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
Applicant’s amendments to the claims, rolling up the previously indicated allowable dependent Claim 8, are acknowledged, but further search and consideration has indicated that a rejection to the above subject matter would be proper. As such, this action is a second Non-Final.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-7 and 9-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2019147679 awarded to Grahn et al.
Regarding Claims 1 and 20, Grahn teaches a A method for configuring neurostimulation (abstract), comprising: selecting one or more desired physiological functions and creating a 3D model of at least a portion of a spinal cord (Para. 0165, “Moreover, the anatomical data and particularly intersegmental correlations provided here may be combined with imaging studies in order to develop a 3D-model of the spinal cord to help in the implementation of specific targeting during implantation procedures”), the modeled portion of the spinal cord including a lumbosacral enlargement (Para. 0086, “Refinement of EES Settings to Enable Motor Function. A biphasic, charge-balanced waveform with a positive pulse width of 0.21 ms was used throughout the study. Initial active electrode configurations were chosen based on intraoperative electrically-evoked spinal motor potentials with reference to previously established topographical maps of electrically-evoked lumbosacral spinal motor potentials. See Grahn PJ, Lavrov IA, Sayenko DG, et al. Enabling Task-Specific Volitional Motor Functions via Spinal Cord”); calculating, based at least in part on the 3D model, for at least one position of an electrode array including a plurality of electrodes, a portion of the lumbosacral enlargement covered by the electrode array at the at least one position (Para. 0086, “Effects of paired transcutaneous electrical stimulation delivered at single and dual sites over lumbosacral spinal cord. Neuroscience Letters 20l5;609(C):229-34. An initial frequency range of 15-40 Hz was used based on prior literature reporting EES -facilitation of tonic and rhythmic motor activity generated by the human spinal cord. See Dimitrijevic MR, Gerasimenko Y, Pinter MM. Evidence for a spinal central pattern generator in humans”); positioning the electrode array with respect to the spinal cord, the positioning based in part on the calculated portion of the lumbosacral enlargement covered by the electrode array at the at least one position and based in part on the selected one or more desired physiological functions, wherein the electrode is positioned at a transcutaneous position (Para. 0086); evoking potentials by applying spinal cord stimulation using the electrode array and determining stimulation thresholds to evoke responses from said spinal cord stimulation (Para. 0056, “Figure 19 depicts motor responses during EES at L4-L6. (A) The multi-array rod electrode (8-contacts rod array, Model 3874, Medtronic, MN) was placed on the midline of the spinal cord at the dorsal rootlets entry levels (L4, L5 and L6) and in approximate locations between the segments (L4-L5 and L5-L6) in subject 2. Gray rectangles in the upper diagram represent the relative position of the multi-array rod electrode. Amplitude of the motor evoked responses is expressed as % (±SEM). Responses were recorded in proximal (upper plot) and distal muscles (bottom plot). (B) Representative averaged traces of motor responses (gray rectangles, 10 ms time window) evoked at 1.4 mA. The electrode was located proximal to L6 dorsal root entry zone (left traces) and in the intersegmental location L4-L5 (right traces). EMG’s of distal and proximal muscles were recorded. Each trace represents the average of ten motor responses. Mean latencies (±SD) of the first (red bar) and second peak (black bar) are shown below traces on left for each muscle”); mapping a spatial relationship between the plurality of electrodes and the evoked responses, and selecting specific electrodes within the plurality of electrodes for activation based on activation of said specific electrodes evoking responses promoting the one or more desired physiological functions (Para. 0005, “The stimulation parameter settings can be independently adjusted for each IPG. The system can select particular electrodes in the array and localize stimulation timing and position over spinal cord regions that are associated with motor functions such as standing and stepping. In some implementations, multiple IPGs are contained in a single implanted device, and the stimulation provided by each IPG is coordinated to achieve desired stimulation of particular locations of the spinal cord. The spinal cord reacts to the stimulations to drive leg or other limb movement”).
