DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 9-12 are objected to because of the following informalities: In regards to claim 9, lines 8-9, the claim language “...nervous system of a patient. Wherein the electrical stimulator is…” should be changed to “…nervous system of a patient, wherein the electrical stimulator is…”. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 3, 9 & 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10/166384. Although the claims at issue are not identical, they are not patentably distinct from each other because although the claims at issue are not identical, they are not patentably distinct from each other because of the following rationale:
Claims 3, 9 & 18 of U.S. Application 18/623297
Claims 2, 14 of U.S Pat. No. 10/166384
An electrical stimulation system comprising: a coiled lead comprising an electrode extending from the lead;
An electrical stimulation system comprising: a percutaneous electrical lead; an electrode…operatively coupled with the lead;
…an (implantable) electrical stimulator connected with the coiled lead…delivers electrical stimulation through the electrode…
…an electrical stimulator coupled with the percutaneous electrical lead, the electrical stimulator delivers electrical stimulation through the electrode…
…wherein the electrical stimulation is configured to evoke…a muscle contraction in a target area (nerve fibers)…of muscles…and…tendon (afferent input)…to sustain functional reorganization of maladaptive neuroplastic changes in a central nervous system of a patient.
…delivers electrical stimulation through the electrode to produce a muscle contraction in a target area and to alter (sustain functional organization of) maladaptive neuroplasticity in a central nervous system…
As depicted above, the limitations of claims 3, 9 & 18 of the present invention differ from claims of claims 2, 14 of U.S Pat. No. 10/166384 in that the system comprises a coiled lead and an implantable electrical stimulator configured to evoke paresthesia and muscle contraction in a target area providing activation of muscle spindles (afferent input) and golgi tendon organs to sustain functional reorganization of maladaptive neuroplastic changes in a central nervous system of a patient. No additional structure or functional limitations between the two claim sets would render the claims patentably distinct from one another.
Claims 3, 9 & 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10/166384. Although the claims at issue are not identical, they are not patentably distinct from each other because although the claims at issue are not identical, they are not patentably distinct from each other because of the following rationale:
Claims 3, 9 & 18 of U.S. Application 18/623297
Claims 1, 7 & 14 of U.S Pat. No. 10/166384
An electrical stimulation system comprising: a coiled lead comprising an electrode extending from the lead;
An electrical stimulation system comprising: a lead; an electrode…operatively coupled with the lead;
…an (implantable) electrical stimulator connected with the coiled lead…delivers electrical stimulation through the electrode…
…an electrical stimulator coupled with the lead, the electrical stimulator delivers electrical stimulation through the electrode…
…wherein the electrical stimulation is configured to evoke…a muscle contraction in a target area (nerve fibers)…of muscles…and…tendon (afferent input)…to sustain functional reorganization of maladaptive neuroplastic changes in a central nervous system of a patient.
…delivers electrical stimulation through the one-electrode…to produce a stimulus…and a muscle contraction providing physiological activation…by sustaining functional organization of maladaptive neuroplasticity in a central nervous system…
As depicted above, the limitations of claims 3, 9 & 18 of the present invention differ from claims of claims 1, 7 & 14 of U.S Pat. No. 11,944,809 in that the system comprises a coiled lead and an implantable electrical stimulator configured to evoke paresthesia and muscle contraction in a target area providing activation of muscle spindles (afferent input) and golgi tendon organs to sustain functional reorganization of maladaptive neuroplastic changes in a central nervous system of a patient. No additional structure or functional limitations between the two claim sets would render the claims patentably distinct from one another.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 3-22 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Strother et al. (US 2007/0123952) in view of Gesotti (US 2008/0208288).
Strother et al. discloses;
3.
An electrical stimulation system comprising: a coiled lead comprising an electrode extending from the coiled lead;
E.G. via the disclosed neurostimulation assemblies 10 and/or a system 54 that provide electrical connections between muscles and nerves inside the body coupled by a percutaneous lead 12 to electrodes 14 {[0013]-[0014], [0055] & (Figs. 1 & 19A)}.
an implantable electrical stimulator connected with the coiled lead, wherein the electrical stimulator delivers electrical stimulation through the electrode, wherein the electrode is configured to be spaced an electrically effective distance from a neurological motor point
E.G. via the disclosed electrical current patterns that are generated and distributed through the leads 12 to the electrodes 14, wherein said electrodes are implanted due to their muscular and/or neurological morphologies to obtain a desired therapeutic and/or functional and/or diagnostic objective ([0053]-[0054]).
Note: The examiner notes that the disclosed electrodes 14 that are implanted to obtain therapeutic and/or functional objectives are capable of performing the intended use of being spaced an electrically effective distance from a neurological motor point, and therefore the claim limitation is met.
and wherein the electrical stimulation is configured to evoke paresthesia and a
muscle contraction in a target area providing physiologic activation to sustain functional reorganization of maladaptive neuroplastic changes in a central nervous system of a patient.
E.G. via the disclosed neurostimulation assembly/system 10/54 used to affect areas of the body and providing excitation and input to the brain, i.e. a neuroplastic effect, enabling the brain to re-learn and regain control of a lost function [0206].
Note: The examiner notes that the disclosed neurostimulation assembly 10 and/or system 54 is capable of performing the intended use of evoking paresthesia and muscle contraction in a target area to sustain functional reorganization of maladaptive neuroplastic changes in a central nervous system of a patient, as is instantly claimed.
Strother et al. discloses the claimed invention utilizing a neurostimulation assembly 10 and/or a system 54 that provides electrical connections between muscles and nerves inside the body coupled by a percutaneous lead 12 to electrodes 14 in order to apply selective patterns of neurostimulation only to a targeted region in order to achieve a neuroplastic effect ([0055] & [0206]) except wherein said target area explicitly provides a physiologic activation of muscle
spindles and golgi tendon organs.
Gesotti teaches the claimed invention having systems and methods for treating movement disorders via providing electrical stimulation of Golgi tendon and muscle spindle afferents that affects muscle stretch reflex of the stimulated muscle [0030].
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the assembly and/or system used to provide a neuroplastic affect as taught by Strother et al. with specifically stimulating the Golgi tendon and muscle spindle afferents as taught by Gesotti since such a modification would provide the predictable results pertaining to effectively provide stimulation to a target area that affects the Golgi tendon and muscle spindle afferents [Gesotti, 0030].
4.
The electrical stimulation system of claim 3, wherein parameters of the electrical stimulation comprise 12 Hz, 20 mA and a pulse duration of 60 µs.
E.G. [Strother, 0068].
5.
The electrical stimulation system of claim 3, wherein a parameter of the electrical stimulation delivered through the electrode comprises a frequency of between 5 Hz and 25 Hz.
E.G. [Strother, 0068].
6.
The electrical stimulation system of claim 3, wherein a parameter of the electrical stimulation delivered through the electrode comprises a pulse duration of between 20 microseconds and 200 microseconds.
E.G. [Strother, 0068].
7.
The electrical stimulation system of claim 3, wherein a parameter of the electrical stimulation delivered through the electrode comprises an amplitude of between 0.1 mA and 20 mA.
E.G. [Strother, 0068].
8.
The electrical stimulation system of claim 3, wherein the electrode is formed from a de-insulated portion of the coiled lead and includes a coiled wire portion.
E.G. (Strother, [0152]-[0153]).
9.
a coiled lead; an electrode extending from a distal end of the coiled lead;
E.G. via the disclosed neurostimulation assemblies 10 and/or a system 54 that provide electrical connections between muscles and nerves inside the body coupled by a percutaneous lead 12 to electrodes 14 {Strother, [0013]-[0014], [0055] & (Figs. 1 & 19A)}.
and an electrical stimulator operatively connected with the coiled lead, wherein the electrical stimulator delivers electrical stimulation through the electrode to a nerve bundle to produce a stimulus evoked paresthesia in a target area providing physiologic activation of afferent input to a central nervous system of the patient to sustain functional reorganization of maladaptive neuroplastic changes in a central nervous system of a patient.
E.G. via the disclosed neurostimulation assembly/system 10/54 used to affect areas of the body and providing excitation and input to the brain, i.e. a neuroplastic effect, enabling the brain to re-learn and regain control of a lost function [Strother, 0206].
AND
E.G. via the disclosed systems and methods for treating movement disorders via providing electrical stimulation of Golgi tendon and muscle spindle afferents that affects muscle stretch reflex of the stimulated muscle [Gesotti, 0030].
Note: The examiner notes that the disclosed neurostimulation assembly 10 and/or system 54 is capable of performing the intended use of evoking paresthesia and muscle contraction in a target area to sustain functional reorganization of maladaptive neuroplastic changes in a central nervous system of a patient, as is instantly claimed.
Wherein the electrical stimulator is configured to be implanted into the patient.
E.G. {Strother, [0013]-[0014], [0055] & (Figs. 1 & 19A)}.
10.
The electrical stimulation system of claim 9, wherein the electrode is formed from the coiled lead.
E.G. {Strother, [0013]-[0014], [0055] & (Figs. 1 & 19A)}.
11.
The electrical stimulation system of claim 10, comprises an insulated covering and the electrode is free from the insulated covering.
E.G. (Strother, [0153]-[0154]).
12.
The electrical stimulation system of claim 10, wherein the electrode forms a distal anchor
E.G. {Strother, [0013]-[0014], [0055] & (Figs. 1 & 19A)}.
13.
An electrical stimulation system comprising: a coiled lead; an electrode extending from a distal end of the coiled lead,
E.G. via the disclosed neurostimulation assemblies 10 and/or a system 54 that provide electrical connections between muscles and nerves inside the body coupled by a percutaneous lead 12 to electrodes 14 {Strother, [0013]-[0014], [0055] & (Figs. 1 & 19A)}.
wherein the electrode is configured for placement at least one millimeter from a nerve bundle;
E.G. via the disclosed electrodes implanted in a target region(s) in order achieve desired therapeutic and/or functional objectives ([0054]-[0055]).
Note: The examiner notes that the disclosed electrodes implanted in a target tissue region(s) is capable of performing the intended use of being configured for placement at least one millimeter from nerve, as instantly claimed.
and an electrical stimulator operatively connected with the coiled lead, wherein the electrical stimulator delivers electrical stimulation through the electrode to the nerve bundle for selective recruitment of target nerve fibers within the nerve bundle to produce a stimulus evoked paresthesia in a target area providing physiologic activation of afferent input to a central nervous system of the patient to sustain functional reorganization of maladaptive neuroplastic changes in a central nervous system of a patient.
E.G. via the disclosed neurostimulation assembly/system 10/54 used to affect areas of the body and providing excitation and input to the brain, i.e. a neuroplastic effect, enabling the brain to re-learn and regain control of a lost function via selectively applying neurostimulation only to the target region (Strother, [0055] & [0206]).
AND
E.G. via the disclosed systems and methods for treating movement disorders via providing electrical stimulation of Golgi tendon and muscle spindle afferents that affects muscle stretch reflex of the stimulated muscle [Gesotti, 0030].
Note: The examiner notes that the disclosed neurostimulation assembly 10 and/or system 54 and the disclosed step of providing stimulation to the muscle spindle afferent as disclosed by Gesotti are capable of performing the intended use of selective recruitment of target nerve fibers within the nerve bundle to produce a stimulus evoked paresthesia in a target area providing physiologic activation of afferent input to a central nervous system of the patient to sustain functional reorganization of maladaptive neuroplastic changes in a central nervous system of a patient, as is instantly claimed.
14.
The electrical stimulation system of claim 13, wherein the target nerve fibers comprise la and lb afferent fibers.
E.G. via the disclosed systems and methods for treating movement disorders via providing electrical stimulation of Golgi tendon and muscle spindle afferents that affects muscle stretch reflex of the stimulated muscle [Goessti, 0030].
15.
The electrical stimulation system of claim 14, wherein the electrical avoids activation of nontargeted nerve fibers.
E.G. via the disclosed neurostimulation assembly selectively applies neurostimulation only to to the targeted region(s) [Strother, 0055].
16.
The electrical stimulation system of claim 15, wherein the nontargeted nerve fibers comprise type III and IV nerve fibers.
E.G. [Goessti, 0030].
17.
The electrical stimulation system of claim 13, wherein the electrical
stimulation comprises an amplitude in the range of about 0.9 to about 1.6 mA.
E.G. [Strother, 0068].
18.
An electrical stimulation system comprising: a coiled lead comprising an electrode extending from the coiled lead;
E.G. via the disclosed neurostimulation assemblies 10 and/or a system 54 that provide electrical connections between muscles and nerves inside the body coupled by a percutaneous lead 12 to electrodes 14 {Strother, [0013]-[0014], [0055] & (Figs. 1 & 19A)}.
an implantable electrical stimulator connected with the coiled lead, wherein the electrical stimulator delivers electrical stimulation through the electrode to a nerve bundle for
selective recruitment of target nerve fibers within the nerve bundle to produce a stimulus
evoked paresthesia in a target area providing physiologic activation of afferent input to a
central nervous system of the patient to sustain functional reorganization of maladaptive neuroplastic changes in a central nervous system of a patient.
E.G. via the disclosed neurostimulation assembly/system 10/54 used to affect areas of the body and providing excitation and input to the brain, i.e. a neuroplastic effect, enabling the brain to re-learn and regain control of a lost function via selectively applying neurostimulation only to the target region (Strother, [0055] & [0206]).
AND
E.G. via the disclosed systems and methods for treating movement disorders via providing electrical stimulation of Golgi tendon and muscle spindle afferents that affects muscle stretch reflex of the stimulated muscle [Gesotti, 0030].
Note: The examiner notes that the disclosed neurostimulation assembly 10 and/or system 54 and the disclosed step of providing stimulation to the muscle spindle afferent as disclosed by Gesotti are capable of performing the intended use of selective recruitment of target nerve fibers within the nerve bundle to produce a stimulus evoked paresthesia in a target area providing physiologic activation of afferent input to a central nervous system of the patient to sustain functional reorganization of maladaptive neuroplastic changes in a central nervous system of a patient, as is instantly claimed.
19.
The electrical stimulation system of claim 18, wherein parameters of the electrical stimulation comprise 12 Hz, 20 mA and a pulse duration of 60 µs.
E.G. [Strother, 0068].
20.
The electrical stimulation system of claim 18, wherein parameters of the electrical stimulation delivered through the electrode comprises a frequency of between 5 Hz and 25 Hz.
E.G. [Strother, 0068].
21.
The electrical stimulation system of claim 18, wherein a parameter of the electrical stimulation delivered through the electrode comprises a pulse duration of between 20 microseconds and 200 microseconds.
E.G. [Strother, 0068].
22.
The electrical stimulation system of claim 18, wherein a parameter of the electrical stimulation delivered through the electrode comprises an amplitude of between 0.1 mA and 20 mA.
E.G. [Strother, 0068].
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.
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/NICOLE F JOHNSON/ Primary Examiner, Art Unit 3796