DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1 and 13 are objected to because of the following informalities: Claim 1 recites “the portion of the signal” in two instances in lines 12-13, but instead should be --. Claim 13 recites “that are past a threshold” in line 3, but instead should be --that are past the threshold--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-5 and 12 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.
Claim 2 recites “determining of the resting value are measurements lower than or equal to the threshold” in the preamble, but is indefinite. If claim 1 requires that the measurements must be past, e.g. above, greater than, etc., a threshold, are the measurements then compared to another threshold? Are the measurements that are above the threshold processed differently and not compared to the resting component threshold? Further clarification required. The same applies to claim 3 because it is unclear if there is another threshold, or is this the same threshold as required by claim 1?
Claim 12 fails to properly depend on any claim. It appears the claim is dependent on claim 1 and will be interpreted as such for examination purposes. Amendment required.
Claims not listed are rejected by virtue of claim dependency.
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 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
STEP 1
Regarding claim 1, the claim recites a series of steps or acts, including determining a resting value and/or dynamic value based on the selected measurements. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of determining a resting value and/or dynamic value based on the selected measurements sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites outputting, via a graphical user interface, the modified measurement value of the mechanical property, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The display of the measurement value does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the displayed measurement value, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of acquiring mechanical property measurement data, obtaining a signal representing variations of the mechanical property, and selecting measurements that are past a threshold of the signal. Acquiring data, obtaining signals, and selecting measurement of the signal that are above a threshold is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the acquiring, retrieving, and comparison steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and processing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 16, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited elastography probe is a generic sensor configured to perform pre-solutional data gathering activity, the display device is a generic device configured to perform measurement displaying, and the processing circuit is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data processing. The obtaining and processing steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-5 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Salcudean et al. (US 20180125455), hereinafter Salcudean, in view of Aladahalli et al. (US 20210145411), hereinafter Aladahalli.
Regarding claims 1 and 16, Salcudean teaches acquiring at a repetition rate of at least 4 measurements per second and for a duration of at least 3 seconds, using an elastography probe of an elastography device (abstract, fig. 6A), measurements of a mechanical property of a region of a body of a subject, said region being a part of a liver of the subject (¶[0002,0051,0067-68], “mechanical exciter should produce vibrations up to a few hundred hertz to measure the elasticity of organs such as the liver” and “such that the tissue displacements will be tracked in 3D space and the temporal delays will be calculated and compensated for in order to create a volumetric dataset of the tissue displacements over specific instances in time. From this dataset, the mechanical properties of the tissue, such as elasticity and viscosity are calculated” (emphasis added). ¶[0013,0015], “ultrasound machines produce images at approximately 40 Hz” indicating the sampling rate is greater than 4 per second. ¶[0007,0079] and fig. 13A-C, “MR elastography typically requires many minutes of acquisition time” and “thin volume can be created from a few images (5-10), or several seconds of scanning can produce a volume consisting of 50-100 slices” indicating that the duration of sampling time can be greater than 3 seconds );
processing, by a processing circuit, the acquired measurements to obtain a signal representative of the variations of the mechanical property with time, said signal comprising at least part of the measurements of the mechanical property determined (abstract and ¶[0015,0016,0045,0076], “Reconstruction of tissue displacements and/or tissue velocities in time and space over a volume” and “ tissue displacements and/or tissue velocities over the measured volume may be interpolated over a regular grid in order to facilitate computation of mechanical properties” A change in the coordinate system is tracked, thus a variation in the mechanical property).
Salcudean fails to teach wherein in at least one portion of the signal, selecting, by the processing circuit, measurements, among the measurements comprised in the portion of the signal that are past a threshold associated with the portion of the signal; determining, by the processing circuit, (i) a resting value of the signal based on the selected measurements, or (ii) a dynamic value of the signal representative of a variation of the mechanical property with time based on the selected measurements, or both (i) and (ii), the resting value or the dynamic value or both the resting and the dynamic values corresponding to a modified measurement value of the mechanical property, and outputting, via a graphical user interface, the modified measurement value of the mechanical property.
