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 .
Claim Objections
Claims 1, 4, 8, 13, 16, and 20 are objected to because of the following informalities:
Regarding claim 1, the limitation “stress” in line 4 should be changed to –a stress--. This also applies to the analogous limitation in claim 13.
Further regarding claim 1, the limitation “a property of the tissue volume” in line 10 should be changed to –[[a]] the property of the tissue volume--. This also applies to the analogous limitation in claim 13.
Regarding claim 4, the limitation “an anti-symmetric Lamb wave or shear-wave function” should be changed to –an anti-symmetric Lamb wave function or a shear-wave function--. This also applies to the analogous limitation in claim 16.
Regarding claim 8, the limitation “a Lamb-wave or shear-wave calculation” should be changed to –a Lamb-wave or a shear-wave calculation--. This also applies to the analogous limitation in claim 20.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 4, 9, 14, 16, and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 2, the limitation “a property of a tissue volume” renders the claim indefinite because it is unclear whether this is the same or different property and tissue volume recited in claim 1. For the present purposes of examination, they have been interpreted as being the same. Further clarification is required. This also applies to the analogous limitation in claim 14.
Regarding claim 4, the limitation “the mechanical deformation” has insufficient antecedent basis in the claim. Further clarification is required. This also applies to the analogous limitation in claim 16.
Regarding claim 9, the limitation “a parameter” in line 2 renders the claim indefinite because it is unclear whether this is the same or different as the parameter recited in claim 1. For the present purposes of examination, the limitations have been interpreted as being the same. If the limitations are not the same, it is unclear whether the limitation “the parameter” in line 3 refers to the parameter in line 2 or the parameter in claim 1. Further clarification is required. This also applies to the analogous limitations in claim 21.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-11 and 13-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Analysis step 1 of Subject Matter Eligibility Test
The claims are directed to a process (i.e., a method for characterizing a parameter representing a property of a tissue volume) of claims 1-11 and a machine (i.e., a system for characterizing a parameter representing a property of a tissue volume) of claims 13-21.
Analysis step 2A, Prong I
The claims recite abstract ideas, in particular mathematical concepts. Claim 1 recites “generating an ensemble of transient peaks from the determined wave speed time series data” which is disclosed as a calculation in at least [0052] of the pre-grant publication of the instant application. Claim 1 also recites “determining the parameter representing a property of the tissue volume from the ensemble of transient peaks” which is disclosed as a calculation in at least [0137] of the pre-grant publication of the instant application.
Claim 3 recites “wherein generating the ensemble of transient peaks includes forming a lower envelope data series and subtracting the lower envelope data series from the wave speed time series data.” Claim 4 recites “calculating a phase velocity of a mechanical deformation propagating along the tissue volume and fitting an anti-symmetric Lamb wave or shear-wave function to account for attenuation of the mechanical deformation in the tissue volume that is caused by geometric boundaries thereof”. Claim 5 recites “removing outlier data points from the wave speed time series data and interpolating the wave speed time series data over the removed outlier data points”. Claim 6 recites “performing a spectral analysis to determine dispersion data representing a mechanical deformation that corresponds to a motion of the tissue wall along a surface of the tissue wall”. Claim 8 recites “estimating a viscoelasticity parameter of the tissue volume using one of a Lamb-wave or shear-wave calculation based on dispersion data”. Claim 9 recites “determining, based on dispersion data, a parameter in association with pressure produced by the tissue wall, wherein the parameter includes one or more of: (i) a phase velocity of a wave associated with a mechanical deformation propagating along the tissue volume, (ii) a group velocity of a wave associated with the mechanical deformation; (iii) a wave-peak velocity associated with the mechanical deformation; (iv) elasticity of the tissue wall; (v) a viscosity of the tissue wall; (vi) compliance of the tissue volume; and (vii) a function of the wave velocity”. Claim 11 recites “wherein the parameter representing a property of the tissue volume is a detrusor overactivity (DO) index I, which is determined as a mathematical function of data series xetp and xle, where xETP(t) representsa continuous signal of the ensemble of transient peaks (ETP) data series and xLE(t) a continuous signal of the lower envelope (LE) data series, each as a function of time”. Claim 2 further defines the parameter. Claim 10 further defines the tissue volume. Claims 13-21 recite analogous limitations.
