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
Applicant's arguments filed 11/7/2025 have been fully considered but they are not persuasive | moot in view of the new grounds of rejection.
Applicant’s arguments with respect to claims 1, 3, 4, 6, 8, and 12 and the Osaka reference have been considered but are moot because the new ground of rejection does not rely on the Osaka reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 11/7/2025 have been fully considered but they are not persuasive. Applicant argues on page 13 of the remarks “The present invention explicitly requires the sampling points to be "specific coordinate points located in the coordinate system, distributed according to a specific pattern," which includes customizable distribution patterns (e.g., avoiding blood vessels), providing flexible sampling strategies”. However the claim recites “which can be distributed according to specific positions”. Therefore the claim does not require the specific coordinate points to be distributed according to a specific pattern.
Applicant's arguments filed 11/7/2025 have been fully considered but they are not persuasive. Applicant argues on pages 13-14 of the remarks “The present invention requires "simultaneously or with mutual delay executing parameter measurement on multiple sampling points," combined with parallel control of array elements, achieving rapid or synchronous data acquisition for multiple points in space". As recited below this is taught by Varghese by teaching capturing data of a data plane by capturing the shear waves at multiple times each time having a different phase delay and measuring propagation of the shear wave 68 in terms of arrival time at various locations along the x-axis. Therefore Varghese teaches with mutual delay executing parameter measurement on multiple sampling points.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
An image acquiring unit in claim 9, claim 9 recites “an image acquiring unit for acquiring an ultrasonic image of a target object”.
A main control unit in claims 9, claim 9 recites “a main control unit, respectively connected with the image acquiring unit and the probe, is used to acquire ultrasonic image of the target object, establish a coordinate system of a sampling region of interest of a corresponding dimension, and determine a number of sampling points and coordinate distribution positions thereof; receive the elastic feature parameters of the corresponding region of interest of the target object, map to generate an elastic map, and superimpose and fuse the elastic map containing elastic distribution data to the ultrasonic image and display it synchronously”.
a control unit in claim 9, claim 9 recites “the control unit is used to receive the ultrasonic image of the image acquiring unit and transmit the ultrasonic image to the processing unit…the control unit is also used to control the low-frequency vibrator to send shear waves to the target object according to the distribution coordinates of the sampling points, and send ultra-high frame rate ultrasound signals to the distribution coordinates of the sampling points with the ultrasonic transducer array elements of the probe, and receive RF signals fed back by the distribution coordinates of the sampling points and transmit the RF signal obtained by the probe and its distribution data to the processing unit”.
a processing unit in claim 9, claim 9 recites “the processing unit is used to determine the distribution coordinates of the sampling points in the region of interest according to the ultrasonic image, and transmit the distribution coordinate information of the sampling points to the control unit…the processing unit is also used to calculate the corresponding elastic feature parameters according to the received RF signal of each coordinate and its distribution data, establish a single dimensional or multi-dimensional state elastic map, and fuse the corresponding map with the ultrasonic image”.
A display unit in claim 9, claim 9 recites “the fused image is synchronously displayed by a display unit”.
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.
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.
The image acquiring unit is disclosed as being different from the ultrasonic probe. Paragraph [0071] discloses “the processor is allowed to execute one-dimensional, two-dimensional and three-dimensional ultrasonic transient elastic detection steps: acquiring the two-dimensional ultrasonic image”. Therefore the image acquiring unit will be interpreted as a processor.
Regarding the main control unit paragraph [0071] discloses “the processor is allowed to execute one-dimensional, two-dimensional and three-dimensional ultrasonic transient elastic detection steps: acquiring the two-dimensional ultrasonic image, determining the position of the region of interest on the two-dimensional ultrasonic image; and establishing the sampling coordinate system of the corresponding dimension in the region of interest, and determining the number of and coordinate position of the sampling points in the selected corresponding dimension sampling coordinate system; measuring at least one elastic feature parameter on each selected sampling point in the region of interest through a probe; mapping and processing corresponding elastic feature parameters measured at each sampling point to construct an elastic map of the sampling coordinate system of the corresponding dimension; superimposing and fusing the elastic map of corresponding dimensions to the two-dimensional ultrasonic image and displaying it simultaneously”. Therefore the main control unit with be interpreted as a processor.
