DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an Abstract Idea without significantly more.
[STEP 1]
Regarding claim 1, the claim is a process/method and is one of the four statutory categories.
[STEP 2A, Prong One]
The claims recite the following limitations that recite an abstract idea: activating the haptic actuator and recording information relative to the activation of the haptic actuator to create an event log associated with the hot flashes, wherein the information includes at least one selected from a group of a timestamp of a cooling session, a duration of a cooling session, a selected intensity of a cooling session, and a number of cooling session in a day (Observation or evaluation which is grouped as mental process under the 2019 PEG). The above limitations are directed to mental processes that can be done by a person simply observing and recording information relative to the activation of the haptic actuator to create an event log associated with the hot flashes.
[STEP 2A, Prong Two]
Claim 1 recites the additional elements of: a haptic actuator.
The haptic actuator is described as being used to “to provide thermal and/or physical sensations to a user to provide subjective symptom relief, as perceived by the user, for a condition of the user” (Specification [0005]), which amounts to merely being the field of use. The recited abstract process does not improve the functioning of the haptic actuator for treating hot flashes of a user by provide cooling thermal sensations to the user to provide subjective symptom relief for the user during an episode of hot flashes, or any other technology or technical field. Nor does the above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above- identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
The recording of information relative to the activation of the haptic actuator to create an event log associated with the hot flashes, wherein the information includes at least one selected from a group of a timestamp of a cooling session, a duration of a cooling session, a selected intensity of a cooling session, and a number of cooling session in a day is mere data gathering. Furthermore, the above- identified additional elements, the haptic actuator, do not add a meaningful limitation to the abstract idea because it amounts to simply performing basic well-understood, routine, conventional functions. See MPEP 2106.05(d). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent claim 1 (and respective dependent claims) is not integrated into a practical application under the 2019 PEG.
[STEP 2B]
The claims do not cite any additional structures that would make it significantly more than the judicial exception. The haptic actuator is described as being used to “to provide thermal and/or physical sensations to a user to provide subjective symptom relief, as perceived by the user, for a condition of the user” (Specification [0005]). These elements are conventional and well-known in the art as shown by Smith (US 20150101788 A1); FIGS. 1A-1C the controller is configured to apply a series of electrical signals to the thermoelectric material(s) to cause a thermal pulse to be generated at a region of the thermoelectric material(s) adjacent the surface as set forth in [0053], the device may be configured to generate a cooling pulse for inducing a perceived cooling effect to the user as set forth in [0062], wherein the temperature sensor(s), in some embodiments, may be configured with the controller to operate in accordance with a feedback loop, for example, to prevent excessive heating or cooling of the device and/or to maintain the temperature at the surface within a preferred range as set forth in [0111]; In some embodiments, the device includes one or more temperature sensors for monitoring the temperature at the surface of the thermoelectric material(s) and/or skin. For example, if the temperature measured at the surface of the thermoelectric material(s) and/or skin exceeds or is lower than a desired temperature, the sensor may send a signal to the controller to adjust the applied electrical signal (e.g., apply a negative (or lower) voltage to reduce the temperature, apply a positive (or higher) voltage to increase the temperature) to result in a preferred temperature profile as set forth in [0110], wherein the device may be used to alleviate hot flashes as set forth in [0113], the hot flashes reflected in the temperature obtained by the sensors. The use of a generic processor, memory and/or any other general computer components, such as an external database (as disclosed in claims 3) to store information and perform basic calculations and outputting said results is considered well-understood, routine, conventional computer functions. See MPEP 2106.05(d). The creation of an event log associated with the information associated with the hot flashes is merely an extra solution activity in that it provides an indication of the result of the abstract determination process. It is well-known analysis technique involving an act of evaluating information that can be practically performed in the human mind. Therefore, in addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is-well-understood or conventional. See MPEP 2106.05((g). The components found in the claim are well-known to be conventional in the art.
Further, dependent claims 2-11 include limitations that either further define the abstract idea by further defining the information recorded in claims 3 and 6-9 (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use, like in claims 4 drawn to a local memory, or like in claims 5 and 10-11 drawn to operation parameters of the haptic actuator and symptom relief thereof, because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
[STEP 1]
Regarding claim 12, the claim is a device/machine and is one of the four statutory categories.
[STEP 2A, Prong One]
The claims recite the following limitations that recite an abstract idea: activating the haptic actuator and recording information relative to the activation of the haptic actuator to create an event log associated with the hot flashes, wherein the information includes at least one selected from a group of a timestamp of a cooling session, a duration of a cooling session, a selected intensity of a cooling session, and a number of cooling session in a day (Observation or evaluation which is grouped as mental process under the 2019 PEG). The above limitations are directed to mental processes that can be done by a person simply observing and recording information relative to the activation of the haptic actuator to create an event log associated with the hot flashes.
[STEP 2A, Prong Two]
Claim 12 recites the additional elements of: a haptic actuator with one or more thermal and/or physical actuators and a controller with one or more processors.
The haptic actuator is described as being used to “to provide thermal and/or physical sensations to a user to provide subjective symptom relief, as perceived by the user, for a condition of the user” (Specification [0005]), and the controller “is configured to: activate the one or more thermal and/or physical actuators to provide thermal and/or physical sensations to a user to provide subjective symptom relief, as perceived by the user, for a condition of the user; determine if the haptic actuator provided a desired amount of subjective symptom relief to the user; and update one or more operating parameters of the haptic actuator if the haptic actuator did not provide the desired amount of subjective symptom relief to the user. “ (Specification [0008]), which amounts to merely being the field of use. The recited abstract process does not improve the functioning of the haptic actuator for treating hot flashes of a user by provide cooling thermal sensations to the user to provide subjective symptom relief for the user during an episode of hot flashes, or any other technology or technical field. Nor does the above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above- identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
The recording of information relative to the activation of the haptic actuator to create an event log associated with the hot flashes, wherein the information includes at least one selected from a group of a timestamp of a cooling session, a duration of a cooling session, a selected intensity of a cooling session, and a number of cooling session in a day is mere data gathering. Furthermore, the above- identified additional elements, the haptic actuator or controller, do not add a meaningful limitation to the abstract idea because it amounts to simply performing basic well-understood, routine, conventional functions. See MPEP 2106.05(d). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent claim 1 (and respective dependent claims) is not integrated into a practical application under the 2019 PEG.
[STEP 2B]
The claims do not cite any additional structures that would make it significantly more than the judicial exception. The haptic actuator is described as being used to “to provide thermal and/or physical sensations to a user to provide subjective symptom relief, as perceived by the user, for a condition of the user” (Specification [0005]). These elements are conventional and well-known in the art as shown by Smith (US 20150101788 A1); FIGS. 1A-1C the controller is configured to apply a series of electrical signals to the thermoelectric material(s) to cause a thermal pulse to be generated at a region of the thermoelectric material(s) adjacent the surface as set forth in [0053], the device may be configured to generate a cooling pulse for inducing a perceived cooling effect to the user as set forth in [0062], wherein the temperature sensor(s), in some embodiments, may be configured with the controller to operate in accordance with a feedback loop, for example, to prevent excessive heating or cooling of the device and/or to maintain the temperature at the surface within a preferred range as set forth in [0111]; In some embodiments, the device includes one or more temperature sensors for monitoring the temperature at the surface of the thermoelectric material(s) and/or skin. For example, if the temperature measured at the surface of the thermoelectric material(s) and/or skin exceeds or is lower than a desired temperature, the sensor may send a signal to the controller to adjust the applied electrical signal (e.g., apply a negative (or lower) voltage to reduce the temperature, apply a positive (or higher) voltage to increase the temperature) to result in a preferred temperature profile as set forth in [0110], wherein the device may be used to alleviate hot flashes as set forth in [0113], the hot flashes reflected in the temperature obtained by the sensors. The use of a generic processor, memory and/or any other general computer components, such as an external database (as disclosed in claim 13) to store information and perform basic calculations and outputting said results is considered well-understood, routine, conventional computer functions. See MPEP 2106.05(d). The creation of an event log associated with the information associated with the hot flashes is merely an extra solution activity in that it provides an indication of the result of the abstract determination process. It is well-known analysis technique involving an act of evaluating information that can be practically performed in the human mind. Therefore, in addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is-well-understood or conventional. See MPEP 2106.05((g). The components found in the claim are well-known to be conventional in the art.
Further, dependent claims 13-20 include limitations that either further define the abstract idea by further defining the information recorded in claims 13 and 16-18 (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use, like in claims 14 drawn to a local memory, or like in claims 15 and 19-20 drawn to operation parameters of the haptic actuator and symptom relief thereof, because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 4-7, 9, 12, 14-16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 20150101788 A1) in view of Rogers (US 20150374538 A1).
Regarding claim 1, Smith discloses a method of operating a haptic actuator (FIGS. 1A-1C Device 100 as set forth in [0041] and as set forth in the abstract) for treating hot flashes of a user (As set forth in [0113]), the method comprising: activating the haptic actuator to provide cooling thermal sensations to the user to provide subjective symptom relief for the user during an episode of hot flashes (FIGS. 1A-1C the controller is configured to apply a series of electrical signals to the thermoelectric material(s) to cause a thermal pulse to be generated at a region of the thermoelectric material(s) adjacent the surface as set forth in [0053], the device may be configured to generate a cooling pulse for inducing a perceived cooling effect to the user as set forth in [0062], wherein the temperature sensor(s), in some embodiments, may be configured with the controller to operate in accordance with a feedback loop, for example, to prevent excessive heating or cooling of the device and/or to maintain the temperature at the surface within a preferred range as set forth in [0111]) and wherein the activation of the device is associated with hot flashes (FIGS. 1A-1C In some embodiments, the device includes one or more temperature sensors for monitoring the temperature at the surface of the thermoelectric material(s) and/or skin. For example, if the temperature measured at the surface of the thermoelectric material(s) and/or skin exceeds or is lower than a desired temperature, the sensor may send a signal to the controller to adjust the applied electrical signal (e.g., apply a negative (or lower) voltage to reduce the temperature, apply a positive (or higher) voltage to increase the temperature) to result in a preferred temperature profile as set forth in [0110], wherein the device may be used to alleviate hot flashes as set forth in [0113], the hot flashes reflected in the temperature obtained by the sensors).
