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 .
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 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.
Withdrawal of Objections and Rejections
Applicant's response, filed 02/10/2026, has been fully considered.
The following rejections and/or objections are either maintained or newly applied for claims 1-20. They constitute the complete set applied to the instant application. Herein, "the previous Office action" refers to the Advisory Action of 03/26/2026.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/10/2026 has been entered.
Status of the Claims
Claims 1-20 are pending.
Claims 1-20 are rejected.
Priority
This application is a 371 of PCT/US2020/012437 01/06/2020 which claims priority from Application No. 62/788,911 (01/06/2019) as reflected in the filing receipt mailed on 12/20/2021. The claims to the benefit of priority are acknowledged. The effective filing date of claims 1-20 is 03/27/2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted Sept. 11, 2025 has been considered.
Claim interpretation
Regarding claims 1-2, 8-9, 11, 16 and 19, this instant specification defines that: 1. “the flow field is a function of arterial geometry, pressures, and flow conditions and may include but is not limited to pressure field, velocity field, wall shear stress field, axial plaque stress, among others, or a combination thereof” [0031 and 0067]; and 2. “blood flow physiological indices that describe pressure losses, such as FFR … may be calculated under a range of simulated activity levels or metabolic demands” [0034]. In the interest of compact prosecution, it is interpreted that:
any combination of the previously listed items such as arterial geometry, pressures, and flow conditions reads on the recited “flow field”;
FFR values determined at different points read on the recited “first and second activity levels” in the claims;
the “flow rate” information determined at various points in the anatomy represented reads on the recited first and second flow rate;
the “flow field” information determined at various points in the anatomy represented reads on the recited first and second flow field; and
acquiring “blood flow characteristics or parameters, such as blood flow velocity, pressure ( or a ratio thereof), flow rate at various points in the anatomy represented by the model reads on velocity field since it is a measure of the velocity of a fluid measured as function of a three-dimensional space as described in the art.
Regarding claims 6-7 and 17-18, this instant specification defines that: 1. “the method may further include calculating a first pressure drop (e.g., at one or more user-designated points and/or other points) for the first activity level (i.e., for the first inflow rate)” [0097]; and 2. “the inflow boundary condition may be a value or a range of values for velocity, flow rate, pressure or other characteristics” [0060]. In the interest of compact prosecution, it is interpreted that the first activity level comprises the first inflow rate which can be any of the following: velocity, flow rate, pressure or other characteristics.
Regarding claim 20, this instant specification defines that “Navier-Stokes equations can be employed to describe the flow field in a coronary artery … as functions of time and three-dimensional space, in some forms, and solely of three-dimensional space in other forms” [0037] (i.e., time-independent). In the interest of compact prosecution, it is interpreted that the use of the same numerical methods adopted by Navier-Strokes equations (i.e., finite difference, finite volume, or finite element methods depending on the specific problem) does read on the recited limitation, considering that these can be used to solve time-dependent or time-independent problems.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 USC § 101 because the claimed inventions are directed to one or more Judicial Exceptions (JEs) without significantly more. Regarding JEs, "Claims directed to nothing more than abstract ideas..., natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 §I). Abstract ideas include mathematical concepts and procedures for evaluating, analyzing or organizing information, which are a type of mental process (MPEP 2106.04(a)(2)). Any newly recited portions are necessitated by claim amendment.
101 background
MPEP 2106 organizes JE analysis into Steps 1, 2A (Prong One & Prong Two), and 2B as analyzed below. MPEP 2106 and the following USPTO website provide further explanation and case law citations: uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter (MPEP 2106.03)?
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Analysis of instant claims
Step 1: Are the claims directed to a 101 process, machine, manufacture, or composition of matter (MPEP 2106.03)?
The instant claims are directed to a method (claims 1-20) which falls within one of the categories of statutory subject matter.
[Step 1: claims 1-20: Yes]
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
Background
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. MPEP § 2106.04(a)(2) further explains that abstract ideas are defined as:
• mathematical concepts (mathematical formulas or equations, mathematical relationships
and mathematical calculations) (MPEP 2106.04(a)(2)(I));
• certain methods of organizing human activity (fundamental economic principles or practices, managing personal behavior or relationships or interactions between people) (MPEP 2106.04(a)(2)(II)); and/or
• mental processes (concepts practically performed in the human mind, including observations, evaluations, judgments, and opinions) (MPEP 2106.04(a)(2)(III)).