Analysis step 2A, Prong II
The judicial exception is not integrated into a practical application because the additional elements of the claims merely add insignificant extra-solution activity to the judicial exception. See MPEP 2106.05 (g).
Claim 1 recites “detecting ultrasonic energy reflected by multiple locations along the tissue volume that is subject to stress to form ultrasonic echo data, wherein the tissue volume is formed by a tissue wall that spatially separates a fluid material from a rigid material; determining wave speed time series data from the ultrasonic echo data”, which is insignificant extra-solution activity, in particular mere data gathering. Claim 13 recites analogous limitations. Claim 7 recites “wherein detecting the ultrasonic energy with the transducer includes causing the stress by applying to the tissue volume at least one of (i) an acoustic radiation force, (ii) an electro-mechanical input; and (iii) a mechanical input” which is insignificant extra-solution activity, in particular mere data gathering. Claim 19 recites analogous limitations.
Analysis step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements merely add insignificant extra-solution activity, in particular mere data gathering, to the judicial exception that are well-understood, routine, and conventional activities previously known to the industry.
Claims 1-11 and 13-21 are therefore directed to a judicial exception without significantly more. The claims are not patent eligible.
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.
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 1-4, 6-10, 13-16, and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Fatemi et al. (US 2014/0296709, October 2, 2014, applicant submitted prior art via the IDS, hereinafter “Fatemi”) in view of Chen et al. (WO 2019/032803, February 14, 2019, hereinafter “Chen”).
Regarding independent claim 1, Fatemi discloses a method for characterizing a parameter representing a property of a tissue volume (“System and method for determining viscoelasticity of curved tissue walls using ultrasound bladder vibrometry (UBV).” Abstract), the method comprising:
with a transducer (“The B-mode scanning can be performed by, for example, a Verasonics ultrasound imaging platform equipped with a C4-2 linear array transducer 602” [0055]), detecting ultrasonic energy reflected by multiple locations along the tissue volume (“at process block 506, a pulse-echo ultrasound 606 (detection beam) is used to measure the motion at several points along a line of propagation 608” [0055]) that is subject to stress (“The process begins at process block 502 with the formation of acoustic radiation force excitation signals that are applied, at process block 504, to a subject to, thereby, apply vibration pulses to tissue of interest. Referring to FIG. 6, a diagram of the fundamental principal of ultrasound bladder vibrometry (UBV) is shown. Again, the term "bladder" may not refer to the "urinary" bladder in the human body, but may, more generally, refer to a tissue volume formed by tissue walls that may have some elasticity. UBV uses focused ultrasound to produce a radiation force 604 (push beam) to excite impulsive Lamb waves (200-600 .mu.s in length) in the medium of interest.” [0051]) to form ultrasonic echo data (“received echoes” [0056]), wherein the tissue volume is formed by a tissue wall that spatially separates a fluid material from a rigid material (“the line of propagation being, for example, a bladder wall, in order to track tissue motion through successive B-modes” [0055]; also see “wherein the tissue volume is formed by a tissue wall that spatially separates a fluid material from a rigid material” claim 1);
determining wave speed time series data from the ultrasonic echo data (“obtained dispersion data are shown in FIG. 9” [0078]; also see Fig. 9, reproduced below, and corresponding description).
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Although Fatemi discloses determining the parameter representing a property of the tissue volume from the determined wave speed time series data (“The Lamb wave dispersion equation (2) for a flat plate 700 can then be fit to the dispersion data to measure bladder elasticity and viscosity, as well as the estimated thickness of the bladder from the B-mode.” [0078]), Fatemi fails to disclose generating an ensemble of transient peaks from the determined wave speed time series data; and determining the parameter representing a property of the tissue volume from the ensemble of transient peaks.
However, Chen teaches, in the same field of endeavor (“One of the first ultrasound methods capable of making hepatic stiffness measurements was transient elastography ("TE"). This method utilizes a small single- element transducer to deliver a mechanical impulse to generate a transient shear wave.” [0004]), generating an ensemble of transient peaks from the determined wave speed time series data (“A determination is then made at decision block 318 whether the resultant signal is an IMF. As one example, if the number of local maxima exceeds the number of zero crossings by more than one, or if the midpoint of the envelope is not identically zero for all points, the resultant signal is not an IMF.” [0036]); and determining the parameter representing a property of the tissue volume from the ensemble of transient peaks (“Mechanical properties that can be computed from the IMFs, and therefore visualized in the mechanical property maps, include shear wave speed, strain, bulk modulus, shear modulus, viscosity, Young's modulus, and so on.” [0038]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Fatemi with generating an ensemble of transient peaks from the determined wave speed time series data; and determining the parameter representing a property of the tissue volume from the ensemble of transient peaks as taught by Chen in order to reduce probe motion artifacts from the ultrasonic echo data ([0007] of Chen).
