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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 10/28/2025 has been entered.
Response to Amendment
This action is in response to the remarks filed on 10/28/2025.
The amendments filed on 10/28/2025 have been entered. Applicant has presently canceled claims 12-13. Accordingly claims 1-11 and 14-20 remain pending. Claims 1, 15, and 17 are presently amended.
The previous prior art rejections of the claims have been withdrawn in light of the Patent Board decision rendered on 08/29/2025, however a new ground of rejection is made below.
Response to Arguments
Applicant's arguments filed 10/28/2025 regarding the 35 U.S.C. 101 rejection of the claims have been fully considered but they are not persuasive.
Applicant’s first argument on pages 8-9 of the remarks that the Decision on Appeal is silent with regard to the other recitations of claim 1 is not persuasive. The Patent Board decision rendered on 08/28/2025 states on page 8 the following.
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Therefore, the Board decision is not silent with regard to the other recitations of claim 1. Further as stated in the Patent Board decision on page 5, “claim 1 is not merely based on or involving mathematical concepts, claim 1 recites the mathematical concepts themselves.”
Applicant’s next argument on pages 9-10 (Prong II) regarding the newly amended limitation of estimating a slope and identifying diastolic dysfunction of the heart when the slope of the end-diastolic pressure-volume relationship exceeds a predetermined threshold is not persuasive. These elements are not additional elements, but rather abstract ideas themselves. As further detailed in the rejection below, estimating a slope is a mathematical concept and the identification of diastolic dysfunction based on determining the slope exceeds a predetermined threshold is a mental process e.g., concepts performed in the human mind (including and observation, evaluation, judgment, opinion).
Applicant’s argument on page 10 regarding an improving another technology or technical field is not persuasive because the claims merely indicate a field of use or technological environment in which to apply a judicial exception (e.g., see MPEP 2106.05(h)).
Finally, applicant’s argument regarding step 2B on pages 11-12 are not persuasive because as stated above, the newly added limitations argued by applicant are not additional elements but rather abstract ideas as well.
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 law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claimed invention is directed to a process (i.e., a method for calculating [...]) and a machine (i.e., a processing unit for calculating [...], “ultrasound system [...]”) (i.e.., Analysis step 1 of Subject Matter Eligibility Test), each recite a judicial exception, for example, an abstract idea without significantly more, specifically to mathematical concepts and mental processes (i.e., Analysis step 2A, Prong I). The claims recite “identifying diastolic dysfunction of a heart of a subject non-invasively” by “determining an end of diastasis volume [...]”, estimating an end of diastasis pressure [...]”, “generating a linearized ventricular pressure-volume relationship [...]”, “calculating an end-diastolic pressure-volume relationship [...]”, and “estimating a slope of the end-diastolic pressure-volume relationship at the end-diastolic volume” in claim 1 and analogous limitations of claims 14, 15, and 17. As can be seen from e.g. paragraphs [0095], [0097]- [0100], [0112], [0113] of the pre-grant publication (pgpub) of the instant application, the limitations stated above involve mathematical concepts. The claims also recite “identifying diastolic dysfunction of the heart when the slope of the end-diastolic pressure-volume relationship exceeds a predetermined value” in claim 1 and analogous limitations of claims 14, 15, and 17, which is a mental process, e.g., concepts performed in the human mind (including and observation, evaluation, judgment, opinion). The “estimating” and “matching” steps of claim 2 further limit the calculating step of claim 1 and therefore involve mathematical concepts. Regarding claim 3, “generating a volume waveform of the left ventricle volume by performing an analytical integration of an aortic flow waveform and a mitral flow waveform” recites mathematic concepts. Regarding claim 4, “the fitting of the volume waveform to the segmentation of the left ventricle comprises performing a least-squares fitting” recites mathematic concepts. The “determining a number of heartbeats represented in the cardiac input” of claim 5 and the “fitting” and “estimating a non-zero intercept” steps of claims 6-10 recite mathematical concepts. Claims 11 and 16 recite “determining a gradient” which are mathematical concepts. Regarding claim 18, “wherein the end of diastasis pressure in the left ventricle is estimated based on segmentation of volume of the left atrium” recites mathematical concepts (e.g. see paragraphs [0093]-[0094] of the pgpub). Regarding claim 19, “estimating an end-diastolic pressure at the end-diastolic volume of the left ventricle based on the linearized ventricular pressure-volume relationship; and matching the estimated end-diastolic pressure to an generalized experimental pressure- volume relationship” recites mathematical concepts. Regarding claim 20, “performing an analytical integration of an aortic flow waveform and a mitral flow waveform to generate a volume waveform of the left ventricle volume.” recites mathematical concepts.
