DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Response to Arguments
3. Applicant’s arguments with respect to claim(s) 1-28 have been considered but are moot because the new ground of rejection does not rely on any reference or combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. It is noted that Claim 29 is newly added.
Claim Rejections - 35 USC § 112
4. Claims 24 and 28 were previous rejected under 35 U.S.C. 112(b) as being indefinite. However, Claims 24 and 28 have been amended to overcome these rejections. Therefore, the rejections are withdrawn.
5. Claims 2, 6, 9, and 11 were previous rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. However, this rejections have been withdrawn.
Claim Rejections - 35 USC § 103
6. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
7. Claims 1, 4, 5, 8, 11, 13, 14, 15, 18, 21, 23, 24, 25, 28, xx are rejected under 35 U.S.C. 103 as being unpatentable over Hendler U.S. 2024/0108272 (earliest filing date 3/13/2020; herein referred to as “Hendler”) and in view of Tadi U.S. 2018/0239430 (herein referred to as “Tadi”).
8. Regarding Claim 1, Hendler teaches a system to guide placement of one or more electrodes on a scalp of a subject to detect brain activities (Figs. 1 and 2A-2B), the system comprising:
a. one or more electrodes configured to measure electroencephalogram (EEG) signals (Fig. 3, ref num 301; para 0134);
b. recording positional data of the one or more electrodes during measurement of a first EEG signal of the EEG signals and a second EEG signal of the EEG signals (Fig. 1, ref num 107; Fig. 4, ref num 403, 405, 406);
c. an electronics unit communicatively coupled to the one or more electrodes (Fig. 2A, ref num 225), the electronics unit comprising:
c.1 a processor (Fig. 2A, ref num 227) and
c.2 a non-transitory computer readable storage medium having a computer program with instructions executable by the processor (Fig. 2A, ref num 231; para 0120; para 0047, “the data processor includes a volatile memory for storing instructions and/or data and/or a non-volatile storage”), such that the processor is configured to:
c.3 calibrate a first position of the one or more electrodes to set an origin location (para 0176, “A potential advantage of such overlap may include facilitating the determining of relative electrode positions between the first set and the second set”),
c.4 receive at least a portion of the positional data of the one or more electrodes to track a second position of the one or more electrodes relative to the origin location and corresponding to re-positioning of the one or more electrodes on the scalp of the subject (para 0176, “the first set is moved away from the scalp (e.g. lifted away), and a second set is moved into pressurized contact with spatial scalp locations different than those contacted by the first electrode set (607)…”; Fig. 4, ref num 405; Fig. 6), and
c.5 output a feedback corresponding to the second position of the one or more electrodes (Fig. 4, ref num 409 and Fig. 6, ref num 613; para 0122).
Hendler fails to teach one or more inertial sensors that are configured to record positional data of the one or more electrodes.
Tadi teaches a system of analogous art (Figs. 1, 2c, and 2d), wherein the system comprises one or more electrodes configured to measure EEG signals (Fig. 2c, ref num 22) and one or more inertial sensors (Fig. 2c, ref num 29) configured to record positional data of the one or more electrodes (para 0204, “Inertial measurement unit (IMU) sensors 29, for instance including an accelerometer, a gyroscope, a magneto-meter: Purpose, to track head movements. This data is used for rendering VR content as well as to segment EEG data where the data quality might be degraded due to movement”; para 0240). This provides the data need to analyze the position of the electrodes on the scalp of the subject without degradation of the data (para 0204). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hendler to include inertial sensors to determine the position of the sensors that measure EEG signals without degradation of the data.
9. Regarding Claim 4, Hendler teaches the processor outputs the feedback based on a strength of the bioelectrical signals detected by the one or more electrodes (para 0154, “processing is based on that neuro-electrographic events are non-homogenous in their spatial characteristics. Distribution of the electric field through the scalp is represented by a set of components with different spatial frequencies”).
10. Regarding Claim 5, Hendler teaches an output interface configured to display an electrode overlay, wherein the origin location and the second position of the one or more electrodes are visualized onto the electrode overlay (Fig. 3, ref nums 301, 303, 304; para 0133-0135, 0122, 0176).
