DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it does not provide a concise description of the invention presently claimed. The current abstract describes different embodiments of a non-invasive method to induce locomotor activity through tSCS. However, the pending claims 25-50 relate entirely to a system that improves or restores upper extremity motor function through spinal cord stimulation.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 29, 42, 43, and 45-48 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.
Regarding claim 29, the claim states that “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 cervical portion of the spinal cord.” Since T1-T12 are not in the cervical portion of the spinal cord, it is unclear if claim 29 provides stimulation which is additional to cervical stimulation, erroneously places T1-T12 in the cervical region, 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.
Regarding claims 42, 43, and 45-48, the instant disclosure describes physical training as a supplemental physical action taken by the user such as “standing, stepping, sitting down, laying down, reaching, grasping, stabilizing sitting posture, and/or stabilizing standing posture”; or in other embodiments “swallowing, chewing, grimacing, shoulder shrugging, and the like” (e.g., paragraph [0014]). Although such physical action is taken in parallel with the stimulation function of the claimed system, it appears to be disclosed as an action made by the user, not a step or feature of the system itself. In contrast, claim 42 states that the system comprises providing physical trainings to the user. This recitation is ambiguous because it is unclear how the system would comprise an method step untethered from its structure, such as the control circuitry. Even if it were claimed such that the control circuitry were configured to provide physical trainings, it would be unclear how control circuitry would provide something which is disclosed as being enacted as a physiological movement of the user (i.e., it is the user, not the system or the method, who reaches, grasps, swallows, or shrugs a shoulder). It is therefore unclear what is being claimed, and whether the scope of the invention includes the user since it is the user effecting the physical training actions.
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.
Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of U.S. Patent No. 12,311,169 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims represent the system necessary to practice the method of the ‘169 patent. More specifically, the limitations of instant independent claim 25 relate to the limitations of patented claims 1 and 17 as follows:
12,311,169 claims 1 and 17
Instant claim 25
of facilitating locomotor activities [wherein facilitating “voluntary movement of the arms” as presented in claim 17 reasonably reads on “improve and restore upper extremity motor function” as now claimed, since the upper extremity is the arm]
for stimulation of the spinal cord to improve and restore upper extremity motor function
in a mammal having a spinal cord injury, an ischemic brain injury, or a neurodegenerative brain injury
in a subject having paralysis due to a spinal cord injury
administering to the mammal a transcutaneous electrical spinal cord stimulation (tSCS)
the stimulation generator comprises control circuitry configured to administer to the subject a transcutaneous electrical spinal cord stimulation (tSCS)
through an electrode
an electrode array connectable to the stimulation generator and comprising a plurality of electrodes; through one or more electrodes of the electrode array
applied to the skin of the mammal
configured to be applied to the skin of the subject
over a predetermined spinal section of the mammal's spinal cord
over a predetermined spinal section of the subject's spinal cord
at a frequency and intensity to activate spinal locomotor networks
at a frequency and intensity to activate spinal locomotor networks
that facilitates the recovery or improved control of the locomotor activities
that facilitates the recovery or improved voluntary movement of the arms
without directly activating muscle cells
without directly activating muscle cells
wherein the transcutaneous electrical spinal cord stimulation enables or induces a locomotor pattern in the mammal [as further limited in claim 17, the locomotor pattern reasonably reads on the improved control of movement of the upper limbs as now claimed]
wherein the transcutaneous electrical spinal cord stimulation enables or induces improved control of movement of the upper limbs of the subject
(17) wherein the locomotor activities comprise postural control, locomotion, voluntary movement of the arms, voluntary movement of the trunk, or voluntary movement of the legs.
As so outlined, the patented method necessarily utilizes every structure and function now claimed. The instant system practices the patented method 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 system claims concurrently with the patented method claims such that the singular invention would reside in a single patent.
