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 .
Response to Arguments
Applicant’s arguments, filed on June 29, 2026 respect to the rejection(s) of claim(s) 1-3, 5-10, 12-17, and 19-23 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection have been made below in view of applicant’s amendments as can be further seen below. Furthermore, newly added claims 24-29 has been acknowledged.
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 1, 5-6, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over US 20180055382 A1 to Woodward et al. (hereinafter “Woodward”) in view of US 2020/0100697 A1 to Derkx et al. (hereinafter “Derkx”) and WO 2016/201367 A1 to Quan.
Regarding claim 1, Woodward teaches:
A system for determining and indicating whether a patient is exhibiting pulseless electrical activity (PEA) or is not exhibiting PEA (abstract), comprising:
A first patient-wearable device/first wearable sensor adapted for attachment to a first body location of the patient
and configured to utilize one or more electrocardiogram (ECG) sensors thereof to generate ECG data (see abstract, lines 1-5, annotated fig. 2 below, para 0027, and para 0033-0034);
a second patient-wearable device that is adapted for attachment to a second body location of the patient and configured to utilize one or more of an inertial motion sensor/accelerometer or an acoustic sensor thereof to generate pulse wave data/pulse rate data (see abstract, lines 5-12, annotated fig. 2 below, para 0027, para 0033, and para 0035);
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and a processing unit/processor (para 0007) that is configured to:
receive the ECG/heart rate data from the first patient-wearable device/first sensor and the pulse wave data/pulse rate data from the second patient-wearable device/second sensor (fig. 2, 110-a-1 and 110-b-1, para 0005, para 0007, and para 0026);
process the ECG /heart rate data to identify one or more ECG waveforms/signals thereof (see annotated fig. 7 below, para 0007, and para 0048-0049);
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process the pulse wave data/pulse rate data to determine whether the pulse wave data includes one or more pulse waveforms/signals that respectively correspond/correlate to the identified one or more ECG waveforms/heart rate waveforms/signals (see annotated fig. 7 below, para 0007, para 0048, para 0050-0051), and generate a user-perceptible indication (alert) that the patient is exhibiting PEA in response to at least determining that the pulse wave data does not include one or more pulse waveforms that respectively correspond/correlate to the identified one or more ECG waveforms/ heart rate signals (which is indicated by the correlation falling outside a predetermined threshold) (see abstract, fig. 8, 835 and 845, para 0005, para 0008, para 0010-0011, para 0036, para 0052-0053, para 0057, para 0062, para 0069),
but does not explicitly disclose wherein the processing unit is further configured to filter the pulse wave data based on the ECG signal data.
However, Derkx teaches a method for generating filtered EMG signal (see abstract, line 1). The system (fig. 1) teaches wherein the processing unit is further configured to filter the EMG data based on the ECG data (see figs. 1-2, para [0026], and para [0127]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Woodward with the system of Derkx to arrive at the claimed invention. Such modification would improve the system and lead to a reasonable expectation for success, since the prior reference of Derkx shows that using ECG data to filter another other physiological data in order to produce a clearer and more precise of the target signal (such as the EMG signal). Although Derkx teaches filtering the target signal data using EMG signals, Woodward nor Derkx explicitly disclose generating a user-perceptible indication that the patient is not exhibiting PEA in response to at least determining that the pulse wave data/pulse rate data includes one or more pulse waveforms/signals that respectively correspond to the identified one or more ECG waveforms/signals.
However, Quan teaches a system for assisting with cardiopulmonary resuscitation (CPR) treatment administered to a patient (see abstract, lines 1-2). The system (fig. 1A) monitors the patient via one or more sensors (which includes ECG sensors and a motion sensors used to capture the movement of the myocardial wall of the patient) used to monitor a patient following CPR treatment. Following the collection of ECG signals and motion signals from the myocardial wall of the patient, one or more processors will use this data to determine the perfusion movement of the heart, and provide an indication/generating a user-perceptible indication (via a user interface) to determine if the patient is not exhibiting PEA (which would cause the user interface to display “Halt chest compressions” shown in Fig. 1A - see annotated fig. 1A below and para 0024-0025)
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In response to at least determining that the pulse wave data/pulse rate data includes one or more pulse waveforms/signals (generated by the motion sensor/ accelerometer) that respectively correspond/correlate to the identified one or more cardiac waveforms/signals (para 0006).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system of Woodward with the teachings of Derkx and Quan to arrive at the claimed invention. Such combination would improve the system by ensuring a health professional is able to quickly and accurately determine if a patient is or is not in need of additional CPR treatment, ultimately ensuring that the rescuer/medical professional does not inadvertently injure the patient following sufficient CPR treatment.