11. Regarding Claim 8, Hendler teaches the processor, when executing the computer program instructions is configured to catalogue the bioelectrical signals detected by the one or more electrodes (para 0120).
12. Regarding Claim 11, Hendler teaches the one or more electrodes are a plurality of electrodes (Fig. 3, ref num 301) and the processor of the electronics unit is configured to record and catalog the EEG signals corresponding to a plurality of EEG signals measured at each electrode of the plurality of electrodes and storing the measured EEG signals and positional data for each of the plurality of electrodes as a configuration (para 0120).
13. Regarding Claims 13 and 14, Hendler teaches a computer implemented method of guiding placement of one or more electrodes on a skin surface of a subject (Figs. 1, 2A-2B, and 3; Fig. 2A, ref num 231; para 0120; para 0047, “the data processor includes a volatile memory for storing instructions and/or data and/or a non-volatile storage”), the system comprising:
a. recording positional data of the one or more electrodes during measurement of a first EEG signal of the EEG signals and a second EEG signal of the EEG signals (Fig. 1, ref num 107; Fig. 4, ref num 403, 405, 406);
b. calibrate a first position of the one or more electrodes to set an origin location (para 0176, “A potential advantage of such overlap may include facilitating the determining of relative electrode positions between the first set and the second set”),
c. tracking a deviation of the second position of the one or more electrodes relative to the initial position (para 0176, “the first set is moved away from the scalp (e.g. lifted away), and a second set is moved into pressurized contact with spatial scalp locations different than those contacted by the first electrode set (607)…”; Fig. 4, ref num 405; Fig. 6), and
d. providing feedback based on the deviations. (Fig. 4, ref num 409 and Fig. 6, ref num 613; para 0122).
Hendler fails to teach using one or more sensors, such as inertial sensor, an image sensor or a combination thereof (claim 14), to track the deviation.
Tadi teaches a system of analogous art (Figs. 1, 2c, and 2d), wherein the system comprises one or more electrodes configured to measure EEG signals (Fig. 2c, ref num 22) and one or more inertial sensors (Fig. 2c, ref num 29) configured to record positional data of the one or more electrodes (para 0204, “Inertial measurement unit (IMU) sensors 29, for instance including an accelerometer, a gyroscope, a magneto-meter: Purpose, to track head movements. This data is used for rendering VR content as well as to segment EEG data where the data quality might be degraded due to movement”; para 0240). This provides the data need to analyze the position of the electrodes on the scalp of the subject without degradation of the data (para 0204). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hendler to include inertial sensors to determine the position of the sensors that measure EEG signals without degradation of the data.
14. Regarding Claim 15, Hendler teaches visualizing an origin position and the second position on the surface through an electrode overlay (Fig. 3, ref nums 301, 303, 304; para 0133-0135, 0122, 0176).
15. Regarding Claim 18, Hendler teaches providing of the feedback is based on a strength of the bioelectrical signals detected by the one or more electrodes (para 0154, “processing is based on that neuro-electrographic events are non-homogenous in their spatial characteristics. Distribution of the electric field through the scalp is represented by a set of components with different spatial frequencies”).
16. Regarding Claim 21, Hendler teaches cataloguing of the one or more electrical signals (para 0120).
17. Regarding Claims 23 and 24, Hendler fails to teach tracking of the deviation comprises detecting deviations from the initial position by at least receiving data from one or more sensors being one or more inertial sensors, the one or more inertial sensors comprise at least one (i) accelerometer or (ii) gyroscope.
Tadi teaches a system of analogous art (Figs. 1, 2c, and 2d), wherein the system comprises one or more electrodes configured to measure EEG signals (Fig. 2c, ref num 22) and one or more inertial sensors (Fig. 2c, ref num 29) configured to record positional data of the one or more electrodes (para 0204, “Inertial measurement unit (IMU) sensors 29, for instance including an accelerometer, a gyroscope, a magneto-meter: Purpose, to track head movements. This data is used for rendering VR content as well as to segment EEG data where the data quality might be degraded due to movement”; para 0240). This provides the data need to analyze the position of the electrodes on the scalp of the subject without degradation of the data (para 0204). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hendler to include inertial sensors to determine the position of the sensors that measure EEG signals without degradation of the data.
