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 .
Claim Objections
Claims 10 and 12 are objected to because of the following informalities: the word “determined” (line 3 and line 2, respectively) should be replaced by the word “determining” for grammatical purposes. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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) 1, 2 and 10-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticiapted by Wagner et al. (Pub. No. 2018/0117316).
Regarding claim 1, Wagner ‘316 discloses a stimulus application system, comprising: an implant device 35 configured to be implanted in a body of a patient (Fig. 2A) including a sensor unit 330 (Fig. 7A) configured to detect physiological signals at a predetermined detection location in the body (pars. 0180, 0185, 0186 etc.) at predetermined time intervals (sensors periodically activated (par. 0181); any computerized physiological sensing system inherently samples physiological signals at predetermined time intervals at the predetermined sampling rate established by its duty/on/off cycle) and a stimulation circuit unit (pulse generator, stimulation electrodes) configured to apply an electrical stimulus to a predetermined stimulation location in the body (the location where the stimulation electrodes are implanted); and at least one processor 364 disposed within the implant device configured to: receive detection information pertaining to the physiological signals detected by the sensor unit at each predetermined time interval (physiological data sampling); process the detection information for each predetermined time interval (par. 0180); and determine a stimulation application mode of the stimulation circuit unit for each predetermined time interval based on the processed detection information (par. 0054 wherein various modes are entered dependent upon at least one parameter of the sensed physiological data).
Regarding claim 2, ‘316 discloses that functions of the therapy manager including those associated with the treatment regimen may be entirely incorporated into an external programmer as is well-known in the art of implantable medical devices (pars. 0042, 0085, 0201).
Regarding claim 10, ‘316 discloses that stimulation amplitude and duration/duty cycle may be controlled and selected for the particular treatment protocol (pars. 0156-0158).
Regarding claim 11, see par. 0079.
Regarding claim 12, ‘316 discloses that the electrode cuff may include multiple, separate cuff electrodes each having at least one operative contact group (par. 0079). Such an arrangement would inherently require the system to determine one or more of the plurality of stimulation electrodes with which to apply the electrical stimulus.
Regarding claim 13, note par. 0186.
Regarding claim 14, note par. 0086.
Regarding claim 15, see abstract, par. 0002, etc.
Claim(s) 1, 2 and 10-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Flaherty et al. (Flaherty ‘436: Pub. No. 2017/0151436).
Regarding claim 1, Flaherty ‘436 discloses a stimulus application system 10, comprising: an implant device 35 configured to be implanted in a body of a patient (par. 0043) including a sensor unit (par. 0014) configured to detect physiological signals at a predetermined detection location in the body (par. 0014) at predetermined time intervals (any computerized physiological sensing system inherently samples physiological signals at predetermined time intervals at the predetermined sampling rate established by its duty/on/off cycle) and a stimulation circuit unit (pulse generator, stimulation electrodes) configured to apply an electrical stimulus to a predetermined stimulation location in the body (the location where the stimulation electrodes are implanted); and at least one processor 153 disposed within the implant device (pars. 0043 and 0183) configured to: receive detection information pertaining to the physiological signals detected by the sensor unit at each predetermined time interval (physiological data sampling); process the detection information for each predetermined time interval (sensor signal assessed, par. 0017); and determine a stimulation application mode of the stimulation circuit unit for each predetermined time interval based on the processed detection information (par. 0017 wherein various modes are entered dependent upon at least one parameter of the sensed physiological data).
Regarding claim 2, note Fig. 1 and associated text discussing the use of controllers (e.g., par. 0108).
Regarding claim 10, note par. 0011 and reference to stimulation frequencies and duty cycles and par. 0182 with respect to amplitude of electrical stimulus.
Regarding claim 11, note use of electrodes (par. 0011).
Regarding claim 12, note par. 0011 and its reference to the selection of the set of electrodes to receive stimulation energy.
Regarding claim 13, note pars. 0014 and 0192 and the use of sensing/microelectrode recording.
Regarding claim 14, note two-way communication paths 20a and 20b (Fig. 1) permitting communication between external controllers and diagnostic device and stimulator unit (see par. 0080).
Regarding claims 15 and 16, see pars. 0050 and 0124.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wagner ‘316 or Flaherty ‘436.
Regarding claim 17, Official Notice is taken that it is old and well-known in the medical implant art to recharge implantable devices using externally located, wearable recharging devices. Such devices permit convenient non-invasive charging of implanted storage elements, thus extending the usable life of the implant, while enabling accurate, consistent positioning between elements for optimized inductive coupling and maximized charging efficiencies. Artisans of ordinary skill in the art would have thus considered such a feature in either the Wagner or the Flaherty system to be a matter of obvious design.
Allowable Subject Matter
Claims 3-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
There does not appear to be a motivation in the prior art of record for modifying the Wagner or Flaherty invention to include the recited processor configured to classify a degree of response of the physiological signals. The systems invoke neural responses and detect the responses, but do not classify the degree of said physiological responses. The applicant uses such classification to determine the application mode.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Tass ‘140 discloses a neural stimulator including mode switching with selectable electrodes.
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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
June 26, 2026
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