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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 20MAY2026, which incorporates the amendments made in the After Final Response filed 21APR2026, has been entered.
Status of Claims
The amendments and remarks filed on 21APR2026 have been entered and considered.
Claims 1-15 are currently pending.
Claims 1-2 & 12 have been amended.
No claims have been withdrawn, canceled, or added.
Claims 1-15 are under examination.
Response to Arguments
Applicant's arguments filed 21APR2026 regarding the rejections under 35 USC 102(a)(1) have been fully considered and have been found to be not persuasive. Parts deemed not persuasive discussed below:
Applicant states (see Pages 8-9 of the Remarks):
Independent claim 1 requires a sensor "arranged for directly or indirectly measuring the movements of the subject over time and having a measurement axis in a predefined orientation with respect to the ECG electrode arrangement." The sensor recited in the claims is a motion sensor - a sensor that measures directional physical quantities such as acceleration, angular velocity, or air pressure changes over time. Such a sensor inherently has one or more measurement axes - specific physical directions along which measurements are sensitive. The predefined orientation of those axes with respect to the ECG electrode arrangement is what makes sensor calibration both necessary and achievable: the ECG electrodes serve as the internal orientation reference that allows the processor to determine how the sensor's measurement axes relate to the subject's anatomical reference frame. The Examiner contends that Meftah's motion sensor satisfies this limitation because "the motion sensor has a fixed orientation due to being in the wearable device." This reasoning is in error for two independent reasons.First, a fixed physical position within a wearable device is not the same as a measurement axis. Many sensors - including SpO2 sensors and temperature sensors - are fixed within a wearable and have a definite position, but they do not have a measurement axis in any meaningful technical sense. The term "measurement axis" refers to the directional sensitivity of a sensor, not merely its physical location. An accelerometer measures acceleration along specific axes (e.g., X, y, z) that are defined relative to its internal structure. A SpO2 sensor or a temperature sensor has no such directional sensitivity - it produces a scalar measurement irrespective of the orientation of the device.
However, the applicant’s arguments are unpersuasive. Regarding the argument that affixed device position does not define a measurement axis, claim 1 requires a sensor for measuring movements. Meftah explicitly discloses a motion sensor utilized as a parameter for detecting position and orientation which inherently operates with directional sensitivity and a baseline operational measurement axis to work as a motion sensor. Because the motion sensor is integrated into a fixed housing of the wearable device with the ECG array, its measurement axis is in a constant defined orientation relative to the ECG electrodes.
Second, and more fundamentally, Meftah et al. does not calibrate the motion sensor based on the ECG-derived orientation. As explicitly stated in Meftah et al. (page 17, lines 22-34 and page 18, lines 3-9, as discussed in the third-round response), the sensors that are calibrated in Meftah et al. are the SpO2 sensor and the temperature sensor - not the motion sensor. The motion sensor in Meftah et al. provides complementary information as an input to the position/orientation determination process; it is not the sensor that is calibrated based on the ECG-derived orientation. The Examiner's reading merges two distinct sensors into one, which is an error under the plain language of the claims.
However, the applicant’s arguments are unpersuasive. Under the broadest reasonable interpretation calibration can simply mean aligning two sensors to the same coordinate system. While Meftah explicitly mentions the calibration of the temperature or SPO2 sensors, the disclosure further teaches a combined sensor system. The motion sensor and ECG sensor work together to determine orientation. The system has to align the motion sensor’s data with a baseline orientation provided by the Ecg sensors. Aligning the frames of references is a form of calibrations and therefore, Meftah teaches the claim limitations.-
Applicant states (see Pages 9-10 of the Remarks):
Independent claim 1 further requires that the processor be programmed to "process the determined orientation of the ECG electrode arrangement in the reference frame of the subject and the predefined orientation of the measurement axis with respect to the ECG electrode arrangement to determine a relationship between the measurement axis of the sensor and the reference frame of the subject."
These limitations require a specific two-step geometric computation: (1) determine the orientation of the ECG electrode arrangement in the subject's reference frame (using ECG signals as described in claim 1), and then (2) use the known fixed geometric relationship between the electrode arrangement and the sensor's measurement axis to derive the orientation of that axis in the subject's reference frame. The result is a geometric transformation - a rotation - that links the sensor's measurement coordinate system to the subject's anatomical coordinate system. The Examiner cites Meftah et al. page 2, lines 39-44 for this limitation, a passage describing the comparison of acquired physiological signal characteristics to a database of predefined characteristics to determine device position and orientation. But this passage describes how the device orientation is determined - it says nothing about determining a relationship between a measurement axis of any sensor and the reference frame of the subject. There is no ECG electrode arrangement whose orientation is first determined, and no subsequent computation of how that orientation maps onto a sensor measurement axis. Meftah et al. simply compares signal patterns to a lookup table; it does not perform the geometric axis-to-reference- frame computation recited in the claims. This distinction is not a matter of claim interpretation. The specification and Figures 4 and 5 of the present application make clear what the claimed computation involves: the processor identifies which electrode pair's lead axis is perpendicular (or parallel) to the cardiac QRS axis, uses that determination to establish the orientation of the electrode array in the body frame, and then - knowing the fixed angle between the electrode array and the accelerometer's measurement axis - derives how the accelerometer's x/y/z axes relate to the subject's anatomical up-down, left-right, and fore-aft directions. Meftah et al. discloses no equivalent process.