18. Regarding Claim 25, Hendler teaches enabling a subject to self-administer an EEG analysis (Claim 24 – “a user interface in communication with said processor, said user interface enabling self-activation by the patient or by a caregiver”).
19. Regarding Claim 28, Hendler teaches a system to guide placement of one or more electrodes on a scalp of a subject to detect brain activities (Figs. 1 and 2A-2B), the system comprising:
a. a barrel unit (Fig. 2A, ref num 201, Fig. 7, ref num 701); and
b. a plurality of extensions extending from the barrel unit (Fig. 7, ref num 705), each extension of the plurality of extensions includes one or more electrodes configured to measure bioelectrical signals including electroencephalogram (EEG) signals (Fig. 3, ref num 301; Fig. 7, ref num 703; para 0134);
c. wherein the barrel unit includes:
c.1 a system tracking unit (Fig. 2A, ref num 209) configured to record positional data of the one or more electrodes during measurement of a first EEG signal of the EEG signals and a second EEG signal of the EEG signals (Fig. 1, ref num 107; Fig. 4, ref num 403, 405, 406);
c.2 an electronics unit communicatively coupled to the one or more electrodes (Fig. 2A, ref num 225), the electronics unit comprising:
c.1 a processor (Fig. 2A, ref num 227) and
c.2 a non-transitory computer readable storage medium having a computer program with instructions executable by the processor (Fig. 2A, ref num 231; para 0120; para 0047, “the data processor includes a volatile memory for storing instructions and/or data and/or a non-volatile storage”), such that the processor is configured to:
c.3 record and categorize EEG information associated with the first EEG signals measured by the one or more electrodes at the first position measured by the system tracking unit and EEG information associated with the second EEG signal measured by the one or more electrodes at the second position (para 0176; Fig. 4, ref num 405; Fig. 6).
Hendler fails to teach one or more sensors that are configured to record data of the one or more electrodes.
Tadi teaches a system of analogous art (Figs. 1, 2c, and 2d), wherein the system comprises one or more electrodes configured to measure EEG signals (Fig. 2c, ref num 22) and one or more inertial sensors (Fig. 2c, ref num 29) configured to record positional data of the one or more electrodes (para 0204, “Inertial measurement unit (IMU) sensors 29, for instance including an accelerometer, a gyroscope, a magneto-meter: Purpose, to track head movements. This data is used for rendering VR content as well as to segment EEG data where the data quality might be degraded due to movement”; para 0240). This provides the data need to analyze the position of the electrodes on the scalp of the subject without degradation of the data (para 0204). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hendler to include inertial sensors to determine the position of the sensors that measure EEG signals without degradation of the data.
20. Claims 6, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hendler and in view of Tadi, and further in view of Kesinger U.S. 2019/0021665 (herein referred to as “Kesinger”).
21. Regarding Claim 6, Hendler fails to teach the electrode overlay comprises a predetermined configuration overlay to depict one or more desired electrode placement locations, and wherein the feedback corresponds to the second position of the one or more electrodes relative to the one or more desired electrode placement locations.
Kesinger teaches a system of analogous art (Figs. 1 and 5), wherein the system has an output interface (Fig. 5, ref num 11c) configured to display electrode overlay (Fig. 5, ref num 9), such that the electrode overlay comprises a predetermined configuration overlay to depict one or more desired electrode placement locations, and wherein the feedback corresponds to the second position of the one or more electrodes relative to the one or more desired electrode placement locations (para 0088, “electrode indicia 9c that are positioned in locations on the representation of the patient head 9a corresponding to positions at which the electrode hubs of headgear 3 are desired to be positioned”; para 0094, 0096). This feedback provides information of whether there is proper connectivity of the electrodes at different placements over the scalp of the subject (para 0094). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hendler to have provided a depiction of desired electrode placement locations, in order to ensure proper connectivity of the electrodes to measure EEG signals.
22. Regarding Claim 16, Hendler teaches setting an origin on the skin surface constituting an initial position (para 0176, “A potential advantage of such overlap may include facilitating the determining of relative electrode positions between the first set and the second set”).
Hendler fails to teach determining one or more desired electrode placement locations relative to the origin.
