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 .
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.
Claims 1-3, 5-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over DiLorenzo (US 8,396,557, hereinafter “DiLorenzo”) in view of Apollo et al. (“Soft, Flexible Freestanding Neural Stimulation and Recording Electrodes Fabricated from Reduced Graphene Oxide,” Adv. Funct. Mater. 2015, 25, 3551-3559).
In regards to claim 1, DiLorenzo discloses a system for neuromodulation applications (col. 4, line 66 to col. 5, line 3), comprising:
- at least one electrode device with at least one stimulation electrode and at least one recording electrode (Fig. 2, elements 37 and 38; col. 9, line 60 to col. 10, line 22),
- at least one control unit (Fig. 2, element 72), and
- at least one sensor unit for determining sensor data (Fig. 2, elements 50-54),
wherein the control unit is configured to adapt and/or initiate a neuromodulation treatment on basis of current signals and/or voltage signals as determined by the at least one recording electrode and/or on basis of sensor data as provided by the at least one sensor unit (e.g., col. 16, lines 1-26).
DiLorenzo does not expressly disclose that the electrode device has at least one electrode made of reduced graphene oxide (rGO). However, Apollo in the same field of endeavor of electrostimulation (Introduction, “[h]igh-resolution electrical communication with the nervous system”) teaches providing at least one electrode made of rGO (section 2.1. Electrode Fabrication) to provide the predictable results of robust electrochemical properties, enhanced quality of the neural interface by reducing fluid gap between electrode and tissue, and reducing the electrical impedance and increasing the capacitance of the electrode interface (“introduction,” first column to second column of page 3552). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify DiLorenzo by providing at least one electrode made of rGO to provide the predictable results of robust electrochemical properties, enhanced quality of the neural interface by reducing fluid gap between electrode and tissue, and reducing the electrical impedance and increasing the capacitance of the electrode interface.
In regards to claim 2, the at least one sensor unit comprises at least one sensor device which is provided as an implantable sensor device or as an external sensor device (col. 13, lines 34-45), and wherein the adapting of the treatment includes an application of electrical pulses via the at least one stimulation electrode (col. 13, lines 34-45).
In regards to claim 3, the at least one sensor unit comprises a plurality of sensor devices (col. 13, lines 34-45),
wherein at least multiple of the plurality of sensor devices are provided as implantable sensor devices or at least multiple of a plurality of sensor devices are provided as external sensor devices (col. 16, lines 36-56).
In regards to claim 5, the system further comprises at least one implantable nerve sensor device, which is communicatively connected with the control unit (col. 16, lines 1-7).
In regards to claim 6, the electrode device is an implantable electrode device or an external electrode device (Fig. 2, elements 37 and 38; col. 9, line 60 to col. 10, line 22).
In regards to claim 7, the system further comprises an external communication unit (Fig. 2, element 55; col. 13, line 46 to col. 14, line 39).
In regards to claim 8, the system comprises at least one external user interface device which is configured to provide a user interface and/or at least one sensor unit (Fig. 2, element 55; col. 13, line 46 to col. 14, line 39).
In regards to claim 9, the at least one user interface device comprises user input means and/or user output means (Fig. 2, element 55; col. 13, line 46 to col. 14, line 39).
In regards to claim 10, the system further comprises a server in (data) communicative connection with the control unit and/or the at least one user interface device (Fig. 2, element 56; col. 13, line 57 to col. 14, line 39).
In regards to claim 11, components of the system are connected with each other by a wired connection (Figs. 1 and 2), in order to provide energy transfer and/or a communicative connection (col. 10, lines 23-37).
In regards to claim 13, the system is configured to be used in one of the following applications:
- Neural-controlled motor prostheses applications;
- Electrocardiography (ECG);
- Electroencephalography (EEG) (Fig. 2, element 51);
- Electromyography (EMG) (Fig. 2, element 50);
- Smart wear applications for vital and/or non-vital monitoring including monitoring of heart rate, tissue oxygenation, blood pressure, skin/body hydration / impedance and/or body measurements of fat, muscles, and/or water (Fig. 2, elements 50-54 and 38; DiLorenzo discloses a wearable device and detecting vital and non-vital parameters);
- Transcutaneous Electrical Nerve Stimulation (TENS) in order to provide pain relief, tremor reduction, stroke recovery, and/or athletic performance;
- Micro-recording electrodes/needles (MER) applications;
- Defibrillation applications;
- Radiofrequency ablation applications;
- Temporal Interference stimulation applications;
- Cochlear device applications; and/or
- Intravascular device applications.
Response to Arguments
Applicant’s arguments with respect to claims 1-3, 5-11 and 13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Please see the new grounds of rejection, necessitated by amendment in view of Apollo above. Applicant’s amendments have overcome the previous grounds of rejection under section 112.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hong et al. (US 2021/0290944) is another example of an electrical stimulator utilizing an rGO electrode.
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 MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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, 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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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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