DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Prosecution Reopened
Prosecution on the merits of this application is reopened on claims 1 - 20 considered unpatentable for the reasons indicated below:
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 1 - 20 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.
Claims 1 and 12 have been amended to recite limitations directed towards diagnosing the subject with a cardiovascular disease when arterial wall stiffening is detected.
The specification does not clearly disclose that the claimed method includes the diagnostic step recited in claim 1. Similarly, the specification does not disclose a computing device configured to perform the diagnostic step recited in claim 12. Moreover, no algorithm is provided in the specification for how to achieve the claimed diagnostic step.
Claims 1, 12, and all claims depending therefrom thus present new matter.
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 - 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a mental-process type abstract idea) without significantly more.
Independent claim 1:
With regard to Step 1, the claim is directed to one of the four statutory categories of invention, i.e., a method.
With regard to Step 2A: Prong 1, the claim recites limitations directed towards:
determining viscoelasticity of the arterial or venous wall based upon a correlation between measured and simulated wall velocity of the ultrasound data, by determining the simulated wall velocity for a wall thickness and viscoelastic modulus of the arterial or venous wall through full wave analysis
determining viscoelasticity of the arterial or venous wall in a sequential manner by determining the elastic part of the viscoelastic modulus by matching measured and simulated group or phase velocities and determining the viscous part of the viscoelastic modulus by matching measured and simulated decay characteristics
determining whether an arterial wall is stiffening based upon the determined viscoelasticity
diagnosing the subject with a cardiovascular disease when arterial wall stiffening is detected
As drafted, these limitations amount to nothing more than steps that can practically be performed in the human mind and/or with the aid of pen/paper. For example:
a human can ‘determine the viscoelasticity based upon the correlation between measured and simulated wall velocity of the ultrasound data’ in one of the recited domains by thinking about the correlation between the measured and simulated wall velocity, and/or values derived by processing the correlation in some way, such as a graphic representing a measurement of the correlation, and arriving at a determination of the viscoelasticity, and/or with the aid of pen and paper. Similarly, a human can ‘determine the simulated wall velocity for a wall thickness and viscoelastic modulus of the arterial or venous wall through full wave analysis’ mentally, and/or with the aid of pen/paper;
a human can ‘determine the viscoelasticity in a sequential manner by determining the elastic part of the viscoelastic modulus by matching measured and simulated group or phase velocities and determining the viscous part of the viscoelastic modulus by matching measured and simulated decay characteristics’ by mentally matching the velocities and characteristics in a sequential manner, and/or with the aid of pen and paper;
a human can ‘determine whether an arterial wall is stiffening based upon the determined viscoelasticity’ by arriving at a conclusion regarding the arterial wall’s stiffening in light of the viscoelasticity’, and/or with the aid of pen and paper; and
a human can ‘diagnose the subject with a cardiovascular disease when arterial wall stiffening is detected’ by arriving at a conclusion regarding whether or not the subject has a cardiovascular disease in light of the stiffening.
Therefore, the limitations recite a mental-process type abstract idea. See MPEP 2106.04(a)(2).
With regard to Step 2A: Prong 2, the claim recites an additional element of “obtaining ultrasound data of an arterial or venous wall for a defined acoustic radiation force (ARF)”, which is pre-solution activity, and reads on simply opening a file. The claim also recites that the correlation is “in a space-time, a wavenumber-frequency, wavenumber-time, or space-frequency domain”, which is merely a description of the correlation. Of note, the claimed method does not recite the calculation of the correlation as a method step. In any case, the description merely limits the judicial exception to a particular technological environment or field of use. Consequently, the recited additional elements do not, either individually or as a whole, integrate the judicial exception into a practical application.
With regard to Step 2B, as explained above, the additional limitations are directed towards pre-solution activity and descriptions that limit the judicial exception to a particular technological environment. Therefore, when considered separately and in combination, the additional limitations do not result in the claim, as a whole, amounting to significantly more than the judicial exception.
Dependent claim 2 recites additional limitations directed towards determining the viscoelastic modulus based upon maximization of a correlation coefficient to within a defined threshold, in the space-time, wavenumber-frequency, wavenumber-time, or space-frequency domain, which reads on a mental step and/or a mathematical concept. Dependent claims 3 - 6 recite additional limitations directed towards matching the measured phase velocity of the ultrasound data with the simulated phase velocity, which read on a mental step. The claims also recite limitations characterizing the simulated phase velocities and/or matching steps, which merely limit the judicial exception to a particular technological environment. Dependent claim 7 recites additional limitations directed towards determining a shear modulus based upon shear wave elastography (SWE) measurements, which read on a mental step. Dependent claim 8 recites additional limitations directed towards characterizing the SWE measurements, which merely limit the judicial exception to a particular technological environment. Dependent claims 9 - 11 recite additional limitations directed towards using and/or generating an interpolation matrix, which read on a mental step and/or a mathematical concept. Therefore, when considered separately and in combination, the additional limitations of dependent claims 2 - 11 do not integrate the judicial exception into a practical application, or result in the claims amounting to significantly more than the judicial exception.
Independent claim 12:
With regard to Step 1, the claim is directed to one of the four statutory categories of invention, i.e., a system.