Regarding independent claim 13, Fatemi discloses a system for characterizing a parameter representing a property of a tissue volume (“System and method for determining viscoelasticity of curved tissue walls using ultrasound bladder vibrometry (UBV).” Abstract), the system comprising:
a transducer (“The B-mode scanning can be performed by, for example, a Verasonics ultrasound imaging platform equipped with a C4-2 linear array transducer 602” [0055]) configured for detecting ultrasonic energy reflected by multiple locations along the tissue volume (“at process block 506, a pulse-echo ultrasound 606 (detection beam) is used to measure the motion at several points along a line of propagation 608” [0055]) that is subject to stress (“The process begins at process block 502 with the formation of acoustic radiation force excitation signals that are applied, at process block 504, to a subject to, thereby, apply vibration pulses to tissue of interest. Referring to FIG. 6, a diagram of the fundamental principal of ultrasound bladder vibrometry (UBV) is shown. Again, the term "bladder" may not refer to the "urinary" bladder in the human body, but may, more generally, refer to a tissue volume formed by tissue walls that may have some elasticity. UBV uses focused ultrasound to produce a radiation force 604 (push beam) to excite impulsive Lamb waves (200-600 .mu.s in length) in the medium of interest.” [0051]) to form ultrasonic echo data (“received echoes” [0056]), wherein the tissue volume is formed by a tissue wall that spatially separates a fluid material from a rigid material (“the line of propagation being, for example, a bladder wall, in order to track tissue motion through successive B-modes” [0055]; also see “wherein the tissue volume is formed by a tissue wall that spatially separates a fluid material from a rigid material” claim 1);
a processor (“The system also includes data processing unit or processor PU structured to calculate one or more parameter P representing a mechanical property or characteristic of the bladder” [0099]) configured to:
determine wave speed time series data from the ultrasonic echo data (“obtained dispersion data are shown in FIG. 9” [0078]; also see Fig. 9, reproduced below, and corresponding description).
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generate an ensemble of transient peaks from the determined wave speed time series data; and
determine the parameter representing a property of the tissue volume from the ensemble of transient peaks.
Although Fatemi discloses determining the parameter representing a property of the tissue volume from the determined wave speed time series data (“The Lamb wave dispersion equation (2) for a flat plate 700 can then be fit to the dispersion data to measure bladder elasticity and viscosity, as well as the estimated thickness of the bladder from the B-mode.” [0078]), Fatemi fails to disclose generate an ensemble of transient peaks from the determined wave speed time series data; and determine the parameter representing a property of the tissue volume from the ensemble of transient peaks.
However, Chen teaches, in the same field of endeavor (“One of the first ultrasound methods capable of making hepatic stiffness measurements was transient elastography ("TE"). This method utilizes a small single- element transducer to deliver a mechanical impulse to generate a transient shear wave.” [0004]), generate an ensemble of transient peaks from the determined wave speed time series data (“A determination is then made at decision block 318 whether the resultant signal is an IMF. As one example, if the number of local maxima exceeds the number of zero crossings by more than one, or if the midpoint of the envelope is not identically zero for all points, the resultant signal is not an IMF.” [0036]); and determine the parameter representing a property of the tissue volume from the ensemble of transient peaks (“Mechanical properties that can be computed from the IMFs, and therefore visualized in the mechanical property maps, include shear wave speed, strain, bulk modulus, shear modulus, viscosity, Young's modulus, and so on.” [0038]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Fatemi with generate an ensemble of transient peaks from the determined wave speed time series data; and determine the parameter representing a property of the tissue volume from the ensemble of transient peaks as taught by Chen in order to reduce probe motion artifacts from the ultrasonic echo data ([0007] of Chen).
Regarding claims 2 and 14, Fatemi modified by Chen discloses the limitations of claims 1 and 13 as stated above and Fatemi further discloses wherein the parameter representing a property of a tissue volume is at least one of group velocity (GV) (“UBV measurements of group velocity” [0024]), group velocity squared (GV2), a power of group velocity, arrival time of an induced Lamb wave, estimated elastic properties of the tissue volume (“elasticity” [0024]; also see [0078]), detrusor pressure (Pdet) (“detrusor pressure” [0004]; also see [0091]), or a detrusor overactivity index of the tissue volume.
