DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Information Disclosure Statement
2. The Information Disclosure Statement submitted on 06 June 2025 has been considered by the Examiner.
Claim Rejections - 35 USC § 102
3. 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
4. Claims 1, 5, 7-17, 19, and 22 are rejected under 35 U.S.C. 102 (a) (1) and (a) (2) as being anticipated by Mahajan et al. (US 2023/0107996 A1).
Regarding claim 1, Mahajan teaches a system (the patient management system 100a comprises an ambulatory system 105 having an ambulatory medical device 110a [abstract, 0047-0049]) comprising:
a cloud computing system (the patient management system 100a comprises an external system 125 which includes a cloud or remote server [0048, 0055]);
a computing device (the remote device 124 is a computing device which communicates with the external system 125 via a telecommunication network 122 [0056, 0059]); and
an insertable cardiac monitor (the ambulatory medical device (AMD) 110a is an implantable device, such as cardiac monitor [0049]) configured to:
sense an electrocardiogram of the patient (the AMD 110a may be coupled to a lead system 108 having electrodes that are configured to sense an electrocardiogram of the patient [0049-0051]);
detect a ventricular tachyarrhythmia based on sensed electrocardiogram (the AMD 110A comprises a detector circuit 160 that is configured to detect a cardiac arrhythmic event (e.g., ventricular tachy-arrhythmia) based on the sensed physiological signals (e.g., ECG signals) [0051-0052, 0078]); and
wirelessly communicate with the computing device in response to the detection of the ventricular tachyarrhythmia, wherein, based on the wireless communication from the insertable cardiac monitor (the remote device 124 may receive patient data, such as medical events (e.g., ventricular tachy-arrhythmia or other detected arrhythmias), from the AMD 110a [0052, 0057]);
the computing device is configured to output a local alarm (the remote device 124 is configured to output an alert, alarms, or emergency calls in response to the detection of the arrhythmia (e.g., ventricular tachy-arrhythmia) [0052, 0058, 0061]); and
wherein processing circuitry of the insertable cardiac monitor (the AMD 110a comprises a microprocessor or microcontroller which communicates with the other components (e.g., external system 125 and remote device 124) of the system patient management system 100a [0057, 0061-0062]) is configuring to:
determine QT intervals based on the electrocardiogram (the AMD 110a is configured to monitor patient QT intervals from the electrocardiogram [0051-0052, 0057]);
during a monitoring period associated with initiating a medication, determine that the QT intervals satisfy one or more QT prolongation criteria (the measure of QT interval and the detection of QT prolongation may be triggered by an initiation of a therapy or a change of therapy, such as medication or device therapies [abstract, 0097]. The Examiner respectfully submits that the QT intervals are monitored to detect QT prolongation [abstract, 0097]. The QT interval satisfies the QT prolongation criteria if the QT interval exceeds a threshold [abstract, 0044]); and
transmit a message indicating QT prolongation of the patient to a clinician based on a determination that the QT intervals satisfy one or more QT prolongation criteria (the AMD 110a is configured to transmit alert notifications to the remote device 124 which may be operated by the clinician [0044, 0057, 0059]. Specifically, alert notifications will notify the clinician about the detection of the QT prolongation [0044, 0057]).
Regarding claim 5, Mahajan teaches wherein the computing device comprises one or more of a smartphone (the remote device 124 may consist of mobile devices, such as phones [0057, 0059]) or a smartwatch (smart watches or smart accessories may be used to monitor data from the AMD 110a [0049]).
Regarding claim 7, Mahajan teaches wherein, to determine that the QT intervals satisfy the one or more QT prolongation criteria, the processing circuitry is configured to determine whether a trend of the QT intervals satisfies the one or more QT prolongation criteria (QT prolongation can be detected if the heart rate corrected QT (QTc) interval trend exceeds a threshold [0038, 0071, 0076, 0096]).
Regarding claim 8, Mahajan teaches wherein to determine that the QT intervals satisfy the one or more QT prolongation criteria, the processing circuitry is configured to determine whether a QT interval change over a time period satisfies a threshold (the QT time intervals are monitored to detect QT prolongation [abstract, 0097]. Specifically, the QT time interval satisfies the QT prolongation criteria if the QT interval exceeds a threshold [abstract, 0044, 0091]).
Regarding claim 9, Mahajan teaches wherein, to determine that the QT intervals satisfy the one or more QT prolongation criteria, the processing circuitry is configured to determine whether a QT interval change relative to a baseline QT interval satisfies a threshold (if the measured QT interval exceeds the baseline QT interval by a threshold, then a QT prolongation is indicated [0077]).
