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 .
Response to Arguments
The Applicant filed Amendments to the Claims and Remarks on December 29, 2025 in response to the Examiner’s Non-Final Office Action, mailed October 8, 2025.
Amendments to the Claims
At this time, claims 1, 3-6, 8-12, 14, and 16-32 are pending. Claims 1, 3, 4, 8, 9, 14, 16, 17, 19, 30, and 31 have been amended. Claims 2, 7, 13, and 15 have been cancelled. The Applicant has added new independent claim 32. The Applicant asserts that no new matter is added. (Remarks, pg. 8)
Claim Rejections - 35 U.S.C. § 101
Claim 31 was previously rejected under 35 U.S.C. 101. (Remarks, pg. 8)
Applicant’s arguments, filed December 29, 2025, with respect to claim 31 have been fully considered and are persuasive. The 35 U.S.C. 101 rejection of October 8, 2025 has been withdrawn.
Claim Rejections - 35 U.S.C. § 102 and 103
Claims 1, 3, 17, 18, 20-24, and 26-31 were previously rejected under 35 U.S.C. 102(a)(1). Claims 4-12, 14-16, 19, and 25 were previously rejected under 35 U.S.C. 103. (Remarks, pg. 9-12)
The Applicant has submitted the arguments that “the combination of Rosenbluth, Amit, and Rocon de Lima fails to disclose or suggest the specific combination of features recited by amended claim 1, including: (1) mechanomyography sensors, and (2) controlling the electrical stimulus to be substantially in- phase with the lower frequency envelope of the sensor output from the agonist muscle's mechanomyography sensor”. (Remarks, pg. 11)
Addressing point (1), the Applicant argues that none of the references from October 8, 2025 disclose a “mechanomyography sensor”. However, claim 27 recites that “the mechanomyography sensor comprises one or more of an acoustic sensor, an accelerometer, a piezoelectric sensor and a force sensor”. In para. [0192], Rosenbluth describes many options describing the sensors of the invention, at least one of which being recited within claim 27 of the instant application, i.e. “a combination of single or multi-axis accelerometers”. ([0192]: “The device or system may include sensors. Sensors for monitoring the tremor may include a combination of single or multi-axis accelerometers, gyroscopes, inclinometers (to measure and correct for changes in the gravity field resulting from slow changes in the device's orientation), magnetometers; fiber optic electrogoniometers, optical tracking or electromagnetic tracking; electromyography (EMG) to detect firing of tremoring muscle; electroneurogram (ENG) signals; cortical recordings by techniques such as electroencephalography (EEG) or direct nerve recordings on an implant in close proximity to the nerve.”) For a least this reason, the Examiner respectfully disagrees that the combination of Rosenbluth, Amit, and Rocon de Lima fails to disclose or suggest a “mechanomyography sensor”.
Addressing point (2), the Applicant argues that none of the references from October 8, 2025 disclose controlling the electrical stimulus to be substantially in- phase with the lower frequency envelope of the sensor output from the agonist muscle's mechanomyography sensor. The Examiner has found these arguments to be persuasive. Therefore, Applicant’s arguments, see Remarks, pg. 9-12, with respect to claims 1-31 have been fully considered and are persuasive. The 35 USC § 102(a)(1) and 35 USC § 103 of October 8, 2025 has been withdrawn.
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, 3-6, 8, 20-24, and 26-31 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenbluth et al.(US 2018/264263, hereinafter referred to as Rosenbluth) in view of Barrella et al. (IT MO20060087, also labelled as WO 2007/107831, hereinafter referred to as Barrella) and further in view of Amit et al. (US 8,626,275, hereinafter referred to as Amit).
Regarding amended, independent claim 1, Rosenbluth discloses a peripheral nerve stimulator can be used to stimulate a peripheral nerve to treat essential tremor, Parkinson tremor, and other forms of tremor. Rosenbluth further discloses an apparatus (tremor altering system 700 in Figs. 7A-7D; [0011]: “The present invention relates systems, devices, and methods for treating tremor, and more specifically relate to system, devices, and methods for treating tremor by stimulation of a peripheral nerve.”) comprising:
at least one processor (processor 797 in Figs. 7A – 7D); and
at least one memory including computer program code (memory 770 in Figs. 7A-7D; [0046]: “…a memory storing instructions…”), the at least one memory and computer program code configured to, with the at least one processor, cause the apparatus to:
receive a sensor output from a mechanomyography sensor (sensor 780 in Figs. 7A – 7D) configured to monitor muscle activity of a muscle in a human or animal body ([0131]: “…a sensor 780 to detect the tremor…”; [0135]: “…a sensor 780 for direct detection of the tremor or neuromuscular activity detected by electroneurography (ENG) or electromyography (EMG)...”; [0136]: “The sensor 780 could include motion sensors including accelerometers, gyroscopes and magnetometers.”); and
control, in response to the received sensor output, an electrical stimulus applied by a muscle stimulator (electrical stimulator 730 in Figs. 7A-7D) to the muscle to modify said muscle activity ([0046]: “…the decision unit comprises a processor and a memory storing instructions that, when executed by the processor, cause the decision unit to: deliver a first electrical stimulus to a first peripheral nerve through the first peripheral nerve effector, the electrical stimulus configured by the controller to reduce tremor in the patient's extremity by modifying the patient's neural network dynamics.”), wherein the electrical stimulus is applied with an amplitude below the motor threshold of the muscle ([0152]: “Stimulating at intensities below the sensory threshold will avoid the discomfort (tingling, numbness, pain) that can be associated with peripheral nerve stimulation.”) simultaneously during monitoring of the muscle activity by the mechanomyography sensor (sensor 780 in Figs. 7A – 7D; [0136]),
wherein the muscle activity is involuntary ([0193]: “The data from these tremor sensors is used measure the patient's current and historical tremor characteristics… These sensors may also be used to determine activities, such as to distinguish involuntary movements (e.g. tremor) from voluntary movements (e.g. drinking, writing)…”), and the apparatus is configured to control the electrical stimulus to decrease the involuntary muscle activity ([0011]: “The present invention relates systems, devices, and methods for treating tremor, and more specifically relate to system, devices, and methods for treating tremor by stimulation of a peripheral nerve.”), and
wherein a first mechanomyography sensor (sensor 780 in Figs. 7A – 7D; [0136]) and muscle stimulator (electrical stimulator 730 in Figs. 7A-7D) are associated with an agonist muscle ([0125]: “The device stimulates the sensory nerves in order to modify the abnormal network dynamics. Over time, this stimulation normalizes the neural firing in the abnormal network and reduces tremor… These regions may also target the musculature including muscles of the shoulder, muscles of the arm, and muscles of the forearm, hand, or fingers. Muscles of the shoulder may include, by non-limiting example, the deltoid, teres major and supraspinatus. Muscles of the arm may include the coracobrachialis and triceps brachii. Muscles of the forearm may include the extensor carpi radialis longus, abductor pollicis longus, extensor carpi unlarnis, and flexor carpi ulnaris.”) and a second mechanomyography sensor (sensor 780 in Figs. 7A – 7D; [0136]) and muscle stimulator (electrical stimulator 730 in Figs. 7A-7D) are associated with an antagonist muscle ([0125])
While Rosenbluth does disclose that muscle stimulation can be applied to agonist and antagonist muscles in [0125], it does not specifically disclose an agonist/antagonistic pair, and wherein the apparatus is configured to control the electrical stimulus applied by the second muscle stimulator to the antagonist muscle such that a periodic or pseudo-periodic signal of the electrical stimulus is substantially in-phase with the lower frequency envelope of the sensor output received from the first mechanomyography sensor associated with the agonist muscle, and vice-versa.