Smith fails to explicitly disclose recording information relative to the activation of the haptic actuator to create an event log associated with the hot flashes, wherein the information includes at least one selected from a group of a timestamp of a cooling session, a duration of a cooling session, a selected intensity of a cooling session, and a number of cooling session in a day.
However, Rogers teaches wherein the controller (Rogers: FIG. 13-15 The controller comprises a memory 110 representative of the overall hierarchy of memory devices containing software and data used to implement the functionality of the controller 11, a network module 11d configured to receive and/or transmit data, a GUI module 11e configured to display information and/or accept user input and/or a feedback module 11f configured to receive, transmit, and/or analyze data as set forth in [0242]) is capable of recording information relative to the activation of the device to create an event log, wherein the information includes at least one selected from a group of a timestamp of a cooling session, a duration of a cooling session, a selected intensity of a cooling session, and a number of cooling session in a day. (Rogers: FIG. 10-11 The GUI module may be configured to display any suitable information, including, but not limited to, data associated with the delivery of one or more thermal waveforms. For example, the GUI module may be configured to display: the amount of time that has elapsed since the onset of delivery of one or more thermal waveforms, the number of treatment sessions that have been administered, the precise time/temperature parameters of the thermal waveform(s) delivered to a patient, the date/time of delivery of the thermal waveform(s) delivered to a patient, subjective measures of efficacy (e.g., a patient-reported pain score), and comments a patient made about his/her treatment sessions as set forth in [0182], the thermal waveforms being delivered to the vestibular or nervous system of a patient by heating or cooling the earpieces as set forth in [0296], and wherein the feedback module is configured to receive and/or analyze patient feedback data, physician feedback data and/or patient information from a GUI module residing in the controller to analyze the effectiveness of the treatment or the effect of modifications of the treatment as set forth in [0191]).
Smith and Rogers are both considered to be analogous to the claimed invention because they are in the same field of methods of treating a subject in need thereof, involving the delivery of a thermal sensation to the user. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Controller and control system and method of the haptic actuator to incorporate the teaching of Rogers and include wherein the controller (Rogers: FIG. 13-15 The controller comprises a memory 110 representative of the overall hierarchy of memory devices containing software and data used to implement the functionality of the controller 11, a network module 11d configured to receive and/or transmit data, a GUI module 11e configured to display information and/or accept user input and/or a feedback module 11f configured to receive, transmit, and/or analyze data as set forth in [0242]) is capable of recording information relative to the activation of the device to create an event log, wherein the information includes at least one selected from a group of a timestamp of a cooling session, a duration of a cooling session, a selected intensity of a cooling session, and a number of cooling session in a day. (Rogers: FIG. 10-11 The GUI module may be configured to display any suitable information, including, but not limited to, data associated with the delivery of one or more thermal waveforms. For example, the GUI module may be configured to display: the amount of time that has elapsed since the onset of delivery of one or more thermal waveforms, the number of treatment sessions that have been administered, the precise time/temperature parameters of the thermal waveform(s) delivered to a patient, the date/time of delivery of the thermal waveform(s) delivered to a patient, subjective measures of efficacy (e.g., a patient-reported pain score), and comments a patient made about his/her treatment sessions as set forth in [0182], the thermal waveforms being delivered to the vestibular or nervous system of a patient by heating or cooling the earpieces as set forth in [0296], and wherein the feedback module is configured to receive and/or analyze patient feedback data, physician feedback data and/or patient information from a GUI module residing in the controller to analyze the effectiveness of the treatment or the effect of modifications of the treatment as set forth in [0191]). Doing so would provide a log of the treatment given to the patient that can be analyzed to determine the effectiveness of the treatment or the effect of modifications of the treatment as set forth in (Rogers: As set forth in [0191]), in the case of Smith as modified, the event log being associated with the hot flashes of the user.
Regarding claim 2, Smith as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Smith as modified by Rogers further teaches, the method further comprising presenting the information to the user (Rogers: FIG. 10-11 GUI module 11e is configured to display information and/or accept user input as set forth in [0242]).
Regarding claim 4, Smith as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Smith as modified by Rogers further teaches wherein recording the information includes recording the information in a local memory of the haptic actuator (Rogers: FIG. 13-15 The controller 11 comprises memory 110, wherein memory 110 is representative of the overall hierarchy of memory devices containing software and data used to implement the functionality of the controller 11 as set forth in [0242]).
Regarding claim 5, Smith as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Smith as modified by Rogers further teaches, the method further comprising updating one or more operating parameters of the haptic actuator during symptom relief in response to input from the user to provide a desired subjective amount of symptom relief (For each of the heating and cooling modes, the user may also adjust various parameters (e.g., magnitude of temperature change, rate of change, duration of each pulse, steady-state temperature, etc.) based on preference as set forth in [0038]; Moreover, methods and devices described herein may provide a user with personal control over his/her level of thermal comfort as set forth in [0039]).
Regarding claim 6, Smith as modified discloses the claimed invention substantially as claimed as set forth for claim 5 above.
Smith as modified by Rogers further teaches, wherein the information includes the updated one or more operating parameters of the haptic actuator (Rogers: FIG. 10-11 The GUI module may be configured to display any suitable information, including, but not limited to, data associated with the delivery of one or more thermal waveforms including: the amount of time that has elapsed since the onset of delivery of one or more thermal waveforms, the number of treatment sessions that have been administered, the precise time/temperature parameters of the thermal waveform(s) delivered to a patient, the date/time of delivery of the thermal waveform(s) delivered to a patient as set forth in [0182], the thermal waveforms being delivered to the vestibular or nervous system of a patient by heating or cooling the earpieces as set forth in [0296], and wherein the feedback module is configured to receive and/or analyze patient feedback data, physician feedback data and/or patient information from a GUI module residing in the controller to analyze the effectiveness of the treatment or the effect of modifications of the treatment as set forth in [0191], which would include those of the updated parameters).
Regarding claim 7, Smith as modified discloses the claimed invention substantially as claimed as set forth for claim 5 above.
Smith as modified by Rogers further teaches wherein the information includes the one or more operating parameters of the haptic actuator before being updated (Rogers: FIG. 10-11 The GUI module may be configured to display any suitable information, including, but not limited to, data associated with the delivery of one or more thermal waveforms including: the amount of time that has elapsed since the onset of delivery of one or more thermal waveforms, the number of treatment sessions that have been administered, the precise time/temperature parameters of the thermal waveform(s) delivered to a patient, the date/time of delivery of the thermal waveform(s) delivered to a patient as set forth in [0182], the thermal waveforms being delivered to the vestibular or nervous system of a patient by heating or cooling the earpieces as set forth in [0296], and wherein the feedback module is configured to receive and/or analyze patient feedback data, physician feedback data and/or patient information from a GUI module residing in the controller to analyze the effectiveness of the treatment or the effect of modifications of the treatment as set forth in [0191], which would include those before the updated parameters).
Regarding claim 9, Smith as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Smith as modified by Rogers further teaches wherein the information includes a subjective severity of the episode of hot flashes as input by the user (Rogers: FIG. 10-11 The GUI module may be configured to display any suitable information, including, subjective measures of efficacy (e.g., a patient-reported pain score), and comments a patient made about his/her treatment sessions as set forth in [0182], wherein the feedback module is configured to receive and/or analyze patient feedback data, physician feedback data and/or patient information from a GUI module residing in the controller to analyze the effectiveness of the treatment or the effect of modifications of the treatment as set forth in [0191]; the reported pain score would be associated with the severity of hot flashes for each treatment session in the device of Smith as modified with the control system and method of Rogers).
Regarding claim 12, Smith discloses a haptic actuator comprising: one thermal actuator configured to apply thermal stimulation to a user (FIGS. 1A-1C Device 100 as set forth in [0041] and as set forth in the abstract); and a controller operatively coupled to the thermal actuator (FIGS. 1A-1C the controller is configured to apply a series of electrical signals to the thermoelectric material(s) to cause a thermal pulse to be generated at a region of the thermoelectric material(s) adjacent the surface as set forth in [0053]), wherein the controller is configured to: activate the haptic actuator to provide cooling thermal sensations to the user to provide subjective symptom relief for the user during an episode of hot flashes (FIGS. 1A-1C the controller is configured to apply a series of electrical signals to the thermoelectric material(s) to cause a thermal pulse to be generated at a region of the thermoelectric material(s) adjacent the surface as set forth in [0053], the device may be configured to generate a cooling pulse for inducing a perceived cooling effect to the user as set forth in [0062], wherein the temperature sensor(s), in some embodiments, may be configured with the controller to operate in accordance with a feedback loop, for example, to prevent excessive heating or cooling of the device and/or to maintain the temperature at the surface within a preferred range as set forth in [0111]; In some embodiments, the device includes one or more temperature sensors for monitoring the temperature at the surface of the thermoelectric material(s) and/or skin. For example, if the temperature measured at the surface of the thermoelectric material(s) and/or skin exceeds or is lower than a desired temperature, the sensor may send a signal to the controller to adjust the applied electrical signal (e.g., apply a negative (or lower) voltage to reduce the temperature, apply a positive (or higher) voltage to increase the temperature) to result in a preferred temperature profile as set forth in [0110], wherein the device may be used to alleviate hot flashes as set forth in [0113], the hot flashes reflected in the temperature obtained by the sensors).
Smith fails to explicitly disclose recording information relative to the activation of the haptic actuator to create an event log associated with the hot flashes, wherein the information includes at least one selected from a group of a timestamp of a cooling session, a duration of a cooling session, a selected intensity of a cooling session, and a number of cooling session in a day and that the controller includes a processor.
