DETAILED ACTION
Notice of 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 may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, 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.
Claim(s) 1-4 and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over He (US 2023/0210490) in view of Roschak (US 2009/0131765).
Regarding claims 1, 13, and 14, He discloses a method, non-transitory computer-readable medium, and system for deriving a measure of blood velocity in a blood vessel of a subject, the method performed in a single measurement session, the method comprising: in a first cardiac cycle: acquiring ultrasound data of the blood vessel, determining a blood velocity profile across a radial cross-section of the blood vessel during the cardiac cycle using the ultrasound data, based on acquiring a plurality of blood velocity measurements at different radial positions across the vessel radial cross-section (Fig. 6). He does not explicitly disclose that in one or more subsequent cardiac cycles: acquiring ultrasound data of the blood vessel, measuring a blood velocity at a single point within the radial cross-section of the vessel using the ultrasound data, and calculating an average blood velocity across the radial cross-section of the vessel based on the measured velocity at a single point and the velocity profile. However, Roschak teaches measuring blood velocity at a central point of the vessel and calculating an averaged blood velocity at the central point ([0068]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the calculation of average blood velocity taught by Roschak to the blood velocity measurement of He, as to provide a robust measurement of blood flow velocity.
Regarding claim 2, while He does not explicitly disclose that the single point is a point of maximum blood velocity, Roschak teaches that the central portion of the blood vessel is where the blood velocity is maximized (Figs. 9a, 9b). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the a maximum blood velocity region as taught by Roschak to the measurement of He, as to provide robust measurement of maximum blood flow velocity.
Regarding claim 3, He discloses that the determining of the velocity profile further comprises acquiring blood velocity measurements at different circumferential positions for each of the different radial positions (Fig. 6).
Regarding claim 4, while He does not explicitly disclose that (a) of claim 1 is executed once and (b) of claim 1 is repeated recurrently for multiple cardiac cycles following execution of (a), using the same velocity profile obtained in (a), Roschak teaches multiple sampling volumes performed across more than one cardiac cycle ([0055]: “a sufficient number of instantaneous velocity profiles during each cardiac cycles”, [0068]: “multiple sampling volumes”). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the iteration of Roschak to the measurement of He, as to provide a robust sampling of data.
Regarding claim 11, while He does not explicitly disclose wherein (b) further comprises determining a blood flow through the blood vessel based on the determined average blood velocity, Roschak teaches determining flow rates based upon time-averaged data ([0077]…[0079]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the flow estimation of Roschak to the measurement of He, as to provide a robust average measurement of blood flow.
Regarding claim 12, while He does not explicitly disclose that (b) further comprises determining an area of the radial cross-section of the blood vessel using B-mode ultrasound data wherein the determining of the blood flow is based on the average blood velocity and the radial cross-section, Roschak teaches determining volumetric flow based upon a calculated circular area of the vessel ([0062]…[0068]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the area consideration of Roschak to the measurement of He, as to provide a robust and accurate measurement based upon the dimensions of the blood vessel.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over He (US 2023/0210490) in view of Roschak (US 2009/0131765), as applied to claim 1 above, in view of Dala (US 2007/0167794).
Regarding claim 8, neither He nor Roschak explicitly disclose that in (b), the measuring the blood velocity at the single point of the vessel is performed using spectral Doppler ultrasound data. However, Dala teaches that spectral Doppler information can be used to obtain a velocity-time profile of blood flow ([0038]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the spectral Doppler of Dala to the measurement of He and Roschak, as to provide a robust and well-known manner of visualizing velocity over time.
Regarding claim 9, neither He nor Roschak explicitly disclose that in (a), the velocity profile is measured recurrently over the course of the first cardiac cycle, at different phase points of the cardiac cycle, to acquire a respective velocity profile for each of the different phase points of the cardiac cycle. However, Dala teaches the use of an ECG to denote phases of the cardiac cycle and that Doppler interrogation may be guided by an ECG signal ([0039]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply phase association of Dala to the measurement of He and Roschak, as to provide robust assessment of the phase of blood flow.
Regarding claim 10, neither He nor Roschak explicitly disclose that (b) comprises determining a phase point of the cardiac cycle at which the velocity at the single point was determined and the calculating of the average velocity is performed based on the velocity profile as measured in (a) at a corresponding phase point of the cardiac cycle. However, Dala teaches the use of an ECG to denote phases of the cardiac cycle and that Doppler interrogation may be guided by an ECG signal ([0039]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply phase association of Dala to the measurement of He and Roschak, as to provide robust assessment of the phase of blood flow.
Claim(s) 5-7 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over He (US 2023/0210490) in view of Roschak (US 2009/0131765), as applied to claims 1 and 14 above, in view of Turcott (US 6477406).
Regarding claims 5-7 and 15, neither He nor Roschak explicitly disclose obtaining an indication of at least one hemodynamic parameter of the subject and retriggering re-excution of (a) responsive to detection of the at least one ultrasound-based hemodynamic parameter that is held against a threshold, meeting one or more pre-defined criteria. However, Turcott teaches an acoustic hemodynamic sensor that registers a motion artifact when a threshold is crossed (19:4-67…20:1-4). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the threshold and error flag of Turcott to the measurement of He and Roschak, as to provide a common and robust manner of detecting a faulty signal.
Conclusion
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/JASON M IP/Primary Examiner, Art Unit 3793