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 .
101 Analysis
Claim 1 was considered for 101 analysis as there is collecting and organizing data for mathematical calculation. However, the ultrasonic beam transmitted into the medium illuminating at least three respective observation points in the medium then acquiring a plurality of [transformed] backscattered signals provides a useful transformation of the signal and thereby has eligible subject matter.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims
particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-6, 8-20 & 22 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites the limitation “a shear wave propagating in a medium” where the clarity of “a shear wave” is unclear as a single shear wave is not measured. Examiner looks to the medium has an element that generates shear waves propagated in the medium [0003].
Claim 1 recites the limitation “the respective observation points are not aligned” which is unclear as aligned requires a reference (i.e. aligned linearly, on a plane, radially from a point). Examiner looks to the specification and interprets aligned as the respective observation points are not aligned in a plane.
Claim 1 has determination and calculation steps that are unclear in that a device is needed to reinforce the steps as concrete steps. Examiner recommends a processor, computer or other processing device is claimed to ensure clarity.
Claims 8 & 21 use the optional language of “may be” where the subsequent limitation is not distinctly claimed. The optional language needs to be remove and active language to distinctly claim the limitation provides a distinct claim.
All dependent claims are rejected for their dependence on a rejected base claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6, 8-20 & 22 are rejected under 35 U.S.C. 103 as being unpatentable over Tabaru (US 20130289402: “Tabaru”)in view of Gennisson ( "4-D ultrafast shear-wave imaging", IEEE Tansactions on Ultrasonics, Ferroelectrics, and Frequency Control, vol. 62, no. 6, p. 1059-1065, 2015-06-01: “Gennisson” applicant provided).
Claim 1. Tabaru discloses a method for determining a velocity of a shear wave propagating in a medium (medium is uniform tissue) [0051]& [0133 source of displacement heart or arterial wall], said shear wave having a wavelength [0041], said method comprising: generating at least one ultrasound beam (1) into the medium illuminating at least three respective observation points (Fig. 5a: x1, x2 & x3) in the medium (tissue) [0050-0051]; acquiring a plurality of backscattered signals backscattered respectively from said observation points (Fig. 5a: x1, x2 & x3) illuminated by said at least one ultrasound beam (Fig. 3: 100)[0045]; determining a respective arrival time for each observation point based on the backscattered signals respectively acquired from the observation point [0042: The transmission beam generating device for detecting displacement 22 is controlled by the central control unit 3 so that the transmission beam generating device applies delay time and weight to a transmission signal every device from the ultrasound probe 1 using a waveform generated in a transmission waveform generating device for detecting displacement 21 so as to focus an ultrasonic beam for detecting displacement in a desired position like the ultrasonic beam for generating displacement]; calculating vector velocity components [0051-0053] of the shear wave based on the plurality of respective arrival times (t1_2, t2_2 & t3_2, t1_2, t2_2 & t3_2,); estimating the velocity (c) of the shear wave based on the calculated vector velocity components [0051: a position x (n) as an axis of ordinates and having time t (n) to be a peak as an axis of abscissas in the heterogeneity detecting device 26 ] wherein the respective observation points (Fig. 5a: x1, x2 & x3) are distinct (Fig. 3: x1, x2 & x3) [0045-0051]. Tabaru does not explicitly disclose:
the respective observation points are not aligned
Gennisson teaches observation points (Fig. 4: 6 points forming three set distances each for each three-axis from a selected focal point) that are not linearly aligned (Fig.4 six points on three-axis are not aligned in a single plane) and the required vector components to determine velocity in page 3 equation (1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use Gennisson’s plurality of observation point on each of three separate planar axis and vector processing with Tabaru’s setting of observation points because measurements in a three-dimensional area of the shear wave improves velocity measurement by reducing erroneous fluctuations measurements that can dominate in a linear slice measurement.
Claim 2. Dependent on the method according to claim 1. Tabaru further discloses at least three ultrasound beams (Fig. 3: 100’s more than three Ultrasound Beams) are generated into the medium illuminating respectively the at least three respective observation points (Fig. 5a: X1, X2 and X3) in the medium (tissue)[0050-0054] .
Claim 3. Dependent on the method according to claim 1. Tabaru further discloses the plurality of backscattered signals is respectively acquired by a plurality of ultrasound transducers (100)[0046], each ultrasound transducer (100) acquiring backscattered signals backscattered respectively from a respective observation point [0045: calculating distance between each focus and a position of each element 100 of the ultrasound probe 1].
Claim 4. Dependent on the method according to claim 3. Tabaru further discloses the at least three ultrasound beams (Fig. 3 beams depicted) are generated respectively by the plurality of ultrasound transducers (100)[0045].
Claim 5. Dependent on the according to claim 3. Tabaru further discloses the at least three ultrasound beams (Fig. 3 beams depicted) are generated respectively by at least three ultrasound transducers (100 seven shown with three groupings targeted at the observation points) of the plurality of ultrasound transducers [0045].
