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 § 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 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burnes et al (US 2017/0304516) (“Burnes”) as evidenced by “Medtronic Reveal LinqTM LNQ11 Insertable Cardiac Monitor” (“Medtronic”) and Walsh (“Medtronic’s tiny implanted cardiac monitor gets approval”) in view of Felix et al (US 2021/0000345) (“Felix 345”) and further in view of Bleyer et al (“Characteristics of sudden death in hemodialysis patients”) (“Bleyer”) and further in view of Fischell (US 2005/0043639) and further in view of Rowlandson (US 2002/0087055) and further in view of Merchant et al (US 2020/0030515) (“Merchant”).
Regarding Claim 1, while Burnes teaches a method for maintaining serum potassium homeostasis through subcutaneous monitoring (Abstract, [0150] subcutaneous sensor, [0157] “The system can adjust the dialysate potassium concentration in step 205 to maintain a constant or near constant potassium gradient.”), comprising the steps of:
maintaining a set of electrocardiographic (ECG) manifestations indicative of at least one of an onset and existence of loss of serum potassium homeostasis in a patient on dialysis ([0152]);
subcutaneously monitoring ECG signals of the patient's heart continuously on a beat-by-beat basis ([0145], [0153]-[0155]) via an implantable cardiac monitor ([0034]-[0035], [0153] an envisioned structure for the implantable sensor device is a “Medtronic, Inc.'s Reveal® series insertable cardiac monitor”), the implantable cardiac monitor comprising:
an implantable housing formed as a cylindrical shape with a first rounded semi spherical endcap and a second semi spherical endcap (Medtronic: Figs. 1, 2, and 40, and Walsh, p1, show the Reveal Linq insertable cardiac monitor as having a “cylindrical shape” Further, the endcaps of the shape are rounded endcaps with a circular shape that is somewhat spherical), the implantable housing comprised of a biocompatible material that is suitable for implantation within a living body (Medtronic: p91-92, Table 14); and
at least one pair of ECG sensing electrodes provided on a ventral surface and on opposite ends of the implantable housing operatively placed about the first rounded semi spherical endcap and the second rounded semi spherical endcap (Medtronic: Table 12, the distance between the electrodes and the dimensions of the system necessitates the electrodes be placed on opposite ends of the implantable housing about the semi spherical endcaps) to facilitate sensing in closest proximity to the low amplitude, low frequency content cardiac action potentials that are generated during atrial and ventricular activation atrial and ventricular repolarization (Examiner recognizes this limitation as intended use);
a component operable to wirelessly communicate with an external device (Burnes: [0150] potassium sensor of the system can wirelessly communicate with an external controller, [0152] where the implanted ECG monitoring of Burnes acts as potassium sensor, Medtronic: p50, 5.3.1 Transmitting patient and device information to the CareLink Network, the Reveal insertable cardiac monitor specifically noted as being operable to wirelessly communicate with an external device for transmitting summary information of a user’s day);
processing the ECG signals in real time as a set of ECG traces with each ECG trace being representative of the net electrical activity of the heart at a given moment in time ([0152]);
evaluating each ECG trace against the set of ECG manifestations ([0152]);
determining an event of loss of serum potassium homeostasis comprising an increase or decrease in serum potassium levels in the patient in real time based directly on a change in the ECG signals matching at least one of the ECG manifestations ([0157]);
determining an urgency of engaging medical assistance for the patient based on a time of dialysis ([0160] the rate of change takes into account a time of dialysis. Too large a change in a preset interval indicates an urgency necessitating action);
generating an alert of medical condition based upon the determination of the event and the urgency ([0157], [0159]-[0160], [0162] both the events of a potassium level threshold being passed and an urgency from an increased rate can be considered together, leading to an alert that accounts for both);
the urgency of the alert of the medical condition relates to the alert occurring during a preset time interval after an onset of a session of the dialysis ([0159]-[0160] rate of change);
increasing or decreasing dialysate concentration of the dialysis during the session of the dialysis based on the alert ([0157]).
Burnes fails to teach the implantable housing formed as a cylindrical shape with a first rounded semispherical endcap and a second semispherical endcap, where the ECG sensing electrodes are operatively placed about the first rounded semispherical endcap and the second semispherical endcap; and
The component operable to wirelessly communicate being a transceiver circuit.
However Felix 345 teaches an implantable medical device for measuring ECG (Abstract) where the implantable housing forms a cylindrical shape with a first rounded semispherical endcap and a second rounded semispherical endcap ([0016]), where the ECG sensing electrodes are operatively placed about the first rounded semispherical endcap and the second semispherical endcap (Figs. 1-2 and 11, [0044], [0075] two different electrode dipole configurations shown for measuring ECG, both with a first electrode placed about the first rounded semispherical endcap and a second electrode placed about the second rounded semispherical endcap); and the implantable cardiac monitor comprises
A transceiver circuit operable to wirelessly communicate with an external device (Abstract, “An implantable medical device is disclosed. A housing includes a hollow body forming a first electrode on an outer surface with end caps affixed to opposite ends, one end cap forming a second electrode… A transceiver circuit is operable to wirelessly communicate with an external data device. The program instructions define instructions to continuously sample the electrocardiographic signals into the non-volatile memory device and to offload the non-volatile memory device to the external data device.” [0016] “An antenna spherical end cap is fixedly disposed on one end of the main cylindrical body and defines an interior cavity with a high frequency antenna housed within… The electronic circuitry also includes an analog front end electrically interfaced to the first and the second electrodes and operable to sense electrocardiographic signals. A transceiver circuit is electrically interfaced to the high frequency antenna and is operable to wirelessly communicate with an external data device.”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the implantable housing of Burnes with partially cylindrical and partially rounded endcaps can be substituted with the implantable housing of Felix 345 with a cylindrical shape with a first rounded semispherical endcap and a second semispherical endcap as a simple substitution of one form of configuring an ECG monitoring implantable system (Burnes: partially rounded ends with monitoring capabilities) for another (Felix 345: fully rounded ends with monitoring capabilities) to obtain predictable results of accurately assessed patient heart activity. Furthermore, it would be obvious that the unnamed wireless communication components of Burnes can be specifically structured as a transceiver circuit as taught by Felix 345 as a way to provide standardization in wireless communication structure, ensuring the system’s consistency across patient applications.
