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 Objections
Claim 13 is objected to because of the following informalities: in line 4, the claim reads “a vibration produced by the phone. the watch or …”, however, there seems to be a period rather than a comma for the list. Examiner interprets that the claim is meant to read “a vibration produced by the phone, the watch or …”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-10, 15-17, and 19-20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Várkuti (EP 3,824,372 B1).
Regarding claim 1, Várkuti teaches a method (¶[0084], where “the present invention incorporates new methods for calibrating a neural interface optimally to the individual and explicitly builds on the brains natural ability of decoding any information-carrying signal of behavioral relevance into a subjectively interpretable perception or translate it into the appropriate corresponding action”), comprising:
delivering a deep brain stimulation (DBS) therapy to a patient having a neurological disorder (¶[0226], where “a DBS electrode 120’ that is used as a neuromodulator, e.g. for treatment of PD symptoms”), wherein the DBS therapy is delivered using a DBS system that includes a DBS neuromodulator (¶[0226], where “a DBS electrode 120’ that is used as a neuromodulator”) and a DBS lead (¶[0226], where “the neuromodulation electrode can also be used for applying neuronal stimulation signals provided by a system … the subthalamic nucleus 320’ is conducted for the tip contacts 330’ to control, for example, the primary PD symptoms more distal contacts 340’, 350’ could be used in combination with the above disclosed invention”); and
cueing patient movement (¶[0226], where “the primary PD symptoms more distal contacts 340’, 350’ could be used in combination with the above disclosed invention to communicate a movement cue and / or a continuous movement biofeedback signal into the brain the patient can utilize to navigate better and/or break free from FOG”) by providing a perceptible output signal to the patient (¶[0234], where “Further, once or while the communication library (i.e. the plurality of relations stored in the memory) is established or is being established for an individual a specific training procedure can be executed … such a pair consists of a given sensory percept corresponding to a given neuronal stimulation signal and a movement cue and /or a piece of proprioceptive information to be associated with said given sensory percept and the corresponding neuronal stimulation signal”) using an external user system that includes a processor and a user interface (¶[0216], where “a control device 130’, that may be implemented by a smartphone or a similar electronic information processing device.” Examiner interprets that a smartphone inherently includes a processor and user interface as these are necessary components.) configured to provide the perceptible output signal (¶[0217], where “control device 130’ may provide the individual with a user interface to adjust the neuronal stimulation signals and / or the neuromodulation therapy applied via the signal generator 110’ and the neuronal stimulation electrode 120’ … the individual 100’ may adjust signal parameters such as a signal frequency, a pulse width, a pulse shape and /or a signal amplitude. For example, the individual may use the control device 130’ to select a perceived periodicity of a movement cue provided by a neuronal stimulation signal to the cortex of the individual 100’”), wherein the processor is configured to execute a cueing application to implement a cueing routine to cue patient movement (¶[0217], where “For example, if the movement cue is used to provide guidance to the individual 100’ during a movement such as walking, the control device 130’ may be used to select and set a movement pace associated with the perceived periodicity of the movement cue”).
Regarding claim 3, Várkuti teaches all limitations of claim 1 as described in the rejection above.
Várkuti teaches that the cueing patient movement relieves a movement disorder or symptom in the patient (¶[0226], where “for example, the primary PD symptoms more distal contacts 340’, 350’ could be used in combination with the above disclosed invention to communicate a movement cue and / or a continuous movement biofeedback signal into the brain the patient can utilize to navigate better and/or break free from FOG”), and the DBS therapy relieves at least one other symptom of the patient (¶[0215], where “the neuronal stimulation electrode 120’ may be already implanted into the brain of the individual 100’ for the purpose of providing a neuromodulation therapy for certain PD symptoms such as tremor, dystonia and / or rigidity,” ¶[0226], where “a DBS electrode 120’ that is used as a neuromodulator, e.g. for treatment of PD symptoms”).
Regarding claim 4, Várkuti teaches all limitations of claim 1 as described in the rejection above.
