DETAILED ACTION
This Office action is responsive to communications filed on 11/07/2025. Claims 1, 3-18 have been amended. Claims 2 is canceled. Claims filed on 11/07/2025 indicate claim 19 as (canceled); however, upon further review, the claims filed on 05/25/2023, there does not exist a claim 19 to be canceled. Claims 20-21 are newly added. Presently, Claims 1, 3-18, 20-21 remain pending and are hereinafter examined on the merits.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
The objections to the Drawings are withdrawn in view of the replacement sheets filed on 11/07/2025.
Previous rejections under 35 USC § 112(b) are withdrawn in view of the amendments filed on 11/07/2025.
Previous claim objections are withdrawn in view of the amendments filed on 11/07/2025.
Previous rejections under 35 USC § 112(a) for claim 9 (only) are withdrawn in view of the amendments filed on 11/07/2025. Previous rejections under 35 USC § 112(a) for claims 11 & 17 are NOT withdrawn in view of the amendments filed 11/07/2025. The Applicant asserts methods commonly used in this field for emptying a region in a picture are applicable to the present application. Further stating, “For example, when the viscosity quality control information of a region fails to meet a predetermined requirement, [...] the region can be set to 0% opacity in the viscosity parameter distribution diagram”.
The Examiner disagrees, and the 35 USC § 112(a) rejection is maintained for claims 11 & 17. The mere use of stating the method is commonly achieved is not sufficient. One of ordinary skill in the art would not be able to implement the described process without disclosure of the specific requirements proper written description describing the underlying methodology, criteria or algorithmic steps for how “emptying” is performed in a step-by-step manner. In addition, the assertion that it could be derived using simulations or test (i.e., the prophetic example provide) does not demonstrate that the inventors actual did so or had possession of the specific functional relationships and constraints to obviate the lack of written description requirement.
The Applicant’s arguments with respect to rejections under 35 USC § 101 have been fully, considered, but are not persuasive. The Examiner directs the Applicant’s attention provided in the Office Action regarding the grounds for rejection of the claims under 35 U.S.C. 101 in view of the amendments filed on 11/07/2025. Specifically, the Examiner response is set forth in the rejection under 35 U.S.C. 101 below.
Previous indication of Allowable subject matter is withdrawn in view of the Applicants amendments filed on 11/07/2025. Previous Office Action filed on 11/07/2025, indicated the following: “Claims 9 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and rewritten or amended to overcome the rejection(s) under 35 USC § 101, U.SC. 112(a), and U.S.C. 112(b), set forth in this Office action. Note; a change in scope in view of the requested corrections will require further search and consideration.”. Accordingly, the amendments filed on 11/07/2025 changed the scope of the claimed invention.
Applicant’s arguments with respect to claim(s) being rejected under 35 USC § 102/35 USC § 103 have been considered but are moot because the new ground of rejection does not rely on Mischi et al alone/the modified combination applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The new grounds of rejection now relies on:
Regarding Claims 1, 3-5, & 7 are rejected under 35 U.S.C. 103 as being unpatentable over Mischi et al (US 2020/0121288 A1) in view of Bhatt et al ("Reconstruction of Viscosity Maps in Ultrasound Shear Wave Elastography," in IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control, vol. 66, no. 6, pp. 1065-1078, June 2019).
Regarding Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mischi et al (US 2020/0121288 A1) in view of Bhatt et al ("Reconstruction of Viscosity Maps in Ultrasound Shear Wave Elastography," in IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control, vol. 66, no. 6, pp. 1065-1078, June 2019), as applied to claim 1, in view of Tabaru et al (US 2015/0133783 A1).
Regarding Claims 8, 10, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mischi et al (US 2020/0121288 A1) in view of Bhatt et al ("Reconstruction of Viscosity Maps in Ultrasound Shear Wave Elastography," in IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control, vol. 66, no. 6, pp. 1065-1078, June 2019), as applied to claim 1, in further view of Yoshikawa (US 2017/0333004 A1).
Regarding Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Mischi et al (US 2020/0121288 A1) in view of Bhatt et al ("Reconstruction of Viscosity Maps in Ultrasound Shear Wave Elastography," in IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control, vol. 66, no. 6, pp. 1065-1078, June 2019) in view of Yoshikawa (US 2017/0333004 A1), as applied to claim 8, in further view of Samsung Medison Co. Ltd. ("S-Shearwave™ Elastography Liver Evaluation: Recommended Values" White Paper, 2017).
Regarding Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Mischi et al (US 2020/0121288 A1) in view of Bhatt et al ("Reconstruction of Viscosity Maps in Ultrasound Shear Wave Elastography," in IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control, vol. 66, no. 6, pp. 1065-1078, June 2019), as applied to claim 1, in further view of Eskandari et al (US 2010/0160778 A1).
Regarding Claims 12-16, 18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Mischi et al (US 2020/0121288 A1) in view of Yoshikawa (US 2017/0333004 A1).
Regarding Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Mischi et al (US 2020/0121288 A1) in view of Yoshikawa (US 2017/0333004 A1), as applied to claim 12, in view of Tabaru et al (US 2015/0133783 A1).
Regarding Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Mischi et al (US 2020/0121288 A1) in view of Yoshikawa (US 2017/0333004 A1), as applied to claim 12, in further view of Eskandari et al (US 2010/0160778 A1)
Examiners Notes
The status of claim 19, 20-21 require proper numbering/status.
Claims filed on 11/07/2025 indicate claim 19 as (canceled); however, upon further review, the claims filed on 05/25/2023, there does not exist a claim 19 to be canceled. Accordingly, claim 20 should recited claim 19, and claim 21 should recite claim 20.
Applicant is reminded of manner of making amendment in application according to 37 C.F.C. 1.121.(c). The current status of all the claims in the application, including any previously canceled or withdrawn claims, must be given. Status is indicated in a parenthetical expression following the claim number by one of the following status identifiers that includes (withdrawn). See MPEP 714,II,C,(A),
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, 3-18, 20-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1, 3-11, 20 are directed to a “method” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Claim 12-18, 21 are directed to a “method” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One:
Claim 1 recite (“sets forth” or “describes”) the abstract idea of “a mental process” (MPEP 2106.04(a)(2).III.), & the abstract idea of “mathematical concepts” (MPEP 2106.04(a)(2).I.), substantially as follows:
“ calculating, [...], a frequency dispersion distribution diagram according to the ultrasonic echo signals;
calculating, [...], a viscosity parameter according to the frequency dispersion distribution diagram;
obtaining, [...], a viscosity quality control characteristic of the viscosity parameter according to the frequency dispersion distribution diagram; and
[...]
wherein the viscosity quality control characteristic comprises one or more of following characteristic quantities:
an effective frequency range for calculating the viscosity parameter;
a degree of matching when performing model fitting for the viscosity parameter according to the frequency dispersion distribution diagram;
a signal-to-noise ratio of the frequency dispersion distribution diagram: and
the shear waves in multiple patterns in the frequency dispersion distribution diagram.”
Claim 12 recite (“sets forth” or “describes”) the abstract idea of “a mental process” (MPEP 2106.04(a)(2).III.), & the abstract idea of “mathematical concepts” (MPEP 2106.04(a)(2).I.), substantially as follows:
“ calculating, [...], a frequency dispersion distribution diagram according to the ultrasonic echo signals;
calculating, [...], a viscosity parameter according to the frequency dispersion distribution diagram; and
performing, [...], quality control on the viscosity parameter according to the frequency dispersion distribution diagram,
wherein the calculating, [...], the viscosity parameter according to the frequency dispersion distribution diagram comprises:
calculating a slope of a frequency dispersion curve in the frequency dispersion distribution diagram with respect to a shear wave frequency and shear wave propagation velocity as the viscosity parameter, or calculating the viscosity parameter according to phase velocities of the shear waves of at least two different frequencies in the frequency dispersion distribution diagram, or calculating the viscosity parameter according to the phase velocities of the shear waves of the at least two different frequencies in the frequency dispersion distribution diagram and corresponding frequencies.”
For each claim (1, 12), the above recited steps are mathematical concepts, which is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations. Specifically, the step of calculating a frequency dispersion distribution diagram” involves generating a graph or dataset reflecting the relationship between frequency and phase velocity of shear waves, which constitutes mathematical process of data derived from a datasheet of signals. The step of calculating a viscosity parameter” comprises the derivation of the quantitative value (e.g., using the viscoelasticity or Voigt model equation) to arrive at a mathematical model or formulas applied to the frequency dispersion data. Similarly, ‘obtaining a viscosity control characteristic” entails further mathematical or statistical analysis of the derived viscosity parameter. In relation to the frequency dispersion diagram, such as determining a measure of accuracy, reliability or consistency, that if further based on mathematical operations. The addition, performing quality control on the viscosity parameter according to the frequency dispersion diagram, remains rooted in abstract idea of mathematical concepts. It amounts to applying mathematical rules or a predetermined threshold and comparing to a previously calculated parameter, based on the mathematical analysis of the frequency distribution dispersion diagram. This involves nothing more than statistical comparison. With respect to the added recitations, these limitations merely define additional evaluative metrics derived from already calculated dispersion data. Determining an effective frequency range entails identifying numerical boundaries within a data set based on predetermined criteria. Assessing a degree of matching when performing model fitting required computing a goodness fit value (i.e., correlation coefficient) between observed data and a selected mathematical model. Calculating a signal-to-noise ration involves computing a ratio between signal magnitude and noise magnitude based on observed data analysis. Identifying shear waves in multiple patterns within the diagram entails recognizing and categorizing patterns based on their mathematical represented characteristics in the dispersion plot. Each of these operations depends on mathematical relationships and statistical calculation, the premise of the instant application with respect to ultrasound image techniques. These limitations specify additional mathematical analysis performed on the data. Similarly, the further recited limitations of claim 12 reinforce that the viscosity parameter itself is derived exclusively through mathematical manipulation of dispersion data. Calculating a slop of frequency dispersion curve is a mathematical concept itself. Calculating a slope of frequency dispersion curve with respect to shear wave frequency and propagation velocity constitutes determining a rate of change (i.e., linear regression-mathematical). Alternatively, calculating the viscosity parameter according the phase velocities at two or more frequencies requires computing differences from data points. These recitations further dividing the calculation of the viscosity parameter are quintessential mathematical concepts.
Each of these steps involves mathematical relationships, formulas, or calculations that are not merely incidental to the claim invention, but are central to the method and its results. In fact, these limitations viewed collectively and as a whole, recite a series of mathematical operations that amount to nothing more than a build-up of mathematical concepts layered upon other mathematical concepts.
