DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The disclosure is objected to because of the following informalities:
On page 1, the status of co-pending applications should be updated.
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.
Claim 3 is 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.
In claim 3, the limitation “same monitor” renders the claim indefinite. It is unclear what “same” refers to in this context.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-11 and 13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kumar et al. (US 2011/0262018; hereinafter Kumar) in view of Yamauchi (US 2002/0102023), Wang et al. (US 2012/0078097; hereinafter Wang) and Guterman et al. (US 2013/0278776; hereinafter Guterman).
Kumar shows an ultrasound diagnosis apparatus and method (abstract) comprising: processing circuitry configured to obtain a plurality of groups of two-dimensional ultrasound image data, each group being generated by performing ultrasound scans for a predetermined time period equal to or longer than one heartbeat, with the ultrasound scans being performed on each of a plurality of cross-sectional planes of a heart, each group corresponding to one of the cross- sectional planes (series of ultrasonic cardiac images over one or more cardiac cycles, [0049]-[0050]; computer implemented system 1200 with various units, [0136]-[0138]); obtain, by performing a two-dimensional speckle tracking process, two- dimensional time-series data of contour positions corresponding each of a plurality of cross- sectional images for each of the plurality of the cross-sectional images, the contour positions being either one of, or both of, a cavity interior and a cavity exterior of the heart included in each of the plurality of groups of two-dimensional ultrasound image data ([0050], [0092]-[0093], [0095]).
Kumar fails to show the plurality of the cross-sectional images including an apical four-chamber view, an apical two-chamber view and an apical long-axis view.
Kumar fails to show two-dimensional time-series data of contour positions corresponding to the apical four-chamber view being two-dimensional time-series data of first contour positions, the first contour positions being either one of, or both of, a cavity interior and a cavity exterior of the heart in the apical four-chamber view included in a first group of two-dimensional ultrasound image data among the plurality of groups of two-dimensional ultrasound image data.
Kumar fails to show two-dimensional time-series data of contour positions corresponding to the apical two-chamber view being two-dimensional time-series data of second contour positions, the second contour positions being either one of, or both of, the cavity interior and the cavity exterior of the heart in the apical two-chamber view included in a second group of two-dimensional ultrasound image data among the plurality of groups of two-dimensional ultrasound image data.
Kumar fails to show two-dimensional time-series data of contour positions corresponding to the apical long-axis view being two-dimensional time-series data of third contour positions, the third contour positions being either one of, or both of, the cavity interior and the cavity exterior of the heart in an apical long-axis view included in a third group of two-dimensional ultrasound image data among the plurality of groups of two-dimensional ultrasound image data.
Kumar fails to show calculate, based on the time-series data corresponding to the apical four- chamber view, the time-series data corresponding to the apical two-chamber view and the time-series data corresponding to the apical long-axis view, volume information of the heart; calculate, based on the two-dimensional time-series data corresponding to the apical four-chamber view, the two-dimensional time-series data corresponding to the apical two-chamber view and the two-dimensional time-series data corresponding to the apical long-axis view, a plurality of pieces of wall information of the heart, each of the plurality of pieces of wall information corresponding to each of the apical four-chamber view, the apical two-chamber view and the apical long-axis view; and exercise control so as to output the volume information and the plurality of pieces of wall information; wherein the processing circuitry is configured to obtain the two-dimensional time-series data corresponding to the apical four-chamber view, the two-dimensional time-series data corresponding to the apical two-chamber view and the two-dimensional time-series data corresponding to the apical long-axis view while a reference phase of the two-dimensional time-series data corresponding to the apical four-chamber view, a reference phase of the two- dimensional time-series data corresponding to the apical two-chamber view and a reference phase of the two-dimensional time-series data corresponding to the apical long-axis view are aligned; wherein the processing circuitry is configured to align starting points of the two-dimensional time- series data corresponding to the apical four-chamber view, the two-dimensional time-series data corresponding to the apical two-chamber view and the two-dimensional time-series data corresponding to the apical long-axis view with a reference phase.
