The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Notice to Applicant
In response to the communication received on 04/21/2025, the following is a Non-Final Office Action for Application No. 19184084.
Status of Claims
Claims 1-20 are pending.
Drawings
The applicant’s drawings submitted on 04/21/2025 are acceptable for examination purposes.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted 07/02/2025 has been acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
As required by M.P.E.P. 201.14(c), acknowledgement is made of applicant’s claim for priority based on: 18390602 filed 12/20/2023 is a Divisional of 16556924 , filed 08/30/2019 ,now U.S. Patent # 11903679 and having 1 RCE-type filing therein.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. US 12295704 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because: referring to MPEP 804 II.B.2. Anticipation Analysis, “The claim under examination is not patentably distinct from the reference claim(s) if the claim under examination is anticipated by the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 1052, 29 USPQ2d 2010, 2015-16 (Fed. Cir. 1993). This type of nonstatutory double patenting situation arises when the claim being examined is, for example, generic to a species or sub-genus claimed in a conflicting patent or application, i.e., the entire scope of the reference claim falls within the scope of the examined claim.” Here, claim under examination is anticipated by the reference claim(s) since the claims recite substantially similar limitations. Particularly, the entire scope of independent claims of Patent US 12295704 B2 falls within the scope of independent claims of the present application.
The following is a mapping of the claims of the Patent against the claims of the present application:
Present Application
Patent US 12295704 B2
Identified differences and rationale as to why that does not amount to a patentable difference.
1. A robotic system for physical therapy, comprising: a stimulus device configured to generate a stimulus, wherein the stimulus device comprises a plurality of slots to detachably attach a plurality of different stimulus sub-devices in the plurality of slots in a modular arrangement; control circuitry configured to: determine a set of test stimuli specific for a user based on a trained Artificial Intelligence (AI)-based system; control the stimulus device to apply the determined set of test stimuli to the user for a first test duration; generate a physical stimulation instructions pack specific for the user based on an output from the trained AI-based system, wherein the physical stimulation instructions pack comprises: a time schedule that defines a specific activation time and a specific duration for the plurality of different stimulus sub-devices to generate a new stimulus in a second duration, wherein the second duration is different from the first test duration, and a set of sense identifiers, wherein each sense identifier of the set of sense identifiers indicates a unique specific sense stimulating item for output based on the time schedule; activate a set of stimulus sub-devices from the plurality of different stimulus sub-devices at a given timepoint in the second duration based on the time schedule in the generated physical stimulation instructions pack; and re-configure the stimulus device based on the activation of the set of stimulus sub-devices to shift at least one condition of the user from a current health state towards a target health state.
2. The robotic system according to claim 1, further comprising: a set of external response sensors configured to sense and measure an external response discernible on a body of the user on application of the stimulus; and a set of internal response sensors configured to sense and measure an internal response within the body of the user on the application of the stimulus from the stimulus device.
3. The robotic system according to claim 2, further comprising a user interface, wherein the control circuitry is further configured to: receive an input via the user interface, wherein the input comprises the current health state and the target health state of the user; retrieve at least one priori stimulus from a knowledge database based on the received input; determine the set of test stimuli specific for the user based on a combination of the current health state, the target health state, the retrieved at least one priori stimulus, and the trained AI-based system; determine, based on the set of internal response sensors, a set of responses within the body of the user from the applied set of test stimuli; and calibrate a set of stimulus parameters for the stimulus device based on the physical stimulation instructions pack, a combination of the determined set of responses, the current health state, the target health state, and the trained AI-based system.
4. The robotic system according to claim 3, wherein the re-configuration of the stimulus device is further based on the activation of the set of stimulus sub-devices at the given timepoint in the second duration, with the calibrated set of stimulus parameters to apply the new stimulus to the at least portion of the body of the user for the second duration.
5. The robotic system according to claim 1, further comprising a phase array antenna component configured to: generate waves in a specific frequency range to monitor health of one or more organs of a body of the user providing a health monitoring functionality; and function as a fixed wireless access (FWA) for 4G or 5G communication along with the health monitoring functionality, thereby providing dual functionality.
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1. A robotic system for physical therapy, comprising:a stimulus device configured to generate a stimulus, wherein the stimulus device comprises a plurality of slots to detachably attach a plurality of different stimulus sub- devices in the plurality of slots in a modular arrangement;a set of external response sensors configured to sense and measure an external response discernible on a body of a user on application of the stimulus;a set of internal response sensors configured to sense and measure an internal response within the body of the user on the application of the stimulus from the stimulus device;a user interface;control circuitry configured to:receive an input via the user interface, wherein the input comprises a current health state and a target health state of the user;retrieve at least one priori stimulus from a knowledge database based on the received input;determine a set of test stimuli specific for the user based on a combination of the current health state, the target health state, the retrieved at least one priori stimulus, and a trained Artificial Intelligence (AI)-based system; control the stimulus device to provideapply the determined set of test stimuli to the user for a first test duration;determine, based on the set of internal response sensors, a set of responses within the body of the user from the provided applied set of test stimuli;generate a physical stimulation instructions pack specific for the user based on an output from the trained Al-based system, wherein the physical stimulation instructions pack comprises:a time schedule that defines a specific activation time and a specific duration for the plurality of different stimulus sub-devices to generate a new stimulus in a second duration, wherein the second duration is different from the first test duration, anda set of sense identifiers, wherein each sense identifier of the set of sense identifiers indicates a unique specific sense stimulating item for output based on the time schedule; activate a set of stimulus sub-devices from the plurality of different stimulus sub-devices at a given timepoint in the second duration based on the time schedule in the generated physical stimulation instructions pack; calibrate a set of stimulus parameters for the stimulus device based on the physical stimulation instructions pack, a combination of the determined set of responses, the current health state, the target health state, and the trained Al-based system;and re-configure the stimulus device, based on the activation of the set of stimulus sub-devices at the given timepoint in the second duration, with the calibrated set of Page 3 of 19 stimulus parameters to apply the new stimulus to at least a portion of the body of the user for the second duration, wherein the use of the new stimulus shifts at least one condition of the user from the current health state towards the target health state; anda phase array antenna component configured to:generate waves in aspecific frequency range to monitor health of one or more organs of the body of the user providing a health monitoring functionality;andfunction as a fixed wireless access (FWA) for 4G or 5G communication along with the health monitoring functionality, thereby providing dual functionality
Claim 1 of the Patent is subdivided into Claims 1-5 of the present application, thus the claim under examination is anticipated by the reference claim(s) since the claims recite substantially similar limitations. Particularly, the entire scope of independent claims of Patent US 12295704 B2 falls within the scope of independent claims of the present application.
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6. The robotic system according to claim 4, wherein the control circuitry is further configured to receive supplementary information via the user interface, the supplementary information includes at least two of physical characteristics of the user, a geography, a feedback from a physical therapy expert, a first set of dosages of a first set of medicines prescribed for the current health state of the user, or diagnostic information from at least one medical diagnosis test, and the received supplementary information is fed to the trained AI-based system in addition to the input of the current health state and the target health state.
