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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/16/2026 has been entered.
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 1 and 3-11 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 1, it is unclear what is required by the recitation of a first and second recording means “are arranged at a recording means distance from one another to detect a stimulus being propagated along a nervous structure for determining a speed of the stimulus” and “are arranged” in a first pattern and second pattern. The claim is an apparatus claim, and the only structural elements positively recited in the claim are a “first recording means” and “second recording means,” each comprising at least two recording elements comprising electrodes or coils, with no other element positively recited (such as some sort of substrate to provide this separation or a controller element to provide the recited functionality of detecting and determining). The examiner is considering the scope of the claim to require recording elements comprising electrodes or coils capable of being used for this purpose, if the user so desires.
In regards to claim 3, similar to above, the only structural elements recited in the claim are recording elements of the first and second recording means. Therefore, it is unclear whether some (unrecited) structural element is present to provide the recording element distances/patterns, or whether this is a method step of intended user placement in an apparatus claim. The examiner is considering the claim to merely require the ability to place the elements at distances between the recording elements.
In regards to claim 4, since the only structural elements recited in the claim are recording elements, it is unclear whether there is some (unrecited) element to establish recording element distances, or whether this is an intended use/method step in an apparatus claim. The examiner is considering this to be an intended use, as no other structural elements are recited.
The remaining claims are rejected by virtue of their dependency.
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.
Claim 1, 3-9 and 11 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Stone et al. (US 2015/0032022, hereinafter “Stone”).
In regards to claim 1 (as best understood, see section 112 rejections above), Stone discloses a system for peripheral nerve stimulation, for detecting and/or monitoring of neuronal and/or muscle activity, comprising at least one neurostimulation device (Fig. 1),
wherein the neurostimulation device comprises at least a first recording means and a second recording means (any pair or more of elements 19, 20, 34, 35, 37 comprise a “recording means”; pars. 0079),
wherein the first recording means and the second recording means are arranged at a recording means distance from one another to detect a stimulus being propagated along a nervous structure for determining a speed of the stimulus being propagated along the nervous structure (pars. 0058-0064, 0079, 0112-0115; e.g., Fig. 3),
the first and second recording means each comprise at least two recording elements, where the recording elements comprise electrodes or coils (par. 0079; “monitoring the EMG responses of the muscle groups innervated by the nerves. In one embodiment, this is accomplished via 8 pairs of EMG electrodes 34 placed on the skin over the major muscle groups on the legs (four per side)”),
wherein the recording elements of the first recording means are arranged in a first pattern (par. 0079, “8 pairs of EMG electrodes 34 placed on the skin over the major muscle groups on the legs”),
wherein the recording elements of the second recording means are arranged in a second pattern, different from the first pattern (par. 0079, “8 pairs of EMG electrodes 34 placed on the skin over the major muscle groups on the legs”; the pattern of a single pair of electrodes is “different” from a pattern of a different pair of electrodes on, e.g., upper leg versus lower leg, right leg versus left leg, etc. because they are on different body locations with different anatomical topology. Additionally, it is unclear (see section 112 rejection above) whether this is an intended use of freely attachable electrodes or some sort of (unrecited) structural feature).
In regards to claim 3 (as best understood, see section 112 rejections above), the first pattern comprises a first recording element distance between the recording elements of the first recording means and the second pattern comprises a second recording element distance between the recording elements of the second recording means (Figs. 1 and 3, par. 0073; flexible leads are used, so can be placed as the user desires).
In regards to claim 4 (as best understood, see section 112 rejections above), the first recording element distance and the second recording element distance necessarily are identical or deviate from each other as this is a closed set (see also Fig. 3 showing various combinations of identical and deviating distances between recording elements).
In regards to claim 5, each recording element comprises at least one electrode or coil (abstract).
In regards to claim 6, the neurostimulation device comprises at least one electrode or coil for transmitting stimulation signals to a patient's tissue in order to initiate neuronal and/or muscle stimulation (abstract, par. 0059).
In regards to claims 7 and 11, recording elements of the first recording means and recording elements of the second recording means comprise different recording sensitivities (par. 0118, depending on whether the user chooses a bipolar or monopolar configuration).
