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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “86”. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “375” and “377”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 4, 5, and 10 are objected to because of the following informalities:
In claim 4, line 1, “the processing circuitry configured to…” should read “the processing circuitry is configured to…”
In claim 5, line 5, “and oxygen saturation signal” should read “an oxygen saturation signal”
In claim 10, line 4, “the sound sensor” should read “a sound sensor”
Appropriate correction 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.
Claims 1, 3-5, 7-8, 13-14, 16-17, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leuthardt et al. (U.S. PGPub No. 2021/0361948).
Regarding claim 1, Leuthardt teaches a system (Fig. 1, Paragraph 0096, line 1, 10) comprising: one or more implantable monitoring devices (Fig. 1, Paragraph 0096, lines 1-2, 20/200) configured to continuously sense a plurality of physiological signals of a subject (Paragraph 0100, lines 1-4) and collect parameter data of the subject based on the sensed physiological signals (Paragraph 0108, lines 9-15), wherein at least one implantable monitoring device of the one or more implantable monitoring devices comprises a housing (Fig. 2, Paragraph 0115, lines 1-2, 202) configured for subcutaneous implantation in the subject (Fig. 5, Paragraph 0117, lines 1-3) and a plurality of electrodes (Fig. 2, Paragraph 0115, lines 7-9, 206/208/210/212) positioned on the housing (Fig. 2), wherein the at least one implantable monitoring device is configured to continuously sense at least one physiological signal of the plurality of physiological signals via the plurality of electrodes (Paragraph 0100, lines 1-4); and processing circuitry (Fig. 1, Paragraph 0096, lines 6-7 and Paragraph 0100, lines 14-26, 14) of one or more of: the at least one implantable monitoring device (Paragraph 0120, lines 1-4); one or more computing devices (Fig. 1, Paragraph 0101, lines 12-15, 70/9/11) configured to wirelessly communicate with the one or more implantable monitoring devices (Paragraph 0101, lines 1-15); or a cloud computing system (Fig. 1, Paragraph 0102, line 3, 31) configured to communicate with at least one of the one or more implantable monitoring devices (Paragraph 0102, lines 9-21) or the one or more computing devices (Paragraph 0102, lines 1-9), the processing circuitry configured to determine a mental state of the subject based on at least one of the sensed physiological signals or the parameter data (Paragraph 0051, lines 1-6, Paragraph 0110, lines 9-12, and Paragraph 0146, lines 1-10).
Regarding claim 3, Leuthardt teaches the system (Fig. 1, Paragraph 0096, line 1, 10) of claim 1, wherein the housing (Fig. 2, Paragraph 0115, lines 1-2, 202) of the at least one implantable monitoring device (Fig. 1, Paragraph 0096, lines 1-2, 20/200) is configured for subcutaneous implantation on a head or neck of the subject (Fig. 5, Paragraph 0117, lines 1-3), and the at least one implantable monitoring device is configured to sense an electroencephalogram (EEG) of the subject via the plurality of electrodes (Paragraph 0100, lines 1-4).
Regarding claim 4, Leuthardt teaches the system (Fig. 1, Paragraph 0096, line 1, 10) of claim 3, wherein the processing circuitry (Fig. 1, Paragraph 0096, lines 6-7 and Paragraph 0100, lines 14-26, 14) configured to determine the mental state of the subject based on a morphology of the EEG (Paragraph 0129, lines 6-11), the morphology of the EEG comprising a respective energy level in one or more frequency bands (Paragraph 0129, lines 8-11) or sensing locations of the EEG.
Regarding claim 5, Leuthardt teaches the system (Fig. 1, Paragraph 0096, line 1, 10) of claim 1, wherein the at least one implantable monitoring device (Fig. 1, Paragraph 0096, lines 1-2, 20/200) comprises an accelerometer (Fig. 1, Paragraph 0105, lines 1-3 and 7-9, 15) and the plurality of physiological signals comprise a signal from the accelerometer indicative of at least one of motion or posture of the subject (Paragraph 0108, lines 9-12), wherein the sensed physiological signals further comprise one or more of a blood pressure signal (Paragraph 0105, lines 6-7), and oxygen saturation signal, a skin conductance signal, a respiration signal, a chemical sensor signal (Paragraph 0105, line 7), or a temperature signal (Paragraph 0105, lines 4-5).