Analysis of instant claims
With respect to the instant claims, under the Step 2A, Prong One evaluation, the claims are found to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information) and mathematical concepts (in particular mathematical relationships and formulas) are as follows:
• "determining a threshold according to the metabolic requirement information" (independent claims 1 and 11);
• "non-invasively determining a first flow field for the arterial segment … simulating blood flow …the first flow field corresponding to a first activity level of the patient; determining a first pressure drop in the arterial segment based on the first flow field" (independent claim 1);
• "non-invasively determining a second flow field for the arterial segment … simulating blood flow …the second flow field corresponding to a second activity level of the patient that is different from the first activity level" (independent claim 1);
• "non-invasively determining a second pressure drop in the arterial segment based on the second flow field; calculating, based on the first pressure drop and the second pressure drop, a range of pressure drops for a range of activity levels, wherein calculating the range of pressure drops comprises determining, for one or more of a plurality of intermediate activity levels between the first activity level and the second activity level, a corresponding pressure drop based on the first pressure drop and the second pressure drop, without …simulating blood flow for each of the one or more of the plurality of intermediate activity levels" (independent claim 1);
• "comparing the range of pressure drops to the threshold" (independent claims 1 and 11);
• "calculating a range of pressure drops for the range of activity levels comprises calculating a range of pressure drops for a range of flow rates" (claim 2);
• "calculating first outflow rates at the two or more outflow boundaries according to the first inflow rate; calculating a first flow field in the arterial by … simulating blood flow … and based on the first inflow rate and the first outflow rates; determining a first pressure drop in the arterial segment based on the first flow field; obtaining a second inflow rate respective of the inflow boundary, the second inflow rate different from the first inflow rate; calculating second outflow rates at the two or more outflow boundaries according to the second inflow rate" (independent claim 1);
• "calculating a second flow field in the arterial segment by … simulating blood flow … and based on the second inflow rate and the second outflow rates; determining a second pressure drop in the arterial segment based on the second flow field; calculating, based on the first pressure drop and the second pressure drop, a range of pressure drops for a range of inflow rates, wherein calculating the range of pressure drops comprises determining, for one or more of a plurality of intermediate activity levels between the first activity level and the second activity level, a corresponding pressure drop based on the first pressure drop and the second pressure drop, without … simulating blood flow for each of the one or more of the plurality of intermediate activity levels" (independent claim 1);
• "calculating the range of pressure drops according to a quadratic relationship between pressure drop and flow rate" (claim 4);
• "determining an activity level at which the pressure drop exceeds the threshold" (claim 8);
• "calculating first outflow rates respective of the arterial segment according to the first inflow rate; and calculating the first flow field in the arterial segment …, the first inflow rate, and the first outflow rates; and determining the second flow field for the arterial segment …" (claim 10);
• "calculating second outflow rates respective of the arterial segment according to the second inflow rate; and calculating the second flow field in the arterial segment …, the second inflow rate, and the second outflow rates" (claim 10);
• "calculating a range of pressure drops for the range of flow rates comprises calculating a range of pressure drops for a range of activity levels" (claim 12);
• "calculating the range of pressure drops according to a quadratic relationship between pressure drop and inflow rate" (claim 14); and
• "determining an activity level at which the pressure drop exceeds the threshold" (claim 16).
Dependent claims 3, 6-7, 9, 13, 15, 17-20 recite further details regarding the calculated values “range”, “flow field”, “rate”, “activity level” or “pressure drop”.
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined to each cover performance either in the mind and/or by mathematical operation. Without further detail as to the methodology involved in "calculating and comparing the range of pressure drops and associated variables to the threshold", under the BRI, one may simply, for example, use pen and paper to perform mathematical steps to arrive at the recited calculations. Further support for the mathematical techniques used in the claims as the only embodiment is provided in the specification at [0031 and 0067] which discloses that “the flow field is a function of arterial geometry, pressures, and flow conditions and may include but is not limited to pressure field, velocity field, wall shear stress field, axial plaque stress, among others, or a combination thereof”; at [0023, 0073, 0084, 0090, 0094, 0096, 0103] which describes values for “range”, “flow field”, “rate”, and “pressure drop” are described to be found via equations; and at [0034] which discloses that “blood flow physiological indices that describe pressure losses, such as FFR … may be calculated under a range of simulated activity levels or metabolic demands.” Thus, the recited terms correspond to verbal equivalents of mathematical concepts because they constitute actions executed by a group of mathematical steps in a form of a mathematical algorithm; thus mathematical concepts (MPEP 2106.04(a)(2)). A mathematical concept need not be expressed in mathematical symbols, because "words used in a claim operating on data to solve a problem can serve the same purpose as a formula." In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989). MPEP 2106.04(a)(2) pertains. The human mind is also sufficiently capable of determine thresholds and compare results yielded from calculations.
[Step 2A Prong One: claims 1-20: Yes ]
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Background
MPEP 2106.04(d).I lists the following example considerations for evaluating whether a judicial exception is integrated into a practical application:
An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
Analysis of instant claims
Instant claims 1, 5, 10-11 and 15 recite additional elements that are not abstract ideas:
• "computer-implemented" (independent claims 1 and 11);
• "computationally" (independent claims 1 and 11);
• "receiving medical image data of the patient, the medical image data including an arterial segment" (independent claim 1);
• "generating a three-dimensional (3-D) electronic model of the arterial segment from the medical image data" (independent claim 1);
• "using the 3-D electronic model" (claims 1 and 10-11);
• "receiving metabolic requirement information of the patient" (independent claims 1 and 11);
• "displaying a result of the comparison" (independent claims 1 and 11);
• "obtaining a three-dimensional (3-D) electronic model of an arterial segment of the patient, the arterial segment comprising an inflow boundary and two or more outflow boundaries" (independent claim 11);
• "obtaining a first inflow rate respective of the inflow boundary" (independent claim 11);
• "displaying the plot of the range of pressure drops and the threshold" (claims 5 and 15); and
• "obtaining a first inflow. rate respective of the arterial segment … obtaining a second inflow rate respective of the arterial segment" (claim 10).
