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 .
Specification
The disclosure is objected to because of the following informalities: The specification lists element 4 as the superficial area, the element, and the second element in paragraphs [0025]-[0028], [0035]-[0038], [0042], [0044], [0046], [0048], [0063]-[066], and [0074] of the pre-grant publication. It is suggested by the examiner to amend each recitation of “element 4” and “second element 4” to recite “superficial area 4”.
Appropriate correction is required.
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 1-10 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.
Regarding claim 1, claim 1 recites “applying a phase aberration correction to the detected ultrasound waves reflected or backscattered from the target imaging area”. In light of the specification it is unclear if this is the same or different from the phase aberration that is applied to the detected ultrasound waves reflected or backscattered from the first element. For examination purposes the claim will be interpreted as “applying a phase aberration correction to the detected ultrasound waves reflected or backscattered from the first element…applying the phase aberration correction to the detected ultrasound waves reflected or backscattered from the target imaging area”.
Regarding claim 2, claim 2 recites “the resource-efficient ray-tracing technique comprises a two-point ray tracing technique”. However the resource-efficient ray-tracing technique has not been previously defined therefore it is unclear what the claim is referring to. For examination purposes the claim will be interpreted as “the phase aberration correction comprises a two-point ray tracing technique”.
Regarding claim 2, claim 2 recites “determining a shortest travel time connecting a pixel in the element, or inside the first element, or in the target imaging area, to a source or receiver element of the ultrasound probe”. It’s unclear what “the element” is referring to. The specification recites in [0035] “determining a shortest travel time connecting a pixel in the element 4, or inside the first element 5, or in the target imaging area 6”. Element 4 is also disclosed as the element number for the superficial area and the second element. For examination purposes the claim will be interpreted as “determining a shortest travel time connecting a pixel in the superficial area, or inside the first element, or in the target imaging area, to a source or receiver element of the ultrasound probe”.
Regarding claim 2, claim 2 recites “a source or receiver element of the ultrasound probe, for each of the plurality Nt of sources and for each of the plurality Nr of receiver elements”. However it is unclear if the sources are the same or different from the first plurality Nt of transmitter elements. It’s also unclear if the plurality Nt of sources and the plurality Nr of receiver elements are the same or different from the first plurality Nt of transmitter elements and the second plurality Nr of receiver elements. For examination purposes the claim will be interpreted as “a transmitter element or a receiver element of the ultrasound probe, for each of the first plurality Nt of transmitter elements and for each of the second plurality Nr of receiver elements”.
Regarding claim 3, claim 3 recites “wherein the ray-tracing technique comprises applying a ray-tracing kernel and a reconstruction kernel”. However it is unclear if the ray-tracing technique is referring to the two-point ray tracing technique as recited in claim 2 or if it is a different ray tracing technique. For examination purposes the claim will be interpreted as “wherein the two-point ray-tracing technique comprises applying a ray-tracing kernel and a reconstruction kernel”.
Regarding claim 4, claim 4 recites “applying a phase aberration correction to the detected ultrasound signal for a second element”. Firstly it is unclear if this is the same or different from the phase aberration recited in claim 1. Secondly in light of the specification it is unclear if the second element is the same as the superficial area. Throughout the specification of the current application the superficial area is labeled as element 4 and the second element is also labeled as element 4. The second element is disclosed as being the skin layer which is the superficial layer of the head. Therefore it is unclear how the second element is different from the superficial area. For examination purposes the claim will be interpreted as “further including applying the phase aberration correction to the detected ultrasound signal for the superficial area, the superficial area having predetermined acoustic properties”.
Claims 5-10 are also rejected due to their dependency.
Claim 10 invalid under 35 USC 112(b) since a claim which purports to be both machine and process is ambiguous and therefore does not particularly point out and distinctly claim the subject matter of the invention. Ex parte Lyell, 17 USPQ2d 1548 (1990). Claim 10 is claiming a system and is also claiming the method of claim 1 therefore it is unclear if claim 10 is a system or method claim.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Vortman (US 20040006272).