2. (Currently Amended) The robotic system according to claim 1, wherein the control circuitry is further configured to receive supplementary information via the user interface, wherein the supplementary information includes at least two of[[:]] physical characteristics of the user, a geography, a feedback from a physical therapy expert, a first set of dosages of a first set of medicines prescribed for the current health state of the user, [[and]]or diagnostic information from at least one medical diagnosis test, whereinand Page 4 of 19 the received supplementary information is fed to the trained Al-based system in addition to the input of the current health state and the target health state
The claims recite substantially similar limitations, the entire scope of claims of Patent US 12295704 B2 falls within the scope of independent claims of the present application. -
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7. The robotic system according to claim 2, wherein the control circuitry is further configured to identify, based on the set of internal response sensors and the application of the set of test stimuli, at least one of a nerve that responds to at least a first stimulus of the set of test stimuli, a muscle that responds to at least a second stimulus of the set of test stimuli, or a change in an activity in a brain area on the application of the set of test stimuli, in the set of responses within the body of the user.
3. (Currently Amended) The robotic system according to claim 1, wherein the control circuitry is further configured to identify, based on the set of internal response sensors and the application of the set of test stimuli, at least one of[[:]] a nerve that responds to at least [[one]]a first stimulus of the set of test stimuli, a muscle that responds to at least [[one]]a second stimulus of the set of test stimuli, or a change in an activity in a brain area on the application of the set of test stimuli, in the first set of responses within the body.
The claims recite substantially similar limitations, the entire scope of claims of Patent US 12295704 B2 falls within the scope of independent claims of the present application. -
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8. The robotic system according to claim 7, wherein the control circuitry is further configured to determine, based on the set of internal response sensors, a modus operandi of the nerve, the muscle, or a pattern of the change in the activity in the brain area on the application of each stimulus of the set of test stimuli.
4. (Currently Amended) The robotic system according to claim 3, wherein the control circuitry is further configured to determine, based on the set of internal response sensors, a modus operandi of the identified nerve, the identified muscle, or a pattern of the identified change in the activity in the brain area on the application of each stimulus of the set of test stimuli.
The claims recite substantially similar limitations, the entire scope of claims of Patent US 12295704 B2 falls within the scope of independent claims of the present application. -
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9. The robotic system according to claim 7, wherein the control circuitry is further configured to quantify, based on the set of internal response sensors, a level of response at the nerve, the muscle, or the brain area on the application of each stimulus of the set of test stimuli.
5. (Currently Amended) The robotic system according to claim 3, wherein the control circuitry is further configured to quantify, based on the set of internal response sensors, a level of response at the identified nerve, the identified muscle, or the brain area on the application of each stimulus of the set of test stimuli
The claims recite substantially similar limitations, the entire scope of claims of Patent US 12295704 B2 falls within the scope of independent claims of the present application.
10. The robotic system according to claim 1, wherein the control circuitry is further configured to identify, based on the set of external response sensors, at least two of: a change in a facial expression of the user on the application of at least one stimulus of the set of test stimuli on the user, a pattern of facial expression of the user on a sequential application of the set of test stimuli on the user, a change in skin color, a body posture, a voice feedback from the user, or a level of pain or comfort experienced by the user based on a deviation in a current user behaviour from a baseline behaviour of the user.
6. (Currently Amended) The robotic system according to claim 1, wherein the control circuitry is further configured to identify, based on the set of external response sensors, at least two of:a change in a facial expression [[on]]of the user on the application of at least one stimulus of the set of test stimuli on the user, a pattern of facial expression [[on]]of the user on a sequential application ofthe set of test stimuli on the user, a change in skin color, a body posture, a voice feedback from the user, [[and]]or a level of pain or comfort experienced by the user based on a deviation in a current user behaviour from a baseline behaviour of the user.
The claims recite substantially similar limitations, the entire scope of claims of Patent US 12295704 B2 falls within the scope of independent claims of the present application. -
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11. The robotic system according to claim 1, wherein the stimulus device is a human senses stimulator device.
7. (Currently Amended) The robotic system according to claim 1, wherein the stimulus device is a human senses stimulator device
The claims recite substantially similar limitations, the entire scope of claims of Patent US 12295704 B2 falls within the scope of independent claims of the present application.
12. The robotic system according to claim 11, wherein each stimulus sub-device of the plurality of different stimulus sub-devices is at least one of a pressure sub-device, a temperature sub-device, a vibrator sub-device, a sound wave control sub-device, a virtual reality (VR) scene projecting sub-device, an odor emitter sub-device, a touch-sense sub-device, a magnetic field generator sub-device, or an integrated digital therapeutic environment generator sub-device.
8. (Currently Amended) The robotic system according to claim 7, wherein each stimulus sub-device of the plurality of different stimulus sub-devices is selected from at least one of[[:]] a pressure sub-device, a temperature sub-device, a vibrator sub-device, a sound wave control sub-device, a virtual reality (VR) scene projecting sub-device, an odor emitter sub-device, a touch-sense sub-device, a magnetic field generator sub-device, [[and]]or an integrated digital therapeutic environment generator sub-device.
The claims recite substantially similar limitations, the entire scope of claims of Patent US 12295704 B2 falls within the scope of independent claims of the present application. -
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13. The robotic system according to claim 11, wherein the physical stimulation instructions pack further comprises a type of control signal for the plurality of different stimulus sub-devices and an intensity of the output in the second duration.
10. (Currently Amended) The robotic system according to claim [[9]]7, wherein the physical stimulation instructions pack further comprises a type of control signal for the plurality of different stimulus sub-devices, a time schedule that defines a specific activation time and a specific duration to generate output in the second duration, and an intensity of the output in the second duration
The claims recite substantially similar limitations, the entire scope of claims of Patent US 12295704 B2 falls within the scope of independent claims of the present application. -
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14. A method of operation of a robotic system for physical therapy, the method comprising: in the robotic system that includes control circuitry: determining, by the control circuitry, a set of test stimuli specific for a user based on a trained Artificial Intelligence (AI)-based system of the robotic system; controlling, by the control circuitry, a stimulus device of the robotic system to apply the determined set of test stimuli to the user for a first test duration, wherein the stimulus device comprises a plurality of slots to detachably attach a plurality of different stimulus sub-devices in the plurality of slots in a modular arrangement; generating, by the control circuitry, a physical stimulation instructions pack specific for the user based on an output from the trained AI-based system, wherein the physical stimulation instructions pack comprises: a time schedule that defines a specific activation time and a specific duration for the plurality of different stimulus sub-devices to generate a new stimulus in a second duration, wherein the second duration is different from the first test duration, and a set of sense identifiers, wherein each sense identifier of the set of sense identifiers indicates a unique specific sense stimulating item for output based on the time schedule; activating, by the control circuitry, a set of stimulus sub-devices from the plurality of different stimulus sub-devices at a given timepoint in the second duration based on the time schedule in the generated physical stimulation instructions pack; and re-configuring, by the control circuitry, the stimulus device based on the activation of the set of stimulus sub-devices to shift at least one condition of the user from a current health state towards a target health state.