Regarding claims 3 and 15, Fatemi modified by Chen discloses the limitations of claims 1 and 13 as stated above, in particular Chen was relied on to teach generating the ensemble of transient peaks as stated above. Chen further teaches, in the same field of endeavor, wherein generating the ensemble of transient peaks includes forming a lower envelope data series (“A lower envelope is also estimated from the input signal, as indicated at step 310.” [0034]) and subtracting the lower envelope data series from the wave speed time series data (“the midline can be estimated by calculating the mean of the upper and lower envelopes at each location. The midline is then subtracted from the input signal, as indicated at step 314, to effectively remove low frequency modulations from the input signal.” [0035]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to further modify the invention of Fatemi with wherein generating the ensemble of transient peaks includes forming a lower envelope data series and subtracting the lower envelope data series from the wave speed time series data as taught by Chen in order to reduce probe motion artifacts from the ultrasonic echo data ([0007] of Chen).
Regarding claims 4 and 16, Fatemi modified by Chen discloses the limitations of claims 1 and 13 as stated above and Fatemi further discloses calculating a phase velocity of a mechanical deformation propagating along the tissue volume (“LDUV is an SDUV-based technique that uses a mechanical actuator or ultrasound radiation force that is focused to excite Lamb waves in the medium of interest and a pulse echo transducer to track the deformation and estimate phase velocity. The Lamb wave dispersion equation is fitted to the measured Lamb wave velocity dispersion (change in phase velocity as a function of frequency) to estimate elasticity and viscosity of the medium.” [0031]) and fitting an anti-symmetric Lamb wave or shear-wave function to account for attenuation of the mechanical deformation in the tissue volume that is caused by geometric boundaries thereof (“In addition, the bladder tissue can experience both geometric attenuation (this attenuation occurs due to boundaries in the geometry) and attenuation due to material viscosity (this attenuation would occur even if the medium was infinite). The geometric attenuation may be accounted for by using the anti-symmetric Lamb wave model, which shows significant dispersion in plates even in the absence of viscosity.” [0069]).
Regarding claims 6 and 18, Fatemi modified by Chen discloses the limitations of claims 1 and 13 as stated above and Fatemi further discloses performing a spectral analysis to determine dispersion data representing a mechanical deformation that corresponds to a motion of the tissue wall along a surface of the tissue wall (“performing spectral analysis to determine dispersion data representing said mechanical deformation that corresponds to a motion of the spatially curved tissue wall along a surface of said tissue wall” claim 5; also see [0056]).
Regarding claims 7 and 19, Fatemi modified by Chen discloses the limitations of claims 1 and 13 as stated above and Fatemi further discloses wherein detecting the ultrasonic energy with the transducer includes causing the stress by applying to the tissue volume at least one of (i) an acoustic radiation force, (ii) an electro-mechanical input; and (iii) a mechanical input (“wherein said detecting ultrasonic energy includes causing said stress by applying to the tissue volume at least one of (i) an acoustic radiation force, (ii) an electro-mechanical input; and (iii) a mechanical input.” Claim 8; also see [0051], [0054]).
Regarding claims 8 and 20, Fatemi modified by Chen discloses the limitations of claims 1 and 13 as stated above and Fatemi further discloses estimating a viscoelasticity parameter of the tissue volume using one of a Lamb-wave or shear-wave calculation based on dispersion data (“estimating a viscoelasticity parameter of said tissue volume with the use of Lamb-wave or shear-wave calculation based on said dispersion data” claim 9; also see [0008]).
Regarding claims 9 and 21, Fatemi modified by Chen discloses the limitations of claims 1 and 13 as stated above and Fatemi further discloses determining, based on dispersion data, a parameter in association with pressure produced by the tissue wall, wherein the parameter includes one or more of: (i) a phase velocity of a wave associated with a mechanical deformation propagating along the tissue volume, (ii) a group velocity of a wave associated with the mechanical deformation; (iii) a wave-peak velocity associated with the mechanical deformation; (iv) elasticity of the tissue wall; (v) a viscosity of the tissue wall; (vi) compliance of the tissue volume; and (vii) a function of the wave velocity (“determining, based on the dispersion data, said parameter in association with pressure produced by said tissue wall, wherein said parameter includes one or more of: (i) a phase velocity of a wave associated with said mechanical deformation, (ii) a group velocity of a wave associated with said mechanical deformation; (iii) a wave-peak velocity associated with said mechanical deformation; (iv) elasticity of the tissue wall, (v) a viscosity of the tissue wall, and (vi) compliance of the tissue volume.” claim 10; also see [0008]).