Kesinger teaches a system of analogous art (Figs. 1 and 5), wherein the system has an output interface (Fig. 5, ref num 11c) configured to display electrode overlay (Fig. 5, ref num 9), such that the electrode overlay comprises a predetermined configuration overlay to depict one or more desired electrode placement locations, and wherein the feedback corresponds to the second position of the one or more electrodes relative to the one or more desired electrode placement locations (para 0088, “electrode indicia 9c that are positioned in locations on the representation of the patient head 9a corresponding to positions at which the electrode hubs of headgear 3 are desired to be positioned”; para 0094, 0096). This feedback provides information of whether there is proper connectivity of the electrodes at different placements over the scalp of the subject (para 0094). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hendler to have provided a depiction of desired electrode placement locations, in order to ensure proper connectivity of the electrodes to measure EEG signals.
23. Regarding Claim 19, Hendler teaches visualizing an origin position and the second position on the skin surface through an electrode overlay (Fig. 3, ref nums 301, 303, 304; para 0133-0135, 0122, 0176).
Hendler fails to teach the electrode overlay comprises a predetermined configuration overlay to depict one or more desired electrode placement locations, and wherein the feedback corresponds to the second position of the one or more electrodes relative to the one or more desired electrode placement locations.
Kesinger teaches a system of analogous art (Figs. 1 and 5), wherein the system has an output interface (Fig. 5, ref num 11c) configured to display electrode overlay (Fig. 5, ref num 9), such that the electrode overlay comprises a predetermined configuration overlay to depict one or more desired electrode placement locations, and wherein the feedback corresponds to the second position of the one or more electrodes relative to the one or more desired electrode placement locations (para 0088, “electrode indicia 9c that are positioned in locations on the representation of the patient head 9a corresponding to positions at which the electrode hubs of headgear 3 are desired to be positioned”; para 0094, 0096). This feedback provides information of whether there is proper connectivity of the electrodes at different placements over the scalp of the subject (para 0094). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hendler to have provided a depiction of desired electrode placement locations, in order to ensure proper connectivity of the electrodes to measure EEG signals.
24. Claims 2, 9, 22, 26, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Hendler and Tadi, and further in view of Bhat EP 3636140A1 (herein referred to as “Bhat”).
25. Regarding Claim 2, Hendler fails to teach a camera in operative communication with the processor, and wherein the processor is configured to receive data from the camera, via the computer program instructions, such that the processor is configured to either (i) track the second position of the one or more electrodes and output the feedback based on the one or more inertial sensors and the camera or (ii) track the second position of the one or more electrodes based on a position of the at least one edge in the one or more images.
Bhat teaches a system of analogous art (Fig. 1), wherein the system comprises one or more inertial sensors with one or more electrodes (Fig. 1, ref nums 11 and 12; para 0053, “Thereby the sensors 11, 12 of the sensor arrangement 10 are provided with a pair of capacitive electrodes (e.g. 2 parallel electrodes), which capacitively contact the skin of the patient and can both transmit and receive signals propagated across the body. In some situations there are advantageously multiple capacitive electrode pairs on a sensor 11, 12”; para 0042) and a processor that executes instructions (Fig. 1, ref num 30; para 0066). The system further comprises a camera (para 0030, 0043, 0063). The camera is in operative communication with the processor, such that, the processor receives data from the camera (para 0054, “the reference position and/or orientation for the first sensor 11 may be determined based on an image, such as a MRI, CT or X-ray image…the processor 30 is configured to determine whether the first sensor 11 is accurately placed at the reference position…by an iterative evaluation”; para 0055, “the position and/or orientation data 45 may be stored in the receiver 40 and be transmitted to the processor 30”). The processor is then configured to track the second position of the one or more electrodes and output the feedback based on the one or more inertial sensors (Fig. 1, ref num 35; para 0055, “the measurement data from the sensors 11, 12…are transmitted to the processor…as well as the actual position and/or orientation 26 of the second sensors 12 tracked by the placement tracker 20”; para 0056, “the processor 30 generates an output signal 35 indicating a difference between the actual position and/or orientation of the second sensors 12 and their respective desired positions”). By tracking, monitoring, and controlling the position of the sensors with the camera, this will improve the measurement quality of the sensors for their intended purpose (para 0059), as well as ensure an easy and reliable system for the placement of the sensors (para 0014). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hendler to include a camera in communication with the processor to track the position of the electrodes and output the feedback, as this aids in the placement so that the measurement data may be improved, as well as provides ease to the user.
