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 .
Election/Restrictions
Applicant’s election without traverse of Invention II (Claims 10-20) in the reply filed on 6/29/2026 is acknowledged.
Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/29/2026.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 12 is rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 12 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 12, in the last 2 lines, recites “one or more stimulating electrodes positioned within the ventral space of the spinal column. Thus, the claim include a human within the scope and are non-statutory. The examiner suggests using the phrase "adapted to be located" or “configured to be” when referring to the location of the one or more electrodes in relation to the ventral space of the spinal column.
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.
Claim 10-20 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 10 recites the limitation "”the spinal cord”" in line 15. There is insufficient antecedent basis for this limitation in the claim. The examiner assumes this should be a spinal cord. Dependent claims inherit the same deficiencies.
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.
Claim(s) 10 and 12-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weber et al (US Publication 2013/0253299).
Referring to Claim 10, Weber et al teaches a system comprising: one or more sensing elements configured to record one or more physiological signals from a subject (e.g. Paragraphs [0003], [0037], [0040] and [0099] and Figures 1, 4, and 9A); a signal generator configured to produce at least one electrical signal (e.g. Paragraphs [0003], [0037] (pulse generator), [0040], Figures 1, 4 and 9A, “effector/stimulator”); one or more stimulating electrodes configured to be positioned within a ventral space of a spinal column of the subject and in electrical communication with the signal generator (e.g. Paragraph [0037] discloses microelectrode array); a controller (e.g. Paragraph [0037] discloses controller/processor) connected to the one or more sensing elements and to the signal generator and comprising: a non-transitory memory configured to store instructions (e.g. Paragraph [0037] necessarily has a memory to control the operations), and a processor configured to execute the instructions to at least: receive a signal comprising at least one recorded physiological signal from at least one of the one or more sensing elements (e.g. Paragraphs [0058-0061] and Figures 1, 4, and 9A); configure at least one electrical signal to stimulate at least one motor fiber in a descending tract of the spinal cord of the subject based on the at least one recorded physiological signal (e.g. Paragraphs [0037], [0050], and [0058-0061] and Figures 1, 4, and 9A); send the at least one electrical signal to the signal generator to be applied through at least one of the one or more stimulating electrodes, wherein the at least one of the one or more stimulating electrodes are configured to apply the at least one electrical signal to the at least one motor fiber to at least partially restore a motor function of the subject (e.g. Paragraphs [0037], [0050], and [0058-0061] and Figures 1, 4, and 9A).
Referring to Claim 12, Weber et al teaches the system of claim 10, further comprising one or more other stimulating electrodes configured to be positioned in a dorsal space of the spinal column and used in conjunction with the one or more stimulating electrodes positioned within the ventral space of the spinal column (e.g. Paragraph [0037] discloses microelectrode array).
Referring to Claim 13, Weber et al teaches the system of claim 12, wherein the one or more other stimulating electrodes are activated to apply at least one other electrical signal in a pattern with the one or more stimulating electrodes (e.g. Paragraph [0029] discloses varying the electrical current pattern applied to the multiple electrodes).
Referring to Claim 14, Weber et al teaches the system of claim 10, wherein the one or more stimulating electrodes are configured to be positioned at one or more levels of the spinal column and/or spinal cord (e.g. Paragraphs [0058-0061]).
Referring to Claim 15, Weber et al teaches the system of claim 14, wherein the one or more stimulating electrodes are configured to be positioned on at least one cervical level, at least one thoracic level, and/or at least one lumbar level of the spinal column and/or spinal cord (e.g. Paragraphs [0058-0061]).
Referring to Claim 16, Weber et al teaches the system of claim 14, wherein the one or more stimulating electrodes are configured to be positioned within the ventral portion of the spinal column based on a portion of the body affected by a stroke and/or spinal cord injury limiting the motor function of the subject (e.g. Paragraphs [0050-0051], [0060], and [0064]).
Referring to Claim 17, Weber et al teaches the system of claim 10, wherein the subject is affected by stroke and/or spinal cord injury (e.g. Paragraphs [0050-0051], [0060], and [0064]).
Referring to Claim 18, Weber et al teaches the system of claim 10, wherein the one or more sensing elements comprise at least one electrode configured to be placed proximal to, on, and/or within at least one nerve and/or at least one muscle fiber (e.g. Paragraphs [0003], [0037], [0040] and [0099] and Figures 1, 4, and 9A).
Referring to Claim 19, Weber et al teaches the system of claim 10, wherein the one or more physiological signals comprise evoked compound action potentials and/or muscle force recordings (e.g. Paragraphs [0023] and [0115] and Figures 12A-12B).
Referring to Claim 20, Weber et al teaches the system of claim 10, wherein the one or more stimulating electrodes are configured to be positioned at a thoracic level to effect motor function in a lower body of the subject and wherein the one or more stimulating electrodes are configured to be positioned at a cervical level to effect motor function in one or more upper limbs of the subject (e.g. Paragraphs [0059-0060] discloses monitoring cervical and stimulation in the thoracic).
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) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weber et al (US Publication 2013/0253299) in view of Dinsmoor (US Publication 2023/0047655).
Referring to Claim 11, Weber et al teaches the system of claim 10, further comprising a user interface connected to the controller (e.g. Figures 1 and 4 and Paragraph [0007]). However, Weber et al does not explicitly disclose wherein the user interface is configured to receive an input comprising a trigger to begin or to end electrical stimulation.
Dinsmoor teaches that it is known to use a user interface with input for starting or stopping of SCS therapy delivery as set forth in Paragraph [0105] to provide improved patient safety by enabling the patient to stop stimulation when treatment causes unacceptable pain. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Weber et al, with a user interface with input for starting or stopping of SCS therapy delivery as taught by Dinsmoor, since such a modification would provide the predictable results of improved patient safety by enabling the patient to stop stimulation when treatment causes unacceptable pain.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Parker et al (US Publication 2026/0183543) discloses a closed-loop spinal cord stimulator which measures movement.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM 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.
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/William J Levicky/Primary Examiner, Art Unit 3796
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