However, the applicant’s arguments are unpersuasive because Meftah inherently performs the claimed steps to make the device work. Under the broadest reasonable interpretation, the two step geometric calculation is relating the sensor’s coordinates and the body’s reference frame (ecg/heart orientations). While Meftah uses a lookup table to match physiological signals to orientations, tyhis cannot be done without already knowing the baseline orientations of the sensors as compared to the body. Because Meftah relies on the general relationship between he sensors and the body’s axis, it is maintained that Meftah teaches the claim limitation.
Applicant states (see Page 10 of the Remarks):
The Calibration in the Claims Is Fundamentally Different from the Calibration in Meftah et al. As amended, claim 1 further specifies that the calibration "adjusts how measurements made along the measurement axis of the sensor are interpreted with respect to the reference frame of the subject." This is a calibration of a directional sensor - one whose measurements are axis-specific - based on a computed geometric rotation. The output of the calibration is a coordinate transformation that allows raw sensor measurements (in the sensor's own frame) to be re-expressed in the subject's anatomical frame, or equivalently, allows posture-detection thresholds defined in the anatomical frame to be projected into the sensor's frame. In contrast, the calibration performed in Meftah et al. adjusts a scalar measurement (e.g., a SpO2 percentage or a temperature value) based on the device's location on the body, because the physiological quantity being measured varies depending on where the sensor is applied. This is a location-based correction to a non-directional scalar sensor, not a geometric axis-to-frame transformation of a directional motion sensor. These are categorically different operations. The Examiner's citation of Meftah et al. page 10, lines 20-29 - describing uses of device position information including "posture algorithm," "energy expenditure measurement," and "calibration constant for SpO2" - confirms this distinction rather than negating it. The fact that position information can be used in a "posture algorithm" does not mean that Meftah et al. teaches calibrating a motion sensor's measurement axis to the subject's reference frame. Using device position as one input to a posture algorithm is not the same as computing a rotation between a sensor's measurement axes and the patient's anatomical frame and then applying that rotation to calibrate the sensor.
However, the applicant’s arguments are unpersuasive because Meftah must perform geometric alignment to make its posture detection features work. Adjusting sensor measurements based on a geometric rotation under the broadest reasonable interpretation includes mapping a motion sensors axis to a body. For a device to correctly read data relative to a patient’s body the data has to be transformed to align the sensor’s coordinate system with the body. Since this alignment is functionally the same as the claimed geometric calibration, the examiner maintains that Meftah teaches the claim limitations.
Applicant states (see Page 11 of the Remarks):
The Examiner's "Inherency" Theory Is Unsupported. To the extent the Examiner relies on inherency to find the "measurement axis" limitation in Meftah et al. - reasoning that because the motion sensor is fixed in the device it inherently has a predefined measurement axis - this theory fails under established law. Inherency requires that the missing limitation is necessarily present in the prior art and not merely possibly or probably present. In re Oelrich, 666 F.2d 578, 581 (C.C.P.A. 1981). The mere fact that a fixed sensor occupies a defined position does not necessarily mean it has a measurement axis, and - critically - does not necessarily mean the apparatus performs the claimed computation of determining the relationship between such an axis and the ECG electrode arrangement. Meftah et al. is silent on this computation entirely; silence is not inherency.
However, the applicant’s arguments are unpersuasive because Meftah’ s motion sensors functionally requires predefined measurement axis to operate. An axis based sensor like a motion sensor cannot function without a designated coordinate axis to determine directional motion. When Meftah teaches tracking body posture and movement, the device is therefore explicitly processing data recorded in reference to this coordinate system. To be able to track motion data to a body frame or Ecg array the system relies on a known spatial orientation of the sensors relative to the device housing. Since the motion sensors cannot detect orientation without using its own measurement axis, this requirement is found in Meftah rather than only possible or probable. Therefore, the Examiner maintains that the reference teaches the claim limitation.
