DETAILED ACTION
The Applicant’s response, received 22 September 2025, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 the Claims
Claims 1-14 and 18-20 are pending.
Claims 1-14 and 18-20 are rejected.
Claims 7, 8, 9, 10, 12, 14, and 20 are objected to.
Priority
This application is a 371 of PCT/EP2020/056000, filed 03/06/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claims 1-14 and 18-20 are given the benefit of priority of EUROPEAN PATENT OFFICE (EPO) Application No. 19161587.1, filed 08 March 2019.
Therefore, the effective filing date of the claimed invention is 08 March 2019.
Drawings
The objection to the drawings in the Office action mailed 20 May 2025 is withdrawn in view of the amendment received 22 September 2025.
The replacement drawings received 22 September 2025 are acceptable and have been entered.
Specification
The amendment to the Specification received 22 September 2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) received on 22 September 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Interpretationi1
The claim interpretations in the Office action mailed 20 May 2025 are updated and/or modified and/or maintained and/or withdrawn as noted below in view of the Applicant’s amendment and arguments/remarks received 22 September 2025.
Independent claim 1 recites the limitations “providing a plurality of implant models, each implant model representing a three-dimensional mesh-based representation of a corresponding real-life cardiac implant device…” and “providing a four-dimensional (4D) patient-specific anatomical model representing a mesh-based representation of a patient-specific cardiac region including deployment positions for the cardiac implant in a plurality of states corresponding to a plurality of moments in a cardiac cycle….” Independent claims 18 and 19 recite variations of these limitation (i.e., claim 18 recites “receive…” and claim 19 recites “retrieve”). These limitations are interpreted to be product-by-process limitations with the products being the implant models and the 4D patient-specific anatomical model, and further interpreted to be limited to the step of providing/receiving/retrieving the products, and not requiring the process of performing the active steps of producing the products.
Claims 1, 18, and 19 recite the limitation “the implant model deployed at the respective deployment position” in the “…calculate, for each combination…” step. This limitation is interpreted to be a product-by-process limitation with the product being the implant model deployed at the deployment site, and further interpreted to not require the process of performing the active steps of deploying the implant model (e.g., positioning the implant, and performing steps that result in mesh nodes of the implant model being in contact with mesh nodes of the patient-specific anatomical model at a deployment site).
Response to Arguments
The Applicant’s arguments/remarks received 22 September 2025 have been fully considered, and are persuasive in part, and not persuasive in part, as noted below.
The Applicant states on page 16 of the Remarks that regarding the “bench” recited in claim 17, the term “bench” refers to a physical test bench for testing actual cardiac implants and not a virtual/in silico simulation.
This argument is persuasive, and it is further noted that claim 17 has been cancelled in the amendment received 22 September 2025.
The Applicant states on page 17-18 of the Remarks that the Applicant traverses the Examiner’s product-by-process characterization of the present claims, and further states that claim 1 is directed to “a method for patient-specific predicting of cyclic loading failure of a cardiac implant,” not a product claim, and that product-by-process analysis applies only to product claims where a product is defined by the process of making it and does not apply to method claims that recite active method steps. The Applicant further states that the “providing” limitations in claim 1 are active method steps that make the implant model and 4D anatomical model available for use the subsequent calculating and determining steps, and that the implant model and 4D anatomical model are input data structures used to perform the claimed method, not products being defined by their manufacture, and further states that the specification supports a functional interpretation by describing the models in terms of their representational capabilities rather than their method of creation.
These arguments are not persuasive, because first, the step of providing/receiving/retrieving the models (i.e., gathering data for use in the claimed process) in the independent claims is treated as an active step of receiving data in the Office action mailed 20 May 2025 and in the claim analyses of the current Office action. Second, the independent claims do not recite active steps of generating the models (i.e., the data in the providing/receiving/retrieving steps), and therefore these models are interpreted to be products (i.e., data) received and used in the claimed method steps recited by the independent claims, but not produced in any of the active steps recited in the independent claims, i.e., the models are products of a process not recited by the independent claims. Third, the MPEP does not exclude “data” as a product, and the various examples provided in the MPEP at 2113 I. are merely examples and are not limiting of the subject matter that can be considered as a product-by-process limitation.
Claim Objections
The objections to claims 1, 2, 11, 13, 14, 18, and 19 in the Office action mailed 20 May 2025 are withdrawn in view of the amendment received 22 September 2025.
The amendment received 22 September 2025 has been fully considered, however after further consideration, new grounds of objection are raised in view of the amendment.
Claims 7, 8, 9, 10, 12, and 20 are objected to because of the following informalities: The status indicator of the claims does not correctly reflect the status of the claims, because the status indicator shows as “(Original)”, however the claims were indicated as having been currently amended and/or new in the claim set received 07 September 2021, and therefore the status indicator of these claims in the current set of claims should show as “(Previously presented)” as required by 37 C.F.R. 1.121 (MPEP 714).
Claim 14 is objected to because of the following informalities: A comma should be inserted between the word “images” and the word “constructing” in line two.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The rejection of claims 1-20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, in the Office action mailed 20 May 2025 is withdrawn in view of the amendment received 22 September 2025.
The Applicant’s amendment received 22 September 2025 has been fully considered, however after further consideration, new grounds of rejection are raised under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, in view of the amendment.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 is indefinite for reciting “wherein the cardiac implant is a valve implant or a stent” because claim 1 recites both “implant model” and “implant device” and therefore it is not clear as to whether the limitation of claim 9 is referring to a simulated implant model used for in silico calculations, or alternatively, an implant device that is implanted into a patient at the “performing real-life percutaneous implantation” step of claim 1. Claim 9 is interpreted to further define the implant device that is implanted into a patient at the “performing real-life percutaneous implantation” step of claim 1.
Claim 14 is indefinite for depending from claim 9 and for failing to remedy the indefiniteness of claim 9.
Claim Rejections - 35 USC § 101
The rejection of claims 1-20 under 35 U.S.C. 101 in the Office action mailed 20 May 2025 is maintained with modification in view of the amendment received 22 September 2025.
The rejection of claims 15, 16, and 17 under 35 U.S.C. 101 in the Office action mailed 20 May 2025 is withdrawn in view of these claims having been cancelled in the amendment received 22 September 2025.
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 1-14 and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite: (a) mathematical concepts, (e.g., mathematical relationships, formulas or equations, mathematical calculations); and (b) mental processes, i.e., concepts performed in the human mind, (e.g., observation, evaluation, judgement, opinion).
