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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/20/2026 has been entered.
Response to Arguments
Applicant’s arguments filed 01/20/2026 have been fully considered but are not persuasive or are moot in view of a new grounds of rejection.
In response to applicant's argument that the proposed modification of Lozano with Raike causes Lozano to become inoperable and destroys its intended function, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In this instance, Lozano teaches a predetermined modulation signal (fig. 6: parameter change needed at 411 would result in a new signal with new parameters, therefore, each signal with a current set of parameters is considered as a discrete signal that ends when a new signal comprising of different parameters is generated; col. 9, lines 10-41) transmittable to a brain motor tissue of a brain motor region (Col. 3, lines 4-11) of the subject for modulating the movement of the body (Col. 8, line 31-64: when signal on sensor 130 exceeds a level, increasing amounts of stimulation is applied; Col. 10, lines 26-63: stimulation can be used to either increase or decrease motor function; Col. 3, lines 13-23; Col. 3, lines 48-54; Col. 9, lines 42-61). Lozano already teaches that pulses may be provided to other regions of the brain (Col. 8, lines 55-58), however, it doesn’t explicitly state the predetermined modulation signal transmittable to a cerebral cortex tissue of a cerebral cortex region of the subject for modulating the movement of the body.
Raike teaches a therapy system (fig. 1: 10) that delivers electrical stimulation to treat a movement disorder [0025] of a patient (12),
wherein a predetermined modulation signal ([0028]: IMD 16 delivers electrical stimulation; [0031]) is transmittable to a cerebral cortex tissue ([0028]: motor cortex is part of cerebral cortex tissue) of a cerebral cortex region of a subject [0028] for modulating movement of a body ([0003]: electrical stimulation may eliminate symptoms such as loss of physical movement (akinesia) i.e. results in modulating movement of a body; [0026-0028]: Parkinson’s disease is treated by reducing or eliminating symptoms such as akinesia; [0031]) and
wherein the generated predetermined modulation signal comprises a discrete signal [0093-0094].
Raike further teaches that Parkinson’s disease may be treated by delivering electrical stimulation to several locations, including the motor cortex [0031], and that treating Parkinson’s disease treats symptoms such as rigidity, akinesia, and/or resting tremor [0026].
Thus, Raike is merely used to teach the predetermined modulation signal of Lozano being transmittable to cerebral cortex tissue of a cerebral cortex region of the subject for modulating the movement of the body, because doing so treats Parkinson’s disease and symptoms such as rigidity, akinesia, and/or resting tremor.
In other words, the features of Raike are not bodily incorporated into the structure of the Lozano.
Applicant argues, “Lozano's continuous loop keeps altering amplitude/frequency/pulse width to pursue a biomechanical target, the phase relationship that is indispensable to Raike' s destructive ( or constructive) interference cannot be maintained-the Lozano loop would continuously change the very parameters Raike must hold stable and phase-locked to the oscillation. This direct conflict breaks Raike's core operating principle (phase-specific burst timing relative to a neural oscillation), and therefore "renders the prior art reference inoperable for its intended purpose" (In re Fritch, 972 F.2d 1260, 1265 n.12; MPEP § 2143.0l(V))... When these are merged, Lozano's ongoing parameter perturbations would de-phase Raike' s bursts and eliminate the destructive interference effect, thereby defeating Raike' s stated purpose. Under Fritch and MPEP § 2143.01 (V), an obviousness rationale that destroys the functioning of the reference to supply the missing element is legally insufficient”
Examiner respectfully states that Raike is merely used to teach providing a predetermined modulation signal transmittable to a cerebral cortex tissue of a cerebral cortex region of the subject for modulating the movement of the body, because doing so will treat Parkinson’s disease via electrical stimulation, which treats symptoms such as rigidity, akinesia, and/or resting tremor (see above).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 11, 15, 23, 28, 33-36, and 38-43 are rejected under 35 U.S.C. 103 as being unpatentable over Lozano et al. (US 6,356,784) in view of Emborg et al. (US 2012/0059432) in view of Raike et al. (US 2019/0290912).