However, Barrella teaches an electrostimulating apparatus and method. The Examiner notes that citations from Barrella are from the translated document, included in this Office Action’s attachments. Barrella further teaches an agonist/antagonistic pair (pg. 5-6, li. 298-301: “In use, the apparatus 1 is connected to a patient affected by spastic phenomena and at least two distinct stimulation channels 2 are used, for example the aforesaid channels 2A and 2B, the electrodes 7 of which are applied respectively to a body region near the specific efferent nerve of a hypertonic muscle (agonist muscle) and at a further body region comprising the corresponding antagonist muscle.”), and wherein the apparatus (apparatus 1 in Fig. 1) is configured to control the electrical stimulus applied by the second muscle stimulator (stimulation channel 2A or 2B with electrodes 7 in Fig. 1) to the antagonist muscle such that a periodic or pseudo-periodic signal of the electrical stimulus is substantially in-phase with the sensor output received from the first mechanomyography sensor associated with the agonist muscle (pg. 6, li. 301-302: “The hypertonic muscle is then stimulated through the DCTR relaxing sequence whilst, simultaneously, the antagonist muscle is stimulated through the ATMC vasoactive sequence.”; pg. 6, li. 328-339 discusses obtaining compound action potentials or “cMAPs”.), and vice-versa.
Barrella is of a similar pursuit to that of Rosenbluth and the instant application in teaching the control of stimulation parameters in medical electrotherapy. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the apparatus of Rosenbluth to include the phase controls of Barrella in order to decrease the involuntary muscle activity of a patient.
The Rosenbluth/Barrella combination is silent to lower frequency envelope of the sensor output.
However, Amit teaches an apparatus and method for detecting myocardial ischemia using analysis of high frequency components of an electrocardiogram. Amit further teaches the lower frequency envelope of the sensor output ([col. 3, li. 15-17]: “…obtaining high frequency QRS components from a QRS complex within the ECG signals and a low frequency envelope around the high frequency QRS components…”).
Such thresholding implementations as using envelope modulation is well known to a person having ordinary skill in the art at the effective filing date of the invention. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to utilize the envelope modulation controls of Amit combined with the apparatus of the Rosenbluth/Barrella combination to properly mitigate the effects of involuntary muscle activity in a patient.
Regarding amended claim 3, in view of the Rosenbluth/Barrello/Amit combination, Rosenbluth discloses that the electrical stimulus and sensor output each comprise the periodic or pseudo-periodic signal ([0148]: “In a preferred embodiment, the stimulation is designed to dephase synchronicity in the brain. The concept of dephasing the abnormal circuit follows on recent work showing neural retraining reduces the network's propensity to fall into an abnormal rhythm. Interestingly, movement disorders are often associated with abnormal periodic synchronous firing in brain circuits.”), and wherein the apparatus is configured to control the phase of the periodic or pseudo-periodic signal of the electrical stimulus relative to that of the sensor output to decrease the involuntary muscle activity ([0011]: “The present invention relates systems, devices, and methods for treating tremor, and more specifically relate to system, devices, and methods for treating tremor by stimulation of a peripheral nerve.”).
Regarding amended claim 4, in view of the Rosenbluth/Barrello/Amit combination, Rosenbluth discloses that the periodic or pseudo-periodic signal of the sensor output ([0148])…, and wherein the apparatus is configured to control the phase of the periodic or pseudo-periodic signal of the electrical stimulus … to decrease the involuntary muscle activity ([0011]: “The present invention relates systems, devices, and methods for treating tremor, and more specifically relate to system, devices, and methods for treating tremor by stimulation of a peripheral nerve.”).
Rosenbluth is silent to a higher frequency component within a lower frequency envelope, and to control the phase of the periodic or pseudo-periodic signal of the electrical stimulus relative to that of the lower frequency envelope of the sensor output.
However, Barrella teaches to control the phase of the periodic or pseudo-periodic signal of the electrical stimulus (pg. 5-6, li. 298-301: “In use, the apparatus 1 is connected to a patient affected by spastic phenomena and at least two distinct stimulation channels 2 are used, for example the aforesaid channels 2A and 2B, the electrodes 7 of which are applied respectively to a body region near the specific efferent nerve of a hypertonic muscle (agonist muscle) and at a further body region comprising the corresponding antagonist muscle.”; pg. 6, li. 301-302: “The hypertonic muscle is then stimulated through the DCTR relaxing sequence whilst, simultaneously, the antagonist muscle is stimulated through the ATMC vasoactive sequence.”; pg. 6, li. 328-339 discusses obtaining compound action potentials or “cMAPs”.).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the apparatus of Rosenbluth to include the phase controls of Barrella in order to decrease the involuntary muscle activity of a patient.
The Rosenbluth/Barrella combination is silent to a higher frequency component within a lower frequency envelope, and to control … the periodic or pseudo-periodic signal of the electrical stimulus relative to that of the lower frequency envelope of the sensor output.