Regarding claim 7, Leuthardt teaches the system (Fig. 1, Paragraph 0096, line 1, 10) of claim 1, wherein the one or more computing devices (Fig. 1, Paragraph 0101, lines 12-15, 70/9/11) comprise a computing device of the subject configured to determine locations of the subject over time (Paragraph 0133, lines 24-26), and the processing circuitry (Fig. 1, Paragraph 0096, lines 6-7 and Paragraph 0100, lines 14-26, 14) is configured to determine the mental state of the subject based on the determined locations over time (Paragraph 0134, lines 1-8).
Regarding claim 8, Leuthardt teaches the system (Fig. 1, Paragraph 0096, line 1, 10) of claim 7, wherein the computing device of the subject (Fig. 1, Paragraph 0101, lines 12-15, 70/9/11) is configured to monitor interactions of the subject with the computing device (Paragraph 0138, lines 1-13 and Paragraph 0139, lines 1-6), and the processing circuitry (Fig. 1, Paragraph 0096, lines 6-7 and Paragraph 0100, lines 14-26, 14) is configured to determine the mental state of the subject based on the interactions (Paragraph 0143, lines 1-4), wherein the interactions comprise interactions with one of more social media accounts of the subject (Paragraph 0141, lines 1-9).
Regarding claim 13, Leuthardt teaches the system (Fig. 1, Paragraph 0096, line 1, 10) of claim 1, wherein the processing circuitry (Fig. 1, Paragraph 0096, lines 6-7 and Paragraph 0100, lines 14-26, 14) is configured to: determine the mental state of the subject based on the at least one of the sensed physiological signals or the parameter data (Paragraph 0051, lines 1-6, Paragraph 0110, lines 9-12, and Paragraph 0146, lines 1-10), the processing circuitry is configured to apply the at least one of the sensed physiological signals or the parameter data to a machine learning model (Paragraph 0129, lines 11-15), the machine learning model trained to generate an output indicating the mental state (Paragraph 0180, lines 1-3) using a training set comprising a plurality of examples of at least one of sensed physiological signals or parameter data labeled with a respective one of a plurality of mental states (Paragraph 0180, lines 8-14).
Regarding claim 14, Leuthardt teaches the system (Fig. 1, Paragraph 0096, line 1, 10) of claim 1, wherein the processing circuitry (Fig. 1, Paragraph 0096, lines 6-7 and Paragraph 0100, lines 14-26, 14) is configured to: determine that the mental state satisfies at least one mental state criterion (Paragraph 0196, lines 1-5); and determine the output based on satisfaction of the at least one mental state criterion (Paragraph 0196, lines 5-18), wherein the output comprises at least one of an alert, a recommendation of an activity or therapy for the subject (Paragraph 0196, lines 5-18), or an instruction for the subject.