Várkuti teaches that the cueing patient movement includes providing a plurality of perceptible output signal instances (¶[0234], where “Further, once or while the communication library (i.e. the plurality of relations stored in the memory) is established or is being established for an individual a specific training procedure can be executed … such a pair consists of a given sensory percept corresponding to a given neuronal stimulation signal and a movement cue and /or a piece of proprioceptive information to be associated with said given sensory percept and the corresponding neuronal stimulation signal”), the method further including controlling timing for providing the plurality of perceptible signal instances (¶[0217], where “For example, if the movement cue is used to provide guidance to the individual 100’ during a movement such as walking, the control device 130’ may be used to select and set a movement pace associated with the perceived periodicity of the movement cue”).
Regarding claim 5, Várkuti teaches all limitations of claim 4 as described in the rejection above.
Várkuti teaches automatically adjusting an interval between consecutive perceptible signal instances (¶[0238], where “three different walking paces (e.g. 1 step per second, 0,5 steps per second, 2 steps per second) may be encoded by providing a pulse train signal via a neuronal stimulation interface and system as discussed above. Such a pulse train (being characterized by signal parameters such as pulse width, pulse frequency, pulse shape and / or pulse amplitude) may elicit a periodic / rhythmic sensory percept in the targeted area of the sensory cortex of the individual … the same neuronal communication channel can also be used to communicate a FOG breakout signal to the individual. For instance, the FOG breakout signal may be encoded by choosing a different combination of pulse train parameters such as a combination of a larger pulse frequency and a larger pulse width,” ¶[0239], where “When occurrence of a FOG event has been determined (either by the neuronal stimulation system itself, a human supervisor or a control device associated with the individual performing the walking task) the neuronal stimulation system may obtain the FOG breakout signal (e.g. from its memory or via a wireless communication interface) and transmits it to an electric contact of a neuronal stimulation electrode such as the DBS electrode,” ¶[0240], where “After a FOG event has been suppressed the neuronal stimulation system can switch into a pacemaker operation mode and may apply a slow periodic movement cue to help the individual to resume normal walking,” ¶[0242], where “Such neuronal excitation measurement equipment may be used to provide the individual with an essentially closed loop stimulation system, wherein measurements motor related neuronal excitation patterns directly affect how the neuronal stimulation system is operating.” Examiner interprets that by applying a slow periodic movement cue after suppression of a FOG even with set parameters, that this automatically changes the interval between instances.).
Regarding claim 6, Várkuti teaches all limitations of claim 1 as described in the rejection above.
Várkuti teaches that the cueing patient movement includes controlling a location for the perceptible output signal (¶[0238], where “Such a pulse train (being characterized by signal parameters such as pulse width, pulse frequency, pulse shape and / or pulse amplitude) may elicit a periodic / rhythmic sensory percept in the targeted area of the sensory cortex of the individual. For instance, such a pulse train signal may be configured to elicit a periodically appearing tough sensation in the palm of the right hand or in a leg of the individual”) or a sequence of more than one location for the perceptible signal and automatically adjusting the location (Examiner interprets that since the pulse train elicits a periodic/rhythmic sensory percept in the targeted area of the sensory cortex of the individual, where targeted areas correlate to a palm or leg, that the location is automatically adjusted based on the targeted area, especially since the stimulation system is closed-loop (See ¶[0242]).) or the sequence of the more than one location.
Regarding claim 7, Várkuti teaches all limitations of claim 1 as described in the rejection above.
Várkuti teaches receiving a user input to determine when to implement the cueing routine (¶[0217], where “The control device 130’ may provide the individual with a user interface to adjust the neuronal stimulation signals and / or the neuromodulation therapy applied via the signal generator 110’ and the neuronal stimulation electrode 120’. For instance, the individual 100’ may adjust signal parameters such as a signal frequency, a pulse width, a pulse shape and /or a signal amplitude. For example, the individual may use the control device 130’ to select a perceived periodicity of a movement cue provided by a neuronal stimulation signal to the cortex of the individual 100’. For example, if the movement cue is used to provide guidance to the individual 100’ during a movement such as walking, the control device 130’ may be used to select and set a movement pace associated with the perceived periodicity of the movement cue,” where setting and selecting a movement pace associated with the perceived periodicity of the movement cue determines when the cueing routine is implemented.).
Regarding claim 8, Várkuti teaches all limitations of claim 1 as described in the rejection above.