Applicant's arguments filed 21APR2026 regarding the rejections under 35 USC 103(a) have been fully considered and have been found to be not persuasive. Parts deemed not persuasive discussed below:
Applicant states (see Page 11 of the Remarks):
Claim 7 was rejected under 35 U.S.C. §103 as being unpatentable over Meftah et al. (WO Publication No. 2017191036; Previously Cited) in view of Lu (US 20190150795). Applicant respectfully traverses this rejection. This rejection falls for the same reasons as the § 102 rejection of the independent claims: Meftah et al. does not teach the underlying subject matter of independent claim 1 from which claim 7 depends, and Lu does not cure these deficiencies. Lu discloses that angular displacement due to body shape differences is factored into a baseline reference value during initial calibration. But Lu cannot supply what Meftah et al. fundamentally lacks - a sensor with a measurement axis, a computation of the geometric relationship between that axis and an ECG electrode arrangement, and an axis-based calibration of a directional motion sensor.
However, the applicant’s arguments are unpersuasive as discussed above in regards to Meftah.
Claim 7 was rejected under 35 U.S.C. §103 as being unpatentable over Meftah et al. (WO Publication No. 2017191036; Previously Cited) in view of Lu (US 20190150795).Moreover, the Examiner's stated motivation to combine Meftah et al. and Lu - that it "removes the device from being an invasive implant to just a wearable version" - is the same boilerplate motivation that was applied to the Zhang/Lu combination in the first two Office Actions and was traversed in those earlier responses. Meftah et al. is already a wearable device. The combination adds nothing relevant to the specific deficiencies identified above, and the motivation is thus unsupported by rational underpinning. KSR Int'l Co. V. Teleflex Inc., 550 U.S. 398 (2007).
However, the applicant’s arguments are unpersuasive because Lu is not referenced to make Meftah a wearable device but rather to integrate a limb shape based determinations into Meftah’ s sensing and processing system where integrated device is capable of a range of wearable options since it can account for different limb shapes. Lu is introduced as a reasonable reference for the body shape limitation since Lu also discusses performing sensor calibrations such as with Meftah. Therefore, the examiner maintains that the combination of references teaches the claim limitations.
Claim Objections
Claim1 is objected to because of the following informalities: Line 11 of claim 1 contains a punctuation error “characteristic,,”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6 & 8-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meftah et al. (WO Publication No. 2017191036; Previously Cited).
Regarding claim 1, Meftah discloses an apparatus arranged for calibrating a sensor of a wearable device to a reference frame of a subject on which the wearable device is worn (Meftah Page 10 Lines 17-19 “At block 408, in some embodiments, the wearable device may be calibrated based on the determined at least one of the position and orientation of the wearable device on the subject. In some embodiments, the determined at least one of the position and orientation of the wearable device on the subject can be used to determine other parameters or information.”), the wearable device comprising an ECG electrode arrangement comprising three or more ECG electrodes that are in a predefined arrangement with respect to each other (Meftah Page 10 Lines 40-42 “The ECG sensor in this exemplary embodiment is in the form of two electrodes. However, it will be understood that any other number of electrodes can also be used. The more electrodes that are used, the more easily and accurately the at least one of the position and orientation of the wearable device on the subject can be determined.”; Page 4 Lines 30-32 “The wearable device can comprise at least one (and any number of) physiological characteristic sensor. The physiological characteristic sensors can be integrated in the wearable device or can be attached to the wearable device. In this exemplary embodiment, the wearable device 100 comprises two physiological characteristic sensors 102, 104 that are integrated into the wearable device 100. The wearable device 100 also comprises a marker 106 that can be used to distinguish between different orientations of the wearable device 100 when applied to a subject.”), and the sensor being arranged for directly or indirectly measuring the movements of the subject over time (Meftah Page 5 Lines 7-9 “A wearable device is positioned to make contact with the skin of the subject. In this way, any physiological characteristic sensors of the wearable device can acquire one or more physiological characteristic signals from the subject. A wearable device may comprise one or a plurality of physiological characteristic sensors.”) and having a measurement axis in a predefined orientation with respect to the ECG electrode arrangement (Meftah Page 8 Lines 56-69 through Page 9 Lines 1-2 “ In some embodiments, the at least one of the position and orientation of the wearable device on the subject is determined by comparing the one or more characteristics of the at least one physiological characteristic signal acquired from the subject to a plurality of predefined (or pre-programmed) characteristics. The plurality of predefined characteristics are each associated with at least one of a predefined position and orientation