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 .
Response to Amendment
Claims 55-74 remain pending in the application in response to the applicant’s amendments to the rejections previously set forth in the Non-Final Office Action mailed 04/08/2026.
Response to Arguments
Applicant's arguments filed 06/29/2026 have been fully considered but they are not persuasive.
For claim 55, the applicant argues that “Itu fails to teach, suggest or disclose "data assimilation" and generating "by data assimilation a reconciled hemodynamic parameter"” (see pg. 2 of applicant’s remarks), and the examiner disagrees.
The claim language does not specify what is considered a “reconciled” hemodynamic parameter, or how a parameter is “reconciled”. Therefore, under broadest reasonable interpretation, the examiner read the limitation as “generating by data assimilation a hemodynamic parameter based on the first set of output parameters”, which reference Itu teaches.
The claim language does not specify what data is “assimilated”, other than generating a parameter based on parameters. Therefore, under broadest reasonable interpretation, generating a parameter by “data assimilation” includes any type of combination of data, including displaying a plurality of data. Therefore, Itu teaches generating a parameter by data assimilation (see para 0033 – “At step 112, the blood flow and pressure computations and the hemodynamic quantities of interest are output. For example, the computed hemodynamic quantities of interest and/or the blood flow and pressure values computed for the plurality of points in the patient-specific anatomical model over the plurality of time steps can be output by displaying the hemodynamic quantities of interest and/or the blood flow and pressure computations on a display of a computer system [data assimilation].”).
The applicant also argues “Furthermore, a person skilled in the art would understand that data assimilation cannot be used without registered (spatialized) pressure measurements… Itu does not teach, suggest or disclose registering the pressure measurements,…” (see pg. 3), and the examiner disagrees.
The claim language does not specifically recite data assimilation is based on registered pressure measurements. Registering visual data (patient-specific anatomical model) with the location of measurement data (blood pressure) to generate and display visual data indicating measurement data is well known in the art. Therefore, under broadest reasonable interpretation, Itu teaches registering the first set of values of the blood pressure with the reconstructed geometry object of the blood vessel (see para. 0030 - "At step 108, a computational blood flow model [registered data] is personalized based on the invasive physiological measurements [blood pressure] and the non-invasive patient data. The computational blood flow model is constructed based on the patient-specific anatomical model [reconstructed geometry object] of the patient's vessels… to computed blood flow and pressure values [blood pressure measurements] at locations in the patient-specific anatomical model [registering]…”).
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.
Claims 55-74 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Itu et al. (US 20170032097 A1, published February 2, 2017), hereinafter referred to as Itu.
Regarding claim 55, and similarly for claims 69 and 74, Itu teaches a method executable by a system comprising a processor in communication with an intravascular pressure measurement device and with an extraluminal imaging device, the method comprising:
acquiring, by the extraluminal (non-invasive) imaging device, a first set of contrast-agent angiographic images of a blood vessel having a contrast agent therein (see para. 0024 "Referring to FIG. 1, at step 102 non-invasive patient data including medical imaging data and non-invasive measurements of the patient is received."; see para. 0025 "In an advantageous embodiment, 3D coronary CT angiography (CTA) images are acquired on a CT scanner. The CTA images ensure that coronary vasculature, including the vessel(s) that contain the stenosis, is adequately imaged using a contrast agent that is injected into the patient.");
generating a reconstructed geometry object of the blood vessel based on the first set of contrast agent angiographic images (Fig. 1, step 104; see para. 0026 "At step 104, a patient-specific anatomical model [reconstructed geometry object] of the patient's vessels is extracted from the medical imaging data.");
based on the first set of contrast-agent angiographic images, estimating a first blood flow in the blood vessel (see para. 0033- "Returning to FIG. 1, at step 110, blood flow simulations are performed using the personalized computational model and hemodynamic quantities of interest are computed based on the blood flow simulations.");
acquiring, by the intravascular pressure measurement device, a first set of values of blood pressure and acquiring, by the extraluminal imaging device, a first set of pressure-measurement angiographic images of the blood vessel without the contrast agent (see para. 0025 "In addition to the medical image data, other non-invasive [extraluminal imaging device] clinical measurements, such as the patient's heart rate and systolic and diastolic blood pressure may also be acquired."; see para. 0029 "Returning to FIG. 1, at step 106, invasive physiological measurements of the patient are received. For example such invasive physiological measurements may include invasive measurements of one or more of pressure, flow rate, velocity, etc. in a patient's vessel acquired using sensors on guidewires or catheters [intravascular pressure measurement device] inserted into the vessel.");
