DETAILED ACTION
Applicant’s arguments, filed 12/05/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 22-51 are pending and hereby under examination.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 42-51 are rejected under 35 U.S.C. 101 because with respect to claims 42-51, the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because they claim a “computer-readable medium”. Without specifying that the computer-readable medium is non-transitory, the claimed invention could be implemented as data incorporated on a digital signal; however, signals are not patentable subject matter. When a claim covers both statutory and non-statutory embodiments, it is proper to reject as including nonstatutory subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 22, 24-26, 28-32, 34-36, 38-42, 44-46, and 48-51 are rejected under 35 U.S.C. 103 as being unpatentable over Raj (US 20190314192 – previously cited) and Sandler (US 20020099286).
Regarding claim 22, Raj discloses a system, comprising:
a first patient-wearable device that that is attachable to a first body location of a patient (Fig. 1, wearable sensor device 110; Paragraph 0020, “wearable sensor device 110 positioned in close proximity to carotid artery”) and that comprises one or more first sensors that are configured to generate first sensor data indicative of a first pulse strength (Paragraph 0028, “FIG. 2 shows a diagrammatic example of a wearable sensor device 200 such as the sensor device 110 or 112 in FIG. 1”; Paragraph 0043, “Of course other sensors can be included on the wearable device 200 to detect the pulse such as the accelerometer 205, a pressure sensor, a strain gauge sensor or an acoustic sensor to measure the mechano-acoustic signatures of the pulse”);
a second patient-wearable device that is attachable to a second body location of the patient (Fig. 1, wearable sensor device 112 on chest) and that comprises one or more second sensors that are configured to generate second sensor data indicative of a second pulse strength (Paragraph 0019, “wearable sensor device 112 that functions as a heartbeat sensor that can, for example, obtain an electro-cardiogram (ECG) signal, a seismocardiogram (SCG) waveform or a PPG signal indicative of the heartbeat. The wearable ECG sensor device 112 can be located on the chest of the user”; Paragraph 0028, “FIG. 2 shows a diagrammatic example of a wearable sensor device 200 such as the sensor device 110 or 112 in FIG. 1”; Paragraph 0040, wherein the accelerometer captures the SCG); and
a processing unit that is communicatively connected to the first patient-wearable device and the second patient-wearable device (Paragraph 0021, “The wearable sensor device 110 and, optionally, wearable ECG sensor device 112 can be in communication with a smart device or hub such as a user device 130”), wherein the processing unit is configured to:
receive from the first patient-wearable device the first sensor data indicative of the first pulse strength; receive from the second patient-wearable device the second sensor data indicative of the second pulse strength (Paragraph 0023, “The user device 130 can include software that processes the sensed data”);
detect the presence of a vascular occlusion in the body of the patient (Paragraph 0056, “the system can be used to gauge frequency and efficacy of blood flow through the carotid artery. This can be accomplished by using the data from the accelerometer 205 in FIG. 2 to determine if there is pulsatile blood flowing through the carotid artery. Section 314 of graph 300 shows the spikes corresponding to the blood flow through the artery. In the absence of these spikes, a patient or caregiver can infer that there is a change to the blood flow characteristics of through the carotid artery. This metric has implications for determining a patient's risk for stroke”).
While Raj discloses the system 100 (with sensors 110/112) are used to detect a presence of a vascular occlusion, Raj fails to explicitly disclose measuring a difference between the pulse strengths to determine a vascular occlusion.
However, Sandler teaches a system of detecting vascular conditions within a body, wherein multiple acoustic sensors/accelerometers are placed on the body (Figs. 1-2, sensors 31-33; Paragraph 0029) and an occlusion may be indicated by the acoustic spectral changes over the region (Paragraphs 0035 and 0059). One of ordinary skill in the art would have applied this known technique of determining an occlusion based on an acoustic changes of Sandler to the known device of Raj that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Raj to incorporate the teachings of Sandler.