Claim 6. Dependent on the method according to claim 1. Tabaru further discloses the respective observation points (X1, X2 & X3) are separated from each other by a separation distance less than the wavelength of the shear wave in the medium [0053: In this case, the number of the detection positions is 3, however, the number is not limited to 3. An interval .DELTA.x of the position x shall be an interval small enough for a wavelength .lamda. of the shear wave, for example, 1/10.lamda].
Claim 8. Dependent on the method according to claim 1. Tabaru further discloses the wave vector direction of the shear wave is known (Fig. 3: wave direction is known towards the transducers), the at least three observation points (Fig. 5a: x1, x2 and x3 aligned perpendicular to wavefront) may be not aligned in the plane that contains the wave vector of the shear wave (Fig. 5a: x1, x2 and x3 aligned perpendicular to wavefront).
Claim 9. Dependent on the method according to claim 8. Tabaru further discloses each arrival time of the plurality of respective arrival times for a respective observation point is determined using a motion estimator (23) on backscattered signals (100)[0046] respectively acquired from this respective observation point [0040: a transmission beam generating device for detecting displacement 22 and a received beam computing device for detecting displacement 23 via a switch for switching transmission and reception 2 that functions as a part for switching transmission and reception] & [0042].
Claim 10. Dependent on the method according to claim 9. Tabaru further discloses each arrival time of the plurality of respective arrival times for a respective observation point is determined based on a respective variation of a tissue velocity determined by the motion estimator (3) at this respective observation point [0050-0052].
Claim 11. Dependent on the method according to claim 1. Tabaru further discloses calculating the vector velocity components of the shear wave further comprises a determination of a plurality of at least three delays (Fig. 6 each observation point has two delay times), each delay (Δt) being determined between two respective arrival times of the plurality of arrival times, and each vector velocity component being function of a respective delay (Δt) of the plurality of at least three delays [components [0047: .rho. .differential. 2 u i .differential. t 2 = .mu. ( .differential. 2 u i .differential. x 2 + .differential. 2 u i .differential. y 2 + .differential. 2 u i .differential. z 2 ) ( 16 ) ##EQU00007## ].
Claim 12. Dependent on the method according to claim 9. Tabaru further discloses each arrival time of a respective observation point determined based on the respective variation of the tissue velocity at this respective observation point is determined by detecting a maximum of the respective variation [0056: the integrated value and the maximum amplitude value are calculated based upon the plural temporal waveforms in half-width of the displacement of the shear wave and the value acquired by dividing the integrated value by the maximum amplitude value is used for the width of the temporal waveforms. The half-width is a calculating method of searching two points having a half value of a maximum amplitude in the waveforms and setting distance between the two points (time difference between two times because an axis of abscissas shows time in this case) as width].
Claim 13. Dependent on the method according to claim 1. Tabaru, as modified, does not explicitly disclose:
estimating of the velocity of the shear wave based on the calculated vector velocity components is performed by using inversion algorithm on the calculated vector velocity components.
Gennisson teaches observation points (Fig. 4: 6 points forming three set distances each for each three-axis from a selected focal point) estimating of the velocity of the shear wave based on the calculated vector velocity components is performed by using inversion algorithm on the calculated vector velocity components required vector components to determine velocity through using inversion algorithm on the calculated velocity components page 3 equation (1)[Page 3 col. 1].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use Gennisson’s plurality of observation point on each of three separate planar axis and vector processing with Tabaru’s setting of observation points because measurements in a three-dimensional area of the shear wave improves velocity measurement by reducing erroneous fluctuations measurements that can dominate in a linear slice measurement.
Claim 14. Dependent on the method according to claim 1. Tabaru further discloses the shear wave is a natural shear wave generated by a natural source of shear waves comprised in the medium [0133: when the shear wave is generated, a well-known method such the movement of a blood vessel, a heart and others may be also used in place of the transmission beam for generating displacement].
Claim 15. Dependent on the method according to claim 14. Tabaru further discloses the natural source of shear waves is a movement of closure valves of a heart or vibration caused by voice or pulse wave propagating in the arterial wall [0133: when the shear wave is generated, a well-known method such the movement of a blood vessel, a heart and others may be also used in place of the transmission beam for generating displacement].
Claim 16. Dependent on the method according to claim 3. Tabaru further discloses the plurality of ultrasound transducers (100) is located on the surface of the medium (tissue) [0044: FIG. 2, a case that a linear array type ultrasound probe 1 is touched to a surface of a body of a subject and an ultrasonic beam for generating displacement is focused on a target section in the body will be described. In this case, a case that a direction of the propagation of the ultrasonic beam for generating displacement (=the transmission beam for generating displacement) on the desired section is a direction perpendicular to the body surface will be described].