However, Rogers teaches wherein the controller (Rogers: FIG. 13-15 The controller comprises a memory 110 representative of the overall hierarchy of memory devices containing software and data used to implement the functionality of the controller 11, a network module 11d configured to receive and/or transmit data, a GUI module 11e configured to display information and/or accept user input and/or a feedback module 11f configured to receive, transmit, and/or analyze data as set forth in [0242]) is capable of recording information relative to the activation of the device to create an event log, wherein the information includes at least one selected from a group of a timestamp of a cooling session, a duration of a cooling session, a selected intensity of a cooling session, and a number of cooling session in a day. (Rogers: FIG. 10-11 The GUI module may be configured to display any suitable information, including, but not limited to, data associated with the delivery of one or more thermal waveforms. For example, the GUI module may be configured to display: the amount of time that has elapsed since the onset of delivery of one or more thermal waveforms, the number of treatment sessions that have been administered, the precise time/temperature parameters of the thermal waveform(s) delivered to a patient, the date/time of delivery of the thermal waveform(s) delivered to a patient, subjective measures of efficacy (e.g., a patient-reported pain score), and comments a patient made about his/her treatment sessions as set forth in [0182], the thermal waveforms being delivered to the vestibular or nervous system of a patient by heating or cooling the earpieces as set forth in [0296], and wherein the feedback module is configured to receive and/or analyze patient feedback data, physician feedback data and/or patient information from a GUI module residing in the controller to analyze the effectiveness of the treatment or the effect of modifications of the treatment as set forth in [0191]), further, the controller includes a processor (Rogers: a processor programmed to carry out a method as set forth in [0026]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Controller and control system and method of the haptic actuator to incorporate the teaching of Rogers and include wherein the controller (Rogers: FIG. 13-15 The controller comprises a memory 110 representative of the overall hierarchy of memory devices containing software and data used to implement the functionality of the controller 11, a network module 11d configured to receive and/or transmit data, a GUI module 11e configured to display information and/or accept user input and/or a feedback module 11f configured to receive, transmit, and/or analyze data as set forth in [0242]) is capable of recording information relative to the activation of the device to create an event log, wherein the information includes at least one selected from a group of a timestamp of a cooling session, a duration of a cooling session, a selected intensity of a cooling session, and a number of cooling session in a day. (Rogers: FIG. 10-11 The GUI module may be configured to display any suitable information, including, but not limited to, data associated with the delivery of one or more thermal waveforms. For example, the GUI module may be configured to display: the amount of time that has elapsed since the onset of delivery of one or more thermal waveforms, the number of treatment sessions that have been administered, the precise time/temperature parameters of the thermal waveform(s) delivered to a patient, the date/time of delivery of the thermal waveform(s) delivered to a patient, subjective measures of efficacy (e.g., a patient-reported pain score), and comments a patient made about his/her treatment sessions as set forth in [0182], the thermal waveforms being delivered to the vestibular or nervous system of a patient by heating or cooling the earpieces as set forth in [0296], and wherein the feedback module is configured to receive and/or analyze patient feedback data, physician feedback data and/or patient information from a GUI module residing in the controller to analyze the effectiveness of the treatment or the effect of modifications of the treatment as set forth in [0191]), further, the controller includes a processor (Rogers: a processor programmed to carry out a method as set forth in [0026]). Doing so would provide a log of the treatment given to the patient that can be analyzed to determine the effectiveness of the treatment or the effect of modifications of the treatment as set forth in (Rogers: As set forth in [0191]), in the case of Smith as modified, the event log being associated with the hot flashes of the user. A processor is a well-known aspect of a controller, programmed to carry out the method (Rogers: As set forth in [0026]).
Regarding claim 14, Smith as modified discloses the claimed invention substantially as claimed as set forth for claim 12 above.
Smith as modified by Rogers further teaches wherein the controller is configured to record the information in a local memory of the haptic actuator (Rogers: FIG. 13-15 The controller 11 comprises memory 110, wherein memory 110 is representative of the overall hierarchy of memory devices containing software and data used to implement the functionality of the controller 11 as set forth in [0242]).
Regarding claim 15, Smith as modified discloses the claimed invention substantially as claimed as set forth for claim 12 above.
Smith as modified by Rogers further teaches, wherein the controller is configured to update one or more operating parameters of the haptic actuator during symptom relief in response to input from the user to provide a desired subjective amount of symptom relief (For each of the heating and cooling modes, the user may also adjust various parameters (e.g., magnitude of temperature change, rate of change, duration of each pulse, steady-state temperature, etc.) based on preference as set forth in [0038]; Moreover, methods and devices described herein may provide a user with personal control over his/her level of thermal comfort as set forth in [0039]).
Regarding claim 16, Smith as modified discloses the claimed invention substantially as claimed as set forth for claim 15 above.
Smith as modified by Rogers further teaches, wherein the information includes the updated one or more operating parameters of the haptic actuator (Rogers: FIG. 10-11 The GUI module may be configured to display any suitable information, including, but not limited to, data associated with the delivery of one or more thermal waveforms including: the amount of time that has elapsed since the onset of delivery of one or more thermal waveforms, the number of treatment sessions that have been administered, the precise time/temperature parameters of the thermal waveform(s) delivered to a patient, the date/time of delivery of the thermal waveform(s) delivered to a patient as set forth in [0182], the thermal waveforms being delivered to the vestibular or nervous system of a patient by heating or cooling the earpieces as set forth in [0296], and wherein the feedback module is configured to receive and/or analyze patient feedback data, physician feedback data and/or patient information from a GUI module residing in the controller to analyze the effectiveness of the treatment or the effect of modifications of the treatment as set forth in [0191], which would include those of the updated parameters).
Regarding claim 18, Smith as modified discloses the claimed invention substantially as claimed as set forth for claim 12 above.
Smith as modified by Rogers further teaches wherein the information includes a subjective severity of the episode of hot flashes as input by the user (Rogers: FIG. 10-11 The GUI module may be configured to display any suitable information, including, subjective measures of efficacy (e.g., a patient-reported pain score), and comments a patient made about his/her treatment sessions as set forth in [0182], wherein the feedback module is configured to receive and/or analyze patient feedback data, physician feedback data and/or patient information from a GUI module residing in the controller to analyze the effectiveness of the treatment or the effect of modifications of the treatment as set forth in [0191]; the reported pain score would be associated with the severity of hot flashes for each treatment session in the device of Smith as modified with the control system and method of Rogers).
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 20150101788 A1) in view of Rogers (US 20150374538 A1) as applied to claim 1, in further view of Yi (US 20170056238 A1).
Regarding claim 3, Smith as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Smith as modified fails to explicitly disclose the method, further comprising transmitting the information to a remotely located database that includes the event log associated with the hot flashes of the user.
However, Yi teaches transmitting information to a remotely located database (Yi: Data parameters, e.g., measured blood pressure, temperature of a contact tip, time or date of use, before, during, or after using the device can be saved into a database and transmitted to the remote data server. Medical or health professionals or users that receive the data through the remote server program can send feedback or instructions).
Smith and Yi are both considered to be analogous to the claimed invention because they are in the same field of a stimulation devices, systems and methods for therapeutic treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control system and method of the haptic actuator to incorporate the teaching of Yi and include wherein the method, further comprises transmitting information to a remotely located database (Yi: Data parameters, e.g., measured blood pressure, temperature of a contact tip, time or date of use, before, during, or after using the device can be saved into a database and transmitted to the remote data server. Medical or health professionals or users that receive the data through the remote server program can send feedback or instructions). Doing so would enable medical or health professionals or users to receive data through the remote server program to provide feedback or instructions (Yi: As set forth in [0158]).
Regarding claim 13, Smith as modified discloses the claimed invention substantially as claimed as set forth for claim 12 above.
Smith as modified fails to explicitly disclose wherein the controller is configured to transmit the information to a remotely located database that includes the event log associated with the hot flashes of the user.
However, Yi teaches transmitting information to a remotely located database (Yi: Data parameters, e.g., measured blood pressure, temperature of a contact tip, time or date of use, before, during, or after using the device can be saved into a database and transmitted to the remote data server. Medical or health professionals or users that receive the data through the remote server program can send feedback or instructions).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control system and method of the haptic actuator to incorporate the teaching of Yi and include wherein the method, further comprises transmitting information to a remotely located database (Yi: Data parameters, e.g., measured blood pressure, temperature of a contact tip, time or date of use, before, during, or after using the device can be saved into a database and transmitted to the remote data server. Medical or health professionals or users that receive the data through the remote server program can send feedback or instructions). Doing so would enable medical or health professionals or users to receive data through the remote server program to provide feedback or instructions (Yi: As set forth in [0158]).
Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 20150101788 A1) in view of Rogers (US 20150374538 A1) as applied to claim 1, in further view of Liao (US 20140206945 A1).
Regarding claim 8, Smith as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Smith as modified fails to explicitly disclose the method, further comprising confirming that the activation of the haptic actuator was associated with a presence of hot flashes, wherein if the activation of the haptic actuator was not associated with presence of hot flashes, the information is not recorded.
However, Liao teaches wherein the method involves the step of confirming with the user that the episode was associated with the condition of the user (Liao: The device receives input from the user that a depression event occurred as set forth in [0086]) and updating the one or more predetermined activation parameters based at least partly on the one or more physiological states of the user and whether or not the episode was associated with the condition of the user (Liao: The user input is used to adjust the parameters of the device for future actuations as set forth in [0088]).
Smith and Liao are both considered to be analogous to the claimed invention because they are in the same field of methods of operating a haptic actuator to provide relief to a user. Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing fate of the invention, to modify the method of Smith to include a step of confirming with the user that the actuation was associated with the presence of hot flashes of the user and updating the parameters based on the confirmation, as taught by Liao, specifically, wherein the method involves the step of confirming with the user that the episode was associated with the condition of the user (Liao: The device receives input from the user that a depression event occurred as set forth in [0086]) and updating the one or more predetermined activation parameters based at least partly on the one or more physiological states of the user and whether or not the episode was associated with the condition of the user (Liao: The user input is used to adjust the parameters of the device for future actuations as set forth in [0088]), for the purpose of better optimizing the operation mode of the device to provide relief when needed during an episode of hot flashes. The condition of Smith is the presence of hot flashes, and so the modification would result in confirmation of an episode of hot flashes, and wherein if the activation of the haptic actuator was not associated with presence of hot flashes, the information is not recorded so as to purpose of better optimize the operation of the device via the control system.
Regarding claim 17, Smith as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Smith as modified fails to explicitly disclose wherein the controller is configured to determine whether the activation of the haptic actuator was associated with a presence of hot flashes, wherein if the activation of the haptic actuator was not associated with presence of hot flashes, the information is not recorded.