In re claim 1, Lozano discloses a computer-implemented method for modulating a movement of a body part of a subject (Col. 2, lines 1-8; Col. 7, lines 3-14; Col. 1, lines 50-65: treatment needed for movement and walking disorders), the method executable by a processor (Fig. 5: 200) of a computer system (Fig. 5; Col. 2, lines 54-56), the method comprising:
acquiring, by the processor, an indication of a movement event of a muscle of the body part of the subject (Col. 7, lines 15-43: sensor 130 detects force in muscles; Fig. 9: 431; Col. 9, lines 42-61: indication of movement event is device 16 reading the feedback sensor),
the movement event defined by at least one movement event parameter (Col. 7, lines 32-48: sensor 130 detects movement event parameter such as force in the muscles; Col. 7, lines 15-18),
the at least one movement event parameter comprising:
a trigger value representative of a first time point in the movement event
(Col. 8, 37-40: a trigger value is when signal from sensor 130 exceeds a level set by a clinician; fig. 9: “yes” response to step 432; and occurs at a first time point in the movement event i.e. when feedback from sensor 130 is read; Col. 9, lines 42-61), and
a target value representative of a second point in time in the movement event (Col. 3, lines 1-11: electrical stimulation controls PPN to achieve desired result i.e. target value representation of a desired movement; Col. 10, lines 26-31),
the second point in time occurring after the first point in time (Col. 10, lines 26-31: desired stimulation that achieves desired result occurs after the first time when the movement event is read by the sensor 130; Fig. 9: 431 occurs and then 434 occurs);
acquiring during a current movement event of the muscle of the body part of the subject (Col. 7, lines 3-14: current movement event is during a symptom of a movement disorder during a closed loop system), by the processor (Col. 7, lines 3-14), current movement data associated with the current movement event of the muscle of the body part of the subject (Col. 7, lines 3-14: closed-loop used to automatically determine level of stimulation needed and provide current movement data associated with a current movement event; Fig. 9: after amplitude is increased at 434, feedback sensor value is read again by going down path 431A; Col. 9, lines 45-61),
the current movement data including current values of the movement event parameter (Fig. 9: 431: closed-feedback loop provides current values each time feedback sensor value is read since it goes through the loop again);
analyzing, by the processor, the current movement data to determine presence of the trigger value in the current movement event (Fig. 9: each time feedback sensor value is read at 431, the trigger value is checked at 432; Col. 9, lines 42-61); and
in response to identification of the trigger value in the current movement data, causing a brain stimulation assembly (Col. 3, lines 1-38; Fig. 1: lead 522A, device 16, and conventional conductor 522), operatively connected to the processor (Col. 10, lines 26-28; Col. 8, lines 41-58),
to apply, at a predetermined time from the identification of the trigger value in the current movement event (Col. 9, lines 42-61: predetermined time is time when updated stimulation signal is applied after identification of trigger value; Col. 8, lines 59-64; Col. 10, lines 1-10),
to generate a predetermined modulation signal comprising a discrete signal (fig. 6: parameter change needed at 411 would result in a new signal with new parameters, therefore, each signal with a current set of parameters is considered as a discrete signal that ends when a new signal comprising of different parameters is generated; col. 9, lines 10-41),
the predetermined modulation signal transmittable to a brain motor tissue of a brain motor region (Col. 3, lines 4-11) of the subject for modulating the movement of the body (Col. 8, line 31-64: when signal on sensor 130 exceeds a level, increasing amounts of stimulation is applied; Col. 10, lines 26-63: stimulation can be used to either increase or decrease motor function; Col. 3, lines 13-23; Col. 3, lines 48-54; Col. 9, lines 42-61) towards the target value representative of a second time point in the movement of the body part
(Col. 7, lines 8-14: closed loop feedback system uses feedback from sensor 130 to automatically determine level of stimulation needed and will apply stimulation until the target value (desired movement result at a second time point in the movement of the body part) is achieved from the trigger value in the current movement event; Col. 3, lines 6-11; Col. 8, lines 59 - Col. 9, lines 14)
from the trigger value in the current movement event representative of a first time point in the movement of the body part (Col. 7, lines 8-14: current movement event is a first time point in the movement of the body part which the closed loop feedback system uses to determine stimulation needed to read the target value and occurs before the second time point; Col. 3, lines 6-11; Col. 8, lines 59 - Col. 9, lines 14),
the first time point before the second time point (see above).