Regarding claim 1, Vortman discloses a method for transcranial ultrasound imaging (Abstract – “A method of imaging a site of interest in a body using an ultrasound probe”, FIG. 6, [0071] – “The transducer array 32 is shown adjacent to the skin 70 and the skull bone tissue 72 for imaging brain tissue 76”), comprising:
sending, by an ultrasound probe, an ultrasound wave to a target imaging area through a superficial area and a first element, wherein the ultrasound wave travels through the target imaging area, the superficial area and the first element at different ultrasound wave speeds ([0072] – “ultrasound beams B 4, B5 are shown being transmitted by transducer elements 33a, 33c…Ray R14 shows the effect of refraction on the beam B4 due to the interface between the bone tissue region 72 and the skin 70. The ray R16 shows the effect of refraction on the ray R14 at the interface between the bone tissue region 72 and the brain tissue region 76”, the speed of sound is different for the skin, the bone tissue, and the brain tissue therefore the ultrasound wave would travel through each type of tissue at different wave speeds);
detecting, by the ultrasound probe, ultrasound waves reflected or backscattered from the target imaging area through the first element and the superficial area, and detecting, by the ultrasound probe, ultrasound waves reflected or backscattered from the first element through the superficial area ([0037] – “receives echo signals detected by the transducer elements 12 a from tissue and other reflecting bodies in the pass zone”);
processing the detected ultrasound waves ([0006] – “detection and processing of echo signals”) by:
using estimates of the wave speed in the superficial area, in the first element and in the target imaging area ([0012] – “The speed of sound in the selected tissue region other than an average speed of sound in body tissue is preferably “about” the speed of sound in the tissue type of the selected tissue region”); and
using the detected ultrasound waves reflected or backscattered from the first element through the superficial area for forming the ultrasound image of the superficial area until the near surface of the first element (Abstract – “obtaining an ultrasound image of a pass zone between the ultrasound probe and the site of interest”); and
determining the position and geometry of the near surface of the first element ([0045] – “During segmentation, the boundaries are defined. Every voxel in the segmented volume is automatically mapped into a pass zone data set and correlated to a tissue type. Each voxel is assigned coordinates identifying its location in space ((X, Y)”); and
applying a phase aberration correction ([0065] – “tissue aberration correction method”, [0017] – “phase shift for each ultrasound beam, caused by passage through the selected tissue region”) to the detected ultrasound waves reflected or backscattered from the first element by defining intermediate points on the near surface of the first element to test different ultrasound ray paths, for forming the ultrasound image of the first element until the far surface of the first element, using the estimates of wave speed, and the position and geometry of the near surface of the first element (Fig. 6, [0072] – “Ray R14 shows the effect of refraction on the beam B4 due to the interface between the bone tissue region 72 and the skin 70”, as shown in Fig. 6 Ray R18 also shows refraction on the beam due to the interface between the near surface of the bone tissue region and the skin, [0073] – “ray segments R 18, R20 need to be generated by the controller 14 between the first transducer element 33 a and the focal point P10, as either forward rays drawn from the transducer element 33 a to the focal point P10 or reverse rays drawn from the focal point P10 to the transducer element 33 a on a segmented image. The lengths of the ray segments R18, R20 may be determined based on the coordinates of the boundaries… The propagation times for ultrasound beams traveling the lengths of the ray segments R18, R20 are determined through Equation 2, above” equation 2 includes the wave speed); and
determining the position and geometry of the far surface of the first element ([0045] – “During segmentation, the boundaries are defined. Every voxel in the segmented volume is automatically mapped into a pass zone data set and correlated to a tissue type. Each voxel is assigned coordinates identifying its location in space ((X, Y)”); and