15. The method according to claim 14, further comprising: receiving, by the control circuitry, an input via a user interface, wherein the input comprises the current health state and the target health state of the user; retrieving, by the control circuitry, at least one priori stimulus from a knowledge database based on the received input; determining, by the control circuitry, a set of responses within a body of the user from the applied set of test stimuli, wherein the determination of the set of responses is based on a set of internal response sensors of the robotic system; and calibrating, by the control circuitry, a set of stimulus parameters for the stimulus device based on the physical stimulation instructions pack, a combination of the determined set of responses, the current health state, the target health state, and the trained AI-based system.
16. The method according to claim 14, further comprising: generating, by a phase array antenna component, waves in a specific frequency range to monitor health of one or more organs of a body of the user providing a health monitoring functionality; and functioning as a fixed wireless access (FWA) for 4G or 5G communication along with the health monitoring functionality, thereby providing dual functionality.
11. (Currently Amended) A method of operation of a robotic system for physical therapy, the method comprising:in the robotic system that includes control circuitry:receiving, by the control circuitry, an input via a user interface, wherein the input comprises a current health state and a target health state of a user;retrieving, by the control circuitry, at least one priori stimulus from a knowledge database based on the received input;determining, by the control circuitry, a set of test stimuli specific for the user based on a combination of the current health state, the target health state, the retrieved at least one priori stimulus, and a trained Artificial Intelligence (AI)-based system of the robotic system;controlling, by the control circuitry, a stimulus device of the robotic system toapply provide the determined set of test stimuli to the user for a first test duration, wherein the stimulus device comprises a plurality of slots to detachably attach a plurality of different stimulus sub-devices in the plurality of slots in a modular arrangement;determining, by the control circuitry, a first set of responses within a body of the user from the provided applied set of test stimuli, wherein the determination of the set of responses is based on a set of internal response sensors of the robotic system;generating, by the control circuitry, a physical stimulation instructions pack specific for the user based on an output from the trained Al-based system, wherein the physical stimulation instructions pack comprises:a time schedule that defines a specific activation time and a specific duration for the plurality of different stimulus sub-devices to generate a new stimulus in a second duration, wherein the second duration is different from the first test duration, anda set of sense identifiers, wherein each sense identifier of the set of sense identifiers indicates a unique specific sense stimulating item for output based on the time schedule; activating, by the control circuitry, a set of stimulus sub-devices from the plurality of different stimulus sub-devices at a given timepoint in the second duration based on the time schedule in the generated physical stimulation instructions pack; calibrating, by the control circuitry, a set of stimulus parameters for the stimulus device based on the physical stimulation instructions pack, a combination Page 8 of 19 of the determined first set of responses, the current health state, the target health state, and the trained Al-based system;re-configuring, by the control circuitry, the stimulus device with the calibrated set of stimulus parameters to apply [[a]]the new stimulus to at least a portion of the body of the user for [[a]]the second duration, wherein the re-configuring is based on the activation of the set of stimulus sub-devices at the given timepoint in the second duration, andthe use of the new stimulus shifts at least one condition of the user from the current health state towards the target health state; generating, by a phase array antenna component, waves in a specific frequency range to monitor health of one or more organs of the body of the user providing a health monitoring functionality; and functioning as a fixed wireless access (FWA) for 4G or 5G communication along with the health monitoring functionality, thereby providing dual functionality.
Claim 11 of the Patent is subdivided into Claims 14-16 of the present application, thus the claim under examination is anticipated by the reference claim(s) since the claims recite substantially similar limitations. Particularly, the entire scope of independent claims of Patent US 12295704 B2 falls within the scope of independent claims of the present application. -
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17. The method according to claim 15, further comprising identifying, by the control circuitry, at least one of a nerve that responds to at least a first stimulus of the set of test stimuli, a muscle that responds to at least a second stimulus of the set of test stimuli, or a change in an activity in a brain area on the application of the set of test stimuli, in the set of responses within the body of the user, wherein the identifying is based on the set of internal response sensors and the application of the set of test stimuli.
12. (Currently Amended) The method according to claim 11, further comprising identifying, by the control circuitry, at least one of[[:]] a nerve that responds to at least [[one]]a first stimulus of the set of test stimuli, a muscle that responds to at least [[one]]a second stimulus of the set of test stimuli, or a change in an activity in a brain area on the application of the set of test stimuli, in the first set of responses within the body,wherein the identifying is based on the set of internal response sensors and the application of the set of test stimuli.
The claims recite substantially similar limitations, the entire scope of claims of Patent US 12295704 B2 falls within the scope of independent claims of the present application. -
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18. The method according to claim 17, further comprising determining, by the control circuitry, a modus operandi of the nerve, the muscle, or a pattern of the change in the activity in the brain area on the application of each stimulus of the set of test stimuli, based on the set of internal response sensors.
13. (Currently Amended) The method according to claim [[11]]12, further comprising determining, by the control circuitry, a modus operandi of the identified nerve, the identified muscle, or a pattern of the identified change in the activity in the brain area onthe application of each stimulus of the set of test stimuli, based on the set of internal response sensors.
The claims recite substantially similar limitations, the entire scope of claims of Patent US 12295704 B2 falls within the scope of independent claims of the present application. -
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19. The method according to claim 17, further comprising: quantifying, by the control circuitry, a level of response at the nerve, the muscle, or the brain area on the application of each stimulus of the set of test stimuli, wherein the quantifying is based on the set of internal response sensors; and identifying, by the control circuitry, at least two of: a change in a facial expression of the user on the application of at least one stimulus of the set of test stimuli on the user, a pattern of facial expression of the user on a sequential application of the set of test stimuli on the user, a change in skin color, a body posture, a voice feedback from the user, or a level of pain or comfort experienced by the user based on a deviation in a current user behavior from a baseline behavior of the user, based on the set of external response sensors.
14. (Currently Amended) The method according to claim [[11]]1further comprising:quantifying, by the control circuitry, a level of response at the identified nerve, the identified muscle, or the brain area on theapplication of each stimulus of the set of test stimuli, wherein the quantifying is based on the set of internal response sensors; andidentifying, by the control circuitry, at least two of:a change in a facial expression [[on]]of the user on the application of at least one stimulus of the set of test stimuli on the user, a pattern of facial expression [[on]]of the user on a sequential application of the set of test stimuli on the user, a change in skin color, a body posture, a voice feedback from the user, [[and]]or a level of pain or comfort experienced by the user based on a deviation in a current user behavior from a baseline behavior of the user, based on the set of external response sensors.