Regarding claim 10, Mahajan teaches wherein the processing circuitry is configured to determine the QT intervals and transmit the message during a monitoring period associated with initiating a medication (the system will determine the QT intervals and transmit the message (e.g., alert notifications, alarms, or other forms of warnings) during a monitoring period associated with initiating a medication [0057, 0086, 0097-0098]).
Regarding claim 11, Mahajan teaches wherein the processing circuitry is configured to operate in a QT interval monitoring mode for the monitoring period in response to receipt of a user command (the user may operate a user interface 240 on the external system 125 to initiate the detection of QT prolongation by measuring the QT intervals [abstract, 0085]).
Regarding claim 12, Mahajan teaches wherein insertable cardiac monitor is configured to detect the ventricular tachyarrhythmia based on application electrocardiogram data from sensed electrocardiogram (the AMD 110a comprises a detector circuit 160 that is configured to detect a cardiac arrhythmic event (e.g., ventricular tachy-arrhythmia) based on the sensed physiological signals (e.g., ECG signals) [0051-0052, 0078]. Specifically, the AMD 110A utilizes machine learning algorithms which consist of a model or application that is trained from previous sets of data (e.g., previous ECG data) to detect the cardiac arrhythmic event from the sensed physiological signals (e.g., ECG signals) [0051-0052, 0061, 0078]), and the computing device is configured to apply one or more machine learning models to the electrocardiogram data to classify the electrocardiogram data (the AMD 110A utilizes machine learning algorithms which consist of a model or application that is trained from previous sets of data (e.g., previous ECG data) to detect the cardiac arrhythmic event from the sensed physiological signals (e.g., ECG signals) [0051-0052, 0061, 0078]).
Regarding claim 13, Mahajan teaches an implantable medical device comprising (the patient management system 100a comprises an ambulatory system 105 having an ambulatory medical device 110a (e.g., implantable device) [abstract, 0047-0049]):
communication circuitry (the ambulatory medical device (AMD) 110a comprises a communication circuit [0051]);
a plurality of electrodes (the AMD 110a comprises a plurality of electrodes [0050-0051]);
sensing circuitry configured to sense an electrocardiogram of a patient via the plurality of electrodes ([0051-0052]); and
processing circuitry ([0051, 0062]) configured to:
detect a ventricular tachyarrhythmia based on sensed electrocardiogram ([0051-0052, 0078]);
determine QT intervals based on the sensed electrocardiogram (the AMD 110a is configured to monitor patient QT intervals from the electrocardiogram [0051-0052, 0057]);
during a monitoring period associated with initiating a medication, determine that the QT intervals satisfy one or more QT prolongation criteria (the measure of QT interval and the detection of QT prolongation may be triggered by an initiation of a therapy or a change of therapy, such as medication or device therapies [abstract, 0097]. The Examiner respectfully submits that the QT intervals are monitored to detect QT prolongation [abstract, 0097]. The QT interval satisfies the QT prolongation criteria if the QT interval exceeds a threshold [abstract, 0044]); and
transmit a message indicating QT prolongation of the patient via the communication circuitry based on the determination that the QT intervals satisfy the one or more QT prolongation criteria (the AMD 110a is configured to transmit alert notifications to the remote device 124 which may be operated by the clinician [0044, 0057, 0059]. Specifically, alert notifications will notify the clinician about the detection of the QT prolongation [0044, 0057]).
Regarding claim 14, Mahajan teaches wherein, to determine that the QT intervals satisfy the one or more QT prolongation criteria, the processing circuitry is configured to determine whether a trend of the QT intervals satisfies the one or more QT prolongation criteria (QT prolongation can be detected if the heart rate corrected QT (QTc) interval trend exceeds a threshold [0038, 0071, 0076, 0096]).
Regarding claim 15, Mahajan teaches wherein, to determine that the QT intervals satisfy the one or more QT prolongation criteria, the processing circuitry is configured to at least one of:
determine whether a QT interval change over a time period satisfies a threshold (the QT time intervals are monitored to detect QT prolongation [abstract, 0097]. Specifically, the QT time interval satisfies the QT prolongation criteria if the QT interval exceeds a threshold [abstract, 0044, 0091]); or
determine whether a QT interval change relative to a baseline QT interval satisfies a threshold (if the measured QT interval exceeds the baseline QT interval by a threshold, then a QT prolongation is indicated [0077]).
