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 .
Status of Claims
In the response dated March 23rd 2026, Applicant amended claims 1, 3-9 and 11-17. Claims 2 and 14 are canceled. Claims 1, 3-13 and 15-21 are pending.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on December 10th, 2024; September 20th, 2021; and June 27th, 2025 are being considered by the examiner.
Response to Arguments
In response to the argument put forward in the amendment, Examiner will address them in the order they were presented.
Regarding pages 7, Applicant’s arguments have been considered but are moot in view of the amended claim language.
Regarding pages 8-10, Applicant’s arguments have been considered but are moot in view of the amended claim language. Applicant argues that the amended claim language cannot be performed in the human mind and therefore recite an amended step that integrates the abstract idea into a practical application. The Examiner submits below that amending the claims to include receiving image datasets from an apparatus is not characterized as being directed to a mental process. As such, this argument cannot be persuasive.
Regarding pages 10-13, Applicant’s arguments have been considered but are moot in view of the amended claim language.
Regarding page 11, Applicant’s arguments have been considered but are unpersuasive. Applicant argues that the prior art of record does not disclose the formula because a volume term is used and the volume term significantly limits the calculation methods. MPEP 2111 states the claims must be “given their broadest reasonable interpretation consistent with the specification”. As previously mapped in claim 6, the prior art uses a calculation that translates normalized position vectors by integrating over the surface area. While the integral’s volumetric limits are exemplary limits applied in this context, this example does not prevent the integral limits to be rewritten in the form of the surface area and will indicate the same information. Thus, Examiner maintains that under broadest reasonable interpretation, the prior art’s equations teach Applicant’s claimed force vector equation, as referenced in claim 6.
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, 3-13 and 15-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter and a judicial exception without significantly more.
Step 1
Claims 1, 3-13 and 15-21 recite(s) subject matter within a statutory category as a process, machine, and/or article of manufacture. However, it will be shown in the following steps, that claims 1, 3-13 and 15-21 are nonetheless unpatentable under 35 U.S.C. 101.
Step 2A Prong One
Claim 1 states:
A computer-implemented method for estimating hemodynamic forces between blood and a surrounding heart chamber, the method comprising:
receiving, from an imaging apparatus, imaging datasets comprising information related to a boundary surface of the heart chamber for making a three-dimensional reconstruction of the boundary surface
expressing the boundary surface S(t) of the heart chamber as a series of meshes s, each mesh identified by a position vector x(s, t);
calculating, based on the information related to the boundary surface of the heart chamber, an instantaneous velocity vector v(s, t) at each position x(s,t);
calculating, or receiving in input, a normal vector n(s,t) normal to the boundary, surface at each position x(s,t);
calculating at each position x(s,t) a surface parameter f(s,t) as a function of the velocity vector v(s,t), the position vector x(s,t) and the normal vector n(s,t); and
deriving a force vector as an estimate of hemodynamic forces by performing an integration of the surface parameter f(s,t) over the boundary surface.
The broadest reasonable interpretation of these steps includes mathematical concepts because each bolded component can practically be performed by the human mind or with pen and paper. Other than reciting generic computer terms like “computer implemented”, nothing in the claims precludes the bold-font portions from practically being performed in the mind. For example, but for the “computer implemented” language, “calculating, based on the information related to the boundary surface of the heart chamber, an instantaneous velocity vector v(s,t) at each position x(s,t)” in the context of this claim encompasses mathematical calculations. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “mathematical concepts” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
These steps of:
A … method for estimating hemodynamic forces between blood and a surrounding heart chamber from sequence images of a boundary surface of such a heart chamber, the method comprising:
calculating, based on the information related to the boundary surface of the heart chamber, an instantaneous velocity vector v(s,t) at each position x(s,t);
calculating, or receiving in input, a normal vector n(s,t) normal to the boundary, surface at each position x(s,t);
calculating at each position x(s,t) a surface parameter f(s,t) as a function of the velocity vector v(s,t), the position vector x(s,t) and the normal vector n(s,t); and
deriving a force vector as an estimate of the hemodynamic forces by performing an integration of the surface parameter f(s,t) over the boundary surface
as drafted, under the broadest reasonable interpretation, includes mathematical concepts.