The claims recite substantially similar limitations, the entire scope of claims of Patent US 12295704 B2 falls within the scope of independent claims of the present application. -
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20. A non-transitory computer readable medium having stored thereon, computer executable instruction, which when executed by a computer, cause the computer to execute operations, the operations comprising: determining a set of test stimuli specific for a user based on a trained Artificial Intelligence (AI)-based system of a robotic system; controlling a stimulus device of the robotic system to apply the determined set of test stimuli to the user for a first test duration, wherein the stimulus device comprises a plurality of slots to detachably attach a plurality of different stimulus sub-devices in the plurality of slots in a modular arrangement; generating a physical stimulation instructions pack specific for the user based on an output from the trained AI-based system, wherein the physical stimulation instructions pack comprises: a time schedule that defines a specific activation time and a specific duration for the plurality of different stimulus sub-devices to generate a new stimulus in a second duration, wherein the second duration is different from the first test duration, and a set of sense identifiers, wherein each sense identifier of the set of sense identifiers indicates a unique specific sense stimulating item for output based on the time schedule; activating a set of stimulus sub-devices from the plurality of different stimulus sub-devices at a given timepoint in the second duration based on the time schedule in the generated physical stimulation instructions pack; and re-configuring the stimulus device based on the activation of the set of stimulus sub-devices to shift at least one condition of the user from a current health state towards a target health state. -
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15. (Currently Amended) A non-transitory computer readable medium having stored thereon, computer executable instruction, which when executed by a computer, cause the computer to execute operations, the operations comprising:Page 10 of 19 receiving an input via a user interface, wherein the input comprises a current health state and a target health state of a user;retrieving at least one priori stimulus from a knowledge database based on the received input;determining a set of test stimuli specific for the user based on a combination of the current health state, the target health state, the retrieved at least one priori stimulus, and a trained Artificial Intelligence (AI)-based [[(AI) ]]system of a robotic system;controlling a stimulus device of the robotic system to apply provide the determined set of test stimuli to the user for a first test duration, wherein the stimulus device comprises a plurality of slots to detachably attach a plurality of different stimulus sub-devices in the plurality of slots in a modular arrangement;determining a set of responses within [[the]]a body of the user from the providedapplied set of test stimuli, wherein the determination of the set of responses is based on a set of internal response sensors of the robotic system;generating a physical stimulation instructions pack specific for the user based on an output from the trained Al-based system, wherein the physical stimulation instructions pack comprises:a time schedule that defines a specific activation time and a specific duration for the plurality of different stimulus sub-devices to generate a new stimulus in a second duration, wherein the second duration is different from the first test duration, andPage 11 of 19 a set of sense identifiers, wherein each sense identifier of the set of sense identifiers indicates a unique specific sense stimulating item for output based on the time schedule; activating a set of stimulus sub-devices from the plurality of different stimulus sub- devices at a given timepoint in the second duration based on the time schedule in the generated physical stimulation instructions pack; calibrating a set of stimulus parameters for the stimulus device based on the physical stimulation instructions pack, a combination of the determined set of responses, the current health state, the target health state, and the trained Al-based system; and re-configuring the stimulus device with the calibrated set of stimulus parameters to apply [[a]]the new stimulus to at least a portion of the body of the user for [[a]]the second duration, wherein the re-configuring is based on the activation of the set of stimulus sub-devices at the given timepoint in the second duration, andthe use of the new stimulus shifts at least one condition of the user from the current health state towards the target health state,andwherein the robotic system further includes a phase array antenna component configured to;generate waves in aspecific frequency range to monitor health of one or more organs of the body of the user providing a health monitoring functionality; and function as a fixed wireless access (FWA) for 4G or 5G communication along with the health monitoring functionality, thereby providing dual functionality.
Claim 15 of the Patent is subdivided within Claim 20 of the present application, thus the claim under examination is anticipated by the reference claim(s) since the claims recite substantially similar limitations. Particularly, the entire scope of independent claims of Patent US 12295704 B2 falls within the scope of independent claims of the present application. -
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Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 of this title, 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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Clark et al. (US 20190189259 A1) hereinafter referred to as Clark in view of Saroka et al. (US 10758150 B2) hereinafter referred to as Saroka in further view of Errico et al. (US 20190111255 A1) hereinafter referred to as Errico.
Clark teaches:
Claim 1. A robotic system for physical therapy, comprising:
a stimulus device configured to generate a stimulus, wherein the stimulus device comprises a plurality of slots to detachably attach a plurality of different stimulus sub-devices in the plurality of slots in a modular arrangement (¶0026 The patient treatment experience may include sense stimulation involving one or more of the five senses of the patient (sight, hearing, smell, taste, touch) and/or cognitive stimulation of the patient);
control circuitry configured to: determine a set of test stimuli specific for a user based on a trained Artificial Intelligence (AI)-based system (¶0040 It will be appreciated that the customized therapy may include one or more aggregations of therapies, including sense stimulation and/or cognitive stimulation. The experience generation system 106 analytically derives and targets the customized therapy for an individual patient using the patient experience generation system 106 and the patient intelligence system 110. The customized therapy executed by the treatment experience system 100 may be triggered by a sensor connected and/or ambient devices and software, animatronic life-like robots, ‘Carebots’, and other devices in various form factors, such as robotic humans, animals, toys, or other sensor connected devices, that monitor and detect changes in patient health, awareness and/or mood with their senses and thought as they impact patient experience factors. Examples of robotic devices that may be utilized for the treatment experience system 100 may be equipped with cameras to read facial expressions, sensors to capture vital signs, and speech recognition. Devices utilized by the treatment experience system 100 may meet the ISO 13482 standard for service robots);
control the stimulus device to apply the determined set of test stimuli to the user for a first test duration (¶0052 In another example, the desired resulting target change may be to slow the patient's respiration rate down during the song by targeted percentage, such as 15%. The algorithm reads the patient's beginning heart rate of 86 beat per minute and sets the matching MIDI tempo of the song playback to match 86 BPM. The treatment experience system 100 determines that a 3-minute song and a target ending heart rate will result in the targeted reduction of 15%; computes that a 5% reduction in heart rate per minute will result in the targeted endpoint heartrate of 73 BPM; and recalibrates the MIDI tempo for song playback to gradually slow down over the 3 minute song to end at a tempo of 73 BPM);
re-configure the stimulus device based on the activation of the set of stimulus sub-devices to shift at least one condition of the user from a current health state towards a target health state (¶0052 In another example, the desired resulting target change may be to slow the patient's respiration rate down during the song by targeted percentage, such as 15%. The algorithm reads the patient's beginning heart rate of 86 beat per minute and sets the matching MIDI tempo of the song playback to match 86 BPM. The treatment experience system 100 determines that a 3-minute song and a target ending heart rate will result in the targeted reduction of 15%; computes that a 5% reduction in heart rate per minute will result in the targeted endpoint heartrate of 73 BPM; and recalibrates the MIDI tempo for song playback to gradually slow down over the 3 minute song to end at a tempo of 73 BPM. During the song playback, the treatment experience system 100 monitors the real time impact of the slowing MIDI tempo on the patient's biometrics, biochemicals and Vital Signs, and if the patient is not responding as desired, for example, the heart rate is not slowing down as desired, the treatment experience system 100 may reset the tempo to match the patient heart rate and start over trying to entrain a slowdown playback, with a new adjusted target).