Considerations under Step 2A, Prong Two
The recited limitations in claims 1, 5, 10-11 and 15 are interpreted as requiring the use of a computer. Hence, the claims explicitly recite steps executed by computers and therefore can be described as computer functions or instructions to implement on a generic computer.
Further steps directed to additional non-abstract elements of a computing device/computer do not describe any specific computational steps by which the "computer parts" perform or carry out the judicial exceptions, nor do they provide any details of how specific structures of the computer are used to implement these functions. The claims state nothing more than a generic computer which performs the functions that constitute the judicial exceptions. The instant claims state nothing more than that a generic computer performs the functions that constitute the abstract idea (MPEP 2106.05(f)).
Limitations of claims 1 and 11 related to "computationally simulating …" are considered to perform the claimed abstract idea with a computer, which is not sufficient to integrate an abstract idea into a practical application (see MPEP 2106.05(f)); since steps that can be performed mentally and merely performing the mental process in a computer environment do not negate the fact that something that can be carried out in the human mind. See MPEP 2106.04(a)(2).III.C.
Claims directed to "receiving" and "obtaining" read on receiving or transmitting data over a network - Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d at 1321 - MPEP 2106.05(a) pertains; which constitutes just necessary data gathering and therefore correspond to insignificant extra-solution activity. Additionally, claims reciting "generating a three-dimensional (3-D) electronic model" and "using the three-dimensional electronic model" read on data gathering activities because the data obtained in the model serves as input to the judicial exception.
The recited claims read on data gathering activities, not amounting to a practical application. The type of data doesn’t change that it is mere data gathering or conventional computer receiving means. Claims directed to "displaying" are interpreted as data outputting (i.e. the output from mathematical calculations in the judicial exception) and as such insignificant extra-solution activity.
Hence, these are mere instructions to apply the abstract idea using a computer and insignificant extra-solution activity and therefore the claims do not integrate that abstract idea into a practical application (see MPEP 2106.04(d) § I; 2106.05(f); and 2106.05(g)). None of the dependent claims recite any additional non-abstract elements; they are all directed to further aspects of the information being analyzed, the manner in which that analysis is performed, or the mathematical operations performed on the information.
In Step 2A, Prong One above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs).
In this Step 2A, Prong Two immediately above claim steps and/or elements were identified as part of one or more additional elements. Additional elements are further discussed in Step 2B below.
Here in Step 2A, Prong Two, no additional step or element clearly demonstrates integration of the JE(s) into a practical application.
[Step 2A Prong Two: claims 1-20: No]
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
According to analysis so far, the additional elements described above do not provide significantly more than the judicial exception. A determination of whether additional elements provide significantly more also rests on whether the additional elements or a combination of elements represents other than what is well-understood, routine, and conventional. Conventionality is a question of fact and may be evidenced as: a citation to an express statement in the specification or to a statement made by an applicant during examination that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
Claims 1, 5, 10-11 and 15 recite a computer or computer functions, interpreted as instructions to apply the abstract idea using a computer, where the computer does not impose meaningful limitations on the judicial exceptions; which can be performed without the use of a computer (MPEP 2106.04(d) § I; and MPEP 2106.05(f)).
With respect to the instant claims, the prior art review to Steinman ("Image-based computational fluid dynamics modeling in realistic arterial geometries." Annals of biomedical engineering 30(4):483-497 (2002)); newly cited) discloses that "generating a three-dimensional (3-D) electronic model" for blood flow data is an additional element which "applies" the judicial exception to a generic computer that is routine, well-understood and conventional in the art. Said portions of the prior art are, for example, pg. 483 col. 2 para. 3.
Further, the courts have found that receiving and outputting/generating data are well-understood, routine, and conventional functions of a computer when claimed in a generic manner or as insignificant extra-solution activity (see Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information), buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network), Versa ta Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015), and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93, as discussed in MPEP 2106.05(d)(Il)(i)).
When the claims are considered as a whole, they do not integrate the abstract idea into a practical application; they do not confine the use of the abstract idea to a particular technology; they do not solve a problem rooted in or arising from the use of a particular technology; they do not improve a technology by allowing the technology to perform a function that it previously was not capable of performing; and they do not provide any limitations beyond generally linking the use of the abstract idea to a broad technological environment. See MPEP 2106.05(a) and 2106.05(h).
The instant claims constitute insignificant extra solution activity, and when considered individually, are insufficient to constitute inventive concepts that would render the claims significantly more than an abstract idea (see MPEP 2106.05(g)). Hence, these elements, when considered individually, are insufficient to constitute inventive concepts that would render the claims significantly more than an abstract idea (see MPEP 2106.05(d)).
[Step 2B: claims 1-20: No]
Conclusion: Instant claims are directed to non-statutory subject matter
For the reasons above, the claims in this instant application, when the limitations are considered individually and as a whole, are directed to an abstract idea and lack an inventive concept not clearly anything significantly more.