26. Regarding Claim 9, Hendler fails to teach a camera in operative communication with the processor, and wherein the processor is configured to receive data from the camera, track the second position of the one or more electrodes, and output the feedback based on the one or more inertial sensors and the camera.
Bhat teaches a system of analogous art (Fig. 1), wherein the system comprises one or more inertial sensors with one or more electrodes (Fig. 1, ref nums 11 and 12; para 0053, “Thereby the sensors 11, 12 of the sensor arrangement 10 are provided with a pair of capacitive electrodes (e.g. 2 parallel electrodes), which capacitively contact the skin of the patient and can both transmit and receive signals propagated across the body. In some situations there are advantageously multiple capacitive electrode pairs on a sensor 11, 12”; para 0042) and a processor that executes instructions (Fig. 1, ref num 30; para 0066). The system further comprises a camera (para 0030, 0043, 0063). The camera is in operative communication with the processor, such that, the processor receives data from the camera (para 0054, “the reference position and/or orientation for the first sensor 11 may be determined based on an image, such as a MRI, CT or X-ray image…the processor 30 is configured to determine whether the first sensor 11 is accurately placed at the reference position…by an iterative evaluation”; para 0055, “the position and/or orientation data 45 may be stored in the receiver 40 and be transmitted to the processor 30”). The processor is then configured to track the second position of the one or more electrodes and output the feedback based on the one or more inertial sensors and the camera (Fig. 1, ref num 35; para 0055, “the measurement data from the sensors 11, 12…are transmitted to the processor…as well as the actual position and/or orientation 26 of the second sensors 12 tracked by the placement tracker 20”; para 0056, “the processor 30 generates an output signal 35 indicating a difference between the actual position and/or orientation of the second sensors 12 and their respective desired positions”). By tracking, monitoring, and controlling the position of the sensors with the camera, this will improve the measurement quality of the sensors for their intended purpose (para 0059), as well as ensure an easy and reliable system for the placement of the sensors (para 0014). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hendler to include a camera in communication with the processor to track the position of the electrodes and output the feedback, as this aids in the placement so that the measurement data may be improved, as well as provides ease to the user.
27. Regarding Claim 22, Hendler teaches the method of claim 21, but fails to teach the one or more sensors comprise an image sensor, and wherein the method further comprises cataloguing images obtained by the image sensor.
Bhat teaches a method of analogous art (Fig. 1), wherein the method comprises one or more sensors (Fig. 1, ref nums 11 and 12), such that the sensor(s) comprise an image sensor (para 0055), such that images obtained by the image sensor are catalogued (para 0055). This stored data may be received in order to provide feedback to the user (para 0012). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hendler to catalogue images collected by an image sensor in order to provide feedback to the user.
28. Regarding Claim 26, Hendler teaches the method of claim 19, but fails to teach the tracking of deviation comprises receiving data from a camera.
Bhat teaches a method of analogous art (Fig. 1), wherein the method comprises tracking a deviation of a second position of one or more electrodes (Fig. 1, ref nums 11 and 12; para 0053) relative to the initial position using one or more sensors (para 0008, 0035). The tracking of deviation comprises receiving data from a camera (para 0030, 0043, 0063; para 0054, “the reference position and/or orientation for the first sensor 11 may be determined based on an image, such as a MRI, CT or X-ray image…the processor 30 is configured to determine whether the first sensor 11 is accurately placed at the reference position…by an iterative evaluation”; para 0055, “the position and/or orientation data 45 may be stored in the receiver 40 and be transmitted to the processor 30”; Fig. 1, ref num 35; para 0055, “the measurement data from the sensors 11, 12…are transmitted to the processor…as well as the actual position and/or orientation 26 of the second sensors 12 tracked by the placement tracker 20”; para 0056, “the processor 30 generates an output signal 35 indicating a difference between the actual position and/or orientation of the second sensors 12 and their respective desired positions”). By tracking, monitoring, and controlling the position of the sensors with the camera, this will improve the measurement quality of the sensors for their intended purpose (para 0059), as well as ensure an easy and reliable system for the placement of the sensors (para 0014). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hendler to include to track the position of the electrodes, as this aids in the placement so that the measurement data may be improved, as well as provides ease to the user.
