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 .
Priority
This action is a national stage entry under 35 USC 371 of PCT/EP2023/082158 filed 17 November 2023 which claims the benefit of foreign priority from EP 22208454.3 filed 21 November 2022.
Response to Amendment
The preliminary amendment filed 15 May 2025 has been acknowledged. Claims 1-20 are pending, wherein claims 15-20 are new.
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.
Claim(s) 1-7, 9-16, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Capogrosso et al. (WO 2023/039207) in view of Kramer et al. (US 2012/0158094).
In regard to claim 1, Capogrosso et al. disclose a neuromodulation/neurostimulation system or treatment of spasticity in a mammal (page 10 lines 18-19), said system comprising:
at least one control unit configured and arranged to provide stimulation data (figure 1, external control unit, page 24 line 26), and
at least one stimulation unit, operatively connected to the at least one control unit (figure 1, an implantable neurostimulator in communication with external control unit; page 24 lines 19-26), said at least one stimulation unit being configured and arranged to deliver epidural electrical stimulation to a spinal cord of said mammal (page 24 line 23-25, electrodes are implanted epidurally in the spinal cavity proximal the dorsal roots), according to said stimulation data,
wherein the at least one stimulation unit includes a biocompatible implantable lead configured and arranged to cover at least a portion of the spinal cord of said mammal to deliver epidural electrical stimulation to dorsal roots (page 24 line 23-25, a spinal lead contains an array of electrodes for being implanted epidurally in the spinal cavity proximal the dorsal roots).
Capogrosso et al. does not expressly state that the particular dorsal roots selected for stimulation are the dorsal roots innervating spastic muscles to target neuronal circuitry responsible for spastic episodes. Kramer et al. is directed to targeted electrical stimulation for treatment of movement disorders, including spasm and localized spasticity (para 57). Kramer et al. teach that stimulation of a particular dorsal root ganglion affects muscles innervated by motor nerves that synapse with that dorsal root ganglion and, consequently, that single muscle, muscle group, pair of opposing muscles or muscle groups, or localizes area may be precisely targeted by stimulation the corresponding dorsal root ganglion. Kramer et al. also expressly teaches that such specificity and targeting is beneficial for treating localizes spasticity (para 57). Therefore, it would have been obvious to one of ordinary skill in the art to configure the epidural dorsal root stimulation system of Capogrosso et al. to select and stimulate targeted dorsal roots innervating spastic muscles to target neuronal circuitry responsible for spastic episodes in order to more selectively recruit the neural pathways associated with the affect musculature and thereby provide targeted suppression of spasticity while minimizing stimulation of neural pathways associated with unaffected muscles, thereby improving anatomical and functional selectivity of the stimulation for the spastic musculature.
In regard to claim 2, Capogrosso et al. expressly teach that implantable lead is configured and arranged to deliver epidural stimulation to the spinal cord of said mammal at a spinal cord level responsible for lower limbs, upper limbs, and/or trunk muscles (page 21 lines 5-24; T11, T12, L2, L3, L4, L5, and/or S1 taught for lower extremities, C3-T2 for upper extremities).
In regard to claim 3, Capogrosso et al. teaches that the at least one control unit is configured and arranged to control the at least one stimulation unit to deliver continuous epidural electrical stimulation to the spinal cord of said mammal (page 22 lines 5-7).
In regard to claim 4, Capogrosso et al. is considered to describe the invention as claimed, including a detection unit (e.g., an EMG to detect electrical muscle activity and apply an electrical stimulus, page 24 lines 27-31), however does not expressly teach that the detection unit is configured and arranged to: detect onset of spastic muscle activity in said mammal, and when onset of spastic muscle activity is detected, transmit an output signal to the at least one control unit wherein the at least one control unit is configured to operate the at least one stimulation unit to provide epidural electrical stimulation to the spinal cord of said mammal in response to the received signal from the detection unit (para 14, 23, 26, and 59, the onset of a disorder is detected by a sensor, and stimulation is provided in response to reduce or avoid the onset of the disorder). Kramer et al. teaches that the sensors may sense the extent of the muscle contraction or limb movement and expressly teaches sensing the status fo spasticity to determine whether a change is the symptom that has occurred (para 60). In response to the sensed change, the electrical stimulation is correspondingly changed to inhibit or diminish the change in the symptom. It would have been obvious to one of ordinary skill in the art to modify the EMG sensor of Capogrosso et al. to detect the onset of symptoms as in Kramer et al. so that stimulation is provided in response to detection of spastic muscle activity in order to provide stimulation responsive to the patient’s actual spastic activity, thereby permitting stimulation to be adjusted or delivered when therapeutically needed.