Response to applicant's remarks in regards of Claim Rejection 35 U.S.C. ~ 101
The Remarks of 02/10/2026 have been fully considered but are not persuasive for the reasons below:
In pg. 7 para. 5 the Applicant asserts:
The Independent Claims do not recite any mathematical relationships, formulas, or equations. Instead, the Independent Claims recite an image-driven computer simulation workflow for determining patient-specific hemodynamic information. (Spec., ,i [0002].) While the Office Action highlights certain generic words (e.g., "determining", "calculating", "range", "flow field", and "pressure drop") as allegedly being mathematical concepts, those words do not recite "mathematical relationships", "formulas", or "equations". Therefore, they are not "mathematical concepts" recited in the Independent Claims, even if they are "based on" or "involve" mathematical concepts
The examines disagrees because the instant claims are not simply based on or involve mathematical concepts. Instead the instant steps actively rely on mathematical concepts as the only embodiment to arrive at the claimed invention which further relates to image-driven computer simulation workflow." In light of the instant specification, values for “pressure drop range”, “flow field", and "flow rate" are described to be found via equations [0023, 0039, 0073, 0084, 0090, 0094, 0096, 0103]. Furthermore, limitations considered as using a computer to perform a judicial exception are not sufficient to integrate an abstract idea into a practical application (see MPEP 2106.05(f)); since steps that can be performed mentally and performing the mental and/or mathematical process in a computer environment do not negate the fact that something that can be carried out in the human mind. See MPEP 2106.04(a)(2).III.C.
In pg. 8 para. 1 the Applicant asserts:
The Independent Claims recite generating a three-dimensional electronic anatomical model and determining flow fields and pressure drops using that model. A human cannot practically perform these operations mentally. For example, a human mind cannot generate a three dimensional electronic anatomical model nor can it compute flow fields and pressure drops in that electronic model for different activity levels via computational fluid dynamics. These are computer-implemented simulation tasks that require computation processing capabilities beyond human mental capability.
The Examiner agrees that some of the limitations, like generating and using the 3D model, do not recite judicial exceptions, thus said limitations have been considered as additional elements. However, the arguments related to computing/determining flow fields and associated steps are not persuasive because said steps remain identified as judicial exceptions, since it recites still recites math. The additional elements related to generating and using the 3D model does not provide a practical improvement because claims reciting "generating a three-dimensional (3-D) electronic model" and "using the three-dimensional electronic model" read on data gathering activities since the data obtained in the model serves as input to the judicial exception.
In pg. 8 para. 3 the Applicant asserts:
The Independent Claims are not limited to the mere collection and display of information. Rather, they recite particular computer operations for transforming medical image data into a three-dimensional electronic anatomical model and generating simulation-derived flow and pressure fields in that model. This is a practical application in a technical field (medical imaging and hemodynamic simulation) and is not "mere instructions to apply" an abstract idea on a generic computer
The Examiner disagrees because step 2A Prong 2 consideration related to effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c), refers to actual real life (i.e. physical) transformation, and not "transforming data”. Therefore, the argued "transformation" from image data to a computer model does not integrate that abstract idea into a practical application. Instead the use of image data for computer simulations read on data gathering activity and insignificant extra-solution activity (MPEP 2106.05(g) The claims states nothing more than that a generic computer performing the functions that constitute the abstract idea (MPEP 2106.05(f)).
In pg. 8 para. 5 the Applicant asserts:
The discussion of the cited references below regarding the § 103 rejection indicates that the cited art does not disclose each element of the Claims. At a minimum, this lack of complete disclosure by the cited references demonstrates that the Claims are not "well-understood, routine, and conventional
The Applicant appears to argue that an alleged claim novelty means that the claims are not well-understood, routine, and conventional at Step 2B. Applicant is reminded that the standard for assessing the conventionality of the additional elements at Step 2B of the 35 USC 101 analysis is separate and distinct from the standard for applying prior art under 35 USC 102 or 103 (see MPEP 2106.05(I)). Because they are separate and distinct requirements from eligibility, patentability of the claimed invention under 35 U.S.C. 102 and 103 with respect to the prior art is neither required for, nor a guarantee of, patent eligibility under 35 U.S.C. 101. This argument is unpersuasive because.
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 negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
A. Claims 1-20 are rejected under 35 U.S.C. 103(a) as being unpatentable over Spilker US Patent Application No. US 20170007332 in view of Uus (“Patient-Specific Blood Flow Modelling in Diagnosis of Coronary Artery Disease” Thesis Dissertation. Department of Electrical and Electronic Engineering. City University London (2016)) as evidenced by Kolli ("Diagnostic performance of pressure drop coefficient in relation to fractional flow reserve and coronary flow reserve." Screening 50:10 (2014)), as cited on the 02/24/2025 Form PTO-892. Any newly recited portions are necessitated by claim amendment.
Claim 1 recites:
receiving medical image data of the patient, the medical image data including an arterial segment; generating a three-dimensional (3-D) electronic model of the arterial segment from the medical image data; receiving metabolic requirement information of the patient; determining a threshold according to the metabolic requirement information
• Spilker teaches methods and systems for determining treatment options by modifying patient-specific geometric models [0001]; including at least one computer system [0009] to use patient anatomic data from coronary computed tomographic angiography [0004] (i.e. receiving image data of a patient including arterial segment); and determine blood flow characteristics or parameters, such as blood flow velocity, pressure, flow rate, FFR at various locations in the aorta, the main coronary arteries, and/or other coronary arteries or vessels downstream from the main coronary arteries [0075] and a graph of shear stress over time [0179] (i.e. stress test); wherein a 3D patient specific geometric model and blood flow simulation is depicted (Fig. 27 sheet 17); wherein the 3D model represents the patient's heart or vasculature based on patient specific data regarding a geometry of the patient's heart or vasculature [0009] (i.e. generating a three-dimensional (3-D) electronic model of the arterial segment from the medical image data); wherein the use of a heart model is determined based on known information regarding the patient: an aortic pressure, the patient's systolic and diastolic blood pressures, the patient's cardiac output (the volume of blood flow from the heart and heart rate) and/or constants determined experimentally [0145] (i.e. receiving metabolic requirement information of the patient); wherein a computer system is configured to determine locations of the patient’s three-dimensional model that exhibit a predetermined threshold level of a blood flow characteristic [0010].
