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 § 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) 1-2, 5-7, 9, 17 & 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kramer et al. (US 2016/0243365) in view of Ganguly et al. (WO 2020/018912).
Kramer et al. teaches a method for treating a motor/movement impairment in a subject by applying a therapeutically effective electrical stimulus to neural structures associated with sensory/motor control to reduce symptoms of the movement disorder ([0010]-[0017], [0036], [0067]-[0073]).
Kramer et al. teaches applying the electrical stimulus to dorsal roots and/or dorsal root ganglia associated with sensory neurons, including selective stimulation of sensory fibers/neurons associated with the reflex arc ([0010]-[0013], [0018]-[0022], [0068]-[0071]).
Kramer teaches that the stimulated sensory/reflex circuitry controls movement of the arm, expressly identifying lower motor neurons controlling movement of the arms and other body regions ([0070]-[0071]).
Kramer et. al further teaches applying the stimulation using one or more electrodes controlled by a neurostimulation system and positioning electrodes relative to the target dorsal root/DRG to selectively stimulate the target neural tissue and reduce symptoms of the movement disorder ([0010]-[0012], [0022]-[0024], [0073]-[0075]).
Kramer et al. therefore teaches treating an arm motor impairment by stimulation of the recited sensory neural structures, but does not expressly teach that the arm impairment is due to stroke.
Ganguly et al. teaches the missing stroke limitation, expressly disclosing electrical neurostimulation for promoting recovery from a stroke-induced loss of motor function (e.g., [0007]-[0009]).
Ganguly et al. further teaches that post-stroke low-frequency oscillatory activity is associated with upper-limb motor recovery and that therapeutic electrical stimulation significantly improves skilled motor/reaching performance following stroke (e.g., [0037]).
Ganguly et al. further teaches electrical neuromodulation for improving motor function following stroke and recognizes stimulation of neural structures, including spinal cord structures, as suitable targets for neuromodulation (e.g., [0052]-[0054], [0081]-[0082], [0088]-[0089]).
It would have been obvious to one of ordinary skill in the art before the effective filing data to apply Kramer’s dorsal-root/DRG sensory stimulation technique for treating arm motor impairment to a subject having stroke-induced motor impairment, as taught by Ganguly, because Ganguly teaches that electrical neuromodulation can promote post-stroke motor recovery and improve upper-limb motor function.
A person of ordinary skill therefore would have had a reason to use Kramer’s known stimulation of sensory/reflex circuitry controlling the arm in the treatment of Ganguly’s known post-stroke motor impairment, with reasonable expectation of improving motor function, thereby arriving at the claimed method.
Accordingly, the combination of Kramer et al. and Ganguly et al. renders claim 1 obvious.
Claim 2.
Claim 2 incorporates the rejection of claim 1.
Kramer et al. further teaches positioning electrodes to selectively stimulate a target dorsal root ganglion/sensory neural tissue associated with the movement disorder {[0010]-[0013], [0018]-[0022], [0073]-[0075] & (Fig 3)}.
Kramer et. al. therefore teaches/suggests positioning the electrode proximate the dorsal root ganglia of sensory neurons associated with the impaired limb, as claimed.
Accordingly, claim 2 would have been obvious over Kramer et al. in view of Ganguly for the reasons discussed with respect to claim 1.
Claim 5.
Claim 5 incorporates the rejection of claim 1.
Kramer et al. teaches treatment of neurological movement disorders and reduction of associated movement symptoms ([0004]-[0010], [0036]-[0037], [0067]).
Ganguly et al. further expressly teaches stroke-induced motor impairment/loss of motor function and improving motor function following stroke ([0037], [0081]-[0089]).
Thus, the combination teaches the claimed impairment being a motor impairment.
Claim 6.
Claim 6 incorporates the rejections of claim 5 and claim 1
Ganguly et al. teaches post-stroke impairment and recovery involving skilled reaching and upper-limb motor tasks, including monitoring/improving motor-task performance ([0009], [0037], [0081]-[0089]).
Such skilled reaching constitutes voluntary movement of the impaired arm. Thus, the combination teaches/suggests the claimed motor impairment comprising an impairment of voluntary movement of the arm.
Claim 7.
Claim 7 incorporates the rejection of claim 5 and claim 1.
Kramer et al. teaches movement disorders involving impaired of abnormal movement, including akinesia, bradykinesia, dystonia, etc. and related motor dysfunction ([0036]-[0037], [0066]-[0067]).
Ganguly et al. further teaches loss and impairment of motor function following stroke ([0037], [0088]-[0089]).
Accordingly, the combined teachings encompass at least one of the alternatively recited forms of reduced muscle control/function recited by claim 7.
Claim 9.
Claim 9 incorporates the rejection of claim 1.
Ganguly et al. teaches subjects having post-stroke motor impairment who retain and/or recover skilled reaching and motor-task performance ([0037], [0081]-[0089]).
Note: Performance of the disclosed reaching/motor tasks demonstrates at least some residual movement of the impaired upper limb.
Thus, Ganguly et al. teaches/suggests a subject retaining at least some residual movement of the impaired arm, as claimed.
Claim 17.
Claim 17 incorporates the rejection of claim 1.
Kramer et al. teaches positioning at least one electrode relative/proximate to a dorsal root ganglion (DRG) to selectively stimulate the target DGR and associated sensory neural tissue ([0010]-[0013], [0073]-[0075]; Fig. 3).
Ganguly et al. supplies the post-stroke impaired-arm application for the reasons discussed with respect to claim 1.
Thus, the combination teaches/suggests implantation of the electrode proximate to dorsal root ganglia of sensory neurons associated with the impaired arm.
Claim 23.
Claim 23 incorporates the rejection of claim 1.
Kramer et al. teaches treating patients suffering from neurological movement disorders and applying stimulation directed to neural structures associated with the movement disorder ([0004], [0015]-[0017]).
Ganguly et al. expressly teaches neurostimulation treatment of subjects having stroke-induced loss/impairment of motor function ([0007]-[0009], [0037]).
Therefore, the combination teaches/suggests selecting a subject having a motor impairment for treatment, as claimed.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify/apply the sensory-neural stimulation teachings of Kramer to the post-stroke motor impairment disclosed by Ganguly et al. because both references concern electrical neuromodulation for improving impaired motor function. Such modification represents application of a known neuromodulation technique to a known motor impairment for its established expectation of improving motor function.
Allowable Subject Matter
Claims 3, 8, 10-12, 20, 24-30 and 34-35 are 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.
The prior art of record, including Kramer et al. in view of Ganguly et al., fails to teach or suggest the additional limitations recited in these claims, including, as applicable, the specifically claimed neural stimulation location, residual corticospinal tract activity, proprioceptive impairment, cervical electrode-array configuration, stimulation threshold relationships, motoneuron/intraspinal neural circuit activation characteristics and stimulation pulse patterns.
A search of the prior art did not disclose or render obvious these additional limitations in combination with the limitations of respective base claims.
Response to Arguments
Applicant’s arguments have been fully considered and are persuasive in part.
The applicant argues, in substance, that the prior art fails to teach of suggest the claimed treatment of an impaired arm using electrical stimulation directed to the recited sensory neural structures and further fails to disclose various amended anatomical, functional, and stimulation limitations.
Applicant’s arguments are not persuasive with respect to claims 1-2, 5-7, 9, 17 & 23. The rejection has been reconsidered in view of the amendments and arguments. As set forth above, Kramer et al. in view of Ganguly et al. teaches or suggests the limitations of these claims. Kramer et al. teaches electrical stimulation of sensory neural structures, including stimulation associated with the DRG and reflex circuitry, for treatment of movement disorders, while Ganguly et al. teaches electrical neuromodulation for improving motor function following stroke, including recovery of upper-lib motor function.
One of ordinary skill in the art would have had reason to apply Kramer’s neural stimulation teachings to the post-stroke motor impairment taught by Ganguly et al. to improve impaired motor function, with a reasonable expectation of success. Accordingly, Applicant’s arguments directed to the references individually do not overcome the rejection because the rejection is based upon the combined teachings of Kramer et al. in view of Ganguly et al., rather than requiring either reference individually to disclose the claimed invention in its entirety.
However, Applicant’s arguments are persuasive with respect to the additional limitations of claims 3, 8, 10-12, 20, 24-30 and 34-35. Upon reconsideration of the prior art and Applicant’s amendments, the prior art of record does not teach or suggest these additional limitations in combination with the limitations of the respective base claims. Accordingly, these claims are objected to as depending from a rejected base claim but are indicated as containing allowable subject matter and would be allowable if rewritten in independent form to include all limitations of the base and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
Prosecution Insights