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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9 in the reply filed on 10/23/2025 is acknowledged.
Claim Objections
Claim(s) 2 recite(s) the limitation “such that […]”. It is suggested to replace the phrase “such that” with the term —wherein— to ensure the positive recitation of all elements in the claim. The use of the phrase “such that” may be interpreted as a negative limitation in the claim, resulting in an interpretation of subsequent limitations (i.e., “the estimated value approximates an MRI-PDFF” in claim 2) as preferred or suggested limitations, and therefore may be excluded from examination.
Claim 2 further recite(s) the limitation “MRI-PDFF”, which is an abbreviated term that should be defined in its first occurrence (e.g., ‘A magnetic resonance imaging (MRI)-proton density fat fraction (PDFF)’ as provided in the instant written description [0004]). Appropriate correction is required.
Claim 7 is objected to because of the following informalities: the limitation “wherein the two-dimensional region corresponds a plurality of reception beams aligned in an electronic scanning direction” appears to contain typographical/ grammatical errors. It is suggested to amend the claim language to read –wherein the two-dimensional region corresponds with a plurality of reception beams aligned in an electronic scanning direction– if this is the Applicant’s intended recitation. Appropriate correction is required.
CLAIM INTERPRETATION
35 U.S.C. 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are: “a forming device that forms an ultrasound image based on reception information” and “a display device that displays the ultrasound image, at least one of the plurality of attenuation coefficients, and the estimated value of the fat fraction” in claim 9.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding the ‘forming device’ and the ‘display device’, upon review the Applicant’s instant specification provides:
“The ultrasound diagnostic apparatus according to the embodiment includes a forming device and a display device. The forming device forms an ultrasound image based on reception information different from the plurality of pieces of reception information. The display device displays the ultrasound image, at least one of the plurality of attenuation coefficients, and the estimated value of the fat fraction.”
[0030] (emphasis added)
“The plurality of tomographic image data are sent to a display device 22 via a display processing unit 20. A plurality of tomographic images are displayed as a moving image on the display device 22. In a case in which a freeze operation is performed, a tomographic image corresponding to a specific time phase is displayed as a still image. The display device 22 is composed of an organic EL display or the like. […]”
[0043] (emphasis added)
In view of Applicant’s disclosure, the ‘display device’ has been interpreted as any screen or monitor for use with an ultrasound apparatus that may display ultrasound images and other visual information related to received ultrasound data. Regarding the ‘forming device’, aside from merely repeating the claim language, the written description does not provide adequate definition of structure for the ‘forming device’ [see 35 U.S.C. §112 section] – for the purposes of examination any processing component capable of forming an ultrasound image based on reception information derived from ultrasound transmission and reception.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. In particular, claim 1 as drafted does not fall within at least one of the four categories of patent eligible subject matter, because the broadest reasonable interpretation of the claim limitations “calculate a plurality of attenuation coefficients based on a plurality of pieces of reception information acquired from a liver […]; and calculate an estimated value of a fat fraction based on a parameter set […]”, are directed to an abstract idea without significantly more.
The limitations “configured to: calculate a plurality of attenuation coefficients based on a plurality of pieces of reception information acquired from a liver […]; and calculate an estimated value of a fat fraction based on a parameter set […]”, as drafted, define a process that, under the broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “a processor configured to” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “a processor configured to” language, ‘calculating’ in the context of this claim encompasses the user manually calculating a plurality of attenuation coefficients based on reception information. The plurality of pieces of reception information acquired from a liver in a subject is directed to extra solution activity. Similarly, the limitation of calculating an estimated value of a fat fraction based on a parameter set, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, but for the “a processor configured to” language, ‘calculating’ in the context of this claim encompasses the user thinking estimating a value from a calculation based on a parameter set. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites one additional element – using a processor to perform both the calculation steps. The processor in both steps is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of calculating values based on reception information or a parameter set) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform both calculation steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claim is not patent eligible.
In view of the above, claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. § 101. Dependent claim(s) 2-9 fail to add additional elements that integrate the judicial exception into a practical application. Claims 2-9 fail to cure the deficiencies of claim 1 by merely reciting additional abstract ideas or further limitations on the abstract idea already recited.
Claim 4 recites “an ultrasound probe”, however, this recitation is not significantly more than what is well-known, routine and conventional in the art. In particular, the recitation “acquires the first reception information by transmitting a first ultrasonic wave having a first center frequency into the subject and that acquires the second reception information by transmitting a second ultrasonic wave having a second center frequency different from the first center frequency into the subject” constitutes insignificant pre-solution activity. Based on the claim language, as drafted, the ultrasound probe is not used for performing the abstract idea; rather, the ultrasound probe generates first and second reception information. The acquisition of reception information using an ultrasound probe based on transmission of ultrasonic waves is not significantly more than what is well-known, routine and conventional in the art.
