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 Objections
Claims 1 and 7 are objected to because of the following informalities:
Claim 1 is objected to because “the non-invasive transcranial neurostimulation device comprises transcranial functional ultrasound stimulation” (2nd paragraph) appears to comprise a grammatical error and/or be missing words. Examiner suggests amending the limitation to recite “the non-invasive transcranial neurostimulation device comprises a transcranial functional ultrasound stimulation device”.
Claim 7 is objected to because “the non-invasive transcranial neurostimulation device further comprises … transcranial electrical stimulation (tDCS/tACS); and transcranial magnetic stimulation (TMS)” appears to comprise grammatical errors and/or be missing words. Examiner suggests amending the limitation to recite “the non-invasive transcranial neurostimulation device further comprises … a transcranial electrical stimulation (tDCS/tACS) device; and a transcranial magnetic stimulation (TMS) device”.
Appropriate correction is required.
Claim Interpretation
Claims 1 and 13 employ the terminology “transcranial functional ultrasound stimulation, tFUS”. However, the specification discloses that tFUS is also known as transcranial focused ultrasound ([0064], as published) stimulation, which is the commonly accepted terminology for such stimulation. Consequently, for the purposes of examination, the term “tFUS” will be interpreted as referring to transcranial focused ultrasound stimulation.
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
“output unit configured to output …” 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 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]
output unit - no specific structure is disclosed
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 1 and 3 - 15 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 1 is indefinite for the following reasons:
The relationship between “a hemodynamic response” in line 4 and the “plurality of hemodynamic responses” in the second to last paragraph is unclear. It is unclear if the “plurality of hemodynamic responses” is required in addition to the hemodynamic response in line 4, or if the latter is a member of the former.
The relationship between the target ROI in line 4 and the “plurality of target ROIS” in the second to last paragraph is unclear. It is unclear if the “plurality of target ROIS” in the second to last paragraph is required in addition to the target ROI in line 4, or if the latter is a member of the former.
The relationship between a “respective set of parameters” in the last paragraph and “a set of parameters” in the 4th paragraph. It is unclear if the set of parameters is a “respective set of parameters”, or if they are both required.
It is unclear if the ‘formation of the hemodynamic brain atlas’ in the last line is required in addition to the ‘formation of the hemodynamic brain atlas’ in the 4th paragraph. It is unclear how many ‘brain atlas formation’ steps are required by the claimed system.
There is insufficient antecedent basis for “the hemodynamic brain atlas usable for calibration of brain hemodynamics” in the last line. The atlas has not been set forth as being “usable for calibration of brain hemodynamics”. It is unclear if the claim requires such.
Claim 3 is indefinite for the following reasons:
There is unclear antecedent basis for “the target ROI”. A plurality of target ROIs has been recited. It is unclear which target ROI is being referred to.
There is unclear antecedent basis for “the set of parameters”. It is unclear if this is the set of parameters “representing an HRF of the further evoked hemodynamic response” or one of the sets of parameters in claim 1.
It is unclear if the ‘formation of the hemodynamic brain atlas’ is required in addition to the ‘formation(s) of the hemodynamic brain atlas’ in claim 1. It is unclear how many ‘brain atlas formation’ steps are required by the claimed system.
Claim 4 is indefinite for the following reasons:
There is unclear antecedent basis for “the target ROI”. It is unclear which target ROI is being referred to.
There is unclear antecedent basis for “the hemodynamic response evoked by the non-invasive transcranial neurostimulation device”. It is unclear which of the HRFs of claim 1 are being referred to.
There is unclear antecedent basis for “the HRF” (last line). It is unclear which of the HRFs are being referred to.
Claim 5 is indefinite for the following reasons:
There is unclear antecedent basis for “the target ROI”. It is unclear which target ROI is being referred to.
There is unclear antecedent basis for “the HRF” (last line). It is unclear which of the HRFs are being referred to.
Claim 6 is indefinite because there is unclear antecedent basis for “the target ROI”. It is unclear which target ROI is being referred to.
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 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”.
Claim 9 is indefinite because the claimed “output unit” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. It is unclear if the term attempts to refer to some sort of display, to hardware components of a computer that transfer data, or to something else. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 13 is indefinite for the following reasons:
There is insufficient antecedent basis for “the non-invasive neuromonitoring device” in line 5. Moreover, it is unclear how a neuromonitoring device may comprise “stimulation”. For the purposes of examination, the limitation will be interpreted as referring to the “non-invasive transcranial neurostimulation device”.