Lozano fails to disclose
the movement event comprising a desired movement of the body part by the subject,
the movement event selected from the group of: walking, running, standing, reaching, grasping, gripping, lifting, and swallowing,
the trigger value corresponding to a voluntary activation of the desired movement,
the target value corresponding to the desired movement of the body part by the subject;
the predetermined modulation signal transmittable to a cerebral cortex tissue of a cerebral cortex region of the subject for modulating the movement of the body towards the target value representative of a second time point in the movement of the body part from the trigger value in the current movement event representative of a first time point in the movement of the body part in order for the subject to achieve the desired movement during the current movement event, the first time point before the second time point.
Regarding the limitations,”
“the movement event comprising a desired movement of the body part by the subject,
the movement event selected from the group of: walking, running, standing, reaching, grasping, gripping, lifting, and swallowing,
the trigger value corresponding to a voluntary activation of the desired movement,
the target value corresponding to the desired movement of the body part by the subject;
the predetermined modulation signal transmittable…in order for the subject to achieve the desired movement during the current movement event”,
Emborg teaches a device and method for rehabilitating patients [0005] and is analogous in using electrical therapy [0005-0007] to modulate a movement of a body part [0007] of a subject [0007], wherein
the body is a leg [0007],
a movement event ([0018]: sensor, such as an accelerometer, senses movement of a person’s foot or leg) comprises a desired movement of a body part by a subject ([0018]: detecting movement of the person’s foot or leg is interpreted as a desired movement that caused the foot or leg to move enough to be detected by the sensor),
the movement event selected from walking ([0018]: movement of the foot or leg are part of walking; [0003]: electrical nerve signals allow patient to walk; [0010]), and
a trigger value ([0018]: sensed movement of the person’s foot or leg is a trigger value; [0015]: stimulation provided in response to a trigger value i.e. a gait cycle measured by feedback signal) corresponds to a voluntary activation of the desired movement ([0018]: person’s foot or leg moving is a voluntary activation of the desired movement; [0060]: feedback signals used to help walk),
a target value ([0010]: desired movement of the leg such as upward or forward once stimulation is applied) corresponds to the desired movement of the body part by the subject ([0010]: target value corresponds to the desired movement of walking);
a predetermined modulation signal ([0010]: stimulation provided to patient; [0007, 0060]) is transmitted [0010, 0039] in order for the subject to achieve the desired movement ([0010]: desired movement is being able to move leg upward and forward so patient can walk) during a current movement event ([0010]: stimulation allows person to move leg upward and forward so they can walk and comprises a current movement event i.e. a first phase of a gait; [0060]);
the current movement event is a phase of a gait ([0010]: current movement event i.e. stimulation of a foot (interpreted as a first phase of a gait) initiates a swing phase of a gait),
the motor output is a distance of lift of a leg of the subject during the phase of the gait ([0010]: motor output is swing phase being initiated which lifts the leg during walking), and
the trigger value and/or first time point is associated with a swing phase of the leg ([0015]: stimulation provided in response to gait cycle measured by feedback signal, which would include being triggered at a first time point of a swing phase of the leg, since gait is related to walking and would require a swing phase).
Emborg further teaches that his approach provides sufficient learning input to the subject’s brain, and helps them regenerate gait control function so the subject can walk while also increasing their quality of life [0010].
Additionally, Emborg teaches that having the feedback signal respond to the gait cycle can allow stimulation parameters to vary based on the feedback signal, and optimize gait according to a target trajectory [0015].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for modulating a movement of a body part of a subject taught by Lozano, to provide wherein the movement event comprises a desired movement of the body part by the subject, the movement event is selected from walking, the trigger value corresponds to a voluntary activation of the desired movement, the target value corresponds to the desired movement of the body part by the subject; the predetermined modulation signal is transmittable in order for the subject to achieve the desired movement during the current movement event; the body part is a leg, the current movement event is a phase of a gait, the motor output is a distance of lift of a leg of the subject during the phase of the gait, and wherein the trigger value and/or the first time point is associated a swing phase of the leg, as taught by Emborg, because doing so will help the subject regenerate gait control function so they can walk and increase their quality of life and will also allow stimulation parameters to be adjusted according to the feedback signal sensing gait cycle, which will allow for gait optimization in respect to a targeted trajectory.