The grouping of “mathematical concepts” in the 2019 PEG includes “mathematical calculations” as an exemplar of an abstract idea. 2019 PEG Section I, 84 Fed. Reg. at 52. Thus, limitation falls into the “mathematical concept” grouping of abstract ideas. The grouping of “mathematical concepts” in the 2019 PEG includes “mathematical calculation”
Therefore, each of the above steps are grouped as mathematical and mental concepts, hence an abstract idea.
Prong Two: Claims 1 and 12 do not include additional elements that integrate the mental process into a practical application.
This judicial exception is not integrated into a practical application. In particular, the claims recites (1) additional steps of transmitting, by a ultrasound probe, ultrasonic waves for detecting shear waves to obtain ultrasonic echo signals, the shear waves being propagated in a region of interest; (claim 1, 12); and (2) further an addition step of outputting displaying viscosity quality control information about the viscosity parameter according to the viscosity quality control characteristic. (claim 1)
The steps in (1) represent merely data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with conventionally used tools (see below Step IIB for further details). Data gathering and mere instructions to implement an abstract idea on a computer do not integrate a judicial exception into a practical application (MPEP 2106.05 (f and g)).
The step in (2) represents merely outputting information outputting by a display as a post-solution activity and is recited at a high level of generality.
Lastly, Regarding the limitations of claim 1 & 12, directed to the “by a processor”/”by the processor” is treated as a generic computer implementation, which falls under mere instructions to apply the abstract idea on a computer and therefore does not place the abstract idea into a practical application that solves a technological solution in a meaningful way or improve the functionality of the technology or generic computer “itself”. Simply, it’s a generic computer implementation of a mental process rather than a meaningful limitation. Regarding the processor language written at such a high level of generality of structural limitations, the processor language amounts to a generic computer component with mere instructions to implement the abstract idea on a computer.
As a whole, the additional elements merely serve to gather and feed information to the abstract idea and to output a notification based on the abstract idea, while generically implementing it on conventionally used tools. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the estimated bio-information is not outputted in any way such that a practical benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Further, there is no evidence of record that would support the assertion that this step is an improvement to a computer or technological solution to a technological problem. Ultimately, the Applicant’s describe improvement in the process of using shear-wave techniques, but this is not an improvement in the function of a computer or other technology (See MPEP 2106.05(a)(ii); “the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology”; See MPEP 2106.04(d)(1); 2106.05(a); and 2106.05(f)). The claims are directed to the abstract idea. Also, there does not appear to be any particular structure or machine, treatment or prophylaxis, transformation, or any other meaningful application that would render the claim eligible at step 2A, prong 2.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1 and 12 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claims recite additional steps of transmitting ultrasonic waves for detecting shear waves to obtain ultrasonic echo signals, the shear waves being propagated in a region of interest. These steps represents mere data gathering, data outputting or pre/post/extra-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality. Furthermore, as discussed above, limitations with respect to the display languages/terms, respectively, amount to mere instructions to implement the abstract idea on a computer. As discussed with respect to Step 2A Prong Two, the additional elements in the claims amount to no more than insignificant extra solution activity and mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B and does not provide an inventive concept. The data gathering steps that were considered insignificant extra-solution activity in Step 2A Prong Two, have been re-evaluated in Step 2B and determined to be well-understood, routine, conventional activity in the field.
As an evidence, Vignon et al (US 2022/0192640 A1) discloses,
¶0038, ‘the ultrasonic imaging system 400 may include an ultrasound probe 412 includes a transducer array 414 for transmitting ultrasound signals (e.g., ultrasonic beams) toward a target region of a subject and receiving echo signals responsive to the ultrasound signals. A variety of transducer arrays are known in the art, e.g., linear arrays, convex arrays or phased arrays. ‘
For these reasons, there is no inventive concept. The claim is not patent eligible. Even when viewed as a whole, nothing in the claim adds significantly more to the abstract idea.
Dependent Claims
The following dependent claims merely further define the abstract idea and, therefore, recite an abstract idea for similar reasons:
Defining wherein plotting the viscosity quality control characteristic on the frequency dispersion distribution diagram to generate a frequency dispersion characteristic graph comprises marking the effective frequency range on the frequency dispersion distribution diagram when the viscosity quality control characteristic comprises the effective frequency range, or marking the effective frequency range and a target frequency range used for calculating the viscosity parameter on the frequency dispersion distribution diagram; and/or obtaining a fitted line in calculation of the viscosity parameter when the viscosity quality control characteristic comprises the degree of matching, and plotting the fitted line on the frequency dispersion distribution diagram; and/or connecting only continuous points of the frequency dispersion curve in the frequency dispersion distribution diagram so as to plot the frequency dispersion curve when the viscosity quality control characteristic comprises the continuity of the frequency dispersion curve in the frequency dispersion distribution diagram; and/or extracting frequency dispersion curves for respective shear waves in multiple patterns and plotting the extracted dispersion curves on the frequency dispersion distribution diagram when the viscosity quality control characteristic comprises different shear waves in multiple patterns in the frequency dispersion distribution diagram. (Claim 4)
Defining wherein displaying the viscosity quality control information about the viscosity parameter by a value characterizing the viscosity quality control characteristic comprises: when the viscosity quality control characteristic comprises the effective frequency range, displaying a value of the effective frequency range, or displaying a value of the effective frequency range and a value of a target frequency range used for calculating the viscosity parameter, or calculating and displaying an overlapping degree of the effective frequency range and a target frequency range; and/or calculating a fitted line of the viscosity parameter and a degree of fit between data used for fitting when the viscosity quality control characteristic comprises the degree of matching, and displaying the degree of fit comprising an average absolute difference value, a mean square error, a root mean square error, a coefficient of determination R2 or a correlation coefficient; and/or calculating and displaying a proportion of continuous or discontinuous segments in the frequency dispersion curve when the viscosity quality control characteristic comprises the continuity of the frequency dispersion curve in the frequency dispersion distribution diagram; and/or calculating and displaying a signal-to-noise ratio of the frequency dispersion distribution diagram when the viscosity quality control characteristic comprises the signal-to-noise ratio of the frequency dispersion distribution diagram; and/or when the viscosity quality control characteristic comprises the different shear waves inmultiple patterns in the frequency dispersion distribution diagram, calculating and displaying a number of the different shear waves in multiple patterns in the frequency dispersion distribution diagram, or, determining a main shear wave and calculating and displaying a degree of influence of other pattern waves on the main shear wave, wherein the degree of influence of other pattern waves on the main shear wave comprises a proportion of energy of other pattern waves or main shear wave. (claim 7) & Defining wherein a value characterizing the characteristic quantities is a proportion of continuous or discontinuous segments in the frequency dispersion curve when the viscosity quality control characteristic comprises the continuity of the frequency dispersion curve in the frequency dispersion distribution diagram.-(claim 21). Regarding the displaying information although it cannot performed in the human mind; hence, it is not part of the abstract idea. However, it is not a practical application either. It is merely an insignificant pre/post-solution activity. In addition, the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the determined information is not outputted in any way such that the practical benefit is realized.
Defining wherein displaying the viscosity quality control information about the viscosity parameter according to the viscosity quality control characteristic comprises: calculating a viscosity quality control score according to the viscosity quality control characteristic; and displaying the viscosity quality control information about the viscosity parameter by the viscosity quality control score. (claim 8). Regarding the displaying information although it cannot performed in the human mind; hence, it is not part of the abstract idea. However, it is not a practical application either. It is merely an insignificant pre/post-solution activity. In addition, the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the determined information is not outputted in any way such that the practical benefit is realized.
Defining wherein calculating a viscosity quality control score according to the viscosity quality control characteristic comprises: performing weighted summation on each value characterizing the characteristic quantities to obtain the viscosity quality control score; wherein, the value characterizing the characteristic quantities is an overlapping degree of the effective frequency range and a target frequency range when the viscosity quality control characteristic comprises the effective frequency range, or the value characterizing the characteristic quantities is a fitted line of the viscosity parameter and a degree of fit between data used for fitting when the viscosity quality control characteristic comprises the degree of matching, or the value characterizing the characteristic quantities is a proportion of continuous or discontinuous segments in the frequency dispersion curve when the viscosity quality control characteristic comprises a continuity of the frequency dispersion curve in the frequency dispersion distribution diagram, or the value characterizing the characteristic quantities is a signal-to-noise ratio of the frequency dispersion distribution diagram when the viscosity quality control characteristic comprises the signal-to-noise ratio of the frequency dispersion distribution diagram; or the value characterizing the characteristic quantities is a degree of influence of other pattern waves on a main shear wave when the viscosity quality control characteristic comprises different shear waves in multiple patterns in the frequency dispersion distribution diagram, the degree of influence of other pattern waves on a main shear wave comprises a proportion of energy of other pattern waves or main shear wave. (claim 9)
Defining wherein displaying the viscosity quality control information about the viscosity parameter by the viscosity quality control score comprises: generating a viscosity quality control distribution diagram of the region of interest according to the viscosity quality control score of each point in the region of interest; and displaying the viscosity quality control distribution diagram. (claim 10) Regarding the displaying information although it cannot performed in the human mind; hence, it is not part of the abstract idea. However, it is not a practical application either. It is merely an insignificant pre/post-solution activity. In addition, the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the determined information is not outputted in any way such that the practical benefit is realized.
Defining wherein displaying the viscosity quality control information about the viscosity parameter according to the viscosity quality control characteristic comprises emptying a region in a viscosity parameter distribution diagram where the viscosity quality control information fails to meet a predetermined requirement according to the viscosity quality control characteristic; and the viscosity parameter distribution diagram is generated based on the viscosity parameter of each point in the region of interest. (claim 11) Regarding the displaying information although it cannot performed in the human mind; hence, it is not part of the abstract idea. However, it is not a practical application either. It is merely an insignificant pre/post-solution activity. In addition, the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the determined information is not outputted in any way such that the practical benefit is realized.
Defining wherein performing quality control on the viscosity parameter according to the frequency dispersion distribution diagram comprises: performing quality control on the viscosity parameter by displaying the frequency dispersion distribution diagram. (claim 13) Regarding the displaying information although it cannot performed in the human mind; hence, it is not part of the abstract idea. However, it is not a practical application either. It is merely an insignificant pre/post-solution activity. In addition, the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the determined information is not outputted in any way such that the practical benefit is realized.
Defining wherein performing quality control on the viscosity parameter according to the frequency dispersion distribution diagram comprises: obtaining a viscosity quality control characteristic of the viscosity parameter according to the frequency dispersion distribution diagram; plotting the viscosity quality control characteristic on the frequency dispersion distribution diagram to generate a frequency dispersion characteristic graph; and performing quality control on the viscosity parameter by displaying the frequency dispersion characteristic graph. (claim 14) Regarding the displaying information although it cannot performed in the human mind; hence, it is not part of the abstract idea. However, it is not a practical application either. It is merely an insignificant pre/post-solution activity. In addition, the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the determined information is not outputted in any way such that the practical benefit is realized.
