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 Objections
Claim 14 is objected to because of the following informalities: there are grammatical mistakes within the claim. It appears “over or more regions” should read “over one or more regions”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They contain numerous grammatical and idiomatic errors which make understanding the claims difficult.
6. Claims 2-14 are rejected at least because they depend from a claim which is indefinite.
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.
Claims 1-14 are rejected under 35 U.S.C 103 as being unpatentable over Edgerton et al. (US Pub.: 2016/0121109 A1) and further in view of Bhagat et al. (US Pub.: 2020/0155841 A1).
Regarding claim 1, Edgerton teaches a system for normalizing bladder and urethral sphincter function of a subject, the system comprising:
an electrical stimulator (e.g. Fig. 3 – neuromodulation stimulator 302);
and a microprocessor in communication with the electrical stimulator (e.g. paragraph 0002),
the microprocessor having programming stored thereon that (e.g. paragraph 0002), when executed, cause the microprocessor to deliver transcutaneous electrical stimulation to a subject at one or more levels of the spinal cord using a biphasic electrical stimulation waveform (e.g. paragraphs 0002, 0084 – biphasic electrical stimulation); to produce simultaneous normalization of bladder storage function or bladder and bowel function or bladder and sexual function or bladder and bowel and sexual function or bladder and cardiovascular function by reducing detrusor overactivity, increasing bladder capacity, improved coordination between detrusor and external urethral sphincter and to improve sensation of bladder fullness (e.g. paragraphs 0060, 0125);
wherein the transcutaneous electrical stimulation includes low frequency pulses that provide an activation signal to the spinal cord (e.g. paragraphs 0084, 0091 – 1-40 Hz stimulus signal) and high frequency carrier pulses comprising a pulse frequency sufficient to reduce or block pain produced by the transcutaneous electrical stimulation (e.g. paragraphs 0091, 0121);
wherein the high frequency carrier pulses are in a frequency range from about 5 kHz up to about 100 KHz, or from about 10 kHz up to about 50 Khz, or from about 10 kHz up to about 30kHz, or from about 10 kHz up to about 20 kHz (e.g. paragraph 0091 – carrier frequency of 5-10 kHz; paragraph 0121);
wherein the low frequency pulses are in frequency range from about 1 Hz up to about 50 Hz, or from about 10 Hz up to about 30Hz (e.g. paragraph 0082 – 40 Hz; paragraph 0091 – 1-40 Hz).
However, Edgerton does not explicitly teach a delayed biphasic electrical stimulation waveform with a DC offset or a charge balance manner sufficient while delivering neuromodulation and to maintain after cessation of the neuromodulation signal via neuroplasticity induced in both brain and spinal cord;
wherein the neuroplasticity effectuates a change in a brain and the spinal cord by exciting certain muscles, neurons or interneurons, inhibiting certain muscles, neurons and interneurons, having no effect on another set of muscles, neurons or interneurons and reconnects the brain to the spinal cord of the subject.
Bhagat, in a same field of endeavor of transcutaneous electrical stimulation, discloses a delayed biphasic electrical stimulation waveform with a DC offset or a charge balance manner (e.g. paragraph 0008, – charged balanced biphasic waveform with a delay).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Edgerton to incorporate a delayed biphasic electrical stimulation waveform with a charge balance manner, as taught and suggested by Bhagat, in order to minimize tissue damage and electrode corrosion during therapy (Bhagat, paragraph 0008).
In regard to the limitations of sufficient while delivering neuromodulation and to maintain after cessation of the neuromodulation signal via neuroplasticity induced in both brain and spinal cord (e.g. Although Edgerton discloses maintaining neuroplasticity after a therapy session (see paragraphs 0053-0054), it should be noted that this is a property of the stimulation pattern. The stimulation pattern of delayed biphasic electrical stimulation with charge balance generates/produces this outcome. This limitation contains functional language (see MPEP 2114) and is intended use of the device. The combined device of the prior art is interpreted to be fully capable of performing this function and therefore meets the scope of the limitation); and wherein the neuroplasticity effectuates a change in a brain and the spinal cord by exciting certain muscles, neurons or interneurons, inhibiting certain muscles, neurons and interneurons, having no effect on another set of muscles, neurons or interneurons and reconnects the brain to the spinal cord of the subject (e.g. Edgerton discloses maintaining neuroplasticity after a therapy session (see paragraphs 0053-0054). Additionally, the combined device of the prior art is structurally is structurally identical to the claimed device and provides the claimed stimulation and therefore it is interpreted to inherently and necessarily produce the claimed treatment outcome of effectuating a change in a brain and the spinal cord and reconnecting the brain to the spinal cord of the subject.).