With regard to Step 2A: Prong 1, the claim recites limitations directed towards:
determining viscoelasticity of the arterial or venous wall based upon a correlation between measured and simulated wall velocity of the ultrasound data, by determining the simulated wall velocity for a wall thickness and viscoelastic modulus of the arterial or venous wall through full wave analysis
determining viscoelasticity of the arterial or venous wall in a sequential manner by determining the elastic part of the viscoelastic modulus by matching measured and simulated group or phase velocities and determining the viscous part of the viscoelastic modulus by matching measured and simulated decay characteristics
determining whether an arterial wall is stiffening based upon the determined viscoelasticity
diagnosing the subject with a cardiovascular disease when arterial wall stiffening is detected
As drafted, these limitations amount to nothing more than steps that can practically be performed in the human mind and/or with the aid of pen/paper. For example:
a human can ‘determine the viscoelasticity based upon the correlation between measured and simulated wall velocity of the ultrasound data’ in one of the recited domains by thinking about the correlation between the measured and simulated wall velocity, and/or values derived by processing the correlation in some way, such as a graphic representing a measurement of the correlation, and arriving at a determination of the viscoelasticity, and/or with the aid of pen and paper. Similarly, a human can ‘determine the simulated wall velocity for a wall thickness and viscoelastic modulus of the arterial or venous wall through full wave analysis’ mentally, and/or with the aid of pen/paper;
a human can ‘determine the viscoelasticity in a sequential manner by determining the elastic part of the viscoelastic modulus by matching measured and simulated group or phase velocities and determining the viscous part of the viscoelastic modulus by matching measured and simulated decay characteristics’ by mentally matching the velocities and characteristics in a sequential manner, and/or with the aid of pen and paper;
a human can ‘determine whether an arterial wall is stiffening based upon the determined viscoelasticity’ by arriving at a conclusion regarding the arterial wall’s stiffening in light of the viscoelasticity’, and/or with the aid of pen and paper; and
a human can ‘diagnose the subject with a cardiovascular disease when arterial wall stiffening is detected’ by arriving at a conclusion regarding whether or not the subject has a cardiovascular disease in light of the stiffening.
Therefore, the limitations recite a mental-process type abstract idea. See MPEP 2106.04(a)(2).
With regard to Step 2A: Prong 2, the claim recites an additional element of “an ultrasound scanner configured for shear wave elastography (SWE)”. However, the scanner is recited at a high level of generality, and is therefore considered to be generic hardware for extra-solution activity. The claim further recites limitations directed towards ‘obtaining ultrasound data of an arterial or venous wall of a subject for a defined acoustic radiation force (ARF), the computing device configured to obtain the ultrasound data via the ultrasound scanner’, which is pre-solution activity. The claim also recites a computing device configured to perform the mental step, which is merely an instruction to implement a judicial exception on a computer. The claim further recites that the correlation is “in a space-time, a wavenumber-frequency, wavenumber-time, or space-frequency domain”, which is merely a description of the correlation. Of note, the claimed system does not recite the computing device is configured to calculate the correlation. In any case, the description merely limits the judicial exception to a particular technological environment or field of use. Consequently, the recited additional elements do not, either individually or as a whole, integrate the judicial exception into a practical application.
With regard to Step 2B, as explained above, the additional limitations are directed towards extra-solution activity, an instruction to implement a judicial exception on a computer, and descriptions that limit the judicial exception to a particular technological environment. Therefore, when considered separately and in combination, the additional limitations do not result in the claim, as a whole, amounting to significantly more than the judicial exception.
Dependent claim 13 recites additional limitations directed towards determining the viscoelastic modulus based upon maximization of a correlation coefficient to within a defined threshold, in the space-time, wavenumber-frequency, wavenumber-time, or space-frequency domain, which reads on a mental step and/or a mathematical concept. The recitation that the computing device performs the step is no more than an instruction to implement a judicial exception on a computer. Dependent claims 14 - 15 recite additional limitations directed towards characterizing the matching step, which merely limit the judicial exception to a particular technological environment. Dependent claims 16 - 18 recite additional limitations directed towards determining a shear modulus, which read on a mental step. The recitation that the computing device performs the step is no more than an instruction to implement a judicial exception on a computer. Dependent claims 19 - 20 recite additional limitations directed towards extra-solution activity (i.e., data-gathering). Therefore, when considered separately and in combination, the additional limitations of dependent claims 13 - 20 do not integrate the judicial exception into a practical application, or result in the claims amounting to significantly more than the judicial exception.
Response to Arguments
Applicant's arguments filed 12/31/2025 regarding the 101 rejections set forth in the Office Action mailed 10/1/2025 have been fully considered but they are not persuasive.
Applicant argues on page 9 that “determining arterial wall stiffening based on the viscoelasticity determined as recited in claims 1 and 12 is an unconventional step that is more than the exception itself as evidenced by the lack of a prior art rejection of the pending claims.”
In response, it is noted that unconventionality is not dispositive of eligibility. Therefore, this argument is not persuasive.
Applicant further argues on page 9 that “the features improve computational cost and accuracy thereby providing a technical improvement.”
However, the alleged improvement must be reflected in the claims, and the he judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See MPEP 2106.05(a).
Applicant further argues on page 10 that “the claimed subject matter is integrated into a practical application by allowing for the non-invasive diagnosis of cardiovascular disease”.
Examiner respectfully disagrees, as the diagnostic step itself is a judicial exception.
Applicant further argues on page 11 that “specific technical approach related to determining viscoelasticity, which is used to determine whether an arterial wall is stiffening and diagnose cardiovascular disease when stiffening is detected.”
In response, examiner asserts that each limitation in the claims has been addressed in the body of the 101 rejections above. The arguments are therefore not persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIE R DAVIS whose telephone number is (571)270-7240. The examiner can normally be reached Monday-Friday, 9:30 - 6:00 PST.
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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.
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798
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