Regarding the control unit paragraph [0071] discloses “When the software execution code and algorithm program are executed by the processor in the process of elasticity dimensional detection of biological tissues… Further, triggering the probe to transmit directional ultra-high frame rate ultrasound signal to track the shear wave for sampling, and calculating the time delay of transmitting and receiving the ultrasonic wave for corresponding array elements in the transducer array before sampling; the sampling mode includes: obtaining a radio frequency (RF)”. Therefore the control unit with be interpreted as a processor.
Regarding the processing unit paragraph [0071] discloses “the processor is allowed to execute one-dimensional, two-dimensional and three-dimensional ultrasonic transient elastic detection steps:… determining the number of and coordinate position of the sampling points in the selected corresponding dimension sampling coordinate system; measuring at least one elastic feature parameter on each selected sampling point in the region of interest through a probe; mapping and processing corresponding elastic feature parameters measured at each sampling point to construct an elastic map of the sampling coordinate system of the corresponding dimension; superimposing and fusing the elastic map of corresponding dimensions to the two-dimensional ultrasonic image and displaying it simultaneously…calculating the elastic feature parameters at the designated position in the multi-dimensional space”. Therefore the processing unit with be interpreted as a processor.
Regarding the display unit paragraph [0044] discloses “The input of the display unit 40 is connected with the output of the main control unit 30, and a personal computer can be used as a carrier or it can be integrated with the main control unit 30”. Therefore the display unit with be interpreted as a personal computer.
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, 3, 6, 8, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Zeng NPL 2018 (“3D Liver Shear Wave Absolute Vibro-Elastography with an xMATRIX Array - A Healthy Volunteer Study”) and further in view of Varghese (US 20140243668) and Osaka (US 20120123263)
Regarding claim 1, Zeng discloses an elasticity dimensional detection method for biological tissue detection (Abstract – “We present a novel matrix array implementation of the 3D Shear Wave Absolute Vibro-Elastography (S-WAVE)”), wherein, the method comprises the following steps:
acquiring an ultrasonic image of a target object (pg. 3 right column – “the liver tissue ROI
is manually segmented based on the B-mode images”);
in response to an external vibration excitation, collecting elastic feature parameters at a designated coordinate position of the target object, and mapping to generate an elastic map (pg. 1 right col. – “Liver tissue shear wave excitation is provided by a shaker board placed underneath the patient’s back”, pg. 2 left column – “sampled axial displacement at voxel x in the 3D volume”, pg. 3 left col. – “Phasor slices and reconstructed elasticity maps are listed in Figure 1 (b), and (c) & (d), respectively”); and
superimposing and fusing the elastic map containing elastic distribution data to the ultrasonic image and simultaneously displaying (Pg. 4, Fig. 2a – “S-WAVE data for healthy volunteer #1. The center slice of the imaging volume for each frequency, including B-mode, shear wave and elasticity maps at the first scan location (rib 8-9) are presented, respectively” the images show the elasticity maps superimposed and fused to the ultrasonic image);
the step of in response to the external vibration excitation, collecting elastic feature parameters at the designated coordinate position of the target object, and mapping to generate the elastic map comprises:
the sampling region of interest is located in the ultrasonic image and is one of the coordinate systems of two-dimensional plane or three-dimensional space (Fig. 1 – “(b) Orthogonal slices of the real phasor volume showing the shear wave pattern at three excitation frequencies. (c) 3D orthogonal slices of the reconstruction result. (d) The center plane of the elasticity map, where the mean and standard deviation of the highlighted ROIs are reported”, pg. 3 left col. – “A 3D ROI at the imaging volume center, with a dimension of 5 cm (X) × 11 cm (Y) × 3 cm (Z), is cropped to sample the elasticity readings”);
measuring elastic feature parameters of the sampling points of the target object (Pg. 3 left col. – “A 3D ROI at the imaging volume center, with a dimension of 5cm (X) × 11 cm (Y) × 3 cm (Z), is cropped to sample the elasticity readings”, the ROI shown in Fig. 1 contains multiple shades of blue therefore there are sampling points within the ROI), the step of measuring elastic feature parameters further comprises: stimulating a probe to apply low-frequency mechanical vibration on a body surface to generate a shear wave to propagate […] in the biological tissue (Pg.3 left col. – “three measurements of the three vibration frequencies were taken from each of the three different imaging planes”, Fig. 1 and Table 1 both show the three frequencies as 38 Hz, 56 Hz, and 78 Hz which are all considered to be low-frequency as defined in the specification of the current application); controlling the array elements in the ultrasonic transducer array to transmit and receive an ultra-high frame rate ultrasonic signal to track the shear wave along the designated coordinate position or different directions of each sampling point (pg. 2 left column – “In EPIQ 7G’s CPA mode, the available color Doppler sampling (pulse repetition) rate ranges from 250 to 3500 Hz and could be maintained by the X6-1 transducer’s 3D scan sequence for all elevation