non-invasively determining a first flow field for the arterial segment computationally simulating blood flow using the 3-D electronic model, the first flow field corresponding to a first activity level of the patient; determining a first pressure drop in the arterial segment based on the first flow field; non-invasively determining a second flow field for the arterial segment computationally simulating blood flow using the 3-D electronic model, the second flow field corresponding to a second activity level of the patient that is different from the first activity level; non-invasively determining a second pressure drop in the arterial segment based on the second flow field … determining, for one or more of a plurality of intermediate activity levels between the first activity level and the second activity level, a corresponding pressure drop based on the first pressure drop and the second pressure drop, without computationally simulating blood flow for each of the one or more of the plurality of intermediate activity levels
• Spilker teaches that the results of the computational analysis (i.e. non-invasively determining) may include blood flow characteristics or parameters, such as blood flow velocity, pressure ( or a ratio thereof), flow rate, FFR at various locations in the aorta, the main coronary arteries, and/or other coronary arteries or vessels downstream from the main coronary arteries [0075] and a graph of shear stress over time [0179] (i.e. parameters that make up flow field – See Claim Interpretation); wherein the 3D patient specific geometric model and blood flow simulation is depicted (Fig. 27 sheet 17); wherein the equations used in the model apply numerical methods to determine (i.e. without computationally simulating blood flow) the information about the coronary blood flow in the patient's anatomy at various points in the anatomy represented by the model [0077] (i.e. determining, for one or more of a plurality of intermediate activity levels between the first activity level and the second activity level, a corresponding pressure drop based on the first pressure drop and the second pressure drop, without computationally simulating blood flow for each of the one or more of the plurality of intermediate activity levels); wherein the FFR measured for the patient is the ratio of the coronary pressure to aortic pressure under conditions of maximum stress [0131] and the calculated FFR drop below the lower limit determines the presence of a functionally significant lesion or other feature that may require intervention [0176]. The recited first activity, second activity and all intermediate activity levels are taught by Spilker since different values for the calculated parameters are determined at various different points in the geometric anatomy represented by the model as described above.
calculating, based on the first pressure drop and the second pressure drop, a range of pressure drops for a range of activity levels, wherein calculating the range of pressure drops comprises … comparing the range of pressure drops to the threshold; and displaying a result of the comparison
• Spilker does not teach the recitation above. However, Uus teaches a method for medical Imaging technologies for diagnosis of coronary artery disease where the FFR index is computed from the measured pressure and visualized in real time with the values below the 0.75-0.8 threshold (i.e. displaying results after compared to a threshold) (pg. 28 para. 2) and the FFR cut-off value defining a critical stenosis varies between 0.75 - 0.8, and accounts for the resulting 25 - 20% drop in the blood pressure (i.e. range of pressure drops) under hyperaemia (pg. 28 para. 2); with the measured instantaneous pressure at the root of the coronary artery Pa and distal along the artery Pd visualized on the screen along with the computed heart-cycle mean values and a significant drop in the measured distal pressure from 78 mmHg to 49 mmHg in pharmacologically-induced hyperaemia, which results in FFR = Pd/Pa = 0.69 being below the critical threshold value (pg. 30 para. 2)(i.e. comparing a pressure drop to the threshold).
Claim 2 recites:
wherein the first activity level is associated with a first flow rate and the second activity level is associated with a second flow rate that is different from the first flow rate, wherein calculating a range of pressure drops for the range of activity levels comprises calculating a range of pressure drops for a range of flow rates
• Spilker teaches that the results of the computational analysis may include blood flow characteristics or parameters, such as blood flow velocity, pressure ( or a ratio thereof), flow rate, FFR at various locations in the aorta, the main coronary arteries, and/or other coronary arteries or vessels downstream from the main coronary arteries [0075] and a graph of shear stress over time [0179]; wherein the equations used in the model apply numerical methods to determine the information about the coronary blood flow in the patient's anatomy at various points in the anatomy represented by the model [0077]; wherein the FFR measured for the patient is the ratio of the coronary pressure to aortic pressure under conditions of maximum stress [0131] and the calculated FFR drop below the lower limit determines the presence of a functionally significant lesion or other feature that may require intervention [0176]. The recited first activity, second activity and all intermediate activity levels are taught by Spilker since different values for the calculated parameters are determined at various different points in the geometric anatomy represented by the model as described above.
Claims 3 and 13 recite:
wherein the range of flow rates is between the first flow rate and the second flow rate
• Spilker does not tech the recitation above. However, Uus teaches a method for medical Imaging technologies for diagnosis of coronary artery disease where the FFR index is computed from the measured pressure and visualized in real time with the values below the 0.75-0.8 threshold (pg. 28 para. 2); wherein The main aim of patient-specific image-based blood flow simulations is the computation of flow patterns that are physiologically realistic and the flow parameters are within the defined interpatient range (pg. 32 para. 3).
