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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/02/2025 has been entered.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP18306309.8, filed on October 4, 2018.
Status of Claims
This Office Action is responsive to the claims filed on 07/02/2025. Claim 1 has been amended. Claim 19 is newly presented. Claims 1-19 are presently pending in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 19 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed “percentage difference between the determined target speed of sound of the target region and the second reference speed of sound is 10% or less” (Claim 19, lines 1-2) is not described in sufficient detail that it would be clear that the applicant had possession of the claimed invention. The specification lacks the specific detail of measuring, detecting, comparing, calculating a “percentage difference” as claimed. Specification pg. 1, line 35 describes a speed of sound of a steatotic liver decreases in general, but the specification fails to describe a step of calculating any percentage difference between the target and reference speeds of sound. Furthermore, the range described in pg. 1, line 35 appears to only include 5-10% and thus does not describe the range of any percentage less than 10%. Thus, such limitations are rendered as new matter. As such the claims are not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention. Therefore, the claims are rejected for including new matter.
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.
Claim 19 is 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 19, lines 1-2 recite the claim limitation “a percentage difference between the determined target speed of sound… and the second reference speed of sound is 10% or less” which is indefinite because it is unclear what the metes and bounds of claim limitation would be. It is unclear if the method requires measuring a percentage difference between the target and second reference speeds of sound and whether the percentage is part of the comparison; OR if the claim limitation is directed toward measuring tissue wherein the difference between the measured speed of sound and a reference value is less than 10%. A claim that requires the exercise of subjective judgment without restriction may render the claim indefinite. In re Musgrave, 431 F.2d 882, 893, 167 USPQ 280, 289 (CCPA 1970). Claim scope cannot depend solely on the unrestrained, subjective opinion of a particular individual purported to be practicing the invention. Datamize LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350, 75 USPQ2d 1801, 1807 (Fed. Cir. 2005)); see also Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1373, 112 USPQ2d 1188 (Fed. Cir. 2014) (holding the claim phrase “unobtrusive manner’ indefinite because the specification did not “provide a reasonably clear and exclusive definition, leaving the facially subjective claim language without an objective boundary’). See MPEP 2173.05 (b) IV. For the purpose of examination, this is understood to mean the method requires measuring a percentage difference between the target and second reference speeds of sound and whether the percentage is part of the comparison; OR if the claim limitation is directed toward measuring tissue wherein the difference between the measured speed of sound and a reference value is less than 10%. A claim that requires the exercise of subjective judgment without restriction may render the claim indefinite.
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.
Claims 1-9 and 12-18 are rejected under 35 U.S.C. 103 as being unpatentable over Yoo (KR-20140014601-A, Translation of KR-20140014601-A is used herein) in view of Ramamurthy (US 20110125017), Duncan (US 20180125451), and Katsuyama (US 20160074014).
Regarding claim 1, Yoo teaches a method for determining a target speed of sound inside a target region of a medium (Pg. 1, Abstract; method for estimating the speed of ultrasonic waves; obtaining the different speed of the ultrasonic waves in each medium layer by using the wave and depth of the ultrasonic waves in a selected ROI, Fig. 7) using an ultrasound imaging system (Paragraph [0062]; apparatus 610 for capturing an ultrasound image, Fig. 6) comprising at least a probe adapted to sense backscattered ultrasound waves (Paragraph [0063]; transducer 10 converts alternating current energy into mechanical vibration by irradiation to the medium, Fig. 6) and to provide sensed signals corresponding to said backscattered ultrasound waves (Paragraph [0063]; obtains the electrical signal from the reflected echo) to a processing unit of the ultrasound system (Paragraph [0065]; processing unit 30, Fig. 6), the medium comprising a tissue of a mammal body (Pg. 3, Para. 7; Embodiments of the present invention distinguish the medium layers… thereby estimating the optimized ultrasonic propagation speed for each different tissue within the human body), the method comprising:
determining from morphological image data a position of at least an interface in the medium (Para [0034]; step 320 distinguishes each medium layer by identifying the boundaries of a plurality of medium layers constituting the medium from the image acquired through step 310, Fig. 3), the interface dividing the medium into an intermediate region of the medium and the target region in a depth direction (Para [0036]; in an image composed of different medium layers, the accumulated ultrasound propagation speed is estimated by selecting a plurality of regions of interest divided by the boundary between the medium layers and the depth direction in the lower medium; Figs. 5 and 7 show an intermediate region comprising layer 1 and layer 2 with ROI1 and a target region comprising layer 3 containing ROI2),