Regarding claim 24, Raj further discloses the one or more first sensors comprise one or more of a first inertial measurement unit (IMU) (Fig. 2 and Paragraph 0049, “the recording and detection of the acceleration waveform and the ECG are performed by the sensors 110 and 112”); and
the one or more second sensors comprise one or more of a second IMU (Fig. 2 and Paragraph 0049, “the recording and detection of the acceleration waveform and the ECG are performed by the sensors 110 and 112”);
Regarding claim 25, Raj further discloses wherein the first body location comprises a location on the chest of the patient (Paragraph 0019, “sensor device 112 can be located on the chest of the user”); and
the second body location comprises one of a location over a carotid artery of the patient (Paragraph 0020, “wearable sensor device 110 positioned in close proximity to carotid artery”);
Regarding claim 26, Raj further discloses wherein the first body location and the second body location are different locations selected from the group consisting of neck and chest (Paragraph 0019, “sensor device 112 can be located on the chest of the user”; Paragraph 0020, “wearable sensor device 110 positioned in close proximity to carotid artery”).
Regarding claim 28, Raj further discloses wherein the first patient-wearable device is communicatively connected to the second patient-wearable device and wherein the processing unit is communicatively connected to the second patient-wearable device via the first patient-wearable device (Fig. 2 and Paragraph 0030, “The wearable device 200 can optionally include one or more wireless transceivers, such as transceiver 207, connected to processor 201 for communicating with other sensor devices such as the sensor devices 110 and 112 or other computing devices such as the user device 130”).
Regarding claim 29, Raj further discloses wherein the processing unit comprises part of a computing device that is separate from and communicatively connected to the first patient-wearable device and the second patient-wearable device (Paragraph 0021, wherein the sensor devices 110 and 112 are in communication with a smart device/user device 130).
Regarding claim 30, Raj further discloses wherein the processing unit comprises part of the first patient-wearable device (Fig. 2, processor 201).
Regarding claim 31, Raj further discloses wherein:
the first sensor data received from the first patient-wearable device includes an identifier of the first patient-wearable device; and the second sensor data received from the second patient-wearable device includes an identifier of the second patient-wearable device (Paragraph 0051, “The handshaking involves sending identification information for the sensor devices 110 and 112 and respective MAC addresses to the user device 130. The user device 130 sets initial configuration data such as the location of the sensor devices 110 and 112 on the body, the sampling rate and applicable storage parameters (402)”).
Regarding claim 32, Raj discloses a method performed by a processing unit, comprising:
establishing communication (Fig. 1 and Paragraphs 0021 and 0023, wherein the user device and cloud servers 140/142 are in communication with sensors 110/112) with a first patient-wearable device that that is attached to a first body location of a patient (Fig. 1, wearable sensor device 110; Paragraph 0020, “wearable sensor device 110 positioned in close proximity to carotid artery”) and that comprises one or more first sensors that are configured to generate first sensor data indicative of a first pulse strength (Paragraph 0028, “FIG. 2 shows a diagrammatic example of a wearable sensor device 200 such as the sensor device 110 or 112 in FIG. 1”; Paragraph 0043, “Of course other sensors can be included on the wearable device 200 to detect the pulse such as the accelerometer 205, a pressure sensor, a strain gauge sensor or an acoustic sensor to measure the mechano-acoustic signatures of the pulse”);
establishing communication with a second patient-wearable device that is attachable to a second body location of the patient (Fig. 1, wearable sensor device 112 on chest) and that comprises one or more second sensors that are configured to generate second sensor data indicative of a second pulse strength (Paragraph 0019, “wearable sensor device 112 that functions as a heartbeat sensor that can, for example, obtain an electro-cardiogram (ECG) signal, a seismocardiogram (SCG) waveform or a PPG signal indicative of the heartbeat. The wearable ECG sensor device 112 can be located on the chest of the user”; Paragraph 0028, “FIG. 2 shows a diagrammatic example of a wearable sensor device 200 such as the sensor device 110 or 112 in FIG. 1”; Paragraph 0040, wherein the accelerometer captures the SCG);
receiving from the first patient-wearable device the first sensor data indicative of the first pulse strength; receiving from the second patient-wearable device the second sensor data indicative of the second pulse strength (Paragraph 0023, “The user device 130 can include software that processes the sensed data”); and
detecting the presence of a vascular occlusion in the body of the patient (Paragraph 0056, “the system can be used to gauge frequency and efficacy of blood flow through the carotid artery. This can be accomplished by using the data from the accelerometer 205 in FIG. 2 to determine if there is pulsatile blood flowing through the carotid artery. Section 314 of graph 300 shows the spikes corresponding to the blood flow through the artery. In the absence of these spikes, a patient or caregiver can infer that there is a change to the blood flow characteristics of through the carotid artery. This metric has implications for determining a patient's risk for stroke”).