Defining wherein performing quality control on the viscosity parameter according to the frequency dispersion distribution diagram comprises: obtaining a viscosity quality control characteristic of the viscosity parameter according to the frequency dispersion distribution diagram; and performing quality control on the viscosity parameter by displaying a value characterizing the viscosity quality control characteristic. (claim 15). Regarding the displaying information although it cannot performed in the human mind; hence, it is not part of the abstract idea. However, it is not a practical application either. It is merely an insignificant pre/post-solution activity. In addition, the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the determined information is not outputted in any way such that the practical benefit is realized.
Defining wherein performing quality control on the viscosity parameter according to the frequency dispersion distribution diagram comprises: obtaining a viscosity quality control characteristic of the viscosity parameter according to the frequency dispersion distribution diagram; calculating a viscosity quality control score according to the viscosity quality control characteristic; and displaying viscosity quality control information about the viscosity parameter by the viscosity quality control score. Regarding the displaying information although it cannot performed in the human mind; hence, it is not part of the abstract idea. However, it is not a practical application either. It is merely an insignificant pre/post-solution activity. In addition, the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the determined information is not outputted in any way such that the practical benefit is realized.
Defining wherein performing quality control on the viscosity parameter according to the frequency dispersion distribution diagram comprises: obtaining a viscosity quality control characteristic of the viscosity parameter according to the frequency dispersion distribution diagram; and emptying a region in a viscosity parameter distribution diagram where the viscosity quality control information fails to meet a predetermined requirement according to the viscosity quality control characteristic, wherein the viscosity parameter distribution diagram is generated based on the viscosity parameter of each point in the region of interest. (claim 17)
Defining wherein the viscosity quality control characteristic comprises one or more of the following characteristic quantities: an effective frequency range for calculating the viscosity parameter; a degree of matching when performing model fitting for the viscosity parameter according to the frequency dispersion distribution diagram; a continuity of a frequency dispersion curve in the frequency dispersion distribution diagram; a signal-to-noise ratio of the frequency dispersion distribution diagram; and the shear waves in multiple patterns in the frequency dispersion distribution diagram. (claim 18).
Defining wherein the calculating, by the processor, the viscosity parameter according to the frequency dispersion distribution diagram comprises: calculating a slope of a frequency dispersion curve in the frequency dispersion distribution diagram with respect to a shear wave frequency and shear wave propagation velocity as the viscosity parameter, or calculating the viscosity parameter according to phase velocities of the shear waves of at least two different frequencies in the frequency dispersion distribution diagram, or calculating the viscosity parameter according to the phase velocities of the shear waves of the at least two different frequencies in the frequency dispersion distribution diagram and corresponding frequencies – (claim 20).
The following dependent claims merely further describe the extra-solution activities and therefore, do not amount to significantly more than the judicial exception or integrate the abstract idea into a practical application for similar reasons:
Describing wherein displaying viscosity quality control information about the viscosity parameter according to the viscosity quality control characteristic comprises: plotting the viscosity quality control characteristic on the frequency dispersion distribution diagram to generate a frequency dispersion characteristic graph; and displaying the frequency dispersion characteristic graph. (claim 3).
Describing performing foreground feature enhancement or background fading process on the frequency dispersion distribution diagram before plotting the viscosity quality control characteristic on the frequency dispersion distribution diagram. (claim 5)
Describing displaying the viscosity quality control information about the viscosity parameter according to the viscosity quality control characteristic comprises: displaying the viscosity quality control information about the viscosity parameter by a value characterizing the viscosity quality control characteristic (claim 6)
Regarding the displaying information although it cannot performed in the human mind; hence, it is not part of the abstract idea. However, it is not a practical application either. It is merely an insignificant pre/post-solution activity. In addition, the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the determined information is not outputted in any way such that the practical benefit is realized.
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11, 17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
ii. Claim 11 & Claim 17 recite: “emptying a region in a viscosity parameter distribution diagram where the viscosity quality control information fails to meet a predetermined requirement”
These limitations of claim 11 & 17 are computer/processor-implemented functional claim limitation as it is directed to a processor controlled algorithm configured to emptying a region in a viscosity parameter distribution diagram where the viscosity quality control information fails to meet a predetermined requirement. Yet the specification does not disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed functions, i.e., determining “constants”, in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. It is not enough to disclose that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015). As the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention, these claims are rejected for lack of written description. For more information regarding the written description requirement, see MPEP §§ 2161, 2162-2163.07(b).
Although the specification states at ¶0174: “the processor 50 may empty a region of the viscosity parameter distribution diagram where the viscosity quality control information fails to meet a predetermined requirement, the viscosity parameter distribution diagram may be generated based on the viscosity parameter of each point in the region of interest. For example, each value characterizing the characteristic quantities may be weighted and summed to obtain the viscosity quality control score, and the viscosity quality control distribution diagram of the region of interest may be generated according to the viscosity quality control score of each point in the region of interest.” & ¶0181. The disclosure lacks proper written description describing the underlying methodology, criteria or algorithmic steps for how “emptying” is performed. Specifically, there is no disclosed procedure of what quantifies as “failing to meet a predetermined requirement”. The system teaching of when a region is emptied is not fully described (e.g., whether pixels are removed, masked, replaced, or rendered null values). The “emptying” is referenced and only shown in FIG. 21, with no explanation of how it is technically implemented in the image generation process or how it integrates with the viscosity quality control score. In addition, asserting that methods such as subtraction method could have been used does not demonstrate that the inventors actually did so or had procession of the specific functional relationship recited in the claims. Without any technical description of how the emptying is executed or determined, and without a generalizable rule or example describing a step-by-step process of how the regions are emptied, one of ordinary skill int eh art would not conclude that the Applicant was in possession of the full scope of the claimed feature at the time of filing. A mere visual illustration without corresponding algorithmic or procedural step-by-step process is insufficient. Consequently, one of ordinary skill in the art would not deem the instant specification having sufficient detail so that they could understand how the inventor intended to achieve the aforementioned emptying.
The dependent claims of the above rejected claims are rejected due to their dependency.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-5, & 7 are rejected under 35 U.S.C. 103 as being unpatentable over Mischi et al (US 2020/0121288 A1) in view of Bhatt et al ("Reconstruction of Viscosity Maps in Ultrasound Shear Wave Elastography," in IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control, vol. 66, no. 6, pp. 1065-1078, June 2019).
Claim 1: Mischi discloses: A viscosity quality control method, (¶Abstract) applied to ultrasonic elasticity imaging (¶Abstract, ¶0075), the method comprising:
transmitting, by an ultrasonic probe (ultrasound transducer 86, FIG. 8), ultrasonic waves for detecting shear waves to obtain ultrasonic echo signals, the shear waves being propagated in a region of interest; (¶0039, ‘The experiments were performed using a Verasonics ultrasound research platform (Redmond, Wash., USA) in combination with an L11-4 linear array transducer. Shear waves (SW) were generated with acoustic radiation force, where the mechanical impulse delivered to the tissue is given by the product of acoustical force density and duration. Hence, to facilitate sufficient medium displacement, a 1500-cycle push-pulse with a center frequency of 4.5 MHz was adopted (excitation duration: 333 μs) […] The resulting SW was tracked using an ultrafast imaging protocol operating at a frame rate of 10 kHz.’; ¶0075, ‘a transducer 86 arranged to send waves to a part of a body 87 and receive echoes returned by tissue in the part of the body 87.’)
calculating, by a processor (CPU 82), a frequency dispersion distribution diagram according to the ultrasonic echo signals;
-Note; the claim recites calculating a frequency dispersion distribution diagram according to the ultrasonic echo signals. As such, the term “according to” implies that the claim invention is derived from or closely related to the ultrasonic echo signals.
-Mischi discloses frequency-dependent phase velocities, which are derived from estimated material properties, including viscosity, ¶0024-0025, ¶0068-0069. The Voigt model, which describes viscoelastic properties, allows for parameterization of phase velocity based on frequency, ¶0007, ¶0045-0051.
- FIG. 4 shows the various levels of viscosity results in SW phase-velocity dispersion. Specifically, FIG. 4A shows that the estimated phase-frequency dependent velocities “matched the true values very well” for all or most stimulations, with the ‘True” and ‘estimate” lines overlapping across the whole range, ¶0024-0025, ¶0069-0071.
calculating, by the processor (CPU 82), a viscosity parameter according to the frequency dispersion distribution diagram;
-Note the claim recites a viscosity parameter according to the frequency dispersion distribution diagram. As such, the term “according to” implies that the claim invention is derived from or closely related to the frequency dispersion distribution diagram.
-Mischi discloses that the viscosity parameter is calculated (i.e., estimated) in a manner that is linked to and accounts for the frequency dispersion distribution of shear waves. The method uses the Voigt model to describe the viscoelastic properties of tissue, ¶0045-0048. To locally estimate ethe visoelastic model parameters in the Voigt model, ¶0053, ns is the viscosity, ¶0046, and w is the angular frequency. This direct dependence of frequency means that the viscosity parameter is and integral part of how the material’s properties, and thus the shear wave’s propagation characteristics (including dispersion), are molded corresponding to the frequency dispersion distribution diagram FIG. 4A.
obtaining, by the processor (CPU 82), a viscosity quality control characteristic of the viscosity parameter according to the frequency dispersion distribution diagram; and
-Note; the claim recites a viscosity quality control characteristic of the viscosity parameter according to the frequency dispersion distribution diagram. As such, the term “according to” implies that the claim invention is derived from or closely related to the frequency dispersion distribution diagram. In addition, the claim does not further define which viscosity quality control characteristic is referred to.
-Note; the claim does not provide a definition for what does and does not meet “quality control”.
-Mischi discloses the estimated viscosity values (ns) were found to be very close to the true values, ¶0067. That is the quality characteristic is the accuracy with which estimated viscosity and shear waves match the true values, ¶0065-0067, ¶0080-0081. Mischi specifically discloses a quality control characteristic of the viscosity parameter comprises characteristic quantities related to the frequency range, signal-to-noise ratio, impacting results, and the frequency dispersion curve.
-Mischi discloses frequency-dependent phase velocities, which are derived from estimated material properties, including viscosity, ¶0024-0025, ¶0068-0069. The Voigt model, which describes viscoelastic properties, allows for parameterization of phase velocity based on frequency, ¶0007, ¶0045-0051.