This judicial exception is not integrated into a practical application (i.e., Analysis step 2A, Prong II). In particular, the claims recite “obtaining a cardiac input representing a region of interest, wherein the cardiac input comprises ultrasound data and/or a cardiac model that takes one or more measurements from the subject to simulate behavior of the heart, wherein the region of interest comprises a left ventricle and a left atrium of the heart of the subject” (claims 1, 14, 15, 17). This element is nothing more than insignificant extra-solution activity (i.e. mere data gathering). The wherein limitations merely provide what the cardiac input is, i.e. type of data. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Claims 11 and 16 recite “generating an alert” which is nothing more than insignificant extra-solution activity (i.e. insignificant application). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. See MPEP 2106.05(g).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception (Analysis step 2B). As discussed above with respect to the discussion of integration of the abstract idea into a practical application, the additional element of obtaining a cardiac input is nothing more than insignificant extra-solution activity (i.e. mere data gathering). The additional element of generating an alert is nothing more than insignificant extra-solution activity (i.e. insignificant application).
Claims 1-20 are therefore directed to an abstract idea without significantly more. The claims are not patent eligible.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5-11, 14-15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Datta (US 2013/0245441, September 19, 2013, applicant submitted prior art via the IDS) in view of Tanaka et al. (US 2012/0041313, February 16, 2012) and Nagueh, S. et al., "Recommendations for the evaluation of left ventricular diastolic function by echocardiography", Eur. J. Echolcardiogr., vol. 10, no. 2, pp. 165-193, 2009.
Regarding claims 1 and 15, Datta discloses a method (and corresponding processing unit for identifying diastolic dysfunction of a heart of a subject non-invasively, the method comprising:
calculating an end-diastolic pressure-volume relationship) for calculating a non-invasive end-diastolic pressure-volume relationship for a subject (“Pressure-volume analysis is provided in medical diagnostic ultrasound imaging. The heart of a patient is scanned multiple times during a given cycle. B-mode and flow information are obtained for various times. The flow information is used to estimate pressure over time. A reference pressure, such as from a cuff, may be used to calibrate the pressure waveform. The B-mode information is used to determine a heart volume over time, such as a left ventricle volume over time. The heart volume over time and pressure over time are plotted, providing a pressure-volume loop. The pressure-volume loop is determined non-invasively with ultrasound.” abstract; also see Fig. 1 and corresponding description; also see [0002], [0003]; also see processor 24 in Fig. 1 and corresponding description), the method comprising:
obtaining a cardiac input representing a region of interest, wherein the cardiac input comprises ultrasound data (“B-mode and flow ultrasound data representing a three-dimensional region of a patient are acquired at a substantially same time.” [0005]) and/or a cardiac model that takes one or more measurements from the subject to simulate behavior of the heart, (“In another embodiment, a knowledge-based system is used. Machine learning or other training is used to determine a matrix of weights for various feature inputs to identify the cavity. The matrix represents a probability mapping of a model of the heart or cavity to the B-mode and/or flow data. The model is scaled, rotated and translated using the probability mapping to best fit to the data for a given patient. The model is annotated to indicate the location for which volume is then calculated. The volume is determined from the model after fitting.” [0060]) wherein the region of interest comprises a left ventricle and a left atrium of a heart of the subject (“The heart of a patient is scanned multiple times during a given cycle. Both B-mode and flow information are obtained for various times.” [0004]; also see [0036]);
determining an end of diastasis volume of the left ventricle at an end of diastasis based on the cardiac input, wherein diastasis is a stage of diastole during a heart cycle before atrial contraction (“In act 42, the volume is calculated. The volume is of a three-dimensional region. The volume for any region is used. For example, the volume of the left ventricle is determined. The volume of the right ventricle, the entire heart, or other cavities may be calculated.” [0056]; also see Fig. 2, reproduced below, and corresponding description);