Claims 16 and 17 covers similar steps of calculating out instantaneous velocity vectors, a normal vector, a surface parameter, and creating a mech of a surface. These claims fall under the same category of an abstract idea and follows the same rationale as claim 1.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claim 4, reciting particular aspects of how “calculating the surface parameter f(s,t) as
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” may be merely mathematical calculations but for recitation of generic computer components).
Dependent claim 13 adds additional elements to their parent claims which will be further inspected in the following steps for a practical application to their abstract idea.
Step 2A Prong Two
This judicial exception of “Mathematical Concepts” is not integrated into a practical application. Independent claim 1’s method recites additional elements such as a computer. In addition to the generic components and additional elements listed above, independent claim 16 and 17’s product and system also includes a computer, memory, processing unit, imaging apparatus, and graphical user interface. The computer, memory, processing unit, and graphical user interface will be treated as a generic computer component. In particular, these additional elements do not integrate the abstract idea into a practical application because the additional elements:
amount to mere instructions to apply an exception (such as recitation of “computer implemented” amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of “receiving, from an imaging apparatus, imaging datasets comprising information related to a boundary surface of the heart chamber for making a three-dimensional reconstruction of the boundary surface” and “expressing the boundary surface S(t) of the heart chamber as a series of meshes s, each mesh identified by a position vector x(st);” amounts to insignificant application, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. For instance, dependent claims 20 add additional elements of “phase-contrast MRI” and an “echographic apparatus” to their parent claims. Additionally, dependent claim 13’s “image datasets are bi- dimensional or three-dimensional” adds insignificant extra-solution activity to the abstract idea which amounts to necessary data outputting, see MPEP 2106.05(g)). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The remaining dependent claims do not recite additional elements or activity but further narrow or define the abstract idea embodied in the claims and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, and add insignificant extra-solution activity to the abstract idea. Additionally, the additional limitations, amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
To elaborate:
“receiving, from an imaging apparatus, imaging datasets comprising information related to a boundary surface of the heart chamber for making a three-dimensional reconstruction of the boundary surface” , is equivalently, receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i);
“expressing the boundary surface S(t) of the heart chamber as a series of meshes s, each mesh identified by a position vector x(st);”, is equivalently, Arranging a hierarchy of groups, sorting information, Versata Dev. Group, Inc. v. SAP Am., Inc., MPEP 2106.05(d)(II)(vi)
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to no more than adding insignificant extra-solution activity to the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims.
As previously noted, the claim recites an additional element of an MRI and imaging apparatus. Per MPEP 2106.05(d), Ikezaki et al. (20030228043) demonstrates in [FIG. 5] “a flow chart showing an operation of parallel imaging processing in a conventional MRI apparatus” that MRIs were conventional long before the priority data of the claimed invention. As such, this additional element, individually and in combination with the prior additional element, does not amount to significantly more.
As previously noted, the claim recites an additional element of an echographic apparatus. Further, Bonnefous (Pat. 5579771) demonstrates in para [11] “The use of linear networks of transducer elements not only enables focusing, but also the execution of the scanning necessary for the formation of a two-dimensional image on the screen of a conventional echographic monitor” that echographic apparatuses were conventional long before the priority data of the claimed invention. As such, this additional element, individually and in combination with the prior additional element, does not amount to significantly more.
To elaborate:
“image datasets are bi- dimensional or three-dimensional”, is equivalently, Arranging a hierarchy of groups, sorting information, Versata Dev. Group, Inc. v. SAP Am., Inc., MPEP 2106.05(d)(II)(vi).
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Claim Rejections - 35 USC § 102
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.
Claims 1-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pedrizzetti et al. (Journal of Biomechanics, Vol. 60, 2017)
Regarding claim 1, Pedrizzetti teaches.
