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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 2, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-8 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tolkowsky et. al. (US Patent US20140121513 A1).
Regarding claim 1, Tolkowsky et. al. discloses a system for determining flow parameters of a lumen, the system comprising one or more processors configured to: receive angiographic data representing at least one of contrast agent injected (Tolkowsky et. al. [0329]: contrast agent injection inducing a hyperemic state) into the lumen in a basal state and injector data representing the injected contrast agent (Tolkowsky et. al. [0354]: the progress and density of the contrast agent along the luminal section proximal and/or distal to the stenosis, and/or other hemodynamic parameters, are measured by blood-velocity-determination functionality 16. For some applications, such measurements are performed automatically. [0392]: parameters include the geometry of the lumen, the aortic pressure, the density of the contrast agent as observed in the angiogram images, the hyperemic flow, and/or the density and viscosity of blood.); determine, based on the received angiographic data (Tolkowsky et. al. [0327]: the hemodynamic measurements include measuring the time it takes for the contrast agent to travel a known distance, i.e., measuring the velocity of the contrast agent, and thereby measuring the velocity of blood flow through the lumen), a temporal window representing a duration of an induced hyperemic state (Tolkowsky et. al. [0327]) subsequent to injection of the contrast agent into the lumen; and output a signal (Sh) indicative of the temporal window (Tolkowsky et. al. [0420]-[0427], the contrast agent injection procedure is evaluated according to the respective time windows being formed by the hyperemic and following/preceding basal states of lumen pressure).
Regarding claim 2, Tolkowsky et. al. discloses the system according to claim 1, wherein: the angiographic data comprises a first temporal sequence of angiographic images, and the one or more processors are further configured to: analyse the first temporal sequence of angiographic images to compute at least one of: an end time of the contrast agent injection, a start time of the contrast agent injection, and an intensity profile of the injected contrast agent; and determine the temporal window based on the computed at least one end time, start time, and intensity profile (Tolkowsky et. al. Figure 2, [0327-[0329]).
Regarding claim 3, Tolkowsky et. al. discloses the system according to claim 1, wherein the one or more processors are further configured to: receive the injector data; and determine the temporal window based on the received injector data, wherein the received injector data represents at least one of: an end time of the contrast agent injection, a start time of the contrast agent injection, and a total injected dose of the injected contrast agent (Tolkowsky et. al. Figure 2, [0327]-[0329]).
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Regarding claim 4, Tolkowsky et. al. discloses the system according to claim 1,wherein the one or more processors are further configured to: output an injector trigger signal (1) for triggering the injector to perform a subsequent contrast agent injection into the lumen the injector trigger signal (1) is-generated within the temporal window (Tolkowsky et. al. [0331], the automated injection device is programmed to inject pulses of contrast agent in a predetermined pattern).
Regarding claim 5, Tolkowsky et. al. discloses the system according to claim 4, wherein the contrast agent injection comprises a first contrast agent injection rate and the subsequent contrast agent injection (Inj2) comprises a second contrast agent injection rate lower than the first contrast agent injection rate (Tolkowsky et. al. [0331]).
Regarding claim 6, Tolkowsky et. al. discloses the system according to claim 4, wherein the angiographic data is generated by an X-ray imaging system and the one or more processors are further configured to; output an imaging trigger signal for triggering the X-ray imaging system to generate second angiographic data comprising a second temporal sequence of angiographic images representing the subsequent contrast agent injection into the lumen (110), the imaging trigger signal is generated within the temporal window (Tolkowsky et. al. [0035], [0365]-[0368]).
Regarding claim 7, Tolkowsky et. al. discloses the system according to claim 6, wherein the one or more processors are further configured to receive the second angiographic data (Tolkowsky et. al. [0331]).
Regarding claim 8, Tolkowsky et. al. discloses the system according to claim 7, wherein the one or more processors are further configured to: receive pressure sensor data representing a proximal pressure (Pa) at a proximal position in the lumen at a time corresponding to the second temporal sequence of angiographic images; segment one or more images in the first temporal sequence of angiographic images to provide a geometric model of the lumen for modelling fluid flow in the lumen; and estimate a distal pressure (Pa) at a distal position in the lumen at the time corresponding to the second temporal sequence of angiographic images based on the geometric model and the proximal pressure (Pa) (Tolkowsky et. al. [0323]-[0325], [0130]).
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.
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.
Claim(s) 9, 11, 13, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Tolkowsky et. al. (US Patent US20140121513 A1) in view of Japanese Patent (JP2015527901A).