determining a first speed of sound of the intermediate region based on at least the sensed backscattered ultrasound waves (Paragraph [0041]; beam reflected from the medium is focused to obtain an ultrasonic image; Para [0044] and [0046]; geometric modeling concept for calculating the unique ultrasonic propagation velocity of each medium layer, Fig. 5 ultrasound speed estimate of layer 2; The model is based on geometric information from the image which is based on an echo signal from the medium) and a first reference speed of sound of the intermediate region (Para [0028]-[0029]; applying the ultrasonic velocity (1590m/s) is estimated in a specific region of interest (ROI1); Para [0033]; one reference speed may be determined as the average ultrasonic propagation speed for the entire medium or the ultrasonic propagation speed in a specific region of interest; The estimated ultrasound velocity in ROI1 used to generate the image and optimize the ultrasound velocity is considered to read on the claimed limitation of the first reference speed of sound of the intermediate region as understood in its broadest reasonable interpretation), and
determining the target speed of sound inside the target region based on at least the sensed backscattered ultrasound waves (Para [0044] and [0046]; calculating the unique ultrasonic propagation velocity of each medium layer, Fig. 5 ultrasound speed estimate of layer 3) and a second reference speed of sound of the target region (Para [0028]-[0029]; applying the ultrasonic velocity (1590m/s) is estimated in a specific region of interest; Para [0033]; one reference speed may be determined as the average ultrasonic propagation speed for the entire medium or the ultrasonic propagation speed in a specific region of interest; The estimated ultrasound velocity is used for each layer. The use of the estimated velocity for the second layer is considered to read on the claimed limitation of the second reference speed of sound of the target region as understood in its broadest reasonable interpretation) and taking into account the position of the interface (Para [0049], [0052], and [0055]; ‘S’ represents the estimated ultrasonic velocity in each region of interest, ‘Depth’ represents the thickness of the medium layer; equation 3 represents the optimal ultrasound velocity … of the nth medium layer; Use of the thickness of the layer is considered to take into account the position of the interface as understood in its broadest reasonable interpretation), and the first speed of sound (Para [0058] and [0060], and equation 3; the ultrasonic velocity calculated previously is used to calculate the ultrasonic velocity for the newly set region of interest; calculated by the speed of ultrasound in each of the medium layer below (Sn) depends on the speed of sound of each of the above layers (SL1-(n-1)) as understood in equation 3 written in Para [0053]; Thus the target speed of sound takes into account the first speed of sound as best understood in its broadest reasonable interpretation).
Yoo does not explicitly teach the intermediate region being an uppermost region of the medium in contact with the probe; and
detecting a condition of the tissue of the mammal body based on the determined target speed of sound;
comparing the determined target speed of sound of the target region to the second reference speed of sound; and
outputting an assessment of a health condition of the tissue of the mammal body based on the comparison.
Ramamurthy, however, teaches a method for determining a target speed of sound inside a target region of a medium (Paragraph [0080]; The apparatus further includes a processing module configured so as to estimate a speed of sound in a first layer encountered by the acoustic energy… and to estimate a speed of sound in the second layer) using an ultrasound imaging system (Paragraph [0080]; disclosure relates to an ultrasound for imaging; Paragraph [0162]-[0165]; imaging device 100; including ultrasound-based devices, Fig. 1) comprising at least a probe (Paragraph [0162]; Transducer array 110, Fig. 1) adapted to sense backscattered ultrasound waves (Paragraph [0372]; receiver 2313 collects backscattered sound waves, Fig. 46) and to provide sensed signals corresponding to said backscattered ultrasound waves to a processing unit of the ultrasound system (Paragraph [0162]; The operation of the interface 112 in providing the signal to the array 110 and/or readout of the received signals from the receivers can be performed by a processor 116, Figs. 1 and 2), the medium comprising a tissue of a mammal body (Paragraph [0069]-[0070]; the tissue includes a human liver; plurality of regions are assumed to be human skin and human fat), the method comprising:
determining from morphological image data (Paragraph [0365]; FIG. 46 shows an example imaging situation where an acoustic energy traverses a plurality of layer interfaces between a given transmitter and a voxel and/or between the voxel and a given receiver) a position of at least an interface in the medium (Paragraph [0080]; to determine a location of a first interface that forms a boundary between the first layer and a second layer; Paragraphs [0372], [0373], and [0377]; More specifically a first interface may be found which defines the posterior surface of a first layer; Fig. 46 shows the first interface 2305), the interface dividing the medium into an intermediate region of the medium (Paragraphs [0372], [0373], and [0377]; First layer, Fig. 46 shows the first layer is between the interface 2305 and the transducers 2303 and 2313) and the target region in a depth direction (Paragraphs [0372], [0373], and [0377]; regions above 2305 including pixel 2309 are a target region. The direction through each layer is considered to be a depth direction), the intermediate region being an uppermost region of the medium in contact with the probe (Paragraph [0365]; one of such layers can be a coupling medium between the transmitter/receiver array and the skin of a tissue being imaged; Fig. 46 