Várkuti teaches using a sensor to determine when to implement the cueing routine (¶[0116], where “By using one or more of such sensors an accurate model of the body posture of the individual may be determined and be used to determine a tailored neuronal stimulation signal that is adapted to communicate precise and reliable proprioceptive information directly to the cortex of the individual,” ¶[0134], where “Similar as for other embodiments discussed above, the provided system may further comprise means for obtaining information about the body posture of the individual via at least one of: a pressure sensor; a tension sensor; a balance sensor; an acceleration sensor; a temperature sensor; an image sensor; a force sensor; a distance sensor; an angle sensor; a speed sensor,” ¶[0222], where “a system that generates and provides electrical signals the brain can interpret as meaningful input, e.g. as a rhythmic movement cue or any other type of movement related information such as a commence movement trigger (e.g. a FOG break-out signal) or information about the current body posture of the individual (e.g. proprioceptive information). As discussed in section 3 above, such information may be provided by different types of measurement devices or sensors,” where Examiner interprets that utilizing body posture of an individual as an input for the electrical signals means that the cueing routine will be implemented based on that input.).
Regarding claim 9, Várkuti teaches all limitations of claim 8 as described in the rejection above.
Várkuti teaches that the sensor includes at least one of an accelerometer, a pressure sensor or an exertion sensor (¶[0134], where “Similar as for other embodiments discussed above, the provided system may further comprise means for obtaining information about the body posture of the individual via at least one of: a pressure sensor; a tension sensor; a balance sensor; an acceleration sensor; a temperature sensor; an image sensor; a force sensor; a distance sensor; an angle sensor; a speed sensor”), the method further including using the sensor to determine at least one of actual patient movement, attempted patient movement or predicted patient movement (Examiner interprets that since the sensor determines patient position that it also inherently determines patient movement since a change in posture is movement.).
Regarding claim 10, Várkuti teaches all limitations of claim 1 as described in the rejection above.
Várkuti teaches that the cueing patient movement includes cueing walking (¶[0217], where “For example, if the movement cue is used to provide guidance to the individual 100’ during a movement such as walking, the control device 130’ may be used to select and set a movement pace associated with the perceived periodicity of the movement cue,” ¶[0238], where “For instance, three different walking paces (e.g. 1 step per second, 0,5 steps per second, 2 steps per second) may be encoded by providing a pulse train signal via a neuronal stimulation interface and system as discussed above. Such a pulse train (being characterized by signal parameters such as pulse width, pulse frequency, pulse shape and / or pulse amplitude) may elicit a periodic / rhythmic sensory percept in the targeted area of the sensory cortex of the individual”).
Regarding claim 15, Várkuti teaches all limitations of claim 1 as described in the rejection above.
Várkuti teaches that the external system includes at least one of a wearable audio-producing device, a wearable haptic sensation producing device, a wearable visual cue producing device, non-wearable audio-producing speakers, a non-wearable visual cue producing device (¶[0216], where “a control device 130’, that may be implemented by a smartphone or a similar electronic information processing device,” ¶[0217], where “The control device 130’ may provide the individual with a user interface.” Examiner interprets that a smartphone inherently includes a non-wearable visual cue since smartphones have a viewable screen.), one or more wearable sensors or one or more location sensors.
Regarding claim 16, see the rejection of claim 1 above. However, claim 16 adds “a non-transitory machine-readable medium including instructions, which when executed by a machine, cause the machine to perform a method” and “a user input configured to provide the perceptible output signal”.
Várkuti teaches a non-transitory machine-readable medium including instructions, which when executed by a machine, cause the machine to perform a method (¶[0164], where “The present disclosure also describes a computer program, comprising instructions to perform any of the methods described herein, when executed by the signal processing circuitry of a neuronal stimulation apparatus such a one of the neuronal stimulation apparatuses mentioned above”) and a user input (¶[0217], where “The control device 130’ may provide the individual with a user interface”) configured to provide the perceptible output signal (¶[0217], where “the individual 100’ may adjust signal parameters such as a signal frequency, a pulse width, a pulse shape and /or a signal amplitude. For example, the individual may use the control device 130’ to select a perceived periodicity of a movement cue provided by a neuronal stimulation signal to the cortex of the individual 100’. For example, if the movement cue is used to provide guidance to the individual 100’ during a movement such as walking, the control device 130’ may be used to select and set a movement pace associated with the perceived periodicity of the movement cue”).