Similarly, claim 9 recites the limitations “a forming device that forms an ultrasound image […]; and a display device that displays the ultrasound image”, however these limitations do not provide significantly more than what is well-known, routine and conventional in the art. The recitations of ‘forming an ultrasound image’ and ‘displaying the ultrasound image’ constitutes insignificant post-solution activity. Neither the “forming device” nor the “display device” are used for performing the abstract idea; rather, the two ‘devices’ are used to form and present an ultrasound image. Generating an ultrasound image and presenting the generated ultrasound image for display is not a process that is significantly more than what is well-known, routine and conventional in the art. Accordingly, the dependent claim(s) 2-9 are rejected under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 112
35 USC § 112(a)
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.
Claim 9 is 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.
Regarding claim 9, the limitations “a forming device that forms an ultrasound image” are not supported in the specification by the written description or drawings. There is no clear definition or description of the ‘forming device’, either written or depicted in a figure, which indicates the structure being claimed. It is suggested to amend the claim to include the structures for required performing the claimed functions. Appropriate correction is required.
35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 5-9 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 6-8 are rejected at least by virtue of dependency upon a rejected claim.
Claim 5 recites the limitations “generate first reference information to be compared with the first reception information and second reference information to be compared with the second reception information” which renders the claim indefinite. Specifically, it is not clear what the either of the ‘first and second reference information’ actually is – there is no definition in the claim which clearly indicates what these values are (e.g., based on received ultrasound data, based on received MR data, or some other metric or measure, etc.) to one of ordinary skill in the art. Upon review of the Applicant’s specification, aside from merely repeating the claim language, the instant written description provides:
“In the embodiment, the first reference information and the second reference information are each defined by a predetermined calculation formula. In this case, an information generator is composed of a calculating device. The first reference information and the second reference information may each be configured as a predetermined numerical value sequence. In that case, the generator may be composed of a memory.”
[0025] (emphasis added)
“A memory 36 is composed of, for example, a semiconductor memory. The memory 36 stores information and a program required for operating the ultrasound diagnostic apparatus 10. The stored information includes information for defining the first reference information and the second reference information used in the fat fraction estimation mode. One or a plurality of examination value data from an external device are input to the information processing unit 24. The examination value data includes, for example, BMI data and blood test data. Each component shown in FIG. 1 is configured of an electronic circuit, a processor, a device, and the like.”
[0047] (emphasis added)
“FIG. 5 shows an estimated value calculation process. The entity of the first reception information is a first reception intensity matrix P1(x), and the entity of the second reception information is a second reception intensity matrix P2(x). The entity of the first reference information is a first reference intensity sequence Pref1(x), and the entity of the second reference information is a second reference intensity sequence Pref2(x).”
[0086] (emphasis added)
The written description appears to define the ‘reference information’ as either a ‘predetermined calculation formula’ and/or a ‘predetermined numerical value sequence’ linked with a ‘reference intensity sequence’. The ‘reference information’ may be stored and retrieved from memory. The specification also points to figure 5, which shows an “estimated value calculation process”, which appears to indicate a flow chart describing how reference and reception information are processed into attenuation matrices and subsequently incorporated into an estimated value (E). However, there is no clear indication of what type of information the ‘reference information’ actually is, how it is derived/generated, and what distinction (if any) exists between the ‘reference’ and ‘reception’ information. For the purposes of examination, the ‘reference information’ is interpreted as any calculated numerical value derived from ultrasound intensity. It is suggested to amend the claim to clearly define the ‘reference information’ and the subsequent calculations performed by the processor.
Claim 9 recites the limitations “a forming device that forms an ultrasound image” which renders the claim indefinite. Aside from merely repeating the claim language, the written description fails to adequately define or clearly link the ‘forming device’ structure. Specifically it is not clear what particular structure performs the ‘forms an ultrasound image’ function, because the instant specification does not clearly link the ‘forming device’ to appropriate structure for performing the function. For the purposes of examination any processing component capable of forming an ultrasound image based on reception information derived from ultrasound transmission and reception.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5 and 9 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Labyed (US20230104771A1, 2023-04-06; hereinafter “Labyed”).
