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 .
Response to Arguments
Regarding 35 U.S.C. 101
Examiner notes that the previously set forth 101 rejections are withdrawn in view of the amendments to the claims. Specifically, examiner notes that the claims as a whole including a head holder configured to hold a plurality of ultrasound probe which are configure to be disposed at positions of a plurality of openings of a head of an infant subject and generation of a plurality of local brain images at a frame rate higher than a Nyquist frequency, combining the plurality of local brain images and performing coordinate transformation are additional elements that when considered as a whole in addition to the judicial exception amount to significantly more than the judicial exception.
Regarding 35 U.S.C. 112(f)
Examiner notes that the previously set forth 112(f) claim interpretation is withdrawn in view of the amendments to the claims.
Regarding 35 U.S.C. 112(b)
Examiner notes that the previously set forth 112(b) rejections are withdrawn in view of the amendments to the claims, however, new 112(b) rejections are necessitated by amendment. Regarding prior art
Applicant’s arguments with respect to claim 1 have been considered but are moot in view of the new grounds of rejection necessitated by amendment, however, examiner will address arguments which remain relevant to the current rejection.
Applicant's arguments filed 10/06/2025 with respect to the teaching of Browning and Lazebnik have been fully considered but they are not persuasive.
For example, applicant argues Browning fails to disclose that “the head holder that implements the probe arrangement specialized for infant subjects and the image processor generating brain functional network information. In particular, Browning fails to disclose generating a correlation of a temporal change of a cerebral blood flow signal intensity among the plurality of brain regions” (REMARKS pg. 18 and 21)
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “a head holder that implements the probe arrangements specialized for infant subjects” and “generating a correlation of a temporal change of a cerebral blood flow signal intensity among the plurality of brain regions”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Examiner notes that the claim merely recites a head holder configured to hold the ultrasound probe and that the probes are configured to be disposed at positions of a plurality of openings of a head of an infant subject. Such a claim is broad and does not explicitly nor implicitly require a head holder that implements the probe arrangement specialized for infant subjects. Nonetheless, it is noted that in the updated rejection Browning is relied upon for a secondary teaching of the head holder and generation of brain functional network and Lazebnik is relied upon as a primary reference for a majority of the claimed invention. In this case, it is noted that a person having ordinary skill in the art would have recognized the use of the helmet/head holder of Browning to be used on the infant subject of Lazebnik in order to secure the probes of Lazebnik to the head of the subject accordingly without any requirement of “specialization” for use accordingly. Furthermore, the claim does not require generating a correlation of a temporal change of a cerebral blood flow signal intensity among the plurality of brain regions, but rather requires generating the brain functional network information based on a correlation of a temporal change of a cerebral blood flow signal intensity among the plurality of brain regions. Thus the generation of the brain functional network information of Browning would necessarily be based on a correlation of a temporal change of a cerebral blood flow signal intensity among the plurality of brain regions. Nonetheless, examiner notes that the limitation for which applicant argues is not taught by Browning is broad and it is noted that Browning is considered to teach a correlation of a temporal change of a cerebral blood flow signal intensity among the plurality of brain regions in at least [0031] disclosing correlation (i.e. comparison) of temporally different images. Applicant’s arguments are found to be merely conclusory without any evidence/suggestion as to why the teachings of [0031] are not found to teach the feature. Applicant’s arguments do not replace evidence where evidence is necessary (MPEP 2145). For at least the reasons listed above, applicant’s arguments are not found persuasive with respect to the teachings of Browning.
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, 5-8, and 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.
Claim 1 recites the limitation “the plurality of ultrasound probes are further configured to be disposed at positions of a plurality of openings of a head of an infant subject”. It is unclear if the positions of the plurality of openings of the head are the same as or different from the head regions. In other words, it is unclear if the claim is attempting to further define the head regions to be or correspond with positions of the plurality of openings or if these are different positions for a different configuration of the ultrasound probe. For examination purposes, it has been interpreted that the openings may be different or the same as the plurality of head regions, however, clarification is required.
Claim 1 recites the limitation “a plurality of local brain images”. It is unclear if the local brain images is or correspond with the ultrasound probes/measurement results therefrom recited previously or if these are different local brain images from a different imaging modality. For examination purposes, it has been interpreted that the plurality of local brain images are generated from data (or the measurement result) received by the ultrasound probes, however, clarification is required.