Claim interpretation
The claim 9 limitation reciting “wherein the cardiac implant is a valve implant or a stent” is interpreted to further define the “cardiac implant device” recited in the “performing real-life percutaneous implantation” step of claim 1.
Subject matter eligibility evaluation in accordance with MPEP 2106.
Eligibility Step 1: Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter?
Claims 1-14 and 20 are directed to a method (i.e., a process); and claim 18 is directed to a system including a processor (i.e., manufacture or machine).
Therefore, these claims are encompassed by the categories of statutory subject matter, and thus, satisfy the subject matter eligibility requirements under step 1.
[Step 1: YES]
Claim 19 is directed to a computer program product including computer-implementable instructions, and further directed to an embodiment that is software per se, because the claim limitation reciting “which when implemented by a programmable computer cause the computer to” is an intended use of the computer program product, which does not require that the computer program product actually be stored on a computer.
Therefore, this claim is not encompassed by the categories of statutory subject matter, and thus, does not satisfy the eligibility requirements under step 1.
[Step 1: NO]
However, in the interest of compact prosecution, claim 19 is examined herein to determine whether it qualifies as eligible at Pathway A or requires further analysis at Step 2A to determine if the claim is directed to a judicial exception.
Eligibility Step 2A: First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in Prong Two whether the recited judicial exception is integrated into a practical application of that exception.
Eligibility Step 2A Prong One: In determining whether a claim is directed to a judicial exception, examination is performed that analyzes whether the claim recites a judicial exception, i.e., whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim.
Independent claim 1 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
calculating, for each combination of implant model and deployment position among the plurality of implant models and a plurality of different deployment positions in the 4D patient-specific anatomical model, deformation of the implant model deployed at the respective deployment position by imposing deformation of the patient-specific anatomical model onto the implant model through contact between the patient-specific anatomical model and the implant model for each of the plurality of states (i.e., mental processes and mathematical concepts);
determining mechanical stresses and/or strain within each mesh element of each implant model at each deployment position for each of the plurality of states (i.e., mental processes and mathematical concepts);
determining an estimate of cyclic loading failure for each combination of implant model and deployment position using the mechanical stresses and/or strains and data representative of a material of the respective cardiac implant device (i.e., mental processes and mathematical concepts); and
selecting, from among the plurality of implant models and the plurality of deployment positions, the combination of implant model and deployment position determined to have the lowest risk of cyclic loading failure for real-life implantation (i.e., mental processes).
Independent claim 18 recites a system including a processor configured to perform the abstract ideas recited in independent claim 1.
Independent claim 19 recites a computer program product to perform the abstract ideas recited in independent claim 1.
Dependent claims 2-8, 10, 12-14, and 20 further recite the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas, as noted below.
Dependent claim 2 further recites:
determining a risk of cyclic loading failure of the cardiac implant on the basis of data representative of deformation history (i.e., mental processes and mathematical concepts).
Dependent claim 3 further recites:
the 4D patient-specific anatomical model represents a mesh-based representation of a patient-specific cardiac region in a plurality of states corresponding to a plurality of moments in the cardiac cycle before deployment (i.e., mathematical concepts).
Dependent claim 4 further recites:
providing a 4D patient-specific intermediate model, having associated nodes associated with nodes of the 4D patient-specific anatomical model, wherein the 4D patient-specific intermediate model represents a mesh-based representation of a patient-specific cardiac region in a plurality of states corresponding to a plurality of moments in the cardiac cycle before deployment, wherein the patient-specific anatomical model transforms through the plurality of states through transferring displacements of associated nodes of the 4D intermediate model via stiffness and/or dashpot elements to the nodes of the 4D patient-specific anatomical model (i.e., mathematical concepts).
Dependent claim 5 further recites:
the 4D patient-specific anatomical model has mechanical properties, including stiffness and/or viscosity, the overall mechanical behavior of the 4D patient-specific anatomical model depending on the combination of the mechanical properties of the 4D anatomical model and mechanical properties of the stiffness and/or dashpot elements connecting associated nodes to nodes of the 4D anatomical model (i.e., mathematical concepts).
Dependent claim 6 further recites:
if a cyclic loading simulation predicts a first fracture in the implant model, a second cyclic loading simulation is performed using a fractured version of the implant model incorporating the first fracture (i.e., mathematical concepts).
Dependent claim 7 further recites
determining the estimate of the risk of cyclic loading failure of the cardiac implant using a rainflow-counting algorithm or strain amplitude (i.e., mental processes and mathematical concepts).
Dependent claim 8 further recites:
determining the mechanical stresses and/or strains within each mesh element comprises determining for each mesh element of the implant model an amplitude of the mechanical stress and/or strain occurring in the course of the cardiac cycle, and determining a risk of cyclic loading failure on the basis of the determined amplitudes (i.e., mental processes and mathematical concepts).
Dependent claim 10 further recites:
the cyclic loading failure includes one or more of high cycle fatigue fracture, implant migration, valve failure (i.e., mental processes and mathematical concepts).
Dependent claim 12 further recites:
constructing the 4D patient-specific anatomical model on the basis of at least quasi, 3D medical images representing the patient-specific cardiac region in the plurality of states corresponding to the plurality of moments in the cardiac cycle (i.e., mathematical concepts).
Dependent claim 13 further recites:
constructing a 3D mesh-based representation of the patient-specific cardiac region on the basis of one of the medical images (i.e., mathematical concepts);
determining a transformation from one medical image to the next (i.e., mathematical concepts); and
applying the transformation to the constructed 3D mesh-based representation, providing the 4D patient-specific anatomical model (i.e., mathematical concepts).
Dependent claim 14 further recites:
for each of a plurality of medical images,
constructing a 3D mesh-based representation of the patient-specific cardiac region (i.e., mathematical concepts);
determining a transformation from one 3D mesh-based representation to the next (i.e., mathematical concepts); and
determining the 4D patient-specific anatomical model on the basis of the plurality of 3D mesh-based representations (i.e., mathematical concepts).
Dependent claim 20 further recites:
the data representative of the material of the cardiac implant comprises a digital S-N curve (i.e., mathematical concepts).