Although not explicitly taught by Clark, Saroka teaches in the analogous art of system for using electromagnetic radiation for monitoring a tissue of a user:
a stimulus device configured to generate a stimulus, wherein the stimulus device comprises a plurality of slots to detachably attach a plurality of different stimulus sub-devices in the plurality of slots in a modular arrangement (C.9 L.61 Reference is now made to FIG. 1, which is a schematic illustration of a wearable monitoring apparatus 100 that is attached to the body of a user, optionally to the thorax, as shown at 101. The wearable monitoring apparatus 100 is optionally connected to a user management unit 102, optionally in a bidirectional wireless connection, according to some embodiments of the present invention. C.10 L.44 The wearable monitoring apparatus 100 may communicate, optionally wirelessly, with a user management unit 102, which may be connected to the hospital IT unit, an emergency center and/or to a disease management center. C.28 L.32 the communication interface 208 is connected to a wireless data interface, such as an example an infrared (IR) interface, a wireless fidelity (Wi-Fi) interface, a Bluetooth™ module, a electromagnetic transducer module, a universal asynchronous receiver transmitter (UART) and the like. Optionally, the connection allows the wearable monitoring apparatus 100 to report on a malfunction in one of one or more front-end sensors 204 and on any other malfunction in the monitoring of the dielectric related properties of fluids in an internal area of the user's body's, for example in the pulmonary tissues of the user 101. C.28 L.56 the wearable monitoring apparatus 100 is connected to a dosage control unit (not shown). The dosage control unit may be integrated, in a detachable or fixed manner, into the wearable monitoring apparatus 100. C.36 L.55 In the group of antenna elements which are depicted in FIGS. 7 and 8 the relative phases of the respective signals feeding the antenna elements are varied in such a manner that the effective radiation power of the phased-array is reinforced in a specific internal area of the user's body, for example in the pulmonary tissues of the user 101, and optionally suppressed in other directions. In an equivalent manner, the phases of the received signals from the different antenna elements may be combined to focus the elements on a specific internal location. As described above, reflections from the pulmonary tissue may be calibrated according to the reflections from reference tissues).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system for using electromagnetic radiation for monitoring a tissue of a user of Saroka with the system for generating an optimized patient treatment experience of Clark for the following reasons:
(1) a finding that there was some teaching, suggestion, or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings, e.g. Clark ¶0004 teaches that it is desirable to correct problems involving patients who are medicated or overmedicated for reasons unrelated to their health or treatment;
(2) a finding that there was reasonable expectation of success since the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single prior art reference, e.g. Clark Abstract teaches systems and methods for generating an optimized treatment experience for a patient, and Saroka Abstract teaches a wearable monitoring apparatus for monitoring at least one biological parameter of an internal tissue of an ambulatory user; and
(3) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness, e.g. Clark at least the above cited paragraphs, and Saroka at least the inclusively cited paragraphs.
Therefore, it would be obvious to one skilled in the art at the time of the invention to combine the system for using electromagnetic radiation for monitoring a tissue of a user of Saroka with the system for generating an optimized patient treatment experience of Clark. The rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and whether there would have been a reasonable expectation of success in doing so." DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006). See MPEP 2143(G).
Although not explicitly taught by Clark in view of Saroka, Errico teaches in the analogous art of system for initial provisioning and refilling of medical devices:
generate a physical stimulation instructions pack specific for the user based on an output from the trained AI-based system, wherein the physical stimulation instructions pack comprises: a time schedule that defines a specific activation time and a specific duration for the plurality of different stimulus sub-devices to generate a new stimulus in a second duration, wherein the second duration is different from the first test duration, and a set of sense identifiers, wherein each sense identifier of the set of sense identifiers indicates a unique specific sense stimulating item for output based on the time schedule, activate a set of stimulus sub-devices from the plurality of different stimulus sub-devices at a given timepoint in the second duration based on the time schedule in the generated physical stimulation instructions pack (¶0113 Parameters for the nerve or tissue stimulation include power level, frequency and train duration (or pulse number). The stimulation characteristics of each pulse, such as depth of penetration, strength and selectivity, depend on the rise time and peak electrical energy transferred to the electrodes, as well as the spatial distribution of the electric field that is produced by the electrodes. The rise time and peak energy are governed by the electrical characteristics of the stimulator and electrodes, as well as by the anatomy of the region of current flow within the patient ¶0287 the medical device 108 can be adjusted to more intensely or less intensely prevent, diagnose, monitor, ameliorate, or treat based on switching between the first mode and the second mode. Likewise, the duration of operation includes a number of defined time periods during which the medical device can at least one of prevent, diagnose, monitor, ameliorate, or treat, such as a number of seconds, minutes, hours, days, weeks, months, or others, whether dependent on usage or independent of usage. As such, the medical device 108 can be adjusted to a least one of prevent, diagnose, monitor, ameliorate, or treat between a first defined time period and a second defined time period.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system for initial provisioning and refilling of medical devices of Errico with the system for generating an optimized patient treatment experience of Clark in view of Saroka for the following reasons:
(1) a finding that there was some teaching, suggestion, or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings, e.g. Clark ¶0004 teaches that it is desirable to correct problems involving patients who are medicated or overmedicated for reasons unrelated to their health or treatment;
(2) a finding that there was reasonable expectation of success since the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single prior art reference, e.g. Clark Abstract teaches systems and methods for generating an optimized treatment experience for a patient, and Saroka Abstract teaches a wearable monitoring apparatus for monitoring at least one biological parameter of an internal tissue of an ambulatory user, and Errico Abstract teaches a system including memory that stores a first content; a medical device coupled to a processor; and a reader coupled to the processor, wherein the reader is configured to read a second content from a storage medium such that the processor switches the medical device from a first mode to a second mode based on the first content corresponding to the second content; and
(3) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness, e.g. Clark in view of Saroka at least the above cited paragraphs, and Errico at least the inclusively cited paragraphs.
Therefore, it would be obvious to one skilled in the art at the time of the invention to combine the system for initial provisioning and refilling of medical devices of Errico with the system for generating an optimized patient treatment experience of Clark in view of Saroka. The rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and whether there would have been a reasonable expectation of success in doing so." DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006). See MPEP 2143(G).
Although not explicitly taught by Clark, Saroka teaches in the analogous art of system for using electromagnetic radiation for monitoring a tissue of a user:
Claim 2. The robotic system according to claim 1, further comprising: a set of external response sensors configured to sense and measure an external response discernible on a body of the user on application of the stimulus; and a set of internal response sensors configured to sense and measure an internal response within the body of the user on the application of the stimulus from the stimulus device (C.9 L.35 According to some embodiments of the present invention there is provided a wearable monitoring apparatus for detecting a posture of a user. The wearable monitoring apparatus may be integrated with the above mentioned apparatuses or with any medical biological probe which is used for monitoring a biological parameter of a patient and may be affected by the posture thereof.. C.6 L.5 According to an aspect of some embodiments of the present invention there is provided an apparatus for detecting a misplacement of a biological probe in relation to an internal tissue of a user.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system for using electromagnetic radiation for monitoring a tissue of a user of Saroka with the system for generating an optimized patient treatment experience of Clark for the following reasons:
(1) a finding that there was some teaching, suggestion, or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings, e.g. Clark ¶0004 teaches that it is desirable to correct problems involving patients who are medicated or overmedicated for reasons unrelated to their health or treatment;
(2) a finding that there was reasonable expectation of success since the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single prior art reference, e.g. Clark Abstract teaches systems and methods for generating an optimized treatment experience for a patient, and Saroka Abstract teaches a wearable monitoring apparatus for monitoring at least one biological parameter of an internal tissue of an ambulatory user; and
(3) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness, e.g. Clark at least the above cited paragraphs, and Saroka at least the inclusively cited paragraphs.