Claim 17. Dependent on Claim 1 detection system for determining a velocity of a shear wave propagating in a medium using a method according to claim 1. said detection system (Fig. 1) comprises: a plurality of ultrasound transducers (100) arranged in a 2D array [0135: a two-dimensional probe] for generating at least one ultrasound beam into the medium and illuminating at least three respective observation points (Fig. 5a: X1, X2 and X3) in the medium (tissue)[0050-0051], and being configured to acquire a respective backscattered signal (100)[0046] generated in response to an interaction between the at least one ultrasound beam and the medium (medium is uniform tissue) [0051]& [0133 source of displacement heart or arterial wall], a control unit (2 & 3) configured for having the ultrasound transducers of the plurality of ultrasound transducers for generating the at least one ultrasound beam [0040-0041], for acquiring a plurality of backscattered signals backscattered (100)[0046] respectively from said at least three respective observation points (Fig. 5a: X1, X2 and X3) illuminated by said at least one ultrasound beam [0040-0041], for determining a respective arrival time for each observation point based on the backscattered signals respectively acquired from the observation point [0050-0051], for calculating vector velocity components [0047] of the shear wave based on the plurality of respective arrival times and for estimating the velocity (c) of the shear wave based on the calculated vector velocity components [0047: .rho. .differential. 2 u i .differential. t 2 = .mu. ( .differential. 2 u i .differential. x 2 + .differential. 2 u i .differential. y 2 + .differential. 2 u i .differential. z 2 ) ( 16 ) ##EQU00007## ] wherein the respective observation points are distinct (Fig. 3: x1, x2 & x3) [0045-0051]. Tobaru, as modified, does not explicitly disclose:
the respective observation points are not aligned
Gennisson teaches observation points (Fig. 4: 6 points forming three set distances each for each three-axis from a selected focal point) that are not linearly aligned (Fig.4 six points on three-axis are not aligned in a single plane) and the required vector components to determine velocity in page 3 equation (1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use Gennisson’s plurality of observation point on each of three separate planar axis and vector processing with Tabaru’s setting of observation points because measurements in a three-dimensional area of the shear wave improves velocity measurement by reducing erroneous fluctuations measurements that can dominate in a linear slice measurement.
Claim 18. Dependent on the detection system according to claim 17. Tabaru further discloses at least three ultrasound beams (Fig. 3) are generated into the medium (tissue) illuminating respectively the at least three respective observation points (Fig. 5a: X1, X2 & X3) in the medium (tissue)[0050-0051].
Claim 19. Dependent on the detection system according to claim 17. Tabaru further discloses each ultrasound transducer (Fig. 3: 100 transducers) of the plurality of ultrasound transducers (100) acquires backscattered signals [0046] backscattered respectively from a respective observation point [0050-0051],
Claim 20. Dependent on the detection system according to claim 17. Tabaru further discloses the shear wave is a natural shear wave generated by a natural source of shear waves comprised in the medium (tissue) [0133: when the shear wave is generated, a well-known method such the movement of a blood vessel, a heart and others may be also used in place of the transmission beam for generating displacement].
Claim 22. Dependent on the detection system according to claim 17. Tabaru further discloses each ultrasound transducer (100) is formed by a matrix of transducer elements [0044: In this embodiment, as shown in FIG. 2, a case that a linear array type ultrasound probe 1 is touched to a surface of a body of a subject and an ultrasonic beam for generating displacement is focused on a target section in the body will be described. In this case, a case that a direction of the propagation of the ultrasonic beam for generating displacement (=the transmission beam for generating displacement) on the desired section is a direction perpendicular to the body surface will be described] adapted to be controlled independently [0040], and the control system (2 & 3) may be configured to control the ultrasound transducer elements so that to emulate an ultrasound transducer generating an ultrasound beam in the medium [0040-0041].
Prior Art Considered but not Utilized
The prior art made of record and not relied upon and is considered pertinent to applicant's disclosure is provided in the following table:
Prior Art Document Identifier
Inventor
Comment
US 20110245678
Tamura; Tadashi
shear waves are detected in the biological tissue based on the received one or more ultrasound signals [Abstract]
US 20170347990
WATANABE Y
a shear wave analyzer detects shear wave propagation velocity inside the ROI based on the tissue displacement,
CN 110573084
XU, Zhi-an et al.
an ultrasonic elastic shear wave elasticity imaging method
CN 104055541
CUI, Xiao-yao et al.
ultrasonic tomography shear wave elasticity imaging method,
WO 2015023081
LEE, MIN-GU et al.
a shear wave is generated by the unfocused push signals; receiving a response signal to the detected ultrasonic signal from the object; and generating an elastic image of the object on the basis of the response signal.
WO 2020047805
XU, Mengling et al.
a shear wave in the detection target and emitting a probe beam used for probing the shear wave to the detection target.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Monica S Young whose telephone number is (303)297-4785. The examiner can normally be reached M-F 08:30-05:30 MST.
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/MONICA S YOUNG/Examiner, Art Unit 2855
/PETER J MACCHIAROLO/Supervisory Patent Examiner, Art Unit 2855
