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 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.
Claim(s) 1, 5-7, and 9-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Georgescu et al. (US 2016/0228190; hereinafter Georgescu) in view of Grbic et al. (US 2016/0171766; hereinafter Grbic).
Georgescu shows a Doppler-based non-invasive method and system for determining dynamic behavior of an aortic valve of a subject, the aortic valve having multiple asymmetric valve leaflets ([0022]) and the method comprising: receiving Doppler echocardiography images of the subject ([0048]); processing the received images to reconstruct a 3D geometry of the valve leaflets ([0049]-[0051]); determining transient pressure boundary conditions for the valve leaflets using a lumped parameter model specific to the subject ([0052]-[0053], [0072]); performing a first finite element simulation to determine one or more geometrical parameters for the valve leaflets, wherein the first finite element simulation is based on the reconstructed 3D geometry of the valve leaflets, the determined transient boundary conditions and an initial value of one or more material parameters of the valve leaflets (numerical discretization approaches including finite element method; [0073]-[0077]).
Georgescu also shows wherein the lumped parameter model comprises one or more of a left ventricle sub-model, a left atrium sub-model, an aortic valve sub-model, a mitral valve sub-model, a pulmonary circulation sub-model, and a systemic circulation sub-model ([0054]); wherein the transient pressure boundary conditions comprise a transient pressure difference between a left ventricle of the subject and an aorta of the subject (LPH model including left ventricle and aortic valve; [0054], [0078]); wherein the indicator indicates one or more of a transient 3D distribution of stress and displacement field for the valve leaflets at different time points of a cardiac cycle, a 3D deformed shape of the valve leaflets and a stiffness of the valve leaflets (hemodynamic parameters including stress on valves; [0020]); wherein the valve leaflets comprise native valve leaflets or prosthetic valve leaflets ([0051]); wherein the measured geometrical parameter for the iterative calibration comprises an angular position or a geometric orifice area of the valve leaflets (aortic valve orifice area, [0051]);
Georgescu fails to show iteratively calibrating the initial value of the one or more material parameters for the subject by comparing the determined one or more geometrical parameters with a measured geometrical parameter; and performing a second finite element simulation, based on the calibrated one or more material parameters, to determine an indicator of the dynamic behavior of the aortic valve.
Georgescu also fails to show diagnosing, monitoring or prognosing aortic valve stenosis (AS) in the subject based on the indicator; wherein the indicator indicates dynamic behavior of each of the valve leaflets; wherein the diagnosing, monitoring or prognosing aortic valve stenosis (AS) is conducted pre-intervention or post-intervention; the intervention is a transcatheter aortic valve replacement (TAVR).
Grbic discloses valve modeling techniques. Grbic teaches iteratively calibrating the initial value of the one or more material parameters for the subject by comparing the determined one or more geometrical parameters with a measured geometrical parameter ([0081]-[0089]); and performing a second finite element simulation ([0022], [0079]), based on the calibrated one or more material parameters, to determine an indicator of the dynamic behavior of the aortic valve (values that result in the biomechanical model performing as indicated; [0089]). Grbic also teaches diagnosing, monitoring or prognosing aortic valve stenosis (AS) in the subject based on the indicator (while Grbic describes analyzing mitral valve stenosis, [0114], it would be within the level of one of ordinary skill in the art to apply such analysis to other known valves to be analyzed such as an aortic valve); wherein the indicator indicates dynamic behavior of each of the valve leaflets ([0043]); wherein the diagnosing, monitoring or prognosing aortic valve stenosis (AS) is conducted pre-intervention or post-intervention ([0031], [0072], [0106]); the intervention is a transcatheter aortic valve replacement (TAVR) (various surgical interventions including transcatheter type; [0106]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Georgescu to iterate and simulate as taught by Grbic, as Grbic teaches that iteratively repeating the calculations using updated values for patient specific material properties allows for determining optimal values for the biomechanical model ([0089]).
An additional rejection of claim 15 is provided below in view of the multiple dependency of claim 15.