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generating a linearized ventricular pressure-volume relationship based on the end of diastasis volume of the left ventricle and the end of diastasis pressure in the left atrium (“In one embodiment, a pressure-volume loop is generated in act 46. The pressure volume loop is one type of output for act 44. FIG. 2 shows an example pressure-volume loop where volume is plotted along the x-axis and pressure is plotted along the y-axis. As the volume changes, the pressure also changes. The loop represents a given heart cycle. The pressure and volumes at different times during the heart cycle are plotted on the graph. Any gaps may be interpolated or filled by fitting a curve, line, or model.” [0066]);
calculating an end-diastolic pressure-volume relationship based on an end-diastolic volume of the left ventricle and the linearized ventricular pressure-volume relationship (“In act 48, a value for a parameter is output. This value is another example of the output of act 44. The value is derived from the pressure and/or volume information, either instantaneous or as a function of time. For example, beat-to-beat parameters, such as stroke volume (SV), contractility (e.g., ejection fraction, SV/EDV, and/or dp/dt Max), preload (EDV or EDP), afterload (aortic and ventricular pressure), compliance (dV/dP), ventricular stiffness (inverse of compliance), and/or elastance (dP/dV), are calculated. As another example, parameters derived from ESPVR and EDPVR, such as PVA Pressure-volume area and/or PE Potential energy, are calculated. In yet another example, processed parameters, such as ESPVR end-systolic pressure-volume relationship, EDPVR end-diastolic pressure-volume relationship, PRSW Preload-recruitable stroke work, DPdtmax vs Ved dPdt max against end-diastolic volume relationship, and/or Emax maximal elastance (computed from the time-varying elastance data), are calculated.” [0068]); and
identifying diastolic dysfunction of the heart (“The pressure-volume loop may be used for evaluation of systolic and diastolic LV function, valve disease, heart failure, Inotropic state or other conditions.” [0071]; also see [0068], [0070]).
Although Datta discloses estimating an end of diastasis pressure in the overall heart based on the cardiac input (“In act 40, the pressure throughout the heart cycle or portion of a heart cycle is estimated. The pressure may be estimated using invasive or minimally invasive approaches. For example, a catheter or other device is inserted into the patient to measure pressure. Using ECG, triggering, or timestamps, the pressure measurement is temporally synchronized at acquisition or after acquisition with the ultrasound data used for volume determination. Where direct pressure measurement is not available, the pressure over time is estimated from ultrasound data. A processor calculates the pressure from velocity or other flow information.” [0046]; also see Fig. 2 and corresponding description), Datta is silent on particularly estimating an end of diastasis pressure in the left atrium at the end of diastasis based on the cardiac input.
However, Tanaka teaches, in the same field of endeavor, estimating an end of diastasis pressure in the left atrium at the end of diastasis based on the cardiac input (“Details of the method of determining the pressure difference calculation method as carried out in step 135 will now be described using FIG. 5. The graph in FIG. 5(a) shows examples of pressure fluctuations over time with respect to one heartbeat. 511 represents pressure fluctuation in the aorta, 512 pressure fluctuation in the left ventricle, and 513 pressure fluctuation in the left atrium.” [0044]; also see “and an end-diastolic pressure-volume relationship curve 543, which represents the relationship between end-diastolic pressure and volume.” [0072]; also see Figs. 5-6 and corresponding descriptions).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Datta with particularly estimating an end of diastasis pressure in the left atrium at the end of diastasis based on the cardiac input as taught by Tanaka in order to make an early diagnosis of or monitoring heart disease ([0002] of Tanaka: “In making an early diagnosis of or monitoring heart disease, temporal pressure information with respect to the left atrium or the left ventricle is used as an index that is directly helpful for diagnostic purposes.”).
Datta also fails to disclose estimating a slope of the end-diastolic pressure-volume relationship at the end-diastolic volume, and the identifying diastolic dysfunction of the heart being when the slope of the end-diastolic pressure-volume relationship exceeds a predetermined value.