registering the first set of values of the blood pressure with the reconstructed geometry object of the blood vessel (see para. 0030 "At step 108, a computational blood flow model is personalized based on the invasive physiological measurements [blood pressure] and the non-invasive patient data. The computational blood flow model is constructed based on the patient-specific anatomical model of the patient's vessels and used to simulate blood flow and pressure in the patient-specific anatomical model [[reconstructed geometry object] using CFD computations or any other standard numerical technique to computed blood flow and pressure values at locations in the patient-specific anatomical model [registering] over a plurality of time steps.");
determining, by the processor, a first set of output parameters based on the first set of values of the blood pressure and the first blood flow, by implementing a first physical model of blood distribution in the blood vessel using the reconstructed geometry object, the first blood flow and a first set of registered pressure measurements (see para. 0033 "Returning to FIG. 1, at step 110, blood flow simulations are performed using the personalized computational model and hemodynamic quantities of interest are computed based on the blood flow simulations. In particular, the personalized computational model [first physical model] computed blood flow and pressure values [output parameters] at each of a plurality of points in the patient-specific anatomical model of the patient's vessels over a plurality of time steps."); and
generating by data assimilation a reconciled hemodynamic parameter based on the first set of output parameters (see para. 0033 "At step 112, the blood flow and pressure computations and the hemodynamic quantities [reconciled hemodynamic parameter] of interest are output. For example, the computed hemodynamic quantities of interest and/or the blood flow and pressure values computed for the plurality of points in the patient-specific anatomical model over the plurality of time steps can be output by displaying the hemodynamic quantities of interest and/or the blood flow and pressure computations on a display of a computer system.").
Furthermore, regarding claim 56, Itu further teaches wherein the first set of contrast-agent angiographic images and the first set of values of the blood pressure are obtained during a hyperemic state of the blood vessel, the blood vessel having a hyperemic agent therein (see para. 0042 "Alternatively, the transit time may be extracted from Angio images recorded at hyperemia, by analyzing the transport of the contrast agent."; see para. 0068 "The above described embodiments for enhancement of blood flow computations for the same patient state as the patient state at which the invasive physiological measurements [blood pressure] are acquired may be used at any patient state (e.g., rest, hyperemia, exercise, pre-stenting, post-stenting).").
Furthermore, regarding claim 57, Itu further teaches wherein the first set of values of the blood pressure is a function of a location within the blood vessel (see para. 0030 " to computed blood flow and pressure values at locations in the patient-specific anatomical model over a plurality of time steps.").
Furthermore, regarding claims 58 and 71, Itu further teaches determining the first set of output parameters, by the processor, based on the first set of values of the blood pressure registered with the first set of the pressure-measurement angiographic images (see para. 0033 "Returning to FIG. 1, at step 110, blood flow simulations are performed using the personalized computational model and hemodynamic quantities of interest are computed based on the blood flow simulations. In particular, the personalized computational model computed blood flow and pressure values at each of a plurality of points in the patient-specific anatomical model of the patient's vessels over a plurality of time steps.").
Furthermore, regarding claims 59 and 72, Itu further teaches wherein the method further comprises, when the blood vessel has a hyperemic agent therein:
acquiring, by the extraluminal imaging device, a second set of contrast-agent angiographic images of the blood vessel having the contrast agent and the hyperemic agent therein; based on the second set of contrast-agent angiographic images, estimating a second blood flow in the blood vessel; acquiring, by the intravascular pressure measurement device, a second set of values of the blood pressure within the blood vessel having the hyperemic agent therein (see para. 0042 "Alternatively, the transit time may be extracted from Angio images recorded at hyperemia, by analyzing the transport of the contrast agent."; see para. 0068 "The above described embodiments for enhancement of blood flow computations for the same patient state as the patient state at which the invasive physiological measurements [blood pressure] are acquired may be used at any patient state (e.g., rest, hyperemia, exercise, pre-stenting, post-stenting)."); and
determining, by the processor, a second set of output parameters based on the second set of values of the blood pressure and the second blood flow, by implementing a second physical model of the blood distribution in the blood vessel and using the reconstructed geometry object; wherein generating the reconciled hemodynamic parameter further comprises adjusting the reconciled hemodynamic parameter based on the first set of the output parameters and the second set of the output parameters (Fig. 1; see para. 0068 "The above described embodiments for enhancement of blood flow computations for the same patient state as the patient state at which the invasive physiological measurements are acquired may be used at any patient state (e.g., rest, hyperemia, exercise, pre-stenting, post-stenting). see para. 0033 "In particular, the personalized computational model computed blood flow and pressure values at each of a plurality of points in the patient-specific anatomical model ofthe patient's vessels over a plurality of time steps. Hemodynamic quantities of interest. can be calculated from the computed blood flow and/or pressure values.").