planes. The RF data captured under such CPA setting is suitable for applying the sector based motion sampling method… response of a divergence-free shear wave field driven by a set of carrier frequencies fm, and we write the sampled axial displacement at voxel x in the 3D volume”),[…] and mapping to generate the elastic map (Abstract – “sample tissue motion and reconstruct the elasticity map in 3D”), the step of mapping to generate the elastic map further comprises: using mapping technology to encode the elastic feature parameters at the designated coordinate position into single value mapping or color mapping to represent the distribution state of elastic features (Fig. 1 and Fig. 2 show color mapping to represent the distribution state of elastic features, therefore one with ordinary skill in the art would find it obvious to use mapping technology to encode the elastic feature parameters at designated coordinate positions to create the color mapping shown in Figs. 1 and 2);
triggering the probe to transmit […] ultra-high frame rate ultrasonic signal to track the shear wave for sampling(pg. 2 left column – “In EPIQ 7G’s CPA mode, the available color Doppler sampling (pulse repetition) rate ranges from 250 to 3500 Hz and could be maintained by the X6-1 transducer’s 3D scan sequence for all elevation planes. The RF data captured under such CPA setting is suitable for applying the sector based motion sampling method… response of a divergence-free shear wave field driven by a set of carrier frequencies fm, and we write the sampled axial displacement at voxel x in the 3D volume”);
the external vibration excitation is continuously applied at a certain repetition rate, and the ultra-high frame rate ultrasonic signal simultaneously tracks the propagation of multiple shear waves generated in the biological tissue by continuous vibration (pg. 1-2 bridging paragraph – “Liver tissue shear wave excitation is provided by a shaker board placed underneath the patient’s back. The vibration of the shaker board is generated by a linear voice coil motor driven through an audio amplifier by a programmable signal generator. The ultrasound radio frequency (RF) data is captured during the examination via a research package provided with the EPIQ 7G and passed to an additional personal computer for offline processing”, pg. 3 left column – “three measurements of the three vibration frequencies were taken”, pg. 1 right col. – “tissue is excited continuously by an external excitation source”).
Conversely Zeng does not explicitly teach based on the ultrasonic image, establishing a coordinate system of a sampling region of interest, and determining the number of sampling points and coordinate distribution positions thereof; […] based on the coordinate system dimension and position of the sampling region of interest, the sampling points are specific coordinate points located in the coordinate system, which can be distributed according to specific positions;
apply low-frequency mechanical vibration on a body surface to generate a shear wave to propagate in a depth direction in the biological tissue […] performing parameter measurements on multiple sampling points simultaneously or with mutual delay;
triggering the probe to transmit directional […] ultrasonic signal to track the shear wave for sampling,
the sampling mode includes: obtaining a radio frequency (RF) signal by stimulating a single array element of the probe, and calculating the elastic feature parameters at a designated position in a single dimensional space; or obtaining the radio frequency (RF) signal by controlling different array elements of the probe in parallel, and calculating the elastic feature parameters at the designated position in a multi-dimensional space;
However Varghese discloses based on the ultrasonic image, establishing a coordinate system of a sampling region of interest, and determining the number of sampling points and coordinate distribution positions thereof ([0055] - "Each of these planes 34 will provide multiple points of echo data over the surface of the plane 34, each point of echo data described, for example, by a z-axis coordinate value (where the z-axis is aligned with axis 11) and an x-axis coordinate value perpendicular to the z-axis and lying within the plane 34", Fig. 2 shows the coordinate system); […] based on the coordinate system dimension and position of the sampling region of interest, the sampling points are specific coordinate points located in the coordinate system, which can be distributed according to specific positions ([0055] - "Each of these planes 34 will provide multiple points of echo data over the surface of the plane 34, each point of echo data described, for example, by a z-axis coordinate value (where the z-axis is aligned with axis 11) and an x-axis coordinate value perpendicular to the z-axis and lying within the plane 34", Fig. 2 shows the coordinate system, [0062] - "develop additional interpolated data points 88 between corresponding data points 86 a and 86 b of adjacent lines 84");
performing parameter measurements on multiple sampling points simultaneously or with mutual delay ([0057] – “obtain data of the data plane 34 capturing the shear waves 68 at multiple times, each time having a different phase delay with respect to the reciprocation of the probe 10”, [0058] – “propagation of the shear wave 68 in terms of arrival time at various locations along the x-axis”);
triggering the probe to transmit directional […] ultrasonic signal to track the shear wave for sampling ([0055] – “these planes may be acquired by beam steering or other techniques”),
Varghese is an analogous art considering it is in the field of measuring elasticity of biological tissue at multiple data points.