Regarding claim 1, Labyed teaches an ultrasound diagnostic apparatus comprising a processor (“A system for liver disease activity estimation, the system comprising: an ultrasound system[…] an processor” [clm 18]; “The functions, acts or tasks illustrated in the figures or described herein are executed in response to one or more sets of instructions stored in or on computer readable storage media […] processing strategies may include multiprocessing, multitasking, parallel processing, and the like. […] the instructions are stored within a given computer, CPU, GPU or system” [0112]; [0017-0068, 0094-0113], [fig. 1-2]) configured to:
calculate a plurality of attenuation coefficients based on a plurality of pieces of reception information acquired from a liver in a subject and having a plurality of different frequency characteristics (“an ultrasound system configured to determine one or more scattering parameters of liver tissue of a patient and a plurality of shear wave parameters of the liver tissue of the patient […] a processor configured to estimate a fat fraction” [clm 18]; “a tissue property (e.g., liver fat fraction) is estimated by transmitting and receiving a sequence of pulses to estimate scattering parameters, and by transmitting and receiving a sequence of pulses to obtain shear wave parameters” [0020]; “scatter parameters include sound speed, […] frequency-dependent attenuation coefficient, attenuation coefficient slope,” [0026]; “the measure of scatter is a frequency dependent measure averaged from multiple transmissions to a same location. Changes in the power spectra as a function of depth, angle, and/or frequency may be measured.” [0029]; “the attenuation coefficient is measured. […] The beamformed samples or acoustic intensity may be converted to the frequency domain, and the calculation performed in the frequency domain.” [0031]; The ultrasound system determines values for a plurality of scattering parameters (e.g., acoustic attenuation coefficients) to estimate liver fat fraction from a series of transmit and receive events, wherein attenuation coefficients are frequency dependent (i.e., having different frequency characteristics) scattering parameters [0019-0044, 0071-0091], [fig. 1-2]); and
calculate an estimated value of a fat fraction based on a parameter set including the plurality of attenuation coefficients (“ the processor is configured to estimate the fat fraction from an acoustic attenuation and an acoustic scattering as the scattering parameters” [clm 19]; “liver fat fraction is estimated using a multi-parametric approach that combines quantitative parameters […] such as scattering and attenuation of longitudinal waves, propagation and attenuation of shear waves, and/or propagation and attenuation of on-axis waves from acoustic radiation force impulse (ARFI)” [0019]; “The measures of scattering may be used for estimating fat fraction, such as using acoustic backscatter (e.g., frequency dependent acoustic backscatter) and acoustic attenuation.” [0078]; The measures of scattering (i.e., parameter set) are used to estimate fat fraction of the liver [0019-0044, 0071-0091], [fig. 1-2]).
Regarding claim 2, Labyed teaches the ultrasound diagnostic apparatus according to claim 1,
Labyed further teaching wherein the processor has a model created such that the estimated value approximates an MRI-PDFF (“The machine learning learns from training data. […] The ground truth for the fat fraction is provided with a magnetic resonance (MR) scan providing proton density fat fraction (PDFF). The MR-PDFF provides a percentage of fat for a location or region.” [0056]; “a linear model is used instead of or in addition to a machine-learnt model. […] For example, the weights are obtained by a least square minimization using MR-PDFF values” [0059]; “The weights and constants are based on minimizing a difference from the fat fraction provided by MR-PDFF.” [0062]; A machine-learnt model (i.e., created model) is trained using MR-PDFF training data as ground truth data so the model may classify fat percentage from ultrasound parameters [0021-0073], [fig. 1-2]), and
the parameter set is given to the model, so that the estimated value is calculated (“The MR-PDFF provides a percentage of fat for a location or region. The percentage of fat is used as the ground truth so that the machine learning learns to classify the percentage of fat from input values for the ultrasound parameters.” [0056]; “Two functions based on scattering parameters are used, where the function for a given estimation is selected based on the shear wave propagation parameter” [0062]; The machine learnt model is trained to minimized the difference between the fat fraction value estimated from input ultrasound scattering parameters and the ground truth fat fraction derived from MR-PDFF [0021-0073], [fig. 1-2]).