Claim 4 recites:
wherein calculating the range of pressure drops for the range of activity levels comprises calculating the range of pressure drops according to a quadratic relationship between pressure drop and flow rate
Claim 14 recites:
wherein calculating the range of pressure drops comprises calculating the range of pressure drops according to a quadratic relationship between pressure drop and inflow rate
• Spilker does not tech the recitation above. However, Uus teaches a method for medical Imaging technologies for diagnosis of coronary artery disease with the FFR cut-off value defining a critical stenosis varies between 0.75 - 0.8, and accounts for the resulting 25 - 20% drop in the blood pressure (i.e. range of pressure drops) under hyperaemia (pg. 28 para. 2); where a pressure drop (Δp = p –(½ × blood density × APV2)) (i.e. quadratic relationship) with p being pressure measured proximal to the stenosis at hyperemia, APV being the average peak flow velocity and Δp being pressure drop; as evidenced by Kolli (pg. 2 para. 2 Kolli).
Claims 5 and 15 recite:
wherein displaying a result of the comparison comprises displaying the plot of the range of pressure drops and the threshold.
• Spilker does not tech the recitation above. However, Uus teaches a method for medical Imaging technologies for diagnosis of coronary artery disease with displayed plots of the computed blood flow waveforms of the inlet compared to the outlets, including flow rate and pressure (pg. 103 Fig. 3.22);
Claim 6 recites:
wherein the first activity level is a resting state
Claim 7 recites:
wherein the second activity level is a hyperemic state
Claim 17 recites:
wherein the first inflow rate is respective of a resting state of the patient
Claim 18 recites:
wherein the second inflow rate is respective of a hyperemic state of the patient
• Spilker teaches a computational analysis as described above that determines information (such as pressure, velocity, FFR, etc.) about the coronary blood flow in the patient's anatomy at various points in the anatomy represented by the model [0077]; with FFR being measured when the patient is at rest [0029] (i.e. resting state as in claims 6 and 17), when the patient is under maximum hyperemia [0030] (i.e. hyperemic state as in claims 7 and 18) and when the patient is under maximum exercise [0031].
Claim 8 and 16 recite:
determining an activity level at which the pressure drop exceeds the threshold
• Spilker teaches that the FFR measured for the patient is the ratio of the coronary pressure to aortic pressure under conditions of maximum stress [0131] and the calculated FFR drop below the lower limit determines the presence of a functionally significant lesion or other feature that may require intervention [0176].
Claim 9 and 19 recite:
wherein the first and second flow fields comprise first and second flow velocity fields, respectively
• Spilker teaches that that the results of the computational analysis may include blood flow characteristics or parameters, such as blood flow velocity, pressure ( or a ratio thereof), flow rate, FFR at various locations in the aorta, the main coronary arteries, and/or other coronary arteries or vessels downstream from the main coronary arteries [0075] and a graph of shear stress over time [0179] (i.e. parameters that make up flow field – See Claim Interpretation).
Claim 10 recites:
wherein determining the first flow field for the arterial segment using the 3-D electronic model comprises: obtaining a first inflow rate respective of the arterial segment; calculating first outflow rates respective of the arterial segment according to the first inflow rate; and calculating the first flow field in the arterial segment according to the 3-D electronic model, the first inflow rate, and the first outflow rates; and determining the second flow field for the arterial segment using the 3-D electronic model comprises: obtaining a second inflow rate respective of the arterial segment; calculating second outflow rates respective of the arterial segment according to the second inflow rate; and calculating the second flow field in the arterial segment according to the 3-D electronic model, the second inflow rate, and the second outflow rates
• Spilker teaches a computational analysis determining the flow field and flow rate parameters determined in the patient's anatomy at various points in the anatomy represented by the model [0077]; wherein the analysis included inflow and outflow boundaries through which flow is directed into and outward from the anatomy of the three-dimensional model respectively, with the inflow being assigned with a prescribed value or field for velocity, flow rate, pressure, or other characteristic, by coupling a heart model and/or a lumped parameter model to the boundary and outflow measuring physiologic characteristics of the patient, such as, but not limited to, cardiac output (the volume of blood flow from the heart), blood pressure, myocardial mass, etc. [0083]; wherein the 3D patient specific geometric model and blood flow simulation is depicted (Fig. 27 sheet 17).