Regarding the limitation, “the predetermined modulation signal transmittable to a cerebral cortex tissue of a cerebral cortex region of the subject for modulating the movement of the body”, Raike teaches a therapy system (fig. 1: 10) that delivers electrical stimulation to treat a movement disorder [0025] of a patient (12),
wherein a predetermined modulation signal ([0028]: IMD 16 delivers electrical stimulation; [0031]) is transmittable to a cerebral cortex tissue ([0028]: motor cortex is part of cerebral cortex tissue) of a cerebral cortex region of a subject [0028] for modulating movement of a body ([0003]: electrical stimulation may eliminate symptoms such as loss of physical movement (akinesia) i.e. results in modulating movement of a body; [0026-0028]: Parkinson’s disease is treated by reducing or eliminating symptoms such as akinesia; [0031]) and
wherein the generated predetermined modulation signal comprises a discrete signal [0093-0094].
Raike further teaches that Parkinson’s disease may be treated by delivering electrical stimulation to several locations, including the motor cortex [0031], and that treating Parkinson’s disease treats symptoms such as rigidity, akinesia, and/or resting tremor [0026].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for modulating a movement of a body part of a subject yielded by the proposed combination, to provide a predetermined modulation signal transmittable to a cerebral cortex tissue of a cerebral cortex region of the subject for modulating the movement of the body, as taught by Raike, because doing so will treat Parkinson’s disease via electrical stimulation, which treats symptoms such as rigidity, akinesia, and/or resting tremor.
In re claim 2, the proposed combination yields (all mapping directed to Lozano unless otherwise stated) wherein the target value comprises an up-regulation of a current motor output of the muscle of the body part of the subject
(Col. 8, lines 37-40: when the signal on the sensor 130 exceeds value, increase stimulation is applied which will result in an up-regulation of current motor output; Col. 10, lines 26-59: desired stimulation delivered to PPN, which is “in a position to control muscle tone, rigidity, posture, balance, and locomotion”, which would include at least partially controlling a contraction of the muscle).
In re claim 3, regarding the limitations, “wherein the motor output comprises a contraction of the muscle of the body part, or a series of contractions of the muscle of the body part”, see in re claim 2 above.
In re claim 4, regarding the limitations,
“wherein the body part is a leg,
the current movement event is a phase of a gait, and
the motor output is a distance of lift of a leg of the subject during the phase of the gait”, see the proposed combination yielded in re claim 1 above.
In re claim 5, regarding the limitations, “wherein the trigger value and/or the first time point is associated with one or more of:
an onset of a leg lift or a contact phase of the gait,
a swing phase of the leg; and
a time point between a contact phase of a foot of the leg and a contact phase of a contralateral foot of a contralateral leg”,
see the proposed combination yielded in re claim 1 above.
In re claim 6, regarding the limitations, “wherein the body part is one or more of: an arm, a leg, a neck, a trunk, a hand, a foot, a finger, and a toe”, see the proposed combination yielded in re claim 1 above.
In re claim 11, the proposed combination yields (all mapping directed to Lozano unless otherwise stated) the processor is arranged to cause the brain stimulation assembly to apply the predetermined modulation signal until the target value of the movement is detected (Col. 7, lines 8-14: closed loop feedback system uses feedback from sensor 130 to automatically determine level of stimulation and therefore will apply stimulation until the target value (desired movement result) is achieved; Col. 3, lines 6-11; Col. 8, lines 59 - Col. 9, lines 14).
In re claim 15, the proposed combination yields (all mapping directed to Lozano unless otherwise stated) wherein the predetermined modulation signal comprises a pulsed electrical signal (Col. 8, lines 55-58: pulses delivered to device 16 are considered to be a pulsed electrical signal).
In re claim 23, the proposed combination yields (all mapping directed to Lozano unless otherwise stated) wherein the current movement data comprises one of:
electromyographic signal data associated with the muscle of the body part of the subject (Col. 8, lines 12-22: sensor 130 can be used to detect muscle EMG), the method further comprising acquiring the electromyographic signal (Col. 8, lines 12-22);
image data associated with the current movement, the method further comprising obtaining the image data;
brain signal data associated with the subject, the method further comprising obtaining the brain signal data; and
acceleration data associated with the current movement, the method further comprising obtaining the acceleration data.