- FIG. 4 shows the various levels of viscosity results in SW phase-velocity dispersion. Specifically, FIG. 4A shows that the estimated phase-frequency dependent velocities “matched the true values very well” for all or most stimulations, with the ‘True” and ‘estimate” lines overlapping across the whole range, ¶0024-0025, ¶0069-0071.
-The Signal-to-Noise-Ratio (SNR) links to “low” SNR to “degrading the esimates” and causes “estimation artifacts”, ¶0086. To address SNR and improve quality, Mischi proposes “supersonic SW generation” to “boost” the SNR and using techniques based on maximum-likelihood estimators to yield robust parameters estimates, ¶0089-0090.
displaying, by a display (display 81) viscosity quality control information about the viscosity parameter according to the viscosity quality control characteristic. (¶0077, ‘In the example of FIG. 8, the system 80 further includes a display 81 for displaying 2D or 3D maps indicative of the viscoelasticity of the material. Possibly the maps are color maps indicating viscosity and elasticity parameters.’)
-Note; the claim recites displaying viscosity quality control information about the viscosity parameter according to the viscosity quality control characteristic. As such, the term “according to” implies that the claim invention is derived from or closely related to the viscosity quality control characteristic. In addition, the claim does not further define which/what viscosity quality control information is displayed.
wherein the viscosity quality control characteristic comprises one or more of the following characteristic quantities:
a continuity of a frequency dispersion curve in the frequency dispersion distribution diagram; (FIG. 4A)
-Fig. 4A is mathematical framework that demonstrates a continuity of the frequency dispersion curve. These graphs show smooth and continuous lines for both the ‘True’ phase velocities and the ‘estimate’ phase velocities across the depicted frequency range. The visual overlap of these smooth lines signifies a continuous and accurate representation of the dispersion.
Mischi fails to disclose one or more of the following:
an effective frequency range for calculating the viscosity parameter;
a degree of matching when performing model fitting for the viscosity parameter according to the frequency dispersion distribution diagram;
a signal-to-noise ratio of the frequency dispersion distribution diagram; and
the shear waves in multiple patterns in the frequency dispersion distribution diagram.
However, Bhatt in the context of reconstruction of viscosity maps in ultrasound shear wave elastography discloses: a degree of matching when performing model fitting for the viscosity parameter according to the frequency dispersion distribution diagram;
-Bhatt discloses, using a coefficient of determination, referred to as the R2-stastic wave, [pg. 1069/Evaluation of Goodness Fit], to evaluate the “quality of fit” or degree of matching of the proposed model to the experimental data. Bhatt also uses F-statistic scores to assess the statistical confidence of this match, [pg. 1069/Evaluation of Goodness Fit]. The degree of matching is calculated for the fit of the Gamma distribution model to the amplitude spectrum (i.e., frequency distribution) of the propagating shear waves, [pg. 1067/ 2) Frequency-Shift Method]. “The closer the R2 -statistic is to 1, the better is the model fit to the SW amplitude spectrum data.”, [pg. 1069/Evaluation of Goodness Fit]. This model fitting is part of the frequency-shift method that estimates the shear wave attenuation. This attenuation is then combined with phase velocity to calculate the viscosity, [pg. 1067/ 2) Frequency-Shift Method]. The model fit matches the experimental frequency spectrum between 92% and 98% at 9 out of 10 measured points, [pg. 1071/Results from Statistical Analyses/ 1) Validation of the Proposed Model Fit], FIG. 8.
-Bhatt teaches in the process of obtaining a fitted model, evaluating its quality via the degree of matching, and plotting this fit against the frequency dispersion. Specifically, by obtaining a fitting line where the “frequency spectrum” of the shear wave is modeled using the Gamma distribution, [pg. 1067/ 2) Frequency-Shift Method]. To calculate the viscosity via the attenuation coefficient (α), the method analyses how the spectrum changes over distance. Specifically, that a parameter of the model is “fitted to a straight line” over the distance, where the slop of the this line yields the attenuation coefficient used to compute viscosity, [pg. 1067/ 2) Frequency-Shift Method – 3) Estimation of the Loss Modulus].
-Bhatt, FIG. 8, presents the plots of the fitted model overlaid on the experimental data (i.e., the frequency dispersion). FIG. 8 is referred to as the amplitude spectrum. This plot visually demonstrates the degree of matching, between the model and the actual frequency distribution of the shear waves, the basis for the viscosity calculation.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the viscosity quality control characteristic of Mischi to include the teachings of Bhatt. The motivation to do this yield predictable results such as to validate the accuracy and reliability of the mathematical model used to reconstruct the viscosity, as suggested by Bhatt [pg. 1069/Evaluation of Goodness Fit].
Claim 3: Modified Mischi discloses all the elements above in claim 1, Mischi discloses, wherein the displaying of the viscosity quality control information about the viscosity parameter according to the viscosity quality control characteristic comprises:
plotting the viscosity quality control characteristics on the frequency dispersion distribution diagram to generate a frequency dispersion characteristic graph; and displaying the frequency dispersion characteristic graph.
-Fig. 4A is a display of mathematical framework that demonstrates a continuity of the frequency dispersion curve. These graphs show smooth and continuous lines for both the plotting of ‘True’ phase velocities and the ‘estimate’ phase velocities across the depicted frequency range. The visual overlap of these smooth lines signifies a continuous and accurate representation of the frequency dispersion indicative of the viscosity quality control characteristics, ¶0065-0067, ¶0080-0081. The system of Mischi further includes a display for displaying 2D or 3D maps indicative of these quality control characteristics, ¶0077.
Claim 4: Modified Mischi discloses all the elements above in claim 3, Mischi fails to disclose: wherein the plotting of the viscosity quality control characteristic on the frequency dispersion distribution diagram to generate a frequency dispersion characteristic graph comprises at least one of:
marking the effective frequency range on the frequency dispersion distribution diagram when the viscosity quality control characteristic comprises the effective frequency range, or marking the effective frequency range and a target frequency range used for calculating the viscosity parameter on the frequency dispersion distribution diagram;
obtaining a fitted line in calculation of the viscosity parameter when the viscosity quality control characteristic comprises the degree of matching, and plotting the fitted line on the frequency dispersion distribution diagram; or
extracting a frequency dispersion curve for each of the shear waves in the multiple patterns and plotting an extracted dispersion curve on the frequency dispersion distribution diagram when the viscosity quality control characteristic comprises the shear waves in the multiple patterns in the frequency dispersion distribution diagram.
However, Bhatt is relied upon above teaches: obtaining a fitted line in calculation of the viscosity parameter when the viscosity quality control characteristic comprises the degree of matching, and plotting the fitted line on the frequency dispersion distribution diagram;
-Bhatt discloses, using a coefficient of determination, referred to as the R2-stastic wave, [pg. 1069/Evaluation of Goodness Fit], to evaluate the “quality of fit” or degree of matching of the proposed model to the experimental data. Bhatt also uses F-statistic scores to assess the statistical confidence of this match, [pg. 1069/Evaluation of Goodness Fit]. The degree of matching is calculated for the fit of the Gamma distribution model to the amplitude spectrum (i.e., frequency distribution) of the propagating shear waves, [pg. 1067/ 2) Frequency-Shift Method]. “The closer the R2 -statistic is to 1, the better is the model fit to the SW amplitude spectrum data.”, [pg. 1069/Evaluation of Goodness Fit]. This model fitting is part of the frequency-shift method that estimates the shear wave attenuation. This attenuation is then combined with phase velocity to calculate the viscosity, [pg. 1067/ 2) Frequency-Shift Method]. The model fit matches the experimental frequency spectrum between 92% and 98% at 9 out of 10 measured points, [pg. 1071/Results from Statistical Analyses/ 1) Validation of the Proposed Model Fit], FIG. 8.
-Bhatt teaches in the process of obtaining a fitted model, evaluating its quality via the degree of matching, and plotting this fit against the frequency dispersion. Specifically, by obtaining a fitting line where the “frequency spectrum” of the shear wave is modeled using the Gamma distribution, [pg. 1067/ 2) Frequency-Shift Method]. To calculate the viscosity via the attenuation coefficient (α), the method analyses how the spectrum changes over distance. Specifically, that a parameter of the model is “fitted to a straight line” over the distance, where the slop of the this line yields the attenuation coefficient used to compute viscosity, [pg. 1067/ 2) Frequency-Shift Method – 3) Estimation of the Loss Modulus].
-Bhatt, FIG. 8, presents the plots of the fitted model overlaid on the experimental data (i.e., the frequency dispersion). FIG. 8 is referred to as the amplitude spectrum. This plot visually demonstrates the degree of matching, between the model and the actual frequency distribution of the shear waves, the basis for the viscosity calculation.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the viscosity quality control characteristic of modified Mischi to include the teachings of Bhatt. The motivation to do this yield predictable results such as to validate the accuracy and reliability of the mathematical model used to reconstruct the viscosity, as suggested by Bhatt [pg. 1069/Evaluation of Goodness Fit].
Claim 5: Modified Mischi discloses all the elements above in claim 3, Mischi discloses: further comprising: performing foreground feature enhancement or background fading process on the frequency dispersion distribution diagram before the plotting of the viscosity quality control characteristic on the frequency dispersion distribution diagram.
-Mischi teaches simulated datasets used to generate the results in FIG. 4A are processed according to Sections II-A to II-D. Within the II-B. Pre-Processing section, it is stated that: “the axial velocity maps were spatially filtered using a 2D Gaussian kernel with a standard deviation of 1.2 samples in both the axial and lateral direction.”,¶0041-Pre-Processing. This spatial filtering with a Gaussian kernal serves as a noise suppression technique smoothing the axial velocity maps before they are used for the results shown in FIG. 4A. Reducing random noise and smoothing out irregularities is enhances features by making them more discernible.
Claim 7: Modified Mischi discloses all the elements above in claim 6, Mischi discloses,
wherein displaying of the viscosity quality control information about the viscosity parameter by characterizing the viscosity quality control characteristic comprises (FIG. 4A)
-Fig. 4A is mathematical framework that demonstrates a continuity of the frequency dispersion curve. These graphs show smooth and continuous lines for both the ‘True’ phase velocities and the ‘estimate’ phase velocities across the depicted frequency range. The visual overlap of these smooth lines signifies a continuous and accurate representation of the dispersion.