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 Zeng to incorporate the coordinate system of Varghese to achieve the same results. One would have motivation to combine because it provides a position in the image for mapping the elasticity data to the B-mode image.
Conversely Zeng and Varghese do not explicitly teach apply low-frequency mechanical vibration on a body surface to generate a shear wave to propagate in a depth direction in the biological tissue,
the sampling mode includes: obtaining a radio frequency (RF) signal by stimulating a single array element of the probe, and calculating the elastic feature parameters at a designated position in a single dimensional space; or obtaining the radio frequency (RF) signal by controlling different array elements of the probe in parallel, and calculating the elastic feature parameters at the designated position in a multi-dimensional space;
However Osaka discloses apply low-frequency mechanical vibration on a body surface to generate a shear wave to propagate in a depth direction in the biological tissue ([0067] - "the vibrator 3 attached to the ultrasonic probe 4, causes the object 5 to generate a shear wave by applying a low-frequency vibration", [0056] - "propagation position of a shear wave is to be determined in advance. It is the depth direction of the object 5 in the present embodiment"),
the sampling mode includes: obtaining a radio frequency (RF) signal by stimulating a single array element of the probe, and calculating the elastic feature parameters at a designated position in a single dimensional space ([0057] – “the ultrasonic wave 21 for detecting propagation position is transmitted only from the transducer preset as a channel from among the plurality of transducers arrayed in the ultrasonic probe 4”); or obtaining the radio frequency (RF) signal by controlling different array elements of the probe in parallel, and calculating the elastic feature parameters at the designated position in a multi-dimensional space;
Osaka is an analogous art considering it is in the field of measuring elasticity of biological 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 Zeng to incorporate the generation of a shear wave to propagate in a depth direction in the biological tissue of Osaka to achieve the same results. One would have motivation to combine because it allows one to measure elasticity in the depth direction.
Regarding claim 3, Zeng, Varghese, and Osaka disclose all the elements of the claimed invention as cited in claim 1.
Zeng further discloses wherein, the elastic feature parameters are parameters related to the elasticity of biological tissues (pg. 3 left col. – “The imaging depth of each 3D S-WAVE sweep was set to 16-18 cm to maximize the coverage of liver tissue….sample the elasticity readings”).
Conversely Zeng does not teach including elastic parameters expressed by Young's modulus, ultrasonic parameters, and two-dimensional ultrasonic image feature parameters.
However Osaka discloses including elastic parameters expressed by Young's modulus, ultrasonic parameters, and two-dimensional ultrasonic image feature parameters ([0058] – “Propagation position of a shear wave can be acquired by the time that the ultrasonic wave 21 for detecting propagation position reflects on a shear wave and returns, and by the velocity of an ultrasonic wave”, [0019] – “As for elasticity information, propagation velocity or the Young's modulus can be used”).
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 Zeng to incorporate the elastic parameters of Osaka to achieve the same results. One would have motivation to combine because it allows one to measure how the biological material behaves under compression.
Regarding claim 6, Zeng, Varghese, and Osaka disclose all the elements of the claimed invention as cited in claim 1.
Conversely Zeng does not teach wherein, the collecting of the three-dimensional data of the three-dimensional ultrasonic transient elasticity detection is realized by single point detection in which the ultrasonic probe, which in this case is a two-dimensional array probe is fixedly placed on a single detection point on the body surface; or by multi-point detection in which the ultrasonic probe, which in this case is a linear probe, a phased probe or a convex array probe are moved on multiple detection points on the body surface.