Regarding claim 17, see the rejection of claim 1 above. However, claim 17 adds “a system”, “a deep brain stimulation (DBS) system configured to use the DBS lead to deliver a DBS therapy to a patient having a neurological disorder”, “an external user system including a processor and a user output configured to provide a perceptible output signal to the patient, wherein the cueing routine is configured to control the user output to provide the perceptible output signal”.
Várkuti teaches a system (¶[0001], where “The present invention relates to signal and data processing systems for providing neuronal stimulation signals”), comprising:
a deep brain stimulation (DBS) system configured to use the DBS lead to deliver a DBS therapy to a patient having a neurological disorder (¶[0226], where “a DBS electrode 120’ that is used as a neuromodulator … the neuromodulation electrode can also be used for applying neuronal stimulation signals provided by a system … the subthalamic nucleus 320’ is conducted for the tip contacts 330’ to control, for example, the primary PD symptoms more distal contacts 340’, 350’ could be used in combination with the above disclosed invention”); and
an external user system including a processor (¶[0216], where “a control device 130’, that may be implemented by a smartphone or a similar electronic information processing device.” Examiner interprets that a smartphone inherently includes a processor as this is a necessary component.) and a user output configured to provide a perceptible output signal to the patient, wherein the cueing routine is configured to control the user output to provide the perceptible output signal (¶[0217], where “The control device 130’ may provide the individual with a user interface to adjust the neuronal stimulation signals and / or the neuromodulation therapy applied via the signal generator 110’ and the neuronal stimulation electrode 120’. For instance, the individual 100’ may adjust signal parameters such as a signal frequency, a pulse width, a pulse shape and /or a signal amplitude. For example, the individual may use the control device 130’ to select a perceived periodicity of a movement cue provided by a neuronal stimulation signal to the cortex of the individual 100’. For example, if the movement cue is used to provide guidance to the individual 100’ during a movement such as walking, the control device 130’ may be used to select and set a movement pace associated with the perceived periodicity of the movement cue”).
Regarding claim 19, Várkuti teaches all limitations of claim 17 as described in the rejection above.
Várkuti teaches that the implemented cueing routine relieves a movement disorder or symptom in the patient (¶[0226], where “for example, the primary PD symptoms more distal contacts 340’, 350’ could be used in combination with the above disclosed invention to communicate a movement cue and / or a continuous movement biofeedback signal into the brain the patient can utilize to navigate better and/or break free from FOG”), and the DBS therapy relieves at least one other symptom of the patient (¶[0215], where “the neuronal stimulation electrode 120’ may be already implanted into the brain of the individual 100’ for the purpose of providing a neuromodulation therapy for certain PD symptoms such as tremor, dystonia and / or rigidity,” ¶[0226], where “a DBS electrode 120’ that is used as a neuromodulator, e.g. for treatment of PD symptoms”).
Regarding claim 20, Várkuti teaches all limitations of claim 17 as described in the rejection above.
Várkuti teaches that the processor is configured to implement the cueing routine (¶[0216], where “a control device 130’, that may be implemented by a smartphone or a similar electronic information processing device,” ¶[0217], where “For example, if the movement cue is used to provide guidance to the individual 100’ during a movement such as walking, the control device 130’ may be used to select and set a movement pace associated with the perceived periodicity of the movement cue.” Examiner interprets that since the smartphone inherently includes a processor, and since the smartphone implements the cueing routine, that the processor is configured to implement the cueing routine.) to provide a plurality of perceptible signal instances (¶[0234], where “Further, once or while the communication library (i.e. the plurality of relations stored in the memory) is established or is being established for an individual a specific training procedure can be executed … such a pair consists of a given sensory percept corresponding to a given neuronal stimulation signal and a movement cue and /or a piece of proprioceptive information to be associated with said given sensory percept and the corresponding neuronal stimulation signal”), and control timing for providing the plurality of perceptible signal instances (¶[0217], where “For example, if the movement cue is used to provide guidance to the individual 100’ during a movement such as walking, the control device 130’ may be used to select and set a movement pace associated with the perceived periodicity of the movement cue”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Várkuti as applied to claim 1 above.