Mischi fails to disclose the viscosity quality control characteristic comprises at least one::
when the viscosity quality control characteristic comprises the effective frequency range, displaying a value of the effective frequency range, or displaying a value of the effective frequency range and a value of a target frequency range used for calculating the viscosity parameter, or calculating and displaying an overlapping degree of the effective frequency range and the target frequency range;
calculating a fitted line of the viscosity parameter and a degree of fit between data used for fitting when the viscosity quality control characteristic comprises the degree of matching, and displaying the degree of fit comprising an average absolute difference value, a mean square error, a root mean square error, a coefficient of determination R2 or a correlation coefficient;
calculating and displaying the signal-to-noise ratio of the frequency dispersion distribution diagram when the viscosity quality control characteristic comprises the signal-to-noise ratio of the frequency dispersion distribution diagram; or
when the viscosity quality control characteristic comprises the shear waves in the multiple patterns in the frequency dispersion distribution diagram, calculating and displaying a number of the shear waves in the multiple patterns in the frequency dispersion distribution diagram, or, determining a main shear wave and calculating and displaying a degree of influence of other pattern waves on the main shear wave, wherein the degree of influence of other pattern waves on the main shear wave comprises a proportion of energy of other pattern waves or the main shear wave.
However, Bhatt is relied upon above discloses, wherein the displaying of the viscosity quality control information about the viscosity parameter by a value characterizing the viscosity quality control characteristic comprises at least one:
-Bhatt discloses in Table III, FIG. 8 a value used to evaluate the quality of fit of the model to the amplitude spectrum, see also FIG. 9 regarding the values of coefficient variation.
calculating a fitted line of the viscosity parameter and a degree of fit between data used for fitting when the viscosity quality control characteristic comprises the degree of matching, and displaying the degree of fit comprising an average absolute difference value, a mean square error, a root mean square error, a coefficient of determination R2 or a correlation coefficient;
-Bhatt discloses, using a coefficient of determination, referred to as the R2-stastic wave, [pg. 1069/Evaluation of Goodness Fit], to evaluate the “quality of fit” or degree of matching of the proposed model to the experimental data. Bhatt also uses F-statistic scores to assess the statistical confidence of this match, [pg. 1069/Evaluation of Goodness Fit]. The degree of matching is calculated for the fit of the Gamma distribution model to the amplitude spectrum (i.e., frequency distribution) of the propagating shear waves, [pg. 1067/ 2) Frequency-Shift Method]. “The closer the R2 -statistic is to 1, the better is the model fit to the SW amplitude spectrum data.”, [pg. 1069/Evaluation of Goodness Fit]. This model fitting is part of the frequency-shift method that estimates the shear wave attenuation. This attenuation is then combined with phase velocity to calculate the viscosity, [pg. 1067/ 2) Frequency-Shift Method]. The model fit matches the experimental frequency spectrum between 92% and 98% at 9 out of 10 measured points, [pg. 1071/Results from Statistical Analyses/ 1) Validation of the Proposed Model Fit], FIG. 8.
-Bhatt teaches in the process of obtaining a fitted model, evaluating its quality via the degree of matching, and plotting this fit against the frequency dispersion. Specifically, by obtaining a fitting line where the “frequency spectrum” of the shear wave is modeled using the Gamma distribution, [pg. 1067/ 2) Frequency-Shift Method]. To calculate the viscosity via the attenuation coefficient (α), the method analyses how the spectrum changes over distance. Specifically, that a parameter of the model is “fitted to a straight line” over the distance, where the slop of the this line yields the attenuation coefficient used to compute viscosity, [pg. 1067/ 2) Frequency-Shift Method – 3) Estimation of the Loss Modulus].
-Bhatt, FIG. 8, presents the plots of the fitted model overlaid on the experimental data (i.e., the frequency dispersion). FIG. 8 is referred to as the amplitude spectrum. This plot visually demonstrates the degree of matching, between the model and the actual frequency distribution of the shear waves, the basis for the viscosity calculation.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the display of the viscosity quality control characteristic of modified Mischi to include the teachings of Bhatt. The motivation to do this yield predictable results such as to validate the accuracy and reliability of the mathematical model used to reconstruct the viscosity, as suggested by Bhatt [pg. 1069/Evaluation of Goodness Fit].
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mischi et al (US 2020/0121288 A1) in view of Bhatt et al ("Reconstruction of Viscosity Maps in Ultrasound Shear Wave Elastography," in IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control, vol. 66, no. 6, pp. 1065-1078, June 2019), as applied to claim 1, in view of Tabaru et al (US 2015/0133783 A1).
Claim 6: Mischi discloses all the elements above in claim 1, Mischi discloses a display to display color maps of indicating the viscosity parameters, ¶0077.
Mischi fails to disclose: wherein the displaying of the viscosity quality control information about the viscosity parameter according to the viscosity quality control characteristic comprises: displaying the viscosity quality control information about the viscosity parameter by a value characterizing the viscosity quality control characteristic.
However, Tabaru in the context of ultrasonic diagnostics discloses, displaying the viscosity quality control information about the viscosity parameter according to the viscosity quality control characteristic comprises: displaying the viscosity quality control information about the viscosity parameter by a value characterizing the viscosity quality control characteristic. (¶0074, ‘the viscosity parameter α, the viscosity parameter β and the shear viscosity coefficient η can be displayed.’.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the display of Mischi to include displaying the viscosity quality control information about the viscosity parameter by a value characterizing the viscosity quality control characteristic as taught by Tabary. The motivation to do this yields predictable results such as improving the relationship between the viscosity coefiffent and viscosity parameter by fitting, thereby providing an effective shear viscosity coefficient, ¶0072 of Tarbaru.
Claims 8, 10, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mischi et al (US 2020/0121288 A1) in view of Bhatt et al ("Reconstruction of Viscosity Maps in Ultrasound Shear Wave Elastography," in IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control, vol. 66, no. 6, pp. 1065-1078, June 2019), as applied to claim 1, in further view of Yoshikawa (US 2017/0333004 A1).
Claim 8: Modified Mischi discloses all the elements above in claim 1, Mischi discloses: wherein the displaying of the viscosity quality control information about the viscosity parameter according to the viscosity quality control characteristic comprises:
-Fig. 4A is a display of mathematical framework that demonstrates a continuity of the frequency dispersion curve. These graphs show smooth and continuous lines for both the plotting of ‘True’ phase velocities and the ‘estimate’ phase velocities across the depicted frequency range. The visual overlap of these smooth lines signifies a continuous and accurate representation of the frequency dispersion indicative of the viscosity quality control characteristics, ¶0065-0067, ¶0080-0081. The system of Mischi further includes a display for displaying 2D or 3D maps indicative of these quality control characteristics, ¶0077.
Mischi fails to disclose:
calculating a viscosity quality control score according to the viscosity quality control characteristic; and displaying the viscosity quality control information about the viscosity parameter by the viscosity quality control score
However, Yoshikawa in the context of ultrasound elasticity evaluation methods discloses, calculating a viscosity quality control score according to the viscosity quality control characteristic; (¶0107-0111-incorperating frequency analysis and deriving parameters like stress-free phase velocity, complex modulus, which include elastic modulus related to viscosity), and frequency-dependent attenuation, the elasticity index is indeed reflective of the viscosity quality characteristics.) and displaying the viscosity quality control information about the viscosity parameter by the viscosity quality control score. (The elasticity evaluation index derived is a “quality-controlled” parameter. The results of this refined elasticity evaluation are displayed on display unit 19 in various forms, numerical values, graphs and maps, ¶0055, ¶0113-¶0115. The displayed elasticity quality control information is directly indicative of the elasticity evaluation index, ¶0113, Claim 12.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the viscosity quality control characteristics of modified Mischi to comprise teachings as taught by Yoshikawa. The motivation to do this yields predictable results such as providing high degrees of accuracy and reproducibility by accounting for variation of an acoustic characteristic, ¶0014 of Yoshikawa. The modified combination would disclose calculating a viscosity quality control score according to the viscosity quality control characteristic; and displaying the viscosity quality control information about the viscosity parameter by the viscosity quality control score.
Claim 10: Modified Mischi discloses all the elements above in claim 8, Mischi fails to disclose: wherein the displaying of the viscosity quality control information about the viscosity parameter by the viscosity quality control score comprises:
generating a viscosity quality control distribution diagram of the region of interest according to the viscosity quality control score of each point in the region of interest; and displaying the viscosity quality control distribution diagram.
However, Yoshikawa is relied upon above discloses: wherein the displaying of the viscosity quality control information about the viscosity parameter by the viscosity quality control score comprises: generating a viscosity quality control distribution diagram of the region of interest according to the viscosity quality control score of each point in the region of interest; and displaying the viscosity quality control distribution diagram. (FIG. 8B8C, an quality control distribution at least according to the viscosity parameter, “deriving an elasticity evaluation index of the test object by using the variation of a plurality of obtained velocity measurement results.” [See Claim 14 of Yoshikawa]; Also see Fig 8B of Yoshikawa above.).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the viscosity quality control information of modified Mischi to comprise teachings as taught by Yoishikawa. The motivation to do this yields predictable results such as providing high degrees of accuracy and reproducibility by accounting for variation of an acoustic characteristic, ¶0014 of Yoshikawa. The modified combination would disclose wherein displaying the viscosity quality control information about the viscosity parameter by the viscosity quality control score comprises: generating a viscosity quality control distribution diagram of the region of interest according to the viscosity quality control score of each point in the region of interest; and displaying the viscosity quality control distribution diagram.
Claim 20: Modified Mischi discloses all the elements above in claim 1, Mischi fails to disclose: wherein the calculating, by the processor, the viscosity parameter according to the frequency dispersion distribution diagram comprises: calculating a slope of a frequency dispersion curve in the frequency dispersion distribution diagram with respect to a shear wave frequency and shear wave propagation velocity as the viscosity parameter, or calculating the viscosity parameter according to phase velocities of the shear waves of at least two different frequencies in the frequency dispersion distribution diagram, or calculating the viscosity parameter according to the phase velocities of the shear waves of the at least two different frequencies in the frequency dispersion distribution diagram and corresponding frequencies.
