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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS, see IDS received 7/30/2026, have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this Office Action.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 9-11 recites limitations related to “the measurement period” and “the analysis period”, however it is unclear what further structural limitations of the system applicant is attempting to encompass within claims 9-11 since claims 9-11 do not recite any additional structural features that are required of the system, clarification is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-4, 6-14 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2017/0172519 to Stergiou et al. (herein Stergiou).
In reference to at least claim 1
Stergiou discloses a system, comprising: a wearable device configured to be mounted on a torso of a subject (e.g. “chest strap sensor configured to be worn around the patient's chest”, para. [0042], “For example, one or more accelerometers may be mounted in an eyeglasses-type support, in a bracelet-type support designed to be worn on the patient's ankle, in a bracelet-type support designed to be worn on the patient's wrist, in a garter-type support designed to be worn on the patient's thigh, in a band designed to be worn around the patient's waist or chest,”, para. [0044], “The heart rate sensor 210 may be any commercially available heart rate sensor 210, such as a chest strap sensor and associated processing electronics”, para. [0047], “Although various ones of the I/O devices 202 (and other components described herein) may be referred to in the singular, any number of I/O devices 202 of any type may be included in the I/O devices 202 (and similarly, any component may include multiple such components).”, para. [0041]), the wearable device comprising multiple electrodes and multiple sensor devices, wherein each one of the multiple electrodes is configured to contact a respective skin area at a respective skin location on the torso of the subject (e.g. “chest strap sensor configured to be worn around the patient's chest”, para. [0042], “For example, one or more accelerometers may be mounted in an eyeglasses-type support, in a bracelet-type support designed to be worn on the patient's ankle, in a bracelet-type support designed to be worn on the patient's wrist, in a garter-type support designed to be worn on the patient's thigh, in a band designed to be worn around the patient's waist or chest,”, para. [0044], “The heart rate sensor 210 may be any commercially available heart rate sensor 210, such as a chest strap sensor and associated processing electronics”, para. [0047]) and wherein the multiple sensor devices include: an electric sensor device functionally coupled with the multiple electrodes and configured to generate first measurement signals during a measurement period (e.g. “chest strap sensor configured to be worn around the patient's chest”, para. [0042], “The heart rate sensor 210 may be any commercially available heart rate sensor 210, such as a chest strap sensor and associated processing electronics”, para. [0047]); and a movement sensor device configured to generate second measurement signals during the measurement period (e.g. “For example, one or more accelerometers may be mounted in an eyeglasses-type support, in a bracelet-type support designed to be worn on the patient's ankle, in a bracelet-type support designed to be worn on the patient's wrist, in a garter-type support designed to be worn on the patient's thigh, in a band designed to be worn around the patient's waist or chest,”, para. [0044]); and a computing device configured to communicate with the wearable device and configured to: receive the first measurement signals and the second measurement signal (e.g. control logic 204, para. [0054]) and determine, using a combination of the first measurement signals and the second measurement signals, a value of a metric or respective values in a combination of metrics, wherein each one of the metric and the combination of metrics is indicative of status of a cardiopulmonary condition of the subject (e.g. “estimate generation logic 228, which may be configured to generate an estimate of COPD severity in the patient by comparison of 1) a cRQA parameter comparing the breathing data and the locomotion data and 2) a reference value.”, para. [0070]-[0071], “In some embodiments, the estimate generation logic 228 may generate a recurrence plot of the cross-recurrence data.”, para. [0074]-[0075]).
In reference to at least claim 2
Stergiou discloses wherein the computing device is further configured to identify, based on a change of the value relative to a past value of the metric, a status change of the cardiopulmonary condition (e.g. “estimate generation logic 228, which may be configured to generate an estimate of COPD severity in the patient by comparison of 1) a cRQA parameter comparing the breathing data and the locomotion data and 2) a reference value.”, para. [0070]-[0071], “As noted above, the estimate generation logic 228 may be configured to generate an estimate of COPD severity in the patient by comparison of 1) a cRQA parameter comparing the breathing data to and the locomotion data (e.g., one or more of the cRQA parameters discussed above) and 2) a reference value”, para. [0084]).
In reference to at least claim 3
Stergiou discloses wherein the computing device is further configured to identify, based on individual changes of the respective values relative to respective past values of the metrics in the combination of metrics, a status change of the cardiopulmonary condition.
