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 .
Priority
Acknowledgement is made to Applicant’s claim to priority to U.S. Provisional App. No. 63/716,900 filed 11/06/2024.
Status of Claims
This Office Action is responsive to the claims filed on 01/14/2026. Claims 1-9 and 11-21 are presently pending in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 and 11-21 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 1, line 12; and claim 21, line 17 recite the limitation "a first and second average integrated backscatter coefficient" which is indefinite because it is unclear what the metes and bounds of “a first and second average integrated backscatter coefficient”. It is unclear if this coefficient is an average of a first integrated backscatter and a second integrated backscatter; OR if this step refers two calculating two different average integrated backscatter coefficients from the first reflected ultrasound energy and the second reflected ultrasound energy. Furthermore, claim 1, line 14-15; and claim 21, line 19-20 recites the limitation “the first and second integrated backscatter coefficients”. There is insufficient antecedent basis for this limitation in the claim. It is further unclear whether this plurality of coefficients refer to the limitations recited in line 12/17 respectively, or if these are newly recited limitations.
The terms “about 90°” and “about 70° to about 110°” recited in claim 6, line 2; claim 7, line 9; claim 12, line 3, respectively, is a relative term which renders the claim indefinite. The terms “about 90°” and “about 70° to about 110°” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, “about 90°” is interpreted to mean “90°”; and “about 70° to about 110°” is considered to mean “70° to 110°”.
Claim 11, lines 4-6 recites the claim limitation “the Gaussian fit”. There is insufficient antecedent basis for this limitation in the claim. It is further indefinite because it is unclear if this “Gaussian fit” is the same Gaussian fit that is already recited in claim 9, line 3. For the purpose of examination, claim 11 is interpreted to be dependent on claim 9 and that “the Gaussian fit” is understood to refer to the “Gaussian fit” recited in claim 9, line 3; OR that the Gaussian fit is a new recited element.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-6, 13, 15, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kanai (US 20050124881 A1).
Regarding claim 1, Kanai teaches a method of characterizing a tissue (Paragraph [0036]; ultrasonic diagnostic system that is capable of acquiring detailed information on local tissue characteristics of cardiac muscle by utilizing ultrasonic backscatter IB), comprising:
providing a set of at least one ultrasound transducers (Paragraph [0077]; ultrasonic diagnostic system; an ultrasonic probe 3, Fig. 1; Beam scanning means 5 transmits the ultrasonic pulse while successively changing over the radiating position of an ultrasonic beam) and a set of at least one ultrasound receivers (Paragraph [0077]; Reflected wave receiving means 6 orthogonally detects the reflected wave signal received from the ultrasonic probe 3, Fig. 1);
insonating the tissue with one of the set of ultrasound transducers from a first position (Paragraph [0120]-[0121]; An ultrasonic pulse is transmitted for scanning one of the ultrasonic beam positions of a B-mode image.; Fig. 17);
collecting a first reflected ultrasound energy with at least one of the set of ultrasound receivers (Paragraph [0119]-[0122]; beam scanning control unit 35 controls the scanning position… The reflected wave signal receiving unit 36 receives and orthogonally detects a reflected wave synchronized; S1: Reflected wave data are collected, Fig. 17);
insonating the tissue with one of the set of ultrasound transducers from a second position (Paragraph [0123]; S2: When there is a next ultrasonic beam position, the process will return to S0 to repeat scanning., Fig. 17);
collecting a second reflected ultrasound energy with at least one of the set of ultrasound receivers (Paragraph [0119]-[0122]; Paragraph [0119]-[0122]; beam scanning control unit 35 controls the scanning position… The reflected wave signal receiving unit 36 receives and orthogonally detects a reflected wave synchronized; S1: Reflected wave data are collected, Fig. 17 shows the step of collecting wave data is repeated);
calculating a first and second average integrated backscatter coefficient of the tissue from the first and second reflected ultrasound energies respectively (Paragraph [0077]; Integrated backscattering intensity detecting means 8 calculates the average power of the backscatter waves from the different points in displacement motion to obtain the integrated backscattering intensity IB; Paragraphs [0127]-[0136]; backscattering intensity from a region comprising only of blood in the heart cavity (IB signal IBblood(t)) is calculated with respected to one beam position; Upon completion of processing one beam, the process returns to S6, the processing is repeated for the next beam position, Fig. 17); and
determining at least one characteristic of the tissue based on the first and second integrated backscatter coefficients (Paragraph [0077]; Variable frequency detecting means 9 measures out the variation frequency or variable cycle of the integrated backscattering intensity IB from the different points in the region of interest, and makes it available as information representing the local tissue characteristics of each point; Paragraph [0132]-[0137]; center of gravity of the power spectrum S(f, t)2 is determined; mean frequency fmean is converted into a suitable color, displayed by superimposing over the position of the matching set point in an M-mode image to obtain an estimated value of thickness variation, Fig. 17).