applying a phase aberration correction ([0065] – “tissue aberration correction method”, [0017] – “phase shift for each ultrasound beam, caused by passage through the selected tissue region”) to the detected ultrasound waves reflected or backscattered from the target imaging area by defining intermediate points on the far surface of the first element to test different ultrasound ray paths, for forming the ultrasound image of the target imaging area using the estimates of wave speed, and the position and geometry of the near and far surfaces of the first element (Fig. 6, [0072] – “ray R16 shows the effect of refraction on the ray R14 at the interface between the bone tissue region 72 and the brain tissue region 76”, as shown in Fig. 6 Ray R20 also shows refraction on the beam due to the interface between the far surface of the bone tissue region and the brain tissue, [0073] – “ray segments R 18, R20 need to be generated by the controller 14 between the first transducer element 33 a and the focal point P10, as either forward rays drawn from the transducer element 33 a to the focal point P10 or reverse rays drawn from the focal point P10 to the transducer element 33 a on a segmented image. The lengths of the ray segments R18, R20 may be determined based on the coordinates of the boundaries… The propagation times for ultrasound beams traveling the lengths of the ray segments R18, R20 are determined through Equation 2, above” equation 2 includes the wave speed);
wherein the phase aberration correction includes the evaluation of the travel times for multiple ultrasound ray paths passing through the intermediate points defined on the near and far surfaces of the first element, and determines the correct ultrasound ray path by selecting the ultrasound ray path with the shortest travel time (Fig. 6 shows multiple ray paths and [0073] discloses “The propagation times for ultrasound beams traveling the lengths of the ray segments R18, R20 are determined through Equation 2, above…The propagation times are summed to obtain a total propagation time for use in computing a transmission delay”, although it is not explicitly disclosed by Vortman it would be obvious to one with ordinary skill in the art to select the ultrasound ray path with the shortest travel time to make the acquisition time faster).
Regarding claim 7, Vortman discloses all the elements of the claimed invention as cited in claim 1.
Vortman further discloses wherein the steps of processing are executed on a graphical processing unit (GPU), a cluster processing system, and/or a central processing unit (CPU) ([0038] – “The controller 14 performs processing…the controller 14 may be a general purpose, or special purpose, digital data processor or computer”).
Claims 2-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Vortman (US 20040006272) as applied to claim 1 above, and further in view of Zachar (US 20190030375).
Regarding claim 2, Vortman discloses all the elements of the claimed invention as cited in claim 1.
Vortman further discloses wherein the ultrasound waves are sent and detected using an ultrasound probe ([0072] – “ultrasound beams B 4, B5 are shown being transmitted by transducer elements 33a, 33c”, [0037] – “receives echo signals detected by the transducer elements 12 a”) […], and the resource-efficient ray-tracing technique comprises a two-point ray tracing technique determining a shortest travel time connecting a pixel in the element, or inside the first element, or in the target imaging area, to a source or receiver element of the ultrasound probe, for each of the plurality Nt of sources and for each of the plurality Nr of receiver elements, via one intermediate point per crossed interface (As seen in Fig. 6 each ray (R14, R16, R18, R20) each connects two points, [0051] – “For the first ray, R1, a distance R1L1 of the ray segment…The distance R1L1 may be computed by identifying the voxel coordinates on the boundary that the beam traverses”, as seen in Fig.6 there would be a ray connecting the transducer element to the first boundary of the skull, as recited by the examiner above it would be obvious to one with ordinary skill in the art to select the ultrasound ray path with the shortest travel time to make the acquisition time faster).
Conversely Vortman doesn’t teach an ultrasound probe having a first plurality Nt of transmitter elements and a second plurality Nr of receiver elements.
However Zachar discloses an ultrasound probe having a first plurality Nt of transmitter elements and a second plurality Nr of receiver elements ([0159] – “the array of receiver element marked by shaded fill cells may be distinct from the array of emitter elements”).
The disclosure of Zachar is an analogous art considering it is in the field of a transcranial ultrasound.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Vortman to incorporate a first plurality of transmitter elements and a second plurality of receiver elements of Zachar to achieve the same results. One would have motivation to combine because it would eliminate the need to switch the transducers between transmit and receive and therefore shorten acquisition time.