Yet their combined efforts fail to teach
determining an urgency of engaging medical assistance for the patient based on a time of the dialysis and a type of the dialysis;
increasing an urgency of the alert of the medical condition if the alert occurs during a preset time interval after an onset of a session of the dialysis;
However Bleyer teaches a dialysis analysis (Abstract) and further teaches that a patient is at an increased risk of death at preset time interval after a session of dialysis based on dialysis frequency (Abstract, p2268, “There were 80 [hemodialysis] HD patients who met the criteria for sudden death. A bimodal distribution of death occurrences was present, with a 1.7-fold increased death risk occurring in the 12 h period starting with the dialysis procedure and a threefold increased risk of death in the 12 h before HD at the end of the weekend interval (P=0.011).”, Discussion, p2271, Col. 1, L. 27 – Col. 2, L. 9).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to determine and modify the urgency of an alert as taught by Burnes at a preset time interval after dialysis as Bleyer teaches that patients may have an increased risk of sudden death at preset time intervals after dialysis. As noted by Bleyer, knowledge of this increased in sudden death would motivate a caregiver to apply additional therapies to the patient (Discussion, p2271, Col. 2, L. 39 – p2272, Col. 1, L. 12), and application of these additional therapies would be enabled by an alarm. Thus, an urgency determination is improved by using two datasets based on a time of dialysis, both by a rate of change during dialysis and alert conditions after dialysis, and is increased when a higher risk of death is present, enabling lifesaving intervention for the patient.
Yet their combined efforts fail to teach determining an urgency of engaging medical assistance for the patient based on a time of the dialysis and a type of the dialysis.
However Fischell teaches a method for decreasing mortality of hemodialysis patients (Abstract) that notes that the one type of dialysis typically occurs at home and another type typically occurs at a hospital (Abstract, [0021]) wherein additional alarm functions are added to patients at home ([0009] audio alarm to wake patient, [0020] voice contact initiated between patient and medical practitioner).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to increase the urgency of the alarm of Burnes as Fischell teaches that the types of dialysis typically differ in setting and thus differ in the need for patient to be awoken and the speed in which medical intervention can arrive.
Yet their combined efforts fail to teach determining an urgency of engaging medical assistance for the patient based on a time of the dialysis, a type of the dialysis, and historical patient-specific medical information retrieved from an electronic medical record, wherein the historical patient-specific medical information includes historical ECG manifestations.
However Rowlandson teaches an ECG-based analysis (Abstract) comprising a historical patient-specific electronic medical record containing ECG manifestations ([0012], [0044]-[0045] ECG manifestations indicative of a left bundle branch block monitored from both the current ECG record and previous ECG records), wherein the historical patient-specific medical information informs the actuation of an alarm ([0045], [0048]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to judge the ECG manifestations specific to serum potassium homeostasis as taught in Burnes in view of patient specific history as Rowlandson teaches that this may differentiate what ECG manifestation variations represent a medically significant change in a patient ([0012]). Furthermore, it would be obvious to increase urgency of an alarm as Rowlandson teaches that judging ECG manifestations in view of what is patient specific acts as a metric to judge whether a patient is in alarm condition or not ([0048]). Specifically, if the “T-wave right slope, T-wave amplitude, T-wave center of gravity, and the ratio of the T-wave amplitude to the R-wave amplitude” of Burnes show consistent changes due to other factors, one would not want to increase the urgency of an alarm. However, if these happen abruptly with no related historical changes, it is much more likely these ECG manifestation changes are due to a loss of serum potassium homeostasis.
Yet their combined efforts fail to teach determining an urgency of engaging medical assistance for the patient based on a time of the dialysis, a type of the dialysis, and historical patient-specific medical information retrieved from an electronic medical record, wherein the historical patient-specific medical information includes historical ECG manifestations and dialysis treatment information.
However Merchant teaches a tailored dialysis treatment of a subject (Abstract) and further teaches determining likelihood of a subject experiencing hypokalemia based on patient-historical dialysis treatment information ([0072] “One exemplary method that a physician can use to prescribe a slope for the gradual reduction of supplemental potassium infusion involves applying knowledge of the patient's propensity or likelihood to be affected by hypokalemia, deduced from analysis of historical dialysis treatments on the patient. While evaluating the effects of hypokalemia can be subjective, a physician or clinician can evaluate physiological properties and/or conditions of the patient after each of a plurality of dialysis treatments… The patient's propensity to suffer or to be affected can, for example, be scaled on a scale of from 0 (zero) to 10 (ten).” Risk of hypokalemia judged in a patient from historical patient-specific information, and used to inform medical decisions on the patient).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to consider the urgency of medical assistance for the patient as taught by Burnes, Felix 345, Bleyer, Fischell, and Rowlandson in view of patient-specific dialysis treatment information taught by Merchant as the urgency of medical intervention in a patient with a propensity of 10 to experience hypokalemia will differ from that of a patient with a propensity of 0 to experience hypokalemia.
Regarding Claim 14, Burnes, Felix 345, Bleyer, Fischell, Rowlandson, and Merchant teach the method in accordance with Claim 1, and Burnes further teaches the method comprising the step of:
communicatively interfacing with equipment used to administer the dialysis to the patient ([0140], [0144]-[0145]).
Regarding Claim 15, Burnes, Felix 345, Bleyer, Fischell, Rowlandson, and Merchant teach the method in accordance with Claim 14, and Burnes further teaches the method comprising the steps of:
maintaining an electronic medical record for the patient comprising one or more of details on a type of dialysis treatment being performed, kinds of dialysates being used along with amount, concentration, frequency and dosage, other medications being used along with amount, concentration, frequency and dosage ([0167]); and
based on the type of dialysis treatment being performed and upon the medical condition underlying the alert, recommending adjustments to one or more of the dialysates and other medications (See Claim 1 Rejection).
Claim(s) 2, 13, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burnes in view of Felix 345 and further in view of Bleyer and further in view of Fischell and further in view of Rowlandson and further in view of Merchant and further in view of Soykan et al (US 2014/0088442) (“Soykan”).
Regarding Claim 2, while Burnes, Felix 345, Bleyer, Fischell, Rowlandson, and Merchant teach the method in accordance with Claim 1, and Burnes notes that potassium levels are related to arrhythmias ([0157], [0160]), their combined efforts fail to teach the method comprising the steps of:
maintaining arrhythmia characteristics further indicative of at least one of the onset and existence of loss of serum potassium homeostasis in the patient on dialysis;
evaluating the ECG traces over time against the arrhythmia characteristics; and
generating the alert of medical condition upon a recognition of at least one of the ECG manifestations in one or more of the ECG traces with a recognition of at least one of the arrhythmias in the ECG traces over time.