Therefore, it would be obvious to one skilled in the art at the time of the invention to combine the system for using electromagnetic radiation for monitoring a tissue of a user of Saroka with the system for generating an optimized patient treatment experience of Clark. The rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and whether there would have been a reasonable expectation of success in doing so." DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006). See MPEP 2143(G).
Clark teaches:
Claim 3. The robotic system according to claim 2, further comprising a user interface, wherein the control circuitry is further configured to: receive an input via the user interface, wherein the input comprises the current health state and the target health state of the user; retrieve at least one priori stimulus from a knowledge database based on the received input; determine the set of test stimuli specific for the user based on a combination of the current health state, the target health state, the retrieved at least one priori stimulus, and the trained AI-based system; determine, based on the set of internal response sensors, a set of responses within the body of the user from the applied set of test stimuli; and calibrate a set of stimulus parameters for the stimulus device based on the physical stimulation instructions pack, a combination of the determined set of responses, the current health state, the target health state, and the trained AI-based system (¶0040 It will be appreciated that the customized therapy may include one or more aggregations of therapies, including sense stimulation and/or cognitive stimulation. The experience generation system 106 analytically derives and targets the customized therapy for an individual patient using the patient experience generation system 106 and the patient intelligence system 110. The customized therapy executed by the treatment experience system 100 may be triggered by a sensor connected and/or ambient devices and software, animatronic life-like robots, ‘Carebots’, and other devices in various form factors, such as robotic humans, animals, toys, or other sensor connected devices, that monitor and detect changes in patient health, awareness and/or mood with their senses and thought as they impact patient experience factors. Examples of robotic devices that may be utilized for the treatment experience system 100 may be equipped with cameras to read facial expressions, sensors to capture vital signs, and speech recognition. Devices utilized by the treatment experience system 100 may meet the ISO 13482 standard for service robots).
Clark teaches:
Claim 4. The robotic system according to claim 3, wherein the re-configuration of the stimulus device is further based on the activation of the set of stimulus sub-devices at the given timepoint in the second duration, with the calibrated set of stimulus parameters to apply the new stimulus to the at least portion of the body of the user for the second duration (¶0052 In another example, the desired resulting target change may be to slow the patient's respiration rate down during the song by targeted percentage, such as 15%. The algorithm reads the patient's beginning heart rate of 86 beat per minute and sets the matching MIDI tempo of the song playback to match 86 BPM. The treatment experience system 100 determines that a 3-minute song and a target ending heart rate will result in the targeted reduction of 15%; computes that a 5% reduction in heart rate per minute will result in the targeted endpoint heartrate of 73 BPM; and recalibrates the MIDI tempo for song playback to gradually slow down over the 3 minute song to end at a tempo of 73 BPM).
Although not explicitly taught by Clark, Saroka teaches in the analogous art of system for using electromagnetic radiation for monitoring a tissue of a user:
Claim 5. The robotic system according to claim 1, further comprising a phase array antenna component configured to: generate waves in a specific frequency range to monitor health of one or more organs of a body of the user providing a health monitoring functionality; and function as a fixed wireless access (FWA) for 4G or 5G communication along with the health monitoring functionality, thereby providing dual functionality (C.9 L.61 Reference is now made to FIG. 1, which is a schematic illustration of a wearable monitoring apparatus 100 that is attached to the body of a user, optionally to the thorax, as shown at 101. The wearable monitoring apparatus 100 is optionally connected to a user management unit 102, optionally in a bidirectional wireless connection, according to some embodiments of the present invention. C.10 L.44 The wearable monitoring apparatus 100 may communicate, optionally wirelessly, with a user management unit 102, which may be connected to the hospital IT unit, an emergency center and/or to a disease management center. C.28 L.32 the communication interface 208 is connected to a wireless data interface, such as an example an infrared (IR) interface, a wireless fidelity (Wi-Fi) interface, a Bluetooth™ module, a electromagnetic transducer module, a universal asynchronous receiver transmitter (UART) and the like. Optionally, the connection allows the wearable monitoring apparatus 100 to report on a malfunction in one of one or more front-end sensors 204 and on any other malfunction in the monitoring of the dielectric related properties of fluids in an internal area of the user's body's, for example in the pulmonary tissues of the user 101. C.28 L.56 the wearable monitoring apparatus 100 is connected to a dosage control unit (not shown). The dosage control unit may be integrated, in a detachable or fixed manner, into the wearable monitoring apparatus 100. C.36 L.55 In the group of antenna elements which are depicted in FIGS. 7 and 8 the relative phases of the respective signals feeding the antenna elements are varied in such a manner that the effective radiation power of the phased-array is reinforced in a specific internal area of the user's body, for example in the pulmonary tissues of the user 101, and optionally suppressed in other directions. In an equivalent manner, the phases of the received signals from the different antenna elements may be combined to focus the elements on a specific internal location. As described above, reflections from the pulmonary tissue may be calibrated according to the reflections from reference tissues).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system for using electromagnetic radiation for monitoring a tissue of a user of Saroka with the system for generating an optimized patient treatment experience of Clark for the following reasons:
(1) a finding that there was some teaching, suggestion, or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings, e.g. Clark ¶0004 teaches that it is desirable to correct problems involving patients who are medicated or overmedicated for reasons unrelated to their health or treatment;
(2) a finding that there was reasonable expectation of success since the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single prior art reference, e.g. Clark Abstract teaches systems and methods for generating an optimized treatment experience for a patient, and Saroka Abstract teaches a wearable monitoring apparatus for monitoring at least one biological parameter of an internal tissue of an ambulatory user; and
(3) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness, e.g. Clark at least the above cited paragraphs, and Saroka at least the inclusively cited paragraphs.
Therefore, it would be obvious to one skilled in the art at the time of the invention to combine the system for using electromagnetic radiation for monitoring a tissue of a user of Saroka with the system for generating an optimized patient treatment experience of Clark. The rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and whether there would have been a reasonable expectation of success in doing so." DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006). See MPEP 2143(G).