However, Yoshikawa in the context of ultrasound and elasticity evaluation discloses: wherein the calculating, by the processor, the viscosity parameter according to the frequency dispersion distribution diagram comprises: calculating a slope of a frequency dispersion curve in the frequency dispersion distribution diagram with respect to a shear wave frequency and shear wave propagation velocity as the viscosity parameter, or calculating the viscosity parameter according to phase velocities of the shear waves of at least two different frequencies in the frequency dispersion distribution diagram, or calculating the viscosity parameter according to the phase velocities of the shear waves of the at least two different frequencies in the frequency dispersion distribution diagram and corresponding frequencies. (“a velocity measurement unit to transmit the second ultrasonic wave to a measurement region set on the basis of the image, generate a shear wave, and measure the propagation velocity of the shear wave by the third ultrasonic wave, ”[claim 1 of Yoshikawa]; also “the velocity measurement unit measures the propagation velocities of the shear waves corresponding to transmission in the directions.” [see claim 6 of Yoshikawa], also” the frequency analysis unit subjects the waveform of measured the shear wave to frequency analysis and outputs an index having frequency dependency." [see claim 10 of Yoshikawa], see, “the difference of the variations of the velocity V1 corresponding to the first direction and the velocity V2 corresponding to the second direction from the variation of a stress index is maximized and the calculation accuracy of a stress-free velocity V0 improves.” [See Specification [0075] of Yoshikawa], “wherein the ultrasound diagnostic device further comprises a frequency analysis unit, and the frequency analysis unit subjects the waveform of measured the shear wave to frequency analysis and outputs an index having frequency dependency.”[see claim 10 of Yoshikawa]; also see Fig 8A and 8B for dispersion slope image; also see Fig 22 for “"the device is configured by adding a frequency analysis unit 221 to the device configuration") (“wherein the velocity measurement unit measures the velocity more than once at an identical site,”[see claim 1 of Yoshikawa]; also “obtains a stress-free phase velocity by deriving a relationship between the propagation velocity and a frequency”[claim 11 of Yoshikawa]; also “Further, the device is configured so that an elasticity evaluation unit 18 obtains a stress-free phase velocity by deriving a relationship between a propagation velocity and a frequency" [see Specification paragraph [0077]]; also see figure 4A and 4B above) (“a velocity measurement unit to transmit the second ultrasonic wave to a measurement region set on the basis of the image, generate a shear wave,”[see claim 1 of Yoshikawa]; also “and outputs a velocity numerical value at the intersection of the approximate straight lines involved in respective propagation directions as the elasticity evaluation index.”[see claim 7 of Yoshikawa]).
PNG
media_image1.png
437
296
media_image1.png
Greyscale
PNG
media_image2.png
419
350
media_image2.png
Greyscale
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the processor of Mischi to include the teachings of Yoshikawa. The motivation to do this yields predictable results such as providing high degrees of accuracy and reproducibility by accounting for variation of an acoustic characteristic, ¶0014 of Yoshikawa.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Mischi et al (US 2020/0121288 A1) in view of Bhatt et al ("Reconstruction of Viscosity Maps in Ultrasound Shear Wave Elastography," in IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control, vol. 66, no. 6, pp. 1065-1078, June 2019) in view of Yoshikawa (US 2017/0333004 A1), as applied to claim 8, in further view of Samsung Medison Co. Ltd. ("S-Shearwave™ Elastography Liver Evaluation: Recommended Values" White Paper, 2017).
Claim 9: Modified Mischi discloses all the elements above in claim 8, Mischi discloses:
wherein the calculating of the viscosity quality control score according to the viscosity quality control characteristic comprises:
-Fig. 4A is a display of mathematical framework that demonstrates a continuity of the frequency dispersion curve. These graphs show smooth and continuous lines for both the plotting of ‘True’ phase velocities and the ‘estimate’ phase velocities across the depicted frequency range. The visual overlap of these smooth lines signifies a continuous and accurate representation of the frequency dispersion indicative of the viscosity quality control characteristics, ¶0065-0067, ¶0080-0081. The system of Mischi further includes a display for displaying 2D or 3D maps indicative of these quality control characteristics, ¶0077.
Mischi fails to disclose:
performing a mathematical model fitting on at least one value characterizing the characteristic quantities to obtain the viscosity quality control score;
wherein, the at least one value characterizing the characteristic quantities comprises at least one of:
an overlapping degree of the effective frequency range and a target frequency range when the viscosity quality control characteristic comprises the effective frequency range,
a fitted line of the viscosity parameter and a degree of fit between data used for fitting when the viscosity quality control characteristic comprises the degree of matching,
the signal-to-noise ratio of the frequency dispersion distribution diagram when the viscosity quality control characteristic comprises the signal-to-noise ratio of the frequency dispersion distribution diagram,
or
a degree of influence of other pattern waves on a main shear wave when the viscosity quality control characteristic comprises the shear waves in the multiple patterns in the frequency dispersion distribution diagram, the degree of influence of other pattern waves on the main shear wave comprises a proportion of energy of other pattern waves or the main shear wave.
However, Bhatt is relied upon above disclose: performing a mathematical model fitting on at least one value characterizing the characteristic quantities to obtain the viscosity quality control score; wherein, the at least one value characterizing the characteristic quantities comprises at least one of: a fitted line of the viscosity parameter and a degree of fit between data used for fitting when the viscosity quality control characteristic comprises the degree of matching,
-Bhatt discloses, using a coefficient of determination, referred to as the R2-stastic wave, [pg. 1069/Evaluation of Goodness Fit], to evaluate the “quality of fit” or degree of matching of the proposed model to the experimental data. Bhatt also uses F-statistic scores to assess the statistical confidence of this match, [pg. 1069/Evaluation of Goodness Fit]. The degree of matching is calculated for the fit of the Gamma distribution model to the amplitude spectrum (i.e., frequency distribution) of the propagating shear waves, [pg. 1067/ 2) Frequency-Shift Method]. “The closer the R2 -statistic is to 1, the better is the model fit to the SW amplitude spectrum data.”, [pg. 1069/Evaluation of Goodness Fit]. This model fitting is part of the frequency-shift method that estimates the shear wave attenuation. This attenuation is then combined with phase velocity to calculate the viscosity, [pg. 1067/ 2) Frequency-Shift Method]. The model fit matches the experimental frequency spectrum between 92% and 98% at 9 out of 10 measured points, [pg. 1071/Results from Statistical Analyses/ 1) Validation of the Proposed Model Fit], FIG. 8.
-Bhatt teaches in the process of obtaining a fitted model, evaluating its quality via the degree of matching, and plotting this fit against the frequency dispersion. Specifically, by obtaining a fitting line where the “frequency spectrum” of the shear wave is modeled using the Gamma distribution, [pg. 1067/ 2) Frequency-Shift Method]. To calculate the viscosity via the attenuation coefficient (α), the method analyses how the spectrum changes over distance. Specifically, that a parameter of the model is “fitted to a straight line” over the distance, where the slop of the this line yields the attenuation coefficient used to compute viscosity, [pg. 1067/ 2) Frequency-Shift Method – 3) Estimation of the Loss Modulus].
-Bhatt, FIG. 8, presents the plots of the fitted model overlaid on the experimental data (i.e., the frequency dispersion). FIG. 8 is referred to as the amplitude spectrum. This plot visually demonstrates the degree of matching, between the model and the actual frequency distribution of the shear waves, the basis for the viscosity calculation.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the calculation of the viscosity quality control score of modified Mischi to include the teachings of Bhatt. The motivation to do this yield predictable results such as to validate the accuracy and reliability of the mathematical model used to reconstruct the viscosity, as suggested by Bhatt [pg. 1069/Evaluation of Goodness Fit].
Mischi as modified fails to disclose that the mathematical model fitting is a weighted summation
However, Samsung Medison Co. Ltd in the context of elastography liver evaluation discloses: a weighted summation ([Methodology, pg 3], ‘The average of the measurements is used to estimate the degree of liver stiffness (Fig. 3). Additionally, the Reliability Measurement Index (RMI) and Variation Range (VR) are provided in the S-Shearwave Profile. The RMI (reliability of the measurement) is a quality control parameter that is calculated by the weighted sum of two factors: the residual of the wave equation, and the magnitude of the shearwave. Therefore, high RMI values are strongly correlated with reproducible measurements. An RMI of 0.0 would indicate significant error, whereas an RMI of 1.0 would indicate no error). While in the S-Shearwave Profile display, the user can easily deselect any unreliable measurements depending on its RMI.’)-Thus Samsung Medison Co. Ltd teaches the required limitation of weighted summation.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modifying the mathematical model fitting of modified Mischi to further including a weighting summation for quality control as taught by Samsung Medison Co. Ltd for the advantage of providing an improved method with such a method being able to providing reproducible and reliable measurements, as suggested by Samsung Medison Co. Ltd, [Methodology, pg 3].
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Mischi et al (US 2020/0121288 A1) in view of Bhatt et al ("Reconstruction of Viscosity Maps in Ultrasound Shear Wave Elastography," in IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control, vol. 66, no. 6, pp. 1065-1078, June 2019), as applied to claim 1, in further view of Eskandari et al (US 2010/0160778 A1).
Claim 11: Modified Mischi discloses all the elements above in claim 1, Mischi discloses:
wherein the displaying of the viscosity quality control information about the viscosity parameter according to the viscosity quality control characteristic comprises a region in a viscosity parameter distribution diagram and the viscosity parameter distribution diagram is generated based on the viscosity parameter of each point in the region of interest. (FIG. 6F, 6H, ¶0030, ¶0077)
Mischi fails to disclose: emptying a region in a viscosity parameter distribution diagram where the viscosity quality control information fails to meet a predetermined requirement according to the viscosity quality control characteristic;
However, Eskandari in the context of determining visoelastic parameters in tissue discloses, emptying a region in a viscosity parameter distribution diagram where the viscosity quality control information fails to meet a predetermined requirement according to the viscosity quality control characteristic; (¶0105, ‘the tissue 28 is divided into one or more sets of segments, such that the viscoelastic parameters for all of the elements 1102 inside each segment are constant. In FIG. 11, for example, shaded area 1106 represent a segment in which all elements 1102 have the same viscosity and elasticity values. The number of unknown parameters will only be twice the number of segments, as all the elements 1102 in the segment share common elasticity and viscosity parameters. This way, the number of the unknown parameters will be reduced and solving the FEM inverse problem will be more efficient.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the viscosity parameter distribution diagram of modified Mischi to include emptying a region in a viscosity parameter distribution diagram where the viscosity quality control information fails to meet a predetermined requirement according to the viscosity quality control characteristic as taught by Eskandari. The motivation to do this yields predictable results such as improving the viscosity estimation by improving the FEM approach, ¶0030 of Eskandari.
Claims 12-16, 18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Mischi et al (US 2020/0121288 A1) in view of Yoshikawa (US 2017/0333004 A1).
Claim 12: Mischi discloses: A viscosity quality control method, applied to ultrasonic elasticity imaging, the method comprising: (¶Abstract, ¶0075)
transmitting, by an ultrasonic probe (ultrasound transducer 86, FIG. 8), ultrasonic waves for detecting shear waves to a region of interest to obtain ultrasonic echo signals, the shear waves being propagating in the region of interest; (¶0039, ‘The experiments were performed using a Verasonics ultrasound research platform (Redmond, Wash., USA) in combination with an L11-4 linear array transducer. Shear waves (SW) were generated with acoustic radiation force, where the mechanical impulse delivered to the tissue is given by the product of acoustical force density and duration. Hence, to facilitate sufficient medium displacement, a 1500-cycle push-pulse with a center frequency of 4.5 MHz was adoptsed (excitation duration: 333 μs) […] The resulting SW was tracked using an ultrafast imaging protocol operating at a frame rate of 10 kHz.’; ¶0075, ‘a transducer 86 arranged to send waves to a part of a body 87 and receive echoes returned by tissue in the part of the body 87.’)
calculating, by a processor (CPU 82), a frequency dispersion distribution diagram according to the ultrasonic echo signals;
-Note; the claim recites calculating a frequency dispersion distribution diagram according to the ultrasonic echo signals. As such, the term “according to” implies that the claim invention is derived from or closely related to the ultrasonic echo signals.