of the wearable device. In other words, the plurality of predefined characteristics are specific to a particular at least one of a predefined position and orientation of the wearable device.”), the apparatus comprising a processor (Meftah Page 3 Lines 20-23; Page 5 Lines 16-21)wherein the processor is configured to: process ECG signals obtained by respective pairs of the ECG electrodes to determine an orientation of the ECG electrode arrangement in the reference frame of the subject (Meftah Page 10 Lines 33-38 “FIG. 5 is an illustration of exemplary embodiment in which a wearable device is placed at different positions and orientations on a subject and an associated electrocardiogram (ECG) signal is acquired from an ECG sensor integrated in the wearable device. In this exemplary embodiment, the at least one of the position and orientation of the wearable device on the subject is determined based on the acquired ECG signal from a subject. In other words, the at least one of the position and orientation of the wearable device on the subject is extracted from an ECG signal acquired from a subject.”), wherein the reference frame of the subject includes a reference axis relating to the heart of the subject, wherein the reference axis is related to a predefined ECG signal characteristic (Meftah Page 12 Lines 50-52 “In one example, a near-field source localization technique may be used to determine a distance and an angle between the wearable device and parts of the heart in order to determine the position and orientation of the wearable device on the subject.” Showing that the positioning of the heart is the reference axis to base changes in orientation off of; Page 12 Lines 56-59 “In some embodiments, an electrocardiogram (ECG) signal may be used to identify the components of the heart sounds of a phonocardiography (PCG) signal. For example, an R peak of an ECG signal can be identified and used to identify the components of the heart sounds of a PCG signal since the R peak of an ECG signal corresponds to the first sound 802 at the beginning of the systole period of a PCG signal.” Showing the relationship of the sensor data to the ECG signals), and wherein determining the orientation of the ECG electrode arrangement comprises identifying, based on the predefined ECG signal characteristic, which pair of ECG electrodes among the respective pairs yields an ECG signal that best meets a criterion related to the predefined ECG signal characteristic, and using the identified pair to determine the orientation; (Meftah Page 9 Lines 23-25 “In some embodiments, it may be determined which of the plurality of predefined characteristics match or most closely match the one or more characteristics of the acquired at least one physiological characteristic signal. In this example, the at least one of the position and orientation of the wearable device on the subject is determined as the at least one of the predefined position and orientation associated with the predefined characteristics determined to match or most closely match the one or more characteristics of the acquired at least one physiological characteristic signal.”) programmed to process the determined orientation of the sensor arrangement in the reference frame of the subject and the predefined orientation of the measurement axis with respect to the sensor arrangement to determine a relationship between the measurement axis of the sensor and the reference frame of the subject (Meftah Page 2 Lines 39-44 “In some embodiments, determining the at least one of the position and orientation of the wearable device on the subject may comprise: comparing the one or more characteristics of the acquired at least one physiological characteristic signal from the subject to a plurality of predefined characteristics, each of the plurality of predefined characteristics associated with at least one of a predefined position and orientation of the wearable device; and determining the at least one of the position and orientation of the wearable device on the subject based on the comparison.”); programmed to calibrate the sensor to the reference frame of the subject, based on the determined relationship between the measurement axis of the sensor and the reference frame of the subject; wherein the calibration adjusts how measurements made along the measurement axis of the sensor are interpreted with respect to the reference frame of the subject. (Meftah Page 3 Lines 15-18 “In some embodiments, the method may further comprise calibrating the wearable device based on the determined at least one of the position and orientation of the wearable device on the subject.”; Page 10 Lines 17-20 “At block 408, in some embodiments, the wearable device may be calibrated based on the determined at least one of the position and orientation of the wearable device on the subject. In some embodiments, the determined at least one of the position and orientation of the wearable device on the subject can be used to determine other parameters or information.”).
Regarding claim 2, Meftah further discloses wherein the processor is configured to determine the orientation of the ECG electrode arrangement by: determining the orientation of the ECG electrode arrangement with respect to the reference frame of the subject based on a first virtual axis defined by the ECG electrodes in the identified ECG electrode pair and the relation between the reference axis and the predefined ECG signal characteristic. (Meftah Page 11 Lines 3-6 through Page 11 Lines 21-25).