A computer-implemented method for estimating hemodynamic forces between blood and a surrounding heart chamber, the method comprising: ([page 203] “we introduce a simplified model based on first principles of fluid dynamics that allows estimating hemodynamic forces without knowing the velocity field inside the LV. The model is validated with 3D phase-contrast MRI (known as 4D flow MRI) in 15 subjects, (5 healthy and 10 patients) using the endocardial surface reconstructed from the three standard long-axis projections.” Where a model comprising 4D flow MRI that estimates hemodynamic forces using endocardial surface reconstruction comprises this method)
receiving, from an imaging apparatus, imaging datasets comprising information related to a boundary surface of the heart chamber for making a three-dimensional reconstruction of the boundary surface ([page 204] “MRI acquisition and quantification procedure was … including balanced steady-state free precession (bSSFP) cine images in standard short- and long-axis projections and four-dimensional (4D - 3D + time) flow measurements by PC-MRI covering the whole heart.”)
expressing the boundary surface S(t) of the heart chamber as a series of meshes s, each mesh identified by a position vector x(s,t); ([equation 2]; see also [page 204] “S(t) is the boundary surface of the fluid domain,” and “The entire LV endocardial surface is then described by its 3D coordinates evaluated by interpolation on a structured mesh made of 36 points along the circumference and 32 points from base to apex” where the mesh comprises a series of connected position vectors to locate the mesh)
calculating, based on the information related to the boundary surface of the heart chamber, an instantaneous velocity vector v(s,t) at each position x(s,t); ([equation 1]; see also [page 204] “Then, the global hemodynamic force vector was evaluated by computing the integral balance of momentum, where V(t) indicates the 3D LV flow domain and the integral is computed as the sum of values on each slice multiplied by the slice thickness; is the velocity vector field measured with PC-MRI” where heart flow is correlated with the surface area of a heart’s interior)
calculating, or receiving in input, a normal vector n(s,t) normal to the boundary, surface at each position x(s,t); ([equation 2]; see also [page 204] “n is the outward unit normal vector.”)
calculating at each position x(s,t) a surface parameter f(s,t) as a function of the velocity vector v(s,t), the position vector x(s,t) and the normal vector n(s,t); and ([equation 2] where integrating an equation comprising a velocity vector, normal vector, and position vector comprises calculating each position.)
deriving a force vector as an estimate of the hemodynamic forces by performing an integration of the surface parameter f(s,t) over the boundary surface ([equation 2] where the integration of this equation comprises deriving a force vector)
Regarding claim 3, Pedrizzetti teaches all of the limitations of claim 1. Pedrizzetti also teaches
determining a projection of the surface parameter f(s,t) on the normal n(s,t) to the surface at each position x(s,t). (see [equation 2] where the dot product of the normal vector n to the position vector v comprises a projection)
Regarding claim 4, Pedrizzetti teaches all of the limitations of claim 1. Pedrizzetti also teaches:
calculating the surface parameter f(s,t) as
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([equation 2] where the surface area equation M(t) of the system comprises the surface parameter.)
Regarding claim 5, Pedrizzetti teaches all of the limitations of claim 1. Pedrizzetti also teaches:
deriving a local force vector f(x,t) as an estimate of the hemodynamic forces as
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where p is the density of the blood. ([equation 2] and [page 204] “the two terms are synthetically indicated by the symbols I(t) and M(t).” where the force vector comprises the integral)
Regarding claim 6, Pedrizzetti teaches all of the limitations of claim 1. Pedrizzetti also teaches:
calculating a force vector F(t) as
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([equation 2] where the force vector comprises the integral of the surface vectors as a factor or the surface area projection and the position vectors)
Regarding claim 7, Pedrizzetti teaches all of the limitations of claim 1. Pedrizzetti also teaches:
calculating as parameter the normal component of the local force vector, related in the integral sense to pressure distribution p(x,t), as
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([equation 2] where determining the force over a region of surface area comprises finding the pressure distribution; see also [equation 4] and [204] “The z-coordinate ranges from 0 to the LV height H(t) and A(t) indicates the transversal LV area at each level z such that the ventricular volume is [equation 3]" where equation three uses the cross sectional area to determine the inertia)
Regarding claim 8, Pedrizzetti teaches all of the limitations of claim 1. Pedrizzetti also teaches:
calculating as parameter the tangential component or the norm of the local force vector f(x,t). ([equation 2] comprises the normalization vector n)
Regarding claim 9, Pedrizzetti teaches all of the limitations of claim 1. Pedrizzetti also teaches:
normalizing the estimated hemodynamic forces over the volume of the heart chamber V(t). ([equation 4]; see also [page 205] “where U(t) is the velocity vector averaged in the entire LV cavity” where averaging the entire velocity vector in the entire cavity comprises normalizing the hemodynamic forces over the volume of the heart chamber)
Regarding claim 10, Pedrizzetti teaches all of the limitations of claim 1. Pedrizzetti also teaches:
wherein the volume of the heart chamber V(t) is calculated as
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([equation 10] where the equation averaged the velocity vector across the LV cavity the volume of the heart by integrating the normalized velocity across the apportioned surface area)
Regarding claim 11, Pedrizzetti teaches all of the limitations of claim 1. Pedrizzetti also teaches:
expressing the boundary surface S(t) of the heart chamber as a series of geometrical figures, with the position vector x(s,t) identifying a center of such figures. ([equation 2] where integrating S(t) comprises infinitesimally small sized geometrical figures comprising a center of x(t))
Regarding claim 12, Pedrizzetti teaches all of the limitations of claim 1. Pedrizzetti also teaches:
wherein the heart chamber has a solid part having surface S1 and at least one aperture having an open boundary surface S2, step b) comprising receiving in input a velocity of the blood crossing the open boundary surface S2 or calculating the velocity vector an average normal velocity across the aperture as
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([equation 2] or [equation 20] where M(t) comprises an integral across the boundaries S(t) that can have open or closed boundary surfaces)
Regarding claim 13, Pedrizzetti teaches all of the limitations of claim 1. Pedrizzetti also teaches:
wherein the image sets are bi- dimensional or three-dimensional. ([page 204] “Three-dimensional (3D) PC-MRI (often referred as 4D flow MRI) was used to evaluate hemodynamic forces … cross-sectional area of the aorta was measured using a separate 2D PC-MR flow acquisition” )
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.
Claims 15-21 are rejected under 35 U.S.C. 103 as being unpatentable over Pedrizzetti et al. in view of Zheng et al. (US9275190).
Regarding claim 15, Pedrizzetti teaches all of the limitations of claim 1. Pedrizzetti does not teach, as taught by Zheng:
wherein parts of the boundary surface corresponding to at least one heart valve are segmented as single circular or polygon mesh. ([39] “The RA is represented as an open mesh with a hole defined by the tricuspid valve… Images (b) and (e) are the mesh triangles and the mesh surface, respectively, of the RA mesh 1404” where triangles of the tricuspid valve
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 have modified Pedrizzetti with the teachings of Zheng, with a reasonable expectation of success, by explicitly using computer components to model blood flow withing the heart using surface topology. This would have integrated the distribution of mesh modeling software across various hospitals to improve cardiac diagnosis across the country. Zheng is adaptable to Pedrizzetti as both inventions use parametric modeling of the heart to distinguish various features. Pedrizzetti would have found Zheng’s teaching while solving the issue that “it is difficult to manually label the correspondence in 3D because many more points are involved and there is no natural ordering of mesh points” [7].
Regarding claim 16, Pedrizzetti teaches:
for performing the method according to claim 1 (see claim 1 above)
Regarding claim 16, Pedrizzetti does not teach, as taught by Zheng:
A non-transitory computer readable medium directly loadable in a memory of a digital computer and comprising software code portions [for performing the method according to claim 1], when the product is run on the computer. ([44] “The heart model can be output by storing the heart model to a memory, storage, or computer readable medium.”)
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 have modified Pedrizzetti with the teachings of Zheng, with a reasonable expectation of success, by explicitly using computer components to model blood flow withing the heart using surface topology. This would have integrated the distribution of mesh modeling software across various hospitals to improve cardiac diagnosis across the country. Zheng is adaptable to Pedrizzetti as both inventions use parametric modeling of the heart to distinguish various features. Pedrizzetti would have found Zheng’s teaching while solving the issue that “it is difficult to manually label the correspondence in 3D because many more points are involved and there is no natural ordering of mesh points” [7].