Furthermore, regarding claim 60, Itu further teaches wherein the second set of values of the blood pressure is a function of a location within the blood vessel (see para. 0068 "The above described embodiments for enhancement of blood flow computations for the same patient state as the patient state at which the invasive physiological measurements [blood pressure] are acquired may be used at any patient state (e.g., rest, hyperemia, exercise, pre-stenting, post-stenting).").
Furthermore, regarding claims 61 and 73, Itu further teaches acquiring, by the extraluminal imaging device, a second set of pressure-measurement angiographic images of the blood vessel and registering the second set of values of the blood pressure with the second set of the pressure measurement angiographic images (see para. 0025 "In addition to the medical image data, other non invasive clinical measurements [extraluminal imaging device], such as the patient's heart rate and systolic and diastolic blood pressure may also be acquired."; see para. 0030 "In a possible implementation, one or more of the parameters or boundary conditions of the computational blood flow model can be personalized based on the non-invasive patient data, such as the medical image data, the patient-specific anatomical model extracted from the medical image data, and/or the non-invasive patient measurements, and one or more parameters or boundary conditions of the computational blood flow model can be personalized based on the invasive physiological measurements or a combination of the non-invasive patient data and the invasive physiological measurements.").
Furthermore, regarding claim 62, Itu further teaches determining the second set of output parameters, by the processor, based on the second set of values of the blood pressure registered with the second set of the pressure-measurement angiographic images (see para. 0025 "In addition to the medical image data, other non-invasive clinical measurements, such as the patient's heart rate and systolic and diastolic blood pressure may also be acquired."; see para. 0030 "In a possible implementation, one or more of the parameters or boundary conditions of the computational blood flow model can be personalized based on the non-invasive patient data, such as the medical image data, the patient-specific anatomical model extracted from the medical image data, and/or the non-invasive patient measurements, and one or more parameters or boundary conditions of the computational blood flow model can be personalized based on the invasive physiological measurements or a combination of the non-invasive patient data and the invasive physiological measurements.").
Furthermore, regarding claim 63, Itu further teaches acquiring, by the extraluminal imaging device, a third set of contrast-agent angiographic images of the blood vessel having a stent and the contrast agent therein; based on the third set of contrast-agent angiographic images, estimating a third blood flow in the blood vessel; acquiring, by the intravascular pressure measurement device, a third set of values of the blood pressure within the blood vessel (see para. 0068 "The above described embodiments for enhancement of blood flow computations for the same patient state as the patient state at which the invasive physiological measurements [blood pressure] are acquired may be used at any patient state (e.g., rest, hyperemia, exercise, pre-stenting, post-stenting)."); and
determining, by the processor, a third set of output parameters based on the third set of values of the blood pressure and the third blood flow, by implementing a third physical model of the blood distribution in the blood vessel using the reconstructed geometry object; wherein the adjusting the reconciled hemodynamic parameter is further based on the third set of the output parameters (Fig. 1; see para. 0068 "The above described embodiments for enhancement of blood flow computations for the same patient state as the patient state at which the invasive physiological measurements are acquired may be used at any patient state (e.g., rest, hyperemia, exercise, pre-stenting, post-stenting)."; see para. 0033 "In particular, the personalized computational model computed blood flow and pressure values at each of a plurality of points in the patient-specific anatomical model of the patient's vessels over a plurality of time steps. Hemodynamic quantities of interest...can be calculated from the computed blood flow and/or pressure values.").
Furthermore, regarding claim 64, Itu further teaches wherein the acquiring of the first set of values of the blood pressure is simultaneous with the acquiring of the first set of pressure-measurement angiographic images of the blood vessel (see para. 0025 "In addition to the medical image data, other non-invasive clinical measurements, such as the patient's heart rate and systolic and diastolic blood pressure may also be acquired."; see para. 0029- "Returning to FIG. 1, at step 106, invasive physiological measurements of the patient are received. For example such invasive physiological measurements may include invasive measurements of one or more of pressure, flow rate, velocity, etc. in a patient's vessel acquired using sensors on guidewires or catheters inserted into the vessel.").