However, Amit teaches an apparatus and method for detecting myocardial ischemia using analysis of high frequency components of an electrocardiogram. Amit further teaches a higher frequency component within a lower frequency envelope ([col. 3, li. 15-17]: “…obtaining high frequency QRS components from a QRS complex within the ECG signals and a low frequency envelope around the high frequency QRS components…”), and to control the periodic or pseudo-periodic signal of the electrical stimulus relative to that of the lower frequency envelope of the sensor output ([col. 3, li. 15-17], with the ECG signals comprising the sensor output. Cardiac output is a pseudo-periodic signal.).
The invention of Amit is a similar stimulation device to the instant invention in being a device utilizing muscle activity as an input and outputting electrical stimulation to mitigate involuntary movement. Such thresholding implementations as using envelope modulation is well known to a person having ordinary skill in the art at the effective filing date of the invention. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to utilize the envelope modulation controls of Amit combined with the apparatus of the Rosenbluth/Barrella combination to properly mitigate the effects of involuntary muscle activity in a patient.
Regarding claim 5, in view of the Rosenbluth/Barrella/Amit combination, Rosenbluth discloses that the apparatus is configured to control the electrical stimulus ([0148]: “In a preferred embodiment, the stimulation is designed to dephase synchronicity in the brain. The concept of dephasing the abnormal circuit follows on recent work showing neural retraining reduces the network's propensity to fall into an abnormal rhythm. Interestingly, movement disorders are often associated with abnormal periodic synchronous firing in brain circuits.”).
The Rosenbluth/Barrella combination is silent to that the periodic or pseudo-periodic signal of the electrical stimulus has an amplitude which is proportional to that of the lower frequency envelope.
Amit teaches that the periodic or pseudo-periodic signal of the electrical stimulus has an amplitude which is proportional to that of the lower frequency envelope ([col. 3, li. 15-17]: “…obtaining high frequency QRS components from a QRS complex within the ECG signals and a low frequency envelope around the high frequency QRS components…”; [col. 2, li. 33-38]: “The high frequency data from the QRS complex are analyzed with imbedded algorithms to determine the presence or absence of reduced amplitude zones, referred to herein as "RAZs". RAZs are displayed as "go, no-go" signals on the computer monitor.”).
Such thresholding implementations as using envelope modulation is well known to a person having ordinary skill in the art at the effective filing date of the invention. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to utilize the envelope modulation controls of Amit combined with the apparatus of the Rosenbluth/Barrella combination to properly mitigate the effects of involuntary muscle activity in a patient.
Regarding claim 6, in view of the Rosenbluth/Barrella/Amit combination, Rosenbluth discloses that the apparatus is configured to compare the amplitude of the lower frequency envelope to a first predefined threshold defining an actionable level of involuntary muscle activity ([0152]: “Stimulating at intensities below the sensory threshold will avoid the discomfort (tingling, numbness, pain) that can be associated with peripheral nerve stimulation.”), and cause application of the electrical stimulus only if the amplitude of the lower frequency envelope exceeds the first predefined threshold ([0064]: “In some embodiments, the memory storing instructions that, when executed by the processor, further cause the decision unit to compare the determined tremor magnitude with a predetermined threshold; and wherein the first electrical stimulus is delivered when the determined tremor magnitude exceeds a predetermined threshold.”).
The Rosenbluth/Barrella combination is silent to the amplitude of the lower frequency envelope.
However, Amit teaches the amplitude of the lower frequency envelope ([col. 3, li. 15-17]: “…obtaining high frequency QRS components from a QRS complex within the ECG signals and a low frequency envelope around the high frequency QRS components…”; [col. 2, li. 33-38]: “The high frequency data from the QRS complex are analyzed with imbedded algorithms to determine the presence or absence of reduced amplitude zones, referred to herein as "RAZs". RAZs are displayed as "go, no-go" signals on the computer monitor.”).
Such thresholding implementations as using envelope modulation is well known to a person having ordinary skill in the art at the effective filing date of the invention. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to utilize the envelope modulation controls of Amit combined with the apparatus of Rosenbluth to properly mitigate the effects of involuntary muscle activity in a patient.
Regarding amended claim 8, Rosenbluth is silent to that the apparatus is configured to control the electrical stimulus applied by the second muscle stimulator to the antagonist muscle such that the periodic or pseudo-periodic signal of the electrical stimulus has a phase difference of substantially 0°, 330-30° or 90-270° relative to the lower frequency envelope of the sensor output received form the first mechanomyography sensor associated with the agonist muscle, and vice-versa.
However, Barrella teaches that the apparatus is configured to control the electrical stimulus applied by the second muscle stimulator to the antagonist muscle such that the periodic or pseudo-periodic signal of the electrical stimulus has a phase difference of substantially 0°, 330-30° or 90-270° relative to … the sensor output received form the first mechanomyography sensor associated with the agonist muscle, and vice-versa (pg. 5-6, li. 298-301: “In use, the apparatus 1 is connected to a patient affected by spastic phenomena and at least two distinct stimulation channels 2 are used, for example the aforesaid channels 2A and 2B, the electrodes 7 of which are applied respectively to a body region near the specific efferent nerve of a hypertonic muscle (agonist muscle) and at a further body region comprising the corresponding antagonist muscle.”; pg. 6, li. 301-302: “The hypertonic muscle is then stimulated through the DCTR relaxing sequence whilst, simultaneously, the antagonist muscle is stimulated through the ATMC vasoactive sequence.”; pg. 6, li. 328-339 discusses obtaining compound action potentials or “cMAPs”.).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the apparatus of Rosenbluth to include the phase controls of Barrella in order to decrease the involuntary muscle activity of a patient.
The Rosenbluth/Barrella combination is silent to a lower frequency envelope.
However, Amit teaches a lower frequency envelope ([col. 3, li. 15-17]: “…obtaining high frequency QRS components from a QRS complex within the ECG signals and a low frequency envelope around the high frequency QRS components…”).
Such thresholding implementations as using envelope modulation is well known to a person having ordinary skill in the art at the effective filing date of the invention. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to utilize the envelope modulation controls of Amit combined with the apparatus of the Rosenbluth/Barrella combination to properly mitigate the effects of involuntary muscle activity in a patient.