Regarding claim 16, Mahajan teaches wherein the processing circuitry is configured to operate in a QT interval monitoring mode for the monitoring period in response to receipt of a user command (the user may operate a user interface 240 on the external system 125 to initiate the detection of QT prolongation by measuring the QT intervals [abstract, 0085]).
Regarding claim 17, Mahajan teaches wherein the implantable medical device comprises an insertable cardiac monitor (the ambulatory medical device (AMD) 110a is an implantable device, such as cardiac monitor [0049]).
Regarding claim 19, Mahajan teaches a method of operating an insertable cardiac monitor (the patient management system 100a comprises an ambulatory system 105 having an ambulatory medical device (AMD) 110A [abstract, 0047-0049]. Specifically, the ambulatory medical device (AMD) 110a is an implantable device, such as cardiac monitor [0049]), the method comprising:
sensing, by sensing circuitry of the insertable cardiac monitor and via a plurality of electrodes of the insertable cardiac monitor, an electrocardiogram of a patient ([0051-0052]);
detecting, by processing circuitry of the insertable cardiac monitor, a ventricular tachyarrhythmia based on the sensed electrocardiogram ([0051-0052, 0062, 0078]);
determining, by the processing circuitry, QT intervals based on the sensed electrocardiogram (the AMD 110a is configured to monitor patient QT intervals from the electrocardiogram [0051-0052, 0057]);
determining, by the processing circuitry and during a monitoring period associated with initiating a medication, that the QT intervals satisfy one or more QT prolongation criteria (the measure of QT interval and the detection of QT prolongation may be triggered by an initiation of a therapy or a change of therapy, such as medication or device therapies [abstract, 0097]. The Examiner respectfully submits that the QT intervals are monitored to detect QT prolongation [abstract, 0097]. The QT interval satisfies the QT prolongation criteria if the QT interval exceeds a threshold [abstract, 0044]); and
transmitting, by the processing circuitry and via communication circuitry of the insertable cardiac monitor, a message indicating QT prolongation of the patient based on the determination that the QT intervals satisfy the one or more QT prolongation criteria (the AMD 110a is configured to transmit alert notifications to the remote device 124 which may be operated by the clinician [0044, 0057, 0059]. Specifically, alert notifications will notify the clinician about the detection of the QT prolongation [0044, 0057]).
Regarding claim 22, Mahajan teaches wherein determining that the QT intervals satisfy the one or more QT prolongation criteria comprises determining that a trend of the QT intervals satisfies the one or more QT prolongation criteria (QT prolongation can be detected if the heart rate corrected QT (QTc) interval trend exceeds a threshold [0038, 0071, 0076, 0096]).
Claim Rejections - 35 USC § 103
5. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
6. Claims 4, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mahajan et al. in view of Reddy (US 2018/0036547 A1).
Regarding claims 4, 18, and 20, Mahajan teaches the system of claim 1, the implantable medical device of claim 13, and the method of claim 19, wherein the insertable cardiac monitor comprises:
a housing configured for subcutaneous implantation in a patient (the AMD 110a is subcutaneously implanted in a chest, abdomen, or other parts of the patient 102 [0049, 0071]), the housing having a length between a first end and a second (the housing of the AMD 110a would inherently have length between a first end of the AMD 110a and a second end of the AMD 110a [0049]), a width, and a depth (the housing of the AMD 110a would inherently have a length, width, and depth [0049, 0071]);
a first electrode coupled to the housing (the sensors or electrodes may be may be included on the housing or body of the AMD 110a [0071]);
a second electrode coupled to the housing (the sensors or electrodes may be included on the housing or body of the AMD 110a [0071]);
and circuitry within the housing and configured to sense the electrocardiogram via the first electrode and the second electrode ([0071]).
Mahajan does not explicitly teach wherein the width is less than the length, the depth is less than the width, wherein the first electrode is disposed at or proximate to the first end; and the second electrode is disposed at or proximate to the second end.
The Examiner respectfully submits, as Mahajan teaches the use of a housing and electrodes (see the explanation above), configuring the exact sizes of the housing (e.g., width less than length, depth less than width) and the arrangement of the respective electrodes at the first and second ends would be a matter of changing the size and rearranging the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Mahajan does not explicitly teach the length of the housing being between 40 millimeters and 60 millimeters.
The prior art by Reddy is analogous to Mahajan, as they both teach an implantable system that is implanted subcutaneously to monitor cardiac rhythms ([0032, 0165, 0168]).
Reddy teaches the length of the housing being between 40 millimeters and 80 millimeters ([0020, 0051]); and
wherein the width is than the length (the width may range from 10 millimeters to 30 millimeters and the length may range from 40 millimeters to 80 millimeters [0020, 0051]).