The abstract ideas recited in the claims are evaluated under the broadest reasonable interpretation (BRI) of the claim limitations when read in light of and consistent with the specification. As noted in the foregoing section, the claims are determined to contain limitations that can practically be performed in the human mind with the aid of a pencil and paper (e.g., selecting, from among the plurality of implant models and the plurality of deployment positions, the combination of implant model and deployment position determined to have the lowest risk of cyclic loading failure for real-life implantation), and therefore recite judicial exceptions from the mental process grouping of abstract ideas. Additionally, the recited limitations that are identified as judicial exceptions from the mathematical concepts grouping of abstract ideas (e.g., determining mechanical stresses and/or strain within each mesh element of each implant model at each deployment position for each of the plurality of states) are abstract ideas irrespective of whether or not the limitations are practical to perform in the human mind (see MPEP 2106.04(a)(2) I. A., i.e., organizing information and manipulating information through mathematical correlations, Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014)).
Evidence that certain steps of the claim limitations recite mathematical concepts, (i.e., mathematical relationships, mathematical formulas or equations, or mathematical calculations), as noted in the foregoing paragraphs, is provided by at least the following references:
Zhang et al. (Computational Methods in Applied Mechanics and Engineering, 2005, Vol. 194, pp. 5083-5106, as cited in the Office action mailed 20 May 2025) shows an algorithm for constructing adaptive and quality 3D meshes directly from volumetric imaging data for use in finite element calculations (Title; and Abstract) and further shows that the imaging data is given in the form of sampled function values on rectilinear grids with indices of x, y, z coordinates, and where a continuous function is constructed through the trilinear interpolation of sampled values for each cubic cell in the volume (pp. 5084-85, and throughout).
Sotiras et al. (IEEE Transactions on Medical Imaging, 2013, Vol. 32, No. 7, pp. 1153-1190, as cited in the Office action mailed 20 May 2025) reviews the fundamental task of deformable image registration in medical image processing and shows one of its most important applications is in longitudinal studies, where temporal structural or anatomical changes are investigated (Title; and Abstract); and further shows that an image registration algorithm involves three main components: 1) a deformation model, 2) an objective function, and 3) an optimization method (page 1153, column 2, para. 6). Sotiras et al. further shows interpolation strategies for geometric transformations using elastic body splines (pp. 1159-1163).
Kiousis et al. (International Journal for Numerical Methods in Engineering, 2008, Vol. 75, pp. 826-855, as cited in the Office action mailed 20 May 2025) reviews smooth contact strategies with emphasis on the modeling of balloon angioplasty with stenting (Title; and Abstract) and shows a contact algorithm where the target surfaces are described by polynomial expressions, and where the contact between the balloon, the stent and the artery wall is numerically modeled (Abstract and throughout).
Cansiz et al. (ZAMM – Journal of Applied Mathematics and Mechanics, 2018, pp. 1-22, as cited in the Office action mailed 20 May 2025) demonstrates the use of finite element analyses of personalized heart models (Title; and Abstract) and shows fundamental variables and kinematics describing the electro-visco-elastic nature of the cardiac tissue (Section 2.1) and the coupled field equations governing the modelling of cardiac mechanics (deformation) and cardiac electrophysiology (Section 2.2), among other equations (throughout).
Therefore, claims 1-14 and 18-20 recite an abstract idea.
[Step 2A Prong One: YES]
Eligibility Step 2A Prong Two: In determining whether a claim is directed to a judicial exception, further examination is performed that analyzes if the claim recites additional elements that when examined as a whole integrates the judicial exception(s) into a practical application (MPEP 2106.04(d)). A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claimed additional elements are analyzed to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d)(I); MPEP 2106.04(d)(III)).
The claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exception(s) because of the reasons noted below.
Dependent claims 3-8, 10, 13, 14, and 20 do not recite any elements in addition to the judicial exception(s), and thus are part of the judicial exception.
The additional elements in independent claim 1 include:
a computer;
providing a plurality of implant models, each implant model representing a three-dimensional mesh-based representation of a corresponding real-life cardiac implant device having different geometrical and/or material properties;
providing a four-dimensional (4D) patient-specific anatomical model representing a mesh-based representation of a patient-specific cardiac region including deployment positions for the cardiac implant in a plurality of states corresponding to a plurality of moments in a cardiac cycle, the plurality of states comprising a first state associated with systole and a second state associated with diastole; and
performing real-life percutaneous implantation of a cardiac implant device corresponding to the selected implant model at the selected deployment position.
The additional elements in independent claim 18 include:
a system including a processor;
receive a plurality of implant models, each implant model representing a three-dimensional mesh-based representation of a corresponding real-life cardiac implant device having different geometrical and/or material properties; and
receive a four-dimensional (4D) patient-specific anatomical model representing a mesh-based representation of a patient-specific cardiac region including deployment positions for the cardiac implant in a plurality of states corresponding to a plurality of moments in a cardiac cycle, the plurality of states comprising a first state associated with systole and a second state associated with diastole.
The additional elements in independent claim 19 include:
a computer;
retrieve a plurality of implant models, each implant model representing a three-dimensional mesh-based representation of a corresponding real-life cardiac implant device having different geometrical and/or material properties; and
retrieve a four-dimensional (4D) patient-specific anatomical model representing a mesh-based representation of a patient-specific cardiac region including a deployment site for the cardiac implant in a plurality of states corresponding to a plurality of moments in a cardiac cycle, the plurality of states comprising a first state associated with systole and a second state associated with diastole.
The additional elements in dependent claims 2, 9, 11, and 12 include:
a computer (claim 2);
the cardiac implant is a valve implant or a stent (claim 9);
providing the 4D patient-specific anatomical model comprises providing the 4D patient-specific anatomical model, or its associated nodes, on the basis of one or more of: segmentation of a 4D preoperative image; landmarks in 4D preoperative images; a 3D or 4D preoperative image in combination with patient-specific measurements of blood volume, flow and/or pressure taken before and/or after deployment of the implant; a 3D or 4D preoperative image in combination with non-patient-specific knowledge of cardiac patho-physiology; or a 3D or 4D preoperative image in combination with non-patient-specific knowledge of heart remodeling at chronic stage (claim 11); and
receiving a plurality of, at least quasi, 3D medical images representing the patient-specific cardiac region in the plurality of states corresponding to the plurality of moments in the cardiac cycle (claim 12).
The additional elements of a computer (claims 1, 2, and 19); and a system including a processor (claim 18); invoke a computer and/or computer-related components merely as tools for use in the claimed process, and therefore are not an improvement to computer functionality itself, or an improvement to any other technology or technical field, and thus, do not integrate the judicial exceptions into a practical application (see MPEP 2106.04(d)(1)).