However Soykan teaches an ECG-based serum potassium homeostasis maintaining method through subcutaneous monitoring (Abstract, [0007] monitoring for potassium disorders, reviewing serum potassium, [0182], [0010] implanted), comprising the steps of
maintaining arrhythmia characteristics further indicative of at least one of the onset and existence of loss of serum potassium homeostasis in the patient on dialysis ([0226] parameters evaluated in [0193]-[0208] also acts as arrythmia characteristics);
evaluating the ECG traces over time against the arrhythmia characteristics ([0038]); and
generating the alert of medical condition upon a recognition of at least one of the ECG manifestations in one or more of the ECG traces with a recognition of at least one of the arrhythmias in the ECG traces over time ([0038]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to maintain arrythmia characteristics and evaluate Burnes’ ECG traces against the characteristics as taught by Soykan to further provide Burnes to not just avoid arrhythmia, but also to detect when the patient is suffering an arrythmia. This provides greater utility to Burnes’ analysis.
Regarding Claim 13, while Burnes, Felix 345, Bleyer, Fischell, and Rowlandson teach the method in accordance with Claim 1, their combined efforts fail to teach
maintaining a schedule for the dialysis
notifying one or more of medical staff, the patient and the patient's caregiver with recommendations to adjust dialysis treatment if the alert occurs during a preset time interval after the session of the dialysis.
However Soykan teaches an ECG-based serum potassium homeostasis maintaining method through subcutaneous monitoring (Abstract, [0007] monitoring for potassium disorders, reviewing serum potassium, [0182], [0010] implanted), comprising the steps of
maintaining a schedule for the dialysis ([0280]-[0282] schedule maintained for dialysis in view of monitored datasets and patient’s response to treatment); and
notifying one or more of medical staff, the patient and the patient's caregiver with recommendations to adjust dialysis treatment if the alert occurs during an interdialytic period of a session of the dialysis ([0135] monitoring during a interdialytic period, [0141] notifying staff and patient of disease risk, which reflects a recommendation to seek medical assistance), wherein the preset time interval after the session of the dialysis is given special consideration (See Claim 1 Rejection), and Soykan further teaches that dialysis operation may be immediately modified ([0181]) and that feedback to a dialysis system may be as a recommendation ([0297]), Soykan fails to teach immediately notifying a recommendation.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the analysis of Burnes as an immediate recommendation to one or more of medical staff, a patient, and a patient caregiver as taught by Soykan as this provides a secondary check that a proposed change by the dialysis system will not create a different adverse affect in the patient.
Regarding Claim 16, Burnes, Felix 345, Bleyer, Fischell, Rowlandson, and Merchant teach the method in accordance with Claim 1, their combined efforts fail to teach
maintaining a schedule for the dialysis; and
immediately notifying one or more of medical staff, the patient, and the patient's caregiver with recommendations to seek medical assistance if the alert occurs during a peri-dialytic period of a session of the dialysis.
However Soykan teaches an ECG-based serum potassium homeostasis maintaining method through subcutaneous monitoring (Abstract, [0007] monitoring for potassium disorders, reviewing serum potassium, [0182], [0010] implanted), comprising the steps of
maintaining a schedule for the dialysis ([0280]-[0282] schedule maintained for dialysis in view of monitored datasets and patient’s response to treatment); and
immediately notifying one or more of medical staff, the patient, and the patient's caregiver with recommendations to seek medical assistance if the alert occurs during a peri-dialytic period of a session of the dialysis ([0135] monitoring for a peridialytic period, [0141] notifying staff and patient of disease risk, which reflects a recommendation to seek medical assistance), and Soykan further teaches that dialysis operation may be immediately modified ([0181]) and that feedback to a dialysis system may be as a recommendation ([0297]), Soykan fails to teach immediately notifying a recommendation.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the analysis of Burnes as an immediate recommendation to one or more of medical staff, a patient, and a patient caregiver as taught by Soykan as this provides a secondary check that a proposed change by the dialysis system will not create a different adverse effect in the patient.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burnes in view of Felix 345 and further in view of Bleyer and further in view of Fischell and further in view of Rowlandson and further in view of Merchant and further in view of Hoskote et al (“Disorders of Potassium Homeostasis: Pathophysiology and Management”) (“Hoskote”).
Regarding Claim 3, while Burnes, Felix 345, Bleyer, Fischell, Rowlandson, and Merchant teach the method in accordance with Claim 1, and Burnes further teaches the method comprising the steps of:
defining the set of ECG manifestations comprising an ST segment ([0152]), their combined efforts fail to teach for a hypokalemic condition, defining the set of ECG manifestations comprising one or more of a depressed ST segment and at least one of a prolonged QT interval and a prolonged QTU interval;
monitoring the ST segment and the QT interval and the QTU interval in each ECG trace.
However Hoskote teaches potassium homeostatsis analysis (Abstract) and further teaches that for a hypokalemic condition, an ECG manifestations comprises one or more of a depressed ST segment and at least one of a prolonged QT interval and a prolonged QTU interval;
the QTU interval can be monitored when evaluating a hypokalemic condition (p686, Col. 2, “Hence, hypokalemia reduces K+ conductance and leads to a prolonged repolarization phase of the cardiac action potential, reflected in the electrocardiogram (ECG) as a prolonged QT (or QU) interval.”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to specify monitored ECG parameters / manifestations in Burnes and the specific changes in the ST segment and QT interval and further include the QTU interval as taught by Hoskote as a means to ensure as accurate a diagnosis as possible based on presented ECG characteristics.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burnes in view of Felix 345 and further in view of Bleyer and further in view of Fischell and further in view of Rowlandson and further in view of Merchant and further in view of Hoskote and further in view of Felix et al (US 2017/0196472) (“Felix 472”).
Regarding Claim 4, while Burnes, Felix 345, Bleyer, Fischell, Rowlandson, Merchant, and Hoskote teach the method in accordance with Claim 3, and Burnes further teaches the method comprising the steps of:
for the hypokalemic condition, defining arrhythmia characteristics;
evaluating the ECG traces over time against the arrhythmia characteristics; and
generating the alert of medical condition upon a recognition of at least one of the ECG manifestations in one or more of the ECG traces over time (See Claim 3 Rejection), their combined efforts fail to teach the arrythmia being specific to ventricular tachycardia.