In regards to claim 8, the system further comprises a control unit configured to operate to control and/or regulate the operation of, the neurostimulation device and/or to provide signal processing of the signals as received from the first and second recording means (pars. 0065-0066).
In regards to claim 9, a recording signal of the recording elements of the first and/or second recording means is forwarded via a signal connection, to the control unit (Fig. 1, element 40, 14, or common leads for elements 34).
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Stone in view of Ruotsalainen et al. (US 2022/0361794, hereinafter “Ruotsalainen”). Ruotsalainen discloses the essential features of the claimed invention except for expressly indicating that the recording elements comprise graphene electrodes or coils.
However, Ruotsalainen in the same field of endeavor of biopotential measurement discloses providing EMG recording electrodes comprising graphene (par. 0033) to provide the predictable results of an electrode with low impedance, good adhesion and uniformity, excellent signal quality, protection against corrosion, protection of the substrate, non-toxicity, and minimization of any chemical reaction between the skin and electrode (par. 0033).
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 Stone by providing electrodes comprising graphene to provide the predictable results of an electrode with low impedance, good adhesion and uniformity, excellent signal quality, protection against corrosion, protection of the substrate, non-toxicity, and minimization of any chemical reaction between the skin and electrode.
Response to Arguments
Applicant's arguments filed 4/16/2026 have been fully considered but they are not persuasive in part and moot in part. In regards to the interpretation of the “means for” language in claim 1, the examiner’s position is that the language no longer invokes section 112(f) because the recitation of “electrodes or coils” is sufficient structure to avoid invocation of 112(f).
In regards to the section 112(b) rejection, the previous and current rejections do not rely on the position that it is unclear whether claim 1’s “recording means” include electrodes or coils. The rejection is based on the position that the only positively-recited elements are a neurostimulation device comprising first and second recording means, each comprising at least two recording elements comprising electrodes or coils; in other words, a neurostimulation device comprising at least four electrodes or coils. That appears to be the only structure positively recited in the claims. The remaining functional limitations drawn to “are arranged at a recording means distance from one another to detect a stimulus being propagated along a nervous structure for determining a speed of the stimulus” and being “arranged in a first pattern” do not require and do not even seem to imply any additional structure (such as a controller element to “detect” and “determine,” or some sort of substrate to locate the electrodes/coils at any particular location on the body). This renders the scope of the claim vague because it is unclear whether the claim requires (1) a neurostimulation device that actually does have a controller and substrate to providing locating functionality, but is unrecited in the claim, (2) a neurostimulation device comprising four electrodes/coils with a series of method steps recited in the apparatus claims, or (3) a neurostimulation device comprising four electrodes/coils, the electrodes/coils being capable of use for the recited functionality if the user so chooses to use them in that way. For prior art purposes (see rejection above and additional explanation below), the examiner is considering scope (3) because no other structural elements are recited and method steps in apparatus claims are violative of 112(b). The claims would appear to avoid Stone (depending on the claim language used) if there was actually structure recited to provide the claimed functionality, but the current claims appear to require a neurostimulation device with four electrodes/coils capable of the use recited in the functional limitations. For instance, a controller programmed to provide detection and determination of a speed of the stimulus when the recording elements are placed as recited appears to avoid Stone.
In regards to the prior art rejections and in view of the discussion drawn to section 112 above, the examiner respectfully maintains that Stone reads on the reasonable scope of the claims, as presented. For instance, Stone discloses a neurostimulation device having at least four electrodes, which can be placed by a user where desired, including in pairs having different patterns (e.g., by placing on different areas of the body, as expressly disclosed in Stone, or varying the spacing as desired), and these electrodes are capable of detecting a stimulus being propagated along a nervous structure for determining a speed of the stimulus, as set forth above. Again, as discussed above, positively reciting some sort of control element that is programmed/configured to detect a stimulus and determine a speed when the electrodes are placed as claimed appears to avoid Stone. Accordingly, the examiner respectfully maintains the rejections in view of Stone.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Boettcher et al. (US 2012/0101358) is another example of a neurostimulation device having at least four electrodes to detect a stimulus for determining a speed of the stimulus, but the pairs of electrodes do not appear to be usable in a first pattern and different second pattern (Fig. 6).
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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