Regarding claim 16, Leuthardt teaches a method for operating (Paragraph 0112, line 1) a system (Fig. 1, Paragraph 0096, line 1, 1) comprising one or more implantable monitoring devices (Fig. 1, Paragraph 0096, lines 1-2, 20/200) to determine a mental state of a subject (Paragraph 0064, lines 1-5), wherein at least one implantable monitoring device of the one or more implantable monitoring devices comprises a housing (Fig. 2, Paragraph 0115, lines 1-2, 202) configured for subcutaneous implantation in the subject (Fig. 5, Paragraph 0117, lines 1-3) and a plurality of electrodes (Fig. 2, Paragraph 0115, lines 7-9, 206/208/210/212) positioned on the housing (Fig. 2), wherein the at least one implantable monitoring device is configured to continuously sense at least one physiological signal of the plurality of physiological signals via the plurality of electrodes (Paragraph 0100, lines 1-4), the method comprising: continuously sensing, by the one or more implantable monitoring devices, a plurality of physiological signals of the subject (Paragraph 0100, lines 1-4); collecting, by the one or more implantable monitoring devices, parameter data of the subject based on the sensed physiological signals (Paragraph 0108, lines 9-15); and determining, by processing circuitry (Fig. 1, Paragraph 0096, lines 6-7 and Paragraph 0100, lines 14-26, 14), a mental state of the subject based on at least one of the sensed physiological signals or the parameter data (Paragraph 0051, lines 1-6, Paragraph 0110, lines 9-12, and Paragraph 0146, lines 1-10), wherein the processing circuitry comprises processing circuitry of one or more of: the at least one implantable monitoring device (Paragraph 0120, lines 1-4); one or more computing devices (Fig. 1, Paragraph 0101, lines 12-15, 70/9/11) configured to wirelessly communicate with the one or more implantable monitoring devices (Paragraph 0101, lines 1-15); or a cloud computing system (Fig. 1, Paragraph 0102, line 3, 31) configured to communicate with at least one of the one or more implantable monitoring devices (Paragraph 0102, lines 9-21) or the one or more computing devices (Paragraph 0102, lines 1-9).
Regarding claim 17, Leuthardt teaches the method (Paragraph 0112, line 1) of claim 16, wherein the housing (Fig. 2, Paragraph 0115, lines 1-2, 202) of the at least one implantable monitoring device (Fig. 1, Paragraph 0096, lines 1-2, 20/200) is configured for subcutaneous implantation on a head or neck of the subject (Fig. 5, Paragraph 0117, lines 1-3), and continuously sensing a plurality of physiological signals comprises continuously sensing an electroencephalogram (EEG) of the subject via the plurality of electrodes (Paragraph 0100, lines 1-4).
Regarding claim 19, Leuthardt teaches the method (Paragraph 0112, line 1) of claim 17, wherein determining the mental state comprises determining the mental state of the subject based on a morphology of the EEG (Paragraph 0129, lines 6-11).
Regarding claim 20, Leuthardt teaches the method (Paragraph 0112, line 1) of claim 17, wherein determining the mental state comprises determining the mental state of the subject based on a respective energy level in one or more frequency bands (Paragraph 0129, lines 8-11) or sensing locations of the EEG.
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.
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Leuthardt et al. (U.S. PGPub No. 2021/0361948) in view of Schulhauser et al. (U.S. PGPub No. 2021/0251497).
Regarding claim 2, Leuthardt teaches the system (Fig. 1, Paragraph 0096, line 1, 10) of claim 1 that includes the at least one implantable monitoring device (Fig. 1, Paragraph 0096, lines 1-2, 20/200). Leuthardt does not teach that the at least one implantable monitoring device comprises an insertable cardiac monitor configured to sense an electrocardiogram of the subject via the plurality of electrodes.
Schulhauser, however, teaches a system for detecting strokes (Fig. 1, Paragraph
0139, line 1, 100) that includes an implantable sensor device (Fig. 1 Paragraph 0140, line
4, 110). Schulhauser teaches that the implantable sensor device comprises a plurality of electrodes (Fig. 1, Paragraph 0143, line 11, 113). Furthermore, Schulhauser teaches that the implantable sensor device can comprise an insertable (Paragraph 0140, line 7) cardiac monitor (Paragraph 0144, lines 12-16) that senses an electrocardiogram (Paragraph 0144, line 3 and Paragraph 0165, lines 12-14) of the subject via the plurality of electrodes (Paragraph 0144, lines 1-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Leuthardt to incorporate the teachings of Schulhauser to include that the at least one implantable monitoring device comprises an insertable cardiac monitor configured to sense an electrocardiogram of the subject via the plurality of electrodes. Doing so would ensure that the at least one implantable monitoring device is able to monitor heart rate variability, arrhythmias, or ventricular fibrillation episodes (Paragraph 0144, lines 14-16), as recognized by Schulhauser.