In re claim 28, the proposed combination yields (all mapping directed to Lozano unless otherwise stated) further comprising
determining, for the subject, the predetermined modulation signal (Col. 10, lines 26-31: type of stimulation i.e. modulation signal is determined),
the determining the predetermined modulation signal comprising applying a preliminary modulation signal to the cerebral cortex tissue of the cerebral cortex region (Lozano: Col. 3, lines 13-23; Lozano: Col. 3, lines 48-54; Col. 8, lines 55-64; also see Raike: [0003, 0028] as discussed in proposed combination yielded in re claim 1 above for modulation signal to the cerebral cortex tissue of the cerebral cortex region), and
adjusting one or more of:
an amplitude (Fig. 9: 434),
a frequency (Fig. 7: 424),
a duration, and
a pulse duration of the preliminary modulation signal (Fig. 7 - Fig. 10).
In re claim 33, the proposed combination yields (all mapping directed to Lozano unless otherwise stated) further comprising tuning the predetermined modulation signal for the subject (Col. 9, lines 10-61; Col. 10).
Regarding the limitation, “the tuning of the predetermined modulation signal comprising: adjusting one or more of:
an amplitude,
a frequency,
a duration,
a pulse duration, and
an interval time of the predetermined modulation signal responsive to a measured value of the movement event parameter at the second time point”, see in re claim 28 above.
In re claim 34, the proposed combination yields (all mapping directed to Lozano unless otherwise stated) a system for modulating a movement of a body part of a subject (see in re claim 1 above), the system comprising:
a sensor assembly (Fig. 3: sensor assembly includes a sensor 130 and analog to digital converter circuit 206; Col. 2, lines 48-49), configured to sense during a current movement event of a muscle of the body part of the subject, current movement data associated with the current movement event of the muscle of the body part of the subject (see in re claim 1, “acquiring during a current movement event of a muscle of the body part of the subject…” in re claim 1 is interpreted to be equivalent to “sense during a current movement event of a muscle of the body part of the subject”); and
…acquiring the current movement data from the sensor assembly (Col. 8, lines 3-14: closed loop automatically obtains current movement data from sensor 130 to automatically determine electrical stimulation; Col. 9, lines 45-61).
Regarding the limitations:
a brain stimulation assembly configured to apply a predetermined modulation signal to a cerebral cortex tissue of a cerebral cortex region of the subject; and
a processor operably communicable with the sensor assembly and the brain stimulation assembly,
the processor being configured to execute:
acquiring an indication of a movement event of the muscle of the body part of the subject,
the movement event comprising a desired movement of the body part by the subject,
the movement event selected from the group of:
walking,
running,
standing,
reaching,
grasping,
gripping,
lifting, and
swallowing,
the movement event defined by at least one movement event parameter, the at least one movement event parameter comprising:
a trigger value representative of a first time point in the movement event,
the trigger value corresponding to a voluntary activation of the desired movement, and
a target value representative of a second point in time in the movement event,
the second point in time occurring after the first point in time;
the target value corresponding to the desired movement of the body part by the subject;
acquiring the current movement data from the sensor assembly and analyzing the current movement data to determine presence of the trigger value in the current movement event; and
in response to identification of the trigger value in the current movement data, causing the brain stimulation assembly
to apply, at a predetermined time from the identification of the trigger value in the current movement event,
to generate the predetermined modulation signal comprising a discrete signal, the predetermined modulation signal transmittable to a cerebral cortex tissue of cerebral cortex region of the subject for modulating the movement of the body part of the subject movement towards the target value representative of a second time point in the movement of the body part from the trigger value in the current movement event representative of a first time point in the movement of the body part in order for the subject to achieve the desired movement during the current movement event,
the first time point before the second time point”.
see the proposed combination yielded in re claim 1 above.
In re claim 35, the proposed combination yields (all mapping directed to Lozano unless otherwise stated) wherein the sensor assembly comprises at least one of: an electromyograph (Col. 8, lines 12-22, a camera, an infrared sensor, a brain signal detector, and an accelerometer (Col. 7, lines 23-25).