However, Liao teaches wherein the control of system involves the step of confirming with the user that the episode was associated with the condition of the user (Liao: The device receives input from the user that a depression event occurred as set forth in [0086]) and updating the one or more predetermined activation parameters based at least partly on the one or more physiological states of the user and whether or not the episode was associated with the condition of the user (Liao: The user input is used to adjust the parameters of the device for future actuations as set forth in [0088]).
It would have been obvious to one skilled in the art, before the time of the effective filing fate of the invention, to modify the method of Smith to include a step of confirming with the user that the actuation was associated with the presence of hot flashes of the user and updating the parameters based on the confirmation, as taught by Liao, specifically, wherein the control involves the step of confirming with the user that the episode was associated with the condition of the user (Liao: The device receives input from the user that a depression event occurred as set forth in [0086]) and updating the one or more predetermined activation parameters based at least partly on the one or more physiological states of the user and whether or not the episode was associated with the condition of the user (Liao: The user input is used to adjust the parameters of the device for future actuations as set forth in [0088]), for the purpose of better optimizing the operation mode of the device to provide relief when needed during an episode of hot flashes. The condition of Smith is the presence of hot flashes, and so the modification would result in confirmation of an episode of hot flashes, and wherein if the activation of the haptic actuator was not associated with presence of hot flashes, the information is not recorded so as to purpose of better optimize the operation of the device via the control system.
Claims 10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 20150101788 A1) in view of Rogers (US 20150374538 A1) as applied to claims 1 and 12, in further view of CalmClinic (“Can Anxiety Cause a Fever?” Internet Archive Wayback Machine, (2015 September 19). Retrieved from web.archive.org/web/20150919064039/https://www.calmclinic.com/anxiety/
symptoms/causing-fever, Retrieved May 14, 2026).
Regarding claim 10, Smith as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Smith as modified further discloses the method activating the haptic actuator to provide the cooling thermal sensations to the user to provide the subjective symptom relief for the user.
Smith as modified fails to explicitly disclose, wherein the subjective symptom relief for the user is during an episode of anxiety.
However, CalmClinic teaches that an episode of anxiety can cause a rise in temperature (CalmClinic: As set forth on page 2).
Smith and CalmClinic are both considered to be analogous to the claimed invention because they are in the same field of the effect of conditions or states of a user on the temperature of the user. Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the method of Smith to include the teaching of CalmClinic, wherein an episode of anxiety can cause a rise in temperature (CalmClinic: As set forth on page 2), to enable the method of the haptic actuator to provide the cooling thermal sensations to the user to provide the subjective symptom relief for the user during an episode of anxiety, in the same way it activates the haptic actuator to provide cooling thermal sensations to the user to provide subjective symptom relief for the user during an episode of hot flashes (FIGS. 1A-1C the controller is configured to apply a series of electrical signals to the thermoelectric material(s) to cause a thermal pulse to be generated at a region of the thermoelectric material(s) adjacent the surface as set forth in [0053], the device may be configured to generate a cooling pulse for inducing a perceived cooling effect to the user as set forth in [0062], wherein the temperature sensor(s), in some embodiments, may be configured with the controller to operate in accordance with a feedback loop, for example, to prevent excessive heating or cooling of the device and/or to maintain the temperature at the surface within a preferred range as set forth in [0111]).
Regarding claim 19, Smith as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Smith as modified further discloses the controller is configured to activate the haptic actuator to provide the cooling thermal sensations to the user to provide the subjective symptom relief for the user.
Smith as modified fails to explicitly disclose, wherein the subjective symptom relief for the user is during an episode of anxiety.
However, CalmClinic teaches that an episode of anxiety can cause a rise in temperature (CalmClinic: As set forth on page 2).
It would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the method of Smith to include the teaching of CalmClinic, wherein an episode of anxiety can cause a rise in temperature (CalmClinic: As set forth on page 2), to enable the method of the haptic actuator to provide the cooling thermal sensations to the user to provide the subjective symptom relief for the user during an episode of anxiety, in the same way it activates the haptic actuator to provide cooling thermal sensations to the user to provide subjective symptom relief for the user during an episode of hot flashes (FIGS. 1A-1C the controller is configured to apply a series of electrical signals to the thermoelectric material(s) to cause a thermal pulse to be generated at a region of the thermoelectric material(s) adjacent the surface as set forth in [0053], the device may be configured to generate a cooling pulse for inducing a perceived cooling effect to the user as set forth in [0062], wherein the temperature sensor(s), in some embodiments, may be configured with the controller to operate in accordance with a feedback loop, for example, to prevent excessive heating or cooling of the device and/or to maintain the temperature at the surface within a preferred range as set forth in [0111]).
Claims 11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 20150101788 A1) in view of Rogers (US 20150374538 A1) as applied to claim 1, in further view of Olivier (Olivier B. Psychogenic fever, functional fever, or psychogenic hyperthermia? Temperature (Austin). 2015 Aug 3;2(3):324-5. doi: 10.1080/23328940.2015.1071701. PMID: 27227037; PMCID: PMC4843918; Accessed 5/14/2026) and Verplaeste (US 20150277572 A1).
Regarding claim 11, Smith as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Smith as modified further discloses the method activating the haptic actuator to provide the cooling thermal sensations to the user to provide the subjective symptom relief for the user.
Smith as modified fails to explicitly disclose, wherein the subjective symptom relief for the user is during an episode of stress
However, Olivier teaches that an episode of stress can cause a rise in temperature (Olivier: Stress leads to a (short-lasting) increase in core temperature, and this temperature increase is part of a complex of stress-related physiological and endocrinological parameters including increases in ACTH, cortisol, blood pressure, tachycardia, and others as set forth on page 1, column 2, paragraph 2).
Smith and Olivier are both considered to be analogous to the claimed invention because they are in the same field of the effect of conditions or states of a user on the temperature of the user. Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the method of Smith to include the teaching of Olivier, wherein an episode of stress can cause a rise in temperature (Olivier: Stress leads to a (short-lasting) increase in core temperature, and this temperature increase is part of a complex of stress-related physiological and endocrinological parameters including increases in ACTH, cortisol, blood pressure, tachycardia, and others as set forth on page 1, column 2, paragraph 2), to enable the method of the haptic actuator to provide the cooling thermal sensations to the user to provide the subjective symptom relief for the user during an episode of stress, in the same way it activates the haptic actuator to provide cooling thermal sensations to the user to provide subjective symptom relief for the user during an episode of hot flashes (FIGS. 1A-1C the controller is configured to apply a series of electrical signals to the thermoelectric material(s) to cause a thermal pulse to be generated at a region of the thermoelectric material(s) adjacent the surface as set forth in [0053], the device may be configured to generate a cooling pulse for inducing a perceived cooling effect to the user as set forth in [0062], wherein the temperature sensor(s), in some embodiments, may be configured with the controller to operate in accordance with a feedback loop, for example, to prevent excessive heating or cooling of the device and/or to maintain the temperature at the surface within a preferred range as set forth in [0111]).
Smith as modified by Olivier teaches wherein the method involves responding to an episode of stress the way it responds to hot flashes and fails to explicitly disclose, wherein the method further comprises measuring electrodermal conductivity of the user associated with one or more stress levels of the user.
However, Verplaetse teaches measuring electrodermal conductivity of the user associated with one or more stress levels of the user (Verplaetse: Skin surface sensors detect parameters purely via measuring non-invasively from the skin surface. For example, a galvanic skin response or electrodermal activity sensor may be used to detect small changes in skin surface conductivity and thereby detect events such as emotional arousal. This can be used as context for an adaptive display modification, such as triggering the backlight or vibrating the device 100 to alert the user to the stress event and help them take action to mitigate it as set forth in [0040]).
Smith and Verplaetse are both considered to be analogous to the claimed invention because they are in the same field of using sensor data to detect an event/condition to trigger the actuation of a device. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control system and method of Smith to incorporate the teaching of Verplaetse and include measuring electrodermal conductivity of the user associated with one or more stress levels of the user (Verplaetse: Skin surface sensors detect parameters purely via measuring non-invasively from the skin surface. For example, a galvanic skin response or electrodermal activity sensor may be used to detect small changes in skin surface conductivity and thereby detect events such as emotional arousal. This can be used as context for an adaptive display modification, such as triggering the backlight or vibrating the device 100 to alert the user to the stress event and help them take action to mitigate it as set forth in [0040]). Doing so would enable the device to use the electrodermal conductivity of the user associated with one or more stress levels of the user to activate the device in response to the detection of a stress episode (Verplaetse: This can be used as context for an adaptive display modification, such as triggering the backlight or vibrating the device 100 to alert the user to the stress event and help them take action to mitigate it as set forth in [0040]), in the case of the device of Smith as modified, trigger the haptic actuator.
Regarding claim 20, Smith as modified discloses the claimed invention substantially as claimed as set forth for claim 12 above.
Smith as modified further discloses the controller is configured to actuate the haptic actuator to provide the cooling thermal sensations to the user to provide the subjective symptom relief for the user.
Smith as modified fails to explicitly disclose, wherein the subjective symptom relief for the user is during an episode of stress
However, Olivier teaches that an episode of stress can cause a rise in temperature (Olivier: Stress leads to a (short-lasting) increase in core temperature, and this temperature increase is part of a complex of stress-related physiological and endocrinological parameters including increases in ACTH, cortisol, blood pressure, tachycardia, and others as set forth on page 1, column 2, paragraph 2).
It would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the method of Smith to include the teaching of Olivier, wherein an episode of stress can cause a rise in temperature (Olivier: Stress leads to a (short-lasting) increase in core temperature, and this temperature increase is part of a complex of stress-related physiological and endocrinological parameters including increases in ACTH, cortisol, blood pressure, tachycardia, and others as set forth on page 1, column 2, paragraph 2), to enable the method of the haptic actuator to provide the cooling thermal sensations to the user to provide the subjective symptom relief for the user during an episode of stress, in the same way it activates the haptic actuator to provide cooling thermal sensations to the user to provide subjective symptom relief for the user during an episode of hot flashes (FIGS. 1A-1C the controller is configured to apply a series of electrical signals to the thermoelectric material(s) to cause a thermal pulse to be generated at a region of the thermoelectric material(s) adjacent the surface as set forth in [0053], the device may be configured to generate a cooling pulse for inducing a perceived cooling effect to the user as set forth in [0062], wherein the temperature sensor(s), in some embodiments, may be configured with the controller to operate in accordance with a feedback loop, for example, to prevent excessive heating or cooling of the device and/or to maintain the temperature at the surface within a preferred range as set forth in [0111]).