Regarding claim 10, Fatemi modified by Chen discloses the limitations of claim 1 as stated above and Fatemi further discloses wherein the tissue volume includes a urinary bladder of a subject (“the urinary bladder is one example of a bladder.” [0007]).
Claims 5 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Fatemi in view of Chen as applied to claims 1 and 13 above and further in view of Shandas et al. (US 2008/0015440, January 17, 2008, hereinafter “Shandas”).
Regarding claims 5 and 17, Fatemi modified by Chen discloses the limitations of claims 1 and 13 as stated above but fails to disclose removing outlier data points from the wave speed time series data and interpolating the wave speed time series data over the removed outlier data points.
However, Shandas teaches, in the same field of endeavor, removing outlier data points from the wave speed time series data and interpolating the wave speed time series data over the removed outlier data points (“the pre-processing on B-mode images can improve, to some extent, the measurement accuracy. However, there are still some obviously incorrect vectors remaining in the vector field, introducing errors to the measured flow velocities. To eliminate those outliers, the vector field is smoothed by numerous customized neighborhood filters, which are followed by interpolation methods.” [0192]; also see [0053], [0195]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Fatemi with removing outlier data points from the wave speed time series data and interpolating the wave speed time series data over the removed outlier data points as taught by Shandas in order to reduce error ([0192] of Shandas).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Fatemi in view of Chen as applied to claim 1 above and further in view of Oh (US 2020/0268302, August 27, 2020, hereinafter “Oh”).
Regarding claim 11, Fatemi modified by Chen discloses the limitations of claim 1 as stated above but fails to disclose wherein the parameter representing a property of the tissue volume is a detrusor overactivity (DO) index I, which is determined as a mathematical function of data series xetp and xle, where xETP(t) represents a continuous signal of the ensemble of transient peaks (ETP) data series and xLE(t) a continuous signal of the lower envelope (LE) data series, each as a function of time.
However, Oh teaches, in the same field of endeavor, wherein the parameter representing a property of the tissue volume is a detrusor overactivity (DO) index I, which is determined as a mathematical function of data series xetp and xle, where xETP(t) represents a continuous signal of the ensemble of transient peaks (ETP) data series and xLE(t) a continuous signal of the lower envelope (LE) data series, each as a function of time (“the physician may analyze the data from filling cystometry to characterize the detrusor activity, such as detrusor overactivity of the patient's bladder. Detrusor overactivity is defined as a urodynamic observation characterized by involuntary detrusor contractions during the storage phase that may be spontaneous or provoked. FIG. 4 shows an exemplary data 400 from filling cystometry according to embodiments of the present disclosure. As depicted, the plots 410, 420, and 430 may represent detrusor pressures (Pdet) of the bladders 412, 422, and 432, respectively. Compared to the normal bladder 412, the overactive bladder 422, 432 may have involuntary detrusor contractions 420, 430, 434, 436 during storage phase without permission to void, where the involuntary detrusor contraction may be spontaneous or provoked. In embodiments, involuntary detrusor contractions 420, 430, 434, 436 during the storage phase may indicate detrusor overactivity.” [0068]; also see [0077]-[0081], Fig. 4, reproduced below, and corresponding description).
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Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Fatemi with wherein the parameter representing a property of the tissue volume is a detrusor overactivity (DO) index I, which is determined as a mathematical function of data series xetp and xle, where xETP(t) represents a continuous signal of the ensemble of transient peaks (ETP) data series and xLE(t) a continuous signal of the lower envelope (LE) data series, each as a function of time as taught by Oh in order to “distinguish various types of bladder/urethral dysfunctions in a single disease entity” ([0003] of Oh).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMINAH ASGHAR whose telephone number is (571)272-0527. The examiner can normally be reached M-F 9am-5pm.
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/A.A./ Examiner, Art Unit 3797
/SERKAN AKAR/ Primary Examiner, Art Unit 3797