Regarding claim 2, Várkuti teaches all limitations of claim 1 as described in the rejection above.
Várkuti teaches using a controller (¶[0217], where “The control device 130’ may provide the individual with a user interface”) to coordinate the DBS therapy with the cueing routine (¶[0217], where “For example, if the movement cue is used to provide guidance to the individual 100’ during a movement such as walking, the control device 130’ may be used to select and set a movement pace associated with the perceived periodicity of the movement cue,” ¶[0221], “For instance, the neuronal stimulation system provided by the present invention may determine the waveform and / or signal parameters of the neuronal stimulation signal such that a desired sensory percept is elicited in a desired area of the sensory cortex of the individual. In some embodiments of the present invention, the cortex of the individual which is receiving the neuronal stimulation signal (i.e. via afferent action potentials of the stimulated afferent axons 230’) may associate the corresponding sensory percept with a movement cue and / or other type of movement related information.” Examiner interprets that the movement cue and DBS therapy are coordinated since the stimulation creates a sensory precept that correlates to a movement cue.) by: changing at least one DBS parameter value when the cueing routine is implemented (¶[0217], where “control device 130’ may provide the individual with a user interface to adjust the neuronal stimulation signals and / or the neuromodulation therapy applied via the signal generator 110’ and the neuronal stimulation electrode 120’ … the individual 100’ may adjust signal parameters”).
Although the above-mentioned embodiment of Várkuti teaches one of the coordination types, where the language of “or” requires only one of the coordination types, the above-mentioned embodiment of Várkuti does not explicitly teach coordinating the DBS therapy with the cueing routine by: changing to a different DBS program when the cueing routine is implemented; activating a second DBS program, and interleaving the second program with a first DBS program that was active before the second DBS program was activated; or intermittently delivering the DBS therapy to avoid delivering the DBS therapy during the cueing routine. However, other embodiments of Várkuti teach these limitations.
A second embodiment of Várkuti teaches coordinating the DBS therapy with the cueing routine by: changing to a different DBS program when the cueing routine is implemented (¶[0107], where “a first neuronal stimulation signal may be adapted to control the movement speed, the pace regularity and/or the balance of the individual and a second neuronal stimulation signal is adapted to counteract a temporary movement impairment of the individual,” ¶[0108], where “the second neuronal stimulation signal may be adapted to provide a FOG breakout signal to the individual and the first a gait pacemaker signal”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of a second embodiment of Várkuti, which teaches coordinating the DBS therapy with the cueing routine by: changing to a different DBS program when the cueing routine is implemented, with the invention of Várkuti in order to end a FOG period and to provide a gait pacemaker signal enhancing gait quality and reducing the occurrence frequency of FOG events (Várkuti ¶[0108]).
Neither the first or second embodiment of Várkuti teaches coordinating the DBS therapy with the cueing routine by: activating a second DBS program, and interleaving the second program with a first DBS program that was active before the second DBS program was activated; or intermittently delivering the DBS therapy to avoid delivering the DBS therapy during the cueing routine.
A third embodiment of Várkuti teaches coordinating the DBS therapy with the cueing routine by: activating a second DBS program, and interleaving the second program with a first DBS program that was active before the second DBS program was activated (¶[0093], where “Alternatively, an electric contact that is used for applying the neuromodulation therapy can also be used in an alternating manner. For instance, the movement cue may be provided during periods wherein the electrode is not used for applying the neuromodulation therapy (e.g. the purpose that is different from providing the movement cue)”); or
intermittently delivering the DBS therapy to avoid delivering the DBS therapy during the cueing routine (¶[0093], where “Alternatively, an electric contact that is used for applying the neuromodulation therapy can also be used in an alternating manner. For instance, the movement cue may be provided during periods wherein the electrode is not used for applying the neuromodulation therapy (e.g. the purpose that is different from providing the movement cue)”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of a third embodiment of Várkuti, which teaches coordinating the DBS therapy with the cueing routine by: activating a second DBS program, and interleaving the second program with a first DBS program that was active before the second DBS program was activated; or intermittently delivering the DBS therapy to avoid delivering the DBS therapy during the cueing routine, with the modified invention of Várkuti in order to reduce cost, complexity, and power consumption of the combined stimulation system (Várkuti ¶[0095]).