Smith as modified by Olivier teaches wherein the method involves responding to an episode of stress the way it responds to hot flashes and fails to explicitly disclose, galvanic skin response sensors which are configured to measure electrodermal conductivity of the user associated with one or more stress levels of the user.
However, Verplaetse teaches galvanic skin response sensors which are configured to measure electrodermal conductivity of the user associated with one or more stress levels of the user (Verplaetse: Skin surface sensors detect parameters purely via measuring non-invasively from the skin surface. For example, a galvanic skin response or electrodermal activity sensor may be used to detect small changes in skin surface conductivity and thereby detect events such as emotional arousal. This can be used as context for an adaptive display modification, such as triggering the backlight or vibrating the device 100 to alert the user to the stress event and help them take action to mitigate it as set forth in [0040]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control system and method of Smith to incorporate the teaching of Verplaetse and include galvanic skin response sensors which are configured to measure electrodermal conductivity of the user associated with one or more stress levels of the user (Verplaetse: Skin surface sensors detect parameters purely via measuring non-invasively from the skin surface. For example, a galvanic skin response or electrodermal activity sensor may be used to detect small changes in skin surface conductivity and thereby detect events such as emotional arousal. This can be used as context for an adaptive display modification, such as triggering the backlight or vibrating the device 100 to alert the user to the stress event and help them take action to mitigate it as set forth in [0040]). Doing so would enable the device to use the electrodermal conductivity of the user associated with one or more stress levels of the user to activate the device in response to the detection of a stress episode (Verplaetse: This can be used as context for an adaptive display modification, such as triggering the backlight or vibrating the device 100 to alert the user to the stress event and help them take action to mitigate it as set forth in [0040]), in the case of the device of Smith as modified, trigger the haptic actuator.
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1 and 2 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 10, 15 and 16 of co-pending Application No. 17/109,790 (referred as ‘790). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding application claim 1, Application number 17/109,790 discloses a method of operating a haptic actuator for treating hot flashes of a user, the method comprising: activating the haptic actuator to provide cooling thermal sensations to the user to provide subjective symptom relief for the user during an episode of hot flashes (As set forth in claim 10; lines 8-10; the thermal dysregulation event being hot flashes); and recording information relative to the activation of the haptic actuator to create an event log associated with the hot flashes, wherein the information includes at least one selected from a group of a timestamp of a cooling session, a duration of a cooling session, a selected intensity of a cooling session, and a number of cooling session in a day (As set forth in claim 15; lines 1-5; the thermal dysregulation event being hot flashes).
Regarding application claim 2, Application number 17/109,790 discloses the method of claim 1 as set forth above.
Application number 17/109,790 further discloses the method further comprising transmitting the information to a remotely located database that includes the event log associated with the hot flashes of the user (As set forth in claim 16; lines 1-3; the thermal dysregulation event being hot flashes).
Claim 3 is provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 10, 15 and 16 of co-pending Application No. 17/109,790 (referred as ‘790) as applied to claim 1 above, in further view of Yi (US 20170056238 A1). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding application claim 3, Application number 17/109,790 discloses the method of claim 1 as set forth above.
Claims 10, 15, and 16 of application ‘790 fails to explicitly disclose, the method, further comprising transmitting the information to a remotely located database that includes the event log associated with the hot flashes of the user.
However, Yi teaches transmitting information to a remotely located database (Yi: Data parameters, e.g., measured blood pressure, temperature of a contact tip, time or date of use, before, during, or after using the device can be saved into a database and transmitted to the remote data server. Medical or health professionals or users that receive the data through the remote server program can send feedback or instructions).
‘790 and Yi are both considered to be analogous to the claimed invention because they are in the same field of a stimulation devices, systems and methods for therapeutic treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control system and method of the haptic actuator to incorporate the teaching of Yi and include wherein the method, further comprises transmitting information to a remotely located database (Yi: Data parameters, e.g., measured blood pressure, temperature of a contact tip, time or date of use, before, during, or after using the device can be saved into a database and transmitted to the remote data server. Medical or health professionals or users that receive the data through the remote server program can send feedback or instructions). Doing so would enable medical or health professionals or users to receive data through the remote server program to provide feedback or instructions (Yi: As set forth in [0158]).
Claims 4-7 and 9 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 10, 15 and 16 of co-pending Application No. 17/109,790 (referred as ‘790) as applied to claim 1 above, in further view of Rogers (US 20150374538 A1). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding application claim 4, Application number 17/109,790 discloses the method of claim 1 as set forth above.
Claims 10, 15, and 16 of application ‘790 fails to explicitly disclose, wherein recording the information includes recording the information in a local memory of the haptic actuator.
However, Rogers teaches, wherein recording the information includes recording the information in a local memory of the haptic actuator (Rogers: FIG. 13-15 The controller 11 comprises memory 110, wherein memory 110 is representative of the overall hierarchy of memory devices containing software and data used to implement the functionality of the controller 11 as set forth in [0242]).
‘790 and Rogers are both considered to be analogous to the claimed invention because they are in the same field of methods of treating a subject in need thereof, involving the delivery of a thermal sensation to the user. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Controller and control system and method of the haptic actuator to incorporate the teaching of Rogers and include wherein recording the information includes recording the information in a local memory of the haptic actuator (Rogers: FIG. 13-15 The controller 11 comprises memory 110, wherein memory 110 is representative of the overall hierarchy of memory devices containing software and data used to implement the functionality of the controller 11 as set forth in [0242]). Doing so would provide a log of the treatment given to the patient that can be analyzed to determine the effectiveness of the treatment or the effect of modifications of the treatment as set forth in (Rogers: As set forth in [0191]), in this case, the event log being associated with the hot flashes of the user.
Regarding application claim 5, Application number 17/109,790 discloses the method of claim 1 as set forth above.
Claims 10, 15, and 16 of application ‘790 fails to explicitly disclose, the method further comprising updating one or more operating parameters of the haptic actuator during symptom relief in response to input from the user to provide a desired subjective amount of symptom relief.
However, Rogers teaches, wherein, the method further comprising updating one or more operating parameters of the haptic actuator during symptom relief in response to input from the user to provide a desired subjective amount of symptom relief (For each of the heating and cooling modes, the user may also adjust various parameters (e.g., magnitude of temperature change, rate of change, duration of each pulse, steady-state temperature, etc.) based on preference as set forth in [0038]; Moreover, methods and devices described herein may provide a user with personal control over his/her level of thermal comfort as set forth in [0039]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Controller and control system and method of the haptic actuator to incorporate the teaching of Rogers and include wherein the method is further comprising updating one or more operating parameters of the haptic actuator during symptom relief in response to input from the user to provide a desired subjective amount of symptom relief (For each of the heating and cooling modes, the user may also adjust various parameters (e.g., magnitude of temperature change, rate of change, duration of each pulse, steady-state temperature, etc.) based on preference as set forth in [0038]; Moreover, methods and devices described herein may provide a user with personal control over his/her level of thermal comfort as set forth in [0039]). Doing so would provide a log of the treatment given to the patient that can be analyzed to determine the effectiveness of the treatment or the effect of modifications of the treatment as set forth in (Rogers: As set forth in [0191]), in this case, the event log being associated with the hot flashes of the user and provide a user with personal control over his/her level of thermal comfort (Rogers: As set forth in [0039]).
Regarding application claim 6, Application number 17/109,790 discloses the method of claim 1 as set forth above.
Claims 10, 15, and 16 of application ‘790 fails to explicitly disclose, wherein the information includes the updated one or more operating parameters of the haptic actuator.
However, Rogers teaches, wherein the information includes the updated one or more operating parameters of the haptic actuator (Rogers: FIG. 10-11 The GUI module may be configured to display any suitable information, including, but not limited to, data associated with the delivery of one or more thermal waveforms including: the amount of time that has elapsed since the onset of delivery of one or more thermal waveforms, the number of treatment sessions that have been administered, the precise time/temperature parameters of the thermal waveform(s) delivered to a patient, the date/time of delivery of the thermal waveform(s) delivered to a patient as set forth in [0182], the thermal waveforms being delivered to the vestibular or nervous system of a patient by heating or cooling the earpieces as set forth in [0296], and wherein the feedback module is configured to receive and/or analyze patient feedback data, physician feedback data and/or patient information from a GUI module residing in the controller to analyze the effectiveness of the treatment or the effect of modifications of the treatment as set forth in [0191], which would include those of the updated parameters).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Controller and control system and method of the haptic actuator to incorporate the teaching of Rogers and include wherein the information includes the updated one or more operating parameters of the haptic actuator (Rogers: FIG. 10-11 The GUI module may be configured to display any suitable information, including, but not limited to, data associated with the delivery of one or more thermal waveforms including: the amount of time that has elapsed since the onset of delivery of one or more thermal waveforms, the number of treatment sessions that have been administered, the precise time/temperature parameters of the thermal waveform(s) delivered to a patient, the date/time of delivery of the thermal waveform(s) delivered to a patient as set forth in [0182], the thermal waveforms being delivered to the vestibular or nervous system of a patient by heating or cooling the earpieces as set forth in [0296], and wherein the feedback module is configured to receive and/or analyze patient feedback data, physician feedback data and/or patient information from a GUI module residing in the controller to analyze the effectiveness of the treatment or the effect of modifications of the treatment as set forth in [0191], which would include those of the updated parameters). Doing so would provide a log of the treatment given to the patient that can be analyzed to determine the effectiveness of the treatment or the effect of modifications of the treatment as set forth in (Rogers: As set forth in [0191]), in this case, the event log being associated with the hot flashes of the user and provide a user with personal control over his/her level of thermal comfort (Rogers: As set forth in [0039]).