shows the first layer between the transducers 2303, 2313 and the first interface 2305 is a skin layer in contact with transducers 2303, 2313 which is considered to read on the claimed limitation of being an uppermost region of the medium in contact with the probe as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Yoo to have performed steps of determining the speed of sound in the first layer of the tissue such thereby resulting in the intermediate region being an uppermost region of the medium in contact with the probe as taught by Ramamurthy because it would have ensured proper focusing of the boundary of the first tissue layer boundary and thereby the propagation time for that layer is determined. Focusing of the next layer can then be facilitated by the knowledge of the first layer. This building of propagation time information can build successively outward away from the receiver (Ramamurthy, Paragraph [0284]). Furthermore a first interface may be found which defines the posterior surface of a first layer. The speed of sound in this layer may then be varied in order to optimize the focus of the posterior surface interface for example, or to optimize the focus of point scatterers within the layer. Once the first layer is determined then a speed of sound may be postulated for the next layer and refracted rays can be calculated. This process may be repeated as required (Paragraph [0377]).
Together Yoo and Ramamurthy further fails to teach detecting a condition of the tissue of the mammal body based on the determined target speed of sound;
comparing the determined target speed of sound of the target region to the second reference speed of sound; and
outputting an assessment of a health condition of the tissue of the mammal body based on the comparison.
Duncan, however, teaches a method for determining a target speed of sound (Paragraph [0008]; a method is provided for imaging speed of sound) inside a target region of a medium (Paragraph [0027]; calculating the speed of sound by location in the one, two, or three-dimensional region of interest; Paragraph [0038]; The speed of sound at each of a plurality of locations is calculated.) using an ultrasound imaging system, the method comprising:
detecting a condition of the tissue of the mammal body based on the determined target speed of sound (Paragraph [0041]; The speed for a location or variation in speed over locations may be used as a biomarker. For example, the speed may indicate whether a liver includes fatty liver tissue. A fat fraction for the liver may be estimated from the speed and displayed as a value with or instead of the speed; The fat fraction is considered to be a condition of the tissue as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Yoo in view of Ramamurthy to have included steps of detecting a condition of the tissue of the mammal body based on the determined target speed of sound as taught by Duncan because it would allow determining whether the fat fraction of an organ such as liver is too high and thereby assist in diagnosis of disease such as fatty liver disease (Duncan, Paragraph [0016]).
Together Yoo, Ramamurthy, and Duncan further fails to teach comparing the determined target speed of sound of the target region to the second reference speed of sound; and
outputting an assessment of a health condition of the tissue of the mammal body based on the comparison.
Katsuyama, however, teaches a method (Paragraph [0011]; ultrasound diagnostic method, and a program capable of diagnosing the tissue characteristics based on the sound speed) comprising determining the target speed of sound inside the target region (Paragraph [0113]; In step S24, based on the reception signal of each channel corresponding to each read scanning line, the sound speed value deriving unit 28 derives the sound speed value V according to the above Equation (2) for each of the reflection points R11 to R17 set by the reflection point setting unit 26) based on at least the sensed backscattered ultrasound waves and a second reference speed of sound of the target region (Paragraph [0114]; diagnostic unit 50 calculates an average value Vave of the sound speed values V corresponding to the reflection points R11 to R17, Fig. 10 and 13) and taking into account the position of the interface, and the first speed of sound (Paragraph [0062]-[0068]; Equation 6 shows the velocities are calculated based on the depths of each layer and the velocities of each layer, which is considered to read on the claimed limitation as understood in its broadest reasonable interpretation);
comparing the determined target speed of sound of the target region to the second reference speed of sound (Paragraph [0114]; when a difference value between the calculated average value Vave and the sound speed value V for each reflection point is equal to or greater than a predetermined threshold value); and
outputting an assessment of a health condition of the tissue of the mammal body based on comparison (Paragraph [0114]; the diagnostic unit 50 determines that an abnormal part is present at the azimuth position of the reflection point; Paragraph [0115]-[0116]; the diagnostic unit 50 supplies information indicating the result of the determination regarding the presence of an abnormal part to the monitor 32... such as a torn muscle portion or a tumor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Yoo in view of Ramamurthy and Duncan to have included steps of comparing the determined target speed of sound of the target region to the second reference speed of sound; and outputting an assessment of a health condition of the tissue of the mammal body based on the comparison as taught by Katsuyama because it would have allowed diagnosing the tissue characteristics based on sound speed value with higher accuracy (Paragraph [0104]) and more reliably determine abnormalities between layers of tissue (Paragraph [0116]).