Regarding claim 18, Várkuti teaches all limitations of claim 17 as described in the rejection above. Furthermore, regarding claim 18, since claim 18 is substantially similar to claim 2, see the rejection of claim 2 above.
Claims 11 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Várkuti as applied to claim 1 above, and further in view of Molnar et al. (hereinafter “Molnar”) (WO 2009/051638 A1).
Regarding claim 11, Várkuti teaches all limitations of claim 1 as described in the rejection above.
Although Várkuti teaches a movement cue (¶[0217], where “For example, if the movement cue is used to provide guidance to the individual 100’ during a movement”), Várkuti does not teach that the cueing patient movement includes cueing hand movement or arm movement.
Molnar teaches a method that includes monitoring a bioelectrical signal from a brain of a patient, determining whether the bioelectrical brain signal indicates the patient is in a movement state, at a first time, controlling delivery of therapy to the patient if the bioelectrical signal indicates the patient is in the movement state, at a second time following the first time, determining whether the patient is in the movement state, and controlling the delivery of the therapy to the patient based on whether the patient is in the movement state at the second time following the first time (¶[0006]), and further teaches that the cueing patient movement includes cueing hand movement or arm movement (¶[0079], where “sensing device 14, which monitors an EEG signal via electrodes 24A-24E (FIG. IB) of electrode array 18 and controls external cue device 16 to deliver a cue to patient 12 to help control the effects of a movement disorder, e.g., to help initiate movement,” ¶[0138], where “sensing device 14 may monitor the EEG signal that is generated when patient 12 initiates a variety of different movements, such as movement of an arm,” ¶[0165], where “In some cases, a clinician or computing device may also correlate a particular EEG signal with a particular movement or an EEG signal from within a particular region of the motor cortex of brain 20 with a particular movement. For example, if patient 12 is afflicted with tremor that affects the patient's arm during arm movement … processor 42 may distinguish between an EEG signal that indicates prospective movement of the patient's arm … Cue generator 54 of external cue device 16 may be configured to deliver different external cues based on the particular movement indicated by the detected EEG signals”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Molnar, which teaches that the cueing patient movement includes cueing hand movement or arm movement, with the modified invention of Várkuti since it is useful for controlling a movement disorder by helping to minimize perception of any movement disorder symptoms by the patient 12, timing the delivery of therapy such that the patient does not substantially perceive an inability to initiate movement or another effect of a movement disorder (Molnar ¶[0166]).
Regarding claim 13, Várkuti teaches all limitations of claim 1 as described in the rejection above.
Várkuti teaches that the external system includes a phone, watch or another wearable configured to execute the cueing application to implement the cueing routine (¶[0216], where “a control device 130’, that may be implemented by a smartphone or a similar electronic information processing device”).
Although Várkuti discusses an auditory movement cue (¶[0238], where “Similar to an auditory movement cue provided to the individual via earphones such a neuronal movement cue may help the individual to walk at a constant pace and without experiencing a FOG period”), Várkuti does not teach that the perceptible output signal used to cue patient movement includes at least one of a sound or a vibration produced by the phone, the watch or the other wearable.
Molnar teaches that the perceptible output signal used to cue patient movement includes at least one of a sound (¶[0056], where “After sensing device 14 determines that patient 12 is in a movement state, external cue device 16 may deliver a sensory cue, such as a visual, somatosensory or auditory cue, to patient 12 in order to help control the movement disorder”) or a vibration produced (¶[0062], where “A device coupled to the patient's wrist may, for example, provide a pulse, pulsed vibration, or other tactile stimulus”) by the phone. the watch or the other wearable (¶[0062], where “Although external cue device 16 is shown as an eyepiece worn by patient 12 in the same manner as glasses, in other examples, external cue device 16 may have different configurations. For example, if an auditory cue is desired, an external cue device may take the form of an ear piece (e.g., an ear piece similar to a hearing aid or head phones). As another example, if a somatosensory cue is desired, an external cue device may take the form of a device worn on the patient's arm or legs (e.g., as a bracelet or anklet), around the patient's waist (e.g., as a belt) or otherwise attached to the patient in a way that permits the patient to sense a somatosensory cue”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Molnar, which teaches that the perceptible output signal used to cue patient movement includes at least one of a sound or a vibration produced by the phone, the watch or the other wearable, with the modified invention of Várkuti in order to help control the movement disorder (Molnar ¶[0056]).