Regarding claim 17, Pedrizzetti teaches:
A system for estimating hemodynamic forces between blood and a surrounding heart chamber, comprising: a) a first input for receiving from an imaging apparatus imaging datasets comprising information related to a boundary surface of the heart chamber for making a three-dimensional reconstruction of the boundary surface; ([page 203] “we introduce a simplified model based on first principles of fluid dynamics that allows estimating hemodynamic forces without knowing the velocity field inside the LV. The model is validated with 3D phase-contrast MRI (known as 4D flow MRI) in 15 subjects, (5 healthy and 10 patients) using the endocardial surface reconstructed from the three standard long-axis projections.” Where a model comprises 4D flow MRI that estimates hemodynamic forces using images of the heart chamber [i.e., the system]; see also [page 204] “MRI acquisition and quantification procedure was … including balanced steady-state free precession (bSSFP) cine images in standard short- and long-axis projections and four-dimensional (4D - 3D + time) flow measurements by PC-MRI covering the whole heart.”))
a) make a three-dimensional reconstruction of the heart chamber boundary surface S(t); ([equation 2]; see also [page 204] “S(t) is the boundary surface of the fluid domain,” and “The entire LV endocardial surface is then described by its 3D coordinates evaluated by interpolation on a structured mesh made of 36 points along the circumference and 32 points from base to apex” where the mesh comprises a position vector associated with each component)
b) divide the boundary surface S(t) of the heart chamber in a series of meshes s; ([equation 2]; see also [page 204] “S(t) is the boundary surface of the fluid domain,” and “The entire LV endocardial surface is then described by its 3D coordinates evaluated by interpolation on a structured mesh made of 36 points along the circumference and 32 points from base to apex” where the mesh comprises a series of connected position vectors to locate the mesh)
c) associate to each mesh a position vector x(s,t); (see [equation 2] and [204] above)
d) calculate based on information related to a boundary surface of the heart chamber, an instantaneous velocity vector v(s,t) at each position x(s,t); ([equation 1]; see also [page 204] “Then, the global hemodynamic force vector was evaluated by computing the integral balance of momentum, where V(t) indicates the 3D LV flow domain and the integral is computed as the sum of values on each slice multiplied by the slice thickness; is the velocity vector field measured with PC-MRI” where heart flow is correlated with the surface area of a heart’s interior)
e) calculate a normal vector n(s,t) normal to the boundary surface at each position x(st); ([equation 2]; see also [page 204] “n is the outward unit normal vector.”)
f) calculate at each position x(s,t) a surface parameter f(s,t) as a function of the velocity vector v(s,t), the position vector x(s,t) and the normal vector n(s,t); ([equation 2] where integrating an equation comprising a velocity vector, normal vector, and position vector comprises calculating each position.)
g) derive a force vector as an estimate of the hemodynamic by performing an integration of the surface parameter f(s,t); ([equation 2] where the integration of this equation comprises deriving a force vector)
Regarding claim 17, Pedrizzetti does not teach, as taught by Zheng:
b) memory to store program instructions; ([46] “The above-described methods for generating a four-chamber heart model may be implemented on a computer using well-known computer processors, memory units, storage devices, computer software, and other components.”)
c) a processing unit (see [46] above)
d) a graphical user interface configured to receive user inputs; ([46] “The computer 2002 also includes other input/output devices 2008 that enable user interaction with the computer 2002 (e.g., display,”)
e) an output for outputting force-related parameters in numeric and/or graphical format, characterized in that processing unit is configured to execute the program instructions to: (see [46] above, where the computer uses the processing unit to display force related parameters using the program instructions; see also [2] “such volume-based models are widely used in finite element based approaches to study the blood flow of a heart.” Where the study of blood flow comprises force-related parameters in
h) output values based on such parameter or parameters over the boundary surface. ([44] “The heart model can also be output by displaying the heart model” where outputting the heart model comprises outputting values based on parameters)
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 have modified Pedrizzetti with the teachings of Zheng, with a reasonable expectation of success, by explicitly using computer components to model blood flow withing the heart using surface topology. This would have integrated the distribution of mesh modeling software across various hospitals to improve cardiac diagnosis across the country. Zheng is adaptable to Pedrizzetti as both inventions use parametric modeling of the heart to distinguish various features. Pedrizzetti would have found Zheng’s teaching while solving the issue that “it is difficult to manually label the correspondence in 3D because many more points are involved and there is no natural ordering of mesh points” [7].