Regarding claim 2, together Yoo, Ramamurthy, Duncan, and Katsuyama teach all of the limitations of claim 1 as noted above.
Yoo further teaches the probe is adapted to transmit excitation waves into the medium (Para [0063]; Transducer transmits mechanical vibrations to the medium) in the depth direction toward the target region (Para [0030]; select multiple regions of interest at different depths of the lower medium for a plurality of media divided in the depth direction), said excitation waves being backscattered in the medium toward the probe (Para [0004]; the echo vibrates the transducer), and wherein the first speed of sound is determined by further taking into account one of a plurality of first supposed speeds of sound (Para [0027] and [0028]; fixed ultrasound propagation speed 1540 m/s and 1590 m/s; Para [0029]; use a plurality of differential ultrasonic speeds rather than a single ultrasonic propagation speed), and
wherein the target speed of sound is determined by taking into account the position of the interface (Para [0049], [0052], and [0055]; S’ represents the estimated ultrasonic velocity in each region of interest, ‘Depth’ represents the thickness of the medium layer; equation 3 represents the optimal ultrasound velocity … of the nth medium layer… ‘Depth’ is the m-th medium layer (layer) denotes the thickness; Use of the thickness of the layer is considered to take into account the position of the interface as understood in its broadest reasonable interpretation), a target reference speed of sound applied to the target region (Para [0028]-[0029]; ultrasound travel speed (1590 m/s) estimated in one specific region of interest is applied; ultrasonic waves are estimated running speed optimized in response to each of the medium layers constituting the composite medium), the first speed of sound applied to the intermediate region (Para [0058] and [0060], and equation 3; the ultrasonic velocity calculated previously is used to calculate the ultrasonic velocity for the newly set region of interest), and one of a plurality of supposed target speeds of sound for the target region (Para [0027]-[0028]; fixed ultrasound propagation speed 1540 m/s and 1590 m/s; Para [0035]; acquiring ultrasound images at a plurality of speeds for the entire medium; The use of a plurality of ultrasound speeds to determine the boundary is considered to read on the claimed limitation of a plurality of supposed target speeds of sound as understood in its broadest reasonable interpretation).
Yoo does not explicitly teach the probe is adapted to be functionally put in contact with an outer surface of the medium.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the probe of Yoo in view of Ramamurthy, Duncan, and Katsuyama to have been functionally put in contact with an outer surface of the medium as it would ensure the ultrasonic waves reach the target region and further reduce artifacts in imaging due to air bubbles or other gaps between the transducer and the patient.
Regarding claim 3, together Yoo, Ramamurthy, Duncan, and Katsuyama teach all of the limitations of claim 2 as noted above.
Yoo further teaches calculating a plurality of first image data associated with a first representative area of the intermediate region before determining the first speed of sound of the intermediate region (Para [0027]; taking an ultrasound image using the ultrasound travel speed for one particular region of interest (ROI1).; Para [0046]-[0049]; Depth is selected from the ROI1 of layer 2; The speed of sound for the ROIs are calculated using the depth data determined from the image data, equation 1), the first speed of sound being based on the plurality of first image data (Para [0047]-[0049]; Speed of sound is determined for ROI1, which is in the intermediate region, layer 2, using the depth data for ROI1, equation 1), each of the first image data being determined based on a beamforming algorithm applied to at least the sensed signals corresponding to the first representative area (Para [0035]; ultrasonic speed that performs the receiving beam focusing… boundary between the upper and lower medium layers is imaged most clearly… applied to the user-selected boundary area of interest; Applicant describes a beamforming algorithm as processing of sensed signals into image data which is known in the art. The process described in Yoo of forming images clearly is understood to read on the claimed limitation of being determined based on a beamforming algorithm applied to at least the sensed signals in its broadest reasonable interpretation) and which takes as a parameter the first reference speed of sound (Para [0041]; ultrasonic image for the entire medium can be restored by using the estimated ultrasonic speed), and one of the plurality of first supposed speeds of sound (Para [0035]; boundary of the medium layer can be identified by acquiring ultrasound images at a plurality of speeds for the entire medium; Para [0041]; ultrasonic image for the entire medium can be restored by using the estimated ultrasonic speed… optimized for each medium layer and applying the ultrasonic propagation speed that varies depending on the depth to be used for focusing the received beam; Para [0064]; acquires an ultrasound image by focusing the beam… and each layer of the medium according to the differential ultrasonic speed).