Regarding application claim 7, Application number 17/109,790 discloses the method of claim 1 as set forth above.
Claims 10, 15, and 16 of application ‘790 fails to explicitly disclose, wherein the information includes the one or more operating parameters of the haptic actuator before being updated.
However, Rogers teaches, wherein the information includes the one or more operating parameters of the haptic actuator before being updated (Rogers: FIG. 10-11 The GUI module may be configured to display any suitable information, including, but not limited to, data associated with the delivery of one or more thermal waveforms including: the amount of time that has elapsed since the onset of delivery of one or more thermal waveforms, the number of treatment sessions that have been administered, the precise time/temperature parameters of the thermal waveform(s) delivered to a patient, the date/time of delivery of the thermal waveform(s) delivered to a patient as set forth in [0182], the thermal waveforms being delivered to the vestibular or nervous system of a patient by heating or cooling the earpieces as set forth in [0296], and wherein the feedback module is configured to receive and/or analyze patient feedback data, physician feedback data and/or patient information from a GUI module residing in the controller to analyze the effectiveness of the treatment or the effect of modifications of the treatment as set forth in [0191], which would include those before the updated parameters).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Controller and control system and method of the haptic actuator to incorporate the teaching of Rogers and include wherein the information includes the one or more operating parameters of the haptic actuator before being updated (Rogers: FIG. 10-11 The GUI module may be configured to display any suitable information, including, but not limited to, data associated with the delivery of one or more thermal waveforms including: the amount of time that has elapsed since the onset of delivery of one or more thermal waveforms, the number of treatment sessions that have been administered, the precise time/temperature parameters of the thermal waveform(s) delivered to a patient, the date/time of delivery of the thermal waveform(s) delivered to a patient as set forth in [0182], the thermal waveforms being delivered to the vestibular or nervous system of a patient by heating or cooling the earpieces as set forth in [0296], and wherein the feedback module is configured to receive and/or analyze patient feedback data, physician feedback data and/or patient information from a GUI module residing in the controller to analyze the effectiveness of the treatment or the effect of modifications of the treatment as set forth in [0191], which would include those before the updated parameters). Doing so would provide a log of the treatment given to the patient that can be analyzed to determine the effectiveness of the treatment or the effect of modifications of the treatment as set forth in (Rogers: As set forth in [0191]), in this case, the event log being associated with the hot flashes of the user and provide a user with personal control over his/her level of thermal comfort (Rogers: As set forth in [0039]).
Regarding application claim 9, Application number 17/109,790 discloses the method of claim 1 as set forth above.
Claims 10, 15, and 16 of application ‘790 fails to explicitly disclose, wherein the information includes a subjective severity of the episode of hot flashes as input by the user.
However, Rogers teaches wherein the information includes a subjective severity of the episode of hot flashes as input by the user (Rogers: FIG. 10-11 The GUI module may be configured to display any suitable information, including, subjective measures of efficacy (e.g., a patient-reported pain score), and comments a patient made about his/her treatment sessions as set forth in [0182], wherein the feedback module is configured to receive and/or analyze patient feedback data, physician feedback data and/or patient information from a GUI module residing in the controller to analyze the effectiveness of the treatment or the effect of modifications of the treatment as set forth in [0191]; the reported pain score would be associated with the severity of hot flashes for each treatment session in the device of Smith as modified with the control system and method of Rogers).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Controller and control system and method of the haptic actuator to incorporate the teaching of Rogers and include wherein the information includes a subjective severity of the episode of hot flashes as input by the user (Rogers: FIG. 10-11 The GUI module may be configured to display any suitable information, including, subjective measures of efficacy (e.g., a patient-reported pain score), and comments a patient made about his/her treatment sessions as set forth in [0182], wherein the feedback module is configured to receive and/or analyze patient feedback data, physician feedback data and/or patient information from a GUI module residing in the controller to analyze the effectiveness of the treatment or the effect of modifications of the treatment as set forth in [0191]; the reported pain score would be associated with the severity of hot flashes for each treatment session in the device of Smith as modified with the control system and method of Rogers). Doing so would provide a log of the treatment given to the patient that can be analyzed to determine the effectiveness of the treatment or the effect of modifications of the treatment as set forth in (Rogers: As set forth in [0191]), in this case, the event log being associated with the hot flashes of the user and provide a user with personal control over his/her level of thermal comfort (Rogers: As set forth in [0039]).
Claim 8 is provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 10, 15 and 16 of co-pending Application No. 17/109,790 (referred as ‘790) as applied to claim 1 above, in further view of Liao (US 20140206945 A1). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding application claim 8, Application number 17/109,790 discloses the method of claim 1 as set forth above.
Claims 10, 15, and 16 of application ‘790 fails to explicitly disclose, the method, further comprising confirming that the activation of the haptic actuator was associated with a presence of hot flashes, wherein if the activation of the haptic actuator was not associated with presence of hot flashes, the information is not recorded.
However, Liao teaches wherein the method involves the step of confirming with the user that the episode was associated with the condition of the user (Liao: The device receives input from the user that a depression event occurred as set forth in [0086]) and updating the one or more predetermined activation parameters based at least partly on the one or more physiological states of the user and whether or not the episode was associated with the condition of the user (Liao: The user input is used to adjust the parameters of the device for future actuations as set forth in [0088]).
‘790 and Liao are both considered to be analogous to the claimed invention because they are in the same field of methods of operating a haptic actuator to provide relief to a user. Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing fate of the invention, to modify the method of Smith to include a step of confirming with the user that the actuation was associated with the presence of hot flashes of the user and updating the parameters based on the confirmation, as taught by Liao, specifically, wherein the method involves the step of confirming with the user that the episode was associated with the condition of the user (Liao: The device receives input from the user that a depression event occurred as set forth in [0086]) and updating the one or more predetermined activation parameters based at least partly on the one or more physiological states of the user and whether or not the episode was associated with the condition of the user (Liao: The user input is used to adjust the parameters of the device for future actuations as set forth in [0088]), for the purpose of better optimizing the operation mode of the device to provide relief when needed during an episode of hot flashes. The condition of Smith is the presence of hot flashes, and so the modification would result in confirmation of an episode of hot flashes, and wherein if the activation of the haptic actuator was not associated with presence of hot flashes, the information is not recorded so as to purpose of better optimize the operation of the device via the control system.
Claims 10 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 10, 15 and 16 of co-pending Application No. 17/109,790 (referred as ‘790) as applied to claim 1 above, in further view of CalmClinic (“Can Anxiety Cause a Fever?” Internet Archive Wayback Machine, (2015 September 19). Retrieved from web.archive.org/web/2
0150919064039/https://www.calmclinic.com/anxiety/symptoms/causing-fever, Retrieved May 14, 2026). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding application claim 10, Application number 17/109,790 discloses the method of claim 1 as set forth above.
Claims 10, 15, and 16 of application ‘790 discloses the method activating the haptic actuator to provide the cooling thermal sensations to the user to provide the subjective symptom relief for the user.
Claims 10, 15, and 16 of application ‘790 fails to explicitly disclose wherein the subjective symptom relief for the user is during an episode of anxiety.
However, CalmClinic teaches that an episode of anxiety can cause a rise in temperature (CalmClinic: As set forth on page 2).
‘790 and CalmClinic are both considered to be analogous to the claimed invention because they are in the same field of the effect of conditions or states of a user on the temperature of the user. Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the method of ‘790 to include the teaching of CalmClinic, wherein an episode of anxiety can cause a rise in temperature (CalmClinic: As set forth on page 2), to enable the method of the haptic actuator to provide the cooling thermal sensations to the user to provide the subjective symptom relief for the user during an episode of anxiety, in the same way it activates the haptic actuator to provide cooling thermal sensations to the user to provide subjective symptom relief for the user during an episode of hot flashes.
Claims 11 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 10, 15 and 16 of co-pending Application No. 17/109,790 (referred as ‘790) as applied to claim 1 above, in further view of Olivier (Olivier B. Psychogenic fever, functional fever, or psychogenic hyperthermia? Temperature (Austin). 2015 Aug 3;2(3):324-5. doi: 10.1080/23328940.2015.1071701. PMID: 27227037; PMCID: PMC4843918; Accessed 5/14/2026) and Verplaeste (US 20150277572 A1). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding application claim 10, Application number 17/109,790 discloses the method of claim 1 as set forth above.
Claims 10, 15, and 16 of application ‘790 discloses the method activating the haptic actuator to provide the cooling thermal sensations to the user to provide the subjective symptom relief for the user.
Claims 10, 15, and 16 of application ‘790 fails to explicitly disclose wherein the subjective symptom relief for the user is during an episode of stress
However, Olivier teaches that an episode of stress can cause a rise in temperature (Olivier: Stress leads to a (short-lasting) increase in core temperature, and this temperature increase is part of a complex of stress-related physiological and endocrinological parameters including increases in ACTH, cortisol, blood pressure, tachycardia, and others as set forth on page 1, column 2, paragraph 2).
‘790 and Olivier are both considered to be analogous to the claimed invention because they are in the same field of the effect of conditions or states of a user on the temperature of the user. Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the method of ‘790 to include the teaching of Olivier, wherein an episode of stress can cause a rise in temperature (Olivier: Stress leads to a (short-lasting) increase in core temperature, and this temperature increase is part of a complex of stress-related physiological and endocrinological parameters including increases in ACTH, cortisol, blood pressure, tachycardia, and others as set forth on page 1, column 2, paragraph 2), to enable the method of the haptic actuator to provide the cooling thermal sensations to the user to provide the subjective symptom relief for the user during an episode of stress, in the same way it activates the haptic actuator to provide cooling thermal sensations to the user to provide subjective symptom relief for the user during an episode of hot flashes.
‘790 as modified by Olivier teaches wherein the method involves responding to an episode of stress the way it responds to hot flashes and fails to explicitly disclose, wherein the method further comprises measuring electrodermal conductivity of the user associated with one or more stress levels of the user.