Regarding claim 5, Woodward as modified teaches:
The system of claim 1, but does not explicitly disclose wherein the processing unit is configured to filter the pulse wave data based on the ECG signal data by synchronizing the pulse wave data and the ECG data.
However, Derkx teaches a method for generating filtered EMG signal (see abstract, line 1). The system (fig. 1) teaches wherein the processing unit is further configured to filter the EMG data based on the ECG signal data, and wherein filtering the EMG data based on the ECG data comprises synchronizing the pulse wave data and the ECG data ( figs. 1-2, abstract – lines 1-3, para [0026], and para [0127]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Woodward with the system of Derkx to arrive at the claimed invention. Such modification would improve the system and lead to a reasonable expectation for success, since the prior reference of Derkx shows that using ECG data to filter another other physiological data in order to produce a clearer and more precise of the target signal (such as the EMG signal). Furthermore, such modification would improve the system by accurately detecting the perfusion movement of a patient’s heart, ultimately ensuring appropriate CPR treatment is properly administered (when needed) to the patient.
Regarding claim 6, Woodward as modified teaches:
The system of claim 1, wherein the processing unit/processor is configured to generate the user-perceptible indication (alert) that the patient is exhibiting PEA by rendering a visual indication/alert condition that the patient is exhibiting PEA to a display/user interface (see fig. 9, 950, para 0007, para 0062, and para 0069), but does not disclose wherein the processing unit/processor is configured to generate the user-perceptible indication that the patient is not exhibiting PEA by rendering a visual indication that the patient is not exhibiting PEA to a display.
However, Quan teaches wherein one or more processors will use the ECG data and myocardial wall data (motion sensor data) to determine the perfusion movement of the heart, and generate a user-perceptible indication (via a user interface) to determine if the patient is not exhibiting PEA by rendering a visual indication/message that the patient is not exhibiting PEA to a display/user interface (which would cause the user interface to display “Halt chest compressions” shown in Fig. 1A) (see annotated fig. 1A below and para 0024-0025).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Woodward with the teachings of Quan to arrive at the claimed invention. Such modification would improve the system by ensuring a health professional is able to quickly and accurately determine if a patient is or is not in need of additional CPR treatment, ultimately ensuring that the rescuer/medical professional does not inadvertently injure the patient following sufficient CPR treatment.
Regarding claim 24, Woodward as modified teaches:
The system of claim 5, wherein the processing unit is configured to synchronize the pulse wave data and the ECG data based on time stamps respectively associated with each of the pulse wave data and the ECG data (see para [0005], para [0091], and para [0038] – “ The correlation may include comparing of a timing of the heart rate and a timing of the pulse rate. For example, a measured cycle of electrical activity of a heartbeat may have a corresponding pulse in a subsequent time period…….Determining the correlation may occur over a period of time where multiple periods of the person's heart rate and pulse rate are determined.”).
Regarding claim 25, Woodward as modified teaches:
The system of claim 5, wherein the processing unit is configured to synchronize the pulse wave data and the ECG data by correlating at least one feature of at least one of the one or more ECG waveforms with at least one feature of at least one of the one or more pulse waveforms (see Quan – see figs. 1C-1D, para [0034], and para [0035] – “ The intrinsic myocardial wall movements 108c in perfusing rhythms (as illustrated in FIG. 1 D) showed periodic oscillations synchronized with R waves in the ECG signal 108a. ”).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Woodward in view of Derkx and Quan, and further in view of US 2019/0374428 A1 to Kaufman et al. (hereinafter “Kaufman”).
Regarding claim 2, Woodward as modified teaches:
The system of claim 1, wherein the first body location (sensor placement) of the patient is placed directly over the heart of the patient
and the second body location is away from the heart of the patient and proximal to one of a carotid artery of the patient, a radial artery of the patient, or a femoral artery of the patient (See annotated fig. 2 below).
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But does not explicitly disclose wherein the first body location of the patient is proximal to a heart of the patient.
However, Kaufman teaches a system and method for providing chest compressions to a patient during cardiopulmonary resuscitation (see abstract, lines 1-3). The system (fig. 1A) teaches where a first body location/one body location of a patient is proximal to the heart of the patient (see annotated fig. 1A below and para 0085).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Woodward with the teachings of Kaufman to arrive at the claimed invention. Such modification would have led to a reasonable expectation for success, since the prior art utilizes a proximal ECG sensor in order to provide an accurate determination of blood flow from the heart throughout the body, ultimately providing an accurate determination of a patient’s true cardiac function prior to performing cardiopulmonary resuscitation.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Woodward in view of Derkx and Quan, and further in view of WO 2018/136462 A1 to Raj et al. (hereinafter “Raj”).