However Felix 472 teaches a physiological monitor (Abstract) and further teaches that ECG can be monitored for arrhythmia changes specific to ventricular tachycardia ([0106]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to specify monitored ECG parameters / manifestations in Burnes and Hoskote for ventricular tachycardia as taught by Felix 472 as a means to ensure as accurate a diagnosis as possible based on presented ECG characteristics.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burnes in view of Felix 345 and further in view of Bleyer and further in view of Fischell and further in view of Rowlandson and further in view of Merchant and further in view of Mattu et al (“Electrocardiographic Manifestations of Hyperkalemia”) (“Mattu”).
Regarding Claim 5, while Burnes, Felix 345, Bleyer, Fischell, Rowlandson, and Merchant teach the method in accordance with Claim 1, and Burnes further teaches the method comprising the steps of:
defining the set of ECG manifestations comprising one or more of a peaked T-wave ([0152]); and
monitoring a T-wave in each ECG trace ([0152]),
Burnes fails to teach for an early hyperkalemic condition, defining the set of ECG manifestations comprising one or more of a peaked T-wave accompanied by P-wave widening or flattening and P-R interval prolongation.
However Mattu teaches an analysis of potassium monitoring through ECG (Abstract) and further teaches that mild / early hyperkalemia may reflect P-wave widening or flattening and P-R interval prolongation (p726, “Mild to moderate hyperkalemia causes depression of conduction between adjacent cardiac myocytes, resulting in progressive prolongation of the PR and QRS intervals as potassium levels rise. Atrial myocytes are most sensitive to hyperkalemia. As a result, P-wave amplitude becomes less prominent early in the course; later, the P-wave may disappear altogether, even in the presence of continued sinus node activity.”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to specify monitored ECG parameters / manifestations for early hyperkalemia in Burnes can further include P-wave widening or flattening and P-R interval prolongation as taught by Mattu as a means to ensure as accurate a diagnosis as possible based on presented ECG characteristics.
Regarding Claim 6, while Burnes, Felix 345, Bleyer, Fischell, Rowlandson, and Merchant teach the method in accordance with Claim 1, and Burnes further teaches the method comprising the steps of:
defining the set of ECG manifestations comprising one or more of a QRS complex, peaked T-wave, longer PR interval, and a lower P-wave ([0152]); and
monitoring a QRS interval in each ECG trace ([0152]),
their combined efforts fail to teach
for a hyperkalemic condition, defining the set of ECG manifestations comprising one or more of a QRS complex widening, peaked T-wave, longer PR interval, and a lower P-wave;
for a medium-term hyperkalemic condition, defining the set of ECG manifestations comprising one or more of a QRS complex widening, peaked T-wave, longer PR interval, and a lower P-wave.
However Mattu teaches an analysis of potassium monitoring through ECG (Abstract) and further teaches that medium-term hyperkalemia may reflect one or more of a QRS complex widening, peaked T-wave, longer PR interval, and a lower P-wave (p727, Table 2).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to specify characteristics in the monitored ECG parameters / manifestations of Burnes for medium-term hyperkalemia as taught by Mattu as a means to ensure as accurate a diagnosis as possible based on presented ECG characteristics.
Regarding Claim 7, while Burnes, Felix 345, Bleyer, Fischell, Rowlandson, and Merchant teach the method in accordance with Claim 1, and Burnes further teaches the method comprising the steps of:
defining the set of ECG manifestations comprising one or more of development of a QRS complex and T-wave ([0152]); and
monitoring the QRST interval in each ECG trace ([0152]),
their combined efforts fail to teach for a lethal hyperkalemic condition, defining the set of ECG manifestations comprising one or more of development of a QRS complex and T-wave that resemble a "sine" wave.
However Mattu teaches an analysis of potassium monitoring through ECG (Abstract) and further teaches that lethal hyperkalemia may reflect one or more of development of a QRS complex and T-wave that resemble a "sine" wave (p727, Table 2).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to specify characteristics in the monitored ECG parameters / manifestations of Burnes for lethal hyperkalemia as taught by Mattu as a means to ensure as accurate a diagnosis as possible based on presented ECG characteristics.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burnes in view of Felix 345 and further in view of Bleyer and further in view of Fischell and further in view of Rowlandson and further in view of Merchant and further in view of Mattu and further in view of Soykan.
Regarding Claim 8, while Burnes, Felix 345, Bleyer, Fischell, Rowlandson, Merchant, and Mattu teach the method in accordance with Claim 7, and further teaches the method comprising the steps of:
for the lethal hyperkalemic condition, defining the set of ECG manifestations comprising one or more of pre-terminal rhythm, pulseless electrical activity (PEA), and wide complex rhythms (See Claim 7 Rejection, Mattu: wide complex rhythm of QRS), their combined efforts fail to teach
evaluating the ECG traces over time against the arrhythmia characteristics
generating the alert of medical condition upon a recognition of at least one of the ECG manifestations in one or more of the ECG traces with a recognition of one or more of pre-terminal rhythm, PEA, and wide complex rhythms in the ECG traces over time.
However Soykan teaches an ECG-based serum potassium homeostasis maintaining method through subcutaneous monitoring (Abstract, [0007] monitoring for potassium disorders, reviewing serum potassium, [0182], [0010] implanted), comprising
evaluating the ECG traces over time against the arrhythmia characteristics ([0226] parameters evaluated in [0193]-[0208] also acts as arrythmia characteristics, [0038]); and
generating the alert of medical condition upon a recognition of at least one of the ECG manifestations in one or more of the ECG traces ([0038]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to specify characteristics in the monitored ECG parameters / manifestations of Burnes with a recognition of one or more of pre-terminal rhythm, PEA, and wide complex rhythms in the ECG traces over time as taught by Mattu and incorporate this with the alert of Soykan as a means to ensure as accurate a diagnosis as possible based on presented ECG characteristics.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burnes in view of Felix 345 and further in view of Bleyer and further in view of Fischell and further in view of Rowlandson and further in view of Merchant and further in view of Mattu and further in view of Gilham et al (US 2012/0232416) (“Gilham”) and further in view of Bongberg et al (US 2021/0154487) (“Bongberg”) and further in view of Sullivan et al (US 2022/0143389) (“Sullivan”).