Regarding claim 3, Meftah further discloses wherein the processor is configured to determine the orientation of the ECG electrode arrangement by: identifying two adjacent ECG electrode pairs in the ECG electrode arrangement for which the ECG signals obtained by the two adjacent ECG electrode pairs best meet a criterion relating to the predefined ECG signal characteristic (Meftah Page 10 Lines 52-59 “In order to determine at least one of the position and orientation of a wearable device on a subject, one or more characteristics of at least one ECG signal acquired from the wearable device on the subject are compared to predefined characteristics of an ECG signal. The predefined characteristics of the ECG signal may be stored in a database (such as in the memory unit 304 of the apparatus 300). In some embodiments, the predefined characteristics may be stored in a database following an initial calibration procedure in which an ECG signal is acquired with the wearable device at each position and orientation on the body of a subject for subsequent comparison with acquired ECG signals.”; Page 4 Lines 39-41“Also, although an example number and arrangement of physiological characteristic sensors have been provided, it will be understood that other numbers and arrangements of physiological characteristic sensors are possible.”); determining a first virtual axis as a virtual axis between a virtual axis defined by the ECG electrodes in a first one of the identified ECG electrode pairs and a virtual axis defined by the ECG electrodes in the other one of the identified ECG electrode pairs (Meftah Page 10 Lines 42-44 “As illustrated in FIGS. 5A-5F, the ECG signals acquired for each of the six different ways in which the wearable device is applied to the subject are specific to the position and orientation of the wearable device on the subject for that ECG signal.”); and determining the orientation of the ECG electrode arrangement with respect to the reference frame of the subject based on the first virtual axis and the relation between the reference axis and the predefined ECG signal characteristic. (Meftah Page 11 Lines 3-6 through Page 11 Lines 21-25).
Regarding claim 4, Meftah further discloses wherein the predefined ECG signal characteristic is the QRS complex (Meftah Page 11 Lines 9-11 “In this embodiment, the locations of at least some of the ECG peaks shown in FIG. 6 (such as at least part of the PQRST pattern of the ECG signal) are detected in the acquired ECG signal. For example, the location of the Q, R and S peaks of FIG. 6 may be detected in the acquired ECG signal.”) and the criterion is met by the ECG signal that has the smallest QRS complex; or the smallest difference in maximum voltage amplitude and minimum voltage amplitude. (Meftah Page 11 Lines 16-18 “Then, the amplitudes of the detected ECG peaks are determined relative to a baseline value 600. The baseline value 600 may, for example, be determined using median filtering or any other technique suitable for determining an ECG baseline. A peak amplitude ratio of the acquired ECG signal may then be determined. For example, where the location of the Q, R and S peaks of FIG. 6 are detected in the acquired ECG signal and the amplitude of those peaks are determined, the peak amplitude ratio may be determined as follows:”).
Regarding claim 5, Meftah further discloses wherein the predefined ECG signal characteristic is the R-peak and the criterion is met by the ECG signal that has the largest R-peak; or the largest difference in maximum voltage amplitude and minimum voltage amplitude. (Meftah Page 11 Lines 16-18 “Then, the amplitudes of the detected ECG peaks are determined relative to a baseline value 600. The baseline value 600 may, for example, be determined using median filtering or any other technique suitable for determining an ECG baseline. A peak amplitude ratio of the acquired ECG signal may then be determined. For example, where the location of the Q, R and S peaks of FIG. 6 are detected in the acquired ECG signal and the amplitude of those peaks are determined, the peak amplitude ratio may be determined as follows:”).
Regarding claim 6, Meftah further discloses wherein the orientation of the reference axis in the reference frame of the subject is dependent on one or more physiological characteristics of the subject and/or clinical information on the subject. (Meftah Page 12 Lines 50-52 “In one example, a near-field source localization technique may be used to determine a distance and an angle between the wearable device and parts of the heart in order to determine the position and orientation of the wearable device on the subject.” Showing that the positioning of the heart is the reference axis to base changes in orientation off of; Page 12 Lines 56-59 “In some embodiments, an electrocardiogram (ECG) signal may be used to identify the components of the heart sounds of a phonocardiography (PCG) signal. For example, an R peak of an ECG signal can be identified and used to identify the components of the heart sounds of a PCG signal since the R peak of an ECG signal corresponds to the first sound 802 at the beginning of the systole period of a PCG signal.” Showing the relationship of the sensor data to the ECG signals).
Regarding claim 8, Meftah further discloses wherein the determined relationship between the measurement axis of the sensor and the reference frame of the subject is a rotation required to (i) rotate measurements obtained by the sensor in the reference frame of the sensor into the reference frame of the subject and/or (ii) rotate one or more parameters or rules defined in the reference frame of the subject into the reference frame of the sensor. (Meftah Page 10 Lines 20-29 “For example, the determined at least one of the position and orientation of the wearable device on the subject can be used in a posture algorithm (for example, to determine lying position such as for the prevention of decubitus), in an energy expenditure measurement, as a calibration constant in the measurement of arterial oxygen saturation (SpO2) adapted automatically to body location, to analyze the gait of the subject from trunk-accelerometry during shuffling or walking in different orthogonal directions (such as mediolateral, anterioposterior, vertical), as a calibration constant for temperature measurements, or in adapting an algorithm for extracting respiration signal”; Page 9 Lines 24-30).