However Varghese discloses wherein, the collecting of the three-dimensional data of the three-dimensional ultrasound transient elasticity detection (Title – “Method and Apparatus for Rapid Acquisition of Elasticity Data in Three Dimensions”) is realized by single point detection in which the ultrasonic probe, which in this case is a two-dimensional array probe is fixedly placed on a single detection point on the body surface ([0067] – “a modified two-dimensional array 104 may be created having scattered ultrasonic elements 106 positioned as needed for the acquisition of the multiple planes 34 without movement of the two-dimensional array 104”); or by multi-point detection in which the ultrasonic probe, which in this case a linear probe, a phased probe or a convex array probe are moved on multiple detection points on the body surface ([0066] – “movement of the ultrasonic transducer 30 may be automated by mounting a one-dimensional or 1.5 D ultrasonic transducer 30 on an axially reciprocating carriage 100”).
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 Zeng to incorporate the three-dimensional elasticity detection of Varghese to achieve the same results. One would have motivation to combine because it would provide a more detailed image of the elasticity measurements and therefore may improve diagnostics or surgical procedures.
Regarding claim 8, Zeng, Varghese, and Osaka disclose all the elements of the claimed invention as cited in claims 1 and 3.
Zeng further discloses the collecting of the ultra-high frame rate ultrasonic signal (pg. 2 left column – “In EPIQ 7G’s CPA mode, the available color Doppler sampling (pulse repetition) rate ranges from 250 to 3500 Hz and could be maintained by the X6-1 transducer’s 3D scan sequence for all elevation planes.)
Conversely Osaka does not teach wherein, the collecting of the […] ultrasonic signal is carried out simultaneously with respect to at least two positions or directions.
However Varghese teaches wherein, the collecting of the […] ultrasonic signal is carried out simultaneously with respect to at least two positions or directions (Fig. 3 one with ordinary skill in the art would recognize the two shear waves 68 along the x-axis could be collected simultaneously in a plane 62).
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 Zeng to incorporate the simultaneous collection of ultrasound signals of Varghese to achieve the same results. One would have motivation to combine because it provides data when waves are traveling in multiple directions .
Regarding claim 12, As cited above Zeng, Varghese, and Osaka teach all of the limitations of claim 1. Zeng additionally discloses in the bridging paragraph of pages 1 and 2 “The ultrasound radio frequency (RF) data is captured during the examination via a research package provided with the EPIQ 7G and passed to an additional personal computer for offline processing.
Conversely Zeng does not explicitly teach a computer-readable storage medium, wherein, comprises a storage unit storing computer programs, when the computer programs are executed by the CPU in the main control unit, the steps of the detection method according to claim 1 are realized.
However Varghese discloses a computer-readable storage medium, wherein, comprises a storage unit storing computer programs, when the computer programs are executed by the CPU in the main control unit (Claim 1 – “an electronic computer receiving the ultrasound data and executing a stored program held in non-transitive medium”). the steps of the detection method according to claim 1 are realized (As cited above Zeng, Varghese, and Osaka teach claim 1).
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 Zeng to incorporate the computer-readable storage medium of Varghese to achieve the same results. One would have motivation to combine because it provides faster data retrieval and instant access to data and computer programs).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Zeng NPL 2018 (“3D Liver Shear Wave Absolute Vibro-Elastography with an xMATRIX Array - A Healthy Volunteer Study”), Varghese (US 20140243668), and Osaka (US 20120123263) as applied to claim 3 above, and further in view of and Kim (US 20080081994).
Regarding claim 4, Zeng, Varghese, and Osaka disclose all the elements of the claimed invention as cited in claims 1 and 3.
Conversely Zeng does no teach further comprising calculating the time delay of transmitting and receiving the ultrasonic signal for corresponding array elements in the transducer array before sampling.
However Kim discloses further comprising calculating the time delay of transmitting and receiving the ultrasonic signal for corresponding array elements in the transducer array before sampling ([0051] – “To estimate the time delay between two measurement sites along the ultrasound probe, the derivatives of the two signals can be cross-correlated. The peak of the correlation coefficient determines the time delay. This time delay includes the time delay introduced by the pulse/receiving sequences”);
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 Zeng to incorporate the calculation of time delay ultrasound of Kim to achieve the same results. One would have motivation to combine because “A high frame rate is needed to measure the time delay” (Kim – [0052]) and the time delay is needed to determine the speed of a shear wave.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Questa (US 20190328364) and further in view of Varghese (US 20140243668), Osaka (US 20120123263), and Kim (US 20080081994).