However, Verplaetse teaches measuring electrodermal conductivity of the user associated with one or more stress levels of the user (Verplaetse: Skin surface sensors detect parameters purely via measuring non-invasively from the skin surface. For example, a galvanic skin response or electrodermal activity sensor may be used to detect small changes in skin surface conductivity and thereby detect events such as emotional arousal. This can be used as context for an adaptive display modification, such as triggering the backlight or vibrating the device 100 to alert the user to the stress event and help them take action to mitigate it as set forth in [0040]).
‘790 and Verplaetse are both considered to be analogous to the claimed invention because they are in the same field of using sensor data to detect an event/condition to trigger the actuation of a device. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control system and method of ‘790 to incorporate the teaching of Verplaetse and include measuring electrodermal conductivity of the user associated with one or more stress levels of the user (Verplaetse: Skin surface sensors detect parameters purely via measuring non-invasively from the skin surface. For example, a galvanic skin response or electrodermal activity sensor may be used to detect small changes in skin surface conductivity and thereby detect events such as emotional arousal. This can be used as context for an adaptive display modification, such as triggering the backlight or vibrating the device 100 to alert the user to the stress event and help them take action to mitigate it as set forth in [0040]). Doing so would enable the device to use the electrodermal conductivity of the user associated with one or more stress levels of the user to activate the device in response to the detection of a stress episode (Verplaetse: This can be used as context for an adaptive display modification, such as triggering the backlight or vibrating the device 100 to alert the user to the stress event and help them take action to mitigate it as set forth in [0040]), in the case of the device of ‘790 as modified, trigger the haptic actuator.
Claims 12, 14-16, and 18 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 10, 15 and 16 of co-pending Application No. 17/109,790 (referred as ‘790), in further view of Smith (US 20150101788 A1) in further view of Rogers (US 20150374538 A1). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding application claim 12, Application number ‘790 discloses a haptic actuator comprising: one or more thermal and/or physical actuators configured to apply thermal and/or physical stimulation to a user (The means in which the thermal sensations are being provided in lines 8-10 of claim 10); and wherein the method is configured to: activate the haptic actuator to provide cooling thermal sensations to the user to provide subjective symptom relief for the user during an episode of hot flashes (Lines 8-10 of claim 10); and record information relative to the activation of the haptic actuator to create an event log associated with the hot flashes, wherein the information includes at least one selected from a group of a timestamp of a cooling session, a duration of a cooling session, a selected intensity of a cooling session, and a number of cooling session in a day (As set forth in claim 15).
Application number ‘790 fails to explicitly disclose a controller operatively coupled to the one or more thermal and/or physical actuators, the controller configured to perform the method steps.
However, Smith teaches a controller operatively coupled to the one or more thermal and/or physical actuators, the controller configured to perform the method steps (FIGS. 1A-1C the controller is configured to apply a series of electrical signals to the thermoelectric material(s) to cause a thermal pulse to be generated at a region of the thermoelectric material(s) adjacent the surface as set forth in [0053], the device may be configured to generate a cooling pulse for inducing a perceived cooling effect to the user as set forth in [0062], wherein the temperature sensor(s), in some embodiments, may be configured with the controller to operate in accordance with a feedback loop, for example, to prevent excessive heating or cooling of the device and/or to maintain the temperature at the surface within a preferred range as set forth in [0111]; In some embodiments, the device includes one or more temperature sensors for monitoring the temperature at the surface of the thermoelectric material(s) and/or skin. For example, if the temperature measured at the surface of the thermoelectric material(s) and/or skin exceeds or is lower than a desired temperature, the sensor may send a signal to the controller to adjust the applied electrical signal (e.g., apply a negative (or lower) voltage to reduce the temperature, apply a positive (or higher) voltage to increase the temperature) to result in a preferred temperature profile as set forth in [0110], wherein the device may be used to alleviate hot flashes as set forth in [0113], the hot flashes reflected in the temperature obtained by the sensors).
‘790 and Smith are both considered to be analogous to the claimed invention because they are in the same field of methods of treating a subject in need thereof, involving the delivery of a thermal sensation to the user. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘790 to incorporate the teaching of Rogers and include wherein, a controller operatively coupled to the one or more thermal and/or physical actuators, the controller configured to perform the method steps (FIGS. 1A-1C the controller is configured to apply a series of electrical signals to the thermoelectric material(s) to cause a thermal pulse to be generated at a region of the thermoelectric material(s) adjacent the surface as set forth in [0053], the device may be configured to generate a cooling pulse for inducing a perceived cooling effect to the user as set forth in [0062], wherein the temperature sensor(s), in some embodiments, may be configured with the controller to operate in accordance with a feedback loop, for example, to prevent excessive heating or cooling of the device and/or to maintain the temperature at the surface within a preferred range as set forth in [0111]; In some embodiments, the device includes one or more temperature sensors for monitoring the temperature at the surface of the thermoelectric material(s) and/or skin. For example, if the temperature measured at the surface of the thermoelectric material(s) and/or skin exceeds or is lower than a desired temperature, the sensor may send a signal to the controller to adjust the applied electrical signal (e.g., apply a negative (or lower) voltage to reduce the temperature, apply a positive (or higher) voltage to increase the temperature) to result in a preferred temperature profile as set forth in [0110], wherein the device may be used to alleviate hot flashes as set forth in [0113], the hot flashes reflected in the temperature obtained by the sensors). Doing so would provide a well-known means in the art for carrying out method steps.
‘790 as modified fails to explicitly disclose, wherein the controller includes a processor.
However, Rogers teaches wherein the controller includes a processor (Rogers: a processor programmed to carry out a method as set forth in [0026]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Controller and control system and method of the haptic actuator to incorporate the teaching of Rogers and include wherein the controller includes a processor (Rogers: a processor programmed to carry out a method as set forth in [0026]). Doing so would provide well-known aspect of a controller, programmed to carry out the method (Rogers: As set forth in [0026]).
Regarding application claim 14, Application number 17/109,790 as modified discloses the device of claim 12 as set forth above.
Claims 10, 15, and 16 of application ‘790 as modified fails to explicitly disclose, wherein the controller is configured to record the information in a local memory of the haptic actuator.
However, Rogers teaches, wherein the controller is configured to record the information in a local memory of the haptic actuator (Rogers: FIG. 13-15 The controller 11 comprises memory 110, wherein memory 110 is representative of the overall hierarchy of memory devices containing software and data used to implement the functionality of the controller 11 as set forth in [0242]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Controller and control system and method of the haptic actuator to incorporate the teaching of Rogers and include wherein the controller is configured to record the information in a local memory of the haptic actuator (Rogers: FIG. 13-15 The controller 11 comprises memory 110, wherein memory 110 is representative of the overall hierarchy of memory devices containing software and data used to implement the functionality of the controller 11 as set forth in [0242]). Doing so would provide a log of the treatment given to the patient that can be analyzed to determine the effectiveness of the treatment or the effect of modifications of the treatment as set forth in (Rogers: As set forth in [0191]), in this case, the event log being associated with the hot flashes of the user and provide a user with personal control over his/her level of thermal comfort (Rogers: As set forth in [0039]).
Regarding application claim 15, Application number 17/109,790 as modified discloses the device of claim 12 as set forth above.
Claims 10, 15, and 16 of application ‘790 as modified further discloses, wherein the controller is configured to update one or more operating parameters of the haptic actuator during symptom relief in response to input from the user to provide a desired subjective amount of symptom relief (As set forth in lines 13-17 of claim 10).
Regarding application claim 16, Application number 17/109,790 as modified discloses the device of claim 12 as set forth above.
Claims 10, 15, and 16 of application ‘790 as modified fails to explicitly disclose, wherein the information includes the updated one or more operating parameters of the haptic actuator
However, Rogers teaches, wherein the information includes the updated one or more operating parameters of the haptic actuator (Rogers: FIG. 10-11 The GUI module may be configured to display any suitable information, including, but not limited to, data associated with the delivery of one or more thermal waveforms including: the amount of time that has elapsed since the onset of delivery of one or more thermal waveforms, the number of treatment sessions that have been administered, the precise time/temperature parameters of the thermal waveform(s) delivered to a patient, the date/time of delivery of the thermal waveform(s) delivered to a patient as set forth in [0182], the thermal waveforms being delivered to the vestibular or nervous system of a patient by heating or cooling the earpieces as set forth in [0296], and wherein the feedback module is configured to receive and/or analyze patient feedback data, physician feedback data and/or patient information from a GUI module residing in the controller to analyze the effectiveness of the treatment or the effect of modifications of the treatment as set forth in [0191], which would include those of the updated parameters).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Controller and control system and method of the haptic actuator to incorporate the teaching of Rogers and include wherein the information includes the updated one or more operating parameters of the haptic actuator (Rogers: FIG. 10-11 The GUI module may be configured to display any suitable information, including, but not limited to, data associated with the delivery of one or more thermal waveforms including: the amount of time that has elapsed since the onset of delivery of one or more thermal waveforms, the number of treatment sessions that have been administered, the precise time/temperature parameters of the thermal waveform(s) delivered to a patient, the date/time of delivery of the thermal waveform(s) delivered to a patient as set forth in [0182], the thermal waveforms being delivered to the vestibular or nervous system of a patient by heating or cooling the earpieces as set forth in [0296], and wherein the feedback module is configured to receive and/or analyze patient feedback data, physician feedback data and/or patient information from a GUI module residing in the controller to analyze the effectiveness of the treatment or the effect of modifications of the treatment as set forth in [0191], which would include those of the updated parameters). Doing so would provide a log of the treatment given to the patient that can be analyzed to determine the effectiveness of the treatment or the effect of modifications of the treatment as set forth in (Rogers: As set forth in [0191]), in this case, the event log being associated with the hot flashes of the user and provide a user with personal control over his/her level of thermal comfort (Rogers: As set forth in [0039]).
Regarding application claim 18, Application number 17/109,790 as modified discloses the device of claim 12 as set forth above.
Claims 10, 15, and 16 of application ‘790 as modified fails to explicitly disclose wherein the information includes a subjective severity of the episode of hot flashes as input by the user.