However, Nagueh teaches, in the same field of endeavor, estimating a slope of the end-diastolic pressure-volume relationship at the end-diastolic volume, and the identifying diastolic dysfunction of the heart being when the slope of the end-diastolic pressure-volume relationship exceeds a predetermined value (“The operating stiffness at any point is
equal to the slope of a tangent drawn to the curve at that point (DP/DV ) and can be approximated with only two dis-tinct pressure-volume measurements. Diastolic dysfunction is present when the slope is .0.20 mm Hg/mL.⁷ On the other hand, it is possible to characterize LV chamber stiffness over the duration of diastole by the slope of the exponential fit to the diastolic pressure-volume relation. Such a curve fit can be applied to the diastolic LV pressure-volume relation of a single beat or to the end-diastolic pressure-volume relation constructed by fitting the lower right corner of multiple pressure-volume loops obtained at various preloads. The latter method has the advantage of being less dependent on ongoing myocardial relaxation. The stiffness modulus, kc, is the slope of the curve and can be used to quantify chamber stiffness. Normal values do not exceed 0.015 (C. Tschope, personal communication).” Page 167).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Datta with estimating a slope of the end-diastolic pressure-volume relationship at the end-diastolic volume, and the identifying diastolic dysfunction of the heart being when the slope of the end-diastolic pressure-volume relationship exceeds a predetermined value as taught by Nagueh in order to determine the chamber stiffness which is a metric associated to diastolic dysfunction (page 166-167 of Nagueh).
Regarding claims 2 and 19, Datta further discloses wherein the calculating of the end- diastolic pressure-volume relationship comprises: estimating an end-diastolic pressure at the end-diastolic volume of the left ventricle based on the linearized ventricular pressure-volume relationship; and matching the estimated end-diastolic pressure to an generalized experimental pressure-volume relationship (“Since the reference pressure may be for less than all the phases of interest in the heart cycle, the estimate of pressure from the velocities for the other phases is used. The ultrasound data may be used to estimate pressure at many times or phases during a heart cycles, such as at ten or more times. The reference pressure for one or two of these times is used to calibrate the estimated pressures throughout the cycle. The computed pressure differential from the reference measurement of the blood pressure (e.g., central or aortic) is used to generate a pressure waveform as a function of time. For example, a difference between the pressure estimated from flow and the reference pressure representing a same point in the cycle is determined. The same difference is applied to the flow estimated pressures for other times in the cycle. Where reference pressures are available for multiple phases, the average difference is used. Alternatively, the amount of difference to be used for calibration is interpolated as a function of time and applied to the flow estimated pressures. The calibrated pressure is used to scale the pressures for other times in the heart cycle.” [0054]; also see [0062]).
Regarding claims 3 and 20, Datta further discloses wherein the determining of the end of diastasis volume of the left ventricle comprises generating a volume waveform of the left ventricle volume by performing an analytical integration of an aortic flow waveform and a mitral flow waveform (see Fig. 2 and corresponding description).
Regarding claim 5, Datta further discloses further comprising determining a number of heartbeats represented in the cardiac input (“By acquiring B-mode and flow data at different locations (e.g., voxels) distributed in three dimensions, real-time volumetric flow and B-mode data is acquired. Beat-to-beat full volume B-mode and/or flow acquisition capability may allow simultaneous volume and flow measurements across inflow and outflow of the heart or left ventricle.” [0033]; also see [0062], [0068]).
Regarding claim 6, Datta further discloses wherein, when the number of heartbeats is greater than one, the generating of the linearized ventricular pressure-volume relationship comprises fitting an intercept to the linearized ventricular pressure-volume relationship (The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim. If the claimed invention requires the first condition to occur, then the broadest reasonable interpretation of the claim requires step A. If the claimed invention requires both the first and second conditions to occur, then the broadest reasonable interpretation of the claim requires both steps A and B. MPEP 2111.04 section II).
Regarding claim 7, Datta further discloses wherein, when the number of heartbeats is one, the generating of the linearized ventricular pressure-volume relationship comprises fitting a constant intercept to the linearized ventricular pressure-volume relationship (The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim. If the claimed invention requires the first condition to occur, then the broadest reasonable interpretation of the claim requires step A. If the claimed invention requires both the first and second conditions to occur, then the broadest reasonable interpretation of the claim requires both steps A and B. MPEP 2111.04 section II).