Regarding Claim 9, while Burnes, Felix 345, Bleyer, Fischell, Rowlandson, Merchant, and Mattu teach the method in accordance with Claim 7, their combined efforts fail to teach the method comprising the steps of:
further defining the ECG manifestations comprising a greater than 5-second pause; and
dispatching EMS upon one or more substantially contiguous occurrences of the greater than a 5-second pause in one or more of the ECG traces.
However Gilham teaches a medical device (Abstract) comprising recognizing that a a pause in heart beating requires the highest urgency alarm ([0037]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the manifestations of Burnes to include a pause in the ECG as taught by Gilham as this reflects a serious condition that requires an immediate alerting of medical personnel.
Yet their combined efforts fail to teach
further defining the ECG manifestations comprising a greater than 5-second pause; and
dispatching EMS upon one or more substantially contiguous occurrences of the greater than a 5-second pause in one or more of the ECG traces.
However Bongberg teaches a medical device network system (Abstract) and teaches that emergency services may be notified in response to ECG-based cardiac abnormalities ([0071]) and Sullivan teaches a defibrillator system (Abstract) where the existence of a cardiac abnormality is confirmed after a five second period ([0056]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the pause causing an alarm in Gilham be specified with a five second gap as taught by Sullivan and the alarm as an EMS dispatch as taught by Bongberg as a means to standardize what patient scenario requires intervention and what that intervention will be.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burnes in view of Felix 345 and further in view of Bleyer and further in view of Fischell and further in view of Rowlandson and further in view of Merchant and further in view of Marcolino Quintao Severgnini et al (US 2021/0031711) (“Marcolino”).
Regarding Claim 10, while Burnes, Felix 345, Bleyer, Fischell, Rowlandson, and Merchant teach a method in accordance with Claim 1, the method comprising increasing an urgency of the alert (See Claim 1 Rejection), their combined efforts fail to teach the method further comprising the steps of:
Increasing an urgency of the alert upon receiving an indication of an acute medical condition affecting the patient.
However Marcolino teaches a medical analysis (Abstract) and further teaches evaluating a subject’s overall health condition and providing an alert urgency based on the overall health condition ([0093]-[0[0096]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to evaluate for potassium homeostasis as taught by Burnes and further for conditions such as influenza and infections like food poisoning as taught by Marcolino to provide an appropriate alert for a subject’s overall health condition.
Regarding Claim 11, Burnes, Felix 345, Bleyer, Fischell, Rowlandson, Merchant, and Marcolino teach the method in accordance with Claim 10, wherein the acute medical condition comprises a health condition selected from the group comprising COVID-19, influenza, anorexia, lower gastrointestinal distress, other infections, and fever (See Claim 10 Rejection).
Claim(s) 17-19 and 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soykan as evidenced by Medtronic and Walsh in view of Felix 345 and further in view of Burnes and further in view of Bleyer and further in view of Fischell and further in view of Rowlandson and further in view of Merchant and further in view of Bardy et al (US 2019/0069800) (“Bardy”). Regarding Claim 17, while Soykan teaches an implantable cardiac monitor for maintaining potassium homeostasis (Abstract, [0007] monitoring for potassium disorders, reviewing serum potassium, [0182], [0010] implanted), comprising:
an implantable housing formed as a cylindrical shape with a first rounded semi spherical endcap and a second semi spherical endcap (Medtronic: Figs. 1, 2, and 40, and Walsh, p1, show the Reveal Linq insertable cardiac monitor as having a “cylindrical shape” Further, the endcaps of the shape are rounded endcaps with a circular shape that is somewhat spherical), the implantable housing comprised of a biocompatible material that is suitable for implantation within a living body (Medtronic: p91-92, Table 14); and
at least one pair of ECG sensing electrodes provided on a ventral surface and on opposite ends of the implantable housing operatively placed about the first rounded semi spherical endcap and the second rounded semi spherical endcap (Medtronic: Table 12, the distance between the electrodes and the dimensions of the system necessitates the electrodes be placed on opposite ends of the implantable housing about the semi spherical endcaps) to facilitate sensing in closest proximity to the low amplitude, low frequency content cardiac action potentials that are generated during atrial and ventricular activation atrial and ventricular repolarization (Examiner recognizes this limitation as intended use);
electronic circuitry provided within the housing assembly (Fig. 1, [0144]), comprising:
a transceiver circuit operable to wirelessly communicate with an external device ([0144] “The hermetically sealed enclosure 14 includes a battery, circuitry that controls device operations and records ECG data in memory registers, and a telemetry transceiver antenna or transceiver electrodes and circuit that receives downlink telemetry commands from and transmits stored data in a telemetry uplink to the external programmer.”);
a microcontroller operable to execute under modular micro program control ([0144] microprocessor);
an ECG front end circuit interfaced to the microcontroller and configured to capture the cardiac action potentials sensed by the pair of ECG sensing electrodes as ECG signals ([0007], [0010], [0168] ECG is capturing cardiac action potentials) comprising a set of ECG traces with each ECG trace being representative of the net electrical activity of the heart at a given moment in time, firmware provided as part of the micro program comprising ECG manifestations recognized in one or more of the ECG traces on a beat-by-beat basis ([0018]-[0019] baseline values / ECG manifestations maintained. [0021], [0174] with baseline / manifestations reflecting normal values, [0190]-[0225] outlined mathematical procedure and manifestations reflecting loss of homeostasis in [0193]-[0208], [0142] storage / memory);
memory interfaced with the microcontroller and operable to store samples of the ECG signals ([0138]);
wherein the microcontroller
determines an event of loss of serum potassium homeostasis comprising an increase or decrease in serum potassium levels in the patient in real time based directly on a change in the ECG signals matching at least one of the ECG manifestations ([0181] during a dialysis session, patient is subject to real-time monitoring of serum potassium based on ECG changes, homeostasis reflects values within a normal range of serum potassium concentration)
generates an event trigger based on the determining of the event ([0016]-[0017], [0182] alert issued if above reflects a disease risk, [0190]-[0225]), and
increasing or decreasing dialysate concentration of dialysis at a following session of the dialysis based on the event trigger ([0135] dialysate concentration of dialysis modified based on detected patient medical condition),
Soykan fails to teach the implantable housing formed as a cylindrical shape with a first rounded semispherical endcap and a second semispherical endcap, where the ECG sensing electrodes are operatively placed about the first rounded semispherical endcap and the second semispherical endcap.