Regarding claim 2, Edgerton in view of Bhagat teaches the system to claim 1 as discussed above, and Edgerton further teaches wherein delivering transcutaneous electrical stimulation to the subject's spinal cord results in reactivation and retraining of the brain and spinal cord (e.g. paragraphs 0053-0055) controlling the lower urinary tract while actively delivering neuromodulation and after cessation of the neuromodulation signal via neuroplasticity induced in the brain and spinal cord (e.g. paragraphs 0017, 0060).
Regarding claim 3, Edgerton in view of Bhagat teaches the system to claim 1 as discussed above, and Edgerton further teaches delivering transcutaneous electrical stimulation to the subject's spinal cord is sufficient to normalize bladder and urethral sphincter function in the subject selected from the group consisting of increasing bladder capacity, increasing sensation of bladder fullness, reducing spasticity in the bladder muscles, increasing tone in the urethral sphincter muscle, reducing urinary incontinence, reducing the uncontrolled urgency to urinate, normalizing the frequency of voiding cycles, increasing voluntary control to hold, improving ability to void voluntarily, reducing the number of catheters needed to empty bladder, improving the ability to catheterize based on the sensation of bladder fullness rather than timed catheterization cycles while actively delivering neuromodulation and after cessation of the neuromodulation signal via neuroplasticity induced in the brain and spinal cord (e.g. paragraphs 0060, 0125).
Regarding claim 4, Edgerton in view of Bhagat teaches the system to claim 1 as discussed above, and Edgerton further teaches wherein applying transcutaneous electrical neuromodulation to the spinal cord of the subject results in reduction in co-contraction of antagonistic muscles (e.g. paragraphs 0121, 0162) and reduction in at least one of: spasticity or uncontrolled activation of muscles while actively delivering neuromodulation and after cessation of the neuromodulation signal via neuroplasticity induced in the brain and spinal cord (e.g. paragraphs 0009, 0148).
Regarding claim 5, Edgerton in view of Bhagat teaches the system to claim 1 as discussed above, and Edgerton further teaches wherein delivering transcutaneous electrical stimulation to the subject's spinal cord is sufficient to improve bowel function in the subject selected from the group consisting of increasing sensation of bowel fullness, increasing motility of the bowels, increasing tone in the anal sphincter muscle, improving voluntary control of abdominal muscles, reducing fecal incontinence, improving the ability to defecate voluntarily, reduce the reliance on digital stimulation to move the bowels and reduce the need for suppositories and enemas while actively delivering neuromodulation and after cessation of the neuromodulation signal via neuroplasticity induced in the brain and spinal cord (e.g. paragraphs 0009, 0017).
Regarding claim 6, Edgerton in view of Bhagat teaches the system to claim 1 as discussed above, and Edgerton further teaches wherein: delivering transcutaneous electrical stimulation to the subject's spinal cord is sufficient to improve sexual function in the subject selected from the group consisting of improving sensation of urogenital organs, returning the ability to have an erection, increasing lubrication, increasing sensation during erection and penetration, increasing ability for voluntary penetration, increasing ability to sustain erection for longer periods of time and increasing degree of orgasm at climax while actively delivering neuromodulation and after cessation of the neuromodulation signal via neuroplasticity induced in the brain and spinal cord (e.g. paragraphs 0048, 0126), and wherein applying the transcutaneous electrical neuromodulation to the spinal cord of the subject is sufficient to increase sperm count, sperm mortality and vitality by the subject while actively delivering neuromodulation and after cessation of the neuromodulation signal via neuroplasticity induced in the brain and spinal cord (e.g. paragraphs 0048, 0126).
Regarding claim 7, Edgerton in view of Bhagat teaches the system to claim 1 as discussed above, and Edgerton further teaches wherein transcutaneous electrical neuromodulation is applied to the subject in independently or in conjunction with physical therapy or exercises such as Kegels or with the subject contributing to muscle control via voluntary effort while actively delivering neuromodulation and after cessation of the neuromodulation signal via neuroplasticity induced in the brain and spinal cord (e.g. paragraphs 0140, 0146, 0176).
Regarding claim 8, Edgerton in view of Bhagat teaches the system to claim 1 as discussed above, and Edgerton further teaches delivering transcutaneous electrical stimulation to the subject's spinal cord is sufficient to maintain voluntary control of one or more of physical motor function, sensory function, and cognitive function, while actively delivering neuromodulation and after cessation of the neuromodulation signal via neuroplasticity induced in the brain and spinal cord (e.g. paragraphs 0009, 0048).
Regarding claim 9, Edgerton in view of Bhagat teaches the system to claim 1 as discussed above, and Edgerton further teaches wherein delivering transcutaneous electrical stimulation to the subject's spinal cord is sufficient to reduce neuropathic pain and chronic muscular pain (e.g. paragraphs 0009, 0121).