Clark teaches:
Claim 6. The robotic system according to claim 4, wherein the control circuitry is further configured to receive supplementary information via the user interface, the supplementary information includes at least two of physical characteristics of the user, a geography, a feedback from a physical therapy expert, a first set of dosages of a first set of medicines prescribed for the current health state of the user, or diagnostic information from at least one medical diagnosis test, and the received supplementary information is fed to the trained AI-based system in addition to the input of the current health state and the target health state (¶0053 The treatment experience system 100 improves healthcare services and related technologies, including any underlying computer technologies, by optimizing the patient treatment experience, resulting in positive recovery and health for patients, lowered drug use and misuse, and reduced economic and human casualty costs associated with healthcare and drug misuse. ¶0059 Mind-body therapies are treatments that are meant to help the mind's ability to affect the functions and symptoms of the body. Complimentary medicine, or integrative medicine, when combined with traditional medicine, as many research studies have shown conclusively, can offer patients an improved mental state to heal faster, feel better about their clinical treatment and be discharged from a clinical setting sooner. The goal of integrative medicine is to maximize the wellness of the whole person, mind, body and spirit, not just an underlying disease or symptom, such as pain, stress, anxiety, or lack of mobility).
Clark teaches:
Claim 7. The robotic system according to claim 2, wherein the control circuitry is further configured to identify, based on the set of internal response sensors and the application of the set of test stimuli, at least one of a nerve that responds to at least a first stimulus of the set of test stimuli, a muscle that responds to at least a second stimulus of the set of test stimuli, or a change in an activity in a brain area on the application of the set of test stimuli, in the set of responses within the body of the user (¶0034 In one implementation, the experience factor assessment system 102 utilizes enhanced facial emotion recognition software using multi-modal algorithms to analyze facial expressions, comparing real time and historical readings, such as multiple separate points on the face, eyebrows, eye corners, nose, mouth, head position and gaze for signs of depression, isolation, anxiety, neuropsychiatric disorders, somatoform disorders, unique changes produced by individual facial muscles or muscle combinations, and/or the like. The current level of the patient experience factor may be expressed, for example, as a numerical reading on a scale (e.g., 1-10), a visual depiction (e.g., a varying selection of emoticon faces), or through a historical comparison of self-reported, calculated or biometrically derived levels. ¶0044 The biometric response data may include, without limitation, body temperature, galvanic skin response (gsr), heart rate, respiration rate, blood pressure, heart rate variability, muscle tension, peripheral oxygen saturation (SpO2), hydration, ECG signal).
Clark teaches:
Claim 8. The robotic system according to claim 7, wherein the control circuitry is further configured to determine, based on the set of internal response sensors, a modus operandi of the nerve, the muscle, or a pattern of the change in the activity in the brain area on the application of each stimulus of the set of test stimuli (¶0074 To aggregate general use templates, individual patient data is scrubbed of any unique patient specific identifiers in compliance with all applicable patient security and privacy guidelines, such as HIPPA, and then combined with additional aggregate patient therapy data to generate processed therapy data allowing the use of views, queries, rules based processing, algorithms and/or AI Machine Learning analysis, research and discovery of new and previously unknown combinations of complementary medicine, integrative medicine or alternative Therapy and traditional medicine to actively promote future patient discovery of individual ways to manage patient experience factors, lowering drug use and improving the patient experience by allowing the patient to positively control an aspect of their own therapeutic healing environment. AI and Machine Learning from the patient intelligence system 110 may redirect and constantly recalibrate the characteristics of the patient treatment experience administration, in a background mode or in real time).
Clark teaches:
Claim 9. The robotic system according to claim 7, wherein the control circuitry is further configured to quantify, based on the set of internal response sensors, a level of response at the nerve, the muscle, or the brain area on the application of each stimulus of the set of test stimuli (¶0459 The treatment experience system 100 contributes valuable, quantifiable insight to the Patient Experience Evaluation, sometimes represented by Survey Questions, as it reflects key areas of Patient Treatment and Clinical methods, highlighted in recent Medicare sponsored guideline Questions for assessing the Patient Experience).
Clark teaches:
Claim 10. The robotic system according to claim 1, wherein the control circuitry is further configured to identify, based on the set of external response sensors, at least two of: a change in a facial expression of the user on the application of at least one stimulus of the set of test stimuli on the user, a pattern of facial expression of the user on a sequential application of the set of test stimuli on the user, a change in skin color, a body posture, a voice feedback from the user, or a level of pain or comfort experienced by the user based on a deviation in a current user behaviour from a baseline behaviour of the user (¶0031 The experience factor assessment system 102 may capture the patient experience data using a variety of techniques and devices as described herein. Further, the experience factor assessment system 102 may determine a current level of the patient experience factor using a variety of techniques based on the patient experience data. For example, the experience factor assessment system 102 may determine the current level of pain through self-reporting of pain levels of the patient on a numeric scale of 1 to 10, by inputs such as the patient responding to numeric prompts, pointing to or selecting a graphical series of facial expressions, pain-related body postures, facial recognition software enabled by a camera reading of micro expressions of the patient, body language, gestures, and/or facial expressions of the patient, and/or the like).
Although not explicitly taught by Clark in view of Saroka, Errico teaches in the analogous art of system for initial provisioning and refilling of medical devices:
Claim 11. The robotic system according to claim 1, wherein the stimulus device is a human senses stimulator device (Fig. 1C. and ¶0290 the memory dongle can include a Universal Serial Bus (USB) dongle, a CompactFlash (CF) card, Secure Digital (SD) card, a MultiMediaCard (MMC) card. Therefore, the card can be a dumb card, a smart card, a memory card, a Wiegand card, a proximity card, or others, whether contact or contactless. Correspondingly, the reader 110B can be a smart card reader, a memory card reader, a Wiegand card reader, a magnetic stripe reader, a proximity reader, or others, whether the reader 110B is a non-intelligent reader, a semi-intelligent reader, or an intelligent reader. The input device 110 can be distinct from the medical device 108 or be a component of the medical device 108. The memory 106 can include the storage medium (e.g., removable memory chip) or vice versa. The memory 106 can exclude the storage medium or vice versa. ¶0332 As shown in FIGS. 20H and 201, the neurostimulator 700 can be used by removing the cap 712 from the housing 702, applying an energy conductive gel to the stimulation surfaces 706, and the positioning the stimulation surfaces 706 adjacent to the skin of the patient. In some embodiments, the energy conductive gel can be applied to the skin of the patient. Then, the power button 708 is turned on and the display 704 can display one or more symbols suitable at that time, as explained above. In embodiments where the housing 702 houses the speaker, then the speaker can output one or more sounds suitable at that time, as explained above. Note that the user can increase the intensity of stimulation by repeatedly pressing a top area of the control button 714 to a maximum level the user can tolerate.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system for initial provisioning and refilling of medical devices of Errico with the system for generating an optimized patient treatment experience of Clark in view of Saroka for the following reasons:
(1) a finding that there was some teaching, suggestion, or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings, e.g. Clark ¶0004 teaches that it is desirable to correct problems involving patients who are medicated or overmedicated for reasons unrelated to their health or treatment;
(2) a finding that there was reasonable expectation of success since the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single prior art reference, e.g. Clark Abstract teaches systems and methods for generating an optimized treatment experience for a patient, and Saroka Abstract teaches a wearable monitoring apparatus for monitoring at least one biological parameter of an internal tissue of an ambulatory user, and Errico Abstract teaches a system including memory that stores a first content; a medical device coupled to a processor; and a reader coupled to the processor, wherein the reader is configured to read a second content from a storage medium such that the processor switches the medical device from a first mode to a second mode based on the first content corresponding to the second content; and
(3) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness, e.g. Clark in view of Saroka at least the above cited paragraphs, and Errico at least the inclusively cited paragraphs.