In regard to claim 5, Capogrosso et al. is considered to describe the invention as claimed, including a detection unit (e.g., an EMG to detect electrical muscle activity and apply an electrical stimulus, page 24 lines 27-31), however does not expressly teach that the detection unit wherein the detection unit is configured and arranged to: detect onset of a spasticity-inducing activity and/or movement in said mammal based on one or more preset parameters stored in a memory, and when onset of spasticity-inducing activity and/or movement is detected, transmit an output signal to the at least one control unit, wherein the at least one control unit is configured to operate the at least one stimulation unit to provide epidural electrical stimulation to the spinal cord of said mammal in response to the received signal from the detection unit, to prevent occurrence of a spastic episode. Kramer et al. further teach sensing a specific patient activity, activity level, position, or particular movement pattern using the sensed information as an input to the stimulation control system to determine the appropriate stimulation (para 61-62). Kramer et al. sense these activities since some movement disorders are correlated to certain activities and often cause problems with the particular activity (para 61), and therefore the sensed information could be an input to dynamically modify the stimulation program to determine the appropriate level of stimulation. Alternatively or additionally, different pre-programmed stimulation algorithms may be designed for an individual patient based on that specific patient's pattern of activity (para 61). It is considered to have been obvious to one of ordinary skill in the art to modify the EMG sensor, neurostimulator and control unit of Capogrosso et al. to perform as Kramer et al. to sense onset of a spasticity-inducing activity and/or movement and when onset of spasticity-inducing activity and/or movement is detected, transmit an output signal to the at least one control unit to provide stimulation since Kramer et al. expressly teaches doing so anticipates an predictable activity and to modify the stimulation program to determine the appropriate level of stimulation and counteract symptoms before they develop.
In regard to claim 6, Capogrosso et al. teaches that the detection unit includes at least one electromyography sensor unit and/or at least one inertial measurement unit (page 24 lines 27-31, an EMG to detect electrical muscle activity and apply an electrical stimulus). Kramer et al. suggests an accelerometer to aid in detecting activity levels and patterns (para 62). An accelerometer is considered equivalent to an inertial measurement sensor. Additionally, the accelerometer of Kramer et al. is considered to comprise an obvious suitable alternative for substitution of the EMG in Capogrosso et al. to sense activity or movement of a patient.
In regard to claim 7, Capogrosso et al. teaches that the stimulation data comprise at least frequency, amplitude, pulse width and/or anodic / cathodic configurations (page 21 line 27-28, page 26 lines 12-16, and more generally page 21 line 25 – page 23 line 35).
In regard to claim 9, Capogrosso et al. teaches that the neurostimulator is configured to output a burst train stimulation pulse (page 15 lines 6-11 and page 21 lines 28-29).
In regard to claim 10, Capogrosso et al. teaches that the neurostimulator is configured to provide at least one burst of several pulses (page 21 lines 27-28 and page 23 lines 26-35).
In regard to claim 11, Capogrosso et al. teaches that the implantable lead includes one or more biocompatible implantable multi-electrode arrays (page 24 line 23-25, a spinal lead contains an array of electrodes for being implanted epidurally in the spinal cavity proximal the dorsal roots).
In regard to claim 12, Capogrosso et al. teaches that the at least one stimulation unit includes an Implantable Pulse Generator (figure 1, an implantable neurostimulator in communication with external control unit; page 24 lines 19-26).
In regard to claim 13, Capogrosso et al. teaches that a mammal such as a human is treated (page 16 lines 3-5), wherein the human affected by spinal cord injury-(SCI) and/or other neurological disorders such as a stroke, multiple sclerosis, cerebral palsy or cancer of neurological tissue (page 16 lines 25-34).
In regard to claim 14, Capogrosso et al. expressly teaches that (page 10 lines 18-19, page 14 lines 5-10, page 28 lines 20-21).