In re claim 36, the proposed combination yields (all mapping directed to Lozano unless otherwise stated) wherein the brain stimulation assembly is an implantable device (Col. 3, lines 13-46; Col. 4, lines 64-67; Fig. 1: 522, 16, 522A).
In re claim 38, the proposed combination yields (all mapping directed to Lozano unless otherwise stated) wherein the implantable device is sized and shaped to be positioned subcutaneously in the subject (Col. 3, lines 15-46: implantable device will be sized and shaped so it can be implanted below the skin of a patient; Col. 4, lines 64-67; Fig. 1: 522, 16, 522A).
In re claim 39, the proposed combination yields (all mapping directed to Lozano unless otherwise stated) wherein the implantable device comprises at least one of: a power supply, a transmitter, a receiver, and a processor (Fig. 5: 200; Col. 10, lines 26-28).
In re claim 40, the proposed combination yields (all mapping directed to Lozano unless otherwise stated) a method of treatment of a movement disorder in a mammal with an incomplete spinal injury (Col. 2, lines 16-19; Col. 4, lines 27-35; Col. 3, lines 35-36).
In re claim 41, regarding the limitation, “the processor is configured to cause the brain stimulation assembly to apply the predetermined modulation signal until the target value of the movement is detected”, see in re claim 11 above.
In re claim 42, regarding the limitations, “a computer-implemented method for modulating a movement of a body part of a subject, the method executable by a processor of a computer system, the method comprising:
acquiring, by the processor, an indication of a movement event of a muscle of the body part of the subject, the movement event comprising a desired movement of the body part by the subject, the movement event defined by at least one movement event parameter,
the at least one movement event parameter comprising: a trigger value representative of a first time point in the movement event,
the trigger value corresponding to a muscle activation of the desired movement,
the trigger value associated with one or more of:
an onset of a reaching movement of an upper limb,
an initiation of a grasping action of a hand or fingers,
an onset of a leg lift or a contact phase of the gait,
a swing phase of the leg; and
a time point between a contact phase of a foot of the leg and a contact phase of a contralateral foot of a contralateral leg; and
a target value representative of a second point in time in the movement event,
the second point in time occurring after the first point in time,
the target value corresponding to the desired movement of the body part by the subject;
acquiring during a current movement event of the muscle of the body part of the subject, by the processor, current movement data associated with the current movement event of the muscle of the body part of the subject,
the current movement data including current values of the movement event parameter;
analyzing, by the processor, the current movement data to determine presence of the trigger value in the current movement event; and
in response to identification of the trigger value in the current movement data, causing a brain stimulation assembly, operatively connected to the processor, to apply, at a predetermined time from the identification of the trigger value in the current movement event, to generate a predetermined modulation signal comprising a discrete signal,
the predetermined modulation signal transmittable to a cerebral cortex tissue of a cerebral cortex region of the subject for modulating the movement of the body part towards the target value representative of a second time point in the movement of the body part from the trigger value in the current movement event representative of a first time point in the movement of the body part in order for the subject to achieve the desired movement during the current movement event, the first time point before the second time point”,
see the proposed combination yielded in re claim 1 above.
In re claim 43, regarding the limitations, “a system for modulating a movement of a body part of a subject, the system comprising:
a sensor assembly configured to sense during a current movement event of a muscle of the body part of the subject, current movement data associated with the current movement event of the muscle of the body part of the subject;
a brain stimulation assembly configured to apply a predetermined modulation signal to a cerebral cortex tissue of a cerebral cortex region of the subject; and
a processor operably communicable with the sensor assembly and the brain stimulation assembly, the processor being configured to execute:
acquiring, by the processor, an indication of a movement event of a muscle of the body part of the subject,
the movement event comprising a desired movement of the body part by the subject,
the movement event defined by at least one movement event parameter, the at least one movement event parameter comprising:
a trigger value representative of a first time point in the movement event,
the trigger value corresponding to a muscle activation of the desired movement,
…a target value representative of a second point in time in the movement event,
the second point in time occurring after the first point in time,
the target value corresponding to the desired movement of the body part by the subject;
acquiring the current movement data from the sensor assembly and analyzing the current movement data to determine presence of the trigger value in the current movement event; and
in response to identification of the trigger value in the current movement data, causing the brain stimulation assembly to apply, at a predetermined time from the identification of the trigger value in the current movement event, to generate the predetermined modulation signal comprising a discrete signal, the predetermined modulation signal transmittable to a cerebral cortex tissue of cerebral cortex region of the subject for modulating the movement of the body part of the subject movement towards the target value representative of a second time point in the movement of the body part from the trigger value representative of a first time point in the movement of the body part in order for the subject to achieve the desired movement during the current movement event,
the first time point before the second time point”,
see in re claim 34 above.