Regarding claim 3, Kanai teaches all of the limitations of claim 1 as noted above.
Kanai further teaches the tissue is selected from the group of: a heart (Paragraph [0077]; the object of diagnosis is the heart 2 of a subject 1; Paragraph [0108]; cardiac muscle are mutually propped by supports comprising collagen fibers, which are bundled into cardiac muscle fiber fascicles, which are further wrapped in a collagen fiber tissue).
Regarding claim 4, Kanai teaches all of the limitations of claim 1 as noted above.
Kanai further teaches positioning the transducer automatically (Paragraph [0119]; The beam scanning control unit 35 controls the scanning position of an ultrasonic beam radiated from the ultrasonic probe 33 and the transmission of an ultrasonic pulse; The control unit controlling the scan position is considered to read on the claimed limitation of positioning the transducer automatically as understood in its broadest reasonable interpretation).
Regarding claim 5, Kanai teaches all of the limitations of claim 1 as noted above.
Kanai further teaches the reflected ultrasound energies comprise a backscattered echo (Paragraph [0077]; Paragraph [0119]; an IB value IBblood based on a scattered wave from the blood in the ventricular lumen behind the heart wall is measured; Claim 1; measure a backscattering intensity by using a scattering wave from a region of interest in the living tissue on a basis of the reflected wave).
Regarding claim 6, Kanai teaches all of the limitations of claim 1 as noted above.
Kanai further teaches at least one of the first position and second position comprise an insonation angle of about 90 degrees relative to the tissue surface (Paragraph [0015]; The resultant reflected signal is detected with an orthogonal detector 24, Fig. 1 and 18; Paragraph [0077]; displacement detecting means 7 analyzes the orthogonally detected signals to obtain the instantaneous velocities of points in the region of interest ROI set on beam positions on a section of the heart wall).
Regarding claim 13, Kanai teaches all of the limitations of claim 1 as noted above.
Kanai further teaches the at least one characteristic of the tissue is a property of the tissue structure (Paragraph [0109]; The cardiac cycle variations of IB were attributed to changes in the orientation or volume density of the interstitial tissue… However, variations in the orientation or volume density of the interstitial tissue are due the extension and contraction of the cardiac muscle; The changes in the orientation or volume density of the interstitial tissue is considered to be a property of the tissue as understood in its broadest reasonable interpretation).
Regarding claim 15, Kanai teaches all of the limitations of claim 1 as noted above.
Kanai further teaches the at least one characteristic of the tissue is a material property of the tissue (Paragraph [0109]; The cardiac cycle variations of IB were attributed to changes in the orientation or volume density of the interstitial tissue… However, variations in the orientation or volume density of the interstitial tissue are due the extension and contraction of the cardiac muscle; The volume density of the interstitial tissue is considered to be a material property of the tissue as understood in its broadest reasonable interpretation).
