DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of Claims
Claims 1-44 are pending and under consideration for patentability; claim 1 was amended and claims 2-44 were added as new claims via a Preliminary Amendment dated 17 April 2026.
Information Disclosure Statement
The Information Disclosure Statements submitted on 23 January 2025, 14 March 2025, and 26 January 2026 (2) have been acknowledged and considered by the Examiner.
Applicant should note that the large number of references in the attached IDS have been considered by the Examiner in the same manner as other documents in Office search files are considered while conducting a search of prior art. See MPEP 609.05(b). Applicant is requested to direct the Examiner to any references in the IDS which may be of particular relevance to the presently claimed invention in response to this Office Action.
Claim Objections
Applicant is advised that should claims 2-15 be found allowable, claims 25-38 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "506" and "508" have both been used to designate the same element in figure 5A. 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. 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.
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 1-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,201,833 B2 in view of Tanrisever (US 2007/0055337 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a neuromodulation system comprising a processor, a signal generator, and a plurality of electrodes configured to deliver transcutaneous spinal cord stimulation to a user, including a specific configuration of the placement of the electrodes on the user.
Regarding independent claims 1, 17, 24, and 39, specifically the limitations of “at least one ground electrode” or “a return electrode” as recited in the pending claims, although the ‘833 patent does not explicitly recite a ground or return electrode, the use of a ground or return electrode is nonetheless obviated by the Tanrisever reference, which specifically describes a neuromodulation system comprising a processor, a signal generator, and a plurality of electrodes including at least one ground or return electrode configured to deliver transcutaneous stimulation to a user (Abstract, [0032], [0034]). As Tanrisever is also directed towards applying stimulation to a user, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a ground or return electrode as described by Tanrisever when using the neuromodulation system recited in the ‘833 patent, as doing so advantageously allows the resulting system to better control the stimulation currents provided to the user.
A brief, but non-exhaustive matching of the pending claims and the issued claims is provided via the table below. The Examiner has expanded upon the matching for pending independent claim 1, for clarification.
U.S. Application No. 19/032,905
Pending Claims
U.S. Patent No. 12,201,833 B2
Issued Claims
1.
A neuromodulation system comprising:
a processor;
a signal generator communicatively coupled to the processor; and
a plurality of electrodes communicatively coupled to the signal generator, the plurality of electrodes comprising at least:
a first electrode,
a second electrode,
a third electrode, and
at least one ground electrode;
wherein the processor in cooperation with the signal generator, the first electrode, the second electrode, the third electrode, and the at least one ground electrode are configured to deliver a transcutaneous spinal cord stimulation to a user having a spinal cord injury, the transcutaneous spinal cord stimulation configured by the processor for inducing voluntary movement in upper limbs of the user,
wherein the first electrode, the second electrode and the third electrode are positioned transcutaneously on a neck of the user and at least one electrode is positioned below the spinal cord injury,
wherein the first electrode is positioned transcutaneously over a cervical portion of a spinal cord of the user,
wherein the second electrode and the third electrode are placed higher on the neck than the first electrode, and laterally offset on either side of the first electrode, on or over at least one of the spinal cord and/or spinal cord dorsal roots, a muscle, or a nerve
1.
A neuromodulation system comprising:
a processor;
a signal generator communicatively coupled to the processor; and
a plurality of electrodes communicatively coupled to the signal generator, the plurality of electrodes comprising at least:
a first electrode,
a second electrode, and
a third electrode,
wherein the processor in cooperation with the signal generator, the first electrode, the second electrode, and the third electrode are configured to deliver a transcutaneous spinal cord stimulation to a user having a spinal cord injury, the transcutaneous spinal cord stimulation configured by the processor for inducing voluntary movement in the user,
wherein the first electrode, the second electrode, and the third electrode are positioned transcutaneously on the user's neck, at least one electrode positioned below the spinal cord injury,
wherein the first electrode is positioned over a cervical portion of the user's spinal cord, and
wherein the second electrode and the third electrode are placed higher on the neck than the first electrode, and laterally offset on either side of the first electrode, on or over at least one of the spinal cord and/or the spinal cord dorsal roots, a muscle, or a nerve.
2
2
3
3
4
4
5
5
6
6
7
7
8
8
9
9
10
10
11
11
12
12
13
13
14
14
15
15
16
* please see note below
17
1, 2
18
3
19
4
20
12
21
13
22
14
23
* please see note below
24
1
25
2
26
3
27
4
28
5
29
6
30
7
31
8
32
9
33
10
34
11
35
12
36
13
37
14
38
15
39
1, 2
40
3
41
4
42
12
43
13
44
14
Regarding claims 16 and 23, Tanrisever further describes wherein the ground electrode is positioned in a pelvic region of the user ([0032], [0134]).