29. Regarding Claim 27, Hendler as modified teaches the method of claim 26, but fails to teach the detecting of the deviation further comprises detecting the origin with the camera and evaluating the position of the origin in a series of images captured by the camera.
Bhat teaches a method of analogous art (Fig. 1), wherein the method includes detecting a deviation of a second position of an electrode relative to an initial position (Fig. 5, reference characters S1, S2, S3, S4; para 0064). This is done via a camera and images captured by said camera (para 0030, 0043, 0063-0064; para 0055, “the measurement data from the sensors 11, 12…are transmitted to the processor…as well as the actual position and/or orientation 26 of the second sensors 12 tracked by the placement tracker 20”; para 0056, “the processor 30 generates an output signal 35 indicating a difference between the actual position and/or orientation of the second sensors 12 and their respective desired positions”). By tracking, monitoring, and controlling the position of the sensors with the camera, this will improve the measurement quality of the sensors for their intended purpose (para 0059), as well as ensure an easy and reliable system for the placement of the sensors (para 0014). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hendler to include a camera track the position of the electrodes and output the feedback, as this aids in the placement so that the measurement data may be improved, as well as provides ease to the user.
30. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hendler, Tadi, and Bhat, and further in view of Deriso U.S. 2019/0125270 (herein referred to as “Deriso”).
31. Regarding Claim 3, Hendler as modified fails to teach one or more force sensors to detect a force being applied by the one or more electrodes to the surface, and wherein the processor, via the computer program instructions, is configured to output the feedback based on the force being applied by the one or more electrodes to the surface.
Deriso teaches a system of analogous art (Fig. 1B), wherein the system comprises one or more electrodes (Figs. 2C and 2F, ref nums 220) and one or more force sensors (Figs. 2E and 2F, ref num 275). The force sensor detects a force being applied to the electrodes (para 0078, “The force sensor 275 is used to measure a force applied onto the electrode to which the force sensor 275 is coupled”). The system also comprises a processor (Fig. 1B, ref num 145) and computer program instructions (Fig. 1B, ref num 155; para 0068, “the memory 155 holds instructions and data used by the processor 145”). Based on the force detected by the force sensors, the processor is configured to output feedback (para 0099, “The controller may also receive confirmation from the force sensor 275 that the heart monitoring device 130 is sufficiently pressed against the subject’s chest…the controller may additionally receive two sets of pressure data from two force sensors 275…the controller transmits all data…to an external system through an established wireless connection”). By having force sensors, the system is able to monitor whether the electrodes have been placed corrected in order to achieve a proper reading of the patient’s bioelectrical signals (paras 0095-0096). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hendler to include force sensors that detect the force applied to the electrodes, and provides feedback thereof, as this ensures proper placement of the electrodes for measuring the bioelectrical signals.
32. Claims 7, 12, 17, 20, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Hendler and Tadi, and further in view of Floyd U.S. 2020/0305795 (herein referred to as “Floyd”).
33. Regarding Claim 7, Hendler fails to teach the electrode overlay is generated based on a head width of the subject, the head length of the subject, a head curvature of the subject, or a combination thereof.
Floyd teaches a system of analogous art (Figs. 1 and 4), wherein the system is configured to display an electrode overlay (Fig. 1, ref num 22 and 18), such that the electrode overlay is generated based on a measurement of the head (para 0047, “processor in determining the correct inter-electrode spacing….measurement of the exact dimensions of the head…measure circumference”; the circumference of the head requires knowing the radius or diameter of the head, which would be the head curvature; para 0049, “when landmarks are found, the computer processor generate a virtual electrode template based on those landmarks”). This serves as a map of locations on the patient’s head where the electrodes/sensors are to be placed (para 0049). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hendler to generate the electrode overlay dependent on head measurements, as this aids in the guidance and mapping of where the electrodes are to be placed.
34. Regarding Claim 12, Hendler fails to teach the electrode overlay is generated based on a head width of the subject, the head length of the subject, a head curvature of the subject, or a combination thereof.