Regarding claim 20, Rosenbluth discloses that the electrical stimulus is applied as one or more stimulation bursts ([0061]: “…to deliver the first electrical stimulus as a plurality of bursts of electrical stimulation…”), and wherein the apparatus is configured to correlate the sensor output with the one or more stimulation bursts to identify induced muscle activity as a result of the applied stimulation ([0152]: “Stimulating at intensities below the sensory threshold will avoid the discomfort (tingling, numbness, pain) that can be associated with peripheral nerve stimulation. Because the exact electrode position, size and surface contact have a large effect on the stimulation level and the anatomical structures that receive the stimulation, the sensory threshold may need to be calibrated for each patient and even for each session. This calibration may be done by the user manually setting the stimulation parameters or otherwise indicating their sensory threshold. Another possible mechanism is for the device to automatically sweep through a range of stimulation parameters and the patient chooses the most comfortable set of parameter values. Another possible mechanism is for the patient to choose from among a set of previously chosen parameter values that provided effective and comfortable stimulation.”). Regarding claim 21, Rosenbluth discloses that the apparatus is configured to decrease an amplitude of the electrical stimulus if the induced muscle activity exceeds a third predefined threshold defining an actionable level of induced muscle activity ([0152]: “Stimulating at intensities below the sensory threshold will avoid the discomfort (tingling, numbness, pain) that can be associated with peripheral nerve stimulation.”).
Regarding claim 22, Rosenbluth discloses that the apparatus is configured to determine the third predefined threshold ([0152]) by increasing the amplitude of the electrical stimulus until the sensor output indicates that the muscle has contracted ([0152]: “Another possible mechanism is for the device to automatically sweep through a range of stimulation parameters and the patient chooses the most comfortable set of parameter values.”).
Regarding claim 23, Rosenbluth discloses that the apparatus is configured to receive a further sensor output from an inertial measurement unit configured to monitor movement of the human or animal body ([0192]: “The device or system may include sensors. Sensors for monitoring the tremor may include a combination of single or multi-axis accelerometers, gyroscopes, inclinometers (to measure and correct for changes in the gravity field resulting from slow changes in the device's orientation), magnetometers; fiber optic electrogoniometers, optical tracking or electromagnetic tracking; electromyography (EMG) to detect firing of tremoring muscle; electroneurogram (ENG) signals; cortical recordings by techniques such as electroencephalography (EEG) or direct nerve recordings on an implant in close proximity to the nerve.”), and control the electrical stimulus in response to the received further sensor output ([0225]).
Regarding claim 24, Rosenbluth discloses that the apparatus is configured to control at least one parameter of the electrical stimulus in response to one or more of the sensor output and further sensor output ([0192]; [0225]: “In some embodiments, the system can be controlled by an event trigger. Event triggers can include defined movements, temperature, voice activation, GPS location, or based on data received by a sensor or any combination thereof. For example, the device can be turned on or off during an intentional movement, such as, before a tremor has started or ended respectively. In another example, the device is turned on or off when a specified temperature is reached. The system may act to achieve a desired tremor suppression profile. For example, the control may activate the device during a period of desired tremor suppression; prior to a period of desired tremor suppression, with effects lasting beyond the use of the device; and/or in response to detection of the tremor.”).
Regarding claim 26, Rosenbluth discloses that the apparatus comprises one or more of the mechanomyography sensor (sensor 780 in Figs. 7A – 7D; [0136]) and the muscle stimulator (electrical stimulator 730 in Figs. 7A-7D).
Regarding claim 27, Rosenbluth discloses that the mechanomyography sensor (sensor 780 in Figs. 7A – 7D; [0136]) comprises one or more of an acoustic sensor, an accelerometer, a piezoelectric sensor and a force sensor ([0136]-[0137]; [0192]: “The device or system may include sensors. Sensors for monitoring the tremor may include a combination of single or multi-axis accelerometers, gyroscopes, inclinometers (to measure and correct for changes in the gravity field resulting from slow changes in the device's orientation), magnetometers; fiber optic electrogoniometers, optical tracking or electromagnetic tracking; electromyography (EMG) to detect firing of tremoring muscle; electroneurogram (ENG) signals; cortical recordings by techniques such as electroencephalography (EEG) or direct nerve recordings on an implant in close proximity to the nerve.”).
Regarding claim 28, Rosenbluth discloses that the muscle stimulator (electrical stimulator 730 in Figs. 7A-7D) comprises one or more electrode pairs configured to apply an electrical current to stimulate the muscle (effector 730 in Figs. 7A-7D; [0139]: “One or more effectors can be used to influence the nerves.”).
Regarding claim 29, Rosenbluth discloses that the one or more electrode pairs (effector 730 in Figs. 7A-7D) are configured for transcutaneous or percutaneous electrical stimulation of the muscle ([0139]: “The effectors may be delivered transcutaneously or subcutaneously. One or more effectors can be used to influence the nerves.”).
Regarding amended, independent claim 30, Rosenbluth discloses method comprising:
receiving a sensor output from a mechanomyography sensor (sensor 780 in Figs. 7A – 7D; [0136]) configured to monitor muscle activity of a muscle in a human or animal body ([0131]: “…a sensor 780 to detect the tremor…”; [0135]: “…a sensor 780 for direct detection of the tremor or neuromuscular activity detected by electroneurography (ENG) or electromyography (EMG)...”; [0136]: “The sensor 780 could include motion sensors including accelerometers, gyroscopes and magnetometers.”); and
controlling, in response to the received sensor output, an electrical stimulus applied by a muscle stimulator (electrical stimulator 730 in Figs. 7A-7D) to the muscle to modify said muscle activity ([0046]: “the decision unit comprises a processor and a memory storing instructions that, when executed by the processor, cause the decision unit to: deliver a first electrical stimulus to a first peripheral nerve through the first peripheral nerve effector, the electrical stimulus configured by the controller to reduce tremor in the patient's extremity by modifying the patient's neural network dynamics.”), wherein the electrical stimulus is applied with an amplitude below the motor threshold of the muscle ([0152]: “Stimulating at intensities below the sensory threshold will avoid the discomfort (tingling, numbness, pain) that can be associated with peripheral nerve stimulation.”) simultaneously during monitoring of the muscle activity by the mechanomyography sensor (sensor 780 in Figs. 7A – 7D; [0136]),
wherein the muscle activity is involuntary ([0193]: “The data from these tremor sensors is used measure the patient's current and historical tremor characteristics… These sensors may also be used to determine activities, such as to distinguish involuntary movements (e.g. tremor) from voluntary movements (e.g. drinking, writing)…”), and the method further comprises controlling the electrical stimulus to decrease the involuntary muscle activity ([0011]: “The present invention relates systems, devices, and methods for treating tremor, and more specifically relate to system, devices, and methods for treating tremor by stimulation of a peripheral nerve.”), and
wherein a first mechanomyography sensor (sensor 780 in Figs. 7A – 7D; [0136]) and muscle stimulator (electrical stimulator 730 in Figs. 7A-7D) are associated with an agonist muscle ([0125]: “The device stimulates the sensory nerves in order to modify the abnormal network dynamics. Over time, this stimulation normalizes the neural firing in the abnormal network and reduces tremor… These regions may also target the musculature including muscles of the shoulder, muscles of the arm, and muscles of the forearm, hand, or fingers. Muscles of the shoulder may include, by non-limiting example, the deltoid, teres major and supraspinatus. Muscles of the arm may include the coracobrachialis and triceps brachii. Muscles of the forearm may include the extensor carpi radialis longus, abductor pollicis longus, extensor carpi unlarnis, and flexor carpi ulnaris.”) and a second mechanomyography sensor and muscle stimulator are associated with an antagonist muscle ([0125]).