Aladahalli teaches an elastography method and device (abstract and ¶[0021]). The electronic unit is configured to determine whether the user’s is holding their breath e.g. not turbulent, resting, or when it is not e.g. dynamic, turbulent (¶[0004,00-15-16,0039,0043], “, the amount of turbulence during a current scan process may be determined by evaluating structural similarity between at least two acquired images,” “The terms “scan” or “scanning” may also be used in this disclosure to refer to acquiring data through the process of transmitting and receiving ultrasonic signals. The term “data” may be used in this disclosure to refer to either one or more datasets acquired with an ultrasound imaging system,” “data may be processed by other or different mode-related modules by the processor 116 (e.g., B-mode, Color Doppler, M-mode, Color M-mode, spectral Doppler, Elastography, TVI, strain, strain rate, and the like) to form 2D or 3D data,” and “convert the image volumes from beam space coordinates to display space coordinates” indicating that 3D data, based on strain, of an organ structure is used to evaluate the similarity between two acquired images. Subsequently, from the generated 3D data, turbulence can estimated). That is, the electronic unit determines and selects which measurements are a resting value (holding breath, non-turbulent) and dynamic (turbulent due to breathing or probe malfunctions) based on the strain/strain rate/elastography data, subsequently the electronic unit is configured to deploy processing protocols thereby modifying the measurement value of the mechanical property (fig. 3A-3B, step 308, 312, 314, 326, 332, 334, 340). The determination and selection is based on whether the measurement value exceeds or is below a first lower threshold (312), a second threshold 314, or a third threshold (332). The electronic unit is further configured to display the modified values as space coordinates or images (¶[0021], “The modules may include, for example, a scan conversion module to perform scan conversion operations to convert the image volumes from beam space coordinates to display space coordinates. A video processor module may be provided that reads the image volumes from a memory and displays an image in real time while a procedure is being carried out on a patient”). Accordingly, Salcudean teaches measuring displacement, e.g. motion of organs between frame, to determine mechanical properties (¶[0052] of Salcudean), which aligns with the teachings of Aladahalli that converts the motion measurement data into 3d strain data (¶[0004,00-15-16,0039,0043] of Aladahalli). Central to the rationale, motion data is therefore, regarding elastography, interpreted as a measurement of a mechanical property because the motion is measured based on changes to the mechanical property.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method or device of Salcudean, such that the measurements are compared to a threshold, selected as dynamic or resting, modified based on the selections, and displayed for the user, as taught by Aladahalli, to aid in improving accuracy of image interpretation, anatomical structure biometry, and labeling with interpretation protocols (¶[0004-7]). Thus the combination provides the added benefit to Salcudean’s invention by providing sharper image interpretation based on the measured data leading to improving the anatomical structure biometry.
Regarding claim 2, Aladahalli teaches wherein determining the resting value comprises: determining a resting component of the signal based on the selected measurements, and calculating the resting value as a function of a mean of the resting component, and wherein the selected measurements for determining the resting value are measurements that are lower than the threshold (¶[0042], the measurements are compared to the first threshold 312, the measurement below the threshold are determined as high quality and as a resting state, which are then processed with an analysis protocol). The measurement values are a function of the amount of turbulence that represent an average amount of turbulence (¶[0036], “the amount of turbulence an average amount of turbulence between the reference frame and each of a desired number of successive frames for the duration of time”).
Regarding claim 3, Aladahalli teaches wherein the selected measurements for determining the dynamic value are measurements that are greater than the threshold (fig. 3A, when the selected measurements are greater than the threshold at 312, 314, or 332 indicates a dynamic value).