However Felix 345 teaches an implantable medical device for measuring ECG (Abstract) where the implantable housing forms a cylindrical shape with a first rounded semispherical endcap and a second rounded semispherical endcap ([0016]), where the ECG sensing electrodes are operatively placed about the first rounded semispherical endcap and the second semispherical endcap (Figs. 1-2 and 11, [0044], [0075] two different electrode dipole configurations shown for measuring ECG, both with a first electrode placed about the first rounded semispherical endcap and a second electrode placed about the second rounded semispherical endcap).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the implantable housing of Soykan with partially cylindrical and partially rounded endcaps can be substituted with the implantable housing of Felix 345 with a cylindrical shape with a first rounded semispherical endcap and a second semispherical endcap as a simple substitution of one form of configuring an ECG monitoring implantable system (Soykan: partially rounded ends with monitoring capabilities) for another (Felix 345: fully rounded ends with monitoring capabilities) to obtain predictable results of accurately assessed patient heart activity.
Yet their combined efforts fail to teach
determining an urgency of engaging medical assistance for the patient based on a time of the dialysis and a type of the dialysis;
generating an alert of medical condition based upon the determining of the event and the urgency; and
increases or decreases dialysate concentration of the dialysis during the session of the dialysis based on the alert
However Burnes teaches a method for maintaining serum potassium homeostasis through subcutaneous monitoring (Abstract, [0150] subcutaneous sensor, [0157] “The system can adjust the dialysate potassium concentration in step 205 to maintain a constant or near constant potassium gradient.”), comprising the steps of:
maintaining a set of electrocardiographic (ECG) manifestations indicative of at least one of an onset and existence of loss of serum potassium homeostasis in a patient on dialysis ([0152]);
subcutaneously monitoring ECG signals of the patient's heart continuously on a beat-by-beat basis ([0145], [0153]-[0155]);
processing the ECG signals in real time as a set of ECG traces with each ECG trace being representative of the net electrical activity of the heart at a given moment in time ([0152]);
evaluating each ECG trace against the set of ECG manifestations ([0152]);
determining an event of loss of serum potassium homeostasis comprising an increase or decrease in serum potassium levels in the patient in real time based directly on a change in the ECG signals matching at least one of the ECG manifestations ([0157]);
determining an urgency of engaging medical assistance for the patient based on a time of dialysis ([0160] the rate of change takes into account a time of dialysis. Too large a change in a preset interval indicates an urgency necessitating action);
generating an alert of medical condition based upon the determination of the event and the urgency ([0157], [0159]-[0160], [0162] both the events of a potassium level threshold being passed and an urgency from an increased rate can be considered together, leading to an alert that accounts for both);
the urgency of the alert of the medical condition relates to the alert occurring during a preset time interval after an onset of a session of the dialysis ([0159]-[0160] rate of change);
increases or decreases dialysate concentration of the dialysis during the session of the dialysis based on the alert ([0157]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to utilize the time of dialysis considerations for the alert as taught by Burnes with the serum potassium homeostasis monitoring of Soykan as both a rate of change of potassium levels and the potassium levels themselves are important contextual parameters to the patient state. Burnes teaches using them together and that they can both inform the real-time dialysate update during dialysis.
Yet their combined efforts fail to teach determining an urgency of engaging medical assistance for the patient based on a time of the dialysis and a type of the dialysis;
increasing an urgency of the alert of the medical condition if the alert occurs during a preset time interval after an onset of a session of the dialysis;
However Bleyer teaches a dialysis analysis (Abstract) and further teaches that a patient is at an increased risk of death at preset time interval after a session of dialysis based on dialysis frequency (Abstract, p2268, “There were 80 [hemodialysis] HD patients who met the criteria for sudden death. A bimodal distribution of death occurrences was present, with a 1.7-fold increased death risk occurring in the 12 h period starting with the dialysis procedure and a threefold increased risk of death in the 12 h before HD at the end of the weekend interval (P=0.011).”, Discussion, p2271, Col. 1, L. 27 – Col. 2, L. 9).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to determine and modify the urgency of an alert as taught by Burnes at a preset time interval after dialysis as Bleyer teaches that patients may have an increased risk of sudden death at preset time intervals after dialysis. As noted by Bleyer, knowledge of this increased in sudden death would motivate a caregiver to apply additional therapies to the patient (Discussion, p2271, Col. 2, L. 39 – p2272, Col. 1, L. 12), and application of these additional therapies would be enabled by an alarm. Thus an urgency determination is improved by using two datasets based on a time of dialysis, both by a rate of change during dialysis and alert conditions after dialysis, and is increased when a higher risk of death is present, enabling life saving intervention for the patient.
Yet their combined efforts fail to teach determining an urgency of engaging medical assistance for the patient based on a time of the dialysis and a type of the dialysis.
However Fischell teaches a method for decreasing mortality of hemodialysis patients (Abstract) that notes that the one type of dialysis typically occurs at home and another type typically occurs at a hospital (Abstract, [0021]) wherein additional alarm functions are added to patient s at home ([0009] audio alarm to wake patient, [0020] voice contact initiated between patient and medical practitioner).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to increase the urgency of the alarm of Burnes as Fischell teaches that the types of dialysis typically differ in setting and thus differ in the need for patient to be awoken and the speed in which medical intervention can arrive.
Yet their combined efforts fail to teach determining an urgency of engaging medical assistance for the patient based on a time of the dialysis, a type of the dialysis, and historical patient-specific medical information retrieved from an electronic medical record, wherein the historical patient-specific medical information includes historical ECG manifestations.
However Rowlandson teaches an ECG-based analysis (Abstract) comprising a historical patient-specific electronic medical record containing ECG manifestations ([0012], [0044]-[0045] ECG manifestations indicative of a left bundle branch block monitored from both the current ECG record and previous ECG records), wherein the historical patient-specific medical information informs the actuation of an alarm ([0045], [0048]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to judge the ECG manifestations specific to serum potassium homeostasis as taught in Burnes in view of patient specific history as Rowlandson teaches that this may differentiate what ECG manifestation variations represent a medically significant change in a patient ([0012]). Furthermore, it would be obvious to increase urgency of an alarm as Rowlandson teaches that judging ECG manifestations in view of what is patient specific acts as a metric to judge whether a patient is in alarm condition or not ([0048]). Specifically, if the “T-wave right slope, T-wave amplitude, T-wave center of gravity, and the ratio of the T-wave amplitude to the R-wave amplitude” of Burnes show consistent changes due to other factors, one would not want to increase the urgency of an alarm. However, if these happen abruptly with no related historical changes, it is much more likely these ECG manifestation changes are due to a loss of serum potassium homeostasis.