While Raj discloses the system 100 (with sensors 110/112) are used to detect a presence of a vascular occlusion, Raj fails to explicitly disclose measuring a difference between the pulse strengths to determine a vascular occlusion.
However, Sandler teaches a system of detecting vascular conditions within a body, wherein multiple acoustic sensors/accelerometers are placed on the body (Figs. 1-2, sensors 31-33; Paragraph 0029) and an occlusion may be indicated by the acoustic spectral changes over the region (Paragraphs 0035 and 0059). One of ordinary skill in the art would have applied this known technique of determining an occlusion based on an acoustic changes of Sandler to the known device of Raj that was ready for improvement and the results would have been predictable to one of ordinary skill in the art.
Regarding claim 34, Raj further discloses the one or more first sensors comprise one or more of a first inertial measurement unit (IMU) (Fig. 2 and Paragraph 0049, “the recording and detection of the acceleration waveform and the ECG are performed by the sensors 110 and 112”); and
the one or more second sensors comprise one or more of a second IMU (Fig. 2 and Paragraph 0049, “the recording and detection of the acceleration waveform and the ECG are performed by the sensors 110 and 112”);
Regarding claim 35, Raj further discloses wherein the first body location comprises a location on the chest of the patient (Paragraph 0019, “sensor device 112 can be located on the chest of the user”); and
the second body location comprises one of a location over a carotid artery of the patient (Paragraph 0020, “wearable sensor device 110 positioned in close proximity to carotid artery”);
Regarding claim 36, Raj further discloses wherein the first body location and the second body location are different locations selected from a group consisting of neck and chest (Paragraph 0019, “sensor device 112 can be located on the chest of the user”; Paragraph 0020, “wearable sensor device 110 positioned in close proximity to carotid artery”).
Regarding claim 38, Raj further discloses wherein the first patient-wearable device is communicatively connected to the second patient-wearable device and wherein establishing communication with the second patient-wearable device comprises:
Establishing communication with the second patient-wearable device via the first patient-wearable device (Fig. 2 and Paragraph 0030, “The wearable device 200 can optionally include one or more wireless transceivers, such as transceiver 207, connected to processor 201 for communicating with other sensor devices such as the sensor devices 110 and 112 or other computing devices such as the user device 130”).
Regarding claim 39, Raj further discloses wherein the processing unit comprises part of a computing device that is separate from the first patient-wearable device and the second patient-wearable device (Paragraph 0021, wherein the sensor devices 110 and 112 are in communication with a smart device/user device 130).
Regarding claim 40, Raj further discloses wherein the processing unit comprises part of the first patient-wearable device (Fig. 2, processor 201).
Regarding claim 41, Raj further discloses wherein:
the first sensor data received from the first patient-wearable device includes an identifier of the first patient-wearable device; and the second sensor data received from the second patient-wearable device includes an identifier of the second patient-wearable device (Paragraph 0051, “The handshaking involves sending identification information for the sensor devices 110 and 112 and respective MAC addresses to the user device 130. The user device 130 sets initial configuration data such as the location of the sensor devices 110 and 112 on the body, the sampling rate and applicable storage parameters (402)”).