Regarding claim 18, Pedrizzetti-Zheng as a combination teaches all of the limitations of claim 17. Pedrizzetti also teaches:
characterized in that it is provided in combination with an echographic, a CT or an MRI apparatus for acquiring sequences of two-dimensional or three-dimensional images of the heart chamber to be transferred to the first input of the device ([page 203] “we introduce a simplified model based on first principles of fluid dynamics that allows estimating hemodynamic forces without knowing the velocity field inside the LV. The model is validated with 3D phase-contrast MRI (known as 4D flow MRI) in 15 subjects, (5 healthy and 10 patients) using the endocardial surface reconstructed from the three standard long-axis projections.” Where a system for estimating hemodynamic forces comprises a 4D MRI for acquiring blood velocity)
Regarding claim 19, Pedrizzetti-Zheng as a combination teaches all of the limitations of claim 17. Regarding claim 19, Pedrizzetti does not teach, as taught by Zheng:
further comprising a second input for receiving values of a velocity of the blood at apertures crossing the boundary surface of the heart chamber, ([46] “An image acquisition device 2020, such as a CT scanning device, can be connected to the computer 2002 to input the 3D volumes to the computer 2002.”) the processing unit being configured to use such values as the velocity of meshes covering such apertures. ([2] “Such volume-based models are widely used in finite element based approaches to study the blood flow of a heart.” [39] “The RA is represented as an open mesh with a hole defined by the tricuspid valve. FIG. 14 illustrates RV and RA meshes.” Where the open meshes are apertures covering valves to measure a heart’s blood flow [i.e., the velocity of meshes covering such apertures)
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 have modified Pedrizzetti with the teachings of Zheng, with a reasonable expectation of success, by explicitly using computer components to model blood flow withing the heart using surface topology. This would have integrated the distribution of mesh modeling software across various hospitals to improve cardiac diagnosis across the country. Zheng is adaptable to Pedrizzetti as both inventions use parametric modeling of the heart to distinguish various features. Pedrizzetti would have found Zheng’s teaching while solving the issue that “it is difficult to manually label the correspondence
Regarding claim 20, Pedrizzetti-Zheng as a combination teaches all of the limitations of claim 19. Pedrizzetti also teaches:
characterized in that it is provided in combination with an echographic apparatus having Doppler capabilities or a phase-contrast MRI apparatus for acquiring the values of the velocity of the blood at apertures crossing boundary surface of the heart chamber to be transferred to the second input. ([page 203] “we introduce a simplified model based on first principles of fluid dynamics that allows estimating hemodynamic forces without knowing the velocity field inside the LV. The model is validated with 3D phase-contrast MRI (known as 4D flow MRI) in 15 subjects, (5 healthy and 10 patients) using the endocardial surface reconstructed from the three standard long-axis projections.” Where a system for estimating hemodynamic forces comprises a 4D MRI for acquiring blood velocity)
Regarding claim 21, Pedrizzetti-Zheng as a combination teaches all of the limitations of claim 17. Pedrizzetti also teaches:
characterized in being configured to be interfaced, or provided in combination, with an imaging apparatus for acquiring two-dimensional or three-dimensional images of a heart of a subject, the processing unit being configured to evaluate a geometry of an endocardial border. ([page 203] “we introduce a simplified model based on first principles of fluid dynamics that allows estimating hemodynamic forces without knowing the velocity field inside the LV. The model is validated with 3D phase-contrast MRI (known as 4D flow MRI) in 15 subjects, (5 healthy and 10 patients) using the endocardial surface reconstructed from the three standard long-axis projections.” Where a model comprising 4D flow MRI that estimates hemodynamic forces using endocardial surface reconstruction comprises this system to measure the geometry of an endocardial border)
Additional Considerations
The prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure can be found on PTO-892 of the prior office action.
Maessen et al. (US20210012887) applies a meshless simulation frame-work for simulating blood flow forces through an imaged cardiac region.
Ionasec et al. (US20120022843) discloses a system for patient-specific modeling of the whole heart anatomy, dynamics, hemodynamics, and fluid structure interaction from 4D medical image data.
Conclusion
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 ROBERT ANTHONY SKROBARCZYK whose telephone number is (571)272-3301. The examiner can normally be reached Monday thru Friday 7:30AM -5PM CST.
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, Unsu Jung can be reached at 571-272-8506. 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.
/R.A.S/Examiner, Art Unit 3792
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
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