Regarding claim 8, Datta further discloses wherein, when the number of heartbeats is one, the generating of the linearized ventricular pressure- volume relationship comprises estimating a non-zero intercept to the linearized ventricular pressure-volume relationship (The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim. If the claimed invention requires the first condition to occur, then the broadest reasonable interpretation of the claim requires step A. If the claimed invention requires both the first and second conditions to occur, then the broadest reasonable interpretation of the claim requires both steps A and B. MPEP 2111.04 section II).
Regarding claim 9, Datta further discloses wherein, when the number of heartbeats is one, the calculating of the end-diastolic pressure-volume relationship comprises fitting the end-diastolic pressure-volume relationship based on a single heartbeat (The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim. If the claimed invention requires the first condition to occur, then the broadest reasonable interpretation of the claim requires step A. If the claimed invention requires both the first and second conditions to occur, then the broadest reasonable interpretation of the claim requires both steps A and B. MPEP 2111.04 section II).
Regarding claim 10, Datta further discloses wherein, when the number of heartbeats is greater than one, the calculating of the end-diastolic pressure-volume relationship comprises performing a least-squares fitting of the end-diastolic pressure-volume relationship based on a plurality of heartbeats (The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim. If the claimed invention requires the first condition to occur, then the broadest reasonable interpretation of the claim requires step A. If the claimed invention requires both the first and second conditions to occur, then the broadest reasonable interpretation of the claim requires both steps A and B. MPEP 2111.04 section II).
Regarding claim 11, Datta discloses the limitations of claim 1 as stated above but fails to disclose comprising: determining a gradient of the end-diastolic pressure-volume relationship at an end diastolic volume; and when the gradient is greater than a predetermined threshold, generating an alert.
However, Tanaka further teaches, in the same field of endeavor, determining a gradient of the end-diastolic pressure-volume relationship at an end diastolic volume (“As shown in FIG. 14(c), in addition to the pressure-volume relationship curve 541, the pressure-volume relationship diagram may also display E.sub.max, which is the gradient of the end-systolic pressure-volume relationship, and an end-diastolic pressure-volume relationship curve 543, which represents the relationship between end-diastolic pressure and volume.” [0072]); and when the gradient is greater than a predetermined threshold, generating an alert (The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim. If the claimed invention requires the first condition to occur, then the broadest reasonable interpretation of the claim requires step A. If the claimed invention requires both the first and second conditions to occur, then the broadest reasonable interpretation of the claim requires both steps A and B. MPEP 2111.04 section II).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Datta with determining a gradient of the end-diastolic pressure-volume relationship at an end diastolic volume; and when the gradient is greater than a predetermined threshold, generating an alert as taught by Tanaka in order to determine absolute pressure inside the heart at a desired location ([0012] of Tanaka).
Regarding claim 14, Datta further discloses a non-transitory computer readable medium storing computer program code that, when executed by a computer, causes the computer to implement the method of claim 1 (“In a second aspect, a non-transitory computer readable storage medium has stored therein data representing instructions executable by a programmed processor for pressure-volume analysis in medical diagnostic ultrasound.” [0006]).
Regarding claim 17, Datta further discloses an ultrasound system comprising the processing unit of claim 15 (“By way of introduction, the preferred embodiments described below include a method, system, computer readable medium, and instructions for pressure-volume analysis with medical diagnostic ultrasound imaging.” [0004]); and
an array transducer probe configured to acquire the ultrasound data, provided to the processing unit as the cardiac input (“The transducer 14 is an array of a plurality of elements.” [0074]).
Regarding claim 18, Datta further discloses wherein the end of diastasis pressure in the left ventricle is estimated based on segmentation of volume of the left atrium (“Any volume determination may be used. In one embodiment, the processor automatically calculates the volume from the ultrasound data by segmenting the heart or heart cavity. The edges or heart walls for the left ventricle are found and lines connected for any gaps. Any approach may be used for automatic, semi-automatic, or manual segmentation of a heart cavity.” [0058]; also see [0061], [0062]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Datta in view of Tanaka and Nagueh as applied to claim 1 above and further in view of Urban et al. (US 2020/0163649, corresponding PCT filed June 5, 2018, hereinafter “Urban”).
