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 .
Response to Arguments
The 35 USC § 112 rejections against 8-9 and 27 are withdrawn in light of the claim amendments received on 12/26/2025.
Applicant's arguments filed 12/29/2025 with respect to the 35 USC § 112 rejections against claims 10-12 have been fully considered but they are not persuasive. The claims recite “a desired dose of neural recruitment”. Neural recruitment occurs due to stimulus, in this case, the neural recruitment is elicited from a stimulation pulse. It is unclear and indefinite what a desired dose of neural recruitment is or could be. The word desire is “to long or hope for : exhibit or feel desire for” or “to express a wish for”. This is subjective language which is based on a personal opinion, feeling or belief. It cannot be determined, for the sake of patent examination, what a desired dose of neural recruitment is or could be. This rejection is not withdrawn.
Applicant's arguments filed 12/29/2025 with respect to the 35 USC § 102(a)(1) rejections against claims 1-22, 24, 26-28, 34, 37 and 39 have been fully considered but they are not persuasive.
Applicant argues on pages 8-9 that the Wagenbach disclosure does not disclose determining characteristics of the ECAP signal and that the stimulus applied is based on the determined characteristic of the ECAP signal. This is considered to be a feedback or closed-loop stimulation paradigm which uses ECAP signals to operably adjust stimulation parameters, as is known in the art.
Wagenbach paragraphs 0041-0051 recite:
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In these paragraphs it is clear that the ECAP is sensed, the ECAP algorithm determines ECAP features, which are characteristics, and then uses those ECAP features to adjust stimulation parameters, in particular amplitude of the stimulation as discussed in paragraph 0052. The ECAP features/characteristics include peak-to-peak height of the ECAP (paragraphs 0042-43), a ratio of peak-to-peak ECAP height (paragraph 0044), ECAP peak width (paragraph 0045), the area under any ECAP peak (paragraph 0046) and a total ECAP area (paragraph 0047).
The claim rejections are not withdrawn.
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 10-12 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.
Claims 10-12 each recite “a desired dose of neural recruitment”. This language is improper. A desired dose of stimulation can be delivered to the tissue to elicit neural recruitment, however there is no desired dose of neural recruitment.
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.
Claims 1-22, 24, 26-28, 34, 37 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wagenbach et al. US 2020/0305745 in the IDS.
Regarding claims 1, 20 and 39: Wagenbach discloses a device 10 (figure 1) which records evoked neural responses (abstract), the device comprising; a plurality of electrodes 16 (figure 1) including stimulation and sensing electrodes (“tissue-stimulating electrodes 16”, paragraph 0004 and “one or more of the electrodes 16 can be used to sense neural responses such as the ECAPs”, paragraph 0038); a stimulation source 28 (figure 1 “stimulation circuitry”, paragraph 0037) for providing a stimulus to be delivered by the electrodes to a neural pathway in order to give rise to an ECAP on the neural pathway (abstract, paragraphs 0035 and 0037); measurement circuitry 115 (figure 4, paragraph 0038) for recording a neural compound action potential signal sensed at sense electrodes, the measurement circuitry being operable to record the neural compound action potential signal during delivery of at least a part of the stimulus (“Thus, the ECAP is specifically sensed during the actively-driven second pulse phase 30b”, paragraph 0070; pulse 30b as seen in figure 6B is the second phase of the stimulation pulse); and a control unit 102 (figure 4) configured to process the recording of the neural compound action potential signal to determine a characteristic of the ECAP (paragraphs 0037, 0040-0053, characteristics of the ECAP are found in paragraphs 0042-0051), the control unit 102 (figure 4) further configured to define at least one characteristic of the stimulus based on the determined characteristic of the ECAP (paragraphs 0037, 0040-0041, paragraph 0052 “In one simple example, the ECAP algorithm 124 can review the height of the ECAP (e.g. its peak-to-peak voltage), and in closed loop fashion adjust the amplitude of the stimulation current to try and maintain the ECAP to a desired value.”).
Regarding claims 2 and 21: Wagenbach discloses that the characteristic of the ECAP reflects and efficacy of the stimulation (the features can be found in paragraphs 0042-0051, the presence of the ECAP demonstrates/reflects that the stimulation is effective in that it elicits a neural response in the form of an ECAP).
Regarding claims 3-4 and 22: Wagenbach discloses that the characteristic of the ECAP is binary (in paragraph 0013 of applicants disclosure this is either the presence or absence of an ECAP which is recruitment shown in figures 6B, 6C and 8).
Regarding claims 5-6 and 24: Wagenbach discloses that the characteristic of the ECAP is that of a measure of the ECAP onset delay time (paragraph 0050), ECAP amplitude (paragraphs 0042-43) or ECAP duration (paragraph 0045 these are considered to be either gradated or scalar).
Regarding claims 7 and 26: Wagenbach discloses that the control unit 102 (figure 4) is configured to cease recording of the ECAP at a time defined relative to when the stimulus ceases (paragraph 0067).
Regarding claims 8 and 27: Wagenbach discloses that the control unit 102 (figure 4) is configured to continue recording the ECAP after the defining the stimulus is completed (the defining phase of what characteristics from the ECAP will be utilized is prior to implantation, this would be inherent to the design).
Regarding claims 9 and 28: Wagenbach discloses that the control unit 102 (figure 4) is configured to determine the characteristic of the ECAP prior to cessation of the stimulus, and to further use the determined characteristic to control how stimulation is applied (this is a feedback control system which continually applies stimulation to the tissue and therefore during the feedback process the characteristic of the ECAP is continually determined in order to adjust feedback control; it is broadly interpreted to include not just the first stimulation pulse but all of the stimulation pulses, paragraph 0052).
Regarding claims 10-13: Wagenbach discloses that the control unit 102 (figure 4) is configured to use the characteristic of the ECAP to alter stimulation parameters in order to control the stimulus to deliver a desired dose (paragraph 0052). Wagenbach uses feedback to control the amplitude of stimulation (paragraph 0052 which is broadly considered to be an amount of charge). Wagenbach discloses the stimulation parameters include amplitude, frequency, pulse width (paragraph 0007, this is inherently considered to be a number of pulses in that the stimulation is not indefinite).
Regarding claim 14: Wagenbach discloses that the control unit 102 (figure 4) is configured to recover imbalance of charge (paragraphs 0016, 0018, 0020 and 0068-69).
Regarding claims 15 and 34: Wagenbach discloses that the control unit 102 (figure 4) is configured to define the characteristic of the stimulation based on a determined characteristic of the previous ECAP (paragraph 0052).
Regarding claims 16-17: Wagenbach discloses that the electrodes are chosen/selected to either be sensing or stimulating electrodes (paragraphs 0007-0008, 0061, 0077 and 0080, all of the electrodes are clearly usable as either sensing or stimulating electrodes), when the electrode is set to sense it will not be used to stimulate this is considered to cover the language in claim 17.
Regarding claims 18-19 and 37: Wagenbach discloses that the control unit 102 (figure 4) can use a blanking period during the first phase 30a of the stimulation pulse (paragraph 0076) which is considered to be during a stimulus transient, this is unblanked during 30b when the sensing occurs (paragraph 0076).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796