The additional elements of providing a plurality of implant models and providing a four-dimensional (4D) patient-specific anatomical model (claim 1); receiving a plurality of implant models and receiving a four-dimensional (4D) patient-specific anatomical model (claim 18); retrieving a plurality of implant models and retrieving a four-dimensional (4D) patient-specific anatomical model (claim 18); providing the 4D patient-specific anatomical model comprises providing the 4D patient-specific anatomical model, or its associated nodes, on the basis of one or more of: segmentation of a 4D preoperative image; landmarks in 4D preoperative images; a 3D or 4D preoperative image in combination with patient-specific measurements of blood volume, flow and/or pressure taken before and/or after deployment of the implant; a 3D or 4D preoperative image in combination with non-patient-specific knowledge of cardiac patho-physiology; or a 3D or 4D preoperative image in combination with non-patient-specific knowledge of heart remodeling at chronic stage (claim 11); and receiving a plurality of, at least quasi, 3D medical images representing the patient-specific cardiac region in the plurality of states corresponding to the plurality of moments in the cardiac cycle (claim 12); are merely pre-solution activities of gathering data for use in the claimed process – nominal additions to the claims that do not meaningfully limit the claims, and therefore do not add more than insignificant extra-solution activity to the judicial exceptions (MPEP 2106.05(g)).
The additional element of the cardiac implant is a valve implant or a stent (claim 9); does not amount to more than generally linking the use of a judicial exception to a particular field of use (e.g., percutaneous implantation of cardiac devices), and therefore does not amount to significantly more than the exceptions themselves (MPEP 2106.05(h)).
The additional element of performing real-life percutaneous implantation of a cardiac implant device corresponding to the selected implant model at the selected deployment position (claim 1) does not apply or use the recited judicial exceptions to effect a particular treatment or prophylaxis for a disease or medical condition (MPEP 2106.04(d)(2)). In particular, this additional element does not satisfy factor a. (i.e., the particularity of generality of the treatment or prophylaxis), which states that the treatment or prophylaxis limitation must be “particular,” i.e., specifically identified. In the case of claim 1, the “performing real-life percutaneous implantation…” step is not particular because the cardiac implant device is not specifically identified, e.g., the claim limitation does not even specify if the device is a valve implant or a stent. Furthermore, the “performing real-life percutaneous implantation…” step does not appear to be specifically limited to the patient in the preamble, i.e., “pre-operatively selecting a cardiac implant for implantation in a patient” and instead appears to be generic to any patient, and therefore does not meaningfully limit the claim by going beyond generally linking the use of the judicial exceptions to a particular technological environment and/or field of use.
Thus, the additionally recited elements merely invoke a computer and/or computer related components as tools; and/or amount to insignificant extra-solution activity; and/or a field of use in which to apply a judicial exception; and/or do not effect a particular treatment or prophylaxis for a disease or medical condition; and as such, when all limitations in claims 1-14 and 18-20 have been considered as a whole, the claims are deemed to not recite any additional elements that would integrate a judicial exception into a practical application, and therefore claims 1-14 and 18-20 are directed to an abstract idea (MPEP 2106.04(d)).
[Step 2A Prong Two: NO]
Eligibility Step 2B: Because the claims recite an abstract idea, and do not integrate that abstract idea into a practical application, the claims are probed for a specific inventive concept. Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself (MPEP 2106.05(I)).
Dependent claims 3-8, 10, 13, 14, and 20 do not recite any elements in addition to the judicial exception(s).
The additional elements recited in independent claims 1, 18, and 19 and dependent claims 2, 9, 11, and 12 are identified above, and carried over from Step 2A Prong Two along with their conclusions for analysis at Step 2B. Any additional element or combination of elements that was considered to be insignificant extra-solution activity at Step 2A Prong Two was re-evaluated at Step 2B, because if such re-evaluation finds that the element is unconventional or otherwise more than what is well-understood, routine, conventional activity in the field, this finding may indicate that the additional element is no longer considered to be insignificant; and all additional elements and combination of elements were evaluated to determine whether any additional elements or combination of elements are other than what is well-understood, routine, conventional activity in the field, or simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, per MPEP 2106.05(d).
The additional elements of a computer (claims 1, 2, and 19); and a system including a processor (claim 18); providing data (claims 1 and 11); receiving data (claims 12 and 18); and retrieving data (claim 19); are conventional (see MPEP at 2106.05(b) and 2106.05(d)(II) regarding conventionality of computer components and computer processes).
The additional elements of performing real-life percutaneous implantation of a cardiac implant device corresponding to the selected implant model at the selected deployment position (claim 1); and the cardiac implant is a valve implant or a stent (claim 9); are conventional. Evidence of the conventionality is shown by Rotman et al. (Expert Review of Medical Devices, 2018, Vol. 15(11), pp. 771-791, as cited in the Office action mailed 20 May 2025). Rotman et al. reviews the principles of transcatheter aortic valve replacement (TAVR) design, modelling, and testing (Title; and Abstract), and shows that traditionally, replacement of a diseased valve with a prosthetic valve has been the most effective treatment for aortic stenosis (page 2, para. 2).
Therefore, when taken alone, all additional elements in claims 1-14 and 18-20 do not amount to significantly more than the above-identified judicial exception(s). Even when evaluated as a combination, the additional elements fail to transform the exception(s) into a patent-eligible application of that exception. Thus, claims 1-14 and 18-20 are deemed to not contribute an inventive concept, i.e., amount to significantly more than the judicial exception(s) (MPEP 2106.05(II)).
[Step 2B: NO]
Response to Arguments
The Applicant’s arguments/remarks received 22 September 2025 have been fully considered, but are not persuasive.
The Applicant states on page 20 (para. 3) of the Remarks that the Applicant disagrees with the characterization that the claims are directed to an abstract idea, however, even assuming arguendo that the claims recite an abstract idea, the amended claims integrate any such judicial exception into a practical application under Step 2A Prong 2 of the eligibility analysis, and further states that the amended claims integrate any alleged abstract idea into the practical application of selecting and implanting an optimal cardiac implant device for a specific patient. The Applicant further states on page 20 (para. 4) through page 21 (para. 1) that the amended independent claims now recite a complete technological solution that evaluates multiple implant models having different geometrical and/or material properties; tests multiple deployment positions within the patient-specific anatomical model; calculates deformation and mechanical stresses for each combination of implant model and deployment position; selects the specific combination with the lowest risk of cyclic loading failure; and performs real-life percutaneous implantation of the selected cardiac implant device at the selected deployment position. The Applicant further states (para. 2) that this represents a practical application that uses any alleged mathematical calculations to achieve a specific technological improvement: optimal selection and placement of cardiac implants to minimize long-term failure risk, and that the claims are directed to solving a technological problem that is “necessarily rooted in technology,” namely, predicting and preventing mechanical failure of cardiac implants based on patient-specific anatomy and cyclic loading conditions.