Claims 25, 27-31, 33-35, 39-43, and 45-50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-50 of copending Application No. 19/,214,843 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims represent the system necessary to practice the method of 19/214,843. More specifically, the limitations of instant independent claim 25 relate to the limitations of claim 25 in the copending application as follows:
Claim 25 of copending 19/214,843
Instant claim 25
of facilitating movement of the arms [wherein “facilitating movement of the arms” reasonably reads on “improve and restore upper extremity motor function” as presently claimed, since the upper extremity is the arm]
for stimulation of the spinal cord to improve and restore upper extremity motor function
in a subject having a spinal cord injury, an ischemic brain injury, or a neurodegenerative brain injury [further limited exclusively to spinal cord injury in claim 32]
in a subject having paralysis due to a spinal cord injury
administering to the subject a transcutaneous electrical spinal cord stimulation (tSCS)
the stimulation generator comprises control circuitry configured to administer to the subject a transcutaneous electrical spinal cord stimulation (tSCS)
through one or more electrodes
an electrode array connectable to the stimulation generator and comprising a plurality of electrodes; through one or more electrodes of the electrode array
applied to the skin of the mammal
configured to be applied to the skin of the subject
over a predetermined spinal section of the subject’s spinal cord
over a predetermined spinal section of the subject's spinal cord
at a frequency and intensity to activate spinal locomotor networks
at a frequency and intensity to activate spinal locomotor networks
that facilitates the recovery or improved voluntary movement of the arms
that facilitates the recovery or improved voluntary movement of the arms
without directly activating muscle cells
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 [where in the arm is reasonably understood to be the upper limb]
wherein the transcutaneous electrical spinal cord stimulation enables or induces improved control of movement of the upper limbs of the subject
As so outlined, the method of copending application 19/214,843 necessarily utilizes every structure and function now claimed. The instant system practices the copending method and no other. The separation of system from method does not arise from a restriction requirement in either application, and nothing would have prevented applicant from filing the instant system claims concurrently with the copending method claims such that the singular invention would reside in a single patent.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant claims 27-28 relate to copending claim 27.
Instant claim 29 relates to copending claims 28-29.
Instant claim 30 relates to copending claim 30.
Instant claim 31 relates to copending claim 31.
Instant claim 33 relates to copending claim 33.
Instant claim 34 relates to copending claim 34.
Regarding instant claim 35, the method of copending application 19/214,843 necessarily utilizes a return electrode (see, e.g., paragraphs [0022], [0023], and [0061] of PG-Pub 2025/0281741 A1).
Instant claim 39 relates to copending claim 39.
Instant claim 40 relates to copending claim 40.
Instant claim 41 relates to copending claim 41.
Instant claim 42 relates to copending claim 42.
Instant claim 43 relates to copending claim 43.
Instant claim 45 relates to copending claim 45.
Instant claim 46 relates to copending claim 46.
Instant claim 47 relates to copending claim 47.
Instant claim 48 relates to copending claim 48.
Instant claim 49 relates to copending claim 49.
Instant claim 50 relates to copending claim 50.
Claims 26, 32, and 36-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-50 of copending Application No. 19/214,843 in view of Simon et al. (US 2012/0185020 A1, hereinafter Simon’020) or Bennett et al. (US 2012/0310302 A1, hereinafter Bennett’302).
Regarding claim 26, Application No. 19/214,843 does not expressly claim wherein stimulation is adjustable for each electrode for at least one of waveform, amplitude, frequency, pulse width, phase or polarity. Bennett’302 teaches that it is known to selectively vary every one of these variables in neural stimulation methods and systems to provide a stimulation pattern that is responsive to sensed feedback and that can approximate or identically mimic the analyzed pattern or alternatively provide a random or pseudo-random stimulation pattern that mimics natural afferent activity (e.g., paragraph [0057]). Simon’020 teaches that it is known to have selectable stimulation variables in order to influence the therapeutic result, namely, stimulating, blocking and/or modulating some or all of the transmission of the selected nerve (e.g., paragraph [0076]) and also to provide individualized treatment (e.g., paragraph [0117]).
Regarding claim 32, Application No. 19/214,843 does not expressly claim wherein the stimulation generator has a portable form factor. Simon’020 teaches that wearable (i.e., portable) stimulators have been around since at least 1957 and are well known in the art (e.g., paragraphs [0004], [0110]) in order to provide compact, portable, and simple to operate systems (e.g., paragraph [0083]). Further, simply making a device portable or movable is not sufficient by itself to patentably distinguish over another device unless there are new or unexpected results. In re Lindberg, 194 F.2d 732, 93 USPQ 23 (CCPA 1952); see MPEP 2144.04.
Regarding claims 36-38, Application No. 19/214,843 does not expressly claim the stimulator receiving instructions from a programmer including control parameters downloaded from a remote site. Bennett’302 teaches that control of the stimulator and/or stimulation parameters may be provided by one or more external controllers such as a clinical programmer, which may be a remote unit (e.g., paragraph [0067]) wherein control signals would be downloaded via wireless telemetry. Simon’020 also teaches that it is known to utilize external devices such as keyboards on a remote computer to input control instructions for the stimulator unit and to view results on the remote system’s monitor, direct results to a printer, etc. (e.g. paragraph [0072]).
Thus, these claimed features fail to distinguish the instant claims from the copending claims in a sufficiently nonobvious manner to warrant separate patentability therefrom.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER A FLORY whose telephone number is (571)270-5305. The examiner can normally be reached Monday, Tuesday, and Thursday, 8:30am-4:30pm (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER A FLORY/Primary Examiner, Art Unit 3792
2 December 2025