Regarding the limitations, “the trigger value associated with one or more of:
an onset of a reaching movement of an upper limb,
an initiation of a grasping action of a hand or fingers,
an onset of a leg lift or a contact phase of the gait,
a swing phase of the leg; and
a time point between a contact phase of a foot of the leg and a contact phase of a contralateral foot of a contralateral leg”,
see the proposed combination yielded in re claim 1 above.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Lozano et al. (US 6,356,784) in view of Emborg et al. (US 2012/0059432) in view of Raike et al. (US 2019/0290912) in view of Courtine (US 2018/0093093) in view of Grahn et al. (US 2021/0052889).
In re claim 20, the proposed combination (all mapping directed to Lozano unless otherwise stated) yields wherein the predetermined modulation signal is at an emission frequency of 300Hz (Lozano: Col. 10, lines 14-17).
The proposed combination fails to yield wherein the body part is a lower limb, and the predetermined modulation signal is a biphasic pulsed signal comprising 200µs/phase, having a length of about 100 ms long, and having an amplitude of one of about 20 µA and about 40 µA.
Regarding the limitation, “wherein the body part is a lower limb, and the predetermined modulation signal….. having an amplitude of one of about 20 µA and about 40 µA”, Courtine teaches a closed-loop system that provides electrical spinal cord stimulation [0031] and is analogous in applying neuromodulation with adjustable stimulation parameters [0032] to a body part [0150], wherein the body part is a lower limb [0041], and wherein a predetermined modulation signal ([0041]: stimulation being applied is a predetermined modulation signal) has an amplitude of one of about 20 µA and about 40 µA ([0102]: amplitude range of 20-50 μA).
Additionally, Courtine teaches that stimulating the lower-limb facilitates standing and walking in a subject [0041].
Courtine further teaches, as shown above, that all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would yield nothing more than predictable results to one of ordinary skill in the art. KSR.
Further, Courtine teaches the same treatment and therapy (i.e. using modulation signal to modulate movement in the subject) as Lozano, so it would be obvious to one of ordinary skill to use known parameters (such as amplitude) for treating the same thing and applying it to the treatment device of Lozano, since they are both concerned with using electrical stimulation to modulate a movement of a body part of a subject and because it would be obvious for a person of ordinary skill in the art to look to similar treatments to choose the appropriate and effective treatment parameters (for instance to treat a walking disorder by stimulating the legs).
Further, Courtine specifically teaches an amplitude range of 20-50 μA (see above), and the claimed “amplitude of one of about 20 µA and about 40 µA” lies inside the amplitude range taught by Courtine, and in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), and see also MPEP 2144.05.
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for modulating a movement of a body part of a subject yielded by the proposed combination, to provide wherein the body part is a lower limb, and wherein a predetermined modulation signal has an amplitude of one of about 20 µA and about 40 µA, as taught by Courtine, because stimulating the lower-limb facilitates standing and walking, and because it’s known to adjust stimulation parameters including amplitude based on the desired stimulation (i.e. treatment) and therapy, especially because Courtine and Lozano are directed towards the same treatment and therapy (i.e. using modulation signal to modulate movement in the subject), as discussed above.
Even if the proposed combination fails to yield wherein a predetermined modulation signal has an amplitude of one of about 20 µA and about 40 µA, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein a predetermined modulation signal has an amplitude of one of about 20 µA and about 40 µA, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Regarding the limitation, “the predetermined modulation signal is a biphasic pulsed signal comprising 200µs/phase, having a length of about 100 ms long”, Grahn teaches a device for activating motor function in individuals with complete or partial paralysis [0003], and is analogous in using electrical stimulation to activate motor function in a body part [0003], and a predetermined modulation signal is a biphasic pulsed signal [0094] comprising 200µs/phase ([0094]: .21 ms is equal to 210 µs), having a length of about 100 ms long ([0060]: pulsed with a duration of 10 microseconds to 1 second).