These arguments are not persuasive, because first, the purported technological solutions of ”evaluates multiple implant models having different geometrical and/or material properties; tests multiple deployment positions within the patient-specific anatomical model; calculates deformation and mechanical stresses for each combination of implant model and deployment position; selects the specific combination with the lowest risk of cyclic loading failure” comprise the judicial exceptions identified at Eligibility Step 2A Prong One in the above rejection, and therefore do not provide a practical application. Second, the purported technological solution of “performs real-life percutaneous implantation of the selected cardiac implant device at the selected deployment position” does not effect a particular treatment or prophylaxis for a disease or medical condition, and therefore does not integrate the judicial exceptions into a practical application, as noted and discussed in the above rejection. Third, the claims do not recite any additional elements that apply, rely on, or use the judicial exceptions in a manner that imposes a meaningful limit on the judicial exception, for the reasons noted and discussed in the above rejection.
The Applicant states on page 21 (para. 3) that the amended claims recite “a particular solution” to the problem of cardiac implant failure by systematically evaluating multiple combinations and selecting the optimal one for actual implantation, and that this is analogous to McRO, Inc. v. Bandai Namco Games America Inc., 837 F.3d 1299 (Fed. Cir. 2016), where claims were found eligible because they used rules in a specific way to achieve an improved technological result. The Applicant further states that the instant claims use patient-specific modeling and fatigue analysis in a specific way to achieve the improved technological result of selecting implants with reduced failure risk.
These arguments are not persuasive, because first, the fact patterns differ between McRO (method for automatically animating lip synchronization and facial expression of animated characters) and the instant application (patient-specific predicting of cyclic loading failure of a cardiac implant). Second, with regard to the Applicant’s attempt at analogizing the instant claims with the eligibility determination in McRO, it is noted that in McRO, when looked at as a whole, claim 1 is directed to a patentable, technological improvement over the existing, manual 3-D animation techniques, i.e., the claim recited “a specific asserted improvement in computer animation” that was directed to the creation of something physical – namely, the display of lip synchronization and facial expressions of animated characters on screens for viewing by human eyes, and therefore was determined to not be directed to an unpatentable abstract idea at Eligibility Step 2A (i.e., Alice step one). In other words, it was not the mere presence of unconventional rules that led to patent eligibility, but rather the claimed technological improvement was to how the physical display operated to produce better quality images. Unlike the technological improvement found in McRO, the instant claimed advantage of using patient-specific modeling and fatigue analysis in a specific way to achieve the improved technological result of selecting implants with reduced failure risk is a purported improvement to the abstract idea (data analysis), and not an improvement to computer functionality itself, or an improvement to another technology or technical field.
The Applicant states on page 21 (para. 4) that the claims provide a technical improvement over existing cardiac implant selection methods by incorporating long-term cyclic loading failure prediction into the pre-operative planning process, and that the specification explains at para. [0005] that “an implant device that has been determined as optimal in view of acute outcome (e.g., deployment) not necessarily is optimal in view of chronic outcome (e.g., cyclic loading failure).” The Applicant further states that the claimed method addresses this technological gap by predicting chronic failure before implantation occurs. The Applicant further states on page 22 (para. 1) that the claims require specific technological inputs (mesh-based representations of actual implants with different properties), apply a specific analytical framework (contact-based deformation through multiple cardiac cycle states), and produce a specific technological output (selection of an optimal implant/position combination for actual surgical implementation).
These arguments are not persuasive, because the claimed improvement by incorporating long-term cyclic loading failure prediction into the pre-operative planning process comprises the judicial exceptions identified at Eligibility Step 2A Prong One in the above rejection, and the specific technological inputs (mesh-based representations of actual implants with different properties) are identified as insignificant extra-solution activities that are part of the gathering of data for use in the claimed process, and therefore do not integrate the recited judicial exceptions into a practical application. Furthermore, the steps that apply a specific analytical framework (contact-based deformation through multiple cardiac cycle states), and produce a specific technological output (selection of an optimal implant/position combination for actual surgical implementation) also comprise the judicial exceptions identified at Eligibility Step 2A Prong One in the above rejection.
The Applicant states on page 22 (para. 2) that notably, the final limitation of claim 1 recites “performing real-life percutaneous implantation,” which confirms that the claims are directed to a practical application with real-world effects, and that this is not merely outputting a number of displaying information, but rather using the computational analysis to guide an actual medical procedure, and therefore the claims thus “effect a transformation or reduction of a particular article to a different state or thing,” namely, transforming a patient’s cardiac condition through optimally selected and positioned implant deployment.
These arguments are not persuasive, because first, the instant claims do not recite any limitations that would effect a transformation or reduction of a particular article to a different state or thing. As noted at MPEP 2106.05(c), an “article” includes a physical object or substance, and the physical object or substance must be particular, meaning it can be specifically identified, and that “transformation” of an article means that the “article” has changed to a different state or thing. Second, the instant claims do not actually even recite the limitation “transforming a patient’s cardiac condition,” and even if this was recited as a claim limitation, it would not satisfy any of the five factors provided at MPEP 2106.05(c) for aiding with the analysis of a claim where a transformation is recited. Third, the claim 1 step of “performing real-life percutaneous implantation” is determined to not integrate the judicial exceptions into a practical application because the limitation does not effect a particular treatment or prophylaxis for a disease or medical condition, as noted and discussed in the above rejection.
Claim Rejections - 35 USC § 103
The Applicant’s amendment received 22 September 2025 has been fully considered, however after further consideration, the rejections of claims 1-20 in the Office action mailed 20 May 2025 are maintained with modification in view of the amendment received 22 September 2025, as noted below.
The rejection of claims 1-3, 7-16, 18, and 19 under 35 U.S.C. 103 as being unpatentable over Dahl et al. in view of Zaeuner et al. in view of Grujicic et al. in the Office action mailed 20 May 2025 is maintained with modification in view of the amendment received 22 September 2025. The rejection of claims 15 and 16 are withdrawn in view of these claims having been cancelled in the amendment received 22 September 2025.