While Rosenbluth does disclose that muscle stimulation can be applied to agonist and antagonist muscles in [0125], it does not specifically disclose an agonist/antagonistic pair, and wherein the method further comprises controlling the electrical stimulus applied by the second muscle stimulator to the antagonist muscle such that the periodic or pseudo-periodic signal of the electrical stimulus is substantially in-phase with the lower frequency envelope of the sensor output received from the first mechanomyography sensor associated with the agonist muscle, and vice-versa.
However, Barrella teaches an electrostimulating apparatus and method. The Examiner notes that citations from Barrella are from the translated document, included in this Office Action’s attachments. Barrella further teaches an agonist/antagonistic pair (pg. 5-6, li. 298-301: “In use, the apparatus 1 is connected to a patient affected by spastic phenomena and at least two distinct stimulation channels 2 are used, for example the aforesaid channels 2A and 2B, the electrodes 7 of which are applied respectively to a body region near the specific efferent nerve of a hypertonic muscle (agonist muscle) and at a further body region comprising the corresponding antagonist muscle.”), and wherein the method further comprises controlling the electrical stimulus applied by the second muscle stimulator (stimulation channel 2A or 2B with electrodes 7 in Fig. 1) to the antagonist muscle such that the periodic or pseudo-periodic signal of the electrical stimulus is substantially in-phase with the sensor output received from the first mechanomyography sensor associated with the agonist muscle (pg. 6, li. 301-302: “The hypertonic muscle is then stimulated through the DCTR relaxing sequence whilst, simultaneously, the antagonist muscle is stimulated through the ATMC vasoactive sequence.”; pg. 6, li. 328-339 discusses obtaining compound action potentials or “cMAPs”.), and vice-versa.
Barrella is of a similar pursuit to that of Rosenbluth and the instant application in teaching the control of stimulation parameters in medical electrotherapy. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the apparatus of Rosenbluth to include the phase controls of Barrella in order to decrease the involuntary muscle activity of a patient.
The Rosenbluth/Barrella combination is silent to lower frequency envelope of the sensor output.
However, Amit teaches an apparatus and method for detecting myocardial ischemia using analysis of high frequency components of an electrocardiogram. Amit further teaches the lower frequency envelope of the sensor output ([col. 3, li. 15-17]: “…obtaining high frequency QRS components from a QRS complex within the ECG signals and a low frequency envelope around the high frequency QRS components…”).
Such thresholding implementations as using envelope modulation is well known to a person having ordinary skill in the art at the effective filing date of the invention. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to utilize the envelope modulation controls of Amit combined with the apparatus of the Rosenbluth/Barrella combination to properly mitigate the effects of involuntary muscle activity in a patient.
Regarding amended claim 31, in view of the Rosenbluth/Barrella/Amit combination, Rosenbluth discloses a non-transitory computer program comprising computer code configured to perform the method of claim 30 ([0046]: “In some embodiments, a system for treating tremor in a patient is provided. The device can include a decision unit; and an interface unit adapted to deliver electrical stimuli to a peripheral nerve, the interface unit comprising a first peripheral nerve effector in communication with the decision unit, the first peripheral nerve effector comprising at least one electrode; wherein the decision unit comprises a processor and a memory storing instructions that, when executed by the processor, cause the decision unit to: deliver a first electrical stimulus to a first peripheral nerve through the first peripheral nerve effector, the electrical stimulus configured by the controller to reduce tremor in the patient's extremity by modifying the patient's neural network dynamics.”).
Claims 9-12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over the Rosenbluth/Barrella/Amit combination in view of Rocon de Lima et al. (US 2014/0336722, hereinafter referred to as Rocon de Lima).
Regarding amended claim 9, in view of the Rosenbluth/Barrella/Amit combination, Rosenbluth discloses that the apparatus is configured to:
receive the sensor output from each mechanomyography sensor (sensor 780 in Figs. 7A – 7D) during a predefined time period.
The Rosenbluth/Barrella combination is silent to determining the lower frequency envelope of the sensor output during the predefined time period; and
predicting the lower frequency envelope of the sensor output during a subsequent predefined time period for use in controlling the electrical stimulus during the subsequent predefined time period.
However, Amit teaches a lower frequency envelope of the sensor output ([col. 3, li. 15-17]: “…obtaining high frequency QRS components from a QRS complex within the ECG signals and a low frequency envelope around the high frequency QRS components…”).
Such thresholding implementations as using envelope modulation is well known to a person having ordinary skill in the art at the effective filing date of the invention. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to utilize the envelope modulation controls of Amit combined with the apparatus of the Rosenbluth/Barrella combination to properly mitigate the effects of involuntary muscle activity in a patient.
The Rosenbluth/Barrella/Amit combination is silent to determining the lower frequency envelope of the sensor output during the predefined time period; and
predicting the lower frequency envelope of the sensor output during a subsequent predefined time period for use in controlling the electrical stimulus during the subsequent predefined time period.