Regarding claim 9, Tolkowsky et. al. discloses the system according to claim 7 wherein: the second temporal comprises a front of the contrast agent injected in the subsequent contrast agent injection sequence of angiographic images (Tolkowsky et. al. [0035], [0365]-[0368]). However, Tolkowsky et. al. fails to disclose the one or more processors are further configured to: analyse one or more images in the first temporal sequence of angiographic images to identify a centerline of the lumen in the one or more images; identify a centerline of the lumen in at least an earlier image and a later image in the second temporal sequence of angiographic images based on a mapping of at least one centerline from the first temporal sequence of angiographic images to the earlier image and to the later image; and determine a transit time (T) taken by the front to pass between a proximal position in the lumen in the earlier image, and a distal position (Pos) in the lumen in the later image, the transit time defined by a time difference between the later image and the earlier image.
Japanese patent JP2015527901A teaches the one or more processors are further configured to: analyse one or more images in the first temporal sequence of angiographic images to identify a centerline of the lumen in the one or more images; identify a centerline of the lumen in at least an earlier image and a later image in the second temporal sequence of angiographic images based on a mapping of at least one centerline from the first temporal sequence of angiographic images to the earlier image and to the later image; and determine a transit time (T) taken by the front to pass between a proximal position in the lumen in the earlier image, and a distal position (Pos) in the lumen in the later image, the transit time defined by a time difference between the later image and the earlier image (JP2015527901A, [0178], [0278], [0204], where the blood velocity identification function can be used to define at least a first temporal sequence and a second region of interest for a second temporal sequence along the lumen centerline in one of the angiographic images, thereby reducing one of the angiographic images). Identification of the lumen centerline is crucial for understanding blood flow and also to guide vascular interventions. Thus, it would have been obvious for one skilled in the art prior to the effective filing date of the claimed invention to have combined the teachings of Tolkowsky et. al. and Japanese Patent JP2015527901 A to include these features in the system to properly identify the centerline of the lumen.
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Regarding claim 11, Tolkowsky et. al. discloses the system according to claim 8. However, Tolkowsky et. al. fails to disclose wherein the one or more processors are further configured to: compute an index of microcirculatory resistance, value for the lumen, the index of microcirculatory resistance value being based on a multiplication of the transit time and the estimated distal pressure.
Japanese Patent JP2015527901A teaches wherein the one or more processors are further configured to: compute an index of microcirculatory resistance, value for the lumen, the index of microcirculatory resistance value being based on a multiplication of the transit time and the estimated distal pressure (JP2015527901A, [0147]). This feature is critical to the claimed invention because it quantifies the resistance to blood flow which is indicative of a pathology. Thus, it would have been obvious to a person skilled in the art prior to the effective filing date of the claimed invention to have included this feature of JP2015527901A with the system of Tolkowsky et. al.) so that the resistance to blood flow is quantified.
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Regarding claim 13, Tolkowsky et. al. discloses the system according to claim 7. However, Tolkowsky et. al. fails to disclose wherein the one or more processors are further configured to: analyse one or more images in the first temporal sequence of angiographic images to identify a centerline of the lumen in the one or more images; identify a lumen in one or more images in the second temporal sequence of angiographic images based on a registration of at least one centerline identified in the first temporal sequence of angiographic images to the one or more images in the second temporal sequence of angiographic images; and determine a temporal velocity profile of the contrast agent injected in the subsequent contrast agent injection along the identified lumen in the second temporal sequence of angiographic images based on temporal variations in an intensity gradient of the contrast agent along the registered centerline in the one or more images in the second temporal sequence of angiographic images.
Japanese Patent JP2015527901A teaches wherein the one or more processors are further configured to: analyse one or more images in the first temporal sequence of angiographic images to identify a centerline of the lumen in the one or more images; identify a lumen in one or more images in the second temporal sequence of angiographic images based on a registration of at least one centerline identified in the first temporal sequence of angiographic images to the one or more images in the second temporal sequence of angiographic images; and determine a temporal velocity profile of the contrast agent injected in the subsequent contrast agent injection along the identified lumen in the second temporal sequence of angiographic images based on temporal variations in an intensity gradient of the contrast agent along the registered centerline in the one or more images in the second temporal sequence of angiographic images (JP2015527901A, [0204]). The lumen centerline identification process is integral to the temporal velocity profiles and accurate understanding of the blood flow based on the contrast agent. Thus, it would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have included these features of JP2015527901A with the system of Tolkowsky et. al. so that the blood flow from the lumen of the blood vessel can be precisely measured.