Regarding claim 9, Questa discloses an elasticity dimensional detection system for biological tissue detection (title – “Method and ultrasound system for shear wave elasticity imaging”, Abstract – “two-dimensional sheare wave elastography”, [0148] – “the measurement of the elasticity of any biological tissue”), comprises an image acquiring unit for acquiring an ultrasonic image of a target object (Fig. 6 element 606, Fig. 5B image includes region of interest element 2) and a probe for transmitting and receiving an ultrasonic wave signal (Fig. 6 element 601- ultrasound probe, [0187] – “The beamformer 603 supplies transmit signals to the probe 601 and performs beamforming of “echo” signals that are received by the probe 601”); wherein, the detection system further comprises:
a main control unit (Fig. 6 element 612-CPU), respectively connected with the image acquiring unit and the probe (as shown in Fig. 6 the CPU 612 is directly or indirectly connected to processor 606 [image acquiring unit] and the probe 606), is used to acquire the ultrasonic image of the target object from the image acquiring unit ([0194] – “the processor 606 and/or CPU 612 analyse the image pixels”), establish a coordinate system of a sampling region of interest of a corresponding dimension (Fig. 1B FP1-FP6 for tracking beams T1-T5), and determine a number of sampling points and coordinate distribution positions thereof ([0040] – “When a number n of tracking point is considered for determining the elasticity parameters, the sub region delimited by the first and last tracking line and by the first and last tracking point along the tracking lines in the depth direction determines the area of the sub region”, Fig. 1B, Figs. 4A-4E); receive the elastic feature parameters of the corresponding region of interest of the target object (Abstract – “transmitting a shear wave excitation pulse focalized on an excitation region…determining elasticity parameters of the regions between two of the tracking focal points at the same depth and on at least two adjacent tracking lines as a function of the displacements caused by the shear wave at the tracking focal points”, Fig. 5B shows elastic features for the region of interest), map to generate an elastic map ([0013] – “Two-dimensional (2D) shear wave elastography presents 2D quantitative shear elasticity maps of tissue”), and superimpose and fuse the elastic map containing elastic distribution data to the ultrasonic image and display it synchronously ([0179] – “the elasticity image can be combined to the B-mode image by displaying the elasticity image overlapped to the B-mode image”);
the ultrasonic probe is arranged by several ultrasonic piezoelectric transducer array elements in a linear, convex or two-dimensional array ([0186] – “The probe 601 may include various transducer array configurations, such as a one-dimensional array, a two-dimensional array, a linear array, a convex array and the like”);
the main control unit (Fig. 6 – CPU element 612) comprises a control unit and a processing unit ([0204] – “A control CPU module 612 is configured to perform various tasks such as implementing the user/interface and overall system configuration/control. In case of fully software implementation of the ultrasound signal path, the processing node usually hosts also the functions of the control CPU”), the control unit is respectively connected with the image acquiring unit ([0194] – “CPU 612 analyse the image pixels”), the probe ([0198] – “CPU 612 also performs conventional ultrasound operations. For example, the processor 606 executes a B/W module to generate B-mode images”) and the processing unit ([0204] – “A control CPU module 612 is configured to perform various tasks such as implementing the user/interface and overall system configuration/control), the control unit is used to receive the ultrasonic image of the image acquiring unit and transmit the ultrasonic image to the processing unit; the processing unit is used to determine […] the sampling points in the region of interest according to the ultrasonic image, and transmit the […] information of the sampling points to the control unit ([0193] – “the CPU 612 may perform one or more of the operations described herein in connection with generation of shear waves, measurement of displacement, calculation of displacement speed, calculation of stiffness values and the like”);
send […] ultrasound signals to the […] sampling points with the ultrasonic transducer array elements of the probe, and receive RF signals fed back by the […] the sampling points and transmit the RF signal obtained by the probe and its distribution data to the processing unit ([0131] – “Ultrasound tracking beams are repeatedly transmitted focused along the tracking lines and the received data are processed in for determining the displacements of the tissue in the region of interest caused by the propagation of the shear wave”, as seen in Fig. 1B the tracking lines contain tracking points, [0206] – “the RX tracking lines (line of sights—LOSs) may be temporarily stored, either as pure RF or as I/Q data, in the front-end local memories. The processing may be implemented by a dedicated processor module 606 and/or a CPU 612”);
the processing unit is also used to calculate the corresponding elastic feature parameters according to the received RF signal of each coordinate and its distribution data ([0193] – “The CPU 612 may perform one or more of the operations described herein in connection with generation of shear waves, measurement of displacement, calculation of displacement speed, calculation of stiffness values and the like”, [0156] – “For each line of sight, the RF signal or the data expressed in phase and quadrature deriving from the reflected acoustic tracking beams after the beamforming in reception is distributed over a series of adjacent segments having predefined length along the corresponding line of sight”), establish a single dimensional or multi-dimensional state elastic map, and fuse the corresponding map with the ultrasonic image (Figs. 4B-4D, Figs. 5A-5B, [0179] – “the elasticity image can be combined to the B-mode image by displaying the elasticity image overlapped to the B-mode image”);
the fused image is synchronously displayed by a display unit connected with the processing unit ([0179] – “the elasticity image can be combined to the B-mode image by displaying the elasticity image overlapped to the B-mode image”, [0092] – “An image display receiving the image data from the image combination unit and displaying the combined image”).