Regarding claim 21, Kanai teaches a system for characterizing a tissue (Paragraph [0036]; ultrasonic diagnostic system that is capable of acquiring detailed information on local tissue characteristics of cardiac muscle by utilizing ultrasonic backscatter IB), comprising:
an imaging device (Paragraph [0077]; an ultrasonic probe 3, Fig. 1;) comprising a set of at least one ultrasound transducers (Paragraph [0077]; Beam scanning means 5 transmits the ultrasonic pulse while successively changing over the radiating position of an ultrasonic beam) and a set of at least one ultrasound receivers (Paragraph [0077]; Reflected wave receiving means 6 orthogonally detects the reflected wave signal received from the ultrasonic probe 3, Fig. 1);
a display (Paragraph [0077]; monitor 11, Fig. 1);
a processor communicatively connected to the imaging device and the display ([0119]; The analytical processing unit 37 is inputted the orthogonally detected signal, detects the displacement of the region of interest accompanying the pulsation of the heart by tracking, and calculates the integrated backscattering intensity… and the result is displayed on the screen of the monitor 38; Fig. 16);
and a non-transitory computer readable medium with instructions stored thereon, which when executed by a processor perform steps (Paragraph [0088]; The ultrasonic diagnosing apparatus 44 can be one of any appropriate conventional type, and the analysis of reflected wave signals based on the invention is processed by a program built into the work station 46, Figs. 1, 3, and 16) comprising:
insonating the tissue with one of the set of ultrasound transducers from a first position (Paragraph [0120]-[0121]; An ultrasonic pulse is transmitted for scanning one of the ultrasonic beam positions of a B-mode image.; Fig. 17);
collecting a first reflected ultrasound energy with at least one of the set of ultrasound receivers (Paragraph [0119]-[0122]; beam scanning control unit 35 controls the scanning position… The reflected wave signal receiving unit 36 receives and orthogonally detects a reflected wave synchronized; S1: Reflected wave data are collected, Fig. 17);
insonating the tissue with one of the set of ultrasound transducers from a second position (Paragraph [0123]; S2: When there is a next ultrasonic beam position, the process will return to S0 to repeat scanning., Fig. 17);
collecting a second reflected ultrasound energy with at least one of the set of ultrasound receivers (Paragraph [0119]-[0122]; Paragraph [0119]-[0122]; beam scanning control unit 35 controls the scanning position… The reflected wave signal receiving unit 36 receives and orthogonally detects a reflected wave synchronized; S1: Reflected wave data are collected, Fig. 17 shows the step of collecting wave data is repeated);
calculating a first and second average integrated backscatter coefficient of the tissue from the first and second reflected ultrasound energies respectively (Paragraph [0077]; Integrated backscattering intensity detecting means 8 calculates the average power of the backscatter waves from the different points in displacement motion to obtain the integrated backscattering intensity IB; Paragraphs [0127]-[0136]; backscattering intensity from a region comprising only of blood in the heart cavity (IB signal IBblood(t)) is calculated with respected to one beam position; Upon completion of processing one beam, the process returns to S6, the processing is repeated for the next beam position, Fig. 17); and
determining at least one characteristic of the tissue based on the first and second integrated backscatter coefficients (Paragraph [0077]; Variable frequency detecting means 9 measures out the variation frequency or variable cycle of the integrated backscattering intensity IB from the different points in the region of interest, and makes it available as information representing the local tissue characteristics of each point; Paragraph [0132]-[0137]; center of gravity of the power spectrum S(f, t)2 is determined; mean frequency fmean is converted into a suitable color, displayed by superimposing over the position of the matching set point in an M-mode image to obtain an estimated value of thickness variation, Fig. 17).
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 2, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kanai in view of Fedewa (US 20220175447 A1).
Regarding claim 2, Kanai teaches all of the limitations of claim 1 as noted above.
Kanai does not explicitly teach the at least one ultrasound transducer of the set is selected from the group of: a single-element transducer, a multi-element transducer, an array transducer, a 1-D array transducer, a 1.5-D array transducer, a 2-D array transducer, a ring array transducer, and a linear array transducer.