Regarding claim 3, Labyed teaches the ultrasound diagnostic apparatus according to claim 1,
Labyed further teaching wherein the plurality of pieces of reception information include first reception information having a first frequency characteristic and second reception information having a second frequency characteristic (“an ultrasound system configured to determine one or more scattering parameters of liver tissue of a patient and a plurality of shear wave parameters of the liver tissue of the patient,” [clm 18]; “Narrow band pulses (e.g., 3 or more cycles) may be transmitted and received at distinct center frequencies with or without overlapping spectra. Narrow band transmit pulses may be used in a single or in multiple transmit and receive events” [0028]; “the ultrasound scanning used for measuring scattering and for measuring shear wave propagation use the same or different transmit and receive events. […] separate transmissions and receptions are used for measuring scattering than used to generate the shear wave and measure the tissue response to the shear wave” [0080]; “The same region may be scanned multiple times using different scan line angles, F numbers, and/or waveform center frequencies” [0098]; Multiple ultrasound transmit and receive events may include narrow band pulses (i.e., first and second reception information) with distinct center frequencies (i.e., first and second frequency characteristics), thus first and second narrow band pulses of 3 cycle sequence have different respective center frequencies [0021-0080], [fig. 1-2]), and
the plurality of attenuation coefficients include a first attenuation coefficient calculated based on the first reception information and a second attenuation coefficient calculated based on the second reception information (“The ultrasound scanner may adapt the scanning for the shear wave parameter measurement. […] for an estimate of the attenuation coefficient of the shear wave, the push pulse adapts. The center frequency, duration, f-number, or other characteristic of the push pulse is changed for a later transmission” [0043]; “The measures of scattering may be used for estimating fat fraction, such as using acoustic backscatter (e.g., frequency dependent acoustic backscatter) and acoustic attenuation” [0078]; Multiple transmissions at different center frequencies generate measures of scattering including corresponding attenuation coefficients [0021-0080], [fig. 1-2]).
Regarding claim 4, Labyed teaches the ultrasound diagnostic apparatus according to claim 3, Labyed further teaching:
an ultrasound probe (“A medical diagnostic ultrasound scanner performs the measurements by acoustically generating the waves and measuring the responses” [0022]; The ultrasound scanner is an ultrasound probe [fig. 1-2]) that acquires the first reception information by transmitting a first ultrasonic wave having a first center frequency into the subject and that acquires the second reception information by transmitting a second ultrasonic wave having a second center frequency different from the first center frequency into the subject (“the ultrasound scanner scans the tissue with ultrasound. A sequence of transmit and receive events is performed to acquire the signals to estimate the quantitative ultrasound scatter parameters. […] Narrow band pulses (e.g., 3 or more cycles) may be transmitted and received at distinct center frequencies with or without overlapping spectra” [0028]; A sequence of transmit beams are generated to scan a two or three-dimensional region, wherein the same region may be scanned multiple times using different scan line angles, F numbers, and/or waveform center frequencies [0021-0080], [fig. 1-2], [see claim 3 rejection]).
Regarding claim 5, Labyed teaches the ultrasound diagnostic apparatus according to claim 1,
Labyed further teaching the processor (“a processor” [clm 18]; [fig. 1-2], [see claim 1 rejection]) further configured to:
generate first reference information to be compared with the first reception information and second reference information to be compared with the second reception information (“Narrow band pulses (e.g., 3 or more cycles) may be transmitted and received at distinct center frequencies with or without overlapping spectra. Narrow band transmit pulses may be used in a single or in multiple transmit and receive events.” [0028]; “In one example, the attenuation coefficient is measured. The reference-phantom method is used, but other measures of the attenuation coefficient may be used […] To remove system effects, the measurement is calibrated based on measures of acoustic intensity as a function of depth in a phantom. The measurement may be subject to less noise by averaging over a one, two, or three-dimensional region. The beamformed samples or acoustic intensity may be converted to the frequency domain, and the calculation performed in the frequency domain” [0031]; Reference phantom provides reference information to calibrate scatter measurement (i.e., first and second reception information) of multiple transmit/receive events [0021-0080], [fig. 1-2], [see claim 4 rejection; see 35 U.S.C. §112 section]),
calculate the first attenuation coefficient based on the first reception information and the first reference information, and calculate the second attenuation coefficient based on the second reception information and the second reference information (“In one example, the attenuation coefficient is measured. The reference-phantom method is used, but other measures of the attenuation coefficient may be used […] To remove system effects, the measurement is calibrated based on measures of acoustic intensity as a function of depth in a phantom. […] The beamformed samples or acoustic intensity may be converted to the frequency domain, and the calculation performed in the frequency domain” [0031]; “A reference scan for a resting state tissue position is performed before the pushing pulse or after the tissue returns to a resting state” [0037]; “The machine learning learns from training data. The training data includes various examples, such as tens, hundreds, or thousands of samples, and the ground truth. The examples include the input data to be used, such as values for scattering and shear wave propagation parameters” [0056]; The attenuation coefficients for different transmission events (i.e., first and second reception information) may be calculated using reference phantom information (i.e., first and second reference information) to calibrate the measurements [0021-0080], [fig. 1-2], [see 35 U.S.C. §112 section]).
