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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“non-invasive neuromonitoring device configured to monitor…” in claim 1, and all claims depending therefrom
“computing device configured to determine …” in claim 1, and all claims depending therefrom
“sensory stimulation device configured to apply …” in claim 4, and all claims depending therefrom
“device for neuromonitoring of brain hemodynamics” in claim 8, and all claims depending therefrom
“device for measuring electrical signals …” in claim 8, and all claims depending therefrom
“input unit configured to receive …” in claim 9, and all claims depending therefrom
“processing unit configured to calibrate …” in claim 9, and all claims depending therefrom
“non-invasive neuromonitoring device for acquiring…” in claim 12, and all claims depending therefrom
Examiner note: the term “non-invasive transcranial neurostimulation device” in claims 1 and 13 is interpreted as reciting sufficient structure to preclude interpretation under 112(f) by virtue of requiring that the stimulation is focused ultrasound stimulation.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the published specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
non-invasive neuromonitoring device - “fMRI, PET, Functional Ultrasound, LIFU, NIRS, EEG, MEG, and OPM” ([0108])
computing device - a processor, etc., as in [0096]
sensory stimulation device - a screen, as in [0082];speaker, as in [0083]; vibrating device, as in [0084]
device for neuromonitoring of brain hemodynamics - no specific structure is disclosed. However, the claimed function is ascribed to the “non-invasive neuromonitoring device” ([0072]).
device for measuring electrical signals - no specific structure is disclosed. However, the claimed function is ascribed to the “non-invasive neuromonitoring device” ([0072]).
input unit - “Ethernet interface, a USB™ interface, a wireless interface such as a WiFi™ or Bluetooth™ or any comparable data transfer interface” ([0093])
processing unit - a processor, etc., as in [0096]
If applicant wishes to provide further explanation or dispute the examiner's interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 8, 12, and 14 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.
Claim 8 is indefinite for the following reasons:
It is unclear what is being referred to by “a device for neuromonitoring of brain hemodynamics”. As noted in the claim interpretations above, the claimed “device” appears to be disclosed as being the “non-invasive neuromonitoring device” ([0072]). It is unclear if the claim attempts to require another (i.e., a second) “non-invasive neuromonitoring device”. It is unclear what the distinction is between the ‘device for neuromonitoring …’ of claim 8 and that of claim 1, as claim 1 already requires that the non-invasive neuromonitoring device monitors brain hemodynamics because the device is configured to monitor the evoked hemodynamic responses in the target ROIs.
It is unclear what is being referred to by “device for measuring electrical signals produced”. As noted in the claim interpretations above, the claimed “device” appears to be disclosed as being the “non-invasive neuromonitoring device” ([0072]). It is unclear if the claim attempts to require another (i.e., a second) “non-invasive neuromonitoring device”. It is unclear what the distinction is between the ‘device for neuromonitoring …’ of claim 8 and that of claim 1. Is the limitation trying to set forth that the neuromonitoring device is configured to monitor the evoked hemodynamic responses in the target ROIs by measuring electrical signals?
Claim 12 is indefinite for the following reasons:
There is insufficient antecedent basis for “the non-invasive neuromonitoring device”. It is unclear what is being referred to.
There is insufficient antecedent basis for “plurality of target
ROls”. It is unclear what is being referred to.
There is unclear antecedent basis for “the device according to claim 9 for calibrating the acquired hemodynamic response”. It is unclear is this is the “device for calibration of brain hemodynamics”. It is unclear which response is being referred to by “the acquired hemodynamic response”.
Claim 14 is indefinite because it is unclear what is meant by “a hemodynamic brain atlas obtained according to claim 12”, as claim 12 is directed to a system. It is unclear how an atlas may be obtained ‘according to a system’, as opposed to ‘according to a method’, for example.
Response to Arguments
Applicant's arguments filed 6/30/2026 have been fully considered but they are not entirely persuasive.
Applicant argues on page 11 that the term “means for” is not recited and that the claim should therefore not be interpreted under 112(f).
Examiner respectfully disagrees because the claims meet the three-prong test for interpretation under 119f) as explained in the claim interpretation section above.
Applicant argues on page 11 that the ‘"computing device" and "processing unit" in particular are terms of art for computers’.
Examiner respectfully disagrees. If application wishes the "computing device" and "processing unit" to be interpreted as referring to a “computer”, then examiner suggests amending the claims to recite a “computer” instead of "computing device" and "processing unit".
Applicant’s arguments, see pages 12 - 15, with respect to the art rejections have been fully considered and are persuasive. The art rejections have been withdrawn.
Allowable Subject Matter
Claims 1, 3 - 7, 9 - 11, 13, and 15 are allowed.
Claims 8, 12, and 15 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is an examiner’s statement of reasons for allowance: as noted above, applicant’s arguments, see pages 12 - 15, with respect to the art rejections are persuasive. Moreover, no other prior art of record teaches or reasonably suggests the combination of features required by each of claims 1, 9, 13, and 15. Claims 1, 9, 13, and 15 are thus found allowable. Dependent claims thereof are allowable at least by virtue of dependency.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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 AMELIE R DAVIS whose telephone number is (571)270-7240. The examiner can normally be reached Monday-Friday, 9:30 - 6:00 PST.
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, Pascal Bui-Pho can be reached at (571)272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798
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