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 March 2, 2026 respect to the rejection(s) of claim(s) 15-19 under 35 U.S.C. 102(a)(1) and claims 1-14, 16, 18, and 20 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 Therefore, the rejection has been withdrawn.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 is made in view of applicant’s amendments as can be further seen below.
Election/Restrictions
Newly submitted claims 21-23 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Invention I is drawn to previously presented claim 1 and Invention II is drawn to newly presented claim 21 are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either:
(1) the process as claimed can be practiced by another and materially different apparatus or by hand, or
(2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)).
Inventions I-II are directed to related distinct products. The related inventions are distinct if:
(1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect;
(2) the inventions do not overlap in scope, i.e., are mutually exclusive; and
(3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j).
In the instant case, the inventions as claimed can have a materially different design, mode of operation, function, or effect, and do not overlap in scope, for the reasons set forth below.
For example, claim 1 of Invention I recites “a first patient-wearable device adapted for attachment to a first body location of the patient and configured to utilize one or more cardiac signal sensors thereof to generate cardiac signal data.” Claim 1 also recites “generate a user-perceptible indication that the patient is not exhibiting PEA in response to at least determining that the pulse wave data includes one or more pulse waveforms that respectively correspond to the identified one or more cardiac waveforms”, and “generate a user-perceptible indication that the patient is exhibiting PEA…….wherein the processing unit is further configured to process the pulse wave data based on the cardiac signal data.” The examiner respectfully submits that although Invention I states this, invention II does not.
Invention II is drawn to newly presented claim 21, Invention III is drawn to previously presented claim 8, and invention IV is drawn to previously presented claim 15 are directed to related distinct products. The related inventions are distinct if:
(1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect;
(2) the inventions do not overlap in scope, i.e., are mutually exclusive; and
(3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j).
In the instant case, the inventions as claimed can have a materially different design, mode of operation, function, or effect, and do not overlap in scope, for the reasons set forth below.
For example, claim 8 of Invention III recites “processing the pulse wave data to determine that the pulse wave data includes one or more pulse waveforms that respectively correspond to the identified one or more cardiac waveforms, wherein processing the pulse wave data includes filtering the pulse wave data based on the cardiac signal data, and recites
“generating a user-perceptible indication that the patient is not exhibiting PEA in response to at least determining that the pulse wave data includes one or more pulse waveforms that respectively correspond to the identified one or more cardiac waveforms.”
The examiner respectfully submits that although Invention III states this, invention II does not.
Furthermore, claim 15 of Invention IV recites “receiving cardiac signal data generated by one or more cardiac signal sensors of a first patient-wearable device that is attached to a first body location of the patient” and recites
“processing the pulse wave data to determine that the pulse wave data does not include one or more pulse waveforms that respectively correspond to the identified one or more cardiac waveforms, wherein processing the pulse wave data includes filtering the pulse wave data based on the cardiac signal data.” The examiner respectfully submits that although Invention IV states this, invention II does not.
Finally, there is nothing in the record to indicate that these inventions are obvious variants of each other.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Searching the different inventions would require, at a minimum, employing different search queries to evaluate the patentability of the unique limitations recited in one inventions and not the other(s). This constitutes a different field of search for the Groups/Inventions, and thus establishes a serious search burden. See MPEP § 808.02. For example, searching for Invention I as described in claim 1 would require one or more queries focused on generating a user-perceptible indication that the patient is not exhibiting PEA in response to at least determining that the pulse wave data includes one or more pulse waveforms that respectively correspond to the identified one or more cardiac waveforms, which would not likely yield art for Invention II. The same logic applies to the queries needed to find particular features unique to Inventions III-IV.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 21-23 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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, 3, and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Woodward in view of US 2021/0275043 A1 to Ahmad et al. (hereinafter “Ahmad”) 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 cardiac signal 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 cardiac signal 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 cardiac signal data/heart rate data to identify one or more cardiac 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 cardiac 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 cardiac 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 process the pulse wave data based on the cardiac signal data.