Kumar also fails to show obtain, by utilizing a configuration which is possible to track contour positions by performing the two-dimensional speckle tracking process, the plurality of pieces of wall motion information in conjunction with the volume information; wherein the processing circuitry is further configured to cause same monitor to display the volume information and the plurality of pieces of wall information; wherein the processing circuitry is further configured to cause a monitor to display the volume information and the plurality of pieces of wall information with a time phase;
wherein the processing circuitry is further configured to generate a temporal change curve of a local strain in a longitudinal direction as each of the plurality of pieces of wall information; wherein the processing circuitry is further configured to calculate, as the volume information, at least one of numerical information about an end-diastolic volume, numerical information about an end-systolic volume, numerical information about an ejection fraction, numerical information about a myocardial mass, and a temporal change curve of a volume; wherein the processing circuitry is further configured to select, from each of the two-dimensional time-series data corresponding to the apical four-chamber view, the two-dimensional time-series data corresponding to the apical two- chamber view and the two-dimensional time-series data corresponding to the apical long-axis view, based on a phase detected as an end systolic phase, a contour position in an end-systolic phase and calculate, by using the selected contour position, volume information at the end- systolic phase; when temporal change information about a volume is calculated as the volume information, the processing circuitry is configured to perform a temporal interpolation process to correct each of the two-dimensional time-series data corresponding to the apical four-chamber view, the two-dimensional time-series data corresponding to the apical two-chamber view and the two-dimensional time-series data corresponding to the apical long-axis view so as to obtain synchronized pieces of time-series data that have contour positions in a substantially a same time phase.
Kumar also fails to show comprising input hardware configured to accept, from an operator, a new end-systolic phase, wherein the processing circuity is further configured to re-calculate, based on the new end- systolic phase received by the input hardware, the volume information;
Yamauchi discloses an ultrasonic diagnostic and image processing device. Yamauchi teaches the plurality of the cross-sectional images including an apical four-chamber view, an apical two-chamber view and an apical long-axis view ([0058], [0160]-[0164]); two-dimensional time-series data of contour positions corresponding to the apical four-chamber view being two-dimensional time-series data of first contour positions, the first contour positions being either one of, or both of, a cavity interior and a cavity exterior of the heart in the apical four-chamber view included in a first group of two-dimensional ultrasound image data among the plurality of groups of two-dimensional ultrasound image data ([0156]-[0165]); two-dimensional time-series data of contour positions corresponding to the apical two-chamber view being two-dimensional time-series data of second contour positions, the second contour positions being either one of, or both of, the cavity interior and the cavity exterior of the heart in the apical two-chamber view included in a second group of two-dimensional ultrasound image data among the plurality of groups of two-dimensional ultrasound image data ([0156]-[0165]). Also, wherein the processing circuitry is configured to obtain the two-dimensional time-series data corresponding to the apical four-chamber view, the two-dimensional time-series data corresponding to the apical two-chamber view and the two-dimensional time-series data corresponding to the apical long-axis view while a reference phase of the two-dimensional time-series data corresponding to the apical four-chamber view, a reference phase of the two- dimensional time-series data corresponding to the apical two-chamber view and a reference phase of the two-dimensional time-series data corresponding to the apical long-axis view are aligned ([0156]-[0165]); wherein the processing circuitry is configured to align starting points of the two-dimensional time- series data corresponding to the apical four-chamber view, the two-dimensional time-series data corresponding to the apical two-chamber view and the two-dimensional time-series data corresponding to the apical long-axis view with a reference phase ([0156]-[0165]).
Wang discloses techniques for computerized characterization of cardiac motion in medical diagnostic ultrasound. Wang teaches two-dimensional time-series data of contour positions corresponding to the apical long-axis view being two-dimensional time-series data of third contour positions, the third contour positions being either one of, or both of, the cavity interior and the cavity exterior of the heart in an apical long-axis view included in a third group of two-dimensional ultrasound image data among the plurality of groups of two-dimensional ultrasound image data (standard heart views including A4C, A2C, and A3C, where A3C is considered an apical long-axis view; [0069]).