Claim(s) 2-4, 8, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Georgescu et al. (US 2016/0228190; hereinafter Georgescu) in view of Grbic et al. (US 2016/0171766; hereinafter Grbic) as applied to claims 1 and 7 above, and further in view of Falahatpisheh et al. (US 2016/0140730; hereinafter Falahatpisheh).
Georgescu fails to show wherein the 3D geometry of the valve leaflets is reconstructed by processing parasternal long-axis view and parasternal short-axis view Doppler echocardiography images; wherein the 3D geometry of the valve leaflets is reconstructed by measuring a base diameter, a diameter of commissures, a valve height and a length of central coaptation from the parasternal long-axis view Doppler echocardiographic image; wherein the 3D geometry of the valve leaflets is reconstructed by measuring multiple leaflet angles from the parasternal short-axis view Doppler echocardiography image; wherein the measured geometrical parameter is measured from a parasternal long-axis view and a parasternal short-axis view Doppler echocardiographic image at the peak systole time frame in which the aortic valve is in its fully open configuration.
Falahatpisheh discloses diagnostic ultrasound imaging techniques. Falahatpisheh teaches wherein the 3D geometry of the valve leaflets is reconstructed by processing parasternal long-axis view and parasternal short-axis view Doppler echocardiography images ([0051], [0053], [0114]-[0115]); wherein the 3D geometry of the valve leaflets is reconstructed by measuring a valve height from the parasternal long-axis view Doppler echocardiographic image (measure length/height; [0020], [0119]); wherein the 3D geometry of the valve leaflets is reconstructed by measuring multiple leaflet angles from the parasternal short-axis view Doppler echocardiography image ([0048]; Figs 9, 12); wherein the measured geometrical parameter is measured from a parasternal long-axis view and a parasternal short-axis view Doppler echocardiographic image at the peak systole time frame in which the aortic valve is in its fully open configuration (images of valve open; [0050]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Georgescu and Grbic to obtain parasternal long-axis and short-axis views as taught by Falahatpisheh, as these particular views are known in the art of ultrasound imaging of the heart, and provide critical diagnostic information pertaining to the state of the cardiovascular system of the patient; and where these particular views enable the user to properly characterize the geometry of the valves of the patient’s heart.
Furthermore, it would be within the level of one of ordinary skill in the art, without undue experimentation, to apply the diagnostic measurements to any of the valves in the patient’s heart, such as the mitral or the aortic valve, depending on the user’s preference or the patient’s particular condition. It is noted that Georgescu analyzes both the mitral and aortic valves.
Furthermore, in regards to the limitation “wherein the 3D geometry of the valve leaflets is reconstructed by measuring a base diameter, a diameter of commissures, a valve height and a length of central coaptation from the parasternal long-axis view Doppler echocardiographic image”, it is noted that Falahatpisheh generally teaches measuring height/length ([0119]) and Grbic teaches measuring the geometrical features of the leaflets at early systole including features such as commissures, basal chordae, and leaflet tips ([0067], [0145]). It would be an obvious design choice to one of ordinary skill in the art, without undue experimentation, to obtain various types of measurements corresponding with the physical properties of the valve, including measuring known geometrical features of a particular valve anatomy, such as measuring a base diameter, a diameter of commissures, a valve height and a length of central coaptation, in order to completely characterize the physical/geometric features of the patient’s anatomy from the diagnostic images and obtain a more accurate measurement of the patient’s anatomy. The expected physical/geometric features of the human anatomy are known within the medical arts. Furthermore, it is within the level of one of ordinary skill in the art to perform ultrasound diagnostic measurements using known ultrasound image analysis graphical user interfaces to measure a particular size of an anatomical structure within a medical ultrasound diagnostic image, and one of ordinary skill in the art may apply such measurements as desired by the user to characterize the size of any particular anatomy, including a heart valve, without undue experimentation.
Conclusion
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/JONATHAN CWERN/ Primary Examiner, Art Unit 3797