Yet their combined efforts fail to teach determining an urgency of engaging medical assistance for the patient based on a time of the dialysis, a type of the dialysis, and historical patient-specific medical information retrieved from an electronic medical record, wherein the historical patient-specific medical information includes historical ECG manifestations and dialysis treatment information.
However Merchant teaches a tailored dialysis treatment of a subject (Abstract) and further teaches determining likelihood of a subject experiencing hypokalemia based on patient-historical dialysis treatment information ([0072] “One exemplary method that a physician can use to prescribe a slope for the gradual reduction of supplemental potassium infusion involves applying knowledge of the patient's propensity or likelihood to be affected by hypokalemia, deduced from analysis of historical dialysis treatments on the patient. While evaluating the effects of hypokalemia can be subjective, a physician or clinician can evaluate physiological properties and/or conditions of the patient after each of a plurality of dialysis treatments… The patient's propensity to suffer or to be affected can, for example, be scaled on a scale of from 0 (zero) to 10 (ten).” Risk of hypokalemia judged in a patient from historical patient-specific information, and used to inform medical decisions on the patient).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to consider the urgency of medical assistance for the patient as taught by Soykan, Felix 345, Burnes, Bleyer, Fischell, and Rowlandson in view of patient-specific dialysis treatment information taught by Merchant as the urgency of medical intervention in a patient with a propensity of 10 to experience hypokalemia will differ from that of a patient with a propensity of 0 to experience hypokalemia.
Yet their combined efforts fail to teach
the implantable housing comprised of a biocompatible material that is suitable for implantation within a living body;
the housing assembly comprising a low power microcontroller;
non-volatile memory to continuously store samples of the ECG signals.
However Bardy teaches an optimized subcutaneous cardiac monitor (Abstract, [0017]) comprising
An implantable housing comprised of a biocompatible material that is suitable for implantation within a living body;
the housing assembly comprising a low power microcontroller;
non-volatile memory to continuously store samples of the ECG signals ([0017]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate the teachings of the subcutaneous cardiac monitor of Bardy with the system of Soykan as Bardy teaches that their system is optimized to evaluate cardiac potentials including specific complexes in the ECG wave (Bardy: [0051]).
Regarding Claim 18, Soykan, Felix 345, Burnes, Bleyer, Fischell, Rowlandson, Merchant, and Bardy teach the subcutaneous insertable cardiac monitor in accordance with Claim 17, and Soykan further teaches further comprising:
the firmware further comprising arrhythmia characteristics recognized in the ECG traces over time ([0226] parameters evaluated in [0193]-[0208] also acts as arrythmia characteristics, [0038]);
wherein the microcontroller generates the alert upon the recognition by the microcontroller of at least one of the ECG manifestations in one or more of the ECG traces and the recognition of at least one of the arrhythmias in the ECG traces over time ([0038]).
Regarding Claim 19, Soykan, Felix 345, Burnes, Bleyer, Fischell, Rowlandson, Merchant, and Bardy teach the subcutaneous insertable cardiac monitor in accordance with Claim 17, and Soykan further teaches further comprising:
for a hypokalemic condition, the firmware comprises the ECG manifestations comprising one or more of a depressed ST segment and at least one of a prolonged QT interval and a prolonged QTU interval ([0191], [0226] hypokalemia is found by DSL, [0195], [0198]).
Regarding Claim 25, Soykan, Felix 345, Burnes, Bleyer, Fischell, Rowlandson, Merchant, and Bardy teach the subcutaneous insertable cardiac monitor in accordance with Claim 17, and Soykan further teaches further comprising:
at least one further ECG sensing electrode further provided on the ventral surface of the implantable housing assembly (See Claim 17 Rejection),
wherein the firmware comprises programmatic selection of one or more pairings of the ECG sensing electrodes ([0140], [0145] when using multiple electrodes, programmatic selection enabled fine tuning selection of electrodes).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to utilize the programmatic selection and multiple electrodes of Brady with the implantable housing of Soykan and Bardy to “accommodate a particular patients ECG signal characteristics post-ICM implant.” (Bardy [0140]).
Regarding Claim 26, Soykan, Felix 345, Burnes, Bleyer, Fischell, Rowlandson, Merchant, and Bardy teach the subcutaneous insertable cardiac monitor in accordance with Claim 17, and Soykan further teaches wherein the ECG front end circuit is optimized to sense the P-wave and T-wave signals in the cardiac action potentials ([0090]-[0091] specifically optimized to sense P-wave and other low amplitude cardiac action potentials like T-wave).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to optimize the ECG circuitry to sense the low amplitude cardiac action potentials as taught in Bardy for the device of Soykan to ensure low amplitude ECG complexes reflecting serum potassium homeostasis are accurately assessed.
Regarding Claim 27, Soykan, Felix 345, Burnes, Bleyer, Fischell, Rowlandson, Merchant, and Bardy teach the subcutaneous insertable cardiac monitor in accordance with Claim 17, and Soykan further teaches the monitor comprising:
an interface adapted to communicatively interface the microcontroller with equipment used to administer the dialysis to the patient ([0031]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soykan in view of Felix 345 and further in view of Burnes and further in view of Bleyer and further in view of Fischell and further in view of Rowlandson and further in view of Merchant and further in view of Bardy and further in view of Felix 472.
Regarding Claim 20, while Soykan, Felix 345, Burnes, Bleyer, Fischell, Rowlandson, Merchant, and Bardy teach the subcutaneous insertable cardiac monitor in accordance with Claim 17, and Soykan further teaches the monitor comprising:
for a hypokalemic condition, the firmware further comprising arrhythmia characteristics ([0226] parameters evaluated in [0193]-[0208] also acts as arrythmia characteristics, [0038]),
wherein the microcontroller generates the alert upon the recognition by the microcontroller of at least one of the ECG manifestations in one or more of the ECG traces and the recognition of the arrhythmia in the ECG traces over time ([0038]), their combined efforts fail to teach the arrythmia being specific to ventricular tachycardia.
However Felix 472 teaches a physiological monitor (Abstract) and further teaches that ECG can be monitored for arrhythmia changes specific to ventricular tachycardia ([0106]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to specify monitored ECG parameters / manifestations in Soykan for ventricular tachycardia as taught by Felix 472 as a means to ensure as accurate a diagnosis as possible based on presented ECG characteristics.