Regarding claim 12, Leuthardt teaches the system (Fig. 1, Paragraph 0096, line 1, 10) of claim 1, wherein the plurality of physiological signals comprises a first plurality of physiological signals and the parameter data comprises first parameter data (Paragraph 0105, lines 1-8), and the one or more implantable monitoring devices (Fig. 1, Paragraph 0096, lines 1-2, 20/200) are configured to continuously sense (Paragraph 0100, lines 1-4) a second plurality of physiological signals (Paragraph 0105, lines 1-8), comprising one or more of an electrocardiogram signal, a respiration signal, a motion signal (Paragraph 0105, line 7), a subcutaneous impedance signal, a blood pressure signal (Paragraph 0105, lines 6-7), or a heart sounds signal, of the subject and collect second parameter data of the subject based on the second plurality of physiological signals (Paragraph 0108, lines 9-15).
Leuthardt does not teach that the processing circuitry is configured to determine a heart failure state of the subject based on at least one of the second physiological signals or the second parameter data.
Schulhauser, however, teaches a system for detecting strokes (Fig. 1, Paragraph
0139, line 1, 100) that includes an implantable sensor device (Fig. 1 Paragraph 0140, line
4, 110). Schulhauser teaches that the implantable sensor device continuously senses a first plurality of physiological signals from first parameter data (Paragraph 0144, lines 1-2) and a second plurality of physiological signals from second parameter data (Paragraph 0144, line 3). Schulhauser further teaches that processing circuitry (Fig. 1, Paragraph 0148, line 8, 123) is configured to determine a heart failure state of the subject (Paragraph 0144, line 13) based on at least one of the second physiological signals or the second parameter data (Paragraph 0144, lines 12-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Leuthardt to incorporate the teachings of Schulhauser to include that the processing circuitry is configured to determine a heart failure state of the subject based on at least one of the second physiological signals or the second parameter data. Doing so would ensure that the at least one implantable monitoring device is capable of assessing the condition of one’s heart (Paragraph 0144, lines 12-13), which can further include determining the patient’s risk of stroke (Paragraph 0191, lines 1-6), as recognized by Schulhauser.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Leuthardt et al. (U.S. PGPub No. 2021/0361948) in view of Miesel et al. (U.S. Patent No. 8,032,224).
Regarding claim 6, Leuthardt teaches the system (Fig. 1, Paragraph 0096, line 1, 10) of claim 1, wherein the processing circuitry (Fig. 1, Paragraph 0096, lines 6-7 and Paragraph 0100, lines 14-26, 14) is configured to: determine patient sleep data of the subject (Paragraph 0062, line 8); and determine the mental state of the subject based on the patient sleep data (Paragraph 0053, lines 1-5).
Leuthardt does not teach that the processing circuitry is configured to: determine at least one of sleep quality or sleep patterns of the subject based on one or more of the physiological signals or parameter data; and determine the mental state of the subject based on the at least one of the sleep quality or sleep patterns.
Miesel, however, teaches techniques for controlling delivery of a therapy to a patient by at least one or more implantable medical devices (Fig. 1A-1B, Col. 4, line 61, 14A/14B). Miesel teaches that the IMD may monitor one or more physiological parameters (Col. 9, lines 21-30), and can determine sleep quality (Col. 30, lines 21-23) and sleep patterns (Col. 10, lines 18-30) of the subject. Furthermore, Miesel teaches that sleep quality metrics can be used to track the status or progression of psychological disorders, such as depression (Col. 27, lines 3-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Leuthardt to incorporate the teachings of Miesel to specify that the sleep patient data comprises at least one of sleep quality or sleep patterns. Doing so would ensure that specific sleep indicators can be used to determine the status or progression of psychological disorders (Col. 27, lines 3-7), as recognized by Miesel.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Leuthardt et al. (U.S. PGPub No. 2021/0361948) in view of Giftakis et al. (U.S. PGPub No. 2010/0280336) and KR 102321520 (herein referred to as Korea).