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Regarding claim 15, Tolkowsky et.al. further discloses the system according to claim 13, wherein the one or more processors are further configured to: compute a haemodynamic index value for the lumen based on a comparison between a fluid velocity in the basal state and a fluid velocity in the hyperemic stated; wherein the one or more processors are configured to determine the fluid velocity in the basal state by: analysing the first temporal sequence of angiographic images to determine a transit period (Tn taken by a front of the injected contrast agent to travel between an upstream position in the lumen and at which a phase in the cardiac cycle has a first phase value , and a downstream position in the lumen and at which the phase in the cardiac cycle has a second value) estimating, from the first temporal sequence of angiographic images, a transit distance (da travelled by the front along the lumen between the upstream position and the downstream position; and dividing the estimated transit distance (da by the transit period (Tn to provide the fluid velocity in the basal state, wherein the one or more processors are configured to determine the fluid velocity in the hyperemic state by: analysing the temporal velocity profile and the corresponding second temporal sequence of angiographic images to identify a time interval starting at a first point in time at which the cardiac phase is equal to the first phase value in the cardiac cycle, and ending at a second point in time within the same cardiac period at which the cardiac phase is equal to the second phase and calculating the average of the velocity profile over the identified time interval to provide the fluid velocity in the hyperemic state (Tolkowsky et. al. Figure 1, [0354]).
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Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Tolkowsky et. al. (US Patent US20140121513 A1) in view of Japanese Patent (JP2015527901 A) as applied to claim 13 above, and further in view of Yu et. al. (US Patent US20190110776 A1).
Regarding claim 14, Tolkowsky et. al. and JP2015527901A discloses the system according to claim 13. However, Tolkowsky et. al. and JP2015527901A fail to disclose wherein the one or more processors are further configured to at least one of: compute a hyperemic microvascular resistance value for the lumen, the hyperemic microvascular resistance value computed based on the ratio of the estimated distal pressure to the average transit velocity from the second angiographic image wherein the average transit velocity is computed as an average of the temporal velocity profile over a complete cardiac cycle; and estimate the distal pressure by further inputting the temporal velocity profile into the model.
Yu et. al. teaches wherein the one or more processors are further configured to at least one of: compute a hyperemic microvascular resistance value for the lumen, the hyperemic microvascular resistance value computed based on the ratio of the estimated distal pressure to the average transit velocity from the second angiographic image wherein the average transit velocity is computed as an average of the temporal velocity profile over a complete cardiac cycle; and estimate the distal pressure by further inputting the temporal velocity profile into the model (Yu et. al. [008] where microvascular resistance is discussed in the clinical context). It is important to the claimed invention to measure microvascular resistance to properly identify different pathology and treatment protocols. Thus, it would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have included the measurement of microvascular resistance to the system of Tolkowsky et. al. with the teachings of JP2015527901A so that these parameters are properly quantified.
Claim(s) 10, 12 are rejected under 35 U.S.C. 103 as being unpatentable over Tolkowsky et. al. (US Patent US20140121513 A1) in view of Japanese Patent (JP2015527901 A) as applied to claim 9 above, and further in view of Turcea et. al.: “Artificial Intelligence for Real Time Estimation of Contrast Agent Velocity and Blood Flow Velocity in Coronary Angiograms”, Prior Art Publishing GMBH, Prior Art Publishing GMBH, Manfred-Von-Richthofen-STR. 9, 12101 Berlin Germany, vol. www.priorartregister.com, 19 September 2019 (2019-09-19), pages 1-9, XP007022779.
Regarding claim 10, Tolkowsky et. al. and JP2015527901A disclose the system according to claim 9. However, Tolkowsky et. al. and JP2015527901A fail to disclose wherein the one or more processors are further configured to: determine a transit length travelled by the front between the proximal position in the lumen in the earlier image and the distal position in the lumen in the later image based on a mapping of the positions of the front in the earlier image and the later image to a common centerline; and compute a transit velocity for the front based on a ratio of the transit length to the transit time.
Turcea et. al. teaches wherein the one or more processors are further configured to: determine a transit length travelled by the front between the proximal position in the lumen in the earlier image and the distal position in the lumen in the later image based on a mapping of the positions of the front in the earlier image and the later image to a common centerline; and compute a transit velocity for the front based on a ratio of the transit length to the transit time (Turcea et. al., page 3, col 2, paragraph 3, where the length travelled by the contrast agent is more accurately estimated). This step is also important to the claimed invention so that the contrast agent can be tracked from each image captured. Thus, it would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have included the features of Turcea et. al. with the teachings of Tolkowsky et. al. and JP2015527901A so that the contrast agent shown in each image frame can be more precisely tracked.
Regarding claim 12, the combination of Tolkowsky et. al., JP2015527901A and Turcea et. al. discloses the system according to claim 10. JP2015527901A further discloses wherein the one or more processors are further configured to: compute a hyperemic microvascular resistance value for the lumen, the hyperemic microvascular resistance value computed based on the ratio of the estimated distal pressure to the computed transit velocity (JP2015527901A, [0147]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA YIFANG LIN whose telephone number is (571)272-6435. The examiner can normally be reached M-F 7:00am-6:15pm, with optional day off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vu Le can be reached at 571-272-7332. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JESSICA YIFANG LIN/Examiner, Art Unit 2668 January 29, 2026
/VU LE/Supervisory Patent Examiner, Art Unit 2668