Regarding claim 4, Datta discloses the limitations of claim 1 as stated above and Datta further discloses wherein determining of the end of diastasis volume of the left ventricle comprises generating a volume segmentation of the left ventricle, generating a volume waveform based on the volume segmentation (“Once segmented, the volume of the heart cavity, such as the left ventricle, is calculated.” [0061]; also see [0058]), and fitting the volume waveform to the volume segmentation of the left ventricle volume by performing a fitting (“The volume is calculated for different times during the heart cycle. In one embodiment, segmentation and volume calculation are performed separately for each acquired volume of B-mode data. In other embodiments, the segmented region is tracked or fit to subsequent or earlier volumes. Once fit to the data of other scans, the volume for the different time of the other scan is calculated based on another fitting at a different time. By calculating the volume for different phases or times in the heart cycle, the volume is determined as a function of time. The three-dimensional beat-to-beat change in cardiac cavity volume is represented as a waveform.” [0062]).
Datta fails to disclose the fitting being a least-squares fitting.
However, Urban teaches, in the same field of endeavor, fitting being a least-squares fitting (“The calculation of the wave velocities, c=f/k, involves a division of the values of the wavenumber coordinates; thus, if the data exhibit significant spread, the wave velocities may also have a large variation. Applying a least-squares polynomial fitting can reduce that variation.” [0046]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Datta with the fitting being a least-squares fitting as taught by Urban in order to reduce large variation in the data ([0046] of Urban).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Datta in view of Tanaka and Nagueh as applied to claim 15 above and further in view of White (US 2019/0343490, filed May 8, 2018).
Regarding claim 16, Datta discloses the limitations of claim 1 as stated above but fails to disclose wherein the method further comprises: determining a gradient of the end-diastolic pressure-volume relationship at an end diastolic volume; and when the gradient is greater than a predetermined threshold, generating an alert.
However, Tanaka further teaches, in the same field of endeavor, determining a gradient of the end-diastolic pressure-volume relationship at an end diastolic volume (“As shown in FIG. 14(c), in addition to the pressure-volume relationship curve 541, the pressure-volume relationship diagram may also display E.sub.max, which is the gradient of the end-systolic pressure-volume relationship, and an end-diastolic pressure-volume relationship curve 543, which represents the relationship between end-diastolic pressure and volume.” [0072]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Datta with determining a gradient of the end-diastolic pressure-volume relationship at an end diastolic volume as taught by Tanaka in order to determine absolute pressure inside the heart at a desired location ([0012] of Tanaka).
Datta modified by Tanaka fails to disclose and when the gradient is greater than a predetermined threshold, generate and alert.
However, White teaches, in the same field of endeavor, and if the gradient is greater than a predetermined threshold, generate and alert (“In some instances, the processor is programmed to produce an alert (visual, audible, tactile etc.) if the variance of the computed physiological parameters exceeds a baseline value by more than a threshold value (for example but not limited to +1-2%, +/−5%, +/−10% or greater from the baseline value). Such an alert may indicate a patient condition or a problem with detecting the echo data (e.g. probe misalignment or malfunction etc.) The baseline and/or threshold values can be based on determined normal ranges for the subject (species, age, race, sex, weight, previously medical history, medications taken etc.) or previous or current measurements from the same subject. Such information can be entered by the operator of the ultrasound imaging machine or can be read by the processor from an electronic patient or subject record (RF id tag on an animal cage, information encoded on a patient's wrist, bar code, QR code, etc.) In some embodiments, current physiological parameters are compared with or displayed alongside with previous parameters that are stored in an electronic medical record.” [0043]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Datta with and whenthe gradient is greater than a predetermined threshold, generate and alert as taught by White in order to indicate a patient condition ([0043] of White).
Conclusion
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/A.A./Examiner, Art Unit 3797
/ANNE M KOZAK/Supervisory Patent Examiner, Art Unit 3797
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