-Mischi discloses frequency-dependent phase velocities, which are derived from estimated material properties, including viscosity, ¶0024-0025, ¶0068-0069. The Voigt model, which describes viscoelastic properties, allows for parameterization of phase velocity based on frequency, ¶0007, ¶0045-0051.
- FIG. 4 shows the various levels of viscosity results in SW phase-velocity dispersion. Specifically, FIG. 4A shows that the estimated phase-frequency dependent velocities “matched the true values very well” for all or most stimulations, with the ‘True” and ‘estimate” lines overlapping across the whole range, ¶0024-0025, ¶0069-0071.
calculating, by the processor (CPU 82), a viscosity parameter according to the frequency dispersion distribution diagram; and
-Note the claim recites a viscosity parameter according to the frequency dispersion distribution diagram. As such, the term “according to” implies that the claim invention is derived from or closely related to the frequency dispersion distribution diagram.
-Mischi discloses that the viscosity parameter is calculated (i.e., estimated) in a manner that is linked to and accounts for the frequency dispersion distribution of shear waves. The method uses the Voigt model to describe the viscoelastic properties of tissue, ¶0045-0048. To locally estimate ethe visoelastic model parameters in the Voigt model, ¶0053, ns is the viscosity, ¶0046, and w is the angular frequency. This direct dependence of frequency means that the viscosity parameter is and integral part of how the material’s properties, and thus the shear wave’s propagation characteristics (including dispersion), are molded corresponding to the frequency dispersion distribution diagram FIG. 4A.
performing, by the processor (CPU 82), quality control on the viscosity parameter according to the frequency dispersion distribution diagram.
-Note; the claim recites performing quality control on the viscosity parameter according to the frequency dispersion distribution diagram. As such, the term “according to” implies that the claim invention is derived from or closely related to the frequency dispersion distribution diagram. In addition, the claim does not further define which constitutes performing quality control. Note; the claim does not provide a definition for what does and does not meet “quality control”.
-Mischi discloses the estimated viscosity values (ns) were found to be very close to the true values, ¶0067. That is the quality characteristic is the accuracy with which estimated viscosity and shear waves match the true values, ¶0065-0067, ¶0080-0081. Mischi specifically discloses a quality control characteristic of the viscosity parameter comprises characteristic quantities related to the frequency range, signal-to-noise ratio, impacting results, and the frequency dispersion curve.
-Mischi discloses frequency-dependent phase velocities, which are derived from estimated material properties, including viscosity, ¶0024-0025, ¶0068-0069. The Voigt model, which describes viscoelastic properties, allows for parameterization of phase velocity based on frequency, ¶0007, ¶0045-0051.
- FIG. 4 shows the various levels of viscosity results in SW phase-velocity dispersion. Specifically, FIG. 4A shows that the estimated phase-frequency dependent velocities “matched the true values very well” for all or most stimulations, with the ‘True” and ‘estimate” lines overlapping across the whole range, ¶0024-0025, ¶0069-0071.
-The Signal-to-Noise-Ratio (SNR) links to “low” SNR to “degrading the esimates” and causes “estimation artifacts”, ¶0086. To address SNR and improve quality, Mischi proposes “supersonic SW generation” to “boost” the SNR and using techniques based on maximum-likelihood estimators to yield robust parameters estimates, ¶0089-0090.
wherein the calculating, by the processor, the viscosity parameter according to the frequency dispersion distribution diagram comprises:
a continuity of a frequency dispersion curve in the frequency dispersion distribution diagram; (FIG. 4A)
-Fig. 4A is mathematical framework that demonstrates a continuity of the frequency dispersion curve. These graphs show smooth and continuous lines for both the ‘True’ phase velocities and the ‘estimate’ phase velocities across the depicted frequency range. The visual overlap of these smooth lines signifies a continuous and accurate representation of the dispersion.
Mischi fails to disclose one or more of the following: wherein the calculating, by the processor, the viscosity parameter according to the frequency dispersion distribution diagram comprises:
calculating a slope of a frequency dispersion curve in the frequency dispersion distribution diagram with respect to a shear wave frequency and shear wave propagation velocity as the viscosity parameter, or
calculating the viscosity parameter according to phase velocities of the shear waves of at least two different frequencies in the frequency dispersion distribution diagram, or
calculating the viscosity parameter according to the phase velocities of the shear waves of the at least two different frequencies in the frequency dispersion distribution diagram and corresponding frequencies.
However, Yoshikawa in the context of ultrasound and elasticity evaluation discloses: wherein the calculating, by the processor, the viscosity parameter according to the frequency dispersion distribution diagram comprises: calculating a slope of a frequency dispersion curve in the frequency dispersion distribution diagram with respect to a shear wave frequency and shear wave propagation velocity as the viscosity parameter, or calculating the viscosity parameter according to phase velocities of the shear waves of at least two different frequencies in the frequency dispersion distribution diagram, or calculating the viscosity parameter according to the phase velocities of the shear waves of the at least two different frequencies in the frequency dispersion distribution diagram and corresponding frequencies. (“a velocity measurement unit to transmit the second ultrasonic wave to a measurement region set on the basis of the image, generate a shear wave, and measure the propagation velocity of the shear wave by the third ultrasonic wave, ”[claim 1 of Yoshikawa]; also “the velocity measurement unit measures the propagation velocities of the shear waves corresponding to transmission in the directions.” [see claim 6 of Yoshikawa], also” the frequency analysis unit subjects the waveform of measured the shear wave to frequency analysis and outputs an index having frequency dependency." [see claim 10 of Yoshikawa], see, “the difference of the variations of the velocity V1 corresponding to the first direction and the velocity V2 corresponding to the second direction from the variation of a stress index is maximized and the calculation accuracy of a stress-free velocity V0 improves.” [See Specification [0075] of Yoshikawa], “wherein the ultrasound diagnostic device further comprises a frequency analysis unit, and the frequency analysis unit subjects the waveform of measured the shear wave to frequency analysis and outputs an index having frequency dependency.”[see claim 10 of Yoshikawa]; also see Fig 8A and 8B for dispersion slope image; also see Fig 22 for “"the device is configured by adding a frequency analysis unit 221 to the device configuration") (“wherein the velocity measurement unit measures the velocity more than once at an identical site,”[see claim 1 of Yoshikawa]; also “obtains a stress-free phase velocity by deriving a relationship between the propagation velocity and a frequency”[claim 11 of Yoshikawa]; also “Further, the device is configured so that an elasticity evaluation unit 18 obtains a stress-free phase velocity by deriving a relationship between a propagation velocity and a frequency" [see Specification paragraph [0077]]; also see figure 4A and 4B above) (“a velocity measurement unit to transmit the second ultrasonic wave to a measurement region set on the basis of the image, generate a shear wave,”[see claim 1 of Yoshikawa]; also “and outputs a velocity numerical value at the intersection of the approximate straight lines involved in respective propagation directions as the elasticity evaluation index.”[see claim 7 of Yoshikawa]).
PNG
media_image1.png
437
296
media_image1.png
Greyscale
PNG
media_image2.png
419
350
media_image2.png
Greyscale
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the processor of Mischi to include the teachings of Yoshikawa. The motivation to do this yields predictable results such as providing high degrees of accuracy and reproducibility by accounting for variation of an acoustic characteristic, ¶0014 of Yoshikawa.
Claim 13: Modified Mischi discloses all the elements above in claim 12, Mischi discloses, wherein the performing of the quality control on the viscosity parameter according to the frequency dispersion distribution diagram comprises: performing the quality control on the viscosity parameter by displaying the frequency dispersion distribution diagram. -Fig. 4A is a display of mathematical framework that demonstrates displaying of the frequency dispersion distribution diagram. These graphs show smooth and continuous lines for both the plotting of ‘True’ phase velocities and the ‘estimate’ phase velocities across the depicted frequency range. The visual overlap of these smooth lines signifies a continuous and accurate representation of the frequency dispersion indicative of the viscosity quality control characteristics, ¶0065-0067, ¶0080-0081. The system of Mischi further includes a display for displaying 2D or 3D maps indicative of these quality control characteristics, ¶0077.
Claim 14: Modified Mischi discloses all the elements above in claim 12, Mischi discloses, wherein the performing of the quality control on the viscosity parameter according to the frequency dispersion distribution diagram comprises: obtaining a viscosity quality control characteristic of the viscosity parameter according to the frequency dispersion distribution diagram;
-Note; the claim recites a viscosity quality control characteristic of the viscosity parameter according to the frequency dispersion distribution diagram. As such, the term “according to” implies that the claim invention is derived from or closely related to the frequency dispersion distribution diagram. In addition, the claim does not further define which viscosity quality control characteristic is referred to.
-Note; the claim does not provide a definition for what does and does not meet “quality control”.
-Mischi discloses the estimated viscosity values (ns) were found to be very close to the true values, ¶0067. That is the quality characteristic is the accuracy with which estimated viscosity and shear waves match the true values, ¶0065-0067, ¶0080-0081. Mischi specifically discloses a quality control characteristic of the viscosity parameter comprises characteristic quantities related to the frequency range, signal-to-noise ratio, impacting results, and the frequency dispersion curve.
-Mischi discloses frequency-dependent phase velocities, which are derived from estimated material properties, including viscosity, ¶0024-0025, ¶0068-0069. The Voigt model, which describes viscoelastic properties, allows for parameterization of phase velocity based on frequency, ¶0007, ¶0045-0051.
- FIG. 4 shows the various levels of viscosity results in SW phase-velocity dispersion. Specifically, FIG. 4A shows that the estimated phase-frequency dependent velocities “matched the true values very well” for all or most stimulations, with the ‘True” and ‘estimate” lines overlapping across the whole range, ¶0024-0025, ¶0069-0071.
-The Signal-to-Noise-Ratio (SNR) links to “low” SNR to “degrading the esimates” and causes “estimation artifacts”, ¶0086. To address SNR and improve quality, Mischi proposes “supersonic SW generation” to “boost” the SNR and using techniques based on maximum-likelihood estimators to yield robust parameters estimates, ¶0089-0090.
plotting the viscosity quality control characteristic on the frequency dispersion distribution diagram to generate a frequency dispersion characteristic graph; and performing the quality control on the viscosity parameter by displaying the frequency dispersion characteristic graph.