Regarding claim 4, together Yoo, Ramamurthy, Duncan, and Katsuyama teach all of the limitations of claim 2 as noted above.
Yoo further teaches calculating a plurality of target image data associated with a target representative area of the target region before determining the target speed of sound inside the target region (Para [0027]; taking an ultrasound image using the ultrasound travel speed for one particular region of interest (ROI2); Para [0046]-[0049]; Depth is selected from the ROI2 of layer 3; The speed of sound for the ROIs are calculated using the depth data determined from the image data, equation 1; Speed of sound is determined for ROI2, which is in the target region, layer 3, using the depth data for ROI2, equation 1), the target speed of sound being based on the plurality of target image data in the representative area of the target region (Para [0036]; selects at least two regions of interest (ROI) for different adjacent media layers among the media layers, and determines the ultrasonic velocity in the selected region of interest), each of the target image data being determined based on a beamforming algorithm applied to at least the sensed signals corresponding to the representative area (Para [0035]; ultrasonic speed that performs the receiving beam focusing… boundary between the upper and lower medium layers is imaged most clearly… applied to the user-selected boundary area of interest; Applicant describes a beamforming algorithm as processing of sensed signals into image data which is known in the art. The process described in Yoo of forming images clearly is understood to read on the claimed limitation of being determined based on a beamforming algorithm applied to at least the sensed signals in its broadest reasonable interpretation) and which takes as parameters the position of the interface (Para [0036]; selecting a plurality of regions of interest divided by the boundary between the medium layers; Para [0065]; use the ultrasonic speed and depth in the selected region of interest to differentially detect each of the media layers), the target reference speed of sound applied to the target region (Para [0041]; ultrasonic image for the entire medium can be restored by using the estimated ultrasonic speed), the first speed of sound applied to the intermediate region (Para [0065]; use the ultrasonic speed and depth in the selected region of interest to differentially detect each of the media layers), and one of the plurality of supposed target speeds of sound for the target region (Para [0035]; boundary of the medium layer can be identified by acquiring ultrasound images at a plurality of speeds for the entire medium; Para [0041]; ultrasonic image for the entire medium can be restored by using the estimated ultrasonic speed… optimized for each medium layer and applying the ultrasonic propagation speed that varies depending on the depth to be used for focusing the received beam; Para [0064]; acquires an ultrasound image by focusing the beam… and each layer of the medium according to the differential ultrasonic speed).
Regarding claim 5, together Yoo, Ramamurthy, Duncan, and Katsuyama teach all of the limitations of claim 2 as noted above.
Yoo further teaches at least one of: the plurality of first supposed speeds of sound and the plurality of supposed target speeds of sound have a same value (Para [0033]; acquires an ultrasound image of the entire medium using one reference speed; The entire image, including both regions may use the same speed of sound, thus the plurality of ultrasound velocity for the first supposed speed of sound and the target supposed speed of sound includes a same value as understood within its broadest reasonable interpretation).
Regarding claim 6, together Yoo, Ramamurthy, Duncan, and Katsuyama teach all of the limitations of claim 1 as noted above.
Yoo further teaches the determination of the position of the interface is based on at least some of the sensed signals (Para [0034]; identifying the boundaries of a plurality of medium layers constituting the medium from the image acquired).
Regarding claim 7, together Yoo, Ramamurthy, Duncan, and Katsuyama teach all of the limitations of claim 1 as noted above.
Yoo further teaches the determination of the position of the interface is based on an automatic image processing of the morphological image data (Para [0035]; acquiring ultrasound images at a plurality of speeds for the entire medium and calculating the absolute distance to the boundary using the speed at which the boundary becomes clearest... various contour recognition technologies used in the image processing technology field can be used to distinguish media layers).
Regarding claim 8, together Yoo, Ramamurthy, Duncan, and Katsuyama teach all of the limitations of claim 1 as noted above.