Grahn further teaches that stimulation parameters can be adjusted [0005], and that a biphasic pulse provides a positive pulse width [0094].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the predetermined modulation signal yielded by the proposed combination, to provide wherein the predetermined modulation signal is a biphasic pulsed signal comprising 200µs/phase, having a length of about 100 ms long, as taught by Grahn, because using a biphasic pulsed signal is common for modulation, and it’s common for stimulation parameters to be adjusted based on desired stimulation.
Even if the proposed combination fails to yield the predetermined modulation signal is a biphasic pulsed signal comprising 200µs/phase, having a length of about 100 ms long, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the predetermined modulation signal has a 200µs/phase, and has a length of about 100 ms long, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Lozano et al. (US 6,356,784) in view of Emborg et al. (US 2012/0059432) in view of Raike et al. (US 2019/0290912) in view of Perez et al. (US 2018/0126158).
In re claim 32, the proposed combination yields (all mapping directed to Lozano unless otherwise stated) yields
wherein said acquiring during the movement of the body part of the subject, by the processor, the current movement data associated with the current movement event of the muscle of the body part of the subject (Col. 7, lines 8-14: closed loop happens continuously which would include being executed daily to automatically (i.e. in real-time) determine the level of electrical stimulation based on current movement data of the muscle where sensor 130 is located);
said analyzing, by the processor, the current movement data to determine presence of the trigger value in the current movement event (Col. 9, lines 15-41: during each iteration of the closed loop, the system checks if parameters are exceeded at a certain threshold i.e. trigger value before proceeding or providing stimulation; Col. 9, lines 59-61); and
in response to identification of the trigger value in the current movement data, said causing the brain stimulation assembly to apply the predetermined modulation signal to the cerebral cortex tissue of the cerebral cortex region of the subject (see the proposed combination yielded in re claim 1 above) to cause the modulation of the muscle of the subject movement (Lozano: Col. 9, lines 10-61; 434; 436; Lozano: Col. 10, lines 14-31, Lozano: Col. 10, lines 47-63; Raike: [0003, 0028]).
The proposed combination fails to yield in response to identification of the trigger value in the current movement data, said causing the brain stimulation assembly to apply the predetermined modulation signal to tissue of a brain motor region of the subject to cause the modulation of the muscle of the subject movement are performed daily.
Perez teaches an analogous method of delivering electrical stimulation to correct movement [0003] wherein in response to identification of a trigger value ([0021]: trigger value is when there is a need for stimulation; [0026]: trigger value can be based on a predetermined threshold) in current movement data ([0021]: trigger based on a comparison of a first map and a reference map; [0017]: map defines position or movement of a region; [0090-0091]: maps are used to measure movement over time; fig. 5B: step 533), said causing brain stimulation assembly (533; [0008, 0071, 0120]) to apply predetermined modulation signal to tissue of a brain of a subject [0008, 0071] to cause modulation of a muscle of the subject movement ([0008]: stimulating brain improves motor function; [0075]: stimulation provided until motor function is corrected; [0021]) are performed daily ([0077]: number of stimulation sessions range from 1 to 24 in a day).
Perez further teaches that various stimulation patterns or protocols comprise adjusting or customizing a plurality of stimulation parameters such as the number of stimulation sessions per day [0084], and that exemplary standard setting range for the number of stimulation sessions per day ranges from 1 to 24 [0084].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for modulating the muscle of the subject yielded by the proposed combination, to provide wherein in response to identification of the trigger value in the current movement data, said causing the brain stimulation assembly to apply the predetermined modulation signal to tissue of a brain of the subject to cause the modulation of the muscle of the subject movement are performed daily, as taught by Perez, because various stimulation protocols comprise adjusting a plurality of stimulation parameters such as the number of stimulation sessions per day, and that exemplary standard setting range for the number of stimulation sessions per day ranges from 1 to 24.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Giuffrida et al. (US 2013/0123666) discloses a treatment delivery system (abstract) that distinguishes between movement disorder symptoms (abstract) and activities of daily living (abstract).
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796