In regard to claim 15, Capogrosso et al. expressly teaches that the implantable lead is configured and arranged to deliver epidural stimulation to the spinal cord of said mammal at the spinal cord level responsible for the lower limbs at level T11/T12-L3 (vertebrae) (page 21 lines 5-24; T11, T12, L2, L3, L4, L5, and/or S1 taught for lower extremities).
In regard to claim 16, Capogrosso et al. expressly teaches implantable lead is configured and arranged to deliver epidural stimulation to the spinal cord of said mammal at the spinal cord level responsible for the upper limbs over a cervical region of the spinal cord (page 21 lines 5-24; C3-T2 taught for upper extremities.
In regard to claim 18, Capogrosso et al. teach with reasonable specificity stimulation parameters that overlap and are within claimed ranges of the frequency between 100 Hz and 1500 Hz, the pulse width is between 60 us and 1000 µs, and the amplitude is around motor threshold level (page 22 line 8 – page 24 line 6; at page 24, lines 1-3, the electrical stimulus is taught be applied at the subject’s motor threshold; at page 23 lines 26-35, stimulation is applied a burst of pulses comprising 2 to 5 pulses with a frequency of 200 Hz to 5oo Hz, other places teach pulse widths of between 80 and 200 microseconds). The specific examples fall within the claimed ranges, and examples that overlap the claimed ranges and would provide a blueprint as the starting point for one of ordinary skill in the art to target stimulation to achieve the intended result.
In regard to claim 19, Capogrosso et al. teaches the at least one burst of several pulses is 2 to 5 pulses (page 23 lines 26-35, stimulation is applied a burst of pulses comprising 2 to 5 pulses).
In regard to claim 20, Capogrosso et al. teaches that a mammal such as a human is treated (page 16 lines 3-5).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Capogrosso et al. (WO 2023/039207) in view of Kramer et al. (US 2012/0158094), further in view of Courtine et al. (EP 3 969 100).
In regard to claim 8, Capogrosso et al. in view of Kramer et al. are considered to substantially describe the invention as claimed, however do not teach that the control unit comprises an oscillation control module, wherein the oscillation control module is configured and arranged to provide an input between 0.1 Hz and 0.2 Hz low frequency oscillation in the amplitude and/or the frequency. Courtine et al. is directed to techniques for the epidural stimulation of the spinal cord (para 33). The system of Courtine et al. includes a stimulation control unit that includes an oscillation control module expressly configured to provide an input of 0.1 Hz to 0.2 Hz frequency oscillation in the amplitude or frequency (para 50-51). It would therefore have been obvious to one of ordinary skill in the art to modify the control unit of Capogrosso et al. to provide an input between 0.1 Hz and 0.2 Hz low frequency oscillation in the amplitude and/or the frequency since this is expressly taught by Courtine et al. in order to provide biomimetic stimulation patterns that more closely reproduce the naturally occurring neural dynamics and thereby provide physiologically relevant modulation of the targeted spinal neural activity.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Capogrosso et al. (WO 2023/039207) in view of Kramer et al. (US 2012/0158094), further in view of Minassian et al. (US 2019/0001138).
In regard to claim 17, Capogrosso et al. in view of Kramer et al. describe the invention substantially as claimed, however do not teach the implantable lead is configured and arranged to deliver epidural stimulation to the spinal cord of said mammal at the spinal cord level responsible for the trunk muscles over a thoracic region of the spinal cord. Minassian et al. discloses a system for neuromodulation and neurostimulation (para 11) for treating disorders related to movement similar to both Capogrosso et al. and Kramer et al. (para 229). The system of Minassian et al. includes a lead configured to deliver epidural stimulation to the spinal cord of said mammal at the spinal cord level responsible for the trunk muscles over a thoracic region of the spinal cord (para 132, Minassian et al. include several epidural electrode arrays arranged over the lumbar, thoracic, and cervical spinal cord (and connected to more than one implantable pulse generator) for the control of lower extremity, trunk, and upper extremity function). Modification of the system and techniques of Capogrosso et al. and Kramer et al. to provide epidural stimulation over the thoracis region of the spinal cord is considered to have been obvious to one of ordinary skill in order to stabilize the trunk and postural control of the subject to provide a stable foundation for controlling upper and lower limb movements during epidural stimulation.
Conclusion
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 28 September 2026