Regarding claim 7, Woodward as modified teaches:
The system of claim 1, further comprising multiple wearable medical devices used for monitoring a patient (para 0026-0027), and generating a user-perceptible indication (alert) that the patient is exhibiting PEA in response to at least determining that the pulse wave data does not include one or more pulse waveforms that respectively correspond/correlate to the identified one or more ECG waveforms/ heart rate signals (which is indicated by the correlation falling outside a predetermined threshold) (see abstract, fig. 8, 835 and 845, para 0005, para 0008, para 0010-0011, para 0036, para 0052-0053, para 0057, para 0062, para 0069),
but does not explicitly disclose using:
a third patient-wearable device/sensor that is adapted for attachment to a third body location of the patient and configured to utilize one or more of an inertial motion sensor or an acoustic sensor thereof to generate additional pulse wave data;
wherein the processing unit is further configured to:
receive the additional pulse wave data from the third patient-wearable device;
and process the additional pulse wave data to determine whether the additional pulse wave data includes one or more pulse waveforms that respectively correspond to the identified one or more ECG waveforms;
wherein the processing unit is configured to generate the user-perceptible indication that the patient is not exhibiting PEA in response to at least determining that either one of the pulse wave data or the additional pulse wave data includes one or more pulse waveforms that respectively correspond to the identified one or more ECG waveforms;
and wherein the processing unit is configured to generate the user-perceptible indication that the patient is exhibiting PEA in response to at least determining that both the pulse wave data and the additional pulse wave data do not include one or more pulse waveforms that respectively correspond to the identified one or more ECG waveforms.
However, Raj teaches a system and method for digital stethoscope using mechano-acoustic sensors for sensing acoustic data through the use of wearable sensors (including an accelerometer sensor) (see abstract and fig. 1). The system (fig. 1) uses:
a third patient-wearable device/sensor (see fig. 1, 114) that is adapted for attachment to a third body location of the patient (see fig. 1, 114) and configured to utilize one or more of an inertial motion sensor or an acoustic sensor thereof to generate additional pulse wave data (data associated with motion and vibrations transmitted through the skin produced by the organs in the body)(see para 0008-0009, para 0011, para 0014, para 0020, and para 0023-0025);
wherein the processing unit is further configured to:
receive the additional pulse wave data from the third patient-wearable device (such as sensor/device 114 or 217) (see para 0024-0025 and para 0031-0032);
and wherein the processing unit/processor is configured to generate the user-perceptible indication that the patient is exhibiting a heart abnormality in response to at least determine that both the pulse wave data and the additional pulse wave data do not include one or more pulse waveforms that respectively correspond to the identified one or more ECG waveforms (see fig. 5, para 0062, para 0064, and para 0066-0068).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Woodward with the teachings of Raj to arrive at the claimed invention. Such modifications would improve the system by further validating the pulse wave data signals and cardiac the waveforms following treatment, ultimately providing a more concrete and accurate medical evaluation of each patient’s cardiac/health state prior to treatment, ensuring each patient is properly treated. Although Raj teaches the one or more pulse waveforms and the cardiac waveforms, they do not explicitly disclose wherein the processing unit is further configured to:
use the additional pulse wave data from the third patient-wearable device,
and process the additional pulse wave data to determine whether the additional pulse wave data includes one or more pulse waveforms that respectively correspond to the identified one or more ECG waveforms;
wherein the processing unit is configured to generate the user-perceptible indication that the patient is not exhibiting PEA in response to at least determining that either one of the pulse wave data or the additional pulse wave data includes one or more pulse waveforms that respectively correspond to the identified one or more cardiac waveforms.
However, Quan teaches wherein the system uses input from multiple sets of sensors/wearable devices attached to various locations on the body, and where the output from multiple sensors is used by the processing unit/processor to generate the user-perceptible indication (display/user interface message) that the patient is not exhibiting PEA (which results in displaying the “Halt chest compressions” message), in response to at least determining that either one of the pulse wave data (data generated from the motion sensor and representative of the myocardial wall movement of the patient) or the additional pulse wave data includes one or more pulse waveforms that respectively correspond to the identified one or more cardiac waveforms/ECG signals (see fig. 1A, para 0004-0006, para 0024, and para 0071).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Woodward with the teachings of Raj and Quan to arrive at the claimed invention. Such modifications would improve the system by ensuring a health professional is able to quickly and accurately determine if a patient is or is not in need of additional CPR treatment, ultimately ensuring that the rescuer/medical professional does not inadvertently injure the patient following sufficient CPR treatment.