Regarding claim 14, Várkuti in combination with Molnar teaches all limitations of claim 13 as described in the rejection above.
Várkuti teaches that the cueing application is configured to use the accelerometer to determine when to implement the cueing routine by determining at least one of actual patient movement, attempted patient movement or predicted patient movement (¶[0116], where “By using one or more of such sensors an accurate model of the body posture of the individual may be determined and be used to determine a tailored neuronal stimulation signal that is adapted to communicate precise and reliable proprioceptive information directly to the cortex of the individual,” ¶[0134], where “Similar as for other embodiments discussed above, the provided system may further comprise means for obtaining information about the body posture of the individual via at least one of: … an acceleration sensor,” ¶[0222], where “a system that generates and provides electrical signals the brain can interpret as meaningful input, e.g. as a rhythmic movement cue or any other type of movement related information such as a commence movement trigger (e.g. a FOG break-out signal) or information about the current body posture of the individual (e.g. proprioceptive information). As discussed in section 3 above, such information may be provided by different types of measurement devices or sensors,” where Examiner interprets that utilizing body posture of an individual as an input for the electrical signals means that the cueing routine will be implemented based on that input of movement.), or the phone, the watch or the other wearable is configured to use a location service to implement the cueing routine by determining a location for at least one of actual patient movement, attempted patient movement or predicted patient movement.
The above-described embodiment of Várkuti does not teach that the phone, the watch or the other wearable includes an accelerometer.
Another embodiment of Várkuti teaches that the phone, the watch or the other wearable includes an accelerometer (¶[0214], where “a continuous gait biofeedback signal into the brain the patient can utilize to navigate better and/or break free from freezing of gait situations. Such a biofeedback signal can consist of e.g. EMG sensor feedback transmitted to the implant via a smartphone, with the EMG glue-on disposable sensors measuring muscle tension or movement patterns or even simple accelerometer data from a smartwatch”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of another embodiment of Várkuti, which teaches that the phone, the watch or the other wearable includes an accelerometer, with the modified invention of Várkuti since a continuous gait biofeedback signal into the brain of the patient can be utilized to navigate better and/or break free from freezing of gait situations (Várkuti ¶[0214]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Várkuti as applied to claim 1 above, and further in view of Moffitt et al. (hereinafter “Moffitt”) (U.S. Pub. No. 2019/0329051 A1).
Regarding claim 12, Várkuti teaches all limitations of claim 1 as described in the rejection above.
Although Várkuti teaches a cueing routine (See ¶[0217]), Várkuti does not teach determining, inferring or accessing a patient medication state, and adjusting the cueing routine based at least in part on the patient medication state.
Moffitt teaches a method implemented by a system configured for use with multiple neuromodulation modes for delivering neuromodulation therapy (¶[0021]), where a user-inputted disease may include Parkinson's disease (¶[0013]), and further teaches determining, inferring or accessing a patient medication state (¶[0093], where “The algorithm inputs may include sensor inputs or user inputs. Candidate inputs include one or more of … medication usages. Examples of diseases that may be candidate inputs include Parkinson's disease”), and adjusting the cueing routine based at least in part on the patient medication state (¶[0090], where “the illustrated system 946 includes an algorithm component 948 that implements an algorithm on received input(s) to produce system output(s). The illustrated system may be implemented with a neuromodulation system such as illustrated previously, and more particularly may be implemented with a system that is capable of delivering multiple neuromodulation modes.” Examiner interprets that since the inputs, such as medication usage, are utilized to determine the system output, that the routine is based in part on the medication usage.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Moffitt, which teaches determining, inferring or accessing a patient medication state, and adjusting the cueing routine based at least in part on the patient medication state, with the modified invention of Várkuti in order to deliver multiple neuromodulation modes (Moffitt ¶[0090]).
Conclusion
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/SEFRA D. MANOS/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792