DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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 2019/147679 granted to Grahn et al (hereinafter “Grahn”).
In reference to claims 1 and 20, Grahn discloses a method for configuring neurostimulation, comprising: selecting one or more desired physiological functions; creating a 3D model of at least a portion of a spinal cord, the modeled portion of the spinal cord including a lumbosacral enlargement [e.g. 165]; 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; 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 [e.g. 7]; evoking potentials by applying spinal cord stimulation using the electrode array and determining stimulation thresholds to evoke responses from said spinal cord stimulation; mapping a spatial relationship between the plurality of electrodes and the evoked responses [e.g. 56]; 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 [e.g. 5].
In reference to claim 2, Grahn discloses wherein the evoked responses are motor muscle responses, non-motor muscle responses, or non-muscle responses [e.g. 11].
In reference to claim 3, Grahn discloses further comprising applying spinal cord stimulation below the determined stimulation thresholds using the specific electrodes to promote the one or more desired physiological functions [e.g. 128].
In reference to claim 4, Grahn discloses wherein the evoked responses are motor muscle responses [e.g. 7].
In reference to claim 5, Grahn discloses 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 [e.g. 128].
In reference to claim 6, Grahn discloses wherein the evoked responses are non-motor muscle responses or non-muscle responses [e.g. 85].
In reference to claim 7, Grahn discloses wherein the lumbosacral enlargement includes a plurality of lumbosacral spinal cord levels [e.g. 135]; wherein each evoked response is evoked by applying spinal cord stimulation to one or more levels of the plurality of spinal cord levels; 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 [e.g. 7].
In reference to claim 9, Grahn discloses wherein the electrode array is positioned at an epidural position [e.g. 8].
In reference to claim 10, Grahn discloses further comprising applying spinal cord stimulation using the specific electrodes to promote the one or more desired physiological functions [e.g. 5].
In reference to claim 11, Grahn discloses further comprising repositioning the electrode array based on said evoking potentials [e.g. 58; 116].
In reference to claim 12, Grahn discloses wherein said repositioning occurs after said evoking potentials and before said mapping [e.g. 56].
In reference to claim 13, Grahn discloses wherein the one or more desired physiological functions is a plurality of non-identical physiological functions [e.g. 49].
In reference to claim 14, Grahn discloses 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 [e.g. 124].
In reference to claims 15 and 16, Grahn discloses wherein the one or more desired physiological functions is one or more of standing, sitting, walking, increasing blood pressure, decreasing blood pressure, maintaining blood pressure, voiding bladder, refraining from voiding bladder, voiding bowels, refraining from voiding bowels [e.g. 5].
In reference to claims 17 and 18, Grahn discloses 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 and mapping a relationship between the plurality of electrodes and the one or more desired physiological functions [e.g. 56].
In reference to claim 19, Grahn discloses 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 functions is achieved [e.g. 6 and 7].
Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/NADIA A MAHMOOD/Primary Examiner, Art Unit 3796
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