Claim 1 recites the limitation “generates a plurality of local brain images for each of the brain regions at a frame rate higher than a Nyquist frequency”. It is unclear what is meant by generating… at a frame rate. For example, the specification appears to describe the frame rate with respect to image measurement, thus it is unclear if the claim is attempting to define a frame rate at which images are generated or if the claim is attempting to define that the ultrasound probes capture data/perform measurement at a frame rate higher than a Nyquist frequency. For examination purposes, it has been interpreted to mean that the frame rate of the images is at a frame rate higher than a Nyquist frequency, however, clarification is required.
Claim 1 recites the limitation “a plurality of local brain images for each of the brain regions” and “the plurality of local brain images”. Examiner notes that the limitation “a plurality of local brain images for each of the brain regions” appears to describe that each of the brain regions has a plurality of local brain images generated therefor, thus it is unclear which “plurality of local brain images” the claim is referring to in the second instance (i.e. which plurality of local brain regions for which brain region). For examination purposes, it has been interpreted to mean that either a local brain image is generated for each of the brain regions resulting in a plurality of local brain images or that the second instance of the plurality of local brain images is referring to any of the plurality of local brain regions for any of the brain regions, however, clarification is required.
Claim 1 recites the limitation “combines the plurality of local brain images by superimposing… and generates a wide-area brain image of the entire brain”. It is unclear if the wide-area brain image is a result of the combining of the plurality of local brain images or if this is a different generated image. For examination purposes, it has been interpreted to mean any wide-area brain image, however, clarification is required.
Claim 10 recites the limitation “the number of links connected to the node i”. The limitaiton lacks sufficient antecedent basis as no links have been previously set forth and no node “I” is previously set forth, thus making it unclear which links and which node the claim is referring to. For examination purposes, it has been interpreted to mean any links and any node, however, clarification is required.
Claim 10 recites the limitation “between nodes i and j”. It is unclear what is meant by node j as no node “j” has been previously set forth.
Claim 10 recites the limitation “the number of triangles having the node I as one node and neighboring nodes connected to each other as nodes by the number of links connected to the node i”. The limitation lacks sufficient antecedent basis and it is unclear what is meant by the number of triangles having the node I as one node and neighboring nodes connected to each other. It is further unclear if the neighboring nodes are or include node j recited previously. For examination purposes, it has been interpreted to mean any clustering coefficient, however, clarification is required.
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.
Claims 1-2 and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Lazebnik et al. (US 20090265760 A1), hereinafter Lazebnik in view of Browning et al. (US 20100160779 A1), hereinafter Browning and Haeusser et al. (US 20200345261 A1), hereinafter Haeusser.
Regarding claim 1,
Lazebnik teaches an ultrasound device (at least fig. 1 (10) and corresponding disclosure in at least [0023]) comprising:
A plurality of ultrasound probes (at least fig. 1 (12) and corresponding disclosure in at least [0024] and [0055] which discloses alternatively multiple transducers are used to allow either sequential or simultaneous scanning from different windows) configured to transmit an ultrasound signal and receive a reflected signal ([0034]),
Wherein the plurality of ultrasound probes (12) are configured to be disposed at a plurality of head regions to transmit the ultrasound signal and receive the reflected signal from a plurality of brain regions ([0035] which discloses one or more scans are performed with the transducer of at least two different fontanel and [0055] which discloses alternatively multiple transducers are used to allow either sequential or simultaneous scanning from different windows);
Wherein the plurality of ultrasound probes are further configured to be disposed at positions of a plurality of openings of a head of an infant subject (see at least fig. 2 and [0055] which discloses For an infant or neo-natal head, the acoustic windows include the anterior fontanel, posterior fontanel, and mastoid fontanel) , and
Wherein the plurality of openings are usable as acoustic windows of the ultrasound signals (see at least fig. 2 and [0055] which discloses For an infant or neo-natal head, the acoustic windows include the anterior fontanel, posterior fontanel, and mastoid fontanel),
A controller (at least fig. 1 (18) and corresponding disclosure in at least [0034]) that controls the plurality of ultrasound probes ([0034] which discloses the ultrasound imaging system 18 causes a scan of an internal region of a patient with the transducer 12); and
An image processor (at least fig. 1 (20) and corresponding disclosure in at least [0038]) that generates a plurality of local brain images for each of the brain regions at a frame rate ([0035] which discloses one or more two-dimensional planes are scanned at each fontanel);
Combines the plurality of local brain images by superimposing on each other overlapping portions of the local brain images and generates a wide-area brain image of the entire brain ([0038] which discloses the processor 20 combines data from scans for the different fontanels into a composite data set. To combine the data, the regions represented by the data sets are spatially registered. In one embodiment, cross-correlation, minimum sum of absolute differences, or other similarity function is used to identify the relative translation and/or orientation of the regions. The best or sufficient match of the data to each other is determined. The translation and/or rotation associated with the match indicate the different or relative positions of the regions represented by the data. The match spatially aligns the data from the scans for the different fontanels, [0041] which discloses where data from multiple sets or different scans represents a same spatial location, the data is combined, such as averaged, [0056] which discloses The data for the acquisitions represents an overlapping region. Some data from each acquisition may represent locations not represented in another acquisition. The data sets are spatially registering to align the overlapping regions and [0007] which discloses volumes from multiple acoustic windows for the infant head are aligned and combined. The combination provides a dataset better representing the entire region of interest)
Performs coordinate transformation on the wide-area image into a three-dimensional brain atlas ([0041] which discloses data from one or more scans may be converted or formatted to a grid associated with another of the scans or a reference grid. For example, the data representing different volumes is interpolated to a three-dimensional reference grid. Such interpolation/association to a reference grid is considered to include a coordinate transformation on the wide-area image into a three-dimensional atlas (i.e. reference grid)).
