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 .
Election/Restrictions
Applicant's election with traverse of claims 1-3 and 5-13 in the reply filed on 2/17/2026 is acknowledged. The traversal is on the ground(s) that the elements of claim 1 represent a special technical feature because a detailed comparison of the claimed system with DiLorenzo demonstrates that the specific combination of features recited in claim 1 is not disclosed or suggested by DiLorenzo, and all of the alleged species share the technical features of claim 1. This is not found persuasive because what is notably absent from the traversal is indication of any feature or features that is lacking from DiLorenzo. The examiner sets forth a detailed comparison in the prior art rejections below. The examiner agrees that all species share the features of claim 1, but respectfully maintains that these features fail to constitute a special technical feature, as set forth in the detailed comparison below. Applicant is reminded of the right to rejoinder should allowable subject matter be presented in claim 1.
The requirement is still deemed proper and is therefore made FINAL.
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 11 and 13 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.
In regards to claim 11, the limitation “the components of the system” lacks antecedent basis, rendering it unclear which element or elements of claim 1 are “the components.” The examiner is considering the claim to require that any two of the elements of claim 1 are connected as recited in claim 11 for prior art purposes, but clarification is respectfully requested.
In regards to claim 13, “Smart wear applications for vital and/or non-vital monitoring such as heart rate, tissue oxygenation, blood pressure, skin/body hydration / impedance and/or body decomposition measurements (fat, muscles, water, etc.)” and “Transcutaneous Electrical Nerve Stimulation (TENS) in order to provide pain relief, tremor reduction, stroke recovery, athletic performance or the like” are vague. The phrases “such as,” “etc.,” and "or the like" render the claim indefinite because the claim includes elements not actually disclosed (those encompassed by “such as,” “etc.,” and "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). Further, it is unclear what is meant by “body decomposition measurements.” As the application appears to be drawn to monitoring in a living patient, it appears that this should read “body composition measurements.” Lastly, the scope of “smart wear applications” is vague. It is unclear what type of body-worn applications would be “smart” and which would not.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-11 and 13 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by DiLorenzo (US 8,396,557, hereinafter “DiLorenzo”).
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).
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, the 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 such as heart rate, tissue oxygenation, blood pressure, skin/body hydration / impedance and/or body decomposition measurements (fat, muscles, water, etc.) (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, athletic performance or the like;
- Micro-recording electrodes/needles (MER) applications;
- Defibrillation applications;
- Radiofrequency ablation applications;
- Temporal Interference stimulation applications;
- Cochlear device applications; and/or
- Intravascular device applications.
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 12 is rejected under 35 U.S.C. 103 as being unpatentable over DiLorenzo in view of Yang et al. (US 2019/0224474, hereinafter “Yang”). DiLorenzo discloses the essential features of the claimed invention including providing a cortical electrode device (col. 10, lines 5-22) and electrodes made of carbon (col. 13, lines 18-22), but does not expressly disclose the electrode device has at least one electrode comprising graphene.
However, Yang in the same field of endeavor of neuromodulation applications (abstract) teaches providing at least one electrode comprising graphene (abstract) to provide the predictable results of superior electrical, mechanical, and thermal properties, and well-known long-term biocompatibility and mechanical flexibility for vulnerable brain tissues (par. 0004). 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 comprising graphene to provide the predictable results of superior electrical, mechanical, and thermal properties, and well-known long-term biocompatibility and mechanical flexibility for vulnerable brain tissues.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Claim 1 is very broadly-recited in the area of neural stimulation. The following are several of many examples of neural stimulation systems that include sensor units: US 12,357,828 to Minassian et al.; US 11,986,652 to Ritzen et al.; US 2024/0041384 to Lee et al.
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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