The relationship between “a hemodynamic response” in line 4 and the “plurality of hemodynamic responses” in the second to last paragraph is unclear. It is unclear if the “plurality of hemodynamic responses” is required in addition to the hemodynamic response in line 4, or if the latter is a member of the former.
The relationship between the target ROI in line 4 and the “plurality of target ROIS” in the second to last paragraph is unclear. It is unclear if the “plurality of target ROIS” in the second to last paragraph is required in addition to the target ROI in line 4, or if the latter is a member of the former.
The relationship between a “respective set of parameters” in the last paragraph and “a set of parameters” in the 4th paragraph. It is unclear if the set of parameters is a “respective set of parameters”, or if they are both required.
It is unclear if the narrative language “the non-invasive transcranial neurostimulation device evokes …” (4th paragraph) attempts to recite a method step or describe the neurostimulation device.
It is unclear if the narrative language “the computing device determines…” (last paragraph) attempts to recite a method step or describe the computing device.
It is unclear if the ‘formation of the hemodynamic brain atlas’ in the last line is required in addition to the ‘formation of the hemodynamic brain atlas’ in the 4th paragraph. It is unclear how many ‘brain atlas formation’ steps are required by the claimed method.
There is insufficient antecedent basis for “the hemodynamic brain atlas usable for calibration of brain hemodynamics” in the last line. The atlas has not been set forth as being “usable for calibration of brain hemodynamics”. It is unclear if the claim requires such.
Claims 7, 10 - 12, and 14 - 15 are indefinite by virtue of 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.
Claims 1, 3, and 5 - 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Etkin (US 2018/0236255).
Regarding claim 1, Etkin shows a system (system, abstract) for creating a hemodynamic (“blood flow … hemoglobin concentration change … brain…”, [0036]) brain atlas for calibration of brain hemodynamics (“reference data set to which individual patient causal connectomes can be compared”, [0110]; [0137]), the system comprising:
a non-invasive transcranial neurostimulation device (“… non-invasive … TMS, focused ultrasound stimulation, transcranial direct current stimulation, transcranial alternating current stimulation”, [0036]. The claimed “device” is mapped to the hardware that achieves the neurostimulation) configured to induce neuronal activity (“transcranial focused ultrasound stimulation … acoustic pressure waves to specific, highly localize, and potentially deep areas of the brain, to influence (e.g., stimulate) neural activity in the targeted brain tissue”, [0108]) to evoke a hemodynamic response (“blood flow … hemoglobin concentration change … brain, of a human … following presentation of a stimulus …focused ultrasound stimulation”, [0036]) in a target region of interest, ROI (“… non-invasive stimulation to a plurality of different brain regions”, [0063]; [0109]), of a brain of a human subject ([0036]), wherein the non-invasive transcranial neurostimulation device comprises transcranial functional ultrasound stimulation, tFUS ([0029]; [0108]);
a non-invasive neuromonitoring device configured to monitor the evoked hemodynamic response in the target ROI (“response … measured … EEG, MEG, fMRI, NIRS, fNIRS”, [0030] - [0031]. The claimed “device” is mapped to the hardware that achieves the neuromonitoring); and
a computing device (computer, [0040]. Also note that processors/software are implicit to the disclosed functions) configured to determine a set of parameters (“… timing of the response, a magnitude … frequency … phase of the response, a duration …”, [0065]) representing a hemodynamic response function, HRF, (“blood flow … hemoglobin concentration change …”, [0036]), of the evoked hemodynamic response in the target ROI, and to associate the set of parameters of the HRF with the target ROI (“causal connectome mapping … determining the causal (e.g. stimulation-evoked) brain response to stimulation at … multiple brain regions”, [0106]; “map brain responses … at a plurality … of sites … high-density causal map …”, [0109]) to form the hemodynamic brain atlas (“reference data set to which individual patient causal connectomes can be compared”, [0110]; [0137]),
wherein the non-invasive transcranial neurostimulation device is configured to evoke a plurality of hemodynamic responses in a plurality of target ROIs (“… plurality of different brain regions”, [0063]; [0109]), each hemodynamic response being evoked in a respective target ROI (implicit); and
wherein the computing device is configured to determine, for each evoked hemodynamic response, a respective set of parameters (“… timing of the response, a magnitude … frequency … phase of the response, a duration …”, [0065]) representing the corresponding HRF and to associate each set of parameters with the corresponding target ROI (“causal connectome mapping … determining the causal (e.g. stimulation-evoked) brain response to stimulation at … multiple brain regions”, [0106]; “map brain responses … at a plurality … of sites … high-density causal map …”, [0109]) to form the hemodynamic brain atlas (“a reference data set…”, [0110]; [0137]) usable for calibration of brain hemodynamics (“… to which individual patient causal connectomes can be compared”, [0110]; [0137]).