Yoo further teaches the position of the interface is determined based on variations of amplitudes of the image data of the medium along the depth direction between the intermediate region and the target region (Para [0035]; calculating the absolute distance to the boundary using the speed at which the boundary becomes clearest.; In the art of imaging, “clearest” means highest contrast between two objects, and amplitude variation is inherent property of the technical term “contrast” ), the image data being determined based on the sensed signals and a beamforming algorithm (Para [0035]; receiving beam focusing is similar to that of the uniform upper medium, the boundary between the upper and lower medium layers is imaged most clearly; Para [0065]; identifies the boundaries of a plurality of medium layers constituting the medium from the acquired image through the beamformer) which takes as a parameter a reference speed of sound (Para [0065]; through the beamformer using one reference speed).
Regarding claim 9, together Yoo, Ramamurthy, Duncan, and Katsuyama teach all of the limitations of claim 1 as noted above.
Yoo further teaches the first speed of sound and the target speed of sound are each calculated using a respective first and target focusing criterion (Paragraph [0035]; ultrasonic speed that performs the receiving beam focusing is similar to that of the uniform upper medium, the boundary between the upper and lower medium layers is imaged most clearly, so various ultrasonic waves are applied to the user-selected boundary area of interest; absolute distance using the speed at which the boundary becomes clearest, or estimate the distance between boundaries; Paragraph [0047]-[0053]; Eqs. 1-3 show the speed of sound is calculated using depth. The depth of each boundary is determined by focusing the beam such that the boundary is the clearest, which is considered to read on the claimed limitation of a focusing criterion as understood in its broadest reasonable interpretation), a plurality of respective first and target focusing values being obtained by applying the respective first and target focusing criterion to, respectively, a plurality of first image data of a first representative area and a plurality of target image data of a target representative area (Paragraph [0035]; receiving beam focusing is similar to that of the uniform upper medium, the boundary between the upper and lower medium layers is imaged most clearly, so various ultrasonic waves are applied to the user-selected boundary area of interest… using the speed at which the boundary becomes clearest; The speeds at which boundary becomes the clearest for each layer is considered to read on the focusing values for the first representative area and target representative area as understood in its broadest reasonable interpretation), the first speed of sound being a selected one of the plurality of respective first focusing values and the target speed of sound being a selected one of the plurality of respective target focusing values (Paragraph [0035]; the boundary of the medium layer can be identified by acquiring ultrasound images at a plurality of speeds for the entire medium and calculating the absolute distance to the boundary using the speed at which the boundary becomes clearest).
Regarding claim 12, together Yoo, Ramamurthy, Duncan, and Katsuyama teach all of the limitations of claim 1 as noted above.
Yoo further teaches determining a position of a sub-interface in the intermediate region (Para [0034]; distinguishes each medium layer by identifying the boundaries of a plurality of medium
layers, Fig. 5, boundary between layer 1 and layer 2), the sub-interface dividing in the depth direction the intermediate region into a second region of the intermediate region proximal to the outer surface and a first region of the intermediate region proximal to the interface (Para [0036]; selecting a plurality of regions of interest divided by the boundary between the medium layers and the depth direction
in the lower medium; Fig. 5, layer 1 and layer 2),
determining a second speed of sound of the second region based on at least some of the sensed signals (Para [0044] and [0046]; concept for calculating the unique ultrasonic propagation velocity of each medium layer in a complex medium; beam reflected from the medium is divided into a sub-aperture to estimate the cumulative ultrasonic velocity) and taking as a parameter the second reference speed of sound (Para [0028]-[0029]; applying the ultrasonic velocity (1590m/s) is estimated in a specific region of interest; Para [0033]; one reference speed may be determined as the average ultrasonic propagation speed for the entire medium or the ultrasonic propagation speed in a specific region of interest; The estimated ultrasound velocity is used for each layer. The use of the estimated velocity for the first layer is considered to read on the claimed limitation of the second reference speed of sound of the target region as understood in its broadest reasonable interpretation), and one of a plurality of second supposed speeds of sound (Para [0027]-[0028]; fixed ultrasound propagation speed 1540 m/s and 1590 m/s; Para [0035]; acquiring ultrasound images at a plurality of speeds for the entire medium; The use of a plurality of ultrasound speeds to determine the boundary is considered to read on the claimed limitation of a plurality of supposed target speeds of sound as understood in its broadest reasonable interpretation), wherein
the determination of the first speed of sound is based on at least some of the sensed signals and takes into account the position of the sub-interface (Para [0049], [0052], and [0055]; ‘S’ represents the estimated ultrasonic velocity in each region of interest, ‘Depth’ represents the thickness of the medium layer; equation 3 represents the optimal ultrasound velocity … of the nth medium layer; Use of the thickness of the layer is considered to take into account the position of the interface as understood in its broadest reasonable interpretation), the first reference speed of sound applied to the first region (Para [0041]; ultrasonic image for the entire medium can be restored by using the estimated ultrasonic speed), the second reference speed of sound applied to the second region (Para [0041]; the ultrasonic image for the entire medium can be restored by using the estimated ultrasonic speed optimized for each medium layer and applying the ultrasonic propagation speed), and one of the plurality of first supposed speeds of sound for the first region (Para [0035]; boundary of the medium layer can be identified by acquiring ultrasound images at a plurality of speeds for the entire medium; Para [0041]; ultrasonic image for the entire medium can be restored by using the estimated ultrasonic speed… optimized for each medium layer and applying the ultrasonic propagation speed that varies depending on the depth to be used for focusing the received beam; Para [0064]; acquires an ultrasound image by focusing the beam… and each layer of the medium according to the differential ultrasonic speed).