Regarding claim 42, Raj discloses a computer readable medium having instructions stored thereon that, when executed by a processing unit, cause the processing unit to perform operations comprising:
establishing communication (Fig. 1 and Paragraphs 0021 and 0023, wherein the user device and cloud servers 140/142 are in communication with sensors 110/112) with a first patient-wearable device that that is attached to a first body location of a patient (Fig. 1, wearable sensor device 110; Paragraph 0020, “wearable sensor device 110 positioned in close proximity to carotid artery”) and that comprises one or more first sensors that are configured to generate first sensor data indicative of a first pulse strength (Paragraph 0028, “FIG. 2 shows a diagrammatic example of a wearable sensor device 200 such as the sensor device 110 or 112 in FIG. 1”; Paragraph 0043, “Of course other sensors can be included on the wearable device 200 to detect the pulse such as the accelerometer 205, a pressure sensor, a strain gauge sensor or an acoustic sensor to measure the mechano-acoustic signatures of the pulse”);
establishing communication with a second patient-wearable device that is attachable to a second body location of the patient (Fig. 1, wearable sensor device 112 on chest) and that comprises one or more second sensors that are configured to generate second sensor data indicative of a second pulse strength (Paragraph 0019, “wearable sensor device 112 that functions as a heartbeat sensor that can, for example, obtain an electro-cardiogram (ECG) signal, a seismocardiogram (SCG) waveform or a PPG signal indicative of the heartbeat. The wearable ECG sensor device 112 can be located on the chest of the user”; Paragraph 0028, “FIG. 2 shows a diagrammatic example of a wearable sensor device 200 such as the sensor device 110 or 112 in FIG. 1”; Paragraph 0040, wherein the accelerometer captures the SCG);
receiving from the first patient-wearable device the first sensor data indicative of the first pulse strength; receiving from the second patient-wearable device the second sensor data indicative of the second pulse strength (Paragraph 0023, “The user device 130 can include software that processes the sensed data”); and
detecting the presence of a vascular occlusion in the body of the patient (Paragraph 0056, “the system can be used to gauge frequency and efficacy of blood flow through the carotid artery. This can be accomplished by using the data from the accelerometer 205 in FIG. 2 to determine if there is pulsatile blood flowing through the carotid artery. Section 314 of graph 300 shows the spikes corresponding to the blood flow through the artery. In the absence of these spikes, a patient or caregiver can infer that there is a change to the blood flow characteristics of through the carotid artery. This metric has implications for determining a patient's risk for stroke”).
While Raj discloses the system 100 (with sensors 110/112) are used to detect a presence of a vascular occlusion, Raj fails to explicitly disclose measuring a difference between the pulse strengths to determine a vascular occlusion.
However, Sandler teaches a system of detecting vascular conditions within a body, wherein multiple acoustic sensors/accelerometers are placed on the body (Figs. 1-2, sensors 31-33; Paragraph 0029) and an occlusion may be indicated by the acoustic spectral changes over the region (Paragraphs 0035 and 0059). One of ordinary skill in the art would have applied this known technique of determining an occlusion based on an acoustic changes of Sandler to the known device of Raj that was ready for improvement and the results would have been predictable to one of ordinary skill in the art.
Regarding claim 44, Raj further discloses the one or more first sensors comprise one or more of a first inertial measurement unit (IMU) (Fig. 2 and Paragraph 0049, “the recording and detection of the acceleration waveform and the ECG are performed by the sensors 110 and 112”); and
the one or more second sensors comprise one or more of a second IMU (Fig. 2 and Paragraph 0049, “the recording and detection of the acceleration waveform and the ECG are performed by the sensors 110 and 112”);
Regarding claim 45, Raj further discloses wherein the first body location comprises a location on the chest of the patient (Paragraph 0019, “sensor device 112 can be located on the chest of the user”); and
the second body location comprises one of a location over a carotid artery of the patient (Paragraph 0020, “wearable sensor device 110 positioned in close proximity to carotid artery”);
Regarding claim 46, Raj further discloses wherein the first body location and the second body location are different locations selected from a group consisting of neck and chest (Paragraph 0019, “sensor device 112 can be located on the chest of the user”; Paragraph 0020, “wearable sensor device 110 positioned in close proximity to carotid artery”).
Regarding claim 48, Raj further discloses wherein the first patient-wearable device is communicatively connected to the second patient-wearable device and wherein establishing communication with the second patient-wearable device comprises:
Establishing communication with the second patient-wearable device via the first patient-wearable device (Fig. 2 and Paragraph 0030, “The wearable device 200 can optionally include one or more wireless transceivers, such as transceiver 207, connected to processor 201 for communicating with other sensor devices such as the sensor devices 110 and 112 or other computing devices such as the user device 130”).
Regarding claim 49, Raj further discloses wherein the processing unit comprises part of a computing device that is separate from the first patient-wearable device and the second patient-wearable device (Paragraph 0021, wherein the sensor devices 110 and 112 are in communication with a smart device/user device 130).
Regarding claim 50, Raj further discloses wherein the processing unit comprises part of the first patient-wearable device (Fig. 2, processor 201).