Regarding claim 4, Aladahalli teaches wherein the determining of the dynamic value comprises: for each portion of the signal among the at least one portion of the signal, determining a representative value of the portion of the signal, the representative value being function of a mean of the measurements selected in the portion of the signal (¶[0036], measurements extracted from the signal obtained and compared to the threshold can be the average amount of turbulence, “the amount of turbulence an average amount of turbulence between the reference frame and each of a desired number of successive frames for the duration of time . . . . reference frame may be based on an ultrasound imaging mode and the anatomical structure under evaluation.” );
determining a dynamic component of the signal based on the representative values determined (fig. 3A-3B and ¶[0049-53], step 312 is the first threshold, when the signal is above the threshold, this indicates that a turbulent portion has been identified. Thereafter, in step 314, the signal is then compared to another threshold to determine which kind of processing protocol will be needed to output based on being above or below the threshold, stop certain algorithms from deploying, deploy other algorithms, such as, denoising, contrast enhancement, etc.), and determining the dynamic value based on the dynamic component (fig. 3A-3B and ¶[0049-53], ], outputting the result based on the protocol deployed).
Regarding claim 5, Aladahalli teaches wherein the dynamic value is a function of a mean of the dynamic component ((¶[0036], “the amount of turbulence an average amount of turbulence between the reference frame and each of a desired number of successive frames for the duration of time.” The measurement values are a function of the amount of turbulence that represent an average amount of turbulence).
Regarding claim 13, Aladahalli teaches wherein said selecting, by the processing circuit, of the measurements, among the measurements comprised in the portion of the signal that are past a threshold associated with the portion of the signal comprises (a) selecting the measurements that are lower than a first threshold associated with the portion of the signal for determining the resting value, or (b) selecting the measurements that are greater than a second threshold associated with the portion of the signal for determining the dynamic value, or both (a) and (b) (fig. 3A-3B and ¶[0049-53], step 312 is the first threshold, when the signal is above the threshold, this indicates that a turbulent portion has been identified. Below the threshold, it is a resting value. Thereafter, in step 314, the signal is then compared to another threshold to determine which kind of processing protocol will be needed to output based on being above or below the threshold, stop certain algorithms from deploying, deploy other algorithms, such as, denoising, contrast enhancement, etc.).
Regarding claim 14, Aladahalli teaches wherein the first and second thresholds are different (fig. 3A, threshold 312 is lower than threshold 314).
Regarding claim 15, Salcudean teaches wherein the processing circuit is the processing circuit of the elastography device (¶[0041], one of ordinary skill in the art understands that a processor would be needed to execute the programs that controls the sensor and calculates the mechanical properties).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Salcudean in view of Aladahalli, as applied to claim 1, further in view of Ali et al. (US 20240398382), hereinafter Ali.
Regarding claim 6, Salcudean-Aladahalli fail to teach wherein, in each portion of the signal among the at least one portion of the signal, the threshold associated with the portion of the signal corresponds to a predefined percentage of a difference between a minimum value and a maximum value of the portion of the signal, the predefined percentage being less than 30%.
Ali teaches a shear wave elastography method which includes generating a liver tissue data (abstract and ¶[0082]). To determine that the data likely corresponds to liver tissue, a threshold may be set to filter out 10% of the darkest pixels (¶[0082], that is, the darkest pixels out of the range of values of pixels e.g. min, max in the image).
Therefore, it would have been obvious to of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Salcudean-Aladahalli, such that the threshold associated with the portion of the signal is less than 30% of a difference between a minimum value and a maximum value of the portion of the signal, as taught by Ali, to aid in determining which pixels are likely to correspond to liver tissue.
Regarding claim 7, Salcudean-Aladahalli fail to teach wherein, in each portion of the signal among the at least one portion of the signal, the selected measurements are lower than or equal to a predetermined percentile of the portion of the signal, the predetermined percentile being comprised between a minimum value and a thirtieth percentile of the signal.
Ali teaches a shear wave elastography method which includes generating a liver tissue data (abstract and ¶[0082]). To determine that the data likely corresponds to liver tissue, a threshold may be set to filter out 10% of the darkest pixels (¶[0082], that is, the darkest pixels out of the range of values of pixels e.g. min, max in the image).
Therefore, it would have been obvious to of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Salcudean-Aladahalli, such that the selected measurements are lower than 30 percent of the portion of the signal, as taught by Ali, to aid in determining which pixels are likely to correspond to liver tissue.
Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Salcudean in view of Aladahalli, as applied to claim 1, further in view of Konofagou et al. (US 20160249880), hereinafter Konofagou.
Regarding claim 8, Salcudean-Aladahalli fail to teach wherein the at least one portion of the signal comprises a plurality of portions of the signal obtained by applying a sliding window to the signal.
Konofagou teaches a system and method for elasticity imaging for detecting electromechanical waves propagation within a body structure and motion of the tissue (abstract and ¶[0011-13]). The electromechanical component of the electromechanical wave is related to the viscoelastic properties of the tissue (¶[0070]). To estimate the motion of the tissue, specifically the axial displacement, a sliding blackman window is used to process two consecutive frames (¶[0086-85]). The sliding window further requires a fixed number of measurements and temporal length (¶[0086], “A sliding Blackman window (100 points, 25 ms) as is known in the art, was moved along the displacement variation at a fixed depth, in steps of 2 ms”). The sliding interval being 2 ms, which is between 1/8000 (0.125 ms) and the temporal length (25ms) (¶[0085-86], “the movie of the axial displacements was processed at a frame rate up to 8000 frame/s for the entire cardiac cycle”).
Therefore it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Salcudean-Aladahalli, such that at least one portion of the signal comprises a plurality of portions of the signal obtained by applying a sliding window to the signal, as taught by Konofagou, to aid in estimating the axial displacement of tissue.
Regarding claim 9, Konofagou teaches wherein the sliding window comprises a fixed number of measurements (¶[0086], “A sliding Blackman window (100 points, 25 ms) as is known in the art, was moved along the displacement variation at a fixed depth, in steps of 2 ms”).
Regarding claim 10, Konofagou teaches wherein the sliding window has a fixed temporal length (¶[0086], “A sliding Blackman window (100 points, 25 ms) as is known in the art, was moved along the displacement variation at a fixed depth, in steps of 2 ms”).
Regarding claim 11, Konofagou teaches wherein the sliding window is associated with a sliding interval comprised between 1/fe and the temporal length of the sliding window, where fe is the repetition rate of the measurements (¶[0085-86], “the movie of the axial displacements was processed at a frame rate up to 8000 frame/s for the entire cardiac cycle,” The sliding interval being 2 ms, which is between 1/8000 (0.125 ms) and the temporal length (25ms).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Salcudean in view of Aladahalli, as applied to claim 1, further in view of Dong et al. (US 11779310), hereinafter Dong.
Regarding claim 12, Salcudean-Aladahalli fail to teach wherein the processing of the acquired measurements to obtain the signal representative of the variations of the mechanical property with time comprises: determining an intermediate signal comprising at least part of the measurements of the mechanical property determined, and applying to the intermediate signal a smoothing algorithm to obtain the signal representative of the variations of the mechanical property with time.
Dong teaches an elastography method for measuring stiffness (abstract and col. 2, lines 14-24). Dong further uses a laplacian of gaussian operator to denoise the data and yield more accurate stiffness maps (col. 6, lines 48-52).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Salcudean-Aladahalli, such that a smoothing algorithm is applied to the signal to obtain the variations of mechanical property, as taught by Dong, to denoise the data and yield more accurate stiffness maps.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Vignon teaches systems and methods for triggering the acquisition of elastography measurements based on motion data. US 20220192640
Audiere teaches accumulating ultrasound attenuation data for the detection of disease or other conditions. US 20200390421
Xu teaches determining mechanical properties of tissue in an individual includes attaching a stretchable and/or flexible ultrasound imaging device to the individual.
Couade teaches Shear wave imaging was evaluated for the in vivo assessment of myocardial biomechanical properties on ten open chest sheep. The use of dedicated ultrasonic sequences implemented on a very high frame rate ultrasonic scanner (>; 5000 frames per second) enables the estimation of the quantitative shear modulus of myocardium several times during one cardiac cycle. In Vivo Quantitative Mapping of Myocardial Stiffening and Transmural Anisotropy During the Cardiac Cycle-2009.
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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