Guterman discloses an ultrasound system for automatic left ventricular function evaluation including using apical four chamber and two chamber views ([0096]) and calculating volume information such as by a Simpson ([0114]) or biplane method ([0115]). Guterman teaches calculate, based on the time-series data corresponding to the apical four- chamber view, the time-series data corresponding to the apical two-chamber view and the time-series data corresponding to the apical long-axis view, volume information of the heart ([0055], [0093]); calculate, based on the two-dimensional time-series data corresponding to the apical four-chamber view, the two-dimensional time-series data corresponding to the apical two-chamber view and the two-dimensional time-series data corresponding to the apical long-axis view, a plurality of pieces of wall information of the heart, each of the plurality of pieces of wall information corresponding to each of the apical four-chamber view, the apical two-chamber view and the apical long-axis view ([0120]-[0121], [0132]-[0137]); and exercise control so as to output the volume information and the plurality of pieces of wall information ([0055], [0122]). Guterman also teaches wherein the processing circuitry is further configured to cause same monitor to display the volume information and the plurality of pieces of wall information ([0089], [0122]-[0131]); wherein the processing circuitry is further configured to cause a monitor to display the volume information and the plurality of pieces of wall information with a time phase ([0089], [0122]-[0131]); wherein the processing circuitry is further configured to generate a temporal change curve of a local strain in a longitudinal direction as each of the plurality of pieces of wall information ([0089]); wherein the processing circuitry is further configured to calculate, as the volume information, at least one of numerical information about an end-diastolic volume, numerical information about an end-systolic volume, numerical information about an ejection fraction, numerical information about a myocardial mass, and a temporal change curve of a volume ([0114], [0131]); wherein the processing circuitry is further configured to select, from each of the two-dimensional time-series data corresponding to the apical four-chamber view, the two-dimensional time-series data corresponding to the apical two- chamber view and the two-dimensional time-series data corresponding to the apical long-axis view, based on a phase detected as an end systolic phase, a contour position in an end-systolic phase and calculate, by using the selected contour position, volume information at the end- systolic phase ([0088]-[0089], [0114], [0131], [0135]); when temporal change information about a volume is calculated as the volume information, the processing circuitry is configured to perform a temporal interpolation process to correct each of the two-dimensional time-series data corresponding to the apical four-chamber view, the two-dimensional time-series data corresponding to the apical two-chamber view and the two-dimensional time-series data corresponding to the apical long-axis view so as to obtain synchronized pieces of time-series data that have contour positions in a substantially a same time phase ([0110]-[0113], [0121]); wherein the processing circuitry is configured to calculate the volume information based on area of a spline closed curve for each of a plurality of discs which are perpendicular to a long axis and a representative value calculated from length of a long axis in the apical four-chamber view, length of a long axis in the apical two-chamber view and length of a long axis in the apical long-axis view, the spline closed curve for each of the plurality of the discs being obtained based on the two-dimensional time-series data corresponding to the apical four-chamber view, the two-dimensional time-series data corresponding to the apical two-chamber view and the two-dimensional time-series data corresponding to the apical long-axis view ([0114]).
It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to have modified the invention of Kumar to acquire and analyze groups of data from a plurality of cross-sectional planes in order to perform a biplane area length method to calculate the volume information as taught by Yamauchi rather than the single plane Simpson’s method, as this will provide a more accurate result. It should be noted that Yamauchi teaches a first embodiment in which data for one cross-sectional plane is obtained (similar to Kumar), and a second embodiment which obtains data for plural cross-sectional planes which allows for calculating capacity/volume with higher accuracy ([0156], [0162]). Additionally, it should be noted that such a technique is known in the art as evidenced by applicant’s disclosure ([0060] of the published specification). Furthermore, in acquiring and analyzing groups of data from a plurality of cross-section planes, it would have been obvious to one of ordinary skill in the art to utilize the data from the additional planes in the calculations of Kumar, such as for ejection fraction or strain, in order to obtain a more accurate result by combining data from multiple regions.