Claim(s) 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soykan in view of Felix 345 and further in view of Burnes and further in view of Bleyer and further in view of Fischell and further in view of Rowlandson and further in view of Merchant and further in view of Bardy and further in view of Mattu.
Regarding Claim 21, while Soykan, Felix 345, Burnes, Bleyer, Fischell, Rowlandson, Merchant, and Bardy teach the subcutaneous insertable cardiac monitor in accordance with Claim 17, further comprising:
for an hyperkalemic condition, the firmware comprises the ECG manifestations comprising one or more of a peaked T-wave accompanied by P-wave widening or flattening and P-R interval prolongation ([0191], [0226] monitoring for hypokalemia, [0201]), their combined efforts fail to teach for an early hyperkalemic condition, defining the set of ECG manifestations comprising one or more of a peaked T-wave accompanied by P-wave widening or flattening and P-R interval prolongation.
However Mattu teaches an analysis of potassium monitoring through ECG (Abstract) and further teaches that mild / early hyperkalemia may reflect P-wave widening or flattening and P-R interval prolongation (p726, “Mild to moderate hyperkalemia causes depression of conduction between adjacent cardiac myocytes, resulting in progressive prolongation of the PR and QRS intervals as potassium levels rise. Atrial myocytes are most sensitive to hyperkalemia. As a result, P-wave amplitude becomes less prominent early in the course; later, the P-wave may disappear altogether, even in the presence of continued sinus node activity.”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to specify monitored ECG parameters / manifestations for early hyperkalemia in Soykan can further include P-wave widening or flattening and P-R interval prolongation as taught by Mattu as a means to ensure as accurate a diagnosis as possible based on presented ECG characteristics.
Regarding Claim 22, while Soykan, Felix 345, Burnes, Bleyer, Fischell, Rowlandson, Merchant, and Bardy teach the subcutaneous insertable cardiac monitor in accordance with Claim 17, further comprising:
for a hyperkalemic condition, the firmware comprises the ECG manifestations comprising one or more of a QRS complex widening, peaked T-wave, longer PR interval, and a lower P-wave ([0191], [0226] monitoring for hypokalemia, [0194], [0196], [0201]), their combined efforts fail to teach for a medium-term hyperkalemic condition, defining the set of ECG manifestations comprising one or more of a QRS complex widening, peaked T-wave, longer PR interval, and a lower P-wave.
However Mattu teaches an analysis of potassium monitoring through ECG (Abstract) and further teaches that medium-term hyperkalemia may reflect one or more of a QRS complex widening, peaked T-wave, longer PR interval, and a lower P-wave (p727, Table 2).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to specify monitored ECG parameters / manifestations for medium-term hyperkalemia in Soykan as taught by Mattu as a means to ensure as accurate a diagnosis as possible based on presented ECG characteristics.
Regarding Claim 23, while Soykan, Felix 345, Burnes, Bleyer, Fischell, Rowlandson, Merchant, and Bardy teach the subcutaneous insertable cardiac monitor in accordance with Claim 17, further comprising:
for a hyperkalemic condition, the firmware comprises the ECG manifestations comprising one or more of development of a QRS complex and T- wave that resemble a "sine" wave ([0191], [0226] monitoring for hypokalemia, [0194], [0208]), their combined efforts fail to teach for a lethal hyperkalemic condition, defining the set of ECG manifestations comprising one or more of development of a QRS complex and T-wave that resemble a "sine" wave.
However Mattu teaches an analysis of potassium monitoring through ECG (Abstract) and further teaches that lethal hyperkalemia may reflect one or more of development of a QRS complex and T-wave that resemble a "sine" wave (p727, Table 2).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to specify monitored ECG parameters / manifestations for lethal hyperkalemia in Soykan as taught by Mattu as a means to ensure as accurate a diagnosis as possible based on presented ECG characteristics.
Regarding Claim 24, while Soykan, Felix 345, Burnes, Bleyer, Fischell, Rowlandson, Merchant, Bardy, and Mattu teach the subcutaneous insertable cardiac monitor in accordance with Claim 23, further comprising:
for the lethal hyperkalemic condition, the firmware further comprising arrhythmia characteristics comprising one or more of pre-terminal rhythm, pulseless electrical activity (PEA), and wide complex rhythms (See Claim 23 Rejection, Mattu: wide complex rhythm of QRS);
wherein the microcontroller generates the alert upon the recognition by the microcontroller of at least one of the ECG manifestations in one or more of the ECG traces and the recognition of one or more of pre-terminal rhythm, PEA, and wide complex rhythms in the ECG traces over time (See Claim 23 Rejection, Soykan teaches alerting based on a disease risk score, which may reflect both arrythmia and hyperkalemia, Mattu teaches that the scores may be configured specifically for lethal hyperkalemia and may include wide complex rhythms).
Response to Arguments
Applicant’s arguments and amendments filed 10/07/2025 with respect to the 35 USC 103 rejection of claims 1 and 17 have been fully considered, but are not persuasive. Applicant argues that the newly included claim limitation adding “a transceiver circuit operable to wirelessly communicate with an external device” to the claims differentiates the claim from the cited references. Examiner respectfully disagrees. With respect to claim 1, as noted above, the primary reference of Burnes indicates a step of wireless communication of sensed potassium data to an external device ([0150]), the desired Medtronic Reveal device describes scheduled wireless communication of results to an external device (p50, 5.3.1 Transmitting patient and device information to the CareLink Network), and Felix teaches the use of a transceiver circuit to accomplish wireless communication from an implanted ECG measuring device (Abstract, [0016]). Thus the prior art renders obvious that wireless communication would be desired by the primary reference, within the scope of the desired implanted ECG measuring device, and can be specifically accomplished by the use of a transceiver circuit.
And with respect to claim 17, the primary reference of Soykan includes a transceiver circuit to wirelessly communicate with an external device as recited in paragraph [0144] (“The hermetically sealed enclosure 14 includes a battery, circuitry that controls device operations and records ECG data in memory registers, and a telemetry transceiver antenna or transceiver electrodes and circuit that receives downlink telemetry commands from and transmits stored data in a telemetry uplink to the external programmer.”).
The rejection stands.
Consequently, Claims 2-11, 13-16, and 18-27 remain rejected due to their dependency on independent Claims 1 and 17.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights