DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS, see IDS filed 2/11/2026, have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this Office Action.
Drawings
The drawings are objected to because at least Figs. 2,5A and 6 are illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 28-29 and 49-50 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. Claim 28 recites "stimulation is applied over the spinal cord over at least two of T1-T12." However, claim 27 from which claim 28 depends states that "stimulation is applied over the spinal cord over at least three of C1-C7." Since T1- T12 are not in at least three of C1-C7 of the spinal cord, it is unclear if claim 28 provides stimulation which is additional to at least three of C1-C7, erroneously places T1-T12 in at least three of C1-C7, or was intended to depend from claim 25 instead of claim 27, such that
thoracic stimulation at T1-T12 would be provided as an alternative to cervical stimulation at least three of C1-C7, clarification is required. Claim 29 recites "stimulation is applied over the spinal cord over at least one of T1-T12." However, claim 27 from which claim 29 depends states that "stimulation is applied over the spinal cord over at least three of C1-C7." Since T1- T12 are not in at least three of C1-C7 of the spinal cord, it is unclear if claim 29 provides stimulation which is additional to at least three of C1-C7, erroneously places T1-T12 in at least three of C1-C7, or was intended to depend from claim 25 instead of claim 27, such that thoracic stimulation at T1-T12 would be provided as an alternative to cervical stimulation at least three of C1-C7, clarification is required. Claim 49 recites “wherein the one or more electrodes further comprise one or more array of one or more electrode.” Which is unclear how many electrodes are being claimed. The claim recites “one or more electrodes” which includes a single electrode or multiple electrodes and “one or more array of one or more electrode” which includes an array of electrodes which would include multiple electrodes, clarification is required. Further, when reciting “one or more array of one or more electrode” it is unclear how “one or more array” could include just one electrode? Clarification is required. Claim 50 recites “wherein the one or more electrodes further comprise one or more lead of one or more electrode.”, which is unclear how many electrodes and leads are being claimed. Does applicant mean that the one or more electrodes comprise one or more leads that include the one or more electrodes? Clarification 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 25-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11,13-22 and 25 of U.S. Patent No. 12,311,169. Although the claims at issue are not identical, they are not patentably distinct from each other because both the claims in the instant application and those within U.S. Patent No. 12,311,169 recite a method of facilitating locomotor activity for a subject having a spinal cord injury, an ischemic brain injury, or a neurodegenerative brain injury with almost identical method steps with the only difference being that the instant application recites the locomotor activity being movement of the arm, the mammal being a subject and improving movement of the arms. The entire scope of the claims in the instant application falls within the scope of the claims within U.S. Patent No. 12,311,169, see claim chart below and MPEP 804.
Instant Application
US Patent No. 12,311,169
Analysis
25. (New) A method of facilitating movement of the arms in a subject having a spinal cord injury, an ischemic brain injury, or a neurodegenerative brain injury, the method comprising: administering to the subject a transcutaneous electrical spinal cord stimulation (tSCS) through one or more electrodes applied to the skin of the mammal over a predetermined spinal section of the subject's spinal cord, at a frequency and intensity to activate spinal locomotor networks that facilitates the recovery or improved voluntary movement of the arms without directly activating muscle cells; wherein the transcutaneous electrical spinal cord stimulation enables or induces improved control of movement of the arms of the subject.
1. A method of facilitating locomotor activities in a mammal having a spinal cord injury, an ischemic brain injury, or a neurodegenerative brain injury, the method comprising: administering to the mammal a transcutaneous electrical spinal cord stimulation (tSCS) through an electrode applied to the skin of the mammal over a predetermined spinal section of the mammal's spinal cord, at a frequency and intensity to activate spinal locomotor networks that facilitates the recovery or improved control of the locomotor activities without directly activating muscle cells; wherein the transcutaneous electrical spinal cord stimulation enables or induces a locomotor pattern in the mammal.
2. The method of claim 1, wherein the mammal is a human.
17. The method of claim 1, wherein the locomotor activities comprise postural control, locomotion, voluntary movement of the arms, voluntary movement of the trunk, or voluntary movement of the legs.
Claim 25 in the instant application and claims 1,2 and 17 within U.S. Patent No. 12,311,169 recite a method of facilitating locomotor activity for a subject having a spinal cord injury, an ischemic brain injury, or a neurodegenerative brain injury with almost identical method steps with the only difference being that the instant application recites the locomotor activity being movement of the arm, the mammal being a subject and improving movement of the arms. The entire scope of the claim 25 in the instant application falls within the scope of the claims 1,2 and 17 within U.S. Patent No. 12,311,169.
26. (New) The method of claim 25, wherein the transcutaneous electrical spinal cord stimulation is under control of the subject.
3. The method of claim 2, wherein the transcutaneous electrical spinal cord stimulation is under control of the human.
See analysis above regarding claim 25 being anticipated by claim 2 of U.S. Patent No. 12,311,169. The limitations of claim 26 are fully disclosed within claim 3 of U.S. Patent No. 12,311,169.
27. (New) The method of claim 25, wherein the transcutaneous electrical spinal cord stimulation is applied over the spinal cord over at least three of C1-C7.
28. (New) The method of claim 27, wherein the transcutaneous electrical spinal cord stimulation is applied over the spinal cord over at least two of T1-T12.
29. (New) The method of claim 27, wherein the transcutaneous electrical spinal cord stimulation is applied over the spinal cord over at least one of T1-T12.
4. The method of claim 2, wherein the transcutaneous electrical spinal cord stimulation is applied over the spinal cord at C4-C5, T11-T12, or L1/L2 vertebrae.
See analysis above regarding claim 25 being anticipated by claim 2 of U.S. Patent No. 12,311,169. The limitations of claims 27-29 are fully disclosed within claim 4 of U.S. Patent No. 12,311,169.
30. (New) The method of claim 25, wherein the transcutaneous stimulation is applied at an intensity ranging from about 30 mA to 200 mA.
5. The method of claim 1, wherein the transcutaneous stimulation is applied at an intensity ranging from about 30 mA to 200 mA.
See analysis above regarding claim 25 being anticipated by claim 1 of U.S. Patent No. 12,311,169. The limitations of claim 30 are fully disclosed within claim 5 of U.S. Patent No. 12,311,169.
31. (New) The method of claim 25, wherein the transcutaneous stimulation is applied at a frequency ranging from about 3 Hz to about 100 Hz.
6. The method of claim 1, wherein the transcutaneous stimulation is applied at a frequency ranging from about 3 Hz to about 100 Hz.
See analysis above regarding claim 25 being anticipated by claim 1 of U.S. Patent No. 12,311,169. The limitations of claim 31 are fully disclosed within claim 6 of U.S. Patent No. 12,311,169.
32. (New) The method of claim 25, wherein the subject has a spinal cord injury.
7. The method of claim 1, wherein the mammal has a spinal cord injury.
See analysis above regarding claim 25 being anticipated by claim 1 of U.S. Patent No. 12,311,169. The limitations of claim 32 are fully disclosed within claim 7 of U.S. Patent No. 12,311,169.
33. (New) The method of claim 32, wherein the subject has a spinal cord injury that is clinically classified as motor complete.
8. The method of claim 7, wherein the mammal has a spinal cord injury that is clinically classified as motor complete.
See analysis above regarding claim 25 being anticipated by claim 1 of U.S. Patent No. 12,311,169. The limitations of claim 33 are fully disclosed within claim 8 of U.S. Patent No. 12,311,169.
34. (New) The method of claim 32, wherein the subject has a spinal cord injury that is clinically classified as motor incomplete.
9. The method of claim 7, wherein the mammal has a spinal cord injury that is clinically classified as motor incomplete.
See analysis above regarding claim 25 being anticipated by claim 1 of U.S. Patent No. 12,311,169. The limitations of claim 34 are fully disclosed within claim 9 of U.S. Patent No. 12,311,169.
35. (New) The method of claim 25, wherein the subject has an ischemic brain injury, brain injury from stroke, or acute trauma.
10. The method of claim 1, wherein the mammal has an ischemic brain injury, brain injury from stroke, or acute trauma.
See analysis above regarding claim 25 being anticipated by claim 1 of U.S. Patent No. 12,311,169. The limitations of claim 35 are fully disclosed within claim 10 of U.S. Patent No. 12,311,169.
36. (New) The method of claim 25, wherein the subject has a neurodegenerative brain injury associated with a condition selected from the group consisting of Parkinson's disease, Huntington's disease, Alzheimer's disease, ischemic stroke, amyotropic lateral sclerosis (ALS), primary lateral sclerosis (PLS), and cerebral palsy.
11. The method of claim 1, wherein the mammal has a neurodegenerative brain injury associated with a condition selected from the group consisting of Parkinson's disease, Huntington's disease, Alzheimer's disease, ischemic stroke, amyotropic lateral sclerosis (ALS), primary lateral sclerosis (PLS), and cerebral palsy.
See analysis above regarding claim 25 being anticipated by claim 1 of U.S. Patent No. 12,311,169. The limitations of claim 36 are fully disclosed within claim 11 of U.S. Patent No. 12,311,169.
37. (New) The method of claim 25, further comprises administration of one or more neuropharmaceuticals.
13. The method of claim 1, further comprises administration of one or more neuropharmaceuticals.
See analysis above regarding claim 25 being anticipated by claim 1 of U.S. Patent No. 12,311,169. The limitations of claim 37 are fully disclosed within claim 13 of U.S. Patent No. 12,311,169.
38. (New) The method of claim 37, wherein the one or more neuropharmaceuticals comprises one or more agents selected from the group consisting of a serotonergic drug, a dopaminergic drug, and a noradrenergic drug.
14. The method of claim 13, wherein the one or more neuropharmaceuticals comprises one or more agents selected from the group consisting of a serotonergic drug, a dopaminergic drug, and a noradrenergic drug.
See analysis above regarding claim 25 being anticipated by claim 1 of U.S. Patent No. 12,311,169. The limitations of claim 38 are fully disclosed within claim 14 of U.S. Patent No. 12,311,169.
39. (New) The method of claim 25, wherein the transcutaneous electrical spinal cord stimulation is superimposed on a carrier frequency that suppresses the sensitivity of pain receptors.
15. The method of claim 1, wherein the transcutaneous electrical spinal cord stimulation is superimposed on a carrier frequency that suppresses the sensitivity of pain receptors.
See analysis above regarding claim 25 being anticipated by claim 1 of U.S. Patent No. 12,311,169. The limitations of claim 39 are fully disclosed within claim 15 of U.S. Patent No. 12,311,169.
40. (New) The method of claim 39, wherein the carrier frequency is about 10 kHz.
16. The method of claim 15, wherein the carrier frequency is about 10 kHz.
See analysis above regarding claim 25 being anticipated by claim 1 of U.S. Patent No. 12,311,169. The limitations of claim 40 are fully disclosed within claim 16 of U.S. Patent No. 12,311,169.
41. (New) The method of claim 25, wherein the transcutaneous electrical spinal cord stimulation additionally facilitates at least one autonomic function.
18. The method of claim 1, wherein the transcutaneous electrical spinal cord stimulation additionally facilitates autonomic function, the autonomic function comprises sexual function, or vasomotor function.
See analysis above regarding claim 25 being anticipated by claim 1 of U.S. Patent No. 12,311,169. The limitations of claim 41 are fully disclosed within claim 18 of U.S. Patent No. 12,311,169.
42. (New) The method of claim 25, further comprises providing physical trainings to the subject.
19. The method of claim 1, further comprises providing physical trainings to the mammal.
See analysis above regarding claim 25 being anticipated by claim 1 of U.S. Patent No. 12,311,169. The limitations of claim 42 are fully disclosed within claim 19 of U.S. Patent No. 12,311,169.
43. (New) The method of claim 42, wherein the physical trainings generate at least one of proprioceptive signals or supraspinal signals.
20. The method of claim 19, wherein the physical trainings generate at least one of postural proprioceptive signals, locomotor proprioceptive signals, or supraspinal signals.
See analysis above regarding claim 25 being anticipated by claim 1 of U.S. Patent No. 12,311,169. The limitations of claim 43 are fully disclosed within claim 20 of U.S. Patent No. 12,311,169.
44. (New) The method of claim 43, wherein the transcutaneous electrical spinal cord stimulation enables or induces the locomotor pattern in response to the at least one of postural proprioceptive signals or supraspinal signals.
21. The method of claim 20, wherein the transcutaneous electrical spinal cord stimulation enables or induces the locomotor pattern in response to the at least one of postural proprioceptive signals, locomotor proprioceptive signals, or supraspinal signals.
See analysis above regarding claim 25 being anticipated by claim 1 of U.S. Patent No. 12,311,169. The limitations of claim 44 are fully disclosed within claim 21 of U.S. Patent No. 12,311,169.
45. (New) The method of claim 42, wherein the physical training comprises inducing a positional change in the arms of the subject.
22. The method of claim 19, wherein the physical training comprises inducing a load bearing positional change in the mammal.
See analysis above regarding claim 25 being anticipated by claim 1 of U.S. Patent No. 12,311,169. The limitations of claim 45 are fully disclosed within claim 22 of U.S. Patent No. 12,311,169.
46. (New) The method of claim 45, wherein the positional change comprises reaching.
17. The method of claim 1, wherein the locomotor activities comprise postural control, locomotion, voluntary movement of the arms, voluntary movement of the trunk, or voluntary movement of the legs.
See analysis above regarding claim 25 being anticipated by claim 1 of U.S. Patent No. 12,311,169. The limitations of claim 46 are fully disclosed within claim 17 of U.S. Patent No. 12,311,169.
47. (New) The method of claim 45, wherein the positional change comprises grasping.
17. The method of claim 1, wherein the locomotor activities comprise postural control, locomotion, voluntary movement of the arms, voluntary movement of the trunk, or voluntary movement of the legs.
See analysis above regarding claim 25 being anticipated by claim 1 of U.S. Patent No. 12,311,169. The limitations of claim 47 are fully disclosed within claim 17 of U.S. Patent No. 12,311,169.
48. (New) The method of claim 42, wherein the physical training comprises robotically guided training.
25. The method of claim 19, wherein the physical training comprises robotically guided training.
See analysis above regarding claim 25 being anticipated by claim 1 of U.S. Patent No. 12,311,169. The limitations of claim 48 are fully disclosed within claim 25 of U.S. Patent No. 12,311,169.
Claims 25,27-34,39-43 and 45-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-7,9-10,15-19,20-23 and 25-26 of U.S. Patent No. US Patent No. 12,722,002. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the instant application represent the method practiced by the patented system of US Patent No. 12,722,002. The method of the instant application necessarily utilizes every structure and function claimed within the patented system of US Patent No. 12,722,002. The patented system practices the method of the instant application and no other. The separation of system from method does not arise from a restriction requirement in the earlier filed application, and nothing would have prevented applicant from filing the instant method claims concurrently with the patented system such that the singular invention would reside in a single patent, see claim chart below and MPEP 804.
Instant Application
US Patent No. 12,722,002
Analysis
25. (New) A method of facilitating movement of the arms in a subject having a spinal cord injury, an ischemic brain injury, or a neurodegenerative brain injury, the method comprising: administering to the subject a transcutaneous electrical spinal cord stimulation (tSCS) through one or more electrodes applied to the skin of the mammal over a predetermined spinal section of the subject's spinal cord, at a frequency and intensity to activate spinal locomotor networks that facilitates the recovery or improved voluntary movement of the arms without directly activating muscle cells; wherein the transcutaneous electrical spinal cord stimulation enables or induces improved control of movement of the arms of the subject.
1. A system for stimulation of the spinal cord to improve and restore upper extremity motor function in a subject having paralysis due to a spinal cord injury, the system comprising: a multichannel stimulation generator; an electrode array connectable to the stimulation generator and comprising a plurality of electrodes configured to be applied to the skin of the subject over a predetermined spinal section of the subject's spinal cord; wherein the stimulation generator comprises control circuitry configured to administer to the subject a transcutaneous electrical spinal cord stimulation (tSCS) through one or more electrodes of the electrode array at a frequency and intensity to activate spinal locomotor networks that facilitates the recovery or improved voluntary movement of the arms without directly activating muscle cells; wherein the transcutaneous electrical spinal cord stimulation enables or induces improved control of movement of the upper limbs of the subject.
Claim 25 in the instant application represent the method practiced by the system of claim 1 of US Patent No. 12,722,002. The method of the instant application necessarily utilizes every structure and function claimed within the patented system of US Patent No. 12,722,002. The patented system practices the method of the instant application and no other. The separation of system from method does not arise from a restriction requirement in the earlier filed application, and nothing would have prevented applicant from filing the instant method claims concurrently with the patented system such that the singular invention would reside in a single patent.
27. (New) The method of claim 25, wherein the transcutaneous electrical spinal cord stimulation is applied over the spinal cord over at least three of C1-C7.
3. The system of claim 1, wherein the transcutaneous electrical spinal cord stimulation is applied over the spinal cord over the cervical portion of the spinal cord.
4. The system of claim 3, wherein the transcutaneous electrical spinal cord stimulation is applied over the spinal cord over one or more of C1-C7.
See analysis above regarding claim 25 unpatentable over claim 1 of U.S. Patent No. 12,722,002. The limitations of claims 27 are fully disclosed within claims 3 and 4 of U.S. Patent No. 12,722,002.
28. (New) The method of claim 27, wherein the transcutaneous electrical spinal cord stimulation is applied over the spinal cord over at least two of T1-T12.
29. (New) The method of claim 27, wherein the transcutaneous electrical spinal cord stimulation is applied over the spinal cord over at least one of T1-T12.
5. The system of claim 1, wherein the transcutaneous electrical spinal cord stimulation is applied over the spinal cord over at least one of T1-T12.
See analysis above regarding claim 25 being unpatentable over claim 1 of U.S. Patent No. 12,722,002. The limitations of claims 28 and 29 are fully disclosed within claim 5 of U.S. Patent No. 12,722,002.
30. (New) The method of claim 25, wherein the transcutaneous stimulation is applied at an intensity ranging from about 30 mA to 200 mA.
6. The system of claim 1, wherein the transcutaneous stimulation is applied at an intensity ranging from about 30 mA to 200 mA.
See analysis above regarding claim 25 being unpatentable over claim 1 of U.S. Patent No. 12,722,002. The limitations of claim 30 are fully disclosed within claim 6 of U.S. Patent No. 12,722,002.
31. (New) The method of claim 25, wherein the transcutaneous stimulation is applied at a frequency ranging from about 3 Hz to about 100 Hz.
7. The system of claim 1, wherein the transcutaneous stimulation is applied at a frequency ranging from about 3 Hz to about 100 Hz.
See analysis above regarding claim 25 being unpatentable over claim 1 of U.S. Patent No. 12,722,002. The limitations of claim 31 are fully disclosed within claim 7 of U.S. Patent No. 12,722,002.
32. (New) The method of claim 25, wherein the subject has a spinal cord injury.
9. The system of claim 1, wherein the subject has a spinal cord injury that is clinically classified as motor complete.
10. The system of claim 1, wherein the subject has a spinal cord injury that is clinically classified as motor incomplete.
See analysis above regarding claim 25 being unpatentable over claim 1 of U.S. Patent No. 12,722,002. The limitations of claim 32 are fully disclosed within claims 9 and 10 of U.S. Patent No. 12,722,002.
33. (New) The method of claim 32, wherein the subject has a spinal cord injury that is clinically classified as motor complete.
9. The system of claim 1, wherein the subject has a spinal cord injury that is clinically classified as motor complete.
.
See analysis above regarding claim 25 being unpatentable over claim 1 of U.S. Patent No. 12,722,002. The limitations of claim 33 are fully disclosed within claim 9 of U.S. Patent No. 12,722,002.
34. (New) The method of claim 32, wherein the subject has a spinal cord injury that is clinically classified as motor incomplete.
10. The system of claim 1, wherein the subject has a spinal cord injury that is clinically classified as motor incomplete.
See analysis above regarding claim 25 being unpatentable over claim 1 of U.S. Patent No. 12,722,002. The limitations of claim 34 are fully disclosed within claim 10 of U.S. Patent No. 12,722,002.
39. (New) The method of claim 25, wherein the transcutaneous electrical spinal cord stimulation is superimposed on a carrier frequency that suppresses the sensitivity of pain receptors.
15. The system of claim 1, wherein the transcutaneous electrical spinal cord stimulation is superimposed on a carrier frequency that suppresses the sensitivity of pain receptors.
See analysis above regarding claim 25 being unpatentable over claim 1 of U.S. Patent No. 12,722,002. The limitations of claim 39 are fully disclosed within claim 15 of U.S. Patent No. 12,722,002.
40. (New) The method of claim 39, wherein the carrier frequency is about 10 kHz.
16. The system of claim 15, wherein the carrier frequency is about 10 kHz.
See analysis above regarding claim 25 being unpatentable over claim 1 of U.S. Patent No. 12,722,002. The limitations of claim 40 are fully disclosed within claim 16 of U.S. Patent No. 12,722,002.
41. (New) The method of claim 25, wherein the transcutaneous electrical spinal cord stimulation additionally facilitates at least one autonomic function.
17. The system of claim 1, wherein the transcutaneous electrical spinal cord stimulation additionally facilitates autonomic function.
See analysis above regarding claim 25 being unpatentable over claim 1 of U.S. Patent No. 12,722,002. The limitations of claim 41 are fully disclosed within claim 17 of U.S. Patent No. 12,722,002.
42. (New) The method of claim 25, further comprises providing physical trainings to the subject.
18. A method for treating a subject having paralysis due to a spinal cord injury, the method comprising: applying stimulation of the spinal cord using the system of claim 1; and providing physical trainings to the subject.
See analysis above regarding claim 25 being unpatentable over claim 1 of U.S. Patent No. 12,722,002. The limitations of claim 42 are fully disclosed within claim 18 of U.S. Patent No. 12,722,002.
43. (New) The method of claim 42, wherein the physical trainings generate at least one of proprioceptive signals or supraspinal signals.
19. The method of claim 18, wherein the physical trainings generate at least one of proprioceptive signals or supraspinal signals.
See analysis above regarding claim 25 being unpatentable over claim 1 of U.S. Patent No. 12,722,002. The limitations of claim 43 are fully disclosed within claim 19 of U.S. Patent No. 12,722,002.
45. (New) The method of claim 42, wherein the physical training comprises inducing a positional change in the arms of the subject.
21. The method of claim 18, wherein the physical training comprises inducing a positional change in the arms of the subject.
See analysis above regarding claim 25 being unpatentable over claim 1 of U.S. Patent No. 12,722,002. The limitations of claim 45 are fully disclosed within claim 21 of U.S. Patent No. 12,722,002.
46. (New) The method of claim 45, wherein the positional change comprises reaching.
22. The method of claim 21, wherein the positional change comprises reaching.
See analysis above regarding claim 25 being unpatentable over claim 1 of U.S. Patent No. 12,722,002. The limitations of claim 46 are fully disclosed within claim 22 of U.S. Patent No. 12,722,002.
47. (New) The method of claim 45, wherein the positional change comprises grasping.
23. The method of claim 21, wherein the positional change comprises grasping.
. See analysis above regarding claim 25 being unpatentable over claim 1 of U.S. Patent No. 12,722,002. The limitations of claim 47 are fully disclosed within claim 23 of U.S. Patent No. 12,722,002.
48. (New) The method of claim 42, wherein the physical training comprises robotically guided training.
20. The method of claim 18, wherein the physical training comprises robotically guided training.
See analysis above regarding claim 25 being unpatentable over claim 1 of U.S. Patent No. 12,722,002. The limitations of claim 48 are fully disclosed within claim 20 of U.S. Patent No. 12,722,002.
49. (New) The method of claim 25, wherein the one or more electrodes further comprise one or more array of one or more electrode.
1. A system for stimulation of the spinal cord to improve and restore upper extremity motor function in a subject having paralysis due to a spinal cord injury, the system comprising: a multichannel stimulation generator; an electrode array connectable to the stimulation generator and comprising a plurality of electrodes configured to be applied to the skin of the subject over a predetermined spinal section of the subject's spinal cord; wherein the stimulation generator comprises control circuitry configured to administer to the subject a transcutaneous electrical spinal cord stimulation (tSCS) through one or more electrodes of the electrode array….
25. The system of claim 1, further comprising a plurality of electrode arrays.
See analysis above regarding claim 25 being unpatentable over claim 1 of U.S. Patent No. 12,722,002. The limitations of claim 49 are fully disclosed within claims 1 and 25 of U.S. Patent No. 12,722,002.
50. (New) The method of claim 25, wherein the one or more electrodes further comprise one or more lead of one or more electrode.
26. The system of claim 1, wherein the electrode array comprises one or more lead of one or more electrodes.
See analysis above regarding claim 25 being unpatentable over claim 1 of U.S. Patent No. 12,722,002. The limitations of claim 50 are fully disclosed within claim 26 of U.S. Patent No. 12,722,002.
Conclusion
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/JENNIFER L GHAND/Examiner, Art Unit 3796