However, Rogers teaches wherein the information includes a subjective severity of the episode of hot flashes as input by the user (Rogers: FIG. 10-11 The GUI module may be configured to display any suitable information, including, subjective measures of efficacy (e.g., a patient-reported pain score), and comments a patient made about his/her treatment sessions as set forth in [0182], wherein the feedback module is configured to receive and/or analyze patient feedback data, physician feedback data and/or patient information from a GUI module residing in the controller to analyze the effectiveness of the treatment or the effect of modifications of the treatment as set forth in [0191]; the reported pain score would be associated with the severity of hot flashes for each treatment session in the device of Smith as modified with the control system and method of Rogers).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Controller and control system and method of the haptic actuator to incorporate the teaching of Rogers and include wherein the information includes a subjective severity of the episode of hot flashes as input by the user (Rogers: FIG. 10-11 The GUI module may be configured to display any suitable information, including, subjective measures of efficacy (e.g., a patient-reported pain score), and comments a patient made about his/her treatment sessions as set forth in [0182], wherein the feedback module is configured to receive and/or analyze patient feedback data, physician feedback data and/or patient information from a GUI module residing in the controller to analyze the effectiveness of the treatment or the effect of modifications of the treatment as set forth in [0191]; the reported pain score would be associated with the severity of hot flashes for each treatment session in the device of Smith as modified with the control system and method of Rogers). Doing so would provide a log of the treatment given to the patient that can be analyzed to determine the effectiveness of the treatment or the effect of modifications of the treatment as set forth in (Rogers: As set forth in [0191]), in this case, the event log being associated with the hot flashes of the user and provide a user with personal control over his/her level of thermal comfort (Rogers: As set forth in [0039]).
Claim 13 is provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 10, 15 and 16 of co-pending Application No. 17/109,790 (referred as ‘790), in further view of Smith (US 20150101788 A1) in further view of Rogers (US 20150374538 A1) as applied to claim 12 above, in further view of Yi (US 20170056238 A1). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding application claim 13, Application number 17/109,790 as modified discloses the device of claim 12 as set forth above.
Claims 10, 15, and 16 of application ‘790 as modified fails to explicitly disclose, wherein the controller is configured to transmit the information to a remotely located database that includes the event log associated with the hot flashes of the user.
However, Yi teaches transmitting information to a remotely located database (Yi: Data parameters, e.g., measured blood pressure, temperature of a contact tip, time or date of use, before, during, or after using the device can be saved into a database and transmitted to the remote data server. Medical or health professionals or users that receive the data through the remote server program can send feedback or instructions).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control system and method of the haptic actuator to incorporate the teaching of Yi and include wherein the method, further comprises transmitting information to a remotely located database (Yi: Data parameters, e.g., measured blood pressure, temperature of a contact tip, time or date of use, before, during, or after using the device can be saved into a database and transmitted to the remote data server. Medical or health professionals or users that receive the data through the remote server program can send feedback or instructions). Doing so would enable medical or health professionals or users to receive data through the remote server program to provide feedback or instructions (Yi: As set forth in [0158]).
Claim 17 is provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 10, 15 and 16 of co-pending Application No. 17/109,790 (referred as ‘790), in further view of Smith (US 20150101788 A1) in further view of Rogers (US 20150374538 A1) as applied to claim 12 above, in further view of Liao (US 20140206945 A1). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding application claim 17, Application number 17/109,790 as modified discloses the device of claim 12 as set forth above.
Claims 10, 15, and 16 of application ‘790 as modified fails to explicitly disclose, wherein the controller is configured to determine whether the activation of the haptic actuator was associated with a presence of hot flashes, wherein if the activation of the haptic actuator was not associated with presence of hot flashes, the information is not recorded.
However, Liao teaches wherein the control of system involves the step of confirming with the user that the episode was associated with the condition of the user (Liao: The device receives input from the user that a depression event occurred as set forth in [0086]) and updating the one or more predetermined activation parameters based at least partly on the one or more physiological states of the user and whether or not the episode was associated with the condition of the user (Liao: The user input is used to adjust the parameters of the device for future actuations as set forth in [0088]).
It would have been obvious to one skilled in the art, before the time of the effective filing fate of the invention, to modify ‘790 to include a step of confirming with the user that the actuation was associated with the presence of hot flashes of the user and updating the parameters based on the confirmation, as taught by Liao, specifically, wherein the control involves the step of confirming with the user that the episode was associated with the condition of the user (Liao: The device receives input from the user that a depression event occurred as set forth in [0086]) and updating the one or more predetermined activation parameters based at least partly on the one or more physiological states of the user and whether or not the episode was associated with the condition of the user (Liao: The user input is used to adjust the parameters of the device for future actuations as set forth in [0088]), for the purpose of better optimizing the operation mode of the device to provide relief when needed during an episode of hot flashes. The condition of ‘790 is the presence of hot flashes, and so the modification would result in confirmation of an episode of hot flashes, and wherein if the activation of the haptic actuator was not associated with presence of hot flashes, the information is not recorded so as to purpose of better optimize the operation of the device via the control system.
Claim 19 is provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 10, 15 and 16 of co-pending Application No. 17/109,790 (referred as ‘790), in further view of Smith (US 20150101788 A1) in further view of Rogers (US 20150374538 A1) as applied to claim 12 above, in further view of CalmClinic (“Can Anxiety Cause a Fever?” Internet Archive Wayback Machine, (2015 September 19). Retrieved from web.archive.org/web/20150919064039/https://www.calmclinic.com/anxiety/
symptoms/causing-fever, Retrieved May 14, 2026). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding application claim 19, Application number 17/109,790 as modified discloses the device of claim 12 as set forth above.
Claims 10, 15, and 16 of application ‘790 as modified disclose the controller is configured to activate the haptic actuator to provide the cooling thermal sensations to the user to provide the subjective symptom relief for the user.
Claims 10, 15, and 16 of application ‘790 as modified fails to explicitly disclose, wherein the subjective symptom relief for the user is during an episode of anxiety.
However, CalmClinic teaches that an episode of anxiety can cause a rise in temperature (CalmClinic: As set forth on page 2).
It would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify ‘790 to include the teaching of CalmClinic, wherein an episode of anxiety can cause a rise in temperature (CalmClinic: As set forth on page 2), to enable the method of the haptic actuator to provide the cooling thermal sensations to the user to provide the subjective symptom relief for the user during an episode of anxiety, in the same way it activates the haptic actuator to provide cooling thermal sensations to the user to provide subjective symptom relief for the user during an episode of hot flashes.
Claim 20 is provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 10, 15 and 16 of co-pending Application No. 17/109,790 (referred as ‘790), in further view of Smith (US 20150101788 A1) in further view of Rogers (US 20150374538 A1) as applied to claim 12 above, in further view of Olivier (Olivier B. Psychogenic fever, functional fever, or psychogenic hyperthermia? Temperature (Austin). 2015 Aug 3;2(3):324-5. doi: 10.1080/23328940.2015.1071701. PMID: 27227037; PMCID: PMC4843918; Accessed 5/14/2026) and Verplaeste (US 20150277572 A1). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding application claim 20, Application number 17/109,790 as modified discloses the device of claim 12 as set forth above.
Claims 10, 15, and 16 of application ‘790 as modified disclose the controller is configured to activate the haptic actuator to provide the cooling thermal sensations to the user to provide the subjective symptom relief for the user.
Claims 10, 15, and 16 of application ‘790 as modified fails to explicitly disclose, wherein the subjective symptom relief for the user is during an episode of stress.
However, Olivier teaches that an episode of stress can cause a rise in temperature (Olivier: Stress leads to a (short-lasting) increase in core temperature, and this temperature increase is part of a complex of stress-related physiological and endocrinological parameters including increases in ACTH, cortisol, blood pressure, tachycardia, and others as set forth on page 1, column 2, paragraph 2).
It would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the ‘790 to include the teaching of Olivier, wherein an episode of stress can cause a rise in temperature (Olivier: Stress leads to a (short-lasting) increase in core temperature, and this temperature increase is part of a complex of stress-related physiological and endocrinological parameters including increases in ACTH, cortisol, blood pressure, tachycardia, and others as set forth on page 1, column 2, paragraph 2), to enable the method of the haptic actuator to provide the cooling thermal sensations to the user to provide the subjective symptom relief for the user during an episode of stress, in the same way it activates the haptic actuator to provide cooling thermal sensations to the user to provide subjective symptom relief for the user during an episode of hot flashes.
‘790 as modified by Olivier teaches wherein the method involves responding to an episode of stress the way it responds to hot flashes and fails to explicitly disclose, galvanic skin response sensors which are configured to measure electrodermal conductivity of the user associated with one or more stress levels of the user.
However, Verplaetse teaches galvanic skin response sensors which are configured to measure electrodermal conductivity of the user associated with one or more stress levels of the user (Verplaetse: Skin surface sensors detect parameters purely via measuring non-invasively from the skin surface. For example, a galvanic skin response or electrodermal activity sensor may be used to detect small changes in skin surface conductivity and thereby detect events such as emotional arousal. This can be used as context for an adaptive display modification, such as triggering the backlight or vibrating the device 100 to alert the user to the stress event and help them take action to mitigate it as set forth in [0040]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control system and method of ‘790 to incorporate the teaching of Verplaetse and include galvanic skin response sensors which are configured to measure electrodermal conductivity of the user associated with one or more stress levels of the user (Verplaetse: Skin surface sensors detect parameters purely via measuring non-invasively from the skin surface. For example, a galvanic skin response or electrodermal activity sensor may be used to detect small changes in skin surface conductivity and thereby detect events such as emotional arousal. This can be used as context for an adaptive display modification, such as triggering the backlight or vibrating the device 100 to alert the user to the stress event and help them take action to mitigate it as set forth in [0040]). Doing so would enable the device to use the electrodermal conductivity of the user associated with one or more stress levels of the user to activate the device in response to the detection of a stress episode (Verplaetse: This can be used as context for an adaptive display modification, such as triggering the backlight or vibrating the device 100 to alert the user to the stress event and help them take action to mitigate it as set forth in [0040]), in the case of the device of ‘790 as modified, trigger the haptic actuator.
Conclusion
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/KEIRA EILEEN CALLISON/ Examiner, Art Unit 3785
/KENDRA D CARTER/ Supervisory Patent Examiner, Art Unit 3785
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