Regarding claim 13, together Yoo, Ramamurthy, Duncan, and Katsuyama teach all of the limitations of claim 12 as noted above.
Yoo further teaches the determination of the position of the sub-interface being based on at least some of the sensed signals (Para [0034]; identifying the boundaries of a plurality of medium layers constituting the medium from the image acquired).
Regarding claim 14, together Yoo, Ramamurthy, Duncan, and Katsuyama teach all of the limitations of claim 12 as noted above.
Yoo further teaches the second region of the intermediate region contains a second representative area, and the first region of the intermediate region contains a first representative area (Para [0052]; setting one region of interest per medium layer).
Regarding claim 15, together Yoo, Ramamurthy, Duncan, and Katsuyama teach all of the limitations of claim 12 as noted above.
Yoo further teaches calculating a plurality of second image data associated with a second representative area of the second region (Para [0027]; taking an ultrasound image using the ultrasound travel speed for one particular region of interest; Para [0052]; setting one region of interest per medium layer) before determining the second speed of sound of the second region based on the plurality of second image data (Para [0047]-[0049]; The speed of sound for the ROIs are calculated using the depth data determined from the image data, equation 1), each of the second image data being determined based on a beamforming algorithm applied to at least the sensed signals corresponding to the second representative area (Para [0035]; ultrasonic speed that performs the receiving beam focusing… boundary between the upper and lower medium layers is imaged most clearly … applied to the user-selected boundary area of interest; Applicant describes a beamforming algorithm as processing of sensed signals into image data which is known in the art. The process described in Yoo of forming images clearly is understood to read on the claimed limitation of being determined based on a beamforming algorithm applied to at least the sensed signals in its broadest reasonable interpretation) and which takes as a parameter the second reference speed of sound (Para [0041]; ultrasonic image for the entire medium can be restored by using the estimated ultrasonic speed), and one of a plurality of second supposed speeds of sound (Para [0035]; boundary of the medium layer can be identified by acquiring ultrasound images at a plurality of speeds for the entire medium; Para [0041]; ultrasonic image for the entire medium can be restored by using the estimated ultrasonic speed… optimized for each medium layer and applying the ultrasonic propagation speed that varies depending on the depth to be used for focusing the received beam; Para [0064]; acquires an ultrasound image by focusing the beam… and each layer of the medium according to the differential ultrasonic speed).
Regarding claim 16, together Yoo, Ramamurthy, Duncan, and Katsuyama teach all of the limitations of claim 1 as noted above.
Yoo further teaches the medium is a mammal body and the outer surface is the skin of the mammal (Paragraph [0003]; ultrasound is irradiated into the human body), and wherein the target region is the liver of the mammal, the intermediate region is a region of the medium comprised between the liver and the skin in the depth direction (Paragraph [0003]; the generation of echoes occurs at the interface (ultrasonic interface) between media with different properties, and even a very small difference in density can form such an interface. Water, blood cells, fat, liver cells, bile, bile duct walls, connective tissues, and fibrous tissues that make up the human body have different densities, and these density differences form an ultrasonic interface).
Regarding claim 17, together Yoo, Ramamurthy, Duncan, and Katsuyama teach all of limitations of claim 1 as noted above. Yoo further teaches an ultrasound imaging system for determining a target speed of sound (Paragraph [0062]; apparatus 610 for capturing an ultrasound image… corresponding to each process constituting the ultrasonic velocity estimation method, Fig. 6) inside a target region of a medium (Paragraph [0003]; ultrasound is irradiated into the human body), said ultrasound imaging system comprising:
a probe (Paragraph [0063]; transducer 10, Fig. 6) adapted to transmit excitation waves into the medium (Paragraph [0003]; ultrasound is irradiated into the human body; Paragraph [0063]; transducer 10 converts alternating current energy into mechanical vibration… irradiates it to the medium 620) in a depth direction toward the target region (Paragraph [0063]; transducer 10 converts alternating current energy into mechanical vibration… irradiates it to the medium 620), said excitation waves being backscattered in the medium toward the probe (Paragraph [0063]; obtains an electrical signal again from the reflected echo), the probe being adapted to sense the backscattered ultrasound waves and to provide corresponding sensed signals to the ultrasound system (Paragraph [0063]; transducer 10 may generate channel data for each of a plurality of channels and transmit it to the beamformer 20.), and
a processing unit (Paragraph [0065]; Processing unit 30… equipped with at least one processor to perform a series of operations defined above, Fig. 6) implementing the method according to claim 1 as described above in the rejection of claim 1.