Fedewa, however, teaches a method of characterizing a tissue (Paragraph [0024]; One use of spectral analysis of ultrasound is to characterize myocardial tissue according to spectral parameters of a backscatter of the incident ultrasound signal) comprising providing a set of at least one ultrasound transducer (Paragraph [0029]; The backscatter time domain signal is a convolution of effects arising from transmit and receive electronics, the transducer), the at least one ultrasound transducer of the set is selected from the group of: an array transducer (Paragraph [0029]; transmit and receive transfer function of the transducer and any system electronics…, transmit/receive line with respect to a transducer array).
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 at least one ultrasound transducer of Kanai to have been an array transducer as taught by Fedewa because it is a well-known and understood element for measuring backscatter signals (Paragraphs [0027] and [0029]) and further can be implemented in catheters for monitoring ablation treatment (Paragraph [0027]).
Regarding claim 17, Kanai teaches all of the limitations of claim 17 as noted above.
Kanai does not explicitly teach the at least one characteristic of the tissue comprises one or more of the group selected from the following: age, inflammation, vascularization, scarring, fibrosis, and steatosis.
Fedewa, however, teaches a method of characterizing a tissue (Paragraph [0024]; One use of spectral analysis of ultrasound is to characterize myocardial tissue according to spectral parameters of a backscatter of the incident ultrasound signal) wherein at least one characteristic of the tissue comprises one or more of the group selected from the following: scarring, fibrosis (Paragraph [0025]; integrated backscatter alone can be an objective measure of myocardial fibrosis; Paragraph [0046]; A comparison of the integrated backscatter (IB), slope, and intercept from unablated atrial myocardium in subjects with paroxysmal vs persistent AF is shown in Table 1. As seen therein, there are statistically significant differences in the IB, slope, and intercept between subjects with paroxysmal and persistent AF).
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 Kanai such that at least one characteristic of the tissue comprises one or more of the group selected from the following: scarring, fibrosis as taught by Fedewa because it would have allowed distinguish paroxysmal from persistent AF, and differentiate degrees of ischemic myocardium for predicting whether myocardial regions will recover from ischemic injury, due to differing degrees of scar and fibrosis and determining the tissue states and whether the tissue may be healthy, scarred/injured, and/or candidates for ablation (Paragraph [0051]-[0052]).
Regarding claim 20, Kanai teaches all of the limitations of claim 1 as noted above.
Kanai does not explicitly teach one or more of the steps selected from the group consisting of: determining a treatment for the subject based on the determination of the at least one characteristic of the tissue and determining a rehabilitation therapy for the subject based on the determination of the at least one characteristic of the tissue.
Fedewa, however, teaches a method of characterizing a tissue (Paragraph [0024]; One use of spectral analysis of ultrasound is to characterize myocardial tissue according to spectral parameters of a backscatter of the incident ultrasound signal) comprising one or more of the steps selected from the group consisting of determining a treatment for the subject based on the determination of the at least one characteristic of the tissue (Paragraph [0011]; determining a spectral parameter of the corresponding backscatter signal; and correlating a value of the spectral parameter with an electrical conductivity of the corresponding portion of myocardial tissue; determining an ablation location based on the correlations, the ablation location being one of the plurality of portions of myocardial tissue; and ablating the myocardial tissue at the ablation location).
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 Kanai to have further included one or more of the steps selected from the group consisting of determining a treatment for the subject based on the determination of the at least one characteristic of the tissue as further taught by Fedewa because it would have assisted in the process of ablation by allowing real-time ablation lesion monitoring and durability prediction (paragraph [0006]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kanai in view of Raum (US 20200129140 A1).
Regarding claim 7, Kanai teaches all of the limitations of claim 1 as noted above.
Kanai further teaches an insonation angle of about 90 degrees relative to the tissue surface (Paragraph [0015]; The resultant reflected signal is detected with an orthogonal detector 24, Fig. 1 and 18; Paragraph [0077]; displacement detecting means 7 analyzes the orthogonally detected signals to obtain the instantaneous velocities of points in the region of interest ROI set on beam positions on a section of the heart wall).