Regarding claim 9, Meftah further discloses wherein the processing unit is configured to: acquire measurements from the sensor (Meftah Abstract); apply the rotation to the acquired measurements to rotate the acquired measurements into the reference frame of the subject and evaluate the rotated measurements to determine the posture of the subject using one or more parameters and/or rules defined with respect to the reference frame of the subject. (Meftah Page 10 Lines 20-29 “For example, the determined at least one of the position and orientation of the wearable device on the subject can be used in a posture algorithm (for example, to determine lying position such as for the prevention of decubitus), in an energy expenditure measurement, as a calibration constant in the measurement of arterial oxygen saturation (SpO2) adapted automatically to body location, to analyse the gait of the subject from trunk-accelerometry during shuffling or walking in different orthogonal directions (such as mediolateral, anterioposterior, vertical), as a calibration constant for temperature measurements, or in adapting an algorithm for extracting respiration signal”; Page 9 Lines 24-30).
Regarding claim 10, Meftah further discloses wherein the processor is configured to: acquire measurements from the sensor (Meftah Abstract); apply the rotation to one or more parameters and/or rules defined with respect to the reference frame of the subject to rotate the one or more parameters and/or rules into the reference frame of the sensor; and evaluate the acquired measurements to determine the posture of the subject using the rotated one or more parameters and/or rules. (Meftah Page 10 Lines 20-29 “For example, the determined at least one of the position and orientation of the wearable device on the subject can be used in a posture algorithm (for example, to determine lying position such as for the prevention of decubitus), in an energy expenditure measurement, as a calibration constant in the measurement of arterial oxygen saturation (SpO2) adapted automatically to body location, to analyse the gait of the subject from trunk-accelerometry during shuffling or walking in different orthogonal directions (such as mediolateral, anterioposterior, vertical), as a calibration constant for temperature measurements, or in adapting an algorithm for extracting respiration signal”; Page 9 Lines 24-30).
Regarding claim 11, Meftah further discloses a system arranged for calibrating a sensor of a wearable device to a reference frame of a subject on which the wearable device is worn (Meftah Page 10 Lines 17-20 “At block 408, in some embodiments, the wearable device may be calibrated based on the determined at least one of the position and orientation of the wearable device on the subject. In some embodiments, the determined at least one of the position and orientation of the wearable device on the subject can be used to determine other parameters or information.”), the system comprising: the wearable device comprising the ECG electrode arrangement, comprising three or more ECG electrodes that are in a predefined arrangement with respect to each other (Meftah Page 10 Lines 40-42 “The ECG sensor in this exemplary embodiment is in the form of two electrodes. However, it will be understood that any other number of electrodes can also be used. The more electrodes that are used, the more easily and accurately the at least one of the position and orientation of the wearable device on the subject can be determined.”; Page 4 Lines 30-32 “The wearable device can comprise at least one (and any number of) physiological characteristic sensor. The physiological characteristic sensors can be integrated in the wearable device or can be attached to the wearable device. In this exemplary embodiment, the wearable device 100 comprises two physiological characteristic sensors 102, 104 that are integrated into the wearable device 100. The wearable device 100 also comprises a marker 106 that can be used to distinguish between different orientations of the wearable device 100 when applied to a subject.”); and the sensor arranged for directly or indirectly measuring the movements of the subject over time (Meftah Page 5 Lines 7-9 “A wearable device is positioned to make contact with the skin of the subject. In this way, any physiological characteristic sensors of the wearable device can acquire one or more physiological characteristic signals from the subject. A wearable device may comprise one or a plurality of physiological characteristic sensors.”) and having the measurement axis in the predefined orientation with respect to the ECG electrode arrangement. (Meftah Page 8 Lines 56-69 through Page 9 Lines 1-2 “ In some embodiments, the at least one of the position and orientation of the wearable device on the subject is determined by comparing the one or more characteristics of the at least one physiological characteristic signal acquired from the subject to a plurality of predefined (or pre-programmed) characteristics. The plurality of predefined characteristics are each associated with at least one of a predefined position and orientation of the wearable device. In other words, the plurality of predefined characteristics are specific to a particular at least one of a predefined position and orientation of the wearable device.”).