Claims 8-10, 12-13, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Woodward in view of Kaufman, and further in view of Derkx and Quan.
Regarding claim 8, Woodward teaches:
A method for determining and indicating whether a patient is exhibiting pulseless electrical activity (PEA) or is not exhibiting PEA (abstract), comprising:
A first patient-wearable device/first wearable sensor adapted for attachment to a first body location of the patient
and configured to utilize one or more ECG sensors thereof to generate ECG data (see abstract, lines 1-5, annotated fig. 2 below, para 0027, and para 0033-0034);
a second patient-wearable device that is adapted for attachment to a second body location of the patient and configured to utilize one or more of an inertial motion sensor/accelerometer or an acoustic sensor thereof to generate pulse wave data/pulse rate data (see abstract, lines 5-12, annotated fig. 2 below, para 0027, para 0033, and para 0035);
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and a processing unit/processor (para 0007) that is configured to:
receive the electrocardiogram ECG data /heart rate data from the first patient-wearable device/first sensor and the pulse wave data/pulse rate data from the second patient-wearable device/second sensor (fig. 2, 110-a-1 and 110-b-1, para 0005, para 0007, and para 0026);
process the ECG data/heart rate data to identify one or more ECG waveforms/signals thereof (see annotated fig. 7 below, para 0007, and para 0048-0049);
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process the pulse wave data/pulse rate data to determine whether the pulse wave data includes one or more pulse waveforms/signals that respectively correspond/correlate to the identified one or more ECG waveforms/heart rate waveforms/signals (see annotated fig. 7 below, para 0007, para 0048, para 0050-0051);
and generate a user-perceptible indication (alert) that the patient is exhibiting PEA in response to at least determining that the pulse wave data does not include one or more pulse waveforms that respectively correspond/correlate to the identified one or more ECG waveforms/ heart rate signals (which is indicated by the correlation falling outside a predetermined threshold) (see abstract, fig. 8, 835 and 845, para 0005, para 0008, para 0010-0011, para 0036, para 0052-0053, para 0057, para 0062, para 0069),
but does not explicitly disclose wherein the system teaches a method for determining and indicating that a patient is not exhibiting pseudo pulseless electrical activity (pseudo-PEA).
However, Kaufman teaches a method for determining and indicating that a patient is not exhibiting pseudo pulseless electrical activity (pseudo-PEA) (by determining if the patient is or is not in a state of PEA or EMD by collecting ECG signals from a patient using ECG sensors and motion/accelerometer sensors) (see fig. 1A,103A-103B, abstract, para 0004, para 0090, para 0112, para 0048, para 0059, para 0067, para 0071, and para 0084).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Woodward with the teachings of Kaufman to arrive at the claimed invention. Such combination would improve the system by allowing the medical professional to properly determine whether a patient is experiencing very little/very weak heart contractions (such as in pseudo-PEA) or no heart muscle contractions( such as in pure PEA), ultimately allowing the medical professional to determine the severity of the patient’s condition while providing the most fitting treatment necessary for each patient as well.
Although Kaufman teaches the pseudo-PEA system, Woodward and Kaufman do not explicitly disclose wherein processing the pulse wave data includes filtering the pulse wave data based on cardiac signal data.
However, Derkx teaches a method for generating filtered EMG signal (see abstract, line 1). The system (fig. 1) teaches wherein the processing unit is further configured to filter the EMG data based on the ECG signal data (see figs. 1-2, para [0026], and para [0127]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Woodward with the system of Derkx to arrive at the claimed invention. Such modification would improve the system and lead to a reasonable expectation for success, since the prior reference of Derkx shows that using ECG data to filter another other physiological data in order to produce a clearer and more precise of the target signal (such as the EMG signal). Although Derkx teaches filtering the target signal data using EMG signals, Woodward nor Derkx explicitly disclose generating a user-perceptible indication that the patient is not exhibiting PEA in response to at least determining that the pulse wave data/pulse rate data includes one or more pulse waveforms/signals that respectively correspond to the identified one or more ECG waveforms/signals.