Yoo does not explicitly teach the probe is adapted to be functionally put in contact with an outer surface of the medium.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the probe of Yoo in view of Ramamurthy, Duncan, and Katsuyama to have been functionally put in contact with an outer surface of the medium as it would ensure the ultrasonic waves reach the target region and further reduce artifacts in imaging due to air bubbles or other gaps between the transducer and the patient.
Regarding claim 18, together Yoo, Ramamurthy, Duncan, and Katsuyama teach all of the limitations of claim 1 as noted above.
Yoo discloses the invention as claimed and discussed above, but fails to explicitly disclose the condition of the tissue of the mammal body comprises a fat content of the tissue of the mammal body.
Duncan, however, further teaches the condition of the tissue of the mammal body comprises a fat content of the tissue of the mammal body (Paragraph [0041]; The speed for a location or variation in speed over locations may be used as a biomarker. For example, the speed may indicate whether a liver includes fatty liver tissue. A fat fraction for the liver may be estimated from the speed and displayed as a value with or instead of the speed; The fat fraction is considered to be a fat content of the tissue as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the method of Yoo in view of Ramamurthy, Duncan, and Katsuyama such that the condition of the tissue of the mammal body comprises a fat content of the tissue of the mammal body as taught by Duncan because it would allow determining whether the fat fraction of an organ such as liver is too high and thereby assist in diagnosis of disease such as fatty liver disease (Duncan, Paragraph [0016]).
Regarding claim 19, together Yoo, Ramamurthy, Duncan, and Katsuyama teach all of the limitations of claim 1 as noted above.
Yoo discloses the invention as claimed and discussed above, but fails to explicitly disclose a percentage difference between the determined target speed of sound of the target region and the second reference speed of sound is 10% or less.
Katsuyama, however, further teaches a percentage difference between the determined target speed of sound of the target region and the second reference speed of sound is 10% or less (Paragraph [0071]-[0072]; when the average sound speed value on the center path r.sub.0 is smaller than the average sound speed value on the peripheral path rl; Fig. 5 shows the speeds of the target region compared to the average speed. The difference between the target (for example at 1600) and the average (at 1500) is less than 10% which is considered to read on the claimed limitation of a percentage difference between the determined target speed of sound of the target region and the second reference speed of sound is 10% or less as understood in its broadest reasonable interpretation in view of the rejection under 35 USC 112(b) as noted above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Yoo in view of Ramamurthy, Duncan, and Katsuyama to have further included a percentage difference between the determined target speed of sound of the target region and the second reference speed of sound is 10% or less as taught by Katsuyama because it would have allowed one to detect abnormalities in the tissue as the sound speed value V derived according to Equation (2) increases continuously without converging on V0 making it more apparent where the tissue abnormality is located (Paragraph [0072]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Yoo in view of Ramamurthy, Duncan, and Katsuyama as applied to claim 9 above, and further in view of Call (US 20130253325).
Regarding claim 10, together Yoo, Ramamurthy, Duncan, and Katsuyama teach all of the limitations of claim 9 as noted above.
Yoo does not explicitly teach the first speed of sound corresponds to the maximum of the plurality of respective first focusing values and/or the target speed of sound corresponds to the maximum of the plurality of respective target focusing values
Call, however, teaches a target speed of sound corresponds to the maximum of the plurality of respective target focusing values (Paragraph [0102]; in some embodiments a multiple aperture ultrasound imaging system may be configured to allow for automatic and/or manual adjustment of an assumed speed of sound value for some or all scatterer paths; Paragraph [0105]; any other "autofocus" algorithms may be applied to adjust a speed-of-sound value until an image quality metric is improved or optimized; obtaining the speed-of-sound value by optimizing the quality metric is considered to read on the claimed limitation of a target speed of sound corresponds to the maximum of the plurality of respective target focusing values as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary ski