Regarding claim 3, Vortman and Zachar disclose all the elements of the claimed invention as cited in claims 1 and 2.
Vortman further discloses wherein the ray-tracing technique comprises applying a ray-tracing kernel and a reconstruction kernel consecutively (As seen in Fig. 1 the ultrasound system 10 comprises a controller 14 and a signal and image processor, [0073] – “ray segments R 18, R20 need to be generated by the controller 14”, [0033] – “The signal and image processor 20 has an input coupled to an output of the RF processor 16 to receive the processed signals for further processing and reconstruction”, therefore the controller is interpreted as the ray-tracing kernel and the signal and image processor is interpreted as reconstruction kernel), first for finding intermediate points on a near surface of the first element, then for finding intermediate points on the far surface of the first element ([0073] – “ray segments R 18, R20 need to be generated by the controller 14”, [0051] – “For the first ray, R1, a distance R1L1 of the ray segment…The distance R1L1 may be computed by identifying the voxel coordinates on the boundary that the beam traverses”), and, finally, to generate the transcranial ultrasound image ([0037] – “The beam former 18 applies suitable reception delays to the echo signals and sends the signals to the RF processor 16 and the signal and image processor 20 for reconstruction and display on the display 22”, [0043] – “A-mode or B-mode images may be reconstructed”).
Regarding claim 4, Vortman discloses all the elements of the claimed invention as cited in claim 1.
Conversely Vortman does not teach further including applying a phase aberration correction to the detected ultrasound signal for a second element, the second element having predetermined acoustic properties.
However Zachar discloses further including applying a phase aberration correction to the detected ultrasound signal for a second element, the second element having predetermined acoustic properties ([0173] – “the focus of our discussion is on detection and correction of reflections between the first skull boundary entry surface 151 and the second skull bone boundary exit surface 152. Yet, this is not meant to be limiting. The inclusion of the scalp layer 155 is a simple extension of the entry reference to the skin surface 153 entry instead of the bone entry surface 151. Hence, the first reflection delay count would be from the path 173, which is identifiable as known in the art to select among the series of echo received signals”, Fig.10C shows the acoustic properties (velocity for soft tissue).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Vortman to incorporate the phase aberration correction to the detected ultrasound signal for the scalp of Zachar to achieve the same results. One would have motivation to combine because it would provide a more accurate phase aberration correction and therefore provide a better image of the target.
Regarding claim 6, Vortman and Zachar disclose all the elements of the claimed invention as cited in claims 1 and 2.
Vortman further discloses wherein the ultrasound probe comprises a one-dimensional array or a two-dimensional array ([0035] – “The transducer array 24 may be a single row or a matrix of transducer elements 12 a”).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Vortman (US 20040006272) and Zachar (US 20190030375) as applied to claim 1 above, and further in view of Ebbini (US 20190308036).
Regarding claim 5, Vortman and Zachar disclose all the elements of the claimed invention as cited in claims 1 and 2.
Conversely Vortman does not teach wherein the ultrasound probe further includes an acoustic lens.
However Ebbini discloses wherein the ultrasound probe further includes an acoustic lens ([0011] – “an ultrasound transducer system including a lens layer”).
The disclosure of Ebbini is an analogous art considering it is in the field of a transcranial ultrasound.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Vortman to incorporate the acoustic lens of Ebbini to achieve the same results. One would have motivation to combine “to partially or completely compensate for a predetermined ultrasound beam distortion associated with an ultrasound obstacle” (Ebbini [0011]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Vortman (US 20040006272) as applied to claim 1 above, and further in view of De’an (CN112764040A) machine translation.
Regarding claim 8, Vortman disclose all the elements of the claimed invention as cited in claim 1.
Conversely Vortman does not teach wherein sending and detecting the ultrasound signal is applied in accordance with a synthetic aperture imaging (SAI) scheme.
However De’an discloses wherein sending and detecting the ultrasound signal is applied in accordance with a synthetic aperture imaging (SAI) scheme ([0032] – “the transmit and receive mode of synthetic aperture imaging technology”).