Regarding claim 9, Labyed teaches the ultrasound diagnostic apparatus according to claim 1, Labyed further teaching:
a forming device that forms an ultrasound image based on reception information different from the plurality of pieces of reception information (“the image processor generates and a display (e.g., display screen) displays the estimate of the disease activity” [0092]; “The image processor 18 is a B-mode detector, Doppler detector, […] field programmable gate array, digital signal processor, analog circuit, digital circuit, combinations thereof” [0106]; The image processor is a forming device [0095-0112], [fig. 1-2], [see 35 U.S.C. §112 section]); and
a display device that displays the ultrasound image, at least one of the plurality of attenuation coefficients, and the estimated value of the fat fraction (“a display configured to display the level of the liver disease activity” [clm 18]; “the ultrasound scanner or a display device displays the estimated tissue parameter” [0063]; “The image may include other data. For example, shear wave information is displayed over or with B-mode information” [0066]; “The additional estimated value of the tissue property is displayed substantially simultaneously with the shear wave, B-mode, color or flow mode, M-mode, contrast agent mode, and/or other imaging […] The component measures used to estimate the tissue property may also be displayed, such as in a table.” [0067]; “shear wave or B-mode and fat fraction images are displayed substantially simultaneously” [0069]; “the image processor generates and a display (e.g., display screen) displays the estimate of the disease activity” [0092]; A B-mode image, fat fraction and estimated value of tissue property (e.g., attenuation coefficients) may be presented on a display [0113], [fig. 1-2]).
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 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.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Labyed as applied to claim 5 above, and further in view of Mammone et al. (US20140066767A1, 2014-03-06; hereinafter “Mammone”).
Regarding claim 6, Labyed teaches the ultrasound diagnostic apparatus according to claim 5,
Labyed further teaching wherein the first reception information and the second reception information are each information acquired from a two-dimensional region within the subject (“a one, two, or three-dimensional region is scanned by a B-mode sequence (e.g., transmit a broadband (e.g., 1-2 cycle) transmit beam and form one or more responsive receive beams).” [0028]; “the attenuation coefficient is measured. The reference-phantom method is used, but other measures of the attenuation coefficient may be used. […] The measurement may be subject to less noise by averaging over a one, two, or three-dimensional region.” [0031]; [fig. 1-2], [see claim 5 rejection]),
the processor (“a processor” [clm 18]; [fig. 1-2], [see claim 1 rejection]) further configured to:
calculate a first matrix based on the first reception information and the first reference information (“The neural network includes one or more convolution layers that learn a filter kernel to distinguish between the values of a tissue property. […] The resulting machine-learnt classifier uses the input values to extract the distinguishing information and then classifies the tissue property based on the extracted information” [0057]; “The training provides one or more matrices. The matrix or matrices relate the input information to the output class. Hierarchal training and a resulting classifier may be used. Different classifiers may be used for different tissue properties. Multiple classifiers may be used for a same tissue property and the results averaged or combined” [0058]; The training produces matrices relating input information to the output class and deriving classifiers for corresponding tissue properties [0021-0093], [fig. 1-2]),
calculate a first parameter group including the first attenuation coefficient, a first attenuation average, and a first attenuation variation based on the first matrix (“the processor is configured to estimate the fat fraction from an acoustic attenuation and an acoustic scattering as the scattering parameters” [clm 19]; “Repetition with or without different transmit and/or receive settings may be used to measure the scatter once or to measure the scatter differently. […] estimates of the attenuation coefficient from different transmit and/or receive angles are averaged to reduce variance or used to quantify the angular dependence of attenuation” [0029]; “The measures of scattering may be used for estimating fat fraction, such as using acoustic backscatter (e.g., frequency dependent acoustic backscatter) and acoustic attenuation.” [0078]; A plurality of scattering measures may be derived, wherein estimates of the attenuation coefficient from different transmissions may be averaged [0021-0093], [fig. 1-2]),
calculate a second matrix based on the second reception information and the second reference information (“The neural network includes one or more convolution layers that learn a filter kernel to distinguish between the values of a tissue property. […] The resulting machine-learnt classifier uses the input values to extract the distinguishing information and then classifies the tissue property based on the extracted information” [0057]; “The training provides one or more matrices. The matrix or matrices relate the input information to the output class. Hierarchal training and a resulting classifier may be used. Different classifiers may be used for different tissue properties. Multiple classifiers may be used for a same tissue property and the results averaged or combined” [0058]; [0021-0093], [fig. 1-2]), and
calculate a second parameter group including the second attenuation coefficient, a second attenuation average, and a second attenuation variation based on the second matrix (“the processor is configured to estimate the fat fraction from an acoustic attenuation and an acoustic scattering as the scattering parameters” [clm 19]; “Repetition with or without different transmit and/or receive settings may be used to measure the scatter once or to measure the scatter differently. […] estimates of the attenuation coefficient from different transmit and/or receive angles are averaged to reduce variance or used to quantify the angular dependence of attenuation” [0029]; “The measures of scattering may be used for estimating fat fraction, such as using acoustic backscatter (e.g., frequency dependent acoustic backscatter) and acoustic attenuation.” [0078]; [0021-0093], [fig. 1-2]), and
the parameter set includes the first parameter group and the second parameter group (“The measures of scattering may be used for estimating fat fraction, such as using acoustic backscatter (e.g., frequency dependent acoustic backscatter) and acoustic attenuation.” [0078]; The measures of scattering from multiple transmission events correspond to the parameter set of multiple parameter groups [fig. 1-2], [see claim 1 rejection]);
but Labyed may fail to explicitly teach the particulars of the attenuation matrix.