The rejection of claims 4 and 5 under 35 U.S.C. 103 as being unpatentable over Dahl et al. in view of Zaeuner et al. in view of Grujicic et al. as applied to claims 1-3, 7-14, 18, and 19 above, and further in view of Pfaller et al. in the Office action mailed 20 May 2025 is maintained in view of the amendment received 22 September 2025.
The rejection of claims 6 and 20 under 35 U.S.C. 103 as being unpatentable over Dahl et al. in view of Zaeuner et al. in view of Grujicic et al. as applied to claims 1-3, 7-14, 18, and 19 above, and further in view of Argente dos Santos in the Office action mailed 20 May 2025 is maintained in view of the amendment received 22 September 2025.
The rejection of claim 17 under 35 U.S.C. 103 as being unpatentable over Dahl et al. in view of Zaeuner et al. in view of Grujicic et al. as applied to claims 1-3, 7-16, 18, and 19 above, and further in view of Li et al. in the Office action mailed 20 May 2025 is withdrawn in view of the cancellation of this claim in the amendment received 22 September 2025.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 7-14, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Dahl et al. (US 2018/0174068, as cited in the Office action mailed 20 May 2025) in view of Zaeuner et al. (US 2011/0153286, as cited in the Office action mailed 20 May 2025 and as cited in the Information Disclosure Statement (IDS) received 07 September 2021) in view of Grujicic et al. (Journal of Materials Engineering and Performance, 2012, Vol. 21(11), pp. 2218-2230, as cited in the Office action mailed 20 May 2025).
Regarding claims 1, 18, and 19, Dahl et al. shows a method and process for providing a subject-specific computational model used for treatment of cardiovascular diseases (Title); a simulation model of a component in the cardiovascular system, for instance a pumping heart, is reconstructed by combining computational fluid dynamics (CFD) and/or fluid structure interaction (FSI) algorithms with medical imaging, such as for example ultrasound, MRI, or CT (Abstract); that to obtain the model, the reconstruction of a 4D (3D + time) volume is achieved over multiple heart cycles (para. [0199]; and paras. [0006] - [0010] for a description of a cardiac cycle including systole and diastole); the subject-specific model can be used to simulate the effect of virtual surgery and thereby optimize treatment (para. [0176]); the term “prosthetic” can refer to an artificial part or component for use as a replacement for a natural body part or component, such as heart valves (para. [0111]); the term “heart device” includes devices that are useful in treatment of heart disease, such as a stent (para. 0112]); assessing optimized positioning and orientation of a valve and compensating for any shear stress on other tissue, i.e., heart or valves or vessels (para. 0123]); time-varying 3D endocardial surface mesh used to create the subject-specific endocardial LV movement throughout systole (para. [0258]); time-steps in the CFD-simulation are modelled by calculating intermediate meshes between the segmented time frames at every CFD time step using spline interpolation (para. [0259]).
Regarding claims 1, 18, and 19, Dahl et al. does not show a deployment site for the cardiac implant in a plurality of states corresponding to a plurality of moments in the cardiac cycle; providing an implant model representing a three-dimensional mesh-based representation of a cardiac implant; having a computer calculate, for each of the plurality of states, deformation of the implant model deployed at the deployment site by imposing deformation of the patient-specific anatomical model onto the implant model through contact between the patient-specific anatomical model and the implant model; having the computer determine mechanical stresses and/or strain with each mesh element of the implant model for each of the plurality of states; and having the computer determine an estimate of cyclic loading failure of the cardiac implant using the mechanical stresses and/or strains and data representative of a material of the cardiac implant.
Regarding claims 1, 18, and 19, Zaeuner et al. shows a method and system for virtual percutaneous valve implantation (Title) wherein a patient-specific anatomical model of a heart valve is estimated based on 3D cardiac medical image data and an implant model representing a valve implant is virtually deployed into the patient-specific anatomical model of the heart valve (Abstract); a library of implant models, each modeling geometrical properties of a corresponding valve implant, is maintained (Abstract); in silico valve implantation under various interventional procedure conditions is performed for identification of an optimal device type of the prosthetic valve, size, and deployment location, and treatment outcome prediction (para. [0018]); selecting one of the implant models for use in a percutaneous valve implantation procedure (para. [0006]; virtual implant deployment is dependent on the extracted patient-specific model (para. [0028]); the virtual implantation can provide an optimal position and orientation for the selected implant with respect to the patient-specific model (para. [0031]); and a library of virtual devices/implant models is maintained based on manufacturers’ descriptions to incorporate realistic geometrical and bio-mechanical properties of various physical devices/implants (para. [0026]).
Regarding claims 1, 18, and 19, Grujicic et al. shows fatigue-life computational analysis for the self-expanding endovascular Nitinol stents (Title) and further shows advanced structural and fluid-structure interaction finite element computational methods that are combined with advanced fatigue-based durability analysis techniques to further enhance the use of the computational engineering analysis tools in the development of vascular stents with improved high-cycle fatigue life (Abstract). Grujicic et al. further shows meshed models for the vascular stent and the artery segment (Section 2.1.1); modelling the stent/artery contact interactions (Section 2.1.6); maximum principal strains within the stent at diastolic pressure troughs after ten loading cycles (Fig. 7(a)); maximum principal-strain amplitude within the stent at the systolic peaks and diastolic pressure troughs (Fig. 8(a)); stent service life preliminary prediction (Section 3.4.4); determining a preliminary prediction of the fatigue life of the stent by identifying the location within the stent which is associated with the smallest number of cardiac cycles to failure (Section 3.4.4); and determining a preliminary prediction of stent service life (Section 3.4.4).
Regarding claim 2, Grujicic et al. further shows simulating loading conditions (Section 2.1.5) and determining the maximum principal strain distribution within the stent at the diastolic pressure troughs after ten loading cycles (page 2224, column 2, para. 1; and Fig. 7(a)) and determining the respective number of cardiac cycles to failure (page 2229, column 1, para. 1).
Regarding claim 7, Grujicic et al. further shows application of the rainflow cycle-counting algorithm to a simple load signal after the peak/trough reconstruction (Fig. 11(a)) and the resulting three-dimensional histogram showing the number of cycles/half-cycles in each mean strain-strain amplitude bin (Fig. 11(b)).
Regarding claim 8, Grujicic et al. further shows maximum principal strain-amplitude vs. fatigue life at a constant (zero) value of the maximum principal mean strain (Fig. 10(a)) and the strain amplitude vs. the mean strain at a constant (107 cycles) fatigue life (Fig. 10(b)).