Claim 11 recites:
obtaining a three-dimensional (3-D) electronic model of an arterial segment of the patient, the arterial segment comprising an inflow boundary and two or more outflow boundaries; receiving metabolic requirement information of the patient; determining a threshold according to the metabolic requirement information; obtaining a first inflow rate respective of the inflow boundary; calculating first outflow rates at the two or more outflow boundaries according to the first inflow rate; calculating a first flow field in the arterial by computationally simulating blood flow using the three-dimensional electronic model and based on the first inflow rate and the first outflow rates; determining a first pressure drop in the arterial segment based on the first flow field; obtaining a second inflow rate respective of the inflow boundary, the second inflow rate different from the first inflow rate; calculating second outflow rates at the two or more outflow boundaries according to the second inflow rate; calculating a second flow field in the arterial segment by computationally simulating blood flow using the three-dimensional electronic model and based on the second inflow rate and the second outflow rates … wherein calculating the range of pressure drops comprises determining, for one or more of a plurality of intermediate activity levels between the first activity level and the second activity level, a corresponding pressure drop based on the first pressure drop and the second pressure drop, without computationally simulating blood flow for each of the one or more of the plurality of intermediate activity levels;
• Spilker teaches methods and systems for determining treatment options by modifying patient-specific geometric models [0001]; including at least one computer system [0009] to use patient anatomic data from coronary computed tomographic angiography [0004] (i.e. receiving image data of a patient including arterial segment); and determine blood flow characteristics or parameters, such as blood flow velocity, pressure, flow rate, FFR at various locations in the aorta, the main coronary arteries, and/or other coronary arteries or vessels downstream from the main coronary arteries [0075] and a graph of shear stress over time [0179] (i.e. stress test); wherein a 3D patient specific geometric model and blood flow simulation is depicted (Fig. 27 sheet 17); wherein the 3D model represents the patient's heart or vasculature based on patient specific data regarding a geometry of the patient's heart or vasculature [0009] (i.e. generating a three-dimensional (3-D) electronic model of the arterial segment from the medical image data); wherein the use of a heart model is determined based on known information regarding the patient: an aortic pressure, the patient's systolic and diastolic blood pressures, the patient's cardiac output (the volume of blood flow from the heart and heart rate) and/or constants determined experimentally [0145] (i.e. receiving metabolic requirement information of the patient); wherein a computer system is configured to determine locations of the patient’s three-dimensional model that exhibit a predetermined threshold level of a blood flow characteristic [0010]; wherein the analysis included inflow and outflow boundaries through which flow is directed into and outward from the anatomy of the three-dimensional model respectively, with the inflow being assigned with a prescribed value or field for velocity, flow rate, pressure, or other characteristic, by coupling a heart model and/or a lumped parameter model to the boundary and outflow measuring physiologic characteristics of the patient, such as, but not limited to, cardiac output (the volume of blood flow from the heart), blood pressure, myocardial mass, etc. [0083]; wherein the 3D patient specific geometric model and blood flow simulation is depicted (Fig. 27 sheet 17); wherein the results of the computational analysis may include blood flow characteristics or parameters, such as blood flow velocity, pressure ( or a ratio thereof), flow rate, FFR at various locations in the aorta, the main coronary arteries, and/or other coronary arteries or vessels downstream from the main coronary arteries [0075] and a graph of shear stress over time [0179] (i.e. parameters that make up flow field – See Claim Interpretation); wherein the 3D patient specific geometric model and blood flow simulation is depicted (Fig. 27 sheet 17); wherein the equations used in the model apply numerical methods to determine (i.e. without computationally simulating blood flow) the information about the coronary blood flow in the patient's anatomy at various points in the anatomy represented by the model [0077] (i.e. determining, for one or more of a plurality of intermediate activity levels between the first activity level and the second activity level, a corresponding pressure drop based on the first pressure drop and the second pressure drop, without computationally simulating blood flow for each of the one or more of the plurality of intermediate activity levels) wherein the FFR measured for the patient is the ratio of the coronary pressure to aortic pressure under conditions of maximum stress [0131] and the calculated FFR drop below the lower limit determines the presence of a functionally significant lesion or other feature that may require intervention [0176]. The recited first activity, second activity and all intermediate activity levels are taught by Spilker since different values for the calculated parameters are determined at various different points in the geometric anatomy represented by the model as described above.
calculating, based on the first pressure drop and the second pressure drop, a range of pressure drops for a range of inflow rates … comparing the range of pressure drops to the threshold; and displaying a result of the comparison
• Spilker does not teach the recitation above. However, Uus teaches a method for medical Imaging technologies for diagnosis of coronary artery disease where the FFR index is computed from the measured pressure and visualized in real time with the values below the 0.75-0.8 threshold (i.e. displaying results after compared to a threshold) (pg. 28 para. 2) and the FFR cut-off value defining a critical stenosis varies between 0.75 - 0.8, and accounts for the resulting 25 - 20% drop in the blood pressure (i.e. range of pressure drops) under hyperaemia (pg. 28 para. 2); with the measured instantaneous pressure at the root of the coronary artery Pa and distal along the artery Pd visualized on the screen along with the computed heart-cycle mean values and a significant drop in the measured distal pressure from 78 mmHg to 49 mmHg in pharmacologically-induced hyperaemia, which results in FFR = Pd/Pa = 0.69 being below the critical threshold value (pg. 30 para. 2)(i.e. comparing a pressure drop to the threshold).
Claim 12 recites:
wherein the first inflow rate is associated with a first activity level and the second inflow rate is associated with a second activity level that is different from the first activity level, wherein calculating a range of pressure drops for the range of flow rates comprises calculating a range of pressure drops for a range of activity levels
• Spilker teaches a computational analysis as described above regarding the flow field and flow rate parameters determined in the patient's anatomy at various points in the anatomy represented by the model [0077]; wherein the analysis included inflow and outflow boundaries through which flow is directed into and outward from the anatomy of the three-dimensional model respectively, with the inflow being assigned with a prescribed value or field for velocity, flow rate, pressure, or other characteristic, by coupling a heart model and/or a lumped parameter model to the boundary and outflow measuring physiologic characteristics of the patient, such as, but not limited to, cardiac output (the volume of blood flow from the heart), blood pressure, myocardial mass, etc. [0083].