Regarding claim 51, Raj further discloses wherein:
the first sensor data received from the first patient-wearable device includes an identifier of the first patient-wearable device; and the second sensor data received from the second patient-wearable device includes an identifier of the second patient-wearable device (Paragraph 0051, “The handshaking involves sending identification information for the sensor devices 110 and 112 and respective MAC addresses to the user device 130. The user device 130 sets initial configuration data such as the location of the sensor devices 110 and 112 on the body, the sampling rate and applicable storage parameters (402)”).
Claims 23, 33, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Raj and Sandler as applied to claims 22, 32, and 42 above, and further in view of Andre (US 20120245439 – cited by Applicant).
Regarding claims 23, 33, and 43, Raj discloses the system of claims 22, 32, and 42 above, wherein the sensing devices comprise various sensors, such as an accelerometer or acoustic sensor to measure the pulse (Paragraph 0043). Raj fails to explicitly disclose measuring a subpulse.
However, Andre discloses a physiological measuring system wherein the device measures a subpulse (Paragraph 0085, “the device and method of the present invention utilizes development of mathematic formulas and/or algorithms to determine the presence of a critical care parameter. As used herein, a critical care parameter is one that indicates the existence of a critical illness or injury. Such illnesses or injury can include, but are not limited to, the following: 1) non-traumatic hemorrhage 2) traumatic hemorrhage”, wherein hemorrhage results in substantial drops of blood pressure, which relates to the definition of “subpulse” described in Paragraph 0003 of the instant application) by the use of acoustic sensors (Paragraph 0177). It would have been obvious to one of ordinary skill in the art to have modified the system of Raj to detect a subpulse as taught by Andre to detect critical care parameters indicating the existence of a critical illness or injury.
Raj, Sandler, and Andre are considered analogous to the claimed invention because they are in the same field of wearable sensors. It would have been obvious to one of ordinary skill in the art to have modified the system of Raj to detect a subpulse as taught by Andre to detect critical care parameters indicating the existence of a critical illness or injury. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Raj and Sandler to incorporate the teachings of Andre.
Claims 27, 37, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Raj and Sandler as applied to claims 22, 32, and 42 above, and further in view of Telfort (US 10441181 – previously cited)
Regarding claims 27, 37, and 47, while Raj discloses processing the data and determining a pulse rate (Paragraph 0024) from accelerometer or acoustic sensor data (Paragraph 0040). Raj fails to disclose filtering the data.
However, Telfort discloses an acoustic sensor attached to a patient (Fig. 2A), wherein the acoustic signals are filtered in the time or frequency domain (Col 11, lines 37-49) to determine a pulse rate (Col 12, lines 40-53). One of ordinary skill in the art would have been capable of filtering data by Telfort to the device of Raj and the results would have been predictable to one of ordinary skill in the art.
Raj, Sandler, and Telfort are considered analogous to the claimed invention because they are in the same field of wearable sensors. One of ordinary skill in the art would have been capable of filtering data by Telfort to the device of Raj and the results would have been predictable to one of ordinary skill in the art. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Raj and Sandler to incorporate the teachings of Andre.
Response to Arguments
Applicant’s arguments, see page 9, filed 12/05/2025, with respect to the claim objections have been fully considered and are persuasive. The objection of the claims has been withdrawn.
Applicant’s arguments, see page 9, filed 12/05/2025, with respect to the 35 U.S.C. §112(b) rejections have been fully considered and are persuasive. Applicant has amended the Markush groups of claims 26, 36, and 46. Additionally, Applicant has amended the “pulse rate” to “pulse strength” for proper antecedent basis of claims 27, 37, and 47. The rejections of the claims has been withdrawn.
Applicant's arguments filed 12/05/2025, with respect to the 35 U.S.C. §101 rejections have been fully considered but they are not persuasive. In response to applicant's argument that the specification expressly defines “computer-readable medium” as excluding transitory signals, this feature is not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Thus, claims 42-51 remain rejected under 35 U.S.C. §101.
Applicant’s arguments, see page 10, filed 12/05/2025, with respect to the rejection(s) of claim(s) 22-51 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 Raj and Sandler.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/RENE T TOWA/Primary Examiner, Art Unit 3791