Kanai does not explicitly teach insonating the tissue with one of the set of ultrasound transducers from a third position;
collecting a third reflected ultrasound energy with at least one of the set of ultrasound receivers; and
calculating a third average integrated backscatter coefficient of the tissue from the third reflected ultrasound energy,
wherein the first position comprises an insonation angle less than 90 degrees relative to the tissue surface, the second position comprises an insonation angle of about 90 degrees relative to the tissue surface, and the third position comprises an insonation angle of greater than 90 degrees relative to the tissue surface,
and wherein determining the at least one characteristic of the tissue is further based on third average integrated backscatter coefficient.
Raum, however, teaches a method (Paragraph [0068]; method provides the acquisition and spectral analysis of reflected and backscattered waves) comprising insonating the tissue with one of the set of ultrasound transducers from a third position (Paragraph [0068]; multidirectional multi-focus transmit sequence; Paragraph [0063]; Arrow 4 refers to a multi-focus and multi-angle beam inclination with respect to the array normal direction, Figs. 1 and 3);
collecting a third reflected ultrasound energy with at least one of the set of ultrasound receivers (Paragraph [0063]; For each transmitted pulse, the received signals on all channels (here 128 channels) are recorded individually); and
calculating a third average integrated backscatter coefficient of the tissue from the third reflected ultrasound energy (Paragraph [0088]; The data analysis may comprise… extracting representative parameters, e.g., a depth- and frequency dependent slope and intercept values of the normalized backscatter spectrum (FIG. 15), and other characteristic features of the normalized backscatter spectrum, e.g., the apparent integrated backscatter intensity (AIB)),
wherein the first position comprises an insonation angle less than 90 degrees relative to the tissue surface (Paragraph [0068]; an oscillating sweep motion of the array in the direction perpendicular to the array long axis within a certain sweep angle range (e.g., ϕ=±15°) in a sealed housing (FIG. 3) is used, Fig. 3 shows the first beam in an angle less than 90 degrees.), the second position comprises an insonation angle of about 90 degrees relative to the tissue surface (Paragraph [0068]; an oscillating sweep motion of the array in the direction perpendicular to the array long axis within a certain sweep angle range (e.g., ϕ=±15°) in a sealed housing (FIG. 3) is used, Fig. 3 shows the second beam in an angle at 90 degrees.), and the third position comprises an insonation angle of greater than 90 degrees relative to the tissue surface (Paragraph [0068]; an oscillating sweep motion of the array in the direction perpendicular to the array long axis within a certain sweep angle range (e.g., ϕ=±15°) in a sealed housing (FIG. 3) is used, Fig. 3 shows the third beam in an angle greater than 90 degrees.),
and wherein determining the at least one characteristic of the tissue is further based on third average integrated backscatter coefficient (Paragraph [0107]-[0108]; The associations of backscatter parameters with bone properties 2410 are discussed in the following section; pore density Ct.Po.Dn and porosity were associated with an intercept value a0 and the AIB amplitude: Fig. 24).
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 Kanai to have further included steps of insonating the tissue with one of the set of ultrasound transducers from a third position; collecting a third reflected ultrasound energy with at least one of the set of ultrasound receivers; and calculating a third average integrated backscatter coefficient of the tissue from the third reflected ultrasound energy, wherein the first position comprises an insonation angle less than 90 degrees relative to the tissue surface, the second position comprises an insonation angle of about 90 degrees relative to the tissue surface, and the third position comprises an insonation angle of greater than 90 degrees relative to the tissue surface, and wherein determining the at least one characteristic of the tissue is further based on third average integrated backscatter coefficient as taught by Raum because it would have further increased the functionality by allowing assessment of bone and determining the thickness and microstructural features in cortical bone (Paragraph [0064]).
Claims 8, 11, 14, 16, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kanai in view of Hall (US 20140276047 A1).
Regarding claim 8, Kanai teaches all of the limitations of claim 6 as noted above.
Kanai does not explicitly teach quantifying a relationship between the average integrated backscatter coefficient and the insonation angle of the position.