Claim 20 recites:
wherein the first and second flow fields are calculated according to three-dimensional, time-independent equations
• Spilker teaches a computational analysis as described above; wherein the equations used in the model apply numerical methods (such as finite difference, finite volume, spectral, lattice Boltzmann, particle-based, level set, finite element methods, etc.) (i.e., comprising all methods used by Navier-Stokes equations) to determine information about the coronary blood flow in the patient's anatomy at various points in the anatomy represented by the model (i.e., as a function of three-dimensional space) [0077].
Rationale for combining (MPEP §2142-2143)
Regarding claims 1-20, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, the methods of Spilker in view of Uus because all references disclose methods for the investigation of medical imaging technologies for diagnosis of coronary artery disease. The motivation would have been to provide accuracy of the blood flow simulations and quality of reconstruction of vessel lumen from medical image datasets (pg. 72 para. 2 Uus);
Therefore it would have been obvious to one of ordinary skill in the art to substitute the method for medical imaging technologies for diagnosis of coronary artery disease of Tuch to the method by Uus because such a substitution is no more than the simple substitution of one known element for another. One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods for investigation of medical imaging technologies for diagnosis of coronary artery disease.
Response to applicant's remarks in regards of Claim Rejection 35 U.S.C. ~ 103
The Remarks of 02/10/2026 have been fully considered but are not persuasive for the reasons below:
In pg. 9 para. 2-3 the Applicant asserts:
Claim 1 recites, in part, "non-invasively determining a first pressure drop in the arterial segment based on the first flow field; ... non-invasively determining a second pressure drop in the arterial segment based on the second flow field; …The cited references do not disclose these claimed elements for the following two reasons … Applicant argued that Uus' "invasive procedure ... is completely different from the claims, in which flow fields and corresponding pressure drops are determined computationally, not though invasive measurements …. Independent claim 1 now recites "non-invasively determining a first/second pressure drop". The cited portions of Uus are directed to invasively determined pressure values from which FFR is calculated. See Uus, p. 29. Accordingly, Uus does not disclose non-invasively determined pressure values
The Examiner disagrees because Applicant's interpretation of the cited art is incorrect. In Uus pg. 29, the art describes an invasive procedure -invasive coronary angiography (ICA) - generally prescribed in cases where the diagnosis outcome of these noninvasive tests shows medium to high risk acute coronary syndrome, being generally performed after FFR based tests as the one described in the art - See Uus pg. 28 last paragraph and pg. 29 first paragraph. Furthermore, Uus teaches an overall approach to develop a methodology for the assessment of functional CAD severity in the context of non-invasive prediction of FFR (pg. 34 para. 2). Thus, the teachings of Spilker and Uus satisfy the contested limitation.
In pg. 10 para. 2-6 the Applicant asserts:
Spilker' s approach to evaluating different physiological conditions is to perform a separate analysis for each condition. E.g., Spilker ,i [0131] and FIGS. 9-11. Nowhere does Spilker disclose determining pressure drops for intermediate activity levels based on the results of two simulated activity levels, as recited in Claim 1. … At no point does Uus disclose determining pressure drops for intermediate activity levels based on the results of two other simulated activity levels, as recited in Claim 1 … For at least the reasons described above with regard to Claim 1, the applied references fail to teach or suggest each element of Claim 11. Reconsideration and withdrawal of the rejection of Claim 11 are respectfully requested
The instant specification [0095 – 0098] discloses the first and second activity levels may be any may be any activity level within the relevant range of activity for the patient. Therefore, the recited intermediate activity levels are defined as levels that fall in between any selection of first and second levels. The arguments directed to Spilker and Uus teaching a method for computing a range of pressure drops for a single activity level instead of a range of activity levels are not persuasive. Spilker teaches the determination of blood flow characteristics or parameters, such as blood flow velocity, pressure, flow rate, FFR at various locations in the aorta, the main coronary arteries, and/or other coronary arteries or vessels downstream from the main coronary arteries [0075] which reads on a range of values. Spilker also teaches that the equations used in the model apply numerical methods to the information about the coronary blood flow in the patient's anatomy at various points in the anatomy represented by the model [0077] which also reads on a range of values.
Furthermore, one of ordinary skill in the art would be motivated to use said teachings and create a method for computing a range of pressure drops for a range of activity levels for any of the taught parameters to achieve routine optimization. A motivation to combine the teachings originates from the "obvious to try" OR OBVIOUS TO OPTIMIZE 2144.05 rationale ,which states that choosing from a finite number of identified, predictable solutions (i.e. optimizing the predictable solutions regarding the cardiovascular treatment options for a patient – Spilker pg. 1 Abstract), with a reasonable expectation of success would motivate one of ordinary skill in the art. See MPEP 2143 (I). See MPEP 2144.05 (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art").
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRANCINI A FONSECA LOPEZ whose telephone number is (571)270-0899. The examiner can normally be reached Monday - Friday 8AM - 5PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Olivia Wise can be reached at (571) 272-2249. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/F.F.L./Examiner, Art Unit 1685
/JANNA NICOLE SCHULTZHAUS/Examiner, Art Unit 1685
Prosecution Insights