Lazebnik fails to explicitly teach a head holder configured to hold the plurality of ultrasound probes,
And the image processor generates brain functional network information calculated from a blood flow state among the plurality of brain regions based on a measurement result acquired from the plurality of ultrasound probes and generates the brain functional network information based on a correlation of a temporal change of a cerebral blood flow signal intensity among the plurality of brain regions.
Browning, in a similar field of endeavor involving ultrasound imaging, teaches a head holder (at least fig. 2A-2B (200) and corresponding disclosure in at least [0019]) configured to hold a plurality of ultrasound probes ([0019] which discloses transducer arrays positioned inside the helmet liner on either side as indicated by the locations of circles 204,206)
An image processor (at least fig. 1 (30) and corresponding disclosure in at least [0018]) that generates brain functional network information calculated from a blood flow state among the plurality of brain regions based on a measurement result acquired from the plurality of ultrasound probes (see at least figs. 6A-6D and corresponding disclosure in at least [0022-[0023] where it is noted that the vascular map is considered to be or include brain functional network information that is generated by an image processor and calculated from a blood flow state among the plurality of brain regions based on a measurement result acquired from the plurality of ultrasound probes (e.g. calculated from doppler data) acquired from the plurality of ultrasound probes from a blood flow state among the plurality of brain regions)
And wherein the image processor generates the brain functional network based on a correlation of a temporal change of a cerebral blood flow signal intensity among the plurality of brain regions ([0031] which discloses successive images of the vasculature are formed at the base station they are stored in an image store 52, and temporally different images are compared to detect changes in flow of the vasculature by operation of flow change detector 50. The flow change detector operates by comparing the identical nature of the temporally different images and As long as successive images and images separated by greater time intervals appear substantially the same in their flow characteristics, e.g., there is no localized change in the flow characteristics of a particular section of the vasculature and no section of the vasculature has ceased to return a Doppler signal indicating the continuation of flow, the flow change detector 50 will continue its monitoring of the vasculature with no change. For example, the vasculature may appear as the vascular network 300 of FIG. 6a for an extended period, and suddenly a section of the flow may cease to be detected as illustrated by the absence of vessels 302 in FIG. 6c. If a flow change such as one of those indicated above is detected by the flow change detector 50, an alarm is activated such as an audible alarm 42 at a nurse's station)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Lazebnik to include a head holder as taught by browning in order to holde the transducers/probes securely against the skin of the subject thereby providing good acoustic contact at the acoustic windows (Browning [0019]).
It would have been further obvious to a person having ordinary skill in the art before the effective filing date to have modified Lazebnik to include generating brain functional network information as taught by Browning in order to monitor the subjects vasculature for clots or occlusions (Browning [0005]). Such a modification would additionally provide valuable diagnostic data of the patient’s vasculature which is an important diagnostic application for neonatal head imaging for which the system of Lazebnik is useful (Lazebnik [0022]).
Lazebnik further fails to explicitly teach the local brain images for each of the brain regions is at a frame rate higher than a Nyquist frequency of the maximum frequency in the hemodynamics associated with neural excitation.
Haeusser, in a similar field of endeavor involving ultrasound imaging, teaches the importance of frame rates above the Nyquist frequency in [0136].
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Lazebnik to include a frame rate higher than a Nyquist frequency as taught by Haeusser in order to permit accurate and reliable reconstruction of the movement of objects or events from frame to frame (Haeusser [0136]).
Examiner notes that in the modified system the Nyquist frequency is associated with the events or objects desired to be captured as taught by Haeusser in [0136], thus would be a Nyquest frequency of the maximum frequency in the hemodynamics associated with neural excitation in the brain acquisition taught by Lazebnik.