Allowable Subject Matter
Claims 1-44 would be allowable if the double patenting rejections and the claim objections noted above were overcome.
The following is a statement of reasons for the indication of allowable subject matter.
The prior art of record does not disclose or suggest a neuromodulation system comprising four electrodes positioned as recited, configured to provide transcutaneous spinal cord stimulation to a user’s cervical region, wherein the stimulation induces voluntary movement in the user. Specifically, the claims recite “wherein the first electrode, the second electrode, and the third electrode are positioned transcutaneously on a neck of the user and at least one electrode is positioned below the spinal cord injury, wherein the first electrode is positioned transcutaneously over a cervical portion of a spinal cord of the user, wherein the second electrode and the third electrode are placed higher on the neck than the first electrode, and laterally offset on either side of the first electrode, on or over at least one of the spinal cord and/or spinal cord dorsal roots, a muscle, or a nerve.” The Examiner borrows the language of independent claim 1 above and respectfully submits that independent claims 17, 24, and 39 recite similar limitations. Applicants previously have described the advantageous properties that result from such an arrangement, for example to “restore movement by ensuring electrical stimulation propagates through damaged spinal cord dorsal roots, muscles, or nerves” (Application No. 18/142,318, Arguments dated 17 July 2024, p. 8).
Analogous prior art includes Palermo et al. (US 2008/0208287 A1) and Lurie et al. (US 2002/0188332 A1).
Palermo describes a neuromodulation system comprising a processor, a signal generator communicatively coupled to the processor ([0018]), and a plurality of electrodes communicatively coupled to the signal generator ([0095]), comprising at least a first electrode, a second electrode, and a third electrode (18a, 18b, 20a, 20b). Palermo further describes wherein the processor, in cooperation with the signal generator, the first electrode, the second electrode, and the third electrode, is configured to deliver a transcutaneous spinal cord stimulation to a user having a spinal cord injury ([0099]), the transcutaneous spinal cord stimulation configured by the processor for inducing voluntary movement in upper limbs of the user ([0012], [0342], [0345]), wherein the first electrode is positioned transcutaneously over a spinal cord ([0220]), and wherein the second and third electrodes are placed on or over at least one of the spinal cord and/or the spinal cord dorsal roots, a muscle, or a nerve ([0220]). However, Palermo does not disclose or suggest “wherein the first electrode, the second electrode, and the third electrode are positioned transcutaneously on a neck of the user and at least one electrode is positioned below the spinal cord injury, wherein the first electrode is positioned transcutaneously over a cervical portion of a spinal cord of the user, wherein the second electrode and the third electrode are placed higher on the neck than the first electrode, and laterally offset on either side of the first electrode,” as recited. Nor does Palermo describe the advantageous properties that would result from such an arrangement.
Lurie also describes a neuromodulation system, including a plurality of electrodes configured to be positioned around the neck of a user and direct transcutaneous stimulation through the user’s neck ([0022]: “transcutaneous phrenic nerve stimulation with a collar-like device placed around the neck which includes one or more electrodes located on both anterior and posterior surfaces to stimulate the phrenic nerve”). However, even though Lurie’s electrodes are placed around the neck, including on both the anterior and posterior surfaces, Lurie does not disclose or suggest the configuration of “wherein the first electrode is positioned transcutaneously over a cervical portion of a spinal cord of the user, wherein the second electrode and the third electrode are placed higher on the neck than the first electrode, and laterally offset on either side of the first electrode,” in order to provide stimulation both above and below the site of spinal cord injury.
The Examiner respectfully submits that, due to the specificity of the positioning of the electrodes as recited, as well as the advantageous properties resulting from such a positioning, the prior art of record does not disclose or suggest the configuration recited in the pending claims.
For the sake of completeness, the Examiner also notes that the prior art of record does not disclose or suggest delivering the transcutaneous stimulation over multiple time periods such that “during a first time period, the transcutaneous stimulation is applied to the user during physical conditioning of the user; during a second time period after the first time period, the transcutaneous stimulation is applied to the user during reduced or no physical conditioning of the user; and during a third time period after the second time period, the transcutaneous stimulation is applied to the user during the physical conditioning of the user, wherein the transcutaneous stimulation applied during the first time period is used to establish a functional baseline of the user” as recited in claims 15 and 38.
Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 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, Niketa Patel, can be reached by telephone at 571-272-4156. 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 at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3796