Hall, however, teaches method of characterizing a tissue (Paragraph [0010]; analysis of the pattern of ultrasonic backscatter loss as a function of angle and depth with respect to cervical tissue) comprising calculating an integrated backscatter coefficient (Paragraph [0066]; an alternative measurement parameterizing backscatter such as … integrated backscatter could be derived from these angle-dependent power spectra and used to describe the cervical tissue in greater detail); and
quantifying a relationship between the average integrated backscatter coefficient and the insonation angle of the position (Paragraph [0065]; an alternative measurement of backscatter computes received backscatter power curves 71 as a function of one or more frequencies at multiple angular measurements 72 for both the phantom described above and the cervical tissue 18, Fig. 8).
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 Kanai to have further included quantifying a relationship between the average integrated backscatter coefficient and the insonation angle of the position as taught by Hall because it would have allowed comparing to an empirically-derived related to the elasticity of the tissue and thereby determine the state or risk of the tissue based on the measurement of the backscatter (Paragraphs [0067]-[0068]).
Regarding claim 11, together Kanai and Hall teach all of the limitations of claim 8 as noted above.
Kanai does not explicitly teach quantifying the relationship between estimated integrated backscatter coefficient and the insonation angle further comprises calculating a metric of the group selected from: the maximum average integrated backscatter coefficient value of the Gaussian fit, the change in amplitude of the Gaussian fit between the maximum value and the value corresponding with any other insonation angle, the linear rate of change of the derivative of the Gaussian fit, and the difference between the first and second average backscatter coefficients.
Hall, however, teaches quantifying the relationship between estimated integrated backscatter coefficient and the insonation angle further comprises calculating a metric of the group selected from: the difference between the first and second average backscatter coefficients (Paragraph [0087]-[0089]; produce a measure of asymmetry according to the formula… Paligned (angles , depths) - Psymm (angles , depths)).
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 Kanai and Hall to have included calculating a metric of the group selected from: the difference between the first and second average backscatter coefficients as further taught by Hall because it would have allowed determining an order parameter which would have been useful for measuring the condition of cervical tissue prior to labor (Paragraphs [0092]-[0095]).
Regarding claim 14, Kanai teaches all of the limitations of claim 13 as noted above.
Kanai does not explicitly teach the property of the tissue structure is one or more of the group selected from: tissue microstructure, extracellular matrix fiber organization, extracellular matrix fiber alignment, collagen fiber organization, collagen fiber alignment, extracellular matrix fiber crosslinking, collagen fiber crosslinking, distribution of extracellular matrix fiber subtypes, distribution of collagen fiber subtypes, extracellular matrix fiber density, collagen fiber density, extracellular matrix fiber length, collagen fiber length, cellular alignment, cellular organization, vascular alignment, and vascular organization.
Hall, however, teaches method of characterizing a tissue (Paragraph [0010]; analysis of the pattern of ultrasonic backscatter loss as a function of angle and depth with respect to cervical tissue) comprising calculating an integrated backscatter coefficient (Paragraph [0066]; an alternative measurement parameterizing backscatter such as … integrated backscatter could be derived from these angle-dependent power spectra and used to describe the cervical tissue in greater detail) wherein the property of the tissue structure is one or more of the group selected from collagen fiber organization, collagen fiber alignment (Paragraph [0009]; This analysis of underlying tissue structure (e.g. collagen fiber organization), in addition to or instead of macroscopic tissue properties such as elasticity; Paragraph [0092]; As shown in process block 149, the results of these measurements may be output, for example, in a table 151 providing in one row, normal values 152, for example, representing cervical tissue having a structure expected for a first birth going to full term).
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 Kanai to have included determining the property of the tissue structure of the group selected from collagen fiber organization, collagen fiber alignment as taught by Hall because it would have allowed measuring the condition of cervical tissue prior to labor (Paragraphs [0092]-[0095]) and evaluating collagenous tissue such as that of the cervix and thus for the evaluation of cervical competence (Paragraph [0009]).
Regarding claim 16, Kanai teaches all of the limitations of claim 13 as noted above.
Kanai does not explicitly teach the material property is one or more of the group selected from: stiffness, Young's modulus, transition strain, transition stress, yield strain, yield stress, ultimate strain, ultimate stress, compressive load, tensional load, and viscoelasticity.