Regarding claim 5,
Lazebnik further teaches wherein the plurality of head regions include two or more of a frontal fontanelle, a posterior fontanelle, and the mastoid fontanel ([0055] which discloses the scanning is from different acoustic windows. Any two or more different acoustic windows may be used. Alternatively, multiple transducers are used to allow either sequential or simultaneous scanning from different windows. For an infant or neo-natal head, the acoustic windows include the anterior fontanel, posterior fontanel, and mastoid fontanel).
Regarding claim 6,
Lazebnik further teaches wherein the controller controls the plurality of ultrasound probes such that the plurality of ultrasound probes transmit and receive ultrasound signals alternately ([0053] which discloses Any type of scanning may be used, such as planar or volume scanning. For planar scanning, multiple planes are sequentially scanned and [0055] which discloses Alternatively, multiple transducers are used to allow either sequential or simultaneous scanning from different windows)
Regarding claim 7,
Lazebnik further teaches wherein each of the plurality of ultrasound probes has a plurality of transducers arranged in an array ([0024] The transducer 12 is a single element transducer, a linear array, a curved linear array, a phased array, a 1.5 dimensional array, a two-dimensional array, a radial array, an annular array, a multidimensional array, a wobbler, or other now known or later developed array of elements) and form a wavefront of an arbitrary shape to transmit the ultrasound signal by controlling the plurality of transducers ([0034] which discloses a transmit beamformer and transmit signals are generated and provided to the transducer. Examiner notes that such beamforming on transmit of an ultrasound transducer necessarily forms a wavefront of an arbitrary shape)
Regarding claim 8,
Lazebnik further teaches wherein the image processor generates an image representing the plurality of brain regions on a three-dimensional atlas coordinate by performing coordinate transformation on the wide-area brain image into a standard brain image prepared in advance ([0041] which discloses data from one or more scans may be converted or formatted to a grid associated with another of the scans or a reference grid. For example, the data representing different volumes is interpolated to a three-dimensional reference grid).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Browning, Lazebnik, and Haeusser as applied to claim 1 above and further in view of Sughrue et al (US 11335453 A1), hereinafter Sughrue.
Regarding claim 10,
Lazebnik, as modified, teaches the elements of claim 1 as previously stated. While Browning, as applied to claim 1 above, further teaches that the vascular flow network is represented as a graphical structure see figs. 6A-6D and corresponding disclosure in at least [0023], it is unclear if such a structure is considered a “graph” structure. Lazebnik thus fails to explicitly teach wherein the brain functional network is represented as a graph structure using:
A set of M of nodes which are ROIs corresponding to the plurality of brain regions; a degree ki which is the number of links connected to the node i, the link corresponding to a correlation coefficient showing the correlation; a shortest path length dij which is the shortest distance between nodes I and j and a clustering coefficient cj which is a value acquired by dividing the number of triangles having the node i as one node and neighboring nodes connected to each other as nods by the number of links connected to the node i.
Sughrue, in a similar field of endeavor involving brain monitoring, teaches wherein a brain functional network is represented as a graph structure (at least fig. 3 (340) and corresponding disclosure in at least Col. 12 lines 36-63) using:
A set of M of nodes (at least fig. 3 (341) and corresponding disclosure in at least Col. 12 lines 36-63) which are ROIs corresponding to a plurality of brain regions (examiner notes that the nodes are considered regions of interest corresponding to a plurality of brain regions);
a degree ki which is the number of links connected to the node i (See at least fig. 3 and Col. 12 lines 36-63 disclosing links/edges connecting the notes where a degree ki is represented by the graph structure 340), the link corresponding to a correlation coefficient showing the correlation (Col. 3 lines 26-28 where the connectivity data represents a degree of correlation);
a shortest path length dij which is the shortest distance between nodes I and j (Col. 14 line 67-Col. 15 line 3 the betweenness centrality for each node may be the number of shortest paths that pass through the node. See also the brain connectivity data depicting a shortest path length between nodes I and j (i.e. any of the nodes)) and
a clustering coefficient cj which is a value acquired by dividing the number of triangles having the node i as one node and neighboring nodes connected to each other as nods by the number of links connected to the node I (Col. 15 line 4-8 which discloses the parameters and metrics can include clustering coefficient, which is a measure of the degree to which nodes tend to cluster together with other nodes of the brain).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Browning to a graph structure as taught by Sughrue in order to provide insights about structures, connectivity, and centrality in a subject’s brain which allow for improved and more informed diagnosis, treatments, operations, research or their combinations (Sughrue Col. 1 lines 43-48)
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 BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
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/BROOKE LYN KLEIN/Examiner, Art Unit 3797
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