However, Quan teaches a system for assisting with cardiopulmonary resuscitation (CPR) treatment administered to a patient (see abstract, lines 1-2). The system (fig. 1A) monitors the patient via one or more sensors (which includes ECG sensors and a motion sensors used to capture the movement of the myocardial wall of the patient) used to monitor a patient following CPR treatment. Following the collection of ECG signals and motion signals from the myocardial wall of the patient, one or more processors will used this data to determine the perfusion movement of the heart, and provide an indication/generating a user-perceptible indication (via a user interface) to determine if the patient is not exhibiting PEA (which would cause the user interface to display “Halt chest compressions” shown in Fig. 1A) (see annotated fig. 1A below and para 0024-0025)
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In response to at least determining that the pulse wave data/pulse rate data includes one or more pulse waveforms/signals (generated by the motion sensor/ accelerometer) that respectively correspond/correlate to the identified one or more ECG waveforms/signals (para 0006).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system of Woodward with the teachings of Kaufman, Derkx, and Quan to arrive at the claimed invention. Such combination would improve the system by ensuring a health professional is able to quickly and accurately determine if a patient is or is not in need of additional CPR treatment, ultimately ensuring that the rescuer/medical professional does not inadvertently injure the patient following sufficient CPR treatment.
Regarding claim 9, Woodward as modified teaches:
The system of claim 8, wherein the first body location (sensor placement) of the patient is placed directly over the heart of the patient
and the second body location is away from the heart of the patient and proximal to one of a carotid artery of the patient, a radial artery of the patient, or a femoral artery of the patient (See annotated fig. 2 below).
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But does not explicitly disclose wherein the first body location of the patient is proximal to a heart of the patient.
However, Kaufman teaches a system and method for providing chest compressions to a patient during cardiopulmonary resuscitation (see abstract, lines 1-3). The system (fig. 1A) teaches where a first body location/one body location of a patient is proximal to the heart of the patient (see annotated fig. 1A below and para 0085).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Woodward with the teachings of Kaufman to arrive at the claimed invention. Such modification would have led to a reasonable expectation for success, since the prior art utilizes a proximal ECG sensor in order to provide an accurate determination of blood flow from the heart throughout the body, ultimately providing an accurate determination of a patient’s true cardiac function prior to performing cardiopulmonary resuscitation.
Regarding claim 12, Woodward as modified teaches:
The method of claim 8, but does not explicitly disclose wherein the processing unit is configured to filter the pulse wave data based on the ECG data by synchronizing the pulse wave data and the ECG data.
However, Derkx teaches a method for generating filtered EMG signal (see abstract, line 1). The system (fig. 1) teaches wherein the processing unit is further configured to filter the EMG data based on the cardiac signal data, and wherein filtering the EMG data based on the ECG data comprises synchronizing the pulse wave data and the ECG data ( figs. 1-2, abstract – lines 1-3, para [0026], and para [0127]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Woodward with the system of Derkx to arrive at the claimed invention. Such modification would improve the system and lead to a reasonable expectation for success, since the prior reference of Derkx shows that using ECG data to filter another other physiological data in order to produce a clearer and more precise of the target signal (such as the EMG signal). Furthermore, such modification would improve the system by accurately detecting the perfusion movement of a patient’s heart, ultimately ensuring appropriate CPR treatment is properly administered (when needed) to the patient.
Regarding claim 13, Woodward as modified teaches:
The method of claim 8, wherein the processing unit/processor is configured to generate the user-perceptible indication (alert) that the patient is exhibiting PEA by rendering a visual indication/alert condition that the patient is exhibiting PEA to a display/user interface (see fig. 9, 950, para 0007, para 0062, and para 0069), but does not disclose wherein the processing unit/processor is configured to generate the user-perceptible indication that the patient is not exhibiting PEA by rendering a visual indication that the patient is not exhibiting PEA to a display.
However, Quan teaches wherein one or more processors will use the ECG data and myocardial wall data (motion sensor data) to determine the perfusion movement of the heart, and generate a user-perceptible indication (via a user interface) to determine if the patient is not exhibiting PEA by rendering a visual indication/message that the patient is not exhibiting PEA to a display/user interface (which would cause the user interface to display “Halt chest compressions” shown in Fig. 1A) (see annotated fig. 1A below and para 0024-0025).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Woodward with the teachings of Quan to arrive at the claimed invention. Such modification would improve the system by ensuring a health professional is able to quickly and accurately determine if a patient is or is not in need of additional CPR treatment, ultimately ensuring that the rescuer/medical professional does not inadvertently injure the patient following sufficient CPR treatment.
Regarding claim 26, Woodward as modified teaches:
The method of claim 12, wherein synchronizing the pulse wave data and the ECG data comprises synchronizing the pulse wave data and the ECG data based on time stamps respectively associated with each of the pulse wave data and the ECG data (see para [0005], para [0091], and para [0038] – “ The correlation may include comparing of a timing of the heart rate and a timing of the pulse rate. For example, a measured cycle of electrical activity of a heartbeat may have a corresponding pulse in a subsequent time period…….Determining the correlation may occur over a period of time where multiple periods of the person's heart rate and pulse rate are determined.”).