It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to have modified the combined invention of Kumar and Yamauchi to utilize additional heart views including an apical long-axis view as taught by Wang, as Wang teaches that an A3C view is a standard heart view used in computerized characterization of cardiac motion ([0069]), and the use of additional views/parameters in the calculations will further improve the accuracy of the result by more accurately defining the borders of the region.
It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to have modified the combined invention of Kumar, Yamauchi, and Wang to automatically obtain the data by performing a tracking process, calculate volume information, detect from a temporal change of the volume information an end-systolic phase, and calculate an ejection fraction based on the phase detected as taught by Guterman, as Guterman teaches that automatically tracking the borders/contours enables computing cardiac parameters related to systolic/diastolic function that would otherwise be obtained by Doppler techniques ([0089]), and automated tracking enables the computer system to more accurately determine the location of the contours over a period of cardiac motion. Furthermore, this information may then be utilized to more accurately calculate advanced cardiac metrics such as ejection fraction which indicates global systolic function by assess the percentage of blood ejected during the systole ([0114]).
While Kumar automatically detects the end-systolic phase, it would have been obvious to one of ordinary skill in the art, at the time the invention was made, to have modified the invention of Kumar to also allow for a manual input of the end-systolic phase, as it would be an obvious design choice to allow the user to have additional control over the diagnostic process. Furthermore, the benefits and drawbacks of automatic vs. manual input are understood in the art and providing a manual input allows for the user to have additional control over the processing system.
Additionally, Kumar discloses displaying various calculated cardiac parameters, and it would have been obvious to one of ordinary skill in the art, at the time the invention was made, to have modified the invention of Kumar to display any intermediate calculated values in addition to those displayed by Kumar, such as displaying notifications corresponding with the phase difference, time period difference, or long-axis difference, as this will provide additional information which the user may find beneficial for the diagnosis. The display of any type of calculated data would be an obvious design choice to one of ordinary skill in the art, depending on the user’s preference for the amount of information to be displayed.
Claim 12 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kumar et al. (US 2011/0262018; hereinafter Kumar) in view of Yamauchi (US 2002/0102023), Wang et al. (US 2012/0078097; hereinafter Wang), and Guterman et al. (US 2013/0278776; hereinafter Guterman) as applied to claim 1 above, and further in view of Pettigrew et al. (US 2009/0300553; hereinafter Pettigrew).
Kumar fails to show wherein the processing circuitry is configured to calculate the volume information based on area of a spline closed curve for each of a plurality of discs which are perpendicular to a long axis and a representative value calculated from length of a long axis in the apical four-chamber view, length of a long axis in the apical two-chamber view and length of a long axis in the apical long-axis view, the spline closed curve for each of the plurality of the discs being obtained based on the two-dimensional time-series data corresponding to the apical four-chamber view, the two-dimensional time-series data corresponding to the apical two-chamber view and the two-dimensional time-series data corresponding to the apical long-axis view.
Pettigrew discloses techniques for defining a border for an image. Pettigrew teaches that spline closed curves are a known image analysis tool ([0114]-[0115], [0124]-[0125]).
It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to have modified the combined invention of Kumar, Yamauchi, Wang, and Guterman to utilize spline closed curves as taught by Pettigrew, as Pettigrew teaches that spline closed curves are a known image analysis tool for accurately defining the borders of a region, and where accurately defining the borders of the region will aid in more accurately calculating the desired volume of the region in the combined invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Li (US 2005/0124887) describes additional details of utilizing temporal interpolation to reduce motion artifacts ([0036]).
Fu (US 2003/0074174) teaches that computing spline curves approximating a sequence of points is a well-established subject with standard methods described in textbooks in the area of geometric design ([0088]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN CWERN whose telephone number is (571)270-1560. The examiner can normally be reached Monday - Friday, 8:00 am - 5:00 pm.
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/JONATHAN CWERN/Primary Examiner, Art Unit 3797