However, Ahmad teaches an ergonomically designed smart wristband used for multiparameter monitoring of a patient (see abstract, lines 1-7 ). The system (fig. 1) teaches where the wristband contains a processor/processing unit configured to process the pulse wave data (the arterial pulse waveform) includes filtering the pulse wave data based on cardiac signal data (see abstract: “Algorithms running on the computing device or onboard microprocessor analyze the acquired data to report parameters like blood pressure, body temperature, respiration, and blood oxygen. ”, para 0081, and claim 30),
but does not 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 cardiac 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 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 Ahmad 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 3, Woodward as modified teaches:
The system of claim 1, wherein the cardiac signal sensor comprises one or more of an electrocardiogram (ECG) sensor, an acoustic sensor or an inertial motion sensor (see abstract, annotated fig. 2 below, para 0027, and para 0033-0034).
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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 cardiac signal data by synchronizing the pulse wave data and the cardiac signal data/ECG signal data
However, Ahmad teaches where the wristband contains a microprocessor/processing unit configured to filter the pulse wave data (the arterial pulse waveform) based on the cardiac signal data by synchronizing the pulse wave data and the cardiac signal data/ECG signal data (see abstract: “Algorithms running on the computing device or onboard microprocessor analyze the acquired data to report parameters like blood pressure, body temperature, respiration, and blood oxygen. ”, para 0081, and claim 30).
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 Ahmad to arrive at the claimed invention. 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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Woodward in view of Ahmad 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 Ahmad 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 cardiac 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 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;
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 cardiac 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 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 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Woodward in view of Kaufman, and further in view of Ahmad 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 cardiac signal 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 cardiac signal 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 cardiac signal data/heart rate data to identify one or more cardiac 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 cardiac 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 cardiac 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, Ahmad teaches an ergonomically designed smart wristband used for multiparameter monitoring of a patient (see abstract, lines 1-7 ). The system (fig. 1) teaches where the wristband contains a processor/processing unit configured to process the pulse wave data (the arterial pulse waveform) includes filtering the pulse wave data based on cardiac signal data (see abstract: “Algorithms running on the computing device or onboard microprocessor analyze the acquired data to report parameters like blood pressure, body temperature, respiration, and blood oxygen. ”, para 0081, and claim 30). Ahmad does not 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 cardiac 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 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 Kaufman, Ahmad, 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 10, Woodward as modified teaches:
The method of claim 8, wherein the cardiac signal sensor comprises one or more of an electrocardiogram (ECG) sensor, an acoustic sensor or an inertial motion sensor (see abstract, annotated fig. 2 below, para 0027, and para 0033-0034).
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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 cardiac signal data by synchronizing the pulse wave data and the cardiac signal data/ECG signal data
However, Ahmad teaches where the wristband contains a microprocessor/processing unit configured to filter the pulse wave data (the arterial pulse waveform) based on the cardiac signal data by synchronizing the pulse wave data and the cardiac signal data/ECG signal data (see abstract: “Algorithms running on the computing device or onboard microprocessor analyze the acquired data to report parameters like blood pressure, body temperature, respiration, and blood oxygen. ”, para 0081, and claim 30).
Therefore, it would have been obvious to one of 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 Ahmad to arrive at the claimed invention. 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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Woodward in view of Kaufman, Ahmad, 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 cardiac 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 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;
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 cardiac 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, 17, and 19 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 Ahmad.
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 cardiac signal 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 cardiac signal 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 cardiac signal data/heart rate data to identify one or more cardiac 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 cardiac 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 cardiac 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 cardiac signal data.
However, Ahmad teaches an ergonomically designed smart wristband used for multiparameter monitoring of a patient (see abstract, lines 1-7 ). The system (fig. 1) teaches where the wristband is configured to process the pulse wave data (the arterial pulse waveform) includes filtering the pulse wave data based on cardiac signal data (see para 0081 and claim 30).
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 Ahmad 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 17, Woodward as modified teaches:
The system of claim 15, wherein the cardiac signal sensor comprises one or more of an electrocardiogram (ECG) sensor, an acoustic sensor or an inertial motion sensor (see abstract, annotated fig. 2 below, para 0027, and para 0033-0034).
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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).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Woodward in view Ahmad, 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 Ahmad, 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 cardiac 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 cardiac 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 cardiac 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.
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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792