Regarding claim 27, Woodward as modified teaches:
The method of claim 12, wherein synchronizing the pulse wave data and the ECG data comprises correlating at least one feature of at least one of the one or more ECG waveforms with at least one feature of at least one of the one or more pulse waveforms (see Quan – see figs. 1C-1D, para [0034], and para [0035] – “ The intrinsic myocardial wall movements 108c in perfusing rhythms (as illustrated in FIG. 1 D) showed periodic oscillations synchronized with R waves in the ECG signal 108a”).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Woodward in view of Kaufman, Derkx, and Quan, and further in view of Raj.
Regarding claim 14, Woodward as modified teaches:
The method of claim 8, further comprising multiple wearable medical devices used for monitoring a patient (para 0026-0027),
and generate a user-perceptible indication (alert) that the patient is exhibiting PEA in response to at least determining that the pulse wave data does not include one or more pulse waveforms that respectively correspond/correlate to the identified one or more ECG waveforms/ heart rate signals (which is indicated by the correlation falling outside a predetermined threshold) (see abstract, fig. 8, 835 and 845, para 0005, para 0008, para 0010-0011, para 0036, para 0052-0053, para 0057, para 0062, para 0069), but does not explicitly disclose using:
a third patient-wearable device/sensor that is adapted for attachment to a third body location of the patient and configured to utilize one or more of an inertial motion sensor or an acoustic sensor thereof to generate additional pulse wave data;
wherein the processing unit is further configured to:
receive the additional pulse wave data from the third patient-wearable device;
and process the additional pulse wave data to determine whether the additional pulse wave data includes one or more pulse waveforms that respectively correspond to the identified one or more ECG waveforms;
wherein the processing unit is configured to generate the user-perceptible indication that the patient is not exhibiting PEA in response to at least determining that either one of the pulse wave data or the additional pulse wave data includes one or more pulse waveforms that respectively correspond to the identified one or more ECG waveforms;
and wherein the processing unit is configured to generate the user-perceptible indication that the patient is exhibiting PEA in response to at least determining that both the pulse wave data and the additional pulse wave data do not include one or more pulse waveforms that respectively correspond to the identified one or more ECG waveforms.
However, Raj teaches a system and method for digital stethoscope using mechano-acoustic sensors for sensing acoustic data through the use of wearable sensors (including an accelerometer sensor) (see abstract and fig. 1). The system (fig. 1) uses:
a third patient-wearable device/sensor (see fig. 1, 114) that is adapted for attachment to a third body location of the patient (see fig. 1, 114) and configured to utilize one or more of an inertial motion sensor or an acoustic sensor thereof to generate additional pulse wave data (data associated with motion and vibrations transmitted through the skin produced by the organs in the body)(see para 0008-0009, para 0011, para 0014, para 0020, and para 0023-0025);
wherein the processing unit is further configured to:
receive the additional pulse wave data from the third patient-wearable device (such as sensor/device 114 or 217) (see para 0024-0025 and para 0031-0032);
and wherein the processing unit/processor is configured to generate the user-perceptible indication that the patient is exhibiting a heart abnormality in response to at least determine that both the pulse wave data and the additional pulse wave data do not include one or more pulse waveforms that respectively correspond to the identified one or more cardiac waveforms (see fig. 5, para 0062, para 0064, and para 0066-0068).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Woodward with the teachings of Raj to arrive at the claimed invention. Such modifications would improve the system by further validating the pulse wave data signals and cardiac the waveforms following treatment, ultimately providing a more concrete and accurate medical evaluation of each patient’s cardiac/health state prior to treatment, ensuring each patient is properly treated. Although Raj teaches the one or more pulse waveforms and the cardiac waveforms, they do not explicitly disclose wherein the processing unit is further configured to:
use the additional pulse wave data from the third patient-wearable device,
and process the additional pulse wave data to determine whether the additional pulse wave data includes one or more pulse waveforms that respectively correspond to the identified one or more cardiac waveforms;
wherein the processing unit is configured to generate the user-perceptible indication that the patient is not exhibiting PEA in response to at least determining that either one of the pulse wave data or the additional pulse wave data includes one or more pulse waveforms that respectively correspond to the identified one or more cardiac waveforms.