Hall, however, teaches method of characterizing a tissue (Paragraph [0010]; analysis of the pattern of ultrasonic backscatter loss as a function of angle and depth with respect to cervical tissue) comprising calculating an integrated backscatter coefficient (Paragraph [0066]; an alternative measurement parameterizing backscatter such as … integrated backscatter could be derived from these angle-dependent power spectra and used to describe the cervical tissue in greater detail) wherein the material property is one or more of the group selected from stiffness, Young's modulus (Paragraph [0068]-[0070]; In one embodiment the excess-backscattered power loss is combined with elasticity data for the same tissue. The elasticity data augments the backscatter data to better distinguish among microstructure with similar backscattering but different elasticities).
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 Kanai such that the material property is one or more of the group selected from: stiffness, Young's modulus as taught by Hall because it would have allowed better distinguish among microstructure with similar backscattering but different elasticities and further allowed resolving two cases with the longer fibers that produce generally a stiffer and less elastic tissue distinguished by their elasticity from the shorter fibers (Paragraph [0068]-[0070]).
Regarding claim 18, Kanai teaches all of the limitations of claim 1 as noted above.
Kanai does not explicitly teach the step of diagnosing a subject based on the determination of the at least one characteristic of the tissue.
Hall, however, teaches a method of characterizing a tissue (Paragraph [0010]; analysis of the pattern of ultrasonic backscatter loss as a function of angle and depth with respect to cervical tissue) comprising calculating an integrated backscatter coefficient (Paragraph [0066]; an alternative measurement parameterizing backscatter such as … integrated backscatter could be derived from these angle-dependent power spectra and used to describe the cervical tissue in greater detail) comprising the step of diagnosing a subject based on the determination of the at least one characteristic of the tissue (Paragraph [0011]; determine a distribution of backscatter power loss as a function of tissue angle and tissue depth. This distribution is used to provide a diagnostic indication to an operator.; Claim 1; process the variation in backscatter power to determine a distribution among the volume elements of backscatter power loss as a function of tissue angle and tissue depth; and (d) output a diagnostic indication to an operator based on the distribution).
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 Kanai to have further included the step of diagnosing a subject based on the determination of the at least one characteristic of the tissue as taught by Hall because it would have allowed the physician to determine the risk of preterm delivery, or state of the cervix with respect to a state for successful delivery (Paragraph [0067]-[0068]).
Regarding claim 19, together Kanai and Hall teach all of the limitations of claim 18 as noted above.
Kanai does not explicitly teach the diagnosis comprises one or more of the group selected from: assigning a risk of tissue injury, diagnosing a subject with an autoimmune disease, diagnosing a subject with a metabolic disease, and determining the healing of an injured tissue.
Hall, however, further teaches the diagnosis comprises one or more of the group selected from: assigning a risk of tissue injury (Paragraph [0067]; The model then provides a statistically founded output related to fundamental information desired by the physician, for example risk of preterm delivery, or state of the cervix with respect to a state for successful delivery).
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 Kanai in view of Hall such that the diagnosis comprises one or more of the group selected from: assigning a risk of tissue injury as further taught by Hall because it would have informed the physician about the risk of performing a delivery and thereby inform the physician about the appropriate time for induced labor and thus reduce the chance of a preterm delivery (Paragraphs [0004]-[0006] and [0073]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kanai in view of Hall as applied to claims 8, and further in view of Yang (CN-107247267-A; translation of CN-107247267-A relied upon herein).
Regarding claim 9, together Kanai and Hall teach all of the limitations of claim 8 as noted above.
Together Kanai and Hall do not explicitly teach quantifying the relationship between the average integrated backscatter coefficient and the insonation angle comprises determining a Gaussian fit of the average integrated backscatter coefficient and the insonation angle.
Yang, however, teaches quantifying the relationship between a backscatter coefficient and the insonation angle comprises (Pg. 3, para. 9; the multi-wave beam reverse scattering intensity data of the original series of pre-treatment working, obtaining angle response only under the influence of the reverse scattering intensity data) determining a Gaussian fit of the average integrated backscatter coefficient and the insonation angle (Pg. 4, para. 1; performing smooth curve fitting to multi-wave beam reverse scattering intensity data using Gaussian fitting method, obtaining response correction parameter of each angle).