Regarding claim 10, Grujicic et al. further shows that established high cycle fatigue behavior of Nitinol is controlled by the local maximum principal-strain amplitude and the mean value of the maximum principal strain (Section 3.4) and that these findings are summarized in Fig. 10(a) and Fig. 10(b).
Regarding claim 3, Dahl et al. further shows a model that is based on real time 3D echocardiography (RT3DE) recordings and uses a dynamic, moving mesh that adapts to the time-varying geometry of the heart (para. [0221]).
Regarding claim 11, Dahl et al. further shows real-time three-dimensional (3D) echocardiography (RT3DE) (also known as four-dimensional (4D) echocardiography) with consecutive segmentation of the endocardial LV wall are the preliminary steps in building the subject-specific cardiac model (para. [0246]).
Regarding claim 12, Dahl et al. further shows real-time three-dimensional (3D) echocardiography (RT3DE) (also known as four-dimensional (4D) echocardiography) with consecutive segmentation of the endocardial LV wall are the preliminary steps in building the subject-specific cardiac model (para. [0246]).
Regarding claim 13, Dahl et al. further shows a time-varying 3D endocardial surface mesh was used to create the prescribed subject-specific LV (left ventricle) movement throughout systole, however a refined surface mesh is required to obtain reasonable accuracy in the simulation, and a refined surface mesh will result in new intermediate nodes in the start geometry which are not a part of the original mesh, which means that their nodal positions are unknown for the subsequent time frames, and therefore the nodal translations of the new refined mesh had to be interpolated from the original segmented mesh (para. [0258]).
Regarding claim 14, Dahl et al. further shows a time-varying 3D endocardial surface mesh was used to create the prescribed subject-specific LV (left ventricle) movement throughout systole, however a refined surface mesh is required to obtain reasonable accuracy in the simulation, and a refined surface mesh will result in new intermediate nodes in the start geometry which are not a part of the original mesh, which means that their nodal positions are unknown for the subsequent time frames, and therefore the nodal translations of the new refined mesh had to be interpolated from the original segmented mesh (para. [0258]).
Regarding claim 9, Zaeuner et al. further shows that the cardiac implant can be a stent (para. [0019]).
Therefore, 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 the method of Dahl et al. by incorporating an implant model with the patient-specific model as shown by Zaeuner et al., and discussed above. One of ordinary skill in the art would have been motivated to combine the methods of Dahl et al. and Zaeuner et al. at least because Dahl et al. discloses that the invention concerns methods for assessing optimized positioning and orientation of a valve to reduce the risk of degeneration leading to the need for replacement (para. [0123]), and Zaeuner et al. at shows a virtual valve implantation framework for modelling and quantitative evaluation of a percutaneous valve implantation procedure, and selecting an implant type and size and deployment location and orientation for percutaneous valve implantation (Abstract). This modification would have had a reasonable expectation of success given that the invention of Dahl et al. is mainly a tool for aiding experts/professionals in the diagnosis or detection of cardiovascular disease and/or identifying the optimal treatment for each individual patient suffering from cardiovascular disease, like for instance mitral valve disease (para. [0124]), and further that the invention supplies a method for making, redesigning or repairing valves (para. [0127]), and Zaeuner et al. shows a method and system of virtual valve implantation for planning, guidance, and assessment of percutaneous valve implantation techniques (para. [0005]).
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Dahl et al. by incorporating methods for computational analysis that can predict the high-cycle fatigue life of vascular stents as shown by Grujicic et al. above. One of ordinary skill in the art would have been motivated to combine the methods of Dahl et al. and Grujicic et al. because Dahl et al. shows the reconstruction a patient-specific 4D (3D + time) model that is achieved over multiple heart cycles (para. [0199]), and Grujicic et al. shows modelling the contact interaction between meshed models of a vascular stent and an artery segment over multiple cardiac cycles (Fig. 8(a) and Fig. 10). This modification would have had a reasonable expectation of success given that the invention of Dahl. et al. uses a computational fluid dynamics (CFD) model that is based on a dynamic, moving mesh that adapts to the time-varying geometry of the hear (para. [0221]), and the invention of Grujicic et al. shows modelling the contact conditions between a meshed models of a stent and an artery and determining the strain distribution changes to the stent over multiple loading cycles and further determining the maximum principal-strain amplitude results using strain values at the systolic peaks and the diastolic pressure troughs (page 2225, column 2).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Dahl et al. in view of Zaeuner et al. in view of Grujicic et al. as applied to claims 1-3, 7-14, 18, and 19 above, and further in view of Pfaller et al. (Biomechanics and Modeling in Mechanobiology, 2019 (Published online: 10 December 2018), Vol. 18, pp. 503-529, as cited in the Office action mailed 20 May 2025).
Regarding claims 4 and 5, Dahl et al. in view of Zaeuner et al. in view of Grujicic et al. as applied to claims 1-3, 7-14, 18, and 19 above, do not show wherein the patient-specific anatomical model transforms through the plurality of states through transferring the displacements of associated nodes of the 4D intermediate model via stiffness and/or dashpot elements to the nodes of the 4D patient-specific anatomical model (claim 4) or wherein the 4D patient-specific anatomical model has mechanical properties, including stiffness and/or viscosity, the overall mechanical behavior of the 4D patient-specific anatomical model depending on the combination of the mechanical properties of the 4D anatomical model and mechanical properties of the stiffness and/or dashpot elements connecting associated nodes to nodes of the 4D anatomical model (claim 5).
Regarding claim 4, Dahl et al. further shows a time-varying 3D endocardial surface mesh was used to create the prescribed subject-specific LV (left ventricle) movement throughout systole, however a refined surface mesh is required to obtain reasonable accuracy in the simulation, and a refined surface mesh will result in new intermediate nodes in the start geometry which are not a part of the original mesh, which means that their nodal positions are unknown for the subsequent time frames, and therefore the nodal translations of the new refined mesh had to be interpolated from the original segmented mesh (para. [0258]).
Regarding claim 5, Pfaller et al. shows the importance of the pericardium for cardia biomechanics in both physiology and computational modeling (Title) and further shows that the influence of the pericardium is essential for predictive mechanical simulations of the heart, thus modelling the pericardial influence as a parallel spring and dashpot acting in normal direction to the epicardium (Abstract). Pfaller et al. further shows deriving a simple mathematical formulation for the pericardial boundary condition wherein the serous pericardium, fibrous pericardium, and neighboring tissue are modeled by a spring (stiffness k) and a dashpot (viscosity c) in parallel (Fig. 3).