However, Quan teaches wherein the system uses input from multiple sets of sensors/wearable devices attached to various locations on the body, and where the output from multiple sensors is used by the processing unit/processor to generate the user-perceptible indication (display/user interface message) that the patient is not exhibiting PEA (which results in displaying the “Halt chest compressions” message), in response to at least determining that either one of the pulse wave data (data generated from the motion sensor and representative of the myocardial wall movement of the patient) or the additional pulse wave data includes one or more pulse waveforms that respectively correspond to the identified one or more cardiac waveforms/ECG signals (see fig. 1A, para 0004-0006, para 0024, and para 0071 ).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Woodward with the teachings Raj and Quan to arrive at the claimed invention. Such modifications would improve the system by ensuring a health professional is able to quickly and accurately determine if a patient is or is not in need of additional CPR treatment, ultimately ensuring that the rescuer/medical professional does not inadvertently injure the patient following sufficient CPR treatment.
Claims 15, 19, and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0055382 A1 to Woodward et al. (hereinafter “Woodward”) in view of Derkx.
Regarding claim 15, Woodward teaches:
A method for determining and indicating whether a patient is exhibiting pulseless electrical activity (PEA) (abstract), comprising:
A first patient-wearable device/first wearable sensor adapted for attachment to a first body location of the patient and configured to utilize one or more ECG sensors thereof to generate cardiac signal data (see abstract, lines 1-5, annotated fig. 2 below, para 0027, and para 0033-0034);
a second patient-wearable device that is adapted for attachment to a second body location of the patient and configured to utilize one or more of an inertial motion sensor/accelerometer or an acoustic sensor thereof to generate pulse wave data/pulse rate data (see abstract, lines 5-12, annotated fig. 2 below, para 0027, para 0033, and para 0035);
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and a processing unit/processor (para 0007) that is configured to:
receive the ECG data/heart rate data from the first patient-wearable device/first sensor and the pulse wave data/pulse rate data from the second patient-wearable device/second sensor (fig. 2, 110-a-1 and 110-b-1, para 0005, para 0007, and para 0026);
process the ECG data/heart rate data to identify one or more ECG waveforms/signals thereof (see annotated fig. 7 below, para 0007, and para 0048-0049);
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process the pulse wave data/pulse rate data to determine whether the pulse wave data includes one or more pulse waveforms/signals that respectively correspond/correlate to the identified one or more ECG waveforms/heart rate waveforms/signals (see annotated fig. 7 below, para 0007, para 0048, para 0050-0051);
and generate a user-perceptible indication (alert) that the patient is exhibiting PEA in response to at least determining that the pulse wave data does not include one or more pulse waveforms that respectively correspond/correlate to the identified one or more ECG waveforms/ heart rate signals (which is indicated by the correlation falling outside a predetermined threshold) (see abstract, fig. 8, 835 and 845, para 0005, para 0008, para 0010-0011, para 0036, para 0052-0053, para 0057, para 0062, para 0069), but does not disclose wherein processing the pulse wave data includes filtering the pulse wave data based on ECG signal data.
However, Derkx teaches a method for generating filtered EMG signal (see abstract, line 1). The system (fig. 1) teaches wherein the processing unit is further configured to filter the EMG data based on the ECG signal data (see figs. 1-2, para [0026], and para [0127]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Woodward with the system of Derkx to arrive at the claimed invention. Such modification would improve the system and lead to a reasonable expectation for success, since the prior reference of Derkx shows that using ECG data to filter another other physiological data in order to produce a clearer and more precise of the target signal (such as the EMG signal). Furthermore, such combination would improve the system by ensuring a health professional is able to quickly and accurately determine if a patient is or is not in need of additional CPR treatment, ultimately ensuring that the rescuer/medical professional does not inadvertently injure the patient following sufficient CPR treatment.
Regarding claim 19, Woodward as modified teaches:
The method of claim 15, wherein the processing unit/processor is configured to generate the user-perceptible indication (alert) that the patient is exhibiting PEA by rendering a visual indication/alert condition that the patient is exhibiting PEA to a display/user interface (see fig. 9, 950, para 0007, para 0062, and para 0069).
Regarding claim 28, Woodward as modified teaches:
The method of claim 15, but does not explicitly disclose wherein filtering the pulse wave data based on the ECG data comprises synchronizing the pulse wave data and the ECG data.
However, Derkx teaches a method for generating filtered EMG signal (see abstract, line 1). The system (fig. 1) teaches wherein the processing unit is further configured to filter the EMG data based on the ECG data, and wherein filtering the EMG data based on the ECG data comprises synchronizing the pulse wave data and the ECG data ( figs. 1-2, abstract – lines 1-3, para [0026], and para [0127]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Woodward with the system of Derkx to arrive at the claimed invention. Such modification would improve the system and lead to a reasonable expectation for success, since the prior reference of Derkx shows that using ECG data to filter another other physiological data in order to produce a clearer and more precise of the target signal (such as the EMG signal).