Regarding claim 9, Leuthardt teaches the system (Fig. 1, Paragraph 0096, line 1, 10) of claim 1, further comprising a sensor configured to sense a voice of the subject (Paragraph 0156, lines 1-5), wherein the processing circuitry (Fig. 1, Paragraph 0096, lines 6-7 and Paragraph 0100, lines 14-26, 14) is configured to determine the mental state of the subject (Paragraph 0053, lines 1-5) based on values of one or more characteristics of the voice of the subject (Paragraph 0062, line 7).
Leuthardt does not teach that the sensor configured to sense a voice of the subject is located within the housing of the at least one implantable monitoring device. Giftakis, however, teaches an anxiety disorder monitoring system that utilizes an implantable medical device (Fig. 1, Paragraph 0036, lines 1-2, 16) with a sensing module that senses physiological signals of a patient (Paragraph 0044, lines 1-2). Giftakis teaches that a voice activity sensor (Fig. 1, Paragraph 0066, lines 1-7, 38), such as a microphone (Paragraph 0068, lines 1-6), can be located within the housing of the IMD (Paragraph 0069, line 3). Furthermore, Giftakis teaches that the voice activity of a patient can be used to determine a mood state (Paragraph 0269, lines 1-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Leuthardt to incorporate the teachings of Giftakis to include that the sensor configured to sense a voice of the subject is located within the housing of the at least one implantable monitoring device. Doing so would allow the voice activity sensor to be located proximate to the vocal cord and larynx in order to improve sensor readings (Paragraph 0069, lines 9-10), as recognized by Giftakis.
Leuthardt also does not teach that the processing circuitry is configured to determine the mental state of the subject based on values of one or more of speech rate, speech rate variability, pitch, pitch variability, length of pauses, frequency of pauses, or pattern of pauses. Korea, however, teaches a system for depression identification through voice analysis that uses a voice recording module (Fig. 2, Paragraph 00042, line 3, 212) to record a user’s voice. Korea teaches that a variety of voice characteristics can be extracted such as speech rate (Paragraph 0063, line 9), speech rate variability (Paragraph 0063, line 9), pitch (Paragraph 0063, line 3), pitch variability (Paragraph 0063, lines 5-6), length of pauses (Paragraph 0063, line 9), frequency of pauses (Paragraph 0063, line 9), or pattern of pauses (Paragraph 0063, line 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Leuthardt to incorporate the teachings of Korea to include that the processing circuitry is configured to determine the mental state of the subject based on values of one or more of speech rate, speech rate variability, pitch, pitch variability, length of pauses, frequency of pauses, or pattern of pauses. Doing so would ensure that a variety of voice characteristics can be used to determine a depression index for a patient (Paragraph 0041, lines 1-3), as recognized by Korea.
Regarding claim 10, Leuthardt teaches the system (Fig. 1, Paragraph 0096, line 1, 10) of claim 9, wherein the implantable monitoring device (Fig. 1, Paragraph 0096, lines 1-2, 20/200) further comprises an accelerometer (Fig. 1, Paragraph 0105, lines 1-3 and 7-9, 15) and is configured to: determine that a motion signal from the accelerometer satisfies a motion threshold (Paragraph 0140, lines 1-13).
Leuthardt does not teach that a sound signal from the sound sensor satisfies one or more sound criteria, wherein the one or more sound criteria comprise one or more of an energy criterion or a zero-crossing criterion; and store the sound signal for determination of the one or more characteristics of the voice of the subject based on the determination.