However, Rocon de Lima teaches determining the lower frequency envelope of the sensor output during the predefined time period; and
predicting the lower frequency envelope of the sensor output during a subsequent predefined time period for use in controlling the electrical stimulus during the subsequent predefined time period ([0130]: “FIG. 6A and FIG. 6B show the flexor and extensor EMG, respectively, and the dashed line is the estimated tremor demodulated from the EMG. The stars denote the estimated centers of the tremorogenic bursts for the EMG captured during the recording window (tremor signal maxima), and the full black circles are the predicted centers of the tremorogenic bursts within the stimulation window. The dashed bars denote the time intervals during which the stimulation bursts are delivered. The occurrences of the predicted bursts match very well those of the actual bursts within the stimulation window, and the stimulation was delivered out of phase with tremorogenic activation.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to utilize the multiple time periods taught by Rocon de Lima in combination with the Rosenbluth/Barrella/Amit combination in order to have multiple phases of treating involuntary muscle activity in a patient.
Regarding claim 10, in view of the Rosenbluth/Barrella/Amit/Rocon de Lima combination, Rosenbluth discloses that the apparatus is configured to:
receive the sensor output from each mechanomyography sensor (sensor 780 in Figs. 7A – 7D; [0136]); and
determine a prediction error between the predicted and determined lower frequency envelopes of the sensor output ([0223]: “The comparison step 2206 can determine the error or difference between the detected tremor characteristics and the target tremor characteristics, and determine whether tremor or reduced tremor is present 2208, or in other words, whether the detected tremor meets or exceeds the target conditions.”).
The Rosenbluth/Barrella combination is silent to the subsequent predefined time period;
determine the lower frequency envelope of the sensor output during the subsequent predefined time period; and
predict, by accounting for the prediction error, the lower frequency envelope of the sensor output during a next subsequent predefined time period for use in controlling the electrical stimulus during the next subsequent predefined time period.
However, Amit teaches a lower frequency envelope of the sensor output ([col. 3, li. 15-17]: “…obtaining high frequency QRS components from a QRS complex within the ECG signals and a low frequency envelope around the high frequency QRS components…”).
Such thresholding implementations as using envelope modulation is well known to a person having ordinary skill in the art at the effective filing date of the invention. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to utilize the envelope modulation controls of Amit combined with the apparatus of the Rosenbluth/Barrella combination to properly mitigate the effects of involuntary muscle activity in a patient.
The Rosenbluth/Barrella/Amit combination is silent to the subsequent predefined time period;
determine the lower frequency envelope of the sensor output during the subsequent predefined time period; and
predict, by accounting for the prediction error, the lower frequency envelope of the sensor output during a next subsequent predefined time period for use in controlling the electrical stimulus during the next subsequent predefined time period.
However, Rocon de Lima teaches the subsequent predefined time period (see Figs 6A and 6B; [0130]-[0131]);
determine a prediction error between the predicted and determined lower frequency envelopes of the sensor output during the subsequent predefined time period (see Figs 6A and 6B; [0130]-[0131]); and
predict, by accounting for the prediction error, the lower frequency envelope of the sensor output during a next subsequent predefined time period for use in controlling the electrical stimulus during the next subsequent predefined time period ([0130]: “FIG. 6A and FIG. 6B show the flexor and extensor EMG, respectively, and the dashed line is the estimated tremor demodulated from the EMG. The stars denote the estimated centers of the tremorogenic bursts for the EMG captured during the recording window (tremor signal maxima), and the full black circles are the predicted centers of the tremorogenic bursts within the stimulation window. The dashed bars denote the time intervals during which the stimulation bursts are delivered. The occurrences of the predicted bursts match very well those of the actual bursts within the stimulation window, and the stimulation was delivered out of phase with tremorogenic activation.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to utilize the multiple time periods taught by Rocon de Lima in combination with the Rosenbluth/Barrella/Amit combination in order to have multiple phases of treating involuntary muscle activity in a patient.
Regarding claim 11, in view of the Rosenbluth/Barrella/Amit/Rocon de Lima combination, the Rosenbluth/Amit combination is silent to each of the predefined, subsequent predefined and next subsequent predefined time periods having substantially the same length.
However, Rocon de Lima teaches that each of the predefined, subsequent predefined and next subsequent predefined time periods have substantially the same length (see Fig. 6B: the “recording window” and the “stimulation window” each are 1000 ms long.; [0130]: “One example of the processing is given in FIG. 6A and FIG. 6B. In this particular example, the recording and stimulation windows were 1 second long.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Rosenbluth such that each of the predefined, subsequent predefined and next subsequent predefined time periods have substantially the same length, as taught by Rocon de Lima, in order to control the on-off time of the stimulation to provide therapeutic results to a patient.
Regarding amended claim 12, in view of the Rosenbluth/Barrella/Amit combination, Rosenbluth discloses that the apparatus is configured to filter the sensor output ([0197]: “Motion data can be taken as each raw sensor channel or by fusing the raw signals of multiple sensors. As one example, multi-axis accelerometer data can be combined into a single numerical value for analysis. The algorithm will extract motion data in the 4 to 12 Hz range to remove motions that are not attributable to the tremor.”).
The Rosenbluth/Barrella/Amit combination is silent to that the filtering increases a signal contribution from the involuntary muscle activity.
However, Rocon de Lima teaches that the filtering increases a signal contribution from the involuntary muscle activity ([0121]: “The strategy for identifying and monitoring the tremor is based on the signals from the sensors (bioelectrical (3) and biomechanical (4)). The EEG signal sensors provide the information about the patient intent to move voluntarily by integrating two Bayesian classifiers that are based on different characteristics of the event related desynchronization (ERD) in EEG signals.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the Rosenbluth/Barrella/Amit combination to include increases a signal contribution from the involuntary muscle activity properly control involuntary versus voluntary motion in a patient who experiences involuntary muscle activity, such as tremors.
Regarding amended claim 19, the Rosenbluth/Barrella/Amit combination is silent to that the sensor output from the first mechanomyography sensor associated with the agonist muscle is received simultaneously with the sensor output from the second mechanomyography sensor associated with the antagonist muscle.