However, in the same field of endeavor, Mammone teaches an ultrasound diagnostic apparatus (“A system for processing an ultrasound signal,” [clm 15]; [fig. 1, 5]);
Mammone further teaching the processor (“a processing unit;” [clm 15]; “A processor or processing unit 122, which may be formed of one or more computer processors, that is local and/or remote from the signal receiver 118 may be configured to execute software 124.” [0041]; [fig. 1, 5]) further configured to:
calculate a first attenuation matrix based on the first reception information and the first reference information (“correcting depth and frequency attenuation of the ultrasound signal by generating an attenuation matrix A and scaling each coefficient by an exponential attenuation factor” [clm 27]; “An attenuation matrix A is derived and an inverse of this matrix provides the attenuation correction matrix to be applied to the measured ultrasound signal.” [0060]; “the process 500 includes a complement of the subsampled Fourier samples for each of the M subsamples” [0116]; “A segmentation and detection module 1302 may be used to segment and detect structures in an image” [0133]; Resampling process includes provides a sample signal 500a (i.e., first) and a complement signal 500b (i.e., second) which generate respective attenuation matrices from respective sets of frequency samples (i.e., first reception and reference information) which are processed using respective inverse fourier transform, envelope detection and signal merging before a final signal merging step [0038-0134], [fig. 1-7; see fig. 5 reproduced below]),
calculate a first parameter group including the first attenuation coefficient, a first attenuation average, and a first attenuation variation based on the first attenuation matrix (“The signal merging module 406 may utilize one or more statistical measure, including average, median, Lee, weighted average, trimmed mean, geometric mean, and so on.” [0115]; “Signal merging modules 514 a and 514 b, too, may be used for generating statistical measures of the subset 504 and complements subset 506 within the time envelope generated by the respective envelope detectors 512 a and 512 b.” [0116]; [0038-0134], [fig. 1-7; see fig. 5 reproduced below]),
calculate a second attenuation matrix based on the second reception information and the second reference information (“correcting depth and frequency attenuation of the ultrasound signal by generating an attenuation matrix A and scaling each coefficient by an exponential attenuation factor” [clm 27]; “An attenuation matrix A is derived and an inverse of this matrix provides the attenuation correction matrix to be applied to the measured ultrasound signal.” [0060]; “the process 500 includes a complement of the subsampled Fourier samples for each of the M subsamples” [0116]; “A segmentation and detection module 1302 may be used to segment and detect structures in an image” [0133]; [0038-0134], [fig. 1-7; see fig. 5 reproduced below]), and
calculate a second parameter group including the second attenuation coefficient, a second attenuation average, and a second attenuation variation based on the second attenuation matrix (“The signal merging module 406 may utilize one or more statistical measure, including average, median, Lee, weighted average, trimmed mean, geometric mean, and so on.” [0115]; “Signal merging modules 514 a and 514 b, too, may be used for generating statistical measures of the subset 504 and complements subset 506 within the time envelope generated by the respective envelope detectors 512 a and 512 b.” [0116]; [0038-0134], [fig. 1-7; see fig. 5 reproduced below]), and
the parameter set includes the first parameter group and the second parameter group (“A signal merging module 514 c may merge merged signals from the signal merging modules 514 a and 514 b.” [0116]; The merged signals from 514a (i.e., first parameter group) and 514b (i.e., second parameter group) are merged at signal merging module 514c to produce parameter set [0038-0134], [fig. 1-7; see fig. 5 reproduced below]).