Furthermore, regarding claim 65, Itu further teaches: determining, by the processor, a second set of output parameters based on a second set of values of the blood pressure having a hyperemic agent therein and without the contrast agent, and a second blood flow determined from a second set of contrast-agent angiographic images acquired when the contrast agent and a hyperemic agent are in the blood vessel (see para. 0042 "Alternatively, the transit time may be extracted from Angio images recorded at hyperemia, by analyzing the transport of the contrast agent [includes images with and without contrast agent]."; see para. 0068 "The above described embodiments for enhancement of blood flow computations for the same patient state as the patient state at which the invasive physiological measurements [blood pressure] are acquired may be used at any patient state (e.g., rest, hyperemia, exercise, pre-stenting, post-stenting.”); and
wherein generating the reconciled hemodynamic parameter further comprises adjusting the reconciled hemodynamic parameter based on the first set of the output parameters and the second set of the output parameters (Fig. 1; see para. 0068 "The above described embodiments for enhancement of blood flow computations for the same patient state as the patient state at which the invasive physiological measurements are acquired may be used at any patient state (e.g., rest, hyperemia, exercise, pre-stenting, post-stenting)."; see para. 0033 "In particular, the personalized computational model computed blood flow and pressure values at each of a plurality of points in the patient-specific anatomical model of the patient's vessels over a plurality of time steps. Hemodynamic quantities of interest. can be calculated from the computed blood flow and/or pressure values.").
Furthermore, regarding claim 66, Itu further teaches acquiring a second set of pressure measurement angiographic images of the blood vessel and registering the second set of values of the blood pressure with the second set of pressure-measurement angiographic images of the blood vessel (see para. 0025 "In addition to the medical image data, other non-invasive clinical measurements, such as the patient's heart rate and systolic and diastolic blood pressure may also be acquired."; see para. 0030 "In a possible implementation, one or more of the parameters or boundary conditions of the computational blood flow model can be personalized based on the non-invasive patient data, such as the medical image data, the patient-specific anatomical model extracted from the medical image data, and/or the non-invasive patient measurements, and one or more parameters or boundary conditions of the computational blood flow model can be personalized based on the invasive physiological measurements or a combination of the non-invasive patient data and the invasive physiological measurements.").
Furthermore, regarding claim 64, Itu further teaches after a stent has been installed in the blood vessel, determining, by the processor, a third set of output parameters based on:
a third set of values of the blood pressure acquired with acquiring of a third set of pressure measurement angiographic images after at least a third period of time elapsed since acquiring the second set of contrast-agent angiographic images and a third blood flow determined from a third set of contrast agent angiographic images acquired when the contrast agent is in the blood vessel (see para. 0068 "The above described embodiments for enhancement of blood flow computations for the same patient state as the patient state at which the invasive physiological measurements [blood pressure] are acquired may be used at any patient state (e.g., rest, hyperemia, exercise, pre-stenting, post-stenting)."); and
wherein adjusting the reconciled hemodynamic parameter is further based on the third set of output parameters (Fig. 1; see para. 0068 "The above described embodiments for enhancement of blood flow computations for the same patient state as the patient state at which the invasive physiological measurements are acquired may be used at any patient state (e.g., rest, hyperemia, exercise, pre-stenting, post-stenting)."; see para. 0033 "In particular, the personalized computational model computed blood flow and pressure values at each of a plurality of points in the patient-specific anatomical model of the patient's vessels over a plurality of time steps. Hemodynamic quantities of interest...can be calculated from the computed blood flow and/or pressure values.").
Furthermore, regarding claim 68, Itu further teaches wherein the reconciled hemodynamic parameter is at least one of an index of microvascular resistance, a fractional flow reserve, a coronary flow reserve, a diastolic pressure ratio, an absolute flow, an absolute resistance, and a ratio of absolute resistance (see para. 0033 "Hemodynamic quantities of interest, such as fractional flow reserve (FFR), coronary flow reserve (CFR), index of microvascular resistance (IMR), instantaneous wave-free ratio (iFR), basal Pd/Pa, basal stenosis resistance, hyperemic stenosis resistance, indication of previous myocardial infarction, etc., can be calculated from the computed blood flow and/or pressure values.").
Furthermore, regarding claim 70, Itu further teaches a display configured to display the reconciled hemodynamic parameter and an image representing a reconciliated pressure field (see para. 0033 "At step 112, the blood flow and pressure computations and the hemodynamic quantities of interest are output. For example, the computed hemodynamic quantities of interest and/or the blood flow and pressure values computed for the plurality of points in the patient-specific anatomical model over the plurality of time steps can be output by displaying the hemodynamic quantities of interest and/or the blood flow and pressure computations on a display of a computer system.").
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Garibaldi (US 20090105579 A1, published April 23, 2009) discloses by combining a diagnostically enhanced 3D or 4D reconstructed data set with a rendition of a remotely controlled navigation device that can be displayed directly or virtually co-registered to the 3D or 4D image data, the system enables an operator to efficiently diagnose conditions and deliver correspondingly appropriate therapy to a plurality of targeted points within the patient anatomy.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nyrobi Celestine whose telephone number is 571-272-0129. The examiner can normally be reached on Monday - Thursday, 7:00AM - 5:00PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached on 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.C./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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