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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 3-10 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 first and second recording means “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 with no other element positively recited. The examiner is considering the scope of the claim to require recording elements (which from the specification appear to be 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 and 3-9 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),
wherein the first and second recording means each comprise at least two recording elements (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 (par. 0079, “8 pairs of EMG electrodes 34 placed on the skin over the major muscle groups on the legs”).
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 claim 7, 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 12/24/2025 have been fully considered but they are not persuasive. Applicant argued that the amendments avoid the previous rejections under section 112(b) and under prior art in view of Stone. However, the examiner respectfully maintains the rejections for similar reasons as previously set forth. For instance, the apparatus claims currently positively recite a neurostimulation device comprising first and second recording means, each comprising at least two recording elements. The limitations drawn to being “arranged in” a first pattern and second pattern appear to remain functional limitations (i.e., requiring recording elements being capable of being arranged in a first pattern and a second pattern). No element is recited in the claims to carry the recording elements, such as a housing or brace, or electrode array backing. As there is no structure actually set forth to maintain a separation or pattern between the recording elements, the examiner respectfully maintains that Stone’s recording elements are capable of being used in the way recited by the claims. Further, Fig. 3 and par. 0079 of Stone indicates that the recording elements are actually used in a first and second pattern due to their various placement by pairs on the muscles of the legs of the patient (although no pending claims are method claims). Accordingly, the examiner respectfully maintains the rejections as set forth above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ang et al. (US 2018/0153430) is another example of utilizing graphene in monitoring electrodes.
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