Regarding claim 3, Etkin discloses the claimed invention substantially as noted above. Etkin further shows the non-invasive neuromonitoring device is configured to monitor a further evoked hemodynamic response in one or more brain regions (“… plurality of different brain regions”, [0063]; [0109]) that have sufficiently strong excitatory connectivity with the target ROI (implicit. Also refer to [0106], [0108], [0110]); and wherein the computing device is configured to determine a set of parameters (“… timing of the response, a magnitude … frequency … phase of the response, a duration …”, [0065]) representing an HRF of the further evoked hemodynamic response in the one or more brain regions, and to associate the set of parameters with the one or more brain regions (“causal connectome mapping … determining the causal (e.g. stimulation-evoked) brain response to stimulation at … multiple brain regions”, [0106]; “map brain responses … at a plurality … of sites … high-density causal map …”, [0109]) to form the hemodynamic brain atlas (“reference data set to which individual patient causal connectomes can be compared”, [0110]; [0137]).
Regarding claim 5, Etkin discloses the claimed invention substantially as noted above. Etkin further shows evoking a sequence of hemodynamic responses in the target ROI, monitoring the sequence, and comparing among the sequence (“response as measured in a subject may be compared to a response previously measured in the same subject, [0039]). The comparison is interpreted as being intended “to correct a potential neurostimulation-induced confound on the HRF”, lacking any positive recitation of such a correction.
Regarding claim 6, Etkin discloses the claimed invention substantially as noted above. Etkin further shows the target ROI is selected from a set of calibration brain regions (“each of plurality of different brain regions of the subject is selected from the group consisting of frontal cortex, temporal cortex, parietal cortex, occipital cortex, hippocampus, amygdala, striatum or brainstem, and subregions thereof”, [0082]; “selection of a plurality (i.e. one or more) of sites for non-invasive stimulation”, [0122]); and wherein an HRF in other brain regions of the brain is derivable from an HRF in the set of calibration brain regions (implicit).
Regarding claim 7, Etkin discloses the claimed invention substantially as noted above. Etkin further shows the non-invasive transcranial neurostimulation further comprises transcranial electrical stimulation (tDCS/tACS) and transcranial magnetic stimulation(TMS) (“non-invasive stimulation is one or more (e.g., 1, 2, 3 or 4) selected from the group consisting of transcranial magnetic stimulation (TMS), focused ultrasound stimulation, transcranial direct current and transcranial alternating current stimulation”, [0085]).
Regarding claim 8, Etkin discloses the claimed invention substantially as noted above. Etkin further shows the non-invasive neuromonitoring device comprises a device for neuromonitoring of brain hemodynamics and a device for measuring electrical signals produced by neurons to measure brain activity (“response … measured … EEG, MEG, fMRI, NIRS, fNIRS”, [0030] - [0031]. The claimed “device” is mapped to the hardware that achieves the neuromonitoring);
Regarding claim 9, Etkin shows a hemodynamic brain atlas obtained according to claim 1 substantially as noted above. Etkin further shows a device for calibration of brain hemodynamics (abstract; “blood flow … hemoglobin concentration change … brain…”, [0036]), the device comprising:
an input unit configured to receive (i) a hemodynamic response (“response … measured … EEG, MEG, fMRI, NIRS, fNIRS”, [0030] - [0031]. The claimed “input unit” is mapped to the hardware that receives the response) in a region of interest, ROI (“… non-invasive stimulation to a plurality of different brain regions”, [0063]; [0109]), of a brain of a human subject ([0036]) acquired by a non-invasive neuromonitoring device (“response … measured … EEG, MEG, fMRI, NIRS, fNIRS”, [0030] - [0031]. The claimed “device” is mapped to the hardware that achieves the neuromonitoring) and (ii) a hemodynamic brain atlas obtained according to claim 1 (“reference data set, to which individual patient causal connectomes can be compared using methods such as multivariate pattern classification … identify for each patient where responses to stimulation were excessive or inadequate… powerful method for characterizing abnormalities in causal cortical signal flow in each of the patients”, [0110]; [0137]. The claimed “input unit” is mapped to the hardware that receives the brain atlas);
wherein the hemodynamic brain atlas (reference data set, [0110]; [0137]) comprises a plurality of brain regions (“causal connectome mapping … multiple brain regions”, [0106]), each brain region being associated with a respective hemodynamic response function, HRF (“blood flow … hemoglobin concentration change … brain…”, [0036]), represented by a set of parameters (“… timing of the response, a magnitude … frequency … phase of the response, a duration …”, [0065]);
a processing unit (computer, [0040]. Alternatively, any processor that performs the comparison in [0110], [0137]) configured to calibrate the acquired hemodynamic response with the hemodynamic brain atlas (“reference data set, to which individual patient causal connectomes can be compared …”, [0110]; [0137]); and
an output unit (computer, [0040]. Alternatively, any processor that outputs the calibrated hemodynamic response [0110], [0137]) configured to output the calibrated hemodynamic response ([0110], [0137]).