Regarding claim 29, Woodward as modified teaches:
The method of claim 28, wherein synchronizing the pulse wave data and the ECG data comprises synchronizing the pulse wave data and the ECG data based on time stamps respectively associated with each of the pulse wave data and the ECG data (see para [0005], para [0091], and para [0038] – “ The correlation may include comparing of a timing of the heart rate and a timing of the pulse rate. For example, a measured cycle of electrical activity of a heartbeat may have a corresponding pulse in a subsequent time period…….Determining the correlation may occur over a period of time where multiple periods of the person's heart rate and pulse rate are determined.”).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Woodward in view Derkx, and further in view of Kaufman.
Regarding claim 16, Woodward as modified teaches:
The system of claim 15, wherein the first body location (sensor placement) of the patient is placed directly over the heart of the patient
and the second body location is away from the heart of the patient and proximal to one of a carotid artery of the patient, a radial artery of the patient, or a femoral artery of the patient (See annotated fig. 2 below).
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But does not explicitly disclose wherein the first body location of the patient is proximal to a heart of the patient.
However, Kaufman teaches a system and method for providing chest compressions to a patient during cardiopulmonary resuscitation (see abstract, lines 1-3). The system (fig. 1A) teaches where a first body location/one body location of a patient is proximal to the heart of the patient (see annotated fig. 1A below and para 0085).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Woodward with the teachings of Kaufman to arrive at the claimed invention. Such modification would have led to a reasonable expectation for success, since the prior art utilizes a proximal ECG sensor in order to provide an accurate determination of blood flow from the heart throughout the body, ultimately providing an accurate determination of a patient’s true cardiac function prior to performing cardiopulmonary resuscitation.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Woodward in view of Derkx, and further in view of Raj.
Regarding claim 20, Woodward as modified teaches:
The method of claim 15, further comprising multiple wearable medical devices used for monitoring a patient (para 0026-0027), and generating a user-perceptible indication (alert) that the patient is exhibiting PEA in response to at least determining that the pulse wave data does not include one or more pulse waveforms that respectively correspond/correlate to the identified one or more ECG waveforms/ heart rate signals (which is indicated by the correlation falling outside a predetermined threshold) (see abstract, fig. 8, 835 and 845, para 0005, para 0008, para 0010-0011, para 0036, para 0052-0053, para 0057, para 0062, para 0069),
but does not disclose wherein the method comprises:
receiving additional pulse wave data generated by one or more of an inertial motion sensor or an acoustic sensor of a third patient-wearable device that is attached to a third body location of the patient;
and processing the additional pulse wave data to determine that the additional pulse wave data does not include one or more pulse waveforms that respectively correspond to the identified one or more ECG waveforms;
wherein generating the user-perceptible indication that the patient is exhibiting PEA comprises generating the user-perceptible indication that the patient is exhibiting PEA in response to at least determining that both the pulse wave data and the additional pulse wave data do not include one or more pulse waveforms that respectively correspond to the identified one or more ECG waveforms.
However, Raj teaches a third patient-wearable device/sensor (see fig. 1, 114) that is adapted for attachment to a third body location of the patient (see fig. 1, 114) and configured to utilize one or more of an inertial motion sensor or an acoustic sensor thereof to generate additional pulse wave data (data associated with motion and vibrations transmitted through the skin produced by the organs in the body)(see para 0008-0009, para 0011, para 0014, para 0020, and para 0023-0025);
wherein the processor/processing unit is configured to:
receive the additional pulse wave data from the third patient-wearable device (such as sensor/device 114 or 217) (see para 0024-0025 and para 0031-0032),
and wherein the processing unit/processor is configured to generate the user-perceptible indication that the patient is exhibiting a heart abnormality in response to at least determine that both the pulse wave data and the additional pulse wave data do not include one or more pulse waveforms that respectively correspond to the identified one or more cardiac waveforms (see fig. 5, para 0062, para 0064, and para 0066-0068).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Woodward with the teachings of Raj to arrive at the claimed invention. Such modifications would improve the system by ensuring a health professional is able to quickly and accurately determine if a patient is experiencing PEA, ultimately ensuring that the rescuer/medical professional provides timely and sufficient CPR treatment needed to properly treat the patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 11,363,952 B2 to Venkatraman et al. teaches systems and methods for real-time biological sensor data transmission from one or more biological sensors for clinical monitoring and analysis.
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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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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