Floyd teaches a system of analogous art (Figs. 1 and 4), wherein the system is configured to display an electrode overlay (Fig. 1, ref num 22 and 18), such that the electrode overlay is generated based on a measurement of the head (para 0047, “processor in determining the correct inter-electrode spacing….measurement of the exact dimensions of the head…measure circumference”; the circumference of the head requires knowing the radius or diameter of the head, which would be the head curvature; para 0049, “when landmarks are found, the computer processor generate a virtual electrode template based on those landmarks”). This serves as a map of locations on the patient’s head where the electrodes/sensors are to be placed (para 0049). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hendler to generate the electrode overlay dependent on head measurements, as this aids in the guidance and mapping of where the electrodes are to be placed.
35. Regarding Claim 17, Hendler teaches the method of claim 13, but fails to teach that calibrating of the initial position comprises applying an edge detection algorithm via a computing device in operative communication with the one or more sensors.
Floyd teaches a method of analogous art (Figs. 1 and 4), wherein the method comprises calibrating an initial position of one or more electrodes (para 0041, 0043, 0047, 0049, 0060), such that the calibrating includes applying an edge detection algorithm via a computer device in communication with sensors (para 0006, 0042, 0052, 0056). This ensures that the electrodes are placed in the correct location (para 0039, 0060). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Hendler and apply an edge detection algorithm, via a computing device, in order to ensure proper/correct placement of the electrodes.
36. Regarding Claim 20, Hendler teaches the method of claim 19, but fails to teach the electrode overlay is generated based on a head width of the subject, the head length of the subject, a head curvature of the subject, or a combination thereof.
Floyd teaches a method of analogous art (Figs. 1 and 4), wherein the method is configured to display an electrode overlay (Fig. 1, ref num 22 and 18), such that the electrode overlay is generated based on a measurement of the head (para 0047, “processor in determining the correct inter-electrode spacing….measurement of the exact dimensions of the head…measure circumference”; the circumference of the head requires knowing the radius or diameter of the head, which would be the head curvature; para 0049, “when landmarks are found, the computer processor generate a virtual electrode template based on those landmarks”). This serves as a map of locations on the patient’s head where the electrodes/sensors are to be placed (para 0049). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hendler to generate the electrode overlay dependent on head measurements, as this aids in the guidance and mapping of where the electrodes are to be placed.
37. Regarding Claim 29, Hendler teaches an output interface configured to display an electrode overlay, wherein the origin location and the second position of the one or more electrodes are visualized onto the electrode overlay (Fig. 3, ref nums 301, 303, 304; para 0133-0135, 0122, 0176).
Hendler fails to teach the electrode overlay is generated based on a head width of the subject, a head length of the subject, a head curvature of the subject, or a combination thereof.
Floyd teaches a system of analogous art (Figs. 1 and 4), wherein the system is configured to display an electrode overlay (Fig. 1, ref num 22 and 18), such that the electrode overlay is generated based on a measurement of the head (para 0047, “processor in determining the correct inter-electrode spacing….measurement of the exact dimensions of the head…measure circumference”; the circumference of the head requires knowing the radius or diameter of the head, which would be the head curvature; para 0049, “when landmarks are found, the computer processor generate a virtual electrode template based on those landmarks”). This serves as a map of locations on the patient’s head where the electrodes/sensors are to be placed (para 0049). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hendler to generate the electrode overlay dependent on head measurements, as this aids in the guidance and mapping of where the electrodes are to be placed.
38. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hendler, Tadi, and Bhat, and further in view of Floyd.
39. Regarding Claim 10, Hendler fails to teach that the processor, upon execution of the computer program instructions, is configured to detect at least one edge of the surface from one or more images captured by the camera, and track the second position of the one or more electrodes based on a position of the at least one edge in the one or more images.
Floyd teaches a system of analogous art (Figs. 1 and 4), wherein the system comprises a processor that executes instructions (para 0006, 0052, 0056) and a camera (para 0052, 0056). Upon execution of the instructions, the processor is configured to detect at least one edge of a surface from one or more images capture by the camera (para 0036, 0049, 0062), as well as track another position of an electrode based on the position of the edge in the images (para 0049, 0062). This ensures that the electrodes are placed in the correct location (para 0039, 0060). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Hendler and have the processor detect an edge of an image in order to ensure proper/correct placement of the electrodes.
Conclusion
40. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
41. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794