Regarding claim 10, Etkin discloses the claimed invention substantially as noted above. Etkin further shows the hemodynamic brain atlas is derivable from previous HRF measurements of the human subject; previous HRF measurements of a group of healthy adults; previous HRF measurements of a specified patient group; and/or previous HRF measurements of a single patient for whom brain regions may have been calibrated (implicit. Also refer to discussion of comparisons in [0039]).
Regarding claim 11, Etkin discloses the claimed invention substantially as noted above. Etkin further shows the ROI is different from the plurality of brain regions of the hemodynamic brain atlas, by definition, as ‘an ROI’ is not identical to ‘a plurality of brain regions of the hemodynamic brain atlas’.
Regarding claim 12, Etkin shows a device according to claim 9 for calibrating the acquired hemodynamic response substantially as noted above. Etkin further shows a non-invasive neuromonitoring device (“response … measured … EEG, MEG, fMRI, NIRS, fNIRS”, [0030] - [0031]. The claimed “device” is mapped to the hardware that achieves the neuromonitoring) for acquiring a hemodynamic (“blood flow … hemoglobin concentration change … brain…”, [0036]) response in a region of interest, ROI, of a brain of a human subject ([0036]).
Regarding claim 13, Etkin shows a method (method, abstract) for creating a hemodynamic (“blood flow … hemoglobin concentration change … brain…”, [0036]) brain atlas for calibration of brain hemodynamics (“reference data set to which individual patient causal connectomes can be compared”, [0110]; [0137]), comprising:
inducing, by a non-invasive transcranial neurostimulation device (“… non-invasive … TMS, focused ultrasound stimulation, transcranial direct current stimulation, transcranial alternating current stimulation”, [0036]), neuronal activity (“transcranial focused ultrasound stimulation … acoustic pressure waves to specific, highly localize, and potentially deep areas of the brain, to influence (e.g., stimulate) neural activity in the targeted brain tissue”, [0108]) to evoke a hemodynamic response (“blood flow … hemoglobin concentration change … brain, of a human … following presentation of a stimulus …focused ultrasound stimulation”, [0036]) in a target region of interest, ROI (“… non-invasive stimulation to a plurality of different brain regions”, [0063]; [0109]), of a brain of a human subject ([0036]), wherein the non-invasive transcranial neurostimulation device comprises transcranial functional ultrasound stimulation, tFUS ([0029]; [0108]);
monitoring, by a non-invasive neuromonitoring device, the evoked hemodynamic response in the target ROI (“response … measured … EEG, MEG, fMRI, NIRS, fNIRS”, [0030] - [0031]);
determining, by a computing device, a set of parameters(“… timing of the response, a magnitude … frequency … phase of the response, a duration …”, [0065]) representing a hemodynamic response function, HRF (“blood flow … hemoglobin concentration change …”, [0036]), of the evoked hemodynamic response in the target ROI; and
associating, by the computing device, the set of parameters of the HRF with the target ROI (“causal connectome mapping … determining the causal (e.g. stimulation-evoked) brain response to stimulation at … multiple brain regions”, [0106]; “map brain responses … at a plurality … of sites … high-density causal map …”, [0109]) to form the hemodynamic brain atlas (“reference data set to which individual patient causal connectomes can be compared”, [0110]; [0137]),
wherein the non-invasive transcranial neurostimulation device is configured to evoke a plurality of hemodynamic responses in a plurality of target ROIs (“… plurality of different brain regions”, [0063]; [0109]), each hemodynamic response being evoked in a respective target ROI (implicit); and
wherein the computing device determines, for each evoked hemodynamic response, a respective set of parameters (“… timing of the response, a magnitude … frequency … phase of the response, a duration …”, [0065]) representing the corresponding HRF and associates each set of parameters with the corresponding target ROI (“causal connectome mapping … determining the causal (e.g. stimulation-evoked) brain response to stimulation at … multiple brain regions”, [0106]; “map brain responses … at a plurality … of sites … high-density causal map …”, [0109]) to form the hemodynamic brain atlas (“a reference data set…”, [0110]; [0137]) usable for calibration of brain hemodynamics (“… to which individual patient causal connectomes can be compared”, [0110]; [0137]).