Therefore, it would be obvious to one skilled in the art at the time of the invention to combine the system for initial provisioning and refilling of medical devices of Errico with the system for generating an optimized patient treatment experience of Clark in view of Saroka. The rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and whether there would have been a reasonable expectation of success in doing so." DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006). See MPEP 2143(G).
Although not explicitly taught by Clark in view of Saroka, Errico teaches in the analogous art of system for initial provisioning and refilling of medical devices:
Claim 12. The robotic system according to claim 11, wherein each stimulus sub-device of the plurality of different stimulus sub-devices is at least one of a pressure sub-device, a temperature sub-device, a vibrator sub-device, a sound wave control sub-device, a virtual reality (VR) scene projecting sub-device, an odor emitter sub-device, a touch-sense sub-device, a magnetic field generator sub-device, or an integrated digital therapeutic environment generator sub-device (¶0163 FIG. 6 illustrates use of the device 30 shown in FIG. 3 (30 in FIG. 8=31+32 in FIG. 3) to stimulate the vagus nerve at that location in the neck, in which the stimulator device 30 is shown to be applied to the target location on the patient's neck as described herein. For reference, FIG. 6 shows the locations of the following vertebrae: first cervical vertebra 71, the fifth cervical vertebra 75, the sixth cervical vertebra 76, and the seventh cervical vertebra 77. Because the smartphone is applied to the patient's neck, the patient will generally need a mirror 29 to view and touch the phone's touchscreen. Therefore, the images displayed on the phone's screen may be reversed when the device is used as shown in FIG. 6. Alternatively, the images displayed on the phone's screen may be transmitted wirelessly to a computer program in the base station, which will display (inclusive of augmented reality) the images on the computer screen of the base station, and the patient may interact with the smartphone wirelessly via the base station. ¶0178 In some embodiments, pairing of vagus nerve stimulation may be with an additional sensory stimulation. The paired sensory stimulation may be bright light, sound, tactile stimulation, or electrical stimulation of the tongue to simulate odor/taste, e.g., pulsating with the same frequency as the vagus nerve electrical stimulation.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system for initial provisioning and refilling of medical devices of Errico with the system for generating an optimized patient treatment experience of Clark in view of Saroka for the following reasons:
(1) a finding that there was some teaching, suggestion, or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings, e.g. Clark ¶0004 teaches that it is desirable to correct problems involving patients who are medicated or overmedicated for reasons unrelated to their health or treatment;
(2) a finding that there was reasonable expectation of success since the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single prior art reference, e.g. Clark Abstract teaches systems and methods for generating an optimized treatment experience for a patient, and Saroka Abstract teaches a wearable monitoring apparatus for monitoring at least one biological parameter of an internal tissue of an ambulatory user, and Errico Abstract teaches a system including memory that stores a first content; a medical device coupled to a processor; and a reader coupled to the processor, wherein the reader is configured to read a second content from a storage medium such that the processor switches the medical device from a first mode to a second mode based on the first content corresponding to the second content; and
(3) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness, e.g. Clark in view of Saroka at least the above cited paragraphs, and Errico at least the inclusively cited paragraphs.
Therefore, it would be obvious to one skilled in the art at the time of the invention to combine the system for initial provisioning and refilling of medical devices of Errico with the system for generating an optimized patient treatment experience of Clark in view of Saroka. The rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and whether there would have been a reasonable expectation of success in doing so." DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006). See MPEP 2143(G).
Although not explicitly taught by Clark in view of Saroka, Errico teaches in the analogous art of system for initial provisioning and refilling of medical devices:
Claim 13. The robotic system according to claim 11, wherein the physical stimulation instructions pack further comprises a type of control signal for the plurality of different stimulus sub-devices and an intensity of the output in the second duration (¶0113 Parameters for the nerve or tissue stimulation include power level, frequency and train duration (or pulse number). The stimulation characteristics of each pulse, such as depth of penetration, strength and selectivity, depend on the rise time and peak electrical energy transferred to the electrodes, as well as the spatial distribution of the electric field that is produced by the electrodes. The rise time and peak energy are governed by the electrical characteristics of the stimulator and electrodes, as well as by the anatomy of the region of current flow within the patient ¶0287 the medical device 108 can be adjusted to more intensely or less intensely prevent, diagnose, monitor, ameliorate, or treat based on switching between the first mode and the second mode. Likewise, the duration of operation includes a number of defined time periods during which the medical device can at least one of prevent, diagnose, monitor, ameliorate, or treat, such as a number of seconds, minutes, hours, days, weeks, months, or others, whether dependent on usage or independent of usage. As such, the medical device 108 can be adjusted to a least one of prevent, diagnose, monitor, ameliorate, or treat between a first defined time period and a second defined time period.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system for initial provisioning and refilling of medical devices of Errico with the system for generating an optimized patient treatment experience of Clark in view of Saroka for the following reasons:
(1) a finding that there was some teaching, suggestion, or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings, e.g. Clark ¶0004 teaches that it is desirable to correct problems involving patients who are medicated or overmedicated for reasons unrelated to their health or treatment;
(2) a finding that there was reasonable expectation of success since the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single prior art reference, e.g. Clark Abstract teaches systems and methods for generating an optimized treatment experience for a patient, and Saroka Abstract teaches a wearable monitoring apparatus for monitoring at least one biological parameter of an internal tissue of an ambulatory user, and Errico Abstract teaches a system including memory that stores a first content; a medical device coupled to a processor; and a reader coupled to the processor, wherein the reader is configured to read a second content from a storage medium such that the processor switches the medical device from a first mode to a second mode based on the first content corresponding to the second content; and
(3) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness, e.g. Clark in view of Saroka at least the above cited paragraphs, and Errico at least the inclusively cited paragraphs.
Therefore, it would be obvious to one skilled in the art at the time of the invention to combine the system for initial provisioning and refilling of medical devices of Errico with the system for generating an optimized patient treatment experience of Clark in view of Saroka. The rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and whether there would have been a reasonable expectation of success in doing so." DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006). See MPEP 2143(G).
As per claims 14,15,16,17,18,19 and 20, the method and medium tracks the system of claims 1,3,5,7&2,8&2,9&10 and 1, respectively, resulting in substantially similar limitations. The same cited prior art and rationale of claims 1,3,5,7&2,8&2,9&10 and 1 are applied to claims 14,15,16,17,18,19 and 20, respectively. Clark discloses that the embodiment may be found as a manufacture (Fig. 1 and ¶0516).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/KURTIS GILLS/Primary Examiner, Art Unit 3624
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