PNG
media_image1.png
680
1369
media_image1.png
Greyscale
The sample signal 500a (i.e., first) and complement signal 500b (i.e., second) are processed to generate corresponding attenuation matrices and respective parameter groups, wherein the sample and complement are subsequently combined with signal merging module 514c (Mammone [fig. 5], annotated)
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the ultrasound diagnostic apparatus as taught by Labyed with the attenuation matrices as taught by Mammone. The physician may be assisted by relatively inexpensive and rapid ultrasound as compared to biopsy or MRI based scoring in scoring activity of a disease, such as NAFLD. Ultrasound is non-invasive, and more readily available and less expensive than MRI (Labyed [0006]). Furthermore, combining both a sample signal and complement of the sample signal provides a higher resolution with better SNR than possible without using the complement of the sample signal (Mammone [0116]).
Regarding claim 7, Labyed and Mammone teach the ultrasound diagnostic apparatus according to claim 6,
wherein the two-dimensional region corresponds a plurality of reception beams aligned in an electronic scanning direction (“a one, two, or three-dimensional region is scanned by a B-mode sequence (e.g., transmit a broadband (e.g., 1-2 cycle) transmit beam and form one or more responsive receive beams). Any scan format may be used, such as linear, sector, or vector. […] Narrow band transmit pulses may be used in a single or in multiple transmit and receive events. The transmit pulses and corresponding receive beams may be formed at different steering angles, such as sampling a same location of tissue from different directions” [0028]; “The two-dimensional images represent spatial distribution in an area” [0113]; [0017-0068, 0094-0113], [fig. 1-2], [see claim 1 rejection]), and
the processor (“a processor” [clm 18]; [fig. 1-2], [see claim 1 rejection]) further configured to:
calculate the first attenuation coefficient based on a specific attenuation sequence selected from the first matrix (“scatter parameters include sound speed, […] frequency-dependent attenuation coefficient, attenuation coefficient slope,” [0026]; “the attenuation coefficient is measured. […] The beamformed samples or acoustic intensity may be converted to the frequency domain, and the calculation performed in the frequency domain.” [0031]; “The scan for measurements is divided into separate sequences of transmit and receive events for the different measurements” [0040]; “The training provides one or more matrices. The matrix or matrices relate the input information to the output class. Hierarchal training and a resulting classifier may be used. Different classifiers may be used for different tissue properties. Multiple classifiers may be used for a same tissue property and the results averaged or combined” [0058]; [0021-0093], [fig. 1-2], [see claim 1, 6 rejections]),
calculate the first attenuation average and the first attenuation variation based on a plurality of attenuation sequences in the first matrix (“Repetition with or without different transmit and/or receive settings may be used to measure the scatter once or to measure the scatter differently. […] estimates of the attenuation coefficient from different transmit and/or receive angles are averaged to reduce variance or used to quantify the angular dependence of attenuation” [0029]; [0021-0093], [fig. 1-2], [see claim 6 rejections]),
calculate the second attenuation coefficient based on a specific attenuation sequence selected from the second matrix (“scatter parameters include sound speed, […] frequency-dependent attenuation coefficient, attenuation coefficient slope,” [0026]; “the attenuation coefficient is measured. […] The beamformed samples or acoustic intensity may be converted to the frequency domain, and the calculation performed in the frequency domain.” [0031]; “The scan for measurements is divided into separate sequences of transmit and receive events for the different measurements” [0040]; “The training provides one or more matrices. The matrix or matrices relate the input information to the output class. Hierarchal training and a resulting classifier may be used. Different classifiers may be used for different tissue properties. Multiple classifiers may be used for a same tissue property and the results averaged or combined” [0058]; [0021-0093], [see claim 1, 6 rejections]), and
calculate the second attenuation average and the second attenuation variation based on a plurality of attenuation sequences in the second matrix (“Repetition with or without different transmit and/or receive settings may be used to measure the scatter once or to measure the scatter differently. […] estimates of the attenuation coefficient from different transmit and/or receive angles are averaged to reduce variance or used to quantify the angular dependence of attenuation” [0029]; [0021-0093], [fig. 1-2], [see claim 6 rejection]);
but Labyed may fail to explicitly teach the particulars of the attenuation matrix.