Regarding claim 12, Meftah discloses a method of calibrating a sensor of a wearable device to a reference frame of a subject on which the wearable device is worn (Meftah Page 10 Lines 17-20 “At block 408, in some embodiments, the wearable device may be calibrated based on the determined at least one of the position and orientation of the wearable device on the subject. In some embodiments, the determined at least one of the position and orientation of the wearable device on the subject can be used to determine other parameters or information.”), the wearable device comprising an ECG electrode arrangement comprising three or more ECG electrodes that are in a predefined arrangement with respect to each other (Meftah Page 10 Lines 40-42 “The ECG sensor in this exemplary embodiment is in the form of two electrodes. However, it will be understood that any other number of electrodes can also be used. The more electrodes that are used, the more easily and accurately the at least one of the position and orientation of the wearable device on the subject can be determined.”; Page 4 Lines 30-32 “The wearable device can comprise at least one (and any number of) physiological characteristic sensor. The physiological characteristic sensors can be integrated in the wearable device or can be attached to the wearable device. In this exemplary embodiment, the wearable device 100 comprises two physiological characteristic sensors 102, 104 that are integrated into the wearable device 100. The wearable device 100 also comprises a marker 106 that can be used to distinguish between different orientations of the wearable device 100 when applied to a subject.”), and the sensor arranged for directly or indirectly measuring the movements of the subject over time (Meftah Page 5 Lines 7-9 “A wearable device is positioned to make contact with the skin of the subject. In this way, any physiological characteristic sensors of the wearable device can acquire one or more physiological characteristic signals from the subject. A wearable device may comprise one or a plurality of physiological characteristic sensors.”) and having a measurement axis in a predefined orientation with respect to the ECG electrode arrangement (Meftah Page 8 Lines 56-69 through Page 9 Lines 1-2 “ In some embodiments, the at least one of the position and orientation of the wearable device on the subject is determined by comparing the one or more characteristics of the at least one physiological characteristic signal acquired from the subject to a plurality of predefined (or pre-programmed) characteristics. The plurality of predefined characteristics are each associated with at least one of a predefined position and orientation of the wearable device. In other words, the plurality of predefined characteristics are specific to a particular at least one of a predefined position and orientation of the wearable device.”), the method comprising: processing ECG signals obtained by respective pairs of the ECG electrodes to determine an orientation of the ECG electrode arrangement in the reference frame of the subject (Meftah Page 10 Lines 33-38 “FIG. 5 is an illustration of exemplary embodiment in which a wearable device is placed at different positions and orientations on a subject and an associated electrocardiogram (ECG) signal is acquired from an ECG sensor integrated in the wearable device. In this exemplary embodiment, the at least one of the position and orientation of the wearable device on the subject is determined based on the acquired ECG signal from a subject. In other words, the at least one of the position and orientation of the wearable device on the subject is extracted from an ECG signal acquired from a subject.”), wherein the reference frame of the subject includes a reference axis relating to the heart of the subject, wherein the reference axis is related to a predefined ECG signal characteristic (Meftah Page 12 Lines 50-52 “In one example, a near-field source localization technique may be used to determine a distance and an angle between the wearable device and parts of the heart in order to determine the position and orientation of the wearable device on the subject.”; Page 12 Lines 56-59 “In some embodiments, an electrocardiogram (ECG) signal may be used to identify the components of the heart sounds of a phonocardiography (PCG) signal. For example, an R peak of an ECG signal can be identified and used to identify the components of the heart sounds of a PCG signal since the R peak of an ECG signal corresponds to the first sound 802 at the beginning of the systole period of a PCG signal.”); characteristic, and wherein determining the orientation of the ECG electrode arrangement comprises identifying, based on the predefined ECG signal characteristic, which pair of ECG electrodes among the respective pairs yields an ECG signal that best meets a criterion related to the predefined ECG signal characteristic, and using the identified pair to determine the orientation; (Meftah Page 9 Lines 23-25 “In some embodiments, it may be determined which of the plurality of predefined characteristics match or most closely match the one or more characteristics of the acquired at least one physiological characteristic signal. In this example, the at least one of the position and orientation of the wearable device on the subject is determined as the at least one of the predefined position and orientation associated with the predefined characteristics determined to match or most closely match the one or more characteristics of the acquired at least one physiological characteristic signal.”), including processing the determined orientation of the sensor arrangement in the reference frame of the subject and the predefined orientation of the measurement axis with respect to the sensor arrangement to determine a relationship between the measurement axis of the sensor and the reference frame of the subject (Meftah Page 2 Lines 39-44 “In some embodiments, determining the at least one of the position and orientation of the wearable device on the subject may comprise: comparing the one or more characteristics of the acquired at least one physiological characteristic signal from the subject to a plurality of predefined characteristics, each of the plurality of predefined characteristics associated with at least one of a predefined position and orientation of the wearable device; and determining the at least one of the position and orientation of the wearable device on the subject based on the comparison.”); and calibrating the sensor to the reference frame of the subject, based on the determined relationship between the measurement axis of the sensor and the reference frame of the subject wherein the calibrating adjusts how measurements made along the measurement axis of the sensor are interpreted with respect to the reference frame of the subject (Meftah Page 3 Lines 15-18 “In some embodiments, the method may further comprise calibrating the wearable device based on the determined at least one of the position and orientation of the wearable device on the subject.”; Page 10 Lines 17-20 “At block 408, in some embodiments, the wearable device may be calibrated based on the determined at least one of the position and orientation of the wearable device on the subject. In some embodiments, the determined at least one of the position and orientation of the wearable device on the subject can be used to determine other parameters or information.”).
