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
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.
(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.
Claim(s) 1-30 & 34-37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kramer et al. (US 2016/0243365).
Kramer et al. discloses;
1.
A method for treating an impairment of a limb in a subject, comprising applying a therapeutically effective amount of an electrical stimulus to sensory neurons innervating the limb of the of the subject; wherein the impairment is a motor impairment and/or a proprioception impairment due to neurological disorder or injury;
E.G. via the disclosed method of providing treatment to a patient having a movement disorder via providing stimulation energy in order to activate a reflex arc, i.e. stimulating at least one sensory neuron so as to activate a motor neuron ([0010]-[0012])
the electrical stimulus is applied with one or more electrodes controlled by a neurostimulator; and an application of the electrical stimulus reduces the motor impairment and/or proprioception impairment of the limb of the subject.
E.G. via the disclosed implantable stimulation system 100 which stimulates a variety of anatomical locations via a lead 104 and electrodes 106 implanted proximate to a target dorsal root ganglion (DRG) {[0072]-[0073] & (Fig 1)}.
2.
The method of claim 1, wherein: the therapeutically effective amount of the electrical stimulus is applied to the dorsal roots, dorsal rootlets, or dorsal root ganglia of the sensory neurons innervating the limb of the subject;
E.G. {[0072]-[0073] & (Fig 1)}.
and the one or more electrodes are implanted in the epidural space at the dorsolateral aspect of the spinal cord and proximate to the dorsal roots or dorsal rootlets of the sensory neurons innervating the limb of the subject or the one or more electrodes are implanted proximate to dorsal root ganglia of sensory neurons innervating the limb of the subject.
E.G. via the disclosed placement of leads 104 toward a target DRG {[0073] & (Fig 2)}.
3.
The method of claim 1, wherein the sensor neurons are stimulated within the dorsal or ventral horn via epidural, subdural or intraspinal stimulation.
E.G. {[0074] & (Fig 3)}.
4.
The method of claim 1, wherein the limb is an arm.
E.G. via the disclosed method stimulating reflex arcs provided by lower motor neurons that control movement such as arms ([0070]-[0071]).
5.
The method of claim 1, wherein the impairment is a motor impairment.
E.G. ([0036]-[0067]).
6.
The method of claim 5, wherein the motor impairment is an impairment of voluntary movement of the limb.
E.G. ([0036]-[0067]).
7.
The method of claim 5, wherein the motor impairment comprises reduced muscle control, reduced muscle function, reduced muscle strength, partial paralysis, uncontrollable muscle tone, reduced dexterity, spasticity, contractures and/or abnormal flexor synergy or contractures.
E.G. via the disclosed target treatment of such conditions as stated in the following paragraphs ([0036]-[0067]).
8.
The method of claim 5, wherein the subject retains at least some residual activity of corticospinal tract neurons innervating the impaired limb.
E.G. via the disclosed stimulation of portions of the neural tissue associated with the peripheral nervous system along the spinal cord, i.e. spinal nerves, while minimizing or excluding undesired stimulation ([0068]-[0069]).
9.
The method of claim 5, wherein the subject retains at least some residual movement of the impaired limb.
E.G. ([0068]-[0069]).
10.
The method of claim 1, wherein the impairment is a proprioception impairment.
E.G. via the disclosed one or more movement disorders included in the paragraphs ([0036]-[0067]).
11.
The method of claim 10, wherein the impairment comprises reduced ability to detect force generated by and/or applied to the limb.
E.G. via the disclosed one or more movement disorders included in the paragraphs ([0036]-[0067]).
12.
The method of claim 10, wherein the proprioception impairment comprises reduced understanding of limb position and/or dynamics.
E.G. ([0036]-[0067]).
13.
The method of claim 1, wherein the impairment is due to stroke.
E.G. ([0036]-[0067]).
14.
The method of claim 1, wherein the impairment is due to cerebral palsy, traumatic brain injury, a neurodegenerative disease, a muscular dystrophy disease, amyotropic lateral scleroiss or Duchenne motor disorder.
E.G. ([0036]-[0067]).
15.
The method of claim 1, wherein the impairment is not due to spinal cord injury.
E.G. ([0036]-[0067]).
16.
The method of claim 1, wherein the one or more electrodes are implanted in the epidural space at the dorsolateral aspect of the spinal cord and proximate to the dorsal roots or dorsal rootlets of the sensory neurons innervating the limb of the subject.
E.G. {[0074] & (Fig 3)}.
17.
The method of claim 1, wherein the one or more electrodes are implanted proximate to dorsal root ganglia of sensory neurons innervating the limb of the subject.
E.G. {[0074] & (Fig 3)}.
18.
The method of claim 1, wherein the one or more electrodes are contained within an array of independently controllable electrodes on a percutaneous lead.
E.G. ([0071] & [0076]).
19.
The method of claim 1, wherein the one or more electrodes are contained within an array of independently controllable electrodes on a paddle lead.
E.G. ([0071] & [0076]).
20.
The method of claim 1, wherein the limb is an arm of the subject and the one or more electrodes are contained within one or more electrode arrays implanted at the dorsolateral aspect of the spinal cord and spanning the C3-T1 nerve roots.
E.G. {[0074] & (Fig 3)}.
21.
The method of claim 1, wherein the limb is a leg of the subject and the one or more electrodes are contained within one or more electrode arrays implanted at the dorsolateral aspect of the spinal cord and spanning the T11-S1 nerve roots.
E.G. {[0074] & (Fig 3)}.
22.
The method of claim 1, wherein the neurostimulator is an external or implanted pulse generator.
E.G. via the disclosed implantable pulse generator (IPG) 102 {[0071] & (Fig 1)}.
23.
The method of claim 1, further comprising selecting the subject with the motor impairment and/or proprioception impairment for treatment.
E.G. ([0036]-[0067]).
24.
The method of claim 1, wherein the electrical stimulus is applied at or below a motor threshold such that the electrical stimulus does not directly elicit movement of the impaired limp.
E.G. via the disclosed stimulation of neurons along the DRG, wherein said stimulation is applied in relation to a ‘comparative stimulation,’ in order to inadvertent stimulation of unrelated or undesired effect [0083].
25.
The method of claim 1, wherein the electrical stimulus is applied at or below a perceptual threshold such that the electrical stimulus does not directly elicit sensations in the impaired limb.
E.G. [0083].
26.
The method of claim 1, wherein the electrical stimulus is applied at or below a motor threshold such that the electrical stimulus does not directly elicit movement of the impaired limp, and above a perceptual threshold such that the electrical stimulus does elicit sensations in the impaired limb.
E.G. [0083].
27.
The method of claim 1, wherein the electrical stimulus does not induce paresthesia in the subject.
E.G. via the disclosed stimulation parameters in which it is inherently known to not induce paresthesia as is instantly claimed [0083].
28.
The method of claim 1, wherein the electrical stimulus increases the firing rate of motoneurons innervating the impaired limb of the subject, thereby reducing the impairment.
E.G. ([0085]-[0086]).
29.
The method of claim 1, wherein the electrical stimulus increases the number of active motoneuron innervating the impaired limb of the subject, thereby reducing the impairment.
E.G. ([0085]-[0086]).
30.
The method of claim 1, wherein the electrical stimulus activates sensory afferent cells of the spinal cord to increase the firing rate of intraspinal neural circuits and motoneurons innervating the impaired limb of the subject.
E.G. ([0085]-[0086]).
36.
The method of claim 31, wherein the pulses are cathodic-first biphasic or monophasic charge balance pulses.
E.G. ([0083]-[0085]).
37.
The method of claim 1, wherein the neurostimulator is activated to apply the electrical stimulus in response to feedback from one or more sensors on the impaired limb.
E.G. via the disclosed IPG comprising circuitry which initiates/modifies electrical stimulation based on a response from one or more sensors ([0085]-[0086]).
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.
Claim(s) 31-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kramer et al. (US 2016/0243365) in view of one having ordinary skill in the art.
Kramer et al. discloses the method of stimulating the DRG via the disclosed stimulation parameters [0083] except wherein the claimed electrical stimulus comprises the specific amplitude, pulse duration and frequency. It would have been obvious to one having ordinary skill in the art at the time the invention was made to utilize the specific amplitude, pulse duration and frequency parameters claimed, 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. In re Aller, 105 USPQ 233.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796