Regarding claim 10, Edgerton in view of Bhagat teaches the system to claim 1 as discussed above, and Edgerton further teaches wherein delivering transcutaneous electrical stimulation to the subject's spinal cord reduces pathological spinal mechanisms, prevents formation of aberrant connections in the brain and spinal cord, between the brain and spinal cord and between the spinal cord and muscles while actively delivering neuromodulation and after cessation of the neuromodulation signal via neuroplasticity induced in the brain and spinal cord (e.g. paragraphs 0054, 0056).
Regarding claim 11, Edgerton in view of Bhagat teaches the system to claim 1 as discussed above, and Edgerton further teaches wherein the subject has a condition selected from the group consisting of spinal cord injury, an ischemic brain injury, from a stroke or acute trauma, and a neurodegenerative condition, selected from the group consisting of stroke, spinal cord injury, Parkinson's disease, Huntington's disease, Alzheimer's disease, amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), dystonia, hemispherectomy, transverse myelitis, conus medularis injury (lower motor neuron injury), spina bifida, autism, hemispherectomy and cerebral palsy (e.g. paragraph 0141).
Regarding claim 12, Edgerton in view of Bhagat teaches the system to claim 1 as discussed above, and Edgerton further teaches wherein the subject has a naturally occurring condition selected from group consisting of aging, obesity, inactivity and post-surgical care (e.g. paragraphs 0055, 0090).
Regarding claim 13, Edgerton in view of Bhagat teaches the system to claim 1 as discussed above, and Edgerton further teaches wherein transcutaneous electrical neuromodulation is delivered to the subject immediately after the traumatic or non-traumatic injury, during the sub-acute phases of recovery, during the acute phases of recovery or during the chronic phases of recovery (e.g. paragraphs 0048-0049).
Regarding claim 14, Edgerton in view of Bhagat teaches the system to claim 1 as discussed above, and Edgerton further teaches wherein transcutaneous electrical neuromodulation is delivered to the subject over or more regions straddling or spanning a region selected from the group consisting of the brainstem, C0-C1, C0-C2, C0-C3, C0-C4, C0-C5, C0-C6, C0-C7, C0-T1, C1-C1, C1-C2, C1-C3, C1-C4, C1-C7, C1-C6, C1-C7, C1-T1, C2-C2, C2-C3, C2-C4, C2-C5, C2-C6, C2-C7, C2-T1, C3-C3, C3-C4, C3-C5, C3-C6, C3-C7, C3-T1, C4-C4, C4-C5, C4-C6, C4-C7, C4-T1, C5-C5, C5-C6, C5-C7, C5-T1, C6-C6, C6-C7, C6-T1, C7-C7, and C7-T1, T1-T1, T1-T2, T1-T3, T1-T4, T1-T5, T1-T6, T1-T7, T1-T8, T1-T9, T1-T10, T1-T11, T1-T12, T2-T2, T2-T3, T2-T4, T2-T5, T2-T6, T2-T7, T2-T8, T2-T9, T2-T10, T2-T11, T2-T12, T3-T3, T3-T4, T3-T5, T3-T6, T3-T7, T3-T8, T3-T9, T3-T10, T3-T11, T3-T12,
T4-T4, T4-T5, T4-T6, T4-T7, T4-T8, T4-T9, T4-T10, T4-T11, T4-T12, T5-T5, T5-T6, T5-
T7, T5-T8, T5-T9, T5-T10, T5-T11, T5-T12, T6-T6, T6-T7, T6-T8, T6-T9, T6-T10, T6-T11,
T6-T12, T7-T7, T7-T8, T7-T9, T7-T10, T7-T11, T7-T12, T8-T8, T8-T9, T8-T10, T8-T11,
T8-T12, T9-T9, T9-T10, T9-T11, T9-T12, T10-T10, T10-T11, T10-T12, T11-T11, T11-T12,
and T12-T12, L1-L1, L1-L2, L1-L3, L1-L4, L1-L5, L1-S1, L1-S2, L1-S3, L1-S4, L1-S5, L2-L2, L2-L3, L2-L4, L2-L5, L2-S1, L2-S2, L2-S3, L2-S4, L2-S5, L3-L3, L3-L4, L3-L5, L3-S1, L3-S2, L3-S3, L3-S4, L3-S5, L4-L4, L4-L5, L4-S1, L4-S2, L4-S3, L4-S4, L4-S5, L5-L5, L5-S1, L5-S2, L5-S3, L5-S4, L5-S5, S1-S1, S1-S2, S1-S3, S1-S4, S1-S5, S2-S2, S2-S3, S2-S4, S2-S5, S3-S3, S3-S4, S3-S5, S4-S4, S4-S5, and S5-S6 (e.g. paragraph 0006 – T11-T12; paragraph 0135).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
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/D.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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