respiration signal, or a physical activity or exertion level signal, a cardiac timing signal, among others.", [0079]: "Examples of the sensors may include an activity sensor (e.g., an accelerometer) to sense physical activity, a respiration sensor (e.g., a thoracic impedance sensor) to sense respiration rate, tidal volume, respiration pattern, among other respiratory parameters. A sensor-driven atrial pacing rate may be determined according to the patient physiologic responses.").
Claim Rejections - 35 USC § 103
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.
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.
Claims 4 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Shuros in view of Brockway et al. (hereinafter ‘Brockway’, PGPub No. 2014/0364756).
In regards to claim 4, Shuros discloses the invention substantially as described in claim 2.
However, Shuros does not disclose that the heart sound metric indicative of the presence or absence of split S1 sound includes a spectral entropy of the S1 sound signal, wherein the controller circuit is configured to detect the presence or absence of split S1 sound based on a comparison of the spectral entropy of the S1 sound signal to a spectral entropy threshold.
Brockway teaches using spectral entropy to determine cardiac activity such as an S1 sound and comparing the activity to a threshold ([0056]: "Computing spectral entropy of atrial cardiac activity from an ECG and comparing to a predetermined threshold…"). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the cardiac management device to use spectral entropy to determine cardiac activity such as S1 sounds, as taught by Brockway, as doing so would assist in accurately determining cardiac events such as specific heart sounds ([0049]: " In some embodiments the variability of R-R intervals is evaluated to determine if AF is present. In other embodiments, the atrial electrical activity is evaluated. In yet other embodiments, a combination of R-R interval characteristics and atrial electrical activity is used to determine is AF is present. If AF persists for more than a predetermined time, an AF event is detected that triggers recording of an ECG strip.").
In regards to claim 16, Shuros discloses the invention substantially as described in claim 13.
However, Shuros does not disclose that the heart sound metric indicative of the presence or absence of split S1 sound includes a spectral entropy of the S1 sound signal, wherein the controller circuit is configured to detect the presence or absence of split S1 sound based on a comparison of the spectral entropy of the S1 sound signal to a spectral entropy threshold.
Brockway teaches using spectral entropy to determine cardiac activity such as an S1 sound and comparing the activity to a threshold ([0056]: "Computing spectral entropy of atrial cardiac activity from an ECG and comparing to a predetermined threshold…"). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the cardiac management device to use spectral entropy to determine cardiac activity such as S1 sounds, as taught by Brockway, as doing so would assist in accurately determining cardiac events such as specific heart sounds ([0049]: " In some embodiments the variability of R-R intervals is evaluated to determine if AF is present. In other embodiments, the atrial electrical activity is evaluated. In yet other embodiments, a combination of R-R interval characteristics and atrial electrical activity is used to determine is AF is present. If AF persists for more than a predetermined time, an AF event is detected that triggers recording of an ECG strip.").
Allowable Subject Matter
Claim 12 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRYAN M LEE whose telephone number is (703)756-1789. The examiner can normally be reached 9:00 am - 6:00 pm.
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/B.M.L./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796