-Fig. 4A is a display of mathematical framework that demonstrates a continuity of the frequency dispersion curve. These graphs show smooth and continuous lines for both the plotting of ‘True’ phase velocities and the ‘estimate’ phase velocities across the depicted frequency range. The visual overlap of these smooth lines signifies a continuous and accurate representation of the frequency dispersion indicative of the viscosity quality control characteristics, ¶0065-0067, ¶0080-0081. The system of Mischi further includes a display for displaying 2D or 3D maps indicative of these quality control characteristics, ¶0077.
Claim 16: Modified Mischi discloses all the elements above in claim 12, Mischi discloses: wherein the performing of the quality control on the viscosity parameter according to the frequency dispersion distribution diagram comprises: obtaining a viscosity quality control characteristic of the viscosity parameter according to the frequency dispersion distribution diagram;
-Note; the claim recites obtaining a viscosity quality control characteristic of the viscosity parameter according to the frequency dispersion distribution diagram. As such, the term “according to” implies that the claim invention is derived from or closely related to the frequency dispersion distribution diagram. In addition, the claim does not further define which viscosity quality control characteristic is referred to.
-Note; the claim does not provide a definition for what does and does not meet “quality control”.
-Mischi discloses the estimated viscosity values (ns) were found to be very close to the true values, ¶0067. That is the quality characteristic is the accuracy with which estimated viscosity and shear waves match the true values, ¶0065-0067, ¶0080-0081. Mischi specifically discloses a quality control characteristic of the viscosity parameter comprises characteristic quantities related to the frequency range, signal-to-noise ratio, impacting results, and the frequency dispersion curve.
-Mischi discloses frequency-dependent phase velocities, which are derived from estimated material properties, including viscosity, ¶0024-0025, ¶0068-0069. The Voigt model, which describes viscoelastic properties, allows for parameterization of phase velocity based on frequency, ¶0007, ¶0045-0051.
- FIG. 4 shows the various levels of viscosity results in SW phase-velocity dispersion. Specifically, FIG. 4A shows that the estimated phase-frequency dependent velocities “matched the true values very well” for all or most stimulations, with the ‘True” and ‘estimate” lines overlapping across the whole range, ¶0024-0025, ¶0069-0071.
-The Signal-to-Noise-Ratio (SNR) links to “low” SNR to “degrading the esimates” and causes “estimation artifacts”, ¶0086. To address SNR and improve quality, Mischi proposes “supersonic SW generation” to “boost” the SNR and using techniques based on maximum-likelihood estimators to yield robust parameters estimates, ¶0089-0090.
Mischi fails to disclose:
calculating a viscosity quality control score according to the viscosity quality control characteristic; and displaying viscosity quality control information about the viscosity parameter by the viscosity quality control score.
However, Yoshikawa in the context of ultrasound elasticity evaluation methods discloses, calculating a viscosity quality control score according to the viscosity quality control characteristic; (¶0107-0111-incorperating frequency analysis and deriving parameters like stress-free phase velocity, complex modulus, which include elastic modulus related to viscosity), and frequency-dependent attenuation, the elasticity index is indeed reflective of the viscosity quality characteristics.) and displaying viscosity quality control information about the viscosity parameter by the viscosity quality control score. (The elasticity evaluation index derived is a “quality-controlled” parameter. The results of this refined elasticity evaluation are displayed on display unit 19 in various forms, numerical values, graphs and maps, ¶0055, ¶0113-¶0115. The displayed elasticity quality control information is directly indicative of the elasticity evaluation index, ¶0113, Claim 12.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the viscosity quality control characteristics of modified Mischi to comprise teachings as taught by Yoshikawa. The motivation to do this yields predictable results such as providing high degrees of accuracy and reproducibility by accounting for variation of an acoustic characteristic, ¶0014 of Yoshikawa. The modified combination would disclose calculating a viscosity quality control score according to the viscosity quality control characteristic; and displaying viscosity quality control information about the viscosity parameter by the viscosity quality control score.
Claim 18: Modified Mischi discloses all the elements above in claim 14, Mischi discloses, wherein the viscosity quality control characteristic comprises one or more of the following characteristic quantities:
an effective frequency range for calculating the viscosity parameter;
a degree of matching when performing model fitting for the viscosity parameter according to the frequency dispersion distribution diagram;
a continuity of a frequency dispersion curve in the frequency dispersion distribution diagram; (FIG. 4A)
-Fig. 4A is mathematical framework that demonstrates a continuity of the frequency dispersion curve. These graphs show smooth and continuous lines for both the ‘True’ phase velocities and the ‘estimate’ phase velocities across the depicted frequency range. The visual overlap of these smooth lines signifies a continuous and accurate representation of the dispersion.
a signal-to-noise ratio of the frequency dispersion distribution diagram; and different shear waves in multiple patterns in the frequency dispersion distribution diagram.
Claim 21: Claim 7: Modified Mischi discloses all the elements above in claim 18, Mischi discloses,
wherein displaying of the viscosity quality control information about the viscosity parameter by characterizing the viscosity quality control characteristic comprises at least one: calculating and displaying a proportion of continuous or discontinuous segments in the frequency dispersion curve when the viscosity quality control characteristic comprises the continuity of the frequency dispersion curve in the frequency dispersion distribution diagram; (FIG. 4A)
-Fig. 4A is mathematical framework that demonstrates a continuity of the frequency dispersion curve. These graphs show smooth and continuous lines for both the ‘True’ phase velocities and the ‘estimate’ phase velocities across the depicted frequency range. The visual overlap of these smooth lines signifies a continuous and accurate representation of the dispersion.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Mischi et al (US 2020/0121288 A1) in view of Yoshikawa (US 2017/0333004 A1), as applied to claim 12, in view of Tabaru et al (US 2015/0133783 A1).
Claim 15: Modified Mischi discloses all the elements above in claim 12, Mischi discloses, wherein the performing of the quality control on the viscosity parameter according to the frequency dispersion distribution diagram comprises: obtaining a viscosity quality control characteristic of the viscosity parameter according to the frequency dispersion distribution diagram; and
-Note; the claim recites a viscosity quality control characteristic of the viscosity parameter according to the frequency dispersion distribution diagram. As such, the term “according to” implies that the claim invention is derived from or closely related to the frequency dispersion distribution diagram. In addition, the claim does not further define which viscosity quality control characteristic is referred to.
-Note; the claim does not provide a definition for what does and does not meet “quality control”.
-Mischi discloses the estimated viscosity values (ns) were found to be very close to the true values, ¶0067. That is the quality characteristic is the accuracy with which estimated viscosity and shear waves match the true values, ¶0065-0067, ¶0080-0081. Mischi specifically discloses a quality control characteristic of the viscosity parameter comprises characteristic quantities related to the frequency range, signal-to-noise ratio, impacting results, and the frequency dispersion curve.
-Mischi discloses frequency-dependent phase velocities, which are derived from estimated material properties, including viscosity, ¶0024-0025, ¶0068-0069. The Voigt model, which describes viscoelastic properties, allows for parameterization of phase velocity based on frequency, ¶0007, ¶0045-0051.
- FIG. 4 shows the various levels of viscosity results in SW phase-velocity dispersion. Specifically, FIG. 4A shows that the estimated phase-frequency dependent velocities “matched the true values very well” for all or most stimulations, with the ‘True” and ‘estimate” lines overlapping across the whole range, ¶0024-0025, ¶0069-0071.
-The Signal-to-Noise-Ratio (SNR) links to “low” SNR to “degrading the esimates” and causes “estimation artifacts”, ¶0086. To address SNR and improve quality, Mischi proposes “supersonic SW generation” to “boost” the SNR and using techniques based on maximum-likelihood estimators to yield robust parameters estimates, ¶0089-0090.
Mischi fails to disclose:
performing the quality control on the viscosity parameter by displaying a value characterizing the viscosity quality control characteristic.
However, Tabaru in the context of ultrasonic diagnostics discloses, performing quality control on the viscosity parameter by displaying a value characterizing the viscosity quality control characteristic. (¶0074, ‘the viscosity parameter α, the viscosity parameter β and the shear viscosity coefficient η can be displayed.’.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the display of modified Mischi to include performing quality control on the viscosity parameter by displaying a value characterizing the viscosity quality control characteristic as taught by Tabary. The motivation to do this yields predictable results such as improving the relationship between the viscosity coefiffent and viscosity parameter by fitting, thereby providing an effective shear viscosity coefficient, ¶0072 of Tarbaru.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Mischi et al (US 2020/0121288 A1) in view of Yoshikawa (US 2017/0333004 A1), as applied to claim 12, in further view of Eskandari et al (US 2010/0160778 A1).
Claim 17: Modified Mischi discloses all the elements above in claim 12, Mischi discloses, wherein the performing of the quality control on the viscosity parameter according to the frequency dispersion distribution diagram comprises: obtaining a viscosity quality control characteristic of the viscosity parameter according to the frequency dispersion distribution diagram; wherein the viscosity parameter distribution diagram is generated based on the viscosity parameter of each point in the region of interest. (FIG. 6F, 6H, ¶0030, ¶0077)
Mischi fails to disclose: and emptying a region in a viscosity parameter distribution diagram where viscosity quality control information fails to meet a predetermined requirement according to the viscosity quality control characteristic,
However, Eskandari in the context of determining visoelastic parameters in tissue discloses, and emptying a region in a viscosity parameter distribution diagram where viscosity quality control information fails to meet a predetermined requirement according to the viscosity quality control characteristic, (¶0105, ‘the tissue 28 is divided into one or more sets of segments, such that the viscoelastic parameters for all of the elements 1102 inside each segment are constant. In FIG. 11, for example, shaded area 1106 represent a segment in which all elements 1102 have the same viscosity and elasticity values. The number of unknown parameters will only be twice the number of segments, as all the elements 1102 in the segment share common elasticity and viscosity parameters. This way, the number of the unknown parameters will be reduced and solving the FEM inverse problem will be more efficient.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the viscosity parameter distribution diagram of modified Mischi to include emptying a region in a viscosity parameter distribution diagram where viscosity quality control information fails to meet a predetermined requirement according to the viscosity quality control characteristic as taught by Eskandari. The motivation to do this yields predictable results such as improving the viscosity estimation by improving the FEM approach, ¶0030 of Eskandari.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Robinson whose telephone number is (571)272-9019. The examiner can normally be reached M-F 9:00AM-5:00PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/N.A.R./
Examiner, Art Unit 3798