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 Kanai in view of Hall to have further included quantifying the relationship between the average integrated backscatter coefficient and the insonation angle comprises determining a Gaussian fit of the average integrated backscatter coefficient and the insonation angle as taught by Yang because the reverse scattering intensity data is affected by angle response, and the angle response correction model cannot accurately to completely correct the reverse of whole strip scattering intensity data, using a Gaussian fitting allows improvement of the angle response correction model, thereby significantly increasing the reverse scattering intensity data precision (Pg. 7).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kanai in view of Hall as applied to claims 8 and 11 above, respectively, and further in view of Raum (US 20200129140 A1) and Yang (CN-107247267-A; translation of CN-107247267-A relied upon herein).
Regarding claim 12, together Kanai and Hall teach all of the limitations of claim 11 as noted above.
Together Kanai and Hall do not explicitly teach the metric is the change in amplitude of the Gaussian fit between the maximum value and the value corresponding with any other insonation angle, and wherein the any other insonation angle is within the range of about 70 degrees to about 110 degrees relative to the tissue surface.
Raum, however, teaches a metric is the change in amplitude between the maximum value and the value corresponding with any other insonation angle (Paragraph [0090]; Conventional threshold and edge detection algorithms 242 are applied to detect the time of flight of the outer bone surface ToFθ(x,ϕ,θ) 80 and after appropriate scaling, local surface inclination maps αθ(x,ϕ,θ) 211 for each transmit beam steering angle θ are obtained; Paragraph [0097]; For z<0, the depth-dependence (i.e. the intensity gradient with depth) of the difference spectrum is affected both by the frequency-dependent attenuation and by the frequency dependence of the backscattered signal. A common parameter reflecting these effects is the AIB 249), and wherein the any other insonation angle is within the range of about 70 degrees to about 110 degrees relative to a surface (Paragraph [0068]; allows an oscillating sweep motion of the array in the direction perpendicular to the array long axis within a certain sweep angle range (e.g., ϕ=±15°); Paragraph [0075]; Multiple transmit beam directions 231, e.g., θ∈[−10°, −5°, 0°, 5, 10°]234, and/or [0078] Multiple sweep angles 230, e.g., ϕ∈[−20°, −18°, . . . , 20° ] 235, Fig. 2 and 3).
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 Kanai in view of Hill such that the metric is the change in amplitude between the maximum value and the value corresponding with any other insonation angle, and wherein the any other insonation angle is within the range of about 70 degrees to about 110 degrees relative to the tissue surface as taught by Raum because it would have allowed determining a bone surface and measuring the distance and thickness to the bones (Paragraph [0088]).
Together Kanai and Hall do not explicitly teach using a Gaussian fit.
Yang, however, teaches quantifying the relationship between a backscatter coefficient and the insonation angle comprises (Pg. 3, para. 9; the multi-wave beam reverse scattering intensity data of the original series of pre-treatment working, obtaining angle response only under the influence of the reverse scattering intensity data) determining a Gaussian fit of the average integrated backscatter coefficient and the insonation angle (Pg. 4, para. 1; performing smooth curve fitting to multi-wave beam reverse scattering intensity data using Gaussian fitting method, obtaining response correction parameter of each angle).
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 Kanai in view of Hall and Raum to have further included quantifying the relationship between the average integrated backscatter coefficient and the insonation angle comprises determining a Gaussian fit of the average integrated backscatter coefficient and the insonation angle as taught by Yang because the reverse scattering intensity data is affected by angle response, and the angle response correction model cannot accurately to completely correct the reverse of whole strip scattering intensity data, using a Gaussian fitting allows improvement of the angle response correction model, thereby significantly increasing the reverse scattering intensity data precision (Pg. 7).
Conclusion
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/DEAN N EDUN/Examiner, Art Unit 3797
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 7/11/26
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