Conversely Questa does not teach the probe comprises an ultrasonic probe and a low-frequency vibrator coupled with the ultrasonic probe; […] the low-frequency vibrator continuously applies mechanical vibration on the body surface at a certain repetition rate to generate a plurality of shear waves propagated in biological tissues by continuous vibration;
the control unit is also used to control a low-frequency vibrator to send shear waves to the target object according to the distribution coordinates of the sampling points,
and ultra- high frame rate ultrasound;
However Varghese discloses distribution coordinates of the sampling points ([0055] – “Each of these planes 34 will provide multiple points of echo data over the surface of the plane 34, each point of echo data described, for example, by a z-axis coordinate value (where the z-axis is aligned with axis 11) and an x-axis coordinate value perpendicular to the z-axis and lying within the plane 34”, Fig. 2 shows the coordinate system),
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 Questa to incorporate the coordinate system of Varghese to achieve the same results. One would have motivation to combine because it provides a position in the image for mapping the elasticity data to the B-mode image.
Conversely Questa and Varghese do not teach the probe comprises an ultrasonic probe and a low-frequency vibrator coupled with the ultrasonic probe; […] the low-frequency vibrator continuously applies mechanical vibration on the body surface at a certain repetition rate to generate a plurality of shear waves propagated in biological tissues by continuous vibration;
the control unit is also used to control a low-frequency vibrator to send shear waves to the target object according to the […] the sampling points, and
ultra- high frame rate ultrasound;
However Osaka discloses the probe comprises an ultrasonic probe and a low-frequency vibrator coupled with the ultrasonic probe ([0040] – “a vibrator 3 capable of being attached/detached to/from the ultrasonic probe 4 configured to apply a low-frequency vibration to the object 5 via the ultrasonic probe 4 to generate a shear wave”); […] the low-frequency vibrator continuously applies mechanical vibration on the body surface at a certain repetition rate to generate a plurality of shear waves propagated in biological tissues by continuous vibration ([0055] – “apply a low-frequency vibration of about ˜1 kHz…The vibration to be generated from the vibrator 3 may either be continuous or a single-shot”);
the control unit is also used to control a low-frequency vibrator to send shear waves to the target object according to the […] the sampling points, ([0040] – “a vibrator 3 capable of being attached/detached to/from the ultrasonic probe 4 configured to apply a low-frequency vibration to the object” [0064] – “a measurement line 22 indicating the position for acquiring elasticity information by a shear wave”),
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 Questa to incorporate the low-frequency vibration of Osaka to achieve the same results. One would have motivation to combine because “it is necessary to apply a low-frequency vibration of about ˜1 kHz in order to cause the object 5 to generate a shear wave” (Osaka – [0055]).
Conversely Questa, Varghese, and Osaka do not teach ultra- high frame rate ultrasound;
However Kim discloses the ultra-high frame rate ultrasound ([0052] – “A specially designed RF collection system with near parallel M-mode employing an ultra high frame rate (up to 500 Hz) with lowered ultrasound beam number (32 beams) is installed on a commercial ultrasound scanner (iU22, Philips, Seattle, Wash.)”).
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 Questa to incorporate the ultra-high frame rate ultrasound of Kim to achieve the same results. One would have motivation to combine because “A high frame rate is needed to measure the time delay” (Kim – [0052]).
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 on 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
/SHAHDEEP MOHAMMED/ Primary Examiner, Art Unit 3797