Regarding claim 14, Etkin shows a hemodynamic brain atlas obtained according to claim 12 substantially as noted above. Etkin further shows a computer-implemented method for calibration of brain hemodynamics (abstract; “blood flow … hemoglobin concentration change … brain…”, [0036]), comprising:
receiving, by an input unit, (i) a hemodynamic response (“response … measured … EEG, MEG, fMRI, NIRS, fNIRS”, [0030] - [0031]. The claimed “input unit” is mapped to the hardware that receives the response) in a region of interest, ROI (“… non-invasive stimulation to a plurality of different brain regions”, [0063]; [0109]), of a brain of a human subject ([0036]) acquired by a non-invasive neuromonitoring device (“response … measured … EEG, MEG, fMRI, NIRS, fNIRS”, [0030] - [0031]. The claimed “device” is mapped to the hardware that achieves the neuromonitoring) and (ii) a hemodynamic brain atlas obtained according to claim 12 (“reference data set, to which individual patient causal connectomes can be compared using methods such as multivariate pattern classification … identify for each patient where responses to stimulation were excessive or inadequate… powerful method for characterizing abnormalities in causal cortical signal flow in each of the patients”, [0110]; [0137]. The claimed “input unit” is mapped to the hardware that receives the brain atlas);
wherein the hemodynamic brain atlas (reference data set, [0110]; [0137]) comprises a plurality of brain regions (“causal connectome mapping … multiple brain regions”, [0106]), each brain region being associated with a respective hemodynamic response function, HRF (“blood flow … hemoglobin concentration change … brain…”, [0036]), represented by a set of parameters (“… timing of the response, a magnitude … frequency … phase of the response, a duration …”, [0065]);
calibrating, by a processing unit (computer, [0040]. Alternatively, any processor that performs the comparison in [0110], [0137]), the acquired hemodynamic response with the hemodynamic brain atlas (“reference data set, to which individual patient causal connectomes can be compared …”, [0110]; [0137]); and
outputting, by an output unit (computer, [0040]. Alternatively, any processor that outputs the calibrated hemodynamic response [0110], [0137]) the calibrated hemodynamic response ([0110], [0137]).
Claim Rejections - 35 USC § 103
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 15 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Etkin (US 2018/0236255).
Regarding claim 15, Etkin shows the method according to claim 13 substantially as noted above. Etkin further shows a computer program element including executable instructions stored on a non-transitory computer readable medium to execute the method (system, abstract; computer, [0040]. Also note that processors and corresponding memory including executable instructions are implicit to the disclosed functions).
Alternatively, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Etkin to include such a non-transitory computer readable medium, in order to allow the system to function as intended.
Allowable Subject Matter
Claim 4 would be allowable if rewritten 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 and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record, either singly or in combination, fails to teach or reasonably suggest system according to claim 1, further comprising:
a sensory stimulation device configured to apply at least one sensory stimulus over a human subject to induce neuronal activity to evoke a hemodynamic response in the target ROI,
wherein the computing device is configured to perform a comparison between the hemodynamic response evoked by the non-invasive transcranial neurostimulation device and the hemodynamic response evoked by the sensory stimulation device to correct a potential neurostimulation-induced confound on the HRF.
Conclusion
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.
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798
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