The disclosure of De’an is an analogous art considering it is in the field of a transcranial ultrasound.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Vortman to incorporate the synthetic aperture imaging scheme of De’an to achieve the same results. One would have motivation to combine because “the dynamic focusing characteristics of its transmit-receive method are utilized to effectively improve the resolution of image reconstruction and maintain the consistency of resolution at different detection depths” (De’an [0032]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Vortman (US 20040006272) as applied to claim 1 above, and further in view of Jiaotong (CN108836389A) machine translation.
Regarding claim 9, Vortman discloses all the elements of the claimed invention as cited in claim 1.
Conversely Vortman does not teach wherein sending and detecting the ultrasound signal is applied in accordance with a multi angle plane wave imaging (MA-PWI) scheme, or a multi angle diverging wave imaging (MA-DWI) scheme.
However Jiaotong discloses wherein sending and detecting the ultrasound signal is applied in accordance with a multi angle plane wave imaging (MA-PWI) scheme, or a multi angle diverging wave imaging (MA-DWI) scheme ([0048] – “The present invention utilizes coherent time delay to reflect the impact of ultrasound on target sampling points at relevant points. When combined with single-angle or multi-angle plane wave adaptive beamforming”).
The disclosure of Jiaotong is an analogous art considering it is in the field of a transcranial ultrasound.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Vortman to incorporate a multi angle plane wave imaging scheme or a multi angle diverging wave imaging scheme of Jiaotong to achieve the same results. One would have motivation to combine because it “improves imaging contrast and resolution by removing unnecessary information, thereby improving imaging image quality” (Jiaotong [0048]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Vortman (US 20040006272) as applied to claim 1 above, and further in view of Hynynen (US 20200205773).
Regarding claim 10, Vortman discloses all the elements of the claimed invention as cited in claim 1.
Vortman discloses a system for transcranial ultrasound imaging (TUI) ([0032] – “FIG. 1 is a schematic representation of an ultrasound imaging system 10”, FIG. 6, [0071] – “The transducer array 32 is shown adjacent to the skin 70 and the skull bone tissue 72 for imaging brain tissue 76”), comprising
an ultrasound unit having an ultrasound probe with a plurality of transmitter and receiver elements for sending and detecting an ultrasound signal ([0010] – “the ultrasound probe comprises a plurality of ultrasound transducer elements”, [0091] – “the ultrasound probe 12 may comprise multiple sections of transducer elements, each for transmitting ultrasound”, [0067] – “echo signals received by the transducer elements”);
a processing unit connected to the ultrasound unit, and arranged for data manipulation and image display (Fig. 1 – signal and image processor (20), [0033] – “The signal and image processor 20 has an input coupled to an output of the RF processor 16 to receive the processed signals for further processing and reconstruction, as is known in the art. The processor 20 provides the reconstructed signals to the display 22”); and
a […] unit connected to the processing unit and arranged to execute the method according to claim 1 (As cited above Vortman teaches claim 1, Vortman also discloses a controller connected to the signal and image processor (20) as shown in Fig. 1, [0038] – “The controller 14 performs processing, logic and timing functions related to the operation of the ultrasound imaging system 10”).
Conversely Vortman does not teach a graphic processing unit.
However Hynynen discloses a graphic processing unit ([0083] – “The image reconstruction algorithms and software in some embodiments may utilize a graphic processing unit (GPU)”).
The disclosure of Hynynen is an analogous art considering it is in the field of a transcranial ultrasound.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Vortman to incorporate a graphic processing unit of Hynynen to achieve the same results. One would have motivation to combine “to rapidly beamform the digitized received RF signals from each transducer element into a three-dimensional (3D) imaging grid” (Hynynen [0083]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE C LANGHALS whose telephone number is (571)272-6258. The examiner can normally be reached Mon.-Thurs. alternate Fridays 8:30-6.
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, Christopher Koharski can be reached at 571-272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/R.C.L./Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797