Regarding Claim 2, Grahn teaches the method of claim 1, wherein the evoked responses are motor muscle responses (Para. 0065, “As further described with respect to example implementation #3 below, improved (e.g., higher) peak-to-peak motor responses to epidural electrical stimulation can be achieved by targeted stimulation of the dorsal root entry zones at one or more locations along the spine. As demonstrated below, experimental results in swine indicate that the magnitude of the motor response to EES is highly dependent on proximity of the stimulating electrodes to the dorsal root entry zones”) and non-motor muscle responses (Para. 0084, “Pre-EES Multi-Modal Rehabilitation. Upon joining the study, the subject performed 22 weeks of MMR (61 sessions total) prior to EES implantation to determine if spontaneous motor recovery would occur from MMR. Sessions consisted of attempts to volitionally activate paralyzed muscles while positioned supine and side-lying, during seated trunk strengthening activities, standing, and treadmill stepping. Trainer assistance and BWS was provided during pre-EES MMR activities”).
Regarding Claim 3, Grahn teaches the method of claim 2, further comprising applying spinal cord stimulation below the determined stimulation thresholds using the specific electrodes to promote the one or more desired physiological functions (Para. 0128, “At lower EES intensities, activation of dorsal spinal structures produces a middle response (MR) in muscles with latencies between 5-9 ms. The difference in timing of these two responses is likely due to an intraspinal synaptic relays from dorsal root structures to ventral hom and ventral roots”).
Regarding Claim 4, Grahn teaches the wherein the evoked responses are motor muscle responses (Para. 0128, “At lower EES intensities, activation of dorsal spinal structures produces a middle response (MR) in muscles with latencies between 5-9 ms. The difference in timing of these two responses is likely due to an intraspinal synaptic relays from dorsal root structures to ventral hom and ventral roots”).
Regarding Claims 5 and 6, Grahn teaches the method of claim 2, further comprising applying spinal cord stimulation at or above the determined stimulation thresholds using the specific electrodes to promote the one or more desired physiological functions, wherein the evoked responses are non- motor muscle responses or non-muscle responses (Paras. 0085-0086).
Regarding Claim 7, Grahn teaches the method of Claim 1, wherein the lumbosacral enlargement includes a plurality of lumbosacral spinal cord levels; wherein each evoked response is evoked by applying spinal cord stimulation to one or more levels of the plurality of spinal cord levels (Para. 0135); and wherein positioning the electrode array includes positioning the electrode array such that the calculated portion of the lumbosacral enlargement covered by the electrode array includes each spinal cord level stimulated in evoking each evoked response promoting the one or more desired physiological functions (Para. 0007).
Regarding Claim 9, Grahn teaches method of claim 1, wherein an additional electrode array is positioned at an epidural position (Para. 0127).
Regarding Claim 10, Grahn teaches the method of claim 1, further comprising applying spinal cord stimulation using the specific electrodes to promote the one or more desired physiological functions (Para. 0127).
Regarding Claim 11, Grahn teaches the method of claim 1, further comprising repositioning the electrode array based on said evoking potentials (Para. 0130).
Regarding Claim 12, Grahn teaches the method of claim 1, wherein said repositioning occurs after said evoking potentials and before said mapping (Para. 0056).
Regarding Claim 13, Grahn teaches the method of claim 1, wherein the one or more desired physiological functions is a plurality of non-identical physiological functions (Para. 0049).
Regarding Claim 14, Grahn teaches the method of claim 13, further comprising applying spinal cord stimulation using the specific electrodes to promote one of the plurality of desired physiological functions then subsequently applying spinal cord stimulation using the specific electrodes to promote a different one of the plurality of desired physiological functions (Para. 0049).
Regarding Claims 15, Grahn teaches the method of claim 1, wherein the one or more desired physiological functions is one or more of standing and walking (Para. 0107).
Regarding Claim 16, Grahn teaches the method of claim 15, wherein the one or more desired physiological functions is a plurality of standing and walking (Para. 0107).
Regarding Claim 17, Grahn teaches the method of claim 1, wherein mapping the spatial relationship between the plurality of electrodes and the evoked responses comprises activating combinations of electrodes within the plurality of electrodes and determining the response evoked from such activation (Para. 0056).
Regarding Claim 18, Grahn teaches the method of claim 1, further comprising, after said mapping the spatial relationship between the plurality of electrodes and the evoked responses, mapping a relationship between the plurality of electrodes and the one or more desired physiological functions (Para. 0056).
Regarding Claim 19, Grahn teaches the method of claim 18, wherein mapping the relationship between the plurality of electrodes and the one or more desired physiological functions comprises activating combinations of electrodes within the plurality of electrodes evoking responses promoting the one or more desired physiological functions and determining if the one or more desired physiological (Para. 0056).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: U.S. 20140163640 awarded to Edgerton, specifically Paras. 0035-0040.
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/JLM/
Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