Regarding claim 13, Meftah further discloses wherein the determined relationship between the measurement axis of the sensor and the reference frame of the subject is a rotation required to rotate measurements obtained by the sensor in the reference frame of the sensor into the reference frame of the subject, and the method further comprises: acquiring measurements from the sensor;applying the rotation to the acquired measurements to rotate the acquired measurements into the reference frame of the subject and evaluating the rotated measurements to determine the posture of the subject using one or more parameters and/or rules defined with respect to the reference frame of the subject (Meftah Page 10 Lines 20-29 “For example, the determined at least one of the position and orientation of the wearable device on the subject can be used in a posture algorithm (for example, to determine lying position such as for the prevention of decubitus), in an energy expenditure measurement, as a calibration constant in the measurement of arterial oxygen saturation (SpO2) adapted automatically to body location, to analyse the gait of the subject from trunk-accelerometry during shuffling or walking in different orthogonal directions (such as mediolateral, anterioposterior, vertical), as a calibration constant for temperature measurements, or in adapting an algorithm for extracting respiration signal”; Page 9 Lines 24-30).
Regarding claim 14, Meftah further discloses wherein the determined relationship between the measurement axis of the sensor and the reference frame of the subject is a rotation required to rotate one or more parameters or rules defined in the reference frame of the subject into the reference frame of the sensor, and the method further comprises: acquiring measurements from the sensor; applying the rotation to one or more parameters and/or rules defined with respect to the reference frame of the subject to rotate the one or more parameters and/or rules into the reference frame of the sensor; and evaluating the acquired measurements to determine the posture of the subject using the rotated one or more parameters and/or rules. (Meftah Page 10 Lines 20-29 “For example, the determined at least one of the position and orientation of the wearable device on the subject can be used in a posture algorithm (for example, to determine lying position such as for the prevention of decubitus), in an energy expenditure measurement, as a calibration constant in the measurement of arterial oxygen saturation (SpO2) adapted automatically to body location, to analyse the gait of the subject from trunk-accelerometry during shuffling or walking in different orthogonal directions (such as mediolateral, anterioposterior, vertical), as a calibration constant for temperature measurements, or in adapting an algorithm for extracting respiration signal”; Page 9 Lines 24-30).
Regarding claim 15, Meftah further discloses a non-transitory computer readable medium, the computer readable medium that stores a computer program product, that when executed by a processor causes the method as claimed in claim 12 to be performed. (Meftah Page 3 Lines 20-23).
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 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.
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) (C) for any potential 35 U.S.C. 102(a) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Meftah et al. (WO Publication No. 2017191036; Previously Cited) in view of Lu. (US Publication Number 20190150795; Previously Cited).
Regarding claim 7, Meftah does not disclose wherein the processor is further configured to determine the relationship between the measurement axis of the sensor and the reference frame of the subject based on a shape of the part of the body of the subject on which the wearable device is to be worn. Lu in a similar endeavor of sensor calibration teaches wherein the processor is further configured to determine the relationship between the measurement axis of the sensor and the reference frame of the subject based on a shape of the part of the body of the subject on which the wearable device is to be worn. (Lu ¶0008 “Initial calibration of each user's system is done while standing, erect, and initializing a calibration function. Once calibrated, any angular displacement due to body shape differences are factored into any baseline reference value.”; ¶0019). Before the effective filing date, it would have been obvious to a person of skill in the art to modify Meftah in view of Lu by combining the system of Meftah with Lu’s the processor is further configured to determine the relationship between the measurement axis of the sensor and the reference frame of the subject based on a shape of the part of the body of the subject on which the wearable device is to be worn. The motivation to integrate this device of Lu with Meftah’s sensor device is because it removes the device from being an invasive implant to just a wearable version of said device. Lu shows the concept for the calibration device as a wearable item, and with the combination Meftah can account for the processing steps needed to determine posture changes based on cardiac signals through a wearable device, including the necessary accommodations such as the body part wearing the device. The wearable aspect allows for a better patient experience, lowered cost of the device & maintenance, and broadens the range of patients the device is accessible to.
Conclusion
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/MEGAN T FEDORKY/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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