In reference to at least claim 4
Stergiou discloses wherein the movement sensor device comprises an inertial sensor device (e.g. “In some embodiments, the locomotion sensor 214 may include one or more accelerometers.”, para. [0044]).
In reference to at least claim 6
Stergiou discloses wherein the computing device is further configured to provide an indication of an action to be executed by the subject prior to the measurement period, the action comprising performing one or more movements to stress a cardiopulmonary system of the subject (e.g. “In some embodiments, the locomotion prompt logic 234 may be coupled to clock logic (not shown in FIG. 2) and may be configured to generate a prompt to the patient to begin locomotion at a particular time or times (e.g., at 9:00 AM each day). The prompt may take the form of a visual or audio message provided to the patient personal computing device 104 for display to the patient, or a tactile, visual, or audio message provided to the wearable computing device 102 (e.g., a vibration or a tone).”, para. [0092], “In Experiment 1, twelve young healthy controls were asked to walk at a self-selected speed and breathe either at their normal pace, a faster pace, or a slower pace to investigate the effect of voluntarily altering breathing rhythm on locomotor respiratory coupling. “, para. [0137], [0194], [0202]).
In reference to at least claim 7
Stergiou discloses wherein the computing device is further configured to: obtain multiple second values of the metric for respective second measurement periods within an analysis period; monitor, over the analysis period, using the value and the multiple second values, a time- dependence of the metric; and identify, based on the time-dependence, a status change of the cardiopulmonary condition (e.g. multiple metrics are determined over various measurement periods which are compared over time to aid in identifying COPD severity, Figs. 13-14, para. [0131]-[0135]).
In reference to at least claim 8
Stergiou discloses wherein the computing device is further configured to: obtain multiple second respective values of the combination of metrics for respective second measurement periods within an analysis period; monitor, over the analysis period, using the respective values and the multiple second respective values, respective time-dependences of the metrics in the combination of metrics; and identify, based on the respective time-dependences, a status change of the cardiopulmonary condition (e.g. multiple metrics are determined over various measurement periods which are compared over time to aid in identifying COPD severity, Figs. 13-14, para. [0131]-[0135]).
In reference to at least claim 9
Stergiou discloses wherein the measurement period has a duration within a range from about 25 seconds to about 120 seconds (e.g. “In some embodiments, at least 45 seconds of breathing data may be received by the breathing signal receipt logic 222.”, para. [0059], “ In some embodiments, at least 45 seconds of locomotion data may be received by the locomotion signal receipt logic 224.”, para. [0063]).
In reference to at least claim 10
Stergiou discloses wherein the measurement period has a duration within a range from about 25 seconds to about five days (e.g. “In some embodiments, at least 45 seconds of breathing data may be received by the breathing signal receipt logic 222.”, para. [0059], “ In some embodiments, at least 45 seconds of locomotion data may be received by the locomotion signal receipt logic 224.”, para. [0063]).
In reference to at least claim 11
Stergiou discloses wherein the analysis period has a duration from at least one hour, with the duration being greater than another duration of the measurement period multiple metrics are determined over various periods including an analysis period of at least an hour, date/time, Fig. 13, para. [0131]-[0132]).
In reference to at least claim 12
Stergiou discloses wherein the computing device is further configured to cause, based on the status change, the wearable device to generate additional measurement signals (e.g. “As shown in FIG. 14, the patent information section 1404 may provide one or more indicators of the patient's activity level (e.g., number of steps per day, number of bouts of movement per day, percentage of day active, etc.). This information may be provided (in raw or processed form) by the locomotion signal receipt logic 224 or other sensors.”, therefore additional measurement signals can be generated based on the COPD status, Fig. 14, para. [0135], “The estimate notification logic 236 may notify the patient and/or care provider of the patient's heart rate in accordance with any of the embodiments discussed above with reference to notification of the COPD severity estimate.”, Fig. 14, para. [0091]).
In reference to at least claim 13
Stergiou discloses wherein the computing device is further configured to prompt, based on a first value of a particular metric or respective second values in a particular combination of metrics, one or more of the subject, a clinician, or a caregiver to cause the wearable device to generate additional measurement signals (e.g. “As shown in FIG. 14, the patent information section 1404 may provide one or more indicators of the patient's activity level (e.g., number of steps per day, number of bouts of movement per day, percentage of day active, etc.). This information may be provided (in raw or processed form) by the locomotion signal receipt logic 224 or other sensors.”, Fig. 14, para. [0135], “The estimate notification logic 236 may notify the patient and/or care provider of the patient's heart rate in accordance with any of the embodiments discussed above with reference to notification of the COPD severity estimate.”, therefore a patient and/or caregiver may choose additional measurement signals that are relevant such as heart rate data, number of steps, number of bouts of movement per day, percentage of day active based on other metrics, Fig. 14, para. [0091]).
In reference to at least claim 14
Stergiou discloses wherein the computing device is further configured to provide an indication of an action to be executed by the subject in response to at least one of a first value of a particular metric, a first value of a combination of metrics, or the status change (e.g. “estimation system 200 determines at 1106 that the received breathing and locomotion signals are not adequate for use in generating a COPD severity estimate, the COPD severity estimation system 200 may proceed to 1108 and generate a notification to the patient. This notification may include instructions to the patient (e.g., “Please walk at a normal pace for 45 seconds”), describe the detected error condition, or simply notify the patient that a COPD severity estimate will not be generated.”, para. [0118]).
In reference to at least claim 16
Stergiou discloses wherein to provide the indication of the action to be executed by the subject, the computing device is configured to cause transmission of an electronic communication to a clinician device or a second electronic communication to a caregiver device, with the electronic communication and the second electronic communication including the indication (e.g. “Each of the wearable computing device 102, the patient personal computing device 104, the dock computing device 106, the remote computing device 108, and the care provider computing device 110 may include COPD estimation components (illustrated in FIG. 1 as COPD estimation components 112, 114, 116, 118, and 120, respectively).”, para. [0026], the computing device communicates with a remote computing device and a care provider computing device, Fig. 1., para. [0027] 1130, Fig. 11, “In some embodiments, the estimate notification logic 236 may be configured to provide a notification of the COPD severity estimate by causing a textual and/or graphic message to be sent to the patient personal computing device 104 and/or the care provider computing device 110.”, para. [0089], [0129]).
.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0172519 to Stergiou et al. (Stergiou) in view of US 2010/0069735 to Berkner (herein Berkner) and US 2019/0282324 to Freeman et al. (herein Freeman).
In reference to at least claim 5
Stergiou discloses a system according to claim 1. Stergiou further discloses ensuring a tight fit during data collection (e.g. “The investigator confirmed that the straps and harness would not slip during data collection, ensuring a tight fit.”, para. [0105]).
However, Stergiou does not explicitly disclose the wearable having a haptic device configured to determine that placement of the wearable device on the torso of the subject fails to satisfy a placement rule; direct the haptic device to cause vibration of the wearable device; determine that an updated placement of the wearable device on the torso of the subject satisfies the placement rule; and direct the haptic device to cease vibration of the wearable device.
It was well known in the art before the effective filing date of the claimed invention to provide a haptic device such as a device that vibrates or vibrating component to provide feedback to a user regarding correct placement of electrode devices on the chest as evidence by Berkner (e.g. “Once the appropriate location is reached the system preferably indicates this to the user, for example with a signal such as a light, sound or vibration, or combination thereof, and indicates that a signal is being acquired.”, para. [0060], [0139]-[0140]) and Freeman (e.g. “If the acute care provider places the electrodes 1010, 1012 on the patient's chest in an incorrect position, the augmented reality device can provide negative feedback to inform the acute care provider that the electrodes 1010, 1012 are not positioned correctly. Negative feedback can include text or visual images alerting the acute care provider about the improper placement. Feedback can also include audio or vibration notifications alerting the acute care provider of the problem.”, para. [0308]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Stergiou to include as part of the wearable device a haptic device such as vibrating component providing feedback to the user to aid in determining correct placement of the wearable device on the chest including providing vibration until a desired placement of the wearable device is satisfied as such technique was known in the art and would have yield the predictable result of allowing easy and accurate placement of the wearable device by the user improving the accuracy of the sensed signals (‘735, para. [0010], [0018]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0172519 to Stergiou et al. (Stergiou) in view of US 2010/0275921 to Schindhelm et al. (herein Schindhelm).
In reference to at least claim 15
Stergiou discloses a system according to claim 14 and further discloses providing a notification (e.g. “estimation system 200 determines at 1106 that the received breathing and locomotion signals are not adequate for use in generating a COPD severity estimate, the COPD severity estimation system 200 may proceed to 1108 and generate a notification to the patient. This notification may include instructions to the patient (e.g., “Please walk at a normal pace for 45 seconds”), describe the detected error condition, or simply notify the patient that a COPD severity estimate will not be generated.”, para. [0118]).
However, Stergiou does not explicitly teach the computing device is configured to cause presentation of a message directing the subject to proceed to an emergency room, a second message directing the subject to contact a primary physician, or a third message directing the subject to contact an aid.
Schindhelm, within the same field of detecting and treating cardiopulmonary conditions, discloses a system (e.g. Fig. 1) which can be used to detect a severity change in COPD and provide one or more warnings or messages to notify a patient to immediately seek medical attention (e.g. “Results of the comparisons may trigger one or more warnings or messages to notify a patient or physician of a pending change to the patient's RI or COPD condition so that the patient may more immediately seek medical attention to treat the condition.”, abstract, “The message may even express that the patient should be considered for additional RI or COPD treatment or an evaluation due to the detection of a potential exacerbation of RI or COPD.”, para. [0057], “the device to provide a warning or message in a form suitable for the patient and/or clinicians to be aware of the status of the patient's situation so that the patient may more efficiently receive the care that is necessary.”, para. [0056], “the second message may more urgently warn that the patient should immediately contact a physician for a medical examination.”, para. [0059]), “such as by sending one or more of the described messages, in electronic form for example, back to the patient monitoring device for display on the device to warn the patient.”, para. [0064]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Stergiou to provide as part of the notification a presentation of a message directing the patient to seek immediate medical attention such as by contacting a primary physician or directing the subject to contact an aid, as taught by Schindhelm, to provide an awareness of the status of the patient so that the patient can efficiently receive the necessary care (‘921, para. [0056]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0172519 to Stergiou et al. (herein Stergiou) in view of US 2014/008118 to Reinhold Jr. et al. (herein Reinhold).
In reference to at least claim 17
Stergiou discloses a system according to claim 14 and further discloses providing a notification (e.g. “estimation system 200 determines at 1106 that the received breathing and locomotion signals are not adequate for use in generating a COPD severity estimate, the COPD severity estimation system 200 may proceed to 1108 and generate a notification to the patient. This notification may include instructions to the patient (e.g., “Please walk at a normal pace for 45 seconds”), describe the detected error condition, or simply notify the patient that a COPD severity estimate will not be generated.”, para. [0118]).
However, Stergiou does not explicitly teach the computing device is configured to present a message directing one or more of the subject, a clinician, or a caregiver to adjust placement of the wearable device on the torso.
Reinhold discloses an electrocardiographic monitoring system that includes an electrode belt (e.g. 16) that is placed on the chest (e.g. “the belt is a chest strap electrode belt on which the skin electrodes are anatomically positioned and wherein said belt having a closure containing electrical connections that electrically connects at least some of said skin electrodes to the personal ECG device”, para. [0039], [0081]) which discloses presenting a message directing one or more of the subject, a clinician, or a caregiver to adjust placement of the wearable device on the torso (e.g. “This screen displays the contact status of the electrodes and will guide the user to correctly position the electrodes in order to improve the contact of the electrodes with the user's body, for example, by displaying visual messages on the displayed image of the human chest (when the personal ECG device is not position correctly), such as "position waist electrode tightly against your skin", "attach device to chest", "tighten strap", etc.”, para. [0092], [0030]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Stergiou to provide as part of the notification a message directing one or more of the subject, a clinician, or a caregiver to adjust placement of the wearable device on the torso, as taught by Reinhold, to improve the contact of the conductive elements with the subject’s body improving the quality of the sensed signals (’118, para. [0092]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0172519 to Stergiou et al. (Stergiou).
In reference to at least claim 18
Stergiou discloses a system according to claim 1. Stergiou further discloses that existing known techniques for classifying the severity of COPD include a questionnaire associated with the cardiopulmonary condition (e.g. “Existing techniques for classifying the severity of COPD in a patient involve lung function testing, spirometry, symptom questionnaires, body mass measurements, and exercise capacity measurements, among others.”, para. [0003]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Stergiou to include presenting a patient reported outcome (PRO) questionnaire associated with the cardiopulmonary condition as such technique was known and would have yielded the predictable result of allowing a patient to provide additional information to aid in classifying the severity of COPD.
Conclusion
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/JENNIFER L GHAND/Examiner, Art Unit 3796
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