Rocon de Lima teaches that the sensor output from the first mechanomyography sensor associated with the agonist muscle is received simultaneously with the sensor output from the second mechanomyography sensor associated with the antagonist muscle ([0059]: “The second stage consists of a control loop for the neuromodulation of afferent pathways, which uses the tremor information obtained in the previous phase, to define the intensity and timing of electrical stimulation of the afferents pathways in order to relieve the symptoms of tremor, preferably, by interrupting the synchronization of tremor-related oscillations at spinal level or brain, thereby preventing the development of tremor.”; [0146]: “…a preferred neuroprosthetic device, which uses a method based on the IHT to estimate tremorogenic EMG activity from the EMG acquired during the recording window, predicts the tremorogenic bursts that will occur within the subsequent stimulation window, and then delivers the stimulation to the antagonistic muscle pair according to this prediction.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of the Rosenbluth/Barrella/Amit combination to further include stimulation of an agonist/antagonistic pair in order to effectively control a tremor of a patient with involuntary muscle activity. Additionally, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to employ simultaneous sensor output receipt in order to more effectively sense involuntary muscle activity in a patient.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over the Rosenbluth/Barrella/Amit/Rocon de Lima combination in view of Klapper (US 2005/0234309).
Regarding claim 25, the Rosenbluth/Barrella/Amit/Rocon de Lima combination is not specific that the apparatus is configured to process one or more of the sensor output and further sensor output using a classifier to determine a severity of a neuromuscular disorder, and control at least one parameter of the electrical stimulus in response to the determined severity.
However, Klapper teaches a method and apparatus for automatically classifying the movement states in Parkinson's disease (including the patient's perception of movement states and severity of symptoms). Klapper further teaches to process one or more of the sensor output and further sensor output using a classifier to determine a severity of a neuromuscular disorder ([0118]: “Rather than a single frequency, an accelerometer actually picks up a spectrum of frequencies. A device might be able to use the predominant frequency in order to better classify what type of movement is occurring. (e.g. voluntary activity versus dyskinesia versus tremor). However, there is more information in the frequency spectrum than simply the peak frequency or mean frequency. The distribution of the frequencies may also help to better classify the type of movement.”).
Klapper teaches a similar pursuit to the instant application in classifying the severity of a neuromuscular disorder via inertial sensors. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the Rosenbluth/Barrella/Amit/Rocon de Lima combination to include a classification of determined severity of a neuromuscular disorder to act as a control of electrical stimulus in order to best treat an individual patient’s specific needs.
Claim 32 and its dependent claims 14- and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenbluth et al. (US 2018/264263, hereinafter referred to as Rosenbluth) in view of Barrella et al. (IT MO20060087, also labelled as WO 2007/107831, hereinafter referred to as Barrella) and further in view of Rocon de Lima et al. (US 2014/0336722, hereinafter referred to as Rocon de Lima).
Regarding new, independent claim 32, Rosenbluth discloses an apparatus comprising:
at least one processor (processor 797 in Figs. 7A – 7D); and
at least one memory including computer program code (memory 770 in Figs. 7A-7D; [0046]: “…a memory storing instructions…”), the at least one memory and computer program code configured to, with the at least one processor ([0064]: “In some embodiments, the memory storing instructions that, when executed by the processor, further cause the decision unit to compare the determined tremor magnitude with a predetermined threshold; and wherein the first electrical stimulus is delivered when the determined tremor magnitude exceeds a predetermined threshold.”), cause the apparatus to:
receive a sensor output from a mechanomyography sensor (sensor 780 in Figs. 7A – 7D; [0136]) configured to monitor muscle activity of a muscle in a human or animal body ([0131]: “…a sensor 780 to detect the tremor…”; [0135]: “…a sensor 780 for direct detection of the tremor or neuromuscular activity detected by electroneurography (ENG) or electromyography (EMG)...”; [0136]: “The sensor 780 could include motion sensors including accelerometers, gyroscopes and magnetometers.”); and
control, in response to the received sensor output, an electrical stimulus applied by a muscle stimulator (electrical stimulator 730 in Figs. 7A-7D) to the muscle to modify said muscle activity ([0046]: “the decision unit comprises a processor and a memory storing instructions that, when executed by the processor, cause the decision unit to: deliver a first electrical stimulus to a first peripheral nerve through the first peripheral nerve effector, the electrical stimulus configured by the controller to reduce tremor in the patient's extremity by modifying the patient's neural network dynamics.”), wherein the electrical stimulus is applied with an amplitude below the motor threshold of the muscle ([0152]: “Stimulating at intensities below the sensory threshold will avoid the discomfort (tingling, numbness, pain) that can be associated with peripheral nerve stimulation.”) simultaneously during monitoring of the muscle activity by the mechanomyography sensor (sensor 780 in Figs. 7A – 7D; [0136]),
wherein the muscle activity is voluntary ([0035]: “iii) To distinguish the tremor from the voluntary movement of the user through a conventional analysis of the bioelectrical characterization signal, the biomechanical characterization signal or the combination of bioelectrical and biomechanical characterization signal…”), and the apparatus is configured to control the electrical stimulus to increase the voluntary muscle activity ([0011]: “The present invention relates systems, devices, and methods for treating tremor, and more specifically relate to system, devices, and methods for treating tremor by stimulation of a peripheral nerve.”), and
wherein a first mechanomyography sensor (sensor 780 in Figs. 7A – 7D; [0136]) and muscle stimulator (electrical stimulator 730 in Figs. 7A-7D) are associated with an agonist muscle ([0125]: “The device stimulates the sensory nerves in order to modify the abnormal network dynamics. Over time, this stimulation normalizes the neural firing in the abnormal network and reduces tremor… These regions may also target the musculature including muscles of the shoulder, muscles of the arm, and muscles of the forearm, hand, or fingers. Muscles of the shoulder may include, by non-limiting example, the deltoid, teres major and supraspinatus. Muscles of the arm may include the coracobrachialis and triceps brachii. Muscles of the forearm may include the extensor carpi radialis longus, abductor pollicis longus, extensor carpi unlarnis, and flexor carpi ulnaris.”) and a second mechanomyography sensor (sensor 780 in Figs. 7A – 7D; [0136]) and muscle stimulator (electrical stimulator 730 in Figs. 7A-7D) are associated with an antagonist muscle ([0125]), and wherein the apparatus is configured to cause application of the electrical stimulus by the first muscle stimulator (electrical stimulator 730 in Figs. 7A-7D) to the agonist muscle ([0125]) immediately upon receipt of the sensor output from the first mechanomyography sensor (sensor 780 in Figs. 7A – 7D; [0136]), and cause application of the electrical stimulus by the second muscle stimulator (electrical stimulator 730 in Figs. 7A-7D) to the antagonist muscle ([0125]) immediately upon receipt of the sensor output from the second mechanomyography sensor (sensor 780 in Figs. 7A – 7D; [0136]).