Therefore, 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 the method of Dahl et al. in view of Zaeuner et al. in view of Grujicic et al. as applied to claims 1-3, 7-14, 18, and 19 above, by incorporating models for mechanical properties such as stiffness and/or viscosity, as shown by Pfaller et al. above. One of ordinary skill in the art would have been motivated to combine the methods of Dahl et al. in view of Zaeuner et al. in view of Grujicic et al. as applied to claims 1-3, 7-14, 18, and 19 above with the methods of Pfaller et al. because incorporating coefficients for mechanical properties such as stiffness and viscosity into the computational model can improve the realism of the model (e.g., Abstract; and page 507, column 1, paras. 2 & 3, and Fig. 3). This modification would have had a reasonable expectation of success given that both Dahl et al. in view of Zaeuner et al. in view of Grujicic et al. as applied to claims 1-3, 7-14, 18, and 19 above and Pfaller et al. are concerned with cardiac mechanical modelling using computational methods.
Claims 6 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dahl et al. in view of Zaeuner et al. in view of Grujicic et al. as applied to claims 1-3, 7-14, 18, and 19 above, and further in view of Argente dos Santos (Journal of the Mechanical Behavior of Biomedical Materials, 2012, Vol. 15, pp. 78-92, as cited in the Office action mailed 20 May 2025).
Regarding claims 6 and 20, Dahl et al. in view of Zaeuner et al. in view of Grujicic et al. as applied to claims 1-3, 7-14, 18, and 19 above, do not show if a cyclic loading simulation predicts a first fracture, a second cyclic loading simulation is performed using the fractured implant model (claim 6) or wherein the data representative of the material of the cardiac implant comprises a digital S-N curve (claim 20).
However, regarding claim 6, Argente dos Santos et al. shows a two-scale plasticity-damage model approach to fatigue life assessment of cardiovascular stents (Title; and Abstract) and further shows a framework for the two-scale plasticity-damage model wherein the accumulation of plasticity is viewed as the phenomenon which is responsible for the initiation of damage, and the accumulation of damage is regarded as to ultimately lead to the formation of microcracks, and therefore, two distinct criteria need to be specified, one to define the initiation of the damage process, whereas the other is to define the microcrack initiation (Section 2.3.). Argente dos Santos et al. further shows the prediction of microcrack initiation (Section 3.2.3.) and notes that the fatigue life assessment method was designed to predict crack initiation and not fatigue rupture, and therefore to predict the total life of the stents up to final failure, the analyses should also take into account the crack propagation effects and proceed with the fatigue analysis using, for instance, a fracture mechanics approach to final failure (page 90, column 1, para. 4).
Regarding claim 20, Argente dos Santos et al. shows fitting results of the two-scale model to the experimental S-N results with the resulting curve correlating maximum stress with the number of cycles (Fig. 7).
Therefore, 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 the method of Dahl et al. in view of Zaeuner et al. in view of Grujicic et al. as applied to claims 1-3, 7-14, 18, and 19 above, by incorporating a cyclic loading simulation for predicting a first fracture (e.g., a microcrack initiation) and a subsequent simulation to determine crack propagation until final failure, as disclosed by Argente dos Santos et al. above. One of ordinary skill in the art would have been motivated to combine the methods of Dahl et al. in view of Zaeuner et al. in view of Grujicic et al. as applied to claims 1-3, 7-14, 18, and 19 above with the methods of Argente dos Santos et al. because the material failure of a stent device in vivo has been often associated with fatigue issues as a result of the high number of cyclic loads these devices are subject to in vivo, and therefore computational modelling of the fatigue life of cardiovascular stents can be used to modify the designs of stents without making and testing numerous real world physical devices (Abstract; pages 85-90: Section 3; and pages 90-91: Section 5). This modification would have had a reasonable expectation of success given that both Dahl et al. in view of Zaeuner et al. in view of Grujicic et al. as applied to claims 1-3, 7-14, 18, and 19 above and Argente dos Santos et al. are concerned with simulation models that can be used as a tool for cardiovascular diagnostics and for evaluating alternative interventions.
Response to Arguments
The Applicant summarizes the rejection under 35 U.S.C. 103 in the Office action mailed 20 May 2025 on pages 22-23 of the Remarks, and states on page 23 (para. 3) that the Applicant disagrees with the Office action’s characterization of the cited references and submits that the combination fails to teach or suggest the claimed invention’s approach to predicting cyclic loading failure of cardiac implants through patient-specific computational modeling, and further states that the present application introduces a fundamentally different technical approach that focuses on mechanical failure prediction rather than the hemodynamic simulation disclosed in Dahl. The Applicant further states (page 23, para. 4 and page 24, para. 1) that the mesh refinement described by Dahl relates to interpolating nodal positions for CFD simulation purposes, not the claimed contact-based deformation mechanism between anatomical and implant models. The Applicant further states (page 24, para. 2) that the claimed invention’s temporal modeling approach specifically addresses cyclic repetition for fatigue analysis, including concepts like deformation history and cumulative damage assessment, features that are absent from Dahl’s single-cycle flow dynamics focus, and further states that Dahl generates flow velocities, pressure distributions, and hemodynamic parameters, which represent fundamentally different output metrics addressing different clinical problems.
These arguments are not persuasive, because first, the Dahl reference is used as part of a combination of references to show that the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date. Second, and not least, the Dahl reference is used to show a method and process for providing a subject-specific computational model used for treatment of cardiovascular diseases, and also shows the reconstruction of a 4D (3D + time) model of multiple heart cycles for modeling time-steps in the simulation by calculating intermediate meshes between the segmented time frames using spline interpolation, as discussed in the above rejection.
The Applicant states on page 24 (bottom) of the Remarks that the Grujicic reference does not appear to teach the patient-specific 4D temporal modeling approach combined with contact-based deformation analysis for cardiac implant failure prediction as claimed, and further states on page 25 (para. 2) that the secondary references do not cure these deficiencies, and further states that for the dependent claims, the applied references similarly fail to disclose the fundamental cyclic loading failure prediction features that distinguish the claimed invention from the cited references.
These arguments are not persuasive, because first, the Grujicic reference is used as part of a combination of references to show that the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date. Second, and not least, the Grujicic reference shows using finite element computational methods, which are an example of one particular type of contact-based deformation modeling. Third, and as noted in the foregoing response to arguments, the Dahl reference is applied to show an approach patient-specific 4D temporal modeling.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/S.W.B./Examiner, Art Unit 1687
/Joseph Woitach/Primary Examiner, Art Unit 1687