However, in the same field of endeavor, Mammone teaches the processor (“a processing unit;” [clm 15]; “A processor or processing unit 122, which may be formed of one or more computer processors, that is local and/or remote from the signal receiver 118 may be configured to execute software 124.” [0041]; [fig. 1, 5]) further configured to:
calculate the first attenuation coefficient based on a specific attenuation sequence selected from the first attenuation matrix (“correcting depth and frequency attenuation of the ultrasound signal by generating an attenuation matrix A and scaling each coefficient by an exponential attenuation factor” [clm 27]; “The total attenuation correction incorporates both time and frequency corrections using the mid-point for distance and frequency” [0058]; “An attenuation matrix A is derived and an inverse of this matrix provides the attenuation correction matrix to be applied to the measured ultrasound signal” [0060]; An inverse matrix provides the attenuation correction matrix based on the original attenuation matrix from sample signal [0038-0134], [fig. 1-7], [see claim 6 rejection]),
calculate the first attenuation average and the first attenuation variation based on a plurality of attenuation sequences in the first attenuation matrix (“the transforms 404 are a single transform that performs the transforms in a serial manner as the resampling is performed. […] The signal merging module 406 may utilize one or more statistical measure, including average, median, Lee, weighted average, trimmed mean, geometric mean, and so on.” [0115]; [0038-0134], [fig. 1-7], [see claim 6 rejection]),
calculate the second attenuation coefficient based on a specific attenuation sequence selected from the second attenuation matrix (“correcting depth and frequency attenuation of the ultrasound signal by generating an attenuation matrix A and scaling each coefficient by an exponential attenuation factor” [clm 27]; “The total attenuation correction incorporates both time and frequency corrections using the mid-point for distance and frequency” [0058]; “An attenuation matrix A is derived and an inverse of this matrix provides the attenuation correction matrix to be applied to the measured ultrasound signal” [0060]; An inverse matrix provides the attenuation correction matrix based on the original attenuation matrix from complementary signal [0038-0134], [fig. 1-7], [see claim 6 rejection]), and
calculate the second attenuation average and the second attenuation variation based on a plurality of attenuation sequences in the second attenuation matrix (“the transforms 404 are a single transform that performs the transforms in a serial manner as the resampling is performed. […] The signal merging module 406 may utilize one or more statistical measure, including average, median, Lee, weighted average, trimmed mean, geometric mean, and so on.” [0115]; [0038-0134], [fig. 1-7], [see claim 6 rejection]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the ultrasound diagnostic apparatus as taught by Labyed with the attenuation matrices as taught by Mammone. The physician may be assisted by relatively inexpensive and rapid ultrasound as compared to biopsy or MRI based scoring in scoring activity of a disease, such as NAFLD. Ultrasound is non-invasive, and more readily available and less expensive than MRI (Labyed [0006]). Furthermore, combining both a sample signal and complement of the sample signal provides a higher resolution with better SNR than possible without using the complement of the sample signal (Mammone [0116]).
Regarding claim 8, Labyed and Mammone teach the ultrasound diagnostic apparatus according to claim 6,
Labyed further teaching wherein the parameter set further includes one or a plurality of parameters acquired from the subject by an examination other than an ultrasound examination (“The machine learning learns from training data. […] The ground truth for the fat fraction is provided with a magnetic resonance (MR) scan providing proton density fat fraction (PDFF). The MR-PDFF provides a percentage of fat for a location or region. The percentage of fat is used as the ground truth so that the machine learning learns to classify the percentage of fat from input values for the ultrasound parameters.” [0056]; “a linear model is used instead of or in addition to a machine-learnt model. […] For example, the weights are obtained by a least square minimization using MR-PDFF values” [0059]; “Two functions based on scattering parameters are used, where the function for a given estimation is selected based on the shear wave propagation parameter […] The weights and constants are based on minimizing a difference from the fat fraction provided by MR-PDFF.” [0062]; [0021-0073], [fig. 1-2], [see claim 2 rejection]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Labyed et al. (US20200205786A1, 2018-10-11) teaches tissue property estimation with ultrasound, multiple different types of measurements are performed by an ultrasound system, including scatter measurements and shear wave propagation measurements. The tissue property, such as liver fat fraction, is estimated using a combination of these different types of measurements [abst].
Cho et al. (US9980677B1, 2018-05-29) teaches a system for estimating fractional fat content of an object of interest, and a machine configured to accept data from the energy emitter and the plurality of thermoacoustic or ultrasonic transducers and calculate a fat concentration [abst].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James F. McDonald III whose telephone number is (571)272-7296. The examiner can normally be reached M-F; 8AM-6PM 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, Chris Koharski can be reached at 5712727230. 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.
JAMES FRANKLIN MCDONALD III
Examiner
Art Unit 3797
/SHAHDEEP MOHAMMED/Primary Examiner, Art Unit 3797