While Rosenbluth does disclose that muscle stimulation can be applied to agonist and antagonist muscles in [0125], it does not specifically disclose an agonist/antagonistic pair.
However, Barrella teaches an electrostimulating apparatus and method. The Examiner notes that citations from Barrella are from the translated document, included in this Office Action’s attachments. Barrella further teaches an agonist/antagonistic pair (pg. 5-6, li. 298-301: “In use, the apparatus 1 is connected to a patient affected by spastic phenomena and at least two distinct stimulation channels 2 are used, for example the aforesaid channels 2A and 2B, the electrodes 7 of which are applied respectively to a body region near the specific efferent nerve of a hypertonic muscle (agonist muscle) and at a further body region comprising the corresponding antagonist muscle.”).
Barrella is of a similar pursuit to that of Rosenbluth and the instant application in teaching the control of stimulation parameters in medical electrotherapy. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the apparatus of Rosenbluth to include the agonist/antagonist pair of Barrella in order to decrease the involuntary muscle activity of a patient.
The Rosenbluth/Barrella combination is silent to the application occurring immediately upon receipt of the sensor output.
However, Rocon de Lima teaches that the application occurs immediately upon receipt of the sensor output ([0058]-[0059]: “The second stage consists of a control loop for the neuromodulation of afferent pathways, which uses the tremor information obtained in the previous phase, to define the intensity and timing of electrical stimulation of the afferents pathways in order to relieve the symptoms of tremor, preferably, by interrupting the synchronization of tremor-related oscillations at spinal level or brain, thereby preventing the development of tremor.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the Rosenbluth/Barrella combination invention to include that the application occurs immediately upon receipt of the sensor output in order to rapidly decrease the occurrence of involuntary muscle activity in a patient.
Regarding amended claim 14, in view of the Rosenbluth/Barrella/Rocon de Lima combination, Rosenbluth discloses that the apparatus is configured to cause application of the electrical stimulus ([0214]: “The device may contain closed-loop control of the stimulation to adaptively respond to detected tremor or activity levels. The device enables sensation of tremor through an activity sensor, data logging and systematic adjustment of the stimulation parameters to achieve an optimal tremor reduction. FIG. 26A is a control diagram showing the basic components of this detection and response system.”).
The Rosenbluth/Barrella combination is silent to the application occurring immediately upon receipt of the sensor output.
However, Rocon de Lima teaches that the application occurs immediately upon receipt of the sensor output ([0058]-[0059]: “The second stage consists of a control loop for the neuromodulation of afferent pathways, which uses the tremor information obtained in the previous phase, to define the intensity and timing of electrical stimulation of the afferents pathways in order to relieve the symptoms of tremor, preferably, by interrupting the synchronization of tremor-related oscillations at spinal level or brain, thereby preventing the development of tremor.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the Rosenbluth/Barrella combination invention to include that the application occurs immediately upon receipt of the sensor output in order to rapidly decrease the occurrence of involuntary muscle activity in a patient.
Regarding amended claim 16, in view of the Rosenbluth/Barrella/Rocon de Lima combination, Rosenbluth discloses that the apparatus is configured to filter the sensor output ([0197]: “The algorithm will extract motion data in the 4 to 12 Hz range to remove motions that are not attributable to the tremor. This may be done using any combination of notch filters, low pass filters, weighted-frequency Fourier linear combiners, or wavelet filters. As each patient has a dominant tremor frequency, this range may be narrowed based on specific knowledge of the patient's tremor or tremor history. For example, for a patient with a 6 Hz tremor an analysis algorithm may extract only motion data in the 5 to 7 Hz range.”)
The Rosenbluth/Barrella is silent to that the filtering increases a signal contribution from the voluntary muscle activity.
However, Rocon de Lima teaches that the filtering increases a signal contribution from the voluntary muscle activity ([0121]: “The strategy for identifying and monitoring the tremor is based on the signals from the sensors (bioelectrical (3) and biomechanical (4)). The EEG signal sensors provide the information about the patient intent to move voluntarily by integrating two Bayesian classifiers that are based on different characteristics of the event related desynchronization (ERD) in EEG signals.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the Rosenbluth/Barrella combination to include increases a signal contribution from the voluntary muscle activity properly control involuntary versus voluntary motion in a patient who experiences involuntary muscle activity, such as tremors.
Regarding amended claim 17, in view of the Rosenbluth/Barrella/Rocon de Lima combination, Rosenbluth discloses that the apparatus is configured to compare the sensor output to a second predefined threshold defining an actionable level of voluntary muscle activity ([0035]: “iii) To distinguish the tremor from the voluntary movement of the user through a conventional analysis of the bioelectrical characterization signal, the biomechanical characterization signal or the combination of bioelectrical and biomechanical characterization signal…”), and cause application of the electrical stimulus only if an amplitude of the sensor output exceeds the second predefined threshold ([0197]: “The algorithm will extract motion data in the 4 to 12 Hz range to remove motions that are not attributable to the tremor. This may be done using any combination of notch filters, low pass filters, weighted-frequency Fourier linear combiners, or wavelet filters. As each patient has a dominant tremor frequency, this range may be narrowed based on specific knowledge of the patient's tremor or tremor history. For example, for a patient with a 6 Hz tremor an analysis algorithm may extract only motion data in the 5 to 7 Hz range.”).
Regarding claim 18, in view of the Rosenbluth/Barrella/Rocon de Lima combination, Rosenbluth discloses that the second predefined threshold is defined according to a noise baseline of the mechanomyography sensor (sensor 780 in Figs. 7A – 7D; [0136]; [0199]: “Sensor fusion techniques can also be used to analyze different aspects of the tremor. For example, a multi-axis accelerometer and gyroscope attached to the backside of the hand could be combined to reduce noise and drift and determine an accurate orientation of the hand in space.”).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.G.S./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796