Reddy does not explicitly teach wherein the length of the housing is between 40 millimeters and 60 millimeters.
However, Applicant’s claimed length of between 40 millimeters and 60 millimeters lies entirely within Reddy’s range of 40 millimeters to 80 millimeters ([0020, 0051]). Therefore, a prima facie case of obviousness exists. Based on the overlapping range, a person having ordinary skill in the art would have found it obvious to modify Reddy’s housing length to range between 40 millimeters and 60 millimeters (MPEP 2144.05). This modification is beneficial, as the length of 40 mm to 60 mm will provide the housing with a smaller size which improves the process for implanting the housing beneath the skin (see paragraphs [0020-0021, 0051] by Reddy).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Mahajan’s length of the housing to be between 40 millimeters and 60 millimeters, as suggested by Reddy. This modification is beneficial, as the length of 40 mm to 60 mm will provide the housing with a smaller size which improves the process for implanting the housing beneath the skin (see paragraphs [0020-0021, 0051] by Reddy).
7. Claims 6 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Mahajan et al. in view of Potapov et al. (US 2021/0330237 A1).
Regarding claims 6 and 21, Mahajan teaches the system of claim 1 and the method of claim 19. Mahajan does not explicitly teach wherein the processing circuitry is configured to determine QT intervals on a beat-to-beat basis.
The prior art by Potapov is analogous to Mahajan, as they both teach the detection of QT Intervals ([abstract]).
Potapov teaches teach wherein the processing circuitry is configured to determine QT intervals on a beat-to-beat basis ([abstract, 0052]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Mahajan’s processing circuitry to detect the QT intervals on a beat-to-beat basis, as taught by Potapov. The advantage of such modification may improve the process for correcting the QT intervals (see the [abstract] and paragraph [0052] by Potapov).
8. Claims 12 is rejected under 35 U.S.C. 103 as being unpatentable over Mahajan et al. in view of Carney (US 2018/0289973 A1).
Regarding claim 12, Mahajan teaches the system of claim 11, wherein insertable cardiac monitor is configured to detect the ventricular tachyarrhythmia based on application electrocardiogram data from sensed electrocardiogram (the AMD 110A comprises a detector circuit 160 that is configured to detect a cardiac arrhythmic event (e.g., ventricular tachy-arrhythmia) based on the sensed physiological signals (e.g., ECG signals) [0051-0052, 0078]. Specifically, the AMD 110A utilizes machine learning algorithms which consist of a model or application that is trained from previous sets of data (e.g., previous ECG data) to detect the cardiac arrhythmic event from the sensed physiological signals (e.g., ECG signals) [0051-0052, 0061, 0078]), and the computing device is configured to apply one or more machine learning models to the electrocardiogram data to classify the electrocardiogram data (the AMD 110A utilizes machine learning algorithms which consist of a model or application that is trained from previous sets of data (e.g., previous ECG data) to detect the cardiac arrhythmic event from the sensed physiological signals (e.g., ECG signals) [0051-0052, 0061, 0078]).
Mahajan does not explicitly teach wherein the application electrocardiogram for detecting the ventricular tachyarrhythmia is based on one or more rules;
wherein the processing circuitry is configured to modify at least one of the one or more rules or the one or more machine learning models in response to the user command.
The prior art by Carney is analogous to Mahajan, as they both teach the detection of ventricular tachyarrhythmia ([0047, 0051, 0055]).
Carney teaches wherein the application electrocardiogram for detecting the ventricular tachyarrhythmia is based on one or more rules (the processing circuitry 70 may utilize a rule-based detection method for detecting the ventricular tachyarrhythmia from the ECG data [0082-0083]);
wherein the processing circuitry is configured to modify at least one of the one or more rules (the user may define the rules (e.g., interval lengths) that are implemented by the processing circuitry 70 to detect the ventricular tachyarrhythmia [0082-0083]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the Mahajan’s application electrocardiogram to utilize one or more rules for detecting the ventricular tachyarrhythmia, as taught by Carney. The advantage of such modification may improve the process for detecting the ventricular tachyarrhythmia (see paragraphs [0082-0083] by Carney).
Conclusion
9. The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure. The Examiner respectfully submits that the prior art by Helfenbein (US 2011/0092838 A1) is analogous to Applicant’s disclosure, as Helfenbein teaches an ECG monitoring system that identifies QT intervals during the administration of a medication ([abstract, 0035])
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached 7:30am -4:30pm.
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/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792
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