Korea, however, teaches a system for depression identification through voice analysis that uses a voice recording module (Fig. 2, Paragraph 00042, line 3, 212) to record a user’s voice. Korea further teaches that a sound signal from the sound sensor is extracted when it satisfies one or more sound criteria, wherein the one or more sound criteria comprise one or more of an energy criterion (Paragraph 0066 lines 2-3 and Paragraph 0067, lines 1-3) or a zero-crossing criterion (Paragraph 0066, lines 1-2). Korea then teaches that the sound signal is stored for determination of the one or more characteristics based on the determination (Paragraph 0063, lines 1-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Leuthardt to incorporate the teachings of Korea to include that a sound signal from the sound sensor satisfies one or more sound criteria, and then is stored for determination of the one or more characteristics of the voice. Doing so would ensure that the voice characteristics can be extracted while noise is reduced (Paragraph 0063, lines 1-14), as recognized by Korea.
Claims 11 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Leuthardt et al. (U.S. PGPub No. 2021/0361948).
Regarding claim 11, Leuthardt teaches the system (Fig. 1, Paragraph 0096, line 1, 10) of claim 1, wherein the processing circuitry (Fig. 1, Paragraph 0096, lines 6-7 and Paragraph 0100, lines 14-26, 14) is configured to: receive data (Paragraph 0062, line 7) indicating a comorbid condition of the subject (Paragraph 0151, lines 1-6); and determine the mental state of the subject based on the data indicating the comorbid condition (Paragraph 0053, lines 1-5), wherein the comorbid condition comprises heart attack, stroke, cardiac surgery, defibrillation shock, traumatic injury, heart failure, post-traumatic stress disorder (Paragraph 0151, line 5), post-partum, or cancer.
Although it is not explicitly disclosed in Leuthardt that data is received that indicates a comorbid condition, Leuthardt teaches that certain speech patterns and sounds can indicate post-traumatic stress disorder (Paragraph 0151, lines 1-6). Furthermore, Leuthardt teaches that EMA data can be received, which can include patient voice content (Paragraph 0062, line 7) from the microphone. Therefore, it would be well understood by a person of ordinary skill in the art that Leuthardt discloses receiving data that indicates a comorbid condition, such as PTSD.
Regarding claim 18, Leuthardt teaches the method (Paragraph 0112, line 1) of claim 16, wherein the at least one implantable monitoring device (Fig. 1, Paragraph 0096, lines 1-2, 20/200) comprises a first implantable monitoring device (Paragraph 0037, lines 1-4 and Paragraph 0107, lines 4-5) comprising a first housing (Fig. 2, Paragraph 0115, lines 1-2, 202) and a first plurality of electrodes (Fig. 2, Paragraph 0115, lines 7-9, 206/208/210/212), wherein the one or more implantable monitoring devices comprise a second implantable monitoring device (Paragraph 0037, lines 1-4 and Paragraph 0107, lines 4-5) comprising a second housing (Fig. 2, Paragraph 0115, lines 1-2, 202) configured for subcutaneous implantation on a head or neck of the subject (Fig. 5, Paragraph 0117, lines 1-3) and a second plurality of electrodes (Fig. 2, Paragraph 0115, lines 7-9, 206/208/210/212) on the housing (Fig. 2), wherein continuously sensing a plurality of physiological signals comprises continuously sensing an electroencephalogram (EEG) of the subject via the second plurality of electrodes (Paragraph 0100, lines 1-4).
Leuthardt does not explicitly teach a first implantable monitoring device and second implantable monitoring device with first and second housings and pluralities of electrodes. However, Leuthardt teaches that the disclosed system can include one or more implantable monitoring devices (Paragraph 0037, lines 1-4 and Paragraph 0107, lines 4-5). Leuthardt then teaches that each implantable monitoring device comprises a housing and a plurality of electrodes. Therefore, it would have been obvious to try using two implantable monitoring devices, each with their own housing and plurality of electrodes in view of Leuthardt.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Schulhauser et al. (U.S. PGPub No. 2021/0251497) in view of Leuthardt et al. (U.S. PGPub No. 2021/0361948).
Regarding claim 15, Schulhauser teaches a medical system (Fig. 1, Paragraph
0139, line 1, 100) comprising: an insertable (Paragraph 0140, line 7) cardiac monitor (Fig. 1 Paragraph 0140, line 4, Paragraph 0144, lines 12-16, 110/210/310) comprising: a housing (Fig. 2A, Paragraph 0158, line 8, 201) configured for subcutaneous implantation in a subject (Paragraph 0158, lines 12-13), the housing having a length between 40 millimeters (mm) and 60 mm (Fig. 3, Paragraph 0167, lines 20-21) between a first end (Fig. 3, Paragraph 0167, line 37, 322) and a second end (Fig. 3, Paragraph 0167, line 37, 324), a width less than the length (Fig. 3, Paragraph 0167, lines 4-5), and a depth less than the width (Fig. 3, Paragraph 0167, lines 4-6); a first electrode (Fig. 3, Paragraph 0167, line 15, 313a) at or proximate to the first end (Fig. 3); a second electrode (Fig. 3, Paragraph 0167, line 16, 313b) at or proximate to the second end (Fig. 3); sensing circuitry (Fig. 1, Paragraph 0143, lines 7-8, 111) within the housing (Paragraph 0158, lines 13-15), the sensing circuitry configured to continuously sense (Paragraph 0165, lines 6-11) a plurality of physiological signals (Paragraph 0144, lines 1-4) including an at least an electrocardiogram (Paragraph 0144, line 3 and Paragraph 0165, lines 12-14) of the subject via the first electrode and the second of electrode (Paragraph 0144, lines 1-3 and Paragraph 0169, lines 8-11); a memory within the housing (Fig. 1, Paragraph 0148, lines 6-8, 125); and processing circuitry within the housing (Fig. 1, Paragraph 0148, lines 6-8, 123), the processing circuitry configured to collect parameter data of the subject based on the sensed physiological signals (Paragraph 0152, lines 1-5); and one or more computing devices (Fig. 1, Paragraph 0141, lines 2-3, 180) in communication with the insertable cardiac monitor (Paragraph 0141, lines 1-3).
Schulhauser does not teach that the insertable cardiac monitor comprises first and second processing circuitry. Schulhauser also does not teach that the one or more computing devices comprise second processing circuitry configured to determine a mental state of the subject based on at least one of the sensed physiological signals or the parameter data.
Leuthardt, however, teaches a system (Fig. 1, Paragraph 0096, line 1, 10) comprising: one or more implantable monitoring devices (Fig. 1, Paragraph 0096, lines 1-2, 20/200) configured to continuously sense a plurality of physiological signals of a subject (Paragraph 0100, lines 1-4) and collect parameter data of the subject based on the sensed physiological signals (Paragraph 0108, lines 9-15). Leuthardt teaches that the one or more implantable monitoring devices can comprise one or more processing circuits (Fig. 1, Paragraph 0098, lines 1-2, 14).
Furthermore, Leuthardt teaches that the system includes one or more computing devices (Paragraph 0102, lines 1-9), wherein processing circuitry is configured to determine a mental state of the subject based on at least one of sensed physiological signals or the parameter data (Paragraph 0051, lines 1-6, Paragraph 0110, lines 9-12, and Paragraph 0146, lines 1-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Schulhauser to incorporate the teachings of Leuthardt to include that the system can include multiple processing circuits, and that the one or more computing devices comprise processing circuitry configured to determine a mental state of the subject based on at least one of the sensed physiological signals or the parameter data. Doing so would ensure that different processors can be used for different functions, and offloading some of the computational burden can occur (Paragraph 0102, lines 15-24), as recognized by Leuthardt.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Morris et al. (U.S. PGPub No. 2021/0118547) teaches systems and methods for monitoring of physiological parameters relative to a mental health baseline state for a patient (Abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Heidi Hilsmier whose telephone number is (571)272-2984. The examiner